Questions
&
Answers
for
the
New
Chemicals
Program
(
Q&
A)

U.
S.
Environmental
Protection
Agency
Office
of
Pollution
Prevention
and
Toxics
Washington,
DC
20460
ii
TABLE
OF
CONTENTS
Page
1.
GENERAL
PROGRAM
INFORMATION
100.
General
............................................................................................................
1­
1
101.
Guidance
for
Completion
of
§
5
Submission
Form
.........................................
1­
6
102.
Inventory
Searches/
Bona
Fides
.......................................................................
1­
17
103.
Chemical
Identification
...................................................................................
1­
22
104.
Nomenclature
..................................................................................................
1­
26
105.
Inventory
Issues
................................................................................................
1­
31
106.
Review
Process
...............................................................................................
1­
31
107.
Notice
of
Commencement
..............................................................................
1­
33
108.
User
Fee
..........................................................................................................
1­
35
109.
Consolidated
Notices
......................................................................................
1­
39
110.
Joint
Submissions
...........................................................................................
1­
41
111.
Toll
Manufacturer
...........................................................................................
1­
42
112.
Foreign
Supplier
..............................................................................................
1­
43
113.
Trade
Mark
Reactant
(
TMR)
Supplier
............................................................
1­
43
114.
Analytical
Method
Recommendations
............................................................
1­
44
115.
Test
Data
Requirements
..................................................................................
1­
45
116.
Environmental
Fate
Data
................................................................................
1­
50
117.
Health
and
Safety
Data
.....................................................................................
1­
50
118.
Ecotoxicity
Data
...............................................................................................
1­
53
119.
Polymer
Issues
(
not
concerning
exemptions)
...................................................
1­
55
120.
Principal
Importer
...........................................................................................
1­
59
121.
Import
Issues
...................................................................................................
1­
59
122.
Biotechnology
.................................................................................................
1­
60
123.
Significant
New
Use
Rule
(
SNUR)
................................................................
1­
61
124.
Pollution
Prevention
.......................................................................................
1­
64
125.
Recycling
.......................................................................................................
1­
64
126.
New
Chemical
Exposure
Limits
(
NCELs)
.....................................................
1­
65
2.
EXCLUSIONS
201.
Impurities
........................................................................................................
2­
1
202.
Mixtures
..........................................................................................................
2­
2
203.
Non­
isolated
Intermediates
.............................................................................
2­
3
204.
Byproducts
......................................................................................................
2­
5
205.
End
Use
Reactions
..........................................................................................
2­
7
206.
Modifier
of
Physicochemical
Characteristics
.................................................
2­
7
207.
Articles
............................................................................................................
2­
7
208.
The
Two
Percent
Rule
for
Polymers
...............................................................
2­
11
iii
209.
Chemicals
Manufactured
Solely
for
Export
....................................................
2­
14
210.
Uses
Covered
by
FIFRA
................................................................................
2­
17
211.
Pesticide
Inerts
................................................................................................
2­
18
212.
Pesticide
Ingredients
.......................................................................................
2­
19
213.
Pesticide
Intermediates
.....................................................................................
2­
19
214.
Uses
Covered
by
FDA
....................................................................................
2­
20
215.
Naturally
Occurring
Substances
......................................................................
2­
22
216.
Precipitation
Inhibitors
....................................................................................
2­
22
217.
pH
Adjustment
................................................................................................
2­
22
218.
40
CFR
§
720.30(
h)(
7)
......................................................................................
2­
23
219.
New
Chemical
Formed
Incidental
to
Storage
..................................................
2­
24
3.
EXEMPTIONS
301.
Research
and
Development
.............................................................................
3­
1
302.
Test
Marketing
Exemption
.............................................................................
3­
5
303.
Low
Volume
Exemption
.................................................................................
3­
7
304.
Polymer
Exemption
........................................................................................
3­
12
305.
LoREX
Exemption
.........................................................................................
3­
13
4.
COMPLIANCE
AND
ENFORCEMENT
401.
Compliance
Issues
...........................................................................................
4­
1
402.
Enforcement
Issues
.........................................................................................
4­
1
403.
European
Community
.....................................................................................
4­
2
404.
Canada
.............................................................................................................
4­
4
iv
HIGHLIGHTS
OF
THE
NEW
CHEMICALS
PROGRAM
Q&
A
Interested
parties
have
asked
many
questions
of
the
New
Chemicals
Program
over
the
years.
While
responsive
to
the
specific
individuals
asking
the
questions,
EPA
recognizes
that
it
would
be
useful
to
a
broader
array
of
stakeholders
to
provide
one,
easily
referenced
document
which
compiles
this
guidance
information.
This
Questions
and
Answers
document
(
the
Q&
A)
is
derived
from
these
compiled
questions,
rather
than
having
been
designed
as
an
overall
explanation
of
the
program.
°
A
general
program
description
is
provided
at
the
New
Chemicals
Website,
at
www.
epa.
gov/
oppt/
newchems/,
and
in
the
New
Chemicals
Brochure,
available
from
the
TSCA
Hotline
at
(
202)
554­
1404,
or
e­
mail
at
tsca­
hotline@
epa.
gov.
°
In
addition,
the
Instruction
Manual
for
submission
of
§
5
notices
(
also
available
at
the
New
Chemicals
Website)
discusses
program
policy
and
intent
in
the
context
of
the
PMN
form.

This
Q&
A
document
is
available
both
in
hard
copy
and
electronically.
Although
the
content
is
the
same,
we
believe
the
electronic
version
will
be
easier
to
use,
utilizing
a
search
function,
if
a
computer
is
available
to
you.
The
electronic
version
can
be
downloaded
from
the
New
Chemicals
Website.
The
paper
version
is
also
available
from
the
TSCA
Hotline
by
mail.

This
Q&
A
document
is
intended
only
to
explain
the
requirements
of
TSCA
§
5
and
selected
EPA
regulations
implementing
§
5,
and
to
provide
useful
information
to
persons
subject
to
these
requirements.
It
is
not
a
substitute
for
applicable
legal
requirements,
nor
is
it
a
regulation
itself.
Thus,
it
does
not
impose
legally­
binding
requirements
on
any
party,
including
EPA
or
the
regulated
community.
Section
1:
General
Program
Information
1­
1
1.
GENERAL
PROGRAM
INFORMATION
100.
General
100­
1.
Q.
How
can
I
obtain
a
copy
of
the
printed
§
5
Pre­
Manufacture
Notice
(
PMN)
form?

A.
The
§
5
PMN
form
(
EPA
Form
7710­
25)
is
available
from
the
TSCA
Hotline
upon
request
by
voice
(
202­
554­
1404),
facsimile
(
202­
554­
5603)
or
by
e­
mail
(
tsca­
hotline@
epa.
gov).
An
instruction
manual
is
also
available
from
the
Hotline
to
assist
you
in
filling
out
the
§
5
submission
form.
There
is
a
printable
copy
(.
pdf)
of
the
form
at
the
New
Chemicals
Website
(
www.
epa.
gov/
oppt/
newchems/).

The
TSCA
Hotline
is
a
source
of
general
program
information.

100­
2.
Q.
When
does
EPA
expect
to
publish
a
format
for
electronic
submissions
so
that
I
can
submit
my
PMNs
electronically?

A.
As
of
this
writing,
EPA
has
developed
an
early
version
of
an
electronic
form.
This
current
version
and
further
instruction
are
available
at
the
New
Chemicals
website
(
www.
epa.
gov/
oppt/
newchems).
Submitters
are
invited
to
download
this
form
and
fill
it
out
on
their
computers.
At
this
time,
we
are
only
accepting
paper
copies
made
using
this
form.
In
the
near
future,
we
intend
to
develop
the
procedures
to
accept
CD­
ROMs
containing
the
PMN
form.
Input
on
such
a
form
is
welcomed,
and
you
may
send
comments
to:

Anna
Coutlakis
New
Chemicals
Program
Chemical
Control
Division,
Mail
Stop
7405M
United
States
Environmental
Protection
Agency
EPA
East
Building
(
ICC)
1200
Pennsylvania
Avenue,
NW
Washington,
DC,
20460
email:
coutlakis.
anna@
epa.
gov
100­
3.
Q.
A
PMN
has
completed
review,
but
when
actual
production
starts,
the
manufacturing
process
must
be
changed.
Is
notification
to
EPA
required?

A.
TSCA
§
5
requires
submission
of
a
PMN
for
a
chemical
substance
or
mixture
that
is
not
on
the
TSCA
Inventory
(
unless
exempt).
Thus,
if
the
change
in
the
manufacturing
process
results
in
a
chemical
substance
or
mixture
whose
identity
is
different
from
that
specified
in
the
PMN
and
is
not
on
the
Inventory,
a
new
PMN
is
required.
40
CFR
720.40(
f)
requires
the
PMN
submitter
to
report
to
EPA
new
information
that
materially
changes
the
information
included
in
Section
1:
General
Program
Information
1­
2
the
PMN,
if
the
information
comes
to
light
during
the
PMN
review
period.
Therefore,
if,
during
the
PMN
review
period,
the
submitter
decides
that
the
manufacturing
process
will
change
from
the
process
described
in
the
original
submission,
EPA
must
be
notified.
EPA
may
require
additional
time
to
review
the
change.

PMN
regulations
at
40
CFR
part
720
do
not
provide
for
notification
to
EPA
of
changes
to
information
reported
in
the
PMN
that
occur
after
the
review
period.
Therefore,
if
the
decision
to
change
was
made
after
the
review
period,
and
there
is
no
change
in
chemical
identity,
a
new
PMN
is
not
required.
In
this
case,
if
the
process
change
takes
place
soon
after
close
of
the
PMN
review
period,
it
is
recommended
that
the
submitter
keep
a
record
of
its
decision
process
which
led
to
the
change,
to
clearly
show
that
this
change
was
not
decided
before
the
close
of
the
PMN
review
period.

100­
4.
Q.
If
there
is
a
change
of
sites
after
submission
and
review
of
the
PMN
by
EPA,
can
that
change
be
made
without
further
review
by
EPA?

A.
Yes.
The
change
of
sites
can
be
made
without
notice
to
EPA.

100­
5.
Q.
When
a
PMN
is
submitted,
or
when
the
review
period
for
a
PMN
expires,
does
EPA
publish
a
notice
in
the
Federal
Register?

A.
EPA
regularly
publishes
monthly
status
reports
in
the
Federal
Register
under
the
title
"
Certain
Chemicals;
Premanufacture
Notices".
These
reports
give
notice
of
PMNs
received
and
their
projected
expiration
dates.
EPA
does
not
publish
a
notice
when
the
review
period
expires,
but
information
on
Notices
of
Commencement
(
NOCs)
received
is
included
in
these
status
reports.
PMN
status
for
notifications
received
in
1999
and
beyond
is
also
posted
on
the
New
Chemicals
website
approximately
midway
through
the
review
period
and
can
be
viewed
at
www.
epa.
gov/
oppt/
newchems/
dropstat.
htm.

100­
6.
Q.
Will
I
be
notified
that
my
PMN
has
been
approved?
Denied?

A.
If,
by
the
expiration
of
the
PMN
review
period,
EPA
does
not
notify
you
that
your
chemical
will
be
subject
to
regulation,
under
§
5,
you
are
free
to
commence
manufacture
of
the
substance
after
the
review
period
expires.
During
the
PMN
review
period,
the
EPA
Program
Manager
or
other
EPA
personnel
may
contact
you
if
EPA
identifies
concerns
or
seeks
clarification
of
information
provided
in
the
PMN.

The
EPA
Program
Manager
will
also
notify
you
before
the
review
period
expires
if
the
review
period
will
be
extended
under
TSCA
§
5(
c)
or
if
regulatory
action
is
being
considered
on
the
new
substance
under
TSCA
§
5(
e)
or
§
5(
f).
You
may
also
refer
to
the
New
Chemicals
Program
website
at
www.
epa.
gov/
oppt/
newchems/
dropstat.
htm
to
obtain
the
status
of
PMNs
or
Section
1:
General
Program
Information
1­
3
Low
Volume
Exemptions
(
LVEs)
currently
under
review
by
EPA.

100­
7.
Q.
What
if
EPA
believes
that
the
scenario
described
in
the
PMN
may
present
unreasonable
risk?

A.
If
the
EPA
review
finds
that
there
is
insufficient
information
to
adequately
assess
the
risk
from
a
chemical,
and
that
human
exposures
and/
or
environmental
releases
associated
with
the
manufacture,
processing,
distribution,
use,
or
disposal
of
a
new
chemical
substance
as
described
in
the
PMN
may
pose
unreasonable
risk,
EPA
may:

°
require
testing,
under
§
5(
e),
before
manufacture
to
assess
the
risk,
if
the
risk
cannot
otherwise
be
adequately
mitigated
°
impose
regulatory
restrictions
via
a
combination
of
§
5
(
e)
Consent
Order
and
Significant
New
Use
Rule
(
SNUR)
to
control
exposures
or
uses
pending
development
of
test
data;
or
°
request
the
submitter
to
amend
its
PMN
to
include
appropriate
exposure
controls
and
issue
a
"
non­
§
5
(
e)
SNUR."

A
§
5(
e)
Consent
Order
places
requirements
on
the
manufacture,
processing,
distribution,
use
or
disposal
of
the
new
chemical
substance
to
reduce
the
risk.
The
Order
may
also
require
the
manufacturer
to
submit
testing
to
EPA
before
exceeding
a
specified
production
volume.
A
5(
e)
SNUR
normally
mirrors
the
terms
of
the
Consent
Order
and
extends
those
terms
to
any
person
who
may
manufacture,
process
or
use
the
subject
chemical.
In
those
cases
where
EPA
does
not
determine
that
the
use/
exposure
scenario
for
a
new
chemical
substance
as
described
in
a
PMN
may
present
an
unreasonable
risk
or
have
the
potential
for
substantial
production
volume
and
substantial
or
significant
human
exposure
or
substantial
environmental
release,
but
where
EPA
has
concerns
about
other
uses,
EPA
may
issue
a
non­
5(
e)
SNUR.
If
the
submitter
wishes
to
engage
in
a
"
significant
new
use(
s)"
as
specified
in
either
type
of
SNUR,
under
§
5(
a)(
1)(
B)
notice
to
EPA
is
required
to
provide
for
an
EPA
review.

100­
8.
Q.
How
do
"
expedited
§
5(
e)
Orders"
work?

A.
The
procedures
that
EPA
uses
to
develop
§
5(
e)
Consent
Orders
provide
for
expedited
handling
in
certain
circumstances.
Much
time
can
be
consumed
by
negotiations
concerning
deviations
from
standardized
or
"
boilerplate"
§
5(
e)
Order
language,
particularly
because
EPA
officials
must
carefully
consider
and
approve
any
deviations
from
previously
approved
language.
Elimination
of
this
negotiation
can
greatly
accelerate
preparation
and
review
of
a
§
5(
e)
Consent
Order.
An
expedited
procedure
can
be
used
when
both
parties
are
expected
to
accept
and
sign
the
Order
(
as
developed
by
EPA),
without
any
modifications.

The
expedited
procedure
has
two
primary
differences
from
a
negotiated
procedure.
First,
instead
of
EPA
sending
a
draft
Order
to
the
submitter
for
comment,
EPA
sends
an
"
Action
Section
1:
General
Program
Information
1­
4
Letter"
intended
to
provide
the
submitter
with
an
understanding
of
the
terms
of
the
proposed
§
5(
e)
Order.
The
Action
Letter
utilizes
the
most
appropriate
model
or
generic
§
5(
e)
Consent
Order
on
EPA's
website
(
www.
epa.
gov/
newchems/
boilerpl.
htm)
and
describes
in
some
detail
the
specific
terms
intended
for
the
individual
case.
Second,
EPA
signs
the
Order
before
the
submitter
signs
it.
These
procedures
eliminate
certain
internal
and
external
review
procedures
and
can
halve
the
time
necessary
for
the
negotiated,
non­
expedited
Consent
Order
process.

This
expedited
procedure
for
developing
§
5(
e)
Orders
has
been
used
by
EPA
since
1988.
This
option
has
been
made
available
in
the
standard
Action
Letters
EPA
sends
to
PMN
submitters
for
every
PMN
which
EPA
intends
to
regulate
by
Order
under
§
5(
e)
of
TSCA.

100­
9.
Q.
Why
do
non­"
expedited"
Consent
Orders
require
so
much
review?

A.
Most
Consent
Orders
are
"
expedited",
and
require
little
review,
because
they
are
developed
using
one
of
several
standard
templates
based
on
EPA's
risk
or
exposure
findings.
If
the
expedited
process
is
not
used,
negotiation
of
the
terms
of
the
§
5(
e)
Order
invariably
delays
completion
of
the
Order
since
additional
consideration
and
approval
by
EPA
personnel
is
required
for
terms
that
differ
from
those
previously
approved.
The
large
variety
of
different
chemicals
and
factual
circumstances
creates
enough
complexity
to
require
that
additional
scrutiny
be
given
to
cases
which
deviate
from
the
norm.
In
cases
where
EPA
or
the
submitter
find
that
they
cannot
agree
to
the
standard
language
or
other
terms,
EPA's
development
of
§
5(
e)
Orders
to
achieve
the
appropriate
balance
between
legal,
risk
management,
economic,
and
other
interests
can
become
lengthy.

100­
10.
Q.
How
do
I
request
a
modification
of
an
existing
§
5(
e)
Order?

A.
Pursuant
to
the
terms
of
a
§
5(
e)
Order,
the
submitting
company
may
petition
EPA
at
any
time
to
modify
the
terms
of
the
Order.
The
petition
should
be
based
on
new
information
about
the
health
or
environmental
effects
of,
human
exposure
to,
or
environmental
release
of
the
PMN
substance.
In
making
a
determination
of
whether
to
grant
or
deny
a
modification,
under
§
5(
e)(
1)
EPA
must
find
that
the
activities
proposed
will
not
increase
the
exposures
or
risk
to
a
level
that
is
unacceptable
or
may
be
unreasonable.
To
petition
for
a
modification,
a
submitter
should
send
a
letter
with
supporting
information
to
the
Chief
of
the
New
Chemicals
Notice
Management
Branch.
Although
OPPT
does
act
on
petitions
for
modifications
to
existing
§
5(
e)
Orders,
Order
modification
petitions
generally
rank
relatively
low
in
the
Agency's
priorities.

To
avoid
the
need
to
request
a
modification
based
on
newly
developed
data,
submitters
are
encouraged
to
ensure
that
any
ongoing
study
is
completed
before
submission
of
the
PMN,
in
which
case
the
study
would
be
provided
along
with
the
PMN
in
accordance
with
40
CFR
§
5720.50.
In
cases
where
the
submitter
hopes
for
new
market
opportunities,
it
is
suggested
that
testing
be
planned
based
on
an
optimistic
sales
scenario
and
anticipated
new
market
opportunities
Section
1:
General
Program
Information
1­
5
to
avoid
losing
time
involved
in
modification
of
a
Consent
Order.

100­
11.
Q.
Is
there
a
production
volume
limit
for
PMNs?

A.
Unless
EPA
takes
regulatory
action
(
such
as
a
§
5(
e)
Order
or
SNUR)
in
response
to
a
PMN,
there
is
no
production
volume
limit
for
the
PMN.
The
anticipated
production
volumes
listed
in
the
PMN
by
the
submitter
do
not
establish
production
volume
limits
for
a
substance.
EPA
may,
however,
place
a
production
limit
on
a
PMN
substance
through
a
§
5(
e)
Order
or
a
SNUR
at
the
time
of
review
where
appropriate
under
§
5.
Production
volume
limits
are
often
used
in
§
5(
e)
Orders
and
SNURs
to
trigger
testing
requirements.
Production
volume
limits
are
often
used
in
§
5(
e)
Orders
and
SNURs
when
EPA
identifies
potential
risk
from
use
of
the
substance.
These
limits
can
often
be
lifted
if
EPA
recommended
testing
is
completed
and
mitigates
the
risk
identified
in
the
review
process.

100­
12.
Q.
What
is
EPA's
exposure­
based
policy
and
has
any
information
on
it
been
published?

A.
EPA's
exposure­
based
policies
for
new
chemical
substances
are
based
on
§
5(
e)(
1)(
A)(
ii)(
II)
of
TSCA
and
are
described
on
the
New
Chemicals
Website
at
www.
epa.
gov/
oppt/
newchems/
expbased.
htm.

TSCA
Section
5(
e)
provides
EPA
with
the
authority
to
regulate
new
substances
pending
development
of
health
and
environmental
effects
data
based
on
either
the
potential
risk
presented
by
the
substance
("
risk­
based")
or
the
potential
for
substantial
production
volume
and
substantial
or
significant
human
exposure
or
substantial
environmental
release
("
exposure­
based").
Action
under
Section
5(
e)
for
a
new
chemical
substance
is
taken
based
under
either
or
both
of
these
authorities.
In
1988,
EPA
developed
internal
guidelines
to
assist
in
identifying
new
chemical
substances
received
as
PMNs
which
would
meet
the
"
exposure­
based"
finding.
These
guidelines
were
announced
to
the
chemical
industry
in
a
letter
to
Geraldine
V.
Cox
of
the
Chemical
Manufacturers
Association
(
now
the
American
Chemistry
Council).
See
www.
epa.
gov/
opptintr/
newchems/
cmaxpltr.
htm.

Limited
test
data
are
submitted
or
otherwise
available
on
new
chemical
substances,
and
as
a
result
EPA
often
relies
on
Structure
Activity
Relationship
(
SAR)
predictions
to
evaluate
potential
effects
associated
with
these
substances.
Data
obtained
from
PMN
submitters
by
EPA
using
the
exposure­
based
finding,
can
better
characterize
the
tested
chemical,
confirm
or
refute
a
"
negative"
prediction
of
no
risk
or
low
risk,
and
supplement
and
validate
the
use
of
SAR
in
the
review
of
PMNs.
Expanded
use
of
this
finding
was
warranted
for
these
reasons
and
because
Congress
intended
that
a
greater
priority
for
testing
exists
for
high
volume/
exposure
chemicals.
Exposure­
based
testing
is
usually
required
via
a
negotiated
5(
e)
consent
order.
These
exposure­
based
guidelines
capture
all
PMN
chemicals
with
estimated
production
volumes
Section
1:
General
Program
Information
1­
6
greater
than
or
equal
to
100,000
kilograms
per
year,
and
include
specific
exposure/
release
criteria
(
such
as
>
10,000
kg/
year
total
release
to
environmental
media
or
>
0.003
mg/
kg/
day
exposure
via
air).
The
objectives
of
this
approach
were
to
encourage
fair
and
consistent
decisions
across
numerous
chemical
categories
and
uses,
to
provide
clear
guidance
to
the
public
and
industry
about
EPA's
policy
and
expectations,
and
to
implement
the
policy
in
the
simplest,
least
resourceintensive
way.

EPA's
exposure­
based
policies
for
new
chemical
substances
are
based
on
§
5(
e)(
1)(
A)(
ii)(
II)
of
TSCA
and
are
described
on
the
New
Chemicals
Website
at
www.
epa.
gov/
oppt/
newchems/
expbased.
htm.

100­
13.
Q.
What
will
happen
if
the
submitter
refuses
to
agree
to
conditions
EPA
regards
as
necessary
if
the
PMN
substance
is
to
be
used
without
unreasonable
risk,
or
under
an
exposurebased
Consent
Order?

A.
If
EPA
and
the
submitter
cannot
agree
on
EPA's
specified
conditions
where
EPA
has
predicted
that
the
activities
proposed
for
the
PMN
substance
may
present
or
will
present
an
unreasonable
risk,
or
projected
production
and
exposure
exceed
EPA's
exposure­
based
policy
criteria,
EPA
can
unilaterally
issue
a
non­
consensual
Order
banning
or
otherwise
controlling
the
substance
under
§
5(
e)
or
§
5(
f)
of
TSCA.
If
the
submitter
objects,
further
proceedings
may
be
necessary
to
enforce
the
order.
This
is
not
a
typical
scenario­
usually
EPA
and
the
submitter
agree
to
a
Consent
Order
under
§
5(
e).
In
order
to
be
effective,
a
§
5(
e)
Order
must
be
issued
before
expiration
of
the
90­
day
review
period.

Usually
a
unilateral
"
extension"
(
under
TSCA
§
5(
c))
or
a
consensual
"
suspension"
(
under
40
CFR
§
720.75(
b)
­
requested
by
the
submitter)
of
the
90­
day
statutory
review
period
is
necessary
to
allow
sufficient
time
for
development
of
an
EPA
response
when
EPA
review
suggests
that
activities
proposed
for
the
PMN
substance
may
or
will
present
an
unreasonable
risk
or
have
the
potential
for
substantial
production
volume
and
substantial
or
significant
human
exposure
or
substantial
environmental
release.
An
EPA
Program
Manager
will
notify
the
submitter
if
regulatory
action
is
being
considered
on
the
new
substance
under
TSCA
§
5(
a),
5(
e)
or
5(
f).
The
EPA
Program
Manager
will
contact
the
submitter
before
the
review
period
expires
to
request
a
consensual
suspension.
If
this
is
not
granted,
EPA
can
unilaterally
extend
the
review
period
under
§
5(
c).
If
an
extension
under
§
5(
c)
is
required,
it
can
be
up
to
and
usually
is
granted
for
90
days.
The
§
5(
e)
or
§
5(
f)
Order
must
be
issued
by
day
135,
which
gives
the
submitter
time
to
respond.

101
Guidance
for
Completion
of
§
5
Submission
Form
101­
1.
Q.
Can
I
use
commercially
available
software
to
generate
the
§
5
submission
form?
Section
1:
General
Program
Information
1­
7
A.
Yes,
if
the
format
generated
by
the
software
has
been
pre­
approved
by
EPA's
TSCA
Document
Control
Officer.
One
such
form
is
sold
by
the
American
Chemistry
Council,
of
Arlington,
Virginia,
and
another
is
sold
by
the
Bureau
of
National
Affairs,
of
Washington,
D.
C.
Please
note
that
EPA
cannot
endorse
the
purchase
of
a
particular
company's
products
or
services,
and
identification
of
these
forms
as
sufficient
for
PMN
use
should
not
be
taken
as
an
endorsement
of
the
software
products.
EPA
is
willing
to
identify
any
other
forms
once
such
forms
are
approved
by
the
Document
Control
Officer.
Information
on
potential
approval
is
available
from
the
Chief
of
the
Records
and
Dockets
Management
Branch
at
202­
564­
8952.

101­
2.
Q.
How
does
the
New
Chemicals
Program
assess
completeness
of
PMNs?

A.
Completeness
of
PMN
submissions
is
determined
by
compliance
with
EPA
regulations
at
40
CFR
§
720.45
and
EPA's
PMN
user
fee
requirements
at
40
CFR
§
700.
These
regulations
are
available
to
all
PMN
submitters
on
the
New
Chemicals
website
or
the
Government
Printing
Office
(
GPO)
web
site.

Once
a
submission
is
received,
it
is
first
prescreened.
In
the
prescreen,
pages
4­
8
are
reviewed
for
completeness
(
is
all
the
information
provided),
correctness
(
is
the
provided
information
right),
and
consistency
(
does
the
information
provided
contradict
itself).
The
chemical
name,
structure
and
CAS
Registry
Number
are
reviewed
as
are
lists
of
impurities
and
byproducts.
The
method
of
chemical
nomenclature
determination,
the
presence
of
a
generic
name
when
identity
is
claimed
as
confidential
business
information
(
CBI),
production
volume
and
TSCA
use,
and
process
diagram
information
are
examined.
Additional
information
required
for
polymers
is
reviewed
on
page5.

When
a
submitted
form
does
not
fulfill
the
above
requirements,
EPA
will
notify
the
submitter.

The
checklist
used
to
notify
submitters
of
the
specific
problems
in
their
submissions
is
presented
below,
and
reflects
the
common
errors
EPA
has
seen
in
PMN
submissions.
The
most
frequent
reason
for
an
incomplete
submission
is
a
chemical
name
which
does
not
conform
with
the
Chemical
Abstracts
Ninth
Collective
Index
(
9CI)
nomenclature
rules
and
conventions,
as
required
by
40
CFR
§
720.45(
a)(
1)(
i).
(
This
definitive
guide
to
Chemical
Abstracts
nomenclature
has
been
used
since
1972.)

§
5
SUBMITTER
ERROR
CHECKLIST
(
REV
1/
7/
98
VER
51)

Your
chemical
identity
information
as
submitted
according
to
Method
1
or
Method
2
is
not
acceptable
because:

________(
a)
The
correct
Chemical
Abstracts
name
has
not
been
provided.
________(
b)
The
correct
CAS
Registry
Number,
if
one
already
exists
for
the
substance,
has
not
been
provided.
________(
c)
The
correct
molecular
formula
has
not
been
provided,
where
applicable.
________(
d)
A
complete,
correct
chemical
structure
diagram
for
a
Class
1
substance
has
not
been
provided.
Section
1:
General
Program
Information
1­
8
________(
e)
A
correct
partial
or
representative
chemical
structure
diagram
has
not
been
provided
for
a
Class
2
substance
or
polymer,
where
such
information
is
known
or
reasonably
ascertainable.
________(
f)
There
is
an
inconsistency
among
two
or
more
parts
of
the
chemical
identity
information,
which
involves
the:
_____
reported
chemical
name,
_____
CAS
Registry
Number,
_____
molecular
formula,
_____
chemical
structure
diagram,
_____
identity
of
immediate
chemical
precursor
or
monomer
_____
manufacturing
process
information,
or
_____
other:
________(
g)
Because
the
reported
substance
is
polymeric,
page
5
of
the
§
5
submission
form
(
concerning
information
on
polymers)
must
be
completely
filled
out.
________(
h)
Correct
chemical
names
and
CAS
Registry
Numbers
(
where
numbers
are
available)
have
not
been
provided
for
all
monomers
and
other
reactants
used
to
manufacture
a
reported
polymer.
________(
I)
Correct
chemical
names
and
CAS
Registry
Numbers
(
where
numbers
are
available)
have
not
been
provided
for
all
immediate
chemical
precursors
used
to
manufacture
a
Class
2
substance.
________(
j)
For
a
Class
2
substance,
information
about
the
nature
of
the
manufacturing
reaction/
process
or
the
typical
(
or
range
of)
product
composition
(
where
appropriate)
has
not
been
provided.
________(
k)
A
letter
of
support
has
not
been
received
from
the
supplier
of
the
reported
substance
or
a
chemical
precursor
in
order
to
provide
the
required
specific
chemical
identity
information
not
included
in
the
notice.
________(
l)
Supporting
information
from
a
prior
notice
(
PMN,
bona
fide
Intent
Notice,
etc.)
you
reference
is
not
consistent
with
your
reported
chemical
identity
information.
________(
m)
The
reported
generic
chemical
name
is
misleading
or
does
not
provide
a
sufficient
level
of
chemical
identity
information.
________(
n)
The
manufacturing
process
information
does
not
include
specific
chemical
names
and/
or
weights
for
all
starting
materials.
________(
o)
Method
1
was
used,
but
the
information
provided
to
the
CAS
Inventory
Expert
Service
is
not
identical
to
that
included
in
the
PMN.
________(
p)
Not
all
of
the
chemical
names
reported
for
substances
in
a
consolidated
PMN
have
been
obtained
from
the
CAS
Inventory
Expert
Service.
________(
q)
Other:

101­
3.
Q.
If
a
PMN
submission
is
judged
to
be
incomplete
well
into
the
90
day
review
period,
will
the
90
day
clock
be
stopped
and
restarted
when
the
additional
information
is
received,
or
will
a
new
90­
day
period
begin
upon
receipt
of
the
new
information?

A.
When
a
notice
is
declared
incomplete,
the
review
period
is
not
considered
to
have
started,
regardless
of
when
in
the
review
period
the
notice
is
declared
incomplete.
Day­
1
of
the
review
period
begins
when
EPA
receives
a
complete
notice.
See
40
CFR
§
720.65(
c)(
2)(
ii).

101­
4.
Q.
What
are
some
common
errors
made
in
filling
out
the
§
5
submissions
form
or
a
Notice
of
bona
fide
Intent?
How
can
I
avoid
having
my
§
5
notice
declared
incomplete?

A.
The
administrative
procedures
applicable
to
incomplete
notices
are
specified
at
40
CFR
§
720.65.
For
more
detail
on
EPA's
review
for
completeness,
see
Q&
A
#
101­
2.
One
of
the
most
frequent
errors
is
incomplete
chemical
identity
information.
Another
very
common
error
in
a
Section
1:
General
Program
Information
1­
9
submission
is
an
inconsistency
between
the
chemical
name,
the
CAS
Registry
Number,
the
structure,
the
molecular
formula,
and/
or
the
manufacturing
process
information.
There
can
be
other
deficiencies
with
respect
to
the
form
that
could
cause
EPA
to
consider
a
notice
incomplete.
See
Q&
A
#
101­
7
The
following
is
a
list
of
chemical
identity
errors
which
under
40
CFR
§
§
720.45
and
720.65
can
result
in
incomplete
notices.

A
§
5
submission
form
(
EPA
Form
7710­
25)
or
a
Notice
of
bona
fide
Intent
to
Manufacture/
Import
will
be
considered
incomplete
if
any
of
the
following
problems
(
1­
10)
exist
with
respect
to
chemical
identity
information
submitted
via
Method
1
or
Method
2
(
see
Q&
A
#
103­
1
below),
according
to
the
Premanufacture
Notification
Regulations
at
40
CFR
720.45.

3.
The
correct
Ninth
Collective
Index
(
9CI)
Chemical
Abstracts
(
CA)
name
of
the
reported
substance
and
the
corresponding
Chemical
Abstracts
Service
(
CAS)
Registry
Number
(
if
a
CAS
Registry
Number
exists
for
the
substance)
are
not
included
in
the
Chemical
Identity
Information
section
of
the
notice
form
(
Part
I,
Section
B).

2.
The
correct
molecular
formula
of
the
reported
substance
(
if
a
single
molecular
formula
is
known
to
exist
for
the
substance
or
is
reasonably
ascertainable)
is
not
included
in
the
chemical
identity
information
section
of
the
notice
form
(
Part
I,
Section
B).

3.
The
complete,
correct
chemical
structure
diagram
for
a
reported
Class
I
substance
is
not
included
in
the
chemical
identity
information
section
of
the
notice
form
(
Part
I,
Section
B).

4.
A
correct
representative
or
partial
chemical
structure
diagram
for
a
reported
polymer
or
Class
2
substance
(
as
complete
as
possible,
based
on
what
is
known
or
reasonably
ascertainable)
is
not
included
in
the
chemical
identity
information
section
of
the
notice
form
(
Part
I,
Section
B).

5.
A
non­
CA
name,
a
generic
chemical
name,
a
chemical
synonym,
a
CAS
Registry
Number,
a
trade
name,
or
the
PMN,
Exemption,
or
bona
fide
Intent
notice
number/
User
Fee
number/
TSCA
accession
number
of
another
notice
is
written
in
the
chemical
name
box
of
the
notice
form
in
place
of
the
correct
CA
name.

6.
When
reporting
a
polymer,
the
submitter
does
not
provide
all
of
the
information
required
in
the
chemical
identity
information
section
for
polymers
(
Part
I,
Section
B.
2)
comprising
page
5
of
the
§
5
submission
form.

Note:
(
1)
A
"
polymer"
includes
an
oligomeric
substance
having
a
molecular
weight
distribution
as
well
as
any
substance
that
is
or
incorporates
a
polymer,
even
if
the
last
reactions
did
not
involve
further
polymerization.
For
example,
persons
who
intend
to
manufacture
salts,
adducts,
or
other
derivatives
or
reaction
products
from
polymers
must
fill
out
page
5
of
the
§
5
submission
Section
1:
General
Program
Information
1­
10
form.
(
2)
Not
all
polymers
contain
the
word
"
polymer",
"
polymers",
or
"
poly"
in
their
CA
names;
for
example,
siloxanes
and
silicones.
These
conventions
have
been
in
place
largely
without
changes
since
the
inception
of
the
Inventory,
and
can
be
found
in
"
TSCA
Inventory
Representation
for
Polymeric
Substances"
at
www.
epa.
gov/
oppt/
newchems/
polymers.
txt.

7.
The
specific
chemical
name
and
corresponding
CAS
Registry
Number
(
if
such
a
number
exists)
for
(
1)
each
monomer
or
other
reactant
used
to
make
a
reported
polymer,
or
(
2)
each
immediate
precursor
substance
used
to
make
a
reported
Class
2
substance,
is
not
included
in
Part
I,
section
B
of
the
notice.
Note:
The
notice
is
considered
incomplete
even
if
the
reported
CA
name
of
the
PMN
substance
itself
is
correct.
The
specific
chemical
names
used
to
identify
such
monomers,
reactants,
or
chemical
precursors
do
not
have
to
be
CA
names
although
correct
CAS
Registry
Numbers
must
be
provided
if
they
exist.

8.
There
is
at
least
one
discrepancy
or
inconsistency
in
the
reported
chemical
identity
information
that
could
possibly
cause
some
ambiguity
about
the
correct
chemical
identity.
This
discrepancy
or
inconsistency
may
involve
the
chemical
name,
CAS
Registry
Number,
molecular
formula,
chemical
structure
diagram,
immediate
chemical
precursors,
monomers,
or
manufacturing
process
information.

9.
A
letter
of
support
has
not
been
submitted
by
a
chemical
supplier
in
order
to
provide
required
chemical
identity
information
not
included
in
the
notice.

10.
The
submitter
indicates
as
part
of
the
manufacturing
process
information
or
precursor
substance/
reactant/
monomer
information
that
a
neutralizing
reagent
is
used,
but
neither
represents
the
reported
substance
as
a
salt
nor
provides
a
reasonable
explanation
for
why
the
substance
should
not
be
considered
a
salt,
even
though
the
process
information
or
list
of
reactants
would
indicate
the
formation
of
a
salt.
This
description
is
inconsistent
with
the
Ninth
Collective
Index
(
9CI)
of
Chemical
Abstracts
nomenclature
rules
and
conventions
as
required
by
40
CFR
720.45(
a).

101­
5.
Q.
When
does
the
PMN
review
period
begin?
Are
the
review
periods
of
90
days
for
PMNs,
30
days
for
Low
Volume
and
Low
Release/
Low
Exposure
Exemptions
(
LVEs/
LoREXs),
and
45
days
for
Test
Marketing
Exemptions
(
TMEs)
based
on
calendar
days
or
working
days?

A.
TSCA
§
5
submissions
review
periods
are
based
on
calendar
days.
If
EPA
determines
that
your
notice
is
"
complete,"
the
review
period
begins
on
the
date
that
the
submission
(
PMN,
LVE,
LoREX,
or
TME)
is
received
and
logged
in
by
EPA's
Document
Control
Officer
(
DCO).
You
will
receive
an
acknowledgment
letter
indicating
the
identification
number
assigned
to
your
notice
by
EPA
and
the
expiration
date
of
the
review
period.
If
your
notice
is
declared
"
incomplete"
as
described
at
40
CFR
720.65,
you
will
receive
written
notification,
and
your
review
period
will
not
begin
until
EPA
receives
a
complete
notice.
Section
1:
General
Program
Information
1­
11
In
addition,
following
receipt
of
a
PMN,
LVE,
LoREX,
or
TME,
EPA
searches
the
TSCA
Chemical
Inventory
to
ensure
that
the
substance
for
which
the
notice
is
submitted
is
not
already
listed.
If
your
chemical
substance
is
on
the
Inventory,
you
will
be
notified
that
your
substance
is
not
subject
to
premanufacture
notification
requirements
and
you
are
free
to
begin
manufacture
immediately.

During
the
review
period,
status
information
on
your
PMN,
LVE,
LoREX,
or
TME
submission
can
be
obtained
at
www.
epa.
gov/
oppt/
newchems/
dropstat.
htm.
The
EPA
Program
Manager
or
other
EPA
technical
personnel
may
contact
you
to
clarify
information
you
have
provided
in
the
notice,
or
if
concerns
are
identified.
If
you
are
not
contacted
before
expiration
of
the
review
period,
you
are
free
to
begin
manufacture
of
the
substance
identified
in
your
notice
once
the
review
period
expires.

101­
6.
Q.
If
a
submitter
objects
to
a
finding
that
the
PMN
is
incomplete,
how
many
days
will
EPA
take
to
decide
on
the
appeal?

A.
As
required
at
40
CFR
720.65(
c)(
5),
EPA
will
notify
the
submitter
in
writing
within
10
days
of
receiving
the
objections.
Please
note
that
objections
must
be
received
within
ten
days
of
EPA
notification
of
the
submitter
for
a
submission
that
is
determined
to
be
incomplete.
See
40
CFR
§
720.65(
c)(
4).

101­
7.
Q.
May
I
claim
information
submitted
on
a
§
5
submission
form
to
be
confidential?

A.
Under
TSCA
§
14
as
specified
in
regulations
at
40
CFR
Part
720
Subpart
E,
you
may
assert
a
claim
of
confidentiality
for
any
§
5
related
information
submitted
to
EPA.
Note,
however,
that
information
in
health
and
safety
studies
is
normally
not
entitled
to
confidentiality,
except
as
provided
in
40
CFR
720.90.
Under
40
CFR
§
720.90(
c)
confidentiality
claims
for
chemical
identity
in
a
health
an
safety
study
may
be
denied
unless
1)
disclosure
would
reveal
manufacturing
or
processing
information,
2)
would
disclose
the
fraction
of
a
mixture
which
the
substance
comprises,
or
3)
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
in
EPA's
definition
of
health
and
safety
studies,
but
other
information
relating
to
the
effects
of
a
chemical
substances
or
mixture
on
health
or
the
environment
is
also
included.

Confidentiality
claims
must
be
made
at
the
time
your
information
is
submitted.
40
CFR
720.80(
b).
After
the
90­
day
review,
you
will
be
required
to
accompany
your
Notice
of
Commencement
(
NOC)
with
substantiation
of
your
confidentiality
claims
for
the
chemical
identity,
40
CFR
720.90(
b),
and
may
be
required
to
substantiate
other
confidentiality
claims
in
the
future
if,
for
example,
EPA
receives
a
Freedom
of
Information
Act
(
FOIA)
request
concerning
that
information.
Dealing
with
TSCA
confidential
business
information
is
a
substantial
burden
for
Section
1:
General
Program
Information
1­
12
EPA,
and
we
discourage
submitters
from
claiming
confidentiality
unless
they
have
sound
business
reasons
for
doing
so.
TSCA
§
14
describes
circumstances
under
which
EPA
shall
disclose
information
even
though
it
has
been
claimed
confidential
by
its
submitter.
See
also
EPA
confidentiality
regulations
at
40
CFR
2.209
and
2.306.
See
Q&
A
#
107­
6
to
obtain
the
requirements
for
substantiation
at
the
time
a
NOC
form
is
submitted
to
EPA
for
a
PMN
substance
which
can
serve
to
guide
your
considerations
about
the
appropriateness
of
making
a
CBI
claim.

To
ensure
that
confidential
information
is
not
disclosed
to
the
public,
you
must
submit
an
additional
copy
of
the
notice
form,
including
attachments,
which
does
not
contain
confidential
information.
This
"
sanitized"
or
redacted
version
will
be
placed
in
the
public
file.
It
must
contain
all
non­
confidential
information,
including
health
and
safety
studies.
"
Health
and
safety
study"
is
defined
at
TSCA
§
3(
b)
and
40
CFR
720.3(
k)
(
see
also
Q&
A
#
117­
1,
#
117­
2,
and
#
117­
3).
You
are
responsible
for
ensuring
that
all
information
claimed
as
confidential
is
removed
from
the
sanitized
version;
EPA
does
not
double­
check
this.

To
assert
confidentiality
for
specific
information
on
the
form
e.
g.,
submitter
identity,
chemical
identity,
or
use
information,
mark
the
"
Confidential"
or
Confidential
Business
Information
(
CBI)
box
located
to
the
right
of
the
information
on
the
form.
Also
mark
the
box
at
the
bottom
of
page
1
of
the
form
if
you
claimed
any
information
in
the
notice
as
confidential.

If
you
do
not
provide
the
"
sanitized"
or
redacted
copy
with
your
submission,
the
submission
will
be
considered
incomplete
and
the
review
period
will
not
begin.
Also
any
subsequent
amendment
to
your
PMN
or
additional
information/
data
you
provide
to
EPA
must
be
accompanied
with
a
non­
confidential
version
for
the
public
file.

101­
8.
Q.
What
should
I
do
to
ensure
that
EPA
will
treat
my
submission
as
confidential?

A.
See
Q&
A
#
101­
7.
You
must
take
the
following
actions
to
meet
EPA's
requirements
regarding
submission
of
confidential
information:

(
1)
Mark
the
appropriate
boxes
on
the
§
5
submission
form,
to
indicate
confidential
information.

(
2)
Submit
appropriate
numbers
of
copies
of
each
notice
form
and
the
attachments
(
three
for
PMNs
and
SNUNs,
one
for
LVEs,
LoREXs,
TMEs).
If
any
information
is
claimed
confidential,
an
additional
"
sanitized"
or
redacted
copy
of
the
relevant
documents
must
also
be
submitted.
The
"
sanitized"
or
redacted
copy
will
be
placed
in
the
public
file.

(
3)
When
submitting
information
in
an
attachment,
also
state
any
confidentiality
claim
in
the
relevant
attachment.
Section
1:
General
Program
Information
1­
13
101­
9.
Q.
How
many
copies
of
the
§
5
submission
form
must
be
sent
to
EPA?

A.
You
must
submit
an
original
and
two
complete
copies
of
the
§
5
submission
form,
including
all
test
data
and
any
other
information
attached
to
the
notice
form,
for
a
PMN
or
a
SNUN
(
Significant
New
Use
Notice).
40
CFR
720.40(
d)(
2).
For
a
Low
Volume
Exemption
(
LVE)
or
Low
Release,
Low
Exposure
Exemption
(
LoREX)
submission,
you
need
only
file
one
copy
of
the
form.
40
CFR
723.50(
e).

If
any
information
is
claimed
as
confidential,
however,
you
must
also
include
a
"
sanitized"
or
redacted
copy
of
the
notice
for
any
§
5
submission
(
PMN,
LVE,
SNUN,
etc).
40
CFR
720.80(
b)(
2).
Information
claimed
as
confidential
must
be
deleted
from
the
"
sanitized"
or
redacted
copy
and
replaced
with
generic
information,
e.
g.,
generic
chemical
identity,
use,
production
volume,
etc.

101­
10.
Q.
What
is
the
definition
of
an
authorized
official?
Must
it
be
a
company
officer?

A.
An
authorized
official
is
one
who
according
to
company
documents,
policy
or
interpretation,
is
responsible
for
the
truth
and
accuracy
of
each
statement
in
the
PMN
notice.
Depending
on
the
size
and
organization
of
the
submitting
company,
this
person
may
be,
for
example,
the
president
or
vice­
president,
or
director
or
manager
of
a
division.
The
submitter
determines
who
will
act
as
the
authorized
official.

101­
11.
Q.
How
can
a
submitter
use
an
agent
to
submit
a
PMN?
What
role
and
responsibility
does
the
agent
assume?

A.
An
agent
is
someone
whom
the
submitter
designates
to
submit
a
PMN,
who
may
have
more
knowledge
or
experience
in
completing
PMN
notices.
Both
the
submitter
and
the
agent
must
sign
the
certification
on
the
form.
The
agent
may
speak
for,
and
bind,
the
person
submitting
the
PMN
.
Responsibility,
however,
is
generally
with
the
submitter.
The
submitter
is
responsible
for
ensuring
accuracy,
and
that
all
information
known
to
or
reasonably
ascertainable
by
the
submitter,
and
all
test
data
in
the
submitter's
possession
or
control,
are
submitted
to
EPA.
See
40
CFR
720.(
e).

101­
12.
Q.
I
have
a
new
site­
limited
chemical
intermediate
that
requires
a
PMN.
My
normal
practice
is
not
to
prepare
a
Material
Safety
Data
Sheet
(
MSDS)
for
site­
limited
intermediates.
Do
I
have
to
prepare
one
to
be
included
with
this
PMN?

A.
Submitters
are
not
required
to
develop
a
MSDS
solely
for
the
purpose
of
submitting
a
PMN.
If
it
is
not
your
practice
to
develop
a
MSDS,
you
need
not
do
so
to
accompany
a
PMN.
However,
as
indicated
on
page
12
of
the
PMN
form,
if
a
MSDS
is
developed
for
the
material,
EPA
strongly
recommends
that
you
should
attach
the
MSDS
to
the
completed
PMN
form.
An
Section
1:
General
Program
Information
1­
14
MSDS
aids
EPA
reviewers
in
the
assessment
of
the
chemical.
It
enables
EPA
reviewers
to
understand
the
precautions
the
submitter
employs
for
worker
safety
and
environmental
release.
If
you
have
prepared
no
MSDS,
it
can
be
helpful
to
prepare
a
summary
statement
on
these
subjects
for
EPA's
consideration.
OSHA's
hazard
communication
requirements
appear
at
29
CFR
1910.

101­
13.
Q.
In
my
early
research,
I
will
be
using
a
batch
process.
Later
on,
during
manufacture,
I
plan
to
use
a
continuous
process.
This
could
lead
to
different
by­
products,
impurities,
etc.
However,
the
only
data
I
have
at
the
time
of
the
PMN
submission
is
batch
data.
Do
I
use
this
for
my
PMN
or
speculate
on
what
I
hope
to
do
in
manufacture?

A.
Both
can
be
useful
to
EPA's
PMN
reviewers.
You
should
provide
information
concerning
your
intended
commercial
activities
to
the
extent
that
is
known
or
reasonably
ascertainable
to
you
(
see
720.40(
d)).
You
should
estimate
the
identity
of
by­
products
and
impurities
to
the
best
of
your
ability
based
on
information
available
to
you,
such
as
the
results
of
R&
D
activity.

101­
14.
Q.
If
one
site
operates
a
batch
type
process
and
another
site
operates
a
continuous
process,
which
process
is
described
in
Section
A?

A.
You
must
describe
both
processes
in
Section
A.
See
40
CFR
720.45(
g)(
2).
Use
a
separate
sheet
for
each
description
and
clearly
indicate
your
intended
operations.

101­
15.
Q.
What
is
the
difference
between
industrial
use
and
commercial
use?

A.
A
use
is
industrial
if
the
new
chemical
substance
or
products
containing
it
will
be
used
at
a
facility
where
chemical
substances
or
mixtures
are
manufactured,
imported
or
processed,
e.
g.,
textile
dyeing
or
paint
formulation.
The
use
is
"
commercial"
if
the
chemical
substance
or
products
containing
it
will
be
used
by
a
commercial
enterprise
providing
saleable
goods
or
a
consumer
service,
e.
g.,
use
by
painting
contractors
or
commercial
dry
cleaning
establishments.
See
40
CFR
721.3.

101­
16.
Q.
Must
information
on
the
trade
name
of
formulated
products
which
contain
the
new
chemical
substance
as
part
of
a
mixture
be
reported
on
page
5
of
the
§
5
submission
form?

A.
No,
trade
names
of
formulated
products
are
helpful
in
the
PMN
review,
but
not
required.
However,
the
trade
name
for
the
PMN
substance
is
required.
40
CFR
720.45(
c).

101­
17.
Q.
Should
I
list
a
pilot
plant
operation
as
an
industrial
site
on
Page
7
of
the
§
5
submission
form?

A.
If
the
pilot
plant
will
continue
to
produce
the
chemical
after
R&
D
is
complete,
it
Section
1:
General
Program
Information
1­
15
should
be
listed
on
the
§
5
submission
form;
if
not,
no.
See
40
CFR
720.36.

101­
18.
Q.
In
the
process
description,
does
the
product
containing
the
PMN
material
constitute
an
environmental
release?
Does
it
have
to
be
numbered
on
the
diagram
and
listed
on
Page
8
of
the
§
5
submission
form?
Is
a
waste
stream
a
release
to
the
environment?
Incineration?
At
page
10
"
industrial
sites
controlled
by
others"
­
should
pesticide
application
be
considered
a
release
to
the
environment?

A.
EPA
is
asking
here
that
you
identify
releases
to
the
environment
in
the
course
of
manufacturing
and
processing
of
the
material,
as
required
by
40
CFR
720.45
(
g)
and
(
h).
This
includes
waste
streams,
process
losses,
incineration,
etc.
To
enable
EPA
to
assess
these
releases,
you
must
clearly
identify
the
steps
in
the
process
description
at
which
the
new
chemical
substance
is
susceptible
to
release.
Clearly,
the
end
product
can
have
environmental
impacts,
depending
on
its
use,
and
EPA
will
consider
environmental
impacts
of
dispersive
uses
in
EPA's
review
(
an
example
of
a
dispersive
use
would
be
as
an
ingredient
in
artificial
smoke
or
in
a
fragrance
formulation
for
outdoor
use).
The
PMN
Instruction
Manual
discusses
dispersive
use/
degree
of
containment
in
the
"
Use
information"
section
(
pp.
8­
9).
See
www.
epa.
gov/
oppt/
newchems/
tscaman2.
pdf.
The
use
will
be
assessed
by
Agency
reviewers,
based
on
the
detailed
description
you
provide
at
I.
C.
2.
on
page
7
of
the
PMN
form.
It
does
not
need
to
be
numbered
and
listed
on
Page
8,
however.

Release
to
the
environment
during
use
as
a
pesticide
is
not
considered
under
TSCA
PMN
review.
Pesticides
are
excluded
from
the
definition
of
"
chemical
substance"
at
40
CFR
720.3(
e)(
2)
and
in
Section
3(
2)(
b)(
ii)
of
the
TSCA.
Pesticides
are
reviewed
under
the
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(
FIFRA).
FIFRA
reviewers
will
consider
the
potential
harm
which
can
be
caused
by
dispersion
of
pesticides
in
the
environment.
Intermediates
used
in
pesticide
manufacture
are
not
excluded
from
consideration
as
chemical
substances,
however,
so
TSCA
PMN
review
is
provided
for
intermediates
used
in
pesticide
manufacture,
and
this
will
include
their
dispersion
into
the
environment.
For
more
on
TSCA
jurisdiction
over
pesticides,
see
Q&
A
#
213­
2.

101­
19.
Q.
For
Environmental
Release
and
Disposal,
the
manufacturers
must
identify
the
media
to
which
the
new
substance
will
be
released
from
the
"
release
point."
Does
that
release
point
refer
to
release
before
or
after
control
technology?

A.
The
PMN
form
provides
specific
places
for
the
submitter
to
provide
environmental
release
information
as
required
by
40
CFR
720.45
(
g)
and
(
h).
For
sites
controlled
by
the
submitter,
the
PMN
form
at
item
II.
A.
3.
calls
for
identification
of
release
directly
to
the
environment
(
item
2a)
and
after
technology
(
item
2b),
identification
of
control
technology
at
(
5a)
and
amount
released
after
technology
at
(
5b).
For
sites
controlled
by
others,
similar
information
is
requested
at
item
II.
B.
2.
This
enables
reviewers
to
assess
release
of
the
substance
both
before
Section
1:
General
Program
Information
1­
16
and
after
control
technology.

101­
20.
Q.
Our
company
has
a
problem
finding
our
old
file
copy
of
a
PMN
we
submitted
to
you
as
confidential
in
1984.
Since
we
filed
the
PMN,
we
have
merged
with
another
company,
the
person
who
filed
the
PMN
has
left,
and
our
company
name
has
changed.
We
want
to
get
a
copy
of
the
confidential
PMN
we
filed
at
that
time.
How
can
we
do
it?

A.
For
EPA
to
send
confidential
information
it
must
be
certain
that
it
is
sending
the
information
to
the
legitimate
owner
of
the
information.
This
includes
successors
to
the
companies
and
individuals
who
originally
filed.
EPA
needs
evidence
that
the
requester
is
legitimately
entitled
to
the
information.
To
initiate
this
request,
a
corporate
officer
should
send
a
signed
letter
(
signature
notarized)
with
as
clear
a
description
as
possible
of
the
information
sought
(
original
submitter
identity
required,
PMN
numbers
and
accession
numbers
are
important,
if
available)
on
company
letterhead
to:

TSCA
Records
and
Dockets
Management
Branch
Information
Management
Division
(
7407M)
Office
of
Pollution
Prevention
and
Toxics
United
States
Environmental
Protection
Agency
1200
Pennsylvania
Avenue,
NW
Washington,
DC
20460.

If
there
is
a
succession
situation,
describe
corporate
changes
which
have
happened
since
the
original
information
was
submitted
to
EPA
(
mergers,
buy­
outs,
etc.)
and
how,
if
we
need
assurance
on
the
situation,
EPA
can
check
the
validity
of
the
succession.

101­
21.
Q.
What
does
the
"
binding
option"
mean
in
legal
terms
when
filing
a
PMN?

A.
In
filing
a
PMN,
the
"
binding
option"
enables
you
to
indicate
your
willingness,
if
EPA
review
finds
it
to
be
necessary,
to
be
bound
to
certain
submitted
information
on
the
form.
By
indicating
your
willingness
to
make
these
commitments,
you
would
be
indicating
an
interest
in
future
negotiations
if
EPA
deems
them
necessary,
generally
in
working
to
a
§
5(
e)
Consent
Order
and/
or
a
SNUR.
The
binding
option
is
offered
for
questions
related
to
the
potential
risks
­
such
as
use,
production
volume,
protective
equipment,
engineering
controls,
and/
or
process
description.

Marking
the
binding
boxes
helps
EPA
(
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
chemical
substances
that
EPA
determines
may
present
an
unreasonable
risk,
substantial
exposures,
or
significant
new
uses,
if
certain
control
actions
are
not
implemented.
This
option
is
intended
to
reduce
delays
that
can
slow
the
development
of
consent
orders
absent
such
agreement.
Should
EPA
wish
to
discuss
development
of
binding
control
measures
for
your
Section
1:
General
Program
Information
1­
17
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.
Low
Volume/
Low
Release,
Low
Exposure),
however,
certain
statements
are
automatically
binding
on
the
submitter
when
EPA
approves
the
exemption
applications.
See
Q&
A
#
303­
5
and
40
CFR
723.50(
j).

102
Inventory
Searches/
Bona
Fides
102­
1.
Q.
A
potential
manufacturer
of
a
substance
needs
to
find
out
whether
the
chemical
substance
is
included
on
the
Inventory.
If
the
chemical
is
on
the
Inventory,
a
PMN
would
not
be
required.
How
is
a
submitter
to
determine
whether
the
chemical
it
wants
to
manufacture
is
on
the
Inventory?

A.
The
potential
manufacturer
("
manufacture"
includes
import)
should
check
the
public
version
of
the
TSCA
Inventory,
which
lists
chemicals
submitted
non­
confidentially
for
the
Inventory.
The
Inventory
is
maintained
at
Federal
depositary
libraries
throughout
the
country.
The
TSCA
Inventory
can
be
purchased
from
the
National
Technical
Information
Service
(
NTIS).

Email
info@
ntis.
gov.
Or
visit
their
website
at
www.
ntis.
gov.
Then
click
on
"
NTIS
Products
and
Services".
Click
on
"
Simple
Search".
Type
in
TSCA
Inventory.
Choose
from
several
Inventory
products
to
buy.

A
submitter
can
also
consult
a
commercial
service
which
has
the
NTIS
computeraccessible
TSCA
Inventory.
These
services
include:

i.
Scientific
and
Technical
Network
International
(
STN),
maintained
by
Chemical
Abstract
Service
(
CAS)
telephone
1­
800­
848­
6538
x3731
ii.
Dialog
Information
Services
(
Lockheed)
File
52,
telephone
1­
800­
334­
2564;

The
Inventory
is
carried,
as
well,
by
Cornell
University,
at
http://
msds.
pdc.
cornell.
edu/
tscasrch.
asp
EPA
cannot
be
responsible
for
the
quality
of
Inventory
data
in
these
outside
services.

If
no
listing
for
the
substance
is
found
on
the
public
Inventory,
the
submitter
may
request
that
EPA
check
the
confidential
portion
of
the
Inventory.
Before
EPA
will
do
so,
the
submitter
must
establish
a
"
bona
fide
intent"
to
manufacture
or
import
the
chemical
pursuant
to
40
CFR
720.25.
Section
1:
General
Program
Information
1­
18
102­
2.
Q.
How
may
a
bona
fide
intent
to
manufacture
or
import
a
chemical
be
established?

A.
In
order
to
establish
a
bona
fide
intent
to
manufacture
or
import
a
chemical,
information
must
be
submitted
to
EPA,
as
described
at
40
CFR
§
720.25.
EPA
in
1995
revised
certain
provisions
of
the
bona
fide
procedures
to
establish
a
genuine
intent
to
manufacture
or
import
a
substance.
(
60
FR
16298,
March
29,
1995)
This
amendment
reduced
and
simplified
the
then­
existing
analytical
information
requirements,
modified
and
clarified
other
existing
information
requirements,
and
requires
submitters
to
provide
some
additional
types
of
information
in
bona
fide
submissions.

Broadly,
the
amendments
identify
an
infrared
spectrum
as
the
usual
practice
for
characterizing
the
new
chemical
substance.
Requirements
for
chemical
identity
information,
and
the
description
of
research
and
development
(
R&
D)
activities
and
use
were
modified
and/
or
clarified.
Three
new
information
requirements
were
established
regarding
the
most
probable
manufacturing
site
and
process
to
be
used,
as
well
as
an
approximate
date
when
the
submitter
would
be
likely
to
submit
a
§
5
notice
for
the
substance
if
it
is
not
found
in
the
Inventory.
The
amendments
enable
submitters
to
demonstrate
a
bona
fide
intent
and
EPA
to
better
protect
the
CBI
of
the
original
submitters
of
Inventory
substances.

Submitters
of
a
bona
fide
must
provide:

(
1)
The
CA
Index
Name,
and
a
correct
CASRN
(
if
the
substance
already
has
a
CASRN
assigned
to
it)
(
correct
CA
nomenclature
is
not
required
when
a
reported
substance
involves
the
use
of
a
purchased
proprietary
reactant.
This
is
due
to
logistical
obstacles
involved
in
generating
correct
CA
identifications
for
substances
based
on
multiple
submissions
of
parts
of
the
overall
identity
from
different
sources.
However,
the
submitter
must
coordinate
with
the
supplier
to
ensure
that
the
remaining
specific
chemical
identity
information
is
sent
by
the
chemical
supplier
directly
to
EPA
in
a
timely
manner,
to
complete
the
bona
fide
request
and
initiate
review
by
EPA.
If
the
appropriate
supporting
document
from
the
supplier
is
not
received
within
30
days
after
EPA
receives
the
submitter's
bona
fide,
the
bona
fide
will
be
considered
incomplete).

(
2)
A
molecular
formula
and
a
complete
or
partial
chemical
structure
diagram
if
these
are 
known
or
reasonably
ascertainable.'
(
Failure
to
fully
comply
with
the
chemical
identification
elements
of
this
requirement
will
result
in
the
bona
fide
being
declared
incomplete
by
EPA
and
returned
to
the
submitter.)

(
3a)
A
brief
description
of
the
research
and
development
activities
conducted
to
date
related
to
the
substance,
including
the
year
in
which
the
person
first
started
to
conduct
research
or
development
activity
on
the
substance,
and
the
general
types
of
research
and
development
activities
conducted
thus
far
(
e.
g.,
synthesis,
substance
isolation/
purification,
Section
1:
General
Program
Information
1­
19
formulating,
product
development,
process
development,
end­
use
application,
toxicity
testing,
etc.).
The
submitter
must
also
indicate
whether
any
pilot
plant
or
production­
scale
plant
evaluations
have
been
conducted
involving
the
manufacture
or
processing
of
the
substance.

(
3b)
(
alternative
to
3a,
above)
If
an
importer
is
unable
to
provide
the
information
described
in
(
3a)
from
a
foreign
manufacturer
or
supplier,
the
following
information
shall
be
submitted
instead:
(
i)
A
brief
statement
indicating
how
long
the
substance
has
been
in
commercial
use
outside
of
the
United
States.
(
ii)
The
name
of
a
country
in
which
it
has
been
commercially
used.
(
iii)
Whether
the
importer
believes
that
the
substance
has
already
been
used
commercially,
in
any
country,
for
the
same
purpose
or
application
that
the
importer
is
intending.

(
4)
A
specific
description
of
the
major
intended
application
or
use
of
the
substance.

(
5)
An
infrared
spectrum
of
the
substance,
or
alternative
spectra
or
other
data
which
identify
the
substance
if
infrared
analysis
is
not
suitable
for
the
substance
or
does
not
yield
a
reasonable
amount
of
structural
information.
When
using
alternative
spectra
or
instrumental
analysis,
the
person
must
submit
a
spectrum
or
instrumental
readout
for
the
substance.

(
6)
The
estimated
date
(
month/
year)
in
which
the
requestor
intends
to
submit
a
Premanufacture
Notice
(
PMN)
or
exemption
request
under
§
5
for
this
substance
if
EPA
informs
the
notice
submitter
that
the
substance
is
not
on
the
Inventory.

(
7)
The
address
of
the
facility
under
the
control
of
the
submitter
at
which
the
manufacture
or
processing
of
the
substance
would
most
likely
occur.
For
an
imported
substance,
the
facility
under
the
control
of
the
importer
at
which
processing
of
the
substance
would
likely
occur,
if
any.

(
8a)
For
substances
intended
to
be
manufactured
in
the
United
States,
a
description
of
the
most
probable
manufacturing
process
that
would
be
used
by
the
submitter
to
produce
the
substance
for
non­
exempt
commercial
purposes.

(
8b)
(
alternative
to
8a,
above)
For
substances
intended
to
be
imported,
a
brief
description
of
how
the
submitter
is
most
likely
to
process
or
use
the
substance
for
a
commercial
purpose.
If
the
substance
is
not
expected
to
be
processed
or
used
at
any
facility
under
the
importer's
control,
a
statement
to
this
effect
must
be
included
along
with
a
description
of
how
the
substance
will
be
processed
or
used
at
sites
controlled
by
others,
if
this
Section
1:
General
Program
Information
1­
20
information
is
known
or
reasonably
ascertainable.

If
an
importer
cannot
provide
the
chemical
identity
information
required
because
it
is
claimed
confidential
by
its
foreign
manufacturer
or
supplier,
the
foreign
manufacturer
or
supplier
must
supply
the
required
information
directly
to
EPA
in
accordance
with
§
720.45(
a)(
4)
and
reference
the
importer's
notice.
If
the
appropriate
supporting
document
from
the
foreign
party
is
not
received
within
30
days
after
EPA
receives
the
importer's
notice,
the
notice
will
be
considered
incomplete.

If
a
manufacturer
cannot
provide
all
of
the
required
information
in
accordance
with
§
720.45(
a)(
1),
(
2),
and
(
3)
because
the
new
chemical
substance
is
manufactured
using
a
reactant
that
has
a
specific
chemical
identity
claimed
as
confidential
by
its
supplier,
the
notice
must
contain
chemical
identity
information
that
is
as
complete
as
known
by
the
manufacturer.
In
addition,
a
letter
of
support
for
the
notice
must
then
be
sent
to
EPA
by
the
chemical
supplier
of
the
confidential
reactant,
providing
the
specific
chemical
identity
of
the
proprietary
reactant,
in
accordance
with
40
CFR
720.45(
a)(
5).
The
letter
of
support
must
reference
the
manufacturer's
notice.
If
the
appropriate
supporting
document
from
the
supplier
is
not
received
within
30
days
after
EPA
receives
the
manufacturer's
notice,
the
notice
will
be
considered
incomplete.

On
receipt
of
an
adequate
statement
of
bona
fide
intention,
EPA
will
search
both
the
non­
confidential
and
the
confidential
portions
of
the
Inventory
for
the
substance;
and
will
notify
the
intended
submitter
whether
the
substance
can
be
found
on
the
Inventory.

102­
3.
Q.
What
are
the
benefits
of
filing
a
Statement
of
bona
fide
Intent
To
Manufacture
instead
of
a
full
PMN
or
LVE
or
LoREX
application?

A.
For
the
submitter,
there
are
benefits
to
each:
there
is
no
fee
for
filing
a
bona
fide,
and
the
review
period
is
shorter
(
30
days).
It
is
frequently
less
costly
to
develop
the
Statement
of
bona
fide
Intent
than
it
is
to
develop
a
PMN
or
exemption
application.
On
the
other
hand,
EPA
will
search
the
Inventory
on
receipt
of
a
PMN
or
exemption
application,
and
will
reject
the
PMN
and
return
your
fee
if
it
is
found
to
be
already
listed
on
the
Inventory.
If
the
material
was
not
on
the
Inventory
the
90­
day
review
period
for
the
PMN
will
start
on
receipt
of
the
PMN.
See
40
CFR
720.65(
a).

102­
4.
Q.
How
soon
will
EPA
notify
the
requester
of
the
results
regarding
an
Inventory
search?

A.
The
submitter
will
be
notified
within
30
days
after
the
submission
is
considered
by
EPA
to
be
complete
and
without
chemical
identity
problems.

102­
5.
Q.
Is
EPA
capable
of
recognizing
if
a
chemical
substance
covered
by
a
submitted
PMN
is
identical
to
one
already
submitted
by
another
submitter?
What
would
be
done
in
this
case?
Section
1:
General
Program
Information
1­
21
A.
Yes.
EPA
has
put
substantial
effort
into
developing
unambiguous
naming
rules
for
chemical
substances,
so
that
Inventory
listings
will
be
unique
and
consistent.
Using
these
rules,
an
Inventory
search
upon
receipt
of
a
§
5
submission
would
identify
other
submissions
for
the
identical
chemical
substance.
If
a
chemical
was
on
the
initial
Inventory
or
if
a
Notice
of
Commencement
has
been
received
for
a
previously
identified
new
chemical,
the
PMN
substance
would
be
viewed
as
an
existing
chemical
substance,
the
PMN
substance
would
be
declared
excluded
from
reporting,
and
the
PMN
submitter
would
be
notified.
In
such
instances,
any
user
fee
submitted
with
the
PMN
would
be
refunded.

102­
6.
Q.
How
can
a
submitter
find
out
whether:
(
a)
a
particular
polymer
is
on
the
confidential
TSCA
Inventory?
or,
(
b)
a
reactant
in
a
particular
polymer
is
on
the
confidential
Inventory?

A.
The
Inventory
status
of
your
polymer
can
be
determined
by
filing
a
Notice
of
bona
fide
Intent
to
Manufacture
(
see
40
CFR
§
720.25
or
contact
the
TSCA
Hotline
on
202
554­
1404).
You
may
not
file
a
Notice
of
bona
fide
Intent
to
Manufacture
on
the
reactant
unless
you
have
a
bona
fide
intent
to
manufacture
or
import
it.
It
is
the
responsibility
of
the
manufacturer
or
importer
of
the
reactant
to
determine
the
Inventory
status
of
the
reactant.
If
you
file
a
PMN
on
your
polymer
EPA
will
check
its
Inventory
status
and,
if
it
is
on
the
Inventory,
will
notify
you
that
you
are
free
to
proceed
with
manufacture
of
the
polymer.

102­
7.
Q.
I
wish
to
import
a
polymer
under
the
Polymer
Exemption
containing
greater
than
two
percent
of
a
reactant
(
monomer)
not
on
the
public
TSCA
Inventory,
but
which
may
be
on
the
confidential
Inventory.
On
what
do
I
file
a
bona
fide?
If
all
I
plan
to
import
is
the
final
polymer,
how
do
I
know
whether
it
now
qualifies
for
the
new
Polymer
Exemption
criteria
or
if
I
need
to
file
a
PMN
for
the
polymer?

A.
If
the
monomer
is
on
the
confidential
Inventory,
your
polymer
may
be
eligible
for
exemption.
See
40
CFR
723.250(
d)(
4).
If
it
is
not,
a
party
that
intends
to
manufacture
or
import
the
monomer
must
have
it
go
through
the
PMN
review
process
and
commence
its
manufacture
or
importation
to
allow
it
to
be
used
in
an
otherwise
exemptible
polymer.
You
may
not
file
a
Notice
of
Bona
Fide
Intent
to
Manufacture
on
the
reactant
(
monomer)
unless
you
have
a
bona
fide
intent
to
manufacture
or
import
it.
Your
supplier,
if
in
the
U.
S.,
could
file
a
bona
fide
on
the
monomer.
If
your
supplier
is
not
in
the
US,
it
does
not
have
standing
to
file
a
bona
fide
on
the
monomer.

There
is
really
no
way
to
find
out
whether
a
substance
is
on
the
confidential
Inventory
unless
you
intend
to
import
or
manufacture
that
substance
itself.
Therefore,
the
only
substance
for
which
you
can
file
a
Notice
of
bona
fide
Intent
is
the
final
polymer.
If
the
polymer
is
on
the
Inventory,
no
PMN
will
be
needed.
If
not,
you
will
need
to
file
a
PMN
for
the
polymer.
See
www.
epa.
gov/
oppt/
newchems/
polyguid.
pdf.

102­
8.
Q.
Is
there
a
required
form
to
use
in
submitting
a
Notice
of
bona
fide
Intent?
Section
1:
General
Program
Information
1­
22
A.
No.

102­
9.
Q.
Can
a
bona
fide
intent
notice
be
sent
by
courier
service?
I
had
a
bona
fide
notice
returned
by
my
courier
service.
What
went
wrong?

A.
The
room
at
which
bona
fide
submissions
are
accepted
is
only
open
until
4
pm.
If
a
courier
service
comes
after
that
time
it
will
be
turned
away.
The
address
for
sending
a
bona
fide
by
courier
is:

Confidential
Business
Information
Center
OPPT
Document
Control
Office
(
DCO)
EPA
East
Building
(
old
ICC)
1201
Constitution
Avenue,
NW
Room
#
6428
Washington,
DC
20004
You
can
give
the
courier
the
phone
number
(
202)
564­
8930,
to
call
if
there
are
delivery
problems.

103
Chemical
Identification
103­
1.
Q.
As
required
by
the
1995
amendments,
how
can
a
correct
Ninth
Collective
Index
(
9CI)
Chemical
Abstracts
(
CA)
name
for
a
new
chemical
substance
be
obtained?

A.
This
is
governed
by
40
CFR
720.45(
a)(
3).
A
CA
name
can
be
obtained
directly
from
the
Chemical
Abstracts
Service
(
CAS)
Inventory
Expert
Service
(
CAS­
IES,
IES),
by
using
an
alternative
source,
or
by
developing
your
own
CA
name.
If
a
source
other
than
the
CAS­
IES
is
used
and
any
chemical
identity
information
is
determined
by
EPA
to
be
incorrect,
the
notice
will
be
declared
incomplete
and
the
submitter
will
be
responsible
for
correcting
the
chemical
name
prior
to
the
start
of
the
review
period.

(
NOTE:
non­
IES
CAS
personnel,
including
other
Registry
Services
employees,
assign
CA
names
and
numbers.
They
are
not
specifically
trained
in
TSCA
Inventory
requirements
and
policies,
and
the
requirements
of
Method
1
are
not
satisfied
by
giving
a
CAS
name
and
number
assigned
by
any
non­
IES
source.
See
www.
epa.
gov/
oppt/
newchems/
guideman.
htm
and
choose
the
link
titled
"
Revisions
of
Premanufacture
Notification
Regulations;
Final
Rules"
(
60
FR
16298;
March
29,
1995)"
for
the
complete
mechanism
for
obtaining
the
CA
nomenclature
under
Method
1
or
Method
2.)

Persons
who
use
the
CAS
Inventory
Expert
Service
must
submit
a
copy
of
the
chemical
identification
report
from
CAS
with
their
notice.
The
person
must
also
identify
in
the
§
5
submission
form
which
method
was
used
to
develop
or
obtain
the
specified
chemical
identity
Section
1:
General
Program
Information
1­
23
information.
Mark
Method
1
for
the
CAS
Inventory
Expert
Service.
Mark
Method
2
for
any
other
source.

You
must
provide
the
correct
CA
name
for
the
substance,
based
on
the
Ninth
Collective
Index
(
9CI)
of
CA
nomenclature
rules
and
conventions,
and
consistent
with
listings
for
similar
substances
in
the
Inventory.
For
each
substance
having
a
chemical
composition
that
can
be
represented
by
a
specific,
complete
chemical
structure
diagram
(
a
Class
1
substance),
a
CA
Index
Name
must
be
provided.
For
each
chemical
substance
that
cannot
be
fully
represented
by
a
complete,
specific
chemical
structure
diagram
(
a
Class
2
substance),
or
if
the
substance
is
a
polymer,
a
CA
Index
Name
or
CA
Preferred
Name
must
be
provided
(
whichever
is
appropriate
based
on
CA
9CI
nomenclature
rules
and
conventions).
In
addition,
for
a
Class
2
substance,
the
notice
must
identify
the
immediate
chemical
precursors
and
reactants
by
specific
chemical
name
and
Chemical
Abstracts
Service
Registry
Number
(
CASRN),
if
the
number
is
available.
Tradenames
or
generic
names
of
chemical
precursors
or
reactants
are
not
acceptable
as
substitutes
for
specific
chemical
names.

EPA
only
considers
a
submitter
to
have
used
Method
1
if
a
copy
of
the
CAS­
IES
report
is
attached
to
the
notice
submitted
to
EPA.
If
a
CAS­
IES
report
is
not
attached
to
the
notice,
EPA
considers
the
chemical
identity
information
to
have
been
obtained
under
Method
2,
even
if
the
Method
1
box
is
marked
on
the
notice.

103­
2.
Q.
How
can
I
obtain
information
about
CAS
Inventory
Expert
Service?

A.
Information
on
this
service
including
available
resource
materials
is
available
via
telephone
(
614­
447­
3600
or
800­
848­
6538
ext.
2308)
or
by
facsimile
(
614­
447­
3747).

103­
3.
Q.
I
am
manufacturing
a
new
chemical
substance
using
my
supplier's
proprietary
chemical
as
a
reagent.
How
can
I
obtain
a
CA
name
for
the
new
substance
when
I
only
possess
partial
information?

A.
You
can't,
and
in
this
case,
you
need
not
obtain
a
CA
name.
You
should
provide
all
the
information
you
have
on
the
chemical
identity
of
the
new
substance
(
including
the
specific
identities
of
the
reactants
you
know,
the
nature
of
the
reaction,
and
the
types
of
products
formed)
and
the
proprietary
reactant
directly
to
EPA
and
also
have
your
supplier
submit
a
letter
of
support
with
the
specific
chemical
identity
of
the
confidential
reactant
to
EPA,
referencing
your
company's
name
and
either
a
prenotice
communication
(
PC)
number
or
the
TSCA
user
fee
identification
number.
See
40
CFR
720.40(
e)(
2).
The
notice
will
not
be
considered
complete
until
the
supplier
has
provided
the
proprietary
chemical
information
to
EPA,
appropriately
referencing
your
notice.
EPA
will
develop
the
name
for
its
own
use
on
the
Confidential
Inventory,
but
will
not
divulge
the
name
to
you.
Section
1:
General
Program
Information
1­
24
103­
4.
Q.
How
does
a
submitter
obtain
a
CAS
Registry
Number
for
a
PMN
substance
when
the
PMN
substance
identity
is
confidential?
Does
EPA
assign
a
CAS
Registry
Number
to
every
chemical
which
has
gone
through
the
PMN
process
and
for
which
a
Notice
of
Commencement
has
been
received?

A.
EPA
itself
does
not
assign
CAS
Registry
Numbers,
they
are
developed
by
the
Chemical
Abstracts
Service.
PMNs
for
chemicals
whose
specific
chemical
identities
are
claimed
as
CBI
in
a
§
5
submission,
and
which
have
no
existing
CAS
Registry
Number,
can
be
submitted
without
a
CAS
Registry
Number.
For
such
a
confidential
substance,
EPA
will
develop
an
Accession
Number.
See
40
CFR
720.25(
b)(
1).
An
Accession
Number
is
a
five­
or
six­
digit
number
used
to
identify
CBI
chemicals
listed
in
the
Inventory
by
their
generic
chemical
names.

If
a
CAS
Registry
Number
is
obtained
for
a
substance,
CAS
will
in
all
cases
publish
that
chemical
name
and
the
number.
The
existence
of
the
substance
will
then
be
public
knowledge
through
CAS's
publicly
available
databases.
However,
a
submitter
can
(
but
need
not)
request
a
CAS
Registry
Number
for
the
substance
in
the
course
of
getting
a
name
from
the
Inventory
Expert
Service,
and
can
claim
that
CAS
Registry
Number
confidential
in
the
filing.
This
can
keep
the
association
of
that
substance
with
the
submission
of
the
PMN
a
secret.
It
is
also
possible
for
a
submitter
to
file
a
PMN
on
a
substance
which
received
a
CAS
Registry
Number
long
before
(
for
R&
D
use,
for
example,
or
for
commerce
in
other
countries),
and
have
the
association
of
that
number
with
the
PMN
be
kept
confidential.
If
there
is
a
CAS
Registry
Number
for
a
substance,
the
submitter
must
include
it
in
the
PMN,
at
least
in
the
CBI
version
of
the
PMN.

In
filing
a
non­
confidential
PMN
for
a
chemical,
the
submitter
need
not
report
a
CAS
Registry
Number
unless
one
already
exists
for
that
substance.
If
the
PMN
successfully
completes
review
and
the
submitter
files
a
Notice
of
Commencement,
EPA
will
then
have
CAS
develop
a
CAS
Registry
Number
for
the
substance.

103­
5.
Q.
How
can
I
obtain
a
Ninth
Collective
Index
(
9CI)
Chemical
Abstracts
(
CA)
name
for
an
imported
substance
whose
identity
is
claimed
as
confidential
by
its
foreign
manufacturer?

A.
Your
foreign
supplier
must
follow
the
same
procedures
as
a
U.
S.
submitter
to
obtain
a
CA
name
and
provide
the
correct
chemical
identity
to
EPA
as
a
letter
of
support,
clearly
referencing
your
notice
and
the
PMN
user
fee
identification
number
or
a
prenotice
communication
number,
if
one
has
been
obtained.
Information
can
be
obtained
from
the
CAS
Inventory
Expert
Service
by
telephone
(
614­
447­
3600
or
800­
848­
6538
x2308)
or
by
facsimile
(
614­
447­
3747).
See
40
CFR
720.40(
e)(
2)
and
the
PMN
Instructions
Manual
for
further
information
on
joint
submissions
or
letters
of
support.

103­
6.
Q.
To
what
extent
must
Chemical
Abstracts
Service
(
CAS)
nomenclature
be
used
in
an
exemption
application
considering
these
substances
are
not
on
the
TSCA
Inventory?
Section
1:
General
Program
Information
1­
25
A.
Correct
CAS
nomenclature
is
required
in
exemption
applications.
See
generally
40
CFR
part
723.
The
efficient
characterization
and
assessment
of
associated
risks
of
a
substance
proposed
for
exemption
in
a
short
time
period
relies
on
the
receipt
of
accurate
and
consistent
nomenclature.
EPA
must
make
the
finding
that
the
substance
proposed
for
exemption
will
not
present
an
unreasonable
risk
before
EPA
may
approve
an
exemption.
A
correct
Ninth
Collective
Index
(
9CI)
Chemical
Abstracts
(
CA)
name
must
be
provided
in
an
exemption
notice.
Submitters
may
directly
use
CAS
Inventory
Expert
Service
or
develop
a
name
on
their
own
or
through
another
source.

103­
7.
Q.
If
a
chemical
substance
is
claimed
confidential,
must
a
generic
chemical
name
be
submitted?

A.
Yes.
A
generic
name
must
be
submitted.
The
name
must
be
only
as
generic
as
necessary
to
protect
the
confidential
chemical
identity
and
must
reveal
chemical
identity
to
the
maximum
extent
possible.
See
40
CFR
720.85(
a)(
2).

103­
8.
Q.
What
would
happen
if
the
PMN
chemical
identity
is
claimed
as
CBI
but
the
generic
name
submitted
in
the
PMN
is
too
broad?
Would
EPA
declare
the
PMN
incomplete?

A.
Typically
we
wouldn't
declare
the
PMN
incomplete.
However,
the
PMN
may
be
declared
incomplete
if
the
generic
chemical
name
is
so
insufficient
as
to
reveal
little
or
nothing
about
the
chemical
composition.
EPA
will
not
usually
review
the
adequacy
of
the
generic
name
or
generic
description
of
uses
during
the
review
period.
We
may
choose
to
review
the
generic
name/
use
at
the
time
we
receive
a
Notice
of
Commencement
under
40
CFR
720.102.
More
importantly,
if
EPA
decides
to
regulate
a
PMN
substance,
we
would
notify
the
submitter
that
she
will
have
to
negotiate
with
us
the
generic
chemical
identity
for
Inventory
purposes
if
that
name
is
not
considered
adequate.

103­
9.
Q.
What
is
EPA's
procedure
when
EPA
develops
a
replacement
generic
name
for
the
Inventory?
Will
the
manufacturer
or
importer
have
an
opportunity
for
input
prior
to
publication?

A.
If
the
generic
name
submitted
on
the
PMN
is
too
general,
as
determined
by
EPA,
the
submitter
is
contacted
and
encouraged
to
work
with
EPA
to
develop
a
generic
name
acceptable
to
both.
See
40
CFR
720.85(
a)(
3).

103­
10.
Q.
I
am
intending
to
submit
a
PMN
on
a
material
which
I
will
make
with
a
confidential
supplied
feedstock,
which
will
be
identified
to
EPA
in
a
Letter
of
Support.
However,
I
have
a
pretty
good
idea
what
is
in
this
material,
and
I
do
not
want
to
be
tied
to
this
supplier
indefinitely
to
make
my
material.
What
do
I
need
to
do
to
be
able
to
use
alternate
sources
for
my
feedstock?
In
a
similar
situation,
I
am
using
a
process
stream
(
byproduct)
material
bought
from
another
company
as
a
raw
material.
What
should
I
call
it?
If
I
call
it
by
the
name
its
maker
sells
it
under,
Section
1:
General
Program
Information
1­
26
am
I
going
to
be
committed
to
purchasing
their
material
only,
even
though
other
materials
(
currently
higher­
priced)
would
serve
my
needs?

A.
If
you
are
unable
to
reach
an
agreement
with
your
supplier
to
divulge
to
you
a
chemical
identity,
or
if
you
are
using
a
material
which
has
a
chemical
name
specific
to
that
provider,
you
can
file
a
consolidated
PMN
with
EPA.
See
48
FR
21734,
May
13,
1983,
and
www.
epa.
gov/
oppt/
newchems/
consix.
htm.
One
of
your
filings
will
include
the
current
intended
feedstock,
and
your
other
filing(
s)
will
include
other
feedstock(
s)
or
reactants
(
either
other
confidential
materials
or
fully
identified
material[
s])
that
can
be
used
to
make
the
PMN
substance
you
want
to
manufacture.
When
you
purchase
a
fully
identified
feedstock
or
reactant,
you
must
use
the
same
name
for
it
as
is
used
by
its
manufacturer
for
TSCA
purposes.

In
the
case
of
a
confidential
material,
EPA
clearly
cannot
offer
you
any
information
about
such
a
consolidated
PMN
which
would
enable
you
to
determine
that
the
PMN
substance
you
plan
to
manufacture
from
a
proprietary
reactant
is
the
same
as
one
you
would
make
from
a
reactant
that
is
fully
identified
to
you.
Thus,
EPA
cannot
respond
to
a
consolidation
in
a
way
that
would
provide
information
which
could
help
you
determine
the
specific
chemical
identity
of
the
confidential
feedstock.

103­
11.
Q.
I
intend
to
submit
a
PMN
on
a
product
which
as
synthesized
will
contain
an
impurity
which
is
difficult
to
remove,
and
therefore
will
remain
in
the
product
as
sold.
What
should
be
tested,
the
intended
sale
product
or
the
product
with
the
impurity
removed?

A.
Test
the
product
as
it
is
intended
to
be
sold.
See
40
CFR
720.45(
a)(
1).
It
is
important
that,
in
the
PMN,
you
ensure
that
the
description
of
the
product
tested
is
unambiguous.

104
Nomenclature
104­
1.
Q.
What
method
does
EPA
prefer
a
submitter
use
when
describing
a
chemical
substance?

A.
40
CFR
§
720.45(
a)
requires
that
submitters
of
§
5
notices
provide
the
correct
Chemical
Abstracts
(
CA)
Name
or
CA
Preferred
Name
for
each
chemical
substance
included
in
the
notice
("
reported
substance")
that
is
consistent
with
TSCA
Inventory
listings
for
similar
substances.

Persons
who
request
a
search
of
the
confidential
Inventory
by
demonstrating
a
bona
fide
intent
to
manufacture
or
import
a
chemical
substance
for
commercial
purposes
("
bona
fide")
are
also
required
to
provide
correct
CA
nomenclature
and
chemical
identity
information
in
accordance
with
40
CFR
§
720.25.
EPA
also
requires
that
a
valid
Chemical
Abstracts
Service
(
CAS)
Registry
Number
(
CASRN)
consistent
with
the
CA
name
be
reported
in
a
Section
5
notice
or
Notice
of
bona
fide
Intent
to
Manufacture
for
the
substance
if
a
CASRN
already
exists
for
that
Section
1:
General
Program
Information
1­
27
substance.

Before
the
1995
amendments,
the
PMN
regulations
indicated
that
CA
nomenclature
was
the
preferred
chemical
nomenclature
system
for
PMN
reporting,
but
it
was
not
required.
Therefore,
submitters
were
able
in
the
past
to
identify
the
PMN
substance
using
alternative
nomenclature.
Currently,
however,
having
the
correct
CA
identification
for
a
substance
is
important
to
EPA
because
the
reporting
of
incorrect,
inconsistent,
ambiguous,
or
obsolete
chemical
names,
molecular
formulas,
or
chemical
structure
information,
or
names
that
are
not
CA
Index
or
CA
Preferred
Names,
causes
extra
resources
to
be
spent
by
EPA
to
search
the
Inventory
and
establish
the
best
descriptions
for
substances
under
TSCA.

Although
the
amended
regulations
only
require
that
CASRNs
be
reported
for
substances
that
already
have
them,
EPA
strongly
recommends
that
submitters
provide
CASRNs
for
all
reported
substances,
especially
when
the
chemical
identity
is
not
being
claimed
as
confidential
business
information
(
CBI).
The
fact
that
a
CASRN
exists
does
not
prohibit
a
submitter
from
claiming
this
information
as
confidential.
Having
more
substances
reported
with
CASRNs
will
save
EPA
resources
involved
with
chemical
review
and
Inventory
searching.

Submitters
must
provide
a
CA
Index
Name
or
CA
Preferred
Name
that
is
consistent
with
the
application
of
the
Ninth
Collective
Index
(
9CI)
of
CA
nomenclature
rules
and
conventions.
(
This
definitive
set
of
rules
and
conventions
for
CA
nomenclature
has
been
used
since
1972.)
Whether
to
report
a
CA
Index
Name
or
Preferred
Name
for
a
substance
depends
on
whether
the
chemical
identity
of
the
substance
is
well­
defined,
indefinitely
described,
or
poorly
defined.

All
of
the
chemical
identification
requirements
described
above
should
be
satisfied
if
the
submitter
uses
the
CAS
Inventory
Expert
Service,
which
is
a
special
service
of
CAS
for
identifying
substances
to
be
submitted
under
TSCA.
Submitters
may
also
choose
to
use
the
services
of
another
chemical
information
service
or
consultant
that
the
submitter
considers
capable
of
generating
correct
CA
names,
chemical
structure
diagrams
or
molecular
formulas
where
appropriate,
and
obtaining
existing
CASRNs.
Alternatively,
the
submitter
can
search
publicly
available
databases
to
retrieve
this
information,
if
available,
or
attempt
to
generate
a
name
without
assistance
from
another
person
or
organization,
if
the
submitter
has
sufficient
knowledge
about
the
Ninth
Collective
(
9CI)
Index
of
CA
nomenclature
rules
and
conventions
and
about
how
similar
substances
are
named
for
the
Inventory.

Information
describing
CA
nomenclature
rules
and
conventions
can
be
obtained
from
CAS.
In
addition,
EPA
has
prepared
a
series
of
Inventory
nomenclature
guidance
documents
that
are
intended
to
generate
better
understanding
of
how
various
classes
of
substances
or
types
of
complex
product
combinations
are
identified
for
TSCA
purposes.
Several
of
these
guidance
documents
have
been
posted
to
the
New
Chemicals
Program's
Internet
site:
New
Chemicals
Program
Website,
which
can
be
found
at
www.
epa.
gov/
oppt/
newchems.
The
Inventory
guidance
documents
provide
informal
technical
guidance
that
is
intended
solely
to
illustrate
how
various
Section
1:
General
Program
Information
1­
28
types
of
substances
are
represented
on
the
TSCA
Inventory
based
on
the
information
provided
by
the
submitters.
The
guidance
documents
are
not
intended
to
be
used
for
identifying
substances
for
reporting
purposes
or
for
determining
the
need
to
report.
Generally,
EPA
has
attempted
to
maintain
a
consistent
Inventory
by
closely
following
the
guidance
contained
in
the
guidance
documents
.
However,
EPA
cannot
guarantee
that
the
guidance
discussed
in
these
guidance
documents
has
been
applied
to
all
substances
listed
on
the
Inventory.

These
guidance
documents
are
also
available
from
the
TSCA
Hotline
at
(
202)
554­
1404,
TTD
(
202)
554­
0551,
or
tsca­
hotline@
epa.
gov
For
well­
defined
substances
appropriately
named
using
CA
Index
nomenclature,
the
specific
chemical
name
chosen
as
most
accurately
describing
the
substance
should
be
based
on
all
information
that
the
submitter
can
reasonably
ascertain
about
its
chemical
structure,
including,
where
applicable,
the
degree
of
structural
specificity
of
the
substance
(
e.
g.,
whether
a
specific
isomer
is
intended
to
be
manufactured
in
the
reaction
that
produces
the
substance).
For
poorly
defined
substances
properly
named
using
CA
Preferred
nomenclature,
the
specific
name
of
choice
should
be
based
on
the
submitter's
knowledge
of
the
identities
and
sources
(
synthetic,
isolated
by
processing
from
certain
naturally
occurring
materials,
etc.)
of
the
chemical
precursors
used,
the
nature
of
the
reaction
or
method
of
isolation,
and
the
types
of
chemical
substances
constituting
the
product
combination,
etc.
For
naming
any
kind
of
substance,
the
submitter's
knowledge
of
impurities
or
byproducts
is
also
a
consideration.

When
more
than
one
substance
results
from
a
reaction,
one
should
determine
whether
the
product
combination
can
be
viewed
for
TSCA
purposes
as
a
mixture
of
separately
reportable
substances.
For
example,
when
the
intended
product
combination
is
known
to
always
be
completely
composed
of
a
specific
number
of
identified
substances
that
do
not
react
with
one
another,
the
combination
can
be
represented
as
a
mixture
of
individual
components.
If
this
is
not
the
case,
a
single
chemical
name
must
be
used
to
collectively
describe
the
product
combination
as
one
substance.
See
40
CFR
§
720.3(
e).
Where
the
chemical
components
can
be
represented
as
a
mixture,
they
may
be
reported
in
a
single
PMN
as
long
as
the
components
are
all
produced
in
the
same
reaction.
Otherwise,
multiple
PMNs
or
a
consolidated
PMN
(
requiring
pre­
approval
by
EPA)
must
be
submitted.

Other
chemical
identity
information
required
at
40
CFR
§
720.45(
a)
includes
molecular
formula
and
chemical
structure
information.
However,
for
substances
not
able
to
be
characterized
by
a
single
chemical
structure,
the
regulations
require
the
submitted
representative
or
partial
structural
diagram
to
be
as
complete
as
known
to
or
reasonably
ascertainable
by
the
submitter.
Failure
to
fully
comply
with
the
chemical
identification
elements
of
this
requirement
will
result
in
the
notice
being
declared
incomplete
by
EPA
pursuant
to
40
CFR
§
720.65(
c)(
1).
Such
incomplete
notices
will
not
be
processed
or
reviewed
by
EPA
until
the
chemical
identification
requirement
is
satisfied,
and
in
some
cases
EPA
will
require
that
the
notices
be
re­
submitted.
Section
1:
General
Program
Information
1­
29
Concerning
the
degree
of
chemical
structure
information
that
can
be
reasonably
ascertained
for
a
given
substance,
submitters
should
understand
that,
for
TSCA
Inventory
purposes,
all
substances
are
categorized
by
EPA
into
two
groups
according
to
the
degree
of
certainty
about
the
chemical
structure
of
a
substance:
Class
1
and
Class
2.
Class
1
substances
are
those
of
precisely
known
chemical
composition
for
which
a
single,
complete
structural
diagram
can
be
drawn.
Class
2
substances
are
those
having
chemical
compositions
not
completely
definite
or
known;
therefore,
a
Class
2
substance
cannot
be
characterized
by
one
definite,
complete
chemical
structure
diagram.
The
amended
regulations
require
complete
structural
diagrams
to
be
provided
for
Class
1
substances;
for
Class
2
substances,
representative
or
partial
structure
diagrams
are
required
that
are
as
complete
as
can
be
reasonably
ascertained
from
the
Class
2
chemical
identity.

104­
2.
Q.
When
a
prepolymer
is
one
of
the
precursors
of
a
polymer,
what
should
be
considered
to
be
the
constituents
of
the
final
polymer:
the
ultimate
reactants
from
which
the
prepolymer
was
manufactured,
the
prepolymer
itself,
or
what?

A.
The
choice
should
follow
Chemical
Abstracts
(
CA)
nomenclature
rules
and
conventions
for
its
Ninth
Collective
Index
(
9CI).
See
40
CFR
720.45(
a)(
1)(
i).
With
relatively
few
exceptions,
polymers
are
named
on
the
basis
of
their
starting
monomers/
reactants.
Thus
the
name
of
a
prepolymer
derived
from
dimethyl
terephthalate
and
1,4­
butanediol
would
be
based
on
those
particular
reactants.
As
an
example
of
an
exception
to
this
generalization,
although
polyethylene
glycol
may
be
thought
of
as
a
homopolymer
of
ethylene
oxide,
it
is
not
named
as
a
homopolymer
under
CA
naming
practices,
but
rather
according
to
the
structural
repeating
unit
(
SRU)
and
end
groups
present:
"
alpha­
Hydro­
omega­
hydroxy­
poly(
oxy­
1,2­
ethanediyl)."
Similarly,
polydimethylsiloxane
is
named
on
the
basis
of
its
structural
unit:
di­
Me
Siloxanes
and
Silicones
(
and
is
considered
to
be
end­
capped
with
trimethylsilyl
groups).
If
a
prepolymer
is
named
so
as
to
represent
a
certain
structural
feature
or
definite
repeating
unit,
its
name
cannot
be
decomposed
into
ultimate
monomers
for
the
purpose
of
naming
the
final
polymer.
EPA's
conventions
for
representation
of
polymeric
substances
are
discussed
in
greater
detail
in
a
1995
nomenclature
guidance
document,
"
Toxic
Substances
Control
Act
Inventory
Representation
for
Polymeric
Substances"
which
can
be
retrieved
at
www.
epa.
gov/
opptintr/
newchms/
polymers.
txt
and
is
also
available
from
the
TSCA
Hotline:
voice
(
202)
554­
1404;
facsimile
(
202)
554­
5603.

104­
3.
Q.
Does
the
"
Two
Percent
Rule"
apply
to
the
actual
reactants
used,
or
to
the
ultimate
or
putative
reactants?

A.
With
relatively
few
exceptions
(
such
as
when
polymers
or
prepolymers
having
SRU
names
are
used),
the
ultimate
reactants
should
be
the
basis
of
the
applicability
of
the
2%
rule
to
the
chemical
identity
of
the
polymer,
if
their
weight
percent
values
are
all
known.
Thus,
if
a
new
polymer
is
made
from
the
polymer
of
dimethyl
terephthalate
and
1,4­
butanediol
in
the
answer
Section
1:
General
Program
Information
1­
30
above,
plus
additional
dimethyl
terephthalate
and
ethylene
glycol,
the
final
polymer
name
would
be
based
on
three
constituents
(
assuming
each
is
used
at
over
2%),
and
the
total
amount
of
dimethyl
terephthalate
would
be
the
sum
of
the
separate
contributions.
If
the
weight
percentage
is
known
for
each
of
the
starting
monomers,
those
contributing
no
more
than
two
percent
by
weight
to
the
final
polymer
may
be
omitted
from
the
identity.
If
a
homopolymer
is
used
as
a
prepolymer
constituent,
the
identity
of
the
derived
polymer
should
be
based
on
the
ultimate
monomer,
except
where
CA
practice
differs
due
to
the
applicability
of
SRU
or
other
structure­
based
nomenclature
(
see
the
document
referenced
in
the
answer
to
the
previous
question).
Although
calculation
of
the
percentage
composition
of
a
polymer
may
be
based
either
on
your
determination
involving
the
amount
incorporated
or
from
the
amount
charged
to
the
reactor,
the
identity
should
be
based
on
the
ultimate
monomers
or
other
reactants
if
their
weight
percentages
are
all
known.

When
a
charged
polymer
(
or
prepolymer)
is
named
using
SRU
or
other
structure­
based
(
e.
g.,
siloxanes
and
silicones)
nomenclature,
the
2%
rule
is
applied
to
the
charged
polymer
as
a
whole,
because
one
doesn't
know
exactly
which
ultimate
monomers
were
used
to
make
that
polymer.
On
the
other
hand,
if
the
charged
polymer
or
prepolymer
has
a
monomer­
based
name
and
one
knows
the
percentage
which
each
of
the
ultimate
monomers
constitutes
in
the
charged
polymer,
then
the
2%
rule
applies
to
the
ultimate
monomers.
Where
one
does
not
know
the
percent
composition
of
each
of
the
ultimate
monomers,
the
2%
rule
should
be
applied
to
the
charged
polymer
as
a
whole
entity.

104­
4.
Q.
Is
a
substance
which
is
chemically
identical
to
one
on
the
Inventory,
except
that
one
of
the
elements
present
has
been
isotopically
enriched,
covered
by
the
Inventory
listing
of
the
material
made
with
the
corresponding
non­
enriched
(
natural
isotopic
ratio)
element?

A.
No,
it
is
not
covered.
For
such
substances
the
depletion/
enrichment
process
is
generally
accomplished
chemically,
not
by
nuclear
reactions.
Consequently,
it
is
differences
in
chemical
properties
which
allow
the
depletion/
separation.
Nuclear­
source
materials,
as
defined
at
§
720.3(
a)(
3),
are
excluded
from
the
definition
of
a
chemical
substance
at
40
CFR
720.3(
e),
and
if
there
were
a
specific
case
of
enrichment
accomplished
by
nuclear
reactions
we
would
consider
whether
this
policy
applied.
Consequently,
EPA
considers
a
substance
of
which
the
isotopic
composition
has
been
modified
to
be
a
different
chemical
substance,
and
if
it
does
not
have
a
separate
Inventory
listing
it
will
be
"
new,"
regardless
of
how
similar
its
chemistry
is
to
that
of
the
ordinary­
ratio
(
non­
depleted,
non­
enriched)
substance.

The
Inventory
contains
a
number
of
listings
for
substances
enriched
for
specific
isotopes
(
e.
g.,
Zinc
oxide
(
ZnO),
Zn­
64
depleted
[
CASRN
175449­
32­
8].)
There
are
also
a
number
of
isotopes
which
have
different
chemical
properties,
which
are
separately
listed
on
the
Inventory
(
e.
g.,
hydrogen,
deuterium,
tritium),
as
well
as
chemical
compounds
which
differ
only
in
the
isotopes
used
to
make
them
(
deuterosulfuric
acid,
D
2
O
4
S,
deuterotrifluoroacetic
acid,
C
2
DF
3
O
2).
Section
1:
General
Program
Information
1­
31
104­
5.
Q.
We
will
be
making
an
isotopically
engineered
product.
We
may
change
our
views
on
which
level
of
enrichment
is
optimal.
Can
we
cover
the
range
from
the
lowest
to
highest
contemplated
level
of
enrichment
in
one
submission?

A.
Yes,
unless
the
enrichment
level
is
so
high
that
the
substance
should
be
considered
and
named
as
containing
just
one
isotope
(
that
is,
the
other
isotopes
would
be
appropriately
considered
to
be
impurities.)

105
Inventory
Issues
105­
1.
Q.
When
the
notice
period
expires
without
specific
action
by
EPA,
is
the
chemical
automatically
listed
on
the
Inventory?

A.
No.
A
new
chemical
substance
is
added
to
the
TSCA
Inventory
only
after
a
Notice
of
Commencement
(
NOC)
of
manufacture
or
import
is
submitted
to
EPA
under
40
CFR
720.102.
The
PMN
submitter
must
submit
the
NOC
to
EPA
no
later
than
30
days
after
the
first
day
of
nonexempt
commercial
manufacture
or
import.
The
NOC
may
NOT
be
submitted
before
manufacture
or
import
commences.

105­
2.
Q.
If
the
non­
hydrated
form
of
a
chemical
substance
is
on
the
Inventory,
must
I
file
a
PMN
on
the
hydrated
form?

A.
A
hydrate
of
a
chemical
substance
or
a
hydrate
ion,
formed
by
association
of
a
substance
with
water,
is
considered
a
mixture
and
not
reportable
as
such
under
TSCA.
Only
the
non­
hydrated
form
is
included
in
the
TSCA
Inventory,
and
this
non­
hydrated
form
will
represent
all
hydrated
forms
of
that
substance.
However,
this
provision
does
not
apply
to
the
products
of
discrete
chemical
reactions
in
which
water
is
a
reactant;
for
example.
a
metal
hydroxide
formed
by
the
reaction
of
a
metal
oxide
and
water
[
See
40
CFR
720.3(
u)(
2).]

106
Review
Process
106­
1.
Q.
What
is
the
review
process
for
a
PMN
or
exemption
notice?

A.
Briefly,
a
PMN,
LVE,
LoREX,
or
TME
submission
is
received
by
EPA
and
initially
checked
for
completeness.
The
Inventory
is
checked
to
see
if
the
subject
material
has
already
been
listed.
If
the
material
is
found
on
the
TSCA
Inventory,
EPA
will
inform
the
submitter
that
they
are
free
to
commence
non­
exempt
commercial
manufacture
of
the
new
chemical
substance.

If
the
substance
is
not
on
the
Inventory,
it
will
be
presented
at
the
Chemical
Review
Meeting,
which
will
consider
the
substance.
"
Early
review
drops"
can
take
place
at
this
stage,
if
the
substance
is
similar
to
already­
reviewed
substances
for
which
EPA
has
little
concern.
EPA
Section
1:
General
Program
Information
1­
32
uses
the
term
"
drop"
to
mean
that
the
chemical
will
not
be
regulated
with
a
§
5(
e)
Consent
Order
or
SNUR.

Most
substances
move
forward
through
a
Structure­
Activity
meeting
(
and
development
of
profiles
of
exposure
and
releases)
to
a
Focus
meeting
at
approximately
Day
23­
27,
which,
for
a
PMN,
can
result
in
the
following
regulatory
decisions:

1.
request
for
up­
front
testing,
2.
a
risk
or
exposure­
based
§
5(
e)
Consent
Order,
3.
a
non
§
5(
e)
SNUR,
4.
a
decision
that
the
PMN
should
move
forward
for
a
"
Standard
Review"
for
further
analysis
by
a
team
of
experts
in
various
disciplines,
5.
a
request
for
a
small
amount
of
additional
information
to
enable
one
of
the
decisions
above
(
called
a
"
short
question"),
or
6.
drop,
or
a
drop
with
a
"
drop
letter"
expressing
EPA's
concern
and
recommending
certain
precautions.

(
Focus
meeting
decisions
are
available
on
the
PMN
Status
Report,
posted
within
2
weeks
of
decision
at
www.
epa.
gov/
oppt/
newchems/
pmnstat.
htm).

It
should
be
noted
that
in
recent
years,
less
than
5%
of
cases
continue
on
from
Focus
through
the
"
Standard
Review"
process.
For
such
substances,
there
is
a
meeting
of
multi­
disciplinary
staff,
followed
by
intensive
hazard­
exposure­
risk
assessment
for
the
substance.
At
Day
79­
82,
an
interdisciplinary
Decision
Meeting
is
held
and
one
of
the
following
regulatory
actions
is
chosen:

1.
request
for
up­
front
testing,
2.
a
risk
or
exposure­
based
§
5(
e)
Consent
Order,
3.
a
non
§
5(
e)
SNUR,
or
4.
drop
or
drop
with
a
"
drop
letter"
expressing
EPA's
concern
and
recommending
certain
precautions.

PMN
exemptions,
such
as
the
45­
day
review
test
market
exemptions,
the
30­
day
review
low
volume
exemptions,
and
the
30­
day
review
low
release/
low
exposure
exemptions,
are
either
granted,
granted
with
conditions,
or
denied
at
the
Focus
Meeting.
Regardless
of
the
point
during
the
review
at
which
a
regulatory
decision
is
made,
pursuant
to
TSCA
§
5
the
submitter
is
not
free
to
begin
manufacture
or
import
until
the
review
period
expires.

107
Notice
of
Commencement
107­
1.
Q.
What
information
is
required
for
a
Notice
of
Commencement
(
NOC)?
Section
1:
General
Program
Information
1­
33
A.
A
submitter
is
required
to
use
the
NOC
form
(
EPA
Form
7710­
56)
to
provide
all
the
information
required
for
a
Notice
of
Commencement.
The
form
must
be
signed
and
dated
by
an
authorized
official.
If
the
chemical
identity
of
the
PMN
substance
was
claimed
confidential
and
the
submitter
wishes
to
maintain
that
claim
of
identity
as
CBI,
the
submitter
is
required
to
substantiate
the
CBI
claim
when
submitting
the
NOC.
Please
refer
to
40
CFR
§
720.102
for
NOC
requirements
and
40
CFR
§
720.85(
b)
for
CBI
substantiation.

107­
2.
Q.
To
whom
is
a
Notice
of
Commencement
(
NOC)
submitted?

A.
The
completed
NOC
form
should
be
submitted
to
the
TSCA
Document
Control
Office.
The
mail
address
is:

United
States
Environmental
Protection
Agency
Office
of
Pollution
Prevention
and
Toxics
Document
Control
Office
(
7407M)
1200
Pennsylvania
Avenue,
NW
Washington,
D.
C.
20460
Attention:
Notice
of
Commencement
If
delivering
in
person
or
sending
by
a
courier
service:

United
States
Environmental
Protection
Agency
Office
of
Pollution
Prevention
and
Toxics
Confidential
Business
Information
Center
(
CBIC)
EPA
East
Building,
Room
6428
1201
Constitution
Avenue,
NW
Washington,
DC
20004­
3302
If
using
a
courier
service,
please
instruct
the
courier
that
the
Confidential
Business
Information
Center
closes
its
doors
at
4
pm,
and
delivery
will
not
succeed
if
attempted
after
4:
00
PM.

107­
3.
Q.
Where
can
a
copy
of
the
Notice
of
Commencement
(
NOC)
form
be
obtained?

A.
The
NOC
form
(
EPA
Form
7710­
56)
is
available
from
the
TSCA
Hotline
at
(
202)
554­
1404,
by
facsimile
(
202­
554
5603),
or
on
EPA
New
Chemicals
Website
at
www.
epa.
gov/
oppt/
newchems/
pmnforms.
htm.

107­
4.
Q.
For
Notice
of
Commencement
(
NOC),
when
does
Day
1
start
for
manufacturing?
Is
it
the
day
the
reactor
is
first
charged
or
the
date
of
completion
of
the
first
lot?
When
does
Day
1
start
for
importation?
Section
1:
General
Program
Information
1­
34
A.
For
a
new
chemical
substance
manufactured
for
nonexempt
commercial
purposes
for
the
first
time
after
expiration
of
the
PMN
review
period,
the
first
day
of
manufacture
for
NOC
purposes
("
Day
1")
is
described
at
40
CFR
720.102(
c)(
iv)
as
the
date
of
completion
of
the
first
lot,
and
for
importation
as
the
date
the
new
chemical
substance
clears
US
Customs.
(
For
more
detail
regarding
import,
see
US
Customs
Service
regulations
at
19
CFR
Part
101
and
§
141.68.)

107­
5.
Q.
Is
a
Notice
of
Commencement
(
NOC)
required
for
the
first
batch
of
a
new
chemical
substance,
after
the
PMN
review
period
is
over,
if
it
is
manufactured
for
R&
D?

A.
If
the
first
batch
of
a
new
chemical
substance
manufactured
after
expiration
of
the
PMN
review
period
is
"
solely
for
R&
D
purposes"
and
the
research
is
conducted
in
compliance
with
the
R&
D
regulations,
the
submitter
need
not
file
a
NOC.
See
40
CFR
720.102(
a).

A
NOC
must
be
submitted
within
30
days
of
manufacture
for
a
nonexempt
commercial
purpose;
"
nonexempt
commercial
purpose"
includes
commercial
R&
D
not
in
compliance
with
the
R&
D
regulations
at
40
CFR
720.36.
Thus,
under
720.102(
a)
if
the
manufacturer
does
not
comply
with
the
R&
D
regulations
and
record
keeping
requirements,
a
NOC
must
be
filed.

107­
6.
Q.
If
you
substantiate
your
confidentiality
claims
up
front
when
you
submit
your
PMN
must
you
repeat
that
substantiation
at
the
time
of
the
Notice
of
Commencement
(
NOC)?

A.
Yes.
You
must
substantiate
your
claim
of
confidentiality
for
chemical
identity
at
the
time
you
submit
a
NOC,
if
you
want
EPA
to
maintain
your
confidentiality
claim
after
you
begin
manufacture.
According
to
40
CFR
720.85(
b),
other
types
of
CBI
claims
need
not
be
substantiated
at
time
of
NOC.(
Notice
of
Commencement
requirements
are
described
in
40
CFR
§
720.102.)
To
substantiate
that
claim,
you
must
provide
EPA
with
detailed
answers
to
the
questions
listed
at
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
request
on
that
information.

107­
7.
Q.
A
submitter
is
required
to
submit
a
Notice
of
Commencement
(
NOC)
on
or
no
later
than
30
days
after
the
first
day
of
manufacture
or
import.
What
is
the
official
reporting
date
of
the
NOC,
the
date
the
letter
is
postmarked
or
the
date
EPA
acknowledges
receipt?

A.
The
date
that
EPA's
Document
Control
Officer
receives
the
letter
is
the
reporting
date
of
the
NOC.
(
This
is
consistent
with
the
rule
for
receipt
of
PMNs
at
40
CFR
720.75(
a)).

107­
8.
Q.
Does
the
Notice
of
Commencement
(
NOC)
only
apply
to
PMN
chemicals
or
does
it
also
apply
to
the
first
time
a
submitter
manufactures
or
imports
an
existing
chemical?

A.
The
NOC
is
used
by
EPA
to
determine
that
a
chemical
substance
which
has
been
Section
1:
General
Program
Information
1­
35
through
PMN
review
has
actually
gone
into
nonexempt
commercial
manufacture.
Once
a
NOC
is
received,
the
substance
is
put
onto
the
Inventory.
Thus,
the
requirement
for
a
NOC
only
applies
to
new
chemicals
manufactured
or
imported
for
the
first
time
for
a
nonexempt
commercial
purpose
by
the
PMN
submitter
after
expiration
of
the
PMN
review
period.

107­
9.
Q.
Can
excess
material
produced
for
R&
D
purposes
be
used
for
commercial
purposes
after
the
PMN
review
period
expires?
How
does
this
impact
Notice
of
Commencement
(
NOC)
requirements?
Must
such
use
be
precleared
with
EPA?

A.
Excess
R&
D
substance
can
be
used
for
commercial
purposes
after
the
PMN
review
period
expires
without
any
additional
authorization
from
EPA.
However,
no
NOC
may
be
filed
until
the
new
chemical
substance
is
first
manufactured
for
a
nonexempt
commercial
purpose
after
expiration
of
the
PMN
review
period.
In
other
words,
a
NOC
may
not
be
filed
solely
on
the
basis
of
quantities
previously
manufactured
under
the
R&
D
exemption.

40
CFR
§
720.30(
e)
and
(
f)
allow
certain
commercial
uses
of
excess
R&
D
materials,
without
the
submission
of
a
PMN
prior
to
such
use.
Additional
information
on
the
R&
D
exemption
is
provided
in
EPA's
Chemical
Information
Bulletin
"
Exemptions
for
R&
D
and
Test
Marketing"
(
1986­
1,
November
1986,
Office
of
Toxic
Substances),
which
is
available
from
the
TSCA
Hotline
and
on
EPA's
New
Chemicals
Website
at
www.
epa.
gov/
oppt/
newchems.

107­
10.
Q.
Is
it
true
that
no
Notice
of
Commencement
(
NOC)
is
required
for
chemicals
whose
use
has
been
approved
under
an
exemption
(
LVE,
TME,
LoREX)

A.
Yes.
No
NOC
is
required
to
initiate
use
of
chemicals
approved
under
an
exemption.
This
is
because
the
NOC
is
used
to
trigger
entry
of
PMN
substances
onto
the
Inventory,
and
exempted
substances
are
not
entered
onto
the
Inventory.

108
User
Fee
108­
1.
Q.
What
are
the
fees
for
submitting
Premanufacture
Notices
and
consolidated
Premanufacture
Notices?

A.
Persons
other
than
small
businesses
are
charged
a
fee
of
$
2,500
for
each
PMN
or
consolidated
PMN
submitted.
The
same
fee
is
required
for
a
Significant
New
Use
Notice
(
SNUN).
See
40
CFR
700.45.

108­
2.
Q.
What
is
the
fee
for
small
businesses
submitting
a
Premanufacture
Notice
or
consolidated
Premanufacture
Notice?

A.
Small
business
concerns
pay
a
fee
of
$
100
for
each
PMN,
consolidated
PMN,
or
Section
1:
General
Program
Information
1­
36
SNUN
submitted
(
small
is
defined
at
40
CFR
§
700.43
as
a
company
having
less
than
$
40
million
in
annual
sales,
where
the
amount
includes
sales
of
any
parent
or
subsidiary
company
as
well
as
those
of
the
submitting
company.
This
includes
a
parent
company's
overseas
sales
as
well
as
those
of
the
United
States
subsidiary
company.
See
40
CFR
700.45).

108­
3.
Q.
What
are
the
fees
for
exemption
applications
and
exemption
notices?

A.
There
is
no
fee
for
a
Test
Market
Exemption,
a
Low
Volume
Exemption,
or
a
Low
Release­
Low
Exposure
(
LoREX)
exemption.

108­
4.
Q.
What
is
the
fee
for
Premanufacture
Notices
(
PMN)
involving
intermediates
in
a
synthetic
sequence?

A.
The
fee
for
each
intermediate
PMN
is
$
1,000,
except
that
small
business
concerns
are
charged
a
fee
of
$
100
for
each
intermediate
as
well
as
each
final
PMN.
The
PMN
for
the
final
product
(
except
for
a
small
business)
is
$
2,500.
Intermediates
MUST
be
in
a
direct
sequence
with
the
final
product
­
the
reduced
fee
for
each
chemical
intermediate
in
a
synthetic
pathway
when
accompanied
by
PMN
for
the
final
substance
on
that
pathway
only
applies
for
a
sequence.
That
is,
if
a
submitter
chooses
to
file
for
"
a",
"
b",
"
c",
and
"
e"
of
a
synthetic
sequence
"
a"

"
b"

"
c"

"
d"

"
e",
the
submitter
can
file
as
an
intermediate
for
"
a"
and
"
b",
must
file
as
a
final
for
"
c",
and
as
a
final
again
for
"
e",
because
"
d"
is
missing
from
the
sequence.
Each
final
product
is
subject
to
a
full
user
fee.
See
40
CFR
700.43
and
700.45.

108­
5.
Q.
Does
a
pesticide
intermediate
qualify
for
the
intermediate
user
fee?

A.
Most
do
not.
A
single
pesticide
intermediate
can
never
qualify
for
the
intermediate
user
fee
of
$
1,000
because
the
final
pesticide
product
does
not
come
under
the
jurisdiction
of
TSCA,
but
rather
FIFRA.
See
40
CFR
700.43.
Therefore
a
substance
which
will
be
transformed
directly
into
a
pesticide
is
a
final
product
in
relation
to
TSCA,
and
does
not
meet
the
definition
of
an
intermediate
Premanufacture
Notice,
at
40
CFR
§
700.43
because
the
final
product
and
intermediate(
s)
cannot
be
submitted
simultaneously
to
the
New
Chemicals
Program.
Thus
a
submitter
of
a
PMN
for
a
substance
which
will
be
made
into
a
pesticide
in
a
single
synthetic
step
pays
the
full
PMN
review
fee.
If,
however,
a
submitter
is
filing
for
"
a",
"
b",
"
c",
and
"
d"
of
a
synthetic
sequence
"
a"

"
b"

"
c"

"
d"

"
e",
where
"
e"
is
a
pesticide,
the
submitter
can
file
intermediate
PMNs
for
"
a"
and
"
b"
and
"
c",
and
must
file
a
final
product
PMN
for
"
d",
because
"
d"
is
the
final
product
subject
to
TSCA
jurisdiction.

108­
6.
Q.
What
is
the
fee
for
a
significant
new
use
notice
(
SNUN)?

A.
The
fee
for
each
SNUN
is
$
2,500,
except
for
small
businesses
the
fee
is
$
100.
See
40
CFR
700.45.
Section
1:
General
Program
Information
1­
37
108­
7.
Q.
What
is
the
fee
for
a
joint
PMN
submission?

A.
Joint
submitters
of
a
§
5
notice
are
required
to
remit
one
appropriate
fee
for
the
type
of
notice
being
submitted,
e.
g.,
a
PMN,
a
consolidated
PMN,
an
intermediate
PMN,
or
a
SNUN,
regardless
of
the
number
of
joint
submitters
for
that
notice.
To
qualify
for
the
reduced
fee
for
small
businesses,
each
joint
submitter
of
a
§
5
notice
must
qualify
as
a
small
business
concern
under
40
CFR
§
700.43
­­
if
any
submitter
is
not
"
small",
the
non­
reduced
fee
must
be
paid.
The
small
business
definition
includes
a
parent
company's
overseas
sales
as
well
as
those
of
the
United
States
subsidiary
company.
See
40
CFR
700.45.

108­
8.
Q.
When
does
EPA
refund
a
fee?

A.
EPA
will
refund
any
fee
paid
for
a
§
5
notice
whenever
EPA
determines
that
the
notice
or
fee
was
not
required.
See,
e.
g.,
40
CFR
720.62.
This
can
happen,
for
example,
when
the
intended
use
described
in
the
PMN
is
not
actually
subject
to
TSCA
jurisdiction
or
when
the
substance
is
already
on
the
Inventory.
In
addition,
EPA
will
refund
when
it
determines
that
a
notice
is
incomplete.

108­
9.
Q.
Are
separate
alpha­
numeric
identification
numbers
used
to
identify
and
link
a
notice
with
the
remittance
fee
otherwise
known
as
"
TS­
numbers"
needed
when
submitting
an
intermediate
notice
and
a
final
product
PMN?

A.
Yes.
A
separate
TS
User
Identification
number
is
needed
when
submitting
for
each
intermediate
and
the
final
product
PMN,
since
they
are
separate
notices.
However,
both/
all
numbers
may
be
used
to
identify
a
single
check.

108­
10.
Q.
We
are
developing
a
3
step
process
to
make
a
new
chemical.
An
Inventory
substance
in
step
#
1
will
yield
new
substance
"
A"
that
will
only
be
used
(
Step
#
2)
as
our
intermediate
to
make
new
chemical
substance
"
B",
then
"
B"
will
be
used
to
make
new
chemical
substance
"
C"
(
Step
#
3).
"
B"
will
predominantly
be
used
as
an
intermediate
for
chemical
"
C"
but
a
small
portion
will
be
sold
to
other
companies.
"
C"
is
entirely
a
final
product
that
will
be
sold
externally.
All
PMNs
will
be
filed
at
the
same
time.
If
the
PMN
filing
fee
for
intermediates
is
$
1,000
if
filed
concurrently
with
the
final
product,
and
the
fee
is
$
2,500
for
a
final
product,
what
filing
fee
must
we
pay
for
chemical
"
B"?

A.
If
any
portion
of
a
PMN
chemical
is
intended
for
sale
or
use
as
a
final
product,
you
must
pay
the
$
2,500
fee.
You
can
file
for
"
A"
as
an
intermediate
at
$
1000,
but
"
B"
and
"
C"
cost
the
full
fee
for
each.
See
40
CFR
720.45.

108­
11.
Q.
How
do
I
submit
the
user
fee
for
PMNs
and
other
§
5
submissions?
Section
1:
General
Program
Information
1­
38
A.
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
TSNumber
is
sent
to
EPA
Headquarters
with
certification
that
payment
has
been
made.
EPA
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).
EPA
will
inform
the
submitter
in
writing
if
this
action
is
taken.

The
notice
and
the
fee
are
sent
separately.
Send
your
completed
notice
with
original
signatures
and
two
copies
to
the
OPPT
Document
Control
Officer
(
DCO),
whose
address
appears
on
page
1
of
the
form.
If
you
claim
any
confidential
business
information
(
CBI),
a
fourth,
"
sanitized"
or
redacted
copy
is
also
required.

108­
12.
Q.
How
do
I
choose
a
user
fee
number
("
TS­
number")?
What
is
it
used
for?

A.
The
submitter
chooses
this
number.
It
is
used
by
the
bank
which
receives
money
for
EPA
when
it
notifies
EPA
that
the
fee
has
been
received,
and
also
to
enable
us
to
assemble
the
parts
of
a
submission
when
additional
communications
(
letters
of
support,
joint
submissions,
corrections)
are
sent
before
a
PMN/
LVE
number
has
been
assigned.
There
are
six
spaces
in
the
TS­
number
block
on
the
PMN
form.
In
the
past,
we
have
actually
had
duplication
of
TS­
numbers,
and
these
instructions
should
make
duplication
less
likely
in
the
future:
your
TS­
number
should
be
a
6­
character
alphanumeric
string.
It
should
include
2,
3,
or
4
letters.
One
or
more
numerals
must
be
interposed
between
two
letters
(
that
is,
LLNNLL,
LNNNLL,
NNLLNL,
NLNLNL
are
okay,
LLLNNN,
NNNNLL
are
not).
We
recommend
against
company
names,
recognizable
words
and
numerical
series
(
ROY01X,
X01DOW
are
not
good
ideas).
The
TS­
number
should
be
unique
to
this
submission
from
your
company.
Do
not
give
this
number
to
a
subsequent
submission.
If
we
get
a
TS­
number
with
a
submission
and
it
does
not
comport
with
this
guidance,
we
will
call
the
submitter
and
ask
for
a
new
number
which
does.
Section
1:
General
Program
Information
1­
39
109
Consolidated
Notices
109­
1.
Q.
Is
there
an
abbreviated
procedure
for
submitting
PMNs
on
structurally
related
new
chemical
substances?

A.
EPA
allows
consolidation
of
PMN
notices
for
up
to
six
chemical
substances
with
similar
use,
structure,
and
probable
toxicology
at
the
same
time
and
for
the
same
fee
as
a
single
substance.
See
48
FR
21734,
May
13,
1983.
Consolidated
PMNs
benefit
submitters
by
reducing
the
administrative
burden
of
developing
multiple
§
5
submission
forms
for
manufacture
of
two
or
more
structurally
related
new
chemical
substances
which
have
similar
use,
exposure,
environmental
release,
and
test
data.
EPA's
review
process
is
also
facilitated
by
reviewing
similar
substances
simultaneously.

EPA
limits
the
number
of
substances
that
may
be
included
in
a
consolidated
PMN
to
six.
See
www.
epa.
gov/
oppt/
newchems/
consix.
htm.

Persons
who
intend
to
submit
a
consolidated
notice
shall
first
contact
the
Prenotice
Coordinator
in
the
New
Chemicals
Prenotice
Branch
(
refer
to
New
Chemicals
Program
Contacts
List)
for
approval
before
submission
of
the
notice.
The
Prenotice
Coordinator
will
determine
if
the
criteria
for
consolidation
are
met.

In
the
consolidated
notice,
the
submitter
shall
identify
new
chemical
substances
individually
by
submitting
a
separate
chemical
identity
page
for
each
new
chemical
substance,
and
each
identification
must
be
supported
by
a
separate
report
from
the
CAS
Inventory
Expert
Service
since
Method
1
must
be
used
to
name
each
substance.
When
other
pages
of
the
§
5
submission
form
differ
between
the
substances
in
the
consolidated
submission,
they
should
be
submitted
separately
as
well
(
generally
identified
as,
e.
g.,
page
6a,
6b,
6c,,
etc).
See
www.
epa.
gov/
oppt/
newchems/
confaq.
htm
for
more
details.
This
is
not
an
abbreviated
procedure:
the
90­
day
statutory
notice
review
period
applies
for
consolidated
PMNs
as
it
does
for
singular
ones.

109­
2.
Q.
Where
is
the
consolidated
PMN
described
in
the
Federal
Register
or
in
other
publications?
What
is
the
justification
for
the
six­
member
limit
on
consolidations?

A.
EPA
announced
a
policy
that
it
would
accept
submission
of
consolidated
notices,
subject
to
the
approval
of
each
submission
by
a
Prenotice
Coordinator,
in
the
preamble
of
the
May
13,
1983
Federal
Register
(
Part
III
(
C)(
1)(
b),
48
FR
21722,
21734­
35)
and
discusses
procedures
for
acceptance
of
consolidated
notices
in
Section
II
(
E)
of
the
Instruction
Manual
for
Premanufacture
Notification
of
New
Chemical
Substances.

When
EPA
initially
accepted
consolidations
there
was
no
limit
on
the
number
of
Section
1:
General
Program
Information
1­
40
substances
which
could
be
submitted
in
one
consolidation.
A
consolidation,
though
less
demanding
of
EPA's
resources
than
the
same
number
of
separate
submissions
of
related
chemicals,
still
requires
a
substantially
increased
amount
of
effort
over
the
assessment
of
a
single
submission.
EPA
has
decided
that
it
is
appropriate
to
limit
the
number
of
substances
in
a
consolidation
to
six.

109­
3.
Q.
Why
must
a
submitter
get
a
name
from
the
Chemical
Abstracts
Service
Inventory
Expert
Service
(
CAS­
IES)
for
each
substance
in
a
consolidation?
Often,
if
one
name
has
been
bought
from
the
Inventory
Expert
Service,
the
others
can
be
easily
determined.
The
additional
reports
from
the
IES
seem
to
be
an
unnecessary
additional
expense
to
the
submitter.

A.
Consolidations
are
a
two­
step
process:
the
intending
submitter
requests
(
from
the
Prenotice
Coordinators)
approval
to
consolidate
the
PMN
submissions
for
two
to
six
substances.
The
Coordinators
approve
or
do
not
approve
that
request
in
consultation
with
New
Chemicals
Program
chemists.
For
that
initial
request,
the
names
used
for
requesting
consolidation
need
not
be
from
the
IES.
They
should
be
specific
enough
that
our
chemists
and
other
review
personnel
can
decide
whether
the
materials
are
similar
enough
(
chemically
and
toxicologically)
that
their
reviews
can
be
conducted
concurrently
with
resulting
savings
of
review
costs.

For
the
PMN
itself,
however,
the
submission
can
lead
to
inclusion
in
the
Inventory.
Sources
other
than
the
IES
have
a
higher,
overall,
error
rate
in
generating
names,
and
this
includes
submitters
who
try
to
develop
additional
names
by
analogy
to
that
of
one
member
of
an
approved
consolidation.
Though
it
has
not
been
required,
EPA
encourages
that
any
PMN
submission
covering
a
single
substance
be
named
by
Method
1
(
i.
e.,
CAS­
IES;
see
40
CFR
720.45(
a)(
3)).
If
a
submission
is
incorrectly
named,
the
process
of
declaring
it
incomplete
and
returning
it
to
the
submitter
diverts
EPA
resources
from
other
important
work
of
the
New
Chemicals
Program.
The
New
Chemicals
Program
will
not
review
any
consolidated
PMN
submission
which
does
not
include
a
complete
and
correct
CAS­
IES
(
that
is,
Method
1)
name
for
each
substance,
to
prevent
EPA
from
having
to
deal
with
one
or
more
nomenclature
errors.
See
www.
epa.
gov/
oppt/
newchems/
confaq.
htm.
The
Method
1
requirement
for
consolidations
is
not
satisfied
by
simply
giving
a
CAS
name
and
registry
number
to
substances
which
have
been
previously
examined
by
non­
IES
CAS
personnel.

Information
on
the
CAS­
IES
service
including
available
resource
materials
is
available
through
614­
447­
3600
or
800­
848­
6538
(
ask
for
the
Inventory
Expert
Service).

109­
4.
Q.
How
should
a
new
chemical
which,
in
aqueous
solution,
exists
in
equilibrium
with
a
"
similar
species"
(
also
a
new
chemical)
be
reported
on
the
§
5
submission
form?

A.
If
you
have
structurally­
related
substances
in
the
situation
described
above,
you
will
likely
be
given
permission
to
submit
a
consolidated
PMN
notice
(
contact
a
Prenotice
Section
1:
General
Program
Information
1­
41
Communications
Coordinator
for
a
PC
number.)
If
there
is
no
intent
to
sell
any
of
the
components
separately,
and
if
they
are
synthesized
together,
such
a
material
can
also
be
reported
as
a
Class
II
chemical
substance
per
40
CFR
720.45(
a)(
2).

109­
5.
Q.
If
production
of
a
series
of
metal
salts
of
a
modified
organic
acid
is
intended
does
each
salt
require
a
PMN
or
can
the
entire
series
be
declared
in
one
PMN?

A.
Each
salt
that
is
intended
to
be
manufactured
must
be
reported
in
a
PMN,
and
a
Notice
of
Commencement
is
required
for
each
salt
that
is
manufactured.
It
may
also
be
possible,
however,
to
submit
a
consolidated
PMN
for
up
to
six
such
salts.
Please
note
that
consolidations
will
not
be
granted
for
substances
which
are
of
different
toxicological
concern
even
if
they
are
chemically
similar.
Consult
a
Prenotice
Communications
Coordinator
for
further
assistance.

110
Joint
Submissions
110­
1.
Q.
May
persons
submit
PMN
notices
jointly?

A.
Yes.
For
example,
a
manufacturer
may
submit
jointly
with
a
toll
manufacturer,
or
an
importer
with
a
customer.
The
person
responsible
for
the
PMN
requirements
under
§
5(
a)
is
required
to
complete
all
mandatory
sections
of
the
form,
to
the
extent
that
he
or
she
knows
or
can
reasonably
ascertain
the
required
information,
even
if
another
person
also
submits
a
certain
section.
If
a
joint
notice
is
submitted,
the
notice
review
period
will
not
begin
until
EPA
has
received
all
required
parts
of
the
notice.
Therefore,
the
person
subject
to
the
notice
requirements
should
indicate
to
EPA
who
else
will
be
submitting
parts
of
the
notice
and
identify
those
parts.
EPA
will
acknowledge
receipt
of
the
notice
when
it
has
received
parts
from
all
of
the
joint
submitters.
Each
person
submitting
the
notice
must
also
assert
all
confidentiality
claims
according
to
the
procedures
specified
in
the
rule.
See
40
CFR
720.40(
e)(
2).

110­
2.
Q.
How
would
a
submitter
file
a
PMN
for
an
imported
substance
whose
identity
is
claimed
as
confidential
by
its
foreign
manufacturer?
How
would
the
submitter
obtain
a
Chemical
Abstract
(
CA)
name?

A.
The
PMN
would
be
submitted
with
a
letter
of
support
from
the
foreign
supplier.
The
foreign
supplier
must
follow
the
same
procedures
as
a
U.
S.
submitter
to
obtain
a
CA
name
and
provide
the
correct
chemical
identity.
Both
submissions
must
clearly
reference
the
PMN
notice
and
PMN
user
fee
identification
number
or
a
prenotice
communication
number.

A
letter
of
support
should
be
provided
on
the
supplier's
company
letterhead.
Since
a
letter
of
support
may
be
received
separately
by
EPA,
an
identification
number
such
as
a
TS­
user
fee
number
or
a
Prenotice
Communications
number
should
be
used
to
link
a
PMN
with
information
from
a
supplier
or
foreign
manufacturer.
The
identical
identification
number
should
appear
on
Section
1:
General
Program
Information
1­
42
both
pieces
of
correspondence
submitted
to
EPA;
otherwise,
there
may
be
a
delay
in
processing
the
PMN.
They
may
be
submitted
no
more
than
30
days
apart.
See
40
CFR
720.40(
e)(
2)
and
the
Instructions
Manual
for
further
information
on
joint
submissions
or
letters
of
support.

Information
on
the
CAS
Inventory
Expert
Service
(
CAS­
IES)
including
available
resource
materials
is
available
through
614­
447­
3600
or
by
facsimile
(
614­
447­
3747).
For
general
Chemical
Abstracts
Services
call
800­
848­
6538.

110­
3.
Q.
What
should
I
do
to
ensure
that
EPA
correctly
identifies
the
parts
of
my
joint
PMN
submission?
Can
a
TS­
number
(
the
alpha­
numeric
identification
number
used
to
identify
and
link
a
notice
with
the
remittance
fee)
be
used
instead
of
a
prenotice
communication
number
to
identify
parts
of
a
joint
PMN
submission?

A.
Identify
the
joint
submitter
in
your
notice
and
identify
the
section(
s)
which
the
person
will
submit.
We
need
an
identifier
which
can
be
used
to
associate
the
different
parts
and
it
can
be
a
TS
number
(
check
ID
number)
or
a
prenotice
communication
number.
The
TS
number
is
required
for
use
in
associating
a
PMN
or
SNUN
with
its
fee,
and
can
also
be
used
to
associate
the
parts
of
a
joint
submission.
A
TS
number
will
not
ordinarily
be
generated
in
the
case
of
a
no­
fee
exemption
application
(
LVE,
LoREX,
etc.),
however
in
cases
where
no
fee
is
required
the
submitter
can
still
generate
a
TS
number
and
use
it
to
associate
the
parts
of
a
joint
submission,
or
can
call
a
Prenotice
Coordinator
to
have
a
prenotice
communication
(
PC)
number
assigned
specifically
to
identify
parts
of
a
joint
submission.

111
Toll
Manufacture
111­
1.
Q.
What
is
the
definition
of
a
"
toll
manufacturer?"

A.
According
to
40
CFR
720.22(
a)(
2),
"
If
a
person
contracts
with
a
manufacturer
to
manufacture
or
produce
a
new
chemical
substance,
and
(
i)
the
manufacturer
manufactures
or
produces
the
substance
exclusively
for
that
person,
and
(
ii)
that
person
specifies
the
identity
of
the
substance,
and
controls
the
total
amount
produced
and
the
basic
technology
for
the
plant
process,
that
person
must
submit
the
notice.
If
it
is
unclear
who
must
report,
EPA
should
be
contacted
to
determine
who
must
submit
the
notice."
The
"
customer"
who
contracts
for
the
specific
material
and
who
has
basic
control
over
the
process,
amount
made,
etc.,
is
for
purposes
of
TSCA
§
5
the
manufacturer,
and
files
the
PMN,
etc.,
and
takes
responsibility
for
the
activity.
The
toll
manufacturer
who
actually
produces
the
chemical
for
the
"
customer",
does
not
file
the
PMN,
though
the
toll
manufacturer
can
in
some
cases
have
proprietary
process
information,
etc.,
which
will
come
to
EPA
with
the
PMN
in
the
form
of
a
letter
of
support
or
joint
submission.

112
Foreign
Supplier
Section
1:
General
Program
Information
1­
43
112­
1.
Q.
How
is
the
chemical
identity
determined
when
the
substance
is
received
from
a
foreign
supplier?

A.
If
a
principal
importer
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
EPA
by
the
foreign
party.
See
40
CFR
720.25(
a)(
3)(
i).
In
this
way,
foreign
manufacturers
can
protect
confidential
business
information.
The
same
holds
true
for
U.
S.
manufacturers
reporting
chemical
substances
made
from
reactants
identified
only
by
a
generic
or
trade
name.
The
submitter
of
the
new
chemical
substance
must
have
the
supplier
provide
specific
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
(
discussed
in
40
CFR
720.40(
e)(
2),
the
PMN
Instruction
Manual,
and
in
Q&
A
section
110,
Joint
Submissions,
above).

112­
2.
Q.
Does
a
letter
of
support
allow
the
supplier
or
foreign
manufacturer
to
keep
information
confidential?

A.
Yes,
a
letter
of
support
allows
the
supplier
or
foreign
manufacturer
to
keep
information
confidential.
The
PMN
submitter
can
substitute
information
not
in
their
possession
or
control
with
a
trade
name
or
brand
name.
However,
the
specifics
of
the
unknown
information
must
be
provided
by
the
supplier
or
foreign
manufacturer
in
order
for
the
PMN
review
period
to
begin.

112­
3.
Q.
How
can
I
obtain
a
CA
name
for
an
imported
substance
whose
identity
is
claimed
confidential
by
its
foreign
manufacturer?

A.
Your
foreign
supplier
must
follow
the
same
procedures
as
a
U.
S.
submitter
to
obtain
a
CA
name
and
provide
the
correct
chemical
identity
to
EPA
as
a
joint
submission
or
letter
of
support,
clearly
referencing
your
notice
and
PMN
user
fee
identification
number.
Information
on
the
IES
service
including
available
resource
materials
is
available
through
614­
447­
3600
or
by
facsimile
(
614­
447­
3747).
Chemical
Abstracts
Services
in
general
can
be
reached
on
800­
631­
1884.
See
40
CFR
720.40(
e)(
2)
and
the
PMN
Instructions
Manual
for
further
information
on
joint
submission
or
letter
of
support.
In
cases
where
the
entire
identity
is
known
to
neither
party,
each
must
tell
EPA
what
it
does
know,
and
provide
EPA
with
a
CA
name
for
the
component(
s)
it
provides.

113
Trade
Mark
Reactant
(
TMR)
Supplier
113­
1.
Q.
Who
is
considered
a
trade
mark
reactant
supplier?

A.
Trade
mark
reactant
suppliers
manufacture
chemicals
and
supply
them
to
other
Section
1:
General
Program
Information
1­
44
companies,
generally
under
a
trade
name.
Trade
mark
reactant
suppliers
can
be
either
foreign
or
domestic
manufacturers.
They
may
or
may
not
be
toll
manufacturers,
depending
on
the
extent
of
control
exerted
by
the
customer
companies.
EPA
requires
the
exact
chemical
identity
of
a
trade
mark
reactant
for
purposes
of
new
chemical
review.
See
40
CFR
720.25(
a)(
3)(
ii).

113­
2.
Q.
How
is
the
identity
of
a
chemical
supplied
by
a
trade
mark
reactant
supplier
determined?

A.
The
chemical
identity
of
the
substance
supplied
by
trade
mark
reactant
suppliers
is
often
kept
confidential.
If
the
company
being
supplied
is
submitting
a
PMN
and
needs
the
chemical
identity
of
the
chemical
substance
supplied
by
the
trade
mark
reactant
suppliers
to
complete
its
PMN,
the
trade
mark
reactant
supplier
can
provide
this
information
to
EPA
by
a
letter
of
support
or
a
joint
submission.
The
trade
mark
reactant
supplier
and
the
company
are
co­
partners
in
providing
chemical
identity.

It
is
our
experience
that
joint
submissions
are
unusual
in
such
cases:
generally
the
trade
mark
reactant
companies
do
not
want
to
get
involved
in
PMN
submissions
and
prefer
to
submit
letters
of
support.
EPA
does
not
have
a
preference
between
letters
of
support
and
joint
submissions.

Manufacturers
do,
in
such
cases,
need
to
take
reasonable
steps
to
protect
themselves
against
a
change
of
materials
in
a
trade
mark
reactant
material
with
confidential
specific
chemical
identity,
if
the
trade
mark
reactant
material
is
used
as
a
constituent
in,
e.
g.,
a
polymer.
EPA
does
not
use
brand
names
in
maintaining
its
Inventory,
in
part
because
formulations
in
branded
materials
can
change
and
in
part
because
the
TSCA
regulatory
apparatus
is
focused
on
substances
rather
than
on
formulations.
Reliance
on
EPA's,
or
a
supplier's,
confirmation
of
TSCA
Inventory
status
at
the
time
of
PMN
filing
should
be
supplemented
with
an
agreement
that
the
supplier
will
notify
the
PMN
submitter
of
any
changes
in
the
chemical
identity
of
the
material.
A
letter
of
support
can
be
used.

114
Analytical
Method
Recommendations
for
Polymers
114­
1.
Q.
There
is
no
guidance
on
measurement
of
oligomer
content.
Is
accumulated
weight
fraction
on
a
gel
permeation
chromatography
(
GPC)
trace
an
adequate
determination?
In
the
absence
of
GPC,
how
can
this
be
done?

A.
Cumulative
weight
fraction
is
a
commonly
accepted
method.
EPA
has
not
prescribed
any
analytical
methodology,
so
others
may
be
acceptable,
depending
on
circumstances.

114­
2.
Q.
What
are
the
analytical
requirements
with
respect
to
insoluble
polymers?
Can
inference
from
melt
flow
data
and
comparison
to
other
polymers
be
adequate?
Can
I
use
Monte
Section
1:
General
Program
Information
1­
45
Carlo
simulation
methods
(
such
as
Oligo
5)
to
estimate
the
MW
of
an
insoluble
polymer
theoretically?

A.
EPA
does
not
require
any
specific
analytical
methodology.
Inference
from
physical
behavior,
from
comparison
to
close
analogues,
and
from
theoretical
calculation
is
acceptable
where
appropriate
or
where
other
methods
are
inapplicable.
Monte
Carlo
methods,
while
widely
used,
have
not
been
subjected
to
much
experimental
verification.
If
your
polymer
is
expected
to
have
values
of
MW
or
oligomer
content
near
the
allowable
thresholds,
you
should
probably
not
rely
too
strongly
on
such
methods.

115
Test
Data
Requirements
115­
1.
Q.
What
is
EPA's
definition
of
health
or
environmental
test
data?

A.
According
to
40
CFR
720.3(
ff),
"
Test
data"
means
data
from
a
formal
or
informal
test
or
experiment,
including
information
concerning
the
objectives,
experimental
methods
and
materials,
protocols,
results,
data
analysis,
recorded
observations,
monitoring
data,
measurements,
and
conclusions
from
a
test
or
experiment.
"
Health
and
safety
study"
is
defined
at
TSCA
§
3(
b)
and
40
CFR
720.3(
k).
The
scope
of
the
definition
is
quite
broad
and
all­
encompassing.
The
statutory
definition
is,
"
any
study
of
any
effect
of
a
chemical
substance
or
mixture
on
health
or
the
environment
or
on
both,
including
underlying
data
and
epidemiological
studies,
studies
of
occupational
exposure
to
a
chemical
substance
or
mixture,
toxicological,
clinical,
and
ecological,
or
other
studies
of
a
chemical
substance
or
mixture,
and
any
test
performed
under
the
Act.
Chemical
identity
is
always
part
of
a
health
and
safety
study."
The
scope
of
the
definition
elaborates
that
the
study
can
be
formal
or
informal,
and
can
include
assessment
of
exposure
effects
and
risk
to
human
health
or
the
environment.
See
Q&
A
section
117
below
for
more
on
health
and
safety
studies.

115­
2.
Q.
What
type(
s)
of
test
data
must
a
submitter
include
with
a
§
5
Notice
to
EPA?

A.
Under
§
5(
d)(
1)
of
TSCA
and
40
CFR
720.50,
each
notice
must
contain
all
test
data
in
the
submitter's
possession
or
control
which
are
related
to
the
effects
on
health
or
the
environment
of
any
manufacture,
processing,
distribution
in
commerce,
use
or
disposal
of
the
new
chemical
substance
or
any
mixture
or
article
containing
the
new
chemical
substance,
or
any
combination
of
such
activities.
This
includes
test
data
concerning
the
new
chemical
substance
in
a
pure,
technical
grade,
or
formulated
form.
The
following
types
of
test
data
must
be
submitted
with
a
full
report
or
standard
literature
citation:
health
effects
data,
ecological
effects
data,
physical
and
chemical
properties
data,
environmental
fate
characteristics,
monitoring
data,
and
other
test
data
related
to
human
exposure
to
or
environmental
release
of
the
chemical
substance.

There
is
no
required
minimum
data
set.
If,
however,
you
are
expecting
to
make
a
high
Section
1:
General
Program
Information
1­
46
volume
of
the
chemical
substance
("
high"
is
100,000
kilograms
per
year
or
greater)
you
are
likely
to
be
asked
to
conduct
the
New
Chemicals
Exposure­
Based
Core
Data
Set
or
High
Production
Volume
Data
Set.
A
related
discussion
can
be
found
on
the
Internet
at:
www.
epa.
gov/
chemrtk/
volchall.
htm.
See
Q&
A
#
100­
12
for
more
on
EPA's
exposure­
based
policy.
If
EPA
reviewers
find
that
they
need
data
not
included
with
the
submission
to
be
able
to
appropriately
assess
the
substance,
the
submitter
will
be
required
either
to
suspend
review
and
develop
the
needed
data
for
submission
to
EPA
before
any
manufacture,
or
to
agree
to
develop
the
data
as
part
of
a
§
5
Consent
Order
with
EPA.
(
There
is
an
exception
to
this
requirement,
if
the
data
is
available
in
the
open
scientific
literature.
See
40
CFR
720.65(
c)(
1)(
iii)
and
Q&
A
#
115­
5.)
In
addition,
all
data
must
be
submitted
in
English.

In
addition,
the
submitter
must
describe
other
data
known
to,
or
reasonably
ascertainable
by,
the
submitter.
See
40
CFR
720.50(
b)
for
additional
details.

115­
3.
Q.
Does
your
office
want
test
data
on
similar
substances
when
a
company
submits
a
PMN?

A.
Test
data
on
similar
substances
can
be
extremely
helpful,
particularly
if
no
data
exist
on
the
new
chemical
substance
itself.
EPA
encourages
the
submission
of
data
on
similar
substances
with
the
premanufacture
notice.
If
the
submitter
plans
to
submit
a
series
of
notices
on
members
of
a
chemical
class,
EPA
encourages
submitters
to
contact
EPA
and
negotiate
a
testing
program
for
that
class
prior
to
submission
of
the
PMNs.

115­
4.
Q.
Can
alternatives
to
the
exposure­
based
base
set
of
tests
requested
by
EPA
be
submitted
if
there
are
valid
scientific
reasons?

A.
Yes,
if
you
reach
agreement
with
EPA
to
do
so,
the
standard
§
5(
e)
Consent
Order
can
be
modified.
EPA
realizes
that
there
are
often
a
number
of
different
but
acceptable
means
to
provide
testing
information.
Companies
can
always
submit
any
data
to
EPA
but
EPA
reviewers
may
not
accept
the
data
as
satisfactorily
addressing
the
risk
assessment
issues
EPA
believes
need
to
be
addressed
for
a
given
chemical.
EPA
believes
that
the
core
tests
on
the
PMN
substance
are
the
preferred
testing
and
in
any
request
to
substitute
a
different
test
protocol,
the
protocol
must
be
submitted
to
EPA
in
writing
with
the
rationale
for
that
change.
EPA
must
then
approve
the
different
test(
s).
EPA's
acceptance
of
a
proposed
test
protocol
not
specified
by
EPA
depends
on
multiple
factors
including
the
specifics
of
the
test
substance,
purpose
of
the
testing,
familiarity
with
specific
procedures
and
equipment,
validation
of
the
method,
etc.
Typical
TSCA
§
5(
e)
Consent
Orders
require
the
use
of
OPPTS
Harmonized
Test
Guidelines.
The
OPPTS
Harmonized
Test
Guidelines
are
available
through
the
Internet
at
www.
epa.
gov/
opptstrs/
home/
guidelin.
htm
­­
these
guidelines
have
been
developed
by
OPPTS
for
use
in
the
testing
of
pesticides
and
toxic
substances,
and
the
development
of
test
data
that
must
be
submitted
to
EPA
for
review
under
Federal
regulations.
Section
1:
General
Program
Information
1­
47
OPPTS
has
developed
these
guidelines
through
a
process
of
harmonization
that
blended
the
testing
guidance
and
requirements
that
existed
in
the
Office
of
Pollution
Prevention
and
Toxics
(
OPPT)
and
appeared
in
title
40,
chapter
I,
subchapter
R
of
the
Code
of
Federal
Regulations
(
CFR),
the
Office
of
Pesticide
Programs
(
OPP)
which
appeared
in
publications
of
the
National
Technical
Information
Service
(
NTIS),
and
the
guidelines
published
by
the
Organization
for
Economic
Cooperation
and
Development
(
OECD).

The
purpose
for
harmonizing
these
guidelines
into
a
single
set
of
OPPTS
guidelines
is
to
minimize
variations
among
the
testing
procedures
that
must
be
performed
to
meet
the
data
requirements
both
of
the
U.
S.
Environmental
Protection
Agency
under
the
Toxic
Substances
Control
Act
(
TSCA)
(
15
U.
S.
C.
2601)
and
the
Federal
Insecticide,
Fungicide
and
Rodenticide
Act
(
FIFRA)
(
7
U.
S.
C.
136
et
seq.)
and
of
other
regulatory
bodies
in
OECD
countries.

115­
5.
Q.
How
should
test
data
be
submitted
if
the
data
is
available
in
open
scientific
literature?

A.
Per
40
CFR
720.50(
a)(
3)(
ii),
if
data
appears
in
the
open
scientific
literature,
the
submitter
need
only
provide
a
standard
literature
citation.
A
standard
literature
citation
includes
author,
title,
periodical
name,
date
of
publication,
volume,
and
page
numbers.
EPA
encourages
the
submitter
to
assist
EPA
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;
open­
literature
reports
can
be
submitted
in
their
original
languages.
If
an
English
translation
is
available,
EPA
encourages
its
submission.

115­
6.
Q.
How
should
test
data
be
submitted
if
the
data
is
not
available
in
the
open
scientific
literature?

A.
Per
40
CFR
720.50(
a)(
3)(
i),
if
the
data
does
not
appear
in
the
open
scientific
literature,
the
submitter
must
provide
a
full
report,
and
it
must
be
in
English.
A
full
report
includes
the
experimental
methods
and
materials,
results,
discussion
and
data
analysis,
conclusions,
references,
and
the
name
and
addresses
of
the
laboratory
that
developed
the
data.

115­
7.
Q.
What
should
a
submitter
do
if
a
study,
report,
or
test
is
not
complete
when
the
notice
is
submitted?

A.
This
question
is
answered
by
40
CFR
720.50(
a)(
4).
EPA
encourages
the
notice
submitter
to
schedule
any
testing
so
that
it
will
be
complete
before
the
submission
of
a
§
5
notice.
However,
if
a
study,
report,
or
test
is
incomplete
when
a
person
submits
a
notice,
the
submitter
must
identify
the
nature
and
purpose
of
the
study;
name
and
address
of
the
laboratory
developing
the
data;
progress
to
date;
types
of
data
collected;
significant
preliminary
results;
and
anticipated
completion
date.
If
a
significant
preliminary
result
of
a
test
or
experiment
is
completed
before
the
notice
review
period
ends,
the
person
must
submit
the
study,
report,
or
test
to
the
address
listed
Section
1:
General
Program
Information
1­
48
on
the
notice
form
within
ten
days
of
receiving
it,
but
no
later
than
five
days
before
the
end
of
the
review
period.
If
information
becomes
available
during
the
last
5
days
of
the
review
period,
the
submitter
must
immediately
inform
EPA
by
telephone.
(
See
also
the
provision
at
40
CFR
720.40(
f)
on
"
new
information"
obtained
during
the
notice
review
period.)

115­
8.
Q.
Does
a
submitter
need
to
resubmit
data
previously
sent
to
EPA?

A.
Not
if
the
data
was
previously
submitted
as
non­
confidential.
Per
40
CFR
720.50(
d)(
1),
a
submitter
need
not
submit
any
data
previously
submitted
to
EPA
with
no
claims
of
confidentiality
if
the
PMN
includes
the
office
or
person
to
whom
the
data
were
submitted,
the
date
of
submission,
and,
if
appropriate,
a
standard
literature
citation.
On
the
other
hand,
if
data
were
submitted
with
claims
of
confidentiality,
the
submitter
must
resubmit
the
data
with
the
§
5
notice
and
any
claim
of
confidentiality
under
40
CFR
§
720.80.

115­
9.
Q.
Does
a
submitter
need
to
collect
data
outside
the
United
States
for
EPA?

A.
Per
40
CFR
720.50(
d)(
3),
a
PMN
submitter
need
not
provide
any
data
which
relates
only
to
exposure
of
humans
or
the
environment
outside
the
United
States.
However,
under
40
CFR
720.50(
b),
any
non­
exposure
data
known
to
or
reasonably
ascertainable
by
the
submitter
such
as
data
on
health
effects
(
including
epidemiological
studies),
ecological
effects,
physical
and
chemical
properties,
or
environmental
fate
characteristics
must
be
provided.

115­
10.
Q.
What
scientific
disciplines
are
represented
on
the
Structure­
Activity
Team
(
SAT)?

A.
The
following
scientific
disciplines
are
represented
on
the
SAT:
chemistry,
environmental
fate,
ecotoxicity,
absorption/
metabolism,
mutagenicity,
oncogenicity,
developmental/
reproductive
toxicity,
neurotoxicity,
acute
toxicity,
and
subchronic/
chronic
toxicity.

115­
11.
Q.
Does
EPA
recommend
pre­
meetings
to
discuss
new
chemical
testing
needs?

A.
Consultation
with
EPA's
personnel
prior
to
submission
of
a
PMN
(
referred
to
as
prenotice
communication)
can
help
submitters
strengthen
future
§
5
submissions.
This
consultation
can
be
accomplished
through
a
letter
to
EPA
outlining
the
proposed
submission
which
may
or
may
not
need
to
be
supplemented
by
a
meeting
with
EPA's
personnel.
If
a
submitter
plans
to
perform
toxicity
or
other
testing
on
a
new
chemical
substance,
EPA
will
provide
guidance
on
the
types
of
tests
that
would
be
useful
to
EPA
in
assessing
the
health
and
environmental
effects
of
the
new
chemical
substance.
This
can
enable
a
potential
submitter
to
begin
needed
work
in
advance
of
PMN
review.
Prenotice
personnel
will
coordinate
EPA's
response
to
a
proposed
submission,
including
scheduling
of
a
meeting
if
necessary.
Prenotice
personnel
can
usually
do
at
least
as
well,
and
often
better,
in
meeting
a
submitter's
information
needs
through
written
communication
Section
1:
General
Program
Information
1­
49
supplemented
by
phone
calls
as
through
a
meeting.

Pre­
notice
meetings,
as
opposed
to
phone
and
letter
consultations,
are
most
often
useful
when
a
potential
submitter
wants
an
overall
understanding
of
the
review
process
and
of
the
criteria
which
will
be
used
to
assess
applications.

115­
12.
Q.
We
have
studies
provided
to
us
by
our
parent
company
in
a
foreign
country.
They
are
not
written
in
English.
We
understand
that
we
have
to
provide
material
to
EPA
in
English.
How
formal
does
our
translation
have
to
be?

A.
The
translation
has
to
be
good
enough
that
our
scientists
can
confidently
use
the
translated
studies
in
assessing
the
risk
potential
of
the
chemical
substance.
A
relatively
informal
translation
can
be
adequate,
if
it
is
clear
to
our
assessors
what
has
been
done
and
how.
If
the
translation
is
unsatisfactory,
the
New
Chemicals
Program
may
ask
you
to
suspend
the
review
period
on
your
PMN
until
an
adequate
translation
is
submitted.

115­
13.
Q.
How
will
the
toxicity
information
I
provide
be
used
by
EPA
to
assess
my
PMN
chemical?

A.
EPA
uses
toxicity
data
for
the
PMN
substance
when
available
and
fills
in
data
gaps
with
toxicity
data
on
other
chemicals
with
molecular
structures
similar
to
the
PMN
substance
("
structural
analogs")
to
conduct
risk
assessments.
If
it
is
determined
that
a
potential
risk
exists
during
any
part
of
the
life
cycle
of
the
chemical,
EPA
will
look
for
ways
to
minimize
potential
risks.
Risk
management
may
be
accomplished
through
use
of
appropriate
controls,
including
prohibition
of
releases
to
water,
use
of
workplace
personal
protective
equipment
or,
for
inhalation
exposures
only,
the
development
of
a
new
chemical
exposure
limit
(
NCEL).
A
NCEL
is
an
airborne
exposure
concentration
in
the
workplace
at
which
an
adult
would
be
unlikely
to
suffer
adverse
effects
if
exposed
for
a
working
lifetime.
Exposures
above
the
NCEL
require
the
use
of
respirators.

To
conduct
a
risk
assessment
for
non­
cancer
endpoints,
EPA
compares
the
estimated
exposures
with
no
adverse
effect
levels
(
NOAELs)
or
lowest
adverse
effect
levels
(
LOAELs)
from
the
toxicity
studies.
The
ratio
between
the
estimated
exposure
level
and
the
NOAEL
or
LOAEL
is
called
the
margin
of
exposure
(
MOE).
The
new
chemicals
program
is
usually
looking
for
a
MOE
of
100
or
greater
for
a
NOAEL
from
a
developmental
toxicity
study
or
a
subchronic
study.
The
MOE
should
be
one
order
of
magnitude
larger
when
using
a
LOAEL
(
a
MOE
of
1000).

To
conduct
a
risk
assessment
for
carcinogens,
the
estimated
exposure
is
multiplied
by
the
q1*
(
or
slope
factor)
derived
from
a
cancer
study
(
usually
for
a
structural
analog)
to
give
a
cancer
risk
estimate.
EPA
generally
uses
an
acceptable
risk
of
10­
5
(
1
in
100,000)
for
workers
and
10­
6
Section
1:
General
Program
Information
1­
50
(
1
in
1,000,000)
for
the
general
population.
A
NCEL
for
a
cancer
concern
is
developed
based
on
a
cancer
risk
of
10­
4
(
1
in
10,000)
but
assumes
a
worker
is
exposed
over
an
entire
lifetime
­
a
maximum
of
250
days
per
year
for
40
years
out
of
a
70
year
lifespan.

116
Environmental
Fate
Data
116­
1.
Q.
What
information
on
physical
and
chemical
properties
is
routinely
needed
for
an
assessment
of
the
environmental
fate
of
a
PMN
substance?

A.
PMN
reviewers
assessing
environmental
fate
generally
need:

°
for
solids,
the
melting
point;
°
for
inorganic
substances,
water
solubility
at
25
degrees
C,
pH
7;
°
for
organics
which
hydrolyze,
hydrolysis
half­
life
at
25
degrees
C,
pH
7;
and
°
results
of
a
ready
aerobic
biodegradation
test
See
Chemical
Assistance
Manual
for
Premanufacture
Notification
Submitters
at
www.
epa.
gov/
oppt/
newchems/
chem­
pmn/
chap2.
pdf.
EPA
guidelines
for
testing
methods,
both
for
Physical/
Chemical
properties
and
specific
environmental
fate
values,
are
at
www.
epa.
gov/
opptstrs/
home/
guidelin.
htm.

117
Health
and
Safety
Data
117­
1.
Q.
What
types
of
data
are
covered
by
EPA's
definition
of
health
and
safety
studies?

A.
"
Health
and
safety
study"
is
defined
at
TSCA
§
3(
6)
and
40
CFR
720.3(
k).
A
health
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
exposure
to
a
chemical
substance
or
mixture,
toxicological,
clinical,
and
ecological,
or
other
studies
of
a
chemical
substance
or
mixture,
and
any
test
performed
under
the
Act.
Chemical
identity
is
always
part
of
a
health
and
safety
study.
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
bearing
on
the
effects
of
a
chemical
substance
on
health
or
the
environment
would
be
included.

117­
2.
Q.
What
types
of
health
studies
is
EPA
interested
in?

A.
Examples
of
health
studies
EPA
is
concerned
with
include:
tests
on
mutagenicity,
carcinogenicity,
developmental
toxicity,
aquatic
toxicity,
etc.;
data
on
behavioral
disorders;
dermal
toxicity;
pharmacological
effects;
mammalian
absorption,
distribution,
metabolism,
and
excretion;
cumulative,
additive,
and
synergistic
effects,
subchronic,
and
chronic
effects;
worker
Section
1:
General
Program
Information
1­
51
inhalation
and
dermal
exposure
monitoring;
and
structure/
activity
analysis.

117­
3.
Q.
What
are
some
of
the
core
health
studies
that
EPA
may
require?
What
are
some
additional
data
which
can
be
useful?

A.
For
those
PMN
substances
meeting
significant
or
substantial
human
exposure
criteria
(
see
www.
epa.
gov/
opptintr/
newchms/
expbased.
htm)
and
warranting
testing
as
determined
by
EPA,
a
submitter
may
be
asked
to
perform
some
or
all
of
the
following
health
core
tests
on
the
PMN
substance:
an
Ames
assay;
an
in
vivo
micronucleus
(
mice,
gavage);
an
acute
oral
toxicity
(
rats,
gavage);
and
a
28­
day
repeated
dose
oral
study.
This
list
is
not
exhaustive;
if
another
study
is
believed
to
be
more
appropriate
for
a
specific
substance,
it
may
be
substituted
for
one
or
more
of
these
studies.
Examples
of
other
types
of
information
which
may
be
sought
include:
for
salts
of
pigments,
dissociation
or
stability
at
pH
1.0;
for
powdered
solids,
particle
size
distribution;
for
aerosols,
aerosol
size
distribution.

EPA's
guidelines
for
testing
methods,
both
for
physical/
chemical
properties
and
specific
environmental
fate
values,
appear
at
www.
epa.
gov/
opptstrs/
home/
guidelin.
htm.
See
Q&
A
section
115
for
more
on
testing.

117­
4.
Q.
What
are
some
of
the
endpoints
of
maternal
toxicity?

A.
Maternal
toxicity
refers
to
mortality,
infertility,
changes
in
body
weight,
lessened
weight
gain,
or
organ
weight,
gestation
length,
clinical
signs
of
toxicity,
food
and
water
consumption,
and
necropsy
and
histopathology
findings.

117­
5.
Q.
What
is
the
study
design
for
a
short­
term
in
vivo
developmental
toxicity
study?

A.
An
example
of
a
satisfactory
short­
term
in
vivo
study
design
is
one
that
includes:
°
timed
mating;
°
implantation
success;
°
exposure
of
the
mother
during
major
organogenesis
midway
to
end
of
term
(
exposure
groups:
vehicle
control,
high
dose­
minimal
maternal
toxicity,
second
dose­
recommended);
and
°
condition
of
offspring
at
term
(
maternal
evaluation,
litter
size/
gross
malformations,
viability/
weight).
(
See
the
OPPTS
Harmonized
Test
Guidelines
#
870.3700
at
www.
epa.
gov/
opptsfrs/
home/
guidelin.
htm.
A
comparable
test
guideline
appears
at
40
CFR
799.9370.)

117­
6.
Q.
What
are
some
of
the
endpoints
of
developmental
toxicity?
Section
1:
General
Program
Information
1­
52
A.
Some
of
the
endpoints
of
developmental
toxicity
are
pre­
implantation
loss,
post­
implantation
loss,
structural
abnormalities,
fetal
weights,
sex
ratio,
stillbirths,
postnatal
offspring
weights,
clinical
signs,
functional
deficits,
necropsy
and
histopathology
findings.

117­
7.
Q.
What
are
the
objectives
of
the
guidelines
for
developmental
toxicity
testing?

A.
The
objectives
of
the
guidelines
on
developmental
toxicity
testing
are
to:
provide
guidance
for
evaluating
risk
to
humans
from
exposure
to
chemicals
during
development;
define
developmental
toxicity
and
provide
the
rationale
for
approaches
to
evaluating
data;
detail
types
of
adverse
effects
seen
in
developing
organisms
and
the
relationship
to
adult
toxicity;
provide
guidance
for
evaluating
animal
study
data;
and
lastly,
establish
consistency
in
evaluating
data
and
assessing
risk
for
developmental
toxicity.

117­
8.
Q.
Who
reviews
toxicology
data
on
a
PMN?

A.
OPPT
toxicologists
who
are
specialists
in
either
human
health
or
environmental/
wildlife
effects
review
PMN
toxicology
data.
The
PMN
review
process
is
diagramed
and
discussed
in
the
New
Chemicals
Program
brochure
(
available
from
the
Hotline)
and
at
www.
epa.
gov/
oppt/
newchems/.

117­
9.
Q.
A
PMN
for
a
chemical
I
wish
to
import
in
liquid
phase
has
just
passed
the
90
day
review.
The
first
batch
we
want
to
import
is
going
to
be
in
powder
phase,
not
liquid,
though
it
is
the
same
exact
chemical
identity.
Does
this
require
submission
of
a
new
PMN?

A.
The
PMN/
§
5
form
asks
for
information
about
the
physical
form
of
the
substance
[
e.
g.,
solid
(
crystals,
granules,
powder,
dust),
liquid
(
solution,
paste,
slurry,
emulsion,
mist,
spray),
gas
(
vapor,
fume),
wet
press
cake]
to
which
individuals
or
the
environment
will
be
exposed,
percent
new
chemical
substance
(
if
in
a
mixture),
and
protective
equipment
and
engineering
controls
employed
to
safeguard
the
worker
from
potential
exposure
associated
with
the
new
chemical
substance,
i.
e.,
gloves,
goggles,
respirators,
etc.
This
is
for
the
purpose
of
enabling
reviewers
to
assess
worker
exposure
and
environmental
release.
Clearly,
if
the
physical
form
identified
in
the
§
5
submission
form
is
not
the
one
which
is
to
be
used,
the
ability
of
EPA
reviewers
to
do
their
job
in
protecting
workers'
health
and
the
environment
effectively
is
compromised.

PMN
submitters
are
required
to
describe
their
intended
process
to
the
best
of
their
knowledge
and
intent
as
of
the
time
the
PMN
is
filed
(
and,
as
required
at
40
CFR
720.40(
f),
to
notify
EPA
of
any
new
information
becoming
available
during
the
PMN
review
period.)
A
NOC
may
be
filed
years
after
the
PMN
was
submitted.
NOC
submitters
are
required
only
to
file
the
information
required
at
40
CFR
§
720.102,
most
recently
amended
at
60
FR
16298­
16351
(
March
29,
1995).
Changes
in
the
submission,
including
physical
form,
is
not
addressed
in
the
NOC.
In
the
interim,
the
information
provided
in
the
original
PMN
may
have
changed
due
to
advances
in
Section
1:
General
Program
Information
1­
53
synthetic
technique,
change
of
location,
change
in
ownership,
change
of
toll
manufacturer,
etc.

It
is
very
important
to
try
to
identify
all
conditions
which
may
be
important
in
assessing
exposure
in
the
originally
submitted
§
5
submission
form,
and
to
describe
the
submitter's
intent
as
accurately
as
possible.
Although
EPA
recognizes
that
a
company
may
make
changes
after
the
PMN
review
period
has
expired
such
as
switching
from
import
to
domestic
manufacture
(
or
vice
versa),
from
liquid
to
powder
form,
changing
synthetic
process,
etc.,
it
would
be
unusual
for
such
a
change
to
happen
immediately
after
the
PMN
review
period
has
expired
without
prior
intent/
knowledge
on
the
part
of
the
submitter.
In
such
a
case,
EPA
may
find
cause
to
investigate
such
changes.
In
a
case
such
as
this,
it
would
be
prudent
for
a
submitter
to
prepare
a
narrative
for
its
files
to
describe
how
it
came
to
make
such
a
shift
so
quickly
after
the
PMN
was
filed,
to
enable
any
future
EPA
inspector
to
understand
how
it
came
to
be.
See,
e.
g.,
In
re
DuPont,
TSCA­
III­
731.
See
www.
epa.
gov/
aljhomep/
orders/
denemour.
htm.

117­
10.
Q.
If
a
high­
volume
PMN
substance
is
recognized
as
having
low
toxicity,
what
size
of
exposed
population
does
EPA
consider
to
be
significant?
Is
there
a
formula?

A.
§
5(
e)(
1)(
A)(
ii)(
II)
of
TSCA
authorizes
EPA
to
regulate
a
new
chemical
for
which
there
is
insufficient
information
about
the
chemical's
effects
on
human
health
and
the
environment
and
for
which
substantial
production
volume
and
substantial
or
significant
human
exposure
or
substantial
environmental
release
is
anticipated.

EPA's
rationale
for
selecting
cases
for
exposure­
based
actions
was
first
discussed
publicly
in
a
September
22,
1988
letter.
This
letter
is
available
through
EPA's
TSCA
Hotline.
A
current
discussion
of
EPA's
exposure­
based
policy,
as
well
as
the
scanned
text
of
this
letter
with
updated
attachments,
is
available
at
www.
epa.
gov/
oppt/
newchems/
expbased.
htm.

118
Ecotoxicity
Data
118­
1.
Q.
What
types
of
ecological
or
other
environmental
effects
studies
is
EPA
interested
in?

A.
EPA
is
concerned
with
studies
on
ecological
or
other
environmental
effects
on
fish,
invertebrates,
or
other
animals,
and
plants.
These
studies
include:
acute
toxicity
tests,
chronic
toxicity
tests,
critical
life
stage
tests,
behavioral
tests,
algal
growth
tests,
seed
germination
tests,
plant
growth
or
damage
tests,
microbial
function
tests,
bioconcentration
or
bioaccumulation
tests,
and
model
ecosystem
(
microcosm)
studies.
EPA's
New
Chemicals
Program
pays
particular
attention
to
potential
aquatic
toxicity.

118­
2.
Q.
What
is
the
base
set
for
ecotoxic
concerns?

A.
The
base
set
for
ecotoxicity
includes
acute
toxicity
to
fish,
acute
toxicity
to
daphnia,
Section
1:
General
Program
Information
1­
54
and
algal
growth
inhibition.
See
www.
epa.
gov/
oppt/
newchems/
expbasedtesting.
htm
and
www.
epa.
gov/
oppt/
newchems/
co­
xbeco.
txt.
Beyond
the
base
set,
additional
testing
will
be
requested
depending
in
part
on
how
an
organism
responds
to
base
set
tests,
comparison
to
similar
substances
(
SAR),
expected
amount
of
the
substance
to
be
released
to
the
environment,
testing
on
biodegradability
and
abiotic
degradation,
and
on
what
the
producers
recommend
as
appropriate.

118­
3.
Q.
What
are
some
of
the
ecotoxicity
tests
that
EPA
may
require?

A.
For
those
PMN
substances
meeting
the
substantial
environmental
release
criterion
and
warranting
testing
as
determined
by
EPA,
submitters
may
be
asked
to
perform
some
or
all
of
the
following
core
environmental
tests
on
the
PMN
substance
(
this
is
called
the
aquatic
acute
toxicity
"
base
set"):
96­
hour
LC50
in
fish
(
flow
through
method
and
measured
concentrations),
48­
hour
LC50
test
in
daphnia
(
flow
through
method
and
measured
concentrations),
and
a
96­
hour
bioassay
in
algae
(
static
method
and
measured
concentrations).

118­
4.
Q.
How
does
EPA
utilize
the
information
from
structure
activity
relationships
(
SARs)?

A.
Structure
activity
relationships
(
SARs)
can
provide
estimates
of
the
inherent
toxicity
of
chemicals
based
upon
the
relationship
among
the
physico­
chemical
properties
of
chemicals
and
toxicity
to
organisms.
Relationships
vary
from
statistical
regression
techniques
to
identification
of
the
nearest
analogs.
The
product
of
statistical
regression
is
generally
an
equation
whose
predictive
capability
is
measured
by
the
degree
of
correlation
between
the
independent
and
dependent
variables.

118­
5.
Q.
What
estimation
methods
are
used
by
EPA
when
characterizing
a
chemical's
ecotoxicity?

A.
Fewer
than
5%
of
all
PMN
submissions
contain
ecotoxicity
data.
Therefore,
when
data
are
not
available
to
characterize
a
chemical's
toxicity,
estimation
methods
are
used
to
predict
the
chemical's
ecotoxicity
based
on
its
chemical
structure
and
physical/
chemical
properties.

The
most
important
estimation
method
is
the
substance's
similarity
to
others
with
known
properties.
This
assessment
is
called
structure
activity
relationship
(
SAR)
analysis.
Current
SAR
techniques
for
ecotoxicity
allow
prediction
of
inherent
toxicity
to
fish,
invertebrates,
and
algae.
Analysis
of
large
ecotoxicity
data
sets
has
revealed
predictive
relationships
which
are
useful
in
determining
a
chemical's
toxicity.
As
examples:

°
when
the
24/
96­
hour
ratio
of
acute
fish
LC50s
or
24/
48­
hour
ratio
of
acute
daphnid
LC50s
are
equal
to
or
greater
than
2,
the
chemical
has
a
higher
probability
for
chronic
toxicity;
Section
1:
General
Program
Information
1­
55
°
when
the
acute
LC
or
EC50
is
less
than
1
ppm
the
chemical
has
a
higher
probability
for
chronic
toxicity;
and
°
for
anionic
surfactants,
the
chronic
value
can
be
predicted
by
dividing
the
fish
and
daphnia
acute
values
by
6.5.

119
Polymer
Issues
119­
1.
Q.
Where
can
I
find
more
information
about
the
Polymer
Exemption
Rule?

A.
See
Q&
A
section
304.

119­
2.
Q.
Is
a
PMN
required
for
Inventory
listing
of
a
polymer
if
the
monomers
comprising
the
polymer
are
on
the
Inventory?

A.
If
the
polymer
is
not
included
on
the
Inventory
then
a
PMN
is
required
for
Inventory
listing
unless
the
polymer
qualifies
for
manufacture
under
one
of
the
Exemptions.
A
PMN
may
be
filed,
even
on
a
polymer
which
is
eligible
for
the
Polymer
Exemption,
if
the
submitter
desires
Inventory
listing.
See
40
CFR
723.250(
d)(
4).

119­
3.
Q.
If
a
polymer
is
on
the
Inventory
but
contains
a
non­
Inventory
monomer,
can
you
import
it?

A.
Yes.
If
the
polymer
is
on
the
Inventory
it
is
an
existing
chemical,
and
no
PMN
or
other
notice
or
exemption
is
required
to
import
it.
Even
if
a
polymer
is
on
the
Inventory,
however,
it
may
not
be
manufactured
domestically
unless
all
the
reactants
are
on
the
Inventory,
because,
in
the
US,
a
chemical
may
not
be
manufactured,
processed,
or
used
unless
it
is
on
the
TSCA
inventory.
See
TSCA
§
5(
a).

Please
note
that
the
Polymer
Exemption
cannot
be
used
for
a
material
which
contains
a
non­
Inventory
monomer
or
reactant.
See
40
CFR
723.250(
d)(
4).
Unless
you
have
a
real
intent
to
import
or
manufacture
a
monomer,
you
cannot
file
a
PMN
or
an
exemption
for
that
monomer.
Thus
a
PMN
(
or
an
LVE
or
LoREX
exemption)
is
the
only
mechanism
to
import
a
polymer
which
contains
a
non­
Inventory
monomer.

119­
4.
Q.
An
imported
polymer
is
described
as
a
sodium
salt
and
the
submitter
determines
analytically
that
sodium
is
present
at
two
percent
or
less.
Can
the
submitter
assume
that
sodium
hydroxide
was
the
neutralizing
agent
used
to
produce
that
material,
and
should
the
submitter
therefore
use
the
sodium
hydroxide
molecular
weight
in
determining
the
percent
incorporated
(
and
hence
the
chemical
identity)?
Section
1:
General
Program
Information
1­
56
A.
Yes.
In
the
absence
of
information
about
the
source
of
the
sodium
ion,
sodium
hydroxide
should
be
used
as
the
default
source
and
the
calculations
should
be
based
on
the
molecular
weight
of
sodium
hydroxide.
The
hydroxides
of
magnesium,
aluminum,
potassium
and
calcium
should
also
be
used
as
the
default
sources
of
the
respective
ions.
See
the
Polymer
Exemption
Guidance
Manual
at
www.
epa.
gov/
opptintr/
newchems/
polyguid.
pdf
for
more
details.

119­
5.
Q.
Is
a
regular
PMN
for
a
polymer
ever
necessary,
if
a
Polymer
Exemption
PMN
was
submitted
prior
to
the
effective
date
(
May
30,
1995)
of
the
1995
amendments
and
approved?
If
a
Polymer
Exemption
PMN
is
already
commercialized,
when
would
the
commercialization
of
such
a
regular
PMN
for
the
polymer
begin,
if
the
manufacturing
process
was
not
changed?

A.
A
pre­
1995
Polymer
Exemption
would
have
been
listed
in
the
Inventory
(
with
a
"
Y1"
flag
if
meeting
the
general
category
for
exemptible
polymers,
and
a
"
Y2"
flag
if
meeting
the
Exemption
category
for
certain
polyester
polymers).
The
filing
on
which
the
listing
was
based
would
ordinarily
have
included
limits
on
composition
(
maximum
percentage
of
residual
amounts
of
unreacted
monomers
and
low
molecular
weight
species
below
500
and
100
molecular
weight,
e.
g.).
If
a
person
plans
to
manufacture
the
polymer
outside
the
composition
limits
of
the
alreadygranted
Polymer
Exemption,
or
if
the
intending
manufacturer
does
not
want
to
meet
the
procedural
requirements
of
the
1995
amended
Polymer
Exemption,
or
if
the
polymer
itself
is
not
compliant
with
the
requirements
of
the
1995
amended
Polymer
Exemption,
then
a
PMN
will
be
required.

As
noted
above,
the
composition
limits
are
not
published
with
the
Inventory,
so
someone
who
was
not
the
original
submitter
of
the
notice
filed
under
the
original
(
pre­
1995)
Polymer
Exemption
could
manufacture
the
material
under
the
exemption
(
if
within
the
composition
limits)
only
after
first
contacting
EPA
to
determine
whether
they
would
satisfy
the
composition
limits.

If
a
PMN
is
filed
for
the
purpose
of
removing
the
composition
limits,
manufacture
after
the
end
of
the
PMN
review
period
can
be
either
within
or
outside
of
the
composition
values
or
ranges
specified
in
the
exemption
notice
submitted
under
the
original
(
pre­
1995)
Polymer
Exemption.
The
submitter
MUST
submit
a
NOC
when
the
polymer
is
manufactured
outside
of
the
compositional
values
or
ranges
specified
in
the
pre­
1995
Polymer
Exemption
notice
for
the
first
time
after
expiration
of
the
PMN
review
period.
See
the
Polymer
Exemption
Guidance
Manual
at
www.
epa.
gov/
opptintr/
newchems/
polyguid.
pdf
for
more
details.

119­
6.
Q.
Is
it
acceptable
to
submit
a
PMN
for
a
polymer
already
being
manufactured
under
the
terms
of
the
Polymer
Exemption?

A.
Yes.
Certain
manufacturers
choose
to
do
so,
in
order
to
have
the
polymer
listed
on
the
TSCA
Inventory.
Section
1:
General
Program
Information
1­
57
119­
7.
Q.
Would
chain
transfer
agents
used
in
polymer
manufacturing
be
in
the
same
category
as
free
radical
initiators
or
must
they
be
included
in
the
polymer
identity?

A.
Chain
transfer
agents
that
are
used
in
the
manufacturing
of
a
polymer
at
a
level
of
greater
than
2%
(
by
weight)
must
be
included
in
the
polymer
description.
If
a
monomer
or
other
reactant,
such
as
a
chain
transfer
agent,
is
used
at
a
level
of
2%
or
less,
the
submitter
has
the
option
to
either
include
or
exclude
it
from
the
polymer
description
to
be
used
in
the
Inventory
listing.

If
a
monomer
or
other
reactant
is
not
included
or
reflected
in
the
Inventory
polymer
name,
that
monomer
or
other
reactant
cannot
later
be
used
at
greater
than
2
percent
in
the
polymer.
See
40
CFR
720.45(
a)(
2)(
iii).
Conversely,
if
monomers
or
other
reactants
are
included
in
the
Inventory
name,
they
may
be
used
at
any
level
as
long
as
they
are
not
eliminated
completely
without
the
resulting
polymer
name
(
not
including
those
monomers/
reactants)
also
being
on
the
Inventory
or
unless
the
manufacturer's
PMN
for
that
resulting
polymer
has
completed
review.
In
such
situations,
it
may
be
appropriate
for
a
manufacturer
to
request
permission
from
the
Prenotice
Coordinator
to
submit
a
consolidated
notice
encompassing
a
series
of
similar
polymers.

Note
that
a
free­
radical
initiator
must
also
be
included
in
a
polymer
name
when
used
at
more
that
2%
unless
the
corresponding
polymer
name
without
the
initiator
was
"
grandfathered"
onto
the
Inventory
by
July
28,
1989.
Refer
below
to
Q&
A
#
119­
8.
Also,
see
the
Polymer
Exemption
Guidance
Manual
at
www.
epa.
gov/
opptintr/
newchems/
polyguid.
pdf
for
more
details.

119­
8.
Q.
Polymer
A­
B­
C
is
already
on
the
Inventory.
A
new
proposed
process
now
uses
a
free­
radical
initiator.
Must
a
PMN
be
filed?

A.
If
the
polymer
A­
B­
C
was
on
the
Inventory
before
July
28,
1989
(
the
effective
date
of
the
FR
notice
clarifying
the
policy
on
manufacturing
polymers
using
free­
radical
initiators),
then
polymers
of
that 
composition
using
initiators
are
also
considered
to
be
A­
B­
C,
and
consequently
on
the
Inventory,
regardless
of
the
level
of
initiator.
If
Polymer
A­
B­
C
was
not
on
the
Inventory
prior
to
July
28,
1989,
and
the
initiator
D
is
used
at
2%
or
more,
the
resulting
polymer
must
be
identified
as
A­
B­
C­
D.
If
that
polymer
is
not
on
the
Inventory,
a
PMN
[
or
exemption]
is
necessary.
Thus,
free­
radical
initiators
must
be
reported
and
included
in
polymer
names
when
used
at
more
than
2%
by
weight
in
the
manufacture
of
any
post
July
28,
1989,
new
polymer.
(
See
54
FR
27174).

119­
9.
Q.
A
submitter
wants
to
manufacture
a
polymer
of
4
monomers
plus
use
an
initiator
at
>
2%
(
The
initiator
will
be
incorporated
into
the
final
polymer).
The
polymer
of
the
4
monomers
plus
the
initiator
is
not
on
the
TSCA
Inventory.
What
options
are
available
to
the
submitter
to
begin
commercialization
as
soon
as
possible?
Section
1:
General
Program
Information
1­
58
A.
If
the
polymer
name
of
the
specified
4
monomers
without
the
free­
radical
initiator
was
not
on
the
Inventory
as
of
July
28,
1989,
then
a
PMN
{
or
Exemption
other
than
the
Polymer
Exemption}
will
need
to
be
filed
unless
the
polymer
qualifies
for
the
1995
amended
Polymer
Exemption.
If
the
polymer
name
without
the
initiator
was
added
to
the
Inventory
after
July
28,
1989,
an
alternative
in
this
situation
could
be
to
switch
to
two
or
more
different
TSCA
listed
initiators,
either
charging
each
at

2%
or
determining
via
the
"
incorporation
method"
that
each
would
be
considered
present
in
the
polymer
at

2%.
(
Refer
to
the
1995
PMN
Rule
Amendments
and
Q&
A
#
119­
10
below.)
In
addition,
one
should
set
up
procedures
to
ensure
that
the
2%
level
will
not
be
exceeded
at
some
later
date.
One
might
also
consider
using
the
Polymer
Exemption,
if
the
polymer
is
eligible
for
it.

119­
10.
Q.
In
light
of
the
modified
"
Two
Percent
Rule,"
which
now
allows
reporting
of
polymers
as
incorporated
as
well
as
charged,
can
all
polymer
listings
on
the
Inventory
now
be
read
either
as
incorporated
or
as
charged?

A.
Yes.
All
polymers
on
the
Inventory
can
be
interpreted
either
as
incorporated
or
as
charged.
Remember
that
"
incorporated"
means
the
minimum
amount
of
free­
radical
initiator
in
theory
required
to
be
charged
in
order
to
account
for
the
amount
of
initiator
molecules
or
fragments
found
in
the
polymer
itself.

119­
11.
Q.
How
do
you
apply
the
molecular
weight
(
MW)
distribution
requirement
of
the
polymer
definition
(
i.
e.,
<
50
percent
of
any
one
MW)
to
highly
cross­
linked
polymers
of
essentially
infinite
MW?

A.
For
polymers
of
"
essentially
infinite"
MW,
unless
the
entire
mass
of
polymer
produced
were
in
one
continuous
phase,
the
actual
molecular
weight
would
be
limited
by
the
size
of
the
individual
droplets,
beads,
pellets,
flakes,
etc.
No
two
of
these
would
be
likely
to
have
the
exact
same
mass,
and
the
distribution
criterion
would
be
met.
For
that
matter,
the
molecular
weight
(
MW)
determination
itself
would
produce
a
range
of
values
because
of
the
finite
precision
of
the
instrument.
See
the
Polymer
Exemption
Guidance
Manual
at
www.
epa.
gov/
opptintr/
newchems/
polyguid.
pdf
for
more
details.

119­
12.
Q.
Would
the
following
example
(
where
the
longest
continuous
chain
of
reactant
units
is
1
+
1
+
2
=
3
+
1)
count
as
a
"
polymer
molecule?"

H(
oxypropylene)­
O­
sorbitol­
O­(
propyleneoxy)
2­
H
A.
No.
Sorbitol
cannot
be
a
repeating
monomer
unit
under
the
conditions
of
the
relevant
polymerization
reaction
(
propoxylation),
so
it
is
considered
an
"
other
reactant".
Therefore
the
longest
sequence
of
monomer
units
(
considered
as
derived
from
propylene
oxide)
is
two.
A
continuous
string
of
at
least
three
monomer
units
is
required,
plus
one
additional
monomer
unit
or
Section
1:
General
Program
Information
1­
59
other
reactant.
See
the
Polymer
Exemption
Guidance
Manual
at
www.
epa.
gov/
opptintr/
newchems/
polyguid.
pdf
for
more
details.

120
Principal
Importer
120­
1.
Q.
Who
is
considered
the
principal
importer?

A.
40
CFR
§
720.3(
z)
states
that:
"
The
principal
importer
is
the
first
importer,
who,
knowing
that
a
new
chemical
substance
will
be
imported
rather
than
manufactured
domestically,
specifies
the
identity
of
the
chemical
substance
and
the
total
amount
to
be
imported.
Only
persons
who
are
incorporated,
licensed
or
doing
business
in
the
United
States
may
be
principal
importers."
The
principal
importer
may
specify
the
chemical
identity
and
amount
either
to
the
foreign
producer
or
to
a
US
entity
(
customs
broker,
e.
g.)
which
transmits
the
order
abroad.

120­
2.
Q.
We
are
the
sole
customer
for
a
compound
being
imported
by
another
company.
Can
we
be
considered
the
principal
importer
and
submit
a
PMN?

A.
The
sole
customer
in
the
U.
S.
may
meet
the
definition
of
"
principal
importer"
by
specifying
the
chemical
substance
and
the
amount
to
be
imported.
The
Prenotice
Communications
Coordinator
can
provide
guidance
on
particular
situations.

121
Import
Issues
121­
1.
Q.
For
the
purpose
of
TSCA,
is
importation
considered
to
be
manufacture?
If
so,
if
a
PMN
has
been
filed
for
an
imported
product,
will
a
domestic
manufacturer
have
to
file
a
PMN
prior
to
manufacture
in
this
country?

A.
TSCA
defines
"
manufacture"
to
include
"
import".
See
TSCA
§
(
3)(
7)
and
40
CFR
720.3(
q).
Once
EPA
receives
a
NOC
and
the
chemical
is
listed
on
the
Inventory,
it
may
be
manufactured
or
imported
by
anyone,
unless
there
is
a
restriction
as
described
below.
If
as
a
result
of
the
original
PMN
submission,
a
Significant
New
Use
Rule
(
SNUR)
was
issued
restricting
the
chemical
to
import
only,
a
Significant
New
Use
Notice
(
SNUN)
would
have
to
be
filed
and
successfully
reviewed
before
the
chemical
could
be
manufactured
domestically.

In
any
case,
even
after
filing
and
successful
review
of
the
submission,
if
no
NOC
has
been
received
by
EPA
from
the
submitter,
no
one
but
the
submitter
can
initiate
manufacture.

121­
2.
Q.
For
imported
chemicals,
what
is
considered
the
first
day
of
commercialization
­
the
day
it
leaves
the
shipping
country,
the
day
it
arrives
in
customs,
or
the
day
it
clears
customs?
Section
1:
General
Program
Information
1­
60
A.
"
Day
1"
is
the
date
the
new
chemical
substance
clears
US
customs.

121­
3.
Q.
How
can
a
Ninth
Collective
Index
(
9CI)
Chemical
Abstracts
(
CA)
name
be
obtained
for
an
imported
substance
whose
identity
is
claimed
as
confidential
by
its
foreign
supplier?

A.
Your
foreign
supplier
must
follow
the
same
procedures
as
a
U.
S.
submitter
to
obtain
a
CA
name
and
provide
the
correct
chemical
identity
to
EPA
as
a
joint
submission
or
letter
of
support,
clearly
referencing
your
notice
and
PMN
user
fee
identification
number.

Information
on
the
CAS
Inventory
Expert
Service
(
CAS­
IES)
including
available
resource
materials
is
available
through
614­
447­
3600
or
by
facsimile
(
614­
447­
3747).
For
general
Chemical
Abstracts
Services
call
800­
848­
6538.

122
Biotechnology
122­
1.
Q.
Are
microbes/
microorganisms
subject
to
TSCA?

A.
Yes,
certain
microorganisms
are
subject
to
TSCA.
However,
the
required
notification
form
called
a
Microbial
Commercial
Activity
Notice
(
MCAN),
is
necessary
only
for
intergeneric
microorganisms
formed
by
the
deliberate
combination
of
genetic
material
originally
isolated
from
organisms
of
different
taxonomic
genera.
Non­
intergeneric
microorganisms
are
considered
implicitly
on
the
Inventory.
See
40
CFR
Part
725;
G2
FR
17910,
April
11,
1997;
and
59
FR
45526,
Sept.
1,
1994.

Microorganisms
that
are
used
as
foods,
food
additives,
drugs,
cosmetics,
medical
devices,
and
pesticides
are
regulated
by
the
Food
and
Drug
Administration
(
FDA),
USDA,
or
EPA's
Office
of
Pesticide
Programs.
Requirements
for
foods,
food
additives,
drugs,
cosmetics,
and
medical
devices
are
described
in
the
FDA
and
USDA
notices
in
the
Federal
Register
and
Code
of
Federal
Regulations.

122­
2.
Q.
Are
plants
and
animals
subject
to
TSCA?

A.
As
EPA
has
previously
stated,
although
plants
and
animals
do
fall
within
the
scope
of
the
definition
of
a
"
chemical
substance"
under
TSCA
§
3,
plants
and
animals
are
not
currently
subject
to
the
new
chemical
provisions
of
TSCA,
either
as
whole
organisms
or
as
in
vitro
cultures.
EPA
has
stated
that
it
is
reserving
authority
under
TSCA
to
screen
transgenic
plants
and
animals
in
the
future
as
needed.
See
59
FR
45526,
45527
(
September
1,
1994).
However,
if
plant
or
animal
gene
segments
are
intentionally
incorporated
into
microorganisms,
the
microorganisms
that
contain
those
plant
or
animal
genes
would
be
subject
to
the
TSCA
§
5
requirements
established
at
40
CFR
part
725,
providing
that
the
microorganism
does
not
fall
within
one
of
the
specific
exclusions
found
in
TSCA
section
3
(
e.
g.,
the
microbe
is
not
itself
a
food,
food
additive,
or
Section
1:
General
Program
Information
1­
61
tobacco).
In
addition,
a
chemical
extracted
from
a
plant
or
animal
would
generally
be
subject
to
TSCA,
presuming
that
it
does
not
fall
within
the
exclusions
listed
at
TSCA
section
3.
See
40
CFR
§
720.3(
e).

123
Significant
New
Use
Rule
(
SNUR)

123­
1.
Q.
What
are
consent
orders
and
significant
new
use
rules?

A.
EPA
review
of
a
PMN
can
result
in
a
finding
of
potential
unreasonable
risk
or
substantial
production
and
exposure.
In
these
cases,
EPA
can
negotiate
a
TSCA
§
5(
e)
Consent
Order,
which
generally
allows
the
PMN
submitter
to
manufacture
or
import
the
new
substance
for
the
PMN­
identified
use(
s)
only
under
specified
conditions
(
e.
g.,
use
of
worker
protective
equipment
or
environmental
release
controls).
However,
a
§
5(
e)
Consent
Order
is
not
binding
on
any
companies
that
may
subsequently
manufacture
or
import
the
substance
other
than
the
submitter
who
signed
the
§
5(
e)
Consent
Order.
Consequently,
after
signing
a
§
5(
e)
Consent
Order
with
the
PMN
submitter,
EPA
generally
promulgates
a
Significant
New
Use
Rule
(
SNUR),
which
applies
similar
restrictions
as
in
the
§
5
(
e)
Consent
Order
to
other
potential
manufacturers
and
processors.
Such
a
SNUR
is
often
referred
to
as
a
"
§
5(
e)
SNUR."
SNURs
require
that
manufacturers,
importers
and
processors
of
certain
substances
notify
EPA
at
least
90
days
before
beginning
any
activity
that
EPA
has
designated
as
a
"
significant
new
use."
The
new
use
designations
in
a
§
5(
e)
SNUR
correspond
with
activities
prohibited
by
the
§
5(
e)
Consent
Order
and
are
generally
promulgated
on
an
expedited
("
direct
final",
see
54
FR
31299)
basis.
The
advance
notification
required
by
SNURs
(
called
a
Significant
New
Use
Notice
or
SNUN)
allows
EPA
to
prevent
or
limit
potentially
adverse
exposure
to,
or
effects
from,
the
new
use
of
the
substance.

When
the
EPA
review
determines
that
the
exposure
scenario
proposed
in
a
PMN
is
not
expected
to
pose
an
unreasonable
risk,
EPA
generally
does
not
issue
a
§
5(
e)
Consent
Order.
The
reviewers
may,
however,
identify
potential
new
uses
different
from
those
identified
in
the
PMN
which
could
result
in
increased
exposures
to
or
releases
of
the
substance,
and
in
turn
a
potential
unreasonable
risk
to
health
or
the
environment.
In
such
cases,
EPA
can
issue
a
SNUR
that
requires
the
submission
of
a
SNUN
90
days
prior
to
commercial
manufacture
not
conforming
to
the
conditions
reviewed
under
the
PMN.
Such
a
SNUR
is
called
a
"
non­
§
5(
e)
SNUR,"
and
may
also
be
issued
on
an
expedited
basis.
(
The
1995
TSCA
PMN
rule
amendments
expanded
the
types
of
significant
new
use
designations
that
EPA
may
promulgate
in
expedited
"
non­
§
5(
e)"
SNURs.
This
change
is
intended
to
improve
the
efficiency
of
the
SNUR
procedure
for
both
EPA
and
the
chemical
industry.
See
Q&
A
#
123­
2
and
60
FR
16298ff.)

123­
2.
Q.
Why
did
EPA
create
the
non­
5(
e)
Significant
New
Use
Rule
(
SNUR)
amendment
to
40
CFR
721.170
(
c)(
1)?
What
did
the
amendment
change?
Section
1:
General
Program
Information
1­
62
A.
EPA
created
the
non­
5(
e)
SNUR
amendment
to
enable
the
regulation
of
potentially
risky
new
chemicals
using
fewer
EPA
resources,
and
to
allow
PMN
submitters
to
commence
commercial
manufacture
sooner.
The
amendment
to
40
CFR
§
721.170(
c)(
1)
eliminated
the
provision
that
prevented
EPA
from
promulgating
expedited
non­
5(
e)
SNURs
containing
worker
protection
or
hazard
communication
requirements.
Before
the
amendment,
expedited
non­
5(
e)
SNURs
were
limited
to
requirements
controlling
disposal
(
§
721.85),
releases
to
water
(
§
721.90),
and
certain
industrial,
commercial
and
consumer
activities
(
§
721.80).
After
the
amendment,
expedited
non­
5(
e)
SNURs
may
include
any
of
the
requirements
in
Subpart
B,
including
worker
protection
(
§
721.63),
hazard
communication
(
§
721.72),
and
all
of
the
industrial,
commercial
and
consumer
activities
(
§
721.80).

123­
3.
Q.
What
chemicals
are
affected
by
the
non­
5(
e)
Significant
New
Use
Rule
(
SNUR)
amendment
to
40
CFR
721.170(
c)(
1)?

A.
This
amendment
of
the
"
Generic
SNUR"
did
not
automatically
apply
to
any
specific
chemical
substance.
It
is
merely
a
procedural
tool
that
EPA
can
use
to
impose
"
significant
new
use"
reporting
requirements
in
individual,
chemical­
specific
SNURs
for
PMN
substances
where
EPA
reviewers
identify
other
potential
uses
that
may
present
unreasonable
risk
or
have
the
potential
for
substantial
production
volume
and
substantial
or
significant
human
exposure
or
substantial
environmental
release.

123­
4.
Q.
What
is
the
difference
between
a
§
5(
e)
Order
and
a
Significant
New
Use
Rule
(
SNUR)?

A.
An
order
under
§
5(
e)
applies
only
to
the
manufacturer
who
submitted
the
PMN.
SNURs
apply
to
everyone
who
manufactures
or
processes
the
chemical
substance.
A
SNUR
establishes
a
requirement
to
notify
EPA
90
days
before
commencing
any
activity
that
the
SNUR
defines
as
a
"
significant
new
use."
In
response
to
a
Significant
New
Use
Notice
(
SNUN),
EPA
will
review
the
proposed
use,
and
may
issue
a
§
5(
e)
Order
to
control
potential
unreasonable
risks
or
substantial
and/
or
significant
exposures
that
may
be
presented
by
the
significant
new
use.

123­
5.
Q.
What
is
the
difference
between
a
§
5(
e)
SNUR
and
a
Non­
5(
e)
SNUR?

A.
A
§
5(
e)
SNUR
is
a
SNUR
which
is
promulgated
only
after
a
§
5(
e)
Order
is
issued
for
the
same
chemical
substance,
and
which
extends
to
all
subsequent
manufacturers/
users
the
provisions
of
the
§
5(
e)
Consent
Order.
"
Non­
5(
e)
SNURs"
are
those
SNURs
which
are
promulgated
without
issuance
of
a
§
5(
e)
Order,
because
EPA
did
not
find
that
the
exposure
scenario
described
in
the
PMN
"
may
present
unreasonable
risk,"
but
other
exposure
scenarios
might.
See
Q&
A
#
100­
12
for
more
on
EPA's
exposure­
based
policy.

123­
6.
Q.
What
is
the
difference
between
a
"
Notice
and
Comment
SNUR"
versus
an
"
Expedited
Section
1:
General
Program
Information
1­
63
SNUR"?

A.
Notice
and
Comment
rulemaking
involves
publishing
a
proposed
rule,
receiving
public
comment,
and
publishing
a
final
rule.
This
is
the
"
standard"
rulemaking
process.
Expedited
rulemaking
involves
publishing
a
"
Direct
Final"
rule
that
automatically
becomes
final
unless
someone
requests
a
comment
period.
Expedited
rulemaking
also
allows
batching
of
individual
SNURs
and
abbreviated
review
within
EPA.
If
a
comment
period
is
requested,
this
process
takes
more
of
EPA's
resources
and
takes
longer
than
Notice
and
Comment
rulemaking.
EPA
uses
expedited
rulemaking
in
cases
where
it
does
not
think
comment
is
likely
(
e.
g.,
SNURs
which
put
into
place
restrictions
already
agreed
upon
between
EPA
and
a
PMN
filer).
Expedited
rulemaking
enables
those
who
wish
to
manufacture
under
the
terms
of
a
SNUR
to
initiate
their
activity
quickly,
and
saves
EPA
resources.
Both
types
of
rulemaking
provide
opportunity
for
comment
by
interested
persons,
as
required
by
the
Administrative
Procedures
Act.
See
40
CFR
721.160(
c)
and
721.170(
d)(
4).

123­
7.
Q.
What
type
of
case
is
appropriate
for
a
non­
5(
e)
SNUR?

A.
A
non­
5(
e)
SNUR
is
typically
appropriate
when
a
PMN
is
filed
for
a
chemical
substance
which
is
expected
to
be
toxic
but
the
PMN
describes
intended
use(
s)
and
an
exposure
scenario
that
is
not
expected
to
pose
unreasonable
risk
of
injury
to
human
health
or
the
environment.
Intended
uses
and
activities
can
be
limited,
or
the
submitter
can
state
that
it
will
implement
control
measures,
or
otherwise
adequately
mitigate
human
exposures
and
environmental
releases.
Although
activities
described
in
such
PMNs
may
be
judged
not
to
present
an
unreasonable
risk
of
injury
to
human
health
or
the
environment,
if
there
are
significant
deviations
from
the
described
activities
the
substance
may
present
an
unreasonable
risk
warranting
the
imposition
of
regulatory
controls
pending
the
development
of
information.
In
those
cases,
a
non­
5(
e)
SNUR
may
be
the
most
appropriate
regulatory
alternative
for
EPA
to
pursue,
as
it
will
allow
the
PMN
submitter
to
proceed
with
planned
activities
while
requiring
notification
to,
and
review
by,
EPA
for
activities
which
have
not
been
reviewed
and
may
involve
significantly
increased
exposures.
Such
review
will
be
undertaken
upon
receipt
of
a
SNUN.

123­
8.
Q.
How
can
I
determine
whether
my
substance
is
subject
to
a
SNUR?

A.
To
facilitate
determining
whether
a
substance
is
subject
to
a
SNUR,
substances
on
the
Inventory
that
are
subject
to
SNUR
requirements
are
indicated
by
an
"
S"
flag
in
the
Inventory
listing
(
In
electronic
versions
of
the
Inventory,
the
flags
may
be
on
another
line,
rather
than
following
the
substance
name.)
If
your
chemical
substance
is
subject
to
a
SNUR
and
you
intend
to
engage
in
an
activity
defined
as
a
"
significant
new
use"
in
the
SNUR,
you
would
be
required
to
submit
a
SNUN
to
EPA
at
least
90
days
before
commencing
that
activity.

Several
options
are
available
to
ascertain
the
TSCA
Inventory/
SNUR
status
of
a
chemical
Section
1:
General
Program
Information
1­
64
substance.
See
Q&
A
section102.
Information
on
non­
confidential
chemical
substances
can
be
found
in
the
TSCA
Chemical
Substance
Inventory.
If
an
intended
manufacturer
submits
a
PMN
or
a
Notice
of
bona
fide
Intent
to
Manufacture
(
pursuant
to
40
CFR
§
720.25)
on
a
substance/
mixture
which
has
a
listing
on
the
Confidential
Inventory,
EPA
will
notify
the
submitter
of
the
existence
of
the
SNUR
when
it
informs
the
submitter
a
PMN
is
not
necessary.
Any
manufacturer
of
a
substance
subject
to
a
SNUR
must
notify
anyone
they
distribute
the
substance
to
about
the
SNUR.

124
Pollution
Prevention
124­
1.
Q.
What
type
of
pollution
prevention
information
does
EPA
want?

A.
EPA
would
like
to
collect
information
on
pollution
prevention
activities,
such
as
source
reduction
and
recycling.
In
addition,
EPA
would
like
waste
management
information
(
i.
e.,
treatment,
and
disposal
data).
This
information
will
be
used
in
the
evaluation
of
the
new
chemical
substance
and
in
comparison
of
the
relative
risks
and
benefits
of
the
substance
as
a
substitute
for
substances
currently
on
the
market.
The
PMN
form
(
EPA
Form
7710­
25)
encourages
submitters
to
report
on
page
11
any
and
all
relevant
information
not
reported
elsewhere
which
is
believed
to
be
important
for
a
thorough
regulatory
evaluation.
There
is
a
substantial
discussion
of
how
to
provide
this
information
in
the
PMN
Manual,
posted
at
www.
epa.
gov/
oppt/
newchems/
tscaman2.
pdf.

125
Recycling
125­
1.
Q.
An
intending
recycler
will
take
articles
from
municipal
waste,
and
grind
and
melt
them
to
cast
them
into
new
articles.
The
recycler
will
make
a
good
faith
effort
to
select
articles
(
for
example,
soda
pop
bottles)
of
uniform
probable
composition,
but
the
chemistry
of
each
article
is
known
to
the
recycler
only
in
general
terms.
In
addition
to
the
intending
recycler's
lack
of
specific
knowledge
and
control
on
the
materials
in
the
articles,
it
is
expected
that,
if
any
new
chemical
substances
had
been
formed
during
final
manufacture
of
the
articles,
they
would
have
been
exempt
from
PMN
requirements
per
40
CFR
§
720.30(
h)(
6)
(
which
excludes
substances
that
form
during
the
manufacture
of
an
article
destined
for
the
marketplace
without
further
chemical
change
("
end­
use")).
Because
of
the
availability
of
the
(
h)(
6)
exclusion,
the
intending
recycler
believes
that
the
articles
were
probably
manufactured
without
premanufacture
notification
(
PMN)
to
EPA
for
any
new
substances
formed
during
manufacture.

The
recycler
intends
to
prepare
for
recycling
by
grinding,
chipping,
or
other
physical
manipulation.
No
actual
chemical
reactions
are
believed
to
be
involved
in
this
process,
just
the
physical
manipulation
of
the
material.
It
is
the
recycler's
plan
to
melt
the
material
and
cast
or
form
it
into
new
articles
for
sale.
Section
1:
General
Program
Information
1­
65
Is
a
PMN
required
for
this
activity?

A.
Where
no
chemical
reactions
are
believed
to
be
taking
place,
EPA
considers
melting
and
manual
grinding
to
constitute
"
processing"
under
TSCA,
and
a
PMN
would
thus
not
be
required.
However,
if
the
component
substances
in
the
articles
were
to
be
chemically
changed
(
e.
g.
partially
de­
synthesized,
depolymerized,
etc.,
e.
g.),
the
intending
recycler
would
need
to
submit
a
PMN
and
describe
the
material
using
a
reaction
product
or
process
type
name
that
indicates
the
nature
of
the
chemical
conversion.
See
40
CFR
720.(
3)(
s)
and
(
aa).

While
TSCA
holds
a
person
strictly
liable
for
the
illegal
manufacture
or
import
of
a
new
chemical
substance,
a
person
processing
an
illegally
manufactured
new
chemical
substance
would
not
be
in
violation
of
TSCA
unless
the
person
knew
or
had
reason
to
know
that
the
substance
had
been
illegally
manufactured.
See
§
15(
2)
of
TSCA.

126
New
Chemical
Exposure
Limits
126­
1.
Q.
What
are
New
Chemical
Exposure
Limits?

A.
New
Chemical
Exposure
Limits
(
NCELs)
are
workplace
respiratory
exposure
limits
established
in
TSCA
5(
e)
Consent
Orders
and
incorporated
by
reference
in
corresponding
TSCA
5(
a)(
2)
SNURs.
They
are
modeled
after
OSHA
Permissible
Exposure
Limits
("
PELs")
and
are
comprehensive
standards.
NCELs
set
what
are
considered
to
be
safe
airborne
concentrations
for
new
chemicals
that
may
cause
toxicity
via
inhalation
exposure.
Periodic
monitoring
is
required
and,
if
concentrations
above
the
NCEL
are
measured,
respirators
must
be
worn.

126­
2.
Q.
Where
can
I
find
the
actual
NCELs
values
listed
for
various
new
chemicals?

A.
The
internet
address
is
www.
epa.
gov/
oppt/
newchems/
nceltbl.
htm.
The
NCELs
values
originate
in
TSCA
§
5(
e)
Consent
Orders
that
are
signed
by
the
individual
PMN
submitters
who
propose
to
manufacture
the
PMN
substance.
The
NCELs
provisions
are
incorporated
by
reference
in
corresponding
TSCA
§
5(
a)(
2)
SNURs,
which
essentially
extend
the
requirements
of
the
§
5(
e)
Order
to
other
manufacturers
and
processors
of
the
same
chemical
substance.
SNURs
are
published
in
40
CFR
Part
721.
126­
3.
Q.
Where
does
EPA's
exposure
limit
jurisdiction
end
and
OSHA's
begin?

A.
There
will
generally
be
no
overlapping
regulation
of
new
chemicals,
because
EPA's
NCELs
apply
to
new
chemicals
with
little
or
no
data,
so
risk
assessment
is
generally
based
on
analog
data
from
similar
substances.
EPA
added
an
explicit
sunset
provision
to
its
§
5(
e)
Orders
which
states
that
the
NCEL
and
respirator
requirements
are
automatically
nullified
if
OSHA
promulgates
a
permissible
exposure
limit
(
PEL)
for
the
same
substance.
(
This
would
automatically
nullify
the
NCELs
in
SNURs
as
well,
since
the
NCELs
provisions
in
SNURs
simply
Section
1:
General
Program
Information
1­
66
incorporate
by
reference
the
§
5(
e)
Consent
Order
provision.)
EPA
may
raise
NCELs
cases
to
the
attention
of
OSHA
and
NIOSH,
in
the
unlikely
event
that
a
referral
is
warranted
by
the
toxicity
data
and
production
volume
associated
with
the
new
chemical
substance.

EPA
has
sought
to
make
its
program
consistent
with
OSHA's
wherever
possible.
EPA
has
ongoing
communication
with
OSHA
and
NIOSH
on
worker
protection
issues
and
has
solicited
input
on
the
NCELs
program.
EPA's
NCELs
provisions
are
modeled
after
OSHA
PELs
and
comprehensive
standards.

126­
4.
Q.
When
setting
NCELs
concentrations
for
specific
chemicals,
does
EPA
consider
feasibility
issues
and
relevant
concentration
limits
set
by
other
organizations?

A.
On
a
case­
by­
case
basis,
EPA
will
consider
setting
NCELs
concentrations
based
on
relevant
OSHA
PELs
and
American
Conference
of
Government
Industrial
Hygienists
(
ACGIH)
Threshold
Limit
Values
(
TLVs),
and
will
consider
economic
and
technological
feasibility,
especially
in
cases
where
there
is
sufficient
evidence
that
the
new
chemical
may
present
less
risk
than
existing
substances
which
the
new
chemical
may
replace.
Section
2:
Exclusions
2­
1
2.
EXCLUSIONS
201
Impurities
201­
1.
Q.
What
is
an
impurity?

A.
"
Impurity"
is
defined
at
40
CFR
§
720.3
to
mean
a
chemical
substance
which
is
unintentionally
present
with
another
chemical
substance.
The
term
"
manufacture
or
import
for
commercial
purposes"
also
applies
to
substances
that
are
produced
coincidentally
during
the
manufacture,
processing,
use,
or
disposal
of
another
substance
or
mixture,
including
byproducts
that
are
separated
from
that
other
substance
or
mixture
and
impurities
that
remain
in
that
substance
or
mixture.
Byproducts
and
impurities
without
separate
commercial
value
are
nonetheless
produced
for
the
purpose
of
obtaining
a
commercial
advantage,
since
they
are
part
of
the
manufacture
of
a
chemical
substance
for
commercial
purposes.
See
40
CFR
720.3(
r).

Information
on
all
impurities
anticipated
to
be
present
with
a
chemical
substance
must
be
included
in
a
PMN,
and
is
considered
in
the
assessment
of
risk
posed
by
that
substance.
Maximum
weight
percent,
as
well
as
the
CASRN,
if
available,
should
be
provided
on
page
6
of
the
§
5
submission
form.
If
the
impurities
are
unidentified,
their
presence
should
be
noted
and
their
total
weight
percent
estimated.

201­
2.
Q.
Are
impurities
included
in
the
chemical
identification
for
the
Inventory?

A.
No,
impurities
are
not
included
in
the
chemical
identification
for
the
Inventory
listing
of
a
chemical
substance.
EPA
has
determined
that
chemical
substances
which
are
identical
except
with
respect
to
their
impurities
will
not
receive
separate
Inventory
listings.
Impurities
that
are
discovered
in
a
chemical
substance
after
a
Notice
of
Commencement
(
NOC)
has
been
submitted
do
not
change
the
Inventory
status
of
the
chemical
substance.
If
there
are
unreasonable
risks
posed
by
impurities
present
in
existing
chemical
substances,
TSCA
§
4,
§
6,
§
7,
and
§
8
can
be
used
to
identify,
prevent,
and
reduce
those
risks.

This
differs
from
the
identification
of
a
new
component
determined
to
be
included
in
a
listed
chemical
substance,
when
that
component
has
commercial
value.
If
a
previously
unknown
commercially
valuable
component
is
found
in
a
listed
chemical
substance
and
if
the
listed
chemical
substance
including
the
new
component
is
determined
not
to
be
accurately
listed
on
the
Inventory,
then
the
manufacturer
of
the
component
chemical
substance
is
considered
to
be
the
manufacturer
of
a
new
chemical
substance.
The
submitter
should
contact
EPA
in
order
to
determine
whether
a
PMN
or
a
Form
C
(
Inventory
correction)
should
be
submitted.

201­
3.
Q.
At
what
level
do
impurities
become
insignificant,
i.
e.,
not
subject
to
reporting?
Section
2:
Exclusions
2­
2
A.
As
defined
in
40
CFR
§
720.3,
an
"
impurity"
means
a
chemical
substance
which
is
unintentionally
present
with
another
chemical
substance.
The
definition
is
not
based
on
the
amount
of
the
substance.
Impurities
at
any
level
are
significant
and
must
be
reported
as
impurities
in
§
5
notices,
to
the
extent
they
are
known
or
reasonably
ascertainable
by
the
submitter.
An
impurity
need
not,
itself,
be
the
subject
of
a
§
5
notice.
See
40
CFR
§
720.30(
h)(
1).

201­
4.
Q.
Is
there
a
restriction
on
the
level
or
amount
of
an
impurity
detected
in
a
chemical
substance?

A.
No.
There
is
no
restriction
on
the
level
or
amount
of
an
impurity
detected
in
a
chemical
substance.
Specifically,
there
is
no
relationship
between
the
impurity
reporting
requirements
and
the
2%
rule
which
applies
in
relation
to
polymers.

202
Mixtures
202­
1.
Q.
What
is
the
definition
of
a
mixture?

A.
"
Mixture"
is
defined
at
§
3(
8)
of
TSCA
and
40
CFR
§
720.3
as
any
combination
of
two
or
more
chemical
substances
if
the
combination
does
not
occur
in
nature
and
is
not,
in
whole
or
in
part,
the
result
of
a
chemical
reaction.
Mixture
also
includes
the
combination
which
occurs,
in
whole
or
in
part,
as
a
result
of
a
chemical
reaction
where
none
of
the
chemical
substances
comprising
the
combination
is
a
new
chemical
substance
and
where
the
combination
could
have
been
manufactured
for
commercial
purposes
without
a
chemical
reaction
at
the
time
the
chemical
substances
comprising
the
combination
were
combined.

202­
2.
Q.
Is
a
PMN
required
for
a
new
mixture?

A.
TSCA
§
5
requires
a
PMN
for
new
chemical
substances,
not
for
new
mixtures.
A
PMN
is
not
required
for
a
mixture
as
a
whole
entity.
However,
if
any
chemical
substance
which
is
included
in
the
mixture
is
a
new
chemical
substance,
a
PMN
is
required
to
be
submitted
for
that
new
chemical
at
least
90
days
before
a
submitter
intends
to
manufacture
or
import
the
mixture.
See
40
CFR
720.30(
b)
and
especially
its
footnote.

202­
3.
Q.
Are
multi­
nutrient
mixed
fertilizers
considered
mixtures
if
they
are
prepared
by
physically
blending
dry
products?

A.
A
multi­
nutrient
mixed
fertilizer
is
considered
a
mixture
of
the
ingredients
being
blended.
Such
multi­
nutrient
mixed
fertilizers
can
be
prepared
by
physically
blending
dry
products
such
as
urea,
superphosphate,
and
potash
or
by
a
method
that
involves
a
chemical
reaction,
such
as
by
combining
liquid
ammonium
phosphate
and
granulating
with
potash.
Per
the
definition
of
`
mixture'
at
40
CFR
720.3(
u),
these
substances
are
considered
mixtures
regardless
of
whether
Section
2:
Exclusions
2­
3
they
are
produced
by
physically
mixing
or
by
chemical
reaction.

202­
4.
Q.
Are
alloys,
inorganic
glasses,
ceramics,
frits,
and
cements,
including
Portland
cement,
considered
mixtures
under
TSCA?

A.
Yes,
alloys,
inorganic
glasses,
ceramics,
frits,
and
cements,
including
Portland
cement,
are
considered
statutory
mixtures
under
TSCA.
See
www.
epa.
gov/
oppt/
newchems/
mixtures.
txt.
In
general,
a
PMN
is
not
required
for
these
products.
However,
as
stated
in
a
note
at
40
CFR
§
710.4(
c)(
2)
and
40
CFR
§
720.30(
b),
the
exclusion
of
these
products
applies
only
to
the
mixture
and
not
to
the
chemical
substances
of
which
the
mixture
is
comprised.
Thus,
any
additive
which
is
contained
in
a
mixture,
other
than
an
impurity,
should
be
included
on
the
Inventory.
The
burden
of
reporting
is
incident
on
the
manufacturers
of
any
new
chemical
additive.

202­
5.
Q.
Does
the
definition
of
mixture
under
TSCA
include
hydrates?

A.
Yes.
EPA
views
a
hydrate
as
a
mixture
of
water
and
the
non­
hydrated
form
of
the
substance.
Hydrated
forms
of
chemical
substances
are
excluded
from
reporting
if
the
corresponding
anhydrous
chemical
substances
are
included
on
the
Inventory.
However,
this
provision
does
not
apply
to
the
products
of
discrete
chemical
reactions
in
which
either
water
or
a
solvent
is
a
reactant,
e.
g.,
water
reacting
with
an
ester
to
form
an
acid
and
an
alcohol.
See
40
CFR
720.3(
u)(
2).

202­
6.
Q.
A
submitter
is
manufacturing
an
alloy
and
the
individual
metals
are
on
the
Inventory,
is
a
PMN
required?

A.
No,
alloys
are
considered
to
be
mixtures.
As
long
as
all
the
components
comprising
the
mixture
are
on
the
Inventory,
a
PMN
is
not
required.
Intermetallic
compounds
of
well­
defined
stoichiometry
such
as
NbAl3
are
not
considered
alloys
and
should
be
reported.
Inventory
nomenclature
guidance
is
available
on
this
question
at
www.
epa.
gov/
oppt/
newchems/
mixtures.
txt
in
the
paper
entitled
Toxic
Substances
Control
Act
Inventory
Representation
For
Products
Containing
Two
or
More
Substances:
Formulated
and
Statutory
Mixtures.

203
Non­
isolated
Intermediates
203­
1.
Q.
What
is
a
nonisolated
intermediate?

A.
Nonisolated
intermediates
are
exempt
from
PMN
per
40
CFR
720.30(
h)(
8).
As
defined
at
40
CFR
720.3(
w),
a
"
nonisolated
intermediate"
is
any
intermediate
that
is
not
intentionally
removed
from
the
equipment
in
which
it
is
manufactured,
including
the
reaction
vessel,
and
any
equipment
through
which
the
chemical
substance
passes
during
a
continuous
flow
Section
2:
Exclusions
2­
4
process,
but
not
including
tanks
or
other
vessels
in
which
the
substance
is
stored
after
its
manufacture.
Questions
on
specific
manufacturing
processes
should
be
directed
to
the
Prenotice
Communication
Coordinator.
A
fact
sheet
on
nonisolated
intermediates
is
available
from
the
TSCA
Hotline.

203­
2.
Q.
What
is
an
isolated
intermediate?

A.
An
isolated
intermediate
is
defined
in
part
as
any
chemical
substance
intentionally
removed
from
the
equipment
in
which
it
is
manufactured.
See
40
CFR
720.3(
w).
This
phrase
includes
the
reaction
vessel
in
which
the
substance
was
manufactured
and
other
equipment
which
is
strictly
ancillary
to
the
reaction
vessel,
and
any
other
equipment
through
which
the
chemical
may
flow
during
a
continuous
flow
process,
but
does
not
include
tanks
or
other
vessels
in
which
the
chemical
substance
is
stored
after
its
manufacture.

Some
manufacturers
have
questioned
whether
storage
for
a
period
of
two
or
three
hours
is
still
considered
to
be
part
of
a
continuous
flow
process.
Without
a
complete
description
of
the
manufacturing
operation,
it
is
difficult
to
give
a
precise
answer.
In
general,
any
chemical
substances
which
are
held
temporarily
in
an
otherwise
continuous
flow
process
for
purposes
that
are
clearly
related
to
the
necessity
of
the
manufacturing
process
­
such
as
heating,
cooling,
filtration
or
reaction
­
are
not
considered
reportable,
while
those
that
are
held
principally
for
purposes
of
storage
would
be
considered
reportable.
If
manufacturers
have
further
questions,
they
should
consult
EPA
individually.

The
following
examples
offer
clarification:

(
1)
Reaction
in
the
Same
Vessel:
Reactants
A
and
B
are
charged
to
a
reaction
vessel
to
form
a
chemical
substance
X.
Then
C
is
added
to
react
with
X
to
form
another
substance
Y,
which
is
then
drummed
for
shipment.
In
this
example,
X
is
considered
to
be
nonisolated,
since
it
is
not
intentionally
removed
from
the
process
equipment
of
manufacture.
Y
will
be
considered
to
be
isolated,
since
it
is
intentionally
removed
by
drumming
for
transport.

(
2)
Reaction
in
one
vessel
with
Purification
in
Another
and
Transfer
to
a
Second
Vessel:
The
reaction
is
carried
out
in
one
enclosed
reactor
and
the
reaction
mixture
is
then
pumped
through
an
enclosed
drum
filter
to
another
vessel
for
the
next
reaction
step.
The
reaction
intermediate
is
considered
to
be
nonisolated
since
there
is
no
intentional
removal
and
all
transfer
is
mechanical
and
through
closed
equipment.
However,
if
the
filtration
is
not
closed
or
if
the
transfer
is
manual
(
for
example,
involving
the
removal
of
the
intermediate
as
a
filter
cake),
then
the
intermediate
would
be
considered
to
be
isolated
since
the
transfer
would
not
be
through
closed
equipment.
A
similar
interpretation
applies
to
other
processing
steps
between
manufacture
and
subsequent
reaction
(
e.
g.,
distillation,
drying
size
reduction,
etc.).

In
the
case
of
batch
processes,
which
for
purposes
of
discussion
also
includes
Section
2:
Exclusions
2­
5
semi­
continuous
processes,
intentional
storage
is
considered
isolation,
regardless
of
whether
the
equipment
is
closed
or
not.
As
discussed
in
the
March
6,
1978
Federal
Register
(
43
FR
9256),
any
chemical
substances
which
are
held
temporarily
in
an
otherwise
continuous
flow
process
principally
for
purposes
of
storage
are
considered
reportable.
The
fact
that
a
material
remains
in
the
reaction
vessel
for
a
period
of
time
does
not
determine
whether
the
material
is
isolated
and
must
be
reported.
It
is
a
matter
of
intent:
if
the
residence
time
is
for
storage
purposes,
the
material
is
reportable.
If
the
material
is
held
for
a
non­
storage
purpose
(
e.
g.,
if
holding
an
intermediate
in
a
vessel
is
to
provide
for
maintenance
or
repair),
it
is
not
considered
to
be
isolated.
The
period
of
time
is
not
crucial,
as
long
as
the
intent
is
not
for
storage.

As
an
example,
the
annual
removal
and
replacement
of
an
enzyme
catalyst
used
in
the
production
process
or
the
exchange
of
filters
during
routine
maintenance
would
not
affect
the
nonisolated
status
of
an
intermediate
in
an
otherwise
closed
system.
However,
if
a
filter
is
opened
to
manually
transfer
a
filter
cake
containing
an
intermediate
substance,
this
intermediate
is
considered
to
be
isolated.
In
addition,
the
removal
of
samples
of
an
intermediate
substance
strictly
for
quality
control
testing
would
not
affect
the
nonisolated
status
of
an
intermediate
substance.

203­
3.
Q.
What
is
the
difference
between
a
batch
and
continuous
flow
process?

A.
In
a
batch
process,
a
reaction
occurs
when
the
reagents
are
charged
as
a
fixed
quantity
(
usually
expressed
as
mass
per
batch)
and
the
reaction
is
allowed
to
go
to
completion.
In
a
continuous
reaction,
the
reagents
are
added
continuously
(
generally
given
in
terms
of
mass
per
unit
time)
and
the
reaction
mixture
is
constantly
flowing;
its
residence
time
in
any
piece
of
equipment
can
only
be
given
by
a
probability
function.

EPA
defines
"
nonisolated
intermediate"
at
40
CFR
720.3(
w)
as
"
any
intermediate
that
is
not
intentionally
removed
from
the
equipment
in
which
it
is
manufactured
....
but
not
including
tanks
or
other
vessels
in
which
the
substance
is
stored
after
its
manufacture."
"
In
general,
any
chemical
substances
which
are
held
temporarily
in
an
otherwise
continuous
flow
process
for
purposes
that
are
clearly
related
to
the
necessity
of
the
manufacturing
process
 
such
as
heating,
cooling,
filtration
or
reaction
 
are
not
considered
reportable,
while
those
that
are
held
principally
for
purposes
of
storage
would
be
considered
reportable."
43
FR
9256,
March
6,
1978.

203­
4.
Q.
Does
removal
of
substance
from
a
reaction
vessel
for
sampling
constitute
isolation?

A.
Quality
control
sampling
of
a
nonisolated
intermediate
is
not
isolation
and
does
not
disqualify
the
intermediate
from
the
premanufacture
notification
exclusion
for
nonisolated
intermediates
at
40
CFR
720.30
(
h)(
8).

204
Byproducts
Section
2:
Exclusions
2­
6
204­
1.
Q.
What
is
the
definition
of
a
byproduct?

A.
As
defined
at
40
CFR
720.3(
d),
a
"
byproduct"
is
a
chemical
substance
produced
without
a
separate
commercial
intent
during
the
manufacture,
processing,
use,
or
disposal
of
another
chemical
substance
or
mixture.
Byproducts
and
impurities
without
separate
commercial
value
are
nonetheless
produced
for
the
purpose
of
obtaining
commercial
advantage,
since
they
are
part
of
the
manufacture
of
a
chemical
substance
for
commercial
purposes.
See
40
CFR
720.3(
r).
A
byproduct
is
subject
to
notification
requirements
unless
its
only
commercial
purpose
is
use
by
public
or
private
organizations
that
burn
it
as
a
fuel,
dispose
of
it
as
a
waste,
or
extract
component
chemical
substances
from
it
for
commercial
purposes.
See
40
CFR
720.30(
g).
(
This
exclusion
only
applies
to
the
byproduct;
it
does
not
apply
to
any
component
substances
extracted
from
the
byproduct.)
In
addition,
any
byproduct
which
is
not
used
for
commercial
purposes
is
not
subject
to
notification
requirements.
See
TSCA
§
5(
i)
and
40
CFR
720.22.

204­
2.
Q.
A
product
is
already
on
the
TSCA
Inventory
but
its
by­
product
is
not
listed
in
the
Inventory.
At
a
later
date,
if
there
is
a
demand
for
the
by­
product,
is
the
manufacturer
required
to
submit
a
PMN
before
he
begins
to
manufacture
the
by­
product
for
commercial
purposes?

A.
Yes,
you
must
submit
a
PMN
if
a
by­
product
begins
to
be
produced
with
a
separate
commercial
intent,
unless
its
only
commercial
purpose
is
for
use
by
public
or
private
organizations
that
burn
it
as
fuel,
dispose
of
if
as
waste,
or
extract
component
chemical
substances
from
it
for
commercial
purposes,
per
40
CFR
720.30(
g).

204­
3.
Q.
Can
a
by­
product
which
is
not
on
the
Inventory
be
used
as
an
intermediate
in
the
manufacture
of
another
chemical
substance
which
is
on
the
Inventory?

A.
Not
without
first
submitting
a
PMN.
As
with
any
new
chemical,
use
as
a
raw
material
or
intermediate
in
the
manufacture
of
another
chemical
is
commercial
use
requiring
submission
of
a
PMN,
unless
the
by­
product
is
on
the
Inventory
or
has
gone
through
PMN
review.
A
by­
product
cannot
(
unless
it
is
never
isolated)
be
used
in
manufacture.

204­
4.
Q.
We
have
filed
a
PMN
and
the
90­
day
review
period
has
expired.
This
is
a
material
which,
until
now,
had
been
manufactured
as
a
waste
byproduct
that
was
typically
disposed
of
by
incineration
(
and
thus
was
exempted
from
PMN
at
40
CFR
§
720.30(
g)(
2)).
Can
we
now
distribute
material
which
had
been
generated
prior
to
the
expiration
date
of
the
PMN
review
period?

A.
Until
the
PMN
review
period
is
over,
a
new
chemical
cannot
be
manufactured
for
commercial
use
or
sale.
During
the
review
period,
the
only
permitted
manufacture
is
for
R&
D
purposes
or
for
disposal
as
a
waste.
Obviously,
once
the
substance
is
manufactured
with
the
intention
of
being
used
for
TSCA­
nonexempt
purposes,
it
is
subject
to
PMN
requirements
if
it
is
Section
2:
Exclusions
2­
7
not
already
included
on
the
TSCA
Chemical
Substance
Inventory
(
Inventory).
See
40
CFR
720.30(
g).

Once
the
PMN
review
period
has
expired,
if
the
substance
was
previously
manufactured
as
a
byproduct,
and
was
stored
with
the
intent
that
it
would
be
disposed
of
in
case
the
PMN
was
not
approved,
it
may
be
used
for
commercial
purposes.
However,
a
Notice
of
Commencement
(
NOC)
cannot
be
filed
until
the
first
manufacture
with
intent
for
commercial
use
after
the
end
of
the
90­
day
PMN
review
period.

The
material
manufactured
prior
to
the
termination
of
the
90­
day
PMN
review
has
to
be
dealt
with
as
a
substance
manufactured
for
R&
D
purposes,
thus
subject
to
the
R&
D
procedural
and
record
keeping
requirements
at
40
CFR
720.36
and
720.78.

Once
a
NOC
has
been
filed
on
later
(
post­
PMN
review)
manufacture
of
the
same
material,
the
material
produced
prior
to
the
termination
of
the
90­
day
PMN
review
period
can
also
be
used
for
commercial
purposes.

205
End
Use
Reactions
205­
1.
Q.
When
is
a
chemical
substance
that
is
formed
upon
end
use
of
another
chemical
substance
(
which
is
on
the
Inventory)
not
subject
to
notification
requirements?

A.
40
CFR
§
720.30(
h)(
5)
excludes
from
PMN
requirements
"
any
chemical
substance
which
results
from
a
chemical
reaction
that
occurs
upon
end
use
of
another
chemical
substance,
mixture,
or
article
such
as
an
adhesive,
paint,
miscellaneous
cleanser
or
other
housekeeping
product,
fuel
additive,
water
softening
and
treatment
agent,
photographic
film,
battery,
match,
or
safety
flare,
and
which
is
not
itself
manufactured
or
imported
for
distribution
in
commerce
or
for
use
as
an
intermediate."

206
Modifier
of
Physicochemical
Characteristics
206­
1.
Q.
When
is
a
substance
that
modifies
a
physicochemical
characteristic
not
subject
to
notification
requirements?

A.
A
substance
is
subject
to
notification
requirements
even
if
its
sole
intention
is
to
act
as
a
modifier
of
a
physicochemical
characteristic.
This
is
to
be
distinguished
from
a
chemical
substance
that
is
exempt
from
PMN
notification
requirements
under
40
CFR
720.30(
h)(
7)(
ii)
if
it
results
from
a
chemical
reaction
that
occurs
when
a
chemical
substance
intended
solely
to
modify
a
specific
physicochemical
characteristic,
functions
as
intended.

207
Articles
Section
2:
Exclusions
2­
8
207­
1.
Q.
What
is
the
definition
of
an
article?

A.
"
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
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
described
in
40
CFR
§
710.4(
d)(
5)
and
40
CFR
§
720.30(
h)(
5),
except
that
fluids
and
particles
are
not
considered
articles
regardless
of
shape
or
design.
Substances
imported
as
part
of
an
article
are
exempt
from
PMN
per
40
CFR
720.22(
b)(
1),
and
certain
chemicals
formed
during
manufacture
of
an
article
are
exempt
from
PMN
per
40
CFR
720.30(
h)(
6).

207­
2.
Q.
Is
brake
fluid
in
a
domestically
manufactured
car
reportable?
Is
brake
fluid
in
an
imported
car
reportable?
Is
the
same
brake
fluid
imported
in
a
drum
reportable?

A.
A
substance
such
as
brake
fluid
would
be
subject
to
premanufacture
notification
when
made
for
installing
in
a
vehicle
that
is
manufactured
domestically.
With
respect
to
imports,
40
CFR
section
720.22(
b)(
1)
states,
that
"
Any
person
who
intends
to
import
a
new
chemical
substance
into
the
United
States
for
commercial
purposes
must
submit
a
notice,
unless
the
substance
is
excluded
under
section
720.30
or
unless
the
substance
is
imported
as
part
of
an
article."
Chemical
substances
or
mixtures
will
be
considered
to
be
imported
as
part
of
an
article
if
the
substance
or
mixture
is
not
intended
to
be
removed
from
that
article
and
has
no
end
use
or
commercial
purpose
separate
from
the
article
of
which
it
is
a
part.
Chemical
substances
or
mixtures
which
are
imported
within
articles
such
as
drums,
barrels,
or
other
containers
used
for
purposes
of
transportation
or
containment
are
considered
to
be
chemical
substances
imported
in
bulk
and
are
subject
to
PMN
reporting
requirements,
because
they
are
intended
to
be
removed
from
the
container
eventually
and
have
an
end
use
or
commercial
purpose
separate
from
the
container.

Therefore,
brake
fluid
is
exempt
from
Inventory/
PMN
reporting
when
imported
as
a
component
of
an
article
(
for
example
in
the
brake
system
of
an
imported
car),
provided
the
article
which
it
accompanies
in
commerce
is
not
solely
a
container
for
it,
and
it
is
not
intended
to
be
released
during
use,
and
does
not
serve
a
function
during
use
that
is
related
to
its
release.
However,
brake
fluid
imported
in
a
drum
would
be
reportable.

207­
3.
Q.
Is
a
pen
an
article?
Is
the
ink
in
the
pen
a
part
of
an
article?

A.
A
pen
meets
the
definition
of
an
article
at
40
CFR
720.3(
c).
However,
the
ink
is
intended
for
release
during
use,
and
thus
is
not
exempt
from
PMN
requirements.
(
Refer
to
the
above
question).
Section
2:
Exclusions
2­
9
207­
4.
Q.
Is
a
candle
an
article?
Is
the
substance
released
by
a
candle
as
it
burns
considered
part
of
an
article?

A.
A
candle
meets
the
definition
of
an
article
at
40
CFR
720.3(
c).
With
respect
to
the
combustion
products
of
a
candle,
40
CFR
720.30(
h)(
5)
excludes
from
PMN
requirements
any
chemical
substance
which
results
from
a
chemical
reaction
that
occurs
upon
end
use
of
an
article
and
which
is
not
itself
manufactured
or
imported
for
distribution
in
commerce
or
for
use
as
an
intermediate.
Therefore,
combustion
products
of
a
candle
are
exempt.

207­
5.
Q.
Is
a
candle
or
pen
that
contains
a
new
chemical
substance
excluded
from
premanufacture
notification?

A.
A
substance
that
forms
during
the
manufacture
of
an
article
destined
for
the
marketplace
without
further
chemical
change
is
excluded
from
premanufacture
notification
per
40
CFR
720.30(
h)(
6).
Thus,
any
new
substances
which
comprise
the
candle
or
pen
would
be
excluded
from
PMN
reporting
as
part
of
an
article,
but
new
substances
isolated
before
the
domestic
manufacture
of
a
candle
or
pen
would
be
reportable.
On
the
other
hand,
ink,
which
is
intended
to
be
released
from
the
pen
is
not
exempt.
See
Q&
A
#
207­
3.

207­
6.
Q.
Are
fibrous
materials
considered
articles?

A.
They
can
be.
Fibrous
materials
are
considered
articles
(
see
40
CFR
§
710.2(
f)
&
§
720.3(
c))
if
their
end­
use
functions
depend
in
whole
or
in
part
upon
their
shape
or
design
and
they
are
functional
in
their
end­
use
without
a
change
of
chemical
composition
except
for
changes
that
have
no
commercial
purpose
separate
from
the
articles
of
which
they
are
a
part.
If
a
person
shapes
a
chemical
substance
into
a
filament
or
fiber,
he
would
be
a
processor
of
that
substance
and
would
not
have
to
report
the
fiber
based
on
the
fact
that
the
final
product
of
the
processing
meets
the
definition
of
an
article.
The
chemical
substance
would
be
reportable
by
the
manufacturer.
However,
if
that
fibrous
material
was
intended
to
be
used
as
an
intermediate
in
the
manufacture
of
another
chemical
substance,
it
would
not
be
considered
an
article,
but
rather
a
chemical
substance
or
mixture.
Particles
are
not
articles
whether
they
are
round
or
asymmetric.
If
a
whisker
or
other
fibrous
material
may
be
used
as
a
particle
in
its
subsequent
processing,
it
would
not
be
considered
an
article.

207­
7.
Q.
Are
dyes
and/
or
fire
retardants
excluded
from
reporting
with
regard
to
the
finishing
process
of
an
article?

A.
The
intent
of
the
exclusions
at
40
CFR
§
§
710.5(
d)(
6)
and
720.30(
h)(
6)
with
regard
to
the
finishing
process
of
an
article
(
i.
e.,
dyes
and
fire
retardants)
is
to
exclude
chemical
substances
that
are
not
manufactured
for
distribution
in
commerce
as
a
chemical
substance
per
se
and
have
no
commercial
purpose
separate
from
the
mixture
or
article
of
which
they
may
be
a
part.
This
Section
2:
Exclusions
2­
10
excludes
chemical
substances
formed
when
the
dye
or
fire
retardant
reacts
with
fibers
of
a
garment
or
other
article
upon
end­
use
of
those
substances
by
a
processor.
The
dyes
and
fire
retardants
themselves
are
not
excluded
from
reporting
requirements
if
applied
domestically,
but
could
be
exempt
when
imported
as
part
of
an
article.
End­
use
reaction
products
should
not
be
reported.

207­
8.
Q.
Please
clarify
what
is
covered
by
the
article
exemption:
what
about
chemical
components
of
articles?

A.
"
Article"
is
defined
at
40
CFR
§
720.3(
c).
In
general,
an
item
would
meet
the
definition
of
an
article
if
it
is
manufactured
in
a
specified
shape
or
design
for
a
particular
end
use
application,
and
this
design
is
maintained
as
an
essential
feature
in
the
finished
product.
An
example
would
be
an
automobile
bumper,
which
had
to
fit
the
auto
model
for
which
it
is
made.
If
an
item
is
manufactured
in
a
particular
shape
for
the
purpose
of
shipping
convenience
and
the
shape
of
the
item
has
no
function
in
the
end
use,
it
would
not
be
viewed
as
an
article.
An
example
would
be
a
metal
ingot,
or
a
pellet
intended
to
be
melted
and
extruded
in
the
manufacture
of
an
article.

Chemical
substances
that
are
imported
"
as
part
of
an
article"
are
excluded
from
the
PMN
requirements
by
40
CFR
§
720.22
(
b)(
1).
It
is
EPA's
policy
that
a
chemical
substance
is
not
"
part
of
an
article"
where
(
1)
the
article
is
a
container
of
the
substance
used
to
transport,
contain,
and/
or
dispense
it,
and/
or
(
2)
the
substance
is
intended
to
be
removed
(
or
released)
from
the
article
and
has
an
end
use
or
commercial
purpose
separate
from
the
article.
A
substance
which
is
intended
to
be
removed
or
released
from
its
article/
container,
and
serves
a
function
during
use
related
to
the
removal/
release
of
the
substance,
is
considered
to
have
an
end
use
or
commercial
purpose
separate
from
the
article.
Components
contained
by
articles
that
are
released
upon
end
use
and
have
a
function
separate
from
the
article
are
subject
to
PMN
reporting
requirements.
Depending
on
circumstances,
the
same
component
can
meet,
or
not
meet,
the
criteria.
For
example,
brake
fluid
contained
in
the
brake
cylinder
of
an
imported
automobile
would
be
part
of
the
automobile,
which
is
an
article.
The
same
brake
fluid
contained
in
a
can
(
which
is
an
article),
and
intended
to
be
installed
in
the
automobile
after
import,
is
considered
to
have
an
end
use
or
commercial
purpose
separate
from
the
article.

207­
9.
Q.
Would
a
chemical
substance
formed
upon
end
use
of
an
article,
such
as
adhesive
or
photographic
film,
be
subject
to
notification
requirements?

A.
No.
40
CFR
§
720.30(
h)(
5)
provides
that
any
chemical
substance
which
results
from
a
chemical
reaction
that
occurs
upon
end
use
of
another
chemical
substance,
mixture,
or
article
such
as
an
adhesive,
paint,
miscellaneous
cleanser
or
other
housekeeping
product,
fuel
additive,
water
softening
and
treatment
agent,
photographic
film,
battery,
match,
or
safety
flare,
and
which
is
not
itself
manufactured
or
imported
for
distribution
in
commerce
or
for
use
as
an
intermediate,
is
Section
2:
Exclusions
2­
11
excluded
from
notification
requirements.

207­
10.
Q.
Would
a
chemical
substance
that
results
from
a
chemical
reaction
that
occurs
upon
use
of
any
other
chemical
substance,
and
formed
during
the
manufacture
of
an
article,
such
as
curable
plastic,
be
subject
to
notification
requirements?

A.
No.
40
CFR
§
720.30(
h)(
6)
exempts
any
chemical
substance
which
results
from
a
chemical
reaction
that
occurs
upon
use
of
curable
plastic
or
rubber
molding
compounds,
inks,
drying
oils,
metal
finishing
compounds,
adhesives,
or
paints,
or
any
other
chemical
substance
formed
during
the
manufacture
of
an
article
destined
for
the
marketplace
without
further
chemical
change
of
the
chemical
substance
except
for
those
chemical
changes
that
occur
as
described
elsewhere
in
§
720.30(
h)
is
excluded
from
notification
requirements.

208
The
Two
Percent
Rule
for
Polymers
208­
1.
Q.
Please
explain
the
changes
in
the
"
two
percent
rule"
for
polymers.

A.
The
"
two
percent
rule,"
which
has
been
in
effect
since
1977,
allows
manufacturers
and
importers
of
polymers
to
add
monomers
or
other
reactants
to
an
Inventory­
listed
polymer
at
levels
of
2
percent
or
less
(
based
on
the
dry
weight
of
the
manufactured
polymer)
without
being
considered
to
have
made
a
polymer
with
a
different
chemical
identity
than
the
Inventory­
listed
polymer.
The
two
percent
rule
also
serves
as
a
basis
for
determining
the
identity
of
a
polymer
that
must
be
reported.
This
method
is
calculated
based
on
the
weight
percentage
of
the
monomer
or
other
reactant
"
charged"
to
the
reaction
vessel.
The
1995
amendments
to
the
New
Chemicals
Program
regulations
(
60
Federal
Register
16298,
16310,
40
CFR
720.45(
a)(
2)(
iii))
allow
persons
greater
flexibility
in
determining
the
two
percent
level.
In
addition
to
being
able
to
use
the
"
charged"
method,
the
1995
amendments
allow
persons
to
use
an
alternative
method,
e.
g.,
to
determine
the
amount
of
monomer
or
other
reactant
that
is
"
chemically
incorporated
(
chemically
combined)"
in
a
polymer,
and
to
report
the
minimum
weight
percent
of
that
monomer
or
reactant
that
is
needed
in
theory
to
account
for
the
amount
incorporated.
A
manufacturer
is
free
to
use
either
method
to
determine
a
two
percent
level,
however
the
"
incorporated"
method,
while
providing
more
flexibility,
also
requires
supporting
analytical
data
or
theoretical
calculations
per
720.45(
a)(
2)(
iv).

This
change
in
the
"
two
percent
rule"
applies
to
all
polymers
under
TSCA,
including
Inventory
listings,
PMN
submissions,
and
Polymer
Exemptions.

208­
2.
Q.
In
light
of
the
modified
"
two
percent
rule,"
which
now
allows
reporting
of
polymers
as
incorporated
as
well
as
charged,
can
all
polymer
listings
on
the
Inventory
now
be
read
either
as
incorporated
or
as
charged?
Section
2:
Exclusions
2­
12
A.
Yes.
All
polymers
on
the
Inventory
can
be
interpreted
either
as
incorporated
or
as
charged.
Remember
that
"
incorporated"
means
the
minimum
amount
that
theory
requires
to
be
charged
in
order
to
account
for
the
amount
of
monomer/
reactant
molecules
or
fragments
found
in
the
polymer
itself.

208­
3.
Q.
Does
a
manufacturer
need
to
test
every
batch
of
polymer
to
prove
that
less
than
two
percent
is
incorporated,
or
would
one
documented
test
on
a
typical
batch
be
sufficient?

A.
A
company
is
not
required
to
test
every
batch,
but
is
required
to
maintain
in
its
records
analytical
data
or
theoretical
calculations
to
demonstrate
compliance
with
the
"
two
percent
rule"
when
using
the
"
incorporated"
method.
See
40
CFR
720.28.
If
the
amount
normally
incorporated
is
expected
to
be
close
enough
to
two
percent
that
occasional
batches
might
exceed
that
level,
either
more
frequent
testing,
or
always
considering
the
reactant
to
be
part
of
the
chemical
identity,
or
manufacturing
a
separate
exempt
polymer
with
the
reactant
present
at
greater
than
two
percent
and
included
in
the
polymer
identity,
might
be
appropriate.

208­
4.
Q.
If
a
non­
Inventory­
listed
monomer
is
charged
or
incorporated
at
less
than
or
equal
to
two
percent
can
the
resultant
polymer
still
be
eligible
for
the
Polymer
Exemption?

A.
Yes.
However,
under
§
5(
a),
if
a
monomer
or
other
reactant
is
not
on
the
Inventory
or
otherwise
excluded
from
reporting
or
exempted
from
§
5
requirements,
it
cannot
be
used
for
domestic
manufacture,
regardless
of
its
concentration
in
the
product
polymer.

A
polymer
containing
a
non­
Inventory­
listed
monomer
at
less
than
or
equal
to
two
percent
may
be
eligible
for
the
polymer
exemption
provided
that
the
monomer
does
not
"
introduce
into
the
polymer
elements,
properties,
or
functional
groups
that
would
render
the
polymer
ineligible
for
the
exemption".
40
CFR
723.250(
g)(
1).

It
is
important
to
note
that
a
non­
Inventory­
listed
monomer
that
is
not
on
the
list
of
permitted
reactants
for
the
§
723.250(
e)(
3)
exemption
(
polyesters)
will
render
it
ineligible
for
that
exemption.
There
are
in
fact
reactants
on
that
list
that
are
not
on
the
Inventory.
These
are
not
subject
to
the
two
percent
limitation,
since
they
have
already
been
reviewed
for
inclusion
in
this
list
by
EPA
and
are
considered
not
to
be
of
concern.

208­
5.
Q.
Can
polymers
that
utilize
less
than
or
equal
to
two
percent
of
non­
Inventory
listed
monomers
be
eligible
for
the
Polymer
exemption?

A.
Such
polymers
would
be
eligible
for
exemption
as
long
as
they
meet
all
the
other
exemption
criteria.
However,
a
monomer
used
at
any
concentration
must
be
on
the
Inventory
or
exempt
before
it
can
be
used
in
the
domestic
manufacture
of
the
polymer.
Section
2:
Exclusions
2­
13
208­
6.
Q.
A
prepolymer
that
is
on
the
Inventory,
is
used
to
make
a
polymer.
The
prepolymer
contains
a
non­
Inventory
monomer,
and
the
final
polymer
contains
greater
than
two
percent
of
that
monomer.
Will
my
polymer
be
ineligible
for
the
Polymer
exemption?

A.
Not
on
the
basis
of
the
non­
Inventory
monomer;
§
723.250(
d)(
4)
bars
the
use
of
"
monomers
and/
or
other
reactants...
that
are
not
already
included
on
the
TSCA
Chemical
Substance
Inventory...".
However,
in
this
case
the
Inventory­
listed
prepolymer
is
the
reactant
that
is
actually
charged
to
the
polymerization
reaction
vessel.
Thus,
the
polymer
is
eligible
for
exemption
as
long
as
it
meets
all
the
other
exemption
criteria.
The
name
of
the
final
polymer
will
include
the
non­
Inventory­
listed
monomer
if
the
prepolymer
is
identified
for
TSCA
Inventory
purposes
with
a
random
monomer­
based
polymer
name.

208­
7.
Q.
If
an
initiator
is
incorporated
at
no
more
than
two
percent,
does
it
have
to
be
on
the
TSCA
Inventory
for
the
polymer
to
be
eligible
for
the
Polymer
Exemption?

A.
An
initiator
or
other
reactant
present
at
no
more
than
two
percent
does
not
have
to
be
on
the
Inventory
for
a
polymer
to
be
eligible
for
the
Polymer
exemption.
However,
if
the
reactant
is
not
on
the
Inventory,
it
cannot
be
used
for
commercial
manufacture
in
the
United
States.
Consequently,
this
discussion
will
for
all
practical
purposes
be
applicable
only
to
imported
polymers.
See
the
Polymer
Exemption
Guidance
Manual
at
www.
epa.
gov/
opptintr/
newchems/
polyguid.
pdf
for
more
details.

208­
8.
Q.
Can
I
use
less
than
or
equal
to
two
percent
of
any
monomer
that
is
on
the
Inventory
and
still
be
eligible
for
the
Polymer
Exemption?

A.
Yes,
as
long
as
that
monomer
does
not
introduce
elements,
groups
or
properties
that
would
render
the
polymer
ineligible
at
the
concentration
of
monomer
used.
Note,
though,
that
for
the
§
723.250(
e)(
3)
"
polyester"
exemption,
all
components
of
the
polymer
must
be
on
the
list
of
allowable
reactants.
In
this
case
the
use
of
non­
listed
monomers,
even
at
two
percent
or
less,
would
render
the
polymer
ineligible
for
the
(
e)(
3)
exemption.

208­
9.
Q.
If
the
"
chemically
combined"
method
is
used
and
a
company
claims
that
two
percent
or
less
of
a
reactant
is
incorporated
into
the
polymer
even
though
the
company
charges
a
higher
level
to
the
reaction
vessel,
what
records
need
to
be
maintained?

A.
The
company's
records
must
contain
analytical
data
or
appropriate
theoretical
calculations
to
demonstrate
that
the
minimum
weight
of
monomer
or
other
reactant
required
in
theory
to
account
for
the
actual
weight
of
monomer
of
other
reactant
molecules
or
fragments
chemically
incorporated
is
2
percent
or
less.
In
addition,
your
records
should
take
into
account
potential
batch­
to­
batch
variation.
See
40
CFR
723.250(
j).
Section
2:
Exclusions
2­
14
208­
10.
Q.
If
a
TSCA­
listed
brominated
flame
retardant
is
mixed
at
greater
than
two
percent
in
a
polymer
base,
is
the
polymer
subject
to
PMN
requirements
or
is
it
exempt?

A.
The
material
is
considered
to
be
a
mixture
of
polymer
and
the
flame
retardant.
Mixtures
are
not
subject
to
reporting
under
TSCA,
provided
that
there
is
no
intended
reaction
between
the
components
of
the
mixture.
The
components
of
the
mixture
are
separately
subject
to
reporting
if
they
are
not
on
the
Inventory.
See
Q&
A
section
202
above
and
40
CFR
720.3(
u).
If
they
are
both
on
the
Inventory,
no
reporting
is
required.
If
the
polymer
is
eligible
for
the
exemption,
the
presence
of
the
other
component
will
not
render
it
ineligible.
See
the
Polymer
Exemption
Guidance
Manual
at
www.
epa.
gov/
opptintr/
newchems/
polyguid.
pdf
for
more
details.

208­
11.
Q.
A
company
has
been
importing
a
polymer
containing
a
cross­
linking
agent
used
at
a
concentration
of
less
than
1%
by
weight.
If
the
cross­
linking
agent
is
used
at
a
level
greater
than
2%,
will
a
PMN
be
required?

A.
Monomers
and
other
reactants
(
including
cross­
linking
agents),
added
at
greater
than
2%
by
weight,
must
be
included
in
the
polymer
description
in
the
Inventory.
See
40
CFR
723.250(
e).
A
PMN
would
be
required
if
no
polymer
is
listed
in
the
Inventory
with
the
same
composition
including
the
cross­
linking
agent.

208­
12.
Q.
It
appears
from
the
Polymer
Exemption
rule
that
a
person
does
not
have
the
option
of
including
a
reactant/
monomer
at
less
than
or
equal
to
two
percent
in
the
polymer
identity.
Is
this
true?

A.
Yes,
it
is
true.
See
40
CFR
723.250(
e).
Polymers
covered
by
a
Polymer
Exemption,
however,
do
not
have
a
formal
name.
The
"
identity"
is
established
by
the
percentages
monomers/
reactants
charged
or
incorporated
in
the
polymer,
and
is
maintained
in
the
exemption­
holder's
records.
If
a
polymer
has
less
than
or
equal
to
two
percent
of
a
monomer/
reactant,
the
identity
does
not
contain
that
monomer/
reactant.
If
an
otherwise
identical
polymer
is
made,
and
the
same
monomer/
reactant
is
used
at
greater
than
two
percent,
the
identity
of
the
second
polymer
is
different
from
the
first.
Two
exemptions
would
have
to
be
claimed
to
cover
both
polymers,
and
a
second
end­
of­
year
notification
would
have
to
be
made
to
EPA.
See
the
Polymer
Exemption
Guidance
Manual
at
www.
epa.
gov/
opptintr/
newchems/
polyguid.
pdf
for
more
details.

For
polymers
for
which
a
PMN
is
submitted,
the
submitter
does
have
the
option
of
including
a
reactant/
monomer
used
at
two
percent
or
less
in
the
polymer
identity.
See
40
CFR
723.250(
e).

209
Chemicals
Manufactured
Solely
for
Export
Section
2:
Exclusions
2­
15
209­
1.
Q.
What
does
"
manufacturing
solely
for
export"
mean?

A.
As
defined
at
40
CFR
720.3(
s),
"
manufacture
solely
for
export"
means
to
manufacture
or
import
a
chemical
substance
solely
for
export
from
the
US,
except
for:
(
1)
distribution
solely
for
export
or
processing
solely
for
export,
or
(
2)
R&
D
per
40
CFR
720.36
and
720.78.
According
to
TSCA
§
12(
a)
and
40
CFR
720.30(
e),
chemicals
manufactured
solely
for
export
and
labeled
as
such
are
exempt
from
much
of
TSCA,
including
§
5
and
the
PMN
requirement.
The
chemical
substance
may
not
be
used
in
the
United
States.
TSCA
§
12(
a)(
1)(
A).

209­
2.
Q.
Do
chemicals
manufactured
solely
for
export
require
premanufacture
notification?

A.
No.
See
Q&
A
#
209­
1.

209­
3.
Q.
Who
is
considered
an
exporter?

A.
An
exporter
is
defined
at
40
CFR
707.63(
b)
(
covering
reporting
regulations
under
§
12(
b)
of
TSCA)
as
the
person
who,
as
the
principal
party
in
interest
in
the
export
transaction,
has
the
power
and
responsibility
for
determining
and
controlling
the
sending
of
the
chemical
substance
or
mixture
to
a
destination
out
of
the
customs
territory
of
the
United
States.

209­
4.
Q.
Under
what
circumstances
is
an
exporter
required
to
notify
EPA
of
export
to
a
particular
country?

A.
Section
12(
b)
of
TSCA
requires
any
person
who
exports
or
intends
to
export
a
chemical
substance
or
mixture
to
notify
EPA
of
the
export
of
that
chemical
to
a
particular
country
if
any
of
the
following
actions
has
been
taken
with
respect
to
the
chemical
substance
or
mixture:

(
4)
Data
are
required
under
§
4
or
§
5(
b);
(
5)
An
order
has
been
issued
under
§
5;
(
6)
A
rule
has
been
proposed
or
promulgated
under
§
5
or
§
6;
or
(
7)
An
action
is
pending
or
relief
has
been
granted
under
§
5
or
§
7.

EPA's
regulations
implementing
TSCA
section
12(
b)
are
at
40
CFR
707
Subpart
D.

209­
5.
Q.
To
whom
at
EPA
must
export
notices
be
sent,
and
what
information
must
they
include?

A.
Mark
the
notice
and
the
envelope
containing
the
notice
"
Section
12(
b)
Notice".
Mail
to:
Section
2:
Exclusions
2­
16
US
EPA
Office
of
Pollution
Prevention
and
Toxics
Document
Control
Office
(
7407M)
1200
Pennsylvania
Ave.,
NW
Washington,
DC
20460
If
the
notice
is
sent
by
courier,
the
delivery
address
is:

US
EPA
Office
of
Pollution
Prevention
and
Toxics
Confidential
Business
Information
Center
(
CBIC)
EPA
East
Building,
Room
6428
1201
Constitution
Ave.
Washington,
DC
20004­
3302
Please
note
that
,
for
courier
deliveries,
the
CBIC
is
open
from
8
AM
to
4
PM.
If
you
send
the
notice
by
courier
service
and
the
courier
comes
after
that
time
he
or
she
will
be
turned
away.
You
can
give
the
courier
the
phone
number
(
202)
564­
8930
and
(
202)
564­
8940,
to
call
if
there
is
a
problem
with
delivery.
If
using
US
mail,
the
room
number
is
not
necessary.
Nonuniformed
(
bicycle,
etc)
couriers
will
be
met
at
the
1201
Constitution
Ave.
entrance
by
CBIC
personnel.
Uniformed
couriers
are
admitted
to
deliver
directly
to
the
CBIC.

Per
40
CFR
707.67,
a
Notice
of
Intent
to
Export
should
contain
the
following
information:

(
1)
the
name
of
the
regulated
chemical
as
it
appears
in
the
§
4,
5,
6,
or
7
action
(
If
a
category
is
regulated,
the
name
of
the
individual
regulated
chemical
within
that
category,
as
well
as
the
name
of
the
category,
must
be
given.
Use
the
name
which
appears
in
Volume
I
of
the
EPA
Chemical
Substance
Inventory
or
its
supplements,
if
the
chemical
appears
there.);
(
2)
the
name
and
address
of
the
exporter;
(
3)
the
country(
ies)
of
import;
(
4)
the
date(
s)
of
export
or
intended
export;
and
(
5)
the
section
of
TSCA
under
which
EPA
has
taken
action.

According
to
40
CFR
707.65,
a
Notice
of
Intent
to
Export
must
be
submitted
for
the
first
export
or
intended
export
to
a
particular
country
in
the
calendar
year
if
the
substance
is
the
subject
of
any
of
the
following
actions:

(
8)
data
are
required
under
§
5(
b),
(
2)
an
order
has
been
issued
under
§
5,
(
3)
a
rule
has
been
proposed
or
promulgated
under
§
5
or
6,
or
(
4)
an
action
is
pending
or
relief
has
been
granted
under
§
5
or
7.
In
addition,
a
Notice
of
Intent
to
Export
must
be
submitted
for
the
first
export
or
intended
Section
2:
Exclusions
2­
17
export
to
a
particular
country
when
data
are
required
under
§
4.

A
Notice
of
Intent
to
Export
must
be
in
writing
(
after
EPA
develops
procedures
for
receipt
of
electronic
notices,
these
will
be
acceptable,
too).
A
Notice
of
Intent
to
Export
must
be
based
on
a
definite
contractual
obligation
or
an
equivalent
intra­
company
agreement,
to
export
the
chemical.
Your
Notice
of
Intent
to
Export
must
be
postmarked
within
seven
days
of
forming
the
intent
to
export
or
on
the
date
of
export,
whichever
is
earlier.

Less
than
2%
of
Notices
of
Intent
to
Export
contain
any
assertion
of
confidential
business
information
(
CBI).
For
submitters
who
do
feel
they
have
a
need
to
have
information
about
their
submissions
kept
confidential,
the
requirements
for
making
a
CBI
claim
are
discussed
at
40
CFR
§
707.75.

209­
6.
Q.
Are
isolated
intermediates
used
in
the
manufacture
of
a
final
chemical
substance
which
is
solely
for
export
subject
to
the
PMN
requirement?

A.
Yes.
Only
the
specific
chemical
substance
which
is
manufactured
solely
for
export
is
excluded
from
PMN
requirements.
See
40
CFR
720.30(
e).

210
Uses
Covered
by
FIFRA
210­
1.
Q.
Are
pesticides
included
in
the
definition
of
a
chemical
substance?

A.
No.
The
definition
of
the
jurisdictional
term"
chemical
substance"
under
§
3(
2)
(
and
at
40
CFR
720.3(
e))
of
TSCA
excludes
any
chemical
when
manufactured,
processed,
or
distributed
in
commerce
for
use
as
a
pesticide,
food,
drug,
cosmetic,
tobacco,
tobacco
product,
or
special
nuclear
material.
The
term
pesticide
has
the
meaning
contained
in
the
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(
FIFRA),
7
U.
S.
C.
136
et
seq.
and
the
regulations
issued
under
it.

210­
2.
Q.
Do
pesticides
fall
under
the
jurisdiction
of
FIFRA
or
TSCA?

A.
Pesticides
are
regulated
under
FIFRA.
A
substance
that
is
regulated
under
FIFRA
would
not
be
regulated
under
TSCA,
unless
the
substance
has
multiple
uses.
In
the
case
of
multiple
uses,
some
of
which
come
under
FIFRA
and
others
which
come
under
TSCA,
the
substance
would
fall
under
the
jurisdiction
of
both
TSCA
and
FIFRA.
If
a
substance
is
manufactured,
processed,
or
distributed
for
undifferentiated
uses,
then
the
substance
will
be
presumed
to
be
subject
to
TSCA.
See
42
FR
64585
(
comment
37),
Dec.
23,
1977.

210­
3.
Q.
How
is
it
determined
whether
a
substance
is
regulated
under
FIFRA
or
TSCA?
Section
2:
Exclusions
2­
18
A.
If
a
manufacturer,
processor,
or
distributor
of
a
substance
has
intent,
either
by
making
express
or
implied
pesticide
claims
for
the
product,
or
by
the
product's
having
no
other
significant
commercially
valuable
use
except
as
a
pesticide,
or
if
the
seller
or
distributor
has
knowledge
that
the
product
will
be
used
or
is
intended
to
be
used
as
a
pesticide,
it
would
be
considered
a
pesticide
within
the
meaning
of
FIFRA.
If
the
manufacturer
is
making
a
pesticidal
claim
for
the
material,
this
is
evidence
that
a
substance
is
a
pesticide
within
the
meaning
of
FIFRA.
Also,
if
the
substance
bears
no
pesticidal
claims,
but
has
no
commercially
valuable
use
except
as
a
pesticide,
it
could
still
be
a
pesticide
under
FIFRA.

211
Pesticide
Inerts
211­
1.
Q.
Are
inert
ingredients
used
in
the
manufacturing
of
a
pesticide
subject
to
the
reporting
requirements
of
TSCA
or
FIFRA?

A.
Inert
ingredients
produced
or
used
in
the
manufacture
of
a
pesticide
are
substances
or
mixtures
which
can
be
regulated
under
TSCA.
In
order
to
be
considered
a
pesticide,
a
substance
must
be
intended
for
use
as
a
pesticide.
An
inert
ingredient
which
is
not
itself
a
pesticide
would,
accordingly,
be
a
chemical
substance
within
the
jurisdiction
of
TSCA;
it
comes
within
the
jurisdiction
of
FIFRA
when
it
becomes
a
component
of
a
pesticide
product.
42
FR
64586
(
comment
39),
Dec.
23,
1977.

211­
2.
Q.
Are
there
situations
where
the
manufacturer,
processor,
or
distributor
of
pesticides
are
covered
by
TSCA
versus
FIFRA?

A.
Any
single
chemical
substance
is
subject
to
TSCA
and
FIFRA
only
if
it
has
both
pesticidal
and
non­
pesticidal
uses.
TSCA
authority
covers
the
substances
involved
in
manufacturing
a
pesticide.
It
also
covers
inert
ingredients
until
they
become
a
part
of
the
pesticide
product,
i.
e.,
the
formulation
of
the
pesticide
product.
Once
formulated,
the
pesticide
product,
including
its
inert
ingredients,
is
solely
regulated
by
FIFRA
for
distribution
and
sale.

If
a
substance
is
also
used
in
non­
pesticide
products,
the
ingredient
may
be
regulated
in
those
products
under
TSCA
at
the
same
time
that
it
is
regulated
under
FIFRA
as
a
component
of
the
pesticide
product.

211­
3.
Q.
Are
ingredients
used
in
either
pesticide
or
non­
pesticide
products
that
fall
under
the
jurisdiction
of
TSCA
eligible
for
the
TSCA
R&
D
exemption?

A.
In
some
circumstances,
yes.
There
is
no
specific
R&
D
exemption
in
FIFRA.
However,
the
pesticide
products
containing
the
inert
ingredients
may
require
an
experimental
use
permit
(
EUP)
under
FIFRA,
or
if
used
in
small
quantities,
may
not
require
an
EUP
(
40
CFR
172.3).
EUP
requirements
apply
only
to
the
pesticide
products,
not
the
ingredients
separately.
Section
2:
Exclusions
2­
19
A
new
chemical
substance
used
in
small
quantities
as
a
pesticide
inert
ingredient
falls
within
the
jurisdiction
of
TSCA
and
is
eligible
for
the
R&
D
exemption
if
the
research
and
development
is
conducted
on
the
inert
substance
itself.
A
new
chemical
will
be
covered
by
TSCA's
R&
D
exemption
until
it
becomes
part
of
a
pesticide
product.
Once
it
becomes
part
of
a
pesticide
product,
it
becomes
subject
solely
to
FIFRA
requirements.
Note
that
40
CFR
720.36(
g)
waives
compliance
with
the
R&
D
requirements
for
activities
intended
solely
to
determine
whether
a
substance
can
be
used
as
a
pesticide.

212
Pesticide
Ingredients
212­
1.
Q.
Are
the
raw
materials
or
intermediates
used
in
the
manufacturing
of
a
pesticide
subject
to
the
reporting
requirements
of
TSCA
or
FIFRA?

A.
Raw
materials
and
intermediates
used
in
the
manufacture
of
a
pesticide
can
be
regulated
under
TSCA.
In
order
to
be
considered
a
"
pesticide"
under
FIFRA,
a
substance
must
be
intended
for
use
as
a
pesticide.
A
raw
material
or
intermediate
which
is
not
itself
a
pesticide
would,
accordingly,
be
a
chemical
substance
within
the
jurisdiction
of
TSCA;
it
would
come
within
the
jurisdiction
of
FIFRA
only
when
it
becomes
a
component
of
a
pesticide
product.
42
FR
64586
(
comment
39),
Dec.
23,
1977.

213
Pesticide
Intermediates
213­
1.
Q.
Are
intermediates
produced
or
used
in
the
manufacturing
of
a
pesticide
subject
to
the
reporting
requirements
of
TSCA
or
FIFRA?

A.
In
order
to
be
considered
a
"
pesticide"
under
FIFRA,
a
substance
must
be
intended
for
use
as
a
pesticide.
An
intermediate
which
is
not
itself
a
pesticide
would,
accordingly,
be
a
chemical
substance
within
the
jurisdiction
of
TSCA;
it
would
come
within
the
jurisdiction
of
FIFRA
when
it
becomes
a
component
of
a
pesticide
product.
42
FR
64586
(
comment
39),
Dec.
23,
1977.

213­
2.
Q.
When
is
reporting
required
under
TSCA
versus
FIFRA
regarding
the
manufacturing,
processing,
or
distribution
of
pesticides?

A.
Discussion
of
EPA's
position
on
this
topic
can
be
found
at
42
FR
64585­
86,
comments
37­
39,
Dec.
23,
1977,
and
51
FR
15098,
April
22,
1986.
To
summarize,
as
a
general
rule,
a
pesticide
may
be
subject
to
TSCA
prior
to
registration
under
FIFRA
or
application
for
an
Experimental
Use
Permit.
However,
"
a
person
who
manufactures
or
imports
a
chemical
substance
in
small
quantities
solely
for
research
and
development
is
not
required
to
comply
with
the
requirements
of
[
the
TSCA
R&
D
exemption
from
the
PMN
requirement]
if
the
person's
exclusive
intention
is
to
perform
research
and
development
activities
solely
for
the
purpose
of
Section
2:
Exclusions
2­
20
determining
whether
the
substance
can
be
used
as
a
pesticide."
40
CFR
720.36(
g).
A
chemical
substance
may
be
subject
to
TSCA
and
FIFRA
if
it
is
manufactured
for
both
pesticidal
and
nonpesticidal
uses.
TSCA
authority
also
covers
substances
involved
in
manufacturing
a
pesticide.
It
also
covers
inert
ingredients
until
they
become
a
part
of
the
pesticide
product,
i.
e.,
the
formulation
of
the
pesticide
product.
Once
formulated,
the
pesticide
product,
including
its
inert
ingredients,
is
solely
regulated
by
FIFRA
for
distribution
and
sale.
If
a
substance
is
also
used
in
non­
pesticide
products,
the
ingredient
may
be
regulated
in
those
products
under
TSCA
at
the
same
time
that
it
is
regulated
under
FIFRA
as
a
component
of
the
pesticide
product.

213­
3.
Q.
Are
pesticide
intermediates
that
fall
under
the
jurisdiction
of
TSCA
eligible
for
the
R&
D
exemption?

A.
The
intermediate
of
a
FIFRA­
registered
pesticide
is
eligible
for
the
R&
D
exemption
only
if
the
research
and
development
is
conducted
on
the
intermediate
itself.
Under
FIFRA,
an
Experimental
Use
Permit
(
EUP)
may
be
used
to
allow
a
pesticide
maker
to
undertake
scientific
experimentation,
research
or
analysis
or
to
determine
customer
acceptance
or
economic
viability.
An
intermediate
for
a
pesticide
allowed
under
an
EUP
is
eligible
for
the
TSCA
R&
D
exemption
if
the
intermediate
is
only
being
used
in
small
quantities
for
scientific
experimentation,
research
or
analysis.

214
Uses
Covered
by
FDA
214­
1.
Q.
Are
food,
food
additives,
drugs,
or
cosmetics
included
in
the
definition
of
a
chemical
substance?

A.
Under
TSCA
§
3(
2)
(
and
40
CFR
720.3(
e)),
the
definition
of
"
chemical
substance"
does
not
include
any
food,
food
additive,
drug,
cosmetic,
or
device,
when
manufactured,
processed,
or
distributed
in
commerce
for
use
as
a
food,
food
additive,
drug,
cosmetic,
or
device.
The
terms
cosmetic,
device,
drug,
food,
and
food
additive
have
the
meanings
contained
in
the
Federal
Food,
Drug,
and
Cosmetic
Act,
21
U.
S.
C.
321
et
seq.,
and
the
regulations
issued
under
it.
However,
if
these
same
chemicals
are
also
intended
for
a
TSCA
use,
then
they
are
subject
to
TSCA.
See
42
FR
64585
(
comment
37),
Dec.
23,
1977.

214­
2.
Q.
What
is
FDA's
definition
of
a
drug?

A.
The
definition
of
"
drug"
in
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA)
includes
articles
intended
for
use
as
a
component
of
substance
included
in
the
definition
of
drug.
(
Note
that
the
FFDCA
uses
the
term
"
article"
in
a
generic
sense
to
mean
item,
thing,
substance,
material,
and
not
the
term
of
art
that
"
article"
connotes
under
TSCA.)
See
http://
www.
fda.
gov/
opacom/
laws/
fdcact/
fdcact1.
htm
for
a
more
complete
definition
of
drug
under
the
FFDCA.
As
used
in
that
Act,
the
term
"
component"
does
not
mean
only
an
item
which
Section
2:
Exclusions
2­
21
may
be
identified
as
an
ingredient
of
a
drug
in
its
final
dosage
form,
but
also
includes
any
item
used
in
the
production
of
the
drug.
Thus,
precursors,
intermediates,
and
catalysts
intended
for
use
in
the
production
of
drugs
in
their
final
dosage
form
are
drugs
within
the
meaning
of
FFDCA.

Moreover,
FFDCA
clearly
covers
drugs
during
the
investigation
or
research
stage.
Consequently,
the
definition
of
drug
in
that
Act
includes
chemical
substances
used
for
drug
research
and
development.
The
same
is
true
of
the
definitions
of
food,
food
additives,
and
cosmetics.

214­
3.
Q.
Are
detergent
substances,
other
than
soap,
included
in
FDA's
definition
of
cosmetics?

A.
In
its
definition
of
the
term
"
cosmetic",
FFDCA
§
201(
i),
21
USC
321(
i),
specifically
excludes
soap.
The
term
"
soap"
is
not
defined
in
the
Act.
At
21
CFR
701.20(
a),
the
Food
and
Drug
Administration
interprets
the
term
"
soap"
to
apply
only
to
articles
that
meet
the
following
conditions:
the
bulk
of
the
nonvolatile
matter
in
the
product
consists
of
an
alkali
salt
of
fatty
acids
and
the
detergent
properties
of
the
article
are
due
to
the
alkali­
fatty
acid
compounds;
and
the
product
is
labeled,
sold,
and
represented
only
as
soap.

Products
intended
for
cleansing
the
human
body
and
which
are
not
soap
as
described
above
are
cosmetics,
thus
they
are
subject
to
the
requirements
of
the
FFDCA
and
its
regulations.
Detergents
NOT
intended
for
cleansing
the
human
body
are
TSCA­
regulated.

214­
4.
Q.
Are
intermediates
and
catalysts
of
a
drug
or
cosmetic
regulated
under
FFDCA
or
TSCA?

A.
The
definitions
of
FFDCA
provide
that
chemical
substances
which
are
intended
for
use
as
a
component
of
a
food,
food
additive,
drug,
cosmetic,
or
device
are
encompassed
within
the
meaning
of
such
terms,
respectively.
The
FDA
considers
intermediates
and
catalysts
to
be
such
components.
Therefore,
they
are
subject
to
regulation
under
FFDCA.
Any
such
substance
is
excluded
from
regulation
under
TSCA
if
it
is
actually
manufactured,
processed,
or
distributed
in
commerce
solely
for
use
in
the
production
of
a
food,
food
additive,
drug,
cosmetic
or
device.

214­
5.
Q.
How
would
a
substance
with
multiple
uses
which
falls
under
the
jurisdiction
of
FFDCA
and
TSCA
be
regulated
in
order
to
avoid
duplicative
requirements?

A.
If
a
substance
has
multiple
uses
only
some
of
which
are
regulated
under
FFDCA,
then
the
manufacturing,
processing,
distribution,
and
use
of
the
substance
for
the
remaining
uses
would
be
within
the
jurisdiction
of
TSCA.
Under
these
regulations,
that
substance
should
be
reported
for
the
Inventory.
EPA
does
not
intend
to
impose
duplicative
requirements
on
manufacturers
and
processors
subject
to
regulation
under
another
Federal
authority.
Accordingly,
EPA
will
consult
with
FDA
or
any
other
Federal
agency,
as
appropriate,
prior
to
taking
regulatory
action
on
Section
2:
Exclusions
2­
22
substances
which
are
also
regulated
under
other
authorities.

214­
6.
Q.
Are
new
substances
that
are
isolated
intermediates
used
only
in
the
manufacture
of
a
drug
subject
to
PMN?

A.
No,
if
the
intermediates
are
regulated
by
FDA,
they
are
not
subject
to
TSCA
requirements.

215
Naturally
Occurring
Substances
215­
1.
Q.
What
is
the
definition
of
a
naturally
occurring
chemical
substance
and
what
are
some
examples?

A.
According
to
40
CFR
710.4(
b),
any
chemical
substance
which
is
naturally
occurring
and
which
is
either
unprocessed
or
processed
only
by
manual,
mechanical,
or
gravitational
means;
by
dissolution
in
water;
by
flotation;
or
by
heating
solely
to
remove
water;
or
which
is
extracted
from
air
by
any
means,
shall
automatically
be
included
in
the
Inventory
under
the
category
Naturally
Occurring
Chemical
Substances.
Examples
of
such
substances
are:
raw
agricultural
commodities;
water,
air,
natural
gas,
and
crude
oil;
and
rocks,
ores,
and
minerals.

216
Precipitation
Inhibitors
216­
1.
Q.
If
a
new
chemical
is
formed
when
a
precipitation
inhibitor
is
added
to
a
product
and
acts
as
intended,
is
the
new
chemical
subject
to
PMN
reporting
requirements?

A.
No
PMN
needs
to
be
filed
for
any
chemical
substance
which
results
from
a
chemical
reaction
that
occurs
when
a
precipitation
inhibitor,
stabilizer,
colorant,
odorant,
antioxidant,
filler,
solvent,
carrier,
surfactant,
plasticizer,
corrosion
inhibitor,
antifoamer
or
defoamer,
dispersant,
precipitation
inhibitor,
binder,
emulsifier,
deemulsifier,
dewatering
agent,
agglomerating
agent,
adhesion
promoter,
flow
modifier,
pH
neutralizer,
sequesterant,
coagulant,
flocculant,
fire
retardant,
lubricant,
chelating
agent,
or
quality
control
reagent
functions
as
intended.
See
40
CFR
§
720.30(
h)(
7)(
i).

217
pH
Adjustment
217­
1.
Q.
If
a
new
chemical
is
formed
when
a
specific
reagent
is
used
to
adjust
the
pH
and
acts
as
intended,
is
the
new
chemical
subject
to
PMN
reporting
requirements?

A.
No.
If
a
new
chemical
substance
is
formed
when
a
pH
adjuster
is
included
in
a
product
and
functions
as
intended,
and
the
pH
adjuster
is
not
the
substance
itself,
the
substance
formed
is
excluded
from
PMN.
See
40
CFR
§
720.30(
h)(
7)(
i).
Section
2:
Exclusions
2­
23
217­
2.
Q.
What
is
the
difference
between
pH
adjustment
and
pH
neutralization?

A.
The
terms
pH
adjustment
and
pH
neutralization
are
not
synonymous
terms.
pH
adjustment
deals
with
the
fine
tuning
of
the
pH
of
a
solution.
For
example,
an
acid
with
a
pH
of
3
is
made
more
acidic
by
adjusting
the
pH
to
2.
In
this
example,
material
used
to
adjust
the
pH
is
of
course
potentially
subject
to
PMN
reporting,
but
the
chemicals
resulting
from
the
adjustment
reaction
are
excluded
from
PMN
reporting.
However,
if
the
change
in
pH
is
undertaken
for
the
purpose
of
making
a
new
substance,
the
substance
with
the
new
pH
will
qualify
for
PMN
reporting.

pH
neutralization,
on
the
other
hand,
means
that
the
pH
of
a
solution
brought
to
neutrality
or
near
neutrality.
This
is
generally
a
larger
change
in
conditions.
For
example,
a
change
in
pH
from
14
to
7
would
be
considered
a
pH
neutralization.
This
change
in
pH
will
usually
result
in
a
substantial
change
in
the
chemical
species
present
and
contribute
to
the
function
of
the
chemical.
The
new
chemicals
resulting
from
the
pH
neutralizing
reaction
are
subject
to
PMN
reporting
requirements.
If
you
have
a
situation
for
which
you
think
this
guidance
is
ambiguous,
it
is
appropriate
to
contact
an
EPA
prenotice
coordinator
for
resolution.

218
The
"(
h)(
7)"
Exemption
­
40
CFR
§
720.30(
h)(
7)

218­
1.
Q.
What
are
the
criteria
that
must
be
met,
for
a
substance
to
be
excluded
from
the
Inventory
or
PMN
reporting
under
40
CFR
720.30(
h)(
7)?

A.
It
must
fully
satisfy
all
of
the
following
criteria:
1.
The
substance
is
formed
from
a
chemical
reaction
that
involves
the
use
of
a
chemical
substance
of
the
type
described
under
40
CFR
710.4(
d)(
7)
or
720.30(
h)(
7);
2.
The
substances
does
not
function
to
provide
one
or
more
primary
properties
that
would
determine
the
use
of
the
product
or
product
mixture
distributed
in
commerce,
even
though
it
may
impart
certain
physicochemical
characteristics
to
the
product
or
product
mixture
of
which
it
is
a
part;
and
3.
The
substance
is
not
itself
the
one
intended
for
distribution
in
commerce
as
a
chemical
substance
per
se.
Although
it
may
be
a
component
of
the
product,
product
mixture,
or
formulation
actually
distributed
in
commerce,
it
has
no
commercial
purpose
separate
from
the
product,
product
mixture,
or
formulation
of
which
it
is
a
component.

(
See
EPA's
published
clarification
on
this
issue
available
through
the
TSCA
Hotline
(
202)
554­
1404:
the
package
from
Joseph
Carra,
Deputy
Director,
Office
of
Pollution
Prevention
and
Toxics,
to
the
regulated
community,
dated
June
29,
1994.)

218­
2.
Q.
If
a
polymer
is
partly
ionized
during
use
by
a
pH
change
which
increases
its
water
absorption
to
greater
than
100
percent
by
weight,
is
the
polymer
no
longer
eligible
for
the
Section
2:
Exclusions
2­
24
exemption?
Does
the
so­
called
"(
h)(
7)"
pH
neutralizer
exclusion
apply
to
polymers
>
10,000
MW
that
absorb
more
than
100
percent
of
their
weight
of
water
upon
neutralization?
Does
the
"(
h)(
7)"
exclusion
take
precedence
over
the
Polymer
Exemption,
or
vice
versa?

A.
If
the
polymer
becomes
water­
absorbing
upon
use
in
neutral
water,
it
is
a
water­
absorbing
polymer,
whether
or
not
ionization
is
involved.
Treatment
of
high­
molecularweight
polymers
in
the
New
Chemicals
Program
is
described
at
"
www.
epa.
gov/
oppt/
newchems/
hmwtpoly.
htm."
Water
absorbing
high
molecular
weight
polymers
are
ineligible
for
the
Polymer
Exemption
per
40
CFR
723.250(
d)(
5).
See
60
Fed.
Reg.
16,319­
16,320
(
March
29,
1995).

If
the
substance
is
deliberately
converted
to
a
water­
absorbing
polymer
by
neutralization,
that
conversion
constitutes
manufacture
for
commercial
purposes
as
a
chemical
substance,
rather
than
processing.
The
resulting
substance
would
be
a
different
polymer
that
would
be
considered
water­
absorbing
and
consequently
not
eligible
for
the
Polymer
Exemption
(
even
if
the
neutralizing
agent
used
is
less
than
or
equal
to
two
percent,
a
polymer
must
still
meet
the
eligibility
requirements
in
order
to
be
exempt).
The
resulting
neutralized
substances
would
also
not
be
excluded
from
reporting
under
720.30(
h)(
7).
The
unneutralized
starting
polymer
could
still
be
eligible
for
the
Polymer
Exemption,
if
it
met
the
other
exemption
criteria.

On
the
other
hand,
if
the
neutralization
results
in
a
substance
excluded
from
reporting
under
40
CFR
§
720.30(
h)(
7)
(
which
basically
covers
processing
rather
than
manufacture),
that
substance
remains
excluded
from
reporting
even
if
it
would
have
been
ineligible
under
the
Polymer
Exemption.
If
an
exempt
polymer
is
converted
into
a
water­
absorbing
substance
as
a
result
of
a
chemical
process
or
reaction
that
produces
a
substance
excluded
from
reporting
under
(
h)
(
7),
the
starting
polymer
remains
exempt.
Both
the
Polymer
Exemption
and
40
CFR
§
720.30(
h)(
7)
apply,
independently,
to
the
respective
substances.

218­
3.
Q.
If
a
chemical
manufacturer
supplies
a
customer
with
a
TSCA
listed
acid
and
the
customer,
without
making
notification
under
§
5,
makes
a
salt
not
on
the
Inventory,
is
the
customer
in
violation
of
TSCA
or
subject
to
an
exclusion?

A.
The
salt
would
be
a
reportable
chemical
substance,
and
therefore
would
be
subject
to
the
PMN
requirements
if
it
is
not
on
the
Inventory.
If,
however,
the
customer
makes
the
salt
under
circumstances
which
are
covered
by
an
exclusion
(
common
exclusions
are
those
at
40
CFR
§
§
720.30(
h)(
5),
(
h)(
6),
and
(
h)(
7)),
notification
is
not
required.

219
New
Chemical
Formed
Incidental
to
Storage
219­
1.
Q.
If
a
chemical
substance
is
formed
incidental
to
storage
or
disposal,
is
the
new
chemical
subject
to
PMN
reporting
requirements?
Section
2:
Exclusions
2­
25
A.
No,
40
CFR
§
720.30(
h)(
4)
excludes
any
chemical
substance
which
results
from
a
chemical
reaction
that
occurs
incidental
to
storage
or
disposal
of
another
chemical
substance,
mixture,
or
article
from
PMN
reporting
requirements.
Section
3:
Exemptions
3­
1
3.
EXEMPTIONS
301
Research
and
Development
301­
1.
Q.
What
does
the
term
"
research
and
development"
(
R&
D)
encompass?

A.
Under
§
5
of
TSCA,
"
research
and
development"
(
R&
D)
has
a
specific
meaning..
First,
§
5(
i)
of
TSCA
and
40
CFR
720.30(
i)
exempt
non­
commercial
research
and
development
from
the
PMN
requirement.
Second,
§
5(
h)(
3)
of
TSCA
and
40
CFR
720.36
exempt
substances
that
are
manufactured
in
small
quantities
solely
for
commercial
research
and
development
(
R&
D)
from
the
§
5(
a)
notice
requirements.
No
application
is
required
for
the
R&
D
exemption
under
§
5(
h)(
3).
To
qualify
for
the
R&
D
Exemption,
the
substance
must
be
manufactured
in
small
quantities
for
research
and
development
and
the
manufacturer
and
users
must
comply
with
the
regulations
at
40
CFR
§
720.36
and
§
720.78.

EPA
has
published
additional
guidance
on
the
R&
D
exemption
in:
the
preamble
to
the
Inventory
Reporting
Requirements
at
42
Fed.
Reg.
64572
(
December
23,
1977);
the
notice
entitled
"
TSCA
Chemical
Substances
Inventory;
Removal
of
Inappropriately
Reported
Synfuel
Substances"
at
48
FR
7683
(
February
23,
1983);
and
the
preambles
to
the
proposed
and
final
revisions
of
the
PMN
regulations
published
at
49
FR
50201
(
December
27,
1984)
and
51
FR
15096
(
April
22,
1986),
respectively.
There
is
a
good
summary
of
R&
D
requirements
in
the
New
Chemical
Information
Bulletin
"
Exemptions
for
Research
and
Development
and
Test
Marketing"
(
1986­
1,
November
1986,
Office
of
Toxic
Substances),
available
from
the
TSCA
Hotline
at
(
202)
554
1404
or
at
www.
epa.
gov/
oppt/
newchems/
tmeranddbulletin.
pdf.

In
the
course
of
R&
D
activities,
professional
researchers
using
the
substances
must
be
engaged
in
collecting
information
about
and
monitoring
tests
of
the
chemical
substances
being
studied
or
developed.
General
distribution
of
chemical
substances
to
consumers
does
not
constitute
R&
D.

Chemical
substances
used
exclusively
for
R&
D
are
eligible
for
the
R&
D
exemption
if
their
manufacturers
meet
all
the
requirements
associated
with
the
exemption.
(
See
discussion
of
requirements
below).
The
substance
must
either
be
the
focus
of
R&
D
itself,
or
be
used
in
an
R&
D
activity
focusing
on
another
chemical
substance.
The
latter
category
encompasses
reagents,
chemicals
to
be
used
as
standards
for
chemical
analysis
in
laboratories,
and
intermediates
used
solely
to
produce
R&
D
substances,
including
intermediates
used
in
the
production
of
pesticides
used
exclusively
for
R&
D.

The
purpose
of
R&
D
is
distinct
from
test
marketing
pursuant
to
TSCA
§
5(
h)(
4)
and
40
CFR
720.38.
The
PMN
regulations
define
R&
D
and
test
marketing
at
40
CFR
720.3(
cc)
and
720.3(
gg),
respectively.
R&
D
focuses
on
the
analysis
of
the
chemical
or
physical
characteristics,
Section
3:
Exemptions
3­
2
the
performance,
or
the
production
characteristics
of
a
chemical
substance,
a
mixture
containing
the
substance,
or
an
article.
Test
marketing
focuses
on
customers'
acceptance
of
a
chemical
substance,
and
the
probable
demand
for
a
product
in
a
market
where
it
will
be
competing
with
other
goods.

R&
D
encompasses
a
wide
range
of
activities
which
may
occur
in
a
laboratory,
pilot
plant,
commercial
plant
outside
the
research
facility,
or
at
other
sites
appropriate
for
R&
D.
The
following
activities
which
test
the
physical,
chemical,
production,
and
performance
characteristics
of
a
substance
may
be
considered
R&
D:

$
chemical
synthesis
and
physical/
chemical
properties
testing
in
the
laboratory,

$
health
and
environmental
effects
testing,

$
tests
or
demonstrations
of
equipment
or
production
processes,
which
typically
take
place
in
pilot
facilities,
but
may
also
involve
production
in
full­
scale
commercial
runs
(
e.
g.,
testing
a
new
chemical
to
ascertain
whether
it
can
be
produced
in
commercial
scale
equipment,
or
testing
a
new
or
modified
process
to
determine
process
capabilities
such
as
yield,
uniformity,
or
process
scale­
ups),

$
efficacy
and
performance
tests
(
e.
g.,
testing
of
color
fastness
of
a
dye,
or
the
efficiency
or
lifetime
of
a
new
catalyst
in
a
chemical
manufacturing
process),
and
$
consumer
panel
testing
of
the
performance
characteristics
of
a
new
chemical
substance.
(
EPA
encourages
manufacturers
and
importers
to
check
with
the
Office
of
Pollution
Prevention
and
Toxics
to
determine
whether
their
consumer
panel
testing
activities
comply
with
the
requirements
of
the
rule.)

Because
consumer
panel
testing
could
involve
broad
exposures
to
new
chemical
substances,
manufacturers
and
importers
using
a
consumer
panel
should
be
sure
that,
to
meet
the
requirements
of
the
R&
D
exemption,
they:
(
1)
consider
the
activities
of
the
consumer
panel
in
any
assessment
of
risk,
(
2)
notify
panel
members
of
the
potential
for
risks
in
a
manner
that
adequately
informs
them,
and
(
3)
provide
the
services
of
a
technically
qualified
individual
who
will
supervise
the
tests
directly
in
a
manner
which
offers
panelists
no
less
protection
than
would
be
provided
to
workers
engaged
in
R&
D
in
a
laboratory.

301­
2.
Q.
Is
R&
D
conducted
entirely
in
laboratories
under
prudent
practices
exempt
from
the
risk
evaluation
requirement?

A.
Yes,
under
40
CFR
720.36(
b)(
2),
R&
D
conducted
entirely
in
laboratories
under
prudent
practices
is
exempted
from
the
requirement
for
risk
evaluation.
EPA
has
determined
that
a
laboratory's
compliance
with
OSHA's
laboratory
standard
at
29
CFR
§
1910.1450,
requiring
the
formulation
and
implementation
of
a
Chemical
Hygiene
Plan,
is
sufficient
to
exempt
a
laboratory
from
the
evaluation
of
risks.
However,
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.
Section
3:
Exemptions
3­
3
301­
3.
Q.
What
records
must
be
retained
when
performing
R&
D?

A.
Per
40
CFR
720.78(
b),
the
following
records
must
be
retained:
information
reviewed
and
evaluated
to
determine
the
need
to
make
any
notification
of
risk,
documentation
of
the
nature
and
method
of
risk
notification,
documentation
of
prudent
lab
practices
used
instead
of
risk
notification
and
evaluation
and,
if
an
R&
D
substance
is
manufactured
at
greater
than
100
kgs/
year,
records
regarding
the
chemical
identity
of
the
substance
to
the
extent
known,
the
production
volume,
and
the
disposition
of
the
R&
D
chemical
must
also
be
retained.

301­
4.
Q.
The
PMN
regulations
state
that
any
R&
D
substance
must
be
supervised
by
a
technically
qualified
individual
(
TQI).
What
is
the
definition
of
a
TQI?

A.
A
TQI
is
defined
at
40
CFR
720.3(
ee)
as
a
person
or
persons
who,
because
of
education,
training,
or
experience,
or
a
combination
of
these
factors,
is
capable
of
understanding
the
health
and
environmental
risks
associated
with
the
chemical
substance
which
is
used
under
his
or
her
supervision.
A
TQI
is
responsible
for
enforcing
appropriate
methods
of
conducting
scientific
experimentation,
analysis,
or
chemical
research
to
minimize
such
risks,
and
who
is
responsible
for
the
safety
assessments
and
clearances
related
to
the
procurement,
storage,
use,
and
disposal
of
the
chemical
substance
as
may
be
appropriate
or
required
within
the
scope
of
conducting
a
research
and
development
activity.

301­
5.
Q.
Is
there
a
production
volume
limit
for
R&
D
exemptions?
How
do
the
PMN
regulations
define
the
term
"
small
quantities"?

A.
"
Small
quantities"
is
defined
at
40
CFR
720.3(
cc)
as
quantities
of
a
chemical
substance
manufactured,
imported,
or
processed
or
proposed
to
be
manufactured,
imported,
or
processed
solely
for
research
and
development
that
are
not
greater
than
reasonably
necessary
for
such
purposes.
EPA
has
not
attempted
to
define
"
small
quantities"
quantitatively.
EPA
recognizes
that
the
quantity
of
a
chemical
substance
needed
for
legitimate
R&
D
activities
varies
considerably
with
the
category
of
substance,
the
use
of
the
substance,
and
the
nature
and
stage
of
R&
D.
For
example,
80,000
barrels
of
crude
shale
oil
produced
in
a
pilot
plant
operation,
500
pounds
of
a
resin
produced
for
performance
testing,
and
1
pound
of
a
dye
additive
developed
at
the
laboratory
stage
may
all
qualify
as
"
small
quantities"
relative
to
the
respective
commercial
activity.

301­
6.
Q.
Our
company
manufactured
substantial
excess
material
under
the
R&
D
exemption,
because,
to
make
the
material
at
all,
we
had
to
make
a
full
batch
in
our
pilot
plant.
Based
on
our
research,
we
have
filed
a
PMN,
and
the
PMN
review
period
has
expired
without
regulatory
action.
Can
this
excess
material
now
be
used
for
commercial
purposes?
How
does
this
impact
Notice
of
Commencement
(
NOC)
requirements?
Must
such
use
be
precleared
with
EPA?

A.
Excess
R&
D
substance
can
be
used
for
commercial
purposes
after
the
PMN
review
Section
3:
Exemptions
3­
4
period
expires.
The
NOC
may
not
be
filed
until
the
new
chemical
substance
is
first
manufactured
for
a
nonexempt
commercial
purpose
after
expiration
of
the
PMN
review
period.
After
the
PMN
is
submitted
and
the
review
period
expires,
no
additional
review
by
EPA
is
required
prior
to
use
of
the
excess
R&
D
material
for
a
nonexempt
commercial
purpose.
In
this
situation,
it
is
prudent
to
make
a
memorandum
to
the
file
describing
the
situation
and
your
reliance
on
this
advice,
particularly
if
a
NOC
will
not
be
filed
until
long
after
expiration
of
the
PMN
review
period.

In
addition,
40
CFR
§
720.30(
e)
and
(
f)
allow
certain
commercial
uses
of
excess
R&
D
materials,
prior
to
clearance
of
a
PMN.
Additional
information
on
the
R&
D
exemption
is
provided
in
EPA's
New
Chemical
Information
Bulletin:
Exemptions
for
R&
D
and
Test
Marketing,
which
is
available
from
the
TSCA
Hotline
at
(
202)
554­
1404
or
at
www.
epa.
gov/
oppt/
newchems/
tmeranddbulletin.
pdf.

301­
7.
Q.
We
are
developing
a
new
polymer
that
is
not
on
the
TSCA
Inventory
but
which
meets
EPA's
Polymer
Exemption
criteria.
Do
I
need
to
follow
the
R&
D
exemption
criteria,
and
if
so,
for
how
long?

A.
Basically,
you
can
choose.
If
you
meet
the
R&
D
exemption
criteria
at
40
CFR
720.36
(
broadly:
you
have
a
clear
plan
of
what
you
are
trying
to
find
out,
you
notify
the
appropriate
people
that
the
material
is
not
on
the
TSCA
Inventory,
the
substance
can
only
be
used
for
R&
D
purposes
under
the
supervision
of
a
Technically
Qualified
Individual
(
TQI),
you
keep
the
required
records,
and
you
supply
a
hazard
information
document)
then
you
need
not
meet
the
Polymer
Exemption
criteria.
If
you
meet
the
criteria
for
using
the
Polymer
Exemption
at
40
CFR
723.250
(
broadly:
you
conduct
an
internal
review
to
verify
that
the
polymer
based
on
the
monomers/
reactants
in
the
name
satisfies
the
criteria,
you
have
an
intent
for
commercial
use,
you
fulfill
record
keeping
requirements
and
year­
end
notification
of
EPA)
you
need
not
meet
the
R&
D
exemption
requirements.

301­
8.
Q.
Please
clarify
the
requirements
for
a
Notice
of
Commencement
(
NOC)
with
regards
to
the
R&
D
exemption?

A.
A
NOC
must
be
submitted
within
30
days
of
manufacture
for
a
nonexempt
commercial
purpose.
"
Nonexempt
commercial
purpose"
includes
commercial
R&
D
not
in
full
compliance
with
the
R&
D
regulations
at
40
CFR
720.36
and
720.78(
b).
If
the
first
batch
of
new
chemical
substance
manufactured
after
expiration
of
the
PMN
review
period
is
"
solely
for
R&
D
purposes"
and
will
be
used
in
compliance
with
the
R&
D
regulations,
the
submitter
may
not
file
a
NOC.
If,
however,
the
manufacturer
does
not
wish
to
comply
with
the
R&
D
regulations
and
record
keeping
requirements,
a
NOC
must
be
filed.

301­
9.
Q.
Direct
shipments
of
chemicals
not
on
the
Inventory
from
foreign
suppliers
to
U.
S.
sites
pose
a
problem
on
how
to
provide
notification
as
an
R&
D
exemption.
How
do
you
suggest
this
Section
3:
Exemptions
3­
5
best
be
handled?

A.
Under
TSCA,
the
importer
of
the
material
has
the
responsibilities
of
a
manufacturer.
Importers
of
R&
D
substances
that
are
not
listed
on
the
Inventory
must
provide
positive
certification
under
section
13
of
TSCA
and
comply
with
the
R&
D
regulations
and
record
keeping
requirements
at
40
CFR
§
720.36
and
720.78(
b).
Persons
who
receive
direct
shipments
of
imported
R&
D
substances
must
also
comply
with
the
R&
D
regulations
and
section
13
certification
requirements.

302
Test
Marketing
Exemption
302­
1.
Q.
What
does
a
test­
marketing
exemption
(
TME)
involve?

A.
As
provided
in
TSCA
§
5(
h)(
1)
and
40
CFR
720.38,
any
person
may
apply
for
an
exemption
(
from
the
requirement
for
PMN)
to
manufacture
or
import
new
chemical
substance
for
test
marketing.
The
manufacturer
is
required
to
submit
a
test­
marketing
exemption
(
TME)
notice
to
EPA
at
least
45
days
prior
to
manufacturing
the
substance.
Under
40
CFR
720.3(
gg),
test
marketing
means
the
distribution
in
commerce
of
no
more
than
a
predetermined
amount
of
a
chemical
substance,
mixture,
or
article
containing
that
chemical
substance
or
mixture,
by
a
manufacturer
or
processor,
to
no
more
than
a
defined
number
of
potential
customers
to
explore
market
capability
in
a
competitive
situation
during
a
predetermined
testing
period
prior
to
the
broader
distribution
of
that
chemical
substance,
mixture,
or
article
in
commerce.

EPA
may
grant
the
TME
if
it
determines
that
activities
involving
the
substance
will
not
present
an
unreasonable
risk
of
injury
to
health
or
the
environment.
In
addition,
EPA
may
grant
an
exemption
subject
to
limitations
such
as
the
use
of
measures/
controls
to
protect
human
health
and
the
environment.
(
TSCA
§
5(
h)(
1)(
B)
and
40
CFR
720.38(
e)).

302­
2.
Q.
What
information
should
be
submitted
when
applying
for
test­
marketing
exemptions
(
TME)?

A.
The
§
5
PMN
form
is
used
to
submit
the
information
required
of
an
TME.
For
an
adequate
review,
test­
marketing
exemption
applicants
should,
at
a
minimum,
include
the
following
information
in
their
applications:

(
1)
all
existing
data
regarding
health
and
environmental
effects
of
the
substance
including
physical/
chemical
properties
or,
in
the
absence
of
such
data,
a
discussion
on
toxicity
based
on
structure­
activity
relationships
and
relevant
data
on
chemical
analogues,
(
2)
the
maximum
amount
to
be
manufactured
or
imported
for
test
marketing,
(
3)
the
maximum
number
of
persons
who
may
be
provided
the
substance
during
test
marketing,
(
4)
the
maximum
number
of
persons
who
may
be
exposed
to
the
substance
as
a
result
of
test
Section
3:
Exemptions
3­
6
marketing,
(
5)
information
on
estimated
duration
and
routes
of
exposure,
and
(
6)
a
description
of
the
test­
marketing
activity,
including
the
length
of
time
that
will
be
required
and
how
the
activity
may
be
distinguished
from
full­
scale
commercial
production
and
from
research
and
development.
These
items
are
set
out
in
40
CFR
§
720.38(
b).

302­
3.
Q.
What
is
EPA's
procedure
after
receiving
a
test­
marketing
exemption
(
TME)
application?

A.
In
accordance
with
§
5(
h)(
6)
of
the
Act,
after
EPA
receives
an
application
for
a
TME,
EPA
will
publish
in
the
Federal
Register
a
notice
containing
a
summary
of
the
information
provided
in
the
application,
to
the
extent
it
has
not
been
claimed
confidential.
No
later
than
45
days
after
EPA
receives
an
application,
EPA
will
either
approve
or
deny
the
application.
Thereafter,
EPA
will
publish
a
notice
in
the
Federal
Register
explaining
the
reasons
for
approval
or
denial.
In
approving
a
TME,
EPA
may
impose
any
restrictions
necessary
to
ensure
that
the
substance
will
not
present
an
unreasonable
risk
of
injury
to
health
and
the
environment
as
a
result
of
test­
marketing.

302­
4.
Q.
What
information
must
be
maintained
by
the
person
or
persons
who
maintain
a
test­
marketing
exemption
(
TME)?

A.
According
to
40
CFR
720.78(
c),
any
person
who
obtains
a
test­
marketing
exemption
must
retain
documentation
of
information
in
the
application
and
documentation
of
compliance
with
any
restrictions
imposed
by
EPA
the
TME
is
granted.
This
information
must
be
retained
for
five
years
from
the
final
date
of
manufacture
or
import
under
the
TME.

302­
5.
Q.
What
is
the
difference
between
test
marketing
and
R&
D?

A.
Test­
marketing
and
R&
D
differ
in
the
following
ways:

Test
marketing
must
be
approved
by
EPA
before
it
is
conducted
and
the
submitter
of
the
application
must
distinguish
the
test
marketing
activity
both
from
R&
D
and
from
full­
scale
commercial
production.
In
any
test
marketing
activity,
the
amount
of
material
produced
and
distributed,
the
number
of
potential
customers
to
whom
it
is
distributed,
and
the
time
period
of
the
test
must
be
specified
to
EPA
in
advance
of
distribution.
Test
marketing
involves
distribution
of
a
chemical
substance
in
commerce
to
a
defined
market
to
evaluate
demand
for,
or
customers'
acceptance
of,
the
substance
being
tested.
See
New
Chemical
Information
Bulletin:
Exemptions
for
Research
and
Development
and
Test
Marketing
at
www.
epa.
gov/
oppt/
newchems/
tmeranddbulletin.
pdf.

R&
D
does
not
involve
pre­
approval
by
EPA.
Persons
must
meet
the
requirements
of
the
Section
3:
Exemptions
3­
7
R&
D
exemption
at
40
CFR
§
720.36
(
procedures)
and
720.78
(
record
keeping.)
R&
D
involves
monitored
tests
of
physical,
chemical,
production
or
performance
characteristics
of
a
substance,
and
requirements
for
R&
D
include
generally
applicable
safeguards
for
workplace
safety
(
presence
of
a
technically
qualified
individual
in
non­
laboratory
settings,
procedures
for
warning
workers
of
potential
hazards,
etc.)

303
Low
Volume
Exemption
303­
1.
Q.
Are
amendments
to
a
low
volume
exemption
effective
on
receipt
or
is
a
review
by
EPA
still
necessary?

A.
Approval
of
LVE
amendments
is
by
no
means
automatic.
Under
40
CFR
720.50(
j),
some
amendments
which
will
result
in
a
change
in
site,
production
volume
or
physical
form,
and
all
amendments
which
will
result
in
a
change
in
use
or
exposure
controls
require
a
submission
of
a
new
exemption
request.
Such
submissions
are
subject
to
the
30
day
review
and
may
not
take
effect
until
the
review
period
expires.

A
manufacturer
may,
without
submitting
a
new
notice,
begin
to
manufacture
the
new
chemical
substance
at
a
site
not
listed
in
its
exemption
application
without
prior
review
by
EPA,
and
notify
EPA
within
30
days
after
initiating
manufacture,
only
under
the
following
conditions
described
at
40
CFR
§
723.50(
j)(
6)(
ii)(
A):
exposure
of
workers
to
the
new
chemical
substance
at
the
new
site
is
equal
to,
or
less
than,
that
at
the
site
for
which
EPA
performed
its
original
risk­
assessment;
and
at
the
new
site
either
the
manufacturer
does
not
release
to
surface
waters
any
of
the
new
chemical
substance,
or
any
waste
streams
containing
the
new
chemical
substance;
or
the
manufacturer
maintains
surface
water
concentrations
of
the
chemical
substance,
resulting
from
direct
or
indirect
discharges
from
the
manufacturing
site,
at
or
below
1
part
per
billion
(
or
an
alternative
level
previously
approved
by
EPA
in
writing).
If
the
manufacture
initiates
manufacture
at
a
new
site
under
this
provision,
it
must
notify
EPA
of
the
new
manufacturing
site
no
later
than
30
days
after
the
commencement
of
manufacture
of
the
new
chemical
substance
under
the
LVE
at
the
new
manufacturing
site.

The
notification
to
EPA
must
contain
the
EPA­
designated
exemption
number
to
which
the
notification
applies,
manufacturer
identity,
the
street
address
of
the
new
manufacturing
site,
the
date
on
which
manufacture
commenced
at
the
new
site,
the
name
and
telephone
number
of
a
technical
contact
at
the
new
site,
any
claim
of
confidentiality,
and
a
statement
that
the
notification
is
an
amendment
to
the
original
exemption
application
under
the
terms
of
this
section.
The
notification
may
be
submitted
on
EPA
form
7710­
56
  
Notice
of
Commencement
of
Manufacture";
however,
the
manufacturer
must
add
the
statement
required
under
paragraph
(
j)(
6)(
ii)(
A)
of
this
section
that
the
notification
is
an
amendment
to
the
original
exemption.
The
notification
must
contain
an
original
signature
of
an
authorized
official
of
the
manufacturer.
Section
3:
Exemptions
3­
8
303­
2.
Q.
What
is
the
maximum
cumulative
production
volume
a
company
must
adhere
to
if
they
want
to
submit
a
LVE?

A.
LVEs
cannot
exceed
10,000
kg/
yr
cumulative
production
for
the
holders.
See
40
CFR
723.50(
a)(
i).
Above
that
volume,
a
regular
PMN
is
needed.
However,
under
40
CFR
723.50(
e)(
2)(
vi),
a
manufacturer
can
bind
themself
to
a
lower
production
volume
and
EPA
will
conduct
its
risk
assessment
at
that
level.

303­
3.
Q.
The
LVE
production
volume
limit
is
stated
in
kilograms
per
year
(
kg/
yr).
Is
that
on
a
calendar
year
or
fiscal
year
basis?

A.
Neither.
It
is
on
an
"
anniversary"
basis.
At
40
CFR
723.50(
a)(
2)(
i)
the
application
is
required
30
days
before
manufacture
begins,
and
at
40
CFR
723.50(
a)(
1)(
i)
manufacture
is
enjoined
at
greater
than
10,000
kg
(
or
smaller
approved
quantity)
per
year.
In
other
words,
EPA
intends
that
the
12­
month
production
volume
period
begins
the
date
following
expiration
of
the
30­
day
notice
review
period.

303­
4.
Q.
How
do
I
designate
a
lower
than
10,000
kg/
yr
production
volume?

A.
Place
the
production
volume
in
the
designated
box
in
Part
I,
Section
(
C)(
1)
of
the
form
and
mark
(
x)
the
corresponding
binding
box.
In
filing
an
LVE
you
are
offering
enforceable
conditions
for
your
use
of
a
substance,
including
amount.
If,
after
the
LVE
is
granted,
you
manufacture
the
substance
outside
of
those
conditions,
you
are
in
violation
of
TSCA.
EPA
bases
its
review
of
an
LVE
on
the
amount
agreed
by
the
submitter,
and
does
not
have
to
consider
plausible
scenarios
for
greater
use
of
the
material.
However,
if
the
binding
box
is
not
checked,
EPA
will
assess
the
LVE
application
at
the
maximum
use
level
of
10,000
kilograms/
year.

303­
5.
Q.
What
does
the
"
binding
option"
mean
in
legal
terms
when
filing
a
LVE?

A.
In
filing
a
LVE
or
a
Low
Release
or
Exposure
Exemption
(
LoREX)
you
are
proposing
enforceable
conditions
for
your
use
of
a
substance.
If,
after
the
LVE/
LoREX
is
granted,
you
manufacture
the
substance
outside
of
those
conditions,
without
first
obtaining
EPA's
approval
of
those
changes,
you
are
in
violation
of
TSCA.
EPA
bases
its
review
of
an
LVE/
LoREX
on
the
conditions
you
have
proposed,
and
does
not
have
to
consider
other
plausible
use
scenarios
for
the
material.
See
in
particular
40
CFR
723.50(
j).

303­
6.
Q.
I
currently
hold
a
LVE
under
the
1,000
kg
ceiling
(
of
the
pre­
1995
LVE
rule).
Do
I
have
to
submit
a
new
LVE
to
continue
making
1,000
kg/
year?

A.
No.
You
are
free
to
continue
manufacturing
your
LVE
substance
under
the
terms
of
that
exemption.
However,
if
you
want
to
make
any
change
(
e.
g.,
increase
the
volume
to
10,000
Section
3:
Exemptions
3­
9
kg/
year
or
change
manufacture
site,
use,
human
exposure
or
environmental
release
controls)
you
will
have
to
apply
for
a
new
LVE
pursuant
to
the
amended
regulations
(
see
40
CFR
§
723.50
(
m)
­
Exemptions
granted
under
superseded
regulations).

303­
7.
Q.
May
an
LVE
application
be
submitted
simultaneously
with
a
PMN?
If
not,
is
there
a
time­
period
after
a
LVE
has
been
submitted
in
which
a
PMN
may
not
be
submitted?

A.
EPA
generally
does
not
allow
the
simultaneous
submission
of
a
LVE
and
PMN
for
the
same
substance
from
the
same
submitter.
Any
LVE
submitter
has
certified
that
he/
she
intends
to
manufacture
under
the
terms
of
the
exemption
which
includes
a
production
volume
at,
or
less,
than
10,000
kg/
yr.
The
simultaneous
submission
of
a
PMN
for
a
greater
production
volume
is
considered
a
contrary
statement
of
intent,
that
is
the
submitter
does
not
intend
to
manufacture
under
the
terms
of
the
exemption.
It
is
EPA's
general
policy
however
that,
following
submission
of
a
LVE
application,
the
same
company
may
submit
a
PMN
for
the
same
chemical
90­
days
before
the
end
of
the
1
year
period
commencing
with
EPA's
approval
of
the
LVE.
This
policy
has
been
adopted
on
the
understanding
that
no
more
than
10,000
kilograms
per
year
would
be
produced
under
the
LVE.
Although
there
is
no
prohibition
in
the
LVE
regulations
against
the
submission
of
a
PMN
immediately
after
the
expiration
of
the
LVE
review
period,
an
applicant's
good
faith
certification
may
be
questioned.

EPA
discourages
such
practices
and
may
request
the
submitter
to
support
the
apparent
change
in
intent.
It
is
important
to
note
here
that
the
burden
of
proving
eligibility
for
an
exemption
rests
with
the
person
claiming
the
exemption.
EPA
advises
manufacturers
and
importers
of
exempt
substances
to
be
prepared
to
meet
this
responsibility
should
a
question
arise
concerning
their
compliance.

303­
8.
Q.
Will
an
LVE
application
be
considered
incomplete
if
the
§
5
submission
form,
which
is
now
required,
is
not
filled
out
completely?

A.
No.
EPA
requires
the
use
of
the
§
5
submission
form
to
standardize
the
presentation
of
information
by
submitters.
EPA's
internal
work
flow
is
improved:
EPA
Form
7710­
25
enables
our
reviewers
to
go
to
the
information
they
need
easily,
and
facilitates
our
review.
You
need
only
provide
the
information
required
for
the
LVE.
Both
for
PMN
and
LVE
submissions,
you
must
provide
all
the
information
you
have
which
can
be
relevant
to
the
risk
case.
If
there
is
information
needed
for
a
PMN
submission
which
you
think
is
not
needed
for
an
LVE
submission,
you
can
leave
the
space
blank
or
contact
a
prenotice
coordinator
to
ask
for
advice.

Before
the
§
5
submission
form
was
required,
reviews
of
many
LVE
applications
were
delayed
because
EPA
had
unresolved
concerns
on
exposures
and
releases,
or
controls
for
either.
Although
submitters
are
encouraged
to
provide
human
exposure
and
environmental
release
information,
submission
of
this
information
is
considered
optional.
The
notice
will
not
be
Section
3:
Exemptions
3­
10
declared
incomplete
without
this
information;
however,
if
not
provided
EPA
will
generate
its
own
estimates
and
there
may
be
delays
in
the
review.
It
is
worth
noting
that
more
information
can
be
necessary
to
support
a
"
will
not
present
an
unreasonable
risk
finding"
for
the
higher
production
volume
chemicals
being
reviewed
under
the
10,000­
kg
expanded
LVE
exemption
than
may
have
been
necessary
for
a
1,000­
kg
LVE.

303­
9.
Q.
What
happens
if
I
do
not
commence
manufacture
of
the
LVE
substance
within
one
year
of
EPA
approval
of
my
LVE
submission
?

A.
In
your
LVE
submission
you
certify
that,
at
the
time
you
are
submitting
the
exemption
application,
to
the
best
of
your
knowledge
it
is
your
intent
to
commence
manufacture
within
one
year.
If
you
fail
to
manufacture
within
that
year,
a
new
notice
would
not
be
required,
however,
you
may
have
additional
reporting
if
there
is
a
second
exemption
request
by
another
manufacturer
for
the
same
substance.
If
EPA
finds
it
is
in
the
position
to
consider
denying
the
second
request
based
on
cumulative
exposures
or
environmental
releases
of
the
substance,
EPA
will
notify
the
first
exemption
holder
that
it
must
provide
certification
to
EPA
that
he/
she
has
commenced
manufacture/
import,
will
commence
manufacture/
import,
or
EPA
may
withdraw
the
exemption.
If
the
first
exemption
holder
does
not
respond
to
EPA
within
the
required
21
days,
EPA
may
revoke
the
exemption.
See
40
CFR
723.50(
f).

303­
10.
Q.
Must
the
§
5
submission
form
be
used
to
make
changes
to
a
LVE?

A.
Any
changes
in
use,
exposure,
release,
controls,
production
volume
(
if
bound
at
a
lower
level),
importation
only,
and
certain
changes
in
site
of
manufacture,
require
the
submission
of
a
new
exemption
application
using
the
§
5
submission
form
(
EPA
form
7710.25).
However,
duplicative
information
need
not
be
re­
submitted.
You
need
only
submit
those
pages
of
the
§
5
submission
form
in
which
new
information
is
provided
in
support
of
the
modification
request.
The
new
notice
must
include
chemical
identity,
manufacturer's
name,
a
name
and
telephone
number
of
a
technical
contact,
new
signed
certifications,
and
the
change.
A
modification
must
also
include
the
identity
of
the
previous
exemption
number.
A
box
on
the
cover
page
of
the
form
is
provided
to
identify
that
the
type
of
notice
is
an
exemption
modification.
See
40
CFR
723.50(
j)(
5).

303­
11.
Q.
What
is
the
advantage
to
me
of
submitting
a
LVE
instead
of
a
PMN
if
I'm
required
to
use
EPA
Form
7710­
25
(
the
§
5
submission
form)
and
provide
the
same
information
in
an
LVE
application
as
in
a
full
PMN.

A.
Each
type
of
submission
has
advantages,
depending
on
the
submitter's
needs.
The
most
substantial
submitter
advantages
to
a
LVE
application
instead
of
a
PMN
are:
1)
a
new
substance
may
be
marketed
earlier
(
30­
day
review
instead
of
90)
and,
2)
it
allows
the
manufacturer
to
self­
impose
exposure
and
release
controls
without
requiring
development
of
a
Section
3:
Exemptions
3­
11
§
5(
e)
Consent
Order
or
SNUR.
For
EPA,
since
an
LVE
application
is
an
agreement
to
make
(
a)
particular
use(
s)
at
(
a)
particular
site(
s),
an
LVE
allows
EPA's
reviewers
to
focus
only
on
the
use
scenario
contemplated
by
the
submitter.
This
self­
limitation
by
the
submitter
simplifies
the
review
and
under
some
circumstances
allows
EPA
to
authorize
materials
for
which
other
plausible
uses
pose
greater
potential
danger
than
the
use(
s)
identified
by
the
submitter.

Although
the
information
requirements
for
a
PMN
and
an
exemption
are
very
similar
they
are,
in
fact,
not
identical.
For
LVEs,
the
submission
of
human
exposure
and
environmental
release
data
for
sites
not
controlled
by
the
submitter
is
optional.
In
addition,
the
exemptions
have
only
a
30­
day
review
period.
As
well,
the
exemptions
do
not
require
the
submission
of
a
fee
or
additional
notice
copies.

303­
12.
Q.
Must
an
LVE
substance
manufacturer
immediately
cease
distribution
of
an
exempt
substance
upon
learning
that
a
customer
is
not
following
all
the
exemption
requirements?

A.
If
a
manufacturer
of
an
LVE
substance
learns
that
a
direct
or
indirect
customer
is
processing
or
using
the
exempt
substance
outside
the
terms
of
the
exemption,
that
manufacturer
must
cease
distribution
to
the
customer
unless
the
manufacturer:
1)
notifies
the
customer
in
writing
within
5
working
days
that
the
customer
has
failed
to
comply
with
the
terms
of
the
exemption,
and
2)
within
15
working
days
of
such
notification,
the
manufacturer
receives
written
assurance
from
the
customer
that
the
customer
is
aware
of
terms
and
will
comply.
The
manufacturer
need
not
report
a
first
offense
to
EPA
if
customer
assurance
is
received.
See
40
CFR
723.50(
k).

303­
13.
Q.
Are
there
any
other
sources
of
information
on
the
terms
of
the
LVE
to
share
with
my
customers?

A.
A
fact
sheet
on
the
March,
1995
revisions
to
the
LVE
regulations
(
60
FR
16336­
16351)
has
been
developed
and
is
available
from
the
TSCA
Information
Service
at
202­
554­
1404.

303­
14.
Q.
How
do
I
make
the
import
certification
under
40
CFR
707.20
if
I
have
obtained
an
LVE
for
a
substance?
Is
it
a
positive
or
a
negative
certification?

A.
The
certification
is
the
same
as
the
certification
for
a
substance
which
has
been
the
subject
of
PMN.
It
would
be
a
positive
certification
assuming
the
import
is
in
compliance
with
the
LVE
and
other
relevant
TSCA
regulations.

303­
15.
Q.
Do
I
need
to
submit
a
NOC
for
a
Low
Volume
Exemption
substance?

A.
No.
A
NOC
is
not
required
for
an
LVE
because
the
purpose
of
a
NOC
is
to
enable
EPA
to
update
the
Inventory,
and
LVE
substances
are
not
put
on
the
Inventory.
Section
3:
Exemptions
3­
12
304
Polymer
Exemption
304­
1
Q.
I
thought
the
new
Polymer
Exemption
was
going
to
excuse
me
from
notifying
EPA
about
a
qualifying
polymer
chemical
substance.
What
is
the
point
of
requiring
the
January
letter?
It
doesn't
even
have
to
include
a
substance
identification
­
why
bother
requiring
a
letter,
if
it
doesn't
give
EPA
any
real
information?
How
do
you
know
you
aren't
getting
notified
several
times
about
the
same
polymer?

A.
The
purpose
of
the
January
letter
(
required
by
40
CFR
723.250(
f))
is
to
enable
EPA
inspectors
to
know
where
they
might
want
to
go
to
monitor
compliance
with
the
Polymer
Exemption
Rule,
particularly
since
EPA
will
no
longer
receive
notification
prior
to
manufacture.
The
January
letters
also
keep
EPA
informed
as
to
the
frequency
of
use
of
the
Polymer
Exemption.

The
requirements
of
the
new
Polymer
Exemption
for
the
manufacturer
are
not
trivial.
The
manufacturer
needs
to
determine
that
the
substance
is
a
qualifying
polymer,
and
needs
to
record
that
determination,
along
with
the
substance
identity,
amount
made,
etc.,
for
ready
retrieval
if
requested
by
an
EPA
inspector.
The
January
letter
notifies
EPA
that
your
company
has
made
a
new
substance
for
the
first
time
under
the
terms
of
the
exemption,
and
you
need
to
tie
it,
internally,
to
the
records
you
are
maintaining.
Thus,
if
an
EPA
inspector
comes
to
your
plant
with
a
copy
of
your
notification
letter,
you
will
be
able
to
provide
that
inspector
with
the
required
information
about
the
material.

It's
quite
possible
that
EPA
receives
multiple
notifications.
Each
manufacturer
is
required
to
tell
EPA
once
about
its
first
manufacture
of
a
non­
Inventory
material.

304­
2
Q.
I
have
a
polymer
which
I
think
conforms
with
the
Polymer
Exemption.
When
I
called
EPA's
Prenotice
Coordinators
to
get
that
confirmed,
they
refused
to
tell
me
whether
it
did
or
not.
Why
won't
they
answer
my
question?

A.
This
is
partly
a
resource
problem.
One
of
the
reasons
the
Polymer
Exemption
Rule
was
changed
in
1995
to
a
notification­
only
system
from
a
review
system
was
to
limit
the
resource
demands
on
EPA
in
reviewing
low­
risk
polymer
substances.
If
EPA
did
such
reviews,
even
people
who
had
a
high
level
of
certainty
that
their
substances
were
compliant
would
request
them,
and
EPA
would
be
back
to
putting
large
amounts
of
staff
time
into
review
of
low­
risk
materials.

304­
3.
Q.
Some
determination/
analysis
has
been
made
to
demonstrate
that
a
polymer
my
firm
intended
to
make
is
eligible
for
the
exemption.
This
evaluation
is
valid.
However,
after
making
it
in
the
plant
for
1
year
my
lab
finds
through
plant
quality
assurance
that
the
material
we
have
been
in
fact
making
is
outside
the
requirements
of
the
exemption.
Does
a
violation
exist?
Section
3:
Exemptions
3­
13
A.
Yes,
you
have
a
violation,
and
you
should
self­
report
to
the
Office
of
Enforcement
and
Compliance
Assistance
(
OECA).
If
the
polymer
as
normally
synthesized
is
expected
to
be
close
enough
to
the
limits
of
the
exemption
that
occasional
batches
might
be
outside
the
limits,
either
plan
to
conduct
more
frequent
testing
or
have
another
strategy
to
ensure
that
you
stay
within
the
limits
of
the
exemption.

304­
4.
Q.
My
company
made
a
material,
which
is
eligible
for
the
Polymer
Exemption,
for
R&
D
last
year.
I
did
not
notify
EPA,
because
I
did
not
have
intent
to
sell
it
outside
the
scope
of
R&
D.
Then
this
year
we
decided
we
could
sell
the
material.
We
have
some
material
left
from
the
synthesis
for
R&
D
use,
and
we
do
not
need
to
make
any
more
of
the
material
to
meet
this
year's
needs.
The
question
is
when
to
notify
EPA?
We
didn't
have
non­
R&
D
commercial
intent
last
year,
and
we're
not
going
to
make
it
this
year.

A.
You
may
not
notify
us
that
you
have
made
a
polymer­
exempt
material
until
you
first
make
it
with
intent
for
non­
R&
D
commercial
use.
See
40
CFR
720.36.
EPA
understands
that
this
may
well
be
next
year.
You
can
sell
the
material
now.
This
is
a
somewhat
unusual
case,
and
it
would
be
prudent
to
make
a
note
to
the
files
so
that
you
can
show
any
inspectors
who
visit
your
plant
that
you
thought
about
the
issue
and
researched
EPA
position
on
the
matter,
if
the
question
is
raised.

305
LoREX
Exemption
305­
1.
Q.
Must
the
§
5
submission
form
be
used
to
make
changes
to
a
LoREX?

A.
Yes.
Any
changes
in
use,
exposure,
release,
controls,
production
volume
(
if
bound
at
a
lower
level),
importation
only,
and
certain
changes
in
site
of
manufacture,
require
the
submission
of
a
new
exemption
application
using
the
§
5
submission
form,
EPA
form
7710.25.
However,
duplicative
information
need
not
be
re­
submitted.
You
need
only
submit
those
pages
of
the
§
5
submission
form
in
which
new
information
is
provided
in
support
of
the
modification
request.
The
new
notice
must
include
chemical
identity,
manufacturer's
name,
a
name
and
telephone
number
of
a
technical
contact,
new
signed
certifications,
and
the
change.
A
modification
must
also
include
the
identity
of
the
previous
exemption
number.
A
box
on
the
cover
page
of
the
form
is
provided
to
identify
that
the
type
of
notice
is
an
exemption
modification.
See
40
CFR
723.50(
j)(
5).

305­
2.
Q.
What
is
the
difference
between
a
LoREX
application
and
a
PMN,
if
I
must
use
the
§
5
submission
form
and
provide
the
same
information
in
a
LoREX
application
as
in
a
full
PMN?
Why
would
I
want
to
submit
a
LoREX?

A.
The
main
advantages
to
the
submitter
of
a
Low
Release
and
Exposure
Exemption
(
LoREX)
application
are
(
1)
with
a
30­
day
review
period,
a
new
substance
may
be
marketed
Section
3:
Exemptions
3­
14
earlier,
and
(
2)
it
allows
manufacturer
to
self­
impose
exposure
and
release
controls
without
developing
a
§
5(
e)
Consent
Order
or
SNUR.
The
LoREX
eligibility
requirements
are
listed
at
40
CFR
§
720.50(
c)(
2).
They
are
similar
to
requirements
often
imposed
through
a
§
5(
e)
Consent
Order.
Thus,
a
submitter,
particularly
one
which
regards
its
candidate
chemical
as
likely
to
require
a
§
5(
e)
Consent
Order,
can
agree
to
restrictions
and
avoid
a
drawn­
out
process
to
receive
approval.
EPA
gets
a
clearer
scenario
for
substance
use,
the
ability
to
re­
review
the
substance
if
new
uses
(
which
may
pose
different
risks)
are
to
be
initiated,
and
also
avoids
the
effort
of
developing
a
§
5(
e)
Order.

The
LoREX
exemption
request
does
not
require
the
submission
of
a
fee
or
additional
notice
copies.

305­
3.
Q.
Is
there
a
volume
or
other
use
restriction
for
LoREX
substances?

A.
There
are
no
manufacturing
volume
or
import
volume
restrictions
for
LoREX
substances.
LoREX
exemption
holders
may
manufacture/
import
any
amount
of
the
exempted
substance
provided
they
maintain
releases
and
exposures
within
the
stated
LoREX
criteria.
Regarding
uses,
LoREX
substances
may
be
used
only
for
uses
described
in
the
approved
exemption
application.
New
uses
will
be
approved
by
EPA
if
the
new
uses
do
not
present
an
unreasonable
risk
to
human
health
or
the
environment,
but
they
must
go
through
a
review
process.
The
fact
that
new
uses
will
be
reviewed
allows
EPA
to
limit
the
review
necessary
for
the
original
application,
and
is
part
of
EPA's
ability
to
expedite
and
limit
review
for
LoREX
substances.

305­
4.
Q.
Please
elaborate
on
how
you
will
determine
potential
for
workers
to
really
use
the
designated
protective
equipment
from
an
exemption
application.
It
seems
EPA
is
more
likely
to
grant
a
LoREX
to
larger
companies
with
a
larger
industrial
hygiene
staff.
Is
this
true?

A.
When
an
applicant
for
any
PMN
exemption
states
in
the
application
that
designated
protective
equipment
will
be
employed,
EPA
has
accepted,
and
will
continue
to
accept,
that
statement
as
true
without
regard
to
the
size
of
the
applicant
company.
If
a
given
applicant
has
an
established
history
of
misrepresenting
actual
workplace
conditions,
or
if
EPA
has
a
known
basis
for
believing
that
specified
exposure
controls
will
not
be
used
under
actual
workplace
conditions,
EPA
may
choose
to
require
additional
documentation
to
ensure
that
the
designated
equipment
is
used.

305­
5.
Q.
Will
the
worker
inhalation
caveat
for
"
adequate
inhalation
protection"
be
tied
to
a
§
5(
e)
Consent
Order?

A.
The
basis
for
a
LoREX
grant
is
essentially
an
agreement
between
the
submitter
and
EPA
that
its
conditions
will
be
adhered
to.
This
agreement
can
be
enforced
by
EPA.
To
a
large
Section
3:
Exemptions
3­
15
extent,
this
has
the
effect
of
a
Consent
Order,
but
no
specific
Order
will
be
developed.

To
provide
"
adequate
inhalation
exposure
controls"
submitters
of
LoREX
exemption
notices
should
(
1)
identify
the
workplace
operations
where
inhalation
exposure
is
likely
to
occur,
(
2)
assess
the
magnitude,
frequency,
and
duration
of
potential
exposure,
(
3)
assess
the
effectiveness
of
the
various
exposure
controls,
and
(
4)
select
the
method
or
combination
of
methods
that
will
provide
workers
with
the
appropriate
protection
for
the
given
workplace.

While
EPA
strongly
encourages
submitters
to
reduce
workplace
exposures
at
their
source,
where
feasible,
submitters
could
also
"
provide
adequate
inhalation
exposure
controls"
based
on
the
use
of
appropriate
respiratory
protection
equipment.
If
there
is
a
potential
for
inhalation
exposure,
EPA
generally
requires
respirator
testing
to
demonstrate
the
adequacy
of
respiratory
equipment
so
that
there
is
"
no
inhalation
exposure",
and
compliance
with
the
general
requirements
regarding
respiratory
protection
used
in
TSCA
§
5(
e)
Consent
Orders
and
SNURs.
These
requirements
stipulate
the
use
of
respiratory
protection
in
accordance
with
the
National
Institute
of
Occupational
Safety
and
Health
(
NIOSH)
regulations
at
30
CFR
part
11,
and
the
Occupational
Safety
and
Health
Administration
(
OSHA)
regulations
at
29
CFR
1910.134.
(
See
generally
40
CFR
§
721.63).
Similarly,
the
inherent
physical
or
chemical
properties
of
the
substance
submitted
for
an
exemption
may
form
the
basis
for
a
conclusion
of
"
no
inhalation
exposure",
as
in
a
nonvolatile
dye
manufactured,
processed,
and
used
only
in
solution,
such
that
inhalation
of
particulates
will
not
occur.

305­
6.
Q.
In
regard
to
the
LoREX
general
population
inhalation
provisions,
what
happens
when
one
renegade
molecule
escapes
from
my
plant
and
is
breathed
by
a
plant
neighbor?
The
general
public
has
been
exposed!
How
do
I
demonstrate
"
no
exposure?"

A.
The
general
population
inhalation
exposure
criterion
was
not
intended
to
preclude
manufacturers
of
substances
with
minute
fugitive
air
emissions
from
utilizing
the
LoREX
exemption.
As
explained
in
the
preamble
to
the
rule,
EPA
has
found,
based
on
its
PMN
review
experience,
that
chemical
substances
with
fugitive
air
emissions
under
23
kilograms
per
site
per
year
are
seldom
found
to
present
an
unreasonable
risk
of
injury
to
the
general
population.
However,
no
absolute
criterion
for
fugitive
emissions
has
been
set
and
EPA
will
review
each
LoREX
application
to
determine
exemption
eligibility
in
regard
to
emissions.
Some
persistent,
bioaccumulative,
and
toxic
materials
may
be
ineligible
even
below
a
23
kg/
year
level.

305­
7.
Q.
Must
a
LoREX
substance
manufacturer
immediately
cease
distribution
of
an
exempt
substance
upon
learning
that
a
customer
is
not
following
all
the
exemption
requirements?

A.
If
a
manufacturer
of
an
LoREX
substance
learns
that
a
direct
or
indirect
customer
is
processing
or
using
the
exempt
substance
outside
the
terms
of
the
exemption,
the
manufacturer
must
cease
distribution
to
customers
unless
the
manufacturer:
1)
notifies
the
customer
in
writing
Section
3:
Exemptions
3­
16
within
5
working
days
that
the
customer
has
failed
to
comply
with
the
terms
of
the
exemption,
and
2)
within
15
working
days
of
such
notification,
the
manufacturer
receives
written
assurance
from
the
customer
that
the
customer
is
aware
of
terms
and
will
comply.
The
manufacturer
need
not
report
a
first
offence
to
EPA
if
customer
assurance
is
received.
See
40
CFR
723.50(
k).

305­
8.
Q.
Incineration
does
not
appear
to
be
an
acceptable
means
of
disposal
unless
complete
decomposition
is
determined.
Is
this
correct?

A.
No.
Incineration
is
permissible
under
the
LoREX
criteria
if
the
estimated
annual
average
concentration
of
the
exempted
substance
after
incineration,
using
the
formula
provided
in
paragraph
(
c)(
2)(
iv)
of
the
rule,
is
at
or
below
1
microgram
per
cubic
meter.
Consult
the
rule
preamble
(
60
FR
16338)
for
further
information
on
the
incineration
criteria.
Section
4:
Compliance
and
Enforcement
4­
1
4.
COMPLIANCE
AND
ENFORCEMENT
401
Compliance
Issues
401­
1.
Q.
I
submitted
a
PMN
for
a
chemical,
and
we
have
been
manufacturing
for
several
years.
I
have
manufactured
a
batch
in
which
there
is
an
impurity
as
a
result
of
a
manufacturing
error.
My
company
had
ordered
a
material
from
my
supplier,
and
the
supplier
had,
in
error,
supplied
us
with
a
small
amount
of
another
raw
material
along
with
the
desired
raw
material.
My
synthesis
then
resulted
in,
along
with
approximately
97­
99%
of
the
desired
(
Inventory)
material,
an
unintentionally
present
impurity
(
non­
Inventory),
by
our
analysis
present
at
approximately
1­
3%
of
the
desired
product.
The
impurity
has
no
commercial
value.
Can
we
use
this
chemical
for
another
purpose
besides
R&
D
or
designation
for
disposal?

A.
Such
an
impurity
is
exempt
from
Premanufacture
Notice
requirements
based
on
40
CFR
§
720.30(
h)(
1)
since
it
was
not
produced
with
a
separate
commercial
intent
during
the
manufacture,
processing,
use
or
disposal
of
another
chemical
substance
or
mixture.
You
can
sell
the
material
containing
it
as
your
Inventory
material,
with
an
impurity
present.

402
Enforcement
Issues
402­
1.
Q.
Since
Polymer
Exemptions
are
based
on
expected
low
risk,
is
there
any
discussion
with
the
Office
of
Enforcement
&
Compliance
Assistance
to
decrease
the
penalty
under
the
gravity
based
penalty
policy?

A.
EPA
has
made
a
finding,
in
developing
the
Polymer
Exemption,
that
polymers
which
qualify
for
the
exemption
have
low
risk.
With
respect
to
penalties
associated
with
failure
to
submit
Polymer
Exemption
notifications
or
PMNs,
EPA's
TSCA
§
5
Enforcement
Response
Policy
does
take
into
account
the
low
risk
associated
with
these
types
of
chemicals.
Violations
of
the
premanufacture
notice
requirement
by
failure
to
submit
a
Polymer
Exemption
notice
can
range
in
penalties
from
$
1,100
to
$
11,000
per
day.
This
can
be
compared
to
other
PMN
violations
which
can
range
in
penalties
from
$
1,100
to
$
27,500.
See
www.
epa.
gov/
Compliance/
resources/
policies/
civil/
tsca/
tsca5erp.
pdf.

OPPT
has
already
exempted
many
polymers
from
PMN
review
via
the
PMN
rule
amendments
which
allow
manufacturers
of
new
polymers
to
notify
EPA
during
January
about
any
new
exempt
polymers
they
first
made
during
the
preceding
year.
Other
polymers
that
do
not
qualify
for
this
exemption
are
required
to
submit
PMNs
because
we
have
not
made
a
finding
that
they
are
not
of
concern
to
EPA,
and
would
not
be
subject
to
the
lowered
penalty
range
discussed
above.
Other
polymers
that
do
not
qualify
for
this
exemption
should
be
submitted
as
PMNs
because
EPA
has
not
made
a
finding
that
these
polymers
will
not
present
unreasonable
risk.
These
polymers
would
not
be
subject
to
the
lowered
penalty
range
discussed
above.
Section
4:
Compliance
and
Enforcement
4­
2
As
for
other
types
of
penalty
reductions
or
mitigations
to
the
gravity­
based
penalty
of
failure
to
submit
Polymer
Exemption
notifications,
companies
can
self­
disclose
via
EPA's
audit
policy.
If
a
company
meets
all
of
the
audit
policy's
requirements
(
and
there
is
no
economic
gain
from
noncompliance),
the
gravity­
based
penalty
can
be
(
depending
on
review
of
the
individual
case)
reduced
to
zero.

402­
2.
Q.
I
have
found
that
I
committed
a
TSCA
violation.
EPA
hasn't
caught
the
violation
and
I
have
fixed
the
problem.
I
don't
think
I
hurt
anybody.
You
are
telling
me
that
I
should
"
selfreport
to
your
Enforcement
group.
Why
should
I?
If
I
don't,
you
may
never
catch
me,
and
your
penalties
are
very
high.

A.
EPA
encourages
self­
disclosures
through
special
incentive
programs.
It
is
possible
EPA
will
find
violations
through
our
inspection
activities
or
through
a
tip.
TSCA
penalties
are
substantially
higher
if
you
don't
self­
report.
TSCA
penalties
may
be
as
high
as
$
27,500
per
violation
per
day.
See
TSCA
§
16
and
40
CFR
Part
19.
Under
EPA's
TSCA
§
5
Enforcement
Response
Policy,
self­
confession
may
earn
a
25%
discount
in
penalty,
and
timely
self­
confession
within
30
days
of
discovery
may
reduce
the
penalty
another
25%,
for
a
total
penalty
discount
of
50%.
(
See
www.
epa.
gov/
Compliance/
resources/
policies/
civil/
tsca/
tsca5erp.
pdf.)

Furthermore,
violators
that
self­
disclose
and
satisfy
all
nine
conditions
of
EPA's
"
Audit
Policy"
 
including
"
systematic
discovery"
of
the
violation
through
an
environmental
audit
or
a
compliance
management
system
 
can
be
excused
from
gravity­
based
penalties.
Gravity­
based
penalties
are
that
portion
of
the
penalty
over
and
above
the
economic
benefit.
EPA
retains
its
discretion
to
collect
any
economic
benefit
that
may
have
been
realized
as
a
result
of
noncompliance.
Entities
that
fail
to
meet
the
first
condition
­­
systematic
discovery
­­
can
still
be
eligible
for
75%
penalty
mitigation
and
for
no
recommendation
for
criminal
violations.
See
"
Incentives
for
Self­
Policing:
Discovery,
Disclosure,
Correction
and
Prevention
of
Violations"
(
65
FR
19,618,
April
11,
2000).
See,
also,
www.
epa.
gov/
compliance/
incentives/
auditing/
auditpolicy.
html.

403
European
Community
403­
1.
Q.
Please
compare
and
contrast
polymer
regulatory
exemptions
in
the
European
Union
with
EPA's
Polymer
Exemptions.

A.
The
EU
and
US
notification
systems
for
polymers
differ
in
several
important
ways:
in
the
US,
there
are
two
major
ways
to
legally
enter
into
commerce
with
a
polymer
that
is
subject
to
TSCA
regulation­
through
the
Polymer
Exemption
(
described
at
40
CFR
§
723.50)
or
through
premanufacture
notification,
resulting
in
an
Inventory
listing
(
if
applicable,
the
Low
Volume
or
Low
Release,
Low
Exposure
exemptions
can
be
used).
A
polymer
which
fits
the
requirements
of
the
Polymer
Exemption
(
these
requirements
were
set
by
EPA
based
on
common
characteristics
of
Section
4:
Compliance
and
Enforcement
4­
3
polymers
which
had
been
reviewed
by
the
New
Chemicals
Program
and
found
not
to
engender
an
unreasonable
risk)
can
be
entered
into
commerce
without
having
been
reviewed
by
EPA,
and
only
a
notice
that
a
new
polymer
has
initiated
manufacture
during
the
preceding
year
need
be
submitted.
Persons
who
want
an
Inventory
listing
for
their
new
polymers
for
commercial
reasons,
and
those
whose
polymers
do
not
fit
the
profile
EPA
has
identified
as
not
posing
an
unreasonable
risk,
need
to
submit
premanufacture
notification.

In
the
EU,
polymers
are
treated
essentially
as
though
they
were
mixtures.
Notification
is
not
required
if
the
polymer
does
not
contain
greater
than
2%
of
any
"
new"
monomer
(
that
is,
a
monomer
which
is
not
on
the
European
Inventory
of
Existing
Commercial
Substances
(
EINECS)
of
approximately
100,000
substances
which
were
in
commerce
in
the
EU
in
1981),
but
if
the
polymer
contains
a
"
new"
monomer
at
greater
than
2%,
the
full
premarket
notification
requirements
apply
for
that
monomer.
The
effects
of
this
policy
are
similar
to
the
effects
of
the
Polymer
Exemption
in
the
US,
except
that
it
is
substantially
more
difficult
to
enter
a
polymer
with
a
non­
EINECS
monomer
onto
the
market
in
the
EU.
The
EU
notification
system
is
described
briefly
below,
as
it
relates
to
polymers:

Polymer­
related
Aspects
of
New
Chemicals
Notification
System
in
the
EU
The
EU
notification
system
was
established
9/
18/
79
via
Directive
79/
831/
EEC,
a.
k.
a.,
the
6th
Amendment
to
the
basic
Directive
67/
548/
EEC,
and
went
into
effect
in
1981.

The
EU
requires
submission
of
a
notification
dossier
before
placing
a
new
substance
on
the
market
in
quantities
greater
than
1
metric
ton
per
year
per
manufacturer.
In
the
case
of
polymers,
the
new
substance
is
the
non­
EINECS
monomer
(
The
EU
scheme
is
premarket
versus
the
U.
S.
scheme
which
is
pre­
manufacture.)
The
EU
does
not
allow
test
marketing.

A
"
new
substance"
is
defined
as
one
not
listed
on
the
European
Inventory
of
Existing
Chemical
Substances
(
EINECS).
EINECS
does
not
include
any
polymers,
because
they
are
treated
as
though
they
were
mixtures
of
their
component
monomers.

New
chemicals
are
not
placed
on
EINECS;
subsequent
marketers
of
the
same
substance
are
also
required
to
notify.

The
notification
dossier
relates
to
the
substance
as
marketed,
rather
than
the
pure
substance.

The
notification
dossier
must
contain
a
"
base
set"
of
tests
approximately
equal
to
the
OECD
Minimum
Pre­
Marketing
Data
(
MPD)
Set.
At
10
tons/
year,
the
authorities
may
require
further
testing,
and
at
100
and
1,000
tons/
year
additional
testing
packages
are
required
(
known
as
the
"
step
system").
Section
4:
Compliance
and
Enforcement
4­
4
The
notifier
can
market
the
substance
anywhere
in
the
EU
45
days
after
submitting
the
notification
dossier
to
the
Member
State
where
the
substance
is
manufactured
or
imported.
That
lead
Member
State
circulates
a
summary
dossier
to
the
other
Member
States,
who
may
request
the
lead
authority
to
make
changes
or
ask
the
notifier
for
further
information.

The
EU
classification
system
generally
only
accepts
testing
on
the
substance
itself
rather
than
reliance
on
Structure
Activity
Relationship
(
SAR)
analysis.
The
EU
classification
system
is
based
on
specific
objective
criteria
(
e.
g.,
"
toxic"
=
rat
oral
LD50
between
X
and
Y
mg/
kg
body
weight)
which
determines
how
a
substance
will
be
classified
and
labeled.

Notable
Differences
Between
EU
System
and
New
Chemicals
Notification
System
in
the
U.
S.

The
U.
S.
notification
system
requires
pre­
manufacture
notification,
which
is
at
an
earlier
point
in
the
development
of
a
chemical
than
the
EU
pre­
market
notification
system.

The
PMN
form
itself
requires
all
available
data
on
chemical
identity,
production
volume,
byproducts,
use,
environmental
release,
disposal
practices,
and
human
exposure.
EPA
also
requires
that
the
following
information
be
submitted
with
the
PMN:
all
existing
health
and
environmental
data
in
the
possession
of
the
submitter,
parent
company,
or
affiliates,
and
a
description
of
any
existing
data
known
to
or
reasonably
ascertainable
by
the
submitter.
However,
no
minimum
set
of
test
data
is
required:
§
5
of
TSCA
does
not
require
chemical
companies
to
test
their
new
chemical
substances
for
potential
toxic
effects.
Therefore,
EPA's
review
(
and
§
5(
e)
regulatory
actions)
are
often
conducted
in
the
absence
of
such
data
and
relies
on
SAR.

A
new
chemical
is
eligible
for
addition
to
the
TSCA
Inventory
after
the
PMN
review
has
been
completed.
To
add
a
substance
to
the
TSCA
Inventory,
the
company
that
submitted
the
PMN
must
provide
a
Notice
of
Commencement
of
Manufacture
or
Import
("
NOC")
to
EPA
within
30
days
of
the
date
the
substance
is
manufactured
or
imported
for
nonexempt
commercial
purposes.
Once
a
substance
is
listed
on
the
TSCA
Inventory,
it
is
considered
an
existing
chemical.
Currently,
about
45%
of
PMN
substances
commence
manufacture.

404
Canada
404­
1.
Q.
Have
the
polymer
eligibility
criteria
been
discussed
with
Environment
Canada
(
EC)?
If
yes,
does
EC
agree
so
that
someday
we
can
get
North
American
harmonization?

A.
A
general
description
of
the
Canada
program
on
new
chemical
substances
can
be
found
at
www.
ec.
gc.
ca/
substances/
nsb/
eng/
index_
e.
htm.
There
are
several
major
features
of
the
Canada
program
which
are
developing
towards
harmony
with
that
of
USEPA;
most
notably
Section
4:
Compliance
and
Enforcement
4­
5
Canada's
process
for
a
substance
moving
from
the
Non­
Domestic
Substances
List
("
NDSL"),
based
on
Inventory
status
in
USA,
to
Domestic
Substances
List
("
DSL")
status,
based
in
part
on
experience
gained
elsewhere.
