Document ID: EPA-HQ-OPPT-2003-0065-0008
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2004-09-07T04:00Z

May
10,
2004
Supporting
Statement
for
a
Request
for
OMB
Review
under
The
Paperwork
Reduction
Act
1
IDENTIFICATION
OF
THE
INFORMATION
COLLECTION
1(
a)
Title
of
the
Information
Collection
TITLE:
Premanufacture
Review
Reporting
and
Exemption
Requirements
for
New
Chemical
Substances
and
Significant
New
Use
Reporting
Requirements
for
Chemical
Substances
EPA
ICR
No:
0574.12
OMB
Control
No.:
2070­
0012
1(
b)
Short
Characterization
The
Environmental
Protection
Agency
(
EPA)
administers
the
New
Chemicals
Program
under
section
5
of
the
Toxic
Substances
Control
Act
(
TSCA).
TSCA
section
5
requires
that
any
person
who
proposes
to
manufacture
or
import
a
"
new
chemical,"
(
i.
e,
a
chemical
not
listed
on
the
TSCA
§
8(
b)
Inventory),
must
provide
a
premanufacture
notice
(
PMN)
to
EPA
at
least
90
days
prior
to
commencing
manufacture
or
import
of
that
chemical.
Similarly,
TSCA
section
5
requires
a
significant
new
use
notice
(
SNUN)
from
any
person
who
proposes
to
manufacture,
import
or
process
a
chemical
for
a
use
that
is
determined
to
be
a
"
significant
new
use."
EPA
considers
genetically
engineered
microorganisms
to
be
chemical
substances
for
purposes
of
the
notification
requirements
found
in
TSCA
section
5;
the
90­
day
notice
for
microorganisms
is
a
Microbial
Commercial
Activity
Notice
(
MCAN).

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

This
information
collection
request
addresses
the
TSCA
section
5
reporting
and
recordkeeping
requirements
associated
with
the
new
chemicals
review
and
regulatory
program,
as
briefly
outlined
above.
May
10,
2004
2
2
NEED
FOR
AND
USE
OF
THE
COLLECTION
2(
a)
Need/
Authority
for
the
Collection
TSCA
section
5(
a)(
1),
15
U.
S.
C.
2604,
requires
manufacturers
and
importers
of
new
chemical
substances
to
submit
to
the
Administrator
of
EPA
a
premanufacture
notice
(
PMN)
of
intent
to
manufacture
or
import
a
new
chemical
substance
at
least
90
days
before
manufacture
or
import
begins.
TSCA
section
5(
a)(
1)
also
requires
notification
from
any
person
who
proposes
to
manufacture,
import
or
process
a
chemical
substance
for
a
use
that
EPA
has
by
rule
determined
to
be
a
significant
new
use.
The
notice
must
include,
insofar
as
known
to
or
is
reasonably
ascertainable
by
the
submitter,
information
described
in
TSCA
section
8(
a)(
2)
(
e.
g.,
chemical
identity,
use
and
exposure
data),
plus
test
data
and
descriptions
of
other
data
related
to
the
effects
on
health
and
the
environment
of
the
manufacture,
processing,
use,
distribution
in
commerce
and
disposal
of
the
new
chemical
substance.
EPA
reviews
the
information
to
evaluate
the
health
and
environmental
effects
of
the
new
chemical
substance.
On
the
basis
of
the
review,
EPA
can
take
further
regulatory
action
under
TSCA
sections
5(
e)
and
5(
f),
if
warranted.
If
EPA
takes
no
action
at
the
end
of
90
days,
the
submitter
is
free
to
manufacture
or
import
the
new
chemical
substance.

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

Significant
New
Use
Rules
(
SNURs)
are
authorized
under
TSCA
section
5(
a)(
2).
Regulations
providing
details
on
EPA's
SNUR
authority
were
promulgated
at
40
CFR
Part
721
on
July
27,
1989
and
at
40
CFR
Part
725
subparts
H­
K
on
April
11,
1997.
EPA
uses
this
authority
to
take
follow
up
action
on
new
or
existing
chemicals
that
may
not
present
an
unreasonable
risk
in
their
original
uses
but
may
present
an
unreasonable
risk
should
other
uses
occur
that
may
result
in
different
and/
or
higher
exposures
to
human
beings
or
the
environment.
EPA
determines
that
a
new
use
is
significant
by
examining
the
specific
circumstances
of
each
case.

A
SNUR
allows
EPA
to
receive
reporting
on
such
uses,
review
them
and,
if
necessary,
regulate
the
uses
before
they
occur.
Once
a
use
is
determined
to
be
a
"
significant
new
use,"
a
person
must
submit
a
SNUN
to
EPA
at
least
90
days
before
that
person
may
manufacture,
process
or
import
a
chemical
substance
for
that
use.
The
same
reporting
requirements
that
apply
to
PMNs
also
apply
to
SNUNs,
and
EPA
has
the
same
authorities
under
TSCA
section
5(
e)
and
5(
f)
to
regulate
the
SNUR
chemical
during
the
notice
review
period.
May
10,
2004
3
TSCA
section
5(
d)(
1)(
B)
requires
notices
to
include
all
test
data
in
the
submitter's
possession
or
control
and
TSCA
section
5(
d)(
1)(
C)
requires
submitters
to
provide
other
data
on
environmental
or
health
effects
that
are
known
to
or
reasonably
ascertainable
by
the
submitter.
These
requirements
are
described
in
40
CFR
720.50.

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

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

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

(
i)
Test­
Marketing
Exemption
(
TME)

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

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

TSCA
section
5(
h)(
3)
exempts
from
PMN
reporting
small
quantities
of
chemical
substances
manufactured
or
imported
only
for
research
and
development
purposes.
Persons
using
this
exemption
must
have
their
research
overseen
by
a
technically
qualified
individual
and
must
notify
any
person
involved
in
the
research
of
any
risk.
See
40
CFR
720.36.
Small
quantities
of
genetically
modified
microorganisms
manufactured
solely
for
research
and
developmental
purposes
are
also
exempt
when
additional
criteria
are
met
as
described
in
40
CFR
725.235,
activities
conducted
inside
a
structure,
and
40
CFR
725.238
and
239,
activities
conducted
outside
a
structure.
May
10,
2004
4
(
iii)
TSCA
Section
5(
h)(
4)
Exemptions
TSCA
section
5(
h)(
4)
authorizes
EPA
to
exempt
any
person
from
the
provisions
of
TSCA
section
5
if
EPA
determines
that
the
chemical
substance
will
not
present
an
unreasonable
risk
of
injury
to
health
or
the
environment
when
manufactured,
processed,
distributed,
used
or
disposed
of
under
the
exemption.
To
date
EPA
has
promulgated
four
rules
under
this
section
for
chemical
substances
and
three
exemptions
for
microbial
products
of
biotechnology:

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

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

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

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

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

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

°
Tier
II
Exemption
­
This
exemption
applies
to
the
same
microorganisms
subject
to
a
Tier
I
exemption
without
specified
physical
containment
and
control
technologies.
EPA
may
grant
the
exemption
if
it
finds
that
the
physical
containment
and
control
technologies
activities
described
by
the
applicant
will
not
present
an
unreasonable
risk
of
injury
to
health
or
the
environment.
The
applicant
must
provide
the
information
necessary
to
make
this
finding
and
EPA
must
grant
or
deny
the
exemption
within
45
days.
If
EPA
grants
the
exemption,
it
may
impose
appropriate
restrictions
on
the
activities
described
in
the
notice.
See
40
CFR
725.428.
May
10,
2004
5
Finally,
under
TSCA
section
26(
b),
EPA
requires
manufacturers,
importers
and
processors
to
pay
fees
for
PMNs,
MCANs,
certain
PMN
exemption
applications
and
notices,
and
Significant
New
Use
Notices
(
SNUNs)
submitted
under
TSCA
sections
5(
a)
and
(
h)
to
help
defray
the
cost
of
administering
TSCA.
EPA
must
take
into
account
a
submitter's
ability
to
pay
the
fee
and
the
cost
of
reviewing
the
submitted
data.
TSCA
section
26(
b)
provides
for
maximum
fees
of
$
100
for
small
business
concerns
and
$
2,500
for
other
PMN
submitters.
The
rule
requires
a
limited
amount
of
additional
information
to
be
submitted
with
the
PMN
or
MCAN
form.
See
40
CFR
700.

Copies
of
TSCA
section
5
and
of
40
CFR
Parts
700,
720,
721
(
excepting
Subpart
E),
723
and
725
are
attached.
40
CFR
Part
721,
Subpart
E,
Significant
New
Uses
for
Specific
Chemical
Substances,
which
consumes
nearly
200
pages
in
the
Code
of
Federal
Regulations,
is
not
attached
due
to
its
volume.
However,
Subpart
E
(
40
CFR
721.225
through
40
CFR
721.9973)
is
accessible
on
the
Internet
at
http://
www.
access.
gpo.
gov/
nara/
cfr/
waisidx_
03/
40cfr721_
03.
html
or
from
the
US
Government
Printing
Office's
"
E­
CFR"
prototype
site
at
http://
www.
gpoaccess.
gov/
ecfr/.

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

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

A
chemical
is
considered
to
be
a
"
new"
chemical
if
it
is
not
listed
in
the
TSCA
section
8(
b)
Inventory
of
chemicals
manufactured
or
processed
in
the
United
States.
The
Inventory
includes
both
public
and
confidential
information.
Chemicals
appear
in
the
public
portion
of
the
Inventory
by
name
if
the
company
manufacturing
the
chemical
does
not
claim
the
name
of
the
chemical
to
be
confidential.
Chemicals
whose
names
are
claimed
confidential
are
identified
in
the
public
portion
of
the
Inventory
by
an
accession
number
and
a
generic
name.
The
specific
chemical
name
of
a
confidential
chemical
appears
only
in
the
confidential
portion
of
the
Inventory,
which
is
not
available
to
the
public.
May
10,
2004
6
A
company
that
intends
to
manufacture
or
import
a
chemical
substance
that
does
not
appear
by
a
specific
name
in
the
public
portion
of
the
Inventory
may
inquire
of
EPA
whether
the
substance
is
included
in
the
confidential
portion
of
the
Inventory
(
i.
e.,
to
determine
whether
the
substance
would
be
considered
new
and
therefore
subject
to
the
TSCA
section
5
notice
requirements).
EPA
will
respond
to
such
an
inquiry
only
if
the
Agency
determines
that
the
company
has
a
"
bona
fide"
intent
to
manufacture
or
import
the
substance.
Reporting
provisions
found
at
40
CFR
720.25
or
40
CFR
725.15
require
additional
information
from
a
submitter
so
as
to
encourage
the
submission
only
of
bona
fides
that
reflect
serious
intent.

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

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

EPA
requires
the
use
of
a
specific
form
(
EPA
Form
No.
7710­
56)
for
Notices
of
Commencement
of
chemical
substances.
The
form
is
not
required
for
microorganisms.
The
use
of
a
standard
form
leads
to
greater
efficiency
by
assisting
EPA
in
readily
identifying
the
type
of
notice,
providing
uniformity
in
recording
responses
in
EPA
databases,
and
providing
manufacturers
a
format
to
assure
that
important
information
is
not
inadvertently
omitted
in
their
submissions.
Before
EPA
required
the
use
of
a
standard
NOC
form,
a
significant
number
of
NOCs
created
difficulty
because
they
were
not
recognized
by
the
Agency
as
a
NOC
or
they
contained
confusing,
missing
or
unnecessary
information.
These
problems
resulted
in
a
waste
of
time
and
resources
for
both
submitters
and
EPA
personnel
who
must
prepare
or
review
these
notices.
The
required
use
of
a
standard
reporting
form
also
reduces
EPA
processing
time
for
NOCs.

To
facilitate
EPA's
ability
to
regulate
new
substances
efficiently
and
expeditiously,
EPA
considers
essential
the
capability
to
promulgate
Significant
New
Use
Rules
(
SNURs)
for
new
chemical
substances
without
first
issuing
a
TSCA
section
5(
e)
consent
order
for
the
substance.
Since
the
reporting
requirements
and
provisions
of
a
non­
section
5(
e)
SNUR
apply
also
to
the
original
PMN
submitter,
only
one
EPA
action
is
required
instead
of
two;
fewer
EPA
resources
are
necessary
and
efficiency
is
gained
as
a
non­
section
5(
e)
SNUR
is
more
efficient
than
a
combination
of
consent
order
and
SNUR
to
regulate
new
chemical
substances.
May
10,
2004
7
EPA
publishes
in
the
Federal
Register
information
summarizing
the
content
of
each
notice,
including
the
generic
class
of
the
chemical
substance,
the
proposed
uses
and
certain
test
data
submitted
with
the
notice,
as
required
by
TSCA
section
5(
d)(
2).
EPA
publishes
at
the
beginning
of
each
month
a
list
of
PMN
notices
and
polymer
exemption
applications
that
have
been
received,
those
that
are
still
under
review
and
those
for
which
the
review
period
has
ended.
This
publication
is
mandated
by
TSCA
section
5(
d)(
3).
TSCA
also
requires
EPA
to
publish
a
notice
of
receipt
of
a
testmarketing
application
so
that
the
public
may
comment,
and
another
notice
stating
whether
the
application
was
granted
or
denied.

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

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

Users
of
these
data
are
EPA
employees
located
primarily
in
the
Office
of
Pollution
Prevention
and
Toxics
(
OPPT),
within
the
Office
of
Prevention,
Pesticides
and
Toxic
Substances,
and
in
the
Office
of
Enforcement
and
Compliance
Assurance
(
OECA),
and
Core
TSCA
Regional
Coordinator
Inspectors.
In
particular,
staff
of
the
New
Chemicals
Branch
of
the
Chemical
Control
Division
within
OPPT
use
this
information
to
review
and
evaluate
the
health
and
environmental
effects
of
new
chemicals
and
significant
new
uses
of
chemicals,
and
to
recommend
and
implement
regulatory
actions
if
warranted.
OPPTS
employees
in
the
Regional
Offices
and
OECA
employees
in
Headquarters
and
in
the
Regions
use
TSCA
section
5
data
for
compliance
monitoring
and
enforcement
purposes.

3
NON­
DUPLICATION,
CONSULTATIONS
AND
OTHER
COLLECTION
CRITERIA
3(
a)
Non­
Duplication
EPA
is
the
only
federal
agency
that
regularly
collects
information
on
new
chemical
substances
used
for
purely
industrial
applications.
(
In
instances
where
chemical
substances
with
industrial
applications
also
have
drug
or
cosmetic
uses,
the
Food
and
Drug
Administration
would
have
concurrent
jurisdiction.)
Therefore,
the
information
submitters
provide
in
a
PMN
or
MCAN
cannot
be
obtained
elsewhere.
However,
data
previously
submitted
to
EPA
need
not
be
resubmitted
if
the
following
conditions
are
met:
the
data
were
submitted
with
no
claims
of
confidentiality
and
the
PMN
(
or
other
TSCA
section
5
notice)
identifies
the
office
or
person
to
whom
the
data
were
submitted
and
May
10,
2004
8
the
date
of
the
submission.

3(
b)
Public
Notice
Required
Prior
to
ICR
Submission
to
OMB
In
proposing
to
renew
this
ICR,
EPA
provided
a
60­
day
public
notice
and
comment
period
that
ended
on
February
13,
2004
(
68
FR
69677,
December
15,
2003
).
EPA
received
no
comments
during
the
comment
period.

3(
c)
Consultations
Since
1983,
EPA
has
received
hundreds
of
public
comments
from
industry,
public
interest
groups,
trade
unions
and
other
governmental
agencies
on
various
aspects
of
the
TSCA
section
5
rules.
Early
in
the
Program,
persons
commented
on
the
final
PMN
rule
and
notice
form,
and
the
clarification
of
polymers
and
revisions
to
four
stayed
provisions
of
the
PMN
regulation,
particularly
the
R&
D
exemption.
Industry
comments
to
the
PMN
rule
led
to
staying
of
various
sections
of
the
PMN
rule
and
clarification
of
other
sections.
All
these
issues
were
resolved
with
the
issuance
of
final
revisions
in
April
1986.

The
Agency
reviewed
and
modified
its
standard
recordkeeping
requirements
associated
with
various
SNUR
reporting
triggers
when
issuing
the
final
General
Provisions
for
New
Chemical
Followup
(
Generic
SNUR)
in
July
1989.
These
more
flexible
recordkeeping
provisions
resulted
from
comments
received
by
the
Agency
during
public
meetings
with
representatives
of
the
Conservation
Foundation,
the
Natural
Resources
Defense
Council,
the
Chemical
Manufacturers
Association,
the
Chemical
Specialties
Manufacturers
Association,
the
Synthetic
Organic
Chemicals
Manufacturer's
Association
and
individual
chemical
companies.
In
1993
and
1995,
EPA
held
several
public
meetings
for
the
general
public
to
discuss
in
detail
the
four
PMN
Rule
Amendments
that
were
published
in
March
1995.
In
December
1989
and
June
1993
the
biotechnology
rule
was
discussed
in
public
meetings
of
the
Biotechnology
Science
Advisory
Committee
before
the
final
biotechnology
rule
was
published
in
1997.

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

EPA
has
arranged
or
actively
participated
in
a
number
of
scientific
meetings
and
symposia
of
immediate
relevance
to
the
PMN
program.
Among
the
programs
for
which
EPA
has
made
substantial
contributions
(
often
in
collaboration
with
others)
are
the
following:
"
Safer
Chemicals
Through
Molecular
Design,"
EPA­
sponsored,
Crystal
City,
VA,
1983;
"
SAR
and
Toxicity
Assessment,"
American
Chemical
Society,
Gaithersburg,
MD,
1984;
workshop
on
"
The
Application
of
the
Techniques
of
Computational
Biological
Chemistry
to
Environmental
Problems,"
EPA
Office
of
Research
and
Development,
Research
Triangle
Park,
NC,
1984;
symposium
on
"
Assessment
for
May
10,
2004
9
Potential
Developmental
Toxicants,"
EPA­
sponsored,
at
the
1985
Teratology
Society
Meeting
in
Calloway
Gardens,
GA.

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

Finally,
in
renewing
this
information
collection,
EPA
contacted
a
number
of
organizations
to
request
their
review
of
and
comments
on
this
ICR.
The
names
of
the
organizations
and
the
respective
staff
person
at
each
organization
EPA
contacted,
along
with
each
person's
telephone
number
and
email
address,
are
listed
below.

American
Chemical
Society
David
Schutt
202­
872­
4477
d_
schutt@
acs.
org
American
Chemistry
Council,
Inc.
Larry
Rampy
703­
741­
5855
larry_
rampy@
americanchemistry.
com
Biotechnology
Industry
Organization
Brent
Erickson
202­
962­
9200
berickson@
bio.
org
Consumer
Specialty
Products
Association
D.
Christopher
Cathcart
703­
907­
7600
ccathcart@
cspa.
org
Environmental
Council
of
the
States
Steve
Brown
202­
624­
3661
ceppstein@
sso.
org
Independent
Petroleum
Association
of
America
Lee
Fuller
202­
857­
4722
lfuller@
ipaa.
org
Synthetic
Organic
Chemical
Manufacturers
Association
Jim
Cooper
202­
721­
4100
copperj@
socma.
com
VA
Department
of
Environmental
Quality
­
FOSTTA
Harry
Gregori
804­
698­
4374
hegregori@
deq.
state.
va.
us
Working
Group
on
Community
Right
to
Know
Paul
Orum
202­
234­
8494
orum@
crtk.
org
In
the
end,
none
of
the
persons
contacted
chose
to
respond
to
EPA's
solicitation
for
comments,
with
the
exception
of
Mr.
Harry
Gregori
of
the
Virginia
Department
of
Environmental
May
10,
2004
10
Quality.
Mr.
Gregori's
response
was
simply
to
inform
EPA
that,
since
his
organization
was
not
a
respondent
to
the
information
collection
but
rather
a
user
of
information
that
resulted
from
the
information
collection,
he
declined
to
offer
any
substantive
comments
on
the
information
collection.
A
copy
of
Mr.
Gregori's
response
appears
as
Attachment
I
to
this
document.

3(
d)
Effects
of
Less
Frequent
Collection
The
frequency
of
the
submission
of
information
under
TSCA
section
5
is
not
under
the
Agency's
control.
Manufacturers
of
new
chemical
substances
typically
submit
a
PMN,
SNUN,
or
MCAN
at
least
90
days
prior
to
anticipated
manufacturing
or
distribution
of
the
substance
for
nonexempt
commercial
use.
Submission
of
information
thus
is
on
an
as­
needed,
on­
occasion
basis,
initiated
by
respondents.
Subsequent
reporting
would
only
be
required
if
EPA
determined
that
a
specific
use
of
a
substance
constituted
a
significant
new
use.
Less
frequent
collection
would
mean
respondents
not
being
required
to
submit
data
at
all.
However,
without
such
data,
EPA
would
be
unable
to
administer
the
new
chemical
review
requirements
found
in
TSCA
and
would
be
unable
to
carry
out
its
mandate
to
protect
the
public
from
unreasonable
risks
to
health
and
the
environment.

3(
e)
General
Guidelines
This
collection
of
information
is
consistent
with
all
OMB
guidelines
under
5
CFR
1320.6
except
with
respect
to
the
maintenance
of
records
by
respondents
for
more
than
three
years.
EPA
believes
a
five­
year
recordkeeping
requirement
is
needed
to
carry
out
an
effective
program.
The
fiveyear
recordkeeping
requirement
is
consistent
with
the
five­
year
statute
of
limitations
under
28
U.
S.
C.
§
2462
held
applicable
to
all
EPA
enforcement
actions,
including
administrative
proceedings
under
TSCA.
3M
Company
v.
Carol
Browner
and
EPA,
17F.
3d
(
DC
Cir.
1994)
In
addition,
a
five­
year
retention
period
comports
with
certain
recordkeeping
requirements
imposed
by
the
Occupational
Safety
and
Health
Administration
and
helps
to
keep
these
requirements
consistent
with
one
another,
thereby
avoiding
different
reporting
obligations.
Therefore,
the
Agency
requires
respondents
to
retain
records
for
more
than
three
years.

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

The
Agency's
policies
allow
public
involvement
while
preserving
confidentiality.
TSCA
section
14(
a)
prohibits,
except
in
limited
circumstances,
the
disclosure
of
trade
secret
information.
TSCA
section
14(
d)
allows
disclosure
of
health
and
safety
studies,
including
underlying
data,
unless
these
studies
disclose
confidential
process
or
mixture
information.
Under
40
CFR
720.85
and
May
10,
2004
11
720.87(
See
also
40
CFR
Part
2),
when
the
specific
chemical
identity
or
use
data
are
claimed
confidential,
the
Agency
requires
the
submitter
to
provide
generic
descriptions
for
inclusion
in
Federal
Register
notices
and
the
public
file.
Additionally,
the
submitter
must
provide
a
"
sanitized"
copy
of
all
health
and
environmental
effects
data,
with
confidential
information
deleted,
for
placement
in
the
public
docket.
Within
the
Agency,
only
personnel
with
the
required
clearance
may
handle
CBI.

Based
on
its
experience,
EPA
expects
that
most
information
included
in
TSCA
section
5
notices
will
be
CBI.
EPA
has
developed
an
elaborate
system
to
prevent
unauthorized
disclosure
of
CBI.
This
system
includes
procedures
for
logging
material
in
and
out
of
the
Confidential
Business
Information
Center
(
CBIC)
at
EPA
headquarters
and
procedures
for
photocopying
and
transmitting
CBI.
These
procedures
apply
to
CBI
submitted
by
manufacturers
as
well
as
CBI
generated
by
EPA
staff
in
the
course
of
their
review.
Access
to
CBI
is
restricted
to
persons
who
need
the
information
for
their
work.
No
one
is
allowed
access
to
CBI
without
first
undergoing
instruction
on
procedures
for
handling
CBI.
Special
procedures
have
been
instituted
to
restrict
access
to
computerized
CBI.
These
procedures
are
detailed
in
the
"
TSCA
CBI
Protection
Manual,"
October
2003.
EPA
believes
these
procedures
protect
confidential
information
while
providing
the
public
with
as
much
information
as
possible.

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

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

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

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

°
the
categories
or
proposed
categories
of
use
of
the
chemical;
May
10,
2004
12
°
an
estimate
of
the
total
amount
of
such
chemical
to
be
manufactured
or
processed,
including
the
amount
to
be
manufactured
or
processed
for
each
use
category;

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

°
an
estimate
of
the
total
number
of
individuals
who
will
be
exposed
to
the
chemical
in
their
places
of
employment,
and
the
duration
of
such
exposure;
and
°
the
manner
or
method
of
the
disposal
of
the
chemical.

In
addition,
the
submitter
must
provide
any
test
data
in
the
submitter's
possession
that
indicates
the
environmental
or
health
effects
of
the
chemical,
and
a
description
of
any
other
data
known
to
the
submitter
concerning
the
environmental
or
health
effects
of
the
chemical.
The
specific
information
requirements
are
spelled
out
in
40
CFR
part
720,
on
the
PMN
reporting
form
itself,
and
in
the
Instruction
Manual.

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

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

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

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

°
Test­
Marketing
Exemption
(
TME)
(
40
CFR
720.38)

Test­
marketing
exemption
applicants
are
not
currently
required
to
use
the
PMN
form
May
10,
2004
13
or
any
other
prescribed
reporting
form.
However,
the
test­
marking
exemption
rule
states
that
applicants
should
provide
the
following
information:

(
1)
all
existing
health
and
environmental
effects
data
on
the
chemical
or
a
discussion
of
toxicity
based
on
structure­
activity
relationships
and
relevant
data
on
chemical
analogues;

(
2)
the
maximum
quantity
of
the
chemical
substance
that
the
applicant
will
manufacture
or
import
for
test­
marketing
purposes;

(
3)
the
maximum
number
of
persons
who
may
be
provided
the
chemical
substance
during
test­
marketing;

(
4)
the
maximum
number
of
persons
who
may
be
exposed
to
the
chemical
substance
as
a
result
of
test­
marketing,
including
information
regarding
the
duration
and
route
of
such
exposure;
and
(
5)
a
description
of
the
test­
marketing
activity,
including
its
length
and
how
it
can
be
distinguished
from
full­
scale
commercial
production
and
research
and
development.

The
Agency
retains
the
right
to
declare
that
an
application
contains
insufficient
information
to
make
an
evaluation.
Any
person
who
receives
a
test­
marketing
exemption
must
retain
documentation
of
any
information
in
the
exemption
application
and
documentation
of
their
compliance
with
any
restrictions
imposed
by
EPA
when
it
granted
the
application.
This
information
must
be
retained
for
five
years
from
the
final
date
of
manufacture
or
import
under
the
exemption.

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

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

°
TSCA
section
5(
h)(
4)
exemptions:

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

2.
The
low
exposure/
low
release
exemption
(
LoREX)
(
40
CFR
723.50(
2))
encourages
the
use
of
pollution
prevention
practices
through
the
development
of
manufacturing,
processing
and
use
techniques
that
minimize
exposure
to
workers,
May
10,
2004
14
consumers,
the
general
public
and
the
environment.
As
with
the
low
volume
exemption,
site,
use,
exposure
and
release
controls
identified
in
the
notice
are
binding.

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

4.
Instant
photographic
film
articles
exemption
notices
(
under
40
CFR
723.175)
must,
at
a
minimum,
identify
the
manufacturer
and
the
new
chemical
substance.
Applicants
must
submit
an
exemption
notice
when
manufacture
begins
and
comply
with
certain
requirements
to
limit
exposure
to
the
chemical.
Applicants
must
retain
certain
records
for
30
years
from
the
final
date
of
manufacture.

5.
A
TSCA
experimental
release
application
(
TERA)(
under
40
CFR
725.250)
applies
to
research
and
development
activities
that
result
in
intentional
environmental
releases
of
microorganisms.
Applicants
are
required
to
include
adequate
information
in
their
exemption
so
that
the
Agency
can
make
a
determination
that
the
microorganism
will
not
present
an
unreasonable
risk.
Submitters
must
follow
the
conditions
described
in
the
TERA
as
well
as
any
conditions
of
EPA's
TERA
approval.

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

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

Notices
of
Commencement
­
Under
40
CFR
720.102
and
725.190,
EPA
requires
companies
to
notify
the
Agency
by
submitting
a
Notice
of
Commencement
(
NOC)
when
non­
exempt
commercial
manufacture
or
importation
of
a
new
chemical
begins.
Required
reporting
information
includes
the
following:
May
10,
2004
15
°
the
specific
chemical
identity
of
the
chemical,
and
a
generic
chemical
name
if
the
specific
name
is
considered
confidential;

°
the
premanufacture
notice
number
assigned
by
EPA;

°
the
date
manufacture
or
importation
commenced;

°
the
address
of
the
site
where
manufacture
commenced;

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

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

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

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

User
Fees
­
The
TSCA
section
26(
b)
rule
(
at
40
CFR
part
700)
that
requires
manufacturers,
importers
and
processors
to
pay
fees
for
PMNs,
MCANs,
certain
PMN
exemption
application
notices,
and
SNUNs
submitted
under
TSCA
sections
5(
a)
and
(
h),
requires
a
limited
amount
of
additional
information
to
be
submitted
with
the
section
5
notice.
This
information
includes
May
10,
2004
16
certification
that
the
firm
is
a
"
small
business
concern,"
(
if
applicable)
a
certification
statement
that
the
submitter
remitted
the
appropriate
fee,
and
the
placement
of
corresponding
identifying
numbers
both
on
the
PMN
form
and
the
fee
remittance.

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

Recordkeeping
requirements
under
SNURs
require
persons
who
manufacture
or
process
a
substance
subject
to
significant
new
use
reporting
to
maintain
records
indicating
their
compliance
with
certain
methods
of
manufacture
or
processing.
Some
Significant
New
Use
Rules
do
not
require
recordkeeping.
Rather,
recordkeeping
requirements
apply
only
to
those
SNURs
for
which
compliance
can
only
be
monitored
by
recordkeeping
or
SNUR
notice
submission
under
TSCA
section
5(
a)(
2).
For
example,
upon
occasion
EPA
will
determine
that
a
specific
set
of
exposure
controls
will
adequately
mitigate
risks
to
workers
by
a
specific
chemical
substance.
In
such
cases
EPA
may
determine,
by
rule,
that
the
failure
to
utilize
such
controls
constitutes
a
significant
new
use.
However,
those
persons
employing
the
controls
identified
in
the
SNUR
are
not
required
to
report
to
EPA.

In
order
to
demonstrate
to
EPA
inspectors
or
to
purchasers
of
the
chemical
substance
that
they
are
properly
employing
worker
exposure
controls
(
to
avoid
SNUR
notification
requirements),
manufacturers
or
processors
will
likely
maintain
some
record
of
their
compliance.
In
instances
such
as
those
described
above,
EPA
would
request
that
records
be
kept
documenting
the
establishment
and
implementation
of
procedures
to
ensure
that
employees
use
applicable
personal
protective
equipment,
and
that
employees
are
informed
of
the
hazards
associated
with
the
chemical
substance
and
are
trained
in
the
use
of
protective
equipment.
These
records
aid
inspectors
in
EPA's
compliance
monitoring
program
during
their
visits
to
plants
where
substances
subject
to
SNUR
requirements
are
manufactured
or
processed.
EPA
does
not
consider
recordkeeping
that
indicates
compliance
with
a
SNUR
to
be
burdensome.
Information
contained
in
these
records
is
not
submitted
to
EPA.
Therefore,
the
costs
of
keeping
such
records
should
be
minimal.

There
are
also
recordkeeping
requirements
for
persons
subject
to
consent
orders
containing
exposure
controls.
Depending
on
the
facts
of
each
case,
submitters
must
keep
records
in
connection
with
the
use
of
the
exposure
controls
including
one
or
more
of
the
following:
(
1)
documentation
of
manufacture
and
importation
volumes
of
the
PMN
substance,
with
associated
dates
of
manufacture
or
importation;
(
2)
documentation
of
the
names
and
addresses
of
all
persons
outside
the
site
of
manufacture
or
import
to
whom
the
submitter
directly
sells
or
transfers
the
substance,
with
associated
dates
of
transfer;
(
3)
documentation
of
the
establishment
and
implementation
of
personal
protective
equipment
program;
(
4)
documentation
of
chemical
protective
clothing
imperviousness
testing;
(
5)
documentation
of
the
hazard
communication
program;
(
6)
copies
of
labels;
(
7)
copies
of
material
safety
data
sheets;
(
8)
documentation
of
compliance
with
industrial,
commercial
and
consumer
use
May
10,
2004
17
limitations;
and
(
9)
documentation
of
compliance
with
disposal
and
release
to
water
limitations.

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

­
Read
regulatory
requirements
and
provisions;
­
Determine
which
provisions
are
applicable
to
their
activities;
­
Gather
information
necessary
to
meet
the
requirements;
­
Substantiate
any
claims
of
confidential
business
information;
­
Submit
information
to
EPA,
as
necessary;
­
Comply
with
any
restrictions
EPA
may
impose
upon
completion
of
review
of
their
submission;
and
­
Maintain
any
necessary
records.

5
THE
INFORMATION
COLLECTED­­
AGENCY
ACTIVITIES,
COLLECTION
METHODOLOGY
AND
INFORMATION
MANAGEMENT
5(
a)
Agency
Activities
In
connection
with
administering
the
TSCA
section
5
new
chemical
review
and
regulatory
program,
EPA
performs
the
following
activities:

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

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

Respondents
are
able
to
submit
TSCA
section
5
notices
electronically,
using
the
"
e­
PMN"
May
10,
2004
18
form
available
at
the
New
Chemicals
website
(
https://
cdx.
epa.
gov/
ssl/
pmn/
download.
asp).
The
form
uses
Adobe
Acrobat
software
that
allows
submitters
to
complete
and
save
the
form
electronically,
but
then
print
it
and
mail
it
to
EPA
as
hard
copy
as
they
have
always
done.
About
15­
20%
of
TSCA
section
5
notices
are
submitted
on
this
form.
This
was
the
first
phase
of
an
e­
PMN
project
that
is
to
be
followed
with
submitters
being
able
to
submit
the
form
electronically
via
diskettes
with
a
hard
copy
signature
page.

The
Agency
is
currently
developing
a
data
entry
tool
using
technology
that
will
allow
pure
electronic
submittal
of
TSCA
section
5
data.
This
technology
will
work
with
DOS­
as
well
as
UNIXbased
computers
and
uses
XML
technology
for
more
efficient
data
transmittal.
This
approach
will
be
designed
so
that
data
can
be
submitted
using
portable
media,
such
as
a
CD
ROM.
However
the
proposed
solution
can
easily
be
scaled
to
enable
eventual
submission
of
data
over
the
Internet.
The
Agency
contemplates
in
time
receiving
electronic
TSCA
section
5
notices
via
the
Internet
once
security
issues
have
been
resolved
and
industry's
preferences
have
been
determined.
No
matter
what
electronic
media
the
Agency
decides
upon,
however,
paper
submissions
will
always
be
accepted.

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

5(
c)
Small
Entity
Flexibility
The
reporting
and
recordkeeping
requirements
associated
with
TSCA
section
5
are
applicable
to
all
affected
entities,
regardless
of
size
of
business.
However,
EPA
provides
specialized
assistance
to
respondents,
particularly
to
small
entities.
TSCA
section
26(
d)
established
the
TSCA
Assistance
Office,
now
known
as
the
Environmental
Assistance
Division
(
EAD),
to
provide
technical
and
other
nonfinancial
assistance
to
manufacturers,
importers
and
processors
of
chemical
substances.
This
office
has
established
a
hotline
to
assist
small
businesses
complying
with
TSCA
rules.
It
provides
material
such
as
copies
of
Federal
Register
notices,
advisories,
and
other
information
on
request.
It
also
publishes
the
bi­
monthly
Chemicals­
in­
Progress
bulletin
that
identifies
activities
in
EPA.
In
addition,
"
small
business
concerns"
submit
a
reduced
fee
of
$
100
(
rather
than
$
2,500)
for
each
TSCA
section
5
notice
submitted
pursuant
to
the
user
fee
regulation
at
40
CFR
700.45(
a)(
1).

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

Also,
as
discussed
above,
EPA
has
issued
several
TSCA
section
5
exemption
rules
that
reduce
PMN
reporting
requirements
thereby
providing
relief
to
submitters
from
the
burden
of
responding
to
the
full
PMN/
MCAN
requirements.
May
10,
2004
1
The
PMN
submission
information
presented
below
is
based
on
the
"
OPPT
New
Chemicals
Annual
Report;"
U.
S.
EPA/
OPPT;
October
2002
(
hereinafter
referred
to
as
OPPT,
2002).
PMN
burden
data
are
from
the
"
Regulatory
Impact
Analysis
of
Amendments
to
Regulations
for
TSCA
Section
5
Premanufacture
Notifications;"
U.
S.
EPA/
OPPT/
Economics,
Exposure
and
Technology
Division/
Regulatory
Impacts
Branch;
September
9,
1994;
(
hereinafter
referenced
as
"
RIA,
1994a").
The
information
on
biotechnology
submissions
is
from
"
Regulatory
Impact
Analysis
of
Regulations
on
Microbial
Products
of
Biotechnology;"
U.
S.
EPA/
OPPT/
Economics,
Exposure
and
Technology
Division;
January
21,
1997;
(
hereinafter
referenced
as
"
RIA,
1997a").

19
Finally,
EPA
provides
the
services
of
pre­
notice
communications
coordinators
and
other
personnel
to
assist
persons
in
a
comprehensive
manner
for
purposes
of
notice
preparation
prior
to
submission.
For
instance,
for
new
chemical
substances
a
PMN
submitter
may,
upon
consultation
with
the
prenotice
communication
coordinator,
prepare
one
"
consolidated
notice"
for
two
or
more
chemical
substances
if
they
are
similar
in
physicochemical
structure
and
use
and
share
common
test
data
or
other
information.
Prenotice
communication
coordinators
respond
to
other
pre­
notice
inquiries
that
may
pertain
to
the
full
scope
of
the
TSCA
section
5
regulations.

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

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

6(
a)
Estimating
Respondent
Burden
The
burden
to
respondents
includes:
1)
reporting
burden
for
submission
of
PMNs,
SNUNs,
exemption
notices,
and
biotechnology
notices;
2)
reporting
burden
associated
with
implementation
of
TSCA
Section
5(
e)
consent
order
restrictions
such
as
the
use
of
exposure
controls
and/
or
performing
toxicity
testing;
and
3)
recordkeeping
burden
associated
with
notice
submissions,
consent
orders,
exposure
controls
and
toxicity
testing.
May
10,
2004
20
6(
b)
Burden
Hours
Associated
with
Reporting
As
shown
in
Table
I,
the
total
respondent
reporting
burden
associated
with
this
information
collection
is
estimated
to
total
160,037
hours.
This
burden
estimate
is
calculated
by
multiplying
the
hours
of
reporting
burden
times
the
revised
number
of
each
type
of
notice
that
EPA
expects
to
receive
and
summing
across
the
notice
types.

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

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

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

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

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

The
various
exemptions
available
to
submitters
since
the
1995
amendments
have
significantly
reduced
the
need
for
consent
order
development
and
post­
notice
data
review.
EPA
data
indicate
that
such
consent
orders
and
post­
notice
data
reviews
will
amount
to
roughly
2%
(
26/
1450)
of
the
total
estimated
1,450
TSCA
Section
5
notices
(
OPPT,
2002).
Based
on
historical
data,
EPA
estimates
26
cases
would
be
subject
to
either
test
data
or
non­
testing
TSCA
Section
5(
e)
burden
with
12
cases
requiring
test
data,
and
14
non­
testing
TSCA
Section
5(
e)
cases.
Testing
is
usually
contracted
out
to
a
laboratory,
thus
the
burden
associated
with
testing
requirements
represents
the
time
that
personnel
from
the
submitting
firm
would
spend
overseeing
the
testing,
assumed
to
be
25%
of
the
May
10,
2004
21
lab
burden.

Table
1
on
the
following
page
displays
the
overall
respondent
reporting
burden.

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

6(
c)
Burden
Hours
Associated
with
Recordkeeping
As
shown
in
Table
II,
the
respondent
recordkeeping
burden
associated
with
this
information
collection
is
estimated
to
total
3,754
hours.
This
burden
estimate
is
calculated
by
multiplying
the
estimated
burden
associated
with
each
type
of
submission
(
RIA,
1994),
by
the
estimated
number
of
submissions
for
each
notice
and
summing
across
notice
types.
Once
the
respondent
presents
information
in
an
initial
TSCA
Section
5
submission,
the
burden
for
maintaining
or
updating
these
records
is
minimal.
The
Agency
assumes
an
aggregate
annualized
recordkeeping
burden
of
two
hours
for
each
PMN,
SNUN,
exemption
submission,
or
biotech
submission.
This
is
based
on
the
recordkeeping
burden
associated
with
essential
technical
requirements,
such
as
records
that
demonstrate
that
the
first
commercial
batch
of
polymer
manufactured
for
commercial
purposes
under
the
exemption
met
certain
eligibility
criteria.
Such
recordkeeping
requirements
allow
the
Agency
substantially
to
eliminate
all
other
data
and
reporting
requirements
associated
with
the
polymer
exemption.
Recordkeeping
burden
for
5(
e)
testing
and
May
10,
2004
22
non­
testing
burden
are
35
and
25
hours,
respectively
(
RIA,
1994)

The
overall
respondent
recordkeeping
burden
is
displayed
below
in
Table
II.

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

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

Respondent
costs
for
all
submissions
consist
of
three
components:
1)
labor
costs,
calculated
by
multiplying
the
estimated
burden
hours
associated
with
each
submission
type
by
the
appropriate
labor
rate;
2)
delay
costs,
estimated
as
the
cost
of
the
delayed
receipt
of
profits
by
chemical
manufactures
as
a
result
of
the
submission
review
process,
and
3)
explicit
costs,
such
as
user
fees
or
lab
testing
fees.
May
10,
2004
23
In
order
to
estimate
total
respondent
cost
associated
with
TSCA
Section
5
submissions,
an
average
cost
was
first
calculated
for
each
type
of
notice.
The
average
cost
per
notice
was
calculated
by
summing
each
of
the
three
cost
components
identified
above
for
each
type
of
notice.
The
average
cost
per
notice
was
then
multiplied
by
the
expected
number
of
notice
submissions
and
summed
across
notice
types
to
obtain
the
total
industry
cost.
Table
III
below
outlines
the
total
average
cost
calculations
for
the
various
types
of
notice
submissions
and
presents
the
total
respondent
cost
estimate.
May
10,
2004
24
Table
III
Total
Respondent
Cost
Calculation
Notice
Average
Annual
Number
of
Responses
Total
Burden
(
reporting
+
recordkeeping)
and
Wage
Rate
by
Labor
Category
Labor
Costs1
Delay
Costs2
Fees3
Total
Avg.

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

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

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

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

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

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

6
While
companies
incur
costs
for
control
equipment,
such
costs
are
outside
the
realm
of
this
ICR.
May
10,
2004
25
Baseline
respondent
wage
rates
used
to
support
the
calculation
of
average
cost
per
submission
were
obtained
from
the
U.
S.
Bureau
of
Labor
Statistics'
March,
2003
Employer
Costs
for
Employee
Compensation
for
Private
Industries,
Manufacturing
Industries,
White
collar
occupations
for
managerial,
technical,
and
clerical
labor
categories.
The
baseline
wage
for
each
labor
category
was
multiplied
by
a
loading
factor
computed
for
each
category
to
determine
the
loaded
average
hourly
wage.
Loading
factors
for
benefits
are
calculated
separately
for
each
labor
category
by
dividing
the
benefits
percentage
of
total
compensation
by
the
wage
percentage
of
total
compensation
for
each
occupational
group.
An
additional
loading
factor
of
17
percent
is
applied
for
overhead.
The
final
loading
factor
is
thus
calculated
as:
(
1
+
benefits
loading
factor
+
.17
overhead
factor).
The
baseline
wage
for
each
labor
category
is
then
multiplied
by
its
respective
loading
factor
to
obtain
the
loaded
hourly
wage
rate.
The
loaded
hourly
labor
rates
for
the
different
labor
categories
used
in
calculation
of
respondent
labor
cost
are
as
follows:
managerial
­
$
57.60;
technical
­
$
44.75;
clerical
­
$
24.71.

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

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

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

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

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

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

The
total
respondent
burden
hours
and
costs
therefore
is
the
sum
of
reporting
hours
and
recordkeeping
hours,
and
the
total
costs
for
all
expected
notice
submissions.
Total
respondent
burden
hours
is
163,791
(
160,037
reporting
hours
+
3,754
recordkeeping
hours).
As
noted
above,
total
respondent
costs
based
on
the
expected
number
of
TSCA
Section
5
notice
submissions
are
$
34,348,733.
6(
e)
Estimating
Agency
Cost
May
10,
2004
2
For
a
description
of
the
calculation
of
extramural
cost,
see
footnote
7
of
figure
2.

26
EPA's
costs
associated
with
this
information
collection
are
estimated
to
total
$
7,307,840,
as
presented
in
Table
IV
below.
Costs
to
the
government
include:
1)
initial
review
of
PMN
substances
(
after
which
the
majority
of
cases
are
dropped
from
further
regulatory
review),
2)
comprehensive
reviews
on
a
minority
of
chemicals,
during
which
the
Agency
conducts
a
more
through
evaluation
of
the
potential
risks
associated
with
manufacturing,
processing,
use
and
disposal
of
the
PMN
substance
including,
if
necessary,
taking
regulatory
action
under
TSCA
Sections
5(
e)
or
5(
f).

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

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

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

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

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

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

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

Finally,
the
Agency
estimates
that
tracking
and
validating
fees
cost
the
Agency
approximately
$
40,000
per
year.

Table
IV
Total
Agency
Cost
Calculations
May
10,
2004
27
Type
of
Notice
Average
Annual
Number
of
Responses
Agency
Labor
Hours
Wage
Rate
Labor
Costs6
Extramural
Costs7
Total
Avg.

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

2
ICR,
2000.

3
RIA,
1997.

4
Estimated
to
be
similar
to
TERA
review.

5
Estimated
to
be
similar
to
PMN
/
SNUN
review.

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

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

8
Agency
labor
costs
plus
extramural
costs.
May
10,
2004
28
6(
f)
Reasons
for
Change
in
Burden
This
request
reflects
a
decrease
in
the
total
estimated
burden
of
20,817
hours
(
from
184,608
hours
to
163,791
hours)
in
the
total
estimated
respondent
burden
from
that
currently
in
the
OMB
inventory.
This
decrease
represents
an
adjustment
in
the
number
of
annual
submissions
to
reflect
EPA's
experiences
since
the
most
recent
ICR.
The
decrease
in
the
number
of
submissions
per
year
is
largely
associated
with
the
polymer
and
other
exemptions
implemented
under
the
1995
amendments.

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

To
comment
on
the
Agency's
need
for
this
information,
the
accuracy
of
the
provided
burden
estimates,
and
any
suggested
methods
for
minimizing
respondent
burden,
including
the
use
of
automated
collection
techniques,
EPA
has
established
a
public
docket
for
this
ICR
under
Docket
ID
No.
OPPT­
2003­
0065,
which
is
available
for
public
viewing
at
the
Pollution
Prevention
and
Toxics
Docket
in
the
EPA
Docket
Center
(
EPA/
DC),
EPA
West,
Room
B102,
1301
Constitution
Ave.,
NW,
Washington,
DC.
The
EPA
Docket
Center
Public
Reading
Room
is
open
from
8:
30
a.
m.
to
4:
30
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
telephone
number
for
the
Reading
Room
is
(
202)
566­
1544
and
the
telephone
number
for
the
Pollution
Prevention
and
Toxics
Docket
is
(
202)
566­
0280.

An
electronic
version
of
the
public
docket
is
available
through
EPA
Dockets
(
EDOCKET)
at
http://
www.
epa.
gov/
edocket.
Use
EDOCKET
to
submit
or
view
public
comments,
access
the
index
listing
of
the
contents
of
the
public
docket,
and
to
access
those
documents
in
the
public
docket
that
are
available
electronically.
Once
in
the
system,
select
"
search,"
then
key
in
the
docket
ID
number
identified
above.
Also,
you
can
send
comments
to
the
Office
of
Information
and
Regulatory
Affairs,
Office
of
Management
and
Budget,
725
17th
Street,
NW,
Washington,
DC
20503,
Attention:
Desk
Office
for
EPA.
Please
include
the
EPA
Docket
ID
No.
OPPT­
2003­
0065
and
OMB
control
number
2070­
0012
in
any
correspondence.
May
10,
2004
28
Attachment
A
Toxic
Substances
Control
Act
Section
5
(
15
U.
S.
C.
2604)
May
10,
2004
Sec.
2604.
­
Manufacturing
and
processing
notices
(
a)
In
general
(
1)
Except
as
provided
in
subsection
(
h)
of
this
section,
no
person
may
­
(
A)
manufacture
a
new
chemical
substance
on
or
after
the
30th
day
after
the
date
on
which
the
Administrator
first
publishes
the
list
required
by
section
2607(
b)
of
this
title,
or
(
B)
manufacture
or
process
any
chemical
substance
for
a
use
which
the
Administrator
has
determined,
in
accordance
with
paragraph
(
2),
is
a
significant
new
use,

unless
such
person
submits
to
the
Administrator,
at
least
90
days
before
such
manufacture
or
processing,
a
notice,
in
accordance
with
subsection
(
d)
of
this
section,
of
such
person's
intention
to
manufacture
or
process
such
substance
and
such
person
complies
with
any
applicable
requirement
of
subsection
(
b)
of
this
section.
(
2)
A
determination
by
the
Administrator
that
a
use
of
a
chemical
substance
is
a
significant
new
use
with
respect
to
which
notification
is
required
under
paragraph
(
1)
shall
be
made
by
a
rule
promulgated
after
a
consideration
of
all
relevant
factors,
including
­
(
A)
the
projected
volume
of
manufacturing
and
processing
of
a
chemical
substance,
(
B)
the
extent
to
which
a
use
changes
the
type
or
form
of
exposure
of
human
beings
or
the
environment
to
a
chemical
substance,
(
C)
the
extent
to
which
a
use
increases
the
magnitude
and
duration
of
exposure
of
human
beings
or
the
environment
to
a
chemical
substance,
and
(
D)
the
reasonably
anticipated
manner
and
methods
of
manufacturing,
processing,
distribution
in
commerce,
and
disposal
of
a
chemical
substance.

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

such
person
may
not,
before
the
expiration
of
the
90
day
period
which
begins
on
the
date
of
the
submission
in
accordance
with
such
rule
of
the
test
data
the
May
10,
2004
submission
or
development
of
which
was
the
basis
for
the
exemption,
manufacture
such
substance
if
such
person
is
subject
to
subsection
(
a)(
1)(
A)
of
this
section
or
manufacture
or
process
such
substance
for
a
significant
new
use
if
the
person
is
subject
to
subsection
(
a)(
1)(
B)
of
this
section.
(
2)(
A)
If
a
person
­
(
i)
is
required
by
subsection
(
a)(
1)
of
this
section
to
submit
a
notice
to
the
Administrator
before
beginning
the
manufacture
or
processing
of
a
chemical
substance
listed
under
paragraph
(
4),
and
(
ii)
is
not
required
by
a
rule
promulgated
under
section
2603
of
this
title
before
the
submission
of
such
notice
to
submit
test
data
for
such
substance,
such
person
shall
submit
to
the
Administrator
data
prescribed
by
subparagraph
(
B)
at
the
time
notice
is
submitted
in
accordance
with
subsection
(
a)(
1)
of
this
section.

(
B)
Data
submitted
pursuant
to
subparagraph
(
A)
shall
be
data
which
the
person
submitting
the
data
believes
show
that
­
(
i)
in
the
case
of
a
substance
with
respect
to
which
notice
is
required
under
subsection
(
a)(
1)(
A)
of
this
section,
the
manufacture,
processing,
distribution
in
commerce,
use,
and
disposal
of
the
chemical
substance
or
any
combination
of
such
activities
will
not
present
an
unreasonable
risk
of
injury
to
health
or
the
environment,
or
(
ii)
in
the
case
of
a
chemical
substance
with
respect
to
which
notice
is
required
under
subsection
(
a)(
1)(
B)
of
this
section,
the
intended
significant
new
use
of
the
chemical
substance
will
not
present
an
unreasonable
risk
of
injury
to
health
or
the
environment.
(
3)
Data
submitted
under
paragraph
(
1)
or
(
2)
shall
be
made
available,
subject
to
section
2613
of
this
title,
for
examination
by
interested
persons.
(
4)(
A)
(
i)
The
Administrator
may,
by
rule,
compile
and
keep
current
a
list
of
chemical
substances
with
respect
to
which
the
Administrator
finds
that
the
manufacture,
processing,
distribution
in
commerce,
use,
or
disposal,
or
any
combination
of
such
activities,
presents
or
may
present
an
unreasonable
risk
of
injury
to
health
or
the
environment.
(
ii)
In
making
a
finding
under
clause
(
i)
that
the
manufacture,
processing,
distribution
in
commerce,
use,
or
disposal
of
a
chemical
substance
or
any
combination
of
such
activities
presents
or
may
present
an
unreasonable
risk
of
injury
to
health
or
the
environment,
the
Administrator
shall
consider
all
relevant
factors,
including
­
(
I)
the
effects
of
the
chemical
substance
on
health
and
the
magnitude
of
human
exposure
to
such
substance;
and
(
II)
the
effects
of
the
chemical
substance
on
the
environment
and
the
magnitude
of
environmental
exposure
to
such
substance.
(
B)
The
Administrator
shall,
in
prescribing
a
rule
under
subparagraph
(
A)
which
lists
any
chemical
substance,
identify
those
uses,
if
any,
which
the
Administrator
determines,
by
rule
under
subsection
(
a)(
2)
of
this
section,
would
constitute
a
significant
new
use
of
such
substance.
(
C)
Any
rule
under
subparagraph
(
A),
and
any
substantive
amendment
or
repeal
of
such
a
rule,
shall
be
promulgated
pursuant
to
the
procedures
May
10,
2004
specified
in
section
553
of
title
5,
except
that
(
i)
the
Administrator
shall
give
interested
persons
an
opportunity
for
the
oral
presentation
of
data,
views,
or
arguments,
in
addition
to
an
opportunity
to
make
written
submissions,
(
ii)
a
transcript
shall
be
kept
of
any
oral
presentation,
and
(
iii)
the
Administrator
shall
make
and
publish
with
the
rule
the
finding
described
in
subparagraph
(
A).

(
c)
Extension
of
notice
period
The
Administrator
may
for
good
cause
extend
for
additional
periods
(
not
to
exceed
in
the
aggregate
90
days)
the
period,
prescribed
by
subsection
(
a)
or
(
b)
of
this
section
before
which
the
manufacturing
or
processing
of
a
chemical
substance
subject
to
such
subsection
may
begin.
Subject
to
section
2613
of
this
title,
such
an
extension
and
the
reasons
therefor
shall
be
published
in
the
Federal
Register
and
shall
constitute
a
final
agency
action
subject
to
judicial
review.
(
d)
Content
of
notice;
publications
in
the
Federal
Register
(
1)
The
notice
required
by
subsection
(
a)
of
this
section
shall
include
­
(
A)
insofar
as
known
to
the
person
submitting
the
notice
or
insofar
as
reasonably
ascertainable,
the
information
described
in
subparagraphs
(
A),
(
B),
(
C),
(
D),
(
F),
and
(
G)
of
section
2607(
a)(
2)
of
this
title,
and
(
B)
in
such
form
and
manner
as
the
Administrator
may
prescribe,
any
test
data
in
the
possession
or
control
of
the
person
giving
such
notice
which
are
related
to
the
effect
of
any
manufacture,
processing,
distribution
in
commerce,
use,
or
disposal
of
such
substance
or
any
article
containing
such
substance,
or
of
any
combination
of
such
activities,
on
health
or
the
environment,
and
(
C)
a
description
of
any
other
data
concerning
the
environmental
and
health
effects
of
such
substance,
insofar
as
known
to
the
person
making
the
notice
or
insofar
as
reasonably
ascertainable.
Such
a
notice
shall
be
made
available,
subject
to
section
2613
of
this
title,
for
examination
by
interested
persons.
(
2)
Subject
to
section
2613
of
this
title,
not
later
than
five
days
(
excluding
Saturdays,
Sundays
and
legal
holidays)
after
the
date
of
the
receipt
of
a
notice
under
subsection
(
a)
of
this
section
or
of
data
under
subsection
(
b)
of
this
section,
the
Administrator
shall
publish
in
the
Federal
Register
a
notice
which
­
(
A)
identifies
the
chemical
substance
for
which
notice
or
data
has
been
received;
(
B)
lists
the
uses
or
intended
uses
of
such
substance;
and
(
C)
in
the
case
of
the
receipt
of
data
under
subsection
(
b)
of
this
section,
describes
the
nature
of
the
tests
performed
on
such
substance
and
any
data
which
was
developed
pursuant
to
subsection
(
b)
of
this
section
or
a
rule
under
section
2603
of
this
title.

A
notice
under
this
paragraph
respecting
a
chemical
substance
shall
identify
the
chemical
substance
by
generic
class
unless
the
Administrator
determines
that
more
specific
identification
is
required
in
the
public
interest.
(
3)
At
the
beginning
of
each
month
the
Administrator
shall
publish
a
list
in
the
Federal
Register
of
May
10,
2004
(
A)
each
chemical
substance
for
which
notice
has
been
received
under
subsection
(
a)
of
this
section
and
for
which
the
notification
period
prescribed
by
subsection
(
a),
(
b),
or
(
c)
of
this
section
has
not
expired,
and
(
B)
each
chemical
substance
for
which
such
notification
period
has
expired
since
the
last
publication
in
the
Federal
Register
of
such
list.
(
e)
Regulation
pending
development
of
information
(
1)
(
A)
If
the
Administrator
determines
that
­
(
i)
the
information
available
to
the
Administrator
is
insufficient
to
permit
a
reasoned
evaluation
of
the
health
and
environmental
effects
of
a
chemical
substance
with
respect
to
which
notice
is
required
by
subsection
(
a)
of
this
section;
and
(
ii)(
I)
in
the
absence
of
sufficient
information
to
permit
the
Administrator
to
make
such
an
evaluation,
the
manufacture,
processing,
distribution
in
commerce,
use,
or
disposal
of
such
substance,
or
any
combination
of
such
activities,
may
present
an
unreasonable
risk
of
injury
to
health
or
the
environment,
or
(
II)
such
substance
is
or
will
be
produced
in
substantial
quantities,
and
such
substance
either
enters
or
may
reasonably
be
anticipated
to
enter
the
environment
in
substantial
quantities
or
there
is
or
may
be
significant
or
substantial
human
exposure
to
the
substance,

the
Administrator
may
issue
a
proposed
order,
to
take
effect
on
the
expiration
of
the
notification
period
applicable
to
the
manufacturing
or
processing
of
such
substance
under
subsection
(
a),
(
b),
or
(
c)
of
this
section,
to
prohibit
or
limit
the
manufacture,
processing,
distribution
in
commerce,
use,
or
disposal
of
such
substance
or
to
prohibit
or
limit
any
combination
of
such
activities.
(
B)
A
proposed
order
may
not
be
issued
under
subparagraph
(
A)
respecting
a
chemical
substance
(
i)
later
than
45
days
before
the
expiration
of
the
notification
period
applicable
to
the
manufacture
or
processing
of
such
substance
under
subsection
(
a),
(
b),
or
(
c)
of
this
section,
and
(
ii)
unless
the
Administrator
has,
on
or
before
the
issuance
of
the
proposed
order,
notified,
in
writing,
each
manufacturer
or
processor,
as
the
case
may
be,
of
such
substance
of
the
determination
which
underlies
such
order.

(
C)
If
a
manufacturer
or
processor
of
a
chemical
substance
to
be
subject
to
a
proposed
order
issued
under
subparagraph
(
A)
files
with
the
Administrator
(
within
the
30­
day
period
beginning
on
the
date
such
manufacturer
or
processor
received
the
notice
required
by
subparagraph
(
B)(
ii))
objections
specifying
with
particularity
the
provisions
of
the
order
deemed
objectionable
and
stating
the
grounds
therefor,
the
proposed
order
shall
not
take
effect.
(
2)(
A)
(
i)
Except
as
provided
in
clause
(
ii),
if
with
respect
to
a
chemical
substance
with
respect
to
which
notice
is
required
by
subsection
(
a)
of
this
section,
May
10,
2004
the
Administrator
makes
the
determination
described
in
paragraph
(
1)(
A)
and
if
­
(
I)
the
Administrator
does
not
issue
a
proposed
order
under
paragraph
(
1)
respecting
such
substance,
or
(
II)
the
Administrator
issues
such
an
order
respecting
such
substance
but
such
order
does
not
take
effect
because
objections
were
filed
under
paragraph
(
1)(
C)
with
respect
to
it,

the
Administrator,
through
attorneys
of
the
Environmental
Protection
Agency,
shall
apply
to
the
United
States
District
Court
for
the
District
of
Columbia
or
the
United
States
district
court
for
the
judicial
district
in
which
the
manufacturer
or
processor,
as
the
case
may
be,
of
such
substance
is
found,
resides,
or
transacts
business
for
an
injunction
to
prohibit
or
limit
the
manufacture,
processing,
distribution
in
commerce,
use,
or
disposal
of
such
substance
(
or
to
prohibit
or
limit
any
combination
of
such
activities).
(
ii)
If
the
Administrator
issues
a
proposed
order
under
paragraph
(
1)(
A)
respecting
a
chemical
substance
but
such
order
does
not
take
effect
because
objections
have
been
filed
under
paragraph
(
1)(
C)
with
respect
to
it,
the
Administrator
is
not
required
to
apply
for
an
injunction
under
clause
(
i)
respecting
such
substance
if
the
Administrator
determines,
on
the
basis
of
such
objections,
that
the
determinations
under
paragraph
(
1)(
A)
may
not
be
made.
(
B)
A
district
court
of
the
United
States
which
receives
an
application
under
subparagraph
(
A)(
i)
for
an
injunction
respecting
a
chemical
substance
shall
issue
such
injunction
if
the
court
finds
that
­
(
i)
the
information
available
to
the
Administrator
is
insufficient
to
permit
a
reasoned
evaluation
of
the
health
and
environmental
effects
of
a
chemical
substance
with
respect
to
which
notice
is
required
by
subsection
(
a)
of
this
section;
and
(
ii)(
I)
in
the
absence
of
sufficient
information
to
permit
the
Administrator
to
make
such
an
evaluation,
the
manufacture,
processing,
distribution
in
commerce,
use,
or
disposal
of
such
substance,
or
any
combination
of
such
activities,
may
present
an
unreasonable
risk
of
injury
to
health
or
the
environment,
or
(
II)
such
substance
is
or
will
be
produced
in
substantial
quantities,
and
such
substance
either
enters
or
may
reasonably
be
anticipated
to
enter
the
environment
in
substantial
quantities
or
there
is
or
may
be
significant
or
substantial
human
exposure
to
the
substance.

(
C)
Pending
the
completion
of
a
proceeding
for
the
issuance
of
an
injunction
under
subparagraph
(
B)
respecting
a
chemical
substance,
the
court
may,
upon
application
of
the
Administrator
made
through
attorneys
of
the
Environmental
Protection
Agency,
issue
a
temporary
restraining
order
or
a
preliminary
injunction
to
prohibit
the
manufacture,
processing,
distribution
in
commerce,
use,
or
disposal
of
such
a
substance
(
or
any
combination
of
such
activities)
if
the
court
finds
that
the
notification
period
applicable
under
subsection
(
a),
(
b),
or
(
c)
of
this
section
to
the
manufacturing
or
processing
of
such
substance
May
10,
2004
may
expire
before
such
proceeding
can
be
completed.
(
D)
After
the
submission
to
the
Administrator
of
test
data
sufficient
to
evaluate
the
health
and
environmental
effects
of
a
chemical
substance
subject
to
an
injunction
issued
under
subparagraph
(
B)
and
the
evaluation
of
such
data
by
the
Administrator,
the
district
court
of
the
United
States
which
issued
such
injunction
shall,
upon
petition
dissolve
the
injunction
unless
the
Administrator
has
initiated
a
proceeding
for
the
issuance
of
a
rule
under
section
2605(
a)
of
this
title
respecting
the
substance.
If
such
a
proceeding
has
been
initiated,
such
court
shall
continue
the
injunction
in
effect
until
the
effective
date
of
the
rule
promulgated
in
such
proceeding
or,
if
such
proceeding
is
terminated
without
the
promulgation
of
a
rule,
upon
the
termination
of
the
proceeding,
whichever
occurs
first.
(
f)
Protection
against
unreasonable
risks
(
1)
If
the
Administrator
finds
that
there
is
a
reasonable
basis
to
conclude
that
the
manufacture,
processing,
distribution
in
commerce,
use,
or
disposal
of
a
chemical
substance
with
respect
to
which
notice
is
required
by
subsection
(
a)
of
this
section,
or
that
any
combination
of
such
activities,
presents
or
will
present
an
unreasonable
risk
of
injury
to
health
or
environment
before
a
rule
promulgated
under
section
2605
of
this
title
can
protect
against
such
risk,
the
Administrator
shall,
before
the
expiration
of
the
notification
period
applicable
under
subsection
(
a),
(
b),
or
(
c)
of
this
section
to
the
manufacturing
or
processing
of
such
substance,
take
the
action
authorized
by
paragraph
(
2)
or
(
3)
to
the
extent
necessary
to
protect
against
such
risk.
(
2)
The
Administrator
may
issue
a
proposed
rule
under
section
2605(
a)
of
this
title
to
apply
to
a
chemical
substance
with
respect
to
which
a
finding
was
made
under
paragraph
(
1)
­
(
A)
a
requirement
limiting
the
amount
of
such
substance
which
may
be
manufactured,
processed,
or
distributed
in
commerce,
(
B)
a
requirement
described
in
paragraph
(
2),
(
3),
(
4),
(
5),
(
6),
or
(
7)
of
section
2605(
a)
of
this
title,
or
(
C)
any
combination
of
the
requirements
referred
to
in
subparagraph
(
B).

Such
a
proposed
rule
shall
be
effective
upon
its
publication
in
the
Federal
Register.
Section
2605(
d)(
2)(
B)
of
this
title
shall
apply
with
respect
to
such
rule.

(
3)(
A)
The
Administrator
may
­
(
i)
issue
a
proposed
order
to
prohibit
the
manufacture,
processing,
or
distribution
in
commerce
of
a
substance
with
respect
to
which
a
finding
was
made
under
paragraph
(
1),
or
(
ii)
apply,
through
attorneys
of
the
Environmental
Protection
Agency,
to
the
United
States
District
Court
for
the
District
of
Columbia
or
the
United
States
district
court
for
the
judicial
district
in
which
the
manufacturer,
or
processor,
as
the
case
may
be,
of
such
substance,
is
found,
resides,
or
transacts
business
for
an
injunction
to
prohibit
the
manufacture,
processing,
or
distribution
in
commerce
of
such
substance.
May
10,
2004
A
proposed
order
issued
under
clause
(
i)
respecting
a
chemical
substance
shall
take
effect
on
the
expiration
of
the
notification
period
applicable
under
subsection
(
a),
(
b),
or
(
c)
of
this
section
to
the
manufacture
or
processing
of
such
substance.
(
B)
If
the
district
court
of
the
United
States
to
which
an
application
has
been
made
under
subparagraph
(
A)(
ii)
finds
that
there
is
a
reasonable
basis
to
conclude
that
the
manufacture,
processing,
distribution
in
commerce,
use,
or
disposal
of
the
chemical
substance
with
respect
to
which
such
application
was
made,
or
that
any
combination
of
such
activities,
presents
or
will
present
an
unreasonable
risk
of
injury
to
health
or
the
environment
before
a
rule
promulgated
under
section
2605
of
this
title
can
protect
against
such
risk,
the
court
shall
issue
an
injunction
to
prohibit
the
manufacture,
processing,
or
distribution
in
commerce
of
such
substance
or
to
prohibit
any
combination
of
such
activities.
(
C)
The
provisions
of
subparagraphs
(
B)
and
(
C)
of
subsection
(
e)(
1)
of
this
section
shall
apply
with
respect
to
an
order
issued
under
clause
(
i)
of
subparagraph
(
A);
and
the
provisions
of
subparagraph
(
C)
of
subsection
(
e)(
2)
of
this
section
shall
apply
with
respect
to
an
injunction
issued
under
subparagraph
(
B).
(
D)
If
the
Administrator
issues
an
order
pursuant
to
subparagraph
(
A)(
i)
respecting
a
chemical
substance
and
objections
are
filed
in
accordance
with
subsection
(
e)(
1)(
C)
of
this
section,
the
Administrator
shall
seek
an
injunction
under
subparagraph
(
A)(
ii)
respecting
such
substance
unless
the
Administrator
determines,
on
the
basis
of
such
objections,
that
such
substance
does
not
or
will
not
present
an
unreasonable
risk
of
injury
to
health
or
the
environment.
(
g)
Statement
of
reasons
for
not
taking
action
If
the
Administrator
has
not
initiated
any
action
under
this
section
or
section
2605
or
2606
of
this
title
to
prohibit
or
limit
the
manufacture,
processing,
distribution
in
commerce,
use,
or
disposal
of
a
chemical
substance,
with
respect
to
which
notification
or
data
is
required
by
subsection
(
a)(
1)(
B)
or
(
b)
of
this
section,
before
the
expiration
of
the
notification
period
applicable
to
the
manufacturing
or
processing
of
such
substance,
the
Administrator
shall
publish
a
statement
of
the
Administrator's
reasons
for
not
initiating
such
action.
Such
a
statement
shall
be
published
in
the
Federal
Register
before
the
expiration
of
such
period.
Publication
of
such
statement
in
accordance
with
the
preceding
sentence
is
not
a
prerequisite
to
the
manufacturing
or
processing
of
the
substance
with
respect
to
which
the
statement
is
to
be
published.
(
h)
Exemptions
(
1)
The
Administrator
may,
upon
application,
exempt
any
person
from
any
requirement
of
subsection
(
a)
or
(
b)
of
this
section
to
permit
such
person
to
manufacture
or
process
a
chemical
substance
for
test
marketing
purposes
­
(
A)
upon
a
showing
by
such
person
satisfactory
to
the
Administrator
that
the
manufacture,
processing,
distribution
in
commerce,
use,
and
disposal
of
such
substance,
and
that
any
combination
of
such
activities,
for
such
purposes
will
not
present
any
unreasonable
risk
of
injury
to
health
or
the
environment,
and
(
B)
under
such
restrictions
as
the
Administrator
considers
appropriate.
May
10,
2004
(
2)(
A)
The
Administrator
may,
upon
application,
exempt
any
person
from
the
requirement
of
subsection
(
b)(
2)
of
this
section
to
submit
data
for
a
chemical
substance.
If,
upon
receipt
of
an
application
under
the
preceding
sentence,
the
Administrator
determines
that
­
(
i)
the
chemical
substance
with
respect
to
which
such
application
was
submitted
is
equivalent
to
a
chemical
substance
for
which
data
has
been
submitted
to
the
Administrator
as
required
by
subsection
(
b)(
2)
of
this
section,
and
(
ii)
submission
of
data
by
the
applicant
on
such
substance
would
be
duplicative
of
data
which
has
been
submitted
to
the
Administrator
in
accordance
with
such
subsection,

the
Administrator
shall
exempt
the
applicant
from
the
requirement
to
submit
such
data
on
such
substance.
No
exemption
which
is
granted
under
this
subparagraph
with
respect
to
the
submission
of
data
for
a
chemical
substance
may
take
effect
before
the
beginning
of
the
reimbursement
period
applicable
to
such
data.
(
B)
If
the
Administrator
exempts
any
person,
under
subparagraph
(
A),
from
submitting
data
required
under
subsection
(
b)(
2)
of
this
section
for
a
chemical
substance
because
of
the
existence
of
previously
submitted
data
and
if
such
exemption
is
granted
during
the
reimbursement
period
for
such
data,
then
(
unless
such
person
and
the
persons
referred
to
in
clauses
(
i)
and
(
ii)
agree
on
the
amount
and
method
of
reimbursement)
the
Administrator
shall
order
the
person
granted
the
exemption
to
provide
fair
and
equitable
reimbursement
(
in
an
amount
determined
under
rules
of
the
Administrator)
­
(
i)
to
the
person
who
previously
submitted
the
data
on
which
the
exemption
was
based,
for
a
portion
of
the
costs
incurred
by
such
person
in
complying
with
the
requirement
under
subsection
(
b)(
2)
of
this
section
to
submit
such
data,
and
(
ii)
to
any
other
person
who
has
been
required
under
this
subparagraph
to
contribute
with
respect
to
such
costs,
for
a
portion
of
the
amount
such
person
was
required
to
contribute.

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

(
C)
For
purposes
of
this
paragraph,
the
reimbursement
period
for
any
previously
submitted
data
for
a
chemical
substance
is
a
period
­
(
i)
beginning
on
the
date
of
the
termination
of
the
prohibition,
imposed
under
this
section,
on
the
manufacture
or
processing
of
such
substance
by
the
person
who
submitted
such
data
to
the
Administrator,
and
May
10,
2004
(
ii)
ending
­
(
I)
five
years
after
the
date
referred
to
in
clause
(
i),
or
(
II)
at
the
expiration
of
a
period
which
begins
on
the
date
referred
to
in
clause
(
i)
and
is
equal
to
the
period
which
the
Administrator
determines
was
necessary
to
develop
such
data,
whichever
is
later.
(
3)
The
requirements
of
subsections
(
a)
and
(
b)
of
this
section
do
not
apply
with
respect
to
the
manufacturing
or
processing
of
any
chemical
substance
which
is
manufactured
or
processed,
or
proposed
to
be
manufactured
or
processed,
only
in
small
quantities
(
as
defined
by
the
Administrator
by
rule)
solely
for
purposes
of
­
(
A)
scientific
experimentation
or
analysis,
or
(
B)
chemical
research
on,
or
analysis
of
such
substance
or
another
substance,
including
such
research
or
analysis
for
the
development
of
a
product,
if
all
persons
engaged
in
such
experimentation,
research,
or
analysis
for
a
manufacturer
or
processor
are
notified
(
in
such
form
and
manner
as
the
Administrator
may
prescribe)
of
any
risk
to
health
which
the
manufacturer,
processor,
or
the
Administrator
has
reason
to
believe
may
be
associated
with
such
chemical
substance.
(
4)
The
Administrator
may,
upon
application
and
by
rule,
exempt
the
manufacturer
of
any
new
chemical
substance
from
all
or
part
of
the
requirements
of
this
section
if
the
Administrator
determines
that
the
manufacture,
processing,
distribution
in
commerce,
use,
or
disposal
of
such
chemical
substance,
or
that
any
combination
of
such
activities,
will
not
present
an
unreasonable
risk
of
injury
to
health
or
the
environment.
A
rule
promulgated
under
this
paragraph
(
and
any
substantive
amendment
to,
or
repeal
of,
such
a
rule)
shall
be
promulgated
in
accordance
with
paragraphs
(
2)
and
(
3)
of
section
2605(
c)
of
this
title.
(
5)
The
Administrator
may,
upon
application,
make
the
requirements
of
subsections
(
a)
and
(
b)
of
this
section
inapplicable
with
respect
to
the
manufacturing
or
processing
of
any
chemical
substance
(
A)
which
exists
temporarily
as
a
result
of
a
chemical
reaction
in
the
manufacturing
or
processing
of
a
mixture
or
another
chemical
substance,
and
(
B)
to
which
there
is
no,
and
will
not
be,
human
or
environmental
exposure.
(
6)
Immediately
upon
receipt
of
an
application
under
paragraph
(
1)
or
(
5)
the
Administrator
shall
publish
in
the
Federal
Register
notice
of
the
receipt
of
such
application.
The
Administrator
shall
give
interested
persons
an
opportunity
to
comment
upon
any
such
application
and
shall,
within
45
days
of
its
receipt,
either
approve
or
deny
the
application.
The
Administrator
shall
publish
in
the
Federal
Register
notice
of
the
approval
or
denial
of
such
an
application.

(
i)
''
Manufacture''
and
''
process''
defined
For
purposes
of
this
section,
the
terms
''
manufacture''
and
''
process''
mean
manufacturing
or
processing
for
commercial
purposes
May
10,
2004
Attachment
B
40
CFR
Part
700
May
10,
2004
40
CFR
Protection
of
Environment
CHAPTER
I
ENVIRONMENTAL
PROTECTION
AGENCY
(
CONTINUED)

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

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

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

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

[
59
FR
13177,
Mar.
18,
1994]

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

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

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

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

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

Final
product
means
a
new
chemical
substance
(
as
"
new
chemical
substance"
is
defined
in
§
720.3
of
this
chapter)
that
is
manufactured
by
a
person
for
distribution
in
commerce,
or
for
use
by
the
person
other
than
as
an
intermediate.
May
10,
2004
Intermediate
premanufacture
notice
or
intermediate
PMN
means
any
PMN
submitted
to
EPA
for
a
chemical
substance
which
is
an
intermediate
(
as
"
intermediate"
is
defined
in
§
720.3
of
this
chapter)
in
the
production
of
a
final
product,
provided
that
the
PMN
for
the
intermediate
is
submitted
to
EPA
at
the
same
time
as,
and
together
with,
the
PMN
for
the
final
product
and
that
the
PMN
for
the
intermediate
identifies
the
final
product
and
describes
the
chemical
reactions
leading
from
the
intermediate
to
the
final
product.
If
PMNs
are
submitted
to
EPA
at
the
same
time
for
several
intermediates
used
in
the
production
of
a
final
product,
each
of
those
is
an
intermediate
PMN
if
they
all
identify
the
final
product
and
every
other
associated
intermediate
PMN
and
are
submitted
to
EPA
at
the
same
time
as,
and
together
with,
the
PMN
for
the
final
product.

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

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

Person
means
a
manufacturer,
importer,
or
processor.

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

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

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

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

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

§
700.45
Fee
payments.

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

(
b)
Fees.
Persons
shall
remit
fee
payments
to
EPA
as
follows:

(
1)
Small
business
concerns.
Small
business
concerns
shall
remit
a
fee
of
$
100
for
each
section
5
notice
submitted.

(
2)
Others.
Persons
other
than
small
business
concerns
shall
remit
fees
according
to
the
type
of
May
10,
2004
section
5
notice
as
follows:

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

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

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

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

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

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

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

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

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

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

(
3)
Persons
who
submit
a
section
5
notice
shall
place
a
unique
identifying
number,
which
must
include
the
letters
"
TS"
followed
by
a
combination
of
6
numbers
(
letters
may
be
substituted
for
some
numbers),
on
the
front
page
of
each
section
5
notice
submitted.
The
same
identifying
number
and
the
submitter's
name
must
appear
on
the
corresponding
fee
remittance
under
this
section.
If
a
remittance
applies
to
more
than
one
section
5
notice,
the
person
shall
include
the
name
of
the
submitter,
the
identifying
number
for
each
section
5
notice
to
which
the
remittance
applies,
and
the
amount
of
the
remittance
which
applies
to
each
notice.
Any
remittance
not
having
the
identifying
name
and
number
described
above
will
be
returned
to
the
remitter.
May
10,
2004
(
4)(
i)
Each
person
who
remits
the
fee
identified
in
paragraph
(
b)(
1)
of
this
section
for
a
PMN,
consolidated
PMN,
intermediate
PMN,
or
significant
new
use
notice
shall
write
or
type
the
words,
"
The
company
named
in
part
1,
section
A
is
a
small
business
concern
under
40
CFR
700.43
and
has
remitted
a
fee
of
$
100
in
accordance
with
40
CFR
700.45(
b)."
under
"
CERTIFICATION"
on
Page
2
of
the
Premanufacture
Notice
for
New
Chemical
Substances
(
EPA
Form
7710­
25
(
4­
26­
83)).

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

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

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

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

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

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

(
iv)
Each
person
who
remits
a
fee
identified
in
paragraph
(
b)(
2)
of
this
section
for
a
MCAN
for
a
microorganism
shall
include
the
words,
"
The
company
identified
in
this
notice
has
remitted
the
fee
specified
in
40
CFR
700.45(
b),"
in
the
certification
required
in
§
725.25(
b)
of
this
chapter.

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

(
1)
That
the
chemical
substance
that
is
the
subject
of
a
PMN,
intermediate
PMN,
exemption
May
10,
2004
application,
or
exemption
notice
is
not
a
new
chemical
substance
as
of
the
date
of
submission
of
the
notice.

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

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

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

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

§
700.49
Failure
to
remit
fees.

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

[
62
FR
17932,
April
11,
1997]
May
10,
2004
Attachment
C
40
CFR
Part
720
May
10,
2004
40
CFR
Protection
of
Environment
CHAPTER
I
ENVIRONMENTAL
PROTECTION
AGENCY
(
CONTINUED)

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

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

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

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

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

Subpart
G
­­
Compliance
and
Inspections
May
10,
2004
720.120
Compliance.
720.122
Inspections.

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

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

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

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

§
720.3
Definitions.

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

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

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

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

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

(
d)
Byproduct
means
a
chemical
substance
produced
without
a
separate
commercial
intent
during
May
10,
2004
the
manufacture,
processing,
use,
or
disposal
of
another
chemical
substance
or
mixture.

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

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

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

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

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

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

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

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

(
2)
Examples
include:

(
i)
Long­
and
short­
term
tests
of
mutagenicity,
carcinogenicity,
or
teratogenicity;
data
on
behavioral
disorders;
dermatoxicity;
pharmacological
effects;
mammalian
absorption,
distribution,
metabolism,
and
excretion;
cumulative,
additive,
and
synergistic
effects;
acute,
subchronic,
and
chronic
effects;
and
structure/
activity
analyses.
May
10,
2004
(
ii)
Tests
for
ecological
or
other
environmental
effects
on
invertebrates,
fish,
or
other
animals,
and
plants,
including:
Acute
toxicity
tests,
chronic
toxicity
tests,
critical
life
stage
tests,
behavioral
tests,
algal
growth
tests,
seed
germination
tests,
plant
growth
or
damage
tests,
microbial
function
tests,
bioconcentration
or
bioaccumulation
tests,
and
model
ecosystem
(
microcosm)
studies.

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

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

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

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

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

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

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

(
o)
Inventory
means
the
list
of
chemical
substances
manufactured
or
processed
in
the
United
States
that
EPA
compiled
and
keeps
current
under
section
8(
b)
of
the
Act.

(
p)
Known
to
or
reasonably
ascertainable
by
means
all
information
in
a
person's
possession
or
control,
plus
all
information
that
a
reasonable
person
similarly
situated
might
be
expected
to
possess,
control,
or
know.

(
q)
Manufacture
means
to
produce
or
manufacture
in
the
United
States
or
import
into
the
customs
territory
of
the
United
States.
May
10,
2004
(
r)
Manufacture
or
import
for
commercial
purposes
means:

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

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

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

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

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

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

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

(
u)
Mixture
means
any
combination
of
two
or
more
chemical
substances
if
the
combination
does
not
occur
in
nature
and
is
not,
in
whole
or
in
part,
the
result
of
a
chemical
reaction;
except
"
mixture"
does
include
(
1)
any
combination
which
occurs,
in
whole
or
in
part,
as
a
result
of
a
chemical
reaction
if
the
combination
could
have
been
manufactured
for
commercial
purposes
without
a
chemical
reaction
at
the
time
the
chemical
substances
comprising
the
combination
were
combined,
and
if
all
of
the
chemical
substances
comprising
the
combination
are
not
new
chemical
substances,
and
(
2)
hydrates
of
a
chemical
substance
or
hydrated
ions
formed
by
association
of
a
chemical
substance
with
water,
so
long
as
the
nonhydrated
form
is
itself
not
a
new
chemical
substance.
May
10,
2004
(
v)
New
chemical
substance
means
any
chemical
substance
which
is
not
included
on
the
Inventory.

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

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

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

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

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

(
ii)
Reasonably
likely
to
have
such
data.

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

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

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

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

(
cc)
Small
quantities
solely
for
research
and
development
(
or
"
small
quantities
solely
for
purposes
May
10,
2004
of
scientific
experimentation
or
analysis
or
chemical
research
on,
or
analysis
of,
such
substance
or
another
substance,
including
such
research
or
analysis
for
the
development
of
a
product")
means
quantities
of
a
chemical
substance
manufactured,
imported,
or
processed
or
proposed
to
be
manufactured,
imported,
or
processed
solely
for
research
and
development
that
are
not
greater
than
reasonably
necessary
for
such
purposes.

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

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

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

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

(
hh)
United
States,
when
used
in
the
geographic
sense,
means
all
of
the
States.
[
48
FR
21742,
May
13,
1983,
as
amended
at
51
FR
15101,
Apr.
22,
1986]

Subpart
B
­­
Applicability
§
720.22
Persons
who
must
report.

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

(
2)
If
a
person
contracts
with
a
manufacturer
to
manufacture
or
produce
a
new
chemical
substance,
and
(
i)
the
manufacturer
manufactures
or
produces
the
substance
exclusively
for
that
person,
and
(
ii)
that
person
specifies
the
identity
of
the
substance,
and
controls
the
total
amount
produced
and
the
basic
technology
for
the
plant
process,
that
person
must
submit
the
notice.
If
it
is
unclear
who
must
report,
EPA
should
be
contacted
to
determine
who
must
submit
the
notice.
May
10,
2004
(
3)
Only
manufacturers
that
are
incorporated,
licensed,
or
doing
business
in
the
United
States
may
submit
a
notice.

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

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

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

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

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

(
2)
To
establish
a
bona
fide
intent
to
manufacture
or
import
a
chemical
substance,
the
person
who
proposes
to
manufacture
or
import
the
substance
must
submit
to
EPA:

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

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

(
iii)(
A)
A
brief
description
of
the
research
and
development
activities
conducted
to
date
related
to
the
substance,
including
the
year
in
which
the
person
first
started
to
conduct
research
or
development
activity
on
the
substance,
and
the
general
types
of
research
and
development
activities
conducted
thus
far
(
e.
g.,
synthesis,
substance
isolation/
purification,
formulating,
product
development,
process
development,
end­
use
application,
toxicity
testing,
etc.).
The
person
must
also
indicate
whether
any
pilot
plant
or
production­
scale
plant
evaluations
have
been
conducted
involving
the
manufacture
or
processing
of
the
substance.
May
10,
2004
(
B)
If
an
importer
is
unable
to
provide
the
information
requested
in
paragraph
(
b)(
2)(
iii)(
A)
of
this
section
from
the
foreign
manufacturer
or
supplier,
the
following
information
shall
be
submitted:

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

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

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

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

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

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

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

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

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

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

(
ii)
If
a
manufacturer
cannot
provide
all
of
the
required
information
in
accordance
with
§
720.45(
a)
(
1),
(
2),
and
(
3)
because
the
new
chemical
substance
is
manufactured
using
a
reactant
that
has
a
specific
chemical
identity
claimed
as
confidential
by
its
supplier,
the
notice
must
contain
chemical
identity
information
that
is
as
complete
as
known
by
the
manufacturer.
In
addition,
a
letter
of
May
10,
2004
support
for
the
notice
must
then
be
sent
to
EPA
by
the
chemical
supplier
of
the
confidential
reactant,
providing
the
specific
chemical
identity
of
the
proprietary
reactant.
The
letter
of
support
must
reference
the
manufacturer's
notice.
If
the
appropriate
supporting
document
from
the
supplier
is
not
received
within
30
days
after
EPA
receives
the
manufacturer's
notice,
the
notice
will
be
considered
incomplete.

(
4)
EPA
will
review
the
information
submitted
by
the
proposed
manufacturer
or
importer
under
this
paragraph
to
determine
whether
it
has
a
bona
fide
intent
to
manufacture
or
import
the
chemical
substance.
If
necessary,
EPA
will
compare
this
information
either
to
the
information
requested
for
the
confidential
chemical
substance
under
§
710.7(
e)(
2)(
v)
of
this
chapter
or
the
information
requested
under
§
720.85(
b)(
3)(
iii).

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

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

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

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

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

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

§
720.30
Chemicals
not
subject
to
notification
requirements.

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

(
a)
Any
substance
which
is
not
a
"
chemical
substance"
as
defined
in
§
720.3(
e).
May
10,
2004
(
b)
Any
mixture
as
defined
in
§
720.3(
u).
A
new
chemical
substance
that
is
manufactured
or
imported
as
part
of
a
mixture
is
subject
to
the
requirements
of
this
part.
This
exclusion
applies
only
to
a
mixture
as
a
whole
and
not
to
any
chemical
substances
which
are
part
of
the
mixture.

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

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

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

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

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

(
g)
Any
byproduct
if
its
only
commercial
purpose
is
for
use
by
public
or
private
organizations
that
(
1)
burn
it
as
a
fuel,
(
2)
dispose
of
it
as
a
waste,
including
in
a
landfill
or
for
enriching
soil,
or
(
3)
extract
component
chemical
substances
from
it
for
commercial
purposes.
(
This
exclusion
only
applies
to
the
byproduct;
it
does
not
apply
to
the
component
substances
extracted
from
the
byproduct.)

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

(
1)
Any
impurity.
(
2)
Any
byproduct
which
is
not
used
for
commercial
purposes.
(
3)
Any
chemical
substance
which
results
from
a
chemical
reaction
that
occurs
incidental
to
exposure
of
another
chemical
substance,
mixture,
or
article
to
environmental
factors
such
as
air,
moisture,
microbial
organisms,
or
sunlight.
(
4)
Any
chemical
substance
which
results
from
a
chemical
reaction
that
occurs
incidental
to
storage
or
disposal
of
another
chemical
substance,
mixture,
or
article.
(
5)
Any
chemical
substance
which
results
from
a
chemical
reaction
that
occurs
upon
end
use
of
another
chemical
substance,
mixture,
or
article
such
as
an
adhesive,
paint,
miscellaneous
cleanser
or
other
housekeeping
product,
fuel
additive,
water
softening
and
treatment
agent,
photographic
film,
battery,
match,
or
safety
flare,
and
which
is
not
itself
manufactured
or
imported
for
distribution
in
commerce
or
for
use
as
an
intermediate.
(
6)
Any
chemical
substance
which
results
from
a
chemical
reaction
that
occurs
upon
use
of
curable
plastic
or
rubber
molding
compounds,
inks,
drying
oils,
metal
finishing
compounds,
adhesives,
or
paints,
or
any
other
chemical
substance
formed
during
the
manufacture
of
an
article
May
10,
2004
destined
for
the
marketplace
without
further
chemical
change
of
the
chemical
substance
except
for
those
chemical
changes
that
occur
as
described
elsewhere
in
this
paragraph.
(
7)
Any
chemical
substance
which
results
from
a
chemical
reaction
that
occurs
when
(
i)
a
stabilizer,
colorant,
odorant,
antioxidant,
filler,
solvent,
carrier,
surfactant,
plasticizer,
corrosion
inhibitor,
antifoamer
or
defoamer,
dispersant,
precipitation
inhibitor,
binder,
emulsifier,
deemulsifier,
dewatering
agent,
agglomerating
agent,
adhesion
promoter,
flow
modifier,
pH
neutralizer,
sequesterant,
coagulant,
flocculant,
fire
retardant,
lubricant,
chelating
agent,
or
quality
control
reagent
functions
as
intented,
or
(
ii)
a
chemical
substance,
which
is
intended
solely
to
impart
a
specific
physiochemical
characteristic,
functions
as
intended.
(
8)
Any
nonisolated
intermediate.

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

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

§
720.36
Exemption
for
research
and
development.

(
a)
This
part
does
not
apply
to
a
chemical
substance
if
the
following
conditions
are
met:

(
1)
The
chemical
substance
is
manufactured
or
imported
only
in
small
quantities
solely
for
research
and
development.
(
2)
The
manufacturer
or
importer
notifies
all
persons
in
its
employ
or
to
whom
it
directly
distributes
the
chemical
substance,
who
are
engaged
in
experimentation,
research,
or
analysis
on
the
chemical
substance,
including
the
manufacture,
processing,
use,
transport,
storage,
and
disposal
of
the
substance
associated
with
research
and
development
activities,
of
any
risk
to
health,
identified
under
paragraph
(
b)
of
this
section,
which
may
be
associated
with
the
substance.
The
notification
must
be
made
in
accordance
with
paragraph
(
c)
of
this
section.
(
3)
The
chemical
substance
is
used
by,
or
directly
under
the
supervision
of,
a
technically
qualified
individual.

(
b)(
1)
To
determine
whether
notification
under
paragraph
(
a)(
2)
of
this
section
is
required,
the
manufacturer
or
importer
must
review
and
evaluate
the
following
information
to
determine
whether
there
is
reason
to
believe
there
is
any
potential
risk
to
health
which
may
be
associated
with
the
chemical
substance:

(
i)
Information
in
its
possession
or
control
concerning
any
significant
adverse
reaction
by
persons
exposed
to
the
chemical
substance
which
may
reasonably
be
associated
with
such
exposure.
(
ii)
Information
provided
to
the
manufacturer
or
importer
by
a
supplier
or
any
other
person
concerning
a
health
risk
believed
to
be
associated
with
the
substance.
(
iii)
Health
and
environmental
effects
data
in
its
possession
or
control
concerning
the
substance.
(
iv)
Information
on
health
effects
which
accompanies
any
EPA
rule
or
order
issued
under
sections
May
10,
2004
4,
5,
or
6
of
the
Act
that
applies
to
the
substance
and
of
which
the
manufacturer
or
importer
has
knowledge.

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

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

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

(
i)
Notify
those
persons
that
the
substance
is
to
be
used
only
for
research
and
development
purposes.
(
ii)
Provide
the
notice
of
health
risks
specified
in
paragraph
(
c)(
1)
of
this
section.

(
3)
The
adequacy
of
any
notification
under
this
section
is
the
responsibility
of
the
manufacturer
or
importer.

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

(
e)
Quantities
of
the
chemical
substance,
or
of
mixtures
or
articles
containing
the
chemical
substance,
remaining
after
completion
of
research
and
development
activities
may
be:

(
1)
Disposed
of
as
a
waste
in
accordance
with
applicable
Federal,
state,
and
local
regulations,
or
(
2)
Used
for
the
following
commercial
purposes:

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

(
f)
Quantities
of
research
and
development
substances
existing
solely
as
impurities
in
a
product
or
incorporated
into
an
article,
in
accordance
with
paragraph
(
d)
of
this
section,
and
quantities
of
May
10,
2004
research
and
development
substances
used
solely
for
commercial
purposes
listed
in
paragraph
(
e)
of
this
section,
are
not
subject
to
the
requirements
of
paragraphs
(
a),
(
b),
and
(
c)
of
this
section,
once
research
and
development
activities
have
been
completed.

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

[
51
FR
15102,
Apr.
22,
1986]

§
720.38
Exemptions
for
test
marketing.

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

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

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

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

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

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

[
48
FR
21742,
May
13,
1983,
as
amended
at
58
FR
34204,
June
23,
1993]
May
10,
2004
Subpart
C
­­
Notice
Form
§
720.40
General.

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

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

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

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

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

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

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

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

(
2)
A
manufacturer
or
importer
may
authorize
another
person,
(
e.
g.,
a
foreign
manufacturer
or
May
10,
2004
supplier,
or
a
toll
manufacturer)
to
report
some
of
the
information
required
in
the
notice
to
EPA
on
its
behalf.
If
separate
portions
of
a
joint
notice
are
not
submitted
together,
the
submitter
should
indicate
which
information
will
be
supplied
by
another
person
and
identify
that
person.
The
other
person
must
submit
the
information
on
the
appropriate
part
of
the
notice
form.
The
manufacturer
or
importer
and
any
other
person
supplying
the
information
must
sign
the
certification
provided
on
their
respective
notice
forms.

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

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

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

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

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

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

(
h)
Chemical
substances
subject
to
a
section
5(
b)(
4)
rule.
(
1)
If
a
person
(
i)
intends
to
manufacture
or
import
a
new
chemical
substance
which
is
subject
to
the
notification
requirements
of
this
part
and
which
is
subject
to
a
rule
issued
under
section
5(
b)(
4)
of
the
Act;
and
(
ii)
is
not
required
by
a
rule
issued
under
section
4
of
the
Act
to
submit
test
data
for
the
substance
before
the
submission
of
a
notice,
the
person
must
submit
to
EPA
data
described
in
May
10,
2004
paragraph
(
h)(
2)
of
this
section
at
the
time
the
notice
is
submitted.

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

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

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

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

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

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

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

(
i)
The
specific
chemical
name
and
CASRN,
if
the
number
is
available,
of
each
monomer
and
other
reactant
used,
at
any
weight
percent,
to
manufacture
the
polymer.
Tradenames
or
generic
names
of
chemical
reactants
or
monomers
are
not
acceptable
as
substitutes
for
specific
chemical
names.
May
10,
2004
(
ii)
The
typical
percent
by
weight
of
each
monomer
and
other
reactant
in
the
polymer
(
weight
of
the
monomer
or
other
reactant
expressed
as
a
percentage
of
the
weight
of
the
polymeric
chemical
substance
manufactured),
and
the
maximum
residual
amount
of
each
monomer
present
in
the
polymer.
(
iii)
For
monomers
and
other
reactants
used
at
2
weight
percent
or
less
(
based
on
the
dry
weight
of
the
polymer
manufactured),
indicate
on
the
PMN
form
any
such
monomers
and
other
reactants
that
should
be
included
as
part
of
the
polymer
description
on
the
Inventory,
where
the
weight
percent
is
based
on
either
(
A)
the
weight
of
monomer
or
other
reactant
actually
charged
to
the
reaction
vessel,
or
(
B)
the
minimum
weight
of
monomer
or
other
reactant
required
in
theory
to
account
for
the
actual
weight
of
monomer
or
other
reactant
molecules
or
fragments
chemically
incorporated
(
chemically
combined)
in
the
polymeric
substance
manufactured.
(
iv)
For
a
determination
that
2
weight
percent
or
less
of
a
monomer
or
other
reactant
is
incorporated
(
chemically
combined)
in
a
polymeric
substance
manufactured,
as
specified
in
paragraphs
(
a)(
2)(
iii)(
B)
of
this
section,
analytical
data
or
appropriate
theoretical
calculations
(
if
it
can
be
documented
that
analytical
measurement
is
not
feasible
or
not
necessary)
to
support
this
determination
must
be
maintained
at
the
site
of
manufacture
or
import
of
the
polymer.
(
v)
Measured
or
estimated
values
of
the
minimum
number­
average
molecular
weight
of
the
polymer
and
the
amount
of
low
molecular
weight
species
below
500
and
below
1,000
molecular
weight,
with
a
description
of
how
the
measured
or
estimated
values
were
obtained.

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

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

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

(
5)
If
a
manufacturer
cannot
provide
all
the
information
specified
in
paragraphs
(
a)
(
1)
and
(
2)
of
this
section
because
the
new
chemical
substance
is
manufactured
using
a
reactant
having
a
specific
chemical
identity
claimed
as
confidential
by
its
supplier,
the
manufacturer
must
submit
a
notice
directly
to
EPA
containing
all
the
information
known
by
the
manufacturer
about
the
chemical
identity
of
the
reported
substance
and
its
proprietary
reactant.
In
addition,
the
manufacturer
must
ensure
that
the
supplier
of
the
confidential
reactant
submit
a
letter
of
support
May
10,
2004
directly
to
EPA
providing
the
specific
chemical
identity
of
the
confidential
reactant,
including
the
CAS
number,
if
available,
and
the
appropriate
PMN
or
exemption
number,
if
applicable.
The
letter
of
support
must
reference
the
manufacturer's
name
and
PMN
User
Fee
Identification
Number
under
§
700.45(
c)(
3)
of
this
chapter.
The
statutory
review
period
will
commence
upon
receipt
of
both
the
notice
and
the
letter
of
support.

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

(
c)
Known
synonyms
or
trade
names
of
the
new
chemical
substance.

(
d)
A
description
of
the
byproducts
resulting
from
the
manufacture,
processing,
use,
and
disposal
of
the
new
chemical
substance.

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

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

(
g)
For
sites
controlled
by
the
submitter:

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

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

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

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

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

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

§
720.50
Submission
of
test
data
and
other
data
concerning
the
health
and
environmental
effects
of
a
substance.
May
10,
2004
(
a)
Test
data
on
the
new
chemical
substance
in
the
possession
or
control
of
the
submitter.
(
1)
Except
as
provided
in
paragraph
(
d)
of
this
section,
each
notice
must
contain
all
test
data
in
the
submitter's
possession
or
control
which
are
related
to
the
effects
on
health
or
the
environment
of
any
manufacture,
processing,
distribution
in
commerce,
use,
or
disposal
of
the
new
chemical
substance
or
any
mixture
or
article
containing
the
new
chemical
substance,
or
any
combination
of
such
activities.
This
includes
test
data
concerning
the
new
chemical
substance
in
a
pure,
technical
grade,
or
formulated
form.

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

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

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

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

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

(
b)
Other
data
concerning
the
health
and
environmental
effects
of
the
new
chemical
substance
that
are
known
to
or
reasonably
ascertainable
by
the
submitter.
(
1)
Except
as
provided
in
paragraph
(
d)
of
this
section,
any
person
who
submits
a
notice
must
describe
the
following
data,
including
any
data
from
a
health
and
safety
study,
if
the
data
are
related
to
the
effects
on
health
or
the
environment
of
any
manufacture,
processing,
distribution
in
May
10,
2004
commerce,
use,
or
disposal
of
the
new
chemical
substance,
of
any
mixture
or
article
containing
the
new
chemical
substance,
or
of
any
combination
of
such
activities:

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

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

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

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

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

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

(
c)
[
Reserved]

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

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

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

[
48
FR
21742,
May
13,
1983,
as
amended
at
51
FR
15102,
Apr.
22,
1986]
May
10,
2004
§
720.57
Imports.

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

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

Subpart
D
­­
Disposition
of
Notices
§
720.60
General.

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

§
720.62
Notice
that
notification
is
not
required.

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

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

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

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

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

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

(
2)
In
the
request
to
correct
the
notice,
EPA
will
explain
the
action
which
the
submitter
must
take
May
10,
2004
to
correct
the
notice.

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

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

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

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

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

(
5)(
i)
EPA
will
consider
the
objections
filed
by
the
submitter.
The
Director,
or
his
or
her
delegate,
will
determine
whether
the
submission
was
complete
or
incomplete,
or
whether
to
modify
the
requirements
for
completing
the
submission.
EPA
will
notify
the
submitter
in
writing
of
EPA's
May
10,
2004
response
within
ten
days
of
receiving
the
objections.
(
ii)
If
the
Director,
or
his
or
her
delegate,
determines,
in
response
to
the
objection,
that
the
submission
was
complete,
the
notice
review
period
will
be
deemed
suspended
on
the
date
EPA
declared
the
notice
incomplete,
and
will
resume
on
the
date
that
the
notice
is
declared
complete.
The
submitter
need
not
correct
the
notice
as
EPA
originally
requested.
If
EPA
can
complete
its
review
within
90
days
from
the
date
of
the
original
submission,
the
Director,
or
his
or
her
delegate,
may
inform
the
submitter
that
the
running
of
the
review
period
will
resume
on
the
date
EPA
originally
declared
it
incomplete.
(
iii)
If
the
Director,
or
his
or
her
delegate,
modifies
the
requirements
for
completing
the
submission
or
concurs
with
EPA's
original
determination,
the
notice
review
period
will
begin
when
EPA
receives
a
complete
notice.

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

§
720.70
Notice
in
the
Federal
Register.

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

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

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

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

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

§
720.75
Notice
review
period.

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

(
b)
Suspension
of
the
running
of
the
notice
review
period.
(
1)
A
submitter
may
voluntarily
suspend
the
running
of
the
notice
review
period
if
the
Director
or
his
or
her
delegate
agrees.
If
the
Director
does
not
agree,
the
review
period
will
continue
to
run,
and
EPA
will
notify
the
May
10,
2004
submitter.
A
submitter
may
request
a
suspension
at
any
time
during
the
notice
review
period.
The
suspension
must
be
for
a
specified
period
of
time.

(
2)
A
request
for
suspension
may
be
made
in
writing
to
the
Document
Control
Office
(
7407),
Office
of
Pollution
Prevention
and
Toxics,
U.
S.
Environmental
Protection
Agency,
Room
G­
099,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460.
The
suspension
also
may
be
made
orally,
including
by
telephone,
to
the
submitter's
EPA
contact
for
that
notice.
EPA
will
send
the
submitter
a
written
confirmation
that
the
suspension
has
been
granted.

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

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

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

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

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

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

(
d)
Notice
of
expiration
of
notice
review
period.
EPA
will
notify
the
submitter
that
the
notice
review
period
has
expired
or
that
EPA
has
completed
its
review
of
the
notice.
Expiration
of
the
review
period
does
not
constitute
EPA
approval
or
certification
of
the
new
chemical
substance,
and
does
not
mean
that
EPA
may
not
take
regulatory
action
against
the
substance
in
the
future.
After
expiration
of
the
statutory
notice
review
period,
in
the
absence
of
regulatory
action
by
EPA
under
section
5(
e),
5(
f),
or
6(
a)
of
the
Act,
the
submitter
may
manufacture
or
import
the
chemical
May
10,
2004
substance
even
if
the
submitter
has
not
received
notice
of
expiration.

(
e)
Withdrawal
of
a
notice
by
the
submitter.
(
1)
A
submitter
may
withdraw
a
notice
during
the
notice
review
period.
A
statement
of
withdrawal
must
be
made
in
writing
to
the
Document
Control
Office
(
7407),
Office
of
Pollution
Prevention
and
Toxics,
U.
S.
Environmental
Protection
Agency,
Room
G­
099,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460.
The
withdrawal
is
effective
upon
receipt
of
the
statement
by
the
Document
Control
Officer.

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

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

§
720.78
Recordkeeping.

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

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

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

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

(
c)
Any
person
who
obtains
a
test­
marketing
exemption
under
this
part
must
retain
documentation
May
10,
2004
of
information
in
the
application
and
documentation
of
compliance
with
any
restrictions
imposed
by
EPA
when
it
granted
the
application.
This
information
must
be
retained
for
five
years
from
the
final
date
of
manufacture
or
import
under
the
exemption.

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

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

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

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

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

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

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

(
c)
EPA
will
disclose
information
that
is
subject
to
a
claim
of
confidentiality
asserted
under
this
section
only
to
the
extent
permitted
by
the
Act,
this
subpart,
and
part
2
of
this
title.

(
d)
If
a
notice
submitter
does
not
assert
a
claim
of
confidentiality
for
information
at
the
time
it
is
submitted
to
EPA,
EPA
may
make
the
information
public
and
place
it
in
the
public
file
without
further
notice
to
the
submitter.

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

§
720.85
Chemical
identity.
May
10,
2004
(
a)
Claims
applicable
to
the
period
prior
to
commencement
of
manufacture
or
import.
(
1)(
i)
A
person
who
submits
information
to
EPA
under
this
part
may
assert
a
claim
of
confidentiality
for
the
chemical
identity
of
the
new
chemical
substance.
This
claim
will
apply
only
to
the
period
prior
to
the
commencement
of
manufacture
or
import
for
commercial
purposes.
A
submitter
may
assert
this
claim
only
if
the
submitter
believes
that
public
disclosure
prior
to
commencement
of
manufacture
or
import
of
the
fact
that
anyone
intends
to
manufacture
or
import
the
specific
chemical
substance
for
commercial
purposes
would
reveal
confidential
business
information.
(
ii)
If
the
notice
includes
a
health
and
safety
study
concerning
the
new
chemical
substance
and
if
the
claim
for
confidentiality
with
respect
to
the
chemical
identity
is
denied
in
accordance
with
§
720.90(
c),
EPA
will
deny
a
claim
asserted
under
this
paragraph.

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

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

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

(
A)
The
chemical
identity
of
the
substance.

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

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

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

(
b)
Claims
applicable
to
the
period
after
commencement
of
manufacture
or
import.
(
1)
Any
claim
of
confidentiality
under
paragraph
(
a)
of
this
section
is
applicable
only
until
the
substance
is
manufactured
or
imported
for
commercial
purposes
and
becomes
eligible
for
inclusion
on
the
Inventory.
To
maintain
the
confidential
status
of
the
chemical
identity
when
the
substance
is
added
to
the
Inventory,
a
submitter
must
reassert
the
confidentiality
claim
and
substantiate
the
claim
in
the
notice
of
commencement
of
manufacture
required
under
§
720.102.
A
submitter
may
not
claim
the
chemical
indentity
confidential
for
the
period
after
commencement
of
manufacture
or
import
unless
the
submitter
claimed
the
chemical
identity
confidential
for
the
period
prior
to
May
10,
2004
commencement
of
manufacture
or
import
under
paragraph
(
a)
of
this
section.

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

(
3)
Any
person
who
asserts
a
confidentiality
claim
for
chemical
identity
must:
(
i)
Comply
with
the
requirements
of
paragraph
(
a)(
3)
of
this
section
regarding
submission
of
a
generic
name.
(
ii)
Agree
that
EPA
may
disclose
to
a
person
with
a
bona
fide
intent
to
manufacture
or
import
the
chemical
substance
the
fact
that
the
particular
chemical
substance
is
included
on
the
confidential
Inventory
for
purposes
of
notification
under
section
5(
a)(
1)(
A)
of
the
Act.
(
iii)
Have
available
for
the
particular
chemical
substance,
and
agree
to
furnish
to
EPA
upon
request:
(
A)
An
elemental
analysis.
(
B)
Either
an
X­
ray
diffraction
pattern
(
for
inorganic
substances),
a
mass
spectrum
(
for
most
other
substances),
or
an
infrared
spectrum
of
the
particular
chemical
substance,
or
if
such
data
do
not
resolve
uncertainties
with
respect
to
the
identity
of
the
chemical
substance,
additional
or
alternative
spectra
or
other
data
to
identify
the
chemical
substance.
(
iv)
Provide
a
detailed
written
substantiation
of
the
claim,
by
answering
the
following
questions:
(
A)
What
harmful
effects
to
your
competitive
position,
if
any,
do
you
think
would
result
if
EPA
publishes
on
the
Inventory
the
identity
of
the
chemical
substance?
How
could
a
competitor
use
such
information
given
the
fact
that
the
identity
of
the
substance
otherwise
would
appear
on
the
Inventory
of
chemical
substances
with
no
link
between
the
substance
and
your
company
or
industry?
How
substantial
would
the
harmful
effects
of
disclosure
be?
What
is
the
casual
relationship
between
the
disclosure
and
the
harmful
effects?
(
B)
For
what
period
of
time
should
confidential
treatment
be
given?
Until
a
specific
date,
the
occurrence
of
a
specific
event,
or
permanently?
Why?

(
C)
Has
the
chemical
substance
been
patented?
If
so,
have
you
granted
licenses
to
others
with
respect
to
the
patent
as
it
applies
to
the
chemical
substance?
If
the
chemical
substance
has
been
patented
and
therefore
disclosed
through
the
patent,
why
should
it
be
treated
as
confidential
for
purposes
of
the
Inventory?
(
D)
Has
the
identity
of
the
chemical
substance
been
kept
confidential
to
the
extent
that
your
competitors
do
not
know
it
is
being
manufactured
on
imported
for
a
commercial
purpose
by
anyone?
(
E)
Is
the
fact
that
someone
is
manufacturing
or
importing
this
chemical
substance
for
commercial
purposes
available
to
the
public,
e.
g.,
in
technical
journals
or
other
publications;
in
libraries;
or
in
State,
local,
or
Federal
agency
public
files?
(
F)
What
measures
have
you
taken
to
prevent
undesired
disclosure
of
the
fact
that
you
are
manufacturing
or
importing
this
substance
for
a
commercial
purpose?
(
G)
To
what
extent
has
the
fact
that
you
are
manufacturing
or
importing
this
chemical
substance
for
a
commercial
purpose
been
disclosed
to
others?
What
precautions
have
you
taken
in
regard
to
these
disclosures?
Has
this
information
been
disclosed
to
the
public
or
to
competitors?
May
10,
2004
(
H)
In
what
form
does
this
particular
chemical
substance
leave
the
site
of
manufacture,
e.
g.,
as
part
of
a
product;
in
an
effluent
or
emission
stream?
If
so,
what
measures
have
you
taken
to
guard
against
discovery
of
its
identity?
(
I)
If
the
chemical
substance
leaves
the
site
of
manufacture
in
a
product
that
is
available
to
either
the
public
or
your
competitors,
can
they
identify
the
substance
by
analyzing
the
product?
(
J)
For
what
purpose
do
you
manufacture
or
import
the
substance?
(
K)
Has
EPA,
another
Federal
agency,
or
any
Federal
court
made
any
pertinent
confidentiality
determinations
regarding
this
chemical
substance?
If
so,
copies
of
such
determinations
must
be
included
in
the
substantiation.
(
L)
If
the
notice
includes
a
health
and
safety
study
concerning
the
new
chemical
substance,
the
submitter
must
also
answer
the
questions
in
§
720.90(
b)(
2).

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

(
5)(
i)
EPA
will
publish
a
generic
name
on
the
public
Inventory
if:
(
A)
The
submitter
asserts
a
claim
of
confidentiality
in
accordance
with
this
paragraph.
(
B)
No
claim
for
confidentiality
of
the
specific
chemical
identity
as
part
of
a
health
and
safety
study
has
been
denied
in
accordance
with
part
2
of
this
title
or
§
720.90.
(
ii)
Publication
of
a
generic
name
on
the
public
Inventory
does
not
create
a
category
for
purposes
of
the
Inventory.
Any
person
who
has
a
bona
fide
intent
to
manufacture
or
import
a
chemical
substance
which
is
described
by
a
generic
name
on
the
public
Inventory
may
submit
an
inquiry
to
EPA
under
§
720.25(
b)
to
determine
whether
the
particular
chemical
substance
is
included
on
the
confidential
Inventory.
(
iii)
Upon
receipt
of
a
request
described
in
§
720.25(
b),
EPA
may
require
the
submitter
which
originally
asserted
confidentiality
for
a
chemical
substance
to
submit
to
EPA
the
information
listed
in
paragraph
(
b)(
3)(
iii)
of
this
section.
(
iv)
Failure
to
submit
any
of
the
information
required
under
paragraph
(
b)(
3)(
iii)
of
this
section
within
ten
days
of
a
request
by
EPA
under
this
paragraph
is
a
waiver
of
the
original
submitter's
confidentiality
claim.
In
this
event,
EPA
may
place
the
specific
chemical
identity
on
the
public
Inventory
without
further
notice
to
the
original
submitter.

(
6)
If
a
submitter
asserts
a
claim
of
confidentiality
under
this
paragraph,
EPA
will
examine
the
generic
chemical
name
proposed
by
the
submitter.
(
i)
If
EPA
determines
that
the
generic
name
proposed
by
the
submitter
is
only
as
generic
as
necessary
to
protect
the
confidential
identity
of
the
particular
chemical
substance,
EPA
will
place
that
generic
name
on
the
public
Inventory.
(
ii)
If
EPA
determines
that
the
generic
name
proposed
by
the
submitter
is
more
generic
than
necessary
to
protect
the
confidential
identity,
EPA
will
propose
in
writing,
for
review
by
the
submitter,
an
alternative
generic
name
that
will
reveal
the
chemical
identity
of
the
chemical
substance
to
the
maximum
extent
possible.
(
iii)
If
the
generic
name
proposed
by
EPA
is
acceptable
to
the
submitter,
EPA
will
place
that
generic
name
on
the
public
Inventory.
(
iv)
If
the
generic
name
proposed
by
EPA
is
not
acceptable
to
the
submitter,
the
submitter
must
explain
in
detail
why
disclosure
of
that
generic
name
would
reveal
confidential
business
information
and
propose
another
generic
name
which
is
only
as
generic
as
necessary
to
protect
the
confidential
identity.
If
EPA
does
not
receive
a
response
from
the
submitter
within
30
days
after
May
10,
2004
the
submitter
receives
the
proposed
name,
EPA
will
place
EPA's
chosen
generic
name
on
the
public
Inventory.
If
the
submitter
does
provide
the
information
requested,
EPA
will
review
the
response.
If
the
submitter's
proposed
generic
name
is
acceptable,
EPA
will
publish
that
generic
name
on
the
public
Inventory.
If
the
submitter's
proposed
generic
name
is
not
acceptable,
EPA
will
notify
the
submitter
of
EPA's
choice
of
a
generic
name.
Thirty
days
after
this
notification,
EPA
will
place
the
chosen
generic
name
on
the
public
Inventory.

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

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

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

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

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

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

§
720.90
Data
from
health
and
safety
studies.

(
a)
Information
other
than
specific
chemical
identity.
Except
as
provided
in
paragraph
(
b)
of
this
section,
EPA
will
deny
any
claim
of
confidentiality
with
respect
to
information
included
in
a
health
and
safety
study,
unless
the
information
would
disclose
confidential
business
information
concerning:

(
1)
Processes
used
in
the
manufacture
or
processing
of
a
chemical
substance
or
mixture.
(
2)
In
the
case
of
a
mixture,
the
portion
of
the
mixture
comprised
by
any
of
the
chemical
substances
in
the
mixture.
(
3)
Information
which
is
not
in
any
way
related
to
the
effects
of
a
substance
on
human
health
or
the
environment,
such
as
the
name
of
the
submitting
company,
cost
or
other
financial
data,
product
development
or
marketing
plans,
and
advertising
plans,
for
which
the
person
submits
a
claim
of
confidentiality
in
accordance
with
§
720.80.

(
b)
Specific
chemical
identity
­­
(
1)
Claims
applicable
to
period
prior
to
commencement
of
manufacture.
A
claim
of
confidentiality
for
the
period
prior
to
commencement
of
manufacture
or
import
for
the
chemical
identity
of
a
chemical
substance
for
which
a
health
and
safety
study
was
submitted
must
be
asserted
in
conjunction
with
a
claim
asserted
under
§
720.85(
a).
(
2)
Claims
applicable
to
period
after
commencement
of
manufacture
or
import
for
commercial
purposes.
To
maintain
the
confidential
status
of
the
chemical
identity
of
a
chemical
substance
for
which
a
health
and
safety
study
was
submitted
after
commencement
of
manufacture
or
import,
the
claim
must
be
reasserted
and
substantiated
in
conjunction
with
a
claim
under
§
720.85(
b).
In
May
10,
2004
addition
to
the
questions
set
forth
in
§
720.85(
b)(
3)(
iv)
of
this
part,
the
submitter
must
answer
the
following
questions:

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

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

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

(
d)
Use
of
generic
names.
When
EPA
discloses
a
health
and
safety
study
containing
a
specific
chemical
identity,
which
the
submitter
has
claimed
confidential,
and
if
the
Agency
has
not
denied
the
claim
under
paragraph
(
c)
of
this
section,
EPA
will
identify
the
chemical
substance
by
the
generic
name
selected
under
§
720.85.

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

§
720.95
Public
file.

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

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

Subpart
F
­­
Commencement
of
Manufacture
or
Import
May
10,
2004
§
720.102
Notice
of
commencement
of
manufacture
or
import.

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

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

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

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

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

(
d)
Where
to
submit.
Notices
of
commencement
of
manufacture
or
import
should
be
submitted
to
the
Document
Control
Office
(
7407),
Office
of
Pollution
Prevention
and
Toxics,
U.
S.
Environmental
Protection
Agency,
Room
G­
099,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460.
May
10,
2004
[
48
FR
21742,
May
13,
1983,
as
amended
at
48
FR
41140,
Sept.
13,
1983;
51
FR
15103,
Apr.
22,
1986;
53
FR
12523,
Apr.
15,
1988;
60
FR
16311,
Mar.
29,
1995;
60
FR
34464,
July
3,
1995;
65
FR
39304,
June
26,
2000]

Subpart
G
­­
Compliance
and
Inspections
§
720.120
Compliance.

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

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

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

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

(
e)
Failure
or
refusal
to
permit
entry
or
inspection
as
required
by
section
11
is
a
violation
of
section
15
of
the
Act
(
15
U.
S.
C.
2614).

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

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

§
720.122
Inspections.

EPA
will
conduct
inspections
under
section
11
of
the
Act
to
assure
compliance
with
section
5
of
the
Act
and
this
rule,
to
verify
that
information
submitted
to
EPA
under
this
rule
is
true
and
correct,
and
to
audit
data
submitted
to
EPA
under
this
rule.
May
10,
2004
Attachment
D
40
CFR
Part
721
May
10,
2004
40
CFR
Protection
of
Environment
CHAPTER
I
ENVIRONMENTAL
PROTECTION
AGENCY
(
CONTINUED)

SUBCHAPTER
R
­­
TOXIC
SUBSTANCES
CONTROL
ACT
PART
721
­­
SIGNIFICANT
NEW
USES
OF
CHEMICAL
SUBSTANCES
Subpart
A
­­
General
Provisions
Sec.
721.1
Scope
and
applicability.
721.3
Definitions.
721.5
Persons
who
must
report.
721.11
Applicability
determination
when
the
specific
chemical
identity
is
confidential.
721.20
Exports
and
imports.
721.25
Notice
requirements
and
procedures.
721.30
EPA
approval
of
alternative
control
measures.
721.35
Compliance
and
enforcement.
721.40
Recordkeeping.
721.45
Exemptions.
721.47
Conditions
for
research
and
development
exemption.

Subpart
B
­­
Certain
Significant
New
Uses
721.50
Applicability.
721.63
Protection
in
the
workplace.
721.72
Hazard
communication
program.
721.80
Industrial,
commercial,
and
consumer
activities.
721.85
Disposal.
721.90
Release
to
water.
721.91
Computation
of
estimated
surface
water
concentrations:
Instructions.

Subpart
C
­­
Recordkeeping
Requirements
721.100
Applicability.
721.125
Recordkeeping
requirements.

Subpart
D
­­
Expedited
Process
for
Issuing
Significant
New
Use
Rules
for
Selected
Chemical
Substances
and
Limitation
or
Revocation
of
Selected
Significant
New
Use
Rules
721.160
Notification
requirements
for
new
chemical
substances
subject
to
section
5(
e)
orders.
721.170
Notification
requirements
for
selected
new
chemical
substances
that
have
completed
premanufacture
review.
721.185
Limitation
or
revocation
of
certain
notification
requirements.

Authority:
15
U.
S.
C.
2604,
2607,
and
2625(
c).
May
10,
2004
Subpart
A
­­
General
Provisions
§
721.1
Scope
and
applicability.

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

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

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

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

§
721.3
Definitions.

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

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

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

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

(
3)
At
least
50
percent
of
the
exposed
mammalian
test
animals
following
administration
of
the
test
substance
for
8
hours
or
less
by
continuous
inhalation
at
a
steady
concentration
in
air
at
0.5
milligrams
or
less
per
liter
of
air
(
LC50).
May
10,
2004
CAS
Number
means
Chemical
Abstracts
Service
Registry
Number
assigned
to
a
chemical
substance
on
the
Inventory.

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

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

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

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

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

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

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

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

Employer
means
any
manufacturer,
importer,
processor,
or
user
of
chemical
substances
or
mixtures.

Environmentally
transformed
A
chemical
substance
is
"
environmentally
transformed"
when
its
chemical
structure
changes
as
a
result
of
the
action
of
environmental
processes
on
it.

Facility
means
all
buildings,
equipment,
structures,
and
other
stationary
items
which
are
located
on
a
single
site
or
on
contiguous
or
adjacent
sites
and
which
are
owned
or
operated
by
the
same
person
(
or
by
any
person
which
controls,
is
controlled
by,
or
under
common
control
with
such
person).
May
10,
2004
Identity
means
any
chemical
or
common
name
used
to
identify
a
chemical
substance
or
a
mixture
containing
that
substance.

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

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

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

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

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

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

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

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

Personal
protective
equipment
means
any
chemical
protective
clothing
or
device
placed
on
the
body
to
prevent
contact
with,
and
exposure
to,
an
identified
chemical
substance
or
substances
in
the
work
area.
Examples
include,
but
are
not
limited
to,
chemical
protective
clothing,
aprons,
hoods,
chemical
goggles,
face
splash
shields,
or
equivalent
eye
protection,
and
various
types
of
respirators.
Barrier
creams
are
not
included
in
this
definition.

Powder
or
dry
solid
form
means
a
state
where
all
or
part
of
the
substance
would
have
the
potential
to
become
fine,
loose,
solid
particles.

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

Process
for
commercial
purposes
means
the
preparation
of
a
chemical
substance
or
mixture
containing
the
chemical
substance,
after
manufacture
of
the
substance,
for
distribution
in
May
10,
2004
commerce
with
the
purpose
of
obtaining
an
immediate
or
eventual
commercial
advantage
for
the
processor.
Processing
of
any
amount
of
a
chemical
substance
or
mixture
containing
the
chemical
substance
is
included
in
this
definition.
If
a
chemical
substance
or
mixture
containing
impurities
is
processed
for
commercial
purposes,
the
impurities
also
are
processed
for
commercial
purposes.

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

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

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

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

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

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

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

Significant
adverse
environmental
effects
means
injury
to
the
environment
by
a
chemical
substance
which
reduces
or
adversely
affects
the
productivity,
utility,
value,
or
function
of
biological,
commercial,
or
agricultural
resources,
or
which
may
adversely
affect
a
threatened
or
endangered
species.
A
substance
will
be
considered
to
have
the
potential
for
significant
adverse
environmental
effects
if
it
has
one
of
the
following:
May
10,
2004
(
1)
An
acute
aquatic
EC50
of
1
mg/
L
or
less.
(
2)
An
acute
aquatic
EC50
of
20
mg/
L
or
less
where
the
ratio
of
aquatic
vertebrate
24­
hour
to
48­
hour
EC50
is
greater
than
or
equal
to
2.0.
(
3)
A
Maximum
Acceptable
Toxicant
Concentration
(
MATC)
of
less
than
or
equal
to
100
parts
per
billion
(
100
ppb).
(
4)
An
acute
aquatic
EC50
of
20
mg/
L
or
less
coupled
with
either
a
measured
bioconcentration
factor
(
BCF)
equal
to
or
greater
than
1,000x
or
in
the
absence
of
bioconcentration
data
a
log
P
value
equal
to
or
greater
than
4.3.

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

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

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

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

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

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

Workplace
means
an
establishment
at
one
geographic
location
containing
one
or
more
work
areas.

[
53
FR
28358,
July
27,
1988,
as
amended
at
54
FR
31306,
July
27,
1989;
58
FR
63516,
Dec.
1,
1993]

§
721.5
Persons
who
must
report.

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

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

(
2)
A
person
who
intends
to
manufacture,
import,
or
process
for
commercial
purposes
a
chemical
May
10,
2004
substance
identified
in
a
specific
section
in
subpart
E
of
this
part,
and
intends
to
distribute
the
substance
in
commerce.
A
person
described
in
this
paragraph
is
not
required
to
submit
a
significant
new
use
notice
if
that
person
can
document
one
or
more
of
the
following
as
to
each
recipient
of
the
substance
from
that
person:
(
i)
That
the
person
has
notified
the
recipient,
in
writing,
of
the
specific
section
in
subpart
E
of
this
part
which
identifies
the
substance
and
its
designated
significant
new
uses.
(
ii)
That
the
recipient
has
knowledge
of
the
specific
section
in
subpart
E
of
this
part
which
identifies
the
substance
and
its
designated
significant
new
uses.
(
iii)
That
the
recipient
cannot
undertake
any
significant
new
use
described
in
the
specific
section
in
subpart
E
of
this
part.

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

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

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

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

(
d)(
1)
If
at
any
time
after
commencing
distribution
in
commerce
of
a
chemical
substance
identified
in
a
specific
section
in
subpart
E
of
this
part
a
person
described
in
paragraph
(
a)(
2)
of
this
section
has
knowledge
that
a
recipient
of
the
substance
is
engaging
in
a
significant
new
use
of
that
substance
designated
in
that
section
without
submitting
a
notice
under
this
part,
the
person
is
required
to
cease
supplying
the
chemical
substance
to
that
recipient
and
to
submit
a
significant
new
use
notice
for
that
chemical
substance
and
significant
new
use,
unless
the
person
is
able
to
document
each
of
the
following:
(
i)
That
the
person
has
notified
the
recipient
and
EPA
enforcement
authorities
(
at
the
address
in
paragraph
(
d)(
1)(
iii)
of
this
section),
in
writing
within
15
working
days
of
the
time
the
person
develops
knowledge
that
the
recipient
is
engaging
in
a
significant
new
use,
that
the
recipient
is
engaging
in
a
significant
new
use
without
submitting
a
significant
new
use
notice.
(
ii)
That,
within
15
working
days
of
notifying
the
recipient
as
described
in
paragraph
(
d)(
1)(
i)
of
this
section,
the
person
received
from
the
recipient,
in
writing,
a
statement
of
assurance
that
the
recipient
is
aware
of
the
terms
of
the
applicable
section
in
subpart
E
of
this
part
and
will
not
engage
in
the
significant
new
use.
(
iii)
That
the
person
has
promptly
provided
EPA
enforcement
authorities
with
a
copy
of
the
recipient's
statement
of
assurance
described
in
paragraph
(
d)(
1)(
ii)
of
this
section.
The
copy
must
be
sent
to
the
Office
of
Enforcement
and
Compliance
Assurance,
Office
of
Compliance
(
2224A),
U.
S.
Environmental
Protection
Agency,
Ariel
Rios,
1200
Pennsylvania
Ave.,
N.
W.,
Washington,
DC,
20044.
May
10,
2004
(
2)
If
EPA
notifies
the
manufacturer,
importer,
or
processor
that
the
recipient
is
engaging
in
a
significant
new
use
after
providing
the
statement
of
assurance
described
in
paragraph
(
d)(
1)(
ii)
of
this
section
and
without
submitting
a
notice
under
this
part,
the
manufacturer,
importer,
or
processor
shall
immediately
cease
distribution
to
that
recipient
until
the
manufacturer,
importer,
or
processor
or
the
recipient
has
submitted
a
significant
new
use
notice
under
this
part
and
the
notice
review
period
has
ended.

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

(
e)
Any
significant
new
use
notice
relating
to
import
of
a
substance
must
be
submitted
by
the
principal
importer.

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

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

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

(
b)
To
establish
a
bona
fide
intent
to
manufacture,
import,
or
process
a
chemical
substance,
the
person
who
intends
to
manufacture,
import,
or
process
the
chemical
substance
must
submit
the
following
information
in
writing
to
the
Document
Control
Office
(
7407),
Office
of
Pollution
Prevention
and
Toxics,
U.
S.
Environmental
Protection
Agency,
Room
G­
099,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460,
ATTN:
SNUR
Bonafide
submissions.

(
1)
The
specific
chemical
identity
of
the
chemical
substance
that
the
person
intends
to
manufacture,
import,
or
process.
(
2)
A
signed
statement
that
the
person
intends
to
manufacture,
import,
or
process
the
chemical
substance
for
commercial
purposes.
(
3)
A
description
of
the
research
and
development
activities
conducted
to
date,
and
the
purpose
for
which
the
person
will
manufacture,
import,
or
process
the
chemical
substance.
(
4)
An
elemental
analysis.
May
10,
2004
(
5)
Either
an
X­
ray
diffraction
pattern
(
for
inorganic
substances),
a
mass
spectrum
(
for
most
other
substances),
or
an
infrared
spectrum
of
the
particular
chemical
substance,
or,
if
such
data
do
not
resolve
uncertainties
with
respect
to
the
identity
of
the
chemical
substance,
additional
or
alternative
spectra
or
other
data
to
identify
the
substance.

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

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

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

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

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

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

§
721.20
Exports
and
imports.

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

[
53
FR
28360,
July
27,
1988]

§
721.25
Notice
requirements
and
procedures.
May
10,
2004
(
a)
Each
person
who
is
required
to
submit
a
significant
new
use
notice
under
this
part
must
submit
the
notice
at
least
90
calendar
days
before
commencing
manufacture,
import,
or
processing
of
a
chemical
substance
identified
in
subpart
E
of
this
part
for
a
significant
new
use.
The
submitter
must
comply
with
any
applicable
requirement
of
section
5(
b)
of
the
Act,
and
the
notice
must
include
the
information
and
test
data
specified
in
section
5(
d)(
1)
of
the
Act.
The
notice
must
be
submitted
on
EPA
Form
7710­
25,
and
must
comply
with
the
requirements
of
part
720
of
this
chapter,
except
to
the
extent
that
they
are
inconsistent
with
this
part
721.

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

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

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

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

§
721.30
EPA
approval
of
alternative
control
measures.

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

(
b)
A
request
for
a
determination
of
equivalency
must
be
submitted
in
writing
to
the
Document
Control
Office
(
7407),
Office
of
Pollution
Prevention
and
Toxics,
U.
S.
Environmental
Protection
Agency,
Room
G­
099,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460;
ATTN:
SNUR
Equivalency
Determination,
and
must
contain:

(
1)
The
name
of
the
submitter.
(
2)
The
specific
chemical
identity
of
the
substance.
(
3)
The
citation
for
the
specific
section
in
subpart
E
of
this
part
which
pertains
to
the
substance
May
10,
2004
for
which
the
request
is
being
submitted.
(
4)
A
detailed
description
of
the
activities
involved.
(
5)
The
specifications
of
the
alternative
worker
exposure
control
measures
or
environmental
release
control
measures.
(
6)
An
analysis
justifying
why
such
alternative
control
measures
provide
substantially
the
same
degree
of
protection
as
the
specific
control
measures
identified
in
the
specific
section
in
subpart
E
of
this
part
which
pertains
to
the
substance
for
which
the
request
is
being
submitted.
(
7)
The
data
and
information
described
in
§
720.50
(
a)
and
(
b)
of
this
chapter
unless
such
data
and
information
have
already
been
submitted
to
the
Office
of
Pollution
Prevention
and
Toxics,
EPA.

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

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

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

§
721.35
Compliance
and
enforcement.

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

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

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

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

(
e)
Violators
of
the
Act
or
of
this
part
may
be
subject
to
the
civil
and
criminal
penalties
in
section
16
of
the
Act
(
15
U.
S.
C.
2615)
for
each
violation.
The
submission
of
false
or
misleading
May
10,
2004
information
in
connection
with
the
requirement
of
any
provision
of
this
part
may
subject
persons
to
penalties
calculated
as
if
they
never
filed
a
notice.

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

(
1)
Seek
to
enjoin
the
manufacture,
import,
or
processing
of
a
chemical
substance
in
violation
of
this
part.
(
2)
Act
to
seize
any
chemical
substance
which
is
being
manufactured,
imported,
or
processed
in
violation
of
this
part.
(
3)
Take
any
other
appropriate
action.

[
53
FR
28361,
July
27,
1988]

§
721.40
Recordkeeping.

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

[
53
FR
28361,
July
27,
1988]

§
721.45
Exemptions.

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

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

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

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

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

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

(
f)
The
person
imports
or
processes
the
substance
as
part
of
an
article.
May
10,
2004
(
g)
The
person
manufactures
or
processes
the
substance
solely
for
export
and,
when
distributing
the
substance
in
commerce,
labels
the
substance
in
accordance
with
section
12(
a)(
1)(
B)
of
the
Act.

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

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

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

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

[
53
FR
28361,
July
27,
1988]

§
721.47
Conditions
for
research
and
development
exemption.

(
a)
A
person
who
manufactures,
imports,
or
processes
a
chemical
substance
identifies
in
subpart
E
of
this
part
for
a
significant
new
use
identified
in
subpart
E
of
this
part
is
not
subject
to
the
notification
requirements
of
§
721.25
if
the
following
conditions
are
met:
(
1)
The
person
manufactures,
imports,
or
processes
the
substance
for
the
significant
new
use
in
small
quantities
solely
for
research
and
development.
(
2)
The
manufacturer,
importer,
or
processor
notifies
all
persons
in
its
employ
or
to
whom
it
directly
distributes
the
chemical
substance,
who
are
engaged
in
experimentation,
research,
or
analysis
on
the
chemical
substance,
including
the
manufacture,
processing,
use,
transport,
storage,
and
disposal
of
the
substance
associated
with
research
and
development
activities,
of
any
risk
to
health,
identified
under
paragraph
(
b)
of
this
section,
which
may
be
associated
with
the
substance.
The
notification
must
be
made
in
accordance
with
paragraph
(
c)
of
this
section.
(
3)
The
chemical
substance
is
used
by,
or
directly
under
the
supervision
of,
a
technically
qualified
individual.
May
10,
2004
(
b)(
1)
To
determine
whether
notification
under
paragraph
(
a)(
2)
of
this
section
is
required,
the
manufacturer,
importer,
or
processor
must
review
and
evaluate
the
following
information
to
determine
whether
there
is
reason
to
believe
there
is
any
risk
to
health
which
may
be
associated
with
the
chemicals
substance:
(
i)
Information
in
its
possession
or
control
concerning
any
significant
adverse
reaction
by
persons
exposed
to
the
chemical
substance
which
may
reasonably
be
associated
with
such
exposure.
(
ii)
Information
provided
to
the
manufacturer,
importer,
or
processor
by
a
supplier
or
any
other
person
concerning
a
health
risk
believed
to
be
associated
with
the
substance.
(
iii)
Health
and
environmental
effects
data
in
its
possession
or
control
concerning
the
substance.
(
iv)
Information
on
health
effects
which
accompanies
any
EPA
rule
or
order
issued
under
section
4,
5,
or
6
of
the
Act
that
applies
to
the
substance
and
of
which
the
manufacturer,
importer,
or
processor
has
knowledge.

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

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

(
2)
If
the
manufacturer,
importer,
or
processor
distributes
a
chemical
substance
manufactured,
imported,
or
processed
under
this
section
to
persons
not
in
its
employ,
the
manufacturer,
importer,
or
processor
must
in
written
form:
(
i)
Notify
those
persons
that
the
substance
is
to
be
used
only
for
research
and
development
purposes.
(
ii)
Provide
the
notice
of
health
risks
specified
in
paragraph
(
c)(
1)
of
this
section.

(
3)
The
adequacy
of
any
notification
under
this
section
is
the
responsibility
of
the
manufacturer,
importer,
or
processor.

(
d)
Quantities
of
the
chemical
substance,
or
of
mixtures
or
articles
containing
the
chemical
substance,
remaining
after
completion
of
research
and
development
activities
may
be:
(
1)
Disposed
of
as
a
waste
in
accordance
with
applicable
Federal,
State,
and
local
regulations,
to
the
extent
the
disposal
activity
is
not
identified
as
a
significant
new
use
for
the
substance
in
subpart
E
of
this
part,
or
(
2)
Used
for
a
commercial
purpose,
to
the
extent
the
use
is
not
identified
as
a
significant
new
use
of
the
substance
in
subpart
E
of
this
part.
May
10,
2004
(
e)(
1)
Persons
who
manufacture,
import,
or
process
a
chemical
substance
under
this
section
must
retain
the
following
records:
(
i)
Copies
of
or
citations
to
information
reviewed
and
evaluated
under
paragraph
(
b)(
1)
of
this
section
to
determine
the
need
to
make
any
notification
of
risk.
(
ii)
Documentation
of
the
nature
and
method
of
notification
under
paragraph
(
c)(
1)
of
this
section
including
copies
of
any
labels
or
written
notices
used.
(
iii)
Documentation
of
prudent
laboratory
practices
used
instead
of
notification
and
evaluation
under
paragraph
(
b)(
2)
of
this
section.
(
iv)
The
names
and
addresses
of
any
persons
other
than
the
manufacturer,
importer,
or
processor
to
whom
the
substance
is
distributed,
the
identity
of
the
substance,
the
amount
distributed,
and
copies
of
the
notifications
required
under
paragraph
(
c)(
2)
of
this
section.

(
2)
[
Reserved]

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

Subpart
B
­­
Certain
Significant
New
Uses
Source:
54
FR
31308,
July
27,
1989,
unless
otherwise
noted.

§
721.50
Applicability.

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

§
721.63
Protection
in
the
workplace.

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

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

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

(
i)
Gloves.
May
10,
2004
(
ii)
Full
body
chemical
protective
clothing.
(
iii)
Chemical
goggles
or
equivalent
eye
protection.
(
iv)
Clothing
which
covers
any
other
exposed
areas
of
the
arms,
legs,
and
torso.
Clothing
provided
under
this
paragraph
need
not
be
tested
or
evaluated
under
the
requirements
of
paragraph
(
a)(
3)
of
this
section.

(
3)
The
employer
is
able
to
demonstrate
that
each
item
of
chemical
protective
clothing,
including
gloves,
selected
provides
an
impervious
barrier
to
prevent
dermal
exposure
during
normal
and
expected
duration
and
conditions
of
exposure
within
the
work
area
by
any
one
or
a
combination
of
the
following:
(
i)
Testing
the
material
used
to
make
the
chemical
protective
clothing
and
the
construction
of
the
clothing
to
establish
that
the
protective
clothing
will
be
impervious
for
the
expected
duration
and
conditions
of
exposure.
The
testing
must
subject
the
chemical
protective
clothing
to
the
expected
conditions
of
exposure,
including
the
likely
combinations
of
chemical
substances
to
which
the
clothing
may
be
exposed
in
the
work
area.
(
ii)
Evaluating
the
specifications
from
the
manufacturer
or
supplier
of
the
chemical
protective
clothing,
or
of
the
material
used
in
construction
of
the
clothing,
to
establish
that
the
chemical
protective
clothing
will
be
impervious
to
the
chemical
substance
alone
and
in
likely
combination
with
other
chemical
substances
in
the
work
area.

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

(
5)
The
following
NIOSH
approved
respirators
meet
the
minimum
requirements
for
paragraph
(
a)(
4)
of
this
section:
(
i)
Category
19C
Type
C
supplied­
air
respirator
operated
in
pressure
demand
or
other
positive
pressure
mode
and
equipped
with
a
full
facepiece.
(
ii)
Category
19C
Type
C
supplied­
air
respirator
operated
in
pressure
demand
or
continuous
flow
mode
and
equipped
with
a
tight­
fitting
facepiece.
(
iii)
Category
19C
Type
C
supplied­
air
respirator
operated
in
pressure
demand
or
continuous
flow
mode
and
equipped
with
a
hood
or
helmet
or
tight­
fitting
facepiece.
(
iv)
Category
21C
air­
purifying
respirator
equipped
with
a
full
facepiece
and
high
efficiency
particulate
filters.
(
v)
Category
21C
powered
air­
purifying
respirator
equipped
with
a
tight­
fitting
facepiece
and
high
efficiency
particulate
filters.
(
vi)
Category
21C
powered
air­
purifying
respirator
equipped
with
a
loose­
fitting
hood
or
helmet
and
high
efficiency
particulate
filters.
(
vii)
Category
21C
air­
purifying
respirator
equipped
with
a
high
efficiency
particulate
filter
including
disposable
respirators.
(
viii)
Category
23C
air­
purifying
respirator
equipped
with
a
full
facepiece
and
combination
cartridges
approved
for
paints,
lacquers,
and
enamels.
(
Approval
label
may
preclude
use
for
some
paints,
lacquers,
or
enamels.)
(
ix)
Category
23C
powered
air­
purifying
respirator
equipped
with
a
tight­
fitting
facepiece
and
combination
cartridges
approved
for
paints,
lacquers,
and
enamels.
(
Approval
label
may
preclude
May
10,
2004
use
for
some
paints,
lacquers,
or
enamels.)
(
x)
Category
23C
powered
air­
purifying
respirator
equipped
with
a
loose­
fitting
hood
or
helmet
and
combination
cartridges
approved
for
paints,
lacquers,
and
enamels.
(
Approval
label
may
preclude
use
for
some
paints,
lacquers,
or
enamels.)
(
xi)
Category
23C
air­
purifying
respirator
equipped
with
combination
cartridges
approved
for
paints,
lacquers,
and
enamels,
including
disposable
respirators.
(
Approval
label
may
preclude
use
for
some
paints,
lacquers,
or
enamels.)
(
xii)
Category
23C
air­
purifying
respirator
equipped
with
a
full
facepiece
and
organic
gas/
vapor
cartridges.
(
xiii)
Category
23C
powered
air­
purifying
respirator
equipped
with
a
tight­
fitting
facepiece
and
organic
gas/
vapor
cartridges.
(
xiv)
Category
23C
powered
air­
purifying
respirator
equipped
with
a
loose­
fitting
hood
or
helmet
and
organic
gas/
vapor
cartridges.
(
xv)
Category
23C
air­
purifying
respirator
equipped
with
organic
gas/
vapor
cartridges,
including
disposable
respirators.

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

(
i)
Dust.
(
ii)
Mist.
(
iii)
Fume.
(
iv)
Smoke.
(
v)
Vapor.
(
vi)
Gas.

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

(
c)(
1)
If
at
any
time
after
commencing
distribution
in
commerce
of
a
chemical
substance
that
is
identified
in
subpart
E
of
this
part
as
subject
to
this
section,
the
person
has
knowledge
that
a
recipient
of
the
substance
is
engaging
in
an
activity
that
is
not
consistent
with
the
implementation
of
a
program
specified
in
paragraph
(
a)
of
this
section,
the
person
is
considered
to
have
knowledge
that
the
recipient
is
engaging
in
a
significant
new
use
and
is
required
to
follow
the
procedures
in
§
721.5(
d)
unless
the
person
is
able
to
document
the
following:
(
i)
That
the
person
has
notified
the
recipient
in
writing
within
15
working
days
of
the
time
the
person
first
has
knowledge
that
the
recipient
is
engaging
in
an
activity
that
is
not
consistent
with
the
implementation
of
a
program
specified
in
paragraph
(
a)
of
this
section,
and
that
the
person
has
knowledge
of
the
failure
of
implementation.
(
ii)
That
within
15
working
days
of
notifying
the
recipient
that
the
recipient
is
engaging
in
an
activity
that
is
not
consistent
with
the
implementation
of
a
program
specified
in
paragraph
(
a)
of
this
section
the
person
has
received
from
the
recipient,
in
writing,
a
statement
of
assurance
that
the
recipient
has
established
the
program
required
under
paragraph
(
a)
of
this
section,
and
will
May
10,
2004
take
appropriate
measures
to
avoid
activities
that
are
inconsistent
with
implementation
of
the
program
required
under
paragraph
(
a)
of
this
section.

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

§
721.72
Hazard
communication
program.

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

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

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

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

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

(
b)
Labeling.
(
1)
Each
employer
shall
ensure
that
each
container
of
the
substance
in
the
workplace
is
labeled
in
accordance
with
this
paragraph
(
b)(
1).
(
i)
The
label
shall,
at
a
minimum,
contain
the
following
information:
(
A)
A
statement
of
health
hazard(
s)
and
precautionary
measure(
s)
for
the
substance,
if
any,
May
10,
2004
identified
in
subpart
E
of
this
part
or
by
the
employer.
(
B)
The
identity
by
which
the
substance
may
be
commonly
recognized.
(
C)
A
statement
of
environmental
hazard(
s)
and
precautionary
measure(
s)
for
the
substance,
if
any,
identified
in
subpart
E
of
this
part
or
by
the
employer.
(
D)
A
statement
of
exposure
and
precautionary
measure(
s),
if
any,
identified
in
subpart
E
of
this
part
or
by
the
employer.
(
ii)
The
employer
may
use
signs,
placards,
process
sheets,
batch
tickets,
operating
procedures,
or
other
such
written
materials
in
lieu
of
affixing
labels
to
individual
stationary
process
containers,
as
long
as
the
alternative
method
identifies
the
containers
to
which
it
is
applicable
and
conveys
information
specified
by
paragraph
(
b)(
1)(
i)
of
this
section.
Any
written
materials
must
be
readily
accessible
to
the
employees
in
their
work
areas
throughout
each
work
shift.
(
iii)
The
employer
need
not
label
portable
containers
into
which
the
substance
is
transferred
from
labeled
containers,
and
which
are
intended
only
for
the
immediate
use
of
the
employee
who
performs
the
transfer.

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

(
2)
Each
employer
shall
ensure
that
each
container
of
the
substance
leaving
its
workplace
for
distribution
in
commerce
is
labeled
in
accordance
with
this
paragraph.
(
i)
The
label
shall,
at
a
minimum,
contain
the
following
information:
(
A)
The
information
required
under
paragraph
(
b)(
1)(
i)
of
this
section.
(
B)
The
name
and
address
of
the
manufacturer
or
a
responsible
party
who
can
provide
additional
information
on
the
substance
for
hazard
evaluation
and
any
appropriate
emergency
procedures.
(
ii)
The
label
shall
not
conflict
with
the
requirements
of
the
Hazardous
Materials
Transportation
Act
(
18
U.
S.
C.
1801
et.
seq.)
and
regulations
issued
under
that
Act
by
the
Department
of
Transportation.
(
3)
The
label,
or
alternative
forms
of
warning,
shall
be
legible
and
prominently
displayed.
(
4)
The
label,
or
alternative
forms
of
warning,
shall
be
in
English;
however,
the
information
may
be
repeated
in
other
languages.
(
5)
If
the
label
or
alternative
form
of
warning
is
to
be
applied
to
a
mixture
containing
a
substance
identified
in
subpart
E
of
this
part
as
subject
to
this
section
in
combination
with
another
substance
identified
in
subpart
E
of
this
part
and/
or
a
substance
defined
as
a
"
hazardous
chemical"
under
the
Occupational
Safety
and
Health
Administration
(
OSHA)
Hazard
Communication
Standard
(
29
CFR
1900.1200),
the
employer
may
prescribe
on
the
label,
MSDS,
or
alternative
form
of
warning,
the
measures
to
control
worker
exposure
or
environmental
release
which
the
employer
determines
provide
the
greatest
degree
of
protection.
However,
should
these
control
measures
differ
from
the
applicable
measures
required
under
subpart
E
of
this
part,
the
employer
must
seek
a
determination
of
equivalency
for
such
alternative
control
measures
pursuant
to
§
721.30
before
prescribing
them
under
this
paragraph.

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

(
2)
Each
MSDS
shall
contain,
at
a
minimum,
the
following
information:
(
i)
The
identity
used
on
the
container
label
of
the
substance
under
this
section,
and,
if
not
claimed
May
10,
2004
confidential,
the
chemical
and
common
name
of
the
substance.
If
the
chemical
and
common
name
are
claimed
confidential,
a
generic
chemical
name
must
be
used.
(
ii)
Physical
and
chemical
characteristics
of
the
substance
known
to
the
employer
(
such
as
vapor
pressure,
flash
point).
(
iii)
The
physical
hazards
of
the
substance
known
to
the
employer,
including
the
potential
for
fire,
explosion,
and
reactivity.
(
iv)
The
potential
human
and
environmental
hazards
as
specified
in
subpart
E
of
this
part
for
the
substance.
(
v)
Signs
and
symptoms
of
exposure,
and
any
medical
conditions
which
are
expected
to
be
aggravated
by
exposure
to
the
substance
known
to
the
employer.
(
vi)
The
primary
routes
of
exposure
to
the
substance.
(
vii)
Precautionary
measures
to
control
worker
exposure
and/
or
environmental
release
identified
in
subpart
E
of
this
part
for
the
substance,
or
alternative
control
measures
which
EPA
has
determined
under
§
721.30
provide
substantially
the
same
degree
of
protection
as
the
identified
control
measures.
(
viii)
Any
generally
applicable
precautions
for
safe
handling
and
use
of
the
substance
which
are
known
to
the
employer,
including
appropriate
hygienic
practices,
protective
measures
during
repair
and
maintenance
of
contaminated
equipment,
and
procedures
for
response
to
spills
and
leaks.
(
ix)
Any
generally
applicable
control
measures
which
are
known
to
the
employer,
such
as
appropriate
engineering
controls,
work
practices,
or
personal
protective
equipment.
(
x)
Emergency
first
aid
procedures
known
to
the
employer.
(
xi)
The
date
of
preparation
of
the
MSDS
or
of
its
last
revision.
(
xii)
The
name,
address,
and
telephone
number
of
the
individual
preparing
or
distributing
the
MSDS,
or
a
responsible
party
who
can
provide
additional
information
on
the
substance
for
hazard
evaluation
and
any
appropriate
emergency
procedures.

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

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

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

(
6)
The
employer
must
ensure
that
persons
receiving
the
substance
from
the
employer
are
provided
an
appropriate
MSDS
with
their
initial
shipment
and
with
the
first
shipment
after
an
MSDS
is
revised.
The
employer
may
either
provide
the
MSDS
with
the
shipped
containers
or
send
it
to
the
person
prior
to
or
at
the
time
of
shipment.
May
10,
2004
(
7)
The
employer
must
maintain
a
copy
of
the
MSDS
in
its
workplace,
and
must
ensure
that
it
is
readily
accessible
during
each
work
shift
to
employees
when
they
are
in
their
work
areas.

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

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

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

(
1)
Information
provided
to
employees
under
this
paragraph
shall
include:
(
i)
The
requirements
of
this
section.
(
ii)
Any
operations
in
the
work
area
where
the
substance
is
present.
(
iii)
The
location
and
availability
of
the
written
hazard
communication
program
required
under
paragraph
(
a)
of
this
section,
including
the
list
of
substances
identified
in
subpart
E
of
this
part
as
subject
to
this
section,
and
MSDSs
required
by
paragraph
(
c)
of
this
section.

(
2)
Training
provided
to
employees
shall
include:
(
i)
Methods
and
observations
that
may
be
used
to
detect
the
presence
or
release
of
the
substance
in
or
from
an
employee's
work
area
(
such
as
monitoring
conducted
by
the
employer,
continuous
monitoring
devices,
visual
appearance,
or
odor
of
the
substance
when
being
released).
(
ii)
The
potential
human
health
and
environmental
hazards
of
the
substance
as
specified
in
subpart
E
of
this
part.
(
iii)
The
measures
employees
can
take
to
protect
themselves
and
the
environment
from
the
substance,
including
specific
procedures
the
employer
has
implemented
to
protect
employees
and
the
environment
from
exposure
to
the
substance,
including
appropriate
work
practices,
emergency
procedures,
personal
protective
equipment,
engineering
controls,
and
other
measures
to
control
worker
exposure
and/
or
environmental
release
required
under
subpart
E
of
the
part,
or
alternative
control
measures
which
EPA
has
determined
under
§
721.30
provide
substantially
the
same
degree
of
protection
as
the
specified
control
measures.
(
iv)
The
requirements
of
the
hazard
communication
program
developed
by
the
employer
under
this
section,
including
an
explanation
of
the
labeling
system
and
the
MSDS
required
by
this
section
and
guidance
on
obtaining
and
using
appropriate
hazard
information.

(
e)
Low
concentrations
in
mixtures.
If
a
substance
identified
in
subpart
E
of
this
part
is
present
in
the
work
area
only
as
a
mixture,
an
employer
is
exempt
from
the
provisions
of
this
section
if
the
concentration
of
the
substance
in
the
mixture
does
not
exceed
a
concentration
set
in
subpart
E
of
this
part.
The
exemption
does
not
apply
if
the
employer
has
reason
to
believe
that
during
intended
use
or
processing
in
the
work
area,
the
substance
in
the
mixture
may
be
concentrated
above
the
May
10,
2004
level
set
in
subpart
E
of
this
part.

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

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

(
1)
Human
health
hazard
statements:
This
substance
may
cause:
(
i)
Skin
irritation.
(
ii)
Respiratory
complications.
(
iii)
Central
nervous
system
effects.
(
iv)
Internal
organ
effects.
(
v)
Birth
defects.
(
vi)
Reproductive
effects.
(
vii)
Cancer.
(
viii)
Immune
system
effects.
(
ix)
Developmental
effects.

(
2)
Human
health
hazard
precautionary
statements:
When
using
this
substance:
(
i)
Avoid
skin
contact.
(
ii)
Avoid
breathing
substance.
(
iii)
Avoid
ingestion.
(
iv)
Use
respiratory
protection.
(
v)
Use
skin
protection.

(
3)
Environmental
hazard
statements:
This
substance
may
be:
(
i)
Toxic
to
fish.
(
ii)
Toxic
to
aquatic
organisms.

(
4)
Environmental
hazard
precautionary
statements:
Notice
to
users:
(
i)
Disposal
restrictions
apply.
(
ii)
Spill
clean­
up
restrictions
apply.
(
iii)
Do
not
release
to
water.

(
5)
Each
human
health
or
environmental
hazard
precautionary
statement
identified
in
subpart
E
of
this
part
for
the
label
on
the
substance
container
must
be
followed
by
the
statement,
"
See
MSDS
for
details."

(
h)
Human
health,
environmental
hazard
exposure
and
precautionary
statements.
(
1)
Whenever
referenced
in
subpart
E
of
this
part
for
a
substance,
the
following
human
health,
environmental
hazard,
exposure,
and
precautionary
statements
shall
appear
on
each
label
as
specified
in
May
10,
2004
paragraph
(
b)
of
this
section.
Additional
statements
may
be
included
as
long
as
they
are
true
and
do
not
alter
the
meaning
of
the
required
statements.

(
i)
Precautionary
statements.
(
A)
The
health
effects
of
this
chemical
substance
have
not
been
determined.
(
B)
When
using
this
substance,
use
skin
protection.
(
C)
Use
respiratory
protection
when
there
is
a
reasonable
likelihood
of
exposure
in
the
work
area
from
dust,
mist,
or
smoke
from
spray
application.
(
D)
Chemicals
similar
in
structure
to
this
substance
have
been
found
to
cause
cancer
in
laboratory
animals.

(
ii)
Human
health
hazard
statements.
This
substance
may
cause:
(
A)
Skin
irritation
(
B)
Respiratory
complications
(
C)
Central
nervous
system
effects
(
D)
Internal
organ
effects
(
E)
Birth
defects
(
F)
Reproductive
effects
(
G)
Cancer
(
H)
Immune
system
effects
(
I)
Developmental
effects
(
iii)
Human
health
hazard
precautionary
statements.
When
using
this
substance:
(
A)
Avoid
skin
contact
(
B)
Avoid
breathing
substance
(
C)
Avoid
ingestion
(
D)
Use
respiratory
protection
(
E)
Use
skin
protection
(
iv)
Environmental
hazard
statements.
This
substance
may
be:
(
A)
Toxic
to
fish
(
B)
Toxic
to
aquatic
organisms
(
v)
Environmental
hazard
precautionary
statements.
Notice
to
Users:
(
A)
Disposal
restrictions
apply
(
B)
Spill
clean­
up
restrictions
apply
(
C)
Do
not
release
to
water.

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

(
2)
Whenever
referenced
in
subpart
E
of
this
part
for
a
substance,
the
following
human
health,
environmental
hazard,
exposure,
and
precautionary
statements
shall
appear
on
each
MSDS
as
specified
in
paragraph
(
c)
of
this
section.
Additional
statements
may
be
included
as
long
as
they
are
true
and
do
not
alter
the
meaning
of
the
required
statements.
May
10,
2004
(
i)
Precautionary
statements.
(
A)
The
health
effects
of
this
chemical
substance
have
not
been
determined.
(
B)
When
using
this
substance,
use
skin
protection.
(
C)
Use
respiratory
protection
when
there
is
a
reasonable
likelihood
of
exposure
in
the
work
area
from
dust,
mist,
or
smoke
from
spray
application.

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

(
ii)
Human
health
hazard
statements.
This
substance
may
cause:
(
A)
Skin
irritation
(
B)
Respiratory
complications
(
C)
Central
nervous
system
effects
(
D)
Internal
organ
effects
(
E)
Birth
defects
(
F)
Reproductive
effects
(
G)
Cancer
(
H)
Immune
system
effects
(
I)
Developmental
effects
(
iii)
Human
health
hazard
precautionary
statements.
When
using
this
substance:
(
A)
Avoid
skin
contact
(
B)
Avoid
breathing
substance
(
C)
Avoid
ingestion
(
D)
Use
respiratory
protection
(
E)
Use
skin
protection
(
iv)
Environmental
hazard
statements.
This
substance
may
be:
(
A)
Toxic
to
fish
(
B)
Toxic
to
aquatic
organisms
(
v)
Environmental
hazard
precautionary
statements.
Notice
to
Users:
(
A)
Disposal
restrictions
apply
(
B)
Spill
clean­
up
restrictions
apply
(
C)
Do
not
release
to
water.

[
54
FR
31308,
July
27,
1989,
as
amended
at
55
FR
45996,
Oct.
31,
1990;
58
FR
34204,
June
23,
1993]

§
721.80
Industrial,
commercial,
and
consumer
activities.

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

(
a)
Use
in
non­
enclosed
processes.
(
b)
Any
manner
or
method
of
manufacture
in
non­
enclosed
processes
associated
with
any
use.
(
c)
Any
manner
or
method
of
processing
in
non­
enclosed
processes
associated
with
any
use.
May
10,
2004
(
d)
Use
beyond
the
site
of
manufacture
or
import.
(
e)
Processing
beyond
the
site
of
manufacture
or
import.
(
f)
Any
manner
or
method
of
manufacture
(
excluding
import)
of
the
substance
associated
with
any
use.

(
g)
Use
other
than
as
an
intermediate.
(
h)
Use
other
than
as
a
site­
limited
intermediate.
(
i)
Use
as
an
intermediate
where
the
concentration
of
the
intermediate
substance
in
the
product
intended
for
distribution
in
commerce
exceeds
the
concentration
specified
in
subpart
E
of
this
part
for
the
substance.
(
j)
Use
other
than
as
described
in
the
premanufacture
notice
referenced
in
subpart
E
of
this
part
for
the
substance.
(
k)
Use
other
than
allowed
by
the
section
5(
e)
consent
order
referenced
in
subpart
E
of
this
part
for
the
substance.
(
l)
Non­
industrial
use.
(
m)
Commercial
use.
(
n)
Non­
commercial
use.
(
o)
Use
in
a
consumer
product.
(
p)
Aggregate
manufacture
and
importation
volume
for
any
use
greater
than
that
specified
in
subpart
E
of
this
part
for
the
substance.
(
q)
Aggregate
manufacture
and
importation
volume
for
any
use
greater
than
that
allowed
by
the
section
5(
e)
consent
order
referenced
in
subpart
E
of
this
part
for
the
substance.
(
r)
Aggregate
manufacture
and
importation
volume
for
any
use
greater
than
that
specified
in
subpart
E
of
this
part
for
the
substance
unless
the
manufacturer
or
importer
has
submitted
the
results
of
the
health
or
environmental
effects
studies
identified
in
subpart
E
of
this
part
for
the
substance
and
those
studies
comply
with
the
procedures
and
criteria
for
developing
and
evaluating
data
identified
in
subpart
E
of
this
part
for
the
substance.
(
s)
Annual
manufacture
and
importation
volume
for
any
use
greater
than
that
specified
in
subpart
E
of
this
part
for
the
substance.
(
t)
Annual
manufacture
and
importation
volume
for
any
use
greater
than
that
allowed
by
the
section
5(
e)
consent
order
referenced
in
subpart
E
of
this
part
for
the
substance.
(
u)
Annual
manufacture
and
importation
volume
for
any
use
greater
than
that
specified
in
subpart
E
of
this
part
for
the
substance
unless
the
manufacturer
or
importer
has
submitted
the
results
of
the
health
or
environmental
effects
studies
identified
in
subpart
E
of
this
part
for
the
substance
and
those
studies
comply
with
the
procedures
and
criteria
for
developing
and
evaluating
data
identified
in
subpart
E
of
this
part
for
the
substance.

(
v)
Use
in
the
form
of:
(
1)
A
powder.
(
2)
A
solid.
(
3)
A
liquid.
(
4)
A
gas.

(
w)
Any
manner
or
method
of
manufacture
of
the
substance
in
the
following
form
associated
with
any
use:
(
1)
A
powder.
(
2)
A
solid.
May
10,
2004
(
3)
A
liquid.
(
4)
A
gas.

(
x)
Any
manner
or
method
of
processing
of
the
substance
in
the
following
form
associated
with
any
use:
(
1)
A
powder.
(
2)
A
solid.
(
3)
A
liquid.
(
4)
A
gas.

(
y)
Use
involving
an
application
method
that
generates:
(
1)
A
vapor,
mist,
or
aerosol.
(
2)
A
dust.

§
721.85
Disposal.

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

(
a)
Disposal
of
the
process
stream
associated
with
any
use
of
the
substance
or
with
any
manner
or
method
of
manufacturing
associated
with
any
use
of
the
substance
other
than
by
the
following.
This
provision
does
not
supercede
any
applicable
Federal,
State,
or
local
laws
and
regulations.
(
1)
Incineration.
(
2)
Landfill.
(
3)
Deep
well
injection.

(
b)
Disposal
of
the
process
stream
associated
with
any
use
or
with
any
manner
or
method
of
processing
associated
with
any
use
other
than
by
the
following.
This
provision
does
not
supercede
any
applicable
Federal,
State,
or
local
laws
and
regulations.
(
1)
Incineration.
(
2)
Landfill.
(
3)
Deep
well
injection.

(
c)
Disposal
of
the
use
stream
associated
with
any
use,
other
than
by
the
following.
This
provision
does
not
supercede
any
applicable
Federal,
State,
or
local
laws
and
regulations.
(
1)
Incineration.
(
2)
Landfill.
(
3)
Deep
well
injection.

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

§
721.90
Release
to
water.
May
10,
2004
Whenever
a
substance
is
identified
in
subpart
E
of
this
part
as
being
subject
to
this
section,
a
significant
new
use
of
the
substance
is:

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

(
1)
Into
the
waters
of
the
United
States.

(
2)
Into
the
waters
of
the
United
States
without
application
of
one
or
more
of
the
following
treatment
technologies
as
specified
in
subpart
E
of
this
part
either
by
the
discharger
or,
in
the
case
of
a
release
through
publicly­
owned
treatment
works,
by
a
combination
of
treatment
by
the
discharger
and
the
publicly­
owned
treatment
works:
(
i)
Chemical
precipitation
and
settling.
(
ii)
Biological
treatment
(
activated
sludge
or
equivalent)
plus
clarification.
(
iii)
Steam
stripping.
(
iv)
Resin
or
activated
carbon
adsorption.
(
v)
Chemical
destruction
or
conversion.
(
vi)
Primary
wastewater
treatment.

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

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

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

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

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

(
1)
Into
the
waters
of
the
United
States.

(
2)
Into
the
waters
of
the
United
States
without
application
of
one
or
more
of
the
following
treatment
technologies
as
specified
in
subpart
E
of
this
part
either
by
the
discharger
or,
in
the
case
of
a
release
through
publicly­
owned
treatment
works,
by
a
combination
of
treatment
by
the
May
10,
2004
discharger
and
the
publicly­
owned
treatment
works:
(
i)
Chemical
precipitation
and
settling.
(
ii)
Biological
treatment
(
activated
sludge
or
equivalent)
plus
clarification.
(
iii)
Steam
stripping.
(
iv)
Resin
or
activated
carbon
adsorption.
(
v)
Chemical
destruction
or
conversion.
(
vi)
Primary
wastewater
treatment.

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

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

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

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

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

(
1)
Into
the
waters
of
the
United
States.

(
2)
Into
the
waters
of
the
United
States
without
application
of
one
or
more
of
the
following
treatment
technologies
as
specified
in
subpart
E
of
this
part
either
by
the
discharger
or,
in
the
case
of
a
release
through
publicly­
owned
treatment
works,
by
a
combination
of
treatment
by
the
discharger
and
the
publicly­
owned
treatment
works:
(
i)
Chemical
precipitation
and
settling.
(
ii)
Biological
treatment
(
activated
sludge
or
equivalent)
plus
clarification.
(
iii)
Steam
stripping.
(
iv)
Resin
or
activated
carbon
adsorption.
(
v)
Chemical
destruction
or
conversion.
(
vi)
Primary
wastewater
treatment.

(
3)
Into
the
waters
of
the
United
States
without
primary
wastewater
treatment,
and
secondary
wastewater
treatment
as
defined
in
40
CFR
part
133.
May
10,
2004
(
4)
Into
the
waters
of
the
United
States
if
the
quotient
from:

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

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

§
721.91
Computation
of
estimated
surface
water
concentrations:
Instructions.

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

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

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

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

(
4)
For
releases
identified
in
the
diagram
that
are
destined
for
water,
estimate
the
amount
of
substance
that
will
be
released
before
the
substance
enters
control
technology.
The
kilograms
of
substance
released
may
be
estimated
based
on:
May
10,
2004
(
i)
The
mass
balance
of
the
operation,
i.
e.,
totaling
inputs
and
outputs,
including
wastes
for
each
part
of
the
process
such
that
outputs
equal
inputs.
The
amount
released
to
water
may
be
the
difference
between
the
amount
of
the
substance
in
the
starting
material
(
or
formed
in
a
reaction)
minus
the
amount
of
waste
material
removed
from
each
part
of
the
process
and
not
released
to
water
and
the
amount
of
the
substance
in
the
final
product.
(
ii)
Physical
properties
such
as
water
solubility
where
a
known
volume
of
water
being
discharged
is
assumed
to
contain
the
substance
at
concentrations
equal
to
its
solubility
in
water.
This
approach
is
particularly
useful
where
the
waste
stream
results
from
separation
of
organic/
water
phases
or
filtration
of
the
substance
from
an
aqueous
stream
to
be
discharged.
(
iii)
Measurements
of
flow
rates
of
the
process/
use
stream
and
known
concentrations
of
the
substance
in
the
stream.

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

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

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

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

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

Subpart
C
­­
Recordkeeping
Requirements
§
721.100
Applicability.

This
subpart
C
identifies
certain
additional
recordkeeping
requirements
applicable
to
May
10,
2004
manufacturers,
importers,
and
processors
of
substances
identified
in
subpart
E
of
this
part
for
each
specific
substance.
The
provisions
of
this
subpart
C
apply
only
when
referenced
in
subpart
E
of
this
part
for
a
substance
and
significant
new
use
identified
in
that
subpart
E.
If
the
provisions
in
this
subpart
C
conflict
with
general
provisions
of
subpart
A
of
this
part,
the
provisions
of
this
subpart
C
shall
apply.

[
54
FR
31313,
July
27,
1989]

§
721.125
Recordkeeping
requirements.

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

(
a)
Records
documenting
the
manufacture
and
importation
volume
of
the
substance
and
the
corresponding
dates
of
manufacture
and
import.
(
b)
Records
documenting
volumes
of
the
substance
purchased
in
the
United
States
by
processors
of
the
substance,
names
and
addresses
of
suppliers,
and
corresponding
dates
of
purchase.
(
c)
Records
documenting
the
names
and
addresses
(
including
shipment
destination
address,
if
different)
of
all
persons
outside
the
site
of
manufacture,
importation,
or
processing
to
whom
the
manufacturer,
importer,
or
processor
directly
sells
or
transfers
the
substance,
the
date
of
each
sale
or
transfer,
and
the
quantity
of
the
substance
sold
or
transferred
on
such
date.
(
d)
Records
documenting
establishment
and
implementation
of
a
program
for
the
use
of
any
applicable
personal
protective
equipment
required
under
§
721.63.
(
e)
Records
documenting
the
determinations
required
by
§
721.63(
a)(
3)
that
chemical
protective
clothing
is
impervious
to
the
substance.
(
f)
Records
documenting
establishment
and
implementation
of
the
hazard
communication
program
required
under
§
721.72.
(
g)
Copies
of
labels
required
under
§
721.72(
b).
(
h)
Copies
of
material
safety
data
sheets
required
under
§
721.72(
c).
(
i)
Records
documenting
compliance
with
any
applicable
industrial,
commercial,
and
consumer
use
limitations
under
§
721.80.
(
j)
Records
documenting
compliance
with
any
applicable
disposal
requirements
under
§
721.85,
including
the
method
of
disposal,
location
of
disposal
sites,
dates
of
disposal,
and
volume
of
the
substance
disposed.
Where
the
estimated
disposal
volume
is
not
known
to
or
reasonably
ascertainable
by
the
manufacturer,
importer,
or
processor,
that
person
must
maintain
other
records
which
demonstrate
establishment
and
implementation
of
a
program
that
ensures
compliance
with
any
applicable
disposal
requirements.
(
k)
Records
documenting
establishment
and
implementation
of
procedures
that
ensure
compliance
with
any
applicable
water
discharge
limitations
under
§
721.90.

[
54
FR
31313,
July
27,
1989]

Subpart
D
­­
Expedited
Process
for
Issuing
Significant
New
Use
Rules
for
Selected
Chemical
May
10,
2004
Substances
and
Limitation
or
Revocation
of
Selected
Significant
New
Use
Rules
Source:
54
FR
31314,
July
27,
1989,
unless
otherwise
noted.

§
721.160
Notification
requirements
for
new
chemical
substances
subject
to
section
5(
e)
orders.

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

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

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

(
2)
Significant
new
use
requirements
and
other
specific
requirements
designated
under
this
section
will
be
listed
in
subpart
E
of
this
part.
For
each
substance,
subpart
E
will
identify:
(
i)
The
chemical
name.
(
ii)
The
activities
designated
as
significant
new
uses.
(
iii)
Other
specific
requirements
applicable
to
the
substance,
including
recordkeeping
requirements
or
any
other
requirements
included
in
the
final
section
5(
e)
order.

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

(
2)
FEDERAL
REGISTER
documents
issued
to
propose
or
establish
significant
new
uses
under
this
section
will
contain
the
following:
(
i)
The
chemical
identity
of
the
substance
or,
if
its
specific
identity
is
claimed
confidential,
an
appropriate
generic
chemical
name
and
an
accession
number
assigned
by
EPA.
(
ii)
The
premanufacture
notice
number.
(
iii)
The
CAS
number,
where
available
and
not
claimed
confidential.
(
iv)
A
summary
of
EPA's
findings
under
section
5(
e)(
1)(
A)
of
the
Act
for
the
final
order
issued
under
section
5(
e).
(
v)
Designation
of
the
significant
new
uses
subject
to,
or
proposed
to
be
subject
to,
notification
and
any
other
applicable
requirements.
May
10,
2004
(
vi)
Any
modifications
of
subpart
A
of
this
part
applicable
to
the
specific
substance
and
significant
new
uses.
(
vii)
If
the
FEDERAL
REGISTER
document
establishes
a
final
rule,
or
notifies
the
public
that
a
final
rule
will
not
be
issued
after
public
comment
has
been
received,
the
document
will
describe
comments
received
and
EPA's
response.

(
3)
Direct
final
rulemaking.
(
i)
When
EPA
uses
the
direct
final
rulemaking
procedure
to
issue
a
significant
new
use
rule,
it
will
issue
a
final
rule
in
the
FEDERAL
REGISTER
following
its
decision
to
develop
a
significant
new
use
rule
under
this
section
for
a
specific
new
chemical
substance.
(
ii)
The
FEDERAL
REGISTER
document
will
state
that,
unless
written
notice
is
received
by
EPA
within
30
days
of
publication
that
someone
wishes
to
submit
adverse
or
critical
comments,
the
rule
will
be
effective
60
days
from
the
date
of
publication.
The
written
notice
of
intent
to
submit
adverse
or
critical
comments
should
state
which
SNUR(
s)
will
be
the
subject
of
the
adverse
or
critical
comments,
if
several
SNURs
are
established
through
the
direct
final
rule.
If
notice
is
received
within
30
days
that
someone
wishes
to
submit
adverse
or
critical
comments,
the
section(
s)
of
the
direct
final
rule
containing
the
SNUR(
s)
for
which
a
notice
of
intent
to
comment
was
received
will
be
withdrawn
by
EPA
issuing
a
document
in
the
final
rule
section
of
the
FEDERAL
REGISTER,
and
a
proposal
will
be
published
in
the
proposed
rule
section
of
the
FEDERAL
REGISTER.
The
proposal
will
establish
a
30­
day
comment
period.
(
iii)
If
EPA,
having
considered
any
timely
comments
submitted
in
response
to
the
proposal,
decides
to
establish
notification
requirements
under
this
section,
EPA
will
issue
a
final
rule
adding
the
substance
to
subpart
E
of
this
part
and
designating
the
significant
new
uses
subject
to
notification.

(
4)
Notice
and
comment
rulemaking.
(
i)
When
EPA
uses
a
notice
and
comment
procedure
to
issue
a
significant
new
use
rule,
EPA
will
issue
a
proposal
in
the
FEDERAL
REGISTER
following
its
decision
to
develop
a
significant
new
use
rule
under
this
section
for
a
specific
new
chemical
substance.
Persons
will
be
given
30
days
to
comment
on
whether
EPA
should
establish
notification
requirements
for
the
substance
under
this
part.
(
ii)
If
EPA,
having
considered
any
timely
comments,
decides
to
establish
notification
requirements
under
this
section,
EPA
will
issue
a
final
rule
adding
the
substance
to
subpart
E
of
this
part
and
designating
the
significant
new
uses
subject
to
notification.

(
5)
Interim
final
rulemaking.
(
i)
When
EPA
uses
the
interim
final
rulemaking
procedure
to
issue
a
significant
new
use
rule,
EPA
will
issue
an
interim
final
rule
in
the
final
rule
section
of
the
FEDERAL
REGISTER
following
its
decision
to
develop
a
significant
new
use
rule
for
a
specific
new
chemical
substance.
The
document
will
state
EPA's
reasons
for
using
the
interim
final
rulemaking
procedure.
(
A)
The
significant
new
use
rule
will
take
effect
on
the
date
of
publication.
(
B)
Persons
will
be
given
30
days
from
the
date
of
publication
to
submit
comments.
(
ii)
Interim
final
rules
issued
under
this
section
shall
cease
to
be
in
effect
180
days
after
publication
unless,
within
the
180­
day
period,
EPA
issues
a
final
rule
in
the
FEDERAL
REGISTER
responding
to
any
written
comments
received
during
the
30­
day
comment
period
specified
in
paragraph
(
c)(
5)(
i)(
B)
of
this
section
and
promulgating
final
significant
new
use
notification
requirements
and
other
requirements
for
the
substance.
May
10,
2004
(
d)
Schedule
for
issuing
significant
new
use
rules.
(
1)
Unless
EPA
determines
that
a
significant
new
use
rule
should
not
be
issued
under
this
section,
EPA
will
issue
a
proposed
rule,
a
direct
final
rule,
or
an
interim
final
rule
within
180
days
of
receipt
of
a
valid
notice
of
commencement
under
§
720.102
of
this
chapter
for
any
substance
for
which
the
notice
of
commencement
was
received
on
or
after
October
10,
1989.

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

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

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

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

(
b)
Concern
criteria.
EPA
may
determine
that
concern
exists
about
a
substance's
health
or
environmental
effects
if
EPA
makes
any
one
of
the
following
findings:
(
1)(
i)
The
substance
may
cause
carcinogenic
effects
because
the
substance:
(
A)
Has
been
shown
by
valid
test
data
to
cause
carcinogenic
effects
in
humans
or
in
at
least
one
species
of
laboratory
animal.
(
B)
Has
been
shown
to
be
a
possible
carcinogen
based
on
the
weight
of
the
evidence
in
short­
term
tests
indicative
of
the
potential
to
cause
carcinogenic
effects.

(
C)
Is
closely
analogous,
based
on
toxicologically
relevant
similarities
in
molecular
structure
and
physical
properties,
to
another
substance
that
has
been
shown
by
test
data
to
cause
carcinogenic
effects
in
humans
or
in
at
least
one
species
of
laboratory
animal,
provided
that
if
there
is
more
than
one
such
analogue,
the
greatest
weight
will
be
given
to
the
relevant
data
for
the
most
appropriate
analogues.
(
D)
Is
known
or
can
reasonably
be
anticipated,
based
on
valid
scientific
data
or
established
scientific
principles,
to
be
metabolized
in
humans
or
transformed
in
the
environment
to
a
substance
which
may
have
the
potential
to
cause
carcinogenic
effects
under
the
criteria
in
paragraphs
(
b)(
1)(
i)
(
A),
(
B),
or
(
C)
of
this
section.
(
ii)
No
substance
may
be
regulated
based
on
a
finding
under
paragraph
(
b)(
1)
of
this
section
unless
EPA
has
also
made
the
finding
under
§
721.170(
c)(
2)(
ii).

(
2)
The
substance
has
been
shown
by
valid
test
data
to
cause
acutely
toxic
effects
in
at
least
one
species
of
laboratory
animal
or
is
closely
analogous,
based
on
toxicologically
relevant
similarities
May
10,
2004
in
molecular
structure
and
physical
properties,
to
another
substance
that
has
been
shown
by
valid
test
data
to
cause
acutely
toxic
effects
in
at
least
one
species
of
laboratory
animal,
provided
that
if
there
is
more
than
one
such
analogue,
the
greatest
weight
will
be
given
to
the
relevant
data
for
the
most
appropriate
analogues.

(
3)
The
substance
may
cause
serious
chronic
effects,
serious
acute
effects,
or
developmentally
toxic
effects
under
reasonably
anticipated
conditions
of
exposure
because
the
substance:
(
i)
Has
been
shown
by
valid
test
data
to
cause
serious
chronic
effects,
serious
acute
effects,
or
developmentally
toxic
effects
in
humans
or
in
at
least
one
species
of
laboratory
animal
at
dose
levels
that
could
be
of
concern
under
reasonably
anticipated
conditions
of
exposure.
(
ii)
Is
closely
analogous,
based
on
toxicologically
relevant
similarities
in
molecular
structure
and
physical
properties,
to
another
chemical
substance
that
has
been
shown
by
valid
test
data
to
cause
serious
chronic
effects,
serious
acute
effects,
or
developmentally
toxic
effects
in
humans
or
in
at
least
one
species
of
laboratory
animal
at
dose
levels
that
could
be
of
concern
under
reasonably
anticipated
conditions
of
exposure,
provided
that
if
there
is
more
than
one
such
analogue,
the
greatest
weight
will
be
given
to
the
relevant
data
for
the
most
appropriate
analogues.
(
iii)
Is
known
or
can
reasonably
be
anticipated,
based
on
valid
scientific
data
or
established
scientific
principles,
to
be
metabolized
in
humans
or
transformed
in
the
environment
to
a
substance
which
may
have
the
potential
to
cause
serious
chronic
effects,
serious
acute
effects,
or
developmentally
toxic
effects
under
the
criteria
in
paragraph
(
b)(
3)
(
i)
and
(
ii)
of
this
section.
(
iv)
Has
been
shown
to
potentially
cause
developmentally
toxic
effects
based
on
the
weight
of
the
evidence
in
short­
term
tests
indicative
of
the
potential
to
cause
developmentally
toxic
effects.

(
4)
The
substance
may
cause
significant
adverse
environmental
effects
under
reasonably
anticipated
conditions
of
release
because
the
substance:
(
i)
Has
been
shown
by
valid
test
data
to
cause
significant
adverse
environmental
effects
at
dose
levels
that
could
be
of
concern
under
reasonably
anticipated
conditions
of
release.
(
ii)
Is
closely
analogous,
based
on
toxicologically
relevant
similarities
in
molecular
structure
and
physical
properties,
to
another
substance
that
has
been
shown
by
valid
test
data
to
cause
significant
adverse
environmental
effects
at
dose
levels
that
could
be
of
concern
under
reasonably
anticipated
conditions
of
release,
provided
that
if
there
is
more
than
one
such
analogue,
the
greatest
weight
will
be
given
to
the
relevant
data
for
the
most
appropriate
analogues.
(
iii)
Has
been
determined,
based
on
calculations
using
the
substance's
physical
and
chemical
properties,
to
be
potentially
able
to
cause
significant
adverse
environmental
effects
at
dose
levels
that
could
be
of
concern
under
reasonably
anticipated
conditions
of
release.

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

(
5)
Concern
exists
about
the
health
or
environmental
effects
of
one
or
more
impurities
or
byproducts
of
the
substance
because
the
impurity
or
byproduct
meets
one
or
more
of
the
criteria
in
paragraph
(
b)
(
1)
through
(
4)
of
this
section
and
either:
(
i)
The
impurity
or
byproduct
is
a
new
chemical
substance
and
may
be
present
in
concentrations
that
could
cause
adverse
health
or
environmental
effects
under
reasonably
anticipated
conditions
May
10,
2004
of
exposure
or
release.
(
ii)
Reasonably
anticipated
manufacture,
processing,
or
use
activities
involving
the
substance
for
which
a
premanufacture
notice
has
been
submitted
may
result
in
significantly
increased
human
exposure
to
or
environmental
release
of
the
impurity
or
byproduct
compared
to
exposure
or
release
levels
resulting
from
existing
activities
involving
the
impurity
or
byproduct.

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

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

(
d)
Procedures
for
issuing
significant
new
use
rules.
(
1)
Significant
new
use
requirements
designated
under
this
section
will
be
listed
in
subpart
E
of
this
part.
For
each
substance,
subpart
E
of
this
part
will
identify:
(
i)
The
chemical
name.
(
ii)
The
activities
designated
as
significant
new
uses,
which
may
include
one
or
more
of
the
activities
described
in
paragraph
(
c)
of
this
section.
(
iii)
Other
specific
requirements
applicable
to
the
substance.

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

(
3)
FEDERAL
REGISTER
documents
issued
to
propose
or
establish
significant
new
uses
under
this
section
will
contain
the
following:
(
i)
The
chemical
identity
of
the
substance
or,
if
its
specific
identity
is
claimed
confidential,
an
appropriate
generic
chemical
name
and
an
accession
number
assigned
by
EPA.
(
ii)
The
premanufacture
notice
number.
(
iii)
The
CAS
number,
where
available
and
not
claimed
confidential.
(
iv)
A
summary
of
the
basis
for
action
under
this
section.
(
v)
Designation
of
the
significant
new
uses
subject
to,
or
proposed
to
be
subject
to,
notification
and
any
other
applicable
requirements.
(
vi)
Any
modifications
of
subpart
A
of
this
part
applicable
to
the
specific
substance
and
significant
new
uses.
(
vii)
If
the
FEDERAL
REGISTER
document
establishes
a
final
rule,
or
notifies
the
public
that
a
final
rule
will
not
be
issued
after
public
comment
has
been
received,
the
document
will
describe
May
10,
2004
comments
received
and
EPA's
response.

(
4)
EPA
will
issue
significant
new
use
rules
under
this
section
by
one
of
the
following
three
processes:
direct
final
rulemaking,
interim
final
rulemaking,
or
notice
and
comment
rulemaking.
EPA
will
use
the
direct
final
rulemaking
process
to
issue
significant
new
use
rules
unless
it
determines
that,
in
a
particular
case,
one
of
the
other
processes
is
more
appropriate.
(
i)(
A)
When
EPA
uses
the
direct
final
rulemaking
procedure
to
issue
a
significant
new
use
rule
it
will
issue
a
direct
final
rule
in
the
final
rule
section
of
the
FEDERAL
REGISTER
following
its
decision
to
develop
a
significant
new
use
rule
under
this
section
for
a
specific
new
chemical
substance.
(
B)
The
FEDERAL
REGISTER
document
will
state
that,
unless
written
notice
is
received
by
EPA
within
30
days
after
the
date
of
publication
that
someone
wishes
to
submit
adverse
or
critical
comments,
the
SNUR
will
be
effective
60
days
from
date
of
publication.
The
written
notice
of
intent
to
submit
adverse
or
critical
comments
should
state
which
SNUR(
s)
will
be
the
subject
of
the
adverse
or
critical
comments,
if
several
SNURs
are
established
through
the
direct
final
rule.
If
notice
is
received
within
30
days
after
the
date
of
publication
that
someone
wishes
to
submit
adverse
or
critical
comments,
the
section(
s)
of
the
direct
final
rule
containing
the
SNUR(
s)
for
which
a
notice
of
intent
to
comment
was
received
will
be
withdrawn
by
EPA
issuing
a
document
in
the
final
rule
section
of
the
FEDERAL
REGISTER,
and
EPA
will
issue
a
proposed
rule
in
the
proposed
rule
section
of
the
FEDERAL
REGISTER.
The
proposed
rule
will
establish
a
30­
day
comment
period.

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

(
ii)(
A)
When
EPA
uses
a
notice
and
comment
procedure
to
issue
a
significant
new
use
rule,
EPA
will
issue
a
proposed
rule
in
the
FEDERAL
REGISTER
following
its
decision
to
develop
a
significant
new
use
rule
under
this
section
for
a
specific
new
chemical
substance.
Persons
will
be
given
30
days
to
comment
on
whether
EPA
should
establish
notification
requirements
for
the
substance
under
this
part.
(
B)
If
EPA,
having
considered
any
timely
comments,
decides
to
establish
notification
requirements
under
this
section,
EPA
will
issue
a
final
rule
adding
the
substance
to
subpart
E
of
this
part
and
designating
the
significant
new
uses
subject
to
notification.
(
iii)(
A)
When
EPA
uses
the
interim
final
rulemaking
procedure
to
issue
a
significant
new
use
rule,
EPA
will
issue
an
interim
final
rule
in
the
final
rule
section
of
the
FEDERAL
REGISTER
following
its
decision
to
develop
a
significant
new
use
rule
for
a
specific
new
chemical
substance.
The
document
will
state
EPA's
reasons
for
using
the
interim
final
rulemaking
procedure.
(
1)
The
significant
new
use
rule
will
take
effect
on
the
date
of
publication.
(
2)
Persons
will
be
given
30
days
from
the
date
of
publication
to
submit
comments.
(
B)
An
interim
final
rule
issued
under
this
section
shall
cease
to
be
in
effect
180
days
after
publication
unless,
within
the
180­
day
period,
EPA
issues
a
final
rule
in
the
FEDERAL
REGISTER
responding
to
any
written
comments
received
during
the
30­
day
comment
period
specified
in
paragraph
(
d)(
4)(
iii)(
A)(
2)
of
this
section
and
promulgating
final
significant
new
use
notification
requirements
and
other
requirements
for
the
substance.
May
10,
2004
(
e)
Schedule
for
issuing
significant
new
use
rules.
(
1)
EPA
will
issue
a
proposed
rule,
an
interim
final
rule,
or
a
direct
final
rule
within
270
days
of
receipt
of
the
notice
of
commencement
under
§
720.102
of
this
chapter
for
any
substance
for
which
the
notice
of
commencement
was
received
on
or
after
October
10,
1989.

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

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

§
721.185
Limitation
or
revocation
of
certain
notification
requirements.

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

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

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

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

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

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

(
6)
For
a
substance
added
to
subpart
E
of
this
part
under
§
721.160,
certain
activities
involving
the
substance
have
been
designated
as
significant
new
uses
pending
the
completion
of
testing,
and
adequate
test
data
developed
in
accordance
with
applicable
procedures
and
criteria
have
been
submitted
to
EPA.
May
10,
2004
(
b)
Procedures
for
limitation
or
revocation.
Modification
or
revocation
of
significant
new
use
notification
requirements
for
a
substance
that
has
been
added
to
subpart
E
of
this
part
using
the
procedures
described
under
§
721.160
or
§
721.170
may
occur
either
at
EPA's
initiative
or
in
response
to
a
written
request.

(
1)
Any
affected
person
may
request
modification
or
revocation
of
significant
new
use
notification
requirements
for
a
substance
that
has
been
added
to
subpart
E
of
this
part
using
the
procedures
described
in
§
721.160
or
§
721.170
by
writing
to
the
Director
of
the
Office
of
Pollution
Prevention
and
Toxics
and
stating
the
basis
for
such
request.
All
requests
should
be
sent
to
the
Document
Control
Office
(
7407),
Office
of
Pollution
Prevention
and
Toxics,
U.
S.
Environmental
Protection
Agency,
Room
G­
099,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460.
ATTN:
Request
to
amend
significant
new
use
rule.
The
request
must
be
accompanied
by
information
sufficient
to
support
the
request.

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

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

[
54
FR
31314,
July
27,
1989,
as
amended
at
58
FR
34204,
June
23,
1993;
60
FR
34464,
July
3,
1995]
May
10,
2004
Attachment
E
40
CFR
Part
723
May
10,
2004
40
CFR
Protection
of
Environment
CHAPTER
I
ENVIRONMENTAL
PROTECTION
AGENCY
(
CONTINUED)

SUBCHAPTER
R
­­
TOXIC
SUBSTANCES
CONTROL
ACT
PART
723
­­
PREMANUFACTURE
NOTIFICATION
EXEMPTIONS
Subpart
A
[
Reserved]

Subpart
B
­­
Specific
Exemptions
Sec.
723.50
Chemical
substances
manufactured
in
quantities
of
10,000
kilograms
or
less
per
year,
and
chemical
substances
with
low
environmental
releases
and
human
exposures.
723.175
Chemical
substances
used
in
or
for
the
manufacture
or
processing
of
instant
photographic
and
peel­
apart
film
articles.
723.250
Polymers.

Authority:
15
U.
S.
C.
2604.

Subpart
A
[
Reserved]

Subpart
B
­­
Specific
Exemptions
§
723.50
Chemical
substances
manufactured
in
quantities
of
10,000
kilograms
or
less
per
year,
and
chemical
substances
with
low
environmental
releases
and
human
exposures.

(
a)
Purpose
and
scope.
(
1)
This
section
grants
an
exemption
from
the
premanufacture
notice
requirements
of
section
5(
a)(
1)(
A)
of
the
Toxic
Substances
Control
Act
(
15
U.
S.
C.
2604(
a)(
1)(
A))
for
the
manufacture
of:
(
i)
Chemical
substances
manufactured
in
quantities
of
10,000
kilograms
or
less
per
year.
(
ii)
Chemical
substances
with
low
environmental
releases
and
human
exposures.

(
2)
To
manufacture
a
new
chemical
substance
under
the
terms
of
this
exemption
a
manufacturer
must:
(
i)
Submit
a
notice
of
intent
to
manufacture
30
days
before
manufacture
begins,
as
required
under
paragraph
(
e)
of
this
section.
(
ii)
Comply
with
all
other
provisions
of
this
section.

(
3)
This
section
does
not
apply
to
microorganisms
subject
to
part
725
of
this
chapter.

(
b)
Definitions.
The
following
definitions
apply
to
this
subpart.

(
1)
Act
means
the
Toxic
Substances
Control
Act
(
15
U.
S.
C.
2601
et
seq).

(
2)
Consumer
means
a
private
individual
who
uses
a
chemical
substance
or
any
product
May
10,
2004
containing
the
chemical
substance
in
or
around
a
permanent
or
temporary
household
or
residence,
during
recreation,
or
for
any
personal
use
or
enjoyment.

(
3)
Environment
has
the
same
meaning
as
in
section
3
of
the
Act
(
15
U.
S.
C.
2602).

(
4)
Environmental
transformation
product
means
any
chemical
substance
resulting
from
the
action
of
environmental
processes
on
a
parent
compound
that
changes
the
molecular
identity
of
the
parent
compound.

(
5)
Metabolite
means
a
chemical
entity
produced
by
one
or
more
enzymatic
or
nonenzymatic
reactions
as
a
result
of
exposure
of
an
organism
to
a
chemical
substance.

(
6)
Serious
acute
effects
means
human
disease
processes
or
other
adverse
effects
that
have
short
latency
periods
for
development,
result
from
short­
term
exposure,
or
are
a
combination
of
these
factors
and
that
are
likely
to
result
in
death,
severe
or
prolonged
incapacitation,
disfigurement,
or
severe
or
prolonged
loss
of
the
ability
to
use
a
normal
bodily
or
intellectual
function
with
a
consequent
impairment
of
normal
activities.

(
7)
Serious
chronic
effects
means
human
disease
processes
or
other
adverse
effects
that
have
long
latency
periods
for
development,
result
from
long­
term
exposure,
are
long­
term
illnesses,
or
are
a
combination
of
these
factors
and
that
are
likely
to
result
in
death,
severe
or
prolonged
incapacitation,
disfigurement,
or
severe
or
prolonged
loss
of
the
ability
to
use
a
normal
bodily
or
intellectual
function
with
a
consequent
impairment
of
normal
activities.

(
8)
Significant
environmental
effects
means:
(
i)
Any
irreversible
damage
to
biological,
commercial,
or
agricultural
resources
of
importance
to
society;
(
ii)
Any
reversible
damage
to
biological,
commercial,
or
agricultural
resources
of
importance
to
society
if
the
damage
persists
beyond
a
single
generation
of
the
damaged
resource
or
beyond
a
single
year;
or
(
iii)
Any
known
or
reasonably
anticipated
loss
of
members
of
an
endangered
or
threatened
species.
Endangered
or
threatened
species
are
those
species
identified
as
such
by
the
Secretary
of
the
Interior
in
accordance
with
the
Endangered
Species
Act,
as
amended
(
16
U.
S.
C.
1531).

(
9)
Site
means
a
contiguous
property
unit.
Property
divided
only
by
a
public
right­
of­
way
is
one
site.
There
may
be
more
than
one
manufacturing
plant
on
a
single
site.

(
10)
The
terms
byproduct,
EPA,
importer,
impurity,
known
to
or
reasonably
ascertainable,
manufacture,
manufacturer,
new
chemical
substance,
person,
possession
or
control,
and
test
data
have
the
same
meanings
as
in
§
720.3
of
this
chapter.

(
c)
Exemption
categories.
Except
as
provided
in
paragraph
(
d)
of
this
section,
this
exemption
applies
to:

(
1)
Any
manufacturer
of
a
new
chemical
substance
manufactured
in
quantities
of
10,000
kilograms
or
less
per
year
under
the
terms
of
this
exemption.
May
10,
2004
(
2)
Any
manufacturer
of
a
new
chemical
substance
satisfying
all
of
the
following
low
environmental
release
and
low
human
exposure
eligibility
criteria:
(
i)
Consumers
and
the
general
population.
For
exposure
of
consumers
and
the
general
population
to
the
new
chemical
substance
during
all
manufacturing,
processing,
distribution
in
commerce,
use,
and
disposal
of
the
substance:
(
A)
No
dermal
exposure.
(
B)
No
inhalation
exposure
(
except
as
described
in
paragraph
(
c)(
2)(
iv)
of
this
section.
(
C)
Exposure
in
drinking
water
no
greater
than
a
1
milligram
per
year
(
estimated
average
dosage
resulting
from
drinking
water
exposure
in
streams
from
the
maximum
allowable
concentration
level
from
ambient
surface
water
releases
established
under
paragraph
(
c)(
2)(
iii)
of
this
section
or
a
higher
concentration
authorized
by
EPA
under
paragraph
(
c)(
2)(
iii)
of
this
section).

(
ii)
Workers.
For
exposure
of
workers
to
the
new
chemical
substance
during
all
manufacturing,
processing,
distribution
in
commerce,
use
and
disposal
of
the
substance:
(
A)
No
dermal
exposure
(
this
criterion
is
met
if
adequate
dermal
exposure
controls
are
used
in
accordance
with
applicable
EPA
guidance).
(
B)
No
inhalation
exposure
(
this
criterion
is
considered
to
be
met
if
adequate
inhalation
exposure
controls
are
used
in
accordance
with
applicable
EPA
guidance).

(
iii)
Ambient
surface
water.
For
ambient
surface
water
releases,
no
releases
resulting
in
surface
water
concentrations
above
1
part
per
billion,
calculated
using
the
methods
prescribed
in
§
§
721.90
and
721.91,
unless
EPA
has
approved
a
higher
surface
water
concentration
supported
by
relevant
and
scientifically
valid
data
submitted
to
EPA
in
a
notice
under
paragraph
(
e)
of
this
section
on
the
substance
or
a
close
structural
analogue
of
the
substance
which
demonstrates
that
the
new
substance
will
not
present
an
unreasonable
risk
of
injury
to
aquatic
species
or
human
health
at
the
higher
concentration.

(
iv)
Incineration.
For
ambient
air
releases
from
incineration,
no
releases
of
the
new
chemical
substance
above
1
microgram
per
cubic
meter
maximum
annual
average
concentration,
calculated
using
the
formula:

(
kg/
day
of
release
after
treatment)
multiplied
by
(
number
of
release
days
per
year)
multiplied
by
(
9.68
×
10­
6)
micrograms
per
cubic
meter.

(
v)
Land
or
groundwater.
For
releases
to
land
or
groundwater,
no
releases
to
groundwater,
to
land,
or
to
a
landfill
unless
the
manufacturer
has
demonstrated
to
EPA's
satisfaction
in
a
notice
under
paragraph
(
e)
of
this
section
that
the
new
substance
has
negligible
groundwater
migration
potential.

(
d)
Chemical
substances
that
cannot
be
manufactured
under
this
exemption.
A
new
chemical
substance
cannot
be
manufactured
under
this
section,
notwithstanding
satisfaction
of
the
criterion
of
paragraphs
(
c)(
1)
or
(
c)(
2)
of
this
section,
if
EPA
determines,
in
accordance
with
paragraph
(
g)
of
this
section,
that
the
substance,
any
reasonably
anticipated
metabolites,
environmental
transformation
products,
or
byproducts
of
the
substance,
or
any
reasonably
anticipated
impurities
in
the
substance
may
cause,
under
anticipated
conditions
of
manufacture,
processing,
distribution
in
commerce,
use,
or
disposal
of
the
new
chemical
substance:
May
10,
2004
(
1)
Serious
acute
(
lethal
or
sublethal)
effects.

(
2)
Serious
chronic
(
including
carcinogenic
and
teratogenic)
effects.

(
3)
Significant
environmental
effects.

(
e)
Exemption
notice.
(
1)
A
manufacturer
applying
for
an
exemption
under
either
paragraph
(
c)(
1)
or
(
c)(
2)
of
this
section
must
submit
an
exemption
notice
to
the
EPA
at
least
30
days
before
manufacture
of
the
new
chemical
substance
begins.
The
notice
must
be
sent
in
writing
to:
TSCA
Document
Control
Officer
(
7407),
Office
of
Pollution
Prevention
and
Toxics,
U.
S.
Environmental
Protection
Agency,
Room
G­
099,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460.
The
date
of
submission
will
be
the
date
on
which
the
notice
is
received
by
the
TSCA
Document
Control
Officer.
EPA
will
acknowledge
the
receipt
of
the
notice
by
letter.
The
letter
will
identify
the
date
on
which
the
review
period
begins.
The
notice
shall
be
submitted
using
EPA
Form
No.
7710­
25
("
the
PMN
form"),
which
may
be
obtained
from
EPA
by
writing
the
Environmental
Assistance
Division,
(
7408),
Office
of
Pollution
Prevention
and
Toxics,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460,
or
by
calling
the
TSCA
Assistance
Information
Service
at
(
202)
554­
1404;
TDD
(
202)
554­
0551;
online
service
modem
(
202)
554­
5603.

(
2)
The
notice
shall
contain
the
information
described
below,
pursuant
to
the
referenced
provisions
of
§
720.45.
(
i)
Manufacturer
identity.
(
ii)
Chemical
identity
(
§
720.45(
a)).
(
iii)
Impurities
(
§
720.45(
b)).
(
iv)
Known
synonyms
or
trade
names
(
§
720.45(
c)).
(
v)
Byproducts
(
§
720.45(
d)).
(
vi)
Production
volume
(
§
720.45(
e)).
(
A)
Manufacturers
submitting
an
exemption
application
under
paragraph
(
c)(
1)
of
this
section
will
be
assumed
to
be
manufacturing
at
an
annual
production
volume
of
10,000
kilograms.
Manufacturers
who
intend
to
manufacture
an
exempted
substance
at
annual
volumes
of
less
than
10,000
kilograms
and
wish
EPA
to
conduct
its
risk
assessment
based
upon
such
lesser
annual
production
level
rather
than
a
10,000­
kilograms
level,
may
so
specify
by
writing
the
lesser
annual
production
volume
in
the
appropriate
box
on
the
PMN
form
and
marking
the
adjacent
binding
option
box.
Manufacturers
who
opt
to
specify
annual
production
levels
below
10,000
kilograms
and
who
mark
the
production
volume
binding
option
box
shall
not
manufacture
more
than
the
specific
annual
amount
of
the
exempted
substance
unless
a
new
exemption
notice
for
a
higher
(
up
to
10,000
kgs)
manufacturing
volume
is
submitted
and
approved
pursuant
to
this
section.

(
B)
Manufacturers
submitting
an
exemption
under
paragraph
(
c)(
2)
of
this
section
shall
list
the
estimated
maximum
amount
to
be
manufactured
during
the
first
year
of
production
and
the
estimated
maximum
amount
to
be
manufactured
during
any
12­
month
period
during
the
first
3
years
of
production.
(
vii)
Description
of
intended
categories
of
use
(
§
720.45(
f)).
(
viii)
For
manufacturer­
controlled
sites,
the
manufacturer
shall
supply
identity
of
manufacturing
sites,
process
descriptions,
and
worker
exposure
and
environmental
release
information
(
§
720.45(
g));
for
sites
not
controlled
by
the
manufacturer,
processing
and
use
operation
descriptions,
estimated
number
of
processing
and
use
sites,
and
worker
exposure/
environmental
May
10,
2004
release
information
(
§
720.45(
h)).
A
manufacturer
applying
for
an
exemption
under
paragraph
(
c)(
1)
of
this
section
need
not
provide
information
on
worker
exposure
and
environmental
release
referenced
in
paragraphs
(
e)(
2)(
viii)
of
this
section
if
such
information
is
not
known
or
not
readily
available
to
the
manufacturer.
To
assist
in
reporting
this
information,
manufacturers
may
obtain
a
copy
of
EPA's
Guidance
for
Reporting
Occupational
Exposure
and
Environmental
Release
Information
under
40
CFR
723.50,
available
from
the
Environmental
Assistance
Division
at
the
address
listed
in
paragraph
(
e)(
1)
of
this
section.
Where
worker
exposure
and
environmental
release
information
is
not
supplied
by
the
manufacturer,
EPA
will
generally
apply
"
bounding
estimates"
(
i.
e.,
exposure
estimates
higher
than
those
incurred
by
persons
in
the
population
with
the
highest
exposure)
to
account
for
uncertainties
in
actual
exposure
and
release
scenarios.
(
ix)
Type
and
category
of
notice.
The
manufacturer
must
clearly
indicate
on
the
first
page
of
the
PMN
form
that
the
submission
is
a
"
TSCA
section
5(
h)(
4)
exemption
notice,"
and
must
indicate
whether
the
notice
is
being
submitted
under
paragraph
(
c)(
1)
or
(
c)(
2)
of
this
section.
Manufacturers
of
chemical
substances
that
qualify
for
an
exemption
under
both
paragraph
(
c)(
1)
and
(
c)(
2)
of
this
section
may
apply
for
either
exemption,
but
not
both.
(
x)
Test
data
(
§
720.50).
(
xi)
Certification.
In
addition
to
the
certifications
required
in
EPA
form
7710­
25,
the
following
certifications
shall
be
included
in
notices
under
this
section.
The
manufacturer
must
certify
that:

(
A)
The
manufacturer
intends
to
manufacture
or
import
the
new
chemical
substance
for
commercial
purposes,
other
than
in
small
quantities
solely
for
research
and
development,
under
the
terms
of
this
section.
(
B)
The
manufacturer
is
familiar
with
the
terms
of
this
section
and
will
comply
with
those
terms.
(
C)
The
new
chemical
substance
for
which
the
notice
is
submitted
meets
all
applicable
exemption
conditions.
(
D)
For
substances
manufactured
under
paragraph
(
c)(
1)
of
this
section,
the
manufacturer
intends
to
commence
manufacture
of
the
exempted
substance
for
commercial
purposes
within
1
year
of
the
date
of
the
expiration
of
the
30­
day
review
period.

(
xii)
Sanitized
copy
of
notice.

(
A)
The
manufacturer
must
make
all
claims
of
confidentiality
in
accordance
with
paragraph
(
l)
of
this
section.
If
any
information
is
claimed
confidential,
the
manufacturer
must
submit
a
second
copy
of
the
notice,
with
all
information
claimed
as
confidential
deleted,
in
accordance
with
paragraph
(
l)(
3)
of
this
section.
(
B)
If
the
manufacturer
does
not
provide
the
second
copy,
the
submission
will
be
considered
incomplete.

(
3)
Incomplete
notices.
If
EPA
receives
a
submission
which
does
not
include
all
of
the
information
required
under
this
paragraph
(
e)
of
this
section,
the
submission
will
be
determined
to
be
incomplete
by
EPA.
When
a
submission
for
a
new
chemical
substance
has
been
determined
to
be
incomplete,
a
manufacturer
reapplying
for
an
exemption
for
the
new
chemical
substance
must
submit
a
new
exemption
notice
containing
all
the
information
required
under
this
paragraph
(
e)
of
this
section
including
a
certification
page
containing
an
original
dated
signature;
partial
submissions
sent
to
EPA
to
supplement
notices
declared
incomplete
will
not
be
accepted.
Photocopied
pages
from
previously
submitted
exemption
forms
will
be
accepted
provided
that
the
May
10,
2004
certifications
page
contains
an
original
dated
signature.

(
f)
Multiple
exemption
holders.
(
1)
A
manufacturer
who
intends
to
manufacture
a
substance
for
which
an
exemption
under
this
section
was
previously
approved
may
apply
for
an
exemption
under
paragraph
(
c)(
1)
or
(
c)(
2)
of
this
section;
however,
EPA
will
not
approve
any
subsequent
exemption
application
under
paragraph
(
c)(
1)
of
this
section
unless
it
can
determine
that
the
potential
human
exposure
to,
and
environmental
release
of,
the
new
chemical
substance
at
the
higher
aggregate
production
volume
will
not
present
an
unreasonable
risk
of
injury
to
human
health
or
the
environment.

(
2)(
i)
If
EPA
proposes
to
deny
an
exemption
application
for
a
substance
for
which
another
manufacturer
currently
holds
an
exemption,
and
that
proposed
denial
is
based
exclusively
on
the
cumulative
human
exposure
or
environmental
release
of
the
substance
which
precludes
the
EPA
from
determining
that
the
subsequent
applicant's
activities
will
not
present
an
unreasonable
risk
of
injury
to
human
health
or
the
environment,
the
EPA
will
notify
the
first
exemption
holder
that
it
must,
within
21
days
of
its
receipt
of
EPA's
notice,
either:

(
A)
Provide
a
new
certification
that
it
has
commenced,
or
that
it
will
commence,
manufacture
of
the
new
chemical
substance
under
this
section
within
1
year
of
the
expiration
of
its
exemption
review
period;
or
(
B)
Withdraw
its
exemption
for
the
new
chemical
substance.

(
ii)
If
the
first
exemption
holder
does
not
respond
to
the
EPA's
notice
under
paragraph
(
f)(
2)(
i)
of
this
section
within
the
prescribed
time
period,
EPA
shall
issue
a
notice
of
ineligibility
to
the
first
exemption
holder
under
the
provisions
of
paragraph
(
h)(
2)
of
this
section.

(
g)
Review
period.
(
1)
EPA
will
review
the
notice
submitted
under
paragraph
(
e)
of
this
section
to
determine
whether
manufacture
of
the
new
chemical
substance
is
eligible
for
the
exemption.
The
review
period
will
end
30
days
after
receipt
of
the
notice
by
the
TSCA
Document
Control
Officer.
To
provide
additional
time
to
address
any
unresolved
issues
concerning
an
exemption
application,
the
exemption
applicant
may,
at
any
time
during
the
review
period,
request
a
suspension
of
the
review
period
pursuant
to
the
provisions
of
§
720.75(
b)
of
this
chapter.

(
2)
Upon
expiration
of
the
30­
day
review
period,
if
EPA
has
taken
no
action,
the
manufacturer
may
consider
its
exemption
approved
and
begin
to
manufacture
the
new
chemical
substance
under
the
terms
described
in
its
notice
and
in
this
section.

(
h)
Notice
of
ineligibility
­­
(
1)
During
the
review
period.
If
the
EPA
determines
during
the
review
period
that
manufacture
of
the
new
chemical
substance
does
not
meet
the
terms
of
this
section
or
that
there
are
issues
concerning
toxicity
or
exposure
that
require
further
review
which
cannot
be
accomplished
within
the
30­
day
review
period,
EPA
will
notify
the
manufacturer
by
telephone
that
the
substance
is
not
eligible.
This
telephone
notification
will
subsequently
be
confirmed
by
certified
letter
that
identifies
the
reasons
for
the
ineligibility
determination.
The
manufacturer
may
not
begin
manufacture
of
the
new
chemical
substance
without
complying
with
section
5(
a)(
1)
of
the
Act
or
submitting
a
new
notice
under
paragraph
(
e)
of
this
section
that
satisfies
EPA's
concerns.
May
10,
2004
(
2)
After
the
review
period.
(
i)(
A)
If
at
any
time
after
the
review
period
specified
in
paragraph
(
g)
of
this
section
the
Assistant
Administrator
for
the
Office
of
Prevention,
Pesticides,
and
Toxic
Substances
("
the
Assistant
Administrator")
makes
a
preliminary
determination
that
manufacture
of
the
new
chemical
substance
does
not
meet
the
terms
of
this
section,
the
Assistant
Administrator
will
notify
the
manufacturer
by
certified
letter
that
EPA
believes
that
the
new
chemical
substance
does
not
meet
the
terms
of
the
section.

(
B)
The
manufacturer
may
continue
to
manufacture,
process,
distribute
in
commerce,
and
use
the
substance
after
receiving
the
notice
under
paragraph
(
h)(
2)(
i)(
A)
of
this
section
if
the
manufacturer
was
manufacturing,
processing,
distributing
in
commerce,
or
using
the
substance
at
the
time
of
the
notification
and
if
the
manufacturer
submits
objections
or
an
explanation
under
paragraph
(
h)(
2)(
ii)
of
this
section.
Manufacturers
not
manufacturing,
processing,
distributing
in
commerce,
or
using
the
substance
at
the
time
of
the
notification
may
not
begin
manufacture
until
EPA
makes
its
final
determination
under
paragraph
(
h)(
2)(
iii)
of
this
section.

(
ii)
A
manufacturer
who
has
received
notice
under
paragraph
(
h)(
2)(
i)(
A)
of
this
section
may
submit,
within
15
days
of
receipt
of
written
notification,
detailed
objections
to
the
determination
or
an
explanation
of
its
diligence
and
good
faith
efforts
in
attempting
to
comply
with
the
terms
of
this
section.

(
iii)
The
Assistant
Administrator
will
consider
any
objections
or
explanation
submitted
under
paragraph
(
h)(
2)(
ii)
of
this
section
and
will
make
a
final
determination.
The
Assistant
Administrator
will
notify
the
manufacturer
of
the
final
determination
by
telephone
within
15
days
of
receipt
of
the
objections
or
explanation,
and
subsequently
by
certified
letter.

(
iv)
If
the
Assistant
Administrator
determines
that
manufacture
of
the
new
chemical
substance
meets
the
terms
of
this
section,
the
manufacturer
may
continue
or
resume
manufacture,
processing,
distribution
in
commerce,
and
use
in
accordance
with
the
terms
of
this
section.

(
v)
If
the
Assistant
Administrator
determines
that
manufacture
of
the
new
chemical
substance
does
not
meet
the
terms
of
this
section
and
that
the
manufacturer
did
not
act
with
due
diligence
and
in
good
faith
to
meet
the
terms
of
this
section,
the
manufacturer
must
cease
any
continuing
manufacture,
processing,
distribution
in
commerce,
and
use
of
the
new
chemical
substance
within
7
days
of
the
written
notification
under
paragraph
(
h)(
2)(
iii)
of
this
section.
The
manufacturer
may
not
resume
manufacture,
processing,
distribution
in
commerce,
and
use
of
the
new
chemical
substance
until
it
submits
a
notice
under
section
5(
a)(
1)
of
the
Act
and
part
720
of
this
chapter
and
the
notice
review
period
has
ended.

(
vi)
If
the
Assistant
Administrator
determines
that
manufacture
of
the
new
chemical
substance
does
not
meet
the
terms
of
this
section
and
that
the
manufacturer
acted
with
due
diligence
and
in
good
faith
to
meet
the
terms
of
this
section,
the
manufacturer
may
continue
manufacture,
processing,
distribution
in
commerce,
and
use
of
the
new
chemical
substance
if:

(
A)
It
was
actually
manufacturing,
processing,
distributing
in
commerce,
or
using
the
chemical
substance
at
the
time
it
received
the
notification
specified
in
paragraph
(
h)(
2)(
i)(
A)
of
this
section.

(
B)
It
submits
a
notice
on
the
new
chemical
substance
under
section
5(
a)(
1)
of
the
Act
and
part
May
10,
2004
720
of
this
chapter
within
15
days
of
receipt
of
the
written
notification
under
paragraph
(
h)(
2)(
iii)
of
this
section.
Such
manufacture,
processing,
distribution
in
commerce,
and
use
may
continue
unless
EPA
takes
action
under
section
5(
e)
or
5(
f)
of
the
Act.

(
3)
Action
under
this
paragraph
does
not
preclude
action
under
sections
7,
15,
16,
or
17
of
the
Act.

(
i)
Additional
information.
If
the
manufacturer
of
a
new
chemical
substance
under
the
terms
of
this
exemption
obtains
test
data
or
other
information
indicating
that
the
new
chemical
substance
may
not
qualify
under
terms
of
this
section,
the
manufacturer
must
submit
these
data
or
information
to
EPA
within
15
working
days
of
receipt
of
the
information.
If,
during
the
notice
review
period
specified
in
paragraph
(
g)
of
this
section,
the
submitter
obtains
possession,
control,
or
knowledge
of
new
information
that
materially
adds
to,
changes,
or
otherwise
makes
significantly
more
complete
the
information
included
in
the
notice,
the
submitter
must
send
that
information
to
the
address
listed
on
the
notice
form
within
10
days
of
receiving
the
new
information,
but
no
later
than
5
days
before
the
end
of
the
notice
review
period.
The
new
submission
must
clearly
identify
the
submitter
and
the
exemption
notice
to
which
the
new
information
is
related.
If
the
new
information
becomes
available
during
the
last
5
days
of
the
notice
review
period,
the
submitter
must
immediately
inform
its
EPA
contact
for
that
notice
by
telephone.

(
j)
Changes
in
manufacturing
site,
use,
human
exposure
and
environmental
release
controls,
and
certain
manufacturing
volumes.
(
1)
Except
as
provided
in
paragraph
(
j)(
6)
of
this
section,
chemical
substances
manufactured
under
this
section
must
be
manufactured
at
the
site
or
sites
described,
for
the
uses
described,
and
under
the
human
exposure
and
environmental
release
controls
described
in
the
exemption
notice
under
paragraph
(
e)
of
this
section.

(
2)
Where
the
manufacturer
lists
a
specific
physical
form
in
which
the
new
chemical
substance
will
be
manufactured,
processed,
and/
or
used,
the
manufacturer
must
continue
manufacturing,
processing,
and/
or
using
the
new
chemical
substance
in
either
the
same
physical
form
described
in
the
notice
under
paragraph
(
e),
or
in
a
physical
form
which
will
not
increase
the
human
exposure
to
or
environmental
release
of
the
new
chemical
substance
over
those
exposures
or
releases
resulting
from
the
specified
physical
form
(
e.
g.,
a
manufacturer
which
specifies
that
the
new
chemical
substance
will
be
produced
in
a
non­
volatile
liquid
form
generally
may
not
change
to
a
respirable
powder
form).

(
3)
The
annual
production
volume
of
chemical
substances
manufactured
under
paragraph
(
c)(
1)
of
this
section
for
which
the
manufacturer
designated
a
binding
annual
production
volume
pursuant
to
paragraph
(
e)(
2)(
vi)
of
this
section
must
not
exceed
that
designated
volume.

(
4)
Any
person
who
manufactures
a
new
chemical
substance
under
paragraph
(
c)(
1)
or
(
c)(
2)
of
this
section
must
comply
with
the
provisions
of
this
section,
including
submission
of
a
new
notice
under
paragraph
(
e)
of
this
section,
before:

(
i)
Manufacturing
the
new
chemical
substance
at
a
site
that
was
not
approved
in
a
previous
exemption
notice
for
the
substance,
except
as
provided
in
paragraph
(
j)(
6)
of
this
section.
(
ii)
Manufacturing
the
new
chemical
substance
for
a
use
that
was
not
approved
in
a
previous
May
10,
2004
exemption
notice
for
the
substance.
(
iii)
Manufacturing
the
new
chemical
substance
without
employing
the
human
exposure
and
environmental
release
controls
approved
in
a
previous
exemption
notice
for
the
substance.
(
iv)
Manufacturing
the
new
chemical
substance
in
a
physical
form
different
than
that
physical
form
approved
in
a
previous
exemption
notice
for
the
substance
and
which
form
may
increase
the
human
exposure
to,
or
environmental
release
of,
the
new
chemical
substance
over
those
exposures
or
releases
resulting
from
the
physical
form
approved
in
the
previous
notice.
(
v)
Manufacturing
the
chemical
substance
in
annual
production
volumes
above
any
volume
designated
by
the
manufacturer
as
binding
under
paragraph
(
e)(
2)(
vi)
of
this
section
in
a
previous
exemption
notice
for
the
substance.

(
5)
In
an
exemption
notice
informing
EPA
of
a
change
in
site,
use,
or
worker
protection,
or
environmental
release
controls,
the
manufacturer
is
not
required
to
provide
all
of
the
same
information
submitted
to
EPA
in
a
previous
exemption
notice
for
that
chemical
substance.
The
new
exemption
notice,
however,
must
indicate
the
identity
of
the
new
chemical
substance;
the
manufacturer's
name;
the
name
and
telephone
number
of
a
technical
contact;
and
location
of
the
new
site,
new
worker
protection
or
environmental
release
controls,
and
new
use
information.
The
notice
must
also
include
the
EPA­
designated
exemption
number
assigned
to
the
previous
notice
and
a
new
certification
by
the
manufacturer,
as
described
in
paragraph
(
e)(
2)(
xi)
of
this
section.

(
6)(
i)
A
manufacturer
may,
without
submitting
a
new
notice,
manufacture
the
new
chemical
substance
at
a
site
not
listed
in
its
exemption
application
under
the
following
conditions:

(
A)
the
magnitude,
frequency,
and
duration
of
exposure
of
individual
workers
to
the
new
chemical
substance
at
the
new
manufacturing
site
is
equal
to,
or
less
than,
the
magnitude,
frequency,
and
duration
of
exposure
of
the
individual
workers
to
the
new
chemical
substance
at
the
manufacturing
site
for
which
the
EPA
performed
its
original
risk­
assessment
pursuant
to
the
original
exemption
notice;
and
(
B)
Either
(
1)
at
the
new
manufacturing
site,
the
manufacturer
does
not
release
to
surface
waters
any
of
the
new
chemical
substance,
or
any
waste
streams
containing
the
new
chemical
substance;
or
(
2)
at
the
new
manufacturing
site,
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
at
or
below
an
alternative
concentration
level
approved
by
the
Agency
in
writing
or
under
the
procedures
described
in
paragraph
(
c)(
2)(
iii)
of
this
section,
using
the
water
concentration
calculation
method
described
at
§
§
721.90
and
721.91.

(
ii)
The
manufacturer
shall
notify
EPA
of
any
new
manufacturing
site
no
later
than
30
days
after
the
commencement
of
manufacture
of
the
new
chemical
substance
under
the
exemption
at
the
new
manufacturing
site
as
follows:

(
A)
The
notification
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.
May
10,
2004
(
B)
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.

(
C)
The
notification
must
contain
an
original
signature
of
an
authorized
official
of
the
manufacturer.

(
k)
Customer
notification.
(
1)
Manufacturers
of
new
chemical
substances
described
in
paragraphs
(
c)(
1)
and
(
c)(
2)
of
this
section
must
notify
processors
and
industrial
users
that
the
substance
can
be
used
only
for
the
uses
specified
in
the
exemption
notice
at
paragraph
(
e)
of
this
section.
The
manufacturer
must
also
inform
processors
and
industrial
users
of
any
controls
specified
in
the
exemption
notice.
The
manufacturer
may
notify
processors
and
industrial
users
by
means
of
a
container
labeling
system,
written
notification,
or
any
other
method
that
adequately
informs
them
of
use
restrictions
or
controls.

(
2)
A
manufacturer
of
a
new
chemical
substance
described
in
paragraph
(
c)(
2)
of
this
section
may
distribute
the
chemical
substance
only
to
other
persons
who
agree
in
writing
to
not
further
distribute
the
substance
until
it
has
been
reacted,
incorporated
into
an
article,
or
otherwise
rendered
into
a
physical
form
or
state
in
which
environmental
releases
and
human
exposures
above
the
eligibility
criteria
in
paragraph
(
c)(
2)
of
this
section
are
not
likely
to
occur.

(
3)
If
the
manufacturer
learns
that
a
direct
or
indirect
customer
is
processing
or
using
the
new
substance
in
violation
of
use
restrictions
or
without
imposing
prescribed
worker
protection
or
environmental
release
controls,
the
manufacturer
must
cease
distribution
of
the
substance
to
the
customer
or
the
customer's
supplier
immediately
unless
the
manufacturer
is
able
to
document
each
of
the
following:

(
i)
That
the
manufacturer
has,
within
5
working
days,
notified
the
customer
in
writing
that
the
customer
has
failed
to
comply
with
the
conditions
specified
in
this
section
and
the
exemption
notice
under
paragraph
(
e)
of
this
section.
(
ii)
That,
within
15
working
days
of
notifying
the
customer
of
the
noncompliance,
the
manufacturer
received
from
the
customer,
in
writing,
a
statement
of
assurance
that
the
customer
is
aware
of
the
terms
of
this
section
and
the
exemption
notice
and
will
comply
with
those
terms.

(
4)
If,
after
receiving
a
statement
of
assurance
from
a
customer
under
paragraph
(
k)(
3)(
ii)
of
this
section,
the
manufacturer
obtains
knowledge
that
the
customer
has
again
failed
to
comply
with
any
of
the
conditions
specified
in
this
section
or
the
exemption
notice,
the
manufacturer
shall
cease
supplying
the
new
chemical
substance
to
that
customer
and
shall
report
the
failure
to
comply
to
EPA
within
15
days
of
obtaining
this
knowledge.
Within
30
days
of
its
receipt
of
the
report,
EPA
will
notify
the
manufacturer
whether,
and
under
what
conditions,
distribution
of
the
chemical
substance
to
the
customer
may
resume.

(
l)
Confidentiality.
(
1)
If
the
manufacturer
submits
information
to
EPA
under
this
section
which
the
manufacturer
claims
to
be
confidential
business
information,
the
manufacturer
must
clearly
identify
the
information
at
the
time
of
submission
to
EPA
by
bracketing,
circling,
or
underlining
it
and
stamping
it
with
"
CONFIDENTIAL"
or
some
other
appropriate
designation.
Any
information
so
identified
will
be
treated
in
accordance
with
the
procedures
in
part
2
of
this
chapter.
Any
May
10,
2004
information
not
claimed
confidential
at
the
time
of
submission
may
be
made
available
to
the
public
without
further
notice.

(
2)(
i)
Any
person
who
asserts
a
claim
of
confidentiality
for
chemical
identity
under
this
paragraph
(
l)
must
provide
a
generic
chemical
name
that
is
only
as
generic
as
necessary
to
protect
the
confidential
chemical
identity
of
the
particular
chemical
substance.
The
name
should
reveal
the
specific
chemical
identity
to
the
maximum
extent
possible.

(
ii)
The
generic
name
provided
by
the
manufacturer
will
be
subject
to
EPA
review
and
approval
in
accordance
with
the
procedures
specified
in
§
720.85(
b)(
6)
of
this
chapter.
The
generic
name
provided
by
the
submitter
or
an
alternative
selected
by
EPA
under
these
procedures
will
be
placed
on
a
public
list
of
substances
exempt
under
this
section.

(
3)
If
any
information
is
claimed
confidential,
the
manufacturer
must
submit
a
second
copy
of
the
notice
with
all
information
claimed
as
confidential
deleted.
EPA
will
place
the
second
copy
in
the
public
file.

(
m)
Exemptions
granted
under
superseded
regulations.
Manufacturers
holding
exemptions
granted
under
the
superseded
requirements
of
this
section
(
as
in
effect
on
May
26,
1995)
shall
either
continue
to
comply
with
those
requirements
(
including
the
production
volume
limit)
or
apply
for
a
new
exemption
pursuant
to
this
section.
EPA
will
not
accept
requests
to
amend
exemptions
granted
under
the
superseded
requirements;
manufacturers
wishing
to
amend
such
exemptions
must
submit
a
new
exemption
under
paragraph
(
e)
of
this
section.
If
a
new
exemption
for
a
new
chemical
substance
is
granted
under
this
exemption
to
the
manufacturer
holding
an
exemption
under
the
superseded
requirements,
the
exemption
under
the
superseded
requirements
for
such
substance
shall
be
void.

(
n)
Recordkeeping.
(
1)
A
manufacturer
of
a
new
chemical
substance
under
paragraph
(
c)
of
this
section
must
maintain
the
records
described
in
this
paragraph
at
the
manufacturing
site
or
site
of
importation
for
a
period
of
5
years
after
their
preparation.

(
2)
The
records
must
include
the
following
to
demonstrate
compliance
with
this
section:

(
i)
Records
of
annual
production
volume
and
import
volume.
(
ii)
Records
documenting
compliance
with
the
applicable
requirements
and
restrictions
of
paragraphs
(
c),
(
e),
(
f),
(
h),
(
i),
(
j),
and
(
k)
of
this
section.

(
3)
Any
person
who
manufactures
a
new
chemical
substance
under
the
terms
of
this
section
must,
upon
request
of
a
duly
designated
representative
of
EPA,
permit
such
person
at
all
reasonable
times
to
have
access
to
and
to
copy
records
kept
under
paragraph
(
n)(
2)
of
this
section.

(
4)
The
manufacturer
must
submit
the
records
listed
in
paragraph
(
n)(
2)
of
this
section
to
EPA
upon
request.
Manufacturers
must
provide
these
records
within
15
working
days
of
receipt
of
such
request.

(
o)
Compliance.
(
1)
Failure
to
comply
with
any
provision
of
this
section
is
a
violation
of
section
15
of
the
Act
(
15
U.
S.
C.
2614).
May
10,
2004
(
2)
Submitting
materially
misleading
or
false
information
in
connection
with
the
requirements
of
any
provision
of
this
section
is
a
violation
of
this
section
and
therefore
a
violation
of
section
15
of
the
Act
(
15
U.
S.
C.
2614).

(
3)
Violators
may
be
subject
to
the
civil
and
criminal
penalties
in
section
16
of
the
Act
(
15
U.
S.
C.
2615)
for
each
violation.

(
4)
EPA
may
seek
to
enjoin
the
manufacture
or
processing
of
a
chemical
substance
in
violation
of
this
section,
or
act
to
seize
any
chemical
substance
manufactured
or
processed
in
violation
of
this
section,
or
take
other
action
under
the
authority
of
section
7
of
the
Act
(
15
U.
S.
C.
2606)
or
section
17
of
the
Act
(
15
U.
S.
C.
1616).

[
60
FR
16346,
Mar.
29,
1995,
as
amended
at
60
FR
34465,
July
3,
1995;
62
FR
17932,
April
11,
1997;
64
FR
31989,
June
15,
1999]

§
723.175
Chemical
substances
used
in
or
for
the
manufacture
or
processing
of
instant
photographic
and
peel­
apart
film
articles.

(
a)
Purpose
and
scope.
(
1)
This
section
grants
an
exemption
from
the
premanufacture
notice
requirements
of
section
5(
a)(
1)(
A)
of
the
Toxic
Substances
Control
Act
(
15
U.
S.
C.
2604(
a)(
1)(
A))
for
the
manufacture
and
processing
of
new
chemical
substances
used
in
or
for
the
manufacture
or
processing
of
instant
photographic
and
peel­
apart
film
articles.
This
section
does
not
apply
to
microorganisms
subject
to
part
725
of
this
chapter.

(
2)
To
manufacture
a
new
chemical
substance
under
the
terms
of
this
exemption,
a
manufacturer
of
instant
photographic
or
peel­
apart
film
articles
must:

(
i)
Submit
an
exemption
notice
when
manufacture
begins
under
paragraph
(
i)
of
this
section.
(
ii)
Comply
with
certain
requirements
to
limit
exposure
to
the
new
chemical
substance
under
paragraphs
(
e),
(
f),
(
g),
and
(
h)
of
this
section.
(
iii)
Comply
with
all
recordkeeping
requirements
under
paragraph
(
j)
of
this
section.

(
b)
Definitions.
(
1)
Act
means
the
Toxic
Substances
Control
Act
(
15
U.
S.
C.
2601
et
seq.).

(
2)
An
article
is
a
manufactured
item
(
i)
which
is
formed
to
a
specific
shape
or
design
during
manufacture,
(
ii)
which
has
end
use
function(
s)
dependent
in
whole
or
in
part
upon
its
shape
or
design
during
end
use,
and
(
iii)
which
has
either
no
change
of
chemical
composition
during
its
end
use
or
only
those
changes
of
composition
which
have
no
commercial
purpose
separate
from
that
of
the
article
and
that
may
occur
as
described
in
§
710.2
of
this
chapter
except
that
fluids
and
particles
are
not
considered
articles
regardless
of
shape
or
design.

(
3)
The
terms
byproduct,
EPA,
impurities,
person,
and
site
have
the
same
meanings
as
in
§
710.3
of
this
chapter.

(
4)
The
term
category
of
chemical
substances
has
the
same
meaning
as
in
section
26(
c)(
2)
of
the
Act
(
15
U.
S.
C.
2625).
May
10,
2004
(
5)
The
terms
chemical
substance,
distribute
in
commerce,
distribution
in
commerce,
environment,
manufacture,
new
chemical
substance,
and
process
have
the
same
meanings
as
in
section
3
of
the
Act
(
15
U.
S.
C.
2602).

(
6)
Director
of
the
Office
of
Pollution
Prevention
and
Toxics
means
the
Director
of
the
EPA
Office
of
Pollution
Prevention
and
Toxics
or
any
EPA
employee
designated
by
the
Office
Director
to
carry
out
the
Office
Director's
functions
under
this
section.

(
7)
The
term
exemption
category
means
a
category
of
chemical
substances
for
which
a
person(
s)
has
applied
for
or
been
granted
an
exemption
under
section
5(
h)(
4)
of
the
Act
(
15
U.
S.
C.
2604).

(
8)
The
term
instant
photographic
film
article
means
a
self­
developing
photographic
film
article
designed
so
that
all
the
chemical
substances
contained
in
the
article,
including
the
chemical
substances
required
to
process
the
film,
remain
sealed
during
distribution
and
use.

(
9)
Intermediate
means
any
chemical
substance
which
is
consumed
in
whole
or
in
part
in
a
chemical
reaction(
s)
used
for
the
intentional
manufacture
of
another
chemical
substance.

(
10)
Known
to
or
reasonably
ascertainable
means
all
information
in
a
person's
possession
or
control,
plus
all
information
that
a
reasonable
person
similarly
situated
might
be
expected
to
possess,
control,
or
know,
our
could
obtain
without
unreasonable
burden
or
cost.

(
11)
The
term
peel­
apart
film
article
means
a
self­
developing
photographic
film
article
consisting
of
a
positive
image
receiving
sheet,
a
light
sensitive
negative
sheet,
and
a
sealed
reagent
pod
containing
a
developer
reagent
and
designed
so
that
all
the
chemical
substances
required
to
develop
or
process
the
film
will
not
remain
sealed
within
the
article
during
and
after
the
development
of
the
film.

(
12)
Photographic
article
means
any
article
which
will
become
a
component
of
an
instant
photographic
or
peel­
apart
film
article.

(
13)
Special
production
area
means
a
demarcated
area
within
which
all
manufacturing,
processing,
and
use
of
a
new
chemical
substance
takes
place,
except
as
provided
in
paragraph
(
f)
of
this
section,
in
accordance
with
the
requirements
of
paragraph
(
e)
of
this
section.

(
14)
Test
data
means:

(
i)
Data
from
a
formal
or
informal
study,
test,
experiment,
recorded
observation,
monitoring,
or
measurement.
(
ii)
Information
concerning
the
objectives,
experimental
methods
and
materials,
protocols,
results,
data
analyses
(
including
risk
assessments),
and
conclusions
from
a
study,
test,
experiment,
recorded
observation,
monitoring,
or
measurement.

(
15)
Used
in
or
for
the
manufacturing
or
processing
of
an
instant
photographic
or
peel­
apart
film
article,
when
used
to
describe
activities
involving
a
new
chemical
substance,
means
the
new
chemical
substance
(
i)
is
included
in
the
article,
or
(
ii)
is
an
intermediate
to
a
chemical
substance
included
in
the
article
or
is
one
of
a
series
of
intermediates
used
to
manufacture
a
chemical
May
10,
2004
substance
included
in
the
article.

(
16)
Wet
mixture
means
a
water
or
organic
solvent­
based
suspension,
solution,
dispersion,
or
emulsion
used
in
the
manufacture
of
an
instant
photographic
or
peel­
apart
film
article.

(
c)
Exemption
category.
The
exemption
category
includes
new
chemical
substances
used
in
or
for
the
manufacture
or
processing
of
instant
photographic
or
peel­
apart
film
articles
which
are
manufactured
and
processed
under
the
terms
of
this
section.

(
d)
Applicability.
This
exemption
applies
only
to
manufacturers
of
instant
photographic
or
peel­
apart
film
articles
who:

(
1)
Manufacture
the
new
chemical
substances
used
in
or
for
the
manufacture
or
processing
of
the
instant
photographic
or
peel­
apart
film
articles.

(
2)
Limit
manufacture
and
processing
of
a
new
chemical
substance
to
the
site(
s)
listed
in
the
exemption
notice
for
that
new
chemical
substance
submitted
under
paragraph
(
i)
of
this
section.

(
3)
Comply
with
the
requirements
of
paragraphs
(
e),
(
f),
(
g),
(
h),
and
(
j)
of
this
section.

(
4)
Do
not
distribute
in
commerce
or
use
a
peel­
apart
film
article
containing
a
new
chemical
substance
until
submission
of
a
premanufacture
notice
under
section
5(
a)(
1)(
A)
of
the
Act
(
15
U.
S.
C.
2604)
and
until
the
review
period
for
the
notice
has
ended
without
EPA
action
to
prevent
distribution
or
use.

(
e)
Conditions
of
manufacture
and
processing
in
the
special
production
area.
All
manufacturing,
processing,
and
use
operations
involving
the
new
chemical
substance
must
be
performed
in
a
special
production
area
under
the
conditions
set
forth
in
this
paragraph
until
the
new
chemical
substance
has
been
incorporated
into
a
wet
mixture,
photographic
article,
or
instant
photographic
or
peel­
apart
film
article.

(
1)
Exposure
limits.
In
the
special
production
area,
the
ambient
air
concentration
of
the
new
chemical
substance
during
manufacture,
processing,
and
use
cannot
exceed
an
8­
hour
time
weighted
average
(
TWA)
of
10
ppm
for
gases
and
vapors
and
50
&
mu;
g/
m
3
for
particulates,
with
an
allowable
TWA
excursion
of
50
percent
above
those
concentrations
for
a
duration
of
30
minutes
or
less.

(
2)
Respiratory
protection
­­
(
i)
Respirator
requirement.
Except
as
specified
in
paragraph
(
e)(
2)(
ii)
of
this
section,
each
person
in
the
special
production
area
must
wear
an
appropriate
respiratory
protection
device
to
protect
against
dusts,
fumes,
vapors,
and
other
airborne
contaminants,
as
described
in
29
CFR
1910.134.
Selection
of
an
appropriate
respirator
must
be
made
according
to
the
guidance
of
American
National
Standard
Practices
for
Respiratory
Protection
Z88.2­
1969
and
the
NIOSH
Certified
Equipment
List,
U.
S.
Department
of
Health
and
Human
Services,
NIOSH
publication
No.
80­
144.

(
ii)
Waiver
of
respirator
requirement.
Employees
are
not
required
to
wear
respirators
if
monitoring
information
collected
and
analyzed
in
accordance
with
paragraph
(
e)(
3)
of
this
section
May
10,
2004
demonstrates
that
the
ambient
8­
hour
TWA
concentration
of
the
new
chemical
substance
in
the
area
is
less
than
1
ppm
for
gases
and
vapors
and
5
&
mu;
g/
m
3
for
particulates
with
an
allowable
TWA
excursion
of
50
percent
above
these
concentrations
for
a
duration
of
30
minutes
or
less.

(
iii)
Quantitative
fit
test.
Each
respirator
must
be
issued
to
a
specific
individual
for
personal
use.
A
quantitative
fit
test
must
be
performed
for
each
respirator
before
its
first
use
by
that
person
in
a
special
production
area.

(
3)
Monitoring
­­
(
i)
When
to
monitor.
(
A)
When
suitable
sampling
and
analytic
methods
exist,
periodic
monitoring
in
accordance
with
this
paragraph
must
be
done
to
ensure
compliance
with
the
exposure
limits
of
paragraphs
(
e)(
1)
and
(
2)(
ii)
of
this
section.

(
B)
When
suitable
sampling
and
analytic
methods
do
not
exist,
compliance
with
the
exposure
limits
of
paragraph
(
e)(
1)
and
the
requirements
of
paragraph
(
e)(
10)
of
this
section
must
be
determined
by
an
evaluation
of
monitoring
data
developed
for
a
surrogate
chemical
substance
possessing
comparable
physical­
chemical
properties
under
similar
manufacturing
and
processing
conditions.

(
ii)
Monitoring
methods.
A
suitable
air
sampling
method
must
permit
personal
or
fixed
location
sampling
by
conventional
collection
methods.
A
suitable
analytic
method
must
have
adequate
sensitivity
for
the
volume
of
sample
available
and
be
specific
for
the
new
chemical
substance
being
monitored.
If
chemical­
specific
monitoring
methods
are
not
available,
nonspecific
methods
may
be
used
if
the
concentration
of
the
new
chemical
substance
is
assumed
to
be
the
total
concentration
of
chemical
substances
monitored.

(
iii)
Monitoring
frequency.
(
A)
When
suitable
air
sampling
and
analytical
procedures
are
available,
monitoring
must
be
done
in
each
special
production
area
during
the
first
three
8­
hour
work
shifts
involving
the
manufacture
or
processing
of
each
new
chemical
substance.
Thereafter,
monitoring
must
be
done
in
each
special
production
area
for
at
least
one
8­
hour
period
per
month,
during
a
production
run
in
which
the
new
chemical
substance
is
manufactured
or
processed.
Samples
must
be
of
such
frequency
and
pattern
as
to
represent
with
reasonable
accuracy
the
mean
level
and
maximum
30­
minute
level
of
employee
exposure
during
an
8­
hour
work
shift.
In
monitoring
for
an
8­
hour
work
shift
or
the
equivalent,
samples
must
be
collected
periodically
or
continuously
for
the
duration
of
the
8­
hour
work
shift.
Samples
must
be
taken
during
a
period
which
is
likely
to
represent
the
maximum
employee
exposure.

(
B)
If
the
manufacturer
demonstrates
compliance
with
the
exposure
limits
for
3
consecutive
months,
further
monitoring
of
the
identical
process
must
be
performed
only
every
6
months
thereafter,
unless
there
is
a
significant
change
in
the
process,
process
design,
or
equipment.
If
there
is
such
a
change,
the
manufacturer
must
begin
monitoring
again
according
to
the
schedule
in
paragraph
(
e)(
3)(
iii)(
A)
of
this
section.

(
iv)
Location
of
monitoring.
Air
samples
must
be
taken
so
as
to
ensure
that
the
samples
adequately
represent
the
ambient
air
concentration
of
a
new
chemical
substance
present
in
each
worker's
breathing
zone.
May
10,
2004
(
4)
Engineering
controls
and
exposure
safeguards.
Engineering
controls
such
as,
but
not
limited
to,
isolation,
enclosure,
local
exhaust
ventilation,
and
dust
collection
must
be
used
to
ensure
compliance
with
the
exposure
limits
prescribed
in
paragraphs
(
e)(
1)
or
(
e)(
2)(
ii)
of
this
section.

(
5)
Training,
hygiene,
and
work
practices
­­
(
i)
Training.
No
employee
may
enter
a
special
production
area
before
the
completion
of
a
training
program.
The
training
program
must
be
adapted
to
the
individual
circumstances
of
the
manufacturer
and
must
address:
The
known
physical­
chemical
and
toxicological
properties
of
the
chemical
substances
handled
in
the
area;
procedures
for
using
and
maintaining
respirators
and
other
personal
safeguards;
applicable
principles
of
hygiene;
special
handling
procedures
designed
to
limit
personal
exposure
to,
and
inadvertent
release
of,
chemical
substances;
and
procedures
for
responding
to
emergencies
or
spills.

(
ii)
Hygiene.
Appropriate
standards
of
hygiene
must
be
observed
by
all
employees
handling
a
new
chemical
substance
in
manufacturing,
processing,
or
transfer
operations.
The
manufacturer
must
provide
appropriate
facilities
for
employee
changing
and
wash­
up.
Food,
beverages,
tobacco
products,
and
cosmetics
must
not
be
allowed
in
special
production
areas.

(
iii)
Work
practices.
Operating
procedures
such
as
those
related
to
chemical
weighing
and
filtering,
or
the
charging,
discharging
and
clean­
up
of
process
equipment,
must
be
designed
and
conducted
to
ensure
compliance
with
the
exposure
limits
prescribed
in
paragraph
(
e)(
1)
or
(
e)(
2)(
ii)
of
this
section.
Written
procedures
and
all
materials
necessary
for
responding
to
emergency
situations
must
be
immediately
accessible
to
all
employees
in
a
special
production
area.
Any
spill
or
unanticipated
emission
must
be
controlled
by
specially
trained
personnel
using
the
equipment
and
protective
clothing
described
in
paragraph
(
e)(
6)
of
this
section.

(
6)
Personal
protection
devices.
All
workers
engaged
in
the
manufacture
and
processing
of
a
new
chemical
substance
in
the
special
production
area
must
wear
suitable
protective
clothing
or
equipment,
such
as
chemical­
resistant
coveralls,
protective
eyewear,
and
gloves.

(
7)
Caution
signs.
Each
special
production
area
must
be
clearly
posted
with
signs
identifying
the
area
as
a
special
production
area
where
new
chemical
substances
are
manufactured
and
processed
under
controlled
conditions.
Each
sign
must
clearly
restrict
entry
into
the
special
production
area
to
qualified
personnel
who
are
properly
trained
and
equipped
with
appropriate
personal
exposure
safeguards.

(
8)
Removal
for
storage
or
transportation.
A
new
chemical
substance
that
is
not
incorporated
into
a
wet
mixture,
photographic
article,
or
instant
photographic
or
peel­
apart
film
article
may
be
removed
from
the
special
production
area
for
purposes
of
storage
between
operational
steps
or
for
purposes
of
transportation
to
another
special
production
area.
Such
storage
or
transportation
must
be
conducted
in
a
manner
that
limits
worker
and
environmental
exposure
through
the
use
of
engineering
controls,
training,
hygiene,
work
practices,
and
personal
protective
devices
appropriate
to
the
chemical
substance
in
question.

(
9)
Labeling.
(
i)
Any
new
chemical
substance
removed
from
a
special
production
area
or
stored
or
transported
between
operational
steps
must
be
clearly
labeled.
The
label
must
show
the
identity
of
the
new
chemical
substance
or
an
appropriate
identification
code,
a
statement
of
any
known
May
10,
2004
hazards
associated
with
it,
a
list
of
special
handling
instructions,
first
aid
information,
spill
control
directions,
and
where
applicable,
the
appropriate
U.
S.
Department
of
Transportation
notations.

(
ii)
No
label
is
required
if
the
new
chemical
substance
has
been
incorporated
into
a
photographic
article,
or
if
it
is
contained
in
a
sealed
reaction
vessel
or
pipeline,
or
if
it
has
been
incorporated
into
an
instant
photographic
or
peel­
apart
film
article.

(
10)
Areas
immediately
adjacent
to
the
special
production
area.
The
ambient
air
concentration
of
the
new
chemical
substance
in
areas
immediately
adjacent
to
the
special
production
area
must
not
exceed
the
exposure
limit
established
in
paragraph
(
e)(
2)(
ii)
of
this
section
for
waiver
of
respirator
protection
within
the
special
production
area.
Periodic
monitoring
in
accordance
with
paragraph
(
e)(
3)
of
this
section
must
be
performed
in
immediately
adjacent
areas
where
it
is
reasonable
to
expect
a
risk
of
inhalation
exposure.

(
f)
Conditions
of
processing
outside
the
special
production
area.
A
wet
mixture
may
be
incorporated
into
a
photographic
article
or
an
instant
photographic
or
peel­
apart
film
article
outside
the
special
production
area
under
the
conditions
listed
in
this
paragraph:

(
1)
Engineering
controls
and
exposure
safeguards.
Engineering
controls
must
limit
the
exposure
to
a
new
chemical
substance
contained
in
a
wet
mixture.

(
2)
Training,
hygiene
and
work
practices
­­
(
i)
Training.
Training
of
employees
involved
in
the
handling
of
wet
mixtures
containing
a
new
chemical
substance
must
be
adapted
to
the
individual
circumstances
of
the
employees'
activities
and
must
address:
Procedures
for
using
personal
exposure
safeguards,
applicable
principles
of
hygiene,
handling
procedures
designed
to
limit
personal
exposure,
and
procedures
for
responding
to
emergencies
and
spills.

(
ii)
Hygiene.
Appropriate
standards
of
hygiene
that
limit
exposure
must
be
observed
by
all
employees
handling
wet
mixtures
that
contain
new
chemical
substances.

(
iii)
Work
practices.
Work
practices
and
operating
procedures
must
be
designed
to
limit
exposure
to
any
new
chemical
substance
contained
in
wet
mixtures.
Any
spills
or
unanticipated
releases
of
a
wet
mixture
must
be
controlled
by
trained
personnel
wearing
appropriate
protective
clothing
or
equipment
such
as
gloves,
eye
protection,
and,
where
necessary,
respirators
or
chemically
imprevious
clothing.

(
3)
Personal
protection
devices.
All
workers
engaged
in
the
processing
of
a
wet
mixture
containing
a
new
chemical
substance
must
wear
suitable
protective
clothing
or
equipment
such
as
coveralls,
protective
eyewear,
respirators,
and
gloves.

(
g)
Incorporation
of
photographic
articles
into
instant
photographic
and
peel­
apart
film
articles.
A
photographic
article
may
be
incorporated
into
the
instant
photographic
or
peel­
apart
film
article
outside
the
special
production
area.
The
manufacturer
must
take
measures
to
limit
worker
and
environmental
exposure
to
new
chemical
substances
during
these
operations
using
engineering
controls,
training,
hygiene,
work
practices,
and
personal
protective
devices.

(
h)
Environmental
release
and
waste
treatment
­­
(
1)
Release
to
land.
Process
waste
from
May
10,
2004
manufacturing
and
processing
operations
in
the
special
production
area
that
contain
a
new
chemical
substance
are
considered
to
be
hazardous
waste
and
must
be
handled
in
accordance
with
the
requirements
of
parts
262
through
267
and
parts
122
and
124
of
this
chapter.

(
2)
Release
to
water.
All
wastewater
or
discharge
which
contain
the
new
chemcial
subtance
must
be
appropriately
pretreated
before
release
to
a
Publicly
Owned
Treatment
Works
(
POTW)
or
other
receiving
body
of
water.
In
the
case
of
release
to
a
POTW,
the
pretreatment
must
prevent
structural
damage
to,
obstruction
of,
or
interference
with
the
operation
of
the
POTW.
The
treatment
of
direct
release
to
a
receiving
body
of
water
must
be
appropriate
for
the
new
chemical
substance's
physical­
chemical
properties
and
potential
toxicity.

(
3)
Release
to
air.
All
process
emissions
released
to
the
air
which
contain
the
new
chemical
substance
must
be
vented
through
control
devices
appropriate
for
the
new
chemical
substance's
physical­
chemical
properties
and
potential
toxicity.

(
i)
Exemption
notice.
An
exemption
notices
must
be
submitted
to
EPA
when
manufacture
of
the
new
chemical
substance
begins.

(
1)
Contents
of
exemption
notice.
The
exemption
notice
must
include
the
following
information:

(
i)
Manufacturer
and
sites.
The
notice
must
identify
the
manufacturer
and
the
sites
and
locations
where
the
new
chemical
substance
and
the
instant
photographic
or
peel­
apart
film
articles
will
be
manufactured
and
processed.

(
ii)
Chemical
identification.
The
notice
must
identify
the
new
chemical
substance
as
follows:

(
A)
Class
1
substances.
For
chemical
substances
whose
composition
can
be
represented
by
a
definite
structural
diagram
(
Class
1
substances),
the
notice
must
provide
the
chemical
name
(
preferably
CAS
or
IUPAC
nomenclature),
the
molecular
formula,
CAS
Registry
Number
(
if
available),
known
synonyms
(
including
trade
names),
and
a
structural
diagram.

(
B)
Class
2
substances.
For
chemical
substances
that
cannot
be
fully
represented
by
a
structural
diagram,
(
Class
2
substances),
the
notice
must
provide
the
chemical
name,
the
molecular
formula,
the
CAS
Registry
Number
(
if
available),
and
known
synonyms
(
including
trade
names).
The
notice
must
identify
the
immediate
precursors
and
reactants
by
name
and
CAS
Registry
Number
(
if
available).
The
notice
must
include
a
partial
or
incomplete
structural
diagram,
if
available.

(
C)
Polymers.
For
a
polymer,
the
notice
must
indentify
monomers
and
other
reactants
used
in
the
manufacture
of
the
polymer
by
chemical
name
and
CAS
Registry
Number.
The
notice
must
indicate
the
amount
of
each
monomer
used
(
by
weight
percent
of
total
monomer);
the
maximum
residual
of
each
monomer
present
in
the
polymer;
and
a
partial
or
incomplete
structural
diagram,
if
available.
The
notice
must
indicate
the
number
average
molecular
weight
of
the
polymer
and
characterize
the
anticipated
low
molecular
weight
species.
The
notice
must
include
this
information
for
each
typical
average
molecular
weight
composition
of
the
polymer
to
be
manufactured.

(
iii)
Impurities.
The
notice
must
identify
the
impurities
that
can
be
reasonably
anticipated
to
be
May
10,
2004
present
in
the
new
chemical
substance
when
manufactured
under
the
exemption
by
name
and
CAS
Registry
Number,
by
class
of
substances,
or
by
process
or
source.
The
notice
also
must
estimate
the
maximum
percent
(
by
weight)
of
each
impurity
in
the
new
chemical
substance
and
the
percent
of
unknown
impurities
present.

(
iv)
Physical­
chemical
properties.
The
notice
must
describe
the
physical­
chemical
properties
of
the
new
chemical
substance.
Where
specific
physical­
chemical
data
are
not
available,
reasonable
estimates
and
the
techniques
used
to
develop
these
estimates
must
be
provided.

(
v)
Byproducts.
The
notice
must
identify
the
name,
CAS
Registry
number
(
if
available),
and
the
volume
of
each
byproduct
that
would
be
manufactured
during
manufacture
of
the
new
chemical
substance.

(
vi)
Production
volume.
The
notice
must
include
an
estimate
of
the
anticipated
maximum
annual
production
volume.

(
vii)
Test
data.
The
notice
must
include
all
information
and
test
data
on
the
new
chemical
substance's
health
and
environmental
effects
that
are
known
to
or
reasonably
ascertainable
by
the
manufacturer.

(
viii)
Identity
of
the
article.
The
notice
must
identify
and
describe
the
instant
photographic
film
article(
s)
or
peel­
apart
film
article(
s)
that
will
contain
the
new
chemical
substance.

(
ix)
Release
to
water.
The
notice
must
include
a
description
of
the
methods
used
to
control
and
treat
wastewater
or
discharge
released
to
a
POTW
or
other
receiving
body
of
water.
The
notice
must
also
identify
the
POTW
or
receiving
body
of
water.

(
x)
Certification.
The
manufacturer
must
certify
in
the
notice
that
it
is
familiar
with
the
terms
of
the
exemption
and
that
the
manufacture,
processing,
distribution,
use,
and
disposal
of
the
new
chemical
substance
will
comply
with
those
terms.

(
2)
Duplication
of
information
in
premanufacture
notice.
If
a
manufacturer
who
submits
an
exemption
notice
under
this
paragraph
has
already
submitted,
or
simultaneously
submits,
a
premanufacture
notice
under
section
5(
a)(
1)(
A)
of
the
Act
for
the
new
chemical
substance,
it
may,
in
lieu
of
submitting
the
information
required
by
this
paragraph,
reference
the
required
information
to
the
extent
it
is
included
in
the
premanufacture
notice.
At
a
minimum,
the
exemption
notice
must
identify
the
manufacturer
and
the
new
chemical
substance,
and
contain
the
certification
required
by
paragraph
(
i)(
1)(
x)
of
this
section.

(
3)
Address.
The
exemption
notice
must
be
addressed
to
the
Document
Control
Office
(
7407),
Office
of
Pollution
Prevention
and
Toxics,
U.
S.
Environmental
Protection
Agency,
Room
G­
099,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460.

(
j)
Recordkeeping.
(
1)
Manufacturers
of
a
new
chemical
substance
under
this
exemption
must
keep
the
following
records
for
30
years
from
the
final
date
of
manufacture.
(
i)
Production
records.
Each
manufacturer
must
maintain
records
of
the
annual
production
volume
of
each
new
chemical
substance
manufactured
under
the
terms
of
the
exemption.
This
May
10,
2004
record
must
indicate
when
manufacture
of
the
new
chemical
substance
began.
(
ii)
Exposure
monitoring
records.
Manufacturers
must
maintain
an
accurate
record
of
all
monitoring
required
by
this
section.
Monitoring
records
may
be
adapted
to
the
individual
circumstances
of
the
manufacturer
but,
at
a
minimum,
must
contain
the
following
information:
The
chemical
identity
of
the
new
chemical
substance,
date
of
the
monitoring,
the
actual
monitoring
data
for
each
monitoring
location
and
sampling,
and
a
reference
to
or
description
of
the
collection
and
analytic
techniques.
If
the
manufacturer
does
not
monitor,
the
manufacturer
must
maintain
a
record
of
the
reasons
for
not
monitoring
and
the
methods
used
to
determine
compliance
with
the
exposure
limits
of
paragraph
(
e)(
1)
of
this
section.
(
iii)
Training
and
exposure
records.
For
each
employee
engaged
in
the
manufacture
or
processing
of
a
new
chemical
substance,
the
company
must
develop
and
maintain
a
record
of
the
worker's
participation
in
required
training.
This
record
must
also
demonstrate
the
regular
use
of
personal
exposure
safeguards,
including
the
results
of
any
personal
exposure
monitoring,
the
results
of
the
quantitative
fit
test
for
the
worker's
personal
respirator,
and
any
additional
information
related
to
the
worker's
occupational
exposure.
(
iv)
Treatment
records.
Manufacturers
who
release
treated
wastewater
or
discharge
containing
a
new
chemical
substance
to
a
POTW
or
other
receiving
body
of
water
must
maintain
records
of
the
method
of
treatment.

(
2)
The
manufacturer
must
make
the
records
listed
in
paragraph
(
j)(
1)
of
this
section
available
to
EPA
upon
written
request
by
the
Director
of
the
Office
of
Pollution
Prevention
and
Toxics.
The
manufacturer
must
provide
these
records
within
15
working
days
of
receipt
of
this
request.

(
k)
Confidentiality.
If
the
manufacturer
submits
information
under
paragraph
(
i)
or
(
j)
of
this
section
which
it
claims
to
be
confidential
business
information,
the
manufacturer
must
clearly
identify
the
information
at
the
time
of
submission
to
the
Agency
by
bracketing,
circling,
or
underlining
it
and
stamping
it
with
"
CONFIDENTIAL"
or
some
other
appropriate
designation.
Any
information
so
identified
will
be
treated
in
accordance
with
the
procedures
in
part
2
of
this
chapter.
Any
information
not
claimed
confidential
at
the
time
of
submission
will
be
made
available
to
the
public
without
further
notice
to
the
submitter.

(
l)
Amendment
and
repeal.
(
1)
EPA
may
amend
or
repeal
any
term
of
this
exemption
if
it
determines
that
the
manufacture,
processing,
distribution,
use,
and
disposal
of
new
chemical
substances
under
the
terms
of
the
exemption
may
present
an
unreasonable
risk
of
injury
to
health
or
the
environment.
EPA
also
may
amend
this
exemption
to
enlarge
the
exemption
category
or
to
reduce
the
restrictions
or
conditions
of
the
exemption.

(
2)
As
required
by
section
5(
h)(
4)
of
the
Act,
EPA
will
amend
or
repeal
the
substantive
terms
of
an
exemption
granted
under
this
part
only
by
the
formal
rulemaking
procedures
described
in
section
6(
c)(
2)
and
(
3)
of
the
Act
(
15
U.
S.
C.
2605(
c)).

(
m)
Prohibition
of
use
of
the
exemption.
The
Director
of
the
Office
of
Pollution
Prevention
and
Toxics
may
prohibit
the
manufacture,
processing,
distribution,
use,
or
disposal
of
any
new
chemical
substance
under
the
terms
of
this
exemption
if
he
or
she
determines
that
the
manufacture,
processing,
distribution
in
commerce,
use,
or
disposal
of
the
new
chemical
substance
may
present
an
unreasonable
risk
of
injury
to
health
or
the
environment.
May
10,
2004
(
n)
Enforcement.
(
1)
A
failure
to
comply
with
any
provision
of
this
part
is
a
violation
of
section
15
of
the
Act
(
15
U.
S.
C.
2614).

(
2)
Submitting
materially
misleading
or
false
information
in
connection
with
the
requirements
of
any
provision
of
this
part
is
a
violation
of
this
regulation
and
therefore
a
violation
of
section
15
of
the
Act
(
15
U.
S.
C.
2614).

(
3)
Violators
may
be
subject
to
the
civil
and
criminal
penalties
in
section
16
of
the
Act
(
15
U.
S.
C.
2615)
for
each
violation.

(
4)
EPA
may
seek
to
enjoin
the
manufacture
of
a
new
chemical
substance
in
violation
of
this
exemption
or
act
to
seize
any
chemical
substances
manufactured
in
violation
of
the
exemption
under
the
authority
of
section
17
of
the
Act
(
15
U.
S.
C.
2616).

[
47
FR
24317,
June
4,
1982,
as
amended
at
53
FR
12523,
Apr.
15,
1988;
60
FR
34465,
July
3,
1995;
62
FR
17932,
April
11,
1997;
68
FR
906,
Jan.
7,
2003]

§
723.250
Polymers.

(
a)
Purpose
and
scope.
(
1)
This
section
grants
an
exemption
from
certain
of
the
premanufacture
notice
requirements
of
section
5(
a)(
1)(
A)
of
the
Toxic
Substances
Control
Act
(
15
U.
S.
C.
2604(
a)(
1)(
A))
for
the
manufacture
of
certain
polymers.
This
section
does
not
apply
to
microorganisms
subject
to
part
725
of
this
chapter.

(
2)
To
manufacture
a
new
chemical
substance
under
the
terms
of
this
section,
a
manufacturer
must:
(
i)
Determine
that
the
substance
meets
the
definition
of
polymer
in
paragraph
(
b)
of
this
section.
(
ii)
Determine
that
the
substance
is
not
specifically
excluded
by
paragraph
(
d)
of
this
section.
(
iii)
Ensure
that
the
substance
meets
the
exemption
criteria
of
paragraph
(
e)
of
this
section.
(
iv)
Submit
a
report
as
required
under
paragraph
(
f)
of
this
section.
(
v)
Comply
with
the
recordkeeping
requirements
of
paragraph
(
j)
of
this
section.

(
b)
Definitions.
In
addition
to
the
definitions
under
section
3
of
the
Act,
15
U.
S.
C.
2602,
the
following
definitions
apply
to
this
part.

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

Biopolymer
means
a
polymer
directly
produced
by
living
or
once­
living
cells
or
cellular
components.

Category
of
chemical
substances
has
the
same
meaning
as
in
section
26(
c)(
2)
of
the
Act
(
15
U.
S.
C.
2625).

Cationic
polymer
means
a
polymer
that
contains
a
net
positively
charged
atom(
s)
or
associated
groups
of
atoms
covalently
linked
to
its
polymer
molecule.

Chemical
substance,
Director,
EPA,
importer,
impurity,
Inventory,
known
to
or
reasonably
May
10,
2004
ascertainable,
manufacture,
manufacturer,
mixture,
new
chemical,
person,
possession
or
control,
process
and
test
data
have
the
same
meanings
as
in
§
720.3
of
this
chapter.

Equivalent
weight
of
a
functional
group
means
the
ratio
of
the
molecular
weight
to
the
number
of
occurrences
of
that
functional
group
in
the
molecule.
It
is
the
weight
of
substance
that
contains
one
formula­
weight
of
the
functional
group.

Internal
monomer
unit
means
a
monomer
unit
that
is
covalently
bonded
to
at
least
two
other
molecules.
Internal
monomer
units
of
polymer
molecules
are
chemically
derived
from
monomer
molecules
that
have
formed
covalent
bonds
between
two
or
more
other
monomer
molecules
or
other
reactants.

Monomer
means
a
chemical
substance
that
is
capable
of
forming
covalent
bonds
with
two
or
more
like
or
unlike
molecules
under
the
conditions
of
the
relevant
polymer­
forming
reaction
used
for
the
particular
process.

Monomer
Unit
means
the
reacted
form
of
the
monomer
in
a
polymer.

Number­
average
molecular
weight
means
the
arithmetic
average
(
mean)
of
the
molecular
weight
of
all
molecules
in
a
polymer.

Oligomer
means
a
polymer
molecule
consisting
of
only
a
few
monomer
units
(
dimer,
trimer,
tetramer)

Other
reactant
means
a
molecule
linked
to
one
or
more
sequences
of
monomer
units
but
which,
under
the
relevant
reaction
conditions
used
for
the
particular
process,
cannot
become
a
repeating
unit
in
the
polymer
structure.

Polyester
means
a
chemical
substance
that
meets
the
definition
of
polymer
and
whose
polymer
molecules
contain
at
least
two
carboxylic
acid
ester
linkages,
at
least
one
of
which
links
internal
monomer
units
together.

Polymer
means
a
chemical
substance
consisting
of
molecules
characterized
by
the
sequence
of
one
or
more
types
of
monomer
units
and
comprising
a
simple
weight
majority
of
molecules
containing
at
least
3
monomer
units
which
are
covalently
bound
to
at
least
one
other
monomer
unit
or
other
reactant
and
which
consists
of
less
than
a
simple
weight
majority
of
molecules
of
the
same
molecular
weight.
Such
molecules
must
be
distributed
over
a
range
of
molecular
weights
wherein
differences
in
the
molecular
weight
are
primarily
attributable
to
differences
in
the
number
of
monomer
units.
In
the
context
of
this
definition,
sequence
means
that
the
monomer
units
under
consideration
are
covalently
bound
to
one
another
and
form
a
continuous
string
within
the
molecule,
uninterrupted
by
units
other
than
monomer
units.

Polymer
molecule
means
a
molecule
which
contains
a
sequence
of
at
least
3
monomer
units
which
are
covalently
bound
to
at
least
one
other
monomer
unit
or
other
reactant.

Reactant
means
a
chemical
substance
that
is
used
intentionally
in
the
manufacture
of
a
polymer
to
become
chemically
a
part
of
the
polymer
composition.
May
10,
2004
Reactive
functional
group
means
an
atom
or
associated
group
of
atoms
in
a
chemical
substance
that
is
intended
or
can
reasonably
be
anticipated
to
undergo
further
chemical
reaction.

Reasonably
anticipated
means
that
a
knowledgeable
person
would
expect
a
given
physical
or
chemical
composition
or
characteristic
to
occur
based
on
such
factors
as
the
nature
of
the
precursors
used
to
manufacture
the
polymer,
the
type
of
reaction,
the
type
of
manufacturing
process,
the
products
produced
in
polymerization,
the
intended
uses
of
the
substance,
or
associated
use
conditions.

(
c)
Applicability.
This
section
applies
to
manufacturers
of
new
chemical
substances
that
otherwise
must
submit
a
premanufacture
notice
to
EPA
under
§
720.22
of
this
chapter.
New
substances
are
eligible
for
exemption
under
this
section
if
they
meet
the
definition
of
"
polymer"
in
paragraph
(
b)
of
this
section,
and
the
criteria
in
paragraph
(
e)
of
this
section,
and
if
they
are
not
excluded
from
the
exemption
under
paragraph
(
d)
of
this
section.

(
d)
Polymers
that
cannot
be
manufactured
under
this
section
­­
(
1)
Cationic
polymers.
A
polymer
cannot
be
manufactured
under
this
section
if
the
polymer
is
a
cationic
polymer
as
defined
under
paragraph
(
b)
of
this
section
or
if
the
polymer
is
reasonably
anticipated
to
become
a
cationic
polymer
in
a
natural
aquatic
environment
(
e.
g.,
rivers,
lakes)
unless:
(
i)
The
polymer
is
a
solid
material
that
is
not
soluble
or
dispersible
in
water
and
will
be
used
only
in
the
solid
phase
(
e.
g.,
polymers
that
will
be
used
as
ion
exchange
beads),
or
(
ii)
The
combined
(
total)
functional
group
equivalent
weight
of
cationic
groups
in
the
polymer
is
equal
to
or
greater
than
5,000.

(
2)
Elemental
limitations.
(
i)
A
polymer
manufactured
under
this
section
must
contain
as
an
integral
part
of
its
composition
at
least
two
of
the
atomic
elements
carbon,
hydrogen,
nitrogen,
oxygen,
silicon,
and
sulfur.
(
ii)
A
polymer
cannot
be
manufactured
under
this
section
if
it
contains
as
an
integral
part
of
its
composition,
except
as
impurities,
any
elements
other
than
the
following:

(
A)
The
elements
listed
in
paragraph
(
d)(
2)(
i)
of
this
section.
(
B)
Sodium,
magnesium,
aluminum,
potassium,
calcium,
chlorine,
bromine,
and
iodine
as
the
monatomic
counterions
Na=,
Mg=
2,
Al=
3,
K=,
Ca=
2,
Cl­,
Br­,
or
I­.

(
C)
Fluorine,
chlorine,
bromine,
and
iodine
covalently
bound
to
carbon.
(
D)
Less
than
0.20
weight
percent
of
any
combination
of
the
atomic
elements
lithium,
boron,
phosphorus,
titanium,
manganese,
iron,
nickel,
copper,
zinc,
tin,
and
zirconium.

(
3)
Polymers
which
degrade,
decompose,
or
depolymerize.
A
polymer
cannot
be
manufactured
under
this
section
if
the
polymer
is
designed
or
is
reasonably
anticipated
to
substantially
degrade,
decompose,
or
depolymerize,
including
those
polymers
that
could
substantially
decompose
after
manufacture
and
use,
even
though
they
are
not
actually
intended
to
do
so.
For
the
purposes
of
this
section,
degradation,
decomposition,
or
depolymerization
mean
those
types
of
chemical
change
that
convert
a
polymeric
substance
into
simpler,
smaller
substances,
through
processes
including
but
not
limited
to
oxidation,
hydrolysis,
attack
by
solvents,
heat,
light,
or
microbial
action.
May
10,
2004
(
4)
Polymers
manufactured
or
imported
from
monomers
and
reactants
not
on
the
TSCA
Chemical
Substance
Inventory.
A
polymer
cannot
be
manufactured
under
this
section
if
the
polymer
being
manufactured
or
imported
is
prepared
from
monomers
and/
or
other
reactants
(
that
are
either
charged
to
the
reaction
vessel
or
incorporated
in
the
polymer
at
levels
of
greater
than
2
weight
percent)
that
are
not
already
included
on
the
TSCA
Chemical
Substance
Inventory
or
manufactured
under
an
applicable
TSCA
section
5
exemption.

(
5)
Water
absorbing
polymers
with
number
average
molecular
weight
(
MW)
10,000
and
greater.
A
polymer
cannot
be
manufactured
under
this
section
if
the
polymer
being
manufactured
or
imported
is
a
water
absorbing
polymer
and
has
a
number
average
MW
greater
than
or
equal
to
10,000
daltons.
For
purposes
of
this
section,
a
water­
absorbing
polymer
is
a
polymeric
substance
that
is
capable
of
absorbing
its
weight
of
water.

(
e)
Exemption
criteria.
To
be
manufactured
under
this
section,
the
polymer
must
meet
one
of
the
following
criteria:

(
1)
Polymers
with
number
average
MW
greater
than
or
equal
to
1,000
and
less
than
10,000
daltons
(
and
oligomer
content
less
than
10
percent
below
MW
500
and
less
than
25
percent
below
MW
1,000).
(
i)
The
polymer
must
have
a
number
average
MW
greater
than
or
equal
to
1,000
and
less
than
10,000
daltons
and
contain
less
than
10
percent
oligomeric
material
below
MW
500
and
less
than
25
percent
oligomeric
material
below
MW
1,000.
(
ii)
The
polymer
cannot
contain
reactive
functional
groups
unless
it
meets
one
of
the
following
criteria:

(
A)
The
polymer
contains
only
the
following
reactive
functional
groups:
carboxylic
acid
groups,
aliphatic
hydroxyl
groups,
unconjugated
olefinic
groups
that
are
considered
"
ordinary,"(
i.
e.,
not
specially
activated
either
by
being
part
of
a
larger
functional
group,
such
as
a
vinyl
ether,
or
by
other
activating
influences,
e.
g.,
strongly
electron­
withdrawing
sulfone
group
with
which
the
olefinic
groups
interact),
butenedioic
acid
groups,
those
conjugated
olefinic
groups
contained
in
naturally­
occurring
fats,
oils,
and
carboxylic
acids,
blocked
isocyanates
(
including
ketoxime­
blocked
isocyanates),
thiols,
unconjugated
nitrile
groups,
and
halogens
(
except
that
reactive
halogen­
containing
groups
such
as
benzylic
or
allylichalides
cannot
be
included).

(
B)
The
polymer
has
a
combined
(
total)
reactive
group
equivalent
weight
greater
than
or
equal
to
1,000
for
the
following
reactive
functional
groups:
acidhalides;
acid
anhydrides;
aldehydes,
hemiacetals;
methylolamides,­
amines
or,­
ureas;
alkoxysilanes
with
alkoxy
greater
than
C2­
alkoxysilanes;
allyl
ethers;
conjugated
olefins;
cyanates;
epoxides;
imines;
or
unsubstituted
positions
ortho
or
para
to
phenolic
hydroxyl;
or
(
C)
If
any
reactive
functional
groups
not
included
in
paragraph
(
e)(
1)(
ii)(
A)
and
(
B)
of
this
section
are
present,
the
combined
(
total)
reactive
group
equivalent
weight,
including
any
groups
listed
in
paragraph
(
e)(
1)(
ii)(
B),
is
greater
than
or
equal
to
5,000.

(
2)
Polymers
with
number
average
MW
greater
than
or
equal
to
10,000
(
and
oligomer
content
less
than
2
percent
below
MW
500
and
less
than
5
percent
below
MW
1,000)
.
The
polymer
must
have
a
number
average
MW
greater
than
or
equal
to
10,000
daltons
and
contain
less
than
2
percent
oligomeric
material
below
MW
500
and
less
than
5
percent
oligomeric
material
below
May
10,
2004
MW
1000.

(
3)
Polyester
polymers.
The
polymer
is
a
polyester
as
defined
in
paragraph
(
b)
of
this
section
and
is
manufactured
solely
from
one
or
more
of
the
reactants
in
the
following
table
1:

Table
1_
List
of
Reactants
From
Which
Polyester
May
be
Made
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Reactant
CAS
No.
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Monobasic
Acids
and
Natural
Oils
Benzoic
acid.............................
65­
85­
0
Canola
oil...............................
120962­
03­
0
Coconut
oil..............................
8001­
31­
8*
Corn
oil.................................
8001­
30­
7*
Cottonseed
oil...........................
8001­
29­
4*
Dodecanoic
acid..........................
143­
07­
7
Fats
and
glyceridic
oils,
anchovy.......
128952­
11­
4*
Fats
and
glyceridic
oils,
babassu........
91078­
92­
1*
Fats
and
glyceridic
oils,
herring........
68153­
06­
0*
Fats
and
glyceridic
oils,
menhaden.....
8002­
50­
4*
Fats
and
glyceridic
oils,
sardine........
93334­
41­
9*
Fats
and
glyceridic
oils,
oiticica.......
8016­
35­
1*
Fatty
acids,
C[
INF]
16­
18[/
INF]
and
67701­
08­
0*
C[
INF]
18[/
INF]­
unsatd..
Fatty
acids,
castor­
oil..................
61789­
44­
4*
Fatty
acids,
coco........................
61788­
47­
4*
Fatty
acids,
dehydrated
castor­
oil.......
61789­
45­
5*
Fatty
acids,
linseed
oil.................
68424­
45­
3*
Fatty
acids,
safflower
oil...............
Fatty
acids,
soya........................
68308­
53­
2*
Fatty
acids,
sunflower
oil...............
84625­
38­
7*
Fatty
acids,
sunflower­
oil,
conjugated.
68953­
27­
5*
Fatty
acids,
tall­
oil....................
61790­
12­
3*
Fatty
acids,
tall­
oil,
conjugated*.......
Fatty
acids,
vegetable
oil...............
61788­
66­
7*
Glycerides,
C[
INF]
16­
18[/
INF]
and
67701­
30­
8*
C[
INF]
18[/
INF]­
unsatd..
Heptanoic
acid...........................
111­
14­
8
Hexanoic
acid............................
142­
62­
1
Hexanoic
acid,
3,3,5­
trimethyl­.........
3302­
10­
1
Linseed
oil..............................
8001­
26­
1*
Linseed
oil,
oxidized....................
68649­
95­
6*
Nonanoic
acid............................
112­
05­
0
Oils,
Cannabis*..........................
Oils,
palm
kernel........................
8023­
79­
8*
Oils,
perilla............................
68132­
21­
8*
Oils,
walnut.............................
8024­
09­
7
May
10,
2004
Safflower
oil............................
8001­
23­
8*
Soybean
oil..............................
8001­
22­
7*
Sunflower
oil............................
8001­
21­
6*
Tung
oil.................................
8001­
20­
5*
1
1
Di
and
Tri
Basic
Acids:...........
1,2­
Benzenedicarboxylic
acid.............
88­
99­
3
1,3­
Benzenedicarboxylic
acid.............
121­
91­
5
1,3­
Benzenedicarboxylic
acid,
1459­
93­
4
diethyl
ester.
1,4­
Benzenedicarboxylic
acid............
100­
21­
0
1,4­
Benzenedicarboxylic
acid,
636­
09­
9
diethyl
ester.
1,4­
Benzenedicarboxylic
acid,
120­
61­
6
dimethyl
ester.
1,2,4­
Benzenetricarboxylic
acid........
528­
44­
9
Butanedioic
acid.........................
110­
15­
6
Butanedioic
acid,
diethyl
ester..........
123­
25­
1
Butanedioic
acid,
dimethyl
ester........
106­
65­
0
2­
Butenedioic
acid
(
E)­..................
110­
17­
8
Decanedioic
acid.........................
111­
20­
6
Decanedioic
acid,
diethyl
ester..........
110­
40­
7
Decanedioic
acid,
dimethyl
ester........
106­
79­
6
Dodecanedioic
acid.......................
693­
23­
2
Fatty
acids,
C[
INF]
18[/
INF]­
unsatd.,
61788­
89­
4*
dimers.
Heptanedioic
acid........................
111­
16­
0
Heptanedioic
acid,
dimethyl
ester......
1732­
08­
7
Hexanedioic
acid.........................
124­
04­
9
Hexanedioic
acid,
dimethyl
ester.......
627­
93­
0
Hexanedioic
acid,
diethyl
ester..........
141­
28­
6
Nonanedioic
acid.........................
123­
99­
9
Nonanedioic
acid,
dimethyl
ester.......
1732­
10­
1
Nonanedioic
acid,
diethyl
ester..........
624­
17­
9
Octanedioic
acid.........................
(
505­
48­
6)
Octanedioic
acid,
dimethyl
ester.........
1732­
09­
8
Pentanedioic
acid........................
.......
1119­
40­
0
Pentanedioic
acid,
diethyl
ester.........
818­
38­
2
Undecanedioic
acid.......................
1852­
04­
6
Polyols
1,3­
Butanediol...........................
107­
88­
0
1,4­
Butanediol...........................
110­
63­
4
1,4­
Cyclohexanedimethanol................
105­
08­
8
1,2­
Ethanediol...........................
107­
21­
1
Ethanol,
2,2[
prime]­
oxybis­..............
111­
46­
6
1,6­
Hexanediol...........................
629­
11­
8
1,3­
Pentanediol,
2,2,4­
trimethyl­........
144­
19­
4
May
10,
2004
1,2­
Propanediol,.........................
57­
55­
6
1,3­
Propanediol,
2,2­
bis(
hydroxymethyl)­.
115­
77­
5
1,3­
Propanediol,
2,2­
dimethyl­...........
126­
30­
7
1,3­
Propanediol,
2­
ethyl­
2­
77­
99­
6
(
hydroxymethyl)­.
1,3­
Propanediol,
2­(
hydroxymethyl)­
2­
77­
85­
0
methyl­.
1,3­
propanediol,
2­
methyl................
2163­
42­
0
1,2,3­
Propanetriol.......................
56­
81­
5
1,2,3­
Propanetriol,
homopolymer..........
25618­
55­
7
2­
Propen­
1­
ol,
polymer
with
25119­
62­
4
ethenylbenzene.

Modifiers
Acetic
acid,
2,2[
prime]­
oxybis­..........
110­
99­
6
1­
Butanol................................
71­
36­
3**
Cyclohexanol.............................
108­
93­
0
Cyclohexanol,
4,4[
prime]­(
1­
80­
04­
6
methylethylidene)
bis­.
Ethanol,
2­(
2­
butoxyethoxy)­.............
112­
34­
5
1­
Hexanol................................
111­
27­
3
Methanol,
hydrolysis
products
with
72318­
84­
4*
trichlorohexylsilane
and
trichlorophenylsilane.
1­
Phenanthrenemethanol,
tetradecahydro­
13393­
93­
6
1,4a­
dimethyl­
7­(
1­
methylethyl)­.
Phenol,
4,4[
prime]­(
1­
25036­
25­
3
methylethylidene)
bis­,
polymer
with
2,2[
prime]­
[(
1­
methylethylidene)
bis(
4,1­
phenyleneoxymethylene)]
bis[
oxirane].
Siloxanes
and
Silicones,
di­
Me,
di­
Ph,
68440­
65­
3*
polymers
with
Ph
silsesquioxanes,
methoxy­
terminated.
Siloxanes
and
Silicones,
di­
Me,
methoxy
68957­
04­
0*
Ph,
polymers
with
Ph
silsesquioxanes,
methoxy­
terminated.
Siloxanes
and
Silicones,
Me
Ph,
methoxy
\
1\
68957­
06­
2*
Ph,
polymers
with
Ph
silsesquioxanes,
methoxy­
and
Ph­
terminated.
Silsesquioxanes,
Ph
Pr...................
\
1\
68037­
90­
1*
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
[
SU]*[/
SU]
Chemical
substance
of
unknown
or
variable
composition,
complex
reaction
products,
and
biological
materials
(
UVCB).
The
CAS
Registry
Numbers
for
UVCB
substances
are
not
used
in
CHEMICAL
ABSTRACTS
and
its
indexes.
[
SU]**[/
SU]
These
substances
may
not
be
used
in
a
substance
manufactured
from
fumaric
or
maleic
acid
because
of
potential
risks
associated
with
May
10,
2004
esters,
which
may
be
formed
by
reaction
of
these
reactants.

(
f)
Exemption
report
for
polymers
manufactured
under
the
terms
of
this
section.
For
substances
exempt
under
paragraphs
(
e)(
1),
(
e)(
2),
and
(
e)(
3)
of
this
section
a
report
of
manufacture
or
import
must
be
submitted
(
postmarked)
by
January
31
of
the
year
subsequent
to
initial
manufacture.
The
notice
must
include:

(
1)
Manufacturer's
name.
This
includes
the
name
and
address
of
the
manufacturer
and
the
name
and
telephone
number
of
a
technical
contact.

(
2)
Number
of
substances
manufactured.
Number
of
substances
manufactured.
The
manufacturer
must
identify
the
number
of
polymers
manufactured
under
terms
of
the
exemption
for
the
first
time
in
the
year
preceding
the
notice.

(
g)
Chemical
identity
information.
For
substances
exempt
under
paragraph
(
e)
of
this
section
the
manufacturer
must
to
the
extent
known
to
or
reasonably
ascertainable
by
the
manufacturer
identify
the
following
and
maintain
the
records
in
accordance
with
paragraph
(
j)
of
this
section:

(
1)
A
specific
chemical
name
and
CAS
Registry
Number
(
or
EPA
assigned
Accession
Number)
for
each
"
reactant,"
as
that
term
is
defined
in
paragraph
(
b)
of
this
section,
used
at
any
weight
in
the
manufacture
of
the
polymer.
For
purposes
of
determining
chemical
identity,
the
manufacturer
may
determine
whether
a
reactant
is
used
at
greater
than
two
weight
percent
according
to
either
the
weight
of
the
reactant
charged
to
the
reaction
vessel
or
the
weight
of
the
chemically
combined
(
incorporated)
reactant
in
the
polymer.
Manufacturers
who
choose
the
"
incorporated"
method
must
have
analytical
data,
or
theoretical
calculations
(
if
it
can
be
documented
that
an
analytical
determination
cannot
be
made
or
is
not
necessary),
to
demonstrate
compliance
with
this
paragraph.
Reactants
that
introduce
into
the
polymer
elements,
properties,
or
functional
groups
that
would
render
the
polymer
ineligible
for
the
exemption
are
not
allowed
at
any
level.

(
2)
A
representative
structural
diagram,
if
possible.

(
h)
Certification.
To
manufacture
a
substance
under
the
terms
of
this
section,
a
manufacturer
must
as
of
the
date
of
first
manufacture,
make
the
following
certification
statements
and
maintain
them
in
accordance
with
paragraph
(
j)
of
this
section:

(
1)
The
substance
is
manufactured
or
imported
for
a
commercial
purpose
other
than
for
research
and
development.

(
2)
All
information
in
the
certification
is
truthful.

(
3)
The
new
chemical
substance
meets
the
definition
of
a
polymer,
is
not
specifically
excluded
from
the
exemption
in
paragraph
(
d)
of
this
section,
and
meets
the
conditions
of
the
exemption
in
paragraph
(
e)
of
this
section.

(
i)
Exemptions
granted
under
superseded
regulations.
Manufacturers
granted
exemptions
under
the
superseded
requirements
of
§
723.250
(
as
in
effect
on
May
26,
1995)
shall
either
continue
to
comply
with
those
requirements
or
follow
all
procedural
and
recordkeeping
requirements
May
10,
2004
pursuant
to
this
section.
If
an
exemption
holder
continues
to
follow
the
superseded
regulations,
the
Notice
of
Commencement
requirements
apply
and
the
exempt
polymer
will
continue
to
be
listed
on
the
Inventory
with
exclusion
criteria
and
exemption
category
restrictions
on
residual
monomer/
reactant
and
low
molecular
weight
species
content
limitations.

(
j)
Recordkeeping.
(
1)
A
manufacturer
of
a
new
polymer
under
paragraphs
(
e)
of
this
section,
must
retain
the
records
described
in
this
paragraph
at
the
manufacturing
site
for
a
period
of
5
years
from
the
date
of
commencement
of
manufacture
or
import.

(
2)
The
records
must
include
the
following
to
demonstrate
compliance
with
the
terms
of
this
section:

(
i)
Chemical
identity
information
as
required
in
paragraph
(
g)
of
this
section.
(
ii)
Information
to
demonstrate
that
the
new
polymer
is
not
specifically
excluded
from
the
exemption.
(
iii)
Records
of
production
volume
for
the
first
3
years
of
manufacture
and
the
date
of
commencement
of
manufacture.
(
iv)
Information
to
demonstrate
that
the
new
polymer
meets
the
exemption
criteria
in
paragraphs
(
e)(
1),
(
e)(
2),
or
(
e)(
3)
of
this
section.
(
v)
Analytical
data,
or
theoretical
calculations
(
if
it
can
be
documented
that
an
analytical
determination
cannot
be
made
or
is
not
necessary),
to
demonstrate
that
the
polymer
meets
the
number­
average
MW
exemption
criteria
in
paragraphs
(
e)(
1)
or
(
e)(
2)
of
this
section.
The
analytical
tests
may
include
gel
permeation
chromatography
(
GPC).
vapor
pressure
osmometry
(
VPO),
or
other
such
tests
which
will
demonstrate
that
the
polymer
meets
the
number­
average
MW
criterion.
(
vi)
Analytical
data,
or
theoretical
calculations
(
if
it
can
be
documented
that
an
analytical
determination
cannot
be
made
or
is
not
necessary),
to
demonstrate
that
the
polymer
meets
the
criteria
in
paragraphs
(
e)(
1)
or
(
e)(
2)
of
this
section,
meets
the
low
MW
content
criteria
in
paragraphs
(
e)(
1)
or
(
e)(
2)
of
this
section.
(
vii)
If
applicable,
analytical
data,
or
theoretical
calculations
(
if
it
can
be
documented
that
an
analytical
determination
cannot
be
made
or
is
not
necessary)
required
in
paragraph
(
g)
of
this
section
for
determining
monomers
or
reactants
charged
to
the
reaction
vessel
at
greater
than
2
weight
percent
but
incorporated
at
2
weight
percent
or
less
in
the
manufactured
polymer.
(
viii)
The
certification
statements
as
required
under
paragraph
(
h)
of
this
section.

(
3)
The
manufacturer
must
submit
the
records
listed
in
paragraph
(
j)(
2)
of
this
section
to
EPA
upon
written
request
by
EPA.
The
manufacturer
must
provide
these
records
within
15
working
days
of
receipt
of
this
request.
In
addition,
any
person
who
manufactures
a
new
chemical
substance
under
the
terms
of
this
section,
upon
request
of
EPA,
must
permit
such
person
at
all
reasonable
times
to
have
access
to
and
to
copy
these
records.

(
k)
Submission
of
information.
Information
submitted
to
EPA
under
this
section
must
be
sent
in
writing
to:
TSCA
Document
Control
Officer,
(
7407),
Office
of
Pollution
Prevention
and
Toxics,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460.

(
l)
Compliance.
(
1)
A
person
who
manufactures
or
imports
a
new
chemical
substance
and
fails
to
comply
with
any
provision
of
this
section
is
in
violation
of
section
15
of
the
Act
(
15
U.
S.
C.
2614).
May
10,
2004
(
2)
Using
for
commercial
purposes
a
chemical
substance
or
mixture
which
a
person
knew
or
had
reason
to
know
was
manufactured,
processed,
or
distributed
in
commerce
in
violation
of
section
5
of
the
Act
is
a
violation
of
section
15
of
the
Act
(
15
U.
S.
C.
2614).

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

(
4)
Failure
or
refusal
to
permit
entry
or
inspection
as
required
by
section
11
of
the
Act
is
a
violation
of
section
15
of
the
Act
(
15
U.
S.
C.
2614).

(
5)
Violators
may
be
subject
to
the
civil
and
criminal
penalties
in
section
16
of
the
Act
(
15
U.
S.
C.
2615)
for
each
violation.
Persons
who
submit
materially
misleading
or
false
information
in
connection
with
the
requirements
of
any
provision
of
this
section
may
be
subject
to
penalties
calculated
as
if
they
never
filed
their
notices.

(
6)
EPA
may
seek
to
enjoin
the
manufacture
or
processing
of
a
chemical
substance
in
violation
of
this
section
or
act
to
seize
any
chemical
substance
manufactured
or
processed
in
violation
of
this
section
or
take
other
actions
under
the
authority
of
section
7
of
the
Act
(
15
U.
S.
C.
2606)
or
section
17
of
the
Act
(
15
U.
S.
C.
2616).

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

(
n)
Confidentiality.
If
a
manufacturer
submits
information
to
EPA
under
this
section
which
the
manufacturer
claims
to
be
confidential
business
information,
the
manufacturer
must
clearly
identify
the
information
at
the
time
of
submission
to
EPA
by
bracketing,
circling,
or
underlining
it
and
stamping
it
with
"
CONFIDENTIAL"
or
some
other
appropriate
designation.
Any
information
so
identified
will
be
treated
in
accordance
with
the
procedures
in
40
CFR
part
2.
Any
information
not
claimed
confidential
at
the
time
of
submission
may
be
made
available
to
the
public
without
further
notice.

[
60
FR
16332,
Mar.
29,
1995,
as
amended
at
62
FR
17932,
April
11,
1997]
May
10,
2004
Attachment
F
40
CFR
Part
725
May
10,
2004
40
CFR
Protection
of
Environment
CHAPTER
I
ENVIRONMENTAL
PROTECTION
AGENCY
(
CONTINUED)

SUBCHAPTER
R
­­
TOXIC
SUBSTANCES
CONTROL
ACT
PART
725
­­
REPORTING
REQUIREMENTS
AND
REVIEW
PROCESSES
FOR
MICROORGANISMS
Subpart
A
­­
General
Provisions
and
Applicability
Sec.
725.1
Scope
and
purpose.
725.3
Definitions.
725.8
Coverage
of
this
part.
725.12
Identification
of
microorganisms
for
Inventory
and
other
listing
purposes.
725.15
Determining
applicability
when
microorganism
identity
or
use
is
confidential
or
uncertain.
725.17
Consultation
with
EPA.

Subpart
B
­­
Administrative
Procedures
725.20
Scope
and
purpose.
725.25
General
administrative
requirements.
725.27
Submissions.
725.28
Notice
that
submission
is
not
required.
725.29
EPA
acknowledgement
of
receipt
of
submission.
725.32
Errors
in
the
submission.
725.33
Incomplete
submissions.
725.36
New
information.
725.40
Notice
in
the
FEDERAL
REGISTER.
725.50
EPA
review.
725.54
Suspension
of
the
review
period.
725.56
Extension
of
the
review
period.
725.60
Withdrawal
of
submission
by
the
submitter.
725.65
Recordkeeping.
725.67
Applications
to
exempt
new
microorganisms
from
this
part.
725.70
Compliance.
725.75
Inspections.

Subpart
C
­­
Confidentiality
and
Public
Access
to
Information
725.80
General
provisions
for
confidentiality
claims.
725.85
Microorganism
identity.
725.88
Uses
of
a
microorganism.
725.92
Data
from
health
and
safety
studies
of
microorganisms.
725.94
Substantiation
requirements.
May
10,
2004
725.95
Public
file.

Subpart
D
­­
Microbial
Commercial
Activities
Notification
Requirements
725.100
Scope
and
purpose.
725.105
Persons
who
must
report.
725.110
Persons
not
subject
to
this
subpart.
725.150
Procedural
requirements
for
this
subpart.
725.155
Information
to
be
included
in
the
MCAN.
725.160
Submission
of
health
and
environmental
effects
data.
725.170
EPA
review
of
the
MCAN.
725.190
Notice
of
commencement
of
manufacture
or
import.

Subpart
E
­­
Exemptions
for
Research
and
Development
Activities
725.200
Scope
and
purpose.
725.205
Persons
who
may
report
under
this
subpart.
725.232
Activities
subject
to
the
jurisdiction
of
other
Federal
programs
or
agencies.
725.234
Activities
conducted
inside
a
structure.
725.235
Conditions
of
exemption
for
activities
conducted
inside
a
structure.
725.238
Activities
conducted
outside
a
structure.
725.239
Use
of
specific
microorganisms
in
activities
conducted
outside
a
structure.
725.250
Procedural
requirements
for
the
TERA.
725.255
Information
to
be
included
in
the
TERA.
725.260
Submission
of
health
and
environmental
effects
data.
725.270
EPA
review
of
the
TERA.
725.288
Revocation
or
modification
of
TERA
approval.

Subpart
F
­­
Exemptions
for
Test
Marketing
725.300
Scope
and
purpose.
725.305
Persons
who
may
apply
under
this
subpart.
725.350
Procedural
requirements
for
this
subpart.
725.355
Information
to
be
included
in
the
TME
application.
725.370
EPA
review
of
the
TME
application.

Subpart
G
­­
General
Exemptions
for
New
Microorganisms
725.400
Scope
and
purpose.
725.420
Recipient
microorganisms.
725.421
Introduced
genetic
material.
725.422
Physical
containment
and
control
technologies.
725.424
Requirements
for
the
Tier
I
exemption.
725.426
Applicability
of
the
Tier
I
exemption.
725.428
Requirements
for
the
Tier
II
exemption.
725.450
Procedural
requirements
for
the
Tier
II
exemption.
725.455
Information
to
be
included
in
the
Tier
II
exemption
request.
May
10,
2004
725.470
EPA
review
of
the
Tier
II
exemption
request.

Subparts
H­
K
[
Reserved]

Subpart
L
­­
Additional
Procedures
for
Reporting
on
Significant
New
Uses
of
Microorganisms
725.900
Scope
and
purpose.
725.910
Persons
excluded
from
reporting
significant
new
uses.
725.912
Exemptions.
725.920
Exports
and
imports.
725.950
Additional
recordkeeping
requirements.
725.975
EPA
approval
of
alternative
control
measures.
725.980
Expedited
procedures
for
issuing
significant
new
use
rules
for
microorganisms
subject
to
section
5(
e)
orders.
725.984
Modification
or
revocation
of
certain
notification
requirements.

Subpart
M
­­
Significant
New
Uses
for
Specific
Microorganisms
725.1000
Scope.
725.1075
Burkholderia
cepacia
complex.

Authority:
15
U.
S.
C.
2604,
2607,
2613,
and
2625.

Source:
62
FR
17932,
April
11,
1997,
unless
otherwise
noted.

Subpart
A
­­
General
Provisions
and
Applicability
§
725.1
Scope
and
purpose.

(
a)
This
part
establishes
all
reporting
requirements
under
section
5
of
TSCA
for
manufacturers,
importers,
and
processors
of
microorganisms
subject
to
TSCA
jurisdiction
for
commercial
purposes,
including
research
and
development
for
commercial
purposes.
New
microorganisms
for
which
manufacturers
and
importers
are
required
to
report
under
section
5(
a)(
1)(
A)
of
TSCA
are
those
that
are
intergeneric.
In
addition,
under
section
5(
a)(
1)(
B)
of
TSCA,
manufacturers,
importers,
and
processors
may
be
required
to
report
for
any
microorganism
that
EPA
determines
by
rule
is
being
manufactured,
imported,
or
processed
for
a
significant
new
use.

(
b)
Any
manufacturer,
importer,
or
processor
required
to
report
under
section
5
of
TSCA
(
see
§
725.100
for
new
microorganisms
and
§
725.900
for
significant
new
uses)
must
file
a
Microbial
Commercial
Activity
Notice
(
MCAN)
with
EPA,
unless
the
activity
is
eligible
for
a
specific
exemption
as
described
in
this
part.
The
general
procedures
for
filing
MCANs
are
described
in
subpart
D
of
this
part.
The
exemptions
from
the
requirement
to
file
a
MCAN
are
for
certain
kinds
of
contained
activities
(
see
§
§
725.424
and
725.428),
test
marketing
activities
(
see
§
725.300),
and
research
and
development
activities
described
in
paragraph
(
c)
of
this
section.

(
c)
Any
manufacturer,
importer,
or
processor
required
to
file
a
MCAN
for
research
and
May
10,
2004
development
(
R&
D)
activities
may
instead
file
a
TSCA
Experimental
Release
Application
(
TERA)
for
a
specific
test
(
see
§
725.250).
A
TERA
is
not
required
for
certain
R&
D
activities;
however
a
TERA
exemption
does
not
extend
beyond
the
research
and
development
stage,
to
general
commercial
use
of
the
microorganism,
for
which
compliance
with
MCAN
requirements
is
required.
The
TERA
exemptions
are
for
R&
D
activities
subject
to
other
Federal
agencies
or
programs
(
see
§
725.232),
certain
kinds
of
contained
R&
D
activities
(
see
§
725.234),
and
R&
D
activities
using
certain
listed
microorganisms
(
see
§
725.238).

(
d)
New
microorganisms
will
be
added
to
the
Inventory
established
under
section
8
of
TSCA
once
a
MCAN
has
been
received,
the
MCAN
review
period
has
expired,
and
EPA
receives
a
Notice
of
Commencement
(
NOC)
indicating
that
manufacture
or
importation
has
actually
begun.
New
microorganisms
approved
for
use
under
a
TERA
will
not
be
added
to
the
Inventory
until
a
MCAN
has
been
received,
the
MCAN
review
period
has
expired,
and
EPA
has
received
an
NOC.

§
725.3
Definitions.

Definitions
in
section
3
of
the
Act
(
15
U.
S.
C.
2602),
as
well
as
definitions
contained
in
§
§
704.3,
720.3,
and
721.3
of
this
chapter,
apply
to
this
part
unless
otherwise
specified
in
this
section.
In
addition,
the
following
definitions
apply
to
this
part:

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

Containment
and/
or
inactivation
controls
means
any
combination
of
engineering,
mechanical,
procedural,
or
biological
controls
designed
and
operated
to
restrict
environmental
release
of
viable
microorganisms
from
a
structure.

Director
means
the
Director
of
the
EPA
Office
of
Pollution
Prevention
and
Toxics.

Exemption
request
means
any
application
submitted
to
EPA
under
subparts
E,
F,
or
G
of
this
part.
General
commercial
use
means
use
for
commercial
purposes
other
than
research
and
development.

Genome
means
the
sum
total
of
chromosomal
and
extrachromosomal
genetic
material
of
an
isolate
and
any
descendants
derived
under
pure
culture
conditions
from
that
isolate.

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

(
1)
It
is
intended
that
the
term
"
health
and
safety
study
of
a
microorganism"
be
interpreted
broadly.
Not
only
is
information
which
arises
as
a
result
of
a
formal,
disciplined
study
included,
but
other
information
relating
to
the
effects
of
a
microorganism
or
microbial
mixture
on
health
or
May
10,
2004
the
environment
is
also
included.
Any
data
that
bear
on
the
effects
of
a
microorganism
on
health
or
the
environment
would
be
included.

(
2)
Examples
include:

(
i)
Tests
for
ecological
or
other
environmental
effects
on
invertebrates,
fish,
or
other
animals,
and
plants,
including:
Acute
toxicity
tests,
chronic
toxicity
tests,
critical
life
stage
tests,
behavioral
tests,
algal
growth
tests,
seed
germination
tests,
plant
growth
or
damage
tests,
microbial
function
tests,
bioconcentration
or
bioaccumulation
tests,
and
model
ecosystem
(
microcosm)
studies.
(
ii)
Long­
and
short­
term
tests
of
mutagenicity,
carcinogenicity,
or
teratogenicity;
dermatoxicity;
cumulative,
additive,
and
synergistic
effects;
and
acute,
subchronic,
and
chronic
effects.
(
iii)
Assessments
of
human
and
environmental
exposure,
including
workplace
exposure,
and
impacts
of
a
particular
microorganism
or
microbial
mixture
on
the
environment,
including
surveys,
tests,
and
studies
of:
Survival
and
transport
in
air,
water,
and
soil;
ability
to
exchange
genetic
material
with
other
microorganisms,
ability
to
colonize
human
or
animal
guts,
and
ability
to
colonize
plants.
(
iv)
Monitoring
data,
when
they
have
been
aggregated
and
analyzed
to
measure
the
exposure
of
humans
or
the
environment
to
a
microorganism.
(
v)
Any
assessments
of
risk
to
health
and
the
environment
resulting
from
the
manufacture,
processing,
distribution
in
commerce,
use,
or
disposal
of
the
microorganism.

Inactivation
means
that
living
microorganisms
are
rendered
nonviable.

Institutional
Biosafety
Committee
means
the
committees
described
in
the
NIH
Guidelines
in
section
IV.
B.
2.

Intergeneric
microorganism
means
a
microorganism
that
is
formed
by
the
deliberate
combination
of
genetic
material
originally
isolated
from
organisms
of
different
taxonomic
genera.

(
1)
The
term
"
intergeneric
microorganism"
includes
a
microorganism
which
contains
a
mobile
genetic
element
which
was
first
identified
in
a
microorganism
in
a
genus
different
from
the
recipient
microorganism.

(
2)
The
term
"
intergeneric
microorganism"
does
not
include
a
microorganism
which
contains
introduced
genetic
material
consisting
of
only
well­
characterized,
non­
coding
regulatory
regions
from
another
genus.

Introduced
genetic
material
means
genetic
material
that
is
added
to,
and
remains
as
a
component
of,
the
genome
of
the
recipient.

Manufacture,
import,
or
process
for
commercial
purposes
means:

(
1)
To
import,
produce,
manufacture,
or
process
with
the
purpose
of
obtaining
an
immediate
or
eventual
commercial
advantage
for
the
manufacturer,
importer,
or
processor,
and
includes,
among
other
things,
"
manufacture"
or
"
processing"
of
any
amount
of
a
microorganism
or
microbial
mixture:
May
10,
2004
(
i)
For
commercial
distribution,
including
for
test
marketing.
(
ii)
For
use
by
the
manufacturer,
including
use
for
product
research
and
development
or
as
an
intermediate.

(
2)
The
term
also
applies
to
substances
that
are
produced
coincidentally
during
the
manufacture,
processing,
use,
or
disposal
of
another
microorganism
or
microbial
mixture,
including
byproducts
that
are
separated
from
that
other
microorganism
or
microbial
mixture
and
impurities
that
remain
in
that
microorganism
or
microbial
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
or
processing
of
a
microorganism
for
commercial
purposes.

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

Microbial
mixture
means
any
combination
of
microorganisms
or
microorganisms
and
other
chemical
substances,
if
the
combination
does
not
occur
in
nature
and
is
not
an
article.

Microorganism
means
an
organism
classified,
using
the
5­
kingdom
classification
system
of
Whittacker,
in
the
kingdoms
Monera
(
or
Procaryotae),
Protista,
Fungi,
and
the
Chlorophyta
and
the
Rhodophyta
of
the
Plantae,
and
a
virus
or
virus­
like
particle.

Mobile
genetic
element
or
MGE
means
an
element
of
genetic
material
that
has
the
ability
to
move
genetic
material
within
and
between
organisms.
"
Mobile
genetic
elements"
include
all
plasmids,
viruses,
transposons,
insertion
sequences,
and
other
classes
of
elements
with
these
general
properties.

New
microorganism
means
a
microorganism
not
included
on
the
Inventory.

NIH
Guidelines
means
the
National
Institutes
of
Health
(
NIH)
"
Guidelines
for
Research
Involving
Recombinant
DNA
Molecules"
(
July
5,
1994).

Non­
coding
regulatory
region
means
a
segment
of
introduced
genetic
material
for
which:

(
1)
The
regulatory
region
and
any
inserted
flanking
nucleotides
do
not
code
for
protein,
peptide,
or
functional
ribonucleic
acid
molecules.

(
2)
The
regulatory
region
solely
controls
the
activity
of
other
regions
that
code
for
protein
or
peptide
molecules
or
act
as
recognition
sites
for
the
initiation
of
nucleic
acid
or
protein
synthesis.

Small
quantities
solely
for
research
and
development
(
or
"
small
quantities
solely
for
purposes
of
scientific
experimentation
or
analysis
or
research
on,
or
analysis
of,
such
substance
or
another
substance,
including
such
research
or
analysis
for
development
of
a
product")
means
quantities
of
a
microorganism
manufactured,
imported,
or
processed
or
proposed
to
be
manufactured,
imported
or
processed
solely
for
research
and
development
that
meet
the
requirements
of
§
725.234.
May
10,
2004
Structure
means
a
building
or
vessel
which
effectively
surrounds
and
encloses
the
microorganism
and
includes
features
designed
to
restrict
the
microorganism
from
leaving.

Submission
means
any
MCAN
or
exemption
request
submitted
to
EPA
under
this
part.

Technically
qualified
individual
means
a
person
or
persons:

(
1)
Who,
because
of
education,
training,
or
experience,
or
a
combination
of
these
factors,
is
capable
of
understanding
the
health
and
environmental
risks
associated
with
the
microorganism
which
is
used
under
his
or
her
supervision,

(
2)
Who
is
responsible
for
enforcing
appropriate
methods
of
conducting
scientific
experimentation,
analysis,
or
microbiological
research
to
minimize
such
risks,
and
(
3)
Who
is
responsible
for
the
safety
assessments
and
clearances
related
to
the
procurement,
storage,
use,
and
disposal
of
the
microorganism
as
may
be
appropriate
or
required
within
the
scope
of
conducting
a
research
and
development
activity.

TSCA
Experimental
Release
Application
or
TERA
means
an
exemption
request
for
a
research
and
development
activity,
which
is
not
eligible
for
a
full
exemption
from
reporting
under
§
725.232,
725.234,
or
725.238,
submitted
to
EPA
in
accordance
with
subpart
E
of
this
part.

Well­
characterized
for
introduced
genetic
material
means
that
the
following
have
been
determined:

(
1)
The
function
of
all
of
the
products
expressed
from
the
structural
gene(
s).
(
2)
The
function
of
sequences
that
participate
in
the
regulation
of
expression
of
the
structural
gene(
s).
(
3)
The
presence
or
absence
of
associated
nucleotide
sequences
and
their
associated
functions,
where
associated
nucleotide
sequences
are
those
sequences
needed
to
move
genetic
material
including
linkers,
homopolymers,
adaptors,
transposons,
insertion
sequences,
and
restriction
enzyme
sites.

§
725.8
Coverage
of
this
part.

(
a)
Microorganisms
subject
to
this
part.
Only
microorganisms
which
are
manufactured,
imported,
or
processed
for
commercial
purposes,
as
defined
in
§
725.3,
are
subject
to
the
requirements
of
this
part.

(
b)
Microorganisms
automatically
included
on
the
Inventory.
Microorganisms
that
are
not
intergeneric
are
automatically
included
on
the
Inventory.

(
c)
Microorganisms
not
subject
to
this
part.
The
following
microorganisms
are
not
subject
to
this
part,
either
because
they
are
not
subject
to
jurisdiction
under
the
Act
or
are
not
subject
to
reporting
under
section
5
of
the
Act.
May
10,
2004
(
1)
Any
microorganism
which
would
be
excluded
from
the
definition
of
"
chemical
substance"
in
section
3
of
the
Act
and
§
720.3(
e)
of
this
chapter.

(
2)
Any
microbial
mixture
as
defined
in
§
725.3.
This
exclusion
applies
only
to
a
microbial
mixture
as
a
whole
and
not
to
any
microorganisms
and
other
chemical
substances
which
are
part
of
the
microbial
mixture.

(
3)
Any
microorganism
that
is
manufactured
and
processed
solely
for
export
if
the
following
conditions
are
met:

(
i)
The
microorganism
is
labeled
in
accordance
with
section
12(
a)(
1)(
B)
of
the
Act,
when
the
microorganism
is
distributed
in
commerce.

(
ii)
The
manufacturer
and
processor
can
document
at
the
commencement
of
manufacturing
or
processing
that
the
person
to
whom
the
microorganism
will
be
distributed
intends
to
export
it
or
process
it
solely
for
export
as
defined
in
§
721.3
of
this
chapter.

§
725.12
Identification
of
microorganisms
for
Inventory
and
other
listing
purposes.

To
identify
and
list
microorganisms
on
the
Inventory,
both
taxonomic
designations
and
supplemental
information
will
be
used.
The
supplemental
information
required
in
paragraph
(
b)
of
this
section
will
be
used
to
specifically
describe
an
individual
microorganism
on
the
Inventory.
Submitters
must
provide
the
supplemental
information
required
by
paragraph
(
b)
of
this
section
to
the
extent
necessary
to
enable
a
microorganism
to
be
accurately
and
unambiguously
identified
on
the
Inventory.

(
a)
Taxonomic
designation.
The
taxonomic
designation
of
a
microorganism
must
be
provided
for
the
donor
organism
and
the
recipient
microorganism
to
the
level
of
strain,
as
appropriate.
These
designations
must
be
substantiated
by
a
letter
from
a
culture
collection,
literature
references,
or
the
results
of
tests
conducted
for
the
purpose
of
taxonomic
classification.
Upon
EPA's
request
to
the
submitter,
data
supporting
the
taxonomic
designation
must
be
provided
to
EPA.
The
genetic
history
of
the
recipient
microorganism
should
be
documented
back
to
the
isolate
from
which
it
was
derived.

(
b)
Supplemental
information.
The
supplemental
information
described
in
paragraphs
(
b)(
1)
and
(
b)(
2)
of
this
section
is
required
to
the
extent
that
it
enables
a
microorganism
to
be
accurately
and
unambiguously
identified.

(
1)
Phenotypic
information.
Phenotypic
information
means
pertinent
traits
that
result
from
the
interaction
of
a
microorganism's
genotype
and
the
environment
in
which
it
is
intended
to
be
used
and
may
include
intentionally
added
biochemical
and
physiological
traits.

(
2)
Genotypic
information.
Genotypic
information
means
the
pertinent
and
distinguishing
genotypic
characteristics
of
a
microorganism,
such
as
the
identity
of
the
introduced
genetic
material
and
the
methods
used
to
construct
the
reported
microorganism.
This
also
may
include
information
on
the
vector
construct,
the
cellular
location,
and
the
number
of
copies
of
the
May
10,
2004
introduced
genetic
material.

§
725.15
Determining
applicability
when
microorganism
identity
or
use
is
confidential
or
uncertain.

(
a)
Consulting
EPA.
Persons
intending
to
conduct
activities
involving
microorganisms
may
determine
their
obligations
under
this
part
by
consulting
the
Inventory
or
the
microorganisms
and
uses
specified
in
§
725.239
or
in
subpart
M
of
this
part.
This
section
establishes
procedures
for
EPA
to
assist
persons
in
determining
whether
the
microorganism
or
the
use
is
listed
on
the
Inventory,
in
§
725.239
or
in
subpart
M
of
this
part.

(
1)
Confidential
identity
or
use.
In
some
cases
it
may
not
be
possible
to
directly
determine
if
a
specific
microorganism
is
listed,
because
portions
of
that
entry
may
contain
generic
information
to
protect
confidential
business
information
(
CBI).
If
any
portion
of
the
microorganism's
identity
or
use
has
been
claimed
as
CBI,
that
portion
does
not
appear
on
the
public
version
of
the
Inventory,
in
§
725.239
or
in
subpart
M
of
this
part.
Instead,
it
is
contained
in
a
confidential
version
held
in
EPA's
Confidential
Business
Information
Center
(
CBIC).
The
public
versions
contain
generic
information
which
masks
the
confidential
business
information.
A
person
who
intends
to
conduct
an
activity
involving
a
microorganism
or
use
whose
entry
is
described
with
generic
information
will
need
to
inquire
of
EPA
whether
the
unreported
microorganism
or
use
is
on
the
confidential
version.

(
2)
Uncertain
microorganism
identity.
The
current
state
of
scientific
knowledge
leads
to
some
imprecision
in
describing
a
microorganism.
As
the
state
of
knowledge
increases,
EPA
will
be
developing
policies
to
determine
whether
one
microorganism
is
equivalent
to
another.
Persons
intending
to
conduct
activities
involving
microorganisms
may
inquire
of
EPA
whether
the
microorganisms
they
intend
to
manufacture,
import,
or
process
are
equivalent
to
specific
microorganisms
described
on
the
Inventory,
in
§
725.239,
or
in
subpart
M
of
this
part.

(
b)
Requirement
of
bona
fide
intent.
(
1)
EPA
will
answer
the
inquiries
described
in
paragraph
(
a)
of
this
section
only
if
the
Agency
determines
that
the
person
has
a
bona
fide
intent
to
conduct
the
activity
for
which
reporting
is
required
or
for
which
any
exemption
may
apply.

(
2)
To
establish
a
bona
fide
intent
to
manufacture,
import,
or
process
a
microorganism,
the
person
who
intends
to
manufacture,
import,
or
process
the
microorganism
must
submit
the
following
information
in
writing
to
the
Office
of
Pollution
Prevention
and
Toxics,
Document
Control
Officer,
7407,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460,
ATTN:
BIOTECH
bona
fide
submission.

(
i)
Taxonomic
designations
and
supplemental
information
required
by
§
725.12.
(
ii)
A
signed
statement
certifying
that
the
submitter
intends
to
manufacture,
import,
or
process
the
microorganism
for
commercial
purposes.
(
iii)
A
description
of
research
and
development
activities
conducted
with
the
microorganism
to
date,
demonstration
of
the
submitter's
ability
to
produce
or
obtain
the
microorganism
from
a
foreign
manufacturer,
and
the
purpose
for
which
the
person
will
manufacture,
import,
or
process
the
microorganism.
(
iv)
An
indication
of
whether
a
related
microorganism
was
previously
reviewed
by
EPA
to
the
May
10,
2004
extent
known
by
the
submitter.
(
v)
A
specific
description
of
the
major
intended
application
or
use
of
the
microorganism.

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

(
d)
EPA
will
review
the
information
submitted
by
the
manufacturer,
importer,
or
processor
under
this
paragraph
to
determine
whether
that
person
has
shown
a
bona
fide
intent
to
manufacture,
import,
or
process
the
microorganism.
If
necessary,
EPA
will
compare
this
information
to
the
information
requested
for
the
confidential
microorganism
under
§
725.85(
b)(
3)(
iii).

(
e)
In
order
for
EPA
to
make
a
conclusive
determination
of
the
microorganism's
status,
the
proposed
manufacturer,
importer,
or
processor
must
show
a
bona
fide
intent
to
manufacture,
import,
or
process
the
microorganism
and
must
provide
sufficient
information
to
establish
identity
unambiguously.
After
sufficient
information
has
been
provided,
EPA
will
inform
the
manufacturer,
importer,
or
processor
whether
the
microorganism
is
subject
to
this
part
and
if
so,
which
sections
of
this
part
apply.

(
f)
If
the
microorganism
is
found
on
the
confidential
version
of
the
Inventory,
in
§
725.239
or
in
subpart
M
of
this
part,
EPA
will
notify
the
person(
s)
who
originally
reported
the
microorganism
that
another
person
(
whose
identity
will
remain
confidential,
if
so
requested)
has
demonstrated
a
bona
fide
intent
to
manufacture,
import,
or
process
the
microorganism
and
therefore
was
told
that
the
microorganism
is
on
the
Inventory,
in
§
725.239,
or
in
subpart
M
of
this
part.

(
g)
A
disclosure
to
a
person
with
a
bona
fide
intent
to
manufacture,
import,
or
process
a
particular
microorganism
that
the
microorganism
is
on
the
Inventory,
in
§
725.239,
or
in
subpart
M
of
this
part
will
not
be
considered
a
public
disclosure
of
confidential
business
information
under
section
14
of
the
Act.

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

§
725.17
Consultation
with
EPA.

Persons
may
consult
with
EPA,
either
in
writing
or
by
telephone,
about
their
obligations
under
this
part.
Written
consultation
is
preferred.
Written
inquiries
should
be
sent
to
the
following
address:
Environmental
Assistance
Division
(
7408),
Office
of
Pollution
Prevention
and
Toxics,
U.
S.
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460,
ATTN:
Biotechnology
Notice
Consultation.
Persons
wishing
to
consult
with
EPA
by
telephone
should
call
(
202)
554­
1404;
hearing
impaired
TDD
(
202)
554­
0551
or
e­
mail:
TSCA­
Hotline@
epamail.
epa.
gov.

Subpart
B
­­
Administrative
Procedures
§
725.20
Scope
and
purpose.
May
10,
2004
This
subpart
describes
general
administrative
procedures
applicable
to
all
persons
who
submit
MCANs
and
exemption
requests
to
EPA
under
section
5
of
the
Act
for
microorganisms.

§
725.25
General
administrative
requirements.

(
a)
General.
(
1)
Each
person
who
is
subject
to
the
notification
provisions
of
this
part
must
complete,
sign,
and
submit
a
MCAN
or
exemption
request
containing
the
information
as
required
for
the
appropriate
submission
under
this
part.
Except
as
otherwise
provided,
each
submission
must
include
all
referenced
attachments.
All
information
in
the
submission
(
unless
certain
attachments
appear
in
the
open
scientific
literature)
must
be
in
English.
All
information
submitted
must
be
true
and
correct.

(
2)
In
addition
to
specific
information
required,
the
submitter
should
submit
all
information
known
to
or
reasonably
ascertainable
by
the
submitter
that
would
permit
EPA
to
make
a
reasoned
evaluation
of
the
human
health
and
environmental
effects
of
the
microorganism
and
any
microbial
mixture
or
article
that
may
contain
the
microorganism.

(
b)
Certification.
Persons
submitting
MCANs
and
exemption
requests
to
EPA
under
this
part,
and
material
related
to
their
reporting
obligations
under
this
part,
must
attach
the
following
statement
to
any
information
submitted
to
EPA.
This
statement
must
be
signed
and
dated
by
an
authorized
official
of
the
submitter:

I
certify
that
to
the
best
of
my
knowledge
and
belief:
The
company
named
in
this
submission
intends
to
manufacture,
import,
or
process
for
a
commercial
purpose,
other
than
in
small
quantities
solely
for
research
and
development,
the
microorganism
identified
in
this
submission.
All
information
provided
in
this
submission
is
complete
and
truthful
as
of
the
date
of
submission.
I
am
including
with
this
submission
all
test
data
in
my
possession
or
control
and
a
description
of
all
other
data
known
to
or
reasonably
ascertainable
by
me
as
required
by
40
CFR
725.160
or
725.260.

(
c)
Where
to
submit
information
under
this
part.
Persons
submitting
MCANs
and
exemption
requests
to
EPA
under
this
part,
and
material
related
to
their
reporting
obligations
under
this
part,
must
send
them
to:
TSCA
Document
Processing
Center
(
7407),
Rm.
L­
100,
Office
of
Pollution
Prevention
and
Toxics,
U.
S.
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460.

(
d)
General
requirements
for
submission
of
data.
(
1)
Submissions
under
this
part
must
include
the
information
described
in
§
725.155,
725.255,
725.355,
or
725.455,
as
appropriate,
to
the
extent
such
information
is
known
to
or
reasonably
ascertainable
by
the
submitter.

(
2)
In
accordance
with
§
725.160
or
725.260,
as
appropriate,
the
submission
must
also
include
any
test
data
in
the
submitter's
possession
or
control
and
descriptions
of
other
data
which
are
known
to
or
reasonably
ascertainable
by
the
submitter
and
which
concern
the
health
and
environmental
effects
of
the
microorganism.

(
e)
Agency
or
joint
submissions.
(
1)
A
manufacturer
or
importer
may
designate
an
agent
to
submit
the
MCAN
or
exemption
request.
Both
the
manufacturer
or
importer
and
the
agent
must
sign
the
May
10,
2004
certification
required
in
paragraph
(
b)
of
this
section.

(
2)
A
manufacturer
or
importer
may
authorize
another
person
(
e.
g.,
a
foreign
manufacturer
or
supplier,
or
a
toll
manufacturer)
to
report
some
of
the
information
required
in
the
MCAN
or
exemption
request
to
EPA
on
its
behalf.
If
separate
portions
of
a
joint
submission
are
not
submitted
together,
the
submitter
must
indicate
which
information
will
be
supplied
by
another
person
and
identify
that
person.
The
manufacturer
or
importer
and
any
other
person
supplying
the
information
must
sign
the
certification
required
by
paragraph
(
b)
of
this
section.

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

(
f)
Microorganisms
subject
to
a
section
4
test
rule.
(
1)
Except
as
provided
in
paragraph
(
f)(
3)
of
this
section,
if
a
person
intends
to
manufacture
or
import
a
new
microorganism
which
is
subject
to
the
notification
requirements
of
this
part,
and
the
microorganism
is
subject
to
a
test
rule
promulgated
under
section
4
of
the
Act
before
the
notice
is
submitted,
section
5(
b)(
1)
of
the
Act
requires
the
person
to
submit
the
test
data
required
by
the
testing
rule
with
the
notice.
The
person
must
submit
the
data
in
the
form
and
manner
specified
in
the
test
rule
and
in
accordance
with
§
725.160.
If
the
person
does
not
submit
the
test
data,
the
submission
is
incomplete
and
EPA
will
follow
the
procedures
in
§
725.33.

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

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

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

(
g)
Microorganisms
subject
to
a
section
5(
b)(
4)
rule.
(
1)
If
a
person:

(
i)
Intends
to
manufacture
or
import
a
microorganism
which
is
subject
to
the
notification
requirements
of
this
part
and
which
is
subject
to
a
rule
issued
under
section
5(
b)(
4)
of
the
Act;
and
(
ii)
Is
not
required
by
a
rule
issued
under
section
4
of
the
Act
to
submit
test
data
for
the
microorganism
before
the
filing
of
a
submission,
the
person
must
submit
to
EPA
data
described
in
paragraph
(
g)(
2)
of
this
section
at
the
time
the
submission
is
filed.

(
2)
Data
submitted
under
paragraph
(
g)(
1)
of
this
section
must
be
data
which
the
person
submitting
the
notice
believes
show
that
the
manufacture,
processing,
distribution
in
commerce,
use,
and
disposal
of
the
microorganism,
or
any
combination
of
such
activities,
will
not
present
an
May
10,
2004
unreasonable
risk
of
injury
to
health
or
the
environment.

(
h)
Data
that
need
not
be
submitted.
Specific
data
requirements
are
listed
in
subparts
D,
E,
F,
G,
and
L
of
this
part.
The
following
is
a
list
of
data
that
need
not
be
submitted
under
this
part:

(
1)
Data
previously
submitted
to
EPA.
(
i)
A
person
need
not
submit
any
data
previously
submitted
to
EPA
with
no
claims
of
confidentiality
if
the
new
submission
includes:
the
office
or
person
to
whom
the
data
were
submitted;
the
date
of
submission;
and,
if
appropriate,
a
standard
literature
citation
as
specified
in
§
725.160(
a)(
3)(
ii).
(
ii)
For
data
previously
submitted
to
EPA
with
a
claim
of
confidentiality,
the
person
must
resubmit
the
data
with
the
new
submission
and
any
claim
of
confidentiality,
under
§
725.80.

(
2)
Efficacy
data.
This
part
does
not
require
submission
of
any
data
related
solely
to
product
efficacy.
However,
including
efficacy
data
will
improve
EPA's
ability
to
assess
the
benefits
of
the
use
of
the
microorganism.
This
does
not
exempt
a
person
from
submitting
any
of
the
data
specified
in
§
725.160
or
725.260.

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

§
725.27
Submissions.

Each
person
who
is
required
to
submit
information
under
this
part
must
submit
the
information
in
the
form
and
manner
set
forth
in
the
appropriate
subpart.

(
a)
Requirements
specific
to
MCANs
are
described
in
§
§
725.150
through
725.160.
(
b)
Requirements
specific
to
TERAs
are
described
in
§
§
725.250
through
725.260.
(
c)
Requirements
specific
to
test
marketing
exemptions
(
TMEs)
are
described
in
§
§
725.350
and
725.355.
(
d)
Requirements
specific
to
Tier
I
and
Tier
II
exemptions
for
certain
general
commercial
uses
are
described
in
§
§
725.424
through
725.470.
(
e)
Additional
requirements
specific
to
significant
new
uses
for
microorganisms
are
described
at
§
725.950.

§
725.28
Notice
that
submission
is
not
required.

When
EPA
receives
a
MCAN
or
exemption
request,
EPA
will
review
it
to
determine
whether
the
microorganism
is
subject
to
the
requirements
of
this
part.
If
EPA
determines
that
the
microorganism
is
not
subject
to
these
requirements,
EPA
will
notify
the
submitter
that
section
5
of
the
Act
does
not
prevent
the
manufacture,
import,
or
processing
of
the
microorganism
and
that
the
submission
is
not
needed.

§
725.29
EPA
acknowledgement
of
receipt
of
submission.

(
a)
EPA
will
acknowledge
receipt
of
each
submission
by
sending
the
submitter
a
letter
that
May
10,
2004
identifies
the
number
assigned
to
each
MCAN
or
exemption
request
and
the
date
on
which
the
review
period
begins.
The
review
period
will
begin
on
the
date
the
MCAN
or
exemption
request
is
received
by
the
Office
of
Pollution
Prevention
and
Toxics
Document
Control
Officer.

(
b)
The
acknowledgement
does
not
constitute
a
finding
by
EPA
that
the
submission
is
in
compliance
with
this
part.

§
725.32
Errors
in
the
submission.

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

(
1)
Failure
to
date
the
submission.
(
2)
Typographical
errors
that
cause
data
to
be
misleading
or
answers
to
any
questions
to
be
unclear.
(
3)
Contradictory
information.
(
4)
Ambiguous
statements
or
information.

(
b)
In
the
request
to
correct
the
submission,
EPA
will
explain
the
action
which
the
submitter
must
take
to
correct
the
submission.

(
c)
If
the
submitter
fails
to
correct
the
submission
within
15
days
of
receipt
of
the
request,
EPA
may
extend
the
review
period.

§
725.33
Incomplete
submissions.

(
a)
A
submission
under
this
part
is
not
complete,
and
the
review
period
does
not
begin,
if:
(
1)
The
wrong
person
files
the
submission.
(
2)
The
submitter
does
not
attach
and
sign
the
certification
statement
as
required
by
§
725.25(
b).
(
3)
Some
or
all
of
the
information
in
the
submission
or
any
attachments
are
not
in
English,
except
for
published
scientific
literature.
(
4)
The
submitter
does
not
provide
information
that
is
required
by
sections
5(
d)(
1)(
B)
and
(
C)
of
the
Act
and
§
725.160
or
725.260,
as
appropriate.
(
5)
The
submitter
does
not
provide
information
required
by
§
725.25,
725.155,
725.255,
725.355,
or
725.455,
as
appropriate,
or
indicate
that
it
is
not
known
to
or
reasonably
ascertainable
by
the
submitter.
(
6)
The
submitter
has
asserted
confidentiality
claims
and
has
failed
to:
(
i)
Submit
a
second
copy
of
the
submission
with
all
confidential
information
deleted
for
the
public
file,
as
required
by
§
725.80(
b)(
2).
(
ii)
Comply
with
the
substantiation
requirements
as
described
in
§
725.94.
(
7)
The
submitter
does
not
include
any
information
required
by
section
5(
b)(
1)
of
the
Act
and
pursuant
to
a
rule
promulgated
under
section
4
of
the
Act,
as
required
by
§
725.25(
f).
(
8)
The
submitter
does
not
submit
data
which
the
submitter
believes
show
that
the
microorganism
will
not
present
an
unreasonable
risk
of
injury
to
health
or
the
environment,
if
EPA
has
listed
the
microorganism
under
section
5(
b)(
4)
of
the
Act,
as
required
in
§
725.25(
g).
(
9)
For
MCANs,
the
submitter
does
not
remit
the
fees
required
by
§
700.45(
b)(
1)
or
(
b)(
2)(
vi)
of
this
chapter.
May
10,
2004
(
b)(
1)
If
EPA
receives
an
incomplete
submission
under
this
part,
the
Director,
or
a
designee,
will
notify
the
submitter
within
30
days
of
receipt
that
the
submission
is
incomplete
and
that
the
review
period
will
not
begin
until
EPA
receives
a
complete
submission.
(
2)
If
EPA
obtains
additional
information
during
the
review
period
for
any
submission
that
indicates
the
original
submission
was
incomplete,
the
Director,
or
a
designee,
may
declare
the
submission
incomplete
within
30
days
after
EPA
obtains
the
additional
information
and
so
notify
the
submitter.

(
c)
The
notification
that
a
submission
is
incomplete
under
paragraph
(
b)
of
this
section
will
include:
(
1)
A
statement
of
the
basis
of
EPA's
determination
that
the
submission
is
incomplete.
(
2)
The
requirements
for
correcting
the
incomplete
submission.
(
3)
Information
on
procedures
under
paragraph
(
d)
of
this
section
for
filing
objections
to
the
determination
or
requesting
modification
of
the
requirements
for
completing
the
submission.

(
d)
Within
10
days
after
receipt
of
notification
by
EPA
that
a
submission
is
incomplete,
the
submitter
may
file
written
objections
requesting
that
EPA
accept
the
submission
as
complete
or
modify
the
requirements
necessary
to
complete
the
submission.

(
e)(
1)
EPA
will
consider
the
objections
filed
by
the
submitter.
The
Director,
or
a
designee,
will
determine
whether
the
submission
was
complete
or
incomplete,
or
whether
to
modify
the
requirements
for
completing
the
submission.
EPA
will
notify
the
submitter
in
writing
of
EPA's
response
within
10
days
of
receiving
the
objections.
(
2)
If
the
Director,
or
a
designee,
determines,
in
response
to
the
objection,
that
the
submission
was
complete,
the
review
period
will
be
deemed
suspended
on
the
date
EPA
declared
the
submission
incomplete,
and
will
resume
on
the
date
that
the
submission
is
declared
complete.
The
submitter
need
not
correct
the
submission
as
EPA
originally
requested.
If
EPA
can
complete
its
review
within
the
review
period
beginning
on
the
date
of
the
submission,
the
Director,
or
a
designee,
may
inform
the
submitter
that
the
running
of
the
review
period
will
resume
on
the
date
EPA
originally
declared
it
incomplete.
(
3)
If
the
Director,
or
a
designee,
modifies
the
requirements
for
completing
the
submission
or
concurs
with
EPA's
original
determination,
the
review
period
will
begin
when
EPA
receives
a
complete
submission.

(
f)
If
EPA
discovers
at
any
time
that
a
person
submitted
materially
false
or
misleading
statements
in
information
submitted
under
this
part,
EPA
may
find
that
the
submission
was
incomplete
from
the
date
it
was
submitted,
and
take
any
other
appropriate
action.

§
725.36
New
information.

(
a)
During
the
review
period,
if
a
submitter
possesses,
controls,
or
knows
of
new
information
that
materially
adds
to,
changes,
or
otherwise
makes
significantly
more
complete
the
information
included
in
the
MCAN
or
exemption
request,
the
submitter
must
send
that
information
to
the
address
listed
in
§
725.25(
c)
within
10
days
of
receiving
the
new
information,
but
no
later
than
5
days
before
the
end
of
the
review
period.

(
b)
The
new
submission
must
clearly
identify
the
submitter,
the
MCAN
or
exemption
request
to
May
10,
2004
which
the
new
information
is
related,
and
the
number
assigned
to
that
submission
by
EPA,
if
known
to
the
submitter.

(
c)
If
the
new
information
becomes
available
during
the
last
5
days
of
the
review
period,
the
submitter
must
immediately
inform
the
EPA
contact
for
that
submission
by
telephone
of
the
new
information.

§
725.40
Notice
in
the
Federal
Register.

(
a)
Filing
of
FEDERAL
REGISTER
notice.
After
EPA
receives
a
MCAN
or
an
exemption
request
under
this
part,
EPA
will
issue
a
notice
in
the
FEDERAL
REGISTER
including
the
information
specified
in
paragraph
(
b)
of
this
section.

(
b)
Contents
of
notice.
(
1)
In
the
public
interest,
the
specific
microorganism
identity
listed
in
the
submission
will
be
published
in
the
FEDERAL
REGISTER
unless
the
submitter
has
claimed
the
microorganism
identity
confidential.
If
the
submitter
claims
confidentiality,
a
generic
name
will
be
published
in
accordance
with
§
725.85.

(
2)
The
categories
of
use
of
the
microorganism
will
be
published
as
reported
in
the
submission
unless
this
information
is
claimed
confidential.
If
confidentiality
is
claimed,
the
generic
information
which
is
submitted
under
§
725.88
will
be
published.
(
3)
A
list
of
information
submitted
in
accordance
with
§
725.160(
a),
725.255,
725.260,
725.355,
or
725.455,
as
appropriate,
will
be
published.
(
4)
The
submitter's
identity
will
be
published,
unless
the
submitter
has
claimed
it
confidential.

(
c)
Publication
of
exemption
decisions.
Following
the
expiration
of
the
appropriate
review
period
for
the
exemption
request,
EPA
will
issue
a
notice
in
the
FEDERAL
REGISTER
indicating
whether
the
request
has
been
approved
or
denied
and
the
reasons
for
the
decision.

§
725.50
EPA
review.

(
a)
MCANs.
The
review
period
specified
in
section
5(
a)
of
the
Act
for
MCANs
runs
for
90
days
from
the
date
the
Document
Control
Officer
receives
a
complete
submission,
or
the
date
EPA
determines
the
submission
is
complete
under
§
725.33,
unless
the
Agency
extends
the
review
period
under
section
5(
c)
of
the
Act
and
§
725.56.

(
b)
Exemption
requests.
The
review
period
starts
on
the
date
the
Document
Control
Officer
receives
a
complete
exemption
request,
or
the
date
EPA
determines
the
request
is
complete
under
§
725.33,
unless
the
Agency
extends
the
review
period
under
§
725.56.
The
review
periods
for
exemption
requests
run
as
follows:
(
1)
TERAs.
The
review
period
for
TERAs
is
60
days.
(
2)
TMEs.
The
review
period
for
TMEs
is
45
days.
(
3)
Tier
II
exemption
requests.
The
review
period
for
Tier
II
exemption
requests
is
45
days.

§
725.54
Suspension
of
the
review
period.

(
a)
A
submitter
may
voluntarily
suspend
the
running
of
the
review
period
if
the
Director,
or
a
May
10,
2004
designee,
agrees.
If
the
Director
does
not
agree,
the
review
period
will
continue
to
run,
and
EPA
will
notify
the
submitter.
A
submitter
may
request
a
suspension
at
any
time
during
the
review
period.
The
suspension
must
be
for
a
specified
period
of
time.

(
b)
A
request
for
suspension
may
be
made
in
writing
to
the
address
listed
in
§
725.25(
c).
The
suspension
also
may
be
made
orally,
including
by
telephone,
to
the
submitter's
EPA
contact
for
that
submission.
EPA
will
send
the
submitter
a
written
confirmation
that
the
suspension
has
been
granted.
(
1)
An
oral
request
may
be
granted
for
no
longer
than
15
days.
To
obtain
a
longer
suspension,
the
Document
Control
Officer
for
the
Office
of
Pollution
Prevention
and
Toxics
must
receive
written
confirmation
of
the
oral
request.
The
review
period
is
suspended
as
of
the
date
of
the
oral
request.
(
2)
If
the
submitter
has
not
made
a
previous
oral
request,
the
running
of
the
review
period
is
suspended
as
of
the
date
of
receipt
of
the
written
request
by
the
Document
Control
Officer
for
the
Office
of
Pollution
Prevention
and
Toxics.

§
725.56
Extension
of
the
review
period.

(
a)
At
any
time
during
the
review
period,
EPA
may
unilaterally
determine
that
good
cause
exists
to
extend
the
review
period
specified
for
MCANs,
or
the
exemption
requests.

(
b)
If
EPA
makes
such
a
determination,
EPA:
(
1)
Will
notify
the
submitter
that
EPA
is
extending
the
review
period
for
a
specified
length
of
time
and
state
the
reasons
for
the
extension.
(
2)
For
MCANs,
EPA
may
issue
a
notice
for
publication
in
the
FEDERAL
REGISTER
which
states
that
EPA
is
extending
the
review
period
and
gives
the
reasons
for
the
extension.

(
c)
The
total
period
of
the
extension
may
be
for
a
period
of
up
to
the
same
length
of
time
as
specified
for
each
type
of
submission
in
§
725.50.
If
the
initial
extension
is
for
less
than
the
total
time
allowed,
EPA
may
make
additional
extensions.
However,
the
sum
of
the
extensions
may
not
exceed
the
total
allowed.

(
d)
The
following
are
examples
of
situations
in
which
EPA
may
find
that
good
cause
exists
for
extending
the
review
period:

(
1)
EPA
has
reviewed
the
submission
and
is
seeking
additional
information.
(
2)
EPA
has
received
significant
additional
information
during
the
review
period.
(
3)
The
submitter
has
failed
to
correct
a
submission
after
receiving
EPA's
request
under
§
725.32.
(
4)
EPA
has
reviewed
the
submission
and
determined
that
there
is
a
significant
possibility
that
the
microorganism
will
be
regulated
under
section
5(
e)
or
section
5(
f)
of
the
Act,
but
EPA
is
unable
to
initiate
regulatory
action
within
the
initial
review
period.

§
725.60
Withdrawal
of
submission
by
the
submitter.

(
a)
A
submitter
may
withdraw
a
submission
during
the
review
period.
A
statement
of
withdrawal
must
be
made
in
writing
to
the
address
listed
in
§
725.25(
c).
The
withdrawal
is
effective
upon
receipt
of
the
statement
by
the
Document
Control
Officer.
May
10,
2004
(
b)
If
a
manufacturer,
importer,
or
processor
who
withdrew
a
submission
later
resubmits
a
submission
for
the
same
microorganism,
a
new
review
period
begins.

§
725.65
Recordkeeping.

(
a)
General
provisions.
(
1)
Any
person
who
submits
a
notice
under
this
part
must
retain
documentation
of
information
in
the
submission,
including:
(
i)
Any
data
in
the
submitter's
possession
or
control;
and
(
ii)
Records
of
production
volume
for
the
first
3
years
of
manufacture,
import,
or
processing.

(
2)
Any
person
who
submits
a
notice
under
this
part
must
retain
documentation
of
the
date
of
commencement
of
testing,
manufacture,
import,
or
processing.

(
3)
Any
person
who
is
exempt
from
some
or
all
of
the
reporting
requirements
of
this
part
must
retain
documentation
that
supports
the
exemption.

(
4)
All
information
required
by
this
section
must
be
retained
for
3
years
from
the
date
of
commencement
of
each
activity
for
which
records
are
required
under
this
part.

(
b)
Specific
requirements.
In
addition
to
the
requirements
of
paragraph
(
a)
of
this
section,
specific
recordkeeping
requirements
included
in
certain
subparts
must
also
be
followed.

(
1)
Additional
recordkeeping
requirements
for
activities
conducted
inside
a
structure
are
set
forth
in
§
725.235(
h).
(
2)
Additional
recordkeeping
requirements
for
TERAs
are
set
forth
in
§
725.250(
f).
(
3)
Additional
recordkeeping
requirements
for
TMEs
are
set
forth
in
§
725.350(
c).
(
4)
Additional
recordkeeping
requirements
for
Tier
I
exemptions
under
subpart
G
of
this
part
are
set
forth
in
§
725.424(
a)(
5).
(
5)
Additional
recordkeeping
requirements
for
Tier
II
exemptions
under
subpart
G
of
this
part
are
set
forth
in
§
725.450(
d).
(
6)
Additional
recordkeeping
requirements
for
significant
new
uses
of
microorganisms
reported
under
subpart
L
of
this
part
are
set
forth
in
§
725.850.
Recordkeeping
requirements
may
also
be
included
when
a
microorganism
and
significant
new
use
are
added
to
subpart
M
of
this
part.

§
725.67
Applications
to
exempt
new
microorganisms
from
this
part.

(
a)
Submission.
(
1)
Any
manufacturer
or
importer
of
a
new
microorganism
may
request,
under
section
5(
h)(
4)
of
the
Act,
an
exemption,
in
whole
or
in
part,
from
this
part
by
sending
a
Letter
of
Application
to
the
Chief,
New
Chemicals
Branch,
Chemical
Control
Division,
Office
of
Pollution
Prevention
and
Toxics,
U.
S.
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460.

(
2)
General
provisions.
The
Letter
of
Application
should
provide
information
to
show
that
any
activities
affected
by
the
requested
exemption
will
not
present
an
unreasonable
risk
of
injury
to
health
or
the
environment.
This
information
should
include
data
described
in
the
following
paragraphs.
May
10,
2004
(
i)
The
effects
of
the
new
microorganism
on
health
and
the
environment.
(
ii)
The
magnitude
of
exposure
of
human
beings
and
the
environment
to
the
new
microorganism.
(
iii)
The
benefits
of
the
new
microorganism
for
various
uses
and
the
availability
of
substitutes
for
such
uses.
(
iv)
The
reasonably
ascertainable
economic
consequences
of
granting
or
denying
the
exemption,
including
effects
on
the
national
economy,
small
business,
and
technological
innovation.

(
3)
Specific
requirements.
In
addition
to
the
requirements
of
paragraph
(
a)(
2)
of
this
section,
the
specific
information
requirements
of
the
relevant
subpart
under
which
the
exemption
is
sought
should
be
met.
(
i)
Exemption
from
MCAN
reporting
under
subpart
D.
Information
requirements
are
set
forth
in
§
§
725.155
and
725.160.

(
ii)
Exemption
from
TERA
reporting
under
subpart
E.
Information
requirements
are
set
forth
in
§
§
725.255
and
725.260.
(
iii)
Listing
a
recipient
microorganism
as
eligible
for
exemption
under
subpart
G.
Information
regarding
the
following
criteria
should
be
addressed
in
an
application
to
list
a
recipient
microorganism
under
§
725.420:

(
A)
Identification
and
classification
of
the
microorganism
using
available
genotypic
and
phenotypic
information;
(
B)
Information
to
evaluate
the
relationship
of
the
microorganism
to
any
other
closely
related
microorganisms
which
have
a
potential
for
adverse
effects
on
health
or
the
environment;
(
C)
A
history
of
safe
commercial
use
for
the
microorganism;
(
D)
Commercial
uses
indicating
that
the
microorganism
products
might
be
subject
to
TSCA;
(
E)
Studies
which
indicate
the
potential
for
the
microorganism
to
cause
adverse
effects
to
health
or
the
environment;
and
(
F)
Studies
which
indicate
the
survival
characteristics
of
the
microorganism
in
the
environment.

(
b)
Processing
of
the
Letter
of
Application
by
EPA
­­
(
1)
Grant
of
the
Application.
If,
after
consideration
of
the
Letter
of
Application
and
any
other
relevant
information
available
to
EPA,
the
Assistant
Administrator
for
Prevention,
Pesticides
and
Toxic
Substances
makes
a
preliminary
determination
that
the
new
microorganism
will
not
present
an
unreasonable
risk
of
injury
to
health
or
the
environment,
the
Assistant
Administrator
will
propose
a
rule
to
grant
the
exemption
using
the
applicable
procedures
in
part
750
of
this
chapter.
(
2)
Denial
of
the
application.
If
the
Assistant
Administrator
decides
that
the
preliminary
determination
described
in
paragraph
(
b)(
1)
of
this
section
cannot
be
made,
the
application
will
be
denied
by
sending
the
applicant
a
written
statement
with
the
Assistant
Administrator's
reasons
for
denial.

(
c)
Processing
of
the
exemption
­­
(
1)
Unreasonable
risk
standard.
Granting
a
section
5(
h)(
4)
exemption
requires
a
determination
that
the
activities
will
not
present
an
unreasonable
risk
of
injury
to
health
or
the
environment.

(
i)
An
unreasonable
risk
determination
under
the
Act
is
an
administrative
judgment
that
requires
balancing
of
the
harm
to
health
or
the
environment
that
a
chemical
substance
may
cause
and
the
magnitude
and
severity
of
that
harm,
against
the
social
and
economic
effects
on
society
of
EPA
May
10,
2004
action
to
reduce
that
harm.

(
ii)
A
determination
of
unreasonable
risk
under
section
5(
h)(
4)
of
the
Act
will
examine
the
reasonably
ascertainable
economic
and
social
consequences
of
granting
or
denying
the
exemption
after
consideration
of
the
effect
on
the
national
economy,
small
business,
technological
innovation,
the
environment,
and
public
health.

(
2)
Grant
of
the
exemption.
The
exemption
will
be
granted
if
the
Assistant
Administrator
determines,
after
consideration
of
all
relevant
evidence
presented
in
the
rulemaking
proceeding
described
in
paragraph
(
b)(
1)
of
this
section,
that
the
new
microorganism
will
not
present
an
unreasonable
risk
of
injury
to
health
or
the
environment.

(
3)
Denial
of
the
exemption.
The
exemption
will
be
denied
if
the
Assistant
Administrator
determines,
after
consideration
of
all
relevant
evidence
presented
in
the
rulemaking
proceeding
described
in
paragraph
(
b)(
1)
of
this
section,
that
the
determination
described
in
paragraph
(
c)(
2)
of
this
section
cannot
be
made.
A
final
decision
terminating
the
rulemaking
proceeding
will
be
published
in
the
FEDERAL
REGISTER.

§
725.70
Compliance.

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

(
b)
A
person
who
manufactures
or
imports
a
microorganism
before
a
MCAN
is
submitted
and
the
MCAN
review
period
expires
is
in
violation
of
section
15
of
the
Act
even
if
that
person
was
not
required
to
submit
the
MCAN
under
§
725.105.

(
c)
Using
a
microorganism
which
a
person
knew
or
had
reason
to
know
was
manufactured,
processed,
or
distributed
in
commerce
in
violation
of
section
5
of
the
Act
or
this
part
is
a
violation
of
section
15
of
the
Act
(
15
U.
S.
C.
2614).

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

(
e)
Failure
or
refusal
to
permit
entry
or
inspection
as
required
by
section
11
of
the
Act
is
a
violation
of
section
15
of
the
Act
(
15
U.
S.
C.
2614).

(
f)
Violators
may
be
subject
to
the
civil
and
criminal
penalties
in
section
16
of
the
Act
(
15
U.
S.
C.
2615)
for
each
violation.
Persons
who
submit
materially
misleading
or
false
information
in
connection
with
the
requirements
of
any
provision
of
this
part
may
be
subject
to
penalties
calculated
as
if
they
never
filed
their
submissions.

(
g)
EPA
may
seek
to
enjoin
the
manufacture
or
processing
of
a
microorganism
in
violation
of
this
part
or
act
to
seize
any
microorganism
manufactured
or
processed
in
violation
of
this
part
or
take
other
actions
under
the
authority
of
section
7
of
the
Act
(
15
U.
S.
C.
2606)
or
section
17
of
the
Act
(
15
U.
S.
C.
2616).
May
10,
2004
§
725.75
Inspections.

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

Subpart
C
­­
Confidentiality
and
Public
Access
to
Information
§
725.80
General
provisions
for
confidentiality
claims.

(
a)
A
person
may
assert
a
claim
of
confidentiality
for
any
information
submitted
to
EPA
under
this
part.
However,
(
1)
Any
person
who
asserts
a
claim
of
confidentiality
for
portions
of
the
specific
microorganism
identity
must
provide
the
information
as
described
in
§
725.85.
(
2)
Any
person
who
asserts
a
claim
of
confidentiality
for
a
use
of
a
microorganism
must
provide
the
information
as
described
in
§
725.88.
(
3)
Any
person
who
asserts
a
claim
of
confidentiality
for
information
contained
in
a
health
and
safety
study
of
a
microorganism
must
provide
the
information
described
in
§
725.92.

(
b)
Any
claim
of
confidentiality
must
accompany
the
information
when
it
is
submitted
to
EPA.
(
1)
When
a
person
submits
any
information
under
this
part,
including
any
attachments,
for
which
claims
of
confidentiality
are
made,
the
claim(
s)
must
be
asserted
by
circling
the
specific
information
which
is
claimed
and
marking
the
page
on
which
that
information
appears
with
an
appropriate
designation
such
as
"
trade
secret,"
"
TSCA
CBI,"
or
"
confidential
business
information."
(
2)
If
any
information
is
claimed
confidential,
the
person
must
submit
two
copies
of
the
document
including
the
claimed
information.
(
i)
One
copy
of
the
document
must
be
complete.
In
that
copy,
the
submitter
must
mark
the
information
which
is
claimed
as
confidential
in
the
manner
prescribed
in
paragraph
(
b)(
1)
of
this
section.
(
ii)
The
second
copy
must
be
complete
except
that
all
information
claimed
as
confidential
in
the
first
copy
must
be
deleted.
EPA
will
place
the
second
copy
in
the
public
file.
(
iii)
If
the
submitter
does
not
provide
the
second
copy,
the
submission
is
incomplete
and
the
review
period
does
not
begin
to
run
until
EPA
receives
the
second
copy,
in
accordance
with
§
725.33.
(
iv)
Any
information
contained
within
the
copy
submitted
under
paragraph
(
b)(
2)(
ii)
of
this
section
which
has
been
in
the
public
file
for
more
than
30
days
will
be
presumed
to
be
in
the
public
domain,
notwithstanding
any
assertion
of
confidentiality
made
under
this
section.
(
3)
A
person
who
submits
information
to
EPA
under
this
part
must
reassert
a
claim
of
confidentiality
and
substantiate
the
claim
each
time
the
information
is
submitted
to
EPA.

(
c)
Any
person
asserting
a
claim
of
confidentiality
under
this
part
must
substantiate
each
claim
in
accordance
with
the
requirements
in
§
725.94.

(
d)
EPA
will
disclose
information
that
is
subject
to
a
claim
of
confidentiality
asserted
under
this
section
only
to
the
extent
permitted
by
the
Act,
this
subpart,
and
part
2
of
this
title.
May
10,
2004
(
e)
If
a
submitter
does
not
assert
a
claim
of
confidentiality
for
information
at
the
time
it
is
submitted
to
EPA,
EPA
may
make
the
information
public
and
place
it
in
the
public
file
without
further
notice
to
the
submitter.

§
725.85
Microorganism
identity.

(
a)
Claims
applicable
to
the
period
prior
to
commencement
of
manufacture
or
import
for
general
commercial
use
­­
(
1)
When
to
make
a
claim.
(
i)
A
person
who
submits
information
to
EPA
under
this
part
may
assert
a
claim
of
confidentiality
for
portions
of
the
specific
microorganism
identity
at
the
time
of
submission
of
the
information.
This
claim
will
apply
only
to
the
period
prior
to
the
commencement
of
manufacture
or
import
for
general
commercial
use.
(
ii)
A
person
who
submits
information
to
EPA
under
this
part
must
reassert
a
claim
of
confidentiality
and
substantiate
the
claim
each
time
the
information
is
submitted
to
EPA.
For
example,
if
a
person
claims
certain
information
confidential
in
a
TERA
submission
and
wishes
the
same
information
to
remain
confidential
in
a
subsequent
TERA
or
MCAN
submission,
the
person
must
reassert
and
resubstantiate
the
claim
in
the
subsequent
submission.

(
2)
Assertion
of
claim.
(
i)
A
submitter
may
assert
a
claim
of
confidentiality
only
if
the
submitter
believes
that
public
disclosure
prior
to
commencement
of
manufacture
or
import
for
general
commercial
use
of
the
fact
that
anyone
is
initiating
research
and
development
activities
pertaining
to
the
specific
microorganism
or
intends
to
manufacture
or
import
the
specific
microorganism
for
general
commercial
use
would
reveal
confidential
business
information.
Claims
must
be
substantiated
in
accordance
with
the
requirements
of
§
725.94(
a).
(
ii)
If
the
submission
includes
a
health
and
safety
study
concerning
the
microorganism
and
if
the
claim
for
confidentiality
with
respect
to
the
specific
identity
is
denied
in
accordance
with
§
725.92(
c),
EPA
will
deny
a
claim
asserted
under
paragraph
(
a)
of
this
section.

(
3)
Development
of
generic
name.
Any
person
who
asserts
a
claim
of
confidentiality
for
portions
of
the
specific
microorganism
identity
under
this
paragraph
must
provide
one
of
the
following
items
at
the
time
the
submission
is
filed:
(
i)
The
generic
name
which
was
accepted
by
EPA
in
the
prenotice
consultation
conducted
under
paragraph
(
a)(
4)
of
this
section.
(
ii)
One
generic
name
that
is
only
as
generic
as
necessary
to
protect
the
confidential
identity
of
the
particular
microorganism.
The
name
should
reveal
the
specific
identity
to
the
maximum
extent
possible.
The
generic
name
will
be
subject
to
EPA
review
and
approval.

(
4)
Determination
by
EPA.
(
i)
Any
person
who
intends
to
assert
a
claim
of
confidentiality
for
the
specific
identity
of
a
new
microorganism
may
seek
a
determination
by
EPA
of
an
appropriate
generic
name
for
the
microorganism
before
filing
a
submission.
For
this
purpose,
the
person
should
submit
to
EPA:
(
A)
The
specific
identity
of
the
microorganism.
(
B)
A
proposed
generic
name(
s)
which
is
only
as
generic
as
necessary
to
protect
the
confidential
identity
of
the
new
microorganism.
The
name(
s)
should
reveal
the
specific
identity
of
the
microorganism
to
the
maximum
extent
possible.
(
ii)
Within
30
days,
EPA
will
inform
the
submitter
either
that
one
of
the
proposed
generic
names
is
adequate
or
that
none
is
adequate
and
further
consultation
is
necessary.
May
10,
2004
(
5)
Use
of
generic
name.
If
a
submitter
claims
microorganism
identity
as
confidential
under
paragraph
(
a)
of
this
section,
and
if
the
submitter
complies
with
paragraph
(
a)(
2)
of
this
section,
EPA
will
issue
for
publication
in
the
FEDERAL
REGISTER
notice
described
in
§
725.40
the
generic
name
proposed
by
the
submitter
or
one
agreed
upon
by
EPA
and
the
submitter.

(
b)
Claims
applicable
to
the
period
after
commencement
of
manufacture
or
import
for
general
commercial
use
­­
(
1)
Maintaining
claim.
Any
claim
of
confidentiality
under
paragraph
(
a)
of
this
section
is
applicable
only
until
the
microorganism
is
manufactured
or
imported
for
general
commercial
use
and
becomes
eligible
for
inclusion
on
the
Inventory.
To
maintain
the
confidential
status
of
the
microorganism
identity
when
the
microorganism
is
added
to
the
Inventory,
a
submitter
must
reassert
the
confidentiality
claim
and
substantiate
the
claim
in
the
notice
of
commencement
of
manufacture
required
under
§
725.190.
(
i)
A
submitter
may
not
claim
the
microorganism
identity
confidential
for
the
period
after
commencement
of
manufacture
or
import
for
general
commercial
use
unless
the
submitter
claimed
the
microorganism
identity
confidential
under
paragraph
(
a)
of
this
section
in
the
MCAN
submitted
for
the
microorganism.
(
ii)
A
submitter
may
claim
the
microorganism
identity
confidential
for
the
period
after
commencement
of
manufacture
or
import
for
general
commercial
use
if
the
submitter
did
not
claim
the
microorganism
identity
confidential
under
paragraph
(
a)
of
this
section
in
any
TERA
submitted
for
the
microorganism,
but
subsequently
did
claim
microorganism
identity
confidential
in
the
MCAN
submitted
for
the
microorganism.

(
2)
Assertion
of
claim.
(
i)
A
person
who
believes
that
public
disclosure
of
the
fact
that
anyone
manufactures
or
imports
the
microorganism
for
general
commercial
use
would
reveal
confidential
business
information
may
assert
a
claim
of
confidentiality
under
paragraph
(
b)
of
this
section.
(
ii)
If
the
notice
includes
a
health
and
safety
study
concerning
the
new
microorganism,
and
if
the
claim
for
confidentiality
with
respect
to
the
microorganism
identity
is
denied
in
accordance
with
§
725.92(
c),
EPA
will
deny
a
claim
asserted
under
paragraph
(
b)
of
this
section.

(
3)
Requirements
for
assertion.
Any
person
who
asserts
a
confidentiality
claim
for
microorganism
identity
must:
(
i)
Comply
with
the
requirements
of
paragraph
(
a)(
3)
of
this
section
regarding
submission
of
a
generic
name.
(
ii)
Agree
that
EPA
may
disclose
to
a
person
with
a
bona
fide
intent
to
manufacture
or
import
the
microorganism
the
fact
that
the
particular
microorganism
is
included
on
the
confidential
Inventory
for
purposes
of
notification
under
section
5(
a)(
1)(
A)
of
the
Act.
(
iii)
Have
available
and
agree
to
furnish
to
EPA
upon
request
the
taxonomic
designations
and
supplemental
information
required
by
§
725.12.
(
iv)
Provide
a
detailed
written
substantiation
of
the
claim,
in
accordance
with
the
requirements
of
§
725.94(
b).

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

(
5)
Acceptance
of
claim.
(
i)
EPA
will
publish
a
generic
name
on
the
public
Inventory
if:
(
A)
The
submitter
asserts
a
claim
of
confidentiality
in
accordance
with
this
paragraph.
(
B)
No
claim
for
confidentiality
of
the
microorganism
identity
as
part
of
a
health
and
safety
study
has
been
denied
in
accordance
with
part
2
of
this
title
or
§
725.92.
May
10,
2004
(
ii)
Publication
of
a
generic
name
on
the
public
Inventory
does
not
create
a
category
for
purposes
of
the
Inventory.
Any
person
who
has
a
bona
fide
intent
to
manufacture
or
import
a
microorganism
which
is
described
by
a
generic
name
on
the
public
Inventory
may
submit
an
inquiry
to
EPA
under
§
725.15(
b)
to
determine
whether
the
particular
microorganism
is
included
on
the
confidential
Inventory.
(
iii)
Upon
receipt
of
a
request
described
in
§
725.15(
b),
EPA
may
require
the
submitter
who
originally
asserted
confidentiality
for
a
microorganism
to
submit
to
EPA
the
information
listed
in
paragraph
(
b)(
3)(
iii)
of
this
section.
(
iv)
Failure
to
submit
any
of
the
information
required
under
paragraph
(
b)(
3)(
iii)
of
this
section
within
10
calendar
days
of
receipt
of
a
request
by
EPA
under
paragraph
(
b)
of
this
section
will
constitute
a
waiver
of
the
original
submitter's
confidentiality
claim.
In
this
event,
EPA
may
place
the
specific
microorganism
identity
on
the
public
Inventory
without
further
notice
to
the
original
submitter.

(
6)
Use
of
generic
name
on
the
public
Inventory.
If
a
submitter
asserts
a
claim
of
confidentiality
under
paragraph
(
b)
of
this
section,
EPA
will
examine
the
generic
microorganism
name
proposed
by
the
submitter.
(
i)
If
EPA
determines
that
the
generic
name
proposed
by
the
submitter
is
only
as
generic
as
necessary
to
protect
the
confidential
identity
of
the
particular
microorganism,
EPA
will
place
that
generic
name
on
the
public
Inventory.
(
ii)
If
EPA
determines
that
the
generic
name
proposed
by
the
submitter
is
more
generic
than
necessary
to
protect
the
confidential
identity,
EPA
will
propose
in
writing,
for
review
by
the
submitter,
an
alternative
generic
name
that
will
reveal
the
identity
of
the
microorganism
to
the
maximum
extent
possible.
(
iii)
If
the
generic
name
proposed
by
EPA
is
acceptable
to
the
submitter,
EPA
will
place
that
generic
name
on
the
public
Inventory.
(
iv)
If
the
generic
name
proposed
by
EPA
is
not
acceptable
to
the
submitter,
the
submitter
must
explain
in
detail
why
disclosure
of
that
generic
name
would
reveal
confidential
business
information
and
propose
another
generic
name
which
is
only
as
generic
as
necessary
to
protect
the
confidential
identity
of
the
microorganism.
If
EPA
does
not
receive
a
response
from
the
submitter
within
30
days
after
the
submitter
receives
the
proposed
name,
EPA
will
place
EPA's
chosen
generic
name
on
the
public
Inventory.
If
the
submitter
does
provide
the
information
requested,
EPA
will
review
the
response.
If
the
submitter's
proposed
generic
name
is
acceptable,
EPA
will
publish
that
generic
name
on
the
public
Inventory.
If
the
submitter's
proposed
generic
name
is
not
acceptable,
EPA
will
notify
the
submitter
of
EPA's
choice
of
a
generic
name.
Thirty
days
after
this
notification,
EPA
will
place
the
chosen
generic
name
on
the
public
Inventory.

§
725.88
Uses
of
a
microorganism.

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

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

(
1)
Report
the
categories
or
proposed
categories
of
use
of
the
microorganism.
(
2)
Provide,
in
nonconfidential
form,
a
description
of
the
uses
that
is
only
as
generic
as
necessary
to
protect
the
confidential
business
information.
The
generic
use
description
will
be
included
in
May
10,
2004
the
FEDERAL
REGISTER
notice
described
in
§
725.40.

(
c)
Generic
use
description.
The
person
must
submit
the
information
required
by
paragraph
(
b)
of
this
section
by
describing
the
uses
as
precisely
as
possible,
without
revealing
the
information
which
is
claimed
confidential,
to
disclose
as
much
as
possible
how
the
use
may
result
in
human
exposure
to
the
microorganism
or
its
release
to
the
environment.

§
725.92
Data
from
health
and
safety
studies
of
microorganisms.

(
a)
Information
other
than
specific
microorganism
identity.
Except
as
provided
in
paragraph
(
b)
of
this
section,
EPA
will
deny
any
claim
of
confidentiality
with
respect
to
information
included
in
a
health
and
safety
study
of
a
microorganism,
unless
the
information
would
disclose
confidential
business
information
concerning:

(
1)
Processes
used
in
the
manufacture
or
processing
of
a
microorganism.
(
2)
Information
which
is
not
in
any
way
related
to
the
effects
of
a
microorganism
on
health
or
the
environment,
such
as,
the
name
of
the
submitting
company,
cost
or
other
financial
data,
product
development
or
marketing
plans,
and
advertising
plans,
for
which
the
person
submits
a
claim
of
confidentiality
in
accordance
with
§
725.80.

(
b)
Microorganism
identity
­­
(
1)
Claims
applicable
to
the
period
prior
to
commencement
of
manufacture
or
import
for
general
commercial
use.
A
claim
of
confidentiality
for
the
period
prior
to
commencement
of
manufacture
or
import
for
general
commercial
use
for
the
specific
identity
of
a
microorganism
for
which
a
health
and
safety
study
was
submitted
must
be
asserted
in
conjunction
with
a
claim
asserted
under
§
725.85(
a).
The
submitter
must
substantiate
each
claim
in
accordance
with
the
requirements
of
§
725.94(
a).

(
2)
Claims
applicable
to
the
period
after
commencement
of
manufacture
or
import
for
general
commercial
use.
To
maintain
the
confidential
status
of
the
specific
identity
of
a
microorganism
for
which
a
health
and
safety
study
was
submitted
after
commencement
of
manufacture
or
import
for
general
commercial
use,
the
claim
must
be
reasserted
and
substantiated
in
conjunction
with
a
claim
under
§
725.85(
b).
The
submitter
must
substantiate
each
claim
in
accordance
with
the
requirements
of
§
725.94(
b).

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

(
1)
The
information
would
disclose
processes
used
in
the
manufacture
or
processing
of
a
microorganism.
(
2)
The
microorganism
identity
is
not
necessary
to
interpret
a
health
and
safety
study.

(
d)
Use
of
generic
names.
When
EPA
discloses
a
health
and
safety
study
containing
a
microorganism
identity,
which
the
submitter
has
claimed
confidential,
and
if
the
Agency
has
not
denied
the
claim
under
paragraph
(
c)
of
this
section,
EPA
will
identify
the
microorganism
by
the
generic
name
selected
under
§
725.85.
May
10,
2004
§
725.94
Substantiation
requirements.

(
a)
Claims
applicable
to
the
period
prior
to
commencement
of
manufacture
or
import
for
general
commercial
use
 
(
1)
MCAN,
TME,
Tier
I
certification,
and
Tier
II
exemption
request
requirements.
Any
person
who
submits
a
MCAN,
TME,
Tier
I
certification,
or
Tier
II
exemption
request
should
strictly
limit
confidentiality
claims
to
that
information
which
is
confidential
and
proprietary
to
the
business.
(
i)
If
any
information
in
the
submission
is
claimed
as
confidential
business
information,
the
submitter
must
substantiate
each
claim
by
submitting
written
answers
to
the
questions
in
paragraphs
(
c),
(
d),
and
(
e)
of
this
section
at
the
time
the
person
submits
the
information.
(
ii)
If
the
submitter
does
not
provide
written
substantiation
as
required
in
paragraph
(
a)(
1)(
i)
of
this
section,
the
submission
will
be
considered
incomplete
and
the
review
period
will
not
begin
in
accordance
with
§
725.33.

(
2)
TERA
requirements.
Any
person
who
submits
a
TERA,
should
strictly
limit
confidentiality
claims
to
that
information
which
is
confidential
and
proprietary
to
the
business.
If
any
information
in
such
a
submission
is
claimed
as
confidential
business
information,
the
submitter
must
have
available
for
each
of
those
claims,
and
agree
to
furnish
to
EPA
upon
request,
written
answers
to
the
questions
in
paragraphs
(
d)
and
(
e)
of
this
section.

(
b)
Claims
applicable
to
the
period
after
commencement
of
manufacture
or
import
for
general
commercial
use.
(
1)
If
a
submitter
claimed
portions
of
the
microorganism
identity
confidential
in
the
MCAN
and
wants
the
identity
to
be
listed
on
the
confidential
Inventory,
the
claim
must
be
reasserted
and
substantiated
at
the
time
the
Notice
of
Commencement
(
NOC)
is
submitted
under
§
725.190.
Otherwise,
EPA
will
list
the
specific
microorganism
identity
on
the
public
Inventory.

(
2)
The
submitter
must
substantiate
the
claim
for
confidentiality
of
the
microorganism
identity
by
answering
all
of
the
questions
in
paragraphs
(
c),
(
d),
and
(
e)
in
this
section.
In
addition,
the
following
questions
must
be
answered:
(
i)
What
harmful
effects
to
the
company's
or
institution's
competitive
position,
if
any,
would
result
if
EPA
publishes
on
the
Inventory
the
identity
of
the
microorganism?
How
could
a
competitor
use
such
information
given
the
fact
that
the
identity
of
the
microorganism
otherwise
would
appear
on
the
TSCA
Inventory
with
no
link
between
the
microorganism
and
the
company
or
institution?
How
substantial
would
the
harmful
effects
of
disclosure
be?
What
is
the
causal
relationship
between
the
disclosure
and
the
harmful
effects?
(
ii)
Has
the
identity
of
the
microorganism
been
kept
confidential
to
the
extent
that
competitors
do
not
know
it
is
being
manufactured
or
imported
for
general
commercial
use
by
anyone?

(
c)
General
questions.
The
following
questions
must
be
answered
in
detail
for
each
confidentiality
claim:

(
1)
For
what
period
of
time
is
a
claim
of
confidentiality
being
asserted?
If
the
claim
is
to
extend
until
a
certain
event
or
point
in
time,
indicate
that
event
or
time
period.
Explain
why
the
information
should
remain
confidential
until
such
point.

(
2)
Briefly
describe
any
physical
or
procedural
restrictions
within
the
company
or
institution
relating
to
the
use
and
storage
of
the
information
claimed
as
confidential.
What
other
steps,
if
any,
May
10,
2004
apply
to
use
or
further
disclosure
of
the
information?

(
3)
Has
the
information
claimed
as
confidential
been
disclosed
to
individuals
outside
of
the
company
or
institution?
Will
it
be
disclosed
to
such
persons
in
the
future?
If
so,
what
restrictions,
if
any,
apply
to
use
or
further
disclosure
of
the
information?

(
4)
Does
the
information
claimed
as
confidential
appear,
or
is
it
referred
to,
in
any
of
the
following
questions?
If
the
answer
is
yes
to
any
of
these
questions,
indicate
where
the
information
appears
and
explain
why
it
should
nonetheless
be
treated
as
confidential.
(
i)
Advertising
or
promotional
materials
for
the
microorganism
or
the
resulting
end
product?
(
ii)
Material
safety
data
sheets
or
other
similar
materials
for
the
microorganism
or
the
resulting
end
product?
(
iii)
Professional
or
trade
publications?
(
iv)
Any
other
media
available
to
the
public
or
to
competitors?
(
v)
Patents?
(
vi)
Local,
State,
or
Federal
agency
public
files?

(
5)
Has
EPA,
another
Federal
agency,
a
Federal
court,
or
a
State
made
any
confidentiality
determination
regarding
the
information
claimed
as
confidential?
If
so,
provide
copies
of
such
determinations.

(
6)
For
each
type
of
information
claimed
confidential,
describe
the
harm
to
the
company's
or
institution's
competitive
position
that
would
result
if
this
information
were
disclosed.
Why
would
this
harm
be
substantial?
How
could
a
competitor
use
such
information?
What
is
the
causal
connection
between
the
disclosure
and
harm?

(
7)
If
EPA
disclosed
to
the
public
the
information
claimed
as
confidential,
how
difficult
would
it
be
for
the
competitor
to
enter
the
market
for
the
resulting
product?
Consider
such
constraints
as
capital
and
marketing
cost,
specialized
technical
expertise,
or
unusual
processes.

(
d)
Microorganism
identity
and
production
method.
If
confidentiality
claims
are
asserted
for
the
identity
of
the
microorganism
or
information
on
how
the
microorganism
is
produced,
the
following
questions
must
be
answered:

(
1)
Has
the
microorganism
or
method
of
production
been
patented
in
the
U.
S.
or
elsewhere?
If
so,
why
is
confidentiality
necessary?
(
2)
Does
the
microorganism
leave
the
site
of
production
or
testing
in
a
form
which
is
accessible
to
the
public
or
to
competitors?
What
is
the
cost
to
a
competitor,
in
time
and
money,
to
develop
appropriate
use
conditions?
What
factors
facilitate
or
impede
product
analysis?
(
3)
For
each
additional
type
of
information
claimed
as
confidential,
explain
what
harm
would
result
from
disclosure
of
each
type
of
information
if
the
identity
of
the
microorganism
were
to
remain
confidential.

(
e)
Health
and
safety
studies
of
microorganisms.
If
confidentiality
claims
are
asserted
for
information
in
a
health
or
safety
study
of
a
microorganism,
the
following
questions
must
be
answered:
May
10,
2004
(
1)
Would
the
disclosure
of
the
information
claimed
confidential
reveal:
confidential
process
information,
or
information
unrelated
to
the
effects
of
the
microorganism
on
health
and
the
environment.
Describe
the
causal
connection
between
the
disclosure
and
harm.
(
2)
Does
the
company
or
institution
assert
that
disclosure
of
the
microorganism
identity
is
not
necessary
to
interpret
any
health
and
safety
studies
which
have
been
submitted?
If
so,
explain
how
a
less
specific
identity
would
be
sufficient
to
interpret
the
studies.

§
725.95
Public
file.

All
information
submitted,
including
any
health
and
safety
study
of
a
microorganism
and
other
supporting
documentation,
will
become
part
of
the
public
file
for
that
submission,
unless
such
materials
are
claimed
confidential.
In
addition,
EPA
may
add
materials
to
the
public
file,
unless
such
materials
are
claimed
confidential.
Any
of
the
nonconfidential
material
described
in
this
subpart
will
be
available
for
public
inspection
in
the
TSCA
Public
Docket
Office,
Rm.
NE­
B607,
401
M
St.,
SW.,
Washington,
DC,
between
the
hours
of
noon
to
4
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.

Subpart
D
­­
Microbial
Commercial
Activities
Notification
Requirements
§
725.100
Scope
and
purpose.

(
a)
This
subpart
establishes
procedures
for
submission
of
a
notice
to
EPA
under
section
5(
a)
of
the
Act
for
persons
who
manufacture,
import,
or
process
microorganisms
for
commercial
purposes.
This
notice
is
called
a
Microbial
Commercial
Activity
Notice
(
MCAN).
It
is
expected
that
MCANs
will
in
general
only
be
submitted
for
microorganisms
intended
for
general
commercial
use.
Persons
who
manufacture,
import,
or
process
a
microorganism
in
small
quantities
solely
for
research
and
development
as
defined
in
§
725.3
are
not
required
to
submit
a
notice
to
EPA.
Persons
who
manufacture,
import,
or
process
a
microorganism
for
research
and
development
activities
that
do
not
fit
the
definition
of
small
quantities
solely
for
research
and
development
may
nonetheless
qualify
for
more
limited
reporting
requirements
in
Subpart
E,
including
the
TERA
which
can
be
used
for
review
of
research
and
development
involving
environmental
release.
(
b)
Persons
subject
to
MCAN
submission
are
described
in
§
725.105.
(
c)
Exclusions
and
exemptions
specific
to
MCAN
submissions
are
described
in
§
725.110.
(
d)
Submission
requirements
applicable
specifically
to
MCANs
are
described
at
§
725.150.
(
e)
Data
requirements
for
MCANs
are
set
forth
in
§
§
725.155
and
725.160.
(
f)
EPA
review
procedures
specific
to
MCANs
are
set
forth
in
§
725.170.
(
g)
Subparts
A
through
C
of
this
part
apply
to
any
MCAN
submitted
under
this
subpart.

§
725.105
Persons
who
must
report.

(
a)
Manufacturers
of
new
microorganisms.
(
1)
MCAN
submission
is
required
for
any
person
who
intends
to
manufacture
for
commercial
purposes
in
the
United
States
a
new
microorganism.
Exclusions
are
described
in
§
725.110.
May
10,
2004
(
2)
If
a
person
contracts
with
a
manufacturer
to
produce
or
process
a
new
microorganism
and
the
manufacturer
produces
or
processes
the
microorganism
exclusively
for
that
person,
and
that
person
specifies
the
identity
of
the
microorganism,
and
controls
the
total
amount
produced
and
the
basic
technology
for
the
plant
process,
then
that
person
must
submit
the
MCAN.
If
it
is
unclear
who
must
report,
EPA
should
be
contacted
to
determine
who
must
submit
the
MCAN.

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

(
b)
Importers
of
new
microorganisms.
(
1)
MCAN
submission
is
required
for
a
person
who
intends
to
import
into
the
United
States
for
commercial
purposes
a
new
microorganism.
Exclusions
are
described
in
§
725.110.

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

(
3)
Except
as
otherwise
provided
in
paragraph
(
b)(
4)
of
this
section,
the
provisions
of
this
subpart
D
apply
to
each
person
who
submits
a
MCAN
for
a
new
microorganism
which
such
person
intends
to
import
for
a
commercial
purpose.
In
addition,
each
importer
must
comply
with
paragraph
(
b)(
4)
of
this
section.

(
4)
EPA
will
hold
the
principal
importer,
or
the
importer
that
EPA
determines
must
submit
the
MCAN
when
there
is
no
principal
importer
under
paragraph
(
b)(
2)
of
this
section,
liable
for
complying
with
this
part,
for
completing
the
MCAN,
and
for
the
completeness
and
truthfulness
of
all
information
which
it
submits.

(
c)
Manufacturers,
importers,
or
processors
of
microorganisms
for
a
significant
new
use.
MCAN
submission
is
required
for
any
person
who
intends
to
manufacture,
import,
or
process
for
commercial
purposes
a
microorganism
identified
as
having
one
or
more
significant
new
uses
in
subpart
M
of
this
part,
and
who
intends
either
to
engage
in
a
designated
significant
new
use
of
the
microorganism
or
intends
to
distribute
it
in
commerce.
Persons
excluded
from
reporting
on
significant
new
uses
of
microorganisms
and
additional
procedures
for
reporting
are
described
in
subpart
L
of
this
part.

§
725.110
Persons
not
subject
to
this
subpart.

Persons
are
not
subject
to
the
requirements
of
this
subpart
for
the
following
activities:

(
a)
Manufacturing,
importing,
or
processing
solely
for
research
and
development
microorganisms
that
meet
the
requirements
for
an
exemption
under
subpart
E
of
this
part.
(
b)
Manufacturing,
importing,
or
processing
microorganisms
for
test
marketing
activities
which
have
been
granted
an
exemption
under
subpart
F
of
this
part.
(
c)
Manufacturing
or
importing
new
microorganisms
under
the
conditions
of
a
Tier
I
or
Tier
II
exemption
under
subpart
G
of
this
part.
May
10,
2004
§
725.150
Procedural
requirements
for
this
subpart.

General
requirements
for
all
MCANs
under
this
part
are
contained
in
subparts
A
through
C
of
this
part.
In
addition,
the
following
requirements
apply
to
MCANs
submitted
under
this
subpart:

(
a)
When
to
submit
a
MCAN.
A
MCAN
must
be
submitted
at
least
90
calendar
days
prior
to
manufacturing
or
importing
a
new
microorganism
and
at
least
90
calendar
days
prior
to
manufacturing,
importing,
or
processing
a
microorganism
for
a
significant
new
use.
(
b)
Section
5(
b)
of
the
Act.
The
submitter
must
comply
with
any
applicable
requirement
of
section
5(
b)
of
the
Act
for
the
submission
of
test
data.
(
c)
Contents
of
a
MCAN.
Each
person
who
submits
a
MCAN
under
this
subpart
must
provide
the
information
and
test
data
described
in
§
§
725.155
and
725.160.
(
d)
Recordkeeping.
Each
person
who
submits
a
MCAN
under
this
subpart
must
comply
with
the
recordkeeping
requirements
of
§
725.65.

§
725.155
Information
to
be
included
in
the
MCAN.

(
a)
Each
person
who
is
required
by
this
part
to
submit
a
MCAN
must
include
the
information
specified
in
paragraphs
(
c)
through
(
h)
of
this
section,
to
the
extent
it
is
known
to
or
reasonably
ascertainable
by
that
person.
However,
no
person
is
required
to
include
information
which
relates
solely
to
exposure
of
humans
or
ecological
populations
outside
of
the
United
States.

(
b)
Each
person
should
also
submit,
in
writing,
all
other
information
known
to
or
reasonably
ascertainable
by
that
person
that
would
permit
EPA
to
make
a
reasoned
evaluation
of
the
health
and
environmental
effects
of
the
microorganism,
or
any
microbial
mixture
or
article,
including
information
on
its
effects
on
humans,
animals,
plants,
and
other
microorganisms,
and
in
the
environment.
The
information
to
be
submitted
under
this
subpart
includes
the
information
listed
in
paragraphs
(
c)
through
(
h)
of
this
section
relating
to
the
manufacture,
processing,
distribution
in
commerce,
use,
and
disposal
of
the
new
microorganism.

(
c)
Submitter
identification.
(
1)
The
name
and
headquarters
address
of
the
submitter.
(
2)
The
name,
address,
and
office
telephone
number
(
including
area
code)
of
the
principal
technical
contact
representing
the
submitter.

(
d)
Microorganism
identity
information.
Persons
must
submit
sufficient
information
to
allow
the
microorganism
to
be
accurately
and
unambiguously
identified
for
listing
purposes
as
required
by
§
725.12.

(
1)
Description
of
the
recipient
microorganism
and
the
new
microorganism.
(
i)
Data
substantiating
the
taxonomy
of
the
recipient
microorganism
and
the
new
microorganism
to
the
level
of
strain,
as
appropriate.
In
lieu
of
data,
EPA
will
accept
a
letter
from
a
culture
collection
substantiating
taxonomy,
provided
EPA,
upon
request
to
the
submitter,
may
have
access
to
the
data
supporting
the
taxonomic
designation.
(
ii)
Information
on
the
morphological
and
physiological
features
of
the
new
microorganism.
(
iii)
Other
specific
data
by
which
the
new
microorganism
may
be
uniquely
identified
for
Inventory
purposes.
May
10,
2004
(
2)
Genetic
construction
of
the
new
microorganism.
(
i)
Data
substantiating
the
taxonomy
of
the
donor
organism(
s).
In
lieu
of
data,
EPA
will
accept
a
letter
from
a
culture
collection
substantiating
taxonomy,
provided
EPA,
upon
request
to
the
submitter,
may
have
access
to
the
data
supporting
the
taxonomic
designation.
(
ii)
Description
of
the
traits
for
which
the
new
microorganism
has
been
selected
or
developed
and
other
traits
known
to
have
been
added
or
modified.
(
iii)
A
detailed
description
of
the
genetic
construction
of
the
new
microorganism,
including
the
technique
used
to
modify
the
microorganism
(
e.
g.,
fusion
of
cells,
injection
of
DNA,
electroporation
or
chemical
poration,
or
methods
used
for
induced
mutation
and
selection).
The
description
should
include,
for
example,
a
description
of
the
introduced
genetic
material,
including
any
regulatory
sequences
and
structural
genes
and
the
products
of
those
genes;
how
the
introduced
genetic
material
is
expected
to
affect
behavior
of
the
recipient;
expression,
alteration,
and
stability
of
the
introduced
genetic
material;
methods
for
vector
construction
and
introduction;
and
a
description
of
the
regulatory
and
structural
genes
that
are
components
of
the
introduced
genetic
material,
including
genetic
maps
of
the
introduced
sequences.

(
3)
Phenotypic
and
ecological
characteristics.
(
i)
Habitat,
geographical
distribution,
and
source
of
the
recipient
microorganism.
(
ii)
Survival
and
dissemination
under
relevant
environmental
conditions
including
a
description
of
methods
for
detecting
the
new
or
recipient
microorganism(
s)
in
the
environment
and
the
sensitivity
limit
of
detection
for
these
techniques.
(
iii)
A
description
of
anticipated
biological
interactions
with
and
effects
on
target
organisms
and
other
organisms
such
as
competitors,
prey,
hosts,
symbionts,
parasites,
and
pathogens;
a
description
of
host
range;
a
description
of
pathogenicity,
infectivity,
toxicity,
virulence,
or
action
as
a
vector
of
pathogens;
and
capacity
for
genetic
transfer
under
laboratory
and
relevant
environmental
conditions.
(
iv)
A
description
of
anticipated
involvement
in
biogeochemical
or
biological
cycling
processes,
involvement
in
rate
limiting
steps
in
mineral
or
nutrient
cycling,
or
involvement
in
inorganic
compounds
cycling
(
such
as
possible
sequestration
or
transformation
of
heavy
metals).

(
e)
Byproducts.
A
description
of
the
byproducts
resulting
from
the
manufacture,
processing,
use,
and
disposal
of
the
new
microorganism.

(
f)
Total
production
volume.
The
estimated
maximum
amount
of
the
new
microorganism
intended
to
be
manufactured
or
imported
during
the
first
year
of
production
and
the
estimated
maximum
amount
to
be
manufactured
or
imported
during
any
consecutive
12­
month
period
during
the
first
3
years
of
production.
This
estimate
may
be
by
weight
or
volume
and
should
include
an
estimation
of
viability
(
i.
e.,
viable
cells
per
unit
volume
or
colony
forming
units
per
unit
dry
weight).

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

(
h)
Worker
exposure
and
environmental
release.
(
1)
For
sites
controlled
by
the
submitter:
(
i)
The
identity
of
sites
where
the
new
microorganism
will
be
manufactured,
processed,
or
used.
For
purposes
of
this
section,
the
site
for
a
person
who
imports
a
new
microorganism
is
the
site
of
May
10,
2004
the
operating
unit
within
the
person's
organization
which
is
directly
responsible
for
importing
the
new
microorganism
and
which
controls
the
import
transaction.
The
import
site
may
in
some
cases
be
the
organization's
headquarters
office
in
the
United
States.
(
ii)
A
process
description
of
each
manufacture,
processing,
and
use
operation,
which
includes
a
diagram
of
the
major
unit
operations
and
conversions,
the
identity
and
entry
point
of
all
feedstocks,
and
the
identity
of
any
possible
points
of
release
of
the
new
microorganism
from
the
process,
including
a
description
of
all
controls,
including
engineering
controls,
used
to
prevent
such
releases.
(
iii)
Worker
exposure
information,
including
worker
activities,
physical
form
of
process
streams
which
contain
the
new
microorganism
to
which
workers
may
be
exposed,
the
number
of
workers,
and
the
duration
of
activities.
(
iv)
Information
on
release
of
the
new
microorganism
to
the
environment,
including
the
quantity
and
media
of
release
and
type
of
control
technology
used.
(
v)
A
narrative
description
of
the
intended
transport
of
the
new
microorganism,
including
the
means
of
transport,
containment
methods
to
be
used
during
transport,
and
emergency
containment
procedures
to
be
followed
in
case
of
accidental
release.
(
vi)
Procedures
for
disposal
of
any
articles,
waste,
clothing,
or
other
equipment
involved
in
the
activity,
including
procedures
for
inactivation
of
the
new
microorganism,
containment,
disinfection,
and
disposal
of
contaminated
items.

(
2)
For
sites
not
controlled
by
the
submitter,
a
description
of
each
type
of
processing
and
use
operation
involving
the
new
microorganism,
including
identification
of
the
estimated
number
of
processing
or
use
sites,
situations
in
which
worker
exposure
to
and/
or
environmental
release
of
the
new
microorganism
will
occur,
the
number
of
workers
exposed
and
the
duration
of
exposure;
procedures
for
transport
of
the
new
microorganism
and
for
disposal,
including
procedures
for
inactivation
of
the
new
microorganism;
and
control
measures
which
limit
worker
exposure
and
environmental
release.

§
725.160
Submission
of
health
and
environmental
effects
data.

(
a)
Test
data
on
the
new
microorganism
in
the
possession
or
control
of
the
submitter.
(
1)
Except
as
provided
in
§
725.25(
h),
and
in
addition
to
the
information
required
by
§
725.155(
d)(
3),
each
MCAN
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
microorganism
or
any
microbial
mixture
or
article
containing
the
new
microorganism,
or
any
combination
of
such
activities.
This
includes
test
data
concerning
the
new
microorganism
in
a
pure
culture
or
formulated
form
as
used
or
as
intended
to
be
used
in
one
of
the
activities
listed
above.

(
2)
A
full
report
or
standard
literature
citation
must
be
submitted
for
the
following
types
of
test
data:
(
i)
Health
effects
data.
(
ii)
Ecological
effects
data.
(
iii)
Physical
and
chemical
properties
data.
(
iv)
Environmental
fate
characteristics.
(
v)
Monitoring
data
and
other
test
data
related
to
human
exposure
to
or
environmental
release
of
the
new
microorganism.
May
10,
2004
(
3)(
i)
If
the
data
do
not
appear
in
the
open
scientific
literature,
the
submitter
must
provide
a
full
report.
A
full
report
includes
the
experimental
methods
and
materials,
results,
discussion
and
data
analysis,
conclusions,
references,
and
the
name
and
address
of
the
laboratory
that
developed
the
data.
(
ii)
If
the
data
appear
in
the
open
scientific
literature,
the
submitter
need
only
provide
a
standard
literature
citation.
A
standard
literature
citation
includes
author,
title,
periodical
name,
date
of
publication,
volume,
and
page
numbers.

(
4)(
i)
If
a
study,
report,
or
test
is
incomplete
when
a
person
submits
a
MCAN,
the
submitter
must
identify
the
nature
and
purpose
of
the
study;
name
and
address
of
the
laboratory
developing
the
data;
progress
to
date;
types
of
data
collected,
significant
preliminary
results;
and
anticipated
completion
date.
(
ii)
If
a
test
or
experiment
is
completed
before
the
MCAN
review
period
ends,
the
person
must
submit
the
study,
report,
or
test,
as
specified
in
paragraph
(
a)(
3)(
i)
of
this
section,
to
the
address
listed
in
§
725.25(
c)
within
10
days
of
receiving
it,
but
no
later
than
5
days
before
the
end
of
the
review
period.
If
the
test
or
experiment
is
completed
during
the
last
5
days
of
the
review
period,
the
submitter
must
immediately
inform
its
EPA
contact
for
that
submission
by
telephone.

(
5)
For
test
data
in
the
submitter's
possession
or
control
which
are
not
listed
in
paragraph
(
a)(
2)
of
this
section,
a
person
is
not
required
to
submit
a
complete
report.
The
person
must
submit
a
summary
of
the
data.
If
EPA
so
requests,
the
person
must
submit
a
full
report
within
10
days
of
the
request,
but
no
later
than
5
days
before
the
end
of
the
review
period.

(
6)
All
test
data
described
under
paragraph
(
a)
of
this
section
are
subject
to
these
requirements,
regardless
of
their
age,
quality,
or
results.
(
b)
Other
data
concerning
the
health
and
environmental
effects
of
the
new
microorganism
that
are
known
to
or
reasonably
ascertainable
by
the
submitter.
(
1)
Except
as
provided
in
§
725.25(
h),
and
in
addition
to
the
information
required
by
§
725.155(
c)(
3),
any
person
who
submits
a
MCAN
must
describe
the
following
data,
including
any
data
from
a
health
and
safety
study
of
a
microorganism,
if
the
data
are
related
to
effects
on
health
or
the
environment
of
any
manufacture,
processing,
distribution
in
commerce,
use,
or
disposal
of
the
microorganism,
of
any
microbial
mixture
or
article
containing
the
new
microorganism,
or
of
any
combination
of
such
activities:

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

(
2)
Data
that
must
be
described
include
data
concerning
the
new
microorganism
in
a
pure
culture
or
formulated
form
as
used
or
as
intended
to
be
used
in
one
of
the
activities
listed
in
paragraph
(
b)(
1)
of
this
section.

(
3)
The
description
of
data
reported
under
paragraph
(
b)
of
this
section
must
include:
(
i)
If
the
data
appear
in
the
open
scientific
literature,
a
standard
literature
citation,
which
includes
the
author,
title,
periodical
name,
date
of
publication,
volume,
and
pages.
May
10,
2004
(
ii)
If
the
data
are
not
available
in
the
open
scientific
literature,
a
description
of
the
type
of
data
and
summary
of
the
results,
if
available,
and
the
names
and
addresses
of
persons
the
submitter
believes
may
have
possession
or
control
of
the
data.

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

§
725.170
EPA
review
of
the
MCAN.

General
procedures
for
review
of
all
submissions
under
this
part
are
contained
in
§
§
725.28
through
725.60.
In
addition,
the
following
procedures
apply
to
EPA
review
of
MCANs
submitted
under
this
subpart:

(
a)
Length
of
the
review
period.
The
MCAN
review
period
specified
in
section
5(
a)
of
the
Act
runs
for
90
days
from
the
date
the
Document
Control
Officer
for
the
Office
of
Pollution
Prevention
and
Toxics
receives
a
complete
MCAN,
or
the
date
EPA
determines
the
MCAN
is
complete
under
§
725.33,
unless
the
Agency
extends
the
period
under
section
5(
c)
of
the
Act
and
§
725.56.

(
b)
Notice
of
expiration
of
MCAN
review
period.
(
1)
EPA
will
notify
the
submitter
that
the
MCAN
review
period
has
expired
or
that
EPA
has
completed
its
review
of
the
MCAN.
Expiration
of
the
review
period
does
not
constitute
EPA
approval
or
certification
of
the
new
microorganism,
and
does
not
mean
that
EPA
may
not
take
regulatory
action
against
the
microorganism
in
the
future.
(
2)
After
expiration
of
the
MCAN
review
period,
in
the
absence
of
regulatory
action
by
EPA
under
section
5(
e),
5(
f),
or
6(
a)
of
the
Act,
the
submitter
may
manufacture
or
import
the
microorganism
even
if
the
submitter
has
not
received
notice
of
expiration.
(
3)
Early
notification
that
EPA
has
completed
its
review
does
not
permit
commencement
of
manufacture
or
import
prior
to
the
expiration
of
the
90­
day
MCAN
review
period.

(
c)
No
person
submitting
a
MCAN
in
response
to
the
requirements
of
this
subpart
may
manufacture,
import,
or
process
a
microorganism
subject
to
this
subpart
until
the
review
period,
including
all
extensions
and
suspensions,
has
expired.

§
725.190
Notice
of
commencement
of
manufacture
or
import.

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

(
b)
When
to
report.
(
1)
If
manufacture
or
import
for
nonexempt,
commercial
purposes
begins
on
or
after
May
27,
1997,
the
submitter
must
submit
the
NOC
to
EPA
no
later
than
30
calendar
days
after
the
first
day
of
such
manufacture
or
import.

(
2)
If
manufacture
or
import
for
nonexempt,
commercial
purposes
began
or
will
begin
before
May
27,
1997,
the
submitter
must
submit
the
NOC
by
May
27,
1997.
May
10,
2004
(
3)
Submission
of
an
NOC
prior
to
the
commencement
of
manufacture
or
import
is
a
violation
of
section
15
of
the
Act.

(
c)
Information
to
be
reported.
The
NOC
must
contain
the
following
information:
Specific
microorganism
identity,
MCAN
number,
and
the
date
when
manufacture
or
import
commences.
If
the
person
claimed
microorganism
identity
confidential
in
the
MCAN,
and
wants
the
identity
to
be
listed
on
the
confidential
Inventory,
the
claim
must
be
reasserted
and
resubstantiated
in
accordance
with
§
725.85(
b).
Otherwise,
EPA
will
list
the
specific
microorganism
identity
on
the
public
Inventory.

(
d)
Where
to
submit.
NOCs
should
be
submitted
to
the
address
listed
in
§
725.25(
c).

Subpart
E
­­
Exemptions
for
Research
and
Development
Activities
§
725.200
Scope
and
purpose.

(
a)
This
subpart
describes
exemptions
from
the
reporting
requirements
under
subpart
D
of
this
part
for
research
and
development
activities
involving
microorganisms.
(
b)
In
lieu
of
complying
with
subpart
D
of
this
part,
persons
described
in
§
725.205
may
submit
a
TSCA
Experimental
Release
Application
(
TERA)
for
research
and
development
activities
involving
microorganisms
or
otherwise
comply
with
this
subpart.
(
c)
Exemptions
from
part
725
are
provided
at
§
§
725.232,
725.234,
and
725.238.
(
d)
Submission
requirements
specific
for
TERAs
are
described
at
§
725.250.
(
e)
Data
requirements
for
TERAs
are
set
forth
in
§
§
725.255
and
725.260.
(
f)
EPA
review
procedures
specific
for
TERAs
are
set
forth
in
§
§
725.270
and
725.288.
(
g)
Subparts
A
through
C
of
this
part
apply
to
any
submission
under
this
subpart.

§
725.205
Persons
who
may
report
under
this
subpart.

(
a)
Commercial
research
and
development
activities
involving
new
microorganisms
or
significant
new
uses
of
microorganisms
are
subject
to
reporting
under
this
part
unless
they
qualify
for
an
exemption
under
this
part.

(
b)
Commercial
purposes
for
research
and
development
means
that
the
activities
are
conducted
with
the
purpose
of
obtaining
an
immediate
or
eventual
commercial
advantage
for
the
researcher
and
would
include:

(
1)
All
research
and
development
activities
which
are
funded
directly,
in
whole
or
in
part,
by
a
commercial
entity
regardless
of
who
is
actually
conducting
the
research.
Indications
that
the
research
and
development
activities
are
funded
directly,
in
whole
or
in
part,
may
include,
but
are
not
limited
to:
(
i)
Situations
in
which
a
commercial
entity
contracts
directly
with
a
university
or
researcher;
or
(
ii)
Situations
in
which
a
commercial
entity
gives
a
conditional
grant
where
the
commercial
entity
holds
patent
rights,
or
establishes
a
joint
venture
where
the
commercial
entity
holds
patent
or
licensing
rights;
or
(
iii)
Any
other
situation
in
which
the
commercial
entity
intends
to
obtain
an
immediate
or
eventual
May
10,
2004
commercial
advantage
for
the
commercial
entity
and/
or
the
researcher.

(
2)
Research
and
development
activities
that
are
not
funded
directly
by
a
commercial
entity,
if
the
researcher
intends
to
obtain
an
immediate
or
eventual
commercial
advantage.
Indications
that
the
researcher
intends
to
obtain
an
immediate
or
eventual
commercial
advantage
may
include,
but
are
not
limited
to:
(
i)
The
research
is
directed
toward
developing
a
commercially
viable
improvement
of
a
product
already
on
the
market;
or
(
ii)
The
researcher
has
sought
or
is
seeking
commercial
funding
for
the
purpose
of
developing
a
commercial
application;
or
(
iii)
The
researcher
or
university
has
sought
or
is
seeking
a
patent
to
protect
a
commercial
application
which
the
research
is
developing;
or
(
iv)
Other
evidence
that
the
researcher
is
aware
of
a
commercial
application
for
the
research
and
has
directed
the
research
toward
developing
that
application.

(
c)
Certain
research
and
development
activities
involving
microorganisms
subject
to
jurisdiction
under
the
Act
are
exempt
from
reporting
under
this
part.
A
person
conducting
research
and
development
activities
which
meet
the
conditions
for
the
exemptions
described
in
§
§
725.232,
725.234,
or
725.238
is
exempt
from
TERA
reporting
under
this
subpart.

(
d)
A
microorganism
is
not
exempt
from
reporting
under
subpart
D
of
this
part
if
any
amount
of
the
microorganism,
including
as
part
of
a
mixture,
is
processed,
distributed
in
commerce,
or
used,
for
any
commercial
purpose
other
than
research
and
development.

(
e)
Quantities
of
the
inactivated
microorganism,
or
mixtures
or
articles
containing
the
inactivated
microorganism,
remaining
after
completion
of
research
and
development
activities
may
be
disposed
of
as
a
waste
in
accordance
with
applicable
Federal,
State,
and
local
regulations.

(
f)
A
person
who
manufactures,
imports,
or
processes
a
microorganism
solely
for
research
and
development
is
not
required
to
comply
with
the
requirements
of
this
section
if:

(
1)
The
person
is
manufacturing
a
microbial
pesticide
identified
in
§
172.45(
c),
or
(
2)
The
person
is
manufacturing
a
microbial
pesticide
for
which
an
Experimental
Use
Permit
is
required,
pursuant
to
§
172.3;
or
(
3)
The
person
is
manufacturing
a
microbial
pesticide
for
which
a
notification
or
an
Experimental
Use
Permit
is
not
required
to
be
submitted.

§
725.232
Activities
subject
to
the
jurisdiction
of
other
Federal
programs
or
agencies.

This
part
does
not
apply
to
any
research
and
development
activity
that
meets
all
of
the
following
conditions.

(
a)
The
microorganism
is
manufactured,
imported,
or
processed
solely
for
research
and
development
activities.
(
b)
There
is
no
intentional
testing
of
a
microorganism
outside
of
a
structure,
as
structure
is
defined
in
§
725.3.
(
c)(
1)
The
person
receives
research
funds
from
another
Federal
agency,
and
the
funds
are
May
10,
2004
awarded
on
the
condition
that
the
research
will
be
conducted
in
accordance
with
the
relevant
portions
of
the
NIH
Guidelines,
or
(
2)
A
Federal
agency
or
program
otherwise
imposes
the
legally
binding
requirement
that
the
research
is
to
be
conducted
in
accordance
with
relevant
portions
of
the
NIH
Guidelines.

§
725.234
Activities
conducted
inside
a
structure.

A
person
who
manufactures,
imports,
or
processes
a
microorganism
is
not
subject
to
the
reporting
requirements
under
subpart
D
of
this
part
if
all
of
the
following
conditions
are
met:

(
a)
The
microorganism
is
manufactured,
imported,
or
processed
solely
for
research
and
development
activities.
(
b)
The
microorganism
is
used
by,
or
directly
under
the
supervision
of,
a
technically
qualified
individual,
as
defined
in
§
725.3.
The
technically
qualified
individual
must
maintain
documentation
of
the
procedures
selected
to
comply
with
paragraph
(
d)
of
this
section
and
must
ensure
that
the
procedures
are
used.
(
c)
There
is
no
intentional
testing
of
a
microorganism
outside
of
a
structure,
as
structure
is
defined
in
§
725.3.
(
d)
Containment
and/
or
inactivation
controls.
(
1)
Selection
and
use
of
containment
and/
or
inactivation
controls
inside
a
structure
for
a
particular
microorganism
shall
take
into
account
the
following:
(
i)
Factors
relevant
to
the
organism's
ability
to
survive
in
the
environment.
(
ii)
Potential
routes
of
release
in
air,
solids
and
liquids;
in
or
on
waste
materials
and
equipment;
in
or
on
people,
including
maintenance
and
custodial
personnel;
and
in
or
on
other
organisms,
such
as
insects
and
rodents.

(
iii)
Procedures
for
transfer
of
materials
between
facilities.

(
2)
The
technically
qualified
individual's
selection
of
containment
and/
or
inactivation
controls
shall
be
approved
and
certified
by
an
authorized
official
(
other
than
the
TQI)
of
the
institution
that
is
conducting
the
test
prior
to
the
commencement
of
the
test.

(
3)
Records
shall
be
developed
and
maintained
describing
the
selection
and
use
of
containment
and/
or
inactivation
controls,
as
specified
in
§
725.235(
c).
These
records,
which
must
be
maintained
at
the
location
where
the
research
and
development
activity
is
being
conducted,
shall
be
submitted
to
EPA
upon
written
request
and
within
the
time
frame
specified
in
EPA's
request.

(
4)
Subsequent
to
EPA
review
of
records
in
accordance
with
paragraph
(
d)(
3)
of
this
section,
changes
to
the
containment/
inactivation
controls
selected
under
paragraph
(
d)(
1)
of
this
section
must
be
made
upon
EPA
order.
Failure
to
comply
with
EPA's
order
shall
result
in
automatic
loss
of
eligibility
for
an
exemption
under
this
section.

(
e)
The
manufacturer,
importer,
or
processor
notifies
all
persons
in
its
employ
or
to
whom
it
directly
distributes
the
microorganism,
who
are
engaged
in
experimentation,
research,
or
analysis
on
the
microorganism,
including
the
manufacture,
processing,
use,
transport,
storage,
and
disposal
of
the
microorganism
associated
with
research
and
development
activities,
of
any
risk
to
health,
identified
under
§
725.235(
a),
which
may
be
associated
with
the
microorganism.
The
notification
must
be
made
in
accordance
with
§
725.235(
b).
May
10,
2004
§
725.235
Conditions
of
exemption
for
activities
conducted
inside
a
structure.

(
a)
Determination
of
risks.
To
determine
whether
notification
under
§
725.234(
e)
is
required,
the
manufacturer,
importer,
or
processor
must
do
one
of
the
following:

(
1)
For
research
conducted
in
accordance
with
the
NIH
Guidelines,
the
manufacturer,
importer,
or
processor
must
meet
the
conditions
laid
out
at
IV­
B­
4­
d
of
the
NIH
Guidelines;
or
(
2)
For
all
other
research
conducted
in
accordance
with
§
725.234,
the
manufacturer,
importer,
or
processor
must
review
and
evaluate
the
following
information
to
determine
whether
there
is
reason
to
believe
there
is
any
risk
to
health
which
may
be
associated
with
the
microorganism:
(
i)
Information
in
its
possession
or
control
concerning
any
significant
adverse
reaction
of
persons
exposed
to
the
microorganism
which
may
reasonably
be
associated
with
such
exposure.
(
ii)
Information
provided
to
the
manufacturer,
importer,
or
processor
by
a
supplier
or
any
other
person
concerning
a
health
risk
believed
to
be
associated
with
the
microorganism.
(
iii)
Health
and
environmental
effects
data
in
its
possession
or
control
concerning
the
microorganism.
(
iv)
Information
on
health
effects
which
accompanies
any
EPA
rule
or
order
issued
under
TSCA
section
4,
5,
or
6
of
the
Act
that
applies
to
the
microorganism
and
of
which
the
manufacturer,
importer,
or
processor
has
knowledge.

(
b)
Notification
to
employees
and
others.
(
1)
The
manufacturer,
importer,
or
processor
must
notify
the
persons
identified
in
§
725.234(
e)
by
means
of
a
container
labeling
system,
conspicuous
placement
of
notices
in
areas
where
exposure
may
occur,
written
notification
to
each
person
potentially
exposed,
or
any
other
method
of
notification
which
adequately
informs
persons
of
health
risks
which
the
manufacturer,
importer,
or
processor
has
reason
to
believe
may
be
associated
with
the
microorganism,
as
determined
under
paragraph
(
a)
of
this
section.

(
2)
If
the
manufacturer,
importer,
or
processor
distributes
a
microorganism
manufactured,
imported,
or
processed
under
this
section
to
persons
not
in
its
employ,
the
manufacturer,
importer,
or
processor
must
in
written
form:
(
i)
Notify
those
persons
that
the
microorganism
is
to
be
used
only
for
research
and
development
purposes
and
the
requirements
of
§
725.234
are
to
be
met.
(
ii)
Provide
the
notice
of
health
risks
specified
in
paragraph
(
b)(
1)
of
this
section.

(
3)
The
adequacy
of
any
notification
under
this
section
is
the
responsibility
of
the
manufacturer,
importer,
or
processor.

(
c)
Recordkeeping.
(
1)
For
research
conducted
in
accordance
with
the
NIH
Guidelines,
a
person
who
manufactures,
imports,
or
processes
a
microorganism
under
this
section
must
retain
the
following
records:
(
i)
Documentation
that
the
NIH
Guidelines
have
been
adhered
to.
Such
documentation
shall
include:
(
A)
For
experiments
subject
to
Institutional
Biosafety
Committee
review,
or
notification
simultaneous
with
initiation
of
the
experiment,
the
information
submitted
for
review
or
notification,
along
with
standard
laboratory
records,
shall
satisfy
the
recordkeeping
requirements
specified
in
§
725.234(
d)(
3).
(
B)
For
experiments
exempt
from
Institutional
Biosafety
Committee
review
or
notification
simultaneous
with
initiation
of
the
experiment,
documentation
of
the
exemption,
along
with
May
10,
2004
standard
laboratory
records,
shall
satisfy
the
recordkeeping
requirement
specified
in
§
725.234(
d)(
3).
(
ii)
Documentation
of
how
the
following
requirements
are
satisfied
under
the
NIH
Guidelines:
(
A)
Copies
or
citations
to
information
reviewed
and
evaluated
to
determine
the
need
to
make
any
notification
of
risk.
(
B)
Documentation
of
the
nature
and
method
of
notification
of
risk,
including
copies
of
any
labels
or
written
notices
used.
(
C)
The
names
and
addresses
of
any
persons
other
than
the
manufacturer,
importer,
or
processor
to
whom
the
substance
is
distributed,
the
identity
of
the
microorganism,
the
amount
distributed,
and
copies
of
the
notifications
required.

(
2)
For
all
other
research
conducted
in
accordance
with
§
725.234,
a
person
who
manufacturers,
imports,
or
processes
a
microorganism
under
this
section,
must
maintain
the
following
records:
(
i)
Records
describing
selection
and
use
of
containment
and/
or
inactivation
controls
required
by
§
725.234(
d)(
3)
and
certification
by
an
authorized
official
required
by
§
725.234(
d)(
2)
for
each
microorganism.
(
ii)
Copies
or
citations
to
information
reviewed
and
evaluated
under
paragraph
(
a)
of
this
section
to
determine
the
need
to
make
any
notification
of
risk.
(
iii)
Documentation
of
the
nature
and
method
of
notification
under
paragraph
(
b)(
1)
of
this
section,
including
copies
of
any
labels
or
written
notices
used.

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

§
725.238
Activities
conducted
outside
a
structure.

(
a)
Exemption.
(
1)
Research
and
development
activities
involving
intentional
testing
in
the
environment
of
certain
microorganisms
listed
in
§
725.239
may
be
conducted
without
prior
review
by
EPA
if
all
of
the
conditions
of
this
section
and
§
725.239
are
met.
(
2)
The
research
and
development
activity
involving
a
microorganism
listed
in
§
725.239
must
be
conducted
by,
or
directly
under
the
supervision
of,
a
technically
qualified
individual,
as
defined
in
§
725.3.

(
b)
Certification.
To
be
eligible
for
the
exemption
under
this
section,
a
manufacturer
or
importer
must
submit
to
EPA
prior
to
initiation
of
the
activity
a
document
signed
by
an
authorized
official
containing
the
following
information:
(
1)
Name,
address,
and
telephone
number
of
the
manufacturer
or
importer.
(
2)
Location,
estimated
duration,
and
planned
start
date
of
the
test.
(
3)
Certification
of
the
following:
(
i)
Compliance
with
the
conditions
of
the
exemption
specified
for
the
microorganism
in
§
725.239.
(
ii)
If
state
and/
or
local
authorities
have
been
notified
of
the
activity,
evidence
of
notification.

(
c)
Recordkeeping.
Persons
who
conduct
research
and
development
activities
under
this
section
must
comply
with
the
recordkeeping
requirements
of
§
725.65
and
retain
documentation
that
supports
their
compliance
with
the
requirements
of
this
section
and
the
specific
requirements
for
the
microorganism
listed
in
§
725.239.
May
10,
2004
§
725.239
Use
of
specific
microorganisms
in
activities
conducted
outside
a
structure.

(
a)
Bradyrhizobium
japonicum.
To
qualify
for
an
exemption
under
this
section,
all
of
the
following
conditions
must
be
met
for
a
test
involving
Bradyrhizobium
japonicum:

(
1)
Characteristics
of
recipient
microorganism.
The
recipient
microorganism
is
limited
to
strains
of
Bradyrhizobium
japonicum.

(
2)
Modification
of
traits.
(
i)
The
introduced
genetic
material
must
meet
the
criteria
for
poorly
mobilizable
listed
in
§
725.421(
c).
(
ii)
The
introduced
genetic
material
must
consist
only
of
the
following
components:
(
A)
The
structural
gene(
s)
of
interest,
which
have
the
following
limitations:
(
1)
For
structural
genes
encoding
marker
sequences,
the
gene
is
limited
to
the
aadH
gene,
which
confers
resistance
to
the
antibiotics
streptomycin
and
spectinomycin.
(
2)
For
traits
other
than
antibiotic
resistance,
the
structural
gene
must
be
limited
to
the
genera
Bradyrhizobium
and
Rhizobium.
(
B)
The
regulatory
sequences
permitting
the
expression
of
solely
the
gene(
s)
of
interest.

(
C)
Associated
nucleotide
sequences
needed
to
move
genetic
material,
including
linkers,
homopolymers,
adaptors,
transposons,
insertion
sequences,
and
restriction
enzyme
sites.
(
D)
The
vector
nucleotide
sequences
needed
for
vector
transfer.
(
E)
The
vector
nucleotide
sequences
needed
for
vector
maintenance.

(
3)
Limitations
on
exposure.
(
i)
The
test
site
area
must
be
no
more
than
10
terrestrial
acres.
(
ii)
The
technically
qualified
individual
must
select
appropriate
methods
to
limit
the
dissemination
of
modified
Bradyrhizobium
japonicum.

(
b)
Rhizobium
meliloti.
To
qualify
for
an
exemption
under
this
section,
all
of
the
following
conditions
must
be
met
for
a
test
involving
Rhizobium
meliloti:

(
1)
Characteristics
of
recipient
microorganism.
The
recipient
microorganism
is
limited
to
strains
of
Rhizobium
meliloti.
(
2)
Modification
of
traits.
(
i)
The
introduced
genetic
material
must
meet
the
criteria
for
poorly
mobilizable
listed
in
§
725.421(
c)
of
this
part.
(
ii)
The
introduced
genetic
material
must
consist
only
of
the
following
components:
(
A)
The
structural
gene(
s)
of
interest,
which
have
the
following
limitations:
(
1)
For
structural
genes
encoding
marker
sequences,
the
gene
is
limited
to
the
aadH
gene,
which
confers
resistance
to
the
antibiotics
streptomycin
and
spectinomycin.
(
2)
For
traits
other
than
antibiotic
resistance,
the
structural
gene
must
be
limited
to
the
genera
Bradyrhizobium
and
Rhizobium.
(
B)
The
regulatory
sequences
permitting
the
expression
of
solely
the
gene(
s)
of
interest.
(
C)
Associated
nucleotide
sequences
needed
to
move
genetic
material,
including
linkers,
homopolymers,
adaptors,
transposons,
insertion
sequences,
and
restriction
enzyme
sites.
(
D)
The
vector
nucleotide
sequences
needed
for
vector
transfer.
(
E)
The
vector
nucleotide
sequences
needed
for
vector
maintenance.

(
3)
Limitations
on
exposure.
(
i)
The
test
site
area
must
be
no
more
than
10
terrestrial
acres.
May
10,
2004
(
ii)
The
technically
qualified
individual
must
select
appropriate
methods
to
limit
the
dissemination
of
modified
Rhizobium
meliloti.

§
725.250
Procedural
requirements
for
the
TERA.

General
requirements
for
all
submissions
under
this
part
are
contained
in
subparts
A
through
C
of
this
part.
In
addition,
the
following
requirements
apply
to
TERAs
submitted
under
this
subpart:

(
a)
When
to
submit
the
TERA.
Each
person
who
is
eligible
to
submit
a
TERA
under
this
subpart
must
submit
the
TERA
at
least
60
calendar
days
before
the
person
intends
to
initiate
the
proposed
research
and
development
activity.

(
b)
Contents
of
the
TERA.
Each
person
who
submits
a
TERA
under
this
subpart
must
provide
the
information
and
test
data
described
in
§
§
725.255
and
725.260.
In
addition,
the
submitter
must
supply
sufficient
information
to
enable
EPA
to
evaluate
the
effects
of
all
activities
for
which
approval
is
requested.

(
c)
A
person
may
submit
a
TERA
for
one
or
more
microorganisms
and
one
or
more
research
and
development
activities,
including
a
research
program.

(
d)
EPA
will
either
approve
the
TERA,
with
or
without
conditions,
or
disapprove
it
under
procedures
established
in
this
subpart.

(
e)
The
manufacturer,
importer,
or
processor
who
receives
a
TERA
approval
must
comply
with
all
terms
of
the
approval,
as
well
as
conditions
described
in
the
TERA,
and
remains
liable
for
compliance
with
all
terms
and
conditions,
regardless
of
who
conducts
the
research
and
development
activity.
Any
person
conducting
the
research
and
development
activity
approved
under
the
TERA
must
comply
with
all
terms
of
the
TERA
approval,
as
well
as
the
conditions
described
in
the
TERA.

(
f)
Recordkeeping.
Persons
submitting
a
TERA
must
comply
with
the
recordkeeping
requirements
of
§
725.65.
In
addition,
the
following
requirements
apply
to
TERAs:

(
1)
Each
person
submitting
a
TERA
under
this
part
must
retain
documentation
of
information
contained
in
the
TERA
for
a
period
of
3
years
from
the
date
that
the
results
of
the
study
are
submitted
to
the
Agency.

(
2)
Summaries
of
all
data,
conclusions,
and
reports
resulting
from
the
conduct
of
the
research
and
development
activity
under
the
TERA
must
be
submitted
to
the
EPA
address
identified
in
§
725.25(
c)
within
1
year
of
the
termination
of
the
activity.

§
725.255
Information
to
be
included
in
the
TERA.

(
a)
To
review
a
TERA,
EPA
must
have
sufficient
information
to
permit
a
reasoned
evaluation
of
the
health
and
environmental
effects
of
the
planned
test
in
the
environment.
The
person
seeking
EPA
approval
must
submit
all
information
known
to
or
reasonably
ascertainable
by
the
submitter
on
the
microorganism(
s)
and
the
research
and
development
activity,
including
information
not
May
10,
2004
listed
in
paragraphs
(
c),
(
d),
and
(
e)
of
this
section
that
the
person
believes
will
be
useful
for
EPA's
risk
assessment.
The
TERA
must
be
in
writing
and
must
include
at
least
the
information
described
in
the
following
paragraphs.

(
b)
When
specific
information
is
not
submitted,
an
explanation
of
why
such
information
is
not
available
or
not
applicable
must
be
included.

(
c)
Persons
applying
for
a
TERA,
must
include
the
submitter
identification
and
microorganism
identity
information
required
for
MCANs
in
§
725.155(
c),
(
d)(
1),
and
(
d)(
2).

(
d)
Persons
applying
for
a
TERA
must
submit
phenotypic
and
ecological
characteristics
information
required
in
§
725.155(
d)(
3)
as
it
relates
directly
to
the
conditions
of
the
proposed
research
and
development
activity.

(
e)
Persons
applying
for
a
TERA
must
also
submit
the
following
information
about
the
proposed
research
and
development
activity:

(
1)
A
detailed
description
of
the
proposed
research
and
development
activity.
(
i)
The
objectives
and
significance
of
the
activity
and
a
rationale
for
testing
the
microorganisms
in
the
environment.
(
ii)
Number
of
microorganisms
released
(
including
viability
per
volume
if
applicable)
and
the
method(
s)
of
application
or
release.
(
iii)
Characteristics
of
the
test
site(
s),
including
location,
geographical,
physical,
chemical,
and
biological
features,
proximity
to
human
habitation
or
activity,
and
description
of
site
characteristics
that
would
influence
dispersal
or
confinement.
(
iv)
Target
organisms
(
if
the
microorganism(
s)
to
be
tested
has
an
intended
target),
including
identification
of
each
target
organism
and
anticipated
mechanism
and
result
of
interaction.
(
v)
Planned
start
date
and
duration
of
each
activity.
(
vi)
If
State
and/
or
local
authorities
have
been
notified
of
the
activity,
evidence
of
notification.

(
2)
Information
on
monitoring,
confinement,
mitigation,
and
emergency
termination
procedures.
(
i)
Confinement
procedures
for
the
activity,
access
and
security
measures,
and
procedures
for
routine
termination
of
the
activity.
(
ii)
Mitigation
and
emergency
procedures.
(
iii)
Measures
to
detect
and
control
potential
adverse
effects.
(
iv)
Name
of
principal
investigator
and
chief
of
site
personnel
responsible
for
emergency
procedures.
(
v)
Personal
protective
equipment,
engineering
controls,
and
procedures
to
be
followed
to
minimize
dispersion
of
the
microorganism(
s)
by
people,
machinery,
or
equipment.
(
vi)
Procedures
for
disposal
of
any
articles,
waste,
clothing,
machinery,
or
other
equipment
involved
in
the
experimental
release,
including
methods
for
inactivation
of
the
microorganism(
s),
containment,
disinfection,
and
disposal
of
contaminated
items.

§
725.260
Submission
of
health
and
environmental
effects
data.

Each
TERA
must
contain
all
available
data
concerning
actual
or
potential
effects
on
health
or
the
environment
of
the
new
microorganism
that
are
in
the
possession
or
control
of
the
submitter
and
a
May
10,
2004
description
of
other
data
known
to
or
reasonably
ascertainable
by
the
submitter
that
will
permit
a
reasoned
evaluation
of
the
planned
test
in
the
environment.
The
data
must
be
reported
in
the
manner
described
in
§
725.160(
a)(
3)
and
(
b)(
3).

§
725.270
EPA
review
of
the
TERA.

General
procedures
for
review
of
all
submissions
under
this
part
are
contained
in
§
§
725.28
through
725.60.
In
addition,
the
following
procedures
apply
to
EPA
review
of
applications
submitted
under
this
subpart:

(
a)
Length
of
the
review
period.
(
1)
The
review
period
for
the
TERA
will
be
60
days
from
the
date
the
Document
Control
Officer
for
the
Office
of
Pollution
Prevention
and
Toxics
receives
a
complete
TERA,
or
the
date
EPA
determines
the
TERA
is
complete
under
§
725.33,
unless
EPA
finds
good
cause
for
an
extension
under
§
725.56.

(
2)
A
submitter
shall
not
proceed
with
the
research
and
development
activity
described
in
the
TERA
unless
and
until
EPA
provides
written
approval
of
the
TERA.
A
submitter
may
receive
early
approval
if
a
review
is
completed
in
less
than
60
days.

(
b)
EPA
decision
regarding
proposed
TERA
activity.
(
1)
A
decision
concerning
a
TERA
under
this
subpart
will
be
made
by
the
Administrator,
or
a
designee.

(
2)
If
EPA
determines
that
the
proposed
research
and
development
activity
for
the
microorganism
does
not
present
an
unreasonable
risk
of
injury
to
health
or
the
environment,
EPA
will
notify
the
submitter
that
the
TERA
is
approved
and
that
the
submitter
can
proceed
with
the
proposed
research
and
development
activity
described
in
the
TERA.

(
3)
EPA
may
include
requirements
and
conditions
in
its
approval
of
the
TERA
that
would
be
stated
in
the
TERA
approval
under
paragraph
(
c)
of
this
section.

(
4)
If
EPA
concludes
that
it
cannot
determine
that
the
proposed
research
and
development
activity
described
in
the
TERA
will
not
present
an
unreasonable
risk
of
injury
to
health
or
the
environment,
EPA
will
deny
the
TERA
and
will
provide
reasons
for
the
denial
in
writing.

(
c)
TERA
approval.
(
1)
A
TERA
approval
issued
by
EPA
under
this
section
is
legally
binding
on
the
TERA
submitter.

(
2)
When
EPA
approves
a
TERA,
the
submitter
must
conduct
the
research
and
development
activity
only
as
described
in
the
TERA
and
in
accordance
with
any
requirements
and
conditions
prescribed
by
EPA
in
its
approval
of
the
TERA.

(
3)
Any
person
who
fails
to
conduct
the
research
and
development
activity
as
described
in
the
TERA
and
in
accordance
with
any
requirements
and
conditions
prescribed
by
EPA
in
its
approval
of
the
TERA
under
this
section,
shall
be
in
violation
of
sections
5
and
15
of
the
Act
and
be
subject
to
civil
and
criminal
penalties
under
section
16
of
the
Act.
May
10,
2004
§
725.288
Revocation
or
modification
of
TERA
approval.

(
a)
Significant
questions
about
risk.
(
1)
If,
after
approval
of
a
TERA
under
this
subpart,
EPA
receives
information
which
raises
significant
questions
about
EPA's
determination
that
the
activity
does
not
present
an
unreasonable
risk
of
injury
to
health
or
the
environment,
EPA
will
notify
the
submitter
in
writing
of
those
questions.

(
2)
The
submitter
may,
within
10
days
of
receipt
of
EPA's
notice,
provide
in
writing
additional
information
or
arguments
concerning
the
significance
of
the
questions
and
whether
EPA
should
modify
or
revoke
the
approval
of
the
TERA.

(
3)
After
considering
any
such
information
and
arguments,
EPA
will
decide
whether
to
change
its
determination
regarding
approval
of
the
TERA.
(
i)
If
EPA
determines
that
the
activity
will
not
present
an
unreasonable
risk
of
injury
to
health
or
the
environment,
it
will
notify
the
submitter
in
writing.
To
make
this
finding,
EPA
may
prescribe
additional
conditions
which
must
be
followed
by
the
submitter.
(
ii)
If
EPA
determines
that
it
can
no
longer
conclude
that
the
activity
will
not
present
an
unreasonable
risk
of
injury
to
health
or
the
environment,
it
will
notify
the
submitter
in
writing
that
EPA
is
revoking
its
approval
and
state
its
reasons.
In
that
event,
the
submitter
must
terminate
the
research
and
development
activity
within
48
hours
of
receipt
of
the
notice
in
accordance
with
directions
provided
by
EPA
in
the
notice.

(
b)
Evidence
of
unreasonable
risk.
(
1)
If,
after
approval
of
a
TERA
under
this
subpart,
EPA
determines
that
the
proposed
research
and
development
activity
will
present
an
unreasonable
risk
of
injury
to
health
or
the
environment,
EPA
will
notify
the
submitter
in
writing
and
state
its
reasons.

(
2)
In
the
notice,
EPA
may
prescribe
additional
safeguards
to
address
or
reduce
the
risk,
or
may
instruct
the
submitter
to
suspend
the
research
and
development
activities.

(
3)
Within
48
hours,
the
submitter
must
implement
the
instructions
contained
in
the
notice.
The
submitter
may
then
submit
additional
information
or
arguments
concerning
the
matters
raised
by
EPA
and
whether
EPA
should
modify
or
revoke
the
approval
of
the
TERA
in
accordance
with
paragraph
(
a)(
2)
of
this
section.

(
4)
EPA
will
consider
the
information
and
arguments
in
accordance
with
paragraph
(
a)(
3)
of
this
section.

(
5)
Following
consideration
of
the
information
and
arguments
under
paragraph
(
a)(
3)
of
this
section,
if
EPA
notifies
the
submitter
that
the
R&
D
activity
must
be
suspended
or
terminted,
the
submitter
may
resume
the
activity
only
upon
written
notice
from
EPA
that
EPA
has
approved
resumption
of
the
activity.
In
approving
resumption
of
an
activity,
EPA
may
prescribe
additional
conditions
which
must
be
followed
by
the
submitter.

(
c)
Modifications.
If,
after
approval
of
a
TERA
under
this
subpart,
the
submitter
concludes
that
it
is
necessary
to
alter
the
conduct
of
the
research
and
development
activity
in
a
manner
which
would
result
in
the
activity
being
different
from
that
described
in
the
TERA
agreement
and
any
May
10,
2004
conditions
EPA
prescribed
in
its
approval,
the
submitter
must
inform
the
EPA
contact
for
the
TERA
and
may
not
modify
the
activity
without
the
approval
of
EPA.

Subpart
F
­­
Exemptions
for
Test
Marketing
§
725.300
Scope
and
purpose.

(
a)
This
subpart
describes
exemptions
from
the
reporting
requirements
under
subpart
D
of
this
part
for
test
marketing
activities
involving
microorganisms.

(
b)
In
lieu
of
complying
with
subpart
D
of
this
part,
persons
described
in
§
725.305
may
submit
an
application
for
a
test
marketing
exemption
(
TME).
(
c)
Submission
requirements
specific
for
TME
applications
are
described
at
§
725.350.
(
d)
Data
requirements
for
TME
applications
are
set
forth
in
§
725.355.
(
e)
EPA
review
procedures
specific
for
TMEs
are
set
forth
in
§
725.370.
(
f)
Subparts
A
through
C
of
this
part
apply
to
any
submission
under
this
subpart.

§
725.305
Persons
who
may
apply
under
this
subpart.

A
person
identified
in
this
section
may
apply
for
a
test
marketing
exemption.
EPA
may
grant
the
exemption
if
the
person
demonstrates
that
the
microorganism
will
not
present
an
unreasonable
risk
of
injury
to
health
or
the
environment
as
a
result
of
the
test
marketing.
A
person
may
apply
under
this
subpart
for
the
following
test
marketing
activities:

(
a)
A
person
who
intends
to
manufacture
or
import
for
commercial
purposes
a
new
microorganism.

(
b)
A
person
who
intends
to
manufacture,
import,
or
process
for
commercial
purposes
a
microorganism
identified
in
subpart
M
of
this
part
for
a
significant
new
use.

§
725.350
Procedural
requirements
for
this
subpart.

General
requirements
for
all
submissions
under
this
part
are
contained
in
subparts
A
through
C
of
this
part.
In
addition,
the
following
requirements
apply
to
applications
submitted
under
this
subpart:

(
a)
Prenotice
consultation.
EPA
strongly
suggests
that
for
a
TME,
the
applicant
contact
EPA
for
a
prenotice
consultation
regarding
eligibility
for
a
TME.

(
b)
When
to
submit
a
TME
application.
Each
person
who
is
eligible
to
apply
for
a
TME
under
this
subpart
must
submit
the
application
at
least
45
calendar
days
before
the
person
intends
to
commence
the
test
marketing
activity.

(
c)
Recordkeeping.
Each
person
who
is
granted
a
TME
must
comply
with
the
recordkeeping
requirements
of
§
725.65.
In
addition,
any
person
who
obtains
a
TME
must
retain
documentation
of
compliance
with
any
restrictions
imposed
by
EPA
when
it
grants
the
TME.
This
information
must
be
retained
for
3
years
from
the
final
date
of
manufacture
or
import
under
the
exemption.
May
10,
2004
§
725.355
Information
to
be
included
in
the
TME
application.

(
a)
To
review
a
TME
application,
EPA
must
have
sufficient
information
to
permit
a
reasoned
evaluation
of
the
health
and
environmental
effects
of
the
planned
test
marketing
activity.
The
person
seeking
EPA
approval
must
submit
all
information
known
to
or
reasonably
ascertainable
by
the
person
on
the
microorganism
and
the
test
marketing
activity,
including
information
not
listed
in
paragraphs
(
c),
(
d),
and
(
e)
of
this
section
that
the
person
believes
will
demonstrate
that
the
microorganism
will
not
present
an
unreasonable
risk
of
injury
to
health
or
the
environment
as
a
result
of
the
test
marketing.
The
TME
application
must
be
in
writing
and
must
include
at
least
the
information
described
in
paragraphs
(
b),
(
c),
(
d),
and
(
e)
of
this
section.

(
b)
When
specific
information
is
not
submitted,
an
explanation
of
why
such
information
is
not
available
or
not
applicable
must
be
included.

(
c)
Persons
applying
for
a
TME
must
submit
the
submitter
identification
and
microorganism
identity
information
required
for
MCANs
in
§
725.155(
c),
(
d)(
1),
and
(
d)(
2).

(
d)
Persons
applying
for
a
TME
must
submit
phenotypic
and
ecological
characteristics
information
required
in
§
725.155(
d)(
3)
as
it
relates
directly
to
the
conditions
of
the
proposed
test
marketing
activity.

(
e)
Persons
applying
for
a
TME
must
also
submit
the
following
information
about
the
proposed
test
marketing
activity:

(
1)
Proposed
test
marketing
activity.
(
i)
The
maximum
quantity
of
the
microorganism
which
the
applicant
will
manufacture
or
import
for
test
marketing.
(
ii)
The
maximum
number
of
persons
who
may
be
provided
the
microorganism
during
test
marketing.
(
iii)
The
maximum
number
of
persons
who
may
be
exposed
to
the
microorganism
as
a
result
of
test
marketing,
including
information
regarding
duration
and
route
of
such
exposures.
(
iv)
A
description
of
the
test
marketing
activity,
including
its
duration
and
how
it
can
be
distinguished
from
full­
scale
commercial
production
and
research
and
development
activities.

(
2)
Health
and
environmental
effects
data.
All
existing
data
regarding
health
and
environmental
effects
of
the
microorganism
must
be
reported
in
accordance
with
§
725.160.

§
725.370
EPA
review
of
the
TME
application.

General
procedures
for
review
of
all
submissions
under
this
part
are
contained
in
§
§
725.28
through
725.60.
In
addition,
the
following
procedures
apply
to
EPA
review
of
TME
applications
submitted
under
this
subpart:

(
a)
No
later
than
45
days
after
EPA
receives
a
TME,
the
Agency
will
either
approve
or
deny
the
application.
(
b)
A
submitter
may
only
proceed
with
test
marketing
activities
after
receipt
of
EPA
approval.
(
c)
In
approving
a
TME
application,
EPA
may
impose
any
restrictions
necessary
to
ensure
that
the
microorganism
will
not
present
an
unreasonable
risk
of
injury
to
health
and
the
environment
as
May
10,
2004
a
result
of
test
marketing.

Subpart
G
­­
General
Exemptions
for
New
Microorganisms
§
725.400
Scope
and
purpose.

(
a)
This
subpart
describes
exemptions
from
reporting
under
subpart
D
of
this
part,
and
from
review
under
this
part
altogether,
for
manufacturing
and
importing
of
certain
new
microorganisms
for
commercial
purposes.
(
b)
Recipient
microorganisms
eligible
for
the
tiered
exemption
from
review
under
this
part
are
listed
in
§
725.420.
(
c)
Criteria
for
the
introduced
genetic
material
contained
in
the
new
microorganisms
are
described
in
§
725.421.
(
d)
Physical
containment
and
control
technologies
are
described
in
§
725.422.
(
e)
The
conditions
for
the
Tier
I
exemption
are
listed
in
§
725.424.
(
f)
In
lieu
of
complying
with
subpart
D
of
this
part,
persons
using
recipient
microorganisms
eligible
for
the
tiered
exemption
may
submit
a
Tier
II
exemption
request.
The
limited
reporting
requirements
for
the
Tier
II
exemption,
including
data
requirements,
are
described
in
§
§
725.450
and
725.455.
(
g)
EPA
review
procedures
for
the
Tier
II
exemption
are
set
forth
in
§
725.470.
(
h)
Subparts
A
through
C
of
this
part
apply
to
any
submission
under
this
subpart.

§
725.420
Recipient
microorganisms.

The
following
recipient
microorganisms
are
eligible
for
either
exemption
under
this
subpart:

(
a)
Acetobacter
aceti.
(
b)
Aspergillus
niger.
(
c)
Aspergillus
oryzae.
(
d)
Bacillus
licheniformis.
(
e)
Bacillus
subtilis.
(
f)
Clostridium
acetobutylicum.
(
g)
Escherichia
coli
K­
12.
(
h)
Penicillium
roqueforti.
(
i)
Saccharomyces
cerevisiae.
(
j)
Saccharomyces
uvarum.

§
725.421
Introduced
genetic
material.

For
a
new
microorganism
to
qualify
for
either
exemption
under
this
subpart,
introduced
genetic
material
must
meet
all
of
the
criteria
listed
in
this
section.

(
a)
Limited
in
size.
The
introduced
genetic
material
must
consist
only
of
the
following:

(
1)
The
structural
gene(
s)
of
interest.
(
2)
The
regulatory
sequences
permitting
the
expression
of
solely
the
gene(
s)
of
interest.
(
3)
Associated
nucleotide
sequences
needed
to
move
genetic
material,
including
linkers,
May
10,
2004
homopolymers,
adaptors,
transposons,
insertion
sequences,
and
restriction
enzyme
sites.
(
4)
The
nucleotide
sequences
needed
for
vector
transfer.
(
5)
The
nucleotide
sequences
needed
for
vector
maintenance.

(
b)
Well­
characterized.
For
introduced
genetic
material,
well­
characterized
means
that
the
following
have
been
determined:

(
1)
The
function
of
all
of
the
products
expressed
from
the
structural
gene(
s).
(
2)
The
function
of
sequences
that
participate
in
the
regulation
of
expression
of
the
structural
gene(
s).
(
3)
The
presence
or
absence
of
associated
nucleotide
sequences
and
their
associated
functions,
where
associated
nucleotide
sequences
are
those
sequences
needed
to
move
genetic
material
including
linkers,
homopolymers,
adaptors,
transposons,
insertion
sequences,
and
restriction
enzyme
sites.

(
c)
Poorly
mobilizable.
The
ability
of
the
introduced
genetic
material
to
be
transferred
and
mobilized
is
inactivated,
with
a
resulting
frequency
of
transfer
of
less
than
10­
8
transfer
events
per
recipient.

(
d)
Free
of
certain
sequences.
(
1)
The
introduced
genetic
material
must
not
contain
a
functional
portion
of
any
of
the
toxin­
encoding
sequences
described
in
this
paragraph
(
d).

(
i)
For
the
purposes
of
this
section,
a
functional
portion
of
a
toxin­
encoding
sequence
means
any
sequence
which
codes
for
a
polypeptide
that
has
one
of
the
following
effects:
(
A)
It
directly
or
indirectly
contributes
to
toxic
effects
in
humans.
Directly
contributes
to
toxic
effects
in
humans
means
those
sequences
encoding
polypeptides
that
have
direct
toxicity
to
target
cells.
An
example
of
a
sequence
which
directly
contributes
to
toxic
effects
in
humans
is
one
which
encodes
the
portion
of
diphtheria
toxin,
listed
in
paragraph
(
d)(
2)
of
this
section,
capable
of
interacting
with
elongation
factor
2,
leading
to
inhibition
of
protein
synthesis
in
target
respiratory,
heart,
kidney,
and
nerve
tissues.
Indirectly
contributes
to
toxic
effects
in
humans
means
a
sequence
whose
encoded
polypeptide
is
not
directly
toxic
to
target
cells,
yet
still
adversely
affects
humans.
An
example
of
a
sequence
which
indirectly
contributes
to
toxic
effects
is
the
sequence
which
encodes
the
portion
of
the
botulinum
toxin,
listed
in
paragraph
(
d)(
3)
of
this
section,
capable
of
blocking
the
release
of
acetylcholine
from
gangliosides.
Botulinum
toxin
affects
neuromuscular
junctions
by
its
blockage
of
acetylcholine
release,
leading
to
irreversible
relaxation
of
muscles
and
respiratory
arrest.
(
B)
It
binds
a
toxin
or
toxin
precursor
to
target
human
cells.
(
C)
It
facilitates
intracellular
transport
of
a
toxin
in
target
human
cells.
(
ii)
While
these
toxins
are
listed
(
with
synonyms
in
parentheses)
in
paragraphs
(
d)(
2)
through
(
d)(
7)
of
this
section
according
to
the
source
organism,
it
is
use
of
the
nucleotide
sequences
that
encode
the
toxins
that
is
being
restricted
and
not
the
use
of
the
source
organisms.
The
source
organisms
are
listed
to
provide
specificity
in
identification
of
sequences
whose
use
is
restricted.
Although
similar
or
identical
sequences
may
be
isolated
from
organisms
other
than
hose
listed
below
in
paragraphs
(
d)(
2)
through
(
d)(
7)
of
this
section,
these
comparable
toxin
sequences,
regardless
of
the
organism
from
which
they
are
derived,
must
not
be
included
in
the
introduced
genetic
material.
May
10,
2004
(
2)
Sequences
for
protein
synthesis
inhibitor.

Sequence
Source
Toxin
Name
Corynebacterium
diphtheriae
&
C.
Diphtheria
toxin
ulcerans
Pseudomonas
aeruginosa
Exotoxin
A
Shigella
dysenteriae
Shigella
toxin
(
Shiga
toxin,
Shigella
dysenteriae
type
I
toxin,
Vero
cell
toxin)
Abrus
precatorius,
seeds
Abrin
Ricinus
communis,
seeds
Ricin
(
3)
Sequences
for
neurotoxins.
Sequence
Source
Toxin
Name
Clostridium
botulinum
Neurotoxins
A,
B,
C1,
D,
E,
F,
G
(
Botulinum
toxins,
botulinal
toxins)
Clostridium
tetani
Tetanus
toxin
(
tetanospasmin)
Proteus
mirabilis
Neurotoxin
Staphylococcus
aureus
Alpha
toxin
(
alpha
lysin)
Yersinia
pestis
Murine
toxin
1
1
Snake
toxins
............................
Bungarus
caeruleus
Caeruleotoxin
Bungarus
multicinctus
Beta­
bungarotoxin
(
phospholipase)
Crotalus
spp.
Crotoxin
(
phospholipase)
Dendroaspis
viridis
Neurotoxin
Naja
naja
varieties
Neurotoxin
Notechia
scutatus
Notexin
(
phospholipase)
Oxyuranus
scutellatus
Taipoxin
Invertebrate
toxins
Chironex
fleckeri
Neurotoxin
Androctnus
australis
Neurotoxin
Centruroides
sculpturatus
Neurotoxin
(
4)
Sequences
for
oxygen
labile
cytolysins.

Sequence
Source
Toxin
Name
Bacillus
alve
Alveolysin
Bacillus
cereus
Cereolysin
May
10,
2004
Bacillus
laterosporus
Laterosporolysin
Bacillus
thuringiensis
Thuringiolysin
Clostridium
bifermentans
Lysin
Clostridium
botulinum
Lysin
Clostridium
caproicum
Lysin
Clostridium
chauvoei
Delta­
toxin
Clostridium
histolyticum
Epsilon­
toxin
Clostridium
novyi
Gamma­
toxin
Clostridium
oedematiens
Delta­
toxin
Clostridium
perfringens
Theta­
toxin
(
Perfringolysin)
Clostridium
septicum
Delta­
toxin
Clostridium
sordellii
Lysin
Clostridium
tetani
Tetanolysin
Listeria
monocytogenes
Listeriolysin
(
A
B)
Streptococcus
pneumoniae
Pneumolysin
Streptococcus
pyogene
Streptolysin
O
(
SLO)

(
5)
Sequences
for
toxins
affecting
membrane
function.
Sequence
Source
Toxin
Name
Bacillus
anthracis
Edema
factor
(
Factors
I
II);
Lethal
factor
(
Factors
II
III)
Bacillus
cereus
Enterotoxin
(
diarrheagenic
toxin,
mouse
lethal
factor)
Bordetella
pertussis
Adenylate
cyclase
(
Heat­
labile
factor);
Pertussigen
(
pertussis
toxin,
islet
activating
factor,
histamine
sensitizing
factor,
lymphocytosis
promoting
factor)
Clostridium
botulinum
C2
toxin
Clostridium
difficile
Enterotoxin
(
toxin
A)
Clostridium
perfringens
Beta­
toxin;
Delta­
toxin
Escherichia
coli
&
other
Heat­
labile
enterotoxins
Enterobacteriaceae
spp.
(
LT);
Heat­
stable
enterotoxins
(
STa,
ST1
subtypes
ST1a
ST1b;
also
STb,
STII)
Legionella
pneumophila
Cytolysin
Vibrio
cholerae
&
Vibrio
mimicus
Cholera
toxin
(
choleragen)

(
6)
Sequences
that
affect
membrane
integrity.

Sequence
Source
Toxin
Name
Clostridium
bifermentans
&
other
Lecithinase
Clostridium
spp
Clostridium
perfringens
Alpha­
toxin
(
phospholipase
C,
lecithinase);
Enterotoxin
Corynebacterium
pyogenes
&
other
Cytolysin
(
phospholipase
C),
Corynebacterium
spp.
Ovis
toxin
(
sphingomyelinase
D)
Staphylococcus
aureus
Beta­
lysin
(
beta
toxin)
May
10,
2004
(
7)
Sequences
that
are
general
cytotoxins.

Sequence
Source
Toxin
Name
Adenia
digitata
Modeccin
Aeromonas
hydrophila
Aerolysin
(
beta­
lysin,
cytotoxic
lysin)
Clostridium
difficile
Cytotoxin
(
toxin
B)
Clostridium
perfringens
Beta­
toxin;
Epsilon­
toxin;
Kappa­
toxin
Escherichia
coli
&
other
Cytotoxin
(
Shiga­
like
toxin,
Enterobacteriaceae
spp.
Vero
cell
toxin)
Pseudomonas
aeruginosa
Proteases
Staphylococcus
aureus
Gamma
lysin
(
Gamma
toxin);
Enterotoxins
(
SEA,
SEB,
SEC,
SED
SEE);
Pyrogenic
exotoxins
A
B;
Toxic
shock
syndrome
toxins
(
TSST­
1)
Staphylococcus
aureus
&
Pseudomonas
aeruginosa
Leucocidin
(
leukocidin,
cytotoxin)
Streptococcus
pyogenes
Streptolysin
S
(
SLS);
Erythrogenic
toxins(
scarlet
fever
toxins,
pyrogenic
exotoxins)
Yersinia
enterocolitica
Heat­
stable
enterotoxins
(
ST)

§
725.422
Physical
containment
and
control
technologies.

The
manufacturer
must
meet
all
of
the
following
criteria
for
physical
containment
and
control
technologies
for
any
facility
in
which
the
new
microorganism
will
be
used
for
a
Tier
I
exemption;
these
criteria
also
serve
as
guidance
for
a
Tier
II
exemption.

(
a)
Use
a
structure
that
is
designed
and
operated
to
contain
the
new
microorganism.
(
b)
Control
access
to
the
structure.
(
c)
Provide
written,
published,
and
implemented
procedures
for
the
safety
of
personnel
and
control
of
hygiene.
(
d)
Use
inactivation
procedures
demonstrated
and
documented
to
be
effective
against
the
new
microorganism
contained
in
liquid
and
solid
wastes
prior
to
disposal
of
the
wastes.
The
inactivation
procedures
must
reduce
viable
microbial
populations
by
at
least
6
logs
in
liquid
and
solid
wastes.
(
e)
Use
features
known
to
be
effective
in
minimizing
viable
microbial
populations
in
aerosols
and
exhaust
gases
released
from
the
structure,
and
document
use
of
such
features.
(
f)
Use
systems
for
controlling
dissemination
of
the
new
microorganism
through
other
routes,
and
document
use
of
such
features.
(
g)
Have
in
place
emergency
clean­
up
procedures.

§
725.424
Requirements
for
the
Tier
I
exemption.

(
a)
Conditions
of
exemption.
The
manufacture
or
import
of
a
new
microorganism
for
commercial
purposes
is
not
subject
to
review
under
this
part
if
all
of
the
following
conditions
are
met
for
all
activities
involving
the
new
microorganism:

(
1)
The
recipient
microorganism
is
listed
in
and
meets
any
requirements
specified
in
§
725.420.
May
10,
2004
(
2)
The
introduced
genetic
material
meets
the
criteria
under
§
725.421.
(
3)
The
physical
containment
and
control
technologies
of
any
facility
in
which
the
microorganism
will
be
manufactured,
processed,
or
used
meet
the
criteria
under
§
725.422.
(
4)
The
manufacturer
or
importer
submits
a
certification
described
in
paragraph
(
b)
of
this
section
to
EPA
at
least
10
days
before
commencing
initial
manufacture
or
import
of
a
new
microorganism
derived
from
a
recipient
microorganism
listed
in
§
725.420.
(
5)
The
manufacturer
or
importer
complies
with
the
recordkeeping
requirements
of
§
725.65
and
maintains
records
for
the
initial
and
subsequent
uses
of
the
new
microorganism
that
verify
compliance
with
the
following:
(
i)
The
certifications
made
in
paragraph
(
b)
of
this
section.
(
ii)
All
the
eligibility
criteria
for
the
Tier
I
exemption
including
the
criteria
for
the
recipient
microorganism,
the
introduced
genetic
material,
the
physical
containment
and
control
technologies.

(
b)
Certification.
To
be
eligible
for
the
Tier
I
exemption
under
this
subpart,
the
manufacturer
or
importer
must
submit
to
EPA
a
document
signed
by
a
responsible
company
official
containing
the
information
listed
in
this
paragraph.

(
1)
Name
and
address
of
manufacturer
or
importer.
(
2)
Date
when
manufacture
or
import
is
expected
to
begin.
(
3)
The
identification
(
genus,
species)
of
the
recipient
microorganism
listed
in
§
725.420
which
is
being
used
to
create
the
new
microorganism
which
will
be
used
under
the
conditions
of
the
Tier
I
exemption.
(
4)
Certification
of
the
following:
(
i)
Compliance
with
the
introduced
genetic
material
criteria
described
in
§
725.421.
(
ii)
Compliance
with
the
containment
requirements
described
in
§
725.422,
including
the
provision
in
paragraph
(
a)(
3)
of
this
section.
(
5)
The
site
of
waste
disposal
and
the
type
of
permits
for
disposal,
the
permit
numbers
and
the
institutions
issuing
the
permits.
(
6)
The
certification
statement
required
in
§
725.25(
b).
Certification
of
submission
of
test
data
is
not
required
for
the
Tier
I
exemption.

§
725.426
Applicability
of
the
Tier
I
exemption.

The
Tier
I
exemption
under
§
725.424
applies
only
to
a
manufacturer
or
importer
of
a
new
microorganism
that
certifies
that
the
microorganism
will
be
used
in
all
cases
in
compliance
with
§
§
725.420,
725.421,
and
725.422.

§
725.428
Requirements
for
the
Tier
II
exemption.

The
manufacturer
or
importer
of
a
new
microorganism
for
commercial
purposes
may
submit
to
EPA
a
Tier
II
exemption
request
in
lieu
of
a
MCAN
under
subpart
D
of
this
part
if
all
of
the
following
conditions
are
met:

(
a)
The
recipient
microorganism
is
listed
in
and
meets
any
requirements
specified
in
§
725.420.
(
b)
The
introduced
genetic
material
meets
the
criteria
under
§
725.421.
(
c)
Adequate
physical
containment
and
control
technologies
are
used.
The
criteria
listed
under
May
10,
2004
§
725.422
for
physical
containment
and
control
technologies
of
facilities
should
be
used
as
guidance
to
satisfy
the
Tier
II
exemption
request
data
requirements
listed
at
§
725.455(
d).
EPA
will
review
proposed
process
and
containment
procedures
as
part
of
the
submission
for
a
Tier
II
exemption
under
this
section.

§
725.450
Procedural
requirements
for
the
Tier
II
exemption.

General
requirements
for
all
submissions
under
this
part
are
contained
in
§
725.25.
In
addition,
the
following
requirements
apply
to
requests
submitted
under
this
subpart:

(
a)
Prenotice
consultation.
EPA
strongly
suggests
that
for
a
Tier
II
exemption,
the
submitter
contact
the
Agency
for
a
prenotice
consultation
regarding
eligibility
for
the
exemption.

(
b)
When
to
submit
the
Tier
II
exemption
request.
Each
person
who
is
eligible
to
submit
a
Tier
II
exemption
request
under
this
subpart
must
submit
the
request
at
least
45
calendar
days
before
the
person
intends
to
commence
manufacture
or
import.

(
c)
Contents
of
the
Tier
II
exemption
request.
Each
person
who
submits
a
request
under
this
subpart
must
provide
the
information
described
in
§
§
725.428
and
725.455,
as
well
as
information
known
to
or
reasonably
ascertainable
by
the
person
that
would
permit
EPA
to
determine
that
use
of
the
microorganism,
under
the
conditions
specified
in
the
request,
will
not
present
an
unreasonable
risk
of
injury
to
health
or
the
environment.

(
d)
Recordkeeping.
Each
person
who
submits
a
request
under
this
subpart
must
comply
with
the
recordkeeping
requirements
of
§
725.65.
In
addition,
the
submitter
should
maintain
records
which
contain
information
that
verifies
compliance
with
the
following:

(
1)
The
certifications
made
in
the
request.
(
2)
All
the
eligibility
criteria
for
the
Tier
II
exemption
request
including
the
criteria
for
the
recipient
microorganism,
the
introduced
genetic
material,
the
physical
containment
and
control
technologies.

§
725.455
Information
to
be
included
in
the
Tier
II
exemption
request.

The
submitter
must
indicate
clearly
that
the
submission
is
a
Tier
II
exemption
request
for
a
microorganism
instead
of
the
MCAN
under
subpart
D
of
this
part
and
must
submit
the
following
information:

(
a)
Submitter
identification.
(
1)
The
name
and
headquarters
address
of
the
submitter.
(
2)
The
name,
address,
and
office
telephone
number
(
including
area
code)
of
the
principal
technical
contact
representing
the
submitter.

(
b)
Microorganism
identity
information.
(
1)
Identification
(
genus,
species,
and
strain)
of
the
recipient
microorganism.
Genus,
species
designation
should
be
substantiated
by
a
letter
from
a
culture
collection
or
a
brief
summary
of
the
results
of
tests
conducted
for
taxonomic
May
10,
2004
identification.
(
2)
Type
of
genetic
modification
and
the
function
of
the
introduced
genetic
material.
(
3)
Site
of
insertion.
(
4)
Certification
of
compliance
with
the
introduced
genetic
material
criteria
described
in
§
725.421.

(
c)
Production
volume.
Production
volume,
including
total
liters
per
year,
and
the
maximum
cell
concentration
achieved
during
the
production
process.

(
d)
Process
and
containment
information.
(
1)
A
description
of
the
process
including
the
following:
(
i)
Identity
and
location
of
the
manufacturing
site(
s).
(
ii)
Process
flow
diagram
illustrating
the
production
process,
including
downstream
separations,
and
indicating
the
containment
envelope
around
the
appropriate
equipment.
(
iii)
Identities
and
quantities
of
feedstocks.
(
iv)
Sources
and
quantities
of
potential
releases
to
both
the
workplace
and
environment,
and
a
description
of
engineering
controls,
inactivation
procedures,
and
other
measures
which
will
reduce
worker
exposure
and
environmental
releases.
(
v)
A
description
of
procedures
which
will
be
undertaken
to
prevent
fugitive
emissions,
i.
e.
leak
detection
and
repair
program.
(
vi)
A
description
of
procedures/
safeguards
to
prevent
and
mitigate
accidental
releases
to
the
workplace
and
the
environment.
(
2)
Certification
of
those
elements
of
the
containment
criteria
described
in
§
725.422
with
which
the
manufacturer
is
in
compliance,
including
stating
by
number
the
elements
with
which
the
manufacturer
is
in
full
compliance.

(
e)
The
site
of
waste
disposal
and
the
type
of
permits
for
disposal,
the
permit
numbers
and
the
institutions
issuing
the
permits.

(
f)
The
certification
statement
required
in
§
725.25(
b).
Certification
of
submission
of
test
data
is
not
required
for
the
Tier
II
exemption.

§
725.470
EPA
review
of
the
Tier
II
exemption
request.

General
procedures
for
review
of
all
submissions
under
this
part
are
contained
in
§
§
725.28
through
725.60.
In
addition,
the
following
procedures
apply
to
EPA
review
of
Tier
II
exemption
requests
submitted
under
this
subpart:

(
a)
Length
of
the
review
period.
The
review
period
for
the
request
will
be
45
days
from
the
date
the
Document
Control
Officer
for
the
Office
of
Pollution
Prevention
and
Toxics
receives
a
complete
request,
or
the
date
EPA
determines
the
request
is
complete
under
§
725.33,
unless
the
Agency
extends
the
review
period
for
good
cause
under
§
725.56.

(
b)
Criteria
for
review.
EPA
will
review
the
request
to
determine
that
the
new
microorganism
complies
with
§
725.428
and
that
its
manufacture,
processing,
use,
and
disposal
as
described
in
the
request
will
not
present
an
unreasonable
risk
of
injury
to
health
or
the
environment.

(
c)
EPA
decision
regarding
the
Tier
II
exemption
request.
A
decision
concerning
a
request
under
May
10,
2004
this
subpart
will
be
made
by
the
Administrator,
or
a
designee.

(
d)
Determination
that
the
microorganism
is
ineligible
for
a
Tier
II
review.
(
1)
EPA
may
determine
that
the
manufacturer
or
importer
is
not
eligible
for
Tier
II
review,
because
the
microorganism
does
not
meet
the
criteria
under
§
725.428
or
the
Administrator,
or
a
designee,
decides
that
there
is
insufficient
information
to
determine
that
the
conditions
of
manufacture,
processing,
use,
or
disposal
of
the
microorganism
as
described
in
the
request
will
not
present
an
unreasonable
risk
to
health
or
the
environment.

(
2)
If
the
Agency
makes
this
determination,
the
Administrator,
or
a
designee
will
notify
the
manufacturer
or
importer
by
telephone,
followed
by
a
letter,
that
the
request
has
been
denied.
The
letter
will
explain
reasons
for
the
denial.

(
3)
If
the
request
is
denied,
the
manufacturer
or
importer
may
submit
the
information
necessary
to
constitute
a
MCAN
under
subpart
D
of
this
part.

(
e)
Approval
or
denial
of
the
Tier
II
exemption
request.
(
1)
No
later
than
45
days
after
EPA
receives
a
request,
the
Agency
will
either
approve
or
deny
the
request.

(
2)
In
approving
a
request,
EPA
may
impose
any
restrictions
necessary
to
ensure
that
the
microorganism
will
not
present
an
unreasonable
risk
of
injury
to
health
and
the
environment
as
a
result
of
general
commercial
use.

(
f)
EPA
may
seek
to
enjoin
the
manufacture
or
import
of
a
microorganism
in
violation
of
this
subpart,
or
act
to
seize
any
microorganism
manufactured
or
imported
in
violation
of
this
section
or
take
other
actions
under
the
authority
of
sections
7
or
17
of
the
Act.

(
g)
A
manufacturer
or
importer
may
only
proceed
after
receipt
of
EPA
approval.

Subparts
H­
K
[
Reserved]

Subpart
L
­­
Additional
Procedures
for
Reporting
on
Significant
New
Uses
of
Microorganisms
§
725.900
Scope
and
purpose.

(
a)
This
subpart
describes
additional
provisions
governing
submission
of
MCANs
for
microorganisms
subject
to
significant
new
use
rules
identified
in
subpart
M
of
this
part.

(
b)
Manufacturers,
importers,
and
processors
described
in
§
725.105(
c)
must
submit
a
MCAN
under
subpart
D
of
this
part
for
significant
new
uses
of
microorganisms
described
in
subpart
M
of
this
part,
unless
they
are
excluded
under
§
§
725.910
or
725.912.

(
c)
Section
725.920
discusses
exports
and
imports.

(
d)
Additional
recordkeeping
requirements
specific
to
significant
new
uses
of
microorganisms
are
described
in
§
725.950.
May
10,
2004
(
e)
Section
725.975
describes
how
EPA
will
approve
alternative
means
of
complying
with
significant
new
use
requirements
designated
in
subpart
M
of
this
part.

(
f)
Expedited
procedures
for
promulgating
significant
new
use
requirements
under
subpart
M
of
this
part
for
microorganisms
subject
to
section
5(
e)
orders
are
discussed
in
§
§
725.980
and
725.984.

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

(
h)
The
provisions
of
subparts
A
through
F
of
this
part
also
apply
to
subparts
L
and
M
of
this
part.
For
purposes
of
subparts
L
and
M
of
this
part,
wherever
the
words
"
microorganism"
or
"
new
microorganism"
appear
in
subparts
A
through
F
of
this
part,
it
shall
mean
the
microorganism
subject
to
subparts
L
and
M
of
this
part.
In
the
event
of
a
conflict
between
the
provisions
of
subparts
A
through
F
and
the
provisions
of
subparts
L
and
M
of
this
part,
the
provisions
of
subparts
L
and
M
of
this
part
shall
govern.

§
725.910
Persons
excluded
from
reporting
significant
new
uses.

(
a)
A
person
who
intends
to
manufacture,
import,
or
process
a
microorganism
identified
in
subpart
M
of
this
part
and
who
intends
to
distribute
it
in
commerce
is
not
required
to
submit
a
MCAN
under
subpart
D
of
this
part,
if
that
person
can
document
one
or
more
of
the
following
as
to
each
recipient
of
the
microorganism
from
that
person:

(
1)
That
the
person
has
notified
the
recipient,
in
writing,
of
the
specific
section
in
subpart
M
of
this
part
which
identifies
the
microorganism
and
its
designated
significant
new
uses,
or
(
2)
That
the
recipient
has
knowledge
of
the
specific
section
in
subpart
M
of
this
part
which
identifies
the
microorganism
and
its
designated
significant
new
uses,
or
(
3)
That
the
recipient
cannot
undertake
any
significant
new
use
described
in
the
specific
section
in
subpart
M
of
this
part.

(
b)
The
manufacturer,
importer,
or
processor
described
in
paragraph
(
a)
of
this
section
must
submit
a
MCAN
under
subpart
D
of
this
part,
if
such
person
has
knowledge
at
the
time
of
commercial
distribution
of
the
microorganism
identified
in
the
specific
section
in
subpart
M
of
this
part
that
a
recipient
intends
to
engage
in
a
designated
significant
new
use
of
that
microorganism
without
submitting
a
MCAN
under
this
part.

(
c)
A
person
who
processes
a
microorganism
identified
in
a
specific
section
in
subpart
M
of
this
part
for
a
significant
new
use
of
that
microorganism
is
not
required
to
submit
a
MCAN
if
that
person
can
document
each
of
the
following:
May
10,
2004
(
1)
That
the
person
does
not
know
the
specific
microorganism
identity
of
the
microorganism
being
processed,
and
(
2)
That
the
person
is
processing
the
microorganism
without
knowledge
that
the
microorganism
is
identified
in
subpart
M
of
this
part.

(
d)(
1)
If
at
any
time
after
commencing
distribution
in
commerce
of
a
microorganism
identified
in
a
specific
section
in
subpart
M
of
this
part,
a
person
who
manufactures,
imports,
or
processes
a
microorganism
described
in
subpart
M
of
this
part
and
distributes
it
in
commerce
has
knowledge
that
a
recipient
of
the
microorganism
is
engaging
in
a
significant
new
use
of
that
microorganism
designated
in
that
section
without
submitting
a
MCAN
under
this
part,
the
person
is
required
to
cease
supplying
the
microorganism
to
that
recipient
and
to
submit
a
MCAN
for
that
microorganism
and
significant
new
use,
unless
the
person
is
able
to
document
each
of
the
following:
(
i)
That
the
person
has
notified
the
recipient
and
EPA
enforcement
authorities
(
at
the
address
in
paragraph
(
d)(
1)(
iii)
of
this
section),
in
writing
within
15
working
days
of
the
time
the
person
develops
knowledge
that
the
recipient
is
engaging
in
a
significant
new
use,
that
the
recipient
is
engaging
in
a
significant
new
use
without
submitting
a
MCAN.
(
ii)
That,
within
15
working
days
of
notifying
the
recipient
as
described
in
paragraph
(
d)(
1)(
i)
of
this
section,
the
person
received
from
the
recipient,
in
writing,
a
statement
of
assurance
that
the
recipient
is
aware
of
the
terms
of
the
applicable
section
in
subpart
M
of
this
part
and
will
not
engage
in
the
significant
new
use.
(
iii)
That
the
person
has
promptly
provided
EPA
enforcement
authorities
with
a
copy
of
the
recipient's
statement
of
assurance
described
in
paragraph
(
d)(
1)(
ii)
of
this
section.
The
copy
must
be
sent
to
the
Director,
Office
of
Compliance
(
2221A),
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460.

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

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

§
725.912
Exemptions.
May
10,
2004
Persons
identified
in
§
725.105(
c)
are
not
required
to
submit
a
MCAN
under
subpart
D
of
this
part
for
a
microorganism
identified
in
subpart
M
of
this
part,
unless
otherwise
specified
in
a
specific
section
in
subpart
M,
if:

(
a)
The
person
submits
a
MCAN
for
the
microorganism
prior
to
the
promulgation
date
of
the
section
in
subpart
M
of
this
part
which
identifies
the
microorganism,
and
the
person
receives
written
notification
of
compliance
from
EPA
prior
to
the
effective
date
of
such
section.
The
MCAN
submitter
must
comply
with
any
applicable
requirement
of
section
5(
b)
of
the
Act.
The
MCAN
must
include
the
information
and
test
data
specified
in
section
5(
d)(
1)
of
the
Act.
For
purposes
of
this
exemption,
the
specific
section
in
subpart
M
of
this
part
which
identifies
the
microorganism
and
§
§
725.3,
725.15,
725.65,
725.70,
725.75,
725.100,
and
725.900
apply;
after
the
effective
date
of
the
section
in
subpart
M
of
this
part
which
identifies
the
microorganism,
§
§
725.105
and
725.910
apply
and
§
725.920
continues
to
apply.
EPA
will
provide
the
MCAN
submitter
with
written
notification
of
compliance
only
if
one
of
the
following
occurs:

(
1)
EPA
is
unable
to
make
the
finding
that
the
activities
described
in
the
MCAN
will
or
may
present
an
unreasonable
risk
of
injury
to
health
or
the
environment
under
reasonably
foreseeable
circumstances,
or
(
2)
EPA
and
the
person
negotiate
a
consent
order
under
section
5(
e)
of
the
Act,
such
order
to
take
effect
on
the
effective
date
of
the
section
in
subpart
M
of
this
part
which
identifies
the
microorganism.

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

§
725.920
Exports
and
imports.

(
a)
Exports.
Persons
who
intend
to
export
a
microorganism
identified
in
subpart
M
of
this
part,
or
in
any
proposed
rule
which
would
amend
subpart
M
of
this
part,
are
subject
to
the
export
notification
provisions
of
section
12(
b)
of
the
Act.
The
regulations
that
interpret
section
12(
b)
appear
at
part
707
of
this
chapter.

(
b)
Imports.
Persons
who
import
a
substance
identified
in
a
specific
section
in
subpart
M
of
this
part
are
subject
to
the
import
certification
requirements
under
section
13
of
the
Act,
which
are
codified
at
19
CFR
§
§
12.118
through
12.127
and
127.28(
i).
The
EPA
policy
in
support
of
the
import
certification
requirements
appears
at
part
707
of
this
chapter.

§
725.950
Additional
recordkeeping
requirements.

Persons
submitting
a
MCAN
for
a
significant
new
use
of
a
microorganism
must
comply
with
the
recordkeeping
requirements
of
§
725.65.
In
addition,
the
following
requirements
apply:
May
10,
2004
(
a)
At
the
time
EPA
adds
a
microorganism
to
subpart
M
of
this
part,
EPA
may
specify
appropriate
recordkeeping
requirements.
Each
manufacturer,
importer,
and
processor
of
the
microorganism
shall
maintain
the
records
for
3
years
from
the
date
of
their
creation.

(
b)
The
records
required
to
be
maintained
under
this
section
may
include
the
following:

(
1)
Records
documenting
the
information
contained
in
the
MCAN
submitted
to
EPA.

(
2)
Records
documenting
the
manufacture
and
importation
volume
of
the
microorganism
and
the
corresponding
dates
of
manufacture
and
import.

(
3)
Records
documenting
volumes
of
the
microorganism
purchased
domestically
by
processors
of
the
microorganism,
names
and
addresses
of
suppliers
and
corresponding
dates
of
purchase.

(
4)
Records
documenting
the
names
and
addresses
(
including
shipment
destination
address,
if
different)
of
all
persons
outside
the
site
of
manufacture
or
import
to
whom
the
manufacturer,
importer,
or
processor
directly
sells
or
transfers
the
microorganism,
the
date
of
each
sale
or
transfer,
and
the
quantity
of
the
microorganism
sold
or
transferred
on
such
date.

§
725.975
EPA
approval
of
alternative
control
measures.

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

(
b)
A
request
for
a
determination
of
equivalency
must
be
submitted
in
writing
to
the
Office
of
Pollution
Prevention
and
Toxics,
Document
Control
Officer,
7407,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460:
ATTN:
SNUR
Equivalency
Determination,
and
must
contain:

(
1)
The
name
of
the
submitter.
(
2)
The
specific
identity
of
the
microorganism.
(
3)
The
citation
for
the
specific
section
in
subpart
M
of
this
part
which
pertains
to
the
microorganism
for
which
the
request
is
being
submitted.
(
4)
A
detailed
description
of
the
activities
involved.
(
5)
The
specifications
of
the
alternative
worker
exposure
control
measures
or
environmental
release
control
measures.
(
6)
A
detailed
analysis
explaining
why
such
alternative
control
measures
provide
substantially
the
same
degree
of
protection
as
the
specific
control
measures
identified
in
the
specific
section
in
subpart
M
of
this
part
which
pertains
to
the
microorganism
for
which
the
request
is
being
May
10,
2004
submitted.
(
7)
The
data
and
information
described
in
§
§
725.155
and
725.160.
If
such
data
and
information
have
already
been
submitted
to
EPA's
Office
of
Pollution
Prevention
and
Toxics,
the
submitter
need
only
document
that
it
was
previously
submitted,
to
whom,
and
the
date
it
was
submitted.

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

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

§
725.980
Expedited
procedures
for
issuing
significant
new
use
rules
for
microorganisms
subject
to
section
5(
e)
orders.

(
a)
Selection
of
microorganisms.
(
1)
In
accordance
with
the
expedited
process
specified
in
this
section,
EPA
will
issue
significant
new
use
notification
requirements
for
each
new
microorganism
that,
after
MCAN
review
under
subpart
D
of
this
part,
becomes
subject
to
a
final
order
issued
under
section
5(
e)
of
the
Act,
except
for
an
order
that
prohibits
manufacture
and
import
of
the
microorganism,
unless
EPA
determines
that
significant
new
use
notification
requirements
are
not
needed
for
the
microorganism.

(
2)
If
EPA
determines
that
significant
new
use
notifications
requirements
are
not
needed
for
a
microorganism
that
is
subject
to
a
final
order
issued
under
section
5(
e)
of
the
Act,
EPA
will
issue
a
notice
in
the
FEDERAL
REGISTER
explaining
why
the
significant
new
use
requirements
are
not
needed.

(
b)
Designation
of
requirements.
(
1)
The
significant
new
use
notification
and
other
specific
requirements
will
be
based
on
and
be
consistent
with
the
provisions
included
in
the
final
order
issued
for
the
microorganism
under
section
5(
e)
of
the
Act.
EPA
may
also
designate
additional
activities
as
significant
new
uses
which
will
be
subject
to
notification.
(
2)
Significant
new
use
requirements
and
other
specific
requirements
designated
under
this
section
will
be
listed
in
subpart
M
of
this
part.
For
each
microorganism,
subpart
M
of
this
part
will
identify:
(
i)
The
microorganism
name.
(
ii)
The
activities
designated
as
significant
new
uses.
(
iii)
Other
specific
requirements
applicable
to
the
microorganism,
including
recordkeeping
requirements
or
any
other
requirements
included
in
the
final
section
5(
e)
order.

(
c)
Procedures
for
issuing
significant
new
use
rules.
(
1)
Possible
processes.
EPA
will
issue
May
10,
2004
significant
new
use
rules
(
SNURs)
under
this
section
by
one
of
the
following
three
processes:
direct
final
rulemaking,
interim
final
rulemaking,
or
notice
and
comment
rulemaking.
EPA
will
use
the
direct
final
rulemaking
process
to
issue
significant
new
use
rules
unless
it
determines
that,
in
a
particular
case,
one
of
the
other
processes
is
more
appropriate.
(
2)
Notice
in
the
FEDERAL
REGISTER.
FEDERAL
REGISTER
documents
issued
to
propose
or
establish
significant
new
uses
under
this
section
will
contain
the
following:
(
i)
The
microorganism
identity
or,
if
its
specific
identity
is
claimed
confidential,
an
appropriate
generic
microorganism
name
and
an
accession
number
assigned
by
EPA.
(
ii)
The
MCAN
number.
(
iii)
A
summary
of
EPA's
findings
under
section
5(
e)(
1)(
A)
of
the
Act
for
the
final
order
issued
under
section
5(
e).
(
iv)
Designation
of
the
significant
new
uses
subject
to,
or
proposed
to
be
subject
to,
notification
and
any
other
applicable
requirements.
(
v)
Any
modification
of
subpart
L
of
this
part
applicable
to
the
specific
microorganism
and
significant
new
uses.
(
vi)
If
the
FEDERAL
REGISTER
document
establishes
a
final
rule,
or
notifies
the
public
that
a
final
rule
will
not
be
issued
after
public
comment
has
been
received,
the
document
will
describe
comments
received
and
EPA's
response.
(
3)
Direct
final
rulemaking.
(
i)
EPA
will
use
direct
final
rulemaking
to
issue
a
significant
new
use
rule,
when
specific
requirements
will
be
based
on
and
be
consistent
with
the
provisions
included
in
the
final
order
issued
for
the
microorganism
under
section
5(
e)
of
the
Act.
EPA
will
issue
a
final
rule
in
the
FEDERAL
REGISTER
following
its
decision
to
develop
a
significant
new
use
rule
under
this
section
for
a
specific
new
microorganism.
(
ii)
The
FEDERAL
REGISTER
document
will
state
that,
unless
written
notice
is
received
by
EPA
within
30
days
of
publication
that
someone
wishes
to
submit
adverse
or
critical
comments,
the
rule
will
be
effective
60
days
from
the
date
of
publication.
The
written
notice
of
intent
to
submit
adverse
or
critical
comments
should
state
which
SNUR(
s)
will
be
the
subject
of
the
adverse
or
critical
comments,
if
several
SNURs
are
established
through
the
direct
final
rule.
If
notice
is
received
within
30
days
that
someone
wishes
to
submit
adverse
or
critical
comments,
the
section(
s)
of
the
direct
final
rule
containing
the
SNUR(
s)
for
which
a
notice
of
intent
to
comment
was
received
will
be
withdrawn
by
EPA
issuing
a
document
in
the
final
rule
section
of
the
FEDERAL
REGISTER,
and
a
proposal
will
be
published
in
the
proposed
rule
section
of
the
FEDERAL
REGISTER.
The
proposal
will
establish
a
30­
day
comment
period.

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

(
4)
Interim
final
rulemaking.
(
i)
EPA
will
use
the
interim
final
rulemaking
procedure
to
issue
a
significant
new
use
rule,
when
specific
requirements
will
be
based
on
and
be
consistent
with
the
provisions
included
in
the
final
order
issued
for
the
microorganism
under
section
5(
e)
of
the
Act.
The
Agency
will
issue
an
interim
final
rule
in
the
FEDERAL
REGISTER
following
its
decision
to
develop
a
significant
new
use
rule
for
a
specific
new
microorganism.
The
document
will
state
EPA's
reasons
for
using
the
interim
final
rulemaking
procedure.
(
A)
The
significant
new
use
rule
will
take
effect
on
the
date
of
publication.
(
B)
Persons
will
be
given
30
days
from
the
date
of
publication
to
submit
comments.
May
10,
2004
(
ii)
Interim
final
rules
issued
under
this
section
shall
cease
to
be
in
effect
180
days
after
publication
unless,
within
the
180­
day
period,
EPA
issues
a
final
rule
in
the
FEDERAL
REGISTER
responding
to
any
written
comments
received
during
the
30­
day
comment
period
specified
in
paragraph
(
c)(
4)(
i)(
B)
of
this
section
and
promulgating
final
significant
new
use
notification
requirements
and
other
requirements
for
the
microorganism.

(
5)
Notice
and
comment
rulemaking.
(
i)
EPA
will
use
a
notice
and
comment
procedure
to
issue
a
significant
new
use
rule,
when
EPA
is
designating
additional
activities
which
are
not
provisions
included
in
the
final
order
issued
for
the
microorganism
under
section
5(
e)
of
the
Act
as
significant
new
uses
which
will
be
subject
to
notification.
EPA
will
issue
a
proposal
in
the
FEDERAL
REGISTER
following
its
decision
to
develop
a
significant
new
use
rule
under
this
section
for
a
specific
new
microorganism.
Persons
will
be
given
30
days
to
comment
on
whether
EPA
should
establish
notification
requirements
for
the
microorganism
under
this
part.
(
ii)
If
EPA,
having
considered
any
timely
comments,
decides
to
establish
notification
requirements
under
this
section,
EPA
will
issue
a
final
rule
adding
the
microorganism
to
subpart
M
of
this
part
and
designating
the
significant
new
uses
subject
to
notification.

(
d)
Schedule
for
issuing
significant
new
use
rules.
(
1)
Unless
EPA
determines
that
a
significant
new
use
rule
should
not
be
issued
under
this
section,
EPA
will
issue
a
proposed
rule,
a
direct
final
rule,
or
an
interim
final
rule
within180
days
of
receipt
of
a
valid
notice
of
commencement
under
§
725.190.

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

§
725.984
Modification
or
revocation
of
certain
notification
requirements.

(
a)
Criteria
for
modification
or
revocation.
EPA
may
at
any
time
modify
or
revoke
significant
new
use
notification
requirements
for
a
microorganism
which
has
been
added
to
subpart
M
of
this
part
using
the
procedures
of
§
725.980.
Such
action
may
be
taken
under
this
section
if
EPA
makes
one
of
the
following
determinations,
unless
other
information
shows
that
the
requirements
should
be
retained:

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

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

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

(
4)
EPA
has
examined
new
information,
or
has
reexamined
the
test
data
or
other
information
May
10,
2004
supporting
its
finding
under
section
5(
e)(
1)(
A)(
ii)(
I)
of
the
Act
and
has
concluded
that
a
rational
basis
no
longer
exists
for
the
findings
that
activities
involving
the
microorganism
may
present
an
unreasonable
risk
of
injury
to
health
or
the
environment
required
under
section
5(
e)(
1)(
A)
of
the
Act.

(
5)
Certain
activities
involving
the
microorganism
have
been
designated
as
significant
new
uses
pending
the
completion
of
testing,
and
adequate
test
data
developed
in
accordance
with
applicable
procedures
and
criteria
have
been
submitted
to
EPA.

(
b)
Procedures
for
limitation
or
revocation.
Modification
or
revocation
of
significant
new
use
notification
requirements
for
a
microorganism
that
has
been
added
to
subpart
M
of
this
part
using
the
procedures
described
in
§
725.980
may
occur
either
at
EPA's
initiative
or
in
response
to
a
written
request.

(
1)
Any
affected
person
may
request
modification
or
revocation
of
significant
new
use
notification
requirements
for
a
microorganism
that
has
been
added
to
subpart
M
of
this
part
using
the
procedures
described
in
§
725.980
by
writing
to
the
Director,
or
a
designee,
and
stating
the
basis
for
such
request.
The
request
must
be
accompanied
by
information
sufficient
to
support
the
request.
All
requests
should
be
sent
to
the
TSCA
Document
Processing
Center
(
7407),
Room
L­
100,
U.
S.
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460,
ATTN:
Request
to
amend
SNUR.

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

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

Subpart
M
­­
Significant
New
Uses
for
Specific
Microorganisms
§
725.1000
Scope.

This
subpart
identifies
uses
of
microorganisms
which
EPA
has
determined
to
be
significant
new
uses
under
the
authority
of
section
5(
a)(
2)
of
the
Toxic
Substances
Control
Act.

§
725.1075
Burkholderia
cepacia
complex.

(
a)
Microorganism
and
significant
new
uses
subject
to
reporting.
(
1)
The
microorganisms
identified
as
the
Burkholderia
cepacia
complex
defined
as
containing
the
following
nine
species,
Burkholderia
cepacia,
Burkholderia
multivorans,
Burkholderia
stabilis,
Burkholderia
vietnamiensis,
Burkholderia
ambifaria,
Burkholderia
pyrrocinia,
Burkholderia
cepacia
genomovar
VIII
(
Burkholderia
anthina),
and
Burkholderia
cepacia
genomovars
III
and
VI
are
subject
to
reporting
under
this
section
for
the
significant
new
uses
described
in
paragraph
(
a)(
2)
of
this
May
10,
2004
section.

(
2)
The
significant
new
use
is
any
use
other
than
research
and
development
in
the
degradation
of
chemicals
via
injection
into
subsurface
groundwater.

(
b)
[
Reserved]

[
68
FR
35320,
June
13,
2003]
May
10,
2004
Attachment
G
Premanufacture
Notice
(
EPA
Form
7710­
25)
May
10,
2004
Attachment
H
Instruction
Manual
for
Reporting
under
the
TSCA
Section
5
New
Chemicals
Program