Document ID: EPA-HQ-OPPT-2003-0038-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2003-07-25T04:00Z

May
5,
2000
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
New
Chemical
Substances
ICR
No.:
EPA
ICR
No.:
574.11;
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
section
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
known
as
a
Microbial
Commercial
Activity
Notice
(
MCAN).

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

This
information
collection
request
addresses
the
TSCA
section
5
reporting
and
recordkeeping
requirements
associated
with
the
new
chemicals
review
and
regulatory
program,
as
briefly
outlined
above.

2
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
RECEIVED
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2003
July
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11:
04AM
OPPT­
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0002
Page
2
of
25
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
(
inter­
generic)
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.

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
Page
3
of
25
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.

(
iii)
TSCA
Section
5(
h)(
4)
Exemptions
TSCA
section
5(
h)(
4)
authorizes
EPA
to
exempt
any
person
from
the
provisions
of
TSCA
section
5
if
EPA
determines
that
the
chemical
substance
will
not
present
an
unreasonable
risk
of
injury
to
health
or
the
environment
when
manufactured,
processed,
distributed,
used
or
disposed
of
under
the
exemption.
To
date
EPA
has
promulgated
four
rules
under
this
section
for
chemical
substances
and
three
exemptions
for
microbial
products
of
biotechnology:

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

o
Low
Release/
Low
Exposure
(
LoREX)
­
This
exemption
applies
to
certain
chemical
Page
4
of
25
substances
that
meet
strict
human
exposure
and
environmental
release
criteria
to
ensure
that
these
substances
will
not
present
an
unreasonable
risk.
See
40
CFR
723.50.

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

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

o
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.

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

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

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

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

2(
b)
Use/
Users
of
the
Data
Page
5
of
25
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
these
chemicals,
EPA
needs
data
on
each
chemical's
structure
and
properties,
its
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
in
order
to
identify
substances
with
analogous
physicochemical
structures
and
properties,
with
similar
manufacturing
processes,
and
with
similar
uses.
The
Agency
reviews
the
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.

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
Page
6
of
25
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.

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
test­
marketing
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
Page
7
of
25
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
was
submitted
with
no
claims
of
confidentiality
and
the
PMN
(
or
other
TSCA
section
5
notice)
identifies
the
office
or
person
to
whom
the
data
were
submitted
and
the
date
of
the
submission.

3(
b)
Public
Notice
Required
Prior
to
ICR
Submission
to
OMB
In
proposing
to
renew
this
ICR,
EPA
provided
a
60­
day
public
notice
and
comment
period
that
ended
on
November
12,
1999
(
64
FR
49484,
September
13,
1999).
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
Page
8
of
25
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.,
Chemical
Manufacturers
Association
and
the
Synthetic
Organic
Chemicals
Manufacturers
Association
in
April
1989,
"
Living
With
TSCA"
seminar
series
in
April
1989,
October
1990,
October
1992,
April
1994,
October
1995,
April
1997,
and
November
1998).

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
"
Risk
Assessment
for
Potential
Developmental
Toxicants,"
EPA­
sponsored,
at
the
1985
Teratology
Society
Meeting
in
Calloway
Gardens,
GA.

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

Finally,
when
proposing
to
previously
renew
this
ICR,
EPA
provided
a
60­
day
public
notice
and
comment
period
that
ended
on
August
28,
1996
(
61
FR
33732,
June
28,
1996).
The
Agency
received
no
comments
on
that
request
to
renew
the
ICR
or
on
the
ICR
itself.

3(
d)
Effects
of
Less
Frequent
Collection
Page
9
of
25
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
carrying
out
an
effective
program.
The
five­
year
recordkeeping
requirement
is
consistent
with
the
five­
year
statute
of
limitations
under
28
U.
S.
C.
§
2462
held
applicable
to
all
EPA
enforcement
actions,
including
administrative
proceedings
under
TSCA.
3M
Company
v.
Carol
Browner
and
EPA,
17F.
3d
(
DC
Cir.
1994)
In
addition,
a
five­
year
retention
period
comports
with
certain
recordkeeping
requirements
imposed
by
the
Occupational
Safety
and
Health
Administration
and
helps
to
keep
these
requirements
consistent
with
one
another,
thereby
avoiding
different
reporting
obligations.
Therefore,
the
Agency
requires
respondents
to
retain
records
for
more
than
three
years.

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

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

Based
on
its
experience,
EPA
expects
that
most
information
included
in
the
notices
is
CBI.
EPA
has
developed
an
elaborate
system
to
prevent
unauthorized
disclosure
of
CBI.
This
system
Page
10
of
25
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
Confidential
Business
Information
Security
Manual,"
April
1995.
EPA
believes
these
procedures
protect
confidential
information
while
providing
the
public
with
as
much
information
as
possible.

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

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

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

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

­
the
categories
or
proposed
categories
of
use
of
the
chemical;

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

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

­
an
estimate
of
the
total
number
of
individuals
who
will
be
exposed
to
the
chemical
in
their
places
of
employment,
and
the
duration
of
such
exposure;
and
Page
11
of
25
­
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
which
is
necessary
for
EPA
to
conduct
an
initial
review
of
a
chemical.
However,
submitters
may
include
additional
or
optional
information
in
their
notices
that
they
believe
EPA
should
consider
in
its
review.
For
example,
submitters
may
identify
pollution
prevention
techniques
being
employed
by
the
submitter
that
may
be
relevant
to
the
Agency's
risk
assessment.
EPA
encourages
submitters
to
provide
information
on
the
benefits
of
the
new
substance
in
comparison
to
existing
chemical
substances,
information
on
the
substitutes,
and
any
additional
information
available
to
them
on
waste
management
techniques.

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

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

­
Test­
Marketing
Exemption
(
TME)
(
40
CFR
720.38)

Test­
marketing
exemption
applicants
are
not
currently
required
to
use
the
PMN
form
or
any
other
prescribed
reporting
form.
However,
the
test­
marking
exemption
rule
states
that
applicants
should
provide
the
following
information:
(
1)
all
existing
health
and
environmental
effects
data
on
the
chemical
or
a
discussion
of
toxicity
based
on
structure­
activity
relationships
and
relevant
data
on
chemical
analogues;
(
2)
the
maximum
quantity
of
the
chemical
substance
that
the
applicant
will
manufacture
or
import
for
test­
marketing
purposes;
(
3)
the
maximum
number
of
persons
who
may
be
provided
the
chemical
substance
during
test­
marketing;
(
4)
the
maximum
number
of
persons
who
may
be
exposed
to
the
chemical
substance
as
a
result
of
testmarketing
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
Page
12
of
25
from
full­
scale
commercial
production
and
research
and
development.
The
Agency
retains
the
right
to
declare
that
an
application
contains
insufficient
information
to
make
an
evaluation.
Any
person
who
receives
a
test­
marketing
exemption
must
retain
documentation
of
any
information
in
the
exemption
application
and
documentation
of
their
compliance
with
any
restrictions
imposed
by
EPA
when
it
granted
the
application.
This
information
must
be
retained
for
five
years
from
the
final
date
of
manufacture
or
import
under
the
exemption.

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

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

­
TSCA
section
5(
h)(
4)
exemptions:

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

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

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

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

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.
Page
13
of
25
6.
Tier
I
exemption
(
40
CFR
725.424)­
This
exemption
applies
to
certain
microorganisms
subject
to
physical
containment
and
control
technologies.
EPA
has
developed
specific
criteria
for
the
host
microorganism,
introduced
genetic
material,
and
containment
technology
to
ensure
that
the
microorganism
will
not
present
an
unreasonable
risk.
Applicants
must
notify
EPA
10
days
before
manufacture
or
import,
certifying
compliance
with
the
exemption
criteria
and
include
the
site
of
manufacture
or
import.

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

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

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

­
the
premanufacture
notice
number
assigned
by
EPA;

­
the
date
manufacture
or
importation
commenced;

­
the
address
of
the
site
where
manufacture
commenced;

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

For
traditional
chemicals
regulated
under
40
CFR
part
720,
Notices
of
Commencement
must
be
submitted
to
EPA
using
the
standard
Notice
of
Commencement
form
(
EPA
Form
7710­
56).
The
submitter
must
provide
the
NOC
to
EPA
on,
or
no
later
than
30
calendar
days
after,
the
day
manufacture
or
importation
began.
The
existing
NOC
form
is
not
appropriate
for
reporting
of
new
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
Page
14
of
25
facility
where
manufacturing
or
processing
will
occur,
and
a
description
of
the
manufacturing
process.

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

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

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

Recordkeeping
requirements
under
SNURs
require
persons
who
manufacture
or
process
a
substance
subject
to
significant
new
use
reporting
to
maintain
records
indicating
their
compliance
with
certain
methods
of
manufacture
or
processing.
Some
Significant
New
Use
Rules
do
not
require
recordkeeping.
Rather,
recordkeeping
requirements
apply
only
to
those
SNURs
for
which
compliance
can
only
be
monitored
by
recordkeeping
or
SNUR
notice
submission
under
TSCA
section
5(
a)(
2).
For
example,
upon
occasion
EPA
will
determine
that
a
specific
set
of
exposure
controls
will
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.
Page
15
of
25
There
are
also
recordkeeping
requirements
for
persons
subject
to
consent
orders
containing
exposure
controls.
Depending
on
the
facts
of
each
case,
submitters
must
keep
records
in
connection
with
the
use
of
the
exposure
controls
including
one
or
more
of
the
following:
(
1)
documentation
of
manufacture
and
importation
volumes
of
the
PMN
substance,
with
associated
dates
of
manufacture
or
importation;
(
2)
documentation
of
the
names
and
addresses
of
all
persons
outside
the
site
of
manufacture
or
import
to
whom
the
submitter
directly
sells
or
transfers
the
substance,
with
associated
dates
of
transfer;
(
3)
documentation
of
the
establishment
and
implementation
of
personal
protective
equipment
program;
(
4)
documentation
of
chemical
protective
clothing
imperviousness
testing;
(
5)
documentation
of
the
hazard
communication
program;
(
6)
copies
of
labels;
(
7)
copies
of
material
safety
data
sheets;
(
8)
documentation
of
compliance
with
industrial,
commercial
and
consumer
use
limitations;
and
(
9)
documentation
of
compliance
with
disposal
and
release
to
water
limitations.

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

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

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
Page
16
of
25
submissions
by
electronic
means
(
see
40
CFR
720.40).
EPA
believes
electronic
submission
reduces
the
reporting
burden
on
industry,
because
it
is
intended
to
reduce
both
the
cost
and
the
time
required
to
enter,
review,
edit
and
transmit
the
data.
Electronic
submission
may
also
improve
data
quality
because
it
facilitates
correcting
incorrect
data
or
adding
omitted
data.
There
is
no
other
new
technology
applicable
to
the
collection
of
this
information
that
would
minimize
the
collection
burden,
nor
has
EPA
been
able
to
identify
a
more
efficient,
less
expensive
or
more
flexible
means
of
obtaining
the
required
data.

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

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

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

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

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

5(
d)
Collection
Schedule
1
The
PMN
submission
information
presented
below
is
based
on
the
"
OPPT
New
Chemicals
Annual
Report;"
U.
S.
EPA/
OPPT;
March
1999
(
hereinafter
referred
to
as
OPPT,
1999).
PMN
burden
data
is
from
the
"
Regulatory
Impact
Analysis
of
Amendments
to
Regulations
for
TSCA
Section
5
Premanufacture
Notifications;"
U.
S.
EPA/
OPPT/
Economics,
Exposure
and
Technology
Division/
Regulatory
Impacts
Branch;
September
9,
1994;
(
hereinafter
referenced
as
"
RIA,
1994").
The
information
on
biotechnology
submissions
is
from
"
Regulatory
Impact
Analysis
of
Regulations
on
Microbial
Products
of
Biotechnology;"
U.
S.
EPA/
OPPT/
Economics,
Exposure
and
Technology
Division;
January
21,
1997;
(
hereinafter
referenced
as
"
RIA,
1997")."

Page
17
of
25
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
a
total
of
about
1,750
TSCA
section
5
notices
each
year
which,
in
turn,
is
based
on
EPA's
experience
over
the
past
several
years.
The
trend
since
FY
1994
has
been
a
significant
decline
in
the
number
of
PMNs
received,
from
2,645
in
FY
1994
to
1,273
(
including
roughly
10%
invalid)
in
FY
1998.
The
1,750
figure
is
conservatively
high.
Amendments
to
the
PMN
rule
in
1995
eliminated
the
PMN
reporting
requirement
for
eligible
polymers,
broadened
the
low
volume
exemption
and
introduced
the
low
release/
low
exposure
exemption.
The
overall
effect
of
these
amendments
over
time
has
been
a
significant
decline
in
the
submission
of
notices
in
general
and
of
full
PMNs
in
particular.
1
In
addition
to
chemical
PMNs,
this
analysis
covers
submissions
of
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.

Burden
Hours
Associated
with
Reporting
The
respondent
reporting
burden
associated
with
this
information
collection
is
estimated
to
total
178,722
hours.

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
test
market
exemption
is
estimated
to
average
98
hours.

As
noted
above,
the
1995
amendments
to
the
PMN
rule
eliminated
PMN
reporting
for
eligible
Page
18
of
25
polymers.
The
rule
now
requires
only
that
manufacturers
submit
a
simple
consolidated
annual
exemption
report
to
EPA.
The
respondent
burden
associated
with
the
submission
of
this
report
is
estimated
to
average
about
two
hours
per
polymer
(
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.
However,
data
since
indicate
that
the
increasing
use
of
the
polymer,
lowvolume
and
low
exposure/
low
release
exemptions
result
in
about
50%
of
all
notices
being
submitted
as
full
PMNs,
or
approximately
875
full
PMNs
per
year.
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.
The
Agency
expects
to
receive
approximately
10
SNUNs
annually
(
OPPT,
1999).

Polymer
exemptions
represent
about
10%
of
all
TSCA
section
5
notice
submissions,
or
approximately
175
per
year.
Since
each
respondent
submits
an
average
of
six
notices
per
year,
it
is
estimated
that
the
Agency
will
receive
about
29
consolidated
polymer
exemption
reports
per
year
(
175
eligible
polymers/
6
notices
submitted
per
respondent)
(
OPPT,
1999).

Low
Volume
Exemptions
and
LoREX
comprise
roughly
38%
of
submissions,
or
665
notices
annually,
and
test
market
exemptions
are
about
1%,
or
18
applications
per
year
(
OPPT,
1999).

The
various
exemptions
available
to
submitters
significantly
reduce
the
need
for
consent
order
development
and
post­
notice
data
review.
EPA
data
indicate
that
such
consent
orders
and
post­
notice
data
reviews
amount
to
roughly
3%
of
the
total
estimated
1,750
TSCA
section
5
notices
(
OPPT,
1999).
Based
on
historical
data
EPA
estimates
60
cases
would
be
subject
to
either
test
data
or
nontesting
TSCA
section
5(
e)
burden
with
50
cases
requiring
test
data,
and
10
non­
testing
TSCA
section
5(
e)
cases.
Testing
is
usually
contracted
out
to
a
laboratory,
thus
the
burden
associated
with
testing
requirements
represents
the
time
that
personnel
from
the
submitting
firm
would
spend
overseeing
the
testing,
assumed
to
be
25%
of
the
lab
burden.

The
overall
respondent
reporting
burden
is
displayed
below
in
Table
I.
Page
19
of
25
Table
I
Reporting
Burden
Avg.
Annual
Reporting
Avg.
Annual
Type
of
Notice
Responses
Hours/
Response
Burden
PMNs
875
105
91,875
Exemptions
TME
18
98
1,764
LVE/
LoREX
665
105
69,825
Polymer
175*
2
350
MCANs
10
302
3,020
TERA
5
522
2,610
Tier
I
or
II
2
114
228
SNUNs
10
105
1,050
5
(
e)
Test
Data
50
155
7,750
Non­
Testing
5(
e)
Burden
10
25
250
TOTAL
RESPONDENT
REPORTING
BURDEN
178,722
*
Although
only
29
notices
are
expected
to
be
submitted,
the
information
requirements
of
the
polymer
exemption
are
estimated
to
apply
to
175
new
polymers
per
year.

Burden
Hours
Associated
with
Recordkeeping
The
respondent
recordkeeping
burden
associated
with
this
information
collection
is
estimated
to
total
5,886
hours.

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,
with
the
exception
of
polymer
exemptions.

The
estimated
recordkeeping
burden
for
the
polymer
exemption
is
four
hours
per
polymer
(
RIA,
1994).
This
is
based
on
the
recordkeeping
burden
associated
with
essential
technical
requirements,
such
as
records
that
demonstrate
that
the
first
commercial
batch
of
polymer
manufactured
for
commercial
purposes
under
the
exemption
met
certain
eligibility
criteria.
Such
recordkeeping
requirements
allow
the
Agency
substantially
to
eliminate
all
other
data
and
reporting
requirements
associated
with
the
polymer
exemption.
Recordkeeping
burden
for
5(
e)
testing
and
non­
testing
burden
are
35
and
25
hours,
respectively
(
RIA,
1994)

The
overall
respondent
recordkeeping
burden
is
displayed
below
in
Table
II.
Page
20
of
25
Table
II
Respondent
Recordkeeping
Burden
Total
Average
Avg.
Annual
Hours
for
Annual
Record­
Type
of
Notice
Responses
Recordkeeping
keeping
Burden
PMN
875
2
1,750
Exemptions
TME
18
2
36
LVE/
LoREX
665
2
1,330
Polymer
175*
4
700
MCAN
10
2
20
TERA
5
2
10
Tier
I
&
II
2
2
4
SNUNs
18
2
36
5(
e)
Test
Data
50
35
1,750
Non­
Testing
5(
e)
Burden
10
25
250
TOTAL
RESPONDENT
RECORDKEEPING
BURDEN
5,886
hours
*
Although
only
29
notices
are
expected
to
be
submitted,
the
information
requirements
of
the
polymer
exemption
are
estimated
to
apply
to
175
new
polymers
per
year.

6(
b)
Estimating
Respondent
Cost
The
respondent
costs
associated
with
this
information
collection
are
estimated
to
total
$
37,991,266.

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.

Baseline
costs
to
respondents
for
all
submissions
have
three
components
1)
labor
costs,
based
on
the
burden
hours,
2)
delay
costs,
based
on
the
costs
of
profits
delayed
by
the
review
process,
and
3)
explicit
costs,
such
as
user
fees
or
lab
testing
fees.

For
PMNs
and
SNUNs,
the
average
cost
to
respondents,
including
the
standard
user
fee
of
$
2,500,
is
estimated
to
be
$
25,773.

The
submission
costs
for
low
volume
exemptions
and
low
release/
low
exposure
exemptions
is
estimated
to
average
$
15,185.
The
cost
for
submission
of
test
market
exemptions
is
estimated
to
average
$
6,311.

As
noted
above,
the
PMN
rule
requires
only
that
manufacturers
submit
a
simple
consolidated
exemption
report
to
EPA
for
polymers.
The
respondent
cost
associated
with
the
submission
of
this
report
is
estimated
to
average
of
$
331.
Page
21
of
25
For
biotech
submissions,
the
average
cost
of
submitting
an
MCAN
is
$
39,462,
including
a
user
fee
of
$
2,500;
the
average
cost
for
a
TERA
is
$
36,023;
and
the
average
for
a
Tier
I
or
Tier
II
exemption
is
$
7,784.

Submitters
required
to
perform
5(
e)
testing
will
incur
an
average
of
$
12,224
in
labor
costs,
plus
lab
fees
averaging
$
73,650,
for
a
total
of
$
85,874.
Non­
Testing
5(
e)
burden
costs
average
$
2,861.

Loaded
hourly
labor
rates
for
different
labor
categories
are:
managerial
­
$
86.86;
technical
­
$
64.30;
clerical
­
$
25.63
(
SOURCE).

Cost
calculations
for
submissions
are
presented
in
Figure
1.
Figure
1:
Respondent
Cost
Calculations
per
notice
Notice
Total
Burden
by
Labor
Category
(
reporting
+
recordkeeping)
Delay
Costsa
Feesb
Total
Average
Costse
Managerial
Technical
Clerical
PMN
18
75
14
$
16,528
$
2,500
$
25,773
TME
17
70
13
$
0
$
0
$
6,311
LVE/
LoREX
18
75
14
$
8,440
$
0
$
15,185
Polymer
1
3
2
$
0
$
0
$
331
MCAN
65
224
15
$
16,528
$
2,500
$
39,462
TERA
129
380
15
$
0
$
0
$
36,023
Tier
I
&
II
23
88
5
$
0
$
0
$
7,784
SNUN
18
75
14
$
16,528
$
2,500
$
25,773
5(
e)
Test
Data
38
130
22
$
0
$
73,650c
$
85,874
Non­
Testing
5(
e)
Burden
10
25
15
$
0
$
0d
$
2,861
a
­
delay
costs
are
from
RIA,
1994,
updated
using
Bureau
of
Labor
Statistics
Producer
Price
Index
data
for
the
chemical
industry.
MCANs
are
assumed
to
have
the
same
delay
costs
as
PMNs.
b
­
User
fees
charged
by
the
EPA,
except
where
noted.
c
­
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),
and
based
on
an
analysis
of
average
costs
for
277
testing
cases.
d
­
While
companies
incur
costs
for
control
equipment,
such
costs
are
outside
the
realm
of
this
ICR.

e
­
Total
costs
equal
the
sum
of
the
burden
hours
times
their
respective
labor
rates,
plus
delay
costs
and
fees.

Overall
respondent
costs
are
displayed
below
in
Table
III.
Page
22
of
25
Table
III
Respondent
Costs
Average
Average
Type
of
AnnualCost/
Total
Notice
Responses
Notice
Avg.
Cost
PMN
875
$
25,773
$
22,551,375
Exemptions
TME
18
$
6,311
$
113,598
LVE/
LoREX
665
$
15,185
$
10,098,025
Polymer
175*
$
331
$
57,925
MCAN
10
$
39,462
$
394,620
TERA
5
$
36,023
$
180,115
Tier
I
&
II
2
$
7,784
$
15,568
SNUNs
10
$
25,773
$
257,730
5(
e)
Test
Data
50
$
85,874
$
4,293,700
Non­
Testing
5(
e)
Burden
10
$
2,861
$
28,610
TOTAL
RESPONDENT
COST
$
37,991,266
*
Although
only
29
notices
are
expected
to
be
submitted,
the
information
requirements
of
the
polymer
exemption
are
expected
to
apply
to
175
new
polymers
per
year.

Total
respondent
burden
hours
and
costs
therefore
are:
(
178,722
reporting
hours
+
5,886
recordkeeping
hours)
=
184,608
total
burden
hours
$
37,991,266
total
costs.

6(
c)
Estimating
Agency
Cost
The
agency
costs
associated
with
this
information
collection
are
estimated
to
total
$
9,514,946.

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).

Agency
costs
are
based
on
the
cost
per
full
time
equivalent
(
FTE),
which
is
estimated
to
be
$
105,221
for
a
fully­
loaded
GS­
13,
step
5
in
Washington,
DC.

Agency
unit
costs
for
review
of
full
PMN
notices
and
SNUNs
are
estimated
to
average
$
3,988.
The
average
cost
to
the
Agency
for
a
test
market
exemption
review
is
estimated
to
be
$
5,514.
Agency
costs
associated
with
the
polymer
exemption
are
minimal
because
no
PMN
is
required
and,
therefore,
there
are
no
evaluation
and
review
costs.
There
are
minor
costs
associated
with
receipt
and
processing
of
polymer
exemption
notices,
estimated
at
one
hour
per
consolidated
submission
or
a
Page
23
of
25
cost
of
approximately
$
51
per
submission.

Agency
unit
costs
for
LVE/
LoREX
reviews
average
$
1,633.

For
biotech
submissions,
agency
costs
average
$
53,976
per
MCAN,
$
74,666
per
TERA,
and
$
9,460
for
a
Tier
I
or
II
exemption
petition.

Agency
costs
to
review
5(
e)
test
data
are
estimated
at
$
75,880,
and
non­
testing
5(
e)
costs
are
estimated
at
$
3,288
per
case.

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

Cost
calculations
for
agency
costs
are
presented
in
Figure
2.

Figure
2:
Agency
Cost
Calculations
Notice
Agency
Labor
Hours
Labor
Costsf
Extramural
Costsg
Total
Average
Costsh
PMN
64a
$
3,238
$
750
$
25,773
TME
109b
$
5,514
$
0
$
6,311
LVE/
LoREX
22a
$
1,113
$
520
$
1,633
Polymer
1a
$
51
$
0
$
51
MCAN
1067c
$
53,976
$
0
$
53,976
TERA
1476c
$
74,666
$
0
$
74,666
Tier
I
&
II
187c
$
9,460
$
0
$
9,460
SNUN
64a
$
3,238
$
750
$
3,988
5(
e)
Test
Data
1500d
$
75,880
$
0
$
75,880
Non­
Testing
5(
e)
Burden
65e
$
3,288
$
0
$
3,288
a
­
RIA,
1994.
b
­
Estimated
based
on
previous
PMN
ICR.
c
­
RIA,
1997.
d
­
Estimated
to
be
similar
to
TERA
review.
e
­
Estimated
to
be
similar
to
PMN/
SNUN
review.
f
­
Labor
hours
multiplied
by
$
51/
hour.
Based
on
full
time
(
2080
hours)
salary
for
Washington,
DC­
area
GS­
13,
step
5
making
$
65,763/
yr
in
1999,
multiplied
by
1.6
to
account
for
benefits.
g
­
Extramural
costs
for
contractor
support.
RIA,
1994,
updated
to
1998$.
h
­
Agency
labor
costs
plus
extramural
costs
Overall
agency
costs
are
displayed
below
in
Table
IV.
Page
24
of
25
Table
IV
Total
Agency
Costs
Average
Annual
Average
Total
Type
of
Notice
Responses
Cost/
Notice
Average
Cost
PMN
Review
875
$
3,988
$
3,489,500
Exemptions
TME
18
$
5,514
$
99,252
LVE/
LoREX
665
$
1,633
$
1,085,945
Polymer
29*
$
51
$
1,479
MCAN
10
$
53,976
$
539,760
TERA
5
$
74,666
$
373,330
Tier
I
&
II
2
$
9,460
$
18,920
SNUNs
10
$
3,988
$
39,880
5(
e)
Test
Data
50
$
75,880
$
3,794,000
Non­
Testing
5(
e)
10
$
3,288
$
32,880
User
Fee
(
tracking
and
validation
costs)
$
40,000
TOTAL
COST
TO
GOVERNMENT
$
9,514,946
*
Each
polymer
exemption
respondent
submits
approximately
six
notices
per
year.
It
is
feasible
that
the
Agency
may
receive
29
consolidated
polymer
exemption
reports
per
year
(
175
eligible
polymers
commenced/
6
notices
submitted
per
respondent).

6(
d)
Reasons
for
Change
in
Burden
This
request
reflects
a
decrease
in
the
total
estimated
burden
of
41,939
hours
(
from
226,547
hours
to
184,608
hours)
in
the
total
estimated
respondent
burden
from
that
currently
in
the
OMB
inventory.
This
decrease
represents
the
elimination
of
first
year
rule
familiarization
burden
related
to
the
biotechnology
rule,
and
an
adjustment
in
the
number
of
annual
submissions
to
reflect
EPA's
experiences
since
the
biotechnology
rule
became
final.
EPA's
experience
since
the
biotechnology
rule
became
final
is
that
the
Agency
is
receiving
an
average
of
only
about
five
submissions
annually,
whereas
the
biotech
rule
ICR
anticipated
submissions
at
a
much
higher
level.
In
finalizing
the
biotechnology
rule,
the
Agency
had
anticipated
about
41,000
hours
of
burden
associated
with
biotechnology
submissions.

6(
e)
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
Page
25
of
25
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.
In
addition,
the
OMB
control
numbers
for
EPA's
regulation,
after
initial
display
in
the
final
rule,
are
listed
in
40
CFR
part
9.

Send
comments
on
the
Agency's
need
for
this
information,
the
accuracy
of
the
provided
burden
estimates,
and
any
suggested
methods
for
minimizing
respondent
burden,
including
through
the
use
of
automated
collection
techniques
to
the
Director,
Regulatory
Information
Division
(
Mail
Code
2137),
U.
S.
Environmental
Protection
Agency,
Ariel
Rios
Building,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460.
Include
the
OMB
control
number
in
any
correspondence,
but
do
not
submit
the
requested
information
to
this
address.
The
requested
information
should
be
submitted
in
accordance
with
the
instructions
accompanying
the
form,
or
as
specified
in
the
corresponding
regulation.

ATTACHMENTS:

[
Note:
The
attachments
are
not
included
in
the
electronic
file
for
this
ICR.
However,
this
information
is
also
available
electronically
via
the
Internet
at
http://
www.
epa.
gov/
opptintr/
newchems/.]

Attachment
A
­
Toxic
Substances
Control
Act
Section
5
Attachment
B
­
40
CFR
Part
700
Attachment
C
­
40
CFR
Part
720
Attachment
D
­
40
CFR
Part
721
Attachment
E
­
40
CFR
Part
723
Attachment
F
­
40
CFR
Part
725
Attachment
G
­
Premanufacture
Notice
(
EPA
Form
7710­
25)

Attachment
H
­
Instruction
Manual
for
Reporting
under
the
TSCA
Section
5
New
Chemicals
Program