Document ID: EPA-HQ-OPPT-2003-0058-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2004-08-20T04:00Z

U.
S.
ENVIRONMENTAL
PROTECTION
AGENCY
OFFICE
OF
PREVENTION,
PESTICIDES,
AND
TOXIC
SUBSTANCES
(
OPPTS)
1200
Pennsylvania
Avenue,
N.
W.
Washington,
D.
C.
20460
OMB
REVIEW
UNDER
EXECUTIVE
ORDER
12866
DOCUMENTATION
OF
CHANGES
MADE
DURING
OMB
REVIEW
Title
of
Action:
Advance
Notice
of
Proposed
Rulemaking;
TSCA
Inventory
Nomenclature
for
Enzymes
and
Proteins
Docket
#:
OPPT­
2003­
0058
FRL#:
7342­
2
RIN
#:
2070­
AJ04
This
action
was
submitted
to
the
Office
of
Management
and
Budget
(
OMB)
for
review
under
Executive
Order
12866,
which
is
entitled
Regulatory
Planning
and
Review
(
58
FR
51735,
October
4,
1993).
According
to
section
6(
a)(
3)(
E)
of
the
Executive
Order,
whenever
the
Agency
makes
publicly
available
a
regulatory
action
that
was
reviewed
under
Executive
Order
12866,
the
Agency
is
also
required
to:
(
1)
Make
available
to
the
public
a
copy
of
the
information
that
was
provided
to
OMB's
Office
of
Information
and
Regulatory
Affairs
(
OIRA)
for
review
under
to
the
Executive
Order,
i.
e.,
the
text
of
the
draft
regulatory
action
and,
if
applicable,
an
assessment
of
the
potential
costs
and
benefits;
as
well
as
additional
information
required
for
those
actions
that
are
determined
to
be
economically
significant
under
section
3(
f)
of
the
Executive
Order
(
see
section
6(
a)(
3)(
B)
&
(
C));
(
2)
Identify
for
the
public
any
substantive
changes
between
the
draft
submitted
to
OMB
and
the
action
that
was
subsequently
issued,
using
a
method
that
is
complete,
clear
and
simple;
and
(
3)
Identify
for
the
public
those
substantive
changes
made
at
the
suggestion
or
recommendation
of
OIRA.

For
this
regulatory
action,
substantive
changes
at
the
suggestion
of
OMB
[
Please
check
the
appropriate
box.]

G
were
[
include
in
the
docket
the
information
identified
in
items
1­
3
below]

O
were
not
[
need
only
include
in
the
docket
the
information
identified
under
item
1
below]
made
to
the
regulatory
action
reviewed
under
Executive
Order
12866.

Accordingly,
the
Agency
has
included
the
following
information
in
the
public
docket
for
this
regulatory
action
[
Please
check
the
appropriate
box.]:

(
4)
A
copy
of
the
information
that
was
provided
to
OIRA
for
review
under
to
the
Executive
Order;

(
5)
Using
one
of
the
following
methods,
documentation
of
any
substantive
changes
that
were
made
to
the
draft
regulatory
text
that
was
submitted
to
OIRA,
when
compared
with
what
subsequently
published:

G
A
copy
of
the
draft
regulatory
action
submitted,
with
redline
and
strikeout
to
show
the
substantive
changes
that
were
made;

G
A
document
that
identifies
the
substantive
changes
that
were
made,
with
page
and
paragraph
references
to
the
draft
regulatory
action
that
was
submitted;
or
G
Other
(
please
describe):

(
6)
Substantive
changes
made
at
the
suggestion
or
recommendation
of
OMB,
if
any,
are
identified:

G
Through
attributions
to
OMB
in
the
redline
and
strikeout
version
or
other
document
identifying
the
changes;

G
Other
(
please
describe):

If
you
have
any
questions
about
the
regulatory
action
or
this
documentation,
please
call
the
contact:

Name:
Jim
Alwood
E­
Mail:
alwood.
jim@
epa.
gov
Phone:
202­
564­
8974
OPPTS/
RCS
­
OMB­
7f
(
09/
17/
97;
rev.
02/
10/
02)
Attachment
1
(
electronic
rendition
of
original)
EXECUTIVE
ORDER
12866
SUBMISSION
Important
Please
read
the
Instructions
on
the
reverse
side
before
completing
this
form.

For
additional
forms
or
assistance
in
completing
this
form,
contact
the
OIRA
Docket
Library,
[
202]
395­
6880,
or
your
OIRA
Desk
Officer.

Send
three
copies
of
this
form
and
supporting
material
(
four
copies
if
Economically
Significant
or
an
Unfunded
Mandate)
to:

Office
of
Information
and
Regulatory
Affairs
Office
of
Management
and
Budget
Attention:
Docket
Library,
Room
3201
725
17th
Street
N.
W.
Washington,
DC
20503
1.
Agency/
Subagency
originating
request:
US
EPA,
Office
of
Prevention,
Pesticides
and
Toxic
Substances
(
OPPTS)
2.
Regulation
Identifier
Number
(
RIN):

2070­
AJ04
3.
Title:
TSCA
Inventory
Nomenclature
for
Enzymes
and
Proteins
4.
Stage
of
Development
X
Prerule
Proposed
Rule
Interim
Final
Rule
Final
Rule
Final
Rule
­
No
material
change
Notice
Other
5.
Legal
Deadline
for
this
Submission:

a)
Q
Yes
O
No
b)
Date:
/
/
DD
MM
YY
c)
Q
Statutory
Q
Judicial
Description
of
Other
6.
Designations
a)
Economically
Significant
(
E.
O.
12866)

Q
Yes
O
No
b)
Unfunded
Mandate
(
2
U.
S.
C.
1532)

Q
Yes
O
No
If
either
of
the
above
is
"
Yes,"
submit
four
(
4)
complete
packages
to
OIRA.
7.
Agency
Contact
(
person
who
can
best
answer
questions
regarding
the
content
of
this
submission):

Angela
F.
Hofmann,
Office
of
the
Assistant
Administrator
Phone
(
202
)
564­
0258
Certification
for
Executive
Order
12866
Submissions
The
authorized
regulatory
contact
and
the
program
official
certify
that
the
agency
has
complied
with
the
requirement
of
E.
O.
12866
and
any
applicable
policy
directives.

Signature
of
Program
Official:

Angela
F.
Hofmann
Angela
F.
Hofmann,
Director
of
Regulatory
Coordination
for
OPPTS
Date:
June
23,
2004
Signature
of
Authorized
Regulatory
Contact:

Lesley
Schaaff
Lesley
Schaaff,
Director,
Regulatory
Policy
Division,
OPEI
Date:

July
13,
2004
OMB
83­
R
Revision:
12/
97
(
Previous
versions
obsolete)
INSTRUCTIONS
FOR
REQUESTING
OMB
REVIEW
UNDER
EXECUTIVE
ORDER
12866
GENERAL
Please
make
sure
to
answer
all
questions
and
have
the
appropriate
officials
sign
the
form.

1.
Agency/
Subagency
Provide
the
name
of
the
agency
or
subagency
originating
the
request.
For
most
Cabinet­
level
agencies,
a
subagency
designation
is
also
necessary.
For
non­
Cabinet
agencies,
the
subagency
designation
is
generally
unnecessary.

EXAMPLE
Check
"
Proposed
Rule"
when
the
action
submitted
will
be
published
in
the
Proposed
Rules
section
of
the
Federal
Register
(
for
example,
an
NPRM).

Check
"
Interim
Final
Rule"
when
the
action
submitted
will
be
published
in
the
Rules
and
Regulations
section
of
the
Federal
Register
with
an
Action
caption
of
lnterim
Rule
or
Interim
Final
Rule.

Check
"
Final
Rule"
when
the
action
submitted
will
be
published
in
the
Rules
and
Regulations
section
of
the
Federal
Register
and
there
have
been
material
changes
in
the
facts
and
circumstances
upon
which
the
previous
action
was
based.

1.
Agency/
Subagency
originating
request:
Department
of
the
Interior
National
Park
Service
or
Office
of
Personnel
Management
Check
"
Final
Rule
­
No
material
change"
when
the
action
submitted
is
associated
with
a
previous
request
(
for
example,
an
NPRM)
and
there
has
been
no
material
change
in
the
facts
and
circumstances
upon
which
the
previous
action
was
based.

2.
Regulation
Identifier
Number
(
RIN)

The
RIN
is
the
means
by
which
rules
are
linked
across
the
Unified
Agenda
of
Federal
Regulations
(
Agenda),
the
Regulatory
Plan,
and
Executive
Order
12866.

RINs
are
assigned
to
items
in
the
Agenda
by
the
Regulatory
Information
Service
Center
(
Center).
For
E.
O.
12866
submissions
that
have
not
appeared
in
the
Agenda,
the
agency
must
obtain
a
RIN
from
the
Center.
The
RIN
is
a
prerequisite
to
the
regulatory
action
being
logged
in
at
OIRA.

EXAMPLE
Check
"
Notice"
when
the
action
submitted
will
be
published
in
the
Notices
section
of
the
Federal
Register.

Check
"
Other"
when
the
action
does
not
meet
the
criteria
of
any
of
the
above
categories.
(
Indicate
on
the
line
provided
what
type
of
action
you
are
submitting;
for
example,
a
policy
statement.)

5.
Legal
Deadline
for
This
Submission
The
deadline
is
for
the
regulatory
action
in
this
submission
only
and
not
for
any
future
or
past
action
in
this
rulemaking
proceeding.

a)
Indicate
whether
the
action
submitted
is
subject
to
any
specific
legal
deadline.
For
example,
if
this
submissions
for
an
NPRM
2.
Regulation
Identifier
Number
(
RIN)
1024­
AA12
and
the
Final
Rule
Stage
has
a
deadline,
check
No.
If
this
submission
is
for
the
Final
Rule,
check
Yes.

3.
Title
Please
provide
a
brief
title
that
describes,
as
specifically
as
you
can,
the
subject
of
this
rulemaking.
Avoid
using
general
headings
or
the
title
of
the
CFR
part
for
your
rulemaking.
To
the
extent
possible,
you
should
keep
the
title
the
same
as
in
the
Agenda.
Also,
you
should
use
the
same
title
for
all
stages
of
a
rulemaking.

4.
Stages
of
Development
Check
the
stage
of
development
for
this
action.

Check
"
Prerule"
when
the
action
submitted
for
review
seeks
to
determine
whether
or
how
to
initiate
rulemaking.
Examples
include
ANPRMs
and
reviews
of
existing
regulations.
b)
If
5a
is
Yes,
provide
the
month,
day,
and
year
of
the
deadline
for
this
action
(
whether
past
or
future).

c)
If
5a
is
Yes,
indicate
whether
the
deadline
is
statutory
of
judicial.

6.
Economically
Significant
Check
Yes
if
the
action
submitted
will
likely
have
an
annual
effect
on
the
economy
of
$
100
million
or
more
or
adversely
affect
in
a
material
way
the
economy,
a
sector
of
the
economy,
productivity,
competition,
jobs,
the
environment,
public
health
and
safety,
or
State,
local,
or
tribal
governments
or
communities.
(
Section
3(
f)(
1)
of
E.
O.
12866.)

7.
Agency
Contact
Provide
the
name
and
telephone
number
of
the
agency
person
best
able
to
answer
questions
regarding
the
content
of
this
submission.

12/
97
Page
1
of
10
Attachment
2
1
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
720
[
OPPT
 
2003
 
0058;
FRL
 
7342
 
2]
RIN
2070
 
AB27AJ04
TSCA
Inventory
Nomenclature
for
Enzymes
and
Proteins
AGENCY:
Environmental
Protection
Agency
(
EPA).

ACTION:
Advance
Notice
of
Proposed
Rulemaking
(
ANPRM).

SUMMARY:
This
ANPRM
alerts
interested
parties
that
EPA
is
considering
new
procedures
and
regulations
for
naming
enzymes
and
proteins
when
listing
such
substances
on
the
Toxic
Substances
Control
Act
(
TSCA)
Chemical
Substances
Inventory
(
Inventory).
More
specifically,
this
ANPRM
outlines
four
identification
elements
that
EPA
currently
believes
are
appropriate
for
use
in
developing
unique
TSCA
Inventory
nomenclature
for
proteinaceous
enzymes.
This
ANPRM
also
solicits
public
comment
on
several
specific
questions
relating
to
this
initiative.

DATES:
Comments
must
be
received
on
or
before
[
insert
date
30
days
after
date
of
publication
in
the
Federal
Register].

ADDRESSES:
Submit
your
comments,
identified
by
docket
ID
number
OPPT
 
2004
 
0058,
by
one
of
the
following
methods:

$
Federal
eRulemaking
Portal:
http://
www.
regulations.
gov/.
Follow
the
on­
line
instructions
for
submitting
comments.

$
Agency
Website:
http://
www.
epa.
gov/
edocket/.
EDOCKET,
EPA's
electronic
public
docket
and
comment
system,
is
EPA's
preferred
method
for
receiving
comments.
Follow
the
on­
line
instructions
for
submitting
comments.

$
E­
mail:
oppt.
ncic@
epa.
gov.

$
Mail:
Document
Control
Office
(
7407M),
Office
of
Pollution
Prevention
and
Toxics
(
OPPT),
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001.

$
Hand
delivery/
courier:
OPPT
Document
Control
Office
(
DCO),
EPA
East
Bldg.,
Rm.
6428,
1201
Constitution
Ave.,
NW.,
Washington,
DC,
Attention:
Docket
ID
number
OPPT
 
2003
 
0058.
The
DCO
is
open
from
8
a.
m.
to
4
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
telephone
number
for
the
DCO
is
(
202)
564
 
8930.
Such
deliveries
are
only
accepted
during
the
Docket's
normal
hours
of
operation,
and
special
arrangements
should
be
made
for
deliveries
of
boxed
information.

Instructions:
Direct
your
comments
to
docket
ID
number
OPPT
 
2004
 
0058.
EPA's
policy
is
that
all
comments
received
will
be
included
***
EO
12866
Review
Draft
of
07/
02/
2004
***

Page
2
of
10
in
the
public
docket
without
change
and
may
be
made
available
online
at
http://
www.
epa.
gov/
edocket/,
including
any
personal
information
provided,
unless
the
comment
includes
information
claimed
to
be
Confidential
Business
Information
(
CBI)
or
other
information
whose
disclosure
is
restricted
by
statute.
Do
not
submit
information
that
you
consider
to
be
CBI
or
otherwise
protected
through
EDOCKET,
regulations.
gov,
or
e­
mail.
The
EPA
EDOCKET
and
the
Federal
regulations.
gov
websites
are
``
anonymous
access''
systems,
which
means
EPA
will
not
know
your
identity
or
contact
information
unless
you
provide
it
in
the
body
of
your
comment.
If
you
send
an
email
comment
directly
to
EPA
without
going
through
EDOCKET
or
regulations.
gov,
your
e­
mail
address
will
be
automatically
captured
and
included
as
part
of
the
comment
that
is
placed
in
the
public
docket
and
made
available
on
the
Internet.
If
you
submit
an
electronic
comment,
EPA
recommends
that
you
include
your
name
and
other
contact
information
in
the
body
of
your
comment
and
with
any
disk
or
CD­
ROM
you
submit.
If
EPA
cannot
read
your
comment
due
to
technical
difficulties
and
cannot
contact
you
for
clarification,
EPA
may
not
be
able
to
consider
your
comment.
Electronic
files
should
avoid
the
use
of
special
characters,
any
form
of
encryption,
and
be
free
of
any
defects
or
viruses.
For
additional
information
about
EPA's
public
docket
visit
EDOCKET
on­
line
or
see
the
Federal
Register
of
May
31,
2002
(
67
FR
38102)
(
FRL
 
7181
 
7).

Docket:
All
documents
in
the
docket
are
listed
in
the
EDOCKET
index
at
http://
www.
epa.
gov/
edocket/.
Although
listed
in
the
index,
some
information
is
not
publicly
available,
i.
e.,
CBI
or
other
information
whose
disclosure
is
restricted
by
statute.
Certain
other
material,
such
as
copyrighted
material,
is
not
placed
on
the
Internet
and
will
be
publicly
available
only
in
hard
copy
form.
Publicly
available
docket
materials
are
available
either
electronically
in
EDOCKET
or
in
hard
copy
at
the
OPPT
Docket,
EPA
Docket
Center
(
EPA/
DC),
EPA
West,
Rm.
B102,
1301
Constitution
Ave.,
NW.,
Washington,
DC.
The
Public
Reading
Room
is
open
from
8:
30
a.
m.
to
4:
30
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
EPA
Docket
Center
Reading
Room
telephone
number
is
(
202)
566
 
1744,
and
the
telephone
number
for
the
OPPT
Docket,
which
is
located
in
the
EPA
Docket
Center,
is
(
202)
566
 
0280.

FOR
FURTHER
INFORMATION
CONTACT:
For
general
information
contact:
Colby
Lintner,
Regulatory
Coordinator,
Environmental
Assistance
Division
(
7408M),
Office
of
Pollution
Prevention
and
Toxics,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
202)
554
 
1404;
email
***
EO
12866
Review
Draft
of
07/
02/
2004
***

Page
3
of
10
address:
TSCA­
Hotline@
epa.
gov.

For
technical
information
contact:
James
Alwood,
Chemical
Control
Division,
(
7405M),
Office
Pollution
Prevention
and
Toxics,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
202)
564
 
8974;
email
address:
alwood.
jim@
epa.
gov.

SUPPLEMENTARY
INFORMATION:
I.
General
Information
A.
Does
this
Action
Apply
to
Me?
You
may
be
potentially
affected
by
this
action
if
you
manufacture,
import,
process,
or
use
chemical
substances
which
are
subject
to
TSCA
jurisdiction.
Potentially
affected
entities
may
include,
but
are
not
limited
to:

$
Chemical
manufacturers
(
NAICS
325),
e.
g.,
persons
manufacturing,
importing,
processing,
or
using
chemicals
for
commercial
purposes.

$
Petroleum
and
coal
product
industries
(
NAICS
324),
e.
g.,
persons
manufacturing,
importing,
processing,
or
using
chemicals
for
commercial
purposes.
This
listing
is
not
intended
to
be
exhaustive,
but
rather
provides
a
guide
for
readers
regarding
entities
likely
to
be
affected
by
this
action.
Other
types
of
entities
not
listed
in
this
unit
could
also
be
affected.
The
North
American
Industrial
Classification
System
(
NAICS)
codes
have
been
provided
to
assist
you
and
others
in
determining
whether
this
action
might
apply
to
certain
entities.
To
determine
whether
you
or
your
business
may
be
affected
by
this
action,
you
should
carefully
examine
the
applicability
provisions
in
title
40
of
the
Code
of
Federal
Regulations
(
CFR)
at
40
CFR
720.22.
If
you
have
any
questions
regarding
the
applicability
of
this
action
to
a
particular
entity,
consult
the
technical
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.

B.
How
Can
I
Access
Electronic
Copies
of
this
Document
and
Other
Related
Information?
In
addition
to
EDOCKET
(
http://
www.
epa.
gov/
edocket/),
you
may
access
this
Federal
Register
document
electronically
through
the
EPA
Internet
under
the
``
Federal
Register''
listings
at
http://
www.
epa.
gov/
fedrgstr/.
A
frequently
updated
electronic
version
of
40
CFR
part
761
is
available
on
E­
CFR
Beta
Site
Two
at
http://
www.
gpoaccess.
gov/
ecfr/.

C.
What
Should
I
Consider
as
I
Prepare
My
Comments
for
EPA?
1.
Submitting
CBI.
Do
not
submit
this
information
to
EPA
through
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EDOCKET,
regulations.
gov,
or
e­
mail.
Clearly
mark
the
part
or
all
of
the
information
that
you
claim
to
be
CBI.
For
CBI
information
in
a
disk
or
CD
ROM
that
you
mail
to
EPA,
mark
the
outside
of
the
disk
or
CD
ROM
as
CBI
and
then
identify
electronically
within
the
disk
or
CD
ROM
the
specific
information
that
is
claimed
as
CBI.
In
addition
to
one
complete
version
of
the
comment
that
includes
information
claimed
as
CBI,
a
copy
of
the
comment
that
does
not
contain
the
information
claimed
as
CBI
must
be
submitted
for
inclusion
in
the
public
docket.
Information
so
marked
will
not
be
disclosed
except
in
accordance
with
procedures
set
forth
in
40
CFR
part
2.
2.
Tips
for
preparing
your
comments.
When
submitting
comments,
remember
to:
i.
Identify
the
rulemaking
by
docket
ID
number
and
other
identifying
information
(
subject
heading,
Federal
Register
date
and
page
number).
ii.
Follow
directions
 
The
Agency
may
ask
you
to
respond
to
specific
questions
or
organize
comments
by
referencing
a
CFR
part
or
section
number.
iii.
Explain
why
you
agree
or
disagree;
suggest
alternatives
and
substitute
language
for
your
requested
changes.
iv.
Describe
any
assumptions
and
provide
any
technical
information
and/
or
data
that
you
used.
v.
If
you
estimate
potential
costs
or
burdens,
explain
how
you
arrived
at
your
estimate
in
sufficient
detail
to
allow
for
it
to
be
reproduced.
vi.
Provide
specific
examples
to
illustrate
your
concerns,
and
suggest
alternatives.
vii.
Explain
your
views
as
clearly
as
possible,
avoiding
the
use
of
profanity
or
personal
threats.
viii.
Make
sure
to
submit
your
comments
by
the
comment
period
deadline
identified.

II.
Background
A.
What
Action
is
the
Agency
Taking?
This
ANPRM
is
alerting
stakeholders
that
EPA
is
considering
changing
procedures
and
requirements
for
naming
enzymes
and
proteins
for
the
purpose
of
listing
those
substances
on
the
TSCA
Inventory.
Specifically,
EPA
has
identified
four
elements
that
it
currently
believes
are
appropriate
for
use
in
creating
unique
and
unambiguous
identities
for
proteinaceous
enzymes
on
the
TSCA
Inventory.
Through
this
ANPRM,
EPA
is
also
soliciting
public
comment
on
the
scientific
appropriateness
and
technical
feasibility
of
using
the
identification
elements
summarized
herein.
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B.
What
is
the
Agency's
Authority
for
Taking
this
Action?
Section
8(
b)
of
TSCA
requires
EPA
to
``
compile,
keep
current,
and
publish
a
list
of
each
chemical
substance
which
is
manufactured
or
processed
in
the
United
States''
(
the
TSCA
Inventory).
In
order
to
fulfill
this
requirement,
EPA
must
continuously
update
and
keep
current
various
types
of
information,
including,
but
not
limited
to,
the
information
used
to
identify
any
new
chemical
substance
that
is
reported
to
be
manufactured
or
processed
in
the
United
States.
EPA
also
makes
corrections,
when
necessary,
of
previously
reported
information
on
the
TSCA
Inventory.

C.
TSCA
Inventory
Background
As
stated
above,
TSCA
section
8(
b)
requires
EPA
to
compile,
keep
current,
and
publish
a
list
of
chemical
substances
which
are
manufactured
(
including
imported)
or
processed
in
the
United
States.
This
listing,
known
as
the
``
TSCA
Inventory,''
informs
the
public
of
which
chemical
substances
are
being
manufactured,
imported,
or
processed
in
the
United
States
for
commercial
purposes.
For
the
TSCA
Inventory
to
accurately
inform
the
public,
it
must
be
continuously
and
accurately
updated
as
new
information
becomes
available.
The
updating
process
includes
adding
to
the
Inventory
the
identities
of
new
chemical
substances
that
are
being
introduced
into
U.
S.
commerce
and
corrections
when
necessary
of
the
identities
of
previously
reported
substances.
The
Agency
has
developed
policies
regarding
the
identification
of
chemical
substances
for
the
purpose
of
assigning
a
unique
description
of
each
substance
on
the
TSCA
Inventory.
Published
nomenclature
guidance
is
currently
available
for
polymeric
substances,
substances
containing
varying
carbon
chain
lengths,
complex
reaction
products,
mixtures,
and
chemical
substances
of
unknown
or
variable
compositions.
Approximately
81,500
chemical
substances,
as
defined
in
section
3
of
TSCA,
are
on
the
TSCA
Inventory
at
this
time.
In
its
implementation
of
TSCA,
EPA
defines
chemical
substances
as
either
``
existing''
chemicals
or
``
new''
chemicals.
The
only
way
to
determine
if
a
substance
is
new
or
existing
is
by
consulting
the
TSCA
Inventory.
Any
substance
that
is
listed
on
the
TSCA
Inventory
is
an
existing
chemical,
otherwise
it
is
a
new
chemical.
If
a
substance
is
a
new
chemical,
generally
it
can
be
manufactured
or
imported
for
nonexempt
commercial
purposes
only
when
a
Premanufacture
Notice
(
PMN)
is
submitted
at
least
90
days
before
the
manufacture
or
import
of
such
substance
begins
(
see
section
5(
a)
of
TSCA
and
40
CFR
part
720).
During
this
90­
day
review
period
EPA
will
evaluate
the
proposed
manufacture,
processing,
use,
distribution
in
commerce,
and
disposal
of
the
substance,
and
if
necessary,
prohibit
or
limit
any
activity
that
may
result
in
an
unreasonable
risk
of
injury
to
human
health
or
the
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environment.
A
new
chemical
substance
also
can
be
manufactured
or
imported
if
it
is
subject
to
an
exemption
from
full
premanufacture
reporting,
for
example
a
Low
Volume
Exemption
or
a
Test
Marketing
Exemption
(
see
40
CFR
part
723
and
40
CFR
720.38).
In
addition
a
new
chemical
substance
is
excluded
from
premanufacture
reporting
under
certain
conditions
such
as
manufacture
or
import
of
small
quantities
for
research
and
development
or
if
the
substance
does
not
meet
the
TSCA
definition
of
chemical
substance
as
defined
in
40
CFR
part
720.3(
e)
(
see
40
CFR
720.30).

D.
Inventory
Listings
of
Enzymes
When
EPA
promulgated
the
TSCA
Inventory
Reporting
Regulations
of
1977
(
42
FR
64572,
December
23,
1977),
the
Agency
did
not
provide
specific
guidance
regarding
how
complex
biological
compounds
should
be
identified.
However,
EPA
did
publish
the
TSCA
Candidates
List
to
provide
examples
of
the
types
of
substances
that
would
be
reportable
for
the
Inventory.
That
list
included
enzymes.
As
a
result,
approximately
150
enzymes
were
reported
and
listed
on
the
TSCA
Inventory
without
specific
agency
guidance
regarding
how
they
should
be
unambiguously
identified.
The
original
Inventory
listings
for
nonenzymatic
proteins
and
other
complex
biological
compounds
are
based
on
information
originally
reported
to
EPA
that
varies
widely
in
the
type
and
specificity
of
information
included.
The
enzymes
currently
on
the
TSCA
Inventory
are
identified
by
a
Chemical
Abstract
Services
(
CAS)
Registry
Number
and
Chemical
Abstracts
9th
Collective
Index
Name.
The
names
assigned
to
these
enzymes
by
EPA
vary
in
the
type
and
specificity
of
information
included
due
to
wide
variation
in
the
type
and
amount
of
information
originally
reported
to
EPA.
For
some
enzymes,
the
name
is
broad,
defining
only
the
most
generic
catalytic
activity
of
the
enzyme
(
e.
g.,
proteinase).
As
a
result
of
the
existing
broad
and
generic
TSCA
Inventory
enzyme
listings,
it
has
been
difficult
for
EPA
to
determine
whether
enzyme
substances
are
new
and
distinct,
or
covered
under
existing
listings.
In
most
cases,
newly
developed
enzymes
appear
to
be
subsumed
under
one
of
the
current
broad
and
generic
TSCA
Inventory
enzyme
listings,
which
means
that,
although
they
are
newly
developed,
they
appear
to
be
existing
chemicals.
This,
in
turn,
means
that
EPA
is
reviewing
very
few
new
enzymes
under
section
5
of
TSCA,
despite
the
ongoing
innovation
in
this
field
as
to
the
specificity
and
functions
of
commercially
available
enzymes.
Under
the
existing
nomenclature
system,
therefore,
EPA
may
not
be
addressing
all
of
the
newly
developed
enzymes
and
considering
the
potential
risks
that
may
be
associated
with
these
substances
under
section
5
of
TSCA.
A
more
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specific
nomenclature
system
would
allow
EPA
to
assess
newly
developed
enzymes
and
take
actions
needed
to
prevent
potential
unreasonable
risks
to
health
and
the
environment
that
may
be
associated
with
these
substances
under
section
5
of
TSCA
before
they
occur.
In
addition,
the
broad
TSCA
Inventory
enzyme
listings,
the
lack
of
clear
reporting
guidelines,
and
the
absence
of
policy
concerning
what
structural
variation
or
changes
trigger
reporting,
also
make
it
difficult
for
manufacturers
to
determine
whether
enzyme
substances
are
new
or
covered
under
existing
listings.
Recognizing
that
enzyme
listings
on
the
Inventory
were
broad,
EPA
developed
an
interim
policy
that
manufacturers
of
enzymes
should
contact
EPA
regarding
submission
of
a
bona
fide
intent
to
manufacture
before
producing
any
enzyme.
EPA
also
routinely
advised
submitters
of
a
Notice
of
Bona
Fide
Intent
to
Manufacture
that
the
Agency
may
modify
the
method
of
listing
enzymes
on
the
Inventory
and
that
this
could
require
reporting
at
a
higher
level
of
detail
than
is
required
at
present.
This
case­
by­
case
determination
creates
uncertainty
and
an
unnecessary
burden
for
both
the
Agency
and
PMN
submitters.
More
specific
guidelines
for
identifying
enzymes
on
the
TSCA
Inventory
would
make
the
process
of
deciding
whether
an
enzyme
is
new
or
existing
more
predictable
and
transparent.
In
order
to
more
effectively
meet
its
statutory
obligation
under
TSCA
to
prevent
unreasonable
risk
to
human
health
and
the
environment
and
to
maintain
a
complete
and
accurate
list
of
all
chemical
substances
manufactured,
imported,
or
processed,
EPA
believes
it
is
necessary
to
refine
its
policies
with
regard
to
enzyme
identification
reporting
requirements.
The
timely
development
of
identification
reporting
guidelines
for
enzymes
is
essential,
given
the
increasing
use
of
enzymes
in
commerce,
the
wide
variety
of
enzymes
that
are
being
produced,
and
the
development
of
new
and
different
manufacturing
techniques.

III.
Identification
Elements
A.
Description
of
Identification
Elements
EPA
has
identified
four
elements
that
it
currently
believes
are
appropriate
to
use
in
combination
to
create
unambiguous
listings
for
proteinaceous
enzymes
on
the
TSCA
Inventory:
1.
Function.
2.
Source.
3.
Processing.
4.
Amino
acid
sequence.
EPA
believes
that
no
individual
element
provides
sufficient
identification
information
by
itself.
Rather,
EPA
anticipates
that
all
four
elements
will
provide
useful
and
necessary
information
for
the
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unambiguous
identification
of
proteinaceous
enzymes
and
that
some
combination
of
these
and/
or
additional
identification
elements
may
be
appropriate
for
other
enzymes
and
proteins.
The
function
of
an
enzyme
refers
to
its
catalytic
activity.
The
internationally
accepted
nomenclature
conventions
of
the
Nomenclature
Committee
of
the
International
Union
of
Biochemistry
and
Molecular
Biology
(
NC­
IUBMB)
describe
and
differentiate
enzymes
based
on
catalytic
activity.
Function,
or
catalytic
activity,
could
be
incorporated
as
an
element
of
chemical
identity
of
an
enzyme
on
the
TSCA
Inventory
using
this
standard
enzyme
nomenclature.
Source
refers
to:
The
organism
from
which
the
gene
encoding
the
enzyme
was
derived
and
the
organism
or
manufacturing
platform
(
e.
g.,
tissue
culture)
in
which
the
enzyme
is
produced.
The
two
sources
may
be
the
same
or
differ
when
the
enzyme
gene
from
one
organism
is
introduced
through
genetic
engineering
into
a
different
organism
or
through
the
use
of
a
synthetic
sequence.
Processing
refers
to
procedures
used
to
isolate
the
enzyme
from
the
production
organism
or
manufacturing
platform,
procedures
used
to
purify
it,
or
any
chemical
reactions
to
which
the
enzyme
is
subjected
to
produce
the
final
product.
The
amino
acid
sequence
of
an
enzyme
or
protein
is
known
as
its
primary
structure.
The
amino
acid
sequence
is
a
systematic
representation
of
the
linear
chain
of
amino
acids
connected
via
amide
bonds
that
produce
a
polypeptide.
An
example
of
enzyme
nomenclature
using
these
identification
elements
would
be
neopullulanase
(
Enzyme
Commission
3.2.1.135),
produced
by
Bacillus
stearothermophilus,
treated
with
acetic
acid,
with
amino
acid
sequence:

Position
#

1
M
R
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A
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A
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F
A
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A
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D
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31
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L
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D
W
Q
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M
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61
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D
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F
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W
F
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P
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G
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91
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V
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D
T
V
W
Y
Q
I
F
P
E
R
F
A
N
G
N
P
151
S
I
S
P
E
G
S
R
P
W
G
S
E
D
P
T
P
T
S
F
F
G
G
D
L
Q
G
I
I
D
181
H
L
D
Y
L
V
D
L
G
I
T
G
I
Y
L
T
P
I
F
R
S
P
S
N
H
K
Y
D
T
A
211
D
Y
F
E
V
D
P
H
F
G
D
K
E
T
L
K
T
L
I
D
R
C
H
E
K
G
I
R
V
M
241
L
D
A
V
F
N
H
C
G
Y
E
F
A
P
F
Q
D
V
W
K
N
G
E
S
S
K
Y
K
D
W
271
F
H
I
H
E
F
P
L
Q
T
E
P
R
P
N
Y
D
T
F
R
F
V
P
Q
M
P
K
L
N
T
301
A
N
P
E
V
K
R
Y
L
L
D
V
A
T
Y
W
I
R
E
F
D
I
D
G
W
R
L
D
V
A
331
N
E
I
D
H
E
F
W
R
E
F
R
Q
E
V
K
A
L
K
P
D
V
Y
I
L
G
E
I
W
H
361
D
A
M
P
W
L
R
G
D
Q
F
D
A
V
M
N
Y
P
F
T
D
G
V
L
R
F
F
A
K
E
391
E
I
S
A
R
Q
F
A
N
Q
M
M
H
V
L
H
S
Y
P
N
N
V
N
E
A
A
F
N
L
L
***
EO
12866
Review
Draft
of
07/
02/
2004
***

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9
of
10
421
G
S
H
D
T
S
R
I
L
T
V
C
G
G
D
I
R
K
V
K
L
L
F
L
F
Q
L
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F
T
451
G
S
P
C
I
Y
Y
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D
E
I
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M
T
G
G
N
D
P
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C
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V
W
D
P
M
481
Q
Q
N
K
E
L
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Q
H
V
K
Q
L
I
A
L
R
K
Q
Y
R
S
L
R
R
G
E
I
S
F
511
L
H
A
D
D
E
M
N
Y
L
I
Y
K
K
T
D
G
D
E
T
V
L
V
I
I
N
R
S
D
Q
541
K
A
D
I
P
I
P
L
D
A
R
G
T
W
L
V
N
L
L
T
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R
F
A
A
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A
E
T
571
L
C
T
S
L
P
P
Y
G
F
V
L
Y
A
I
E
H
W
This
is
one
version
of
enzyme
nomenclature
using
these
four
identification
elements.
Actual
nomenclature
would
vary
widely
depending
on
use
of
all
four
elements,
nomenclature
used
for
each
element,
and
the
level
of
detail
ultimately
used
for
each
element.

B.
Issues
for
Public
Comment
EPA
is
soliciting
comments
on
all
aspects
of
the
discussion
presented
in
this
document
regarding
nomenclature
issues
for
enzymes
and
proteins,
for
purposes
of
listing
these
chemical
substances
on
the
TSCA
Inventory.
EPA
is
particularly
interested
in
receiving
comments
on
the
following
topics.
EPA
has
identified
four
elements
(
listed
in
Unit
III.
A.),
that
it
currently
believes
are
appropriate
to
derive
unique
nomenclature
for
the
purpose
of
unambiguously
listing
proteinaceous
enzymes
on
the
TSCA
Inventory.
EPA
is
seeking
comments
on
the
scientific
appropriateness
of
using
these
identification
elements,
the
level
of
detail
necessary
to
create
specific,
unambiguous
TSCA
Inventory
listings,
the
technical
feasibility
of
providing
such
information,
and
any
additional
or
alternative
elements
that
could
be
used
to
identify
proteinaceous
enzymes
on
the
TSCA
Inventory.
Are
the
identification
elements
proposed
for
proteinaceous
enzymes
scientifically
appropriate
and
sufficiently
comprehensive
for
non­
proteinaceous
enzymes
and
non­
enzymatic
proteins?
Are
there
additional
or
alternative
identification
elements
that
should
be
used
in
creating
TSCA
Inventory
listings
for
non­
proteinaceous
enzymes
and
non­
enzymatic
proteins?
If
so,
what
are
these
alternatives,
and
why
is
it
believed
that
these
alternatives
are
preferable.

IV.
Do
Any
Statutory
or
Executive
Order
Reviews
Apply
to
this
Action?
Under
Executive
Order
12866,
entitled
Regulatory
Planning
and
Review
(
58
FR
51735,
October
4,
1993),
it
has
been
determined
that
this
ANPRM
is
a
``
significant
regulatory
action''
under
section
3(
f)
of
the
Executive
order.
The
Agency
therefore
submitted
this
document
to
OMB
for
the
10­
day
review
period
afforded
under
this
Executive
order.
Any
changes
made
in
response
to
OMB
comments
during
that
review
have
been
documented
in
the
docket
as
required
by
the
Executive
order.
Since
this
ANPRM
does
not
impose
or
propose
any
requirements,
and
instead
seeks
comments
and
suggestions
for
the
Agency
to
consider
in
developing
a
subsequent
notice
of
proposed
rulemaking,
the
various
***
EO
12866
Review
Draft
of
07/
02/
2004
***

Page
10
of
10
other
review
requirements
that
apply
when
an
agency
imposes
requirements
do
not
apply
to
this
action.
As
part
of
your
comments
on
this
ANPRM
you
may
include
any
comments
or
information
that
you
have
regarding
these
requirements.
In
particular,
any
comments
or
information
that
would
help
the
Agency
to
assess
the
potential
impact
of
a
rule
on
small
entities
pursuant
to
the
Regulatory
Flexibility
Act
(
RFA)
(
5
U.
S.
C.
601
et
seq.);
to
consider
voluntary
consensus
standards
pursuant
to
section
12(
d)
of
the
National
Technology
Transfer
and
Advancement
Act
of
1995
(
NTTAA),
Public
Law
104
 
113,
section
12(
d)
(
15
U.
S.
C.
272
note);
or
to
consider
environmental
health
or
safety
effects
on
children
pursuant
to
Executive
Order
13045,
entitled
Protection
of
Children
from
Environmental
Health
Risks
and
Safety
Risks
(
62
FR
19885,
April
23,
1997).
The
Agency
will
consider
such
comments
during
the
development
of
any
subsequent
notice
of
proposed
rulemaking
as
it
takes
appropriate
steps
to
address
any
applicable
requirements.

List
of
Subjects
in
40
CFR
Part
720
Environmental
protection,
Chemicals,
Hazardous
substances,
Reporting
and
recordkeeping
requirements.

Dated:
____________________

__________________________
Administrator.
[
FR
Doc.
04
 
?
?????
Filed
??
 
?
?
 
04;
8:
45
am]
BILLING
CODE
6560
 
50
 
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