60386
Federal
Register
/
Vol.
68,
No.
204
/
Wednesday,
October
22,
2003
/
Notices
allergenic
proteins,
which
typically
are
present
at
1
 
80%
of
the
total
protein
in
an
offending
food,
the
average
PMI
concentration
measured
in
raw
grain
derived
from
a
line
of
transformed
corn
plants
represents
less
than
0.00002%
of
the
total
protein.
(
This
calculation
is
based
on
corn
grain
containing
10%
total
protein
by
weight,
and
assumes
2
ppm
PMI
in
the
grain.)
Additionally,
due
to
degradation
via
food
processing
methods,
PMI
will
not
likely
be
present
in
processed
food
products,
or
will
be
present
in
only
trace
quantities.
PMI
produced
in
transformed
plants
is
not
targeted
to
a
cellular
pathway
for
glycosylation.
PMI
activity,
and
therefore
tertiary
protein
structure,
is
lost
upon
heating
at
65
degrees
C
for
30
minutes.
PMI
rapidly
degrades
upon
exposure
to
simulated
mammalian
gastric
and
intestinal
fluids.
The
genetic
material
occurring
in
the
subject
inert
ingredient
has
been
adequately
characterized.
This
genetic
material
(
i.
e.,
the
nucleic
acids
deoxyribonucleic
acid
(
DNA)
and
ribonucleic
acid
(
RNA)),
including
regulatory
regions,
necessary
for
the
production
of
PMI
as
an
inert
ingredient
in
all
crops
will
not
present
a
dietary
safety
concern.
``
Regulatory
regions''
are
the
DNA
sequences
such
as
promoters,
terminators,
and
enhancers
that
control
the
expression
of
the
genetic
material
encoding
the
protein.
Based
on
the
ubiquitous
occurrence
and
established
safety
of
nucleic
acids
in
the
food
supply,
a
tolerance
exemption
under
the
FFDCA
regulations
has
been
established
for
residues
of
nucleic
acids
that
are
part
of
plant­
incorporated
protectants
or
associated
inert
ingredients
40
CFR
174.475
(
66
FR
37817)
(
FRL
 
6057
 
5).
Therefore,
no
mammalian
toxicity
is
anticipated
from
dietary
exposure
to
the
genetic
material
necessary
for
the
production
of
PMI
protein
in
all
crops.

D.
Aggregate
Exposure
1.
Dietary
exposure
 
i.
Food.
Due
to
the
ubiquitous
occurrence
of
PMI
in
nature,
it
is
conceivable
that
the
human
diet
has
always
contained
small
amounts
of
PMI
proteins
that
are
similar
to
that
produced
in
plants
transformed
with
the
E.
coli
pmi
gene.
The
levels
of
PMI
measured
in
raw
grain
from
a
line
of
transformed
corn
plants
averaged
ca.
1
 
2
ppm.
Processed
plant
products
or
by­
products
used
in
food
are
unlikely
to
have
measurable
PMI
protein,
or
will
have
only
trace
amounts.
Oral
exposure
is
not
expected
to
result
in
adverse
health
effects,
because
of
a
demonstrated
lack
of
toxicity
to
mammals
and
the
rapid
digestibility
of
the
PMI
protein.
It
is
expected
that
any
PMI
protein
consumed
will
be
digested
as
conventional
dietary
protein.
ii.
Drinking
water.
Little
to
no
exposure
via
drinking
water
is
anticipated.
Due
to
the
demonstrated
mammalian
safety
profile
of
PMI,
such
exposure
would
not
present
a
risk.
2.
Non­
dietary
exposure.
Non­
dietary
exposure
is
not
anticipated,
due
to
the
proposed
use
pattern
of
the
product.
Exposure
via
dermal
or
inhalation
routes
is
unlikely
because
the
inert
ingredient
is
contained
within
plant
cells.
However,
if
exposure
were
to
occur
by
non­
dietary
routes,
no
risk
would
be
expected
because
the
PMI
protein
is
not
toxic
to
mammals.

E.
Cumulative
Exposure
Because
there
is
no
indication
of
mammalian
toxicity
of
the
PMI
protein
or
the
genetic
material
necessary
for
its
production,
it
is
reasonable
to
conclude
that
there
will
be
no
cumulative
effects
for
this
inert
ingredient.

F.
Safety
Determination
1.
U.
S.
population.
The
lack
of
mammalian
toxicity
at
high
levels
of
exposure
to
the
PMI
protein
demonstrates
the
safety
of
the
product
at
levels
well
above
possible
maximum
exposure
levels
anticipated
via
consumption
of
food
products
produced
from
pmi­
transformed
plants.
Moreover,
little
to
no
human
dietary
exposure
to
PMI
protein
is
expected
to
occur
via
pmi­
transformed
food
crops.
Due
to
the
digestibility
and
lack
of
toxicity
of
the
PMI
protein,
and
its
very
low
potential
to
become
an
allergen
in
food,
dietary
exposure
is
not
anticipated
to
pose
any
harm
for
the
U.
S.
population.
No
special
safety
provisions
are
applicable
for
consumption
patterns
or
for
any
population
sub­
groups.
2.
Infants
and
children.
Based
on
the
mammalian
safety
profile
of
the
inert
ingredient
and
the
proposed
use
pattern,
there
is
ample
evidence
to
conclude
a
reasonable
certainty
of
no
harm
to
infants
and
children.

G.
Effects
on
the
Immune
and
Endocrine
Systems
The
inert
ingredient
is
derived
from
sources
that
are
not
known
to
exert
an
influence
on
the
endocrine
or
immune
systems.

H.
Existing
Tolerances
The
registrant
is
not
aware
of
any
known
existing
tolerances
or
exemptions
for
PMI
and
the
genetic
material
necessary
for
its
production
as
an
inert
ingredient.
I.
International
Tolerances
The
registrant
is
not
aware
that
any
Codex
maximum
residue
levels
exist
for
the
PMI
protein
and
the
genetic
material
necessary
for
its
production.
[
FR
Doc.
03
 
26412
Filed
10
 
21
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
[
OPPT
 
2003
 
0034;
FRL
 
7331
 
2]

Draft
Instructions
for
Reporting
for
the
2006
Partial
Updating
of
the
TSCA
Chemical
Inventory
Database;
Request
for
Comment;
Notice
of
Public
Meeting
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Notice.

SUMMARY:
EPA
is
convening
a
1
 
day
public
meeting
to
receive
comments
from
persons
reporting
data
required
by
the
Inventory
Update
Rule
(
IUR)
on
the
draft
instructions
for
reporting
in
2006.
The
instructions
have
been
revised
in
response
to
amendments
to
40
CFR
part
710
promulgated
on
January
7,
2003,
which
substantially
modify
the
information
which
must
be
reported
for
the
partial
updating
of
the
Toxic
Substances
Control
Act
(
TSCA)
Chemical
Inventory
Database
beginning
in
2006.
DATES:
The
public
meeting
will
commence
at
9:
30
a.
m.
on
Wednesday,
October
22,
2003,
and
end
at
approximately
2
p.
m.
ADDRESSES:
The
public
meeting
will
be
held
at
the
Sheraton
Suites
Houston,
2400
West
Loop
South,
Houston,
TX
77027.
Persons
planning
to
attend
the
public
meeting
are
encouraged
to
register
with
the
technical
contact
person
identified
below.
Persons
registering
for
the
meeting
will
receive
by
e­
mail
a
copy
of
the
draft
instructions
prior
to
the
meeting.
Prior
registration
is
not
required
to
attend
the
public
meeting.
FOR
FURTHER
INFORMATION
CONTACT:
For
general
information
contact:
Barbara
Cunningham,
Director,
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;
e­
mail
address:
TSCAHotline
epa.
gov.
For
technical
information
contact:
Fredric
C.
Arnold,
Economics,
Exposure,
and
Technology
Division
(
7406M),
Office
of
Pollution
Prevention
and
Toxics,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,

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RECEIVED
OPPT
NCIC
2003
October
22
8:
15AM
60387
Federal
Register
/
Vol.
68,
No.
204
/
Wednesday,
October
22,
2003
/
Notices
Washington,
DC
20460
 
0001;
telephone
number:
(
202)
564
 
8521;
e­
mail
address:
arnold.
fred@
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
chemical
substances
currently
subject
to
reporting
under
the
IUR
as
amended
on
January
7,
2003,
and
codified
as
40
CFR
part
710.
Persons
who
process
chemical
substances
but
who
do
not
manufacture
or
import
chemical
substances
are
not
required
to
comply
with
the
requirements
of
40
CFR
part
710.
Potentially
affected
entities
may
include,
but
are
not
limited
to:
Chemical
manufacturers
and
importers
currently
subject
to
IUR
reporting,
including
manufacturers
and
importers
of
inorganic
chemical
substances
(
NAICS
codes
325
and
32411).
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
at
40
CFR
710.48.
If
you
have
any
questions
regarding
the
applicability
of
this
action
to
a
particular
entity,
consult
the
technical
contact
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.

B.
How
Can
I
Get
Copies
of
this
Document
and
Other
Related
Information?

1.
Docket.
EPA
has
established
an
official
public
docket
for
this
action
under
docket
identification
(
ID)
number
OPPT
 
2003
 
0034.
The
official
public
docket
consists
of
the
documents
specifically
referenced
in
this
action,
any
public
comments
received,
and
other
information
related
to
this
action.
Although
a
part
of
the
official
docket,
the
public
docket
does
not
include
Confidential
Business
Information
(
CBI)
or
other
information
whose
disclosure
is
restricted
by
statute.
The
official
public
docket
is
the
collection
of
materials
that
is
available
for
public
viewing
at
EPA's
Docket
Center,
Rm.
B102­
Reading
Room,
EPA
West,
1301
Constitution
Ave.,
NW.,
Washington,
DC.
EPA's
Docket
Center
is
open
from
8:
30
a.
m.
to
4:
30
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
EPA's
Docket
Center
Reading
Room
telephone
number
is
(
202)
566
 
1744
and
the
telephone
number
for
the
OPPT
Docket,
which
is
located
in
EPA
Docket
Center,
is
(
202)
566
 
0280.
2.
Electronic
access.
You
may
access
this
Federal
Register
document
electronically
through
the
EPA
Internet
under
the
Federal
Register
listings
at
http://
www.
epa.
gov/
fedrgstr/.
An
electronic
version
of
the
public
docket
is
available
through
EPA's
electronic
public
docket
and
comment
system,
EPA
Dockets.
You
may
use
EPA
Dockets
at
http://
www.
epa.
gov/
edocket/
to
submit
or
view
public
comments,
access
the
index
listing
of
the
contents
of
the
official
public
docket,
and
to
access
those
documents
in
the
public
docket
that
are
available
electronically.
Although
not
all
docket
materials
may
be
available
electronically,
you
may
still
access
any
of
the
publicly
available
docket
materials
through
the
docket
facility
identified
in
Unit
I.
B.
1.
Once
in
the
system,
select
``
search,''
then
key
in
the
appropriate
docket
ID
number.

II.
Background
EPA
is
convening
a
public
meeting
to
receive
comments
on
the
instructions
for
reporting
to
the
2006
partial
updating
of
TSCA
Chemical
Substance
Inventory
Database.
EPA
is
required
by
section
8(
b)
of
TSCA
to
compile
and
update
an
inventory
of
chemical
substances
manufactured
or
imported
in
the
United
States.
Every
4
years,
manufacturers
(
including
importers)
of
certain
chemical
substances
on
the
Chemical
Substance
Inventory
have
been
required
to
report
data
specified
in
the
TSCA
section
8(
a)
IUR,
40
CFR
part
710.
Past
updates
included
information
on
the
chemical's
production
volume,
site­
limited
status,
and
plant
site
information.
Amendments
to
the
IUR
promulgated
on
January
7,
2003
(
68
FR
848)
(
FRL
 
6767
 
4)
expanded
the
data
reported
on
certain
chemicals
to
assist
EPA
and
others
in
screening
potential
exposures
and
risks
resulting
from
manufacturing,
processing,
and
use
of
TSCA
chemical
substances.
At
the
same
time,
EPA
amended
the
IUR
regulations
to
increase
the
production
volume
threshold,
which
triggers
reporting
requirements
from
10,000
lbs
per
year
to
25,000
lbs
per
year
and
established
a
new
higher
threshold
of
300,000
lbs
per
year
above
which
manufacturers
must
report
additional
information
on
downstream
processing
and
use
of
their
chemical
substances.
The
2003
amendments
to
the
IUR
also
revoked
the
exemption
from
reporting
for
inorganic
chemical
substances,
provided
a
partial
exemption
from
reporting
of
processing
and
use
information
for
chemical
substances
of
low
current
interest,
and
continued
the
current
exemption
from
reporting
for
polymers,
microorganisms,
and
naturally
occurring
chemical
substances.
These
changes
modify
requirements
for
information
collected
in
calendar
year
2005
and
submitted
in
2006
and
thereafter.
The
public
meeting
may
be
of
interest
to
persons
currently
reporting
under
the
IUR
and
to
manufacturers
of
inorganic
chemical
substances.
The
public
meeting
will
include
a
series
of
presentations
by
representatives
of
EPA
on
the
instructions
for
reporting
for
the
2006
partial
updating
of
the
TSCA
Chemical
Inventory
Database.
Presentation
topics
will
include
reporting
requirements,
instructions
for
completing
the
reporting
form,
how
to
assert
confidentiality
claims,
and
how
to
submit
completed
reports
to
EPA.
After
each
presentation,
persons
attending
the
public
meeting
will
be
invited
to
comment
on
the
clarity,
completeness,
and
usefulness
of
the
instructions.
Comments
may
also
be
submitted
in
writing
following
the
public
meeting.
Comments
should
be
submitted
within
30
days
after
the
meeting
to
receive
timely
attention.
The
purpose
of
the
public
meeting
is
to
receive
input
for
improving
the
instructions;
subsequent
meetings
are
planned
for
2004,
to
provide
training
to
persons
who
must
report
in
2006,
under
the
IUR.
There
is
no
charge
for
attending
this
public
meeting.

List
of
Subjects
Environmental
protection,
Chemicals,
Reporting
and
recordkeeping
requirements.

Dated:
October
17,2003.

Charles
M.
Auer,

Director,
Office
of
Pollution
Prevention
and
Toxics.
[
FR
Doc.
03
 
26737
Filed
10
 
20
 
03;
2:
26
pm]

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CODE
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