Document ID: EPA-HQ-OPPT-2002-0054-0277
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2002-11-25T05:00Z

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1
ENVIRONMENTAL
PROTECTION
AGENCY
2
40
CFR
Part
710
3
[
OPPTS­
82053A;
FRL­
6767­
4]
4
RIN
2070­
AC61
5
TSCA
Inventory
Update
Rule
Amendments
6
AGENCY:
Environmental
Protection
Agency
(
EPA).
7
ACTION:
Final
rule.
8
_______________________________________________________________________
9
SUMMARY:
EPA
is
promulgating
amendments
to
the
Toxic
Substances
Control
Act
(
TSCA)
10
section
8(
a)
Inventory
Update
Rule
(
IUR).
The
IUR
currently
requires
manufacturers
(
including
11
importers)
of
certain
chemical
substances
on
the
TSCA
Chemical
Substances
Inventory
to
report
12
data
on
each
chemical's
current
production
volume,
site­
limited
status,
and
plant
site
information
13
every
four
years.
Through
these
IUR
amendments
(
IURA),
EPA
is
requiring
the
reporting
of
14
additional
data
for
certain
chemicals
to
assist
EPA
and
others
in
screening
potential
exposures
and
15
risks
resulting
from
industrial
chemical
operations
and
commercial
and
consumer
uses
of
TSCA
16
chemical
substances.
EPA
is
also
modifying
the
IUR
reporting
and
recordkeeping
requirements,
17
removing
one
reporting
exemption
and
creating
others,
and
modifying
its
procedures
for
making
18
and
retaining
Confidential
Business
Information
(
CBI)
claims.
EPA
is
also
making
certain
non­
19
substantive
technical
corrections.
20
DATES:
This
final
rule
is
effective
on
[
insert
date
90
days
after
date
of
publication
in
the
21
Federal
Register].
For
purposes
of
judicial
review,
this
rule
shall
be
promulgated
at
1pm
eastern
22
daylight/
standard
time
on
[
insert
date
2
weeks
after
publication
in
the
FR]
(
See
40
CFR
23.5).
23
FOR
FURTHER
INFORMATION
CONTACT:
For
general
information
contact:
Barbara
24
2
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or
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­
Not
for
Public
Release
**
Cunningham,
Acting
Director,
Environmental
Assistance
Division,
Office
of
Pollution
Prevention
25
and
Toxics
(
7401),
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
26
Washington,
DC
20460;
telephone
number:
(
202)
564­
8170;
e­
mail
address:
27
TSCA­
Hotline@
epa.
gov.
28
For
technical
information
contact:
Susan
Sharkey,
Project
Manager,
Economics,
29
Exposure
and
Technology
Division,
(
7406),
Office
of
Pollution
Prevention
and
Toxics,
30
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460;
31
telephone
number:
202­
564­
8789;
e­
mail
address:
sharkey.
susan@
epa.
gov.
32
SUPPLEMENTARY
INFORMATION:
33
I.
General
Information
34
A.
Does
this
Action
Apply
to
Me?
35
You
may
be
affected
by
this
action
if
you
manufacture
(
defined
by
statute
to
include
36
import)
chemical
substances
currently
subject
to
reporting
under
the
Inventory
Update
Rule
37
(
IUR)
at
40
CFR
part
710
or
if
you
manufacture
inorganic
chemical
substances.
Any
use
of
the
38
term
"
manufacture"
in
this
document
will
encompass
"
import,"
unless
otherwise
stated.
In
the
39
past,
persons
that
only
are
processors
of
chemical
substances
have
not
been
required
to
comply
40
with
the
requirements
of
40
CFR
part
710.
These
amendments
do
not
change
the
status
of
41
processors
under
the
regulations
at
40
CFR
part
710.
Potentially
affected
categories
and
entities
42
may
include,
but
are
not
limited
to:
43
°
Chemical
manufacturers
(
defined
by
statute
to
include
importers)
currently
subject
to
44
IUR
reporting,
and
chemical
manufacturers
(
defined
by
statute
to
include
importers)
of
inorganic
45
chemical
substances
(
NAICS
codes
325,
32411).
46
3
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for
Public
Release
**
This
listing
is
not
intended
to
be
exhaustive,
but
rather
provides
a
guide
for
readers
47
regarding
entities
likely
to
be
affected
by
this
action.
Other
types
of
entities
not
listed
in
the
table
48
in
this
unit
could
also
be
affected.
North
American
Industrial
Classification
System
(
NAICS)
49
codes
have
been
provided
to
assist
you
and
others
in
determining
whether
this
action
applies
to
50
certain
entities.
To
determine
whether
you
or
your
business
is
affected
by
this
action,
you
should
51
carefully
examine
the
applicability
provisions
in
section
710.28
in
the
regulatory
text.
If
you
have
52
any
questions
regarding
the
applicability
of
this
action
to
a
particular
entity,
consult
the
technical
53
contact
person
listed
under
"
FOR
FURTHER
INFORMATION
CONTACT."
54
B.
How
Can
I
Get
Additional
Information,
Including
Copies
of
this
Document
or
Other
Related
55
Documents?
56
1.
Electronically.
You
may
obtain
electronic
copies
of
this
document,
and
certain
other
57
related
documents
that
are
available
electronically,
from
the
EPA
Internet
Home
Page
at
58
http://
www.
epa.
gov/.
To
access
this
document,
on
the
Home
Page
select
"
Laws
and
59
Regulations"
and
then,
using
the
publication
date,
look
up
the
entry
for
this
document
under
60
"
Federal
Register­­
Environmental
Documents."
You
can
also
go
directly
to
the
Federal
61
Register
listings
at
http://
www.
epa.
gov/
fedrgstr/.
62
EPA's
Office
of
Pollution
Prevention
and
Toxics
(
OPPT)
has
a
homepage
at
63
www.
epa.
gov/
opptintr.
You
may
also
find
more
information
on
the
IUR
and
IURA
at
64
www.
epa.
gov/
opptintr/
iuramend.
65
2.
In
person.
The
Agency
has
established
an
official
record
for
this
action
under
docket
66
control
number
OPPTS­
82053.
The
official
record
consists
of
the
documents
specifically
67
referenced
in
this
action,
any
public
comments
received
during
an
applicable
comment
period,
and
68
4
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for
Public
Release
**
other
information
related
to
this
action,
including
any
information
claimed
as
Confidential
69
Business
Information
(
CBI).
The
official
record
includes
the
documents
that
are
physically
70
located
in
the
docket,
as
well
as
the
materials
that
are
referenced
in
those
documents.
The
public
71
version
of
the
official
record
does
not
include
any
information
claimed
as
CBI.
The
public
version
72
of
the
official
record,
which
includes
printed,
paper
versions
of
any
electronic
comments
73
submitted
during
an
applicable
comment
period,
is
available
for
inspection
in
the
TSCA
74
Nonconfidential
Information
Center,
North
East
Mall
Rm.
B­
607,
Waterside
Mall,
401
M
St.,
75
SW.,
Washington,
DC.
The
Center
is
open
from
noon
to
4
p.
m.,
Monday
through
Friday,
76
excluding
legal
holidays.
The
telephone
number
for
the
Center
is
(
202)
260­
7099.
77
II.
Background
78
A.
What
Action
is
the
Agency
Taking?
79
1.
Substantive
Changes
to
the
CFR.
EPA
is
promulgating
amendments
to
the
IUR
which
80
were
proposed
on
August
26,
1999
(
64
FR
46772).
By
this
action,
EPA
is
making
several
81
changes
to
the
current
IUR
reporting
requirements
described
at
40
CFR
part
710,
taking
into
82
consideration
comments
received
on
the
proposal.
The
following
is
a
brief
listing
of
the
primary
83
changes,
which
are
described
in
more
detail
in
this
document,
along
with
a
summary
of
the
84
comments
received
and
the
Agency's
summary
response
to
those
comments.
A
sample
copy
of
85
revised
reporting
Form
U
is
located
in
Unit
II.
F.
of
this
preamble.
86
First,
EPA
is
amending
40
CFR
710.28
and
710.32
to
raise
the
production
volume
basic
87
reporting
threshold
from
the
current
10,000
pounds
(
lbs.)
per
year
to
25,000
lbs.
per
year,
and
to
88
add
a
new
larger­
volume
reporting
threshold
of
300,000
lbs.
per
year
for
the
reporting
of
89
exposure­
related
processing
and
use
information.
90
5
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Draft
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Cite
or
Quote
­
Not
for
Public
Release
**
Second,
EPA
is
amending
40
CFR
710.32
to
add
exposure­
related
information
to
the
91
reporting
requirements
for
chemical
substances
covered
by
the
IUR.
Specifically,
the
Agency
is
92
requiring
that
manufacturers
subject
to
the
amended
rule
("
submitters")
report,
in
ranges:
(
1)
the
93
number
of
workers
reasonably
likely
to
be
exposed
to
the
chemical
substance
at
the
site
of
94
manufacture;
(
2)
the
physical
form(
s)
in
which
the
chemical
substance
is
sent
off­
site;
(
3)
the
95
percentage
of
total
reported
production
volume
associated
with
each
physical
form;
and,
(
4)
the
96
maximum
concentration
of
the
chemical
substance
at
the
time
it
is
reacted
on­
site
to
produce
a
97
different
chemical
substance
or
it
leaves
the
submitter's
manufacturing
site.
98
Third,
EPA
is
amending
40
CFR
710.32
to
require
chemical
manufacturers
of
chemical
99
substances
with
production
volumes
of
300,000
lbs.
or
greater
to
report
certain
exposure­
related
100
information
concerning
the
processing
and
use
of
each
reportable
chemical
substance
that
is
101
conducted
at
sites
controlled
by
the
submitter
and
at
  
downstream''
sites
that
receive
the
102
reportable
chemical
substance
from
the
submitter
directly
or
indirectly
(
including
through
a
103
broker/
distributor,
from
a
customer
of
the
submitter,
etc.).
Specifically,
manufacturers
of
these
104
larger­
production
volume
chemical
substances
will
be
required
to
report,
to
the
extent
the
105
information
is
readily
obtainable:
106
1.
The
type
of
industrial
processing
or
use
operation
at
each
site,
including
downstream
107
sites.
108
2.
The
five­
digit
North
American
Industrial
Classification
System
("
NAICS")
codes
that
109
best
describe
the
industrial
activities
during
the
processing
or
use
operation.
110
3.
The
"
industrial
functions"
of
each
chemical
substance
during
the
processing
or
use
111
operation,
for
each
NAICS
code
reported.
112
4.
The
percentages
of
the
submitter's
production
volume
used
in
each
industrial
function
113
6
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or
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for
Public
Release
**
category.
114
5.
The
number
of
sites
where
the
various
processing
and
use
operations
occur.
115
6.
The
number
of
workers
reasonably
likely
to
be
exposed
to
the
chemical
substance
in
116
each
processing
or
use
operation.
117
7.
The
categories
of
commercial
and
consumer
uses
of
the
reportable
chemical
substance.
118
8.
An
indication
of
the
presence
of
the
reportable
chemical
substance
in
consumer
119
products
intended
for
use
by
children.
120
9.
The
percentages
of
the
submitter's
production
volume
associated
with
each
commercial
121
and
consumer
product
use
category.
122
10.
The
maximum
concentration
of
the
reportable
chemical
substance
in
each
commercial
123
and
consumer
product
use
category.
124
Fourth,
EPA
is
revoking
the
current
full
exemption
from
IUR
reporting
at
40
CFR
125
710.26(
a)
for
inorganic
chemical
substances,
and
is
phasing
in
reporting
for
these
substances.
For
126
the
first
submission
period
following
promulgation
of
these
amendments,
EPA
is
requiring
partial
127
reporting
for
these
substances
(
i.
e.,
inorganic
chemical
substances
would
not
be
subject
to
the
128
reporting
of
processing
and
use
information).
In
subsequent
submission
periods,
manufacturers
of
129
an
inorganic
substance
will
be
subject
to
the
processing
and
use
information
reporting
130
requirements,
to
the
extent
that
they
manufacture
at
least
300,000
lbs.
of
the
substance
at
a
site.
131
Fifth,
EPA
is
amending
40
CFR
710.26
to
create
a
partial
reporting
exemption
for
certain
132
chemical
substances
termed
"
petroleum
process
streams"
for
purposes
of
reporting
under
the
133
amended
IUR.
134
Sixth,
EPA
is
amending
40
CFR
710.26
to
provide
a
full
exemption
from
IUR
reporting
135
for
certain
forms
of
natural
gas.
136
7
**
Working
Draft
­
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Not
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or
Quote
­
Not
for
Public
Release
**
Seventh,
EPA
is
amending
40
CFR
710.32
to
require
the
reporting
of
more
specific
137
information
to
assist
in
the
accurate
identification
of
plant
sites
reporting
under
IUR.
138
Eighth,
EPA
is
amending
40
CFR
710.28,
710.32,
and
710.33
to
change
the
period
for
139
which
reporting
is
required
from
a
corporate
fiscal
year
to
a
calendar
year
basis.
140
Ninth,
EPA
is
amending
40
CFR
710.32
to
allow
submitters
to
claim
their
production
141
volume
range
as
CBI,
in
addition
to
the
existing
requirement
that
submitters
report
a
specific
142
production
volume
number
and
the
CBI
status
of
that
specific
number.
Under
the
IURA,
some
143
submitters
may
choose
to
assert
a
confidentiality
claim
for
specific
production
volume
information
144
while
releasing
the
more
general
production
volume
range
as
public
information.
145
Tenth,
EPA
is
amending
40
CFR
710.38
to
require
substantiation
of
plant
site
146
confidentiality
claims
at
the
time
such
claims
are
made
in
IUR
submissions
to
EPA
(
i.
e.,
"
upfront
147
substantiation"),
in
a
manner
similar
to
the
upfront
substantiation
of
chemical
identity,
which
will
148
continue
to
be
required
under
40
CFR
710.38.
149
Eleventh,
EPA
is
adding
a
new
section,
40
CFR
710.39,
to
require
submitters
in
reporting
150
years
after
the
2006
submission
period
to
reassert
CBI
claims
made
in
reports
submitted
to
EPA
151
under
the
IURA
in
order
to
retain
their
confidential
status.
152
Finally,
EPA
is
amending
40
CFR
710.37
to
extend
the
records
retention
period
from
four
153
years
to
five
years.
154
2.
Necessary
Conforming
Technical
Changes
to
the
CFR.
The
amendments
to
the
IUR
155
that
are
contained
in
this
final
rule,
as
well
as
the
parts
of
40
CFR
part
710
that
are
unchanged
by
156
these
amendments,
are
codified
in
new
40
CFR
part
711.
EPA
believes
that
establishing
a
new
40
157
CFR
part
711
will
avoid
confusion
within
the
regulated
community
and
will
enable
EPA
to
158
publish
these
amendments
in
a
timely
fashion.
Because
promulgation
of
these
regulations
159
8
**
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Draft
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Not
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or
Quote
­
Not
for
Public
Release
**
overlaps
a
current
reporting
cycle,
EPA
must
maintain
40
CFR
part
710
as
it
currently
stands
until
160
December
31,
2002.
The
existing
regulations
at
40
CFR
part
710
will
therefore
be
in
effect
161
throughout
the
2002
reporting
cycle
and
submission
period.
Submitters
filing
IUR
reports
in
162
2002
must
follow
the
regulations
at
40
CFR
part
710.
On
January
1,
2003,
the
regulations
at
40
163
CFR
part
711
will
become
effective.
Since
the
Agency
has
duplicated
in
40
CFR
part
711
those
164
provisions
from
40
CFR
part
710
that
are
unchanged
by
these
amendments,
once
the
current
165
reporting
cycle
is
complete,
40
CFR
part
710
will
no
longer
be
applicable
and
the
Agency
will
166
issue
a
technical
correction
to
remove
it
from
the
CFR.
The
creation
of
40
CFR
part
711
does
167
not
make
any
substantive
changes
other
than
those
that
have
been
presented
as
corrections
in
this
168
final
rule.
169
Although
there
are
no
substantive
changes
to
the
provisions
from
40
CFR
part
710
that
170
have
been
incorporated
into
the
new
40
CFR
part
711,
the
Agency
has
made
a
few
minor
171
technical
corrections
to
those
provisions.
Specifically,
the
Agency
is
correcting
several
172
typographical
errors
that
appear
in
the
text
from
40
CFR
part
710,
and
is
making
a
few
other
173
minor
non­
substantive
edits
to
that
text.
These
technical
corrections
are
more
completely
174
described
in
this
section.
175
In
accordance
with
plain
language
principles,
EPA
has
substituted
"
will"
or
"
must"
for
176
"
shall."
These
three
terms
are
considered
to
be
equivalent,
and
delineate
requirements
to
be
177
followed
or
met.
Corrections
were
made
in
the
following
sections:
sec.
711.1(
e)
[
sec.
710.1(
c)];
178
711.3(
a)
[
sec.
710.2(
a)];
sec.
711.3(
b)
[
sec.
710.2(
b)];
sec.
711.3(
c)
[
sec.
710.2(
c)];
sec.
711.3(
d)
179
in
the
definition
for
"
Administrator"
[
sec.
710.2(
e)];
sec.
711.3(
d)
in
the
definition
for
"
site"
[
sec.
180
710.2(
w)];
sec.
711.3(
d)
in
the
note
following
the
definition
for
"
small
quantities
for
research
and
181
development"
[
sec.
710.2(
y)];
sec.
711.4(
b)(
2)
[
sec
710.4(
b)(
2)];
and
sec.
711.4(
d)
in
the
note
182
9
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
following
the
section
[
sec.
710.4(
d)].
183
EPA
has
corrected
some
punctuation
and
spelling
errors:
in
sec.
711.3(
d)
a
comma
was
184
added
in
the
definition
for
"
small
quantities
for
research
and
development"
and
a
comma
was
185
removed
in
the
note
following
the
definition
"
small
quantities
for
research
and
development"
[
sec.
186
710.2(
y)];
in
sec.
711.3(
d)
"
appropriate"
was
substituted
for
"
appropriated"
in
the
definition
for
187
"
technically
qualified
person"
[
sec.
710.2(
aa)(
2)];
and
in
sec.
711.4(
d)(
5)
"
photographic
films"
188
was
substituted
for
"
photographic,
films"
[
sec.
710.4(
d)(
5)].
189
EPA
has
made
certain
additional
non­
substantive
changes.
In
sec.
711.3(
d),
EPA
190
substituted
"
1,000
lbs.
(
455
kg)"
for
"
1,000
pounds"
in
the
note
following
the
definition
for
191
"
small
quantities
for
research
and
development"
[
sec.
710.2(
y)];
in
sec.
711.40(
c)(
1),
EPA
192
substituted
"
By
telephone"
for
"
By
phone"
[
sec.
710.39(
c)(
1)];
in
sec.
711.40(
c)(
2),
EPA
193
substituted
"
TSCA­
Hotline@
epa.
gov"
for
"
TSCA­
Hotline@
epamail.
epa.
gov"
[
sec.
710.39(
c)(
2)];
194
and
in
secs.
711.40(
c)
and
711.40(
d)
EPA
substituted
"
Environmental
Protection
Agency"
for
195
"
U.
S.
Environmental
Protection
Agency"
[
sec.
710.39(
c)(
3)].
EPA
has
substituted
"
his/
her"
for
196
"
his"
in
sections
where
the
word
"
his"
was
used:
in
two
instances
in
sec.
711.3(
d)
in
the
definition
197
for
"
Administrator"
[
Sec
710.2(
e)];
in
sec.
711.3(
d)
in
the
definition
for
importer
[
sec.
198
710.2(
l)(
2)];
and
in
sec.
711.3(
d)
in
the
definition
for
"
technically
qualified
person"
[
Sec
199
710.2(
aa)].
200
EPA
made
minor
revisions
to
clarify,
but
not
change,
the
meaning
of
certain
provisions.
201
In
sec.
711.32(
c)(
1)
"
submitter"
was
substituted
for
"
respondent"
and
"
as
described
in
section
202
711.40"
for
"
from
EPA
at
the
address
set
forth
in
sec.
710.39"[
secs
710.32(
c)(
1)];
in
sec.
203
711.32(
c)(
3)(
iii)
"
designation
indicating,
for
each
reportable
chemical
substance
at
each
site,
"
204
was
substituted
for
"
statement
for
each
substance
for
which
information
is
being
submitted
205
10
**
Working
Draft
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Not
Cite
or
Quote
­
Not
for
Public
Release
**
indicating"[
sec.
710.32(
c)(
6)];
in
sec.
711.32(
c)(
3)(
iv)
"
reportable"
was
substituted
for
206
"
subject"[
sec.
710.32(
c)(
7)];
in
sec.
711.38(
c)
"
Chemical
identity."
was
added
as
a
section
header
207
to
more
clearly
identify
the
topic
of
the
section
[
sec.
710.38(
c)];
in
sec.
711.38(
c)(
1)(
vi)
208
substituted
"
have
been
taken"
for
"
have
you
taken"
and
"
the"
for
"
this"[
sec.
710.38(
c)(
1)(
vi)];
in
209
sec.
711.38(
c)(
2)
"
listed
in
section
711.38(
c)(
1)"
was
added
for
clarification
purposes,
210
"
submitter"
was
substituted
for
"
person"
and
"
clearly
identify
the
information
that
is
claimed
211
confidential
by
marking
the
specific
information
on
each
page
with
a
label
such
as
`
confidential
212
business
information,'
`
proprietary,'
or
`
trade
secret.'"
was
substituted
for
"
mark
that
information
213
as
`
trade
secret,'
`
confidential,'
or
other
appropriate
designation."
[
sec.
710.38(
c)(
2)];
and
in
sec.
214
711.38(
e)
"
is
indicated
on
the
reporting
form"
was
substituted
for
"
accompanies
information
at
215
the
time
it
is"
and
"
confidentiality
claim
substantiation"
was
substituted
for
"
substantiation"
216
[
sec.
710.38(
d)].
217
EPA
replaced
"
manufactured
or
imported"
with
"
manufactured
(
including
imported)"
to
218
provided
consistency
and
clarification.
EPA
made
this
change
in:
sec.
711.32(
c)(
3)(
iv)
[
sec.
219
710.32(
c)(
7)];
sec.
711.38(
c)(
1)(
v)
[
sec.
710.38(
c)(
1)(
v)];
sec.
711.38(
c)(
1)(
vi)
[
sec.
220
710.38(
c)(
1)(
vi)];
sec.
711.38(
c)(
1)(
vii)
[
sec.
710.38(
c)(
1)(
vii)];
sec.
711.38(
c)(
1)(
viii)
[
sec.
221
710.38(
c)(
1)(
viii)];
sec.
711.38(
c)(
1)(
x)
[
sec.
710.38(
c)(
1)(
x)];
and
sec.
711.28
[
sec.
710.28].
222
EPA
made
certain
changes
in
recognition
of
the
different
numbering
system
and
223
organization
of
part
711:
in
sec.
711.38(
c)(
1)(
i)
"
subpart"
was
substituted
for
"
part"[
sec.
224
710.38(
c)(
1)(
i)];
in
sec.
711.3(
d)
"
definition"
was
substituted
for
"
section"
[
sec.
710.2(
i)];
in
sec.
225
711.3(
d)
"
this
paragraph"
was
substituted
for
"
paragraph
(
aa)(
3)
of
this
section"
[
sec.
226
710.2(
aa)(
3)];
and
in
sec.
711.3(
d)
"
paragraph
(
1)
of
this
definition"
was
substituted
for
227
"
paragraph
(
aa)(
1)
of
this
section"
[
Sec
710.2(
aa)(
3)].
The
last
three
changes
were
made
in
228
11
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Not
Cite
or
Quote
­
Not
for
Public
Release
**
recognition
that
the
definitions
are
no
longer
separated
into
sections,
but
are
contained
within
229
section
(
d).
EPA
also
corrected
references
to
section
numbers
in
accordance
with
the
new
part
230
711
numbering.
For
instance,
in
sec.
711.3(
d)
"
sec.
711.4(
d)(
5)"
was
substituted
for
"
sec.
231
710.4(
d)(
5)"
[
sec.
710.2(
f)].
232
Section
553
of
the
Administrative
Procedure
Act
(
APA),
5
U.
S.
C.
553(
b)(
B),
provides
233
that,
when
an
agency
for
good
cause
finds
that
notice
and
public
procedure
are
impracticable,
234
unnecessary
or
contrary
to
the
public
interest,
the
agency
may
issue
a
final
rule
without
providing
235
notice
and
an
opportunity
for
public
comment.
EPA
has
determined
that
there
is
good
cause
for
236
making
these
minor
regulatory
changes
in
this
final
rule
without
prior
proposal
and
opportunity
237
for
comment
because
the
provisions
affected
were
promulgated
after
notice
and
comment
and
238
these
minor
corrections
are
non­
substantive
and
do
not
affect
the
meaning
or
legal
affect
of
the
239
provisions
affected,
which
remains
the
same
as
it
was
when
the
provision
appeared
in
40
CFR
part
240
710.
Thus,
notice
and
public
procedure
are
unnecessary
for
these
minor
changes
to
the
provisions
241
from
40
CFR
part
710
that
are
incorporated
into
the
new
40
CFR
part
711.
EPA
finds
that
this
242
constitutes
good
cause
under
5
U.
S.
C.
553(
b)(
B).
243
B.
What
is
the
Agency's
Authority
for
Taking
this
Action?
244
EPA
is
required
under
TSCA
section
8(
b),
15
U.
S.
C.
2607(
b),
to
compile
and
keep
245
current
an
inventory
of
chemical
substances
in
commerce.
This
inventory
is
known
as
the
TSCA
246
Chemical
Substances
Inventory
("
the
TSCA
Inventory").
In
1977,
EPA
promulgated
a
rule
(
42
247
FR
64572,
December
23,
1977)
under
TSCA
section
8(
a),
15
U.
S.
C.
2607(
a),
to
compile
an
248
inventory
of
chemical
substances
in
commerce
at
that
time.
In
1986,
EPA
promulgated
the
initial
249
IUR
at
40
CFR
710
(
51
FR
21447,
June
12,
1986),
also
under
TSCA
section
8(
a),
to
facilitate
the
250
12
**
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Not
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or
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­
Not
for
Public
Release
**
periodic
updating
of
the
inventory
and
to
support
activities
associated
with
the
implementation
of
251
TSCA.
252
TSCA
section
8(
a)(
1)
authorizes
the
EPA
Administrator
to
promulgate
rules
under
which
253
manufacturers
and
processors
of
chemical
substances
and
mixtures
(
referred
to
hereafter
as
254
  
chemical
substances'')
must
maintain
such
records
and
submit
such
information
as
the
255
Administrator
may
reasonably
require.
Under
TSCA
section
8(
a),
the
Agency
may
collect
256
information
associated
with
chemical
substances
to
the
extent
that
it
is
known
to,
or
reasonably
257
ascertainable
by
the
submitter.
TSCA
section
8(
a)
gives
EPA
broad
discretion
in
determining
the
258
information
for
which
reporting
can
be
required.
Some
of
the
types
of
information
which
can
be
259
required
under
TSCA
section
8(
a)(
2)
include:
categories
of
use
for
each
chemical
substance,
260
estimates
of
the
amount
manufactured
or
processed
for
each
category
of
use,
a
description
of
the
261
byproducts
resulting
from
the
manufacture,
processing,
use,
or
disposal
of
each
chemical
262
substance,
an
estimate
of
the
number
of
individuals
exposed
in
their
places
of
employment,
and
263
the
duration
of
such
exposure.
264
TSCA
section
8(
a)
generally
excludes
small
manufacturers
and
processors
of
chemical
265
substances
from
the
reporting
requirements
established
in
TSCA
section
8(
a).
However,
EPA
is
266
authorized
by
TSCA
section
8(
a)(
3)
to
require
TSCA
section
8(
a)
reporting
from
small
267
manufacturers
and
processors
with
respect
to
any
chemical
substance
that
is
the
subject
of
a
rule
268
proposed
or
promulgated
under
TSCA
section
4,
5(
b)(
4),
or
6,
or
that
is
the
subject
of
an
order
269
under
TSCA
section
5(
e),
or
that
is
the
subject
of
relief
that
has
been
granted
pursuant
to
a
civil
270
action
under
TSCA
sections
5
or
7.
The
standard
for
determining
whether
an
entity
qualifies
as
a
271
"
small
manufacturer"
for
purposes
of
40
CFR
section
710.29,
and
for
40
CFR
part
710
generally,
272
is
defined
in
40
CFR
704.3.
Processors
are
not
currently
subject
to
the
regulations
at
40
CFR
273
13
**
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or
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for
Public
Release
**
part
710.
274
This
document
amends
40
CFR
part
710,
which
contains
the
Inventory
Update
Reporting
275
regulations.
Failure
to
comply
fully
with
any
provision
of
this
final
rule
will
be
a
violation
of
276
TSCA
section
15
and
will
subject
the
violator
to
the
penalties
of
TSCA
sections
16
and
17.
277
C.
What
is
the
Inventory
Update
Rule
(
IUR)?
278
The
IUR
requires
U.
S.
manufacturers
of
organic
chemicals
to
report
to
EPA
every
4
279
years
the
identity
of
chemical
substances
manufactured
annually
during
the
reporting
year
in
280
quantities
of
10,000
lbs.
or
more
at
each
plant
site
they
own
or
control.
The
current
IUR
excludes
281
several
categories
of
substances
from
its
reporting
requirements,
including
polymers,
inorganic
282
substances,
microorganisms,
and
naturally
occurring
chemical
substances.
Plant
sites
subject
to
283
the
rule
are
currently
required
to
report
information
such
as
company
name,
plant
site
location,
284
plant
site
Dun
and
Bradstreet
number(
s),
identity
of
the
reportable
chemical
substance,
and
285
production
volume
of
each
reportable
chemical
substance.
Data
were
reported
to
EPA
under
the
286
IUR
in
1986,
1990,
1994,
and
1998,
and
a
collection
will
occur
in
2002.
287
The
data
reported
under
IUR
are
used
to
update
the
information
maintained
on
the
TSCA
288
Inventory,
which
is
a
listing
of
chemical
substances
in
commerce.
EPA
uses
the
TSCA
Inventory
289
and
data
reported
under
the
IUR
to
support
many
TSCA­
related
activities
and
to
provide
overall
290
support
for
a
number
of
EPA
and
other
Federal
health,
safety,
and
environmental
protection
291
activities
(
See
Unit
II.
E.
of
this
preamble
for
further
explanation
of
some
of
these
activities).
292
D.
Why
is
EPA
amending
the
IUR?
293
EPA
is
amending
the
IUR
for
three
primary
reasons:
(
1)
to
tailor
the
chemical
substance
294
14
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or
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­
Not
for
Public
Release
**
reporting
requirements
to
more
closely
match
the
Agency's
information
needs;
(
2)
to
obtain
new
295
and
updated
information
relating
to
potential
exposures
to
a
subset
of
chemical
substances
listed
296
on
the
TSCA
Inventory;
and
(
3)
to
improve
the
utility
of
the
information
reported.
EPA
believes
297
that
these
amendments
will
enhance
the
information
collected
through
the
IUR,
improve
the
scope
298
of
chemicals
covered
by
the
rule,
and
improve
specification
of
CBI
requirements,
thereby
299
accomplishing
these
three
goals.
300
These
goals
are
supported
by
the
policy
in
section
2(
b)(
1)
of
TSCA,
that
  
adequate
data
301
should
be
developed
with
respect
to
the
effect
of
chemical
substances
and
mixtures
on
health
and
302
the
environment
and
that
the
development
of
such
data
should
be
the
responsibility
of
those
who
303
manufacture
and
those
who
process
such
chemical
substances
and
mixtures.''
EPA
believes
that
304
the
data
currently
available
to
EPA
are
generally
inadequate
for
risk
screening
purposes.
TSCA
305
section
8(
a)(
2)
authorizes
EPA
to
require
manufacturers
and
processors
of
chemical
substances
to
306
report
a
wide
variety
of
data,
including
exposure­
related
information
which
would
be
reported
for
307
certain
chemical
substances
under
these
amendments
to
the
IUR.
These
amendments
remove
308
certain
reporting
requirements
and
add
others
to
focus
reporting
under
the
IUR
on
that
309
information
which
is
most
needed
by
EPA
and
other
Federal
agencies
for
screening,
assessing,
310
and
managing
risk.
The
availability
of
these
data
will
enhance
public
awareness
of
basic
311
information
about
chemical
substances.
312
Any
evaluation
of
potential
  
risk''
is
generally
based
on
a
combination
of
hazard
313
information
and
exposure
information.
EPA
relies
on
risk
screening
to
indicate
which
chemical
314
substances
pose
a
potential
risk
to
human
health
or
the
environment,
and
thus
warrant
a
more
315
detailed,
resource­
intensive
analysis.
The
EPA
Science
Advisory
Board's
report
  
Reducing
Risk:
316
Setting
Priorities
and
Strategies
for
Environmental
Protection''
(
Ref.
1)
and
the
National
317
15
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
Academy
of
Public
Administration's
report
  
Setting
Priorities,
Getting
Results,
A
New
Direction
318
for
EPA''
(
Ref.
2)
recognize
that
EPA's
ability
to
use
risk
screening
to
set
priorities
and
allocate
319
its
limited
resources
has
been
significantly
impeded
by
a
lack
of
exposure
data.
The
320
manufacturing,
processing,
and
use
of
chemicals
on
the
TSCA
Inventory
result
in
a
wide
array
of
321
exposure
scenarios.
The
exposure­
related
data
included
in
these
IUR
amendments
will
greatly
322
improve
EPA's
ability
to
conduct
risk
screening
to
identify
chemical
substances
that
could
pose
323
an
unreasonable
risk
to
human
health
or
to
the
environment,
or
that
otherwise
warrant
further
324
investigation.
325
E.
What
are
EPA's
TSCA­
Related
Chemical
Screening
and
Assessment
Activities?
326
TSCA
authorizes
EPA
to
gather
chemical
hazard
and
exposure
data,
as
well
as
related
327
information
such
as
production
volume,
to
determine
whether
a
chemical
may
pose
an
328
unreasonable
risk
of
injury
to
human
health
or
the
environment.
The
Agency
is
able
to
institute
329
risk
management
actions
when
necessary
to
mitigate
or
avoid
unreasonable
risk.
Important
330
elements
in
a
successful
chemical
risk
management
program
include
identifying
the
chemical
331
substances,
manufacturing
sites,
and
exposure
scenarios
of
greatest
potential
concern,
and
using
332
that
information
to
set
priorities
for
more
detailed
risk
assessment,
further
research,
advisory
333
notices,
or
other
appropriate
actions.
To
help
fulfill
its
TSCA
responsibilities,
EPA
has
334
established
the
IUR
and
other
regulations
to
collect
information
on
commercial
chemicals.
335
The
TSCA
Inventory
currently
includes
more
than
76,000
chemical
substances.
336
Approximately
8,900
of
these
chemical
substances
are
non­
polymer,
organic
chemical
substances
337
manufactured
in
quantities
of
10,000
lbs.
or
more
per
year,
as
reported
under
the
1998
IUR
data
338
collection.
EPA
estimates
that
the
amended
IUR
will
continue
to
collect
information
on
339
16
**
Working
Draft
­
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Not
Cite
or
Quote
­
Not
for
Public
Release
**
approximately
8,900
chemical
substances.
However,
the
set
of
substances
that
will
be
reported
340
under
the
amended
IUR
will
be
somewhat
different
than
the
set
of
substances
that
was
reported
341
under
the
previous
IUR
collections
primarily
because
of
two
changes:
raising
the
basic
reporting
342
threshold
(
see
Unit
II.
F.
2.
of
this
preamble)
and
adding
reporting
on
the
manufacture
of
inorganic
343
chemical
substances
(
see
Unit
II.
F.
1.
a.
of
this
preamble).
Data
collected
under
the
amended
IUR
344
will
enable
EPA
to
more
effectively
conduct
initial
risk
screening
on
a
subset
of
the
chemical
345
substances
within
its
purview,
as
described
in
the
remaining
part
of
this
section
and
in
Unit
346
III.
A.
1.
of
this
preamble.
347
EPA
conducted
tiered
risk
evaluations
of
chemical
substances
even
prior
to
the
enactment
348
of
TSCA
in
1976.
A
tiered
approach
allows
EPA
to
sort
through
many
chemicals,
focus
on
349
those
of
greatest
concern,
and
take
appropriate
actions.
The
Agency
is
thus
able
to
optimize
350
resources
while
limiting
overall
regulatory
burdens.
The
essential
steps
of
the
tiered
risk
351
evaluation
include:
an
initial
evaluation
(
sometimes
preceded
by
a
prescreen
of
candidate
352
chemicals);
basic
risk
management
decisions
resulting
from
the
initial
screening;
more
detailed
risk
353
assessment
when
appropriate;
and
resulting
risk
management
actions,
such
as
regulatory
or
354
voluntary
efforts
to
reduce
risk.
Each
of
these
steps
is
only
as
effective
as
the
available
data
355
inputs­­
if
little
data
exist
to
inform
the
process,
each
step
suffers
as
a
result.
356
Exposure­
related
information
collected
through
the
IURA
will
inform
the
initial
risk
357
screening
step.
Initial
risk
screening
is
conducted
using
readily
accessible
information
from
the
358
scientific
literature,
as
well
as
other
data
readily
available
to
the
Agency,
such
as
those
provided
359
by
manufacturers
and
processors.
This
information
set
often
is
incomplete
or
of
insufficient
360
quality
to
allow
the
Agency
to
reach
definitive
conclusions
about
the
set
of
chemicals
under
361
review,
but
may
be
sufficient
to
decide
which
chemicals
appear
to
warrant
further
evaluation,
or
362
17
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
conversely,
appear
to
be
low
priority
and
therefore
do
not
currently
warrant
further
review.
These
363
initial
reviews
are
often
more
qualitative
than
quantitative.
Also,
continual
updates
to
these
data,
364
such
as
the
recurring
reporting
of
exposure­
related
data
under
these
IURA,
will
ensure
that
the
365
most
serious
concerns
will
be
addressed
even
as
chemical
quantities
and
exposure
potentials
366
change
between
submission
periods.
367
The
effectiveness
of
risk
screening,
risk
assessment,
and
risk
management
are
dependent
368
upon
the
quality
as
well
as
the
availability
of
both
hazard
and
exposure
information.
While
past
369
approaches
to
priority
setting
have
emphasized
relative
chemical
hazards
and
used
production
370
volume
as
a
simple
surrogate
for
exposure,
EPA
must
increase
its
emphasis
on
the
exposure
371
component
of
risk
screening
and
assessment.
EPA
no
longer
believes
that
reporting
under
the
372
current
IUR
is
adequate
for
these
purposes.
The
IURA
will
provide
EPA
with
data
that
will
more
373
accurately
and
realistically
gauge
potential
exposures.
The
exposure­
related
information
reported
374
under
the
IURA
will
be
used
in
combination
with
hazard
information
developed
under
TSCA
375
section
4
test
rules
and
enforceable
consent
agreements/
orders,
through
voluntary
efforts
such
as
376
the
High
Production
Volume(
HPV)
Challenge
Program
(
see
www.
epa.
gov/
opptintr/
chemrtk/),
377
and
other
sources.
These
more
current
and
complete
data
from
the
IURA
will
allow
the
Agency
378
and
others
to
screen
and
prioritize
chemicals
based
on
potential
risk
more
effectively
than
it
is
379
currently
able
to
do.
380
Although
the
inherent
hazard
associated
with
a
chemical
substance
will
often
remain
the
381
same
over
time,
exposure
to
workers
and
affected
populations
can
change
significantly.
If
the
382
amount
of
a
chemical
substance
produced
increases
significantly,
releases
to
the
environment
and
383
human
exposures
would
also
be
expected
to
increase.
Conversely,
if
the
amount
produced
384
remains
constant,
environmental
releases
and
human
exposures
may
decline
as
engineering
385
18
**
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Draft
­
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Not
Cite
or
Quote
­
Not
for
Public
Release
**
controls
are
added
and
pollution
prevention
practices
are
implemented.
Although
the
hazard
386
associated
with
a
chemical
generally
remains
constant,
the
risk
associated
with
the
manufacturing,
387
processing,
and
use
of
a
chemical
substance
will
change
as
exposure
increases
or
changes.
The
388
Agency
needs
to
be
able
to
identify
changes
in
exposures
as
well
as
specific
exposure
scenarios,
389
making
it
important
to
collect
exposure
data
on
a
regular
basis.
Chemicals
that
present
low
390
hazard
may
still
pose
a
risk
if
they
are
produced
in
significant
amounts
and
have
high
exposure
391
potential,
are
released
into
the
environment
at
high
volumes
and/
or
concentrations,
or
involve
392
exposures
to
particularly
sensitive
subpopulations.
393
A
voluntary
effort
called
the
Use
and
Exposure
Information
Project
(
UEIP)
demonstrated
394
that
useful
screening­
level
exposure
information
is
available
to
and
can
be
reported
by
industry.
395
The
UEIP
was
a
cooperative
effort
begun
in
the
fall
of
1992
between
government
and
industry
in
396
recognition
of
the
difficulties
encountered
in
obtaining
accurate
and
up­
to­
date
exposure
397
information
on
TSCA
chemicals.
Participants
included
EPA,
the
Chemical
Manufacturers
398
Association
(
CMA)
(
now
the
American
Chemistry
Council,
or
ACC),
the
Chemical
Specialty
399
Manufacturers
Association
(
CSMA),
the
Synthetic
Organic
Chemical
Manufacturers
Association
400
(
SOCMA),
and
the
American
Petroleum
Institute
(
API)
(
Ref.
3).
Data
collected
by
EPA
under
401
the
UEIP
were
similar
to
those
required
under
the
IURA,
and
included
the
following:
production
402
volume,
site
location,
percentage
of
production
volume
for
a
given
use,
environmental
releases,
403
number
of
workers,
worker
activities,
monitoring
data,
and
industrial
and
consumer
uses.
EPA's
404
experience
with
UEIP
has
shown
that
the
types
of
data
requested
by
the
UEIP
are
available
from
405
industry
and
can
be
used
to
prepare
screening
level
exposure
assessments.
406
The
UEIP,
however,
provided
one­
time
reporting
of
information
by
a
subset
of
the
407
manufacturers
of
a
small
number
of
selected
high
production
volume
(
HPV)
chemicals.
Given
408
19
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
these
efforts,
the
limitations
of
the
data
available
from
past
and
current
information
collections
409
that
are
described
in
detail
in
the
proposal
for
these
amendments
(
64
FR
46772,
August
26,1999),
410
and
the
amount
of
time
it
would
otherwise
take
to
acquire
screening­
level
exposure
data
for
the
411
chemical
substances
on
the
Inventory,
it
is
appropriate
to
develop
a
more
systematic
and
broadly
412
applied
approach
to
the
prioritization
process.
The
Agency
is
doing
this
by
requiring
that
new,
413
key,
additional
exposure­
related
information
be
reported
under
this
amended
rule
instead
of
414
collecting
the
information
through
a
one­
time
voluntary
program.
415
F.
What
Are
the
Requirements
of
the
Amended
IUR?
416
The
revised
reporting
form,
Form
U,
reflects
the
requirements
of
the
final
rule
and
is
417
included
in
this
unit
to
help
explain
the
reporting
requirements,
as
amended.
The
regulatory
text
418
describes
the
specific
reporting
requirements.
EPA
is
also
developing
an
electronic
version
of
419
Form
U,
which
may
look
different
from
the
Form
U
below.
Additionally,
the
Agency
may
change
420
the
format
of
Form
U
in
future
reporting
years;
should
the
format
of
Form
U
change,
EPA
will
421
make
the
revised
Form
U
available
to
submitters.
Submitters
should
note
that
the
information
in
422
sections
710.32(
c)(
1)
and
(
2)
of
the
new
regulatory
text
(
Part
I
of
Form
U)
and
the
CBI
423
reassertion
information
(
Part
IV
of
Form
U)
need
only
be
reported
once
per
reporting
cycle
per
424
submitter,
while
the
information
in
sections
710.32(
c)(
3)
and
(
4)
of
the
new
regulatory
text
(
Parts
425
II
and
III
of
Form
U,
respectively)
will
be
reported
for
each
reportable
chemical.
426
20
**
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­
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Not
Cite
or
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­
Not
for
Public
Release
**
Form
U
page
1
427
21
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
Form
U
page
2
428
22
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
Form
U
page
3
429
23
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
1.
What
are
the
changes
to
the
chemical
substances
covered
by
IUR?
a.
Inorganic
430
Chemical
Substances.
EPA
is
requiring
partial
reporting
for
inorganic
chemical
substances
for
431
reporting
year
2005
information
submitted
to
EPA
during
the
2006
submission
period,
and
full
432
reporting
for
inorganic
chemical
substances
in
subsequent
submission
periods
(
see
the
amended
433
regulatory
text
at
section
710.26(
a)).
Partial
reporting
means
that
the
submitter
must
report
the
434
information
described
in
sections
710.32(
c)(
1),
(
2),
and
(
3),
as
well
as
sections
710.38
and
710.39
435
of
the
amended
regulatory
text,
as
applicable
(
i.
e.,
Parts
I,
II,
and
IV
of
revised
reporting
Form
436
U.).
Full
reporting
means
that
the
submitter
must
additionally
report
the
information
described
in
437
section
710.32(
c)(
4)
of
the
amended
regulatory
text
(
i.
e.,
all
parts
of
revised
reporting
Form
U).
438
EPA
intends
to
screen
potential
risks
associated
with
inorganic
chemical
substances
to
set
439
priorities
for
testing,
more
detailed
risk
assessment
and
potential
risk
management.
The
phasing­
in
440
of
inorganic
chemical
reporting
provides
manufacturers
of
these
chemicals
with
the
opportunity
to
441
familiarize
themselves
with
IUR
reporting
while
providing
EPA
and
others
with
needed
basic
442
manufacturing
information
on
inorganic
chemicals.
Future
full
reporting
of
exposure­
related
443
information
will
provide
EPA
and
others
with
needed
additional
information
for
those
inorganic
444
chemicals
with
production
volumes
of
300,000
lbs.
or
more
at
a
site.
See
Unit
III.
A.
1.
for
a
445
discussion
of
the
importance
of
this
exposure­
related
information
to
EPA
and
others
for
both
446
organic
and
inorganic
chemicals.
Unit
III.
C.
1.
a.
contains
a
discussion
specific
to
inorganic
447
chemicals.
The
basic
impetus
for
collecting
information
on
organic
chemicals
also
holds
for
448
inorganic
chemicals.
449
b.
Petroleum
process
streams.
EPA
is
exempting
certain
chemical
substances,
termed
450
  
petroleum
process
streams''
for
purposes
of
IURA,
from
reporting
the
exposure­
related
data
451
contained
in
the
regulatory
text
at
710.32(
c)(
4)
(
Part
III
of
Revised
Form
U).
For
purposes
of
452
24
**
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Draft
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Not
Cite
or
Quote
­
Not
for
Public
Release
**
this
rule,
the
petroleum
process
streams
included
in
the
exemption
are
the
multi­
component
453
complex
chemical
substances
listed
by
Chemical
Abstracts
Service
(
CAS)
Registry
Number
in
the
454
new
regulatory
text
at
Sec.
710.26(
d).
Chemical
substances
listed
as
petroleum
process
streams
in
455
the
new
regulatory
text
were
derived
from
the
1983
publication
of
the
API
entitled
  
Petroleum
456
Process
Stream
Terms
Included
in
the
Chemical
Substances
Inventory
Under
the
Toxic
457
Substances
Control
Act
(
TSCA)''
(
Ref.
4).
Chemical
substances
listed
in
the
API
document
458
consisting
of
a
single
component
chemical,
except
for
water,
will
not
be
considered
petroleum
459
process
streams
for
IURA
reporting
purposes.
Water
(
CAS
number
7732­
18­
5)
is
partially
460
exempt
from
IURA
reporting
under
the
petroleum
process
stream
exemption.
461
The
basis
for
this
exemption
is
not
because
these
streams
are
of
known
low
toxicity.
EPA
462
believes
that
petroleum
process
streams
are
often
toxicologically
active.
However,
nearly
all
463
petroleum
process
streams
are
processed
at
the
site
where
they
are
produced
in
vessels
which
are
464
closed
to
minimize
losses
and,
coincidentally,
the
potential
for
exposure.
The
processing
of
these
465
petroleum
streams
is
accomplished
by
remotely­
controlled,
electro­
mechanical
systems
which
466
minimize
contact
with
workers
involved
in
refining
the
petroleum
process
streams.
The
467
flammable
nature
of
these
products
requires
that
they
also
be
transported,
processed,
and
stored
468
in
closed
containers.
For
these
reasons,
EPA
believes
worker
exposure
to
petroleum
process
469
streams
is
minimal.
EPA
will
take
action
to
revoke
this
exemption
if
circumstances
warrant.
470
In
the
final
rule,
EPA
is
making
selected
changes
to
the
partial
exemption
list
of
petroleum
471
process
stream
chemicals
published
in
the
proposed
rule.
Certain
chemicals
are
being
added
to
472
the
list
because
they
were
inadvertently
left
off
the
proposed
list
covered
by
the
exemption.
473
These
multi­
component
chemicals,
all
of
which
are
listed
in
the
1983
API
publication
entitled
474
"
Petroleum
Process
Stream
Terms
Included
in
the
Chemical
Substances
Inventory
Under
the
475
25
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
Toxic
Substances
Control
Act
(
TSCA)"
(
Ref.
4),
include
the
following
chemical
substances
(
CAS
476
numbers):
8052­
41­
3,
64742­
21­
8,
64742­
26­
3,
64742­
94­
5,
68476­
32­
4,
68515­
29­
7,
68783­
477
12­
0,
68918­
98­
9,
68919­
15­
3,
68953­
80­
0,
and
70693­
06­
0.
478
In
the
final
rule,
EPA
is
also
removing
a
number
of
chemicals
from
the
petroleum
process
479
stream
partial
exemption
list
published
in
the
proposed
rule.
These
chemicals
fall
into
three
480
groups:
(
1)
Certain
chemicals
that
are
already
part
of
the
broader
natural
gas
or
polymer
481
exemptions.
Those
already
exempted
under
the
natural
gas
exemption
are:
8006­
14­
2,
8006­
61­
482
9,
64741­
48­
6,
68410­
63­
9,
68425­
31­
0,
and
68919­
39­
1.
Additionally,
an
incorrect
CAS
483
registry
number
68425­
31­
1
was
corrected
to
read
68425­
31­
0,
which,
again,
has
been
removed
484
from
the
partial
exemption
because
it
is
already
fully
exempt
from
IUR
reporting
under
the
natural
485
gas
exemption.
Chemicals
removed
because
they
are
already
fully
exempt
under
the
polymer
486
exemption
are:
64741­
71­
5,
64741­
72­
6,
67891­
77­
4,
67891­
78­
5,
68131­
77­
1,
68131­
79­
3,
487
68131­
80­
6,
68131­
81­
7,
68131­
83­
9,
68131­
99­
7,
68132­
00­
3,
68410­
01­
5,
68410­
10­
6,
488
68410­
13­
9,
68410­
14­
0,
68410­
16­
2,
68410­
59­
3,
68425­
27­
4,
68425­
28­
5,
68476­
87­
9,
489
68477­
37­
2,
68477­
43­
0,
68477­
45­
2,
68477­
46­
3,
68477­
50­
9,
68477­
51­
0,
68477­
52­
1,
490
68478­
07­
9,
68478­
09­
1,
68527­
24­
2,
68527­
25­
3,
68783­
10­
8,
68783­
11­
9,
and
68955­
30­
6.
491
(
2)
Single
component
chemicals,
except
for
water,
should
not
have
been
included
in
the
petroleum
492
process
streams
partial
exemption.
As
stated
in
the
proposed
rule,
the
exemption
was
intended
493
to
include
only
certain
multi­
component
chemicals
derived
from
the
1983
API
publication.
As
a
494
result,
the
following
single­
component
chemicals
have
been
removed
from
the
petroleum
process
495
streams
partial
exemption
list
as
proposed:
8007­
45­
2
and
10024­
97­
2.
(
3)
Certain
chemicals
that
496
are
not
included
on
the
TSCA
Inventory
and
therefore
are
not
currently
reportable
under
IUR
497
have
also
been
removed
from
the
exemption
list:
64741­
93­
1,
64741­
94­
2,
64742­
00­
3,
64742­
498
26
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
02­
5,
64742­
17­
2,
64742­
66­
1,
64742­
74­
1,
64742­
84­
3,
and
64754­
96­
7.
499
In
this
final
rule,
EPA
is
also
making
some
additional
corrections
to
the
petroleum
500
process
streams
partial
exemption
list
published
in
the
proposed
rule.
(
1)
Incorrect
CAS
numbers
501
for
certain
chemicals
were
provided
in
the
proposed
rule.
These
CAS
numbers
were
incorrect
502
because
of
typographical
errors
in
the
proposed
rule.
The
correct
CAS
numbers
are
as
follows:
503
8006­
20­
0,
64742­
18­
3,
64742­
20­
7,
68187­
60­
0,
68459­
78­
9,
68513­
14­
4,
68513­
19­
9,
and
504
68514­
38­
5.
Two
additional
incorrect
CAS
numbers
were
provided
in
the
proposed
rule,
i.
e.
505
64742­
36­
2
and
68741­
41­
9.
The
corrected
CAS
numbers
for
these
chemicals,
i.
e.
64742­
36­
5
506
and
64741­
41­
9
respectively,
were
also
provided
in
the
proposed
rule.
(
2)
Several
duplicate
CAS
507
numbers
that
were
included
in
the
proposed
rule
have
been
removed.
(
3)
CAS
numbers
for
508
certain
chemicals
have
been
superceded
by
new
CAS
numbers.
The
new
CAS
numbers
are
as
509
follows
(
superceded
CAS
numbers
are
in
parenthesis):
68187­
58­
6(
68334­
31­
6),
68410­
13­
510
9(
68477­
56­
5),
68308­
08­
7(
68478­
21­
7),
68334­
30­
5(
68512­
90­
3),
68918­
99­
0(
68513­
26­
8),
511
64742­
83­
2(
6851­
30­
7),
68988­
79­
4(
68515­
31­
1),
64742­
93­
4(
68516­
21­
2),
68606­
10­
512
0(
68606­
35­
9),
and
64742­
93­
4(
68650­
78­
2).
513
c.
Natural
gas.
EPA
is
exempting
certain
forms
of
natural
gas
from
IUR
reporting.
These
514
substances
are
listed
in
the
new
regulatory
text
at
section
710.26(
f).
EPA
believes
that,
to
date,
515
adequate
IUR
information
has
been
collected
on
these
chemical
substances
to
fulfill
EPA's
and
516
other
IUR
information
users'
current
needs.
,
EPA
will
take
action
to
revoke
this
exemption
if
517
circumstances
warrant
in
the
future.
518
d.
Polymers.
As
a
result
of
recent
inquiries
regarding
the
exclusion
of
polymers
from
519
IUR
reporting,
EPA
is
clarifying
this
existing
exemption.
The
exemption
does
not
apply
to
a
520
polymeric
substance
that
has
been
hydrolyzed,
depolymerized,
or
otherwise
chemically
modified,
521
27
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
except
in
cases
where
the
intended
product
of
this
reaction
is
totally
polymeric
in
structure.
The
522
Agency's
intent
under
the
exemption
at
40
CFR
section
710.26(
b)
has
always
been
that
the
523
products
of
such
reactions
carried
out
on
polymeric
materials
are
excluded
from
IUR
reporting
524
only
if
they
are
intended
to
have
a
totally
polymeric
composition.
There
is
no
change
in
the
IUR
525
status
of
polymeric
materials
that
have
not
undergone
such
reactions
and
are
identified
with
the
526
"
XU"
flag
in
the
Inventory.
527
e.
Microorganisms.
EPA
is
clarifying
this
existing
definition
to
ensure
that
the
definition
528
used
for
IURA
purposes
is
consistent
with
the
microorganisms
rule
at
40
CFR
part
725
and
to
529
clarify
the
status
of
chemicals
produced
from
living
microorganisms.
530
2.
How
have
the
reporting
thresholds
changed?
EPA
is
raising
the
basic
IUR
reporting
531
threshold
from
a
production
volume
of
10,000
lbs.
per
year
per
site
to
25,000
lbs.
per
year
per
532
site.
Every
person
manufacturing
a
non­
excluded
chemical
substance
at
or
above
the
threshold
533
will
be
required
to
report
the
information
in
Parts
I,
II,
and
IV
of
Revised
Reporting
Form
U
(
see
534
the
regulatory
text
at
sections
710.32(
c)(
1),
(
2),
and
(
3),
710.38,
and
710.39).
The
increased
535
IUR
reporting
threshold
makes
the
IUR
and
Toxics
Release
Inventory
(
TRI)
reporting
thresholds
536
equivalent
for
manufacturers.
These
thresholds
also
approximate
the
current
TSCA
section
5
537
premanufacture
notification
(
PMN)
low
volume
exemption
threshold
of
10,000
kg
(
approximately
538
22,000
lbs.).
EPA
is
raising
the
basic
IUR
reporting
threshold
in
order
to
reduce
the
number
of
539
reports
filed,
thus
reducing
the
overall
industry
burden
associated
with
this
regulation.
The
new
540
reporting
threshold
does
not
represent
a
finding
of
low
exposure
or
low
risk.
541
EPA
is
also
instituting
a
second,
higher
production
volume
threshold
of
300,000
lbs.
per
542
year
per
site.
Persons
who
manufacture
a
non­
excluded
substance
at
or
above
this
level
will
be
543
required
to
report
the
information
in
Part
III
of
Revised
Reporting
Form
U
(
see
the
regulatory
544
28
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
text
at
section
710.32(
c)(
4))
in
addition
to
the
information
in
Parts
I,
II,
and
IV.
The
information
545
reported
on
Part
III
of
the
form
relates
to
the
processing
and
use
of
chemical
substances.
EPA
is
546
instituting
this
separate
threshold
to
limit
processing
and
use
data
reporting
to
a
subset
of
a
few
547
thousand
IUR
reportable
chemicals
out
of
the
approximately
76,000
chemicals
listed
on
the
548
TSCA
Inventory.
549
Information
concerning
lower
production
volume
chemical
substances
is
valuable,
550
especially
for
identifying
trends
and
additional
substitute
chemicals.
However,
wherever
possible,
551
the
Agency
has
attempted
to
limit
the
reporting
burden.
In
the
future,
EPA
may
find
it
necessary
552
to
collect
information
on
chemicals
at
reporting
thresholds
below
the
thresholds
introduced
in
this
553
action.
Although
both
the
25,000
lbs.
and
300,000
lbs.
thresholds
are
significantly
higher
than
the
554
current
IUR
10,000
lbs.
threshold,
the
enhanced
information
will
be
gathered
under
the
amended
555
rule
will
enable
the
Agency
and
others
to
more
efficiently
identify
those
chemical
substances
556
warranting
further,
more
in­
depth
review,
as
well
as
chemicals
of
lesser
concern
(
see
Ref.
5).
557
3.
Have
the
reporting
year,
the
submission
period,
or
the
reporting
frequency
changed?
558
EPA
is
changing
the
IUR
reporting
year
to
a
calendar
year
basis
from
a
corporate
fiscal
559
year
basis.
This
change
standardizes
reporting
time
frames
across
IUR
submitters
and
across
560
various
other
reporting
programs,
such
as
the
TRI
program.
561
Under
the
current
IUR
regulations
at
40
CFR
710.33(
b),
submitters
are
required
to
report
562
on
a
recurring
basis
between
August
25
and
December
23
(  
the
submission
period'')
every
4
563
years.
In
a
separate
action
following
this
final
rule,
EPA
intends
to
propose
changing
the
564
submission
period
from
August
25
through
December
23
to
April
1
through
July
31.
This
565
potential
change
is
related
in
part
to
the
change
in
this
final
rule
from
fiscal
year
to
calendar
year
566
29
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
for
the
development
of
the
data
reported
during
the
submission
period.
The
August
25
date
was
567
originally
used
as
a
result
of
the
fact
that
many
companies'
fiscal
years
end
in
July,
and
starting
568
the
IUR
submission
period
in
late
August
allowed
these
companies
to
report
their
most
current
569
information.
Companies
will
now
report
on
a
calendar
year
basis,
making
an
earlier
submission
570
period
more
appropriate.
EPA
may
propose
to
change
the
beginning
of
the
submission
period
to
571
April
1:
(
1)
to
allow
the
Agency
to
obtain
the
information
early
in
the
year,
thereby
increasing
the
572
timeliness
of
the
data
by
allowing
the
Agency
to
process
the
data
more
closely
in
time
to
their
573
generation
and
(
2)
to
allow
sites
to
submit
their
information
closer
to
the
period
during
which
it
574
was
generated.
The
Agency
does
not
intend
to
choose
a
date
earlier
in
the
year
than
April
1
in
575
order
to
give
sites
time
to
generate
tax
reports,
and
therefore
allow
the
possible
use
of
576
information
from
those
reports
for
IUR
reporting.
577
EPA
has
not
changed
the
reporting
frequency
(
every
four
years),
although
EPA
did
578
consider
alternative
reporting
frequencies
(
see
the
"
Revised
Economic
Analysis
for
the
Amended
579
Inventory
Update
Rule,"
Ref.
6.).
This
means,
for
example,
that
the
information
reported
under
580
the
IURA
during
the
first
submission
period
(
i.
e.
from
August
25
to
December
23
or,
as
may
be
581
proposed,
April
1
to
July
31,
in
the
year
2006)
would
be
from
calendar
year
2005.
Subsequent
582
submission
periods
will
occur
every
four
years.
Guidance
can
be
found
in
"
Guidance
Document:
583
2006
Reporting
for
Updating
the
Chemical
Substances
Inventory
Database
Under
the
Toxic
584
Substances
Control
Act
(
TSCA)."
EPA
had
proposed
an
effective
date
for
these
amendments
585
which
would
have
required
reporting
calendar
year
2001
data
in
2002.
Since
the
final
rule
is
586
being
promulgated
in
2002,
the
effective
date
has
been
changed
to
require
reporting
of
calendar
587
year
2005
data
in
2006.
588
In
a
separate
action
following
this
final
rule,
EPA
intends
to
propose
changing
the
initial
589
30
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
reporting
year
from
2006
(
reporting
calendar
year
2005
data)
to
2004
(
reporting
calendar
year
590
2003
data).
The
four­
year
cycle
would
continue
from
that
date,
with
the
next
reporting
occurring
591
in
2008
(
reporting
calendar
year
2007
data).
EPA
may
propose
to
change
the
initial
reporting
592
year
to
2004:
(
1)
to
allow
the
Agency
to
obtain
needed
exposure
based
information
for
the
HPV
593
Challenge
program
and
(
2)
to
allow
the
Agency
to
meet
its
GPRA
requirements
to
screen
all
594
chemicals
by
2005.
595
4.
How
have
the
recordkeeping
requirements
changed?
596
EPA
is
requiring
that
persons
subject
to
reporting
under
the
amended
IUR
retain
records
597
that
document
any
information
reported
to
EPA
under
the
IURA
for
a
period
of
5
years
beginning
598
with
the
effective
date
of
that
submission
period
(
see
section
710.37
of
the
regulatory
text).
The
599
effective
date
of
the
submission
period
is
the
last
day
of
the
submission
period
(
currently
600
December
23,
although
EPA
intends
to
propose
to
change
this
to
July
1,
see
Unit
II.
F.
3.)
in
a
year
601
in
which
data
must
be
reported
under
IURA.
Previously,
submitters
were
required
to
retain
602
records
for
4
years.
Under
the
IURA,
if
a
person
submits
a
report
in
the
year
2006,
that
person
603
will
retain
the
records
on
which
the
report
is
based
until
December
23,
2011.
This
change
ensures
604
that
the
submitter
will
have
the
previous
submission
available
when
determining
future
reporting.
605
The
change
will
also
aid
in
EPA's
enforcement
of
the
IUR
by
requiring
that
submitters
maintain
606
records
that
span
successive
submission
periods,
which
will
continue
to
occur
every
4
years
as
607
under
the
existing
IUR.
608
Persons
who
are
not
required
to
report
under
the
existing
IUR
because
they
manufacture
609
less
than
the
10,000
lb.
reporting
threshold
have
been
required
to
retain
volume
records
as
610
evidence
to
support
decisions
not
to
submit
a
report.
In
this
rulemaking,
EPA
is
eliminating
this
611
provision
because
EPA
believes
that
this
type
of
information
is
routinely
retained
by
companies
in
612
31
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
the
normal
course
of
business.
613
5.
How
have
the
data
elements
reported
by
all
submitters
changed?
614
The
new
and
revised
data
elements
to
be
reported
under
the
amended
rule
are
discussed
in
615
this
section.
Data
elements
that
are
currently
reported
under
IUR
but
that
are
not
revised
by
these
616
amendments
are
not
generally
discussed.
617
a.
Technical
contact
identification
(
Section
710.32(
c)(
2)(
i)
of
the
regulatory
text;
Part
I,
618
Section
II
of
Revised
Reporting
Form
U
).
In
addition
to
the
name
of
a
person
who
will
serve
as
619
technical
contact
for
the
submitter
company,
the
parent
company
name,
the
contact
person's
full
620
mailing
address,
and
the
contact
person's
telephone
number,
submitters
must
report
the
contact
621
person's
e­
mail
address
and
the
parent
company
Dun
and
Bradstreet
Number.
The
technical
622
contact
person
must
be
able
to
answer
questions
about
the
IUR
and
IURA
information
submitted
623
by
the
company
to
EPA.
624
b.
Plant
site
identification
(
Section
710.32(
c)(
2)(
ii)
of
the
regulatory
text;
Part
I,
Section
625
III
of
Revised
Reporting
Form
U).
Submitters
must
report
the
plant
site
county
or
parish
in
626
addition
to
the
information
currently
required
for
each
plant
site
that
is
subject
to
reporting
.
627
EPA
had
additionally
proposed
to
require
submitters
to
report
a
plant
site
identification
628
number
in
order
to
clearly
identify
the
reporting
site
in
a
way
that
would
allow
the
cross­
linking
of
629
IUR
information
with
information
reported
about
the
same
plant
site
contained
in
other
databases.
630
EPA
had
proposed
requiring
the
reporting
of
a
newly
assigned
Facility
Registration
Identifier
631
(
FRI),
or,
if
the
Facility
Registry
System
was
not
yet
in
place,
the
submitter
would
report
the
632
site's
RCRA
number,
if
one
had
been
assigned
to
the
site.
In
this
final
rule,
EPA
has
decided
not
633
to
require
the
submission
of
a
site
identification
number
in
addition
to
the
Dun
and
Bradstreet
634
32
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
number
that
submitters
must
continue
to
report.
The
Agency
may
instead
make
number
635
assignments
either
directly
on
the
reporting
form
after
it
is
returned
to
EPA,
or
prior
to
mailing
636
out
the
form
to
a
submitter.
Submitters
will
not
be
responsible
for
obtaining
or
reporting
this
637
number.
638
c.
Chemical
identification
(
Section
710.32(
c)(
3)(
i)
of
the
regulatory
text;
Part
II,
Section
639
I
of
Revised
Reporting
Form
U).
Submitters
must
indicate
which
type
of
chemical
identifying
640
number
they
are
reporting,
in
addition
to
the
number
itself.
EPA
no
longer
allows
the
use
of
641
certain
of
the
previously
used
substitute
identifying
numbers
(
such
as
EPA­
assigned
numbers
for
642
Test
Market
Exemption
Applications,
original
Inventory
form
numbers,
and
Notices
of
Bona
Fide
643
Intent
to
Manufacture)
because
they
are
difficult
to
cross­
reference
to
CAS
Registry
Numbers.
644
Submitters
may
report
a
CAS
registry
number,
an
EPA­
designated
accession
number
for
645
confidential
substances,
or
a
PMN
case
number.
646
d.
Confidentiality
of
production
volume
range
(
Section
710.32(
c)(
3)(
v)
of
the
regulatory
647
text;
Part
II,
Section
II
of
revised
reporting
Form
U).
Submitters
must
continue
to
report
the
648
specific
production
volume
of
the
reportable
chemical
and
may
claim
CBI
protection
for
that
649
production
volume.
Additionally,
submitters
may
claim
as
CBI
a
pre­
determined
production
650
volume
range
corresponding
to
the
reported
production
volume
number.
This
claim,
if
needed,
651
would
be
separate
from
a
CBI
claim
for
the
specific
production
volume.
652
Submitters
of
CBI
production
volume
data
may
allow
the
release
of
more
general
range
653
information.
EPA
expects
that
roughly
50%
of
submitters
of
CBI
production
volume
data
will
654
allow
the
public
release
of
volume
ranges.
This
expectation
of
reduced
CBI
claims
is
based
on
the
655
CBI
claim
statistics
associated
with
the
development
of
the
original
TSCA
Inventory
(
See
656
"
Inventory
Update
Rule
(
IUR)
Technical
Support
Document:
Evaluation
of
Likelihood
of
657
33
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
Confidential
Business
Information
Claims
for
Production
Volume
Information"
(
Ref.
7))
as
well
658
as
comments
received
from
industry
concerning
potential
TSCA
CBI
reforms
(
Ref.
8).
The
range
659
option
will
allow
the
public
greater
access
to
data
on
chemical
production
volumes,
and
the
660
Agency
will
be
better
equipped
to
publicly
release
more
aggregate
production
volume
data
661
relevant
to
its
risk
screening
decisions.
662
The
production
volume
ranges
in
the
final
rule
are
25,000
to
300,000
lbs.;
300,000
to
663
1,000,000
lbs.;
1,000,000
to
10,000,000
lbs.;
10,000,000
to
50,000,000
lbs.;
50,000,000
to
664
100,000,000
lbs.;
100,000,000
to
500,000,000
lbs.;
500,000,000
to
1,000,000,000
lbs.;
and
665
greater
than
1,000,000,000
lbs.
These
ranges
are
similar
to
those
first
used
in
the
development
of
666
the
original
TSCA
Inventory,
except
for
two
changes.
First,
the
lowest
range
starts
at
the
667
amended
IUR
reporting
threshold
of
25,000
lbs.
rather
than
the
10,000
lb.
threshold
that
was
used
668
in
the
original
IUR.
Second,
the
upper
end
of
the
first
range
and
the
lower
end
of
the
second
669
range
was
raised
to
300,000
lbs.
from
the
100,000
lbs.
range
limit
included
in
the
proposal,
670
resulting
in
ranges
of
25,000
­
300,000
lbs.
and
300,000
­
1,000,000
lbs.
The
second
change
671
makes
the
ranges
consistent
with
the
second
reporting
threshold
of
300,000
lbs.
or
more
(
see
672
section
710.32(
c)(
4)
of
the
regulatory
text),
and
provides
additional
protection
for
submitters'
673
production
volume
range
CBI
claims.
674
Under
the
proposed
rule's
100,000
lbs.
range
limit
for
the
lowest
production
volume
675
range,
submitters
who
did
not
claim
the
production
volume
range
as
CBI
might
have
inadvertently
676
provided
the
public
with
more
information
than
they
intended.
For
instance,
for
a
submitter
677
whose
production
volume
was
in
the
100,000
to
1,000,000
lbs.
range,
who
did
not
claim
their
678
production
volume
range
CBI,
and
who
did
not
report
any
information
in
Part
III
of
reporting
679
Form
U
(
the
industrial
processing
and
use
and
the
commercial
and
consumer
use
information),
680
34
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
public
users
of
the
data
would
be
able
to
infer
that
the
submitter's
production
was
somewhere
681
between
100,000
to
300,000
lbs­
 
information
which
the
submitter
might
have
considered
CBI.
682
To
protect
against
such
inadvertent
disclosures
of
CBI,
EPA
changed
the
production
volume
683
ranges
to
reflect
the
second
reporting
threshold
of
300,000
lbs.
EPA
does
not
believe
that
the
684
change
significantly
affects
the
utility
of
the
data
to
the
public.
685
e.
Number
of
potentially
exposed
workers
(
Section
710.32(
c)(
3)(
vi)
of
the
regulatory
686
text;
Part
II,
Section
II
of
Revised
Reporting
Form
U).
Submitters
must
report
the
range
code
687
that
corresponds
to
their
estimate
of
the
total
number
of
workers
reasonably
likely
to
be
exposed
688
to
each
reportable
chemical
substance
at
each
plant
site.
EPA
defines
  
reasonably
likely
to
be
689
exposed''
as
an
exposure
to
a
chemical
substance
which,
under
foreseeable
conditions
of
690
manufacture,
processing,
distribution
in
commerce,
or
use
of
the
chemical
substance,
is
more
691
likely
to
occur
than
to
not
occur.
Such
exposures
would
normally
include,
but
not
be
limited
to,
692
exposure
during
activities
such
as
charging
reactor
vessels;
drumming;
bulk
loading;
cleaning
693
equipment;
maintenance
operations;
materials
handling
and
transfers;
and
analytical
operations.
694
Covered
exposures
include
exposures
through
any
route
of
entry
(
inhalation,
ingestion,
skin
695
contact
or
absorption,
etc.),
but
exclude
accidental
or
theoretical
exposures.
696
Workers
involved
in
chemical
manufacturing,
processing
and
use
are
a
subpopulation
of
697
concern
to
EPA,
the
Occupational
Safety
and
Health
Administration
(
OSHA)
(
Ref.
9),
the
698
National
Institute
of
Occupational
Safety
and
Health
(
NIOSH)
(
Ref.
10),
and
other
organizations
699
(
e.
g.,
labor
unions).
Workers
may
often
be
exposed
to
chemical
substances
in
higher
doses
and
700
with
greater
frequency
than
the
general
population,
and
may
therefore
be
at
potentially
greater
701
risk
of
adverse
health
effects.
The
number
of
workers
reasonably
likely
to
be
exposed
to
specific
702
chemical
substances
is
important
to
EPA
and
other
organizations
in
developing
the
most
accurate
703
35
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
screening
level
exposure
scenarios
possible.
These
scenarios
are
then
used
to
develop
priorities
704
for
testing,
more
detailed
risk
assessment,
and
risk
management.
705
Submitters
are
required
to
use
ranges
rather
than
specific
values
for
reporting
certain
706
data,
including
the
number
of
workers
reasonably
likely
to
be
exposed
and
the
number
of
707
processing
or
use
sites.
The
ranges
for
reporting
the
estimated
number
of
potentially
exposed
708
workers
are
found
in
section
710.32(
c)(
3)(
vi)
of
the
regulatory
text.
In
general,
reporting
these
709
ranges
reduces
the
potential
burden
to
submitters
of
developing
a
precise
point
estimate
for
the
710
data
element.
The
use
of
ranges
should
reduce
CBI
claims
because
ranges
tend
to
reveal
less
711
sensitive
information
than
specific
estimates
while
still
conveying
sufficient
information
useful
to
712
effectively
screen
chemical
risks.
Submitters
are
permitted
to
claim
the
reported
ranges
as
713
confidential
if
revealing
even
this
general
information
would
disclose
information
of
a
sensitive
714
nature.
715
f.
Maximum
concentration
(
Section
710.32(
c)(
3)(
vii)
of
the
regulatory
text;
Part
II,
716
Section
II
of
Revised
Reporting
Form
U).
Submitters
must
report
the
maximum
concentration,
717
measured
by
weight,
of
the
reportable
chemical
substance
at
the
time
it
is
reacted
on­
site
to
718
produce
a
different
chemical
substance
or
it
leaves
the
submitter's
manufacturing
site.
This
719
information
is
to
be
reported
regardless
of
the
various
physical
forms
in
which
the
chemical
may
720
be
sent
off­
site.
Concentration
ranges
for
use
in
IUR
reporting
under
the
amended
rule
are
found
721
in
section
710.32(
c)(
3)(
vii)
of
the
regulatory
text.
722
Concentration
is
an
important
variable
to
consider
when
estimating
the
magnitude
of
723
potential
exposures.
Information
about
the
maximum
concentration
of
a
chemical
substance
724
present
at
processing
and
use
sites
is
frequently
used
in
chemical
risk
screening
in
the
review
of
725
Premanufacture
Notices
(
PMNs)
for
new
chemical
substances
required
by
Section
5
of
TSCA
and
726
36
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
is
used
to
the
extent
it
is
available
in
screening
chemicals
on
the
TSCA
Inventory.
For
example,
727
EPA
has
developed
standard
methods
to
estimate
dermal
exposures
that
workers
may
experience
728
while
performing
common
industrial
operations
such
as
sampling
and
loading
chemicals
into
729
drums.
These
standard
methods
use
maximum
concentration
to
estimate
upper
limits
to
exposure
730
estimates.
If
EPA
is
aware
that
a
chemical
substance
is
processed
or
used
only
as
a
fraction
of
a
731
mixture
with
other
chemical
substances,
exposure
estimates
may
be
adjusted
downward
732
accordingly.
For
example,
a
chemical
substance
which
is
a
component
of
a
liquid
mixture
exerts
a
733
lower
vapor
pressure
than
it
would
as
a
pure
chemical
substance.
Because
higher
vapor
pressure
734
is
associated
with
increasing
inhalation
exposure
to
a
chemical
substance,
the
concentration
of
a
735
chemical
substance
in
a
liquid
mixture
impacts
the
exposure
assessment.
736
A
chemical
may
be
produced
in
multiple
physical
forms
and
in
multiple
formulations
and
737
products.
As
described
in
Unit
II.
F.
5.
g.
of
this
preamble,
EPA
is
requiring
reporting
of
each
of
738
the
physical
forms
in
which
a
chemical
is
sent
off­
site.
For
the
purpose
of
exposure
screening,
739
EPA
is
requiring
only
the
reporting
of
the
maximum
concentration,
regardless
of
various
physical
740
forms
in
which
a
chemical
may
be
sent
off­
site.
741
EPA
had
proposed
that
submitters
also
report
the
average
concentration
of
the
chemical
742
when
leaving
the
manufacturing
site
(
64
FR
46772,
46788).
EPA
eliminated
this
requirement
743
because
of
the
potential
difficulty
of
determining
the
average
concentration.
For
example,
a
744
submitter
could
produce
many
formulations
containing
a
particular
chemical
substance,
making
a
745
determination
of
average
concentration
difficult.
746
g.
Physical
Form
(
Section
710.32(
c)(
3)(
viii)
of
the
regulatory
text;
Part
II,
Section
II
of
747
Revised
Reporting
Form
U).
Submitters
must
report
the
physical
form(
s)
of
the
chemical
at
the
748
time
it
is
reacted
on
site
or
as
it
leaves
the
site
of
manufacture.
The
list
of
physical
forms
from
749
37
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
which
submitters
must
select
is
found
in
section
710.32(
c)(
3)(
viii)
of
the
regulatory
text.
Further
750
discussion
on
physical
form
reporting
is
found
in
Unit
III.
B.
1.
a.
of
this
preamble.
751
The
physical
form
of
a
chemical
is
an
important
factor
to
consider
when
estimating
752
magnitudes
and
concentrations
of
potential
exposures.
EPA's
analyses
of
TRI
and
PMN
data
753
demonstrated
that
the
physical
state
of
a
chemical
is
a
determining
factor
in
predicting
the
754
potential
for
industrial
releases
of
chemicals,
and
hence,
exposures
to
humans
and
the
755
environment.
The
results
of
the
analyses
are
provided
in
a
technical
support
document
that
was
756
developed
by
EPA
in
support
of
this
rule
("
Inventory
Update
Rule
(
IUR)
Amendments
Technical
757
Support
Document:
Exposure­
Related
Data
Useful
for
Chemical
Risk
Screening,"
Ref.
11).
The
758
physical
state,
which
provides
information
on
volatility
and
how
the
chemical
is
likely
to
be
759
handled
during
manufacturing,
processing,
and
use,
is
an
important
data
element
for
the
purposes
760
of
exposure
and
risk
screening.
761
h.
Percent
production
volume
(
Section
710.32(
c)(
3)(
ix)
of
the
regulatory
text;
Part
II,
762
Section
II
of
Revised
Reporting
Form
U).
Submitters
are
required
to
report
the
percentage
of
763
total
production
volume
(
as
reported
under
regulatory
text
section
710.32(
c)(
3)(
iv))
of
the
764
reportable
chemical
substance
that
is
associated
with
each
physical
form
reported.
Percent
765
production
volume
estimates
will
allow
the
Agency
to
aggregate,
on
a
case
by
case
basis,
the
766
production
volume
of
a
particular
physical
form
for
a
given
chemical
across
multiple
sites.
These
767
determinations
will
allow
EPA
to
better
characterize
the
risk
associated
with
chemicals
that
are
768
manufactured
in
physical
forms
that
typically
result
in
higher
exposures,
such
as
volatile
liquids
or
769
powders,
but
that
are
produced
in
small
quantities.
These
percent
production
volume
estimates
770
will
help
put
the
physical
form
information
into
context.
Estimates
must
be
rounded
off
to
the
771
nearest
10%
of
production
volume.
However,
for
a
particular
physical
form
which
accounts
for
772
38
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
5%
or
less
of
the
total
production
volume
of
a
reportable
chemical
substance,
submitters
are
not
773
permitted
to
round
off
to
zero
percent
if
the
production
volume
attributable
to
that
physical
form
774
is
300,000
lbs.
or
more.
In
such
cases,
submitters
must
report
the
percentage
of
production
775
volume
attributable
to
that
physical
form
to
the
nearest
1%
of
production
volume.
This
exception
776
to
the
general
rounding
off
rule
will
ensure
that
adequate
use
information
is
reported
for
the
larger
777
production
volume
chemical
substances.
The
break­
off
of
300,000
lbs.
was
selected
for
778
consistency
with
the
processing
and
use
data
reporting
threshold.
779
6.
What
new
definitions
have
been
added
to
explain
the
requirements
associated
with
780
reporting
by
larger
production
volume
manufacturers?
(
Section
710.23
of
the
regulatory
text).
781
EPA
has
reorganized
the
definition
section
of
the
regulatory
text
associated
with
the
original
782
Inventory
and
the
IUR.
There
are
now
two
definition
sections.
Section
710.2
contains
definitions
783
relevant
primarily
to
the
compilation
of
the
original
Inventory,
although
a
few
of
these
definitions
784
are
also
relevant
to
both
the
IUR
and
the
IURA.
Section
710.23
contains
definitions
relevant
only
785
to
the
IUR
and
the
IURA.
Any
changes
to
the
definitions
themselves
were
included
in
the
786
proposed
rule.
This
reorganization
simply
clarifies
the
relationships
between
the
definitions
and
787
the
various
rules,
and
has
no
substantive
effect.
788
Certain
new
definitions
are
being
added
to
40
CFR
part
710
as
a
result
of
this
final
rule:
789
a.
Readily
obtainable
information.
TSCA
section
8(
a)(
2)
authorizes
EPA
to
require
790
persons
to
report
information
that
is
known
to
or
reasonably
ascertainable
by
the
submitter.
Under
791
the
amended
IUR,
a
submitter
will
report
processing
and
use
information
(
i.
e.,
the
information
792
reported
for
sites
at
which
the
300,000
lbs.
threshold
has
been
met
or
exceeded)
only
to
the
extent
793
that
such
information
is
  
readily
obtainable''
by
the
submitter's
management
and
supervisory
794
employees
responsible
for
manufacturing,
processing,
distributing,
technical
services,
and
795
39
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
marketing
(
see
regulatory
text
section
710.23).
Extensive
file
searches
are
not
required.
The
796
  
readily
obtainable''
standard
for
processing
and
use
information
requires
less
effort
on
the
part
797
of
the
submitter
than
the
  
known
to
or
reasonably
ascertainable
by''
standard
that
applies
to
all
798
other
IUR
reporting
(
see
regulatory
text
section
710.23),
while
providing
sufficiently
precise
799
processing
and
use
information
for
screening
level
reviews.
In
addition,
the
"
readily
obtainable"
800
standard
limits
the
reporting
burden
associated
with
processing
and
use
reporting
and
is
identical
801
to
the
standard
currently
in
effect
under
EPA's
TSCA
Section
8(
a)
Preliminary
Assessment
802
Information
Rule
(
PAIR)
(
See
40
CFR
712.7).
The
"
readily
obtainable"
definition
is
further
803
discussed
in
Unit
III.
D.
3.
of
this
preamble.
804
b.
Use.
For
the
purpose
of
IUR
reporting,
EPA
is
defining
"
use"
as
any
utilization
of
a
805
chemical
substance
or
mixture
that
is
not
otherwise
covered
by
the
terms
"
manufacture"
or
806
"
process"
(
see
regulatory
text
section
710.23).
For
example,
the
activity
of
processing
a
solvent
807
into
a
paint
formulation
is
considered
"
processing"
rather
than
"
use"
because
the
activity
808
incorporates
the
chemical
substance
(
the
solvent)
into
a
formulation.
If
the
paint
formulation
809
containing
the
solvent
is
then
applied
to
a
metal
or
wood
surface
(
e.
g.
cars),
this
application
810
would
be
considered
a
use
activity.
811
c.
Industrial
Use.
EPA
defines
  
industrial
use''
for
purposes
of
IUR
reporting
as
use
at
a
812
site
at
which
one
or
more
chemical
substances
or
mixtures
are
manufactured
or
processed
(
see
813
regulatory
text
section
710.23).
814
d.
Commercial
and
consumer
use.
For
purposes
of
IUR
reporting,
EPA
defines
815
"
commercial
use"
as
the
use
of
a
chemical
substance
or
mixture
in
a
commercial
enterprise
816
providing
saleable
goods
or
a
service,
such
as
painting
contractors
using
paint
products.
A
817
"
consumer
use,"
on
the
other
hand,
means
the
use
of
a
chemical
substance
that
is
directly,
or
as
818
40
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
part
of
a
mixture,
sold
to
or
made
available
to
consumers
for
their
use
in
or
around
a
permanent
819
or
temporary
household
or
residence,
a
school,
or
recreational
areas
(
see
regulatory
text
section
820
710.23).
Exposures
to
commercial
and
consumer
products
are
similar
for
risk
screening
purposes
821
because
existing
screening
level
assessment
methods
are
not
sophisticated
enough
to
distinguish
822
between
these
exposures.
823
e.
Repackaging.
For
the
purpose
of
IUR
reporting,
"
repackaging"
is
defined
as
the
824
physical
transfer
of
a
chemical
substance
or
mixtures
(
as
is)
from
one
container
to
another
825
container
or
containers
in
preparation
for
distributing
the
chemical
substance
or
mixture
in
826
commerce.
This
definition
does
not
apply
to
sites
that
only
relabel
or
redistribute
the
reportable
827
chemical
substance
without
removing
the
chemical
substance
from
the
container
in
which
it
is
828
received
or
purchased.
829
7.
What
new
data
elements
are
reportable
by
only
larger
production
volume
830
manufacturers?
As
described
in
Unit
II.
F.
2.
of
this
preamble,
EPA
is
replacing
the
current
IUR
831
reporting
threshold
of
10,000
lbs.
per
year
per
site
with
two
new
production
volume
reporting
832
thresholds
of
25,000
lbs.
and
300,000
lbs.
per
year
per
site.
Each
person
manufacturing
a
833
reportable
substance
at
or
above
the
25,000
lbs.
per
year
per
site
threshold
is
required
to
complete
834
at
least
a
partial
report
containing
the
information
in
Parts
I,
II,
and
IV
of
Revised
Reporting
835
Form
U.
Persons
who
manufacture
a
reportable
substance
at
or
above
the
300,000
lbs.
per
year
836
per
site
threshold
are
required
to
complete
a
full
report,
providing
the
information
in
Part
III
in
837
addition
to
the
information
in
Parts
I,
II,
and
IV.
Part
III
concerns
the
processing
and
use
of
838
chemical
substances.
839
a.
Processing
and
Use
Information
(
Section
710.32(
c)(
4)
of
the
regulatory
text;
Part
III
840
of
revised
reporting
Form
U).
Submitters
with
plant
sites
at
which
a
reportable
chemical
841
41
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
substance
is
manufactured
in
annual
quantities
of
300,000
lbs.
or
more
must
report
processing
and
842
use
information
under
the
amended
IUR.
EPA
requires
submitters
to
report
the
information
843
described
in
section
710.32(
c)(
4)
of
the
regulatory
text
concerning
the
processing
and
use
of
each
844
reportable
chemical
substance
both
at
sites
the
submitter
controls,
and
at
sites
receiving
a
845
reportable
chemical
substance
from
the
submitter
either
directly
or
indirectly
(
including
through
a
846
broker/
distributor,
from
a
customer
of
the
submitter,
etc.).
Processing
and
use
information
must
847
be
reported
only
to
the
extent
that
the
data,
or
an
estimate,
is
"
readily
obtainable"
by
the
submitter
848
(
see
Unit
II.
F.
6.
a.
of
this
preamble).
849
i.
Industrial
processing
or
use
operations
(
Section
710.32(
c)(
4)(
i)(
A)
of
the
regulatory
850
text;
Part
III,
Section
I
a
of
revised
reporting
Form
U).
Submitters
must
report
the
industrial
851
process
or
use
operation(
s)
at
the
site
that
are
associated
with
each
reportable
chemical.
The
852
categories
for
reporting
are
listed
in
section
710.32(
c)(
4)(
i)(
A)
of
the
regulatory
text.
853
ii.
North
American
Industrial
Classification
System
(
NAICS)
Code
(
Section
854
710.32(
c)(
4)(
i)(
B)
of
the
regulatory
text;
Part
III,
Section
I
b
of
revised
reporting
Form
U).
855
Submitters
must
report
the
five­
digit
NAICS
code(
s)
that
best
describe(
s)
the
industrial
856
processing
or
use
activities
at
the
sites
under
the
control
of
the
submitter,
as
well
as
at
the
sites
857
that
receive
a
reportable
chemical
substance
from
the
submitter
either
directly
or
indirectly
858
(
including
through
a
broker/
distributor,
from
a
customer
of
the
submitter,
etc.).
The
NAICS
859
codes,
published
by
the
Office
of
Management
and
Budget
(
OMB),
have
superseded
the
prior
860
system
of
Standard
Industrial
Classification
(
SIC)
Codes
(
Ref.
12).
Submitters
must
report
these
861
codes
to
the
extent
the
information
is
readily
obtainable
for
processing
or
use
activities
at
sites
862
within
the
submitter's
control
as
well
as
at
downstream
sites.
EPA
does
not
intend
for
863
manufacturers
to
survey
their
customers
or
distributors
to
precisely
identify
the
appropriate
864
42
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
NAICS
codes
at
their
downstream
sites.
865
The
NAICS
classification
system
is
being
used
in
the
amended
IUR
to
describe
the
866
industrial
setting
in
which
chemical
exposures
associated
with
the
industrial
processing
or
use
of
a
867
chemical
substance
may
occur.
Exposure
to
a
chemical
substance
typically
varies
among
868
industries.
The
NAICS
code
in
conjunction
with
the
industrial
function
category
(
IFC)
code
will
869
define
the
industrial,
commercial,
or
consumer
setting
so
that
the
appropriate
scenarios
can
be
870
applied
to
estimate
worker,
community,
and
environmental
exposures
to
the
chemical
substance.
871
The
NAICS
codes
which
best
describe
the
industrial
activities
associated
with
each
872
reported
industrial
processing
or
use
operation
must
be
provided.
If
more
than
10
NAICS
codes
873
apply
to
a
reportable
chemical
substance,
submitters
need
only
report
the
NAICS
codes
that
874
cumulatively
represent
the
largest
percentage
of
the
substance's
production
volume,
measured
by
875
weight.
This
limitation
on
reporting
is
intended
to
minimize
submitters'
reporting
burden.
876
iii.
Industrial
Function
Category
(
Section
710.32(
c)(
4)(
i)(
C)
of
the
regulatory
text;
Part
877
III,
Section
I
c
of
revised
reporting
Form
U
).
Submitters
must
report
the
industrial
function
878
categories
that
best
represent
the
specific
manner
in
which
a
chemical
substance
is
used
within
879
each
NAICS
code
reported.
Submitters
may
report
the
same
function
category
under
different
880
NAICS
codes.
Submitters
may
also
report
the
same
NAICS
code
multiple
times
if
the
chemical
881
being
reported
has
several
industrial
functions.
The
industrial
function
categories
to
be
used
are
882
listed
in
the
regulatory
text
at
section
710.32(
c)(
4)(
i)(
C).
883
A
NAICS
code
and
industrial
function
category
combination
sufficiently
defines
a
884
potential
exposure
scenario
for
risk
screening
and
priority­
setting
purposes.
EPA
conducted
885
studies
to
determine
whether
information
regarding
the
industrial
sectors
in
which
a
chemical
886
substance
is
produced
and
used,
and
information
regarding
the
function
a
chemical
substance
887
43
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
performs
within
industrial
processes,
are
useful
for
the
purpose
of
screening
level
exposure
888
assessments.
These
studies
demonstrated
that
this
type
of
information
provides
indications
of
the
889
route,
magnitude,
and
concentration
of
potential
chemical
exposures
to
humans
and
to
the
890
environment.
The
results
of
the
studies
are
provided
in
two
of
the
technical
support
documents
891
that
EPA
developed
in
support
of
this
rule
(
Refs.
11
and
13).
892
Industrial
function
categories
are
also
useful
in
estimating
the
frequency
and
duration
of
893
chemical
substance
exposures
by
indicating
the
type
of
application
in
which
a
chemical
will
be
894
used
(
eg.
Solvents(
for
Cleaning
and
Degreasing)
or
Intermediate).
The
relationship
between
895
industrial
function
categories
and
the
frequency
and
duration
of
exposure
to
chemical
substances
896
is
particularly
useful
in
developing
exposure
assessments
in
EPA's
New
Chemicals
Program.
897
These
data
elements
are
important
elements
in
developing
useful
exposure
scenarios.
In
the
898
absence
of
these
data,
EPA
often
uses
conservative
estimates
that
may
indicate
a
greater
risk
than
899
is
actually
the
case.
Data
that
will
be
obtained
under
the
amended
IUR
will
enable
EPA
to
make
900
more
realistic
characterizations
of
exposure,
instead
of
  
worst
case''
assumptions.
901
iv.
Percentage
of
production
volume
attributable
to
each
combination
of
NAICS
code
902
and
industrial
function
category
in
each
processing
and
use
operation
(
Section
903
710.32(
c)(
4)(
i)(
D)
of
the
regulatory
text;
Part
III,
Section
I
d
of
revised
reporting
Form
U).
904
Submitters
must
estimate
the
percentage
of
total
production
volume
attributable
to
each
reported
905
combination
of
NAICS
code
and
industrial
function
category
(
IFC)
in
each
processing
and
use
906
operation,
to
the
extent
that
such
information
is
readily
obtainable.
Estimates
must
be
rounded
off
907
to
the
nearest
10%
of
production
volume.
Submitters
are
not
permitted
to
round
off
to
zero
908
percent
if
the
production
volume
attributable
to
a
NAICS/
IFC
combination
is
300,000
lbs.
or
909
more
and
accounts
for
5%
or
less
of
the
total
production
volume
of
a
reportable
chemical
910
44
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
substance.
In
such
cases,
submitters
must
report
the
percentage
of
production
volume
911
attributable
to
that
NAICS/
IFC
combination
to
the
nearest
1%
of
production
volume.
This
912
exception
to
the
general
rounding
rule
will
ensure
that
adequate
use
information
is
reported
for
913
the
larger
production
volume
chemical
substances.
The
300,000
lbs.
level
was
selected
for
914
consistency
with
the
threshold
for
reporting
processing
and
use
data.
915
The
total
percent
production
volumes
associated
with
the
NAICS
code/
IFC
combinations
916
may
add
up
to
more
than
100%,
given
that
the
submitter
is
reporting
on
distribution
of
a
chemical
917
to
sites
in
its
control
as
well
as
downstream
sites,
some
of
which
are
not
immediate
purchasers
918
from
the
original
manufacturing
site.
Additionally,
the
total
percent
production
volume
may
add
919
up
to
less
than
100%
if
the
submitter
cannot
readily
obtain
information
about
how
all
of
its
920
production
volume
is
processed
or
used
by
industry.
921
v.
Number
of
processing
and
use
sites
(
Section
710.32(
c)(
4)(
i)(
E)
of
the
regulatory
text;
922
Part
III,
Section
I
e
of
revised
reporting
Form
U).
Submitters
must
report
estimates
of
the
total
923
number
of
industrial
sites,
including
those
beyond
the
submitter's
control,
that
process
or
use
each
924
reportable
chemical
substance
manufactured
by
the
submitter,
with
respect
to
each
combination
of
925
NAICS
code
and
industrial
function
category
in
each
processing
and
use
operation.
The
ranges
926
that
will
be
used
for
reporting
the
number
of
sites
can
be
found
at
section
710.32(
c)(
4)(
i)(
E)
of
927
the
regulatory
text.
For
risk
screening
purposes,
the
number
of
sites
at
which
chemical
substances
928
are
manufactured,
processed,
and
used
is
a
useful
indicator
of
the
number
of
ecosystems
and
the
929
size
of
the
general
population
potentially
exposed
to
the
chemical
substances.
930
vi.
Number
of
workers
(
Section
710.32(
c)(
4)(
i)(
F)
of
the
regulatory
text);
Part
III,
931
Section
I
f
of
revised
reporting
Form
U).
Submitters
must
report
estimates
of
the
total
number
of
932
workers,
including
those
at
sites
not
under
the
submitter's
control,
that
are
reasonably
likely
to
be
933
45
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
exposed
while
processing
or
using
the
reportable
chemical
substance,
with
respect
to
each
934
combination
of
NAICS
code
and
industrial
function
category
in
each
processing
and
use
935
operation.
The
approximate
number
of
workers
will
be
reported
using
the
same
definitions
and
936
ranges
described
under
Unit
II.
D.
5.
e.
of
this
preamble.
The
difference
in
reporting
worker
937
exposure
information
under
this
section
is
that
such
information
need
be
reported
only
to
the
938
extent
that
it
is
readily
obtainable.
939
b.
Commercial
and
Consumer
Use
Information
(
Section
710.32(
c)(
4)(
ii)
of
the
regulatory
940
text;
Part
III,
Section
II
of
revised
reporting
Form
U).
Submitters
must
report
information
941
concerning
the
commercial
and
consumer
uses
of
each
reportable
chemical
substance
that
is
942
manufactured
at
sites
the
submitter
controls
and
at
sites
controlled
by
persons
to
whom
the
943
submitter
either
directly
or
indirectly
distributes
the
reportable
chemical
substance
(
including
944
through
a
broker/
distributor
or
from
a
customer
of
the
submitter,
etc.).
As
for
the
industrial
945
processing
and
use
information
described
in
Unit
II.
D.
7.
of
this
preamble,
commercial
and
946
consumer
use
information
must
be
reported
only
by
sites
at
which
a
chemical
substance
is
947
manufactured
in
annual
quantities
of
300,000
lbs.
or
more,
and
submitters
will
only
be
required
to
948
report
the
information
to
the
extent
that
it
is
readily
obtainable.
949
Consumers
comprise
a
subpopulation
of
particular
concern
to
EPA,
the
Consumer
950
Products
Safety
Commission
(
CPSC),
and
other
governmental
and
non­
governmental
951
organizations.
Information
from
submitters
about
whether
the
chemical
substances
they
952
manufacture
are
used
in
consumer
products
is
useful
in
estimating
the
potential
risks
to
consumers
953
that
result
from
chemical
exposures.
In
the
absence
of
more
specific
data,
EPA
often
assumes
for
954
risk
screening
purposes
that
large,
unprotected
populations
may
potentially
be
exposed
to
the
955
chemical
substances
in
consumer
products.
EPA
is
also
working
with
industry
and
other
956
46
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
stakeholders
to
develop
hazard,
exposure,
and
risk
assessments
regarding
chemicals
to
which
957
children
are
exposed.
The
commercial
and
consumer
product
information
that
will
be
reported
958
under
these
IUR
amendments
will
be
used
by
EPA
in
the
identification
of
chemicals
that
might
be
959
included
in
these
programs,
and
may
contribute
to
exposure
assessments
for
these
chemicals.
960
i.
Commercial
and
consumer
product
categories
(
Section
710.32(
c)(
4)(
ii)(
A)
of
the
961
regulatory
text;
Part
III,
Section
II
a
of
revised
reporting
Form
U).
Submitters
must
report
up
to
962
10
categories
that
best
describe
the
commercial
and
consumer
products
that
the
reportable
963
chemical
substance
is
used
in,
both
at
sites
under
the
control
of
the
submitter,
as
well
as
at
sites
964
that
receive
a
reportable
chemical
substance
from
the
submitter
either
directly
or
indirectly
965
(
including
through
a
broker/
distributor,
from
a
customer
of
the
submitter,
etc.).
This
information
966
must
be
submitted
to
the
extent
that
this
information
is
readily
obtainable.
If
more
than
10
967
categories
apply,
submitters
need
only
report
the
categories
for
the
chemical
substance
that
968
cumulatively
represent
the
largest
percentage
of
production
volume,
measured
by
weight.
The
969
commercial
and
consumer
product
(
CCP)
categories
are
listed
at
section
710.32(
c)(
4)(
ii)(
A)
of
970
the
regulatory
text.
Information
on
the
use
of
chemicals
in
CCPs
is
useful
in
estimating
the
971
frequency
and
duration
of
chemical
substance
exposures.
In
the
absence
of
other
information,
972
consumers
are
often
assumed
to
experience
less
controlled,
but
less
frequent
exposures
than
973
workers.
The
data
that
will
be
obtained
under
the
IURA
will
enable
EPA
to
make
more
realistic
974
characterizations
of
exposure,
instead
of
  
worst
case,''
overly
conservative
assumptions.
975
ii.
Products
intended
for
use
by
children
(
Section
710.32(
c)(
4)(
ii)(
B)
of
the
regulatory
976
text;
Part
III,
Section
II
a
of
revised
reporting
Form
U
).
Submitters
must
indicate,
within
each
977
reported
CCP
category,
whether
any
amount
of
each
reportable
chemical
substance
manufactured
978
47
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
by
the
submitter
is
present
in
(
for
example,
a
plasticizer
chemical
used
to
make
pacifiers)
or
on
979
(
for
example,
as
a
component
in
the
paint
on
a
toy)
any
products
intended
for
use
by
children
980
(
aged
14
or
younger),
regardless
of
the
concentration
of
the
substance
(
see
section
981
710.32(
c)(
4)(
ii)(
B)
of
the
regulatory
text).
982
Information
indicating
the
use
of
a
chemical
in
a
product
intended
for
use
by
children
will
983
enable
the
Agency
and
others
to
focus
attention
on
chemicals
affecting
this
particularly
sensitive
984
population.
Submitters
are
required
to
indicate,
within
each
CCP
category
reported,
that
the
985
reportable
chemical
substance
is
used
in
the
manufacture
of
a
product
intended
for
use
by
986
children,
is
not
used
in
any
such
product,
or
that
such
information
is
not
readily
obtainable.
987
In
the
proposed
rule,
EPA
stated
its
intent
to
use
the
consumer
use
information
collected
988
under
the
amended
IUR
"
to
propose
a
test
rule
to
develop
hazard
data
regarding
chemicals
in
989
consumer
products
to
which
children
are
exposed."
64
FR
46772,
46791.
EPA
believes
990
information
indicating
the
potential
presence
of
a
chemical
in
a
product
intended
for
use
by
991
children
will
enable
the
Agency
and
others
to
focus
attention
on
chemicals
that
could
affect
this
992
particularly
sensitive
population.
Examples
of
products
intended
for
use
by
children
include,
but
993
are
not
limited
to:
994
Code
995
Category
Examples
of
Children's
Products
C01
996
Artists'
supplies
Crayons,
children's
markers
C02
997
Adhesives
and
sealants
Craft
glue,
model
glue
C03
998
Automotive
care
products
NA
C04
999
Electrical
and
electronic
products
Electronic
games,
remote
control
cars,
toys
C05
1000
Glass
and
ceramic
products
Porcelain
dolls
C06
1001
Fabrics,
textiles
and
apparel
Pajamas
C07
1002
Lawn
and
garden
products
(
non­
NA
48
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
pesticidal)
C08
1003
Leather
products
Shoes,
jackets,
baseball
gloves
C09
1004
Lubricants,
greases
and
fuel
additives
NA
C10
1005
Metal
products
Toy
trucks,
toy
cars
C11
1006
Paper
products
Diapers,
baby
wipes,
coloring
books
C12
1007
Paints
and
coatings
Finger
paints,
interior
paints
marketed
for
children's
rooms
C13
1008
Photographic
chemicals
NA
C14
1009
Polishes
and
sanitation
goods
NA
C15
1010
Rubber
and
plastic
products
Pacifiers,
action
figure,
balls
C16
1011
Soaps
and
detergents
Baby
shampoo,
children's
bubble
bath
C17
1012
Transportation
products
NA
C18
1013
Wood
and
wood
furniture
Baby
cribs,
changing
tables,
wooden
toys
C19
1014
Other
Other
items
specifically
intended
for
use
by
children
1015
iii.
Percentage
of
production
volume
attributable
to
each
commercial
and
consumer
1016
product
category
(
Section
710.32(
c)(
4)(
ii)(
C)
of
the
regulatory
text;
Part
III,
Section
II
b
of
1017
revised
reporting
Form
U).
Submitters
must
estimate
the
percentage
of
their
production
volume
1018
for
each
reportable
chemical
substance
that
is
attributable
to
each
specific
commercial
and
1019
consumer
end­
use
carried
out
at
sites
under
the
control
of
the
submitter,
as
well
as
at
sites
that
1020
receive
a
reportable
chemical
substance
from
the
submitter
either
directly
or
indirectly
(
including
1021
through
a
broker/
distributor,
from
a
customer
of
the
submitter,
etc.).
This
information
must
be
1022
submitted
to
the
extent
that
it
is
readily
obtainable.
Estimates
must
be
rounded
off
to
the
nearest
1023
10%
of
production
volume.
However,
a
CCP
category
which
accounts
for
5%
or
less
of
the
total
1024
production
volume
of
a
reportable
chemical
substance
cannot
be
rounded
off
to
zero
percent
if
the
1025
production
volume
attributable
to
that
CCP
category
is
greater
than
or
equal
to
300,000
lbs.
In
1026
such
cases,
submitters
must
report
the
percentage
of
production
volume
attributable
to
that
CCP
1027
49
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
category
to
the
nearest
1%
of
production
volume.
This
exception
to
the
general
rounding
rule
will
1028
ensure
that
adequate
use
information
is
reported
for
the
larger
production
volume
chemical
1029
substances.
The
300,000
lbs.
level
was
selected
for
consistency
with
the
threshold
for
reporting
1030
processing
and
use
data
(
see
Unit
II.
F.
2.
of
this
preamble).
1031
The
total
percent
production
volumes
reported
may
add
up
to
more
than
100%,
given
1032
that
the
submitter
is
reporting
on
distribution
of
a
chemical
to
sites
in
its
control
as
well
as
1033
downstream
sites,
some
of
which
are
not
immediate
purchasers
from
the
original
manufacturing
1034
site.
Additionally,
the
total
percent
production
volume
may
add
up
to
less
than
100%
if
the
1035
submitter
cannot
readily
obtain
information
about
how
all
of
its
production
volume
is
used
in
1036
commercial
and
consumer
products.
1037
iv.
Maximum
concentration
in
commercial
and
consumer
products
(
Section
1038
710.32(
c)(
4)(
ii)(
D)
of
the
regulatory
text;
Part
III,
Section
II
c
of
revised
reporting
Form
U).
1039
Submitters
must
report
the
maximum
concentration
(
measured
by
weight)
of
each
reportable
1040
chemical
substance
in
each
commercial
and
consumer
product
category.
In
complying
with
this
1041
requirement,
submitters
will
select
from
the
list
of
concentration
ranges
provided
in
section
1042
710.32(
c)(
3)(
vii)
in
the
regulatory
text.
Concentration
is
further
discussed
in
Unit
III.
B.
1.
b.
of
1043
this
preamble.
As
with
the
other
processing
and
use
information
that
submitters
must
report,
such
1044
information
will
be
reported
only
to
the
extent
that
it
is
readily
obtainable
by
the
submitter.
1045
8.
What
changes
have
been
made
to
requirements
for
making
confidential
business
1046
information
claims?
Submitters
are
able
to
claim
information
submitted
to
EPA
under
this
1047
amended
rule
as
confidential
if
they
have
reason
to
believe
that
release
of
the
information
would
1048
reveal
trade
secrets
or
confidential
commercial
or
financial
information,
as
provided
by
section
14
1049
of
TSCA
and
40
CFR
part
2.
Claims
of
confidentiality
must
be
asserted
at
the
time
information
is
1050
50
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
submitted
to
EPA.
EPA's
procedures
for
processing
and
reviewing
confidentiality
claims
are
set
1051
forth
at
40
CFR
part
2,
subpart
B.
EPA
strongly
encourages
submitters
to
review
confidentiality
1052
claims
carefully
to
ensure
that
the
information
in
question
falls
within
the
protection
of
TSCA
1053
section
14,
and
to
limit
invalid
confidentiality
claims
as
much
as
possible.
1054
Submitters
will
have
an
opportunity
to
make
CBI
claims
for
most
of
the
information
1055
reported
under
the
amended
IUR.
To
claim
information
as
confidential,
a
submitter
must
check
1056
the
appropriate
box
and
sign
the
certification
statement
on
the
reporting
form.
If
a
submitter
fails
1057
to
do
so,
EPA
could
release
the
information
to
the
public
without
further
notice
to
the
submitter.
1058
As
in
the
last
four
TSCA
Inventory
Update
collections
and
the
initial
TSCA
Inventory
collection,
1059
by
signing
the
certification
statement
the
submitter
certifies
that
its
claims
of
confidentiality
are
1060
true
and
correct.
Procedures
for
claiming
information
submitted
electronically
(
such
as
a
1061
submission
on
diskette)
as
CBI
will
be
specified
in
the
instruction
manual
that
will
be
available
1062
each
submission
period
as
described
in
section
710.40
of
the
regulatory
text.
CBI
should
not
be
1063
submitted
by
e­
mail.
A
discussion
about
CBI
claims
under
the
amended
IUR
is
provided
in
this
1064
unit.
1065
a.
Upfront
Substantiation
for
Plant
Site
Identity.
Submitters
are
required
to
provide
1066
upfront
substantiation
for
CBI
claims
for
plant
site
identity,
in
a
manner
similar
to
the
upfront
1067
substantiation
of
chemical
identity
under
the
existing
IUR
(
see
40
CFR
710.38).
Under
the
1068
amended
IUR,
a
submitter
may
assert
a
claim
of
confidentiality
for
a
plant
site
identity
if
the
1069
submitter
believes
that
releasing
that
identity
would
reveal
trade
secrets
or
confidential
1070
commercial
or
financial
information,
as
provided
by
TSCA
section
14.
Submitters
in
past
IUR
1071
information
collections,
have
claimed
in
excess
of
15%
of
plant
site
identities
as
CBI.
While
the
1072
Agency
does
not
question
the
occasional
need
for
this
claim,
it
believes
that
these
claims
should
1073
51
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
be
limited
to
only
those
circumstances
in
which
it
is
necessary.
Further
discussion
on
upfront
1074
substantiation
is
found
in
Unit
III.
E.
2.
of
this
preamble.
1075
In
order
to
assert
a
claim
of
confidentiality
for
a
plant
site
identity
under
this
amended
1076
rule,
the
submitter
must
check
the
appropriate
box
on
the
reporting
form
indicating
a
1077
confidentiality
claim
for
plant
site
identity
and
substantiate
the
claim
in
writing
by
answering
1078
certain
questions
provided
in
Sec.
710.38(
d)
of
the
regulatory
text.
If
a
submitter
fails
to
1079
substantiate
the
plant
site
CBI
claim,
EPA
could
make
the
information
available
to
the
public
1080
without
further
notice
to
the
submitter.
1081
b.
CBI
claims
for
Chemical
Production
Volume
Information.
EPA
did
not
change
the
1082
ability
of
the
submitter
to
assert
a
claim
of
confidentiality
for
production
volume
information
if
the
1083
release
of
that
information
would
reveal
trade
secrets
or
confidential
commercial
or
financial
1084
information
as
provided
by
section
14
of
TSCA.
However,
submitters
may
make
separate
CBI
1085
claims
for
both
actual
plant
site
production
volume
information
and
a
corresponding
production
1086
volume
range.
Production
volume
ranges
are
similar
to
those
used
in
the
implementation
of
the
1087
original
TSCA
Inventory
collection
and
can
be
found
at
section
710.32(
c)(
3)(
v)
of
the
regulatory
1088
text.
1089
In
the
last
four
IUR
submission
periods
when
EPA
sought
actual
production
volume
1090
information,
approximately
65%
of
the
information
was
claimed
as
confidential.
1091
In
contrast,
only
35%
of
production
volume
data
collected
in
ranges
in
the
original
TSCA
1092
inventory
collection
were
claimed
as
confidential..
This
difference
indicates
that
submitters
may
1093
be
significantly
less
likely
to
make
CBI
claims
for
production
volume
information
reported
in
1094
ranges
than
for
discrete
production
volume
figures.
The
high
proportion
of
CBI
claims
in
IUR
1095
reports
has
severely
limited
EPA's
ability
to
convey
production
volume
information
to
the
public,
1096
52
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
even
in
the
form
of
a
national
aggregate
production
volume
for
the
chemical.
EPA
needs
to
be
1097
able
to
convey
production
volume
information
to
the
public
to
explain
its
chemical
risk
1098
assessment
and
risk
management
decisions.
Effective
communication
of
this
information
is
vital
to
1099
EPA's
overall
mission.
EPA
has
added
the
ability
to
claim
production
volume
range
information
1100
CBI
in
an
effort
to
address
this
problem.
In
some
cases,
submitters
may
choose
to
claim
their
1101
actual
production
volume
as
CBI,
while
allowing
the
more
general
production
volume
range
to
1102
be
made
public.
1103
c.
Reasserting
Claims.
Submitters
must
reassert
CBI
claims
made
in
their
previous
IUR
1104
reporting
to
retain
the
CBI
claim
(
see
section
710.39
of
the
regulatory
text;
Part
IV
of
revised
1105
reporting
Form
U).
CBI
claims
made
in
IUR
submissions
prior
to
2006
(
the
first
IUR
reporting
1106
year
under
these
amendments)
are
not
subject
to
this
reassertion
requirement.
A
submitter
who
is
1107
reasserting
a
previous
claim
(
made
during
reporting
year
2006
or
in
subsequent
years),
is
1108
communicating
to
EPA
that
it
believes
that
the
information
continues
to
qualify
as
CBI
and
that
1109
EPA
should
continue
protecting
the
information
as
CBI.
Reassertion
must
be
made
on
a
per
1110
chemical
basis,
i.
e.,
each
reassertion
covers
information
associated
with
only
one
previously
1111
reported
chemical
for
which
some
or
all
of
the
previously
reported
information
was
claimed
as
1112
CBI,
and
for
which
the
submitter
would
like
to
retain
some
or
all
of
the
previous
claims.
1113
Since
1990,
EPA
has
been
engaged
in
a
dialogue
with
the
public
on
issues
associated
with
1114
TSCA
CBI.
During
this
dialogue,
industry
has
confirmed
EPA's
understanding
that
the
need
for
1115
certain
confidentiality
claims
is
reduced
or
eliminated
over
time
(
Ref.
14).
See
the
discussion
1116
located
in
Unit
III.
E.
3.
b.
in
this
preamble.
The
new
procedures
in
this
amended
rule
will
help
1117
ensure
that
the
submitter
has
an
on­
going
need
for
continued
CBI
protection.
Under
these
1118
procedures,
submitters
will
be
required,
in
subsequent
submission
periods,
to
affirmatively
1119
53
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
represent
the
need
for
the
continued
CBI
protection
of
the
claims
made
in
previous
IURA
1120
submission
periods.
These
requirements
begin
in
the
second
submission
period
under
the
1121
amended
IUR,
i.
e.,
reassertion
of
CBI
claims
made
during
the
2006
submission
period
will
occur
1122
in
the
2010
reporting
period,
as
necessary.
1123
To
illustrate,
in
the
2014
submission
period,
a
submitter
will
be
required
to
affirmatively
1124
represent
on
the
reporting
form
that:
(
1)
The
specific
CBI
claims
made
for
the
first
time
in
1125
reporting
year
2010
and
(
2)
the
specific
CBI
claims
reasserted
in
reporting
year
2010
(
i.
e.,
claims
1126
originally
made
in
reporting
year
2006)
continue
to
be
necessary
in
order
to
protect
trade
secrets
1127
or
confidential
commercial
or
financial
information
as
provided
by
TSCA
section
14.
The
CBI
1128
reassertion
statements
are
contained
in
Part
IV.
of
Revised
Reporting
Form
U.
If
the
submitter
1129
does
not
reassert
prior
CBI
claims,
EPA
will
assume
that
the
submitter
is
waiving
those
claims
of
1130
confidentiality
to
the
underlying
information
contained
in
the
earlier
filings
and
the
information
1131
will
be
subject
to
public
disclosure
without
further
notice.
1132
For
data
elements
requiring
upfront
substantiation
of
CBI
claims
(
i.
e.,
chemical
identity
1133
and
plant
site
identity),
submitters
must
revisit
their
answers
to
the
substantiation
questions
in
1134
section
710.38
of
the
regulatory
text
when
reasserting
these
CBI
claims.
The
submitter
must
1135
submit
amended
answers
if
the
original
answers
to
any
of
the
questions
have
changed.
If
the
1136
answers
have
not
changed,
the
submitter
does
not
need
to
take
any
special
action.
1137
A
submitter
who
asserts
a
CBI
claim
in
a
prior
submission
period
may
not
be
required
to
1138
report
under
the
current
IUR
submission
period
because
of
low
production
volume
or
other
1139
applicable
exclusions.
However,
if
that
submitter
wishes
to
retain
the
claim,
it
must
nevertheless
1140
reassert
its
prior
CBI
claim
during
the
current
submission
period
by
filling
out
and
submitting
only
1141
Parts
I
and
IV
on
Form
U
(
along
with
amended
answers
to
any
substantiation
questions,
if
1142
54
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
necessary).
Submitters
must
send
a
separate
reassertion
for
each
chemical
for
which
the
submitter
1143
is
reasserting
CBI
claims.
Again,
CBI
claims
made
in
IUR
submissions
prior
to
2006
(
the
first
1144
IUR
reporting
year
under
these
amendments)
are
not
be
subject
to
this
reassertion
requirement.
1145
EPA
will
undertake
certain
precautions
in
order
to
ensure
that
persons
who
make
CBI
1146
claims
in
IUR
submissions
in
the
2006
submission
period
and
subsequent
submission
periods
are
1147
aware
of
the
requirement
that
these
claims
be
reasserted,
as
appropriate,
in
subsequent
submission
1148
periods
in
order
to
retain
CBI
protections.
Prior
to
each
IUR
submission
period,
EPA
will
send
an
1149
IUR
reporting
package
to
each
person
who
submitted
an
IUR
report
or
CBI
reassertion
in
the
1150
previous
submission
period.
This
package
will
contain
a
cover
letter
which
will:
(
1)
Remind
the
1151
submitters
of
the
reassertion
requirements
and
(
2)
advise
that
failure
to
affirmatively
reassert
prior
1152
CBI
claims
will
result
in
the
removal
of
CBI
protections
for
this
information.
The
package
will
1153
also
contain
a
reporting
form
and
reporting
instructions
which
will
reiterate
these
reminders.
In
1154
addition,
EPA
intends
to
publish
a
Federal
Register
notice
at
least
2
weeks
before
the
end
of
each
1155
submission
period
which
will
remind
those
persons
who
have
not
reasserted
their
prior
CBI
claims
1156
of
the
pending
declassification
of
these
claims
if
they
do
not
reassert
by
the
end
of
the
submission
1157
period.
In
addition
to
these
reminders,
EPA
also
intends
to
publicize
the
need
to
reexamine
and
1158
reassert
past
CBI
claims
via
the
EPA/
OPPT
Homepage
(
http://
www.
epa.
gov)
on
the
Internet,
and
1159
in
communications
with
trade
associations
through
their
publications
as
well
as
through
other
1160
relevant
publications.
1161
III.
Public
Comments
1162
EPA
carefully
considered
the
comments
it
received
on
the
proposed
IUR
amendments.
1163
Major
comments
are
discussed
below.
Additional
comment
summaries
and
more
detailed
1164
55
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
responses
are
contained
in
the
"
Summary
of
EPA's
Responses
to
Public
Comments
Submitted
in
1165
Response
to
Proposed
TSCA
Inventory
Update
Rule
Amendments
(
64
FR
46772)."
(
Ref.
15)
1166
A.
General
Comments
1167
1.
How
will
EPA
and
others
use
the
new
exposure­
related
data
collected
under
these
1168
amendments?
Several
commenters
expressed
the
view
that
EPA
has
not
provided
1169
adequate
justification
supporting
the
Agency's
need
for
the
new
IUR
data,
nor
enough
specific
1170
examples
showing
how
EPA
would
use
the
data
for
its
intended
purpose.
1171
EPA
has
an
obligation
under
TSCA
to
protect
human
health
and
the
environment
from
1172
unreasonable
risks
associated
with
chemicals
under
its
jurisdiction.
In
order
to
evaluate
potential
1173
chemical
risks,
EPA
has
determined
that
a
portion
of
the
chemicals
(
both
inorganic
and
organic)
1174
on
the
TSCA
Inventory
currently
warrant
the
collection
of
manufacturing
information,
and
that
a
1175
subset
of
those
chemicals
(
i.
e.,
those
produced
in
annual
quantities
of
300,000
lbs.
or
more
at
a
1176
site)
currently
warrant
the
collection
of
supplementary
processing
and
use
information.
EPA
is
1177
amending
the
IUR
to
provide
an
accurate
and
readily
available
source
of
basic
exposure­
related
1178
information
for
approximately
4,000
of
the
76,000
substances
listed
on
the
Inventory.
The
1179
amendments
significantly
limit
industry's
reporting
burden
while
providing
EPA
with
information
1180
needed
to
screen
for
risks
to
human
health
and
the
environment.
1181
EPA's
primary
use
of
these
data
will
be
to
identify
priority
TSCA
chemicals
for
more
1182
detailed
information
gathering,
risk
assessment,
and
risk
management
in
order
to
develop
targeted
1183
programs,
allowing
the
Agency
to
be
proactive
in
protecting
human
health
and
the
environment.
1184
Screening
chemical
risks
generally
requires
a
combination
of
both
hazard
and
exposure
1185
information.
The
lack
of
exposure­
related
data
beyond
production
volume
data
in
the
current
IUR
1186
has
severely
limited
the
usefulness
of
the
current
IUR
data
for
risk
screening.
Moreover,
the
1187
56
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
exposure­
related
data
that
will
be
collected
under
the
amended
IUR
are
not
otherwise
readily
1188
available
from
publicly
available
data
sources
(
see
Unit
III.
A.
3.
of
this
preamble).
This
lack
of
1189
exposure­
related
data
has
made
it
difficult
for
EPA
and
others
to
identify
chemicals
with
potential
1190
exposures
of
concern,
and
has
resulted
in
the
generation
of
overly
conservative
screening
level
1191
exposure
assessments.
1192
The
addition
of
manufacturing,
processing
and
use
exposure­
related
data
to
the
IURA,
1193
especially
when
compiled
by
EPA
into
a
searchable
database
format,
will
enable
EPA
and
others
1194
to
more
readily
screen
chemicals
for
exposure
and
risk.
These
reviews
will
allow
for
better
1195
prioritization
of
chemicals
to
identify
those
warranting
more
detailed
assessments
and
to
eliminate
1196
chemicals
of
lesser
concern
from
further
review.
1197
Data
generated
by
the
IURA
will
be
used
in
a
wide
variety
of
programs
fundamental
to
1198
fulfilling
the
Agency's
TSCA
statutory
mandate.
These
programs
range
from
the
more
traditional
1199
existing
chemicals
risk
screening
efforts,
to
voluntary
programs
such
as
EPA's
Design
for
the
1200
Environment
program
(
see
http://
www.
epa.
gov/
opptintr/
dfe),
to
individual
requests
for
analysis
of
1201
chemicals
not
specifically
associated
with
a
particular
program.
The
IURA
database
will
be
1202
searched
to
identify
chemicals
or
use
scenarios
meeting
specific
criteria.
For
instance,
the
1203
database
could
be
searched
to
identify
chemicals
that
have
the
greatest
potential
for
consumer
1204
exposure,
creating
a
list
of
chemicals
arranged
according
to
the
production
volumes
associated
1205
with
different
consumer
uses.
Additional
examples
of
uses
for
the
amended
IUR
data
are
1206
provided
in
this
section
and
in
EPA's
"
IURA
Data
Use
Plan"
(
Ref.
16).
The
Agency
anticipates
1207
that,
as
was
true
even
for
the
basic
production
data
reported
under
the
existing
IUR,
new
uses
of
1208
IURA
data
by
EPA
and
by
others
will
continually
emerge
and
cannot
be
predicted
at
this
time.
1209
Results
from
EPA
tools
such
as
the
Use
Cluster
Scoring
System
(
UCSS)
will
be
greatly
1210
57
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
improved
by
the
amended
IUR
data.
The
UCSS
is
a
computerized
tool
that
combines
hazard
and
1211
exposure
information
from
a
variety
of
data
sources,
analyzes
the
data
in
relation
to
groupings
by
1212
commercial
use,
or
"
clusters,"
and
identifies
clusters
of
potential
concern
to
EPA.
EPA's
Science
1213
Advisory
Board
(
SAB)
commented
in
its
evaluation
of
the
UCSS
that
the
lack
of
exposure
1214
information
in
the
system
has
impaired
its
usefulness
(
The
SAB
report
is
found
at
1215
http://
www.
epa.
gov/
sab/
eec95017.
pdf).
The
amended
IUR
database
will
provide
exposure
1216
information
that
the
UCSS
will
be
able
to
download
directly
and
use.
(
For
a
description
of
1217
UCSS,
see
http://
www.
epa.
gov/
opptintr/
cbep/
actlocal/
39­
use.
htm.)
1218
EPA
will
also
use
IUR
data
to
perform
preliminary
exposure
and
risk
screening
across
a
1219
portion
of
the
Inventory
chemicals.
Some
of
the
same
type
of
data
that
will
be
collected
under
the
1220
amended
IUR
have
been
collected
under
the
Agency's
TSCA
Existing
and
New
Chemicals
1221
Programs
(
ECP)
and
(
NCP)
and
have
aided
EPA
in
performing
exposure
and
risk
screening.
1222
These
exposure­
related
data
were
submitted
as
part
of
programs
such
as:
the
voluntary
Use
and
1223
Exposure
Information
Project
(
UEIP)
(
see
http://
www.
epa.
gov/
opptintr/
sids/
vueip.
txt
for
a
1224
description
of
this
project)
and
the
Premanufacture
Notice
(
PMN)
program
under
TSCA
section
1225
5.
Although
the
UEIP
and
PMN
programs
involve
the
submission
of
certain
data
that
are
the
1226
same
as
or
similar
to
data
being
submitted
under
IURA,
these
programs
cannot
sufficiently
serve
1227
the
needs
that
IURA
will
serve
(
see
Units
V.
A.
1.
and
V.
B.
5.
of
the
proposed
rule
(
64
FR
46772,
1228
46775
and
46780)).
However,
these
programs
are
examples
of
the
usefulness
of
certain
IURA
1229
data
elements.
1230
For
example,
several
IURA
data
elements
were
used
in
an
Existing
Chemicals
Program
1231
initial
review
of
the
chemical
methyl
ethyl
ketoxime
(
MEKO).
This
review
relied
in
part
upon
data
1232
submitted
by
industry
under
the
UEIP.
Some
of
the
data
are
similar
to
those
that
will
be
reported
1233
58
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
under
the
IUR
Amendments
and
include
the
following:
production
volume,
manufacturing
1234
process,
industry
sector,
industrial
processing/
use
activity,
functional
use,
number
of
sites,
number
1235
of
workers,
physical/
chemical
properties,
and
consumer
product
information.
Other
UEIP
1236
information
submitted
by
industry
on
MEKO
are
not
of
the
sort
that
will
be
collected
under
the
1237
amended
IUR,
such
as
environmental
releases
(
releases
to
air,
water,
etc.),
worker
exposure
1238
activities
and
monitoring
data.
The
IUR
Amendments
are
designed
to
obtain
information
that
is
1239
the
most
critical
for
generating
screening­
level
exposure
profiles.
1240
The
UEIP
submissions
for
MEKO
indicated
that
there
were
one
manufacturer
and
two
1241
importers
of
MEKO
in
1993
and
five
primary
end
uses
(
with
the
percentages
of
MEKO
1242
production
and
import
volumes
devoted
to
each
use).
The
submissions
also
reported
the
number
1243
of
workers
at
the
manufacturing
site,
the
physical
forms
of
products
containing
MEKO,
and
the
1244
MEKO
weight
fraction
in
each
use.
1245
The
MEKO
use
information
was
combined
with
data
and
information
from
available
1246
workplace
monitoring
studies
and
modeling
approaches
to
compile
a
screening­
level
workplace
1247
exposure
assessment.
The
UEIP
information
on
use
provided
crucial
information
to
allow
EPA
to
1248
postulate
process
operations,
worker
activities,
and
possible
exposures.
For
example,
MEKO's
1249
primary
use
(
92%
of
production
and
import
volume)
is
as
a
paint
additive.
This
fact
allows
EPA
1250
to
refer
to
information
on
paint
manufacturing
and
use
to
estimate
exposures
to
workers
who
1251
either
formulate
paints
or
apply
the
paints
using
spray
guns
or
other
techniques.
MEKO
use
in
1252
paint
indicates
a
potential
for
exposure
to
several
large
populations
(
workers
and
consumers)
1253
because
exposure
to
even
small
amounts
of
paint
can
result
in
significant
exposure
levels
to
1254
chemicals
in
paints.
Such
use
information
can
also
be
used
by
EPA
to
generate
estimated
1255
numbers
of
workers
in
very
small
businesses
(<
10
workers)
that
may
be
poorly
represented
by
1256
59
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
existing
National
Occupation
Exposure
Survey
(
NOES)
data.
In
the
MEKO
case,
such
a
1257
population
would
be
commercial
painters.
Without
the
information
about
MEKO
use
in
paints
1258
and
the
large
percentage
of
MEKO
volume
devoted
to
this
use,
exposed
populations
and
1259
exposure
level
estimates
may
have
been
severely
underestimated
or
left
as
a
data
gap
(
not
1260
estimated).
Such
underestimations
and
data
gaps
can
artificially
lower
the
appropriate
level
of
1261
concern
for
potential
risk(
s)
from
a
chemical.
1262
The
usefulness
of
IURA
data
elements
is
also
demonstrated
by
EPA's
use
of
similar
data
1263
in
its
New
Chemicals
Program.
Premanufacture
Notices
(
PMNs)
for
new
chemical
substances
1264
submitted
to
EPA
under
TSCA
section
5
require
many
of
the
same
exposure­
related
data
1265
elements
that
will
be
reported
under
the
IUR
Amendments.
Exposure­
related
data
in
PMNs
1266
include
estimates
of
production
volume,
categories
of
use,
percent
production
volume
in
the
1267
categories
of
use,
maximum
numbers
of
workers
exposed,
and
concentrations
and
physical
forms
1268
of
the
chemical.
EPA
uses
these
exposure­
related
data
to
generate
screening­
level
risk
1269
assessments
for
regulatory
decision
making
under
TSCA
section
5.
1270
The
manufacturer
of
a
new
chemical
provided
the
following
information
in
a
recent
PMN
1271
submission:
an
estimated
import
volume;
chemical
uses
and
the
percentages
of
the
import
volume
1272
devoted
to
each
use
(
cosmetic
applications
exempt
from
TSCA
(
25%)
and
non­
cosmetic
1273
applications
as
a
component
of
a
fragrance
formulation
used
in
household
products
such
as
1274
detergents,
cleaners,
soaps,
room
fresheners,
etc.
(
75%));
numbers
of
sites
and
workers;
and,
1275
consumer
product
information
(
weight
percent
in
products).
EPA
used
this
information
in
1276
combination
with
technical
references
and
other
research
to
estimate
the
number
of
manufacturers
1277
of
household
products
who
may
use
the
new
substance.
Releases
of
the
new
substance
from
the
1278
fragrance
formulation
process
and
from
the
household
products
manufacturers
were
estimated,
1279
60
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
resulting
in
estimated
environmental
concentrations
of
the
new
substance
due
to
its
release
and
1280
estimated
general
population
exposures
to
the
new
substance.
EPA
also
used
the
information
on
1281
processing
and
use
in
combination
with
modeling
techniques
to
estimate
the
numbers
of
workers
1282
and
consumers
who
may
be
exposed
to
the
new
substance
and
their
estimated
exposures
to
the
1283
new
substance.
These
exposure­
related
estimates,
when
combined
with
information
on
the
1284
estimated
hazards
of
the
new
substance,
indicated
that
the
estimated
risks
to
potentially­
exposed
1285
workers,
the
general
population,
consumers,
and
aquatic
species
were
all
below
levels
of
concern.
1286
Therefore,
because
EPA
did
not
identify
any
significant
risks,
the
Agency
could
determine
that
no
1287
further
regulation
under
TSCA
section
5
was
needed
for
this
new
substance.
In
contrast,
without
1288
this
information,
EPA
would
have
had
to
rely
on
generic
assumptions
for
approximating
potential
1289
exposures.
These
types
of
assumptions
are
intended
to
be
conservative
in
nature
and
therefore
1290
often
result
in
higher
than
likely
exposure
estimates.
1291
Information
from
the
amended
IUR
may
also
be
used
in
efforts
to
identify
single
chemicals
1292
to
support
potential
exposure
prevention
efforts.
For
example,
EPA
recently
learned
that
certain
1293
imports
of
zinc
sulfate
were
contaminated
with
cadmium.
Using
the
IURA
processing
and
use
1294
data
on
inorganic
substances,
EPA
could
have
quickly
identified
importers
of
zinc
sulfate
and
1295
segments
of
industry
or
the
general
population
that
might
use
the
chemical.
EPA
then
could
have
1296
targeted
warnings
of
the
potential
for
exposure
to
cadmium
more
effectively,
thereby
preventing
1297
exposures
to
these
groups
likely
to
be
the
most
highly
exposed.
1298
Other
Federal
Agencies
have
also
long
recognized
the
need
for
and
importance
of
1299
exposure
data.
OSHA,
NIOSH,
and
CPSC
have
written
letters
supporting
EPA's
and
their
own
1300
need
for
exposure
data
(
Refs.
9,
10,
17,
18,
and
19).
In
May
2000,
the
Government
Accounting
1301
Office
(
GAO)
stated
that
"
Various
federal
agencies
have
collected
such
human
exposure
data
for
1302
61
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
a
number
of
purposes;
historically,
these
collection
efforts
have
been
limited
to
selected
chemicals,
1303
subpopulations,
and
time
periods"(
Ref.
20).
1304
Other
government
agencies,
industry,
public
interest
groups,
and
the
public
in
general
will
1305
also
be
able
to
access
and
use
the
non­
CBI
portion
of
the
IURA
information.
The
IURA
1306
exposure­
related
data
will
be
important
to
users
beyond
those
who
accessed
the
original
IUR
in
1307
the
past
solely
for
production
volume
information.
The
Natural
Resources
Defense
Council,
for
1308
example,
has
expressed
interest
in
using
the
IURA
information
(
Ref.
21).
In
another
case,
1309
persons
interested
in
reviewing
the
HPV
Challenge
Program
screening­
level
hazard
data
(
see
1310
http://
www.
epa.
gov/
opptintr/
chemrtk/
volchall.
htm)
will
be
able
to
use
the
exposure­
related
IURA
1311
data
(
non­
CBI
data)
to
put
the
hazard
data
into
context.
Risks
identified
via
evaluation
of
these
1312
screening­
level
hazard
and
exposure
data
then
can
be
addressed.
1313
This
section
described
a
wide
variety
of
uses
for
the
new
IURA
exposure­
related
data.
1314
However,
the
Agency
anticipates
that
even
more
opportunities
exist
for
use
of
this
information,
as
1315
was
true
for
the
basic
production
data
reported
under
the
current
IUR.
1316
2.
What
is
the
practical
utility
of
the
new
exposure­
related
data?
Commenters
have
1317
questioned
whether
the
data
collected
as
a
part
of
this
rulemaking
will
have
"
practical
utility."
1318
Practical
utility
is
defined
in
the
Paperwork
Reduction
Act
of
1995
(
PRA)
(
44
U.
S.
C.
3502(
11))
1319
to
mean
"
the
ability
of
an
Agency
to
use
information,
particularly
the
capability
to
process
such
1320
information
in
a
timely
and
useful
fashion."
The
Office
of
Management
and
Budget's
(
OMB)
1321
regulatory
definition
of
"
practical
utility"
at
5
CFR
Part
1320.3(
l)
addresses
not
only
the
1322
theoretical
or
potential
usefulness
of
information
to
an
Agency,
but
also
its
actual
usefulness,
1323
taking
into
account
its
accuracy,
validity,
adequacy,
and
reliability,
the
Agency's
ability
to
1324
process
the
information
in
a
useful
and
timely
fashion,
and
whether
the
Agency
demonstrates
1325
62
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
actual
timely
use
of
the
data
by
the
Agency's
own
functions.
The
following
discussion
addresses
1326
commenters'
concerns
in
two
parts:
first,
the
adequacy,
accuracy,
validity,
and
reliability
of
the
1327
data;
and
second,
the
timely
use
of
the
data
by
EPA.
1328
a.
How
has
the
Agency
ensured
that
the
data
will
be
accurate,
valid,
adequate,
and
1329
reliable?
Commenters
asserted
that
the
data
EPA
proposed
to
collect
through
the
amended
IUR
1330
will
not
be
adequate
for
the
purposes
stated
by
EPA,
and
will
not
be
accurate,
valid,
or
reliable.
1331
Commenters
stated
that
the
information
collected
through
the
IURA
would
be
of
limited
accuracy
1332
and
would
be
inferior
to
data
the
Agency
has
collected
in
other
programs.
Commenters
also
1333
stated
that
the
information
will
be
so
uncertain
that
it
will
not
be
useful
to
predict
chemical
risk,
1334
and
that
there
are
so
many
other
factors
that
affect
exposure,
such
as
engineering
controls,
that
1335
the
data
will
provide
a
limited
and
potentially
inaccurate
view
of
potential
exposure.
Additionally,
1336
commenters
asserted
that
they
do
not
know
how
their
chemicals
are
used
downstream
of
the
1337
manufacturing
site,
resulting
in
data
that
are
unreliable.
1338
EPA
considered
the
types
of
information
needed
for
screening­
level
exposure
and
risk
1339
assessments
and
believes
the
information
that
will
be
collected
through
the
amended
IUR
will
1340
have
the
necessary
level
of
adequacy,
accuracy,
validity,
and
reliability
for
such
assessments.
EPA
1341
agrees
that
there
are
many
ways
to
increase
the
accuracy,
validity,
and
reliability
of
the
data.
1342
However,
in
developing
the
amended
IUR
and
considering
various
alternatives,
EPA
relied
on
1343
experience
from
programs
such
as
TSCA's
PMN
program
and
the
UEIP
data
collection,
and
1344
maintained
a
balance
between
data
needs
for
exposure
screening
and
priority
setting
and
the
1345
burden
associated
with
providing
the
information.
If
the
Agency
had
required
very
precise,
1346
specific
reporting,
submitter
burden
would
have
increased
beyond
that
which
is
appropriate
for
a
1347
screening­
level
data
collection.
EPA
also
agrees
that
there
are
many
factors
that
can
affect
1348
63
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
exposure
potential;
however,
the
data
provided
by
the
submitters
will
provide
baseline
information
1349
sufficient
for
an
initial
screen
of
exposure
potential.
1350
i.
Adequacy
of
the
data.
Before
proposing
the
IUR
Amendments,
EPA
analyzed
various
1351
exposure
data
collections
and
assessments
to
determine
the
data
elements
needed
for
a
screening
1352
level
exposure
assessment.
This
discussion
and
analysis
are
in
the
document
  
Inventory
Update
1353
Rule
(
IUR)
Amendment
Technical
Support
Document:
Exposure­
Related
Data
Useful
for
1354
Chemical
Risk
Screening''
(
Ref.
11).
Commenters'
suggestions
implied
that
more
extensive
1355
information
about
exposures
would
be
necessary
for
even
a
screening
level
analysis
of
potential
1356
exposure.
One
commenter
stated
that
there
are
many
other
factors
that
can
significantly
affect
the
1357
potential
for
exposure.
These
factors
include
engineering
controls
and
personal
protective
1358
equipment
practices,
the
nature
of
the
activities
in
which
workers
are
engaged,
and
the
1359
physicochemical
characteristics
of
the
chemical
substances.
This
commenter
also
stated
that
the
1360
data
collected
under
IURA
will
provide
a
limited
and
potentially
inaccurate
view
of
potential
1361
exposure.
However,
as
summarized
in
Unit
III.
A.
1.
of
this
preamble,
risk
analyses
performed
by
1362
the
Agency
in
general
and
OPPT
in
particular
are
graduated
and
data­
driven.
As
the
initial
levels
1363
of
concern
and
the
quantity
and
quality
of
data
increase,
the
need
for
methodologies
used
in
risk
1364
review
become
more
detailed
and
exacting,
while
the
reviews
become
more
accurate
and
reliable.
1365
Based
on
its
experience
assessing
chemical
risks
through
such
programs
as
the
TSCA
New
1366
Chemicals
Program,
the
Agency
believes
the
IURA
data
will
provide
information
adequate
to
1367
perform
initial
screens
of
chemicals.
The
Agency
also
believes
that
it
will
be
able
to
prioritize
and
1368
make
basic
risk
management
decisions
about
those
chemicals
of
greatest
concern
as
indicated
by
1369
the
available
data.
These
better
informed
decisions
can
enhance
confidence
that
the
most
1370
appropriate
chemicals
are
selected
for
more
detailed
assessments.
1371
64
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
ii.
Accuracy
and
reliability
of
the
data.
The
Agency
considered
the
data
accuracy
and
1372
reliability
needed
for
screening
level
exposure
analyses,
and
took
several
steps
to
ensure
the
1373
IURA
data
meet
those
needs.
Screening
level
data
need
not
be
absolutely
precise,
but
should
be
1374
accurate
and
reliable
enough
to
make
usable
and
defensible
technical
assessments.
The
amended
1375
IUR
will
supply
exposure­
related
information
the
Agency
currently
does
not
have,
recognizing
1376
that
industry
has
a
greater
knowledge
than
EPA
about
its
own
operations
and
the
uses
of
1377
chemicals
it
manufactures
and
sells.
Without
this
information,
EPA
either
would
not
screen
these
1378
chemicals,
would
screen
them
using
outdated
or
anecdotal
exposure
information,
or
would
rely
on
1379
exposure
estimates
(
typically
conservative)
using
modeling
data
.
1380
Commenters
stated
that
the
accuracy
and
reliability
of
much
of
the
information
reported
in
1381
Part
III
of
the
revised
Form
U
(
section
710.32(
c)(
4)
of
the
regulatory
text)
would
be
highly
1382
questionable
because
it
relates
to
sites,
activities,
and
products
that
are
not
under
the
direct
or
1383
indirect
control
of
the
reporting
company.
Industry
programs
such
as
the
American
Chemistry
1384
Council's
(
ACC;
formerly
the
Chemical
Manufacturers
Association)
Responsible
Care
Program
1385
(
see
http://
www.
cmahq.
com
for
more
information)
require
that,
as
part
of
the
program,
member
1386
companies
work
with
customers,
carriers,
suppliers,
distributors
and
contractors
to
foster
the
safe
1387
use,
transport
and
disposal
of
chemicals.
The
Responsible
Care
Program,
coupled
with
basic
1388
marketing
and
sales
force
activities,
suggest
that
companies
are
well
informed
about
downstream
1389
uses
of
their
chemicals.
EPA
recognizes
that
submitters
may
not
always
have
detailed
information
1390
about
how
the
chemical(
s)
they
make
are
used.
As
a
result,
submitters
will
only
be
required
to
1391
report
this
information
to
the
extent
it
is
"
readily
obtainable"
(
see
Unit
II.
F.
6.
a.
of
this
preamble).
1392
In
addition,
the
Agency
believes,
based
on
its
experience
with
the
New
Chemicals
Program,
the
1393
UEIP,
stakeholder
meetings,
discussions
with
industry
about
voluntary
risk
management
1394
65
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
programs,
and
industry's
various
self­
regulation
initiatives,
that
most
submitters
have
at
least
1395
some
basic
information
about
downstream
uses,
such
as
the
information
that
will
be
reported
1396
under
the
amended
IUR.
These
data
will
be
of
sufficient
reliability
for
use
by
the
Agency
and
1397
others
for
purposes
such
as
screening­
level
risk
assessments
and
prioritization.
1398
EPA
also
requires
much
of
the
IURA
information
to
be
submitted
in
EPA
specified
1399
ranges.
This
requirement
benefits
both
the
Agency
and
submitters.
First,
range
reporting
is
less
1400
burdensome
for
the
submitter
than
calculating
specific
quantity
estimates.
Demanding
greater
1401
data
accuracy
increases
the
burdens
associated
with
data
collection.
Second,
information
1402
reported
in
discrete
numeric
values
can
indicate
a
level
of
accuracy
that
is
not
necessarily
present.
1403
EPA
believes
that
a
higher
level
of
confidence
in
data
accuracy
can
be
achieved
by
specifying
1404
ranges.
1405
Commenters
suggested
that
EPA
use
other
methods
to
obtain
processing
and
use
1406
information,
such
as
voluntary
data
collection
programs.
However,
voluntary
industry
efforts
are
1407
not
uniformly
reliable
for
collecting
data,
and
the
Agency
generally
cannot
ensure
that
data
1408
submitted
under
voluntary
efforts
will
be
complete
and
accurate.
For
example,
the
Use
and
1409
Exposure
Information
Project
(
UEIP)
was
undertaken
by
EPA
and
the
Chemical
Manufacturers
1410
Association
(
CMA,
now
ACC),
the
Chemical
Specialty
Manufacturers
Association
(
CSMA),
the
1411
Synthetic
Organic
Chemical
Manufacturers
Association
(
SOCMA),
and
the
American
Petroleum
1412
Institute
(
API)
to
collect
relatively
detailed
information
on
60
high
production
volume
chemicals.
1413
EPA
received
data
for
48
of
the
60
UEIP
chemicals.
Many
of
the
forms
received
for
those
48
1414
chemicals
were
not
completely
filled
out,
and
only
a
subset
of
manufacturers
submitted
data.
1415
Thus,
while
the
information
that
EPA
received
was
quite
useful,
it
was
insufficiently
complete
to
1416
fulfill
expectations
for
a
data
collection
such
as
the
IURA.
Therefore,
EPA's
experience
with
1417
66
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
UEIP
is
an
indicator
that
data
collected
under
a
voluntary
effort
are
likely
to
be
uneven
and
fall
1418
short
of
meeting
EPA's
needs.
1419
iii.
Validity
of
the
data.
Another
commenter
had
concerns
about
the
validity
of
the
1420
worker
exposure
data
and
felt
that
an
auditing
program
would
be
necessary
to
ensure
an
1421
acceptable
quality
of
data.
1422
EPA
agrees
that
validated
exposure
data
are
the
most
useful
for
the
full
range
of
Agency
1423
risk
assessment
activities.
EPA's
experience
with
similar
data
collecting
efforts
such
as
TSCA's
1424
New
Chemical
Program
demonstrates
that
the
type
of
data
EPA
is
collecting
under
the
amended
1425
IUR
are
sufficient
for
the
purpose
of
screening
to
prioritize
follow­
on
efforts
for
risk
assessment
1426
and
management.
A
rigorous
validation
process
would
impose
significant
additional
burdens
on
1427
industry
and
the
Agency.
As
discussed
in
Unit
III.
A.
above,
EPA
exposure
and
risk
evaluations
1428
are
typically
tiered
and
data­
dependent:
the
level
of
detail
in
the
assessment
is
directly
1429
proportional
to
the
quantity
and
quality
of
the
available
data,
while
the
level
of
uncertainty
is
1430
inversely
proportional
to
those
factors.
The
IURA
data
will
be
useful
to
the
Agency
in
evaluating
1431
potential
exposures
and
risks,
serving
as
indicators
as
to
what
levels
and
types
of
exposures
from
1432
which
chemicals
need
greater
review
and
possible
attention.
1433
b.
Will
the
Agency
use
the
data
in
a
timely
manner?
Many
commenters
questioned
1434
whether
EPA
will
be
able
to
make
effective
and
timely
use
of
the
IURA
processing/
use
1435
information,
stating
that
the
large
amount
of
data
submitted
would
overwhelm
the
Agency.
EPA
1436
acknowledges
that
the
IURA
will
generate
a
significant
quantity
of
new
data
that
EPA
has
not
1437
handled
under
past
IUR
data
collections.
However,
EPA
has
carefully
designed
the
IUR
1438
Amendments
data
collection
to
facilitate
efficient
data
management
and
use.
Data
collected
1439
through
the
amended
IUR
will
be
put
into
a
relational
database
format,
which
can
be
easily
1440
67
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
searched,
compared,
and
used.
The
collection
of
specific
data,
organized
by
codes
rather
than
1441
textural
information
presented
in
a
unstructured
manner,
lends
itself
to
such
a
database
format.
In
1442
addition,
providing
for
electronic
IURA
submissions
allows
data
to
be
entered
into
the
database
1443
more
accurately
and
expeditiously,
resulting
in
a
quick
turnaround
between
the
submission
of
the
1444
data
to
the
Agency
and
the
availability
of
the
data
for
use.
The
Agency
anticipates
that
1445
approximately
95%
of
all
reports
will
be
submitted
electronically
or
on
disks,
as
opposed
to
hard
1446
copies.
This
compares
with
70%
that
were
submitted
on
disks
in
1998.
These
IUR
amendments
1447
will
facilitate
EPA's
information
management
and
the
data
will
be
available
quickly
for
the
1448
Agency's
use.
1449
3.
Why
doesn't
EPA
use
other
available
sources
of
data
or
mechanisms
to
collect
the
1450
data
sought
under
the
amended
IUR?
EPA
requested
comments
on
specific
mechanisms
or
data
1451
sources
it
could
use
to
obtain
needed
exposure­
related
information
with
greater
ease
and
less
1452
burden
to
industry.
Commenters
responded
with
a
variety
of
sources,
ranging
from
current
data
1453
collection
mechanisms
within
EPA
(
such
as
TSCA
8(
a)
PAIR,
UEIP,
and
cooperative
approaches
1454
such
as
the
Diisocyanates
Panel
Dialogue
Group's
response
to
the
TSCA
Interagency
Testing
1455
Committee)
to
public
data
sources
such
as
the
Hazardous
Substances
Data
Bank
(
HSDB).
In
1456
addition,
many
commenters
stated
that
EPA
has
not
made
effective
use
of
the
exposure­
related
1457
data
it
has
collected
already
under
current
or
prior
rules.
For
example,
they
stated
that
data
1458
collected
under
two
other
TSCA
rules
 
the
PAIR
and
CAIR
rule
 
have
not
been
used
1459
effectively
to
support
Agency
risk
assessment
or
risk
management
decisions.
Commenters
went
1460
on
further
to
say
that
under
the
voluntary
Use
and
Exposure
Information
Project
(
UEIP),
EPA
1461
was
furnished
exposure­
related
data
on
60
HPV
chemicals
(
actually
only
48),
but
only
two
1462
reached
the
initial
risk
assessment
stage.
1463
68
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
The
alternate
data
sources
commenters
described
were
generally
sources
that
EPA
had
1464
already
evaluated
in
its
analysis
for
the
proposed
rule
or
with
which
EPA
was
otherwise
familiar.
1465
EPA
explored
a
wide
variety
of
public
data
sources,
as
demonstrated
in
the
following:
"
Inventory
1466
Update
Rule
(
IUR)
Amendments
Technical
Support
Document:
Exposure­
Related
Data
Useful
1467
for
Chemical
Risk
Screening"
(
Ref.
11),
"
Economic
Analysis
of
Proposed
Amendments
to
the
1468
TSCA
Section
8
Inventory
Update
Rule"
(
Ref.
22),
and
"
A
Review
of
Existing
Exposure­
Related
1469
Data
Sources
and
Approaches
to
Screening
Chemicals:
A
Response
to
CMA"(
Ref.
23)
(
see
also
1470
Unit
V.
B.
5.
of
the
proposed
rule
(
64
FR
46772,
46778)).
Commenters
did
not
provide
EPA
with
1471
any
new
sources
or
additional
support
for
these
alternate
data
sources.
EPA
believes
the
decision
1472
not
to
use
an
alternate
data
source
as
a
replacement
for
amending
the
IUR
is
still
confirmed
by
the
1473
Agency's
support
documents.
1474
EPA
has
spent
considerable
effort
and
resources
evaluating
other
data
sources
that
could
1475
potentially
provide
the
accurate
and
up­
to­
date
information
that
the
Agency
needs.
A
primary
1476
consideration,
as
mandated
by
TSCA,
was
not
to
subject
industry
to
unnecessary
or
duplicative
1477
reporting.
The
exposure
information
sought
under
the
IURA
is
not
currently
accessible
to
EPA.
1478
Although
some
useful
exposure­
related
data
exist
in
some
sources,
the
data
are
insufficient,
1479
typically
because
they
lack
currency
and
detail.
Without
the
IURA,
EPA
has
difficulty
efficiently
1480
screening
potential
risks
posed
by
a
large
number
of
chemicals
on
the
TSCA
Inventory.
1481
Commenters
stated
that,
if
EPA
were
to
have
specific
concerns
about
information
1482
collection
for
substances
or
categories,
the
selective
use
of
TSCA
Preliminary
Assessment
1483
Information
Reporting
(
PAIR)
(
40
CFR
part
712)
reporting
would
be
more
cost
effective
than
1484
requiring
all
manufacturers
exceeding
a
production
trigger
to
report
production,
use,
and
1485
exposure
information.
EPA
disagrees
with
the
suggestion
that
PAIR
rules
would
be
an
efficient
1486
69
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
or
cost
effective
way
to
compile
a
database
to
allow
the
large­
scale
risk
screening
of
chemicals
on
1487
the
TSCA
Inventory.
PAIR
is
a
very
useful
data
collection
tool
when
one
or
a
small
group
of
1488
chemicals
is
targeted
for
risk
assessment;
however,
PAIR
is
limited
when
collecting
information
1489
on
a
large
number
of
chemicals.
Additionally,
the
PAIR
rule
has
fewer,
less
definitive
data
1490
elements
than
the
IURA,
is
a
one­
time
collection
versus
the
every
four
years
collection
of
the
1491
IURA,
and
will
not
provide
data
sufficient
to
meet
the
goals
of
the
IURA.
Use
of
PAIR
only
1492
implies
that
EPA
should
continue
to
set
risk
screening
priorities
based
on
hazard
and
production
1493
volume
alone,
or
in
response
to
requests
from
others.
As
discussed
in
the
document
entitled
"
A
1494
Review
of
Existing
Exposure­
Related
Data
Sources
and
Approaches
to
Screening
Chemicals:
A
1495
Response
To
CMA"
(
Ref.
23),
this
approach
greatly
hinders
EPA's
ability
to
make
effective
and
1496
efficient
risk
management
decisions.
1497
EPA
plans
to
continue
using
existing
data
sources
and
information
sets.
However,
the
1498
existing
sources
are
generally
best
used
when
conducting
a
more
detailed
risk
assessment
of
a
1499
specific
chemical
of
concern,
rather
than
preliminary
risk
screening
of
a
large
set
of
chemicals.
1500
The
amended
IUR
submissions
will
provide
a
consistent
set
of
screening­
level
exposure
data
that
1501
will
allow
EPA
to
better
identify
on
a
relative
basis
the
chemicals
of
highest
priority
for
further
1502
risk
evaluation.
EPA
will
use
the
amended
IUR
data
to
identify
those
specific
chemicals
which
1503
are
of
potential
concern
and
need
follow
up
assessment.
For
instance,
the
amended
IURA
1504
exposure
data
integrated
with
HPV
Challenge
Program
hazard
data
will
provide
the
input
needed
1505
to
effectively
develop
risk­
based
priorities
for
more
detailed
assessment
of
chemicals.
Once
EPA
1506
has
determined
that
a
specific
chemical
(
or
group
of
chemicals)
has
sufficient
potential
for
1507
exposure
or
risk
to
warrant
further
assessment,
the
Agency
will
use
the
other
information
sources
1508
and
data
gathering
tools
as
appropriate.
1509
70
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
4.
Can
TSCA
Information
Be
Used
for
Right­
to­
Know
Purposes?
Some
of
the
1510
commenters
stated
that
TSCA
does
not
authorize
EPA
to
promulgate
the
IURA
based
in
part
on
1511
EPA's
goal
of
providing
"
right­
to­
know"
information
to
non­
governmental
entities
and
private
1512
organizations.
In
addition,
some
commenters
noted
that
OSHA
and
other
agencies
have
their
1513
own
authorities
to
collect
information
on
chemicals.
1514
TSCA
contains
many
of
the
principles
embodied
in
the
right­
to­
know
concept.
For
1515
instance,
TSCA
section
14(
b)
specifically
authorizes
EPA
to
disclose
health
and
safety
data
1516
collected
under
the
statute.
TSCA
section
14
embodies
the
legislative
determination
that
certain
1517
TSCA
data
should
be
available
to
the
public
and
interested
parties.
In
addition,
sections
4,
5,
6,
1518
as
well
as
section
21,
for
example,
provide
opportunities
for
public
participation
in
chemical
1519
management
decisions.
Participation
must
be
meaningful,
and
to
be
meaningful
the
public
must
1520
have
access
to
TSCA
non­
confidential
information.
1521
TSCA
was
designed
in
part
to
address
the
lack
of
health,
safety,
and
exposure
information
1522
government
agencies
and
the
public
faced
in
dealing
with
chemicals.
See,
H.
R.
Rep.
94­
1341
at
6
1523
(
1976),
reprinted
in
Legislative
History
of
the
Toxic
Substances
Control
Act,
at
414
(
1976)
1524
("
Present
authorities
for
protecting
against
and
regulating
hazardous
chemicals
are
fragmented
1525
and
inadequate
.
.
.
Most
significant
among
the
deficiencies
are
.
.
.
(
3)
No
authority
exists
for
1526
collection
of
data
to
determine
the
totality
of
human
and
environmental
exposure
to
chemicals.").
1527
TSCA
was
seen
as
a
way
of
providing
federal
agencies
and
the
public
with
access
to
health,
1528
safety,
and
exposure
data
so
that
the
risks
of
chemical
substances
could
be
more
fully
evaluated
1529
and
understood.
See,
Statement
of
Sen.
Hartke,
Cong.
Rec.,
March
26,
1976
[
S4397­
4432],
1530
reprinted
in
Legislative
History
of
the
Toxic
Substances
Control
Act,
at
218
(
1976)
("[
T]
he
1531
essential
element
of
this
legislation
is
that
it
has
attempted
to
provide
for
the
individual­
not
only
1532
71
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
who
works,
but
for
the
rest
of
American
society­
the
right
to
know
what
is
in
store
as
far
as
the
1533
toxicity
of
the
chemicals
is
concerned.").
In
light
of
these
statements,
Congress
envisioned
TSCA
1534
as
a
method
of
providing
the
public
and
others
with
health,
safety,
and
exposure
information
1535
about
chemical
substances.
1536
Finally,
TSCA
does
not
limit
use
or
disclosure
of
data
(
except
if
data
is
considered
1537
confidential)
collected
under
the
statute.
Congress
drafted
TSCA
in
part
to
provide
basic
health,
1538
safety,
and
exposure
information
to
other
federal
agencies,
as
well
as
state,
local
and
international
1539
governments.
TSCA
provides
several
mechanisms­­
TSCA
sections
9,
10
and
12
for
example­­
1540
for
sharing
health
and
safety
data
among
various
levels
of
government.
These
sections
again
1541
demonstrate
TSCA's
role
as
a
tool
for
gathering
and
disseminating
information
regarding
1542
chemical
risk.
1543
B.
Comments
on
Specific
Data
Elements
1544
1.
Manufacturing
Information.
a.
Physical
Form.
EPA
requested
comment
on
its
1545
proposed
requirement
that
submitters
report
the
physical
form
of
a
chemical
as
it
leaves
the
site
of
1546
manufacture.
Several
commenters
suggested
variations
on
the
specifics
of
physical
form
1547
reporting,
but
generally
agreed
with
reporting
the
physical
form
as
the
chemical
leaves
the
site
of
1548
manufacture.
For
instance,
one
commenter
suggested
expanding
the
types
of
physical
forms
that
1549
can
be
reported.
EPA
has
determined
that
the
six
categories
proposed
(
see
section
1550
710.32(
c)(
3)(
viii)
of
the
regulatory
text)
will
be
adequate
for
risk
screening
purposes,
and
is
not
1551
adding
additional
physical
form
categories
at
this
time.
Experience
with
the
same
six
physical
form
1552
categories
as
part
of
EPA's
exposure
screening
assessment
of
over
20,000
chemicals
in
its
New
1553
Chemicals
Program
indicates
that
the
categories
of
physical
forms
that
EPA
is
using
under
the
1554
IURA
will
be
adequate.
1555
72
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
Other
commenters
recommended
that
EPA
allow
submitters
to
report
more
than
one
1556
physical
form
for
each
reportable
substance,
because
a
substance
may
leave
a
site
in
more
than
1557
one
physical
form.
EPA
agrees
with
this
comment
and
is
requiring
in
this
final
rule
that
submitters
1558
report
all
physical
forms
of
a
substance
when
the
substance
is
sent
off­
site.
Reporting
on
all
1559
physical
forms
in
the
IURA
will
lead
to
a
better
assessment
of
exposure
to
a
chemical
substance.
1560
For
example,
processing
a
fine,
nonagglomerating
powder
could
result
in
occupational
exposure
1561
by
inhalation
of
chemical
dust.
Processing
the
same
chemical
as
a
liquid
solution
would
eliminate,
1562
or
at
least
reduce,
the
inhalation
risk
(
the
liquid
could
become
an
aerosol
and
be
inhaled,
1563
depending
on
the
processing
activity).
By
combining
data
elements
on
the
physical
form
of
a
1564
chemical
substance,
its
production
volume,
and
the
fraction
directed
to
each
industrial
processing
1565
or
use
activity,
a
screening
estimate
of
the
potential
exposure
associated
with
manufacturing
or
1566
processing
of
a
chemical
substance
can
be
derived.
The
resulting
exposure
assessment
will
be
1567
more
representative
and
less
conservative
than
if
the
physical
form(
s)
were
unknown.
For
these
1568
reasons,
EPA
is
requiring
the
reporting
of
all
physical
forms
in
which
a
chemical
substance
leaves
1569
the
manufacturing
site.
1570
b.
Concentration.
EPA
originally
proposed
to
require
the
reporting
of
both
maximum
1571
and
average
concentrations
of
each
reportable
chemical
substance
at
the
time
the
substance
is
sent
1572
off­
site.
A
number
of
commenters
felt
that
this
information
would
be
difficult
to
report
for
the
1573
following
reasons:
chemicals
may
be
used
in
many
product
formulations
at
a
given
plant
site
and
1574
there
may
often
be
no
consistent
average
or
maximum
concentration
of
an
individual
chemical
1575
across
these
formulations;
such
information
does
not
reside
in
any
currently
available
databases
1576
and
would
need
to
be
generated
for
IUR
reporting
(
which
would
be
particularly
difficult
with
1577
respect
to
average
concentration
information);
and
average
and
maximum
concentrations
may
1578
73
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
vary
in
product
formulations
during
different
IUR
reporting
cycles.
Commenters
suggested
that
1579
maximum
concentration
information
will
be
misleading
if
only
a
small
amount
of
the
reportable
1580
chemical
substance
is
made
available
commercially
at
that
concentration,
while
the
bulk
of
the
1581
total
quantity
leaving
the
site
has
a
lower
concentration.
They
also
indicated
that
determining
1582
average
concentration
requires
a
complicated
calculation
which
falls
outside
the
definition
of
1583
"
reasonably
ascertainable"
information.
Commenters
suggested
that
average
concentration
can
be
1584
calculated
by
product
or
by
the
weighted
average
of
each
product,
and
each
of
the
calculations
1585
can
result
in
tremendously
different
answers.
1586
The
Agency
has
determined
that
average
concentration
information
is
not
critical
for
1587
purposes
of
screening­
level
exposure
assessment
and
has
eliminated
this
element
from
the
IURA.
1588
Screening
level
review
is
typically
meant
to
serve
as
a
method
of
identifying
chemicals
that
even
at
1589
their
maximum
concentration
would
not
potentially
endanger
human
health
or
the
environment.
1590
Average
concentration
information
cannot
be
used
to
make
such
a
determination.
1591
EPA
recognizes
that
the
concentration
of
an
IUR­
reportable
chemical
may
vary
from
1592
shipment
to
shipment
leaving
a
submitter's
site.
However,
maximum
concentration
is
to
be
1593
reported
in
wide
ranges
and
not
specific
numbers,
thereby
alleviating
the
need
to
determine
1594
specific
concentrations.
Additionally,
EPA
does
not
intend
for
submitters
to
go
to
great
lengths
1595
to
determine
what
maximum
concentration
ranges
to
select
for
IUR
reporting.
Instead,
EPA
is
1596
simply
requiring
that
submitters
select
a
range
of
concentrations
from
a
list
of
given
ranges
(
less
1597
than
1%
by
weight;
1­
30%
by
weight;
31­
60%
by
weight;
61
­
90%
by
weight,
and
greater
that
1598
90%
by
weight)
to
indicate
the
maximum
concentration
of
an
IUR­
reportable
chemical
in
1599
shipments
leaving
the
submitter's
site
or
when
reacted
on­
site
to
produce
a
different
chemical
1600
substance.
1601
74
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
One
commenter
was
concerned
that
EPA
did
not
specify
whether
it
would
require
1602
submitters
to
conduct
specific
chemical
testing
or
statistical
analysis
in
order
to
report
1603
concentration
data,
or
whether
submitters
should
merely
estimate
concentrations.
In
addition,
1604
the
commenter
was
unsure
whether
a
submitter
should
report
the
maximum
concentration
level
1605
for
each
product
it
sells/
imports,
or
simply
estimate
the
overall
maximum
concentration
of
the
1606
chemical
substance.
EPA
recognizes
that
concentration
data
may
vary
from
product
to
product
1607
and
from
shipment
to
shipment,
and
may
be
difficult
to
report
in
some
instances,
particularly
in
1608
product
formulations.
EPA
is
not
requiring
the
reporting
of
concentrations
in
all
products
and
1609
formulations
but
rather
only
one
maximum
concentration,
regardless
of
the
chemical
substance's
1610
physical
form(
s)
or
product
formulation(
s).
Because
concentration
information
will
be
reported
in
1611
ranges
and
not
as
individual
values,
this
information
or
at
least
an
estimate
should
be
known
to
or
1612
reasonably
ascertainable
by
most
submitters.
Providing
the
information
generally
should
not
1613
require
specific
chemical
testing
or
statistical
analysis
beyond
any
testing
or
analyses
already
done
1614
by
the
submitter
as
part
of
normal
operations.
EPA
anticipates
that
chemical
importers
will
1615
frequently
receive
maximum
concentration
information
from
their
suppliers,
and
manufacturers
1616
will
obtain
this
information
from
samples
analyzed
for
quality
control.
This
information
is
often
1617
found
in
the
physical
property
or
hazardous
constituents
sections
of
the
MSDS.
Reporters
are
1618
not
expected
to
conduct
chemical
testing
specifically
for
reporting
maximum
concentration
1619
information
to
the
IUR.
1620
2.
Industrial
Processing
and
Use.
The
Agency
received
three
comments
regarding
the
1621
industrial
function
categories
(
IFCs)
to
be
reported
by
submitters
that
have
plant
sites
at
which
1622
300,000
lbs.
or
more
of
a
reportable
chemical
substance
are
manufactured.
The
first
comment
1623
questioned
how
the
IFCs
would
apply
to
chemicals
with
multiple
industrial
uses.
The
second
1624
75
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
comment
suggested
that
the
Agency
provide
submitters
with
a
"
free
response"
option
if
their
1625
industrial
function
is
not
represented
among
the
IFCs.
The
third
comment
stated
that
the
IFCs
1626
selected
by
EPA
are
adequate.
1627
Submitters
are
required
to
report
up
to
ten
unique
combinations
of
processing
and
use
1628
categories,
IFCs,
and
NAICS
codes
(
see
sections
710.32(
c)(
4)(
i)(
A),
(
B),
and
(
C)
of
the
1629
regulatory
text).
In
making
their
selection
from
among
the
IFC
codes,
submitters
must
determine
1630
which
IFC
best
represents
the
specific
industrial
use
of
the
reportable
chemical
within
a
given
1631
NAICS
code/
processing
and
use
category.
The
Agency
will
provide
examples
of
how
to
select
1632
which
code
"
best
represents"
an
industrial
use
in
the
instruction
manual
that
will
be
available
to
all
1633
submitters
(
see
section
710.40
of
the
regulatory
text).
Submitters
may
report
multiple
IFCs
for
1634
the
same
NAICS
code,
and
multiple
NAICS
codes
may
be
paired
with
the
same
IFC.
Unit
II.
F.
7.
1635
of
this
preamble
provides
further
information
on
reporting
industrial
processing
and
use
1636
information.
1637
The
set
of
IFCs
adopted
by
EPA
at
section
710.32(
c)(
4)(
i)(
C)
encompasses
the
vast
1638
majority
of
uses
for
chemicals
subject
to
IUR
reporting.
EPA
did
not
include
all
IFCs
or,
as
one
1639
commenter
suggested,
allow
the
submitter
to
supply
an
IFC
not
on
the
EPA
list
because
the
1640
Agency
wishes
to
limit
the
number
of
scenarios
which
must
be
analyzed
for
risk
characterization.
1641
By
aggregating
similar
uses
under
a
single
NAICS
and
a
single
IFC
code,
EPA
will
be
able
to
1642
more
effectively
characterize
the
risk
associated
with
the
totality
of
the
production
of
each
1643
chemical
substance.
By
requiring
the
submitter
to
identify
the
appropriate
IFC
code(
s)
from
the
1644
provided
list,
EPA
seeks
to
minimize
the
errors
that
could
occur
if
the
Agency,
rather
than
the
1645
submitter,
attempted
to
aggregate
uses
other
than
those
identified
in
the
prescribed
list
of
IFCs.
1646
3.
Commercial
and
Consumer
Use.
a.
Commercial
and
consumer
product
categories.
1647
76
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
In
the
proposed
rule,
the
Agency
requested
comment
on
the
appropriateness
of
the
commercial
1648
and
consumer
product
categories.
Commenters
had
a
range
of
opinions
about
the
proposed
1649
categories.
One
commenter
felt
that
EPA
should
adopt
the
use
categories
used
by
the
European
1650
Commission
(
EC)
(
Ref.
24).
Another
commenter
stated
that
the
categories
appear
to
be
1651
adequate.
A
third
commenter
suggested
that
the
"
C­
19
Other"
category
be
deleted
and
that
the
1652
Agency
consider
requiring
the
submitter
to
identify
the
specific
use.
1653
EPA
is
not
changing
the
commercial
and
consumer
product
use
categories
at
this
time,
1654
although
the
Agency
may
revisit
these
categories
in
the
future
should
a
need
arise
for
more
1655
specific
commercial
and
consumer
use
information.
EPA
has
evaluated
the
EC's
set
of
use
1656
categories
and
has
determined
that
these
categories
blend
functional
use
information
with
end
use
1657
information.
They
therefore
constitute
a
more
complex
identification
system
than
the
one
that
1658
will
be
used
under
the
IURA.
For
the
screening
level
purposes
of
the
amended
IUR
data,
EPA
1659
currently
believes
that
focusing
on
end
use
information
alone
for
commercial
and
consumer
uses
1660
provides
the
necessary
level
of
detail
for
its
screening­
level
reviews.
EPA
is
concerned
that
the
1661
use
of
EC's
scheme
for
the
commercial
and
consumer
reporting
would
be
overly
burdensome
for
1662
the
current
needs
identified
by
EPA,
due
to
the
greater
number
of
categories
(
55
EC
categories
1663
vs.
19
IURA
categories).
Further
guidance
on
the
relationship
between
EC
and
IURA
categories
1664
can
be
found
in
"
Guidance
Document:
2006
Reporting
for
Updating
the
Chemical
Substances
1665
Inventory
Database
Under
the
Toxic
Substances
Control
Act
(
TSCA)."
1666
In
addition,
the
EC
system
does
not
appear
to
describe
the
commercial
or
consumer
end
1667
uses
in
a
way
that
meets
the
needs
identified
by
EPA
and
targeted
by
the
IURA.
For
example,
a
1668
chemical
that
is
used
as
a
propellant
would
be
listed
under
the
category
"
aerosol
propellants"
1669
using
the
EC
system.
Such
a
listing
would
not
provide
the
Agency
with
the
information
it
needs
1670
77
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
about
the
type
of
commercial/
consumer
product
in
which
the
submitter
uses
the
propellant
(
e.
g.
1671
paint,
a
lubricant,
etc.).
For
more
information
on
EPA's
commercial
and
consumer
category
1672
analysis,
see
the
document
"
Inventory
Update
Rule
(
IUR)
Technical
Support
Document
Selection
1673
of
Consumer
and
Commercial
End­
Use
Categories."
(
Ref.
25)
EPA
will
provide
examples
of
the
1674
types
of
products
that
fit
into
its
commercial
and
consumer
product
categories
in
the
instruction
1675
manual
that
will
be
made
available
to
all
submitters
(
see
section
710.40
of
the
regulatory
text).
1676
EPA
considered
requiring
submitters
to
identify
the
specific
use
of
the
product,
rather
than
1677
allow
them
to
use
a
miscellaneous
"
Other"
category,
however
the
Agency
prefers
to
require
1678
submitters
to
choose
from
among
the
commercial
and
consumer
product
categories
provided
at
1679
section
710.32(
c)(
4)(
ii)(
A)
of
the
regulatory
text.
The
Agency
wishes
to
limit
the
number
of
1680
scenarios
which
must
be
analyzed
for
risk
characterization.
By
aggregating
similar
product
1681
categories,
EPA
will
more
effectively
characterize
the
risk
associated
with
the
totality
of
the
use
1682
of
each
chemical
substance.
Requiring
the
submitter
to
identify
the
appropriate
product
1683
categories
from
the
provided
list
will
minimize
the
errors
that
could
occur
if
the
Agency,
rather
1684
than
the
submitter
,
attempted
to
aggregate
uses
other
than
those
identified
in
the
prescribed
list
1685
of
product
categories.
1686
b.
Non­
TSCA
End
Uses.
Three
commenters
requested
that
EPA
not
only
continue
to
1687
exempt
non­
TSCA
chemicals
(
such
as
pesticides,
drugs,
cosmetics,
etc.)
from
all
IURA
reporting,
1688
but
also
exempt
manufacturers
of
IURA­
reportable
TSCA
chemicals
from
the
requirement
that
1689
non­
TSCA
downstream
uses
be
reported
(
such
as
use
of
a
TSCA
chemical
by
a
downstream
1690
processor
in
making
a
pesticide,
etc.).
These
commenters
assert
that
EPA
does
not
have
1691
authority
under
TSCA
to
implement
requirements
of
this
sort.
1692
EPA
agrees
that
non­
TSCA
substances,
as
described
in
TSCA
section
3(
2)(
B),
are
1693
78
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
exempt
from
all
TSCA
requirements
and
are
not
subject
to
reporting
under
the
amended
IUR.
1694
Therefore,
substances
that
are
intended
at
the
time
of
manufacture
to
be
used
for
non­
TSCA
1695
purposes
(
e.
g.,
as
a
pesticide,
as
a
drug)
do
not
have
to
be
reported.
1696
The
Agency
also
agrees
that
submitters
under
the
IURA
will
not
be
required
to
report
on
1697
the
non­
TSCA
downstream
uses
of
the
TSCA
chemicals
that
they
manufacture.
Descriptions
of
1698
industrial
function
categories
(
see
section
710.32(
c)(
4)(
i)(
C)
of
the
regulatory
text)
have
been
1699
clarified
to
reflect
the
fact
that
they
only
include
TSCA
uses.
For
example,
one
of
the
industrial
1700
function
categories
is
called
"
Agricultural
chemicals
(
non­
pesticidal)."
The
consumer
and
1701
commercial
product
categories
(
see
section
710.32(
c)(
4)(
ii)(
A)
of
the
regulatory
text)
are
also
1702
restricted
to
TSCA
uses.
An
example
of
one
of
these
categories
is
"
Lawn
and
garden
products
1703
(
non­
pesticidal)."
This
category
includes
chemicals
such
as
compressed
gasses
in
delivery
systems
1704
for
many
pesticides
used
indoors
and
outdoors,
and
other
intermediates
and
inert
chemicals,
but
1705
does
not
include
pesticides.
Additionally,
many
lawn
amendments
such
as
fertilizers
contain
1706
chemicals
that
may
be
regulated
under
TSCA,
(
e.
g.,
surfactants).
1707
c.
Exempt
reporting
of
use
information
for
chemicals
in
articles.
Two
commenters
1708
believed
that
to
the
extent
a
submitter's
reportable
chemical
is
used
in
an
article,
the
submitter
1709
should
be
exempt
from
the
reporting
of
consumer
and
commercial
end­
use
information
(
i.
e.,
1710
section
710.32(
c)(
4)(
ii)
of
the
regulatory
text;
Part
III,
Section
II
of
revised
reporting
Form
U).
1711
The
commenters
stated
that
there
is
no
reason
to
believe
that
consumer
exposure
will
result
from
1712
chemicals
in
articles.
1713
EPA
does
not
agree
that
manufacturers
of
chemicals
that
are
later
incorporated
into
1714
articles
should
be
exempt
from
the
reporting
of
consumer
and
commercial
end­
use
information.
1715
Certain
exposures
do
result
from
chemicals
incorporated
in
articles.
For
example,
potential
1716
79
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
dermal
and
inhalation
exposures
occur
from
chemicals
incorporated
into
products
in
the
category
1717
"
fabrics,
textiles
and
apparel."
Specific
cases,
such
as
formaldehyde
from
pressed
wood
products
1718
used
in
mobile
homes
or
chlorinated
flame
retardants
used
on
children's
sleep
wear,
show
that
1719
potentially
harmful
exposures
can
occur
from
articles.
1720
d.
Usefulness
of
percent
production
data
and
maximum
concentration
data.
A
1721
commenter
felt
that
in
the
case
of
consumer
products
in
particular,
it
is
unclear
whether
the
1722
percent
production
data
and
maximum
concentration
data
required
under
section
1723
710.32(
c)(
4)(
ii)(
C)
and
(
D)
of
the
regulatory
text
(
Part
III,
Section
II
of
Form
U)
would
add
any
1724
material
information
to
the
production
volume
information
already
required
under
the
existing
1725
IUR.
The
commenter
stated
that
the
volumes
of
chemicals
they
will
report
as
having
been
1726
manufactured,
and
for
which
they
will
report
maximum
concentration
information,
are
in
the
1727
products
the
commenter
sells.
Therefore,
the
Agency
will
already
have
the
needed
production
1728
volume
and
concentration
information
and
doesn't
need
to
collect
these
particular
data
elements
1729
for
consumer
products.
1730
Production
volume
and
concentration
information
reported
at
the
manufacturing
site
is
1731
typically
different
information
than
percent
production
volume
and
concentration
in
consumer
and
1732
commercial
categories.
Often
manufacturers
will
sell
a
chemical
to
multiple
uses,
or
the
chemical
1733
will
be
used
multiple
times
before
reaching
the
consumer/
commercial
product.
In
order
to
1734
determine
different
exposure
scenarios,
EPA
needs
information
pertaining
to
specific
scenarios.
1735
For
instance,
a
manufacturer
may
report
that
a
chemical
is
used
in
three
different
1736
consumer/
commercial
product
categories
 
20%
of
the
manufactured
production
volume
is
used
1737
in
category
A,
35%
in
category
B,
and
45%
in
category
C.
Additionally,
while
the
manufacturer
1738
sells
the
product
at
a
certain
concentration
(
say
90%),
the
final
product
likely
has
a
different
1739
80
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
concentration.
For
instance,
the
final
product
may
contain
only
5%
of
the
chemical.
The
1740
resulting
potential
exposure
scenario
would
be
very
different
from
a
scenario
where
the
1741
concentration
is
90%.
The
Agency,
therefore,
is
retaining
the
commercial/
consumer
production
1742
volume
and
concentration
data
elements.
1743
7.
General
Data
Elements
Comments.
a.
Workers
who
are
"
reasonably
likely
to
be
1744
exposed"
to
a
reportable
chemical.
EPA
requested
comment
on
alternative
definitions
of
1745
  
potentially
exposed
worker''
and
  
reasonably
likely
to
be
exposed.''
Specifically,
EPA
requested
1746
comment
on
whether
the
OSHA
definition
of
"
employee"
in
its
hazard
communication
standard
1747
(
29
CFR
1910.1200(
c))
is
more
appropriate
for
use
in
the
amended
IUR.
The
hazard
1748
communication
standard
defines
  
employee''
as
a
worker
who
may
be
exposed
to
hazardous
1749
chemicals
under
normal
operating
conditions
or
in
foreseeable
emergencies.
Workers
such
as
1750
office
workers
or
bank
tellers
who
encounter
hazardous
chemicals
only
in
non­
routine,
isolated
1751
instances
are
not
covered.
The
Standard
also
defines
  
exposure''
or
  
exposed''
as
the
exposure
of
1752
an
employee
to
a
hazardous
chemical
in
the
course
of
employment
through
any
route
of
entry
1753
(
inhalation,
ingestion,
skin
contact
or
absorption,
etc.)
and
includes
potential
(
e.
g.
accidental
or
1754
possible)
exposure.
1755
One
commenter
stated
that
OSHA's
definition
of
an
employee
was
appropriate
to
identify
1756
persons
reasonably
likely
to
be
exposed
to
chemical
substances.
This
commenter
stated
that
the
1757
Agency
should
broaden
the
definition
of
exposure
in
the
IURA
to
include
potential
accidental
or
1758
possible
exposures
to
chemical
substances
which
workers
may
experience
in
the
course
of
their
1759
employment.
This
commenter
also
stated
that
this
is
what
worker
exposure
entails
in
the
real
1760
world
and
to
exclude
some
portion
of
those
worker
exposures,
as
EPA
proposed,
is
1761
inappropriate.
A
second
commenter
felt
that
persons
who
could
be
exposed
to
a
chemical
1762
81
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
substance
in
foreseeable
emergencies
should
be
included
in
EPA's
new
definition
for
persons
who
1763
are
reasonably
likely
to
be
exposed
to
a
reportable
substance.
1764
EPA
has
determined
that
the
OSHA
definition
of
"
employee"
does
not
provide
a
more
1765
appropriate
standard
than
the
one
proposed
and
finalized
in
the
IURA.
Whereas
OSHA
wanted
1766
to
provide
all
persons
who
could
foreseeably
be
exposed
to
a
chemical
substance
with
knowledge
1767
of
the
potential
hazards
of
that
chemical,
EPA
is
seeking
to
specifically
identify
those
persons
1768
routinely
exposed
to
chemical
substances
and
for
whom
engineering
controls
and
personal
1769
protective
equipment
are
likely
to
provide
the
greatest
benefit.
The
definition
adopted
by
EPA
for
1770
a
person
"
reasonably
likely
to
be
exposed"
in
this
rule
will
target
those
individuals
who
routinely
1771
have
the
potential
to
be
exposed
to
chemical
substances,
and
for
whom
chronic
risks
are
greatest.
1772
This
definition
provides
more
useful
and
realistic
information
for
risk
screening
purposes.
1773
b.
Personal
Protective
Equipment.
EPA
requested
comment
on
whether
the
Agency
1774
should
collect
information
on
the
use
of
personal
protective
equipment
(
PPE)
during
the
1775
manufacture
of
chemicals
reported
under
the
amended
IUR.
Several
commenters
stated
that
EPA
1776
should
not
collect
PPE
information
for
the
purposes
of
risk
screening.
After
reviewing
these
1777
comments,
EPA
agrees
that
collecting
information
on
the
availability
of
PPE
would
not
enhance
1778
the
initial
risk
screening
process,
and
has
determined
that
this
data
element
should
not
be
added
to
1779
the
IUR
as
part
of
this
rulemaking.
Because
EPA
cannot
ensure
that
protective
equipment
will
be
1780
available
to
all
employees
and,
if
available,
will
be
used
properly
in
a
well
managed
hygiene
1781
program,
the
potential
risk
encountered
in
the
manufacture,
processing,
or
use
of
a
chemical
1782
substance
is
initially
assessed
by
EPA
in
the
absence
of
PPE
information.
The
IURA
is
designed
1783
primarily
to
collect
only
screening
level
information.
Inclusion
of
PPE
in
risk
assessment
would
1784
require
collection
and
integration
of
location­
specific
information
on
physical
conditions
and
the
1785
82
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
PPE
used,
and
would
greatly
complicate
the
risk
assessment.
This
type
of
information
is
more
1786
likely
to
be
included
in
assessments
more
detailed
than
the
initial
risk
screening
assessment
for
1787
which
the
IURA
information
will
be
used.
1788
A
commenter
suggested
that
EPA
use
PPE
information
as
a
way
to
submit
lower
1789
estimates
for
various
IUR
data
elements,
such
as
the
number
of
workers.
For
the
reasons
provided
1790
in
the
previous
paragraph,
EPA
will
not
use
PPE
information
to
lower
the
estimates
of
workers
1791
reasonably
likely
to
be
exposed.
Because
the
reporting
of
PPE
information
would
not
contribute
1792
to
the
initial
risk
screening
process
and
would
impose
an
additional
burden
on
persons
reporting
1793
under
the
IUR,
EPA
is
not
including
information
on
PPE
in
the
reporting
requirements
for
this
1794
rule.
1795
c.
Metric
System
Reporting.
Under
the
IUR,
data
are
currently
reported
using
the
U.
S.
1796
customary
system
of
measurement
units
(
e.
g.
pounds,
yards,
etc.).
EPA
requested
comment
on
1797
changing
reporting
requirements
to
require
metric
system
reporting
instead
(
e.
g.
kilograms,
1798
meters,
etc.).
Two
commenters
suggested
that
EPA
convert
to
metric
system
units
or
at
least
1799
give
submitters
the
option
of
using
either
metric
or
U.
S.
customary
units.
One
commenter
1800
requested
that
EPA
continue
to
require
the
use
of
U.
S.
customary
units
or
give
submitters
the
1801
option
of
reporting
in
either
metric
or
U.
S.
customary
units.
EPA
has
decided
to
continue
to
1802
require
the
use
of
the
U.
S.
customary
system
because
at
least
in
the
short
term,
this
allows
the
1803
IUR
database
to
remain
compatible
with
other
Agency
databases,
especially
TRI,
which
also
1804
typically
use
the
U.
S.
customary
system.
EPA
believes
allowing
for
reporting
using
either
the
1805
U.
S.
customary
or
metric
systems
of
units
would
create
confusion
and
increase
reporting
and
1806
administrative
error.
EPA
may
revisit
this
issue
in
future
IUR
amendments.
1807
C.
Reporting
Universe
Comments.
1808
83
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
EPA
received
a
variety
of
comments
concerning
which
chemicals
and
sites
should
be
1809
subject
to
reporting
requirements,
including
recordkeeping
requirements.
1810
1.
Chemical
Categories
Undergoing
Changes
in
Reporting
Status.
In
the
IURA
1811
proposal,
EPA
created
exemptions
from
reporting
for
several
groups
of
chemicals
that
would
1812
otherwise
be
IUR­
reportable.
The
IUR
currently
contains
full
reporting
exemptions
for
inorganic
1813
chemicals,
polymers,
and
naturally
occurring
chemicals.
EPA
proposed
to
modify
these
1814
exemptions
by
(
1)
substituting
phased­
in
reporting
for
inorganic
chemicals
in
lieu
of
the
existing
1815
full
exemption;
(
2)
creating
a
partial
reporting
exemption
for
chemical
substances
termed
1816
"
petroleum
process
streams"
for
purposes
of
reporting
under
the
amended
IUR;
and,
(
3)
creating
1817
a
full
exemption
for
certain
forms
of
natural
gas.
EPA
also
requested
comment
on
the
creation
of
1818
additional
exemptions,
but
asked
that
commenters
provide
a
clear
supporting
rationale
for
1819
creating
such
exemptions.
1820
a.
Inorganic
Chemicals
­
Many
commenters
submitted
comments
about
the
removal
of
1821
the
full
exemption
for
inorganic
chemicals.
1822
EPA
originally
created
the
inorganic
chemical
exemption
because
it
believed
that
the
1823
hazard
potential
of
many
inorganics
was
  
relatively
well­
established''
(
50
FR
9944,
9947,
March
1824
12,
1985)
and
that
hazard
information
alone
was
sufficient
for
prioritization
within
inorganic
1825
chemical
substance
risk
assessments.
EPA
now
intends
to
increase
the
consideration
given
to
1826
exposure,
another
component
of
risk,
in
screening
chemicals
and
in
setting
priorities
for
risk
1827
assessment
and
risk
management
activities.
The
Agency
no
longer
believes
that
chemical
hazard
1828
information
alone
provides
a
sufficient
basis
for
prioritization
for
these
purposes.
As
a
result,
the
1829
former
basis
for
this
exemption
is
no
longer
applicable.
1830
i.
Why
does
the
Agency
need
basic
IUR
information
on
inorganic
chemical
substances?
1831
84
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
During
interagency
review
prior
to
proposal
it
was
suggested
that
EPA
first
collect
the
IUR
1832
information
in
sections
710.32(
c)(
1),
(
c)(
2),
(
c)(
3),
710.38,
and
710.39
of
the
regulatory
text
1833
(
Parts
I,
II,
and
IV
of
the
revised
reporting
Form
U)
on
inorganic
substances
before
collecting
the
1834
processing
and
use
information
in
section
710.32(
c)(
4)
of
the
regulatory
text
(
Part
III
of
the
1835
revised
reporting
Form
U).
It
was
thought
that
partial
reporting
would
allow
EPA
to
become
1836
generally
familiar
with
the
production
volumes
of
inorganic
chemicals,
and
would
permit
1837
manufacturers
of
these
substances
to
familiarize
themselves
with
the
most
basic
IUR
requirements
1838
before
being
required
to
comply
with
the
processing
and
use
data
requirements.
Many
1839
commenters
stated
that
EPA
had
not
demonstrated
the
practical
utility
of
collecting
basic
1840
information
on
inorganic
substances.
Other
commenters
felt
the
Agency
should
collect
these
data
1841
and
that
inorganic
chemical
manufacturers
should
not
have
had
an
exemption
under
the
IUR.
1842
EPA
uses
basic
IUR
information
in
a
wide
variety
of
ways
(
as
described
in
Units
III.
C.
and
1843
E.
of
this
preamble)
and
expects
the
basic
IUR
information
on
inorganic
chemicals
to
be
used
in
1844
similar
ways.
For
example,
EPA
used
IUR
information
in
the
HPV
Challenge
Program
(
see
1845
http://
www.
epa.
gov/
opptintr/
chemrtk/
volchall.
htm)
to
identify
chemicals
produced
in
aggregate
1846
national
volumes
of
one
million
pounds
or
more.
The
HPV
Challenge
Program
was
not
able
to
1847
include
inorganic
chemicals
as
EPA
did
not
have
the
necessary
production
volume
information
on
1848
the
inorganic
chemicals
produced
in
or
imported
into
this
country.
Additionally,
the
TSCA
1849
Interagency
Testing
Committee
(
ITC)
has
encountered
difficulties
in
its
attempts
to
identify
1850
inorganic
chemicals
for
recommendations
to
EPA
for
testing
or
other
further
evaluations
due
to
1851
the
lack
of
even
the
most
basic
IUR
data
for
these
chemicals
(
Ref.
26).
1852
ii.
Why
is
EPA
phasing
in
reporting
for
inorganic
chemical
substances?
EPA
requested
1853
comment
on
completely
removing
the
inorganic
chemicals
exemption,
requiring
reporting
of
all
of
1854
85
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
the
amended
IUR
information,
including
the
information
described
in
section
710.32(
c)(
4)
of
the
1855
regulatory
text
on
inorganic
chemicals
manufactured
in
volumes
of
300,000
lbs.
or
more
at
a
site.
1856
Some
commenters
supported
phased­
in
reporting
of
this
information,
where
EPA
would
maintain
1857
a
partial
exemption
(
i.
e.
requiring
the
reporting
of
all
of
the
amended
IUR
information
except
the
1858
information
in
section
710.32(
c)(
4))
for
the
first
submission
period
only
and
would
require
full
1859
reporting
in
subsequent
submission
periods.
EPA
agrees
with
this
approach
because
it
provides
1860
new
submitters
with
an
opportunity
to
become
familiar
with
basic
IUR
reporting,
allows
EPA
to
1861
become
familiar
with
the
current
inorganic
chemical
industry,
and
provides
basic
production
1862
information
in
the
first
submission
period.
Requiring
full
reporting
for
inorganic
chemicals
in
1863
subsequent
submission
periods
provides
EPA
with
the
processing
and
use
exposure­
related
1864
information
needed
to
continue
efforts
begun
with
the
first
reporting
year
information.
1865
EPA's
primary
use
of
both
the
basic
data
collected
during
the
first
submission
period
and
1866
the
additional
exposure­
related
data
collected
during
subsequent
submission
periods
will
be
to
1867
identify
priority
TSCA
chemicals
for
more
detailed
information
gathering,
risk
assessment,
and
1868
risk
management
in
order
to
develop
targeted
programs
to
protect
human
health
and
the
1869
environment.
Screening
chemical
risks
generally
requires
a
combination
of
both
hazard
and
1870
exposure
information.
The
absence
of
exposure­
related
data
for
inorganic
chemicals,
beyond
even
1871
the
basic
production
data
collected
during
the
first
submission
period
under
the
IURA,
will
1872
severely
limit
the
usefulness
of
IUR
data
for
risk
screening.
See
Unit
III.
A.
1.
of
this
preamble
for
1873
further
discussion
of
additional
uses
of
the
IURA
exposure­
related
data.
1874
While
some
commenters
supported
the
phasing­
in
approach,
other
commenters
suggested
1875
that
EPA
review
the
information
collected
on
inorganic
chemicals
from
the
partial
exemption
and
1876
collect
additional
information
on
these
chemicals
through
a
future
rulemaking.
Commenters
1877
86
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
suggested
a
variety
of
ways
to
collect
this
additional
information,
including
specifically
listing
1878
chemicals
that
would
be
subject
to
future
IUR
collections
or
using
PAIR.
However,
EPA
has
1879
tried
using
information
from
other
sources
or
collecting
information
using
PAIR
for
organic
1880
chemicals,
and
has
found
this
approach
to
be
insufficient,
as
discussed
in
Unit
III.
A.
3.
of
this
1881
preamble.
1882
iii.
Why
doesn't
EPA
use
already
available
information
on
inorganic
chemical
1883
substances?
Commenters
stated
that
the
inorganic
chemicals
data
that
EPA
needs
to
conduct
1884
screening­
level
risk
assessments
are
already
available
from
a
variety
of
sources,
including
the
U.
S.
1885
Geological
Survey's
annual
reports
on
mineral
production,
health
assessment
documents
prepared
1886
by
the
Agency
for
Toxic
Substances
and
Disease
Registry,
studies
by
the
Occupational
Safety
and
1887
Health
Administration,
the
Toxics
Release
Inventory
compiled
by
EPA,
and
literature
published
1888
by
trade
associations.
EPA
closely
examined
these
data
sources,
and
concluded
that,
while
1889
useful,
these
sources
are
inadequate
to
meet
the
Agency's
data
needs
for
inorganic
chemicals.
1890
Some
of
the
suggested
data
sources
pertain
to
naturally
occurring
substances
which
are
1891
excluded
from
the
Inventory
by
40
CFR
710.4(
b).
Many
of
the
remaining
data
sources
identified
1892
by
commenters
pertain
to
metallic
alloys
or
studies
of
a
single
metal
species
and
do
not
include
1893
information
on
the
multiplicity
of
pigments,
flocculating
agents,
oxidants,
photochromic
salts,
1894
flame
retardants,
catalysts,
and
other
inorganic
compounds
for
which
data
are
sought
through
the
1895
IURA.
In
some
cases,
the
data
sources
are
one­
time
collections
of
information
and
therefore
1896
would
not
provide
current
information
on
the
inorganic
chemical
industries.
Others,
although
1897
revised
from
time
to
time,
do
not
identify
the
chemicals
with
sufficient
specificity,
do
not
identify
1898
the
manufacturing
site
or
a
technical
contact,
and/
or
o
not
provide
information
on
the
use
of
the
1899
inorganic
chemical.
In
sum,
the
data
sources
identified
by
commenters
and
by
EPA
are
not
1900
87
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
sufficient
to
provide
the
information
sought
through
the
IURA.
Additional
discussion
of
the
1901
applicability
of
available
data
sources
is
found
in
"
Summary
of
EPA's
Responses
to
Public
1902
Comments
Submitted
in
Response
to
Proposed
TSCA
Inventory
Update
Rule
Amendments
(
64
1903
FR
46772)"
(
Ref.
15)
and
in
"
Inorganic
Chemicals:
Sources
of
Information
Suggested
by
1904
Commenters
to
the
Proposed
Inventory
Update
Rule
Amendments"
(
Ref.
27).
1905
b.
Partial
Exemption
for
Petroleum
Process
Streams.
EPA
proposed
a
partial
exemption
1906
from
IURA
reporting
for
certain
petroleum
process
streams
and
requested
comment
on
1907
duplication
of
reporting
under
the
information
collections
conducted
by
DOE's
Energy
1908
Information
Administration
(
EIA)
through
EIA
forms
EIA
810,
EIA
816,
and
EIA
64A.
1909
Operators
of
all
operating
and
idle
petroleum
refineries,
blending
plants
or
blending
terminals
1910
must
complete
form
EIA
810
to
provide
a
monthly
refinery
report
on
their
operations
to
DOE.
1911
Operators
that
extract
liquid
hydrocarbons
from
a
natural
gas
stream
and/
or
separate
a
liquid
1912
hydrocarbon
stream
into
its
component
products
must
complete
form
EIA
816
to
provide
a
1913
monthly
natural
gas
liquids
report
to
DOE.
Operators
of
domestic
natural
gas
processing
plants
1914
must
complete
form
EIA
64A
to
provide
an
annual
report
of
the
geographical
location
and
1915
geological
formation
of
natural
gas
liquids
production
to
DOE.
In
the
IURA
proposal,
EPA
1916
stated
its
intention
to
work
with
DOE
to
identify
potential
duplication
and
to
further
investigate
1917
the
potential
usefulness
of
DOE's
information
collections
in
fulfilling
EPA's
statutory
obligations
1918
under
TSCA.
1919
One
commenter
stated
that
EPA
could
use
the
DOE
data
along
with
other
supplemental
1920
information
sources
to
generate
the
type
of
petroleum
process
stream
information
that
the
IURA
1921
proposed
to
collect.
Several
commenters
also
stated
that
the
proposed
IURA
reporting
would
be
1922
duplicative
of
DOE
reporting
for
certain
chemicals,
particularly
fuel
oil
#
2
and
kerosene,
and
that
1923
88
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
EPA
should
therefore
fully
exempt
manufacturers
of
those
chemicals
from
reporting
under
the
1924
IURA.
1925
EPA
has
investigated
the
information
collection
conducted
by
DOE
through
EIA
forms
1926
EIA
64A,
EIA
810,
and
EIA
816,
and
has
determined
that
chemical
substances
are
not
sufficiently
1927
identified
for
EPA's
purposes
in
the
DOE
reports.
For
example,
many
of
the
chemical
substances
1928
in
the
DOE
reports
are
identified
by
a
various
types
of
names
other
than
the
CAS
nomenclature
1929
used
by
EPA
for
TSCA
purposes,
are
identified
in
broad
categories,
or
are
not
identified
by
CAS
1930
number.
Many
of
the
chemical
names
used
by
DOE
are
either
generic
or
represent
groups
of
1931
chemicals.
For
example,
distillate
fuel
oil,
reported
on
EIA
Form
810,
may
refer
to
several
1932
chemicals
on
the
TSCA
Inventory,
such
as
Fuel
oil
#
2,
Fuel
oil
#
4,
or
Fuel
oil
#
6.
This
lack
of
1933
specific
identifier
information
means
that
EPA
and
others
cannot
distinguish
which
information
1934
collected
by
DOE
is
attributable
to
which
chemical.
More
specific
identification
is
needed
to
1935
attribute
the
appropriate
hazard
and
physical
and
chemical
properties
to
the
petroleum
stream.
1936
The
DOE
information
also
lacks
important
exposure
components
and
identifiers
that
are
1937
necessary
for
exposure
and
risk
screening
activities.
For
example,
the
DOE
information
does
not
1938
contain
the
number
of
workers
reasonably
likely
to
be
exposed
to
a
chemical
or
the
maximum
1939
concentration
of
the
chemical.
In
addition,
it
may
be
difficult
to
discern
from
the
DOE
data
if
a
1940
petroleum
process
stream
is
used
as
a
solvent
in
a
consumer
product
or
as
a
combustible
fuel.
1941
This
is
an
important
distinction
because
the
likelihood
of
exposure
to
a
petroleum
process
stream
1942
depends
on
its
use.
These
data
are
needed
elements
that
will
fill
a
vital
data
gap
in
chemical
risk
1943
screening.
1944
Several
persons
commented
that
there
is
no
need
to
collect
exposure
data
for
petroleum
1945
process
stream
manufacturing
operations
because
physical
hazards
existing
at
many
sites
currently
1946
89
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
necessitate
extensive
safety
precautions
that
limit
worker
exposure.
The
Agency's
view
is
that
1947
manufacturing
exposure­
related
data
(
such
as
maximum
concentration,
and
the
number
of
1948
workers
reasonably
likely
to
be
exposed)
for
petroleum
process
stream
chemicals
are
needed.
1949
First,
there
is
no
correlation
between
the
physical
hazards
of
ignitability,
corrosiveness,
or
1950
reactivity
and
the
presence
of
a
toxicological
hazard
to
human
health.
A
chemical
substance
which
1951
is
stable,
nonflammable,
and
nonirritating
would
not
necessitate
the
separation
of
the
worker
from
1952
the
chemical
substance
on
the
basis
of
physical
hazard
alone.
However,
the
same
chemical
1953
substance
may
be
carcinogenic,
teratogenic,
mutagenic,
or
an
endocrine
disruptor;
these
hazards
1954
sometimes
are
not
addressed
by
measures
to
protect
workers
from
physical
dangers.
Second,
the
1955
screening
level
risk
associated
with
a
chemical
is
typically
characterized
in
the
absence
of
1956
engineering
controls
or
personal
protective
equipment.
For
these
reasons,
EPA
is
requiring
the
1957
submission
of
worker
exposure
information
that
will
enable
the
Agency
to
focus
on
those
1958
industries
and
uses
of
chemicals
where
the
greatest
risk
exists.
1959
c.
Exemption
for
Certain
Forms
of
Natural
Gas.
EPA
proposed
that
six
natural
gas
1960
substances
be
fully
exempt
from
reporting
under
the
amended
IUR.
In
addition,
EPA
requested
1961
comment
on
whether
reporting
for
the
six
substances
should
be
required
in
upcoming
submission
1962
periods
and
whether
they
are
the
appropriate
natural
gas
substances
for
inclusion
in
this
1963
exemption.
Commenters
expressed
support
for
the
full
exemption
of
the
six
natural
gas
streams
1964
listed
in
the
proposed
IUR
amendments.
1965
These
commenters
also
recommended
adding
fuel
oil
#
2,
kerosene,
methane,
ethane,
1966
propane,
butane,
pentane,
and
hexane,
and
liquefied
natural
gas,
to
the
full
exemption
list.
The
1967
commenters
stated
that
an
exemption
is
warranted
for
these
chemicals
because:
(
1)
DOE
already
1968
requires
annual
and
monthly
reports
for
the
chemicals
which
contain
the
same
information
1969
90
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
requested
by
EPA;
(
2)
the
chemicals
are
similar
in
chemical
composition
to
the
six
exempt
1970
streams;
(
3)
their
chemical
structure
and
identity
remain
the
same
throughout
processing;
(
4)
a
1971
similar
amount
of
data
is
available
for
these
chemicals
as
for
the
six
exempt
chemicals;
and,
(
5)
a
1972
similar
number
of
TSCA
reports
are
filed
for
these
chemicals
as
for
the
six
exempt
streams.
1973
EPA
has
retained
the
exemption
for
certain
forms
of
natural
gas
as
proposed.
Adequate
1974
IUR
information
has
been
collected
on
these
chemical
substances
to
fulfill
EPA's
and
other
IUR
1975
information
users'
current
needs.
EPA
will
take
action
to
revoke
this
exemption
if
circumstances
1976
warrant
in
the
future.
EPA
did
not
rely
on
the
data
contained
in
the
DOE
reports
discussed
in
1977
Unit
III.
C.
1.
b.
for
the
natural
gas
exemption.
While
some
useful
information
for
these
chemicals
1978
is
included
in
the
DOE
reports,
it
is
insufficient
for
exposure
or
risk
screening
(
see
Unit
II.
C.
1.
b.
1979
for
a
discussion
of
why
the
information
contained
in
the
DOE
reports
is
insufficient
for
EPA
1980
purposes).
Downstream
processing
and
use
exposure
information
collected
through
the
IURA
for
1981
these
chemicals
will
not
duplicate
information
collected
by
DOE.
1982
2.
Exemption
of
Additional
Groups
of
Chemicals
From
IURA
Reporting
or
From
the
1983
Reporting
of
Specific
Data
Elements.
EPA
requested
comment
in
the
proposed
rule
on
the
1984
selection
of
chemicals
that
might
be
exempted
from
reporting
under
the
IURA
and
on
specific
1985
criteria
to
distinguish
these
chemicals
from
those
that
remain
subject
to
reporting.
Although
EPA
1986
considered
including
a
"
low
priority"
chemicals
exemption
in
the
proposed
rule,
the
Agency
could
1987
not
develop
adequate
criteria
that
would
allow
submitters
and
EPA
to
independently
identify
and
1988
agree
upon
which
chemicals
are
covered
by
the
exemption.
In
order
to
successfully
implement
a
1989
"
low
priority"
exemption,
the
regulations
must
be
clear
enough
to
allow
those
reading
the
1990
regulations
to
identify
the
chemicals
EPA
intended
to
exempt
from
reporting.
The
"
low
priority"
1991
exemption
would
be
of
no
use
if
submitters
and
EPA
could
not
agree
in
advance
of
reporting
1992
91
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
which
chemicals
were
included
in
the
exemption.
EPA
received
many
industry
comments
in
favor
1993
of
creating
a
new
exemption
for
chemicals
that
may
be
considered
to
be
"
low
priority,"
but
1994
commenters
provided
little
information
to
indicate
clear
criteria
for
establishing
such
exemptions.
1995
In
addition,
commenters
suggested
groups
of
chemicals
for
exemption
either
due
to
a
"
low
1996
priority"
status
or
for
other
reasons,
as
described
in
this
section.
EPA
has
determined
that
none
of
1997
the
suggested
exemptions
can
be
implemented
at
this
time.
EPA's
reasons
for
this
determination
1998
are
also
discussed
in
this
section.
1999
a.
HPV
Chemicals.
A
number
of
commenters
stated
that
industry
is
already
providing
2000
EPA
with
sufficient
hazard
data
via
the
HPV
Challenge
Program
(
see
2001
http://
www.
epa.
gov/
opptintr/
chemrtk/),
as
well
as
exposure
data
through
other
voluntary
2002
programs
(
e.
g.,
International
Council
of
Chemical
Associations
(
ICCA)
data
collections
and
2003
UEIP).
Therefore,
providing
exposure­
related
information
on
HPV
chemicals
via
the
amended
2004
IUR
would
be
duplicative
and
unnecessary.
Some
commenters
suggested
that
EPA
limit
its
2005
IURA
reporting
requirements
to
HPV
chemicals
not
sponsored
by
industry
under
the
HPV
2006
Challenge
Program,
in
order
to
acquire
the
full
range
of
HPV
data.
2007
The
Agency
recognizes
that
a
variety
of
voluntary
and
regulatory
efforts
to
collect
hazard
2008
data
are
underway,
such
as
the
voluntary
HPV
Challenge
Program.
However,
the
scope
and
2009
expected
output
from
the
HPV
Challenge
Program
differ
markedly
from
those
anticipated
under
2010
the
IURA.
The
HPV
Challenge
Program
centers
on
providing
hazard
data
for
HPV
chemicals,
2011
which
are
a
subset
of
the
IURA
chemicals.
The
IURA
focus
on
gathering
exposure­
related
2012
information
for
moderate
and
high
volume
chemicals
in
a
wide
range
of
industrial
operations,
2013
involving
multiple
sites
and
covering
manufacturing,
processing,
and
use
of
the
chemical
2014
substances.
2015
92
**
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Draft
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or
Quote
­
Not
for
Public
Release
**
The
Agency
is
unable
to
limit
its
IURA
information
collection
efforts
to
HPV
chemicals
2016
alone,
for
several
reasons.
First,
the
Agency
could
not
know
definitively
which
chemicals
are
2017
HPV
substances
in
any
particular
IURA
reporting
cycle
as
of
that
reporting
year.
Production
2018
volumes
can
vary
significantly
over
a
four­
year
reporting
cycle,
and
it
is
not
uncommon
for
2019
chemicals
to
rise
above
or
fall
below
the
HPV
threshold
each
reporting
cycle.
Second,
the
2020
number
of
HPV
chemicals
identified
to
date
represents
only
a
portion
of
the
chemicals
for
which
2021
EPA
would
need
current
data
in
order
to
adequately
screen
for
risks.
Limiting
IURA
submissions
2022
to
HPV
chemicals
would
effectively
exempt
many
chemicals
that
should
be
Agency
priorities,
2023
thereby
reducing
the
usefulness
of
the
rule
itself.
Also,
EPA
recognizes
that
the
IURA
collection
2024
could
be
limited
to
the
HPV
Challenge
chemicals
(
i.
e.,
the
baseline
set
of
chemicals
for
the
2025
program,
consisting
of
chemicals
that
were
HPV
according
to
1990
IUR
information).
However,
2026
that
restricts
the
IURA's
ability
to
supply
screening­
level
exposure
information
to
only
those
HPV
2027
chemicals.
This
would
severely
limit
the
usefulness
of
the
IURA
and
compromise
the
Agency's
2028
broader
responsibility
for
risk
screening.
2029
b.
Existing
Chemicals
Program
"
low
concern"
chemicals.
Commenters
recommended
2030
that
the
chemicals
previously
determined
by
EPA
to
be
of
low
concern
via
the
Existing
Chemicals
2031
Program
be
exempt
from
reporting
under
IURA.
However,
commenters
did
not
provide
2032
sufficient
criteria
that
would
clearly
distinguish
the
exempted
chemicals
from
others
subject
to
2033
IUR
reporting.
EPA
cannot
create
exemptions
without
a
clear
basis
or
justification.
During
the
2034
development
of
these
amendments,
EPA
considered
exempting
chemicals
previously
reviewed
by
2035
the
Existing
Chemicals
Program,
but
was
unable
to
develop
clear
criteria
for
such
an
exemption
2036
(
See
Ref.
28
and
Unit
IX.
3.
of
the
proposal
preamble,
64
CFR
46772,
46794).
Under
the
existing
2037
chemical
program,
no
standard
criteria
was
used
for
determining
a
low
priority
chemical.
2038
93
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Draft
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Not
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or
Quote
­
Not
for
Public
Release
**
Additionally,
many
chemicals
were
analyzed
within
a
specific
use,
and
other
uses
of
that
chemical
2039
were
not
examined.
EPA
remains
unable
to
develop
clear
criteria
for
creating
an
exempt
category
2040
of
low
concern
chemicals.
2041
c.
Organization
for
Economic
Cooperation
and
Development
(
OECD)
Chemicals.
2042
Commenters
recommended
that
the
chemicals
for
which
EPA
has
a
minimum
set
of
hazard
and
2043
exposure
data,
such
as
OECD's
SIDS
chemicals
that
have
completed
the
SIDS
process,
be
2044
exempt
from
reporting
under
the
IURA.
Commenters
also
suggested
that
chemicals
in
the
2045
International
Council
of
Chemical
Association
(
ICCA)
screening
level
data
collection
programs
be
2046
included
in
this
exemption.
2047
EPA
disagrees
that
data
collection
efforts
through
the
OECD
and
ICCA
programs
provide
2048
sufficient
exposure
information
to
replace
the
IURA
information.
Data
collection
efforts
under
2049
the
auspices
of
OECD
and
ICCA
concentrate
on
the
development
of
hazard
assessments
and
2050
generally
provide
only
a
small
fraction
of
the
exposure­
related
data
called
for
under
the
IURA.
A
2051
goal
of
the
ICCA
Program
is
to
process
chemical
cases
through
OECD's
HPV
SIDS
Program,
2052
which
develops
hazard
information
for
the
program
chemicals.
As
hazard
data
does
not
change
2053
from
year
to
year,
the
data
collection
supports
a
one­
time
report.
The
IURA
will
provide
current
2054
exposure­
related
information
for
risk
screenings
and
preliminary
assessments.
Exposure
2055
information,
as
collected
under
the
IURA,
will
vary
from
reporting
year
to
reporting
year
and
2056
therefore
needs
to
be
collected
on
a
continuing
basis.
While
the
OECD
HPV
SIDS
Program
does
2057
not
specifically
disallow
the
collection
of
exposure
information,
the
program
does
leave
such
2058
collection
to
the
discretion
of
the
sponsor
country
(
Ref.
29).
Exposure
information
available
via
2059
SIDS
is
therefore
generally
not
specific
to
U.
S.
uses
and
concerns.
Additionally,
commenters
2060
provided
no
criteria
to
define
a
minimum
set
of
exposure
data
that
would
serve
to
justify
the
2061
94
**
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Draft
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Not
Cite
or
Quote
­
Not
for
Public
Release
**
exemption
of
this
group
of
chemicals,
and
that
would
clearly
distinguish
the
exempted
chemicals
2062
from
those
subject
to
reporting
under
the
IURA.
Without
clear
criteria
that
can
be
described
2063
within
a
regulatory
framework,
EPA
is
unable
to
establish
this
suggested
exemption.
2064
d.
Metals.
Various
commenters
stated
that
either
metals
as
a
group,
or
specific
metals
2065
such
as
zinc
and
copper,
should
be
granted
special
consideration
for
IURA
reporting.
Several
2066
commenters
asserted
that
providing
information
on
maximum
concentrations
is
unnecessary
for
2067
the
metals,
because
they
will
generally
have
close
to
100
percent
concentrations
when
they
leave
2068
the
manufacturing
site
or
whenever
they
are
present
in
consumer
or
commercial
products.
2069
Further,
the
only
exposure
potential
for
these
substances
in
commercial
or
consumer
products
will
2070
be
dermal
(
not
inhalation
or
ingestion).
Additionally,
a
commenter
stated
that
workers
"
in
2071
proximity"
to
or
handling
solid
metal
articles
should
not
be
considered
to
be
exposed
for
reporting
2072
purposes,
because
the
metal
is
in
a
form
in
which
neither
inhalation
nor
dermal
exposure
will
2073
occur.
Other
commenters
believed
that
any
IUR
reporting
on
metals
is
unnecessary
because
ample
2074
information
on
metals
production
and
exposure
potentials
is
already
available
from
other
sources,
2075
such
as
the
United
States
Geological
Survey
(
USGS),
or
because
specific
metals,
such
as
copper
2076
and
zinc,
are
beneficial.
One
commenter
stated
that
metals
incorporated
in
"
articles"
should
be
2077
exempted.
2078
EPA
agrees
that
metals
present
some
unique
issues
regarding
exposure
potential.
2079
However,
the
information
that
will
be
collected
under
IURA
on
metals
concentrations
is
needed
2080
and
valuable.
Not
all
metal­
containing
products
will
be
pure
metal.
For
example,
metal
powders
2081
used
in
fine
arts,
metal
pastes
used
in
repairs,
and
commercial
metallic
paints
will
all
have
varying
2082
percentages
of
metals.
In
addition,
although
some
metals
in
trace
quantities,
such
as
chromium,
2083
are
essential
nutrients
to
plants
and/
or
animals,
in
greater
exposure
concentrations
these
same
2084
95
**
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Draft
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Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
metals
can
be
harmful.
2085
Because
metals
are
ubiquitous
and
can
be
present
in
a
variety
of
physical
forms,
different
2086
routes
of
exposure
are
possible.
Chronic
exposure
to
solutions
containing
metals
such
as
nickel
2087
may
result
in
contact
dermatitis.
Milling
of
metal
parts
containing
antimony
and
beryllium
creates
2088
dusts
which,
if
inhaled,
can
result
in
acute
chemical
pneumonitis.
Inhalation
of
fumes
containing
2089
chromium
resulted
in
an
elevated
incidence
of
bronchial
carcinoma
among
workers
in
the
U.
S.
2090
chromate
industry
before
the
source
of
the
exposure
was
recognized
and
corrected.
Exposure
by
2091
ingestion
is
of
concern
for
metals
that
may
enter
water
sources
following
improper
disposal
of
2092
used
materials.
For
example,
the
use
of
cadmium
in
batteries
for
portable
electronic
devices,
2093
including
computers,
is
increasing;
long­
term
exposure
to
cadmium
has
a
potential
to
cause
2094
kidney,
liver,
bone,
and
blood
damage.
2095
EPA
has
exempted
submitters
that
would
otherwise
be
subject
to
IUR
reporting
from
2096
reporting
with
respect
to
chemicals
that
are
imported
in
the
form
of
an
article
(
see
40
CFR
2097
710.30(
b)).
However,
submitters
that
manufacture
a
reportable
chemical
and
incorporate
it
into
2098
an
article
will
continue
to
be
subject
to
reporting
under
these
IUR
amendments.
2099
The
Agency
reviewed
a
number
of
sources
that
provide
information
about
metals
2100
production
and
characteristics,
including
USGS
data
specifically
noted
by
commenters
(
Ref.
27).
2101
The
information,
although
useful
for
depicting
global
mining
and
production
of
the
major
2102
commercial
metals,
is
not
comparable
to
the
national
scale
and
domestic
exposures
data
that
2103
would
be
provided
under
the
IURA.
Further,
because
metals
are
subject
chemicals
in
many
EPA
2104
programs,
including
the
Great
Lakes
Binational
Toxics
Strategy;
the
Persistent,
Bioaccumulative,
2105
and
Toxic
(
PBT)
Initiative;
the
revised
drinking
water
standards;
the
revised
emission
standards
2106
for
secondary
metal
refinishers;
and
the
Waste
Minimization
National
Plan,
to
name
a
few,
current
2107
96
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or
Quote
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Not
for
Public
Release
**
information
about
domestic
metals
production
and
use
would
benefit
many
EPA
offices
and
2108
programs.
2109
e.
Other
Chemical
Categories.
Commenters
suggested
EPA
exempt
a
variety
of
2110
additional
groups
of
chemicals
from
either
full
or
partial
amended
IUR
reporting.
These
groups
2111
included
fossil
fuel
combustion
byproducts
such
as
coal
combustion
products;
fertilizers;
2112
substances
encapsulated
in
a
polymer
matrix;
pesticides,
and
other
chemicals
outside
of
TSCA
2113
jurisdiction
(
such
as
drugs).
Commenters
stated
that
exposures
associated
with
fossil
fuel
2114
combustion
byproducts
are
already
well
known,
with
information
currently
being
submitted
to
2115
EPA
and
other
federal
organizations
such
as
DOE,
well
beyond
the
amount
needed
for
"
basic
2116
screening."
Commenters
argued
that
reporting
on
these
byproducts
under
IURA
would
be
2117
duplicative
(
therefore
unnecessary)
and
overly
burdensome,
especially
because
these
chemicals
are
2118
considered
"
beneficially
used
in
an
environmentally
sound
manner"
by
EPA's
Office
of
Solid
2119
Waste(
OSW).
A
parallel
argument
was
made
for
fertilizers,
in
that
industry
considers
them
to
be
2120
well­
characterized
and
generally
"
safe."
Similarly,
a
commenter
believed
encapsulated
substances
2121
are
of
little
concern,
due
to
low
exposure
potentials
for
the
encapsulated
chemicals,
as
implied
by
2122
the
Agency's
treatment
of
such
substances
under
Significant
New
Use
Rules
(
SNURs);
when
2123
chemicals
are
secured
within
a
polymer
matrix,
the
SNUR
requirements
no
longer
apply.
2124
Commenters
also
stated
that
pesticides
and
other
chemicals
not
subject
to
TSCA
should
be
fully
2125
exempt
from
reporting.
2126
Comments
specific
to
these
different
groups
of
chemicals
are
addressed
below.
2127
i.
Fossil
fuel
combustion
byproducts.
Commenters
stated
that
fossil
fuel
combustion
2128
byproducts
have
been
sufficiently
studied
for
beneficial
reuse
to
justify
their
full
exemption
from
2129
IURA
reporting.
EPA's
Office
of
Solid
Waste
(
OSW)
had
adequately
reviewed
data
on
these
2130
97
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Draft
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Not
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or
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Not
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Public
Release
**
substances
to
allow
their
use
as
solid
waste
in
situations
where
exposures
were
possible,
such
as
2131
in
the
case
of
soil
amendments.
The
commenters
believe
that
EPA
offices
such
as
OPPT
and
2132
OSW
must
coordinate
their
efforts
related
to
fossil
fuel
combustion
byproducts
prior
to
2133
undertaking
any
actions
under
TSCA,
and
suggested
that
continued
reporting
on
these
chemicals
2134
would
be
particularly
burdensome.
2135
EPA
disagrees
with
these
comments.
Review
of
the
recent
OSW
Report
to
Congress
on
2136
the
subject
of
fossil
fuel
combustion
byproducts,
(
Ref.
30),
indicates
that
these
products
can
be
2137
hazardous
to
human
health
and
the
environment
when
mismanaged.
These
products
not
only
2138
typically
contain
heavy
metals
such
as
cadmium,
chromium,
lead,
and
mercury,
but
leachates
from
2139
fuel
combustion
byproducts
can
contain
significant
concentrations
of
arsenic.
Despite
these
2140
concerns,
OSW
has
decided
to
exempt
these
substances
from
regulation
as
hazardous
waste
when
2141
they
are
beneficially
reused.
While
OSW
was
not
able
to
identify
damage
cases
or
significant
risks
2142
to
human
health
or
the
environment
associated
with
these
types
of
beneficial
uses
based
on
2143
available
data,
OSW
plans
to
assess
new
information
on
risks
as
that
information
becomes
2144
available.
The
IURA
will
be
instrumental
in
providing
production,
use,
and
exposure
data
for
2145
fossil
fuel
combustion
byproducts
to
enable
OSW
to
monitor
the
potential
risk
associated
with
2146
these
chemical
substances.
Additionally,
as
with
any
chemical
byproduct
with
a
use,
EPA
in
2147
general
needs
information
to
be
able
to
screen
these
chemicals
for
potential
concerns
outside
of
2148
the
OSW
purview.
Review
of
such
contemporary
data,
as
shared
between
OPPT
and
OSW,
2149
would
allow
EPA
to
make
well­
informed
risk
management
decisions
by
constructing
realistic
2150
screening
level
exposure
profiles
for
these
substances.
These
profiles
could
be
adjusted
as
the
2151
production
dynamics
changed
between
reporting
cycles.
EPA
believes
the
importance
of
accurate
2152
exposure­
related
data
in
formulating
sound
risk
management
decisions
for
fossil
fuel
combustion
2153
98
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
byproducts
justifies
the
associated
reporting
burden.
2154
ii.
Fertilizers.
Inorganic
fertilizers
compose
a
class
of
chemical
substances
that
have
been
2155
exempt
from
the
IUR
in
the
past.
A
number
of
commenters
emphasized
that,
in
general,
fertilizers
2156
are
chemicals
whose
risks
have
already
have
been
well­
characterized.
According
to
the
2157
commenters,
ample
recent
hazard
and
exposure
data
from
studies
conducted
by
EPA's
Office
of
2158
Solid
Waste
(
OSW)
indicate
that
fertilizers
generally
are
of
low
toxicity,
and
some
constituents
of
2159
major
fertilizer
types
are
"
safe"
because
the
exposure
potentials
are
low.
Further,
recent
SIDS
2160
program
studies
on
urea,
a
common
fertilizer,
described
the
chemical
to
be
"
of
low
priority"
for
2161
further
investigation,
thereby
implying
that
the
chemical
poses
little
hazard
to
human
health
and
2162
the
environment,
and
that
adequate
risk
information
is
available.
Commenters
stated
that
because
2163
they
believe
the
constituents
are
not
harmful
to
human
health
or
the
environment,
fertilizers
2164
should
be
exempt
from
downstream
use
and
exposure
reporting
under
the
IURA
(
i.
e.,
a
partial
2165
exemption
from
IURA
reporting).
Other
commenters
stated
that
fertilizers
should
be
granted
a
2166
blanket
exemption
from
IURA
reporting,
or
that
EPA
should
exempt
certain
fertilizers
to
be
listed
2167
by
CAS
number.
One
commenter
suggested
that
the
following
20
substances,
listed
by
CAS
2168
number,
be
included
in
the
fertilizer
list:
7664­
417
(
anhydrous
ammonia);
1336­
21­
6
(
aqua
2169
ammonia);
6484­
52­
2
(
ammonium
nitrate);
7783­
20­
2
(
ammonium
sulfate);
7783­
18­
8
2170
(
ammonium
thiosulfate);
12593­
60­
1
(
ammonium
phosphate
sulfate);
7783­
28­
0
(
diammonium
2171
phosphate);
7722­
76­
1
(
monoammonium
phosphate);
7631­
99­
4
(
sodium
nitrate);
7757­
79­
1
2172
(
potassium
nitrate);
7757­
79­
1/
763
1
99­
4
(
potassium
sodium
nitrate);
8011­
76­
5
(
single
2173
superphosphate);
65996­
95­
4
(
granular
triple
superphosphate);
7447­
40­
7
(
potassium
chloride­),
2174
14168­
73­
1
(
potassium
magnesium
sulfate);
7778­
80­
5
(
potassium
sulfate);
7778­
18­
9
(
calcium
2175
sulfate);
7664­
38­
2
(
phosphoric
acid);
7697­
37­
2
(
nitric
acid);
and
7664­
93­
9
(
sulfuric
acid).
2176
99
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
EPA
does
not
believe
the
suggested
IURA
exemptions
for
fertilizers
and
fertilizer
2177
materials
are
warranted
at
this
time.
The
Agency
does
not
agree
with
industry
comments
citing
a
2178
1999
EPA
OSW
risk
evaluation
on
"
non­
nutritive"
components
in
fertilizers
as
adequate
2179
justification
for
classifying
fertilizers
as
"
safe,"
and
therefore
eligible
for
exemption.
The
cited
2180
report
addresses
trace
quantities
of
metal
contaminants
in
those
fertilizers
(
i.
e.,
the
non­
nutritive
2181
elements),
not
the
fertilizers
themselves.
A
review
of
basic
hazard
identification
guides,
such
as
2182
the
Merck
Index,
the
Condensed
Chemical
Dictionary,
and
Dangerous
Properties
of
Industrial
2183
Materials,
shows
that
exposure
to
many
fertilizers
and
fertilizer
materials,
including
those
cited
in
2184
industry
comments
such
as
anhydrous
ammonia,
potassium
sulfate,
and
urea,
can
cause
both
2185
reversible
and
irreversible
adverse
health
effects
ranging
from
acute
to
chronic.
The
Agency
2186
therefore
believes
it
is
appropriate
to
require
reporting
for
fertilizers
under
the
IUR
amendments.
2187
iii.
Encapsulated
substances.
A
commenter
stated
that
the
import
volumes
of
IUR
2188
reportable
components
contained
within
compounded
imported
polymers
should
be
exempt
from
2189
IURA
reporting.
The
volumes
of
these
encapsulated
components
are
difficult
to
determine.
Such
2190
components
include
antioxidants,
colorants,
lubricants,
and
stabilizers
that
are
commonly
used
2191
additives
in
polymer
products.
The
polymers
are
sometimes
manufactured
by
a
foreign
company
2192
and
imported
into
the
United
States.
These
additives,
which
are
encapsulated
in
a
polymer
2193
matrix,
are
typically
present
in
the
matrix
at
a
few
weight
percent.
2194
Although
EPA
appreciates
the
difficulty
in
requesting
quantitative
production
information
2195
from
manufacturers
outside
direct
U.
S.
jurisdiction,
exempting
IUR
reportable
components
2196
encapsulated
in
a
polymer
matrix
is
not
warranted.
Not
all
polymers
are
inviolable.
Additives
2197
such
as
colorants
and
lubricants,
which
can
be
hazardous
to
human
health
or
the
environment,
2198
can
leach
from
the
polymer
matrix,
resulting
in
subsequent
exposures.
Also,
additives
which
are
2199
100
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
inherently
insoluble
in
the
polymer
will
migrate
to
the
surface
of
the
polymeric
material
and
be
2200
released
over
time
from
the
polymer.
Because
these
components
are
reportable
and
might
be
2201
released
into
the
environment,
they
do
not
qualify
for
exemption
if
imported
above
the
stated
2202
thresholds.
Readily
available
information
can
be
used
to
estimate
these
import
quantities.
2203
iv.
Pesticides.
Some
commenters
stated
that
the
Agency
should
exempt
pesticide
2204
chemicals
from
reporting
under
the
IURA,
and
also
should
exempt
those
substances
outside
its
2205
purview,
including
drugs
and
cosmetics.
2206
The
original
IUR
did
not
include
non­
TSCA
chemicals
as
reportable.
Similarly,
in
the
2207
IURA,
amounts
of
an
otherwise
IUR­
reportable
substance
that
are
intended
at
the
time
of
2208
manufacture
to
be
used
for
non­
TSCA
purposes
(
e.
g.,
as
a
pesticide,
as
a
drug)
do
not
have
to
be
2209
reported.
For
example,
if
a
company
were
to
manufacture
300,000
lbs.
of
an
IUR­
reportable
2210
substance,
170,000
lbs.
of
which
were
intended
at
the
time
of
manufacture
to
be
sold
as
a
drug
2211
precursor,
and
130,000
lbs.
of
which
were
intended
at
the
time
of
manufacture
to
be
used
for
a
2212
TSCA
purpose,
only
130,000
lbs.
of
the
substance
would
have
to
be
reported
under
the
IUR.
2213
The
company
would
not
have
to
report
the
processing
and
use
information
described
in
section
2214
710.32(
c)(
4)
of
the
regulatory
text
for
that
chemical
at
that
plant
site,
since
the
company
did
not
2215
manufacture
a
total
of
at
least
300,000
lbs.
of
the
chemical
for
TSCA
purposes.
Many
2216
substances,
such
as
the
pesticide
"
active
ingredient"
pentachlorophenol,
are
also
used
in
2217
industrial/
commercial
applications
regulated
under
TSCA.
In
those
cases,
the
chemicals
would
be
2218
reportable
under
the
IURA.
2219
iv.
Food
additives.
Commenters
stated
that
low
hazard
chemicals,
such
as
food
additives,
2220
should
be
categorically
excluded
from
the
new
reporting
requirements.
The
commenter
stated
2221
that
food
use
substances
are
regulated
by
the
Food
and
Drug
Administration
(
FDA)
and
must
2222
101
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
either
be
generally
recognized
as
safe
(
GRAS),
the
subject
of
a
prior
sanction,
or
the
subject
of
a
2223
food
additive
regulation
promulgated
by
FDA.
EPA
disagrees
with
this
comment.
According
to
2224
FDA's
Office
of
Premarket
Approval
(
OPA),
food
use
substances
for
FDA's
purposes
are
those
2225
that
are
added
directly
to
food,
and
could
inadvertently
contact
and
be
incorporated
into
food
2226
because
of
use
in
packaging
material
or
in
food
processing.
2227
FDA
does
not
evaluate
chemicals
for
environmental
effects
 
only
for
human
health
2228
effects.
The
chemicals
subject
to
FDA
rules
are
not
inherently
low
hazard
in
many
cases.
For
2229
example,
substances
such
as
plasticizers,
lubricants,
release
agents,
acids
(
e.
g.,
hydrochloric
acid),
2230
boiler
water
additives,
and
solvents
(
e.
g.,
acetone
and
hexane)
are
included
as
food
use
2231
substances.
Furthermore,
even
direct
(
i.
e.,
listed)
GRAS
chemicals
can
be
of
concern
when
used
2232
at
industrial
concentrations,
such
as
sulfuric
acid
(
direct
GRAS
chemical
no.
184.1095).
Thus,
as
2233
is
true
with
all
chemical
substances,
food
additives
can
present
a
risk
to
human
health
or
the
2234
environment
depending
on
use
and
the
resulting
exposure
pathways.
EPA
does
not
believe
a
2235
categorical
exemption
is
warranted
at
this
time.
2236
3.
Thresholds.
EPA
requested
comment
on
the
300,000
lbs.
threshold
for
reporting
2237
industrial
processing
and
use,
and
consumer
and
commercial
use
information
(
required
under
2238
section
710.32(
c)(
4)
of
the
regulatory
text).
Commenters
generally
were
supportive
of
having
a
2239
second,
higher
reporting
threshold
for
this
exposure­
related
information.
However,
one
2240
commenter
stated
that
the
300,000
lbs.
threshold
is
too
low,
and
that
it
should
be
set
at
one
2241
million
pounds
to
coincide
with
the
HPV
Challenge
Program
threshold.
2242
EPA
considered
chemicals
with
aggregate,
nationwide,
U.
S.
production
and
importation
2243
volumes
of
one
million
pounds
or
more
(
based
on
1990
IUR
data)
for
the
HPV
Challenge
2244
Program.
That
is,
if
one
million
pounds
of
a
certain
chemical
were
reported
for
the
1990
IUR
as
2245
102
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
being
produced
or
imported
collectively,
by
all
manufacturers
throughout
the
United
States,
then
2246
that
chemical
was
identified
as
an
HPV
chemical
for
purposes
of
the
HPV
Challenge
Program.
2247
The
300,000
lbs.
IURA
threshold
captures
at
least
one
report
for
more
than
95%
of
the
HPV
2248
chemicals
reported
to
the
1990
IUR.
2249
The
production
volume
that
defines
chemicals
as
HPV
should
not
be
confused
with
the
2250
300,000
lbs.
per
year
reporting
threshold
for
processing
and
use
data
reporting
in
the
amended
2251
IUR.
The
300,000
lbs.
threshold
applies
to
the
amount
manufactured
at
a
single
site
and
is
not
an
2252
aggregate,
industry­
wide
production
number.
EPA
is
implementing
the
300,000
lbs.
per
year
2253
reporting
threshold
for
individual
IUR
submitters
because
it
limits
the
increase
in
burden
2254
associated
with
the
new
IURA
processing
and
use
reporting
requirements
and
it
limits
the
number
2255
of
chemicals
for
which
exposure­
related
data
will
be
reported
to
approximately
4,000.
This
2256
number
is
consistent
with
the
several
thousand
chemicals
suggested
by
GAO
in
its
1995
report
2257
  
EPA
Should
Focus
Its
Chemical
Use
Inventory
on
Suspected
Harmful
Substances,''
(
Ref.
31),
2258
and
ensures
that
exposure­
related
data
will
be
reported
for
almost
all
HPV
chemicals
(
defined
by
2259
national
aggregate
production).
Increasing
the
300,000
lbs.
threshold
to
one
million
lbs.
would
2260
drastically
undermine
the
Agency's
collection
of
processing
and
use
exposure­
related
data.
The
2261
higher
threshold
would
reduce
the
number
of
chemicals
for
which
this
information
is
submitted
2262
and
eliminate
processing
and
use
data
reporting
on
many
of
the
HPV
chemicals.
The
Agency
2263
would
be
left
with
very
little
information
with
which
to
conduct
the
needed
screening­
level
2264
assessments
and
the
resulting
prioritization
would
be
less
meaningful.
2265
In
the
proposed
IURA,
EPA
also
solicited
comments
on
the
possibility
of
replacing
the
2266
chemicals
identified
using
the
300,000
lbs.
annual
production
volume
threshold
(
by
site)
with
five
2267
other
groups
of
chemicals.
Those
groups
include:
1)
a
set
of
HPV
chemicals
that
submitters
2268
103
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
identify
as
being
produced
nationwide
in
excess
of
one
million
lbs;
2)
chemicals
that
are
currently
2269
subject
to
testing
under
TSCA
section
4
(
i.
e.,
test
rules
and
enforceable
consent
agreements
2270
(
ECAs));
3)
chemicals
identified
for
voluntary
testing;
4)
chemicals
designated
for
testing
by
the
2271
ITC;
and
5)
chemicals
listed
in
the
Agency's
Master
Testing
List
(
the
current
edition
is
available
at
2272
http://
www.
epa.
gov/
opptintr/
chemtest/
mtl.
htm).
2273
Specifically,
the
Agency
asked
for
comment
on:
1)
whether
manufacturers
would
be
able
2274
to
determine
which
chemicals
have
exceeded
the
nationally
aggregated
HPV
threshold
in
a
given
2275
submission
period,
especially
given
how
frequently
chemical
production
rises
above
and
falls
2276
below
this
threshold
from
IUR
submission
period
to
submission
period;
2)
what
additional
2277
burdens
such
a
determination
would
place
on
submitters;
and
3)
whether
the
IURA
data
would
be
2278
less
useful
if
processing
and
use
data
reporting
were
limited
to
HPV
chemicals.
2279
Many
commenters
favored
use
of
the
set
of
HPV
chemicals
in
lieu
of
the
proposed
IURA
2280
reporting
with
the
300,000
lbs.
threshold,
yet
none
directly
responded
to
the
specific
Agency
2281
questions.
Commenters
failed
to
take
into
account
the
added
burden
of
aggregating
chemical
2282
production
to
determine
which
substances
are
HPV
chemicals.
They
also
offered
no
justification
2283
for
substituting
the
300,000
lbs.
plant
site­
specific
threshold
with
a
one
million
lbs.
national
2284
aggregate
threshold,
beyond
stating
that
relevant
information
is
being
provided
already
through
2285
other
programs.
Nor
did
they
offer
possible
solutions
to
the
problem
of
reliably
aggregating
2286
production
volumes.
2287
EPA
does
not
believe
that
submitters
will
be
able
to
effectively
aggregate
nationwide
2288
production
volumes.
Aggregation
is
especially
difficult
in
light
of
continual,
market­
driven
2289
changes
in
production,
many
submitters'
interest
in
protecting
individual
plant
site
production
2290
volume
information
as
CBI,
and
the
frequency
with
which
chemical
volumes
rise
above
and
fall
2291
104
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
below
the
current
threshold.
For
a
nationally
aggregated
one
million
lbs.
threshold
to
be
2292
effective,
it
must
be
able
to
accommodate
the
frequency
with
which
individual
chemicals
may
rise
2293
above
or
fall
below
the
HPV
threshold
criteria
of
a
U.
S.
aggregate
production
volume
of
one
2294
million
lbs.
or
more
per
year.
For
example,
17%
of
the
chemicals
which
were
HPVs
according
to
2295
data
submitted
under
the
1990
IUR
were
not
HPVs
according
to
data
submitted
under
the
1994
2296
IUR.
2297
D.
Definitions
and
Clarification
Requests
2298
1.
How
is
the
definition
of
"
inorganic
chemical
substance"
affected
by
these
2299
amendments?
One
commenter
suggested
that
the
definition
of
"
inorganic
chemical
2300
substance"
in
40
CFR
710.26(
a)
is
faulty.
It
seems
to
say
that
carbon,
graphite,
diamond,
carbon
2301
dioxide,
carbon
monoxide,
and
various
carbides
and
other
materials
that
a
chemist
would
define
2302
as
inorganic
are
actually
organic.
2303
This
action
does
not
change
the
definition
of
inorganic
chemical
substances
for
IURA
2304
reporting
purposes.
The
Agency
believes
that
the
existing
definition
of
inorganic
chemical
2305
substance
is
adequate
and
necessary
to
the
implementation
of
the
IURA.
For
purposes
of
the
2306
IURA,
inorganic
chemical
substances
will
continue
to
be
defined
as
any
chemical
substance
that
2307
does
not
contain
carbon
or
contains
carbon
only
in
the
form
of
carbonato
[=
CO3],
cyano
[­
CN],
2308
isocyano
[­
NC],
cyanato
[­
OCN],
or
isocyanato
[­
NCO],
groups,
or
the
chalcogen
analogues
of
2309
these
groups
(
see
section
710.26(
a)
of
the
regulatory
text).
This
definition
does
not
imply
that
2310
certain
inorganic
substances
are
viewed
as
organic
under
this
rule.
Although
chemists
may
differ
2311
on
their
classification,
the
Agency
considers
carbon
black
[
CASRN
1333­
86­
4],
carbon
[
CASRN
2312
7440­
44­
0],
graphite
[
CASRN:
7782­
42­
5],
diamond
[
CASRN:
7782­
40­
3],
and
charcoal
2313
105
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
[
CASRN:
16291­
96­
6]
to
be
inorganic
chemical
substances
for
purposes
of
the
IURA,
and
as
2314
such,
these
chemicals
will
be
subject
to
the
IURA
reporting
requirements
for
inorganic
chemical
2315
substances.
However,
due
to
their
absence
from
the
inorganic
definition,
the
other
substances
2316
mentioned,
i.
e.,
carbon
dioxide,
carbon
monoxide
and
various
carbides,
are
considered
to
be
2317
organic
chemical
substances.
Under
the
IURA,
inorganic
substances
will
be
initially
subject
only
2318
to
partial
reporting,
whereas
organic
substances,
unless
specifically
excluded
from
reporting
under
2319
710.26,
will
be
subject
to
full
IUR
reporting.
2320
2.
Is
mining
considered
manufacturing?
Commenters
asked
whether
mining
is
2321
considered
"
manufacturing"
under
TSCA.
Under
TSCA,
the
term
"
manufacture"
includes
2322
production
or
importation
of
a
chemical
substance
as
well
as
its
manufacture
(
TSCA
section
2323
3(
7)).
Mining,
which
includes
extracting
metal
ores
or
minerals
from
their
natural
deposits
by
any
2324
means,
including
secondary
recovery
of
metal
ore
from
reuse
or
other
storage
piles,
wastes,
or
2325
rock
dumps,
or
from
mill
tailings
derived
from
the
mining,
cleaning,
or
concentration
of
metal
2326
ores,
is
production
and
is
considered
to
be
a
manufacturing
activity
under
TSCA.
2327
However,
chemical
substances
which
are
naturally
occurring
and
which,
among
other
2328
things,
are
unprocessed
or
processed
only
by
manual,
mechanical,
or
gravitational
means
(
see
40
2329
CFR
710.4(
b)(
1))
are
currently
excluded
from
IUR
reporting
and
continue
to
be
excluded
under
2330
these
IUR
amendments
(
see
40
CFR
710.26(
d)).
For
example,
rocks,
ores,
and
minerals
are
not
2331
IURA­
reportable
to
the
extent
they
are
manufactured
only
via
the
means
described
in
40
CFR
2332
710.4(
b).
The
section
710.4(
b)
exclusion
is
a
process
specific
exclusion
rather
than
a
chemical
or
2333
industry
specific
one.
Therefore,
persons
who
manufacture
a
substance
in
a
manner
other
than
as
2334
specified
in
section
710.4(
b)
are
required
to
report
under
IURA
unless
they
or
the
substance
they
2335
manufacture
are
otherwise
excluded.
As
a
result,
many
mined
materials
are
listed
on
the
TSCA
2336
106
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
Inventory
because
at
least
some
of
the
time
they
are
produced
by
other
than
manual,
mechanical,
2337
or
gravitational
means.
2338
Section
710.26(
d)
intentionally
exempts
from
IURA
reporting
any
chemical
substance
2339
which
is
isolated/
removed
from
nature,
for
a
commercial
purpose,
by
any
means
listed
in
section
2340
710.4(
b).
It
also
exempts
any
other
chemical
substance
derived
or
separated
from
the
substance
2341
originally
removed
from
nature,
provided
such
derivation
involved
only
the
means
specified
in
2342
section
710.4(
b).
For
example,
when
using
manual,
mechanical,
or
gravitational
processes
to
2343
separate
one
or
more
substances
from
a
naturally­
occurring
mixture,
these
isolated
component
2344
substances
are
also
considered
naturally­
occurring
and
excluded
from
reporting.
However,
any
2345
substance
manufactured
from
a
naturally
occurring
precursor
substance
via
a
chemical
reaction
is
2346
not
considered
naturally
occurring
and,
therefore,
not
excluded
from
reporting
under
section
2347
710.26(
d).
2348
3.
What
is
the
difference
between
"
reasonably
ascertainable"
information
and
"
readily
2349
obtainable"
information?
A
number
of
commenters
raised
concerns
about
the
meaning
of
2350
"
readily
obtainable"
and
"
reasonably
ascertainable,"
what
level
of
effort
is
required
for
each,
and
2351
the
difference
in
the
level
of
effort
required.
Commenters
also
stated
that
the
expectation
that
2352
submitters
will
provide
data
on
users
outside
their
control
seems
to
be
an
unworkable
and
2353
unrealistic
mandate.
The
reporting
standard
of
Section
8(
a)(
2)
is
"
reasonably
ascertainable,"
and
2354
commenters
stated
that
this
should
not
be
construed
to
include
data
that
are
not
in
the
possession
2355
of
the
person
reporting.
2356
"
Known
to
or
reasonably
ascertainable
by"
is
the
current
standard
for
data
collection
2357
under
which
the
IUR
operates
and
is
the
standard
authorized
by
TSCA
section
8(
a).
"
Known
to
2358
or
reasonably
ascertainable
by"
means
all
information
in
a
person's
possession
or
control,
plus
all
2359
107
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
information
that
a
reasonable
person
similarly
situated
might
be
expected
to
possess,
control,
or
2360
know.
The
"
known
to
or
reasonably
ascertainable
by"
standard
is
applicable
to
the
information
2361
required
under
sections
710.32(
c)(
1),
(
c)(
2),
and
(
c)(
3)
of
the
regulatory
text.
2362
"
Readily
obtainable"
is
a
lesser
standard
EPA
is
applying
to
the
reporting
of
information
2363
concerning
the
processing
and
use
of
chemicals
subject
to
the
IURA
(
section
710.32(
c)(
4)
of
the
2364
regulatory
text).
The
readily
obtainable
standard
is
less
inclusive
than
the
reasonably
ascertainable
2365
standard.
The
readily
obtainable
standard
is
limited
to
information
known
or
available
to
2366
management
or
supervisory
employees
of
the
submitter,
and
does
not
require
additional
effort
to
2367
collect
information
on
processing
or
use
of
chemicals
by
others
not
under
the
control
of
the
2368
submitter.
Although
the
Agency
is
requiring
submitters
to
provide
only
information
in
their
2369
possession,
EPA
believes
that
submitters
will
often
possess
some
knowledge
concerning
use
of
2370
chemicals
sold
by
the
submitter
to
their
customers,
even
though
the
submitter
does
not
control
its
2371
customers'
sites.
EPA's
experience
with
over
30,000
TSCA
section
5
PMNs
demonstrates
that
2372
companies
do
know
the
ultimate
use,
as
well
as
intervening
processing
steps,
of
their
products.
In
2373
choosing
the
readily
obtainable
standard,
the
Agency
is
lessening
the
burden
on
submitters
2374
compared
to
the
"
known
to
or
reasonably
ascertainable
by"
standard,
while
recognizing
that
the
2375
submitter
is
supplying
data
on
uses
of
chemicals
that
are
beyond
his
or
her
control.
The
standard
2376
for
reporting
information
on
processing
and
use
of
chemical
substances
is
the
same
as
adopted
in
2377
the
PAIR.
(
See
40
CFR
712.7)
2378
E.
Confidential
Business
Information
2379
The
Agency's
intent
under
these
regulations
is
to
achieve
balance
and
ensure
that
the
2380
submitter
only
claims
as
confidential
that
information
which
is
legally
entitled
to
confidential
2381
108
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
treatment.
EPA
believes
that
these
amendments
will
discourage
the
assertion
or
maintenance
of
2382
invalid
CBI.
2383
1.
General
CBI.
a.
Reducing
the
amount
of
CBI
claims.
EPA
solicited
suggestions
2384
from
commenters
on
what
could
be
done
to
the
IUR
reporting
process
and
data
elements
to
2385
reduce
CBI
claims,
thereby
allowing
better
public
access
to
the
data.
Some
commenters
2386
responded
by
requesting
that
EPA
not
focus
on
reducing
CBI
claims,
especially
by
imposing
2387
burdens
apparently
designed
to
discourage
legitimate
CBI
claims
or
by
making
assertion
of
such
2388
claims
overly
burdensome.
Some
commenters
stated
that
the
new
data
elements
that
are
being
2389
added
by
these
amendments
raise
significant
CBI
concerns
and
that
the
IUR
amendments
can
be
2390
expected
to
result
in
a
significant
increase
in
the
number
of
legitimate
CBI
claims.
2391
EPA
agrees
that
submitters
will
make
CBI
claims
for
the
new
data
elements
that
are
being
2392
added
by
these
amendments,
most
likely
resulting
in
a
greater
number
of
CBI
claims
overall.
2393
However,
EPA
is
requiring
reporting
for
most
of
the
new
data
elements
in
ranges,
a
reporting
2394
method
EPA
believes
will
result
in
fewer
CBI
claims
compared
to
reporting
discrete
numbers.
2395
Additionally,
EPA
is
amending
the
IUR
to
encourage
that
only
legally
valid
CBI
claims
are
2396
asserted
and
maintained,
and
to
ensure
that
CBI
claims
are
well
thought
out
by
the
submitter.
2397
These
amendments
include
a
new
requirement
to
reassert
previous
CBI
claims
which
the
2398
submitter
wishes
to
maintain
as
CBI,
and
which
continue
to
meet
the
established
legal
criteria
2399
found
at
40
CFR
2.208
(
as
judged
to
be
met
by
reviewing
a
claimant's
answers
to
the
questions
2400
found
at
40
CFR
710.38).
The
IUR
amendments
also
include
a
new
requirement
to
provide
2401
upfront
substantiation
of
CBI
claims
for
site
identity.
In
both
cases,
the
amendments
will
2402
minimize
claims
by
prompting
submitters
to
perform
an
initial
evaluation
of
the
need
for
and
2403
validity
of
a
CBI
claim
for
plant
site
identity,
an
essential
data
element,
and
a
quadrennial
2404
109
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
evaluation
of
the
continued
legitimacy
of
their
claims.
EPA
believes
these
efforts
will
greatly
2405
assist
in
limiting
CBI
claims
to
those
that
are,
and
that
continue
to
be,
legitimate.
2406
Many
commenters
have
suggested
that
EPA
is
trying
to
discourage
legitimate
CBI
claims
2407
even
though
TSCA
provides
that
certain
submitted
information
may
be
claimed
confidential.
EPA
2408
wishes
to
clarify
that
it
is
not
attempting
to
discourage
legitimate
confidentiality
claims;
rather,
the
2409
Agency
intends
only
to
discourage
inappropriate
claims.
This
allows
the
Agency
to
protect
2410
legitimate
CBI
while
also
increasing
the
amount
of
information
available
for
public
use.
2411
EPA
has
information
indicating
the
existence
of
inappropriate
or
no
longer
valid
CBI
2412
claims.
For
instance,
when
EPA
has
selectively
challenged
CBI
claims
in
the
past,
many
of
these
2413
claims
have
been
amended
by
the
companies
to
make
the
information
available
to
the
public.
2414
Additionally,
OPPT's
Administrative
Record
00125
contains
state
CBI
data
reviews,
published
2415
articles,
industry
letters,
and
other
papers
discussing
CBI
issues.
For
instance,
the
Georgia
2416
Department
of
Natural
Resources
reported
in
a
1996
CBI
Data
Review
that
IUR
data
identified
as
2417
confidential
was
available
in
other
non­
confidential
databases
(
Ref.
32).
The
Administrative
2418
Record
is
in
the
same
location
as
the
Docket,
and
available
by
following
the
procedures
identified
2419
in
Unit
II.
B.
2.
of
the
Preamble
for
the
final
rule.
2420
Some
commenters
suggested
reducing
the
number
of
data
elements
that
will
be
collected
2421
under
the
IURA,
perhaps
using
instead
a
format
such
as
the
one
used
by
OECD
for
SIDS
2422
chemicals,
which
aggregates
information
for
all
manufacturers
and
thus
protects
company­
specific
2423
information.
EPA
considered
alternate
reporting
formats
with
different
data
elements,
and
has
2424
determined
that
the
reporting
of
site­
specific
information
by
the
individual
sites
is
the
best
way
to
2425
collect
the
information
needed.
EPA
will
continue
to
perform
the
aggregating
function
when
2426
providing
the
public
with
information
that
is
subject
to
a
site­
specific
CBI
claim.
Collecting
only
2427
110
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
national
aggregate
values
would
drastically
reduce
the
usefulness
of
the
information
to
the
2428
Agency,
even
though
it
may
reduce
the
number
of
CBI
claims.
The
IUR
is
used
to
address
both
2429
national
needs
and
local
issues.
For
example,
IUR
production
volume
information
was
used
to
2430
identify
the
national
list
of
High
Production
Volume
(
HPV)
chemicals
for
the
Agency's
HPV
2431
Challenge
Program
(
see
http://
www.
epa.
gov/
opptintr/
chemrtk/).
Moreover,
site­
specific
IUR
2432
information
is
used
to
secure
a
better
overall
understanding
of
activities
at
individual
sites.
This
2433
information
is
used
for
site­
specific
risk
assessments
for
the
use
of
federal,
state
and
local
entities.
2434
b.
Protection
of
CBI.
Some
commenters
expressed
concern
about
the
Agency

s
ability
to
2435
protect
against
the
inappropriate
release
of
CBI
and
stated
that,
under
Section
14
of
TSCA,
EPA
2436
has
a
statutory
obligation
to
protect
information
properly
claimed
as
CBI.
These
commenters
are
2437
concerned
about
past
releases
of
information
claimed
as
confidential,
and
would
like
to
see
the
2438
Agency
take
steps
to
guarantee
greater
protection
of
CBI
data.
2439
EPA
agrees
that
it
has
a
statutory
obligation
to
protect
information
properly
claimed
CBI
2440
and
is
continually
involved
in
exploring
ways
to
better
protect
such
information.
In
this
light,
2441
these
amendments
reflect
the
Agency's
efforts
to
assure
that
information
it
protects
qualifies,
and
2442
continues
to
qualify,
for
that
protection
under
the
established
legal
standards.
The
new
IURA
2443
requirements
will
help
insure
that
EPA's
system
of
information
protection
is
limited
to
valid
2444
claims.
2445
c.
Production
volume
ranges.
EPA
requested
comment
on
the
use
of
production
volume
2446
ranges
as
a
mechanism
to
reduce
the
number
of
confidentiality
claims
by
allowing
2447
characterizations
of
site
specific
chemical
and
specific
production
volume
information
without
2448
releasing
CBI.
In
general,
commenters
felt
that
the
use
of
the
ranges
would
not
necessarily
result
2449
in
reduced
CBI
claims.
Commenters
cited
a
few
examples
of
times
where
production
volume
2450
111
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
would
still
be
claimed
CBI,
even
with
the
ranges.
Other
commenters
suggested
using
broader
2451
ranges.
2452
Despite
these
comments,
the
Agency
has
determined
that
it
is
worthwhile
to
require
2453
submitters
to
consider
whether
their
production
volumes,
within
the
original
Inventory
ranges,
2454
warrant
protection
as
CBI.
EPA
recognizes
that
some
submitters
will
make
CBI
claims
for
both
2455
the
specific
and
the
ranged
production
volume
information.
However,
EPA
believes
that
in
many
2456
cases
submitters
will
allow
the
release
of
ranged
production
volume
information.
This
belief
is
2457
supported
by
some
industry
organizations.
For
example,
in
a
1993
letter,
Union
Carbide
2458
suggested
the
use
of
the
original
Inventory
production
volume
ranges
for
non­
confidential
2459
reporting.
While
Union
Carbide
did
state
that
"
conceivably,
a
submitter
could
be
able
to
justify
a
2460
CBI
claim
for
a
range,"
the
conclusion
was
that
many
companies
would
be
satisfied
with
non­
2461
confidential
reporting
(
Ref.
8).
These
conclusions
are
further
supported
by
EPA's
experience
2462
with
the
original
Inventory,
where
only
35%
of
production
volume
values
reported
to
the
original
2463
TSCA
Inventory
were
claimed
CBI,
compared
to
the
typical
claim
level
of
65%
for
production
2464
volumes
under
the
IUR.
2465
EPA
made
adjustments
to
the
original
Inventory
range
by
making
the
ranges
consistent
2466
with
the
second
reporting
threshold
of
300,000
lbs.,
as
described
in
Unit
II.
F.
5.
d.
of
this
2467
preamble.
This
was
done
to
further
protect
information
submitted
by
industry
and
to
encourage
2468
industry
to
allow
the
public
release
of
ranged
production
volume
data.
Under
the
proposed
ranges
2469
using
the
100,000
lbs.
division,
submitters
who
did
not
claim
the
production
volume
range
as
CBI
2470
may
have
inadvertently
provided
the
public
with
more
information
than
they
intended.
This
is
2471
illustrated
by
the
example
of
a
submitter
whose
production
volume
was
in
the
100,000
to
one
2472
million
lbs.
range,
who
did
not
claim
their
production
volume
range
CBI,
and
who
did
not
report
2473
112
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
any
information
in
Part
III
of
reporting
Form
U
(
the
industrial
processing
and
use
and
the
2474
commercial
and
consumer
use
information
for
manufacturers
of
300,000
lbs.
or
greater).
Public
2475
users
of
that
submitter's
data
could
infer
that
the
submitter's
production
was
in
the
range
of
2476
100,000
to
300,000
lbs.
EPA's
change
to
the
range
helps
protect
against
similar
inadvertent
2477
disclosures
of
CBI.
2478
d.
Disclosing
customer
confidential
information.
A
commenter
expressed
concern
that,
2479
as
a
producer
of
chemical
feedstocks,
they
might
inadvertently
report
customer
data
and
not
claim
2480
the
data
as
CBI,
while
their
customer
reports
the
same
data
and
does
claim
the
data
as
CBI.
2481
EPA
does
not
believe
that
this
will
be
a
significant
issue.
The
downstream
processing
and
2482
use
information
that
some
submitters
will
be
required
to
provide
under
the
IURA
is
not
tied
to
2483
customer
identities.
Submitters
will
not
report
where
or
who
their
customers
are
or
how
much
2484
their
individual
customers
produce.
In
addition,
CBI
claims
can
be
made
as
necessary
for
any
2485
information
provided
on
Form
U.
2486
2.
Upfront
Substantiation.
a.
Authority
for
substantiation.
A
commenter
stated
that
the
2487
plant
site
identity
substantiation
requirement
is
not
authorized
under
TSCA.
Another
commenter
2488
felt
that
requiring
upfront
substantiation
is
overly
burdensome
and
an
arbitrary
exercise
of
2489
authority.
The
commenter
stated
that
substantiation
should
only
be
required
if
and
when
a
2490
request
for
public
disclosure
is
made,
and
substantial
and
reasonable
need
are
demonstrated.
2491
Under
TSCA
Section
14(
c),
"
a
[
confidential]
designation
under
this
paragraph
shall
be
2492
made
in
writing
and
in
such
manner
as
the
Administrator
may
prescribe."
EPA
is
continuing
to
2493
require
that
those
reporting
under
the
IURA
substantiate
their
chemical
identity
CBI
claims,
and
is
2494
requiring
under
these
amendments
that
submitters
also
substantiate
any
plant
site
identity
CBI
2495
claims.
Section
710.38
of
the
regulatory
text
requires
submitters
to
substantiate
these
claims
2496
113
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
submitted
under
the
IUR
by
providing
answers
to
specified
questions.
EPA
has
long
required
2497
upfront
substantiation
for
specified
CBI
claims
under
the
authority
specified
in
TSCA
(
see,
e.
g.,
2498
40
CFR
710.38(
c))
and
will
continue
to
require
upfront
substantiation
where
appropriate.
2499
The
Agency
is
adding
upfront
substantiation
requirements
for
plant
site
identity
2500
information
because
EPA
has
observed
that,
on
occasion,
plant
site
information
has
been
claimed
2501
as
confidential
even
though
it
was
revealed
in
filings
required
under
sections
311,
312
and
313
of
2502
the
Emergency
Planning
and
Community
Right­
to­
Know
Act
(
EPCRA),
42
U.
S.
C.
sections
2503
11001
to
11050.
EPA
believes
that
many
of
these
CBI
claims
are
inappropriate
and
that
the
new
2504
substantiation
requirement
would
reduce
the
occurrence
of
inappropriate
claims.
A
decrease
in
the
2505
number
of
CBI
claims
under
the
new
substantiation
requirement
would
facilitate
EPA's
ability
to
2506
make
current
plant
site
information
available
to
other
Federal
agencies
and
the
public
because
2507
more
information
submitted
under
IUR
could
be
released
publicly.
2508
Upfront
substantiation
of
CBI
claims
imposes
some
additional
burden,
though
not
2509
substantial.
EPA's
economic
analysis
for
this
rule
estimates
0.2
to
0.3
hours
per
plant
site
2510
reporting
under
IURA
for
the
incremental
costs
of
reporting
all
elements
of
plant
site
identity
2511
information.
The
burden
of
upfront
substantiation
for
plant
site
identity
CBI
claims
is
included
in
2512
this
estimate.
2513
b.
Alternate
substantiation
questions.
One
commenter
suggested
a
simplified
set
of
2514
substantiation
questions,
consisting
of
two
questions:
(
1)
Are
the
specified
data
confidential?
and,
2515
(
2)
In
as
much
detail
as
possible,
explain
why
this
information
should
be
given
CBI
protection.
2516
EPA
believes
that
requiring
responses
to
its
list
of
substantiation
questions
in
section
2517
710.38
of
the
regulatory
text
is
necessary
to
ensure
that
information
submitted
for
confidential
2518
protection
qualifies
for
that
protection.
The
commenter

s
proposed
questions,
while
providing
2519
114
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
the
opportunity
for
a
submitter
to
express
its
business
reasons
and
preferences
regarding
the
2520
information,
do
not
provide
all
of
the
necessary
information
to
definitively
evaluate
the
eligibility
2521
of
the
information
for
confidential
treatment.
2522
3.
Reassertion.
EPA
received
a
number
of
comments
regarding
the
new
CBI
reassertion
2523
provisions.
All
of
these
comments
were
opposed
to
the
new
requirement.
Some
comments
2524
expressed
the
position
that
reassertion
is
overly
burdensome
and
even
punitive,
requiring
2525
submitters
to
retrace
old
steps
by
answering
all
the
original
substantiation
questions
anew.
2526
Reassertion
could
possibly
require
the
retention
of
voluminous
old
records.
Similarly,
some
2527
commenters
stated
that
submitters
who
may
otherwise
be
exempt
from
reporting
in
a
given
cycle
2528
must
nevertheless
complete
an
entirely
new
Form
U,
as
well
as
resubstantiate
their
claim.
One
2529
commenter
stated
that
the
new
requirement
weakens
legitimate
CBI
by
discouraging
reassertion,
2530
resulting
in
lost
CBI
rights.
Others
felt
the
new
standards
violate
the
Agency's
obligation
under
2531
TSCA
to
protect
confidential
information
and
that
EPA
goes
beyond
the
law
in
requiring
2532
substantiation­­
which
is
not
specifically
mentioned
in
the
language
of
the
statute­­
at
all.
Another
2533
commenter
was
concerned
that
inadvertently
forgetting
to
reassert
a
still
valid
 
and
valuable
 
claim
2534
could
result
in
a
harmful
public
release
of
information.
Finally,
some
commenters
felt
the
2535
reassertion
provisions
are
a
statement
by
EPA
that
CBI
value
automatically
diminishes
over
time.
2536
EPA
has
considered
these
industry
comments,
and
weighed
the
concerns
expressed
2537
against
the
public

s
need
for
access
to
information
on
chemicals
in
commerce
in
the
United
States.
2538
In
doing
so,
the
Agency
believes
the
requirement
to
reassert
old
claims
of
CBI
is
justified
as
a
2539
practical
measure
to
ensure
that
information
withheld
meets
the
legal
criteria.
Moreover,
many
of
2540
the
comments,
and
the
expressions
of
concern
relating
to
burden
with
this
new
reassertion
2541
requirement,
appear
to
be
the
result
of
a
misunderstanding
of
the
practical
aspects
of
the
2542
115
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
reassertion
requirement.
2543
a.
Reassertion
requirements
and
associated
burden.
Reassertion
will
result
in
added
2544
burden
to
submitters.
However,
this
burden
in
determining
the
continued
legal
validity
of
an
2545
previous
CBI
claim
is
not
overly
burdensome,
and
certainly
not
intended
by
the
Agency
to
be
2546
punitive.
EPA
disagrees
that
old
records
(
i.
e.,
those
records
more
than
five
years
old)
will
need
to
2547
be
searched.
Rather,
the
submitter
is
verifying
that
the
previously
submitted
information
2548
continues
to
meet
the
requirements
for
a
CBI
claim.
The
submitter
needs
to
verify,
for
instance,
2549
that
the
protected
information
was
not
publicly
released
during
the
previous
four
years.
The
2550
submitter
does
not
need
to
verify
that
the
initial
claim
was
valid,
which
would
likely
require
2551
records
older
than
four
years.
EPA
estimates
the
burden
for
reassertion
ranges
from
1
to
2
hours
2552
for
a
partial
form
to
8
to
9
hours
for
a
full
form,
as
described
in
Unit
III.
G.
1.
of
this
preamble
and
2553
in
the
economic
analysis
(
Ref.
6).
2554
Two
data
elements
will
require
upfront
substantiation
under
the
IURA;
chemical
identity
2555
(
substantiation
is
currently
required
for
this
data
element,
see
40
CFR
710.38)
and
plant
site
2556
identity
(
see
section
710.38(
d)
of
the
regulatory
text).
The
substantiation
questions
which
were
2557
answered
at
the
time
of
original
CBI
claim
do
not
need
to
be
resubmitted
to
EPA
if
none
of
the
2558
answers
have
changed.
However,
submitters
do
need
to
review
their
previous
responses
and
2559
submit
updated
responses
to
EPA
to
the
extent
they
have
changed
since
the
last
submission
2560
period.
Amended
responses
will
be
submitted
along
with
the
completed
Part
I,
Section
I
and
Part
2561
IV
of
Form
U.
2562
EPA
is
also
not
requiring
persons
who
wish
to
reassert
past
CBI
claims
to
fill
out
an
2563
entirely
new
Form
U
if
they
are
otherwise
exempt
from
reporting
in
a
given
year.
They
will
only
2564
need
to
fill
out
Part
I,
Section
I
and
Part
IV
of
the
reporting
form
relating
to
reassertion
of
CBI.
2565
116
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
b.
Time
value
of
CBI
information.
CBI
value
does
not
automatically
diminish
over
time.
2566
However,
some
of
the
circumstances
which
justify
the
protection
of
some
information
as
CBI
may
2567
change
over
the
years.
Common
examples
of
changing
circumstances
include
publication
of
a
2568
plant
site's
chemical
identity
in
a
trade
journal,
or
a
product
innovation
by
a
competitor
which
2569
may
render
the
confidential
information
commercially
insignificant
in
an
ever­
changing
market.
2570
The
public
is
encouraged
to
review
OPPT
Administrative
Record
00125
for
detailed
information
2571
on
this
issue.
More
specifically
see
Docket
Entry
00125A,
B1a­
011.
Agency
Document:
"
Final
2572
Action
Plan:
Confidential
Business
Information
Reform,
June
24,
1994,"
Comments
43,
44,
and
2573
45.
(
Ref.
14)
2574
c.
Protection
of
CBI.
Section
14(
c)
of
TSCA
invests
the
Agency
with
the
authority
to
2575
prescribe
the
manner
in
which
CBI
shall
be
designated.
In
these
amendments,
EPA
chose
to
2576
require
that
claims
be
reasserted
each
reporting
cycle,
and
that
the
act
of
initially
designating
2577
certain
data
elements
(
i.
e.,
chemical
identity
and
plant
site
identity)
as
CBI
be
complete
only
after
2578
receipt
of
responses
to
the
substantiation
questions
found
at
40
CFR
710.38.
EPA
takes
very
2579
seriously
its
responsibility
to
aggressively
protect
appropriately
claimed
CBI
from
wrongful
public
2580
disclosure.
2581
EPA
is
particularly
sensitive
to
the
issue
of
unintended
public
release
of
CBI.
In
2582
countering
the
possibility
of
a
submitter's
inadvertent
failure
to
reassert,
the
Agency
intends
to
2583
implement
additional
notification
features.
These
include
personal
mailings
to
CBI
submitters,
as
2584
well
as
public
notification
in
the
Federal
Register
reminding
the
regulated
community
of
the
need
2585
to
maintain
CBI
through
reassertion.
2586
d.
Disclosing
CBI
without
required
notice.
Commenters
stated
that
EPA
does
not
have
2587
the
authority
to
release
information
which
has
been
designated
as
CBI,
without
notice
to
the
2588
117
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
submitter.
2589
The
Agency
agrees
that
EPA
is
required
to
provide
notification
of
intent
to
disclose
2590
confidential
information.
Under
TSCA
Section
14
(
c),
15
USC
Section
2613(
c),
"...
if
the
2591
Administrator
proposes
to
release
for
inspection
data
which
has
been
designated
under
2592
paragraph
(
1)(
A),
the
Administrator
shall
notify,
in
writing
and
by
certified
mail,
the
2593
manufacturer,
processor,
or
distributor
in
commerce
who
submitted
such
data
of
the
intent
to
2594
release
such
data."
Thus,
before
releasing
information
protected
by
a
valid
CBI
claim,
EPA
must
2595
first
provide
written
notice.
2596
The
IURA
includes
a
periodic
reassertion
requirement
as
a
necessary
component
of
2597
claiming
IUR
information
as
confidential.
A
CBI
claim
under
the
IURA
will
be
effective
until
the
2598
subsequent
submission
period.
If
it
is
not
reasserted
at
that
time,
the
claim
will
be
considered
2599
abandoned
or
withdrawn
and
will
cease
to
be
a
valid
claim
for
continued
CBI
protection.
Section
2600
14(
c)
does
not
require
EPA
to
provide
written
notice
before
disclosure
of
information
that
is
not
2601
protected
as
CBI.
However,
given
the
possibility
that
a
submitter
may
inadvertently
fail
to
2602
reassert
a
CBI
claim,
EPA
will
provide
notice
to
submitters
before
disclosing
previously
protected
2603
information.
2604
F.
Administrative
Comments
2605
1.
Frequency
of
Reporting.
Several
commenters
stated
that
one­
time
reporting
of
the
2606
IURA
information
would
be
more
appropriate
in
most
cases
for
the
intended
purposes
expressed
2607
by
EPA.
In
general,
commenters
stated
that
EPA
could
use
tools
such
as
PAIR
to
identify
2608
changes
in
a
particular
chemical's
exposure
or
use
profile
at
the
time
the
Agency
decides
to
do
a
2609
risk
analysis
for
that
chemical
(
see
Unit
III.
A.
3.
of
this
preamble).
A
few
commenters
stated
that
2610
118
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
there
is
insufficient
change
in
the
chemical
industry
to
warrant
recurring
reporting
of
the
IURA
2611
information,
especially
for
higher
volume
chemicals.
2612
EPA's
experience
with
past
IUR
reporting
demonstrates
that
the
chemical
industry
is
2613
indeed
dynamic,
with
a
30%
change
in
the
number
of
chemicals
reported
from
one
submission
2614
period
to
the
next.
The
specific
chemicals
that
are
reported
or
not
reported
in
any
single
2615
submission
period
change
at
a
variety
of
production
volumes;
this
change
is
by
no
means
limited
2616
to
lower
production
volume
chemicals
and
does
affect
higher
production
volume
chemicals
as
2617
well.
2618
Although
a
chemical's
hazards
may
be
fully
characterized,
EPA
needs
up­
to­
date
exposure
2619
information
to
stay
current
with
developments
and
adequately
screen
chemicals
for
possible
risks
2620
to
human
health
and
the
environment.
Although
the
toxicity
of
a
chemical,
once
known,
does
not
2621
change
(
although
new
information
can
modify
the
assessment
or
identify
new
concerns),
a
2622
chemical's
exposure
profile
can
vary
greatly
over
time.
Human
and/
or
environmental
exposures
2623
to
the
substance
can
at
one
time
be
minor,
but
as
uses
change
from
industrial
applications
to
2624
consumer
uses,
or
as
production
volumes
increase,
exposures
also
increase.
Therefore,
because
2625
exposure
and
uses
can
and
do
change
over
time
as
technologies
develop
or
innovations
arise,
2626
updated
exposure
information
is
needed
to
maintain
an
adequate
understanding
of
current
2627
exposures.
EPA
did
consider
one­
time
reporting
for
the
IURA
processing
and
use
data,
but
the
2628
information
would
quickly
become
out
of
date.
2629
The
goal
of
the
IURA
is
to
provide
a
database
of
exposure­
related
information
which
can
2630
be
used
for
screening
level
purposes
to
identify
chemicals
for
further
assessment,
as
well
as
2631
chemicals
of
lesser
concern
(
see
Unit
III.
A.
1
of
this
preamble).
EPA
intends
to
use
other
data
2632
sources
and
collection
tools,
as
appropriate,
once
a
chemical
has
been
identified
as
a
candidate
for
2633
119
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
further
assessment.
2634
2.
Calendar
year
reporting.
One
commenter
stated
that
the
requirement
to
report
data
2635
on
a
calendar
year
basis
instead
of
a
company
fiscal
year
basis
would
increase
systems
2636
development
needs
for
companies
who
report
their
volume
manufacturing
on
a
fiscal
year
versus
a
2637
calendar
year
(
by
creating
the
need
for
a
second
tracking
system),
while
creating
no
additional
2638
value
or
accuracy
in
the
reporting
of
manufacturing
data.
This
commenter
pointed
out
that
2639
because
the
most
that
companies'
fiscal
years
can
differ
from
a
calendar
year
is
six
months
and
2640
IUR
reporting
occurs
every
four
years
(
instead
of
every
year),
there
can
be
little
difference
in
the
2641
data
with
a
maximum
six
month
time
frame
shift.
Two
other
commenters
supported
the
change
2642
to
a
calendar
year
basis,
supporting
the
idea
of
having
a
consistent
time
frame
to
better
enable
2643
linkages
with
other
databases.
2644
EPA
has
retained
the
calendar
year
reporting
cycle
as
proposed.
By
moving
the
collection
2645
to
a
calendar
year
basis,
the
IURA
data
collection
becomes
more
compatible
with
other
databases
2646
such
as
the
Toxics
Release
Inventory
(
TRI).
This
compatibility
increases
the
data's
usefulness
by
2647
allowing
the
IURA
data
to
be
combined
with
data
from
other
data
collections.
Generally,
2648
companies
should
be
sufficiently
familiar
with
their
production
that
this
provision
should
not
2649
present
special
challenge
that
would
be
unaccounted
for
in
the
burden
estimates
provided
by
2650
survey
respondents,
as
described
in
the
economic
analysis.
2651
G.
Economic
Impact
Estimates
2652
Commenters
raised
a
number
of
concerns
about
the
economic
analysis.
In
response,
EPA
2653
has
made
a
number
of
changes
to
make
the
analysis
a
more
readable
document
and
to
incorporate
2654
changes
made
to
the
final
IURA
requirements.
2655
120
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
1.
General
Burden
comments.
Commenters
raised
a
variety
of
concerns
about
the
size
of
2656
the
burden
associated
with
the
amendments,
and
EPA's
estimates
of
that
burden.
In
general,
2657
commenters
felt
that
the
Agency's
burden
estimates
were
too
low.
However,
few
commenters
2658
provided
evidence
as
to
why
they
felt
EPA
underestimated
the
burden,
and
none
provided
any
2659
specific
analytical
basis
for
amending
the
estimates.
Some
commenters
claimed
that
the
revised
2660
form
represents
a
5­,
10­,
or
30­
fold
increase
in
burden,
at
least
partly
based
upon
the
fact
that
the
2661
original
Form
U
was
only
one
page
and
the
revised
Form
U
is
3
pages.
2662
In
response
to
these
comments,
EPA
reviewed
the
burden
analysis
and
determined
that
the
2663
comments
do
not
warrant
modifications
to
the
Agency's
general
approach
to
the
analysis.
EPA
2664
based
much
of
the
burden
analysis
on
a
survey
of
78
industry
respondents
(
Ref.
6).
In
addition,
2665
EPA
considered
the
burden
associated
with
such
programs
as
the
UEIP
(
described
in
Unit
III.
A.
1.
2666
of
this
preamble),
a
voluntary
project
in
which
EPA
collected
information
similar
in
some
ways
to
2667
the
IURA
information.
UEIP
respondents
provided
estimates
of
the
amount
of
time
they
used
to
2668
complete
the
survey
forms
(
Ref.
6).
However,
EPA
did
reassess
the
results
of
the
burden
survey
2669
and
did
make
some
changes
to
the
analysis.
The
burden
from
the
analysis
associated
with
the
2670
proposed
rule
was
$
36
to
$
51
million
in
the
first
year,
and
$
27
million
to
$
41
million
in
future
2671
reporting
years.
Changes
in
the
rule
and
methodology
raised
costs
of
the
final
rule
to
between
2672
$
74
and
$
91
million
in
the
first
and
future
reporting
cycles.
These
changes
are
primarily
due
to
2673
revising
the
analysis
from
the
survey
data,
revising
the
analysis
to
supplement
the
reassertion
2674
burden,
and
updating
the
number
of
report
submissions
to
incorporate
the
1998
IUR
data
2675
collection.
These
changes
are
discussed
further
in
"
Revised
Economic
Analysis
for
the
Amended
2676
Inventory
Update
Rule"
(
Ref.
6).
2677
a.
Burden
Over
Time.
Commenters
raised
concerns
about
specific
burden
issues.
Several
2678
121
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
commenters
felt
that
burden
will
not
decrease
over
time
because
of
the
four­
year
time
lapse
2679
between
submission
periods.
Those
commenters
believe
that
the
four­
year
period
between
2680
submission
periods
will
result
in
changes
to
product
lines
and
personnel
such
that
a
complete
2681
reintroduction
to
IUR
reporting
will
be
necessary
in
each
reporting
cycle.
EPA
disagrees,
and
2682
expects
rule
familiarization
to
require
the
most
effort
in
the
first
year
of
reporting.
EPA
believes
2683
that
there
will
be
some
similarity
in
the
information
reported
from
one
submission
period
to
the
2684
next,
especially
for
Parts
I
and
II
of
Form
U.
Subsequent
reporting
will
be
facilitated
by
the
site's
2685
maintenance
of
their
previous
reporting
year's
records.
2686
b.
Substantiation
and
reassertion
costs.
Commenters
stated
that
CBI
substantiation
and
2687
reassertion
costs
are
underestimated.
A
more
in­
depth
discussion
of
these
issues
is
in
Unit
2688
III.
E.
3.
a.
of
this
preamble.
EPA
has
reevaluated
its
estimates
for
CBI
substantiation
and
2689
reassertion.
The
economic
analysis
for
the
proposed
rule
estimates
two
to
four
hours
per
form
for
2690
CBI
reassertion,
regardless
of
whether
the
reassertion
was
for
a
partial
or
full
form.
After
careful
2691
consideration
of
the
many
factors
involved
in
CBI
reassertion,
EPA
believes
that
reassertion
will
2692
present
a
burden
proportional
to
the
burden
of
preparing
the
original
Form
U,
rather
than
an
2693
independent
estimate.
EPA
now
estimates
that
CBI
reassertion
will
require
10%
of
the
average
2694
burden
of
preparation
and
submission
(
baseline
and
incremental),
which
amounts
to
1
to
2
hours
2695
for
a
partial
form,
and
8
to
9
hours
for
a
full
form.
2696
c.
Characterization
of
burden
reduction.
Commenters
asserted
that
the
economic
2697
analysis
was
misleading
in
its
characterization
of
the
actions
that
constitute
burden
reduction
and
2698
cost
savings.
Specifically,
commenters
referred
to
EPA's
claim
of
a
burden
reduction
and
cost
2699
associated
with
the
300,000
lbs.
threshold
for
reporting
of
Form
U,
Part
III
information
on
2700
industrial
processing
and
use,
and
consumer
and
commercial
use.
EPA
simply
meant
that
2701
122
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
providing
a
partial
exemption
for
chemicals
below
the
300,000
lbs.
threshold
is
a
concession
to
2702
the
burden
that
the
rule
imposes
on
reporting
sites,
and
that
the
Agency
has
no
other
basis
for
this
2703
exemption
other
than
to
mitigate
the
increase
in
burden.
EPA
presented
a
similar
discussion
2704
comparing
options
considered
under
the
rule
for
other
partial
reporting
exemptions
such
as
the
2705
petroleum
streams
exemption.
These
discussions
are
put
into
the
appropriate
context
in
the
2706
economic
analysis.
A
commenter
also
took
issue
with
the
fact
that
EPA
asserts
that
reporting
2707
processing
and
use
information
on
the
top
ten
NAICS
codes
will
reduce
costs
(
versus
reporting
2708
on
an
unlimited
number
of
NAICS
codes),
given
that
identifying
these
top
ten
could
take
2709
considerable
effort.
EPA
continues
to
believe
that
reporting
only
the
top
ten
NAICS
codes
will
2710
be
less
burdensome
than
reporting
all
NAICS
codes
associated
with
industrial
processing
and
use
2711
operations.
2712
2.
Cost
comments.
Two
commenters
asserted
that
compliance
costs
for
chemicals
2713
manufactured
in
amounts
below
the
25,000
lbs.
threshold
are
not
zero
and
that,
as
production
2714
volume
for
a
chemical
approaches
the
threshold,
tracking
costs
will
accrue
to
determine
if
2715
production
will
cross
the
threshold.
Compliance
determination
(
the
act
of
determining
the
need
to
2716
comply
with
a
regulation)
occurs
on
a
per­
site
basis.
This
means
that
all
sites
that
report
under
2717
the
IURA
are
assumed
to
incur
the
same
average
cost
for
determining
compliance,
regardless
of
2718
the
number
of
chemicals
reported.
Some
small
number
of
firms
that
are
not
required
to
report
2719
may
incur
some
negligible
costs
in
this
regard,
but
EPA
does
not
believe
the
costs
to
be
significant
2720
given
that
it
is
standard
procedure
for
a
business
to
be
aware
of
the
volumes
it
produces.
The
2721
existence
of
voluntary
reporters
does
not
imply
that
below­
threshold
compliance
costs
are
non­
2722
zero;
it
simply
indicates
that
some
firms
choose
to
respond
to
the
IUR
when
not
required.
EPA
2723
has
no
basis
for
including
costs
beyond
the
requirements
of
the
rule.
2724
123
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
Another
commenter
determined
that
member
companies
in
its
organization
would
2725
experience
no
savings
from
raising
the
threshold
from
10,000
lbs.
to
25,000
lbs.
as
no
reports
are
2726
eliminated.
In
1994,
EPA
received
approximately
3,800
reports
for
chemicals
produced
in
2727
quantities
between
10,000
and
25,000
lbs.
As
a
result,
the
Agency
anticipates
that
a
significant
2728
number
of
reports
will
be
eliminated
by
raising
the
reporting
threshold.
2729
3.
Benefits
comments.
Commenters
stated
that
EPA
has
overestimated
the
benefits
of
2730
this
rule
and
should
quantify
the
benefits.
It
is
impossible
to
quantify
the
benefits
of
the
rule,
2731
given
that
it
is
an
information
rule
and
its
benefits
are
therefore
indirect.
Only
by
collecting
the
2732
information
on
the
amended
IUR
can
EPA
begin
to
assess
thoroughly
the
risks
from
a
portion
of
2733
the
more
than
76,000
chemicals
in
commerce.
The
risk­
management
actions
that
result
from
EPA
2734
review
of
the
IUR
data
will
have
direct
health
benefits,
benefits
that
typically
can
be
quantified.
2735
Commenters
offered
no
alternate
assessment,
quantitative
or
otherwise,
of
the
benefits
from
IUR
2736
amendments.
In
the
absence
of
quantified
benefit
figures,
it
is
impossible
to
make
simple
2737
comparisons
to
estimates
of
reporting
costs.
Thus,
EPA
must
balance
the
needs
of
the
Agency
2738
for
data
with
which
to
address
critical
environmental
and
health
risks,
with
the
burdens
of
2739
obtaining
such
data.
In
doing
so,
the
uses
of
and
need
for
the
data
are
carefully
addressed
both
2740
within
the
Agency,
and
during
interagency
review.
EPA
has
made
every
attempt
to
approach
the
2741
point
at
which
it
collects
only
the
information
necessary
to
meet
Agency
goals,
and
EPA
believes
2742
that
the
selected
option
most
closely
represents
that
point.
2743
4.
Small
Business
Impact
Comments.
Several
commenters
argued
that
EPA's
analysis
of
2744
the
impacts
of
the
IURA
on
small
businesses
is
insufficient
to
meet
the
requirements
of
the
Small
2745
Business
Regulatory
Enforcement
Fairness
Act
(
SBREFA).
EPA's
analysis
of
small
business
2746
impacts
fully
complies
with
SBREFA.
SBREFA
requires
the
Agency
to
certify
that
the
rule
is
not
2747
124
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
likely
to
have
a
"
significant
impact
on
a
substantial
number
of
small
entities."
EPA's
analysis
2748
determining
this
certification
can
be
found
in
"
Revised
Economic
Analysis
for
the
Amended
2749
Inventory
Update
Rule."
The
Small
Business
Administration
participated
in
the
Interagency
2750
review
for
the
proposed
rule
and
did
not
have
objections.
In
addition,
small
businesses,
according
2751
to
the
TSCA
Section
8
definition
at
40
CFR
704.3,
are
mostly
exempt
from
IURA
reporting
2752
requirements.
This
exemption
is
unchanged
by
these
amendments.
2753
5.
Non­
regulatory
alternatives.
Commenters
also
stated
that
EPA
did
not
identify
any
2754
non­
regulatory
alternatives
and
fails
to
assess
the
relative
costs
and
benefits
of
an
alternative
2755
approach.
In
the
economic
analysis
for
the
proposed
rule,
the
Agency
did
not
specifically
identify
2756
non­
regulatory
alternatives
to
the
reporting
requirements.
However,
the
Agency
did
consider
2757
non­
regulatory
alternatives
and
has
added
a
discussion
to
the
economic
analysis.
2758
The
Agency
primarily
considered
two
non­
regulatory
alternatives.
First,
the
Agency
2759
considered
using
publicly
available
information,
as
discussed
in
Unit
III.
A.
3.
of
this
preamble.
2760
The
Agency
found
that
the
information
to
be
collected
through
the
amended
IUR
was
not
publicly
2761
available
and
therefore
this
was
not
a
viable
option.
Second,
the
Agency
considered
a
voluntary
2762
approach
to
collecting
this
information,
similar
to
the
UEIP
collection
discussed
in
Unit
III.
A.
1.
2763
of
this
preamble.
However,
information
collected
through
a
voluntary
program
may
not
be
2764
consistent
enough,
or
collections
may
not
occur
on
a
recurring
basis,
and
therefore
would
not
2765
fully
serve
the
purposes
of
the
amended
IUR
information.
Therefore,
a
voluntary
approach
was
2766
not
a
viable
option.
2767
IV.
Materials
in
the
Rulemaking
Record
2768
The
public
version
of
the
official
record
for
this
rulemaking
has
been
established
as
2769
125
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
described
in
Unit
I.
B.
2.
under
docket
control
number
OPPTS­
82053.
This
record
includes
the
2770
documents
located
in
the
docket
as
well
as
the
documents
that
are
referenced
in
those
documents.
2771
The
following
is
a
listing
of
the
documents
that
are
specifically
referenced
in
this
final
rule.
These
2772
documents,
and
the
documents
referenced
therein,
are
also
included
in
the
public
version
of
the
2773
official
record.
Please
note
that
some
referenced
documents
are
already
publicly
available
and
this
2774
list
includes
the
relevant
location
information.
2775
1.
U.
S.
EPA,
  
Reducing
Risk:
Setting
Priorities
and
Strategies
for
Environmental
2776
Protection,''
Science
Advisory
Board,
(
SAB­
EC­
90­
021),
1990.
2777
2.
National
Academy
of
Public
Administration,
  
Setting
Priorities,
Getting
Results
­
A
2778
New
Direction
for
EPA,''
1995.
2779
3.
Chemical
Manufacturers
Association,
Synthetic
Organic
Chemical
Manufacturers
2780
Association,
U.
S.
EPA,
Chemical
Specialties
Manufacturing
Association,
American
Petroleum
2781
Institute,
  
Round
3
of
the
UEIP
(
Use
and
Exposure
Information
Project),''
June
3,
1996.
2782
4.
American
Petroleum
Institute,
  
Petroleum
Process
Stream
Terms
Included
in
the
2783
Chemical
Substances
Inventory
Under
the
Toxic
Substances
Control
Act
(
TSCA),''
Health
and
2784
Safety
Regulation
Committee
Task
Force
on
Toxic
Substances
Control,
February
1985.
2785
5.
U.
S.
EPA,
  
EPA
Needs
Exposure­
Related
Data:
A
Discussion
of
the
Justification
for
2786
Collecting
Exposure­
Related
Data
Through
the
IUR
Amendments,''
OPPT/
EETD/
EPAB,
1998.
2787
6.
U.
S.
EPA,
"
Revised
Economic
Analysis
for
the
Amended
Inventory
Update
Rule,"
2788
OPPT,
August
7,
2001
.
2789
7.
U.
S.
EPA,
"
Inventory
Update
Rule
(
IUR)
Technical
Support
Document:
Evaluation
2790
of
Likelihood
of
Confidential
Business
Information
Claims
for
Production
Volume
Information,"
2791
OPPT,
August
26,
1996.
2792
126
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
8.
Letter
from
Mark
N.
Duvall,
Union
Carbide,
to
EPA,
"
Additional
Comments
of
Union
2793
Carbide
Corporation
on
EPA's
Preliminary
Actions
to
Reform
TSCA
Confidential
Business
2794
Information,
Docket
No.
OPPTS­
00125,''
August
31,
1993.
2795
9.
Letter
from
Stephen
A.
Newell,
Occupational
Safety
and
Health
Administration,
to
2796
Wardner
G.
Penberthy,
EPA,
October
15,
1996.
2797
10.
Letter
from
Paul
A.
Schulte,
National
Institute
for
Occupational
Safety
and
Health,
to
2798
Wardner
G.
Penberthy,
EPA,
October
8,
1996.
2799
11.
U.
S.
EPA,
  
Inventory
Update
Rule
(
IUR)
Amendment
Technical
Support
Document:
2800
Exposure­
Related
Data
Useful
for
Chemical
Risk
Screening,''
Volumes
1
and
2,
OPPT,
July
19,
2801
1996.
2802
12.
U.
S.
Census
Bureau,
North
American
Industrial
Classification
System
(
NAICS),
2803
http://
www.
census.
gov/
epcd/
www/
naics.
html,
1999.
2804
13.
U.
S.
EPA,
"
Preliminary
Assessment
Information
Rule
(
PAIR)
Database,
2805
Manufacturing
Process
Type/
Release
Analysis
and
Number
of
Workers/
Production
Quantity
2806
Analysis,"
OPPT,
September
26,
1996.
2807
14.
U.
S.
EPA,
"
Final
Action
Plan:
Confidential
Business
Information
Reform,
June
24,
2808
1994,"
Docket
Entry
00125A,
B1a­
011.
Comments
43,
44,
and
45.
2809
15.
U.
S.
EPA,
"
Summary
of
EPA's
Responses
to
Public
Comments
Submitted
in
2810
Response
to
Proposed
TSCA
Inventory
Update
Rule
Amendments
(
64
FR
46772),"
2811
OPPT/
EETD,
January
18,
2001.
2812
16.
U.
S.
EPA,
"
IURA
Data
Use
Plan,"
OPPT,
August
2001.
2813
17.
Letter
from
Michael
A.
Babich,
U.
S.
Consumer
Product
Safety
Commission,
to
2814
Wardner
G.
Penberthy,
EPA,
June
24,
1996.
2815
127
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
18.
Letter
from
Robert
Franklin,
U.
S.
Consumer
Product
Safety
Commission,
to
EPA,
2816
December
23,
1999.
2817
19.
Letter
from
Paul
A.
Schulte,
Ph.
D.,
National
Institute
for
Occupational
Safety
&
2818
Health,
to
EPA,
December
21,
1999.
2819
20.
General
Accounting
Office,
"
Toxic
Chemicals:
Long­
Term
Coordinated
Strategy
2820
Needed
to
Measure
Exposures
in
Humans,"
GAO/
HEHS­
00­
80,
May
2,
2000.
2821
21.
Letter
from
Linda
Greer,
Ph.
D.,
Natural
Resources
Defense
Council,
to
Carol
2822
Browner,
U.
S.
EPA,
February
12,
1999.
2823
22.
U.
S.
EPA,
  
Economic
Analysis
of
Proposed
Amendments
to
the
TSCA
Section
8
2824
Inventory
Update
Rule,''
OPPT/
EETD/
EPAB,
March
1,
1999.
2825
23.
U.
S.
EPA,
  
A
Review
of
Existing
Exposure­
Related
Data
Sources
and
Approaches
2826
to
Screening
Chemicals:
A
Response
to
CMA,''
OPPT,
March
1999.
2827
24.
European
Commission,
"
Technical
Guidance
document
in
support
of
commission
2828
directive
93/
67/
EEC
on
risk
assessment
for
new
notified
substances
and
commission
regulation
2829
(
EC)
No
1488/
94
on
Risk
Assessment
for
Existing
Substances;
Part
III"
2830
25.
U.
S.
EPA,
  
Inventory
Update
Rule
(
IUR)
Technical
Support
Document:
Selection
of
2831
Consumer
and
Commercial
End­
Use
Categories,''
OPPT,
1996.
2832
26.
Letter
from
John
D.
Walter,
TSCA
Interagency
Testing
Committee,
to
Mary
Ellen
2833
Weber,
EPA,
June
15,
1999.
2834
27.
U.
S.
EPA,
"
Inorganic
Chemicals:
Sources
of
Information
Suggested
by
Commenters
2835
to
the
Proposed
Inventory
Update
Rule
Amendments,"
OPPT,
June
2000.
2836
28.
Memorandum
from
Sandy
Zavolta,
U.
S.
Environmental
Protection
Agency,
to
Heidi
2837
King,
Office
of
Management
and
Budget,
May
21,
1999.
2838
128
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
29.
OECD,
"
Guidance
for
Collection
and
Transmission
of
Exposure
Information
for
2839
SIDS
Initial
Assessment,"
OECD
SIDS
Manual
(
Third
Revision),
Section
2.5,
July
1997,
2840
available
at
http://
www.
epa.
gov/
opptintr/
sids/
sidsman.
htm.
2841
30.
U.
S.
EPA,
"
Report
to
Congress:
Wastes
from
the
Combustion
of
Fossil
Fuels,"
2842
OSW,
April
25,
2000,
available
at
http://
www.
epa.
gov/
epaoswer/
other/
fossil/
index.
htm.
2843
31.
General
Accounting
Office,
  
EPA
Should
Focus
Its
Chemical
Use
Inventory
on
2844
Suspected
Harmful
Substances,''
GAO/
RCED­
95­
165,
July
7,
1995.
2845
32.
Confidential
Business
Information
Data
Review,
Georgia
Department
of
Natural
2846
Resources,
Docket
entry
00125
B2a­
010
filed
June
19,
1996,
page
4
2847
V.
Regulatory
Assessment
Requirements
2848
A.
Executive
Order
12866
2849
Under
Executive
Order
12866,
entitled
Regulatory
Planning
and
Review
(
58
FR
51735,
2850
October
4,
1993),
the
Office
of
Management
and
Budget
(
OMB)
has
determined
that
this
is
a
2851
"
significant
regulatory
action"
under
section
3(
f)
of
the
Executive
Order,
because
it
raises
"
novel
2852
legal
or
policy
issues
arising
out
of
legal
mandates"
relating
to
information
collection.
This
action
2853
was
therefore
submitted
to
OMB
for
review
under
this
Executive
Order
,
and
any
comments
or
2854
changes
made
during
that
review
have
been
documented
in
the
public
record.
2855
In
addition,
EPA
has
prepared
an
economic
analysis
of
the
potential
impacts
of
this
action,
2856
which
is
contained
in
a
document
entitled
"
Economic
Analysis
for
the
Amended
Inventory
Update
2857
Rule"
(
Ref.
6).
The
Agency,
in
promulgating
this
rule,
is
required
under
TSCA
to
consider
the
2858
potential
costs
and
benefits
associated
with
the
IUR
amendments.
The
analysis
was
therefore
2859
used
by
the
decision­
makers
to
help
in
the
selection
of
the
final
rule
requirements
presented
in
this
2860
129
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
document.
This
document
is
available
as
a
part
of
the
public
version
of
the
official
record
for
this
2861
action
and
is
briefly
summarized
here.
2862
EPA
estimates
that
these
amendments
will
cost
between
$
74
to
$
90
million
for
the
first
2863
year
of
reporting
,
and
for
future
years
of
reporting
(
every
four
years
thereafter)
as
well,
resulting
2864
in
an
annualized
cost
of
$
20
to
$
23
million
over
the
next
twenty
years.
2865
Under
these
amendments,
approximately
8,900
chemicals
will
be
subject
to
reporting,
and
2866
the
Agency
expects
that
it
will
receive
approximately
26,800
submissions
during
the
first
2867
reporting
cycle.
In
the
first
reporting
year,
approximately
9,800
of
those
submissions
(
providing
2868
information
on
about
4,000
chemicals)
will
be
full
reports
which
include
information
found
in
Part
2869
III
of
Revised
Reporting
Form
U.
The
remainder
will
report
only
company,
site
and
chemical
2870
identification
and
manufacturing
information
(
Parts
I,
II,
and
IV
of
Revised
Reporting
Form
U),
2871
or
only
Parts
I
and
IV
if
the
submitter
is
only
reasserting
past
CBI
claims
but
not
reporting
new
2872
information.
In
future
reporting
years,
with
the
addition
of
full
reporting
for
inorganic
chemicals,
2873
EPA
expects
to
receive
over
12,300
full
forms,
covering
4,600
chemicals.
In
order
to
keep
the
2874
reporting
burden
as
low
as
possible,
EPA
is
requiring
that
certain
information
be
reported
in
2875
ranges,
that
only
the
top
ten
NAICS
codes
be
accounted
for
when
reporting
industrial
processing
2876
and
use
information,
and
that
only
readily
obtainable
information
in
Part
III
be
reported.
2877
EPA
analyzed
the
effects
of
a
number
of
different
alternatives
for
the
rule,
including
2878
variations
in
exemptions,
different
thresholds
for
both
partial­
(
i.
e.,
Parts
I,
II,
and
IV
of
Revised
2879
Reporting
Form
U)
and
full­
form
(
i.
e.,
all
parts
of
Revised
Reporting
Form
U)
reporting,
and
2880
various
frequencies
of
collection.
These
options
are
explored
further
in
the
Economic
Analysis.
2881
EPA
considered
continuing
the
existing
full
exemption
from
IUR
reporting
for
inorganic
2882
chemicals
and
adding
a
full
exemption
for
site­
limited
petroleum
streams.
EPA
examined
the
2883
130
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
effects
of
keeping
the
partial­
form
threshold
at
10,000
lbs.
and
considered
full­
form
thresholds
of
2884
100,000,
300,000,
500,000,
and
one
million
lbs.,
as
well
as
a
phased­
in
100,000/
500,000
full­
form
2885
threshold.
EPA
also
considered
changes
in
the
reporting
cycle,
such
as
a
one­
time
collection,
and
2886
a
two­
year
cycle.
The
rule
also
includes
an
exemption
for
certain
forms
of
natural
gas
and
2887
phased­
in
reporting
for
inorganic
chemicals.
2888
EPA
believes
that
this
final
rule
represents
an
appropriate
balance
between
the
burden
2889
placed
on
industry
to
provide
information
and
the
Agency's
need
for
that
information
to
fill
its
2890
statutory
obligations
and
fulfill
its
mission
under
TSCA.
2891
The
costs
of
these
amendments
will
be
borne
by
two
groups:
the
chemical
industry
and
2892
EPA.
Industry
costs
are
associated
with
complying
with
the
regulation,
while
EPA
costs
are
2893
associated
with
administering
the
regulation
and
maintaining
the
collected
data.
In
this
2894
rule­
making
effort,
EPA
has
made
every
attempt
to
balance
data
needs
with
collection
costs
and
2895
burden.
Wherever
possible,
EPA
has
used
exemptions
or
partial
exemptions
to
reduce
the
2896
number
of
reports
that
would
potentially
be
filed
by
industry.
EPA
has
provided
an
second
2897
threshold
for
reporting
use
information
required
in
Part
III
of
Revised
Reporting
Form
U,
2898
reducing
the
per­
report
burden
for
submitters.
Recognizing
that
this
information
will
be
used
for
2899
screening­
level
purposes,
EPA
has
reduced
the
specificity
of
the
information
that
will
be
required
2900
in
three
ways:
2901
°
By
requiring
the
reporting
of
only
readily
obtainable
information
for
the
processing
and
2902
use
exposure­
related
data;
2903
°
By
requiring
that
submitters
report
much
of
the
information
in
ranges,
reducing
the
need
2904
to
generate
precise
estimates;
and,
2905
°
By
requiring
processing
and
use
exposure­
related
information
on
only
the
top
ten
2906
131
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
uses/
NAICS
codes,
as
determined
by
percent
of
the
chemical's
volume.
2907
These
steps
limit
the
amount
of
information
required,
reducing
the
time
and
effort
spent
by
the
2908
chemical
industry
in
complying
with
the
amendments.
2909
EPA
assumes
that
the
burden
associated
with
reporting
under
the
IUR
amendments
will
2910
decrease
over
time
as
industry's
familiarity
with
the
reporting
rule
increases
and
to
the
extent
that
2911
the
information
being
reported
remains
somewhat
constant
from
one
submission
period
to
the
2912
next.
Projected
costs
to
EPA
are
relatively
small
and
are
estimated
to
be
$
576,000
in
the
first
2913
reporting
year,
and
$
270,000
in
subsequent
reporting
years.
2914
Substantial
changes
in
the
economic
analysis
(
EA)
have
occurred
since
the
economic
2915
analysis
produced
for
the
proposed
rule,
which
is
summarized
in
Unit
XI
of
the
proposed
rule
2916
(
August
26,
1999
(
64
FR
46772,
46799).
The
economic
analysis
was
revised
primarily
on
the
2917
basis
of
three
factors:
1)
changes
to
correct
errors,
2)
changes
due
to
comments
received
during
2918
the
public
comment
period,
3)
changes
to
the
cost
methodology
that
more
fully
reflect
potential
2919
industry
burden.
The
revised
economic
analysis
in
support
of
this
final
rule
can
be
found
in
the
2920
public
version
of
the
official
record
for
this
rulemaking
(
Ref.
6).
2921
Changes
that
were
made
prior
to
proposal
include
adding
a
partial
exemption
for
inorganic
2922
chemicals,
a
full
exemption
for
natural
gas,
and
raising
the
threshold
for
processing
and
use
2923
exposure­
related
data
to
300,000
lbs.
Changes
made
due
to
public
comments
include
deleting
the
2924
average
concentration
data
element,
and
phasing­
in
full
reporting
for
inorganic
chemicals.
2925
Changes
made
to
the
cost
methodology
include
increasing
the
burden
estimate
for
CBI
2926
reassertion,
and
increasing
burden
estimates
for
reporting
processing
and
use
data.
Both
of
the
2927
increases
in
burden
were
initiated
in
response
to
industry
comment,
and
stemmed
from
differences
2928
in
the
survey
instrument
used
to
estimate
costs
of
the
IUR
Amendments
in
1996,
and
the
Form
U
2929
132
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
as
proposed
in
1999.
CBI
reassertion,
which
was
not
considered
in
1996,
was
not
included
in
the
2930
survey.
Estimates
in
the
proposed
EA
(
2
­
4
hours
per
report
for
both
full
and
partial
Form
Us)
2931
were
based
on
professional
judgement,
but
after
review
of
public
comments,
EPA
decided
that
a
2932
more
appropriate
estimate
would
reflect
the
time
necessary
to
review,
and
possibly
revise,
the
2933
previous
report.
Thus,
EPA
now
estimates
that
CBI
reassertion
will
require
10%
of
the
burden
2934
for
report
preparation
and
submission
of
the
original
report.
2935
Estimates
for
reporting
processing
and
use
data
were
revised
upward
after
reviewing
2936
public
comments
and
the
survey
data.
Differences
between
the
survey
instrument
and
the
2937
proposed
Form
U
required
EPA
to
aggregate
certain
responses.
After
reading
the
comments,
2938
EPA
is
using
more
conservative
assumptions
in
this
process.
Therefore,
it
is
more
likely
that
EPA
2939
cost
estimates
overestimate,
rather
than
underestimate,
actual
costs.
2940
B.
Regulatory
Flexibility
Act
2941
Pursuant
to
section
605(
b)
of
the
Regulatory
Flexibility
Act
(
5
U.
S.
C.
601
et
seq.),
the
2942
Agency
hereby
certifies
that
this
final
rule
will
not
have
a
significant
economic
impact
on
a
2943
substantial
number
of
small
entities.
The
factual
basis
for
the
Agency's
determination
is
presented
2944
in
the
small
entity
impact
analysis
prepared
as
part
of
the
economic
analysis
for
this
rule
(
Ref.
6),
2945
and
is
briefly
summarized
here.
2946
Small
entities
include
small
businesses,
small
not­
for­
profit
organizations,
and
small
2947
governmental
jurisdictions
(
5
U.
S.
C.
601(
6)).
Because
not­
for­
profit
organizations
and
2948
governmental
jurisdictions
will
not
be
affected
by
this
rule,
"
small
entity"
for
purposes
of
this
final
2949
rule
is
synonymous
with
"
small
business."
Section
601(
3)
of
the
RFA
establishes
as
the
default
2950
definition
of
small
business
the
definition
used
in
section
3
of
the
Small
Business
Act
(
15
U.
S.
C.
2951
133
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
632)
under
which
the
Small
Business
Administration(
SBA)
establishes
small
business
size
2952
standards
(
13
CFR
121.201).
The
RFA
recognizes,
however,
that
it
may
be
appropriate
at
times
2953
for
Federal
agencies
to
use
an
alternate
definition
of
small
business.
As
a
result,
RFA
section
2954
601(
3)
provides
that
an
Agency
may
establish
a
different
definition
of
small
business
after
2955
consultation
with
the
SBA
Office
of
Advocacy
and
after
notice
and
an
opportunity
for
public
2956
comment.
EPA
established
a
different
definition
of
small
business,
found
in
the
existing
IUR
at
40
2957
CFR
704.3,
in
accordance
with
these
requirements.
Manufacturers
who
meet
the
40
CFR
704.3
2958
definition
of
small
business
are
generally
exempted
from
IUR
reporting
in
40
CFR
710.29.
This
2959
exemption
is
retained
under
these
amendments
and
was
not
reopened
for
comment.
In
general,
2960
EPA
strives
to
minimize
potential
adverse
impacts
on
small
entities
when
developing
regulations
2961
to
achieve
the
environmental
and
human
health
protection
goals
of
the
statute
and
the
Agency.
2962
Despite
the
fact
that
small
manufacturers
that
fully
meet
the
40
CFR
704.3
definition
of
2963
small
manufacturers
are
generally
exempt
from
reporting
under
the
IUR,
and
thus
are
not
2964
significantly
impacted
by
these
amendments
to
the
IUR,
EPA
conducted
an
analysis
of
the
2965
potential
impact
for
submitters
that
meet
only
part
of
the
40
CFR
704.3
definition.
Specifically,
2966
an
analysis
of
the
potential
impact
was
conducted
only
for
those
submitters
that
meet
the
first
2967
criterion
in
the
40
CFR
704.3
definition
of
"
small
manufacturer
or
importer,"
i.
e.
total
annual
2968
sales
of
less
than
$
40
million,
but
that
do
not
meet
the
second
criterion,
i.
e.
production
or
import
2969
volume
of
less
than
100,000
pounds
at
all
sites.
2970
For
small
manufacturers
of
organic
chemicals
subject
to
reporting,
the
Agency
estimates
2971
the
impact
to
be
0.16%
to
0.19%
of
sales.
For
small
manufacturers
of
inorganic
chemicals
2972
subject
to
reporting,
the
Agency
estimates
the
impact
to
be
0.07%
to
0.23%
of
sales.
2973
134
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
C.
Paperwork
Reduction
Act
2974
The
OMB
has
approved
the
information
collection
requirements
contained
in
this
rule
2975
under
the
provisions
of
the
Paperwork
Reduction
Act
(
PRA),
44
U.
S.
C.
3501
et
seq.,
and
has
2976
assigned
OMB
control
number
2070­[
to
be
inserted
later].
In
accordance
with
the
procedures
at
2977
5
CFR
1320.11,
EPA
submitted
an
Information
Collection
Request
(
ICR)
document
to
OMB
in
2978
(
identified
as
EPA
ICR
No.
1884.02),
which
is
also
included
in
the
public
version
of
the
official
2979
record
that
is
described
in
Unit
I.
B.
2.
2980
The
information
that
will
be
reported
under
these
amendments
to
the
IUR
will
better
2981
enable
EPA
to
screen
thousands
of
chemical
substances
for
potential
risk.
Risk
screening
is
2982
necessary
in
order
to
conserve
limited
Agency
resources
by
focusing
risk
assessment
work
on
2983
chemical
substances
for
which
some
level
of
potential
risk
has
been
indicated.
As
described
in
2984
Unit
IV,
the
new
information
that
will
be
reported
under
this
rule
is
critical
to
the
risk
screening
2985
process
and
is
unavailable
through
other
sources.
Responses
to
this
collection
of
information
will
2986
be
mandatory,
pursuant
to
TSCA
section
8(
a).
2987
CBI
claims
may
be
made
for
all
or
part
of
the
new
information
that
will
be
reported
under
2988
these
amendments
to
IUR.
This
action
includes
new
substantiation
procedures
for
CBI
claims
2989
regarding
plant
site
identity
(
See
section
710.38(
d)
in
the
regulatory
text).
In
addition,
a
new
2990
provision
for
the
reassertion
of
CBI
claims
are
being
added
(
See
section
710.39
of
the
regulatory
2991
text).
This
provision
states
that
all
CBI
claims
made
in
one
submission
period
are
valid
only
until
2992
the
end
of
the
submission
period
immediately
following
the
submission
period
in
which
the
2993
information
was
claimed
as
confidential.
To
maintain
the
confidential
status
of
information,
the
2994
submitter
will
need
to
certify
during
every
submission
period
following
the
one
in
which
the
2995
original
claim
of
confidentiality
was
made,
that
the
information
should
continue
to
be
treated
as
2996
135
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
confidential
by
EPA.
For
chemical
identity
and
plant
site
identity
data,
which
require
upfront
2997
substantiation
of
CBI
claims,
submitters
reasserting
claims
will
need
to
review
the
substantiation
2998
questions
and
provide
amended
answers,
if
necessary.
Reassertions
must
be
made
to
maintain
2999
confidentiality
even
if
the
submitter
is
not
required
to
report
during
a
given
submission
period.
If
3000
a
submitter
fails
in
a
submission
period
to
reassert
the
confidentiality
claims
made
in
the
previous
3001
submission
period,
the
claims
are
presumed
to
be
waived
and
EPA
may
make
the
information
3002
available
to
the
public
without
further
notice
to
the
submitter
(
See
section
710.39
of
the
3003
regulatory
text).
3004
The
following
annual
burden
and
cost
figures
represent
the
cost
of
a
four­
year
reporting
3005
cycle
spread
over
four
years,
despite
the
fact
that
most
or
all
of
the
burden
will
fall
in
the
first
year
3006
of
the
cycle.
The
public
reporting
burden
for
this
collection
of
information
is
estimated
to
be
3007
268,000
to
326,000
hours
for
each
of
the
four
years
in
the
first
reporting
cycle
for
approximately
3008
3,000
respondents.
The
average
annual
reporting
burden
per
report
is
10
to
12
hours,
with
the
3009
average
company
reporting
8.9
times
per
collection,
and
each
information
collection
occurring
3010
every
four
years.
The
public
reporting
cost
burden
for
operation
and
maintenance
expenses
is
3011
estimated
to
be
$
20
to
$
23
million
annually
for
the
first
four­
year
reporting
cycle,
and
roughly
the
3012
same
in
each
reporting
cycle
after
that.
The
total
capital
and
start­
up
costs,
as
well
as
the
3013
purchase
of
services,
are
estimated
to
be
zero.
3014
Under
the
PRA,
"
burden"
means
the
total
time,
effort,
or
financial
resources
expended
by
3015
persons
to
generate,
maintain,
retain,
or
disclose
or
provide
information
to
or
for
a
Federal
3016
Agency.
This
includes
the
time
needed
to:
review
instructions;
develop,
acquire,
install,
and
3017
utilize
technology
and
systems
for
the
purposes
of
collecting,
validating,
and
verifying
3018
information,
processing
and
maintaining
information,
and
disclosing
and
providing
information;
3019
136
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
adjust
the
existing
ways
to
comply
with
any
previously
applicable
instructions
and
requirements;
3020
train
personnel
to
be
able
to
respond
to
a
collection
of
information;
search
data
sources;
complete
3021
and
review
the
collection
of
information;
and
transmit
or
otherwise
disclose
the
information.
3022
An
Agency
may
not
conduct
or
sponsor,
and
a
person
is
not
required
to
respond
to
a
3023
collection
of
information
unless
it
displays
a
currently
valid
OMB
control
number.
The
currently
3024
approved
ICR
control
numbers
issued
by
OMB
for
various
EPA
regulations
are
listed
in
40
CFR
3025
Part
9
and
48
CFR
Chapter
15.
EPA
is
amending
the
table
in
40
CFR
Part
9
to
list
the
3026
information
requirements
contained
in
this
final
rule.
This
listing
of
the
OMB
control
numbers
3027
and
their
subsequent
codification
in
the
CFR
satisfies
the
requirements
of
the
Paperwork
3028
Reduction
Act
(
44
U.
S.
C.
3501
et
seq.)
and
OMB's
implementing
regulations
at
5
CFR
Part
3029
1320.
This
ICR
was
previously
subject
to
public
notice
and
comment
prior
to
OMB
approval.
3030
Due
to
the
technical
nature
of
the
table,
EPA
finds
that
further
notice
and
comment
is
3031
unnecessary.
As
a
result,
EPA
finds
that
there
is
"
good
cause"
under
section
553(
b)(
B)
of
the
3032
Administrative
Procedure
Act,
5
U.
S.
C.
553(
b)(
B),
to
amend
this
table
without
further
notice
and
3033
comment.
3034
D.
Unfunded
Mandates
Reform
Act
3035
Pursuant
to
Title
II
of
the
Unfunded
Mandates
Reform
Act
of
1995
(
Public
Law
104­
4),
3036
EPA
has
determined
that
this
regulatory
action
does
not
contain
a
Federal
mandate
that
may
3037
result
in
expenditures
of
$
100
million
or
more
for
State,
local,
and
tribal
governments,
in
the
3038
aggregate,
or
for
the
private
sector
in
any
one
year.
The
analysis
of
the
costs
associated
with
this
3039
action
are
described
in
Unit
V.
A.
of
this
preamble.
In
addition,
EPA
has
determined
that
this
rule
3040
does
not
significantly
or
uniquely
affect
small
governments.
Accordingly,
this
rule
is
not
subject
3041
137
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
to
the
requirements
of
sections
202,
203,
204,
and
205
of
UMRA.
3042
E.
Executive
Order
13132
3043
Executive
Order
13132,
entitled
Federalism
(
64
FR
43255,
August
10,
1999),
requires
3044
EPA
to
develop
an
accountable
process
to
ensure
"
meaningful
and
timely
input
by
State
and
local
3045
officials
in
the
development
of
regulatory
policies
that
have
federalism
implications."
"
Policies
3046
that
have
federalism
implications"
is
defined
in
the
Executive
Order
to
include
regulations
that
3047
have
"
substantial
direct
effects
on
the
States,
on
the
relationship
between
the
national
government
3048
and
the
States,
or
on
the
distribution
of
power
and
responsibilities
among
the
various
levels
of
3049
government."
3050
This
final
rule
does
not
have
federalism
implications,
because
it
will
not
have
substantial
3051
direct
effects
on
the
States,
on
the
relationship
between
the
national
government
and
the
States,
3052
or
on
the
distribution
of
power
and
responsibilities
among
the
various
levels
of
government,
as
3053
specified
in
Executive
Order
13132.
Thus,
Executive
Order
13132
does
not
apply
to
this
rule.
3054
F.
Executive
Orders
13084
and
13175
3055
Under
Executive
Order
13084,
entitled
Consultation
and
Coordination
with
Indian
Tribal
3056
Governments
(
63
FR
27655,
May
19,
1998),
EPA
may
not
issue
a
regulation
that
is
not
required
3057
by
statute,
that
significantly
or
uniquely
affects
the
communities
of
Indian
tribal
governments,
and
3058
that
imposes
substantial
direct
compliance
costs
on
those
communities,
unless
the
Federal
3059
government
provides
the
funds
necessary
to
pay
the
direct
compliance
costs
incurred
by
the
tribal
3060
governments,
or
EPA
consults
with
those
governments.
3061
If
EPA
complies
by
consulting,
Executive
Order
13084
requires
EPA
to
provide
to
the
3062
138
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
Office
of
Management
and
Budget,
in
a
separately
identified
section
of
the
preamble
to
the
rule,
a
3063
description
of
the
extent
of
EPA's
prior
consultation
with
representatives
of
affected
tribal
3064
governments,
a
summary
of
the
nature
of
their
concerns,
and
a
statement
supporting
the
need
to
3065
issue
the
regulation.
In
addition,
Executive
Order
13084
requires
EPA
to
develop
an
effective
3066
process
permitting
elected
officials
and
other
representatives
of
Indian
tribal
governments
"
to
3067
provide
meaningful
and
timely
input
in
the
development
of
regulatory
policies
on
matters
that
3068
significantly
or
uniquely
affect
their
communities."
3069
This
rule
does
not
significantly
or
uniquely
affect
the
communities
of
Indian
tribal
3070
governments,
nor
does
it
impose
substantial
direct
compliance
costs
on
such
communities.
3071
Accordingly,
the
requirements
of
section
3(
b)
of
Executive
Order
13084
do
not
apply
to
this
rule.
3072
On
November
6,
2000,
the
President
issued
Executive
Order
13175,
entitled
Consultation
3073
and
Coordination
with
Indian
Tribal
Governments
(
65
FR
67249).
Executive
Order
13175
took
3074
effect
on
January
6,
2001,
and
revokes
Executive
Order
13084
as
of
that
date.
EPA
developed
3075
this
rule,
however,
during
the
period
when
Executive
Order
13084
was
in
effect;
thus,
EPA
3076
addressed
tribal
considerations
under
Executive
Order
13084.
3077
G.
Executive
Order
12898
3078
Pursuant
to
Executive
Order
12898,
entitled
Federal
Actions
to
Address
Environmental
3079
Justice
in
Minority
Populations
and
Low­
Income
Populations
(
59
FR
7629,
February
16,
1994),
3080
the
Agency
has
considered
environmental
justice­
related
issues
with
regard
to
the
potential
3081
impacts
of
this
action
on
the
environmental
and
health
conditions
in
minority
and
low­
income
3082
populations.
The
Agency
believes
that
the
information
collected
under
this
rule
will
assist
EPA
3083
and
others
in
determining
the
risks
and
exposures
associated
with
the
chemicals
covered
by
the
3084
139
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
rule.
Although
not
directly
impacting
environmental
justice­
related
concerns,
this
information
will
3085
enable
the
Agency
to
protect
human
health
and
the
environment
by
being
better
able
to
prioritize
3086
chemical
substances
of
concern.
3087
H.
Executive
Order
13045
3088
This
rulemaking
does
not
require
special
consideration
pursuant
to
the
terms
of
Executive
3089
Order
13045,
entitled
"
Protection
of
Children
from
Environmental
Health
Risks
and
Safety
Risks"
3090
(
62
FR
19885,
April
23,
1997),
because
it
is
not
likely
to
have
an
annual
effect
on
the
economy
of
3091
$
100
million
or
more
and
it
does
not
have
a
potential
effect
or
impact
on
children.
As
discussed
3092
in
this
preamble,
this
rule
will
provide
the
Agency
with
information
needed
to
screen
and
3093
prioritize
chemical
substances,
including
information
on
potential
exposures
to
children.
This
3094
information
will
allow
the
Agency
and
others
to
determine
which
chemical
substances
have
3095
potential
risks,
allowing
the
Agency
and
others
to
take
appropriate
action
to
investigate
and
3096
mitigate
those
risks.
3097
I.
National
Technology
Transfer
and
Amendment
Act
3098
This
regulatory
action
does
not
involve
any
technical
standards
that
would
require
3099
Agency
consideration
of
voluntary
consensus
standards
pursuant
to
section
12(
d)
of
the
National
3100
Technology
Transfer
and
Advancement
Act
of
1995
(
NTTAA),
Public
Law
104­
113,
§
12(
d)
(
15
3101
USC
272
note).
Section
12(
d)
of
NTTAA
directs
EPA
to
use
voluntary
consensus
standards
in
3102
its
regulatory
activities
unless
to
do
so
would
be
inconsistent
with
applicable
law
or
otherwise
3103
impractical.
Voluntary
consensus
standards
are
technical
standards
(
e.
g.,
materials
specifications,
3104
test
methods,
sampling
procedures,
business
practices,
etc.)
that
are
developed
or
adopted
by
3105
140
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
voluntary
consensus
standards
bodies.
The
NTTAA
requires
EPA
to
provide
Congress,
through
3106
OMB,
explanations
when
the
Agency
decides
not
to
use
available
and
applicable
voluntary
3107
consensus
standards.
3108
J.
Executive
Order
12630
3109
EPA
has
complied
with
Executive
Order
12630,
entitled
Governmental
Actions
and
3110
Interference
with
Constitutionally
Protected
Property
Rights
(
53
FR
8859,
March
15,
1988),
by
3111
examining
the
takings
implications
of
this
rule
in
accordance
with
the
"
Attorney
General's
3112
Supplemental
Guidelines
for
the
Evaluation
of
Risk
and
Avoidance
of
Unanticipated
Takings"
3113
issued
under
the
Executive
Order.
3114
K.
Executive
Order
12988
3115
In
issuing
this
rule,
EPA
has
taken
the
necessary
steps
to
eliminate
drafting
errors
and
3116
ambiguity,
minimize
potential
litigation,
and
provide
a
clear
legal
standard
for
affected
conduct,
as
3117
required
by
section
3
of
Executive
Order
12988,
entitled
Civil
Justice
Reform
(
61
FR
4729,
3118
February
7,
1996).
3119
L.
Executive
Order
13211
3120
This
rule
is
not
a
"
significant
energy
action"
as
defined
in
Executive
Order
13211,
Actions
3121
Concerning
Regulations
That
Significantly
Affect
Energy
Supply,
Distribution,
or
Use
(
66
FR
3122
28355,
May
22,
2001)
because
it
is
not
likely
to
have
a
significant
adverse
effect
on
the
supply,
3123
distribution,
or
use
of
energy.
This
final
rule
modifies
the
existing
IUR
reporting
and
3124
recordkeeping
requirements
that
apply
to
chemical
manufacturers
and
importers.
As
such,
we
3125
141
**
Working
Draft
­
Do
Not
Cite
or
Quote
­
Not
for
Public
Release
**
have
concluded
that
this
rule
is
not
likely
to
have
adverse
energy
effects.
3126
VII.
Submission
to
Congress
and
the
Comptroller
General
3127
The
Congressional
Review
Act,
5
U.
S.
C.
801
et
seq.,
as
added
by
the
Small
Business
3128
Regulatory
Enforcement
Fairness
Act
of
1996,
generally
provides
that
before
a
rule
may
take
3129
effect,
the
Agency
promulgating
the
rule
must
submit
a
rule
report,
which
includes
a
copy
of
the
3130
rule,
to
each
House
of
the
Congress
and
the
Comptroller
General
of
the
United
States.
EPA
will
3131
submit
a
report
containing
this
rule
and
other
required
information
to
the
U.
S.
Senate,
the
U.
S.
3132
House
of
Representatives
and
the
Comptroller
General
of
the
United
States
prior
to
publication
of
3133
the
rule
in
the
Federal
Register.
This
rule
is
not
a
"
major
rule"
as
defined
by
5
U.
S.
C.
804(
2).
3134
List
of
Subjects
in
40
CFR
Part
9
3135
Environmental
protection,
Reporting
and
recordkeeping
requirements.
3136
List
of
Subjects
in
40
CFR
Part
711
3137
Environmental
protection,
Chemicals,
Hazardous
materials,
Reporting
and
recordkeeping
3138
requirements.
3139
Dated:___________________
3140
______________________________________
3141
Assistant
Administrator
for
Prevention,
3142
Pesticides
and
Toxic
Substances.
3143
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3144