Document ID: EPA-HQ-OPPT-2002-0054-0271
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2002-11-22T05:00Z

Summary
of
EPA's
Responses
to
Public
Comments
Submitted
for
the
Proposed
TSCA
Inventory
Update
Rule
Amendments
(
64
FR
46772)

US.
Environmental
Protection
Agency
Office
of
Pollution
Prevention
and
Toxics
11/
20/
02
Table
of
Contents
Acronyms.........
p.
1
A.
General
Comments
1.
Justification
for
Rule/
Practical
Utility
.........
p.
3
2.
Ability
to
Use
Data.........
p
14
3.
Other
Sources
of
Data
and
Methods
of
Collecting
Data.........
p
18
4.
Rule
Development
Process.........
p
29
5.
Right­
to­
Know
Comments..........
p
30
6.
Industrial
Expionage
and
Terrorism.........
p
31
7.
Violating
Federal
Law...........
p
36
B.
Specific
Data
Elements
Comments
1.
General
Data
Quality
and
Accuracy......
p
39
2.
Double
Counting
of
Data.......
p
43
3.
Site
and
Company
Identification......
p
46
4.
Form
U,
Part
II
Data
Elements
­
Manufacturing
Information.....
p
47
a.
Production
volume.......
p
47
b.
Concentration
data.......
p
48
c.
Physical
form..........
p
49
5.
Form
U,
Part
III
Data
Elements
­
Processing
and
Use
Information....
p
50
a.
General
Downstream
Reporting......
p
50
b.
Process
or
Use
Codes......
p
55
c.
Industrial
Function
Categories.......
p
56
d.
Commercial
and
consumer
product
categories......
p
57
6.
General
Data
Elements
Comments........
p
61
a.
"
Reasonably
Likely
to
be
Exposed"
Workers......
p
61
b.
Personal
Protective
Equipment......
p
69
c.
Metric
System
Reporting......
p
70
d.
Use
volume
accuracy
and
reliability......
p
70
C.
Reporting
Universe
Comments...
p
71
1.
Inorganic
Chemicals.....
p
71
a.
Removal
of
Exemption
for
Inorganic
Chemical
Substances...
p
71
b.
Retention
of
Exemption
for
Inorganic
Chemical
Substances...
p
71
c.
Phasing
in
Reporting.....
p
79
d.
Alternatives
for
Reporting.....
p
81
e.
Specific
Substances....
p
87
2.
Natural
Gas
Exemption.....
p
98
3.
Petroleum
Process
Streams.....
p
101
4.
Other
Chemical
Categories.....
p
102
a.
HPV
Chemicals...
p
102
b.
Low
Priority
Chemicals...
p
106
5.
Thresholds....
p
116
D.
Definitions
and
Clarification
Requests...
p
120
1.
Inorganic
Chemical
Substance...
p
120
2.
Chemical
Industry...
p
122
3.
Site.....
p
122
4.
Importers....
p
123
E.
Confidential
Business
Information...
p
126
1.
General
CBI.....
p
126
a.
Protection
of
CBI...
p
128
b.
Disclosing
customer
confidential
information....
p
129
c.
Production
volume
ranges....
p
130
2.
Up­
front
Substantiation...
p
130
3.
Reassertion...
p
132
F.
Administrative
Comments...
p
136
1.
Frequency
of
Reporting...
p
136
2.
Calendar
year
reporting...
p
137
3.
Form
U
comments...
p
138
G.
Economics...
p
140
1.
Burden...
p
141
2.
Cost...
p
147
3.
Benefits....
p
151
4.
Small
Business
Analysis...
p
152
5.
E.
O.
12866....
p
154
References....
p
155
Appendix
1:
Docket
Commenter
Number
Cross
Reference
List
of
Legacy
Docket
to
E­
Docket
Page
1
of
159
Acronyms
ACC
American
Chemistry
Council
(
formerly
the
Chemical
Manufacturers
Association)
ATSDR
Agency
for
Toxic
Substances
and
Disease
Registry
API
American
Petroleum
Institute
BRS
Biennial
Reporting
System
CAIR
Comprehensive
Assessment
Information
Rule
CAS
Chemical
Abstracts
Service
CBI
Confidential
Business
Information
CCP
Commercial
and
Consumer
Product
CMA
Chemical
Manufacturers
Association
(
now
the
American
Chemistry
Council)
CPSC
Consumer
Product
Safety
Commission
CSMA
Chemical
Specialty
Manufacturers
Association
DfE
Design
for
the
Environment
DOE
Department
of
Energy
EC
European
Commission
ECP
Existing
Chemicals
Program
EPCRA
Emergency
Planning
and
Community
Right­
To­
Know
Act
FDA
Food
and
Drug
Administration
FIFRA
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
GAO
Government
Accounting
Office
HPV
High
Production
Volume
IARC
International
Agency
for
Research
on
Cancer
ICCA
International
Council
of
Chemical
Associations
IFC
Industrial
Function
Category
ITC
Interagency
Testing
Committee
IUR
Inventory
Update
Rule
IURA
Inventory
Update
Rule
Amendments
MSDS
Material
Safety
Data
Sheet
NAICS
North
American
Industrial
Classification
System
NCP
New
Chemicals
Program
NIOSH
National
Institute
of
Occupational
Safety
and
Health
NOES
National
Occupation
Exposure
Survey
NOHS
National
Occupational
Hazard
Survey
NTP
National
Toxicology
Program
OECD
Organization
for
Economic
Cooperations
and
Development
OMB
Office
of
Management
and
Budget
OPPT
Office
of
Pollution
Prevention
and
Toxics
OSHA
Occupational
Safety
and
Health
Administration
PAIR
Preliminary
Assessment
Information
Rule
PMN
Premanufacturing
Notice
PRA
Paperwork
Reduction
Act
PPE
Personal
Protective
Equipment
Page
2
of
159
RM­
1
Risk
Management­
1
SAB
Science
Advisory
Board
SIAR
SIDS
Initial
Assessment
Report
SIC
Standard
Industrial
Classification
SIDS
Screening
Information
Data
Set
SOCMA
Synthetic
Organic
Chemical
Manufacturers
Association
TSCA
Toxic
Substances
Control
Act
TRI
Toxics
Release
Inventory
UCSS
Use
Cluster
Scoring
System
USGS
U.
S.
Geological
Survey
UEIP
Use
and
Exposure
Information
Project
Page
3
of
159
A.
General
Comments
1.
Justification
for
Rule/
Practical
Utility
Comment
A.
1­
1:
Several
of
the
commenters
stated
that
EPA
has
not
provided
adequate
justification
supporting
the
Agency's
need
for
the
IURA
data,
and
has
not
provided
enough
specific
examples
showing
how
the
data
would
be
used
for
EPA's
intended
purpose.
Certain
comments
questioned
whether
EPA
currently
has
an
effective
risk
screening
program
in
place
to
use
the
new
IUR
data
as
it
is
reported.
Overall,
commenters
indicated
that
it
is
unreasonable
for
EPA
to
enact
these
amendments
until
a
clearly
articulated
and
specific
plan
for
using
the
data
is
in
place.

Source:
C1­
001,
C1­
010,
C1­
011,
C1­
014,
C1­
015,
C1­
016,
C1­
017,
C1­
018,
C1­
019,

C1­
021,
C1­
023,
C1­
024,
C1­
026,
C1­
027,
C1­
031,
C1­
032,
C1­
033,
C1­
038,
C1­
041,

C1­
044,
C1­
045,
C1­
046,
C1­
055,
C1­
056,
C1­
071
Response
A.
1­
1:
EPA
has
developed
a
Data
Use
Plan
(
Ref.
1),
which
more
fully
describes
uses
of
the
IURA
data
and
provides
selected
specific
examples
of
these
uses.
As
explained
in
the
plan,
the
IURA
database
will
be
a
fairly
shallow
collection
of
exposure
related
information
on
a
fairly
large
number
of
chemicals.
As
a
whole,
these
data
do
not
currently
exist
and
EPA,
through
TSCA,
is
the
only
Agency
that
has
the
ability
to
reach
so
many
chemicals
and
to
collect
this
type
of
information
on
those
chemicals
on
a
regular
enough
basis
that
information
remains
current
and
trends
can
be
identified.
This
exposure
database
is
needed
to:

°
Support
priority
setting
and
risk­
based
screening
of
chemicals
(
for
example,
IURA
data
can
be
used
to
provide
a
risk
based
context
for
hazard
information
being
submitted
under
the
HPV
Challenge
Program);

°
Empower
resource
allocation
decisions;

°
Provide
a
first
place
to
look
when
a
new
concern
is
identified;

°
Provide
an
overview
of
chemical
processing
and
use,
over
time,
in
a
unique
database;

°
Inform
a
variety
of
Agency
and
other
programs,
such
as
the
TSCA
testing
program,
OSW
programs,
and
NIOSH,
OSHA,
and
CPSC
programs;
and
°
Provide
initial
exposure
information
for
the
development
of
Agency
and
public
programs,

such
as
the
Voluntary
Children's
Chemical
Evaluation
Program
(
VCCEP)
and
Design
for
the
Environment
(
DfE)
voluntary
programs.

The
data
use
plan
contains
specific
examples
to
support
these
more
general
uses
of
the
IURA
Page
4
of
159
data.

Although
the
plan
contains
an
example
of
a
basic
screening
of
the
whole
IURA
database,

there
are
many
other
uses;
data
generated
by
the
IURA
will
be
used
in
a
wide
variety
of
programs
fundamental
to
fulfilling
the
Agency's
TSCA
statutory
mandate.
These
programs
range
from
the
more
traditional
existing
chemicals
risk
screening
efforts
to
voluntary
programs
to
individual
requests
for
analysis
of
chemicals
not
specifically
associated
with
a
particular
program.
The
IURA
database
will
be
searched
to
identify
chemicals
or
use
scenarios
meeting
specific
criteria.

For
instance,
if
there
was
a
need
to
identify
chemicals
that
have
the
greatest
potential
for
consumer
exposure,
the
database
could
be
searched,
resulting
in
a
listing
of
chemicals
arranged
according
to
the
production
volumes
associated
with
different
consumer
uses.
The
Agency
anticipates
that,
as
was
true
even
for
the
basic
production
data
reported
under
the
existing
IUR,

new
uses
of
IURA
data
by
EPA
and
by
others
will
continually
emerge
and
cannot
be
predicted
at
this
time.

Results
from
EPA
tools
such
as
the
Use
Cluster
Scoring
System
(
UCSS)
will
be
greatly
improved
by
the
IURA
data.
The
UCSS
is
a
computerized
tool
that
combines
hazard
and
exposure
information
from
a
variety
of
data
sources,
analyzes
the
data
in
relation
to
groupings
by
commercial
use,
or
"
clusters,"
and
identifies
clusters
of
potential
concern
to
EPA.
The
EPA
Science
Advisory
Board
(
SAB),
in
its
evaluation
of
the
UCSS,
commented
that
there
has
been
a
lack
of
exposure
information
in
the
system,
which
has
impaired
the
utility
of
the
system.
(
Ref.
2)

The
IURA
database
will
provide
exposure
information
that
the
UCSS
will
be
able
to
directly
download
and
use.
(
For
a
description
of
UCSS,
see
http://
www.
epa.
gov/
opptintr/
cbep/
actlocal/
39­
use.
htm.)

EPA
will
also
use
IURA
data
to
perform
preliminary
exposure
and
risk
screening
across
a
portion
of
the
Inventory
chemicals.
Some
of
the
data
of
the
type
that
will
be
collected
under
IURA
have
been
collected
under
the
Agency's
TSCA
Existing
Chemicals
Program
(
ECP)
and
in
the
TSCA
New
Chemicals
Program
(
NCP),
and
have
aided
EPA
in
performing
exposure
and
risk
screening
These
exposure
related
data
were
submitted
as
part
of
programs
such
as
the
voluntary
Use
and
Exposure
Information
Project
(
UEIP)
(
see
http://
www.
epa.
gov/
opptintr/
sids/
vueip.
txt
for
a
description
of
this
project)
and
the
Premanufacture
Notice
(
PMN)
program
under
TSCA
section
5.
Although
the
UEIP
and
PMN
programs
involve
the
submission
of
certain
data
that
are
the
same
as
or
similar
to
data
that
will
be
submitted
under
IURA,
these
programs
cannot
sufficiently
serve
the
needs
that
IURA
will
fill
(
see
Units
V.
A.
1.
and
V.
B.
5.
of
the
proposed
rule
(
64
FR
46772,
46775
and
46780)).
However,
these
programs
do
serve
as
examples
of
the
usefulness
of
certain
IURA
data
elements.
Page
5
of
159
For
example,
several
IURA
data
elements
were
utilized
in
an
Existing
Chemicals
Program
initial
review
of
the
chemical
methyl
ethyl
ketoxime
(
MEKO)
(
Ref.
3).
This
review
relied
in
part
upon
data
submitted
by
industry
under
the
UEIP,
some
of
which
are
similar
to
those
that
will
be
reported
under
IURA
and
include
the
following:
production
volume,
manufacturing
process,

industry
sector,
industrial
processing/
use
activity,
functional
use,
number
of
sites,
number
of
workers,
physical/
chemical
properties,
and
consumer
product
information.
Other
UEIP
information
submitted
by
industry
on
MEKO
are
not
of
the
sort
that
will
be
collected
under
IURA,
such
as
environmental
releases
(
releases
to
air,
water,
etc.),
worker
exposure
activities
and
monitoring
data.
IURA
is
designed
to
obtain
information
that
is
the
most
critical
for
generating
screening­
level
exposure
profiles.

The
UEIP
submissions
for
MEKO
showed
that
there
were
one
manufacturer
and
two
importers
of
MEKO
in
1993.
Five
primary
end
uses
with
the
percentages
of
MEKO
production
and
import
volumes
devoted
to
each
use
were
indicated
in
these
submissions.
The
number
of
workers
at
the
manufacturing
site,
the
physical
forms
of
products
containing
MEKO
and
the
MEKO
weight
fraction
in
each
use
were
also
reported.

The
MEKO
use
information
was
combined
with
data
and
information
from
some
available
workplace
monitoring
studies
and
modeling
approaches
to
develop
a
screening­
level
workplace
exposure
assessment.
The
UEIP
information
on
use
provided
crucial
information
to
allow
EPA
to
postulate
process
operations,
worker
activities,
and
possible
exposures.
For
example,
MEKO's
primary
use
(
92%
of
production
and
import
volume)
is
as
a
paint
additive.
This
fact
allows
EPA
to
refer
to
information
on
paint
manufacturing
and
use
to
estimate
exposures
to
workers
who
either
formulate
paints
or
apply
the
paints
using
spray
guns
or
other
techniques.
MEKO
use
in
paint
indicates
a
potential
for
exposure
to
several
large
populations
(
workers
and
consumers)

because
even
small
amounts
of
paint
can
result
in
significant
exposure
levels
to
chemicals
in
paints.
Such
use
information
can
also
be
used
by
EPA
to
generate
estimated
numbers
of
workers
in
very
small
businesses
(<
10
workers)
that
may
be
poorly
represented
by
existing
National
Occupation
Exposure
Survey
(
NOES)
data;
in
the
MEKO
case,
such
a
population
would
be
commercial
painters.
Without
the
information
about
MEKO
use
in
paints
and
the
large
percentage
of
MEKO
volume
devoted
to
this
use,
exposed
populations
and
exposure
level
estimates
may
have
been
severely
underestimated
or
left
as
a
data
gap
(
not
estimated).
Such
underestimations
and
data
gaps
can
artificially
lower
the
appropriate
level
of
concern
for
potential
risk(
s)
from
a
chemical.

The
usefulness
of
IURA
data
elements
is
also
demonstrated
by
EPA's
use
of
similar
data
in
its
New
Chemicals
Program.
Premanufacture
Notices
(
PMNs)
for
new
chemical
substances
Page
6
of
159
submitted
to
EPA
under
TSCA
section
5
require
many
of
the
same
exposure­
related
data
elements
that
will
be
reported
under
the
IURA.
Exposure­
related
data
in
PMNs
include
estimates
of
production
volume,
categories
of
use,
percent
production
volume
in
the
categories
of
use,

maximum
numbers
of
workers
exposed,
and
concentrations
and
physical
forms
of
the
chemical.

EPA
uses
these
exposure­
related
data
to
generate
screening­
level
risk
assessments
for
regulatory
decision
making
under
TSCA
section
5.

In
a
recent
PMN
submission,
the
manufacturer
of
a
new
chemical
provided
the
following
information:
an
estimated
import
volume;
chemical
uses
and
the
percentages
of
the
import
volume
devoted
to
each
use
(
cosmetic
applications
exempt
from
TSCA
(
25%)
and
non­
cosmetic
applications
as
a
component
of
a
fragrance
formulation
used
in
household
products
such
as
detergents,
cleaners,
soaps,
room
fresheners,
etc.
(
75%));
numbers
of
sites
and
workers;
and
consumer
product
information
(
weight
percent
in
products).
Using
this
information
in
combination
with
technical
references
and
other
research,
EPA
was
able
to
estimate
the
number
of
manufacturers
of
household
products
who
may
use
the
new
substance.
Releases
of
the
new
substance
from
the
fragrance
formulation
process
and
from
the
household
products
manufacturers
were
estimated,
resulting
in
estimated
environmental
concentrations
of
the
new
substance
due
to
its
release
and
estimated
general
population
exposures
to
the
new
substance.
EPA
also
used
the
information
on
processing
and
use
in
combination
with
modeling
techniques
to
estimate
the
numbers
of
workers
and
consumers
who
may
be
exposed
to
the
new
substance
and
their
estimated
exposures
to
the
new
substance.
These
exposure­
related
estimates,
when
combined
with
information
on
the
estimated
hazards
of
the
new
substance,
indicated
that
the
estimated
risks
to
potentially­
exposed
workers,
the
general
population,
consumers,
and
aquatic
species
were
all
below
levels
of
concern.
Therefore,
since
EPA
did
not
identify
any
significant
risks,
the
Agency
could
determine
that
no
further
regulation
under
TSCA
section
5
was
needed
for
this
new
substance.
Without
the
limited
processing
and
use
information
from
IURA
reporting,
the
Agency
would
have
to
rely
only
on
generic
assumptions
for
approximating
potential
exposures.
Using
generic
scenarios
only
is
too
inaccurate
to
use
to
evaluate
exposures;
the
Agency
needs
the
IURA
information
to
begin
incorporating
exposure
into
screening
efforts.

Information
from
IURA
may
also
be
used
in
efforts
to
identify
single
chemicals,
in
order
to
support
potential
exposure
prevention
efforts.
For
example,
EPA
recently
learned
that
certain
imports
of
zinc
sulfate
were
contaminated
with
cadmium.
Using
the
IURA
processing
and
use
data
on
inorganic
substances,
EPA
could
have
quickly
identified
importers
of
zinc
sulfate
and
segments
of
industry
or
the
general
population
that
might
use
the
chemical.
EPA
could
then
have
targeted
warnings
of
the
potential
for
exposure
to
cadmium
more
effectively,
thereby
preventing
Page
7
of
159
exposures
to
these
groups
likely
to
be
the
most
highly
exposed.

The
TSCA
Interagency
Testing
Committee
(
ITC)
will
use
IURA
to
identify
chemicals
as
candidates
to
recommend
for
further
testing
or
information
reporting.
The
ITC
has
sixteen
(
16)

U.
S.
Government
member
organizations.
The
National
Toxicity
Program
(
NTP)
determines
the
need
for
federally­
funded
research
for
determining
the
toxicity
of
chemicals.
IURA
information
could
be
used
to
identify
the
chemicals
with
exposure
concerns,
thereby
identifying
those
chemicals
for
which
NTP
will
need
to
determine
toxicity.

Other
Federal
agencies
have
also
long
recognized
the
need
for
and
importance
of
exposure
data.
OSHA,
NIOSH,
and
CPSC
have
written
letters
supporting
EPA's
and
their
own
need
for
exposure
data
(
Refs.
4,
5,
6,
7,
and
8).
In
May
2000,
the
Government
Accounting
Office
(
GAO)

stated
that
"
Various
federal
agencies
have
collected
such
human
exposure
data
for
a
number
of
purposes;
historically,
these
collection
efforts
have
been
limited
to
selected
chemicals,

subpopulations,
and
time
periods"
(
Ref.
9).

Other
government
agencies,
industry,
public
interest
groups,
and
the
public
in
general
will
also
be
able
to
access
and
use
non­
CBI
IURA
information.
The
IURA
exposure
related
data
will
be
important
to
users
beyond
those
who
accessed
the
current
IUR
in
the
past
solely
for
production
volume
information.
For
instance,
the
Natural
Resources
Defense
Council
has
expressed
interest
in
using
the
IURA
information
(
Ref.
10).
Persons
interested
in
reviewing
the
HPV
Challenge
Program
screening­
level
hazard
data
(
see
http://
www.
epa.
gov/
opptintr/
chemrtk/
volchall.
htm)
will
be
able
to
use
the
exposure
related
IURA
data
(
to
the
extent
that
IURA
data
is
not
CBI)
to
put
the
hazard
data
into
context.
Risks
identified
via
evaluation
of
this
screening­
level
hazard
and
exposure
data
then
can
be
addressed.

Other
examples
of
uses
by
non­
EPA
groups
are:

CPSC:
The
U.
S.
Consumer
Product
Safety
Commission
(
CPSC)
will
utilize
IURA
data
to
assist
in
identifying
household
chemical
product
ingredients,
which
may
lead
to
a
determination
of
which
products
should
be
labeled
as
"
hazardous
substances."

Currently,
there
is
no
comprehensive
source
of
information
on
the
ingredients
of
household
chemical
products
and
CPSC
does
not
have
the
authority
to
collect
this
type
of
comprehensive
information.
(
Refs.
6
&
7)

OSHA:
The
Office
of
Safety
and
Health
Administration
(
OSHA)
strongly
supports
EPA's
collection
of
information
on
the
processing
and
use
of
chemicals.
The
addition
of
information
which
links
the
number
of
potentially
exposed
workers
to
specified
quantities
of
specific
chemicals
at
specific
establishments
would
be
extremely
useful
to
OSHA
in
setting
priorities,
developing
health
standards,
and
targeting
intervention
efforts
including
Page
8
of
159
outreach
and
training.
This
information
will
be
instrumental
in
helping
OSHA
identify
which
industry
groups
have
a
greater
potential
for
worker
exposure
issues,
to
identify
which
chemicals
have
limited
concerns
and
which
are
of
potential
concern
to
which
industries,
and
to
identify
changes
in
industry
behavior
and
use
patterns.
(
Ref.
4)

States:
IURA
would
provide
the
data
needed
by
states
to
focus
their
multimedia
pollution
prevention
(
P2)
initiatives.
While
the
initiatives
vary
from
state
to
state
in
focus
and
design,
a
shared
characteristic
is
that
there
is
an
initial
examination
of
the
whole
plant,
the
full
range
of
public
health
and
environmental
protection
issues,

and
existing
regulatory
controls.
Through
this
multifaceted,
multi­
media
review,

the
states
reexamine
the
overall
management
scheme
and,
in
partnership
with
industry,
rework
the
overall
management
plan
to
more
efficiently
address
environmental
and
public
health
risk.
Improved
targeting
of
these
programs,

possible
with
the
use
of
IURA
data,
would
save
both
the
program
office
and
industry
partners
time
and
money.
States
can
also
utilize
IURA
information
to
support
their
State
Regulatory
Development
Processes.
IURA
would
also
provide
information
to
states
for
use
in
addressing
Federal
delegated
responsibilities
(
CAA
and
CWA
permit
authorities,
etc.)
and
state
authorities
(
California
Proposition
65,

etc).

This
response
described
a
wide
variety
of
uses
for
the
new
IURA
exposure­
related
data.

However,
the
Agency
anticipates
that
even
more
opportunities
exist
for
use
of
this
information,
as
was
true
even
for
the
basic
production
data
reported
under
the
current
IUR.

Discussions
of
the
need
for
and
expected
uses
of
the
IURA
data
are
in
the
preamble
to
the
proposal,
the
economic
analysis,
letters
to
the
Office
of
Management
and
Budget
(
OMB),
and
in
the
report
"
EPA
Needs
Exposure­
Related
Data:
A
Discussion
of
the
Justification
for
Collecting
Exposure­
Related
Data
Through
the
IUR
Amendments"
(
Ref.
11).
All
of
these
documents
are
in
the
public
version
of
the
official
record
for
this
rulemaking,
docket
number
OPPT­
2002­
0054.

Comment
A.
1­
2:
Commenters
suggested
that
EPA
should
use
a
more
targeted
approach
to
collect
only
the
information
for
which
there
is
defined
utility.
Commenters
questioned
why
EPA
needs
information
on
chemical
substances
that
have
already
been
screened.

Source:
C1­
045,
C1­
056
Response
A.
1­
2:
Contrary
to
the
commenters'
belief,
EPA
is
collecting
targeted
Page
9
of
159
information
for
which
there
is
a
defined
utility.
As
described
in
the
documents
listed
in
comment
A.
1­
1,
EPA
and
others
have
a
need
for
a
broad­
based
source
of
screening
level
use
and
exposure
information
on
chemical
substances.
A
primary
purpose
for
collecting
IURA
data
is
to
enable
the
Agency
to
screen
a
relatively
broad
set
of
Inventory
chemicals
based
on
potential
exposure.
The
Agency
and
others
will
be
able
to
use
the
screening
results
to
help
focus
efforts
and
resources
by
identifying
those
chemicals
that
warrant
further
analysis,
as
well
as
setting
priorities
for
conducting
further
analyses,
including
hazard
testing,
risk
assessment,
and
risk
management.
This
basic
information
on
exposure
and
use
will
allow
the
Agency
to
consider
available
hazard
information
in
the
context
of
potential
exposure.

EPA
focused
the
IURA
on
a
subset
of
chemicals
on
the
TSCA
Inventory.
The
Agency
is
requiring
the
reporting
of
processing
and
use
information
on
only
4,000
of
the
more
than
76,000
chemicals
listed
on
the
TSCA
Inventory.
Additionally,
EPA
has
eliminated
processing
and
use
reporting
for
listed
petroleum
processing
stream
chemicals
and
for
specific
listed
chemical
substances
for
which
EPA
has
a
low
current
need
for
IURA
processing
and
use
information.

Further
restricting
the
chemicals
for
which
data
are
collected
would
reduce
the
effectiveness
of
this
screening
tool
and
ultimately
the
effectiveness
and
efficiency
of
various
risk
management
programs.
Instead
of
having
a
database
of
information
that
allows
EPA
to
act
proactively,

identifying
areas
of
potential
concern
for
exposure
or
risk,
and
to
react
in
a
timely
manner
to
requests
and
demands
for
action
for
specific
concerns,
EPA
would
have
to
identify
which
chemicals
are
going
to
be
of
interest
for
the
future
­
up
to
eight
or
ten
years
before
the
information
is
needed.
Additionally,
EPA
would
not
have
a
baseline
of
information
to
track
the
progress
of
different
Agency
and
public
programs,
would
not
be
able
to
identify
trends
in
the
industry,
and
would
not
be
able
to
help
identify
future
issues
associated
with
chemical
substances
(
i.
e.,
identifying
that
the
use
of
a
specific
chemical
is
increasing).

At
times,
EPA
needs
to
collect
further
screening­
level
information
on
chemicals
which
have
already
been
screened.
One
very
basic
reason
for
this
need
is
the
fact
that,
although
a
chemical's
toxicity
is
inherent
to
the
chemical
itself,
exposures
associated
with
that
chemical
may
vary
substantially
over
time.
As
a
result,
a
chemical
that
appears
to
be
very
risky
due
to
high
exposure
could
appear
much
less
so
if
that
exposure
is
reduced
over
time.
Alternatively,
a
chemical
that
does
not
appear
to
be
risky
due
to
low
exposure
could
appear
much
more
so
if
that
exposure
increases
over
time.
Screenings
need
to
occur
periodically
in
order
to
account
for
such
changes
­
otherwise,
the
screenings
and
data
become
outdated
and
less
reflective
of
current
conditions.

There
are
a
variety
of
other
reasons
EPA
may
need
further
screening­
level
information
on
Page
10
of
159
chemicals
which
have
already
been
screened.

$
Chemicals
are
often
screened
for
specific
purposes,
such
as
for
a
specific
end
use
or
type
of
release.
IURA
data
will
enable
the
Agency
to
identify
other
issues
of
importance
for
chemicals
that
have
already
been
reviewed.

$
Both
regulatory
and
voluntary
programs
may
be
instituted
for
chemicals
that
have
been
reviewed.
The
effectiveness
of
these
programs
may
be
evaluated
using
IURA
data
by
tracking
the
volumes
of
particular
chemicals
being
produced
or
the
rate
of
increase
or
decrease
of
particular
end
uses.

$
New
issues
associated
with
a
chemical
may
arise.
For
example,
if
the
Agency
saw
the
need
for
an
enhanced
focus
on
children's
health,
a
chemical
previously
screened
or
assessed
may
need
to
be
reexamined.
Another
example
is
the
discovery
of
the
importance
of
endocrine
disruption
and
the
need
for
information
as
to
whether
a
particular
chemical
may
have
endocrine
disrupting
potential.

The
chemical
industry
is
a
dynamic,
ever­
changing
industry.
New
uses
for
chemicals
are
discovered,
or
old
uses
revived.
With
information
submitted
on
chemicals
that
have
already
been
screened
or
otherwise
assessed,
the
Agency
can
identify
trends
associated
with
those
chemicals.

The
trend
information
will
allow
the
Agency
to
identify,
upfront,
new
issues
associated
with
a
chemical
or
a
particular
type
of
use
or
exposure.

Comment
A.
1­
3:
Commenters
stated
that
EPA
is
violating
the
Paperwork
Reduction
Act
(
PRA)
of
1995
by
failing
to
demonstrate
that
the
proposed
collection
of
information
is
necessary
for
the
proper
performance
of
the
functions
of
the
agency
and
that
the
information
shall
have
practical
utility
as
required
by
Section
3506
of
the
PRA.

Source:
C1­
024,
C1­
033,
C1­
038,
C1­
044,
C1­
069
Response
A.
1­
3:
EPA
has
demonstrated
that
the
IURA
is
"
necessary
for
the
proper
performance
and
functions
of
the
agency."
TSCA
mandates
that
EPA
control
unreasonable
risks
of
chemicals
in
commerce.
For
new
chemicals,
EPA
requires
firms
wishing
to
introduce
chemicals
into
commerce
to
supply
the
information
of
the
sort
that
will
be
required
by
the
IURA.

EPA
has
had
little
information
to
use
to
screen
the
risks
posed
by
the
roughly
76,000
existing
chemicals
in
commerce.
IURA
offers
the
opportunity
to
partially
address
this
lack
of
data.

Any
screening
of
"
risk"
is
based
on
some
amount
of
hazard
information
in
combination
with
some
amount
of
exposure
information.
EPA
relies
on
risk
screening
to
indicate
which
Page
11
of
159
chemical
substances
may
present
a
risk,
and
thus
warrant
more
resource­
intensive
assessment.

The
EPA
Science
Advisory
Board's
"
Reducing
Risk:
Setting
Priorities
and
Strategies
for
Environmental
Protection"
report
(
Ref.
12)
and
the
National
Academy
of
Public
Administration's
"
Setting
Priorities,
Getting
Results,
A
New
Direction
for
EPA"
report
(
Ref.
13)
recognize
that
EPA's
ability
to
set
priorities
through
risk
screening
and
EPA's
ability
to
allocate
its
limited
resources
has
been
significantly
impeded
by
a
lack
of
exposure
data.
Industry
agrees
that
EPA
needs
exposure
data.
In
a
letter
to
EPA
dated
March
24,
2000,
CMA
(
now
ACC)
supported
collecting
exposure
information
to
evaluate
chemicals
in
EPA's
voluntary
Children's
Safety
Program
(
Ref.
14).
CMA
stated
that
"
exposure
assessment
has
long
been
recognized
as
one
of
the
weak
links
in
the
risk
assessment
process.
Real
data
have
been
hard
to
come
by,
and
default
assumptions
have
often
bordered
on
the
absurd"
(
Ref.
15).
Screening
the
potential
risks
posed
by
the
chemical
substances
included
in
the
TSCA
Inventory
and
setting
priorities
for
more
detailed
risk
assessment
and
possible
risk
management
is
an
enormous
challenge.
The
manufacturing,

processing,
and
use
of
Inventory
chemicals
result
in
a
wide
array
of
exposure
scenarios.
By
collecting
the
exposure­
related
data
included
in
IURA,
the
Agency
will
acquire
information
that
will
greatly
improve
EPA's
ability
to
identify,
through
risk
screening,
the
chemical
substances
that
could
pose
a
risk
to
human
health
and
to
the
environment.

The
term
"
practical
utility"
is
defined
in
the
Paperwork
Reduction
Act
(
PRA)
at
44
United
States
Code
section
3502(
11),
i.
e.,
"
the
term
`
practical
utility'
means
the
ability
of
an
agency
to
use
information,
particularly
the
capability
to
process
such
information
in
a
timely
and
useful
fashion."
OMB's
regulatory
definition
of
"
practical
utility"
at
5
CFR
Part
1320.3(
l)
addresses
not
only
the
theoretical
or
potential
usefulness
of
information
to
an
Agency,
but
its
actual
usefulness,

taking
into
account
its
accuracy,
validity,
adequacy,
and
reliability,
and
the
Agency's
ability
to
process
the
information
in
a
useful
and
timely
fashion,
and
taking
into
account
whether
the
Agency
demonstrates
actual
timely
use
of
the
data
either
by
the
Agency
to
carry
out
the
Agency's
own
functions
or
by
third
parties.

The
Agency
had
ensured
that
the
data
will
be
accurate,
valid,
adequate,
and
reliable,
as
needed
for
screening
level
data.
EPA
considered
the
types
of
information
needed
for
screeninglevel
exposure
and
risk
assessments
and
believes
the
information
collected
through
the
IURA
will
have
the
necessary
level
of
adequacy,
accuracy,
validity,
and
reliability
for
such
assessments.
In
developing
the
IURA
and
considering
various
alternatives,
EPA
relied
on
experience
from
programs
such
as
TSCA's
PMN
program
and
the
UEIP
data
collection.
EPA
also
maintained
a
balance
between
data
needs
for
exposure
screening
and
the
burden
associated
with
providing
the
information.
If
the
Agency
had
required
very
precise,
specific
reporting,
company
burden
would
Page
12
of
159
have
increased
beyond
that
which
is
appropriate
for
a
screening­
level
data
collection.
There
are
many
factors
that
can
affect
exposure
potential.
The
data
provided
by
the
submitters
will
provide
baseline
information
sufficient
for
an
initial
screen
of
exposure
potential.

EPA
ensured
the
adequacy
of
the
data
that
will
be
collected
under
IURA
by
analyzing
the
usefulness
of
the
data
elements
covered
by
various
exposure
data
collections
and
assessments
to
determine
the
data
elements
most
needed
for
a
screening
level
exposure
assessment.
This
discussion
and
analysis
is
in
the
document
"
Inventory
Update
Rule
(
IUR)
Amendment
Technical
Support
Document:
Exposure­
Related
Data
Useful
for
Chemical
Risk
Screening"
(
Ref.
16).

Commenters'
suggestions
implied
that
more
extensive
information
about
exposures
would
be
necessary
for
even
a
screening
level
analysis
of
potential
exposure.
As
summarized
in
Unit
III.
A.
1.
of
the
Final
Rule
preamble,
risk
analyses
performed
by
the
Agency
in
general
and
OPPT
in
particular
are
graduated
and
data­
driven.
As
the
initial
levels
of
concern
and
the
quantity
and
quality
of
data
increase,
the
need
for
and
methodologies
used
in
risk
review
become
more
detailed
and
exacting,
while
the
reviews
become
more
accurate
and
reliable.
Based
on
its
experience
assessing
chemical
risks
through
such
programs
as
the
TSCA
New
Chemicals
Program,
the
Agency
believes
the
IURA
data
will
provide
information
adequate
to
perform
initial
screens
of
chemicals,
and
to
prioritize
and
make
basic
risk
management
decisions
about
those
chemicals
of
greatest
concern
as
indicated
by
the
available
data.
These
better
informed
decisions
will
enhance
confidence
that
the
most
appropriate
chemicals
are
selected
for
more
detailed
assessments.

The
Agency
considered
the
data
accuracy
and
reliability
needed
for
screening
level
exposure
analyses
and
took
several
steps
to
ensure
the
IURA
data
meet
those
needs.
Screening
level
data
need
not
be
absolutely
precise,
but
should
be
accurate
and
reliable
enough
to
make
usable
and
defensible
technical
assessments.
The
IURA
will
supply
exposure
related
information
the
Agency
does
not
currently
have,
recognizing
that
industry
has
a
greater
knowledge
than
EPA
about
its
own
operations
and
the
uses
of
chemicals
it
manufactures
and
sells.
Without
this
information,
EPA
either
would
not
screen
these
chemicals,
would
screen
them
using
outdated
or
anecdotal
exposure
information,
or
would
rely
on
exposure
estimates
(
which
are
typically
conservative)
using
modeling
data.

Much
of
the
IURA
information
will
be
submitted
to
EPA
within
specified
ranges,
rather
than
as
discrete
figures.
This
requirement
benefits
both
the
Agency
and
submitters.
First,
range
reporting
is
less
burdensome
for
the
submitter
than
calculating
specific
quantity
estimates.

Demanding
greater
data
precision
increases
the
burdens
associated
with
data
collection.
Second,

information
reported
in
discrete
numeric
values
can
indicate
a
precise
level
that
is
not
necessarily
present.
By
specifying
ranges,
a
higher
level
of
confidence
in
the
data
accuracy
is
attained.
Page
13
of
159
EPA's
experience
with
similar
data
collecting
efforts
such
as
under
the
TSCA
New
Chemicals
Program
demonstrates
that
the
type
of
data
EPA
will
collect
under
IURA
are
sufficient
for
the
purpose
of
screening
to
prioritize
follow­
on
efforts
for
risk
assessment
and
management.

As
discussed
in
Unit
III.
A.
of
the
final
rule
preamble,
EPA
exposure
and
risk
evaluations
are
typically
tiered
and
data
dependent:
the
level
of
detail
in
the
assessment
is
directly
proportional
to
the
quantity
and
quality
of
the
available
data,
while
the
level
of
uncertainty
is
inversely
proportional
to
those
factors.
IURA
data
will
be
useful
to
the
Agency
in
evaluating
potential
exposures
and
risks,
serving
as
indicators
as
to
what
exposures
from
what
chemicals
need
greater
review
and
possible
attention.

Comment
A.
1­
4:
One
commenter
stated
EPA
should
address
the
competing
demands
of
government
and
private
resources,
laboratory
capacity,
scientific
and
information
capabilities,
and
animal
welfare.

Source:
C1­
033
Response
A.
1­
4:
EPA
is
concerned
about
the
various
competing
demands,
as
suggested
by
the
commenter.
During
the
development
of
the
IURA,
EPA
took
into
consideration
the
demands
of
government
and
private
resources
by
working
to
balance
the
Agency's
need
for
screening
level
exposure
information
with
the
burden
imposed
on
industry.
In
order
to
keep
the
burden
associated
with
reporting
low,
EPA
raised
the
initial
reporting
threshold
from
10,000
lbs.

to
25,000
lbs.
and
instituted
a
second
reporting
threshold
of
300,000
lbs,
rather
than
its
preferred
second
reporting
threshold
of
100,000
lbs.
These
changes
result
in
fewer
submissions
and,

therefore,
lower
burden
than
if
these
changes
were
not
implemented.
EPA
also
is
requiring
reporting
for
much
of
the
new,
exposure
related
information
at
a
"
readily
obtainable"
standard
and
in
ranges.
The
"
readily
obtainable"
standard
involves
less
effort
than
is
required
for
the
reporting
of
other
IUR
information,
which
is
subject
to
the
"
reasonably
ascertainable"
standard
(
see
Unit
III.
D.
2.
of
the
final
rule
preamble
for
more
information).
All
of
these
additions
to
the
IUR
were
devised
in
an
effort
to
reduce
the
reporting
burden
associated
with
the
IURA.

The
Agency
plans
to
use
the
IURA
information
to
better
target
Agency
programs,

resulting
in
more
targeted
requirements
for
the
use
of
labs,
conducting
testing,
or
gathering
additional
information.
Furthermore,
as
the
development
of
IURA
information
will
not
involve
the
use
of
any
animals
and
will
not
involve
conducting
any
testing,
neither
animal
welfare
nor
laboratory
capacity
concerns
are
implicated.
Page
14
of
159
Comment
A.
1­
5:
EPA
is
using
volume
as
a
surrogate
for
risk
in
setting
priorities.

Source:
C1­
043
Response
A.
1­
5:
Under
IUR
(
and
IURA),
production
volume
determines
which
chemicals
must
be
reported
by
a
given
site
and
which
do
not.
EPA
recognizes
that
some
chemicals
produced
in
volumes
below
25,000
lbs.
may
have
hazards
high
enough
that
the
potential
risk
is
of
sufficient
level
to
require
additional
attention
and
there
may
be
a
need
for
additional
processing
and
use
information
on
chemicals
produced
in
volumes
below
300,000
lbs.

However,
EPA
also
recognizes
that
a
cutoff
has
to
be
made
at
some
point.

While
past
approaches
to
priority
setting
have
been
primarily
based
on
relative
chemical
hazards
and
production
volume
as
a
simple
surrogate
for
exposure,
EPA
has
increased
its
emphasis
on
the
exposure
component
of
risk
screening
and
assessment.
As
a
result,
through
IURA,
EPA
is
attempting
to
reduce
its
reliance
upon
production
volume
as
a
surrogate
for
exposure,
and
will
instead
gather
data
that
will
allow
the
Agency
and
others
to
make
more
accurate
and
realistic
estimates
of
exposure.
The
exposure­
related
information
reported
under
the
IURA,
in
combination
with
hazard
information
such
as
that
developed
under
TSCA
section
4
test
rules
and
enforceable
consent
agreements,
or
through
voluntary
efforts
such
as
the
HPV
Challenge
Program,
will
allow
the
Agency
to
more
effectively
screen
and
prioritize
chemicals
based
on
potential
risk.
By
collecting
the
exposure­
related
data
included
in
the
IURA,
the
Agency
will
have
access
to
information
that
will
greatly
improve
EPA's
ability
to
identify,
through
risk
screening,
certain
chemical
substances
that
could
pose
a
risk
to
human
health
or
to
the
environment.

2.
Ability
to
Use
the
Data
Comment
A.
2­
1:
Many
commenters
state
that
EPA
could
not
begin
to
make
effective
and
timely
use
of
even
a
small
portion
of
the
IURA
processing
and
use
information
for
4,000
chemicals.
Commenters
indicated
that
the
large
amount
of
data
submitted
would
overwhelm
the
Agency,
even
though
EPA
acknowledges
that
its
ability
to
utilize
the
information
is
critical
to
realizing
any
benefits
from
the
proposed
IURA.
Commenters
stated
that
EPA
did
not
explain
how
its
programs
and
resources
would
be
able
to
analyze
and
use
the
vast
amount
of
information
that
would
be
reported
under
the
rule
in
a
meaningful
time
frame.
Several
commenters
suggested
that
a
more
limited
program
be
used
as
a
first
step.
Page
15
of
159
Source:
C1­
002,
C1­
007,
C1­
009,
C1­
010,
C1­
011,
C1­
013,
C1­
016,
C1­
017,
C1­
018,

C1­
019,
C1­
021,
C1­
024,
C1­
027,
C1­
032,
C1­
033,
C1­
038,
C1­
042,
C1­
046,
C1­
055
Response
A.
2­
1:
EPA
acknowledges
that
the
IURA
will
generate
a
significant
quantity
of
new
data
that
EPA
has
not
handled
under
past
IUR
data
collections.
However,
EPA
has
carefully
designed
the
IURA
data
collection
to
facilitate
efficient
data
management
and
data
use.
Data
collected
through
IURA
will
be
put
into
a
relational
database
format,
which
can
be
easily
searched,
compared,
and
used.
The
collection
of
specific
data,
organized
by
codes,
instead
of
textural
information
presented
in
a
unstructured
manner,
lends
itself
to
such
a
database
format.
In
addition,
electronic
IURA
submissions
allow
data
to
be
entered
into
the
database
accurately
and
expeditiously,
resulting
in
a
quick
turnaround
between
the
submission
of
the
data
to
the
Agency
and
the
availability
of
the
data
for
use.
The
Agency
anticipates
that
approximately
95%
of
all
reports
will
be
submitted
electronically
or
on
disks,
as
opposed
to
hard
copy
submissions.
In
1998,
about
70%
of
submissions
were
on
disks.
The
IURA
will
facilitate
EPA's
information
management
and
data
will
be
quickly
available
for
the
Agency's
use.

EPA
intends
to
use
the
IURA
data,
including
the
processing
and
use
data.
These
data
will
serve
a
vital
function
in
many
Agency
programs
and
activities.
However,
the
Agency
does
not
plan
to
conduct
a
full
risk
analysis
for
each
and
every
chemical.
EPA
will
use
the
data
to
determine,
on
a
relative
basis,
which
chemicals
will
result
in
potentially
higher
exposures
or,
when
combined
with
hazard
data,
risks
and
thus
merit
further
assessment.
EPA
has
carefully
designed
the
IURA
data
collection
to
facilitate
efficient
data
management
and
use.

Comment
A.
2­
2:
Commenters
mentioned
a
GAO
report
which
stated
"
we
continue
to
question
the
need
for,
and
EPA's
ability,
to
effectively
manage
and
utilize
data
on
as
many
as
12,000
substances."
One
commenter
stated
that
EPA
misinterpreted
the
GAO
report
it
is
using
to
support
the
proposal.

Source:
C1­
032,
C1­
042
Response
A.
2­
2:
EPA
considered
the
1995
GAO
report
("
EPA
Should
Focus
Its
Chemical
Use
Inventory
on
Suspected
Harmful
Substances,''
ref.
17)
when
developing
the
IURA.
EPA
has
done
what
the
GAO
report
recommended,
which
is
to
limit
use
reporting
to
several
thousand
chemicals.
GAO's
conclusion
in
the
1995
report
reads:

"
In
our
opinion,
implementing
the
inventory
on
a
smaller
scale
than
currently
envisioned
Page
16
of
159
by
EPA,
initially
covering
possibly
as
many
as
several
thousand
of
the
chemicals
suspected
to
present
the
greatest
risk,
would
provide
key
data
on
chemical
use
and
exposure
while
limiting
the
reporting
burden
on
the
chemical
industry
and
EPA's
data
management
requirements.
This
approach
would
also
give
EPA
the
opportunity
to
assess
the
data
obtained,
reconsider
the
chemicals
and
type
of
data
included
in
the
inventory,
and
make
any
necessary
adjustments
to
its
approach."

EPA
does
not
believe
that
it
misinterpreted
the
GAO
report
in
developing
the
IURA.
By
limiting
the
chemicals
for
which
downstream
exposure­
related
data
will
be
reported
to
4,000
in
the
first
year
and
4,600
in
reporting
periods
that
include
full
reporting
for
inorganics,
EPA
has
ensured
that
IURA
is
consistent
with
recommendations
from
the
GAO
report.

Comment
A.
2­
3:
One
commenter
stated
that
the
information
collected
would
be
useless
without
toxicity
data.
Another
commenter
stated
that
EPA
does
not
explain
how
it
will
conduct
risk
screens
when
it
may
not
have
toxicity
data
and
there
is
no
working
process
in
place
to
conduct
the
screens.

Source:
C1­
010,
C1­
032,
C1­
071
Response
A.
2­
3:
Risk
is
composed
of
both
exposure
and
hazard,
or
toxicity.
A
risk
screen
cannot
be
conducted
without
both
exposure­
related
data
and
hazard­
related
data.
To
date,

the
Agency
has
used
many
techniques
to
determine
whether
to
collect
exposure­
related
or
hazardrelated
data
on
a
particular
chemical.
For
instance,
the
HPV
Challenge
Program
used
production
volume
as
a
proxy
for
an
initial
exposure
screen
to
determine
which
chemicals
to
include
in
the
program,
which
collects
screening
level
toxicity
information
on
high
volume
chemicals.
A
large
portion
of
the
IURA
chemicals
fit
within
the
parameters
of
the
chemicals
included
in
the
HPV
Challenge,
and
EPA
will
therefore
have
both
exposure
and
hazard
information
for
those
chemicals.
In
addition
to
the
HPV
Challenge,
there
are
a
variety
of
processes
in
place
to
collect
needed
hazard
information,
including
TSCA
section
4
test
rules,
enforceable
consent
agreements,

and
other
voluntary
efforts.

However,
EPA
will
also
use
the
IURA
exposure­
related
data
to
conduct
exposure
screens
as
well
as
risk
screens,
and
will
use
the
information
in
a
variety
of
other
uses
(
see
comment
response
A.
2­
1
for
a
discussion
of
additional
uses).
The
exposure
information
will
also
be
used
to
evaluate
which
chemicals
warrant
the
development
of
toxicity
information
through
other
EPA
programs.
Page
17
of
159
Comment
A.
2­
4:
One
commenter
stated
that
EPA
would
collect
massive
amounts
of
exposure
data
each
reporting
cycle
under
IURA.
Furthermore,
the
commenter
stated
that
by
the
time
the
Agency
were
to
complete
its
preliminary
risk
analyses
based
on
the
massive
volume
of
data
it
collects,
many
of
the
chemicals
on
which
data
were
collected
that
were
formerly
produced
at
high
volumes,
would
no
longer
be
produced
at
high
volumes­
meaning
that
they
would
be
lower
risk
chemicals.
The
commenter
believes
this
results
from
the
inherent
variability
of
chemical
production
volumes
from
year
to
year,
coupled
with
the
length
of
time
that
would
be
needed
to
review
the
large
amount
of
data
that
would
be
generated
every
four
years
under
the
proposed
IURA.

Source:
C1­
024
Response
A.
2­
4:
The
variability
of
the
chemical
industry
­
the
fact
that
production
volumes
can
vary
significantly
from
year
to
year
and
that
chemicals
go
in
and
out
of
production
and
markets
­
is
a
compelling
fact
supporting
the
collection
of
IURA
information.
EPA's
experience
with
past
IUR
reporting
demonstrates
that
there
is
a
30%
change
in
the
chemicals
reporting
from
one
reporting
period
to
the
next.
The
Agency
considered
collecting
this
information
every
two
years,
with
the
expectation
that
more
frequent
collection
of
information
would
allow
earlier
identification
of
potential
exposure
concerns
and
significant
trends
in
the
chemical
industry.
However,
EPA
recognizes
the
need
to
keep
within
the
spirit
of
the
PRA
and
to
keep
the
public
reporting
burden
as
minimal
as
possible.
While
the
final
rule
indicates
that
subsequent
reporting
years
and
submission
periods
will
occur
every
four
years,
in
a
separate
action
following
the
final
rule,
EPA
intends
to
change
the
reporting
frequency
after
the
first
reporting
year
under
IURA
(
i.
e.,
2005,
with
submission
to
EPA
in
2006)
from
every
four
years
to
every
five
years.
This
will
be
accompanied
by
a
change
to
the
recordkeeping
requirement,

extending
the
record
retention
period
to
six
years.

As
described
in
the
response
to
comment
A.
2­
1,
the
data
collection
is
designed
to
facilitate
efficient
data
management
and
use,
allowing
EPA
to
fully
utilize
the
IURA
data.

3.
Other
Sources
of
Data
and
Methods
of
Collecting
Data
Comment
A.
3­
1:
Commenters
suggested
using
PAIR
to
collect
chemical­
specific
data
instead
of
amending
the
IUR.
A
commenter
stated
that
EPA
developed
PAIR
for
the
purpose
of
obtaining
exposure
information
on
chemicals
of
concern
to
the
Agency
(
4A
See
47
Fed.
Reg.
Page
18
of
159
26992
(
June
22,
1982)).
This
commenter
felt
that
the
PAIR
rule
is
a
more
rational
tool
to
use
because
it
was
promulgated
for
the
specific
purpose
of
gathering
exposure
information
on
defined
groups
of
chemicals,
whereas
the
IUR
was
promulgated
for
the
purpose
of
gathering
production
information
on
virtually
all
chemicals
listed
on
the
TSCA
Inventory.
Another
commenter
stated
that
EPA
could
use
PAIR
to
collect
information
on
a
chemical
when
"
there
is
concern
that
a
particular
chemical's
exposure
or
use
profile
may
have
changed
in
a
manner
that
has
risk
implications,
and
where
EPA
is
prepared
to
review
the
risk
of
that
chemical."
This
commenter
stated
that
PAIR
could
be
revised
to
collect
the
use
information
by
consumer
groups
and
NAICS
codes,
which
are
currently
not
part
of
the
PAIR
form.
EPA
could
also
modify
the
PAIR
rule
to
require
periodic
reporting.

Source:
C1­
016,
C1­
024,
C1­
055,
C1­
068
Response
A.
3­
1:
EPA
believes
it
is
more
appropriate
to
amend
the
IUR
than
PAIR
for
purposes
of
collecting
basic
exposure
information
on
the
portion
of
the
TSCA
Inventory
covered
by
IURA
reporting.

IUR
was
not
promulgated
for
the
purpose
of
gathering
production
information
on
virtually
all
of
the
chemicals
listed
on
the
TSCA
Inventory.
The
current
IUR
collects
information
on
approximately
9,000
chemicals
out
of
the
more
than
76,000
chemicals
listed
on
the
TSCA
Inventory
B
approximately
12%
of
the
TSCA
Inventory.
Additionally,
as
further
explained
in
preamble
to
the
final
rule
(
Unit
II.
B.),
the
Agency
is
well
within
its
authority
to
collect
exposurerelated
information
using
the
IUR.

Information
collected
through
IURA
is
designed
to
feed
directly
into
a
database,
allowing
users
of
the
information
to
readily
search
that
data,
as
described
in
the
response
to
comment
A.
2­

1.
PAIR
information
is
not
provided
in
a
manner
which
can
readily
feed
into
an
easily
searchable
database.
The
Agency
needs
this
exposure
information
in
a
database,
enabling
the
information
to
be
used
in
a
wide
variety
of
applications
for
a
wide
variety
of
uses.
Selective
use
of
PAIR,
as
the
commenters
suggest,
would
not
address
the
lack
of
exposure
information
EPA
currently
faces.

Using
only
PAIR
implies
that
EPA
should
continue
to
set
risk
screening
priorities
based
on
hazard
and
production
volume
alone.
As
discussed
in
the
document
titled
"
A
Review
of
Existing
Exposure­
Related
Data
Sources
and
Approaches
to
Screening
Chemicals:
A
Response
To
CMA,"

this
approach
greatly
hinders
EPA's
ability
to
make
effective
and
efficient
risk
management
decisions.
Page
19
of
159
Comment
A.
3­
2:
Many
commenters
stated
that
EPA
has
not
made
effective
use
of
the
use
and
exposure
data
it
has
already
collected
under
existing
or
former
rules.
For
example,
they
stated
that
data
collected
under
two
other
TSCA
rules
C
the
PAIR
and
the
Comprehensive
Assessment
Information
Rule
(
CAIR)
rules
C
have
not
been
effectively
used
to
support
Agency
risk
assessment
or
risk
management
decisions.
They
went
on
further
to
say
that
under
the
voluntary
Use
and
Exposure
Information
Project
(
UEIP),
EPA
was
furnished
exposure­
related
data
on
60
HPV
chemicals,
but
only
two
made
it
into
the
RM­
1
process.
Commenters
also
stated
that
EPA
should
rely
on
data
in
sources
that
are
already
existing,
such
as
those
described
in
CMA's
(
now
ACC)
document
"
U.
S.
Chemical
Production,
Use
and
Exposure
Data;
A
Study
of
Existing
Information
Sources"
(
August
1,
1997).
Specifically,
commenters
mentioned
sources
such
as
the
Use
Cluster
Scoring
System
(
UCSS),
the
Toxics
Release
Inventory
(
TRI),
the
Biennial
Reporting
System
(
BRS),
the
Screening
Information
Data
Set
(
SIDS),
Material
Safety
Data
Sheets
(
MSDS),
and
information
in
EPA's
own
library
system
and
the
public
library
system.

Source:
C1­
007,
C1­
009,
C1­
010,
C1­
011,
C1­
014,
C1­
016,
C1­
017,
C1­
018,
C1­
019,

C1­
021,
C1­
023,
C1­
024,
C1­
027,
C1­
031,
C1­
032,
C1­
033,
C1­
035,
C1­
037,
C1­
038,

C1­
041,
C1­
042,
C1­
044,
C1­
046,
C1­
048,
C1­
055,
C1­
060,
C1­
065,
C1­
071,
C1­
073
Response
A.
3­
2:
The
Agency
and
others
have
used
data
collected
under
existing
or
former
rules
or
though
voluntary
programs.
For
instance,
data
previously
collected
have
been
used
to
screen
chemicals
to
determine
if
further
assessment
or
actions
is
needed.
PAIR
data
have
been
used
to
inform
Agency
test
rule
development
and
to
inform
Interagency
Testing
Committee
(
TSCA
sec.
4(
e))
recommendations.
CAIR
data
were
collected
over
15
years
ago;
as
the
CAIR
rule
was
revoked,
it
can
no
longer
be
used
to
collect
current
exposure­
related
data;
it
is
important
to
have
current
exposure­
related
data
since,
unlike
hazard
data,
exposure­
related
data
changes
over
time.
Data
collected
through
the
UEIP
have
been
summarized
in
either
an
exposure
profile
report
or
a
data
summary
report,
depending
on
the
amount
of
data
EPA
received.
The
reports
are
being
used
to
prepare
preliminary
risk
assessments,
or
risk
management
level
1
(
RM1)
reports
and,
through
OECD
efforts,
to
prepare
SIDS
Initial
Assessment
Reports,
or
SIARs.
The
SIARs
are
then
used
to
reach
risk
management
decisions
concerning
each
chemical.

The
alternate
data
sources
commenters
described
were
sources
that
EPA
had
already
evaluated
in
its
analysis
for
the
proposed
rule.
EPA
explored
a
wide
variety
of
public
data
sources,
as
demonstrated
by:
"
Inventory
Update
Rule
(
IUR)
Amendments
Technical
Support
Page
20
of
159
Document:
Exposure­
Related
Data
Useful
for
Chemical
Risk
Screening,"
"
Economic
Analysis
of
Proposed
Amendments
to
the
TSCA
Section
8
Inventory
Update
Rule,"
and
"
A
Review
of
Existing
Exposure­
Related
Data
Sources
and
Approaches
to
Screening
Chemicals:
A
Response
to
CMA"
(
Refs.
14,
16,
and
17).
Commenters
did
not
provide
EPA
with
new
or
additional
support
for
these
alternate
data
sources.
The
Agency's
support
documents
confirm
that
these
alternate
data
sources
do
not
provide
adequate
information
to
meet
the
needs
EPA
envisions
the
IURA
information
will
satisfy.

EPA
spent
considerable
effort
and
resources
evaluating
other
data
sources
that
could
potentially
provide
the
accurate
and
up­
to­
date
information
that
the
Agency
needs
to
meet
its
mandate
of
protecting
human
health
and
the
environment.
A
primary
consideration,
as
mandated
by
TSCA,
was
to
avoid
unnecessary
or
duplicative
reporting.
As
summarized
in
the
proposal,
the
exposure
information
sought
using
the
IURA
is
not
currently
available.
Although
some
useful
exposure­
related
data
exist
in
several
sources,
the
data
are
outdated,
lack
detail,
do
not
cover
the
scope
of
chemicals
that
will
be
covered
under
IURA,
or
do
not
cover
the
data
elements
that
will
be
covered
under
IURA.
As
a
result,
EPA
remains
unable
to
efficiently
screen
potential
risks
posed
by
the
large
number
of
chemicals
on
the
TSCA
Inventory.
In
addition,
EPA
may
at
times
identify?
potential
new
hazards
that
must
be
considered
such
as
endocrine
disruption
and
hazards
related
to
children's
health.
It
is
important
to
link
these
new
hazards
with
potential
for
exposure.

Although
exposure­
related
information
has
been
collected
under
certain
regulatory
and
voluntary
programs
in
the
past,
there
is
a
need
for
current
exposure­
related
information
on
a
relatively
broad­
based
set
of
chemicals.
Additionally,
EPA
plans
to
continue
using
existing
data
sources
and
information
sets.
However,
the
existing
sources
are
best
used
for
conducting
assessments
of
specific
chemicals
of
concern,
depending
upon
the
data
actually
available.
Data
from
public
sources
is
not
sufficient
for
the
preliminary
risk
screening
of
a
large
set
of
chemicals.

The
IURA
submissions
will
provide
an
extensive
set
of
exposure
data
that
will
allow
EPA
to
better
identify
on
a
relative
basis
the
chemicals
of
highest
priority
for
further
risk
evaluation.
EPA
will
use
the
IURA
data,
as
described
in
the
response
to
comments
A.
1­
1
and
A.
1­
2,
to
identify
those
specific
chemicals
which
are
of
potential
concern
and
need
follow
up
assessment.
For
instance,
the
IURA
exposure
data
coupled
with
the
HPV
Challenge
Program
screening­
level
hazard
data
will
provide
the
input
needed
to
effectively
develop
program
priorities
for
follow
up
assessment
of
chemicals
in
the
HPV
Challenge
Program.
Once
EPA
has
determined
that
a
specific
chemical
(
or
group
of
chemicals)
has
sufficient
potential
for
exposure
to
warrant
further
assessment,
the
Agency
will
utilize
the
other
information
sources
and
data
gathering
tools
as
appropriate.
Page
21
of
159
Comment
A.
3­
3:
One
commenter
stated
that,
while
EPA
has
developed
exposure
profiles
from
information
collected
through
PAIR
and
CAIR
data,
the
voluntary
industry
effort
to
provide
data
under
the
UEIP,
and
data
available
under
the
OECD
SIDS
program,
the
Agency
has
chosen
not
to
make
use
of
the
information.
The
exposure
profiles
are
not
likely
to
have
changed
significantly
since
the
information
was
first
provided,
and
an
"
update"
of
this
information
through
the
IUR
is
not
an
effective
use
of
either
the
industry's
or
EPA's
resources.
Additionally,
EPA
could
amend
CAIR,
as
planned
when
the
Agency
revoked
it
in
1995.

Source:
C1­
016,
C1­
033
Response
A.
3­
3:
EPA
has
made
use
of
the
data
collected
through
the
various
sources
listed
by
the
commenters,
as
described
in
response
A.
3­
2
above.
EPA
plans
to
continue
using
existing
data
sources
and
information
sets.
However,
the
existing
sources
are
best
used
when
one
is
assessing
specific
chemicals
due
to
the
type
of
information
available
and
the
format
of
the
information.
For
instance,
a
source
might
have
somewhat
detailed
information
on
a
specific
chemical,
and
enclose
that
information
in
paragraph
format.
In
contrast,
the
IURA
information
will
be
in
a
readily
searchable
database,
from
which
information
can
be
searched
based
on
specific
criteria
and
the
results
downloaded
into
various
models.
EPA
will
use
the
IURA
data
to
identify
those
specific
chemicals.
Once
EPA
has
determined
that
a
specific
chemical
(
or
group
of
chemicals)
has
sufficient
potential
for
exposure
or
risk
to
warrant
further
assessment,
EPA
will
utilize
the
other
information
sources
and
data
gathering
tools
on
an
as
needed
basis.

EPA
has
used
the
information
on
occupational
exposure
submitted
in
response
to
previous
rules.
Under
the
voluntary
UEIP,
data
were
submitted
on
only
48
of
the
60
chemicals
for
which
information
was
solicited.
The
data
submitted
on
13
of
the
UEIP
chemicals
were
insufficient
to
prepare
data
summaries;
the
Agency
summarized
this
information
for
future
reference.
For
the
35
chemicals
for
which
adequate
information
was
received,
an
exposure
profile
or
a
data
summary
report
was
prepared.
The
exposure
profiles
have
been
used
to
prepare
preliminary
risk
assessments
for
six
chemicals;
an
additional
twelve
risk
assessment
reports
are
in
preparation.

The
preliminary
risk
assessments
have
been
used
to
support
risk
management
decisions
including
test
rules
and
product
restrictions.

UEIP
data
have
also
been
used
in
the
development
of
Screening
Information
Data
Set
(
SIDS)
reports
by
the
Organization
for
Economic
Cooperation
and
Development
(
OECD).
To
date,
OECD
has
prepared
Screening
Information
Assessment
Reports
(
SIARs)
for
111
chemicals.

For
those
chemicals
for
which
OECD
has
completed
the
SIDS,
the
Agency
will
use
the
SIDS
and
Page
22
of
159
the
SIAR
in
preparing
its
own
risk
assessment.

The
Agency
agrees
that
the
exposure
profile
for
a
chemical
may
not
change
if
the
processes
used
to
produce
the
chemical
and
the
uses
of
the
chemical
remain
the
same.
However,

over
time
new
uses
for
existing
chemicals
may
develop
and
the
quantity
directed
to
different
uses
may
change
over
time.
Because
new
uses
for
existing
chemicals
may
be
found
and
past
data
collection
efforts
such
as
the
UEIP
and
CAIR
have
not
provided
information
on
a
relatively
broad­
based
set
of
chemicals
existing
at
the
time
of
the
voluntary
program
or
rule,
a
new
effort
is
needed
to
assemble
this
information
in
a
format
readily
usable
by
EPA.
This
is
one
objective
of
the
IURA.

CAIR
is
not
a
suitable
substitute
for
the
IURA.
In
order
to
collect
information
through
CAIR,
a
regulation
which
has
been
revoked,
the
Agency
published
a
specific
list
of
chemicals
subject
to
the
rule.
To
use
CAIR,
EPA
needed
to
identify,
upfront,
the
specific
chemicals
of
current
interest
and
the
specific
data
elements
of
interest.
In
contrast,
the
IURA
data
collection
was
designed
to
allow
the
Agency
and
others
to
proactively
identify
chemicals
of
concern
by
providing
the
data
needed
to
complete
an
initial
screening
based
on
exposure
or,
with
the
addition
of
hazard
information,
on
risk.
Additionally,
past
IUR
data
demonstrates
that
the
chemical
industry
is
dynamic;
there
has
been
a
change
of
30%
in
the
chemicals
reported
from
one
reporting
period
to
the
next.

This
experience
with
past
IUR
data
also
demonstrates
that
exposure
scenarios
are
expected
to
change
over
time;
as
chemical
production
volumes
change,
it's
expected
that
uses
or
other
aspects
of
the
exposure
scenario
are
likely
to
change
as
well.

Comment
A.
3­
4:
Commenters
suggested
EPA
use
voluntary
methods
to
collect
the
exposure­
related
data
sought
by
the
IURA.
A
commenter
suggested
EPA
build
on
the
"
positive
experience
with
the
UEIP
program."
Another
commenter
suggested
using
voluntary
reporting
in
connection
with
the
ICCA­
HPV
program,
using
the
SIAR
format
to
collect
exposure
information.

Additionally,
commenters
suggested
using
other
voluntarily
provided
information,
such
as
that
to
be
provided
through
the
HPV
Challenge
Program
and
the
Voluntary
Children's
Chemical
Evaluation
Program
(
VCCEP).

Source:
C1­
017,
C1­
032,
C1­
033
Response
A.
3­
4:
EPA
considered
using
voluntary
reporting
as
a
way
to
collect
the
processing
and
use
information
that
will
be
collected
using
the
IURA,
but
determined
that
Page
23
of
159
voluntary
reporting
would
not
provide
information
sufficient
to
meet
the
needs
the
IURA
is
designed
to
satisfy.
As
described
in
Units
II.
E.,
III.
A.
1,
and
III.
A.
2.
a.
ii.
of
the
final
rule
preamble,

voluntary
programs
are
not
uniformly
reliable
for
collecting
data,
and
the
Agency
generally
cannot
ensure
that
data
submitted
under
voluntary
efforts
will
be
complete
and
accurate.
For
example,

the
UEIP
was
undertaken
by
EPA
in
partnership
with
industry
to
collect
relatively
detailed
information
on
60
high
production
volume
chemicals.
EPA
received
data
for
48
of
the
60
UEIP
chemicals.
Many
of
the
forms
received
for
those
48
chemicals
were
not
completely
filled
out,
and
only
a
subset
of
manufacturers
submitted
data.
Thus,
while
the
information
that
EPA
received
was
quite
useful,
it
was
insufficiently
complete
for
the
purposes
to
which
IURA
information
will
be
put.
Additionally,
as
described
in
the
response
to
comment
A.
1­
3,
the
Agency
designed
the
IURA
data
collection
to
meet
data
standards
needed
for
preliminary
screening
of
TSCA
Inventory
chemicals.
Based
in
part
upon
EPA's
experience
with
information
provided
through
the
UEIP,

the
limitations
of
the
data
available
from
past
and
current
information
collections
that
are
described
in
detail
in
the
IURA
proposal
(
64
FR
46772,
August
26,1999),
and
the
amount
of
time
it
would
otherwise
take
to
acquire
screening­
level
exposure
data
for
the
chemical
substances
on
the
TSCA
Inventory,
it
is
appropriate
to
develop
a
more
systematic
and
broadly
applied
approach
to
the
prioritization
process.
The
Agency
is
doing
this
by
requiring
that
certain
basic
exposure­
related
information
be
reported
under
this
amended
rule
instead
of
collecting
the
information
through
a
one­
time
voluntary
program.
EPA
plans
to
continue
using
voluntary
methods
to
collect
data
specific
to
certain
programs,
either
to
collect
information
on
chemicals
not
reporting
under
IURA
or
to
collect
more
detailed
information.

It
was
also
suggested
that
the
Agency
use
the
SIAR
format
to
collect
exposure
information
in
connection
with
voluntary
programs
(
e.
g.
via
ICCA­
HPV
Program).
As
stated
above,
EPA's
experience
with
voluntary
programs
(
e.
g.
UEIP)
will
not
be
sufficient
for
EPA's
purposes.
Furthermore,
EPA's
experience
with
the
OECD
SIDS
program
indicates
that
a
majority
of
SIARs
contain
very
limited
exposure
information
since
the
focus
is
on
hazard.
The
quality
of
information
also
varies
among
the
SIARs
since
submission
of
exposure
information
is
voluntary.
Some
contain
detailed
exposure
information
while
others
lack
many
of
the
data
elements
being
collected
under
IURA
such
as
maximum
concentration
and
number
of
workers
potentially
exposed.

The
Agency
recognizes
that
many
voluntary
and
regulatory
efforts
to
collect
health
and
environmental
hazard
data
are
underway,
and
that
a
premier
effort
is
the
HPV
Challenge
Program.
However,
the
scope
and
expected
output
from
the
HPV
Challenge
Program
markedly
differ
from
those
anticipated
under
IURA.
The
HPV
Challenge
Program
centers
on
providing
Page
24
of
159
hazard
data
for
a
limited
set
of
HPV
chemicals,
whereas
the
focus
of
IURA
is
on
gathering
exposure­
related
information
for
chemicals
in
a
wide
range
of
industrial,
commercial,
and
consumer
operations,
including
both
manufacturing
and
downstream
applications.
The
commenter
also
suggested
VCCEP
as
a
tool
to
collect
part
of
the
IURA
information.
As
with
the
HPV
Challenge
Program,
the
scope
and
expected
output
from
VCCEP
differ
from
those
anticipated
under
IURA,
and
any
exposure­
related
information
collected
through
VCCEP
will
focus
on
children's
exposures.
In
addition
to
the
other
concerns
mentioned
earlier
with
collected
IURA­
type
information
through
a
voluntary
program,
VCCEP
information
would
likely
be
too
narrow
to
meet
the
needs
of
the
IURA,
even
for
those
chemicals
included
in
the
VCCEP
pilot.

Comment
A.
3­
5:
Commenters
suggested
that
EPA
could
use
the
National
Institute
of
Occupational
Safety
and
Health
(
NIOSH)
as
a
source
for
exposure­
related
data.
Commenters
specifically
mentioned
NIOSH's
National
Occupational
Exposure
Survey
(
NOES)
and
stated
that
it
would
be
far
more
effective
and
less
burdensome
to
industry
to
update
this
survey
than
to
attempt
to
gather
the
information
on
IUR
forms.
One
commenter
stated
that
EPA
has
not
used
the
NOES
survey
data.
Another
commenter
stated
that
the
NOES
data
are
not
outdated
and
that
historical
data
can
be
used
to
identify
particular
chemicals
for
which
more
data
is
needed.
A
comment
from
NIOSH
stated
"
NIOSH
is
in
the
process
of
planning
another
hazard
survey
similar
to
the
National
Occupational
Hazard
Survey
(
NOHS)
and
the
NOES.
Enhancements
are
planned
in
the
next
survey,
including
expanding
the
scope
of
industries
and
hazards
to
be
surveyed.

NIOSH
views
the
data
collected
from
the
proposed
IUR
updated
rule
and
the
NIOSH
survey
data
as
complementary."

Source:
C1­
013,
C1­
040,
C1­
065
Response
A.
3­
5:
EPA
has
used
the
NOES
data
extensively
in
its
exposure
assessments
for
well
over
10
years.
For
each
existing
chemical
assessment,
whether
it
has
been
in
support
of
a
risk
management
level
1(
RM1)
decision,
test
rule,
Design
for
the
Environment`
s
Cleaner
Technologies
Substitute
Assessment,
or
other
type,
the
NOES
database
has
been
searched
for
that
existing
chemical,
and
when
data
are
present
in
the
NOES,
those
data
have
been
included
in
the
assessment.

As
described
in
the
proposed
rule
preamble
(
64
FR
46780,
August
26,1999),
NIOSH's
NOES
and
EPA's
IURA
data
collections
have
significantly
differing
scopes
and
approaches.
For
instance,
the
NOES
collection
focused
on
worker
issues,
whereas
IURA
includes
consumer
and
Page
25
of
159
commercial
information
as
well
as
manufacturing
and
industrial
processing.
The
NOES
collection
also
does
not
include
concentration
of
the
chemical
processing
and
use
information,
or
the
percent
production
volume
for
various
uses.
These
are
key
data
elements
for
determining
the
magnitude
of
potential
exposure.
Therefore,
EPA
collaboration
in
the
NOES
updating
process
cannot
fulfill
the
needs
EPA
intends
to
satisfy
via
IURA.
EPA
agrees
with
NIOSH
that
the
data
collected
by
the
IURA
and
the
new
NIOSH
are
complementary
rather
than
duplicative.

Although
a
valuable
data
source,
use
of
the
NIOSH
NOES
data
for
EPA's
purposes
has
become
increasing
difficult.
This
is
due
to
factors
such
as
the
age
of
data
(
the
survey
was
completed
in
1983
and
is
now
almost
20
years
old),
and
the
uncertainty
in
extrapolation
from
the
small
sample
of
facilities
surveyed
to
make
national
estimates
of
exposure.
While
NIOSH
is
developing
a
new
survey,
it
will
initially
focus
on
specific
industries
such
as
the
health
services
sector
and
on
certain
classes
of
chemical
agents,
such
as
antineoplastics
and
high
level
disinfectants.
NIOSH's
new
survey
will
probably
begin
in
2004
(
Ref
18).
As
with
NOES,
EPA
will
find
information
from
NIOSH's
new
survey
useful,
but
it
is
not
expected
to
serve
as
a
replacement
for
IURA.

Comment
A.
3­
6:
Several
commenters
thought
OSHA
should
be
responsible
for
collecting
exposure
information
rather
than
EPA.
One
commenter
stated
that
EPA
should
rely
on
existing
government
agencies
(
OSHA)
whose
experience
is
in
exposure
rather
than
develop
duplicative,

separate
and
possibly
inconsistent
or
misleading
databases.
Another
commenter
stated
OSHA
is
the
preeminent
federal
agency
with
the
responsibility
for
protecting
workers
and,
therefore,

OSHA's
chemical
exposure
standards
should
be
used
as
the
threshold
for
triggering
exposure
reporting
under
the
IUR.
In
addition,
some
commenters
noted
that
OSHA
and
other
agencies
have
their
own
authorities
to
use
as
appropriate.
Some
commenters
felt
that,
under
TSCA,
EPA
must
defer
to
other
statutes
that
address
the
same
concerns.

Source:
C1­
013,
C1­
015,
C1­
019,
C1­
020,
C1­
042
Response
A.
3­
6:
EPA
believes
that
the
data
collected
by
the
IURA
will
complement
data
collected
by
OSHA,
not
be
duplicative
of
OSHA's
data.
EPA,
OSHA,
and
other
Federal
Agencies
do
share
information,
and
information
collected
by
OSHA
was
considered
when
EPA
developed
the
IURA.
For
instance,
OSHA,
NIOSH,
and
EPA
meet
regularly
(
in
ONE
committee
meetings)
to
discuss
activities
of
mutual
interest;
the
IURA
was
discussed
during
these
meetings.

Additionally,
OSHA
provided
review
and
comment
as
the
rule
was
developed.
OSHA
submitted
Page
26
of
159
several
letters
in
support
of
the
IURA,
all
of
which
are
in
the
public
record
for
this
rulemaking.

OSHA's
authority
to
implement
the
general
duty
clause
and
to
develop
industry
standards
based
upon
substantial
evidence
of
hazard
to
employees
is
distinct
from
EPA's
authority
to
collect
information
under
TSCA.
The
authority
of
EPA
to
maintain
and
update
the
TSCA
inventory
of
chemical
substances
is
derived
from
sections
8(
a)
and
8(
b)
of
TSCA.
Section
8(
a)(
2)(
F)
of
TSCA
(
15
U.
S.
C.
2607(
a)(
2)(
F))
permits
EPA
to
require
maintenance
of
records
and
reporting
of
"
the
number
of
individuals
exposed,
and
reasonable
estimates
of
the
number
who
will
be
exposed,

to
such
substances
or
mixtures
in
their
places
of
employment
and
the
duration
of
such
exposures."

OSHA
has
traditionally
developed
rules
for
limiting
workplace
exposure
to
chemical
substances
one
chemical
at
a
time.
Updating
the
TSCA
inventory
of
over
76,000
chemicals
by
individual
rules
for
each
chemical
is
not
practical.

TSCA
embodies
the
policy
of
Congress
to
develop
adequate
data
on
the
effect
of
chemical
substances
and
mixtures
on
health
and
the
environment
(
TSCA
§
2).
TSCA
seeks
to
develop
information
through
test
rules
(
TSCA
§
4),
review
of
premanufacture
notification
requirements
for
new
chemicals
(
TSCA
§
5),
and
collection
and
compilation
of
information
on
chemical
substances
(
TSCA
§
8).
Although
other
statues
may
include
clauses
similar
to
the
authority
given
to
EPA
to
regulate
chemicals
under
TSCA,
this
does
not
preclude
EPA
from
exercising
its
full
authority
under
TSCA.
For
example,
the
objectives
of
TSCA
and
the
OSH
Act
are
complimentary
in
protecting
worker
health,
but
the
authority
under
TSCA
is
much
broader
in
allowing
EPA
to
collect
and
utilize
information
about
chemical
hazards
to
protect
not
only
employees
but
also
public
health
and
the
environment.

TSCA
does
not
limit
use
of
data
collected
under
the
statute
to
EPA.
EPA
believes
Congress
drafted
TSCA
in
part
to
provide
basic
health
and
safety
information
to
other
federal
agencies,
as
well
as
state,
local
and
international
governments.
TSCA
provides
several
mechanisms,
TSCA
§
§
9,
10
and
12
for
example,
for
sharing
health
and
safety
data
among
various
levels
of
government.
These
sections
again
demonstrate
TSCA's
role
as
a
tool
for
gathering
and
disseminating
information
regarding
chemical
risk.

TSCA
section
8(
a)(
1)
authorizes
the
EPA
to
promulgate
rules
under
which
manufacturers
and
importers
of
chemical
substances
must
maintain
such
records
and
submit
such
information
as
the
Agency
may
reasonably
require.
Under
TSCA
section
8(
a),
the
Agency
may
collect
information
to
the
extent
that
it
is
known
to,
or
reasonably
ascertainable
by,
the
submitter,
on
the
manufacture
(
including
import)
and
processing
of
chemical
substances.
This
section
gives
EPA
broad
discretion
in
determining
the
information
for
which
reporting
can
be
required.
Some
of
the
types
of
information
which
can
be
required
under
TSCA
section
8(
a)(
2)
include:
categories
of
use
Page
27
of
159
for
each
chemical
substance,
estimates
of
the
amount
manufactured
or
processed
for
each
category
of
use,
a
description
of
the
byproducts
resulting
from
the
manufacture,
processing,
use,

or
disposal
of
each
chemical
substance,
an
estimate
of
the
number
of
individuals
exposed
in
their
places
of
employment,
and
the
duration
of
such
exposure.

OSHA
has
established
regulations
for
protection
of
employees
in
the
workplace
from
respiratory
contaminants
for
which
a
OSHA
Permissible
Exposure
Limit
(
PEL)
has
been
promulgated
(
29CFR
1910.134).
OSHA
PELs
exist
for
only
a
few
thousand
chemical
substances;

the
majority
of
the
over
76,000
chemicals
on
the
TSCA
inventory
subject
to
the
IURA
are
not
regulated
by
the
respiratory
protection
standard
and,
without
the
IURA,
potential
exposure
to
these
chemicals
would
never
be
reported.
In
addition,
the
OSHA
respiratory
protection
standard
pertains
only
to
respiratory
hazards;
relying
on
this
standard
to
trigger
reporting
would
miss
chemical
substances
which
are
hazardous
if
ingested,
deposited
on
the
skin,
or
which
enter
the
body
through
the
eye.

Comment
A.
3­
7:
The
Chemical
Manufacturers
Association
(
CMA)
(
now
the
American
Chemical
Society)
completed
a
pilot
study
to
assess
publicly
available
exposure
information
for
five
chemicals.
CMA
chose
these
five
chemicals
because
they
are
in
the
SIDS
program,
are
considered
HPVs,
and
fit
the
objectives
of
ongoing
assessment
programs.
CMA's
data
search
methodology
revealed
that
use
and
exposure
information
do
not
generally
appear
in
the
same
data
sources.
From
their
study,
CMA
concluded
that
data
sufficient
to
conduct
a
risk
screen
are
available.
Additionally,
CMA
believes
that
the
available
data
are
more
extensive
than
that
required
under
the
IURA.

Source:
C1­
018,
C1­
033,
C1­
055
Response
A.
3­
7:
CMA
attempted
to
demonstrate
the
usefulness
of
the
existing
data
sources
through
its
study
of
five
chemicals.
However,
CMA
did
not
demonstrate
that
these
data
sources
could
satisfy
the
needs
the
IURA
is
designed
to
address,
as
described
in
the
responses
to
comments
A.
1­
1,
A.
1­
2,
and
A.
1­
3.
In
fact,
the
CMA
study
highlighted
the
insufficiency
of
existing
use
and
exposure
information
as
it
relates
to
the
data
to
be
collected
through
IURA,

which
seeks
to
collect
use
and
exposure
data
elements
along
with
identifiers
(
NAICS,
code,

Industrial
Function
Code,
etc.)
that
will
allow
the
Agency
to
compile
and
analyze
the
data
in
a
way
that
is
both
efficient
and
useful
for
risk
screening,
as
well
as
for
other
purposes.
Collecting
and
assembling
use
and
exposure
data
in
a
way
that
the
CMA
study
suggests
would
create
an
Page
28
of
159
extremely
uneven
database
of
information
from
various
sources
with
varying
degrees
of
data
elements,
quality,
and
age.
In
contrast,
IURA
information
will
be
used
to
create
a
shallow
pool
of
data
for
a
broad
set
of
chemicals;
the
data
will
cover
a
similar
time
period,
will
be
collected
under
similar
circumstances,
and
will
be
in
a
format
readily
applicable
to
a
database.
CMA
seems
to
suggest
that
the
data
available
for
five
selectively
determined
chemicals
is
indicative
of
the
availability
of
use
and
exposure
data
for
a
majority
of
the
IURA
chemical
substances.
EPA
disagrees
with
this
suggestion,
as
demonstrated
in
"
U.
S.
Chemical
Production,
Use,
and
Exposure
Data:
A
Study
of
Existing
Information
Sources."
(
Ref
19).
Rather,
CMA
demonstrated
that
certain
data
did
exist
for
chemicals
that
are
currently
under
assessment.
EPA
does
not
dispute
this.
However,
EPA
finds
a
need
to
collect
IURA
information
on
these
and
other
chemicals
currently
under
assessment
in
order
to
track
future
potential
exposures,
changes
in
the
uses
and
production
of
these
chemicals,
and
to
maintain
an
updated
TSCA
Inventory.

Comment
A.
3­
8:
A
commenter
stated
that
sufficient
information
is
readily
available
under
the
data
submitted
through
the
TRI
reporting
requirements.
Another
commenter
stated
that
EPA
underestimated
the
amount
of
data
currently
being
reported
under
the
TRI,
pursuant
to
Section
313
of
the
Emergency
Planning/
Community
Right
to
Know
Act
(
EPCRA).
This
commenter
states
"
In
the
face
of
the
TRI
database
alone
­
over
32,000
reporting
facilities
filing
more
than
137,000
reports
annually,
with
5,100
more
facilities
and
15,000
more
reports
likely
to
be
added
in
the
next
year
­
it
is
difficult
to
understand
the
need
to
impose
additional,
sweeping
reporting
requirements
on
a
broad
swath
of
American
industry
that
is
already
subject
to
extensive
reporting
requirements."

Source:
C1­
014,
C1­
019
Response
A.
3­
8:
Sufficient
data
to
serve
the
purposes
of
IURA
data
is
not
available
through
TRI;
IURA
data
and
TRI
data
do
not
overlap.
TRI
reporting
serves
a
very
different
purpose
than
IURA
reporting.
TRI
does
not
collect
the
same
data
that
will
be
collected
under
IURA,
focusing
instead
on
release
data
from
manufacturers,
processors,
and
users
in
specific
industrial
sectors
manufacturing
or
using
any
of
approximately
600
chemicals.
In
contrast,
IURA
collects
very
different
information,
including
downstream
use
and
exposure
related
information
as
well
as
manufacturing
information
on
approximately
9,000
chemicals
from
the
over
76,000
listed
on
the
TSCA
Inventory.
IURA
data
will
allow
the
Agency
and
others
to
screen
for
potential
exposures
to
chemicals
from
sources
other
than
the
specific,
known
release
information
collected
Page
29
of
159
under
TRI.

4.
Rule
Development
Process
Comment
A.
4­
1:
It
appears
that
the
data
that
EPA
relied
upon
to
develop
this
rule
were
outdated.
Many
references
that
are
cited
in
the
references
for
the
technical
support
document
on
commercial
and
consumer
categories
are
approaching
20
years
old
and
include
outdated
use
scenarios.
In
addition,
EPA's
analysis
of
potential
industrial
function
categories
was
based
on
SIC
Codes
yet
EPA
is
requiring
reporting
under
the
more
appropriate
NAICS
codes
which
indicate
that
EPA
has
failed
to
update
it
own
analyses.

Source:
C1­
033,
C1­
073
Response
A.
4­
1:
During
the
development
of
this
rule,
EPA
used
the
best
technical
references
available
and
based
the
development
of
the
industrial
and
commercial/
consumer
function
categories
on
information
from
the
PMN
Program,
UCSS,
UEIP,
and
EU
programs,
as
well
as
other
data.
EPA
recognizes
that
use
scenarios
may
change
over
time.
In
the
preamble
to
the
IURA
proposal,
EPA
states
that
the
industrial
and
commercial/
consumer
function
categories
"
are
likely
to
be
revised
as
analysis
of
reported
IUR
data
is
further
refined
over
time"
(
64
FR
46771,
46790).

The
Standard
Industrial
Classification
(
SIC)
system
was
the
most
current
industrial
classification
source
during
the
development
of
this
rule.
Even
today,
information
is
still
collected
using
the
SIC
classification
system.
Tables
do
exist
to
crosslink
the
SIC
system
with
the
NAICS
system,
which
was
published
in
Spring
of
1998.
EPA
believes
the
results
for
the
function
categories
would
not
change
if
the
analysis
used
to
determine
those
categories
was
redone
using
the
NAICS
codes.
The
NAICS
is
based
on
many
of
the
old
SIC
industrial
sectors.
For
instance,

the
SIC
system
had
10
industrial
sectors
and
the
NAICS
expanded
those
industrial
sectors
into
20.
Careful
review
of
the
crosswalks
between
the
NAICS
and
SIC
systems
reveals
that
many
of
the
NAICS
industrial
sectors
contain
only
modest
changes
from
the
original
SIC
sector
(
e.
g.,

manufacturing
went
from
459
industries
under
SIC
to
474
industries
under
NAICS).
In
addition,

NAICS
has
strong
agreement
with
the
SIC
system
at
the
2
digit
level.
EPA
is
requiring
submitters
to
report
under
the
NAICS
because
it
reflects
the
current
universe
of
industries.

5.
Right­
to­
Know
Comments
Page
30
of
159
Comment
A.
5­
1:
Many
commenters
disagreed
with
EPA's
characterization
of
TSCA
as
a
right­
to­
know
statute,
stating
that
the
objective
of
the
IURA
"
to
provide
`
right­
to­
know'

information
to
non­
governmental
entities
and
private
organizations...
is
not
authorized
by
TSCA."

Some
commenters
felt
that
EPA
was
trying
to
unlawfully
shift
the
burden
by
using
TSCA
to
expand
TRI
reporting
requirements.

Source:
C1­
007,
C1­
011,
C1­
019,
C1­
032,
C1­
033,
C1­
038,
C1­
043,
C1­
055,
C1­
069,

C1­
073
Response
A.
5­
1:
TSCA
contains
many
of
the
principals
embodied
in
the
right
to
know
concept
and
does
authorize
the
Agency
to
provide
information
to
the
public.
TSCA
was
designed
in
part
to
address
the
lack
of
health
and
safety
information
government
agencies
and
the
public
faced
in
dealing
with
chemicals.
See,
H.
R.
Rep.
94­
1341
at
6
(
1976),
reprinted
in
Legislative
History
of
the
Toxic
Substances
Control
Act,
at
414
(
1976)
("
Present
authorities
for
protecting
against
and
regulating
hazardous
chemicals
are
fragmented
and
inadequate
.
.
.
Most
significant
among
the
deficiencies
are
.
.
.
(
3)
No
authority
exists
for
collection
of
data
to
determine
the
totality
of
human
and
environmental
exposure
to
chemicals.").
TSCA
was
seen
as
a
way
of
providing
agencies
and
the
public
with
better
health
and
safety
data
so
that
the
risks
of
chemical
substances
could
be
more
fully
evaluated
and
understood.
See,
Statement
of
Sen.
Hartke,
Cong.

Rec.,
March
26,
1976
[
S4397­
4432],
reprinted
in
Legislative
History
of
the
Toxic
Substances
Control
Act,
at
218
(
1976)
("[
T]
he
essential
element
of
this
legislation
is
that
it
has
attempted
to
provide
for
the
individual­
not
only
who
works,
but
for
the
rest
of
American
society­
the
right
to
know
what
is
in
store
as
far
as
the
toxicity
of
the
chemicals
is
concerned."
Thus,
Congress
clearly
envisioned
TSCA
as
a
method
of
providing
the
public
and
others
with
health
and
safety
information
about
chemical
substances.

In
addition,
TSCA
authorizes
EPA
in
a
number
of
sections
to
disclose
health
and
safety
data
to
the
public.
For
example,
TSCA
§
14(
b)
specifically
authorizes
EPA
to
disclose
health
and
safety
data
collected
under
the
statute,
including
data
collected
under
TSCA
§
8.
TSCA
§
14
embodies
the
legislative
determination
that
health
and
safety
data
collected
under
TSCA
should
be
available
to
the
public
and
interested
parties.
In
addition,
each
of
the
chemical
management
sections
of
TSCA,
§
§
4,
5,
6
and
21,
for
example,
provide
opportunities
for
public
participation
in
chemical
management
decisions.
Participation
must
be
meaningful,
and
to
be
meaningful
the
public
must
have
access
to
TSCA
non­
confidential
information.

The
IURA
is
not
associated
with
TRI
(
Toxics
Release
Inventory)
reporting
under
the
Page
31
of
159
Emergency
Planning
and
Community
Right­
to­
Know
Act,
42
U.
S.
C.
secs.
11001­
11050.
EPA
has
considered
expanding
TRI
reporting
to
include
materials
accounting
information
and
did
publish
an
advanced
notice
of
proposed
rulemaking
(
61
FR
51321
published
on
10/
01/
96).
For
additional
information
on
this
topic,
please
see
the
EPA's
website,
currently
http://
www.
epa.
gov/
triinter/
program.
htm.
TRI
data
serve
a
very
different
purpose
than
the
proposed
IUR
data.
TRI
data
are
useful
for
site­
specific
assessments
of
potential
general
population
or
environmental
exposures
to
populations
near
facilities
that
manufacture,
process
or
use
EPCRA
section
313
listed
toxic
chemicals.
However,
the
TRI
universe
of
chemicals
is
limited
to
a
small
portion
of
the
chemicals
on
the
TSCA
Inventory.

6.
Industrial
Espionage
and
Terrorism
Comment
A.
6­
1:
President
Clinton
acknowledged
in
his
1995
Annual
Report
to
Congress
on
Foreign
Economic
Collection
and
Industrial
Espionage
that
many
competitors
"
take
advantage
of
the
vast
amount
of
competitive
information
that
is
legally
and
openly
available
in
the
United
States."
The
1996
Annual
Report
to
Congress
on
Foreign
Economic
Collection
and
Espionage
further
substantiates
that
foreign
economic
espionage
is
increasing
at
a
significant
rate.
In
addition
to
using
illegal
means
of
organizing
confidential
business
information,
foreign
companies
are
apt
to
"
use
accessible
databases
and
information
systems,
including
the
Internet,
to
identify
and
target
information."
That
industrial
espionage
presents
a
viable
threat
to
the
vitality
of
U.
S.

business
concerns
is
further
demonstrated
by
the
Economic
Espionage
Act
of
1996,
which
is
designed
to
protect
against
the
theft
and
misuse
of
proprietary
business
information.
The
expanded
list
of
information
sought
by
the
EPA
under
the
proposed
amendment
poses
a
potential
threat
to
the
economic
health
of
the
nation.
In
addition,
Federal
intelligence
agencies
believe
that
EPA's
expansive
collection
of
data
gives
too
much
information
about
industrial
chemicals
to
militia
groups
and
would­
be
terrorists.
Inside
EPA
(
December
6,
1996).

Source:
C1­
019
Response
A­
6.1:
The
commenter
is
correct
that
the1995
Annual
Report
to
Congress
on
Foreign
Economic
Collection
and
Espionage
indicates
that
competitors
take
advantage
of
openly
available
information.
However,
the
quote
that
the
commenter
has
used
fails
to
put
the
issue
in
context.
The
report
describes
many
methods
used
to
conduct
industrial
espionage,
including
classic
agent
recruitment;
US
volunteers;
surveillance
and
surreptitious
entry;
specialized
technical
Page
32
of
159
operations;
tasking
foreign
students
studying
in
the
United
States;
tasking
foreign
employees
of
US
firms
and
agencies;
debriefing
of
foreign
visitors
to
the
United
States;
recruitment
of
emigres;

elicitation
during
international
conferences
and
trade
fairs;
open­
source
information;
use
of
private­
sector
organizations,
front
companies,
and
joint
ventures;
corporate
mergers
and
acquisitions;
headhunting
and
hiring
competitor's
employees;
corporate
technology
agreements;

sponsorship
of
research
activities
in
the
United
States;
hiring
information
brokers
and
consultants;

fulfillment
of
classified
U.
S.
government
contracts
and
exploitation
of
DOD­
sponsored
technology
sharing
agreements;
and
tasking
liaison
officers
at
government­
to­
government
projects.
Within
the
open­
source
data
such
as
the
Internet
that
the
commenter
mentions,
the
report
also
lists
commercial
databases,
trade
and
scientific
journals,
computer
bulletin
boards,
and
corporate
publications,
as
well
as
openly
available
U.
S.
government
data.

The
industrial
espionage
risk
to
companies
is
largely
internal.
As
the
1995
Annual
Report
to
Congress
on
Foreign
Economic
Collection
and
Espionage
points
out,
"
The
individuals
most
likely
to
improperly
acquire
a
company's
information
are
the
company's
own
employees".
And
as
the
1996
Annual
Report
to
Congress
on
Foreign
Economic
Collection
and
Espionage
noted,
"
74
percent
of
intellectual
or
proprietary
losses
stemmed
from
actions
of
"
trusted
relationships"
­

employees,
former
employees,
contractors,
suppliers,
and
so
forth".
According
to
a
Department
of
Justice
web
site
(
www.
cybercrime.
gov/
eeapub.
htm),
most
of
the
cases
prosecuted
under
the
Economic
Espionage
Act
of
1996
have
been
against
current
or
former
employees
of
companies
who
stole
information
from
their
employer.

Despite
the
intelligence
risks,
companies
and
their
employees
will
continue
to
participate
in
activities
such
as
conferences,
trade
and
scientific
journals,
and
corporate
publications
because
of
the
benefits
that
these
activities
generate,
although
they
should
take
precautions.
Similarly,
the
government
will
continue
to
collect
information
because
of
the
benefits
that
result.
In
the
case
of
the
IURA,
EPA
needs
this
information
to
carry
out
initial
chemical
screening.
In
order
to
safeguard
the
information,
EPA
has
provided
ample
protection
against
industrial
espionage
through
the
CBI
provisions
of
the
rule.

The
commenter
is
correct
that
the
Economic
Espionage
Act
of
1996
(
EEA)
is
designed
to
protect
against
the
theft
of
trade
secrets.
The
reporting
of
IURA
information
to
EPA
clearly
does
not
constitute
a
violation
of
the
EEA.
This
is
highlighted
by
section
1833
of
the
Act,
which
states
that
it
does
not
prohibit
"
any
otherwise
lawful
activity
conducted
by
a
governmental
entity
of
the
United
States,
a
State,
or
a
political
subdivision
of
a
State".

While
it
is
true
that
before
the
enactment
of
the
EEA
there
were
not
federal
statutes
specifically
targeted
towards
prosecuting
the
theft
of
trade
secrets,
this
does
not
mean
that
the
Page
33
of
159
federal
government
did
not
understand
or
appreciate
the
importance
of
trade
secret
information.

The
mechanisms
that
EPA
has
established
for
the
protection
of
TSCA
CBI
far
predate
the
passage
of
the
EEA.
EPA
has
and
will
continue
to
protect
information
that
is
legitimately
claimed
as
TSCA
CBI.

The
commenter
has
provided
no
information
to
justify
its
claim
that
the
information
to
be
collected
under
the
IURA
poses
a
potential
threat
to
the
economic
health
of
the
nation.
EPA
has
carefully
established
mechanisms
for
the
protection
of
TSCA
CBI,
including
any
such
information
collected
under
the
IURA,
and
companies
should
follow
these
procedures
if
they
have
legitimate
CBI
claims.
Therefore,
EPA
disagrees
that
the
additional
information
being
collected
under
the
IURA
poses
a
threat
to
the
economic
health
of
the
nation.

EPA
disagrees
with
the
commenter's
suggestion
that
the
IURA
will
give
too
much
information
to
militia
groups
and
would­
be
terrorists.
The
December
6
Inside
EPA
article
that
the
commenter
cites
as
proof
is
not
about
the
IURA
and
is
not
accurate
in
any
event.
The
article
related
to
EPA's
announcement
in
1996
that
it
was
considering
collecting
materials
accounting
data
as
part
of
the
Toxics
Release
Inventory
(
TRI)
program
under
section
313
of
the
Emergency
Planning
&
Community
Right­
to­
Know
Act
(
EPCRA).
According
to
the
article,
industry
sources
claimed
that
EPA's
plan
"
could
lead
to
an
unprecedented
amount
of
information
on
the
Internet
detailing
when
and
how
chemicals
will
move
through
communities,
and
when
and
how
they
will
be
entering
and
exiting
facilities."
This
suggests
that
EPA
planned
to
provide
information
on
the
routes,
dates,
and
methods
of
shipment
for
chemicals
entering
and
exiting
facilities
as
part
of
the
TRI
program,
which
is
not
correct.
EPA
had
suggested
collecting
a
generalized
group
of
materials
accounting
data
elements,
with
the
data
aggregated
over
a
one­
year
time
period
and
not
related
to
particular
shipments.

The
comment
is
not
germane
to
the
IURA
rulemaking
because
there
are
a
number
of
differences
between
the
materials
accounting
data
that
EPA
was
discussing
under
the
TRI
program
and
the
information
that
it
is
collecting
under
IURA.
For
example,
the
CBI
provisions
under
TSCA
are
substantially
different
than
the
trade
secret
provisions
under
EPCRA.
The
materials
accounting
data
elements
suggested
for
TRI
were
different
than
the
new
data
elements
being
added
by
IURA.
And
TRI
applies
to
facilities
manufacturing
(
including
importing),

processing,
or
otherwise
using
a
substance,
while
IURA
only
applies
to
manufacturers
and
importers.

In
addition,
EPA
also
disagrees
with
the
comment
because
the
commenter
has
mischaracterized
the
Inside
EPA
article
it
cites.
The
commenter
claims
that
the
article
indicates
that
"
Federal
intelligence
agencies
believe
that
EPA's
expansive
collection
of
data
gives
too
much
Page
34
of
159
information
about
industrial
chemicals
to
militia
groups
and
would­
be
terrorists,"
but
the
article
makes
no
such
statement.
The
article
states
that
according
to
"
industry
sources"
(
which
are
not
named),
members
of
the
regulated
community
met
with
representatives
of
intelligence
communities,
including
the
Federal
Bureau
of
Investigation
and
the
Central
Intelligence
Agency,

to
discuss
industry's
concerns
with
collecting
materials
accounting
data
under
TRI.
The
article
does
not
state
that
any
representatives
of
these
federal
agencies
agreed
with
the
industry
claims
or
even
made
any
statements
about
the
intelligence
impacts
of
the
TRI
information.
Nor
does
the
article
state
that
these
federal
intelligence
agencies
developed
an
official
position
on
TRI
materials
accounting
data
or
any
other
EPA
data.
Inaccurate
claims
by
unnamed
"
industry
sources"
do
not
equate
to
conclusions
by
federal
intelligence
agencies
about
the
potential
impacts
of
TRI
data
or
any
other
information
the
Agency
might
collect.

Comment
A­
6.2:
The
commenter
states
that,
to
the
extent
that
EPA
is
intent
on
making
more
site­
specific
information
available
through
the
IUR
to
the
general
public,
there
are
significant
concerns
raised
by
the
industry,
Congress,
and
law
enforcement
experts
concerning
the
threat
of
terrorism
aimed
at
chemical
facilities.
The
commenter
encourages
EPA
to
carefully
evaluate
what
information
is
required
for
the
limited
purpose
of
risk
screening,
and
to
further
limit
Form
U
to
only
those
data
elements.

Source:
C1­
033
Response
A­
6.2:
The
Agency
is
quite
aware
of
homeland
security
concerns
and,
while
maintaining
such
information
in­
house,
will
not
be
releasing
information
to
the
public
that
EPA
considers
inappropriate.
EPA
has
carefully
evaluated
the
information
that
is
required
for
initial
chemical
screening
and
related
purposes,
and
limited
the
IURA
to
those
data
elements.
See
the
responses
to
comments
A.
1­
2
and
A.
1­
3
for
further
discussion
of
the
utility
of
IURA
information
and
the
consideration
given
to
the
choice
of
data
elements
during
the
development
of
the
IURA.

Comment
A­
6.3:
EPA
has
proposed
revisions
to
its
TSCA
Inventory
Rule
which
would,

inter
alia,
require
additional
disclosure
of
plant
site
identification
and
maximum
inventories
of
TSCA­
IUR
chemical
substances.
EPA
also
proposes
to
require
reporting
of
detailed
processing
and
use
information
by
companies
reporting
these
chemical
substances.
...
The
commenter
states
that
it
believes
that
disclosures
of
site
information
surrounding
the
use
of
its
facilities,
descriptions
of
explosives
contained
therein
and
other
locator
information
to
the
public
through
governmental
Page
35
of
159
submittals
would
represent
a
significant
security
risk
because
it
could
potentially
give
terrorist
and
others
with
criminal
intent
information
about
the
location
of
and
access
to
explosive
materials.

According
to
the
commenter,
this
has
national
security
complications.
The
commenter
states
that
it
actively
takes
measures
in
its
regulatory
submittals
to
exclude
or
restrict
such
details
so
as
to
avoid
divulging
explosives­
related
location
information,
and
that
it
often
works
with
regulatory
agencies
on
effective
alternatives
to
submittal
of
explosive
site
details
that
will
satisfy
the
agency's
need
for
review,
while
at
the
same
time
protect
sensitive
information.
This
has
included
options
such
as
making
the
information
available
for
on­
site
review,
redesigning
of
documents
such
as
site
maps
to
remove
explosives
locations
and
other
creative
solutions
to
prevent
such
information
from
reaching
the
public
domain.

Source:
C1­
004
Response
A­
6.3:
The
commenter
is
confused
about
the
information
that
EPA
will
be
collecting
under
the
IURA.
Neither
the
proposed
nor
the
final
IURA
require
companies
to
report
the
maximum
inventory
of
reportable
substances.
Furthermore,
IURA
does
not
collect
detailed
location
information
such
as
the
site
maps
that
the
commenter
mentions.
The
site
and
location
information
being
added
by
IURA
includes
the
county
a
plant
site
is
located
in,
and
the
mailing
address
of
the
plant
site
where
this
is
different
from
the
physical
address.
EPA
does
not
believe
the
this
information
represents
a
significant
security
risk.
Furthermore,
general
location
information
(
including
on
the
commenter's
facilities)
is
already
available
through
a
variety
of
sources
on
the
Internet.

The
IURA
adds
processing
and
use
information
to
the
current
IUR
data
collection.
EPA
does
not
believe
that
this
information
presents
an
undue
security
risk.
In
the
case
of
the
commenter,
the
company's
web
site
contains
detailed
information
on
the
explosive
characteristics
of
its
products.
By
contrast,
IURA
collects
information
on
potential
exposure
to
chemicals.

While
the
information
on
the
commenter's
web
site
is
different
from
the
processing
and
use
data
to
be
collected
under
IURA,
it
demonstrates
that
making
even
detailed
technical
information
about
explosive
products
readily
available
on
the
Internet
does
not
necessarily
create
an
unacceptable
risk.
EPA
remains
sensitive
to
security
concerns.
But
based
on
the
information
that
is
already
publicly
available
on
the
commenter's
web
site
and
through
other
sources,
EPA
does
not
believe
that
IURA
data
present
a
significant
security
risk
that
outweighs
its
utility
for
risk
screening.

The
IURA
has
been
structured
to
limit
the
data
collection
to
the
information
that
is
most
Page
36
of
159
critical
to
EPA.
This
may
serve
to
exclude
information
that
would
be
of
concern
to
the
commenter.
For
example,
IURA
raises
the
threshold
for
reporting
manufacturing
information
from
10,000
pounds
to
25,000
pounds
or
more
per
site,
which
limits
reporting
to
about
9,000
chemicals
out
of
the
76,000
on
the
TSCA
Inventory.
A
second
threshold
of
300,000
pounds
limits
processing
and
use
data
to
approximately
4,500
chemicals.
To
the
extent
that
the
commenter
is
manufacturing
mixtures,
it
should
note
that
a
person
who
creates
a
mixture
by
combining
existing
substances
without
a
chemical
reaction
is
not
a
manufacturer
of
those
substances
and
therefore
does
not
report
those
substances
under
IUR
or
IURA.
Also,
certain
firearms
and
ammunition
are
exempt
from
TSCA
regulation
under
TSCA
section
3(
2)(
B)(
v).

7.
Violating
Federal
Law
Comment
A.
7­
1:
Commenters
claimed
that
the
proposed
rule
did
not
satisfy
the
requirements
of
the
Paperwork
Reduction
Act
(
PRA).
Specifically,
commenter
0030
writes:

The
proposal
is
inconsistent
with
the
Paperwork
Reduction
Act.
Section
5(
a)(
1)
requires
EPA,
by
FY
2000,
to
have
reduced
paperwork
burdens
by
40
percent
over
FY
1995
levels.
EPA's
1995
baseline
was
around
100
million
burden
hours.
In
FY1998
EPA's
PRA
burden
was
actually
119
million
burden
hours,
and
in
FY
1999,
the
burden
increased
to
120
million
burden
hours.
The
1999
calculation
marks
a
20%
increase
in
paperwork
burden
from
the
1995
baseline.
SOCMA
is
concerned
that
the
proposed
IUR
rule
would
exacerbate
this
trend.

Source:
C1­
009,
C1­
016,
C1­
018,
C1­
024,
C1­
026,
C1­
032,
C1­
033,
C1­
038,
C1­
041,

C1­
043,
C1­
044,
C1­
048,
C1­
055,
C1­
060,
C1­
069
Response
A.
7­
1:
As
stated
by
the
Office
of
Management
Budget
(
OMB)
in
the
Fiscal
Year
2002
Information
Collection
Budget:
"
To
carry
out
its
responsibilities
carefully,
effectively,

fairly
and
efficiently,
the
Federal
Government
needs
access
to
information
B
lots
of
information."

(
To
access
OMB's
annual
ICB
reports
go
to
http://
www.
whitehouse.
gov/
omb/
inforeg/
infocoll.
html#
icbusg.)

The
Paperwork
Reduction
Act
(
PRA)(
44
USC
3501
et
seq.)
provides
a
framework
for
ensuring
that
all
of
the
Federal
Government's
information
collections
satisfy
a
programmatic
need,

that
the
information
has
practical
utility,
and
that
the
burden
on
the
public
of
these
activities
is
Page
37
of
159
curtailed.
To
fulfill
its
mission
of
protecting
human
health
and
the
environment,
the
Environmental
Protection
Agency
(
EPA)
relies
upon
reports,
recordkeeping,
and
third­
party
reporting
requirements
to
monitor
compliance
with
environmental
statutes
and
regulations.

The
PRA
(
44
USC
3505(
a)(
1)),
directs
the
Director
of
OMB
to
establish
annual
government
wide
paperwork
reduction
goals
of
at
least
10%
for
fiscal
years
1996
and
1997,
at
least
5%
for
fiscal
years
1998
through
2001,
and
to
set
annual
goals
to
continue
those
efforts
after
2001.
These
are
government
wide
goals,
not
agency
specific.
OMB
uses
its
annual
ICB
to
establish
the
government
wide
goals,
as
well
as
individual
agency
goals.
Each
year
EPA
reports
its
achievements
towards
these
goals,
along
with
any
anticipated
burden
increases,
in
EPA's
annual
Information
Collection
Budget
(
ICB)
that
is
submitted
to
OMB
for
inclusion
in
the
OMB
ICB
for
the
federal
government.

As
reported
by
OMB
in
the
Fiscal
Year
2002
Information
Collection
Budget,
a
government
wide
decrease
in
annual
paperwork
burden
was
realized
in
only
one
year
since
1989
(
i.
e.,
1993).
According
to
OMB,
given
the
continued
expansion
of
Federal
responsibilities
and
the
growth
of
the
nation
over
the
last
20
years,
the
PRA
goals
in
the
aggregate
are
well
beyond
what
is
reasonably
achievable.
"
In
fact,
in
retrospect,
of
course,
it
would
have
been
virtually
impossible
for
the
Federal
government
to
achieve
all
of
the
goals
over
the
last
20
years.
The
goals
do
encourage
agencies
to
target
burden
reduction.
However,
had
the
goals
been
achieved,
the
Federal
government
would
be
collecting
only
about
40%
of
the
information
it
did
in
1980."
(
See
page
3
of
OMB's
Report
"
The
Fiscal
Year
2001
Information
Collection
Budget.")

The
PRA
directs
all
federal
agencies
to
make
efforts
to
reduce
the
overall
federal
paperwork
burden,
but
the
need
to
reduce
burden
is
secondary
to
the
requirement
to
fulfill
the
Agency's
obligations
to
uphold
the
Nation's
environmental
laws.
In
the
March
1995
Reinventing
Environmental
Information
(
REI)
report,
EPA
established
a
long
term
commitment
to
identify
and
eliminate
obsolete,
duplicative,
and
unnecessary
monitoring,
reporting,
and
record
keeping
requirements.
For
instance,
by
the
end
of
fiscal
year
1998,
program
changes
and
adjusted
burden
estimates
reduced
overall
burden
by
more
than
24
million
baseline
hours.

EPA
is
extremely
sensitive
to
the
PRA's
directive
for
federal
agencies
to
reduce
unnecessary
burden,
and
has
worked
consistently
to
find
areas
in
which
burden
can
be
decreased
to
the
maximum
extent
practical,
and
has
carefully
evaluated
new
information
collections
to
ensure
that
our
needs
are
met
with
the
minimal
burden
possible.
For
IURA,
this
meant
that
EPA
strived
during
the
development
of
the
amendments
to
ensure
that
any
burden
increase
would
be
minimized
to
the
greatest
extent
practical.
For
example,
as
reflected
in
the
proposal,
EPA
raised
the
overall
reporting
thresholds,
created
exemptions
for
certain
groups
of
chemicals,
and
Page
38
of
159
exempted
small
businesses
from
reporting.
During
OMB
review
of
the
final
rule,
EPA
added
another
exemption
based
on
low
current
interest
in
the
IURA
information,
along
with
a
process
for
adding
chemicals
under
this
exemption,
and
agreed
to
extending
the
reporting
cycle
to
5
years,

after
the
first
cycle
in
4
years.
In
addition,
the
screening
level
information
provided
under
the
IURA
will
allow
the
Agency
to
prioritize
other
collection
activities
for
more
detailed
information
about
these
chemicals.

As
a
result,
EPA
believes
that
the
IURA
is
consistent
with
the
letter
and
spirit
of
the
PRA.

Comment
A.
7­
2:
Commenters
expressed
reservation
that
the
IUR
would
be
duplicative
of
information
available
to
EPA
through
other
means,
thereby
violating
both
the
PRA
and
Section
8(
a)
TSCA.
One
commenter
maintained
that:

in
order
to
avoid
unnecessary
and
duplicative
reporting
under
Section
8(
a)
of
TSCA,
EPA
must
make
a
particularized
showing
justifying,
for
each
targeted
chemical,
the
Agency's
need
to
collect
specific
downstream
use
and
exposure
information.
See,
e.
g.,
AFL­
CIO
v.

Occupational
Safety
and
Health
Admin.,
965
F.
2d
962
(
11
th
Cir.
1992).

Source:
C1­
003,
C1­
016,
C1­
024,
C1­
027,
C1­
031,
C1­
033,
C1­
037,
C1­
043,
C1­
048,

C1­
055
Response
A.
7­
2:
Regarding
the
requirements
of
TSCA
Section
8
and
the
PRA
to
avoid
duplication,
EPA
has
demonstrated
in
supporting
documents
to
the
proposed
and
final
rules
that
data
currently
available
through
alternative
sources
is
inadequate
for
the
Agency
to
fulfil
its
legal
mandate
in
TSCA
to
control
chemical
risks.
Site­
level
data
on
production
and
use
is
simply
unavailable
from
any
other
source.
The
duplication
issue
is
addressed
more
fully
in
comments
in
section
A.
3
of
this
document.
EPA
finds
the
cited
case,
AFL­
CIO
v.
OSHA,
to
be
inapplicable.

That
case
involves
the
ability
of
OSHA
to
established
PELs
under
the
OSH
Act.
It
does
not
address
EPA
authority
under
TSCA
section
8.

Comment
A.
7­
3:
A
commenter
writes:
"
The
NPRM
provides
insufficient
justification
that
the
Agency
has
acted
in
conformity
with
the
congressional
intent
expressed
in
section
2(
c)
of
TSCA
to
implement
the
act
`
in
a
reasonable
and
prudent
manner'
and
to
`
consider
the
environmental,
economic,
and
social
impact'
of
its
proposed
and
final
actions."
Page
39
of
159
Source:
C1­
043
Response
A.
7­
3:
EPA
believes
the
benefits
to
IURA
as
proposed
justify
the
costs,
as
outlined
in
chapter
V
of
the
economic
analysis
for
the
proposed
rule.
In
summary,
as
EPA
and
the
public
do
not
have
the
necessary
information
to
make
educated
decisions
about
controlling
risks
from
chemicals
in
commerce,
IURA
corrects
that
failure
and
will
result
in
better
risk
management,
both
public
and
private.
While
the
benefits
are
impossible
to
quantify
a
priori,
EPA
believes
they
will
be
substantial.

Comment
A.
7­
4:
One
commenter
stated
that
the
proposed
IURA
will
impede
innovation
by
"
imposing
defacto
restrictions
on
the
use
of
certain
materials,
adding
new
burdens,
and
causing
the
disclosure
of
CBI."
The
commenter
stated
that
the
proposal
runs
counter
to
an
underlying
TSCA
policy
prohibiting
barriers
to
innovation.

Source:
C1­
069
Response
A.
7­
4:
The
Agency
disagrees
with
the
submitter's
contention
that
the
IURA
will
impede
innovation.
The
amendments
in
no
way
impose
restrictions
on
the
use
of
materials.

Rather,
as
further
explained
in
Section
E
of
this
document,
the
CBI
revisions
will
improve
the
Agency's
ability
to
protect
legitimate
CBI
while
helping
to
ensure
that
data
that
do
not
meet
the
CBI
requirements
are
available
for
use.
The
amendments
do
increase
the
burden
associated
with
reporting
under
the
IUR.
However,
these
increases
are
outweighed
by
the
expected
benefits
from
the
use
of
the
reporting
information.
Further
discussion
on
burden
of
these
amendments
can
be
found
in
Section
G
of
this
document.

The
comment
"...
causing
the
disclosure
of
CBI"
refers
to
the
proposed
CBI
reassertion
requirement,
which
EPA
did
not
finalize.

B.
Specific
Data
Elements
Comments
1.
General
Data
Quality
and
Accuracy
Comment
B.
1­
1:
A
number
of
commenters
stated
that
the
data
provided
through
the
IURA
would
be
of
limited
accuracy
and
would
be
inferior
to
the
data
the
Agency
has
collected
in
other
programs.
The
commenters
felt
that
the
IURA
data
will
be
so
uncertain
that
they
will
not
Page
40
of
159
be
useful
to
predict
chemical
risk.
One
commenter
stated
that
there
are
many
other
factors
that
can
significantly
affect
the
potential
for
exposure,
such
as
engineering
controls
and
personal
protective
equipment
practices,
the
nature
of
the
activities
in
which
workers
are
engaged,
and
the
physicochemical
characteristics
of
the
chemical
substances.
This
commenter
believes
that
the
data
collected
under
the
IURA
will
provide
a
limited
and
potentially
inaccurate
view
of
potential
exposure.

Source:
C1­
007,
C1­
011,
C1­
015,
C1­
017,
C1­
018,
C1­
020,
C1­
021,
C1­
024,
C1­
026,

C1­
030,
C1­
031,
C1­
033,
C1­
038,
C1­
047,
C1­
048,
C1­
051,
C1­
055,
C1­
060
Response
B.
1­
1:
EPA
considered
the
types
of
information
needed
for
screening­
level
exposure
and
risk
assessments
and
believes
the
information
collected
through
the
IURA
will
have
the
necessary
level
of
adequacy,
accuracy,
validity,
and
reliability
for
these
assessments.
Before
proposing
the
IURA,
EPA
analyzed
various
exposure
data
collections
and
analyses
to
determine
the
data
elements
needed
for
a
screening
level
exposure
assessment.
This
discussion
and
analysis
are
in
the
document
"
Inventory
Update
Rule
(
IUR)
Amendment
Technical
Support
Document:

Exposure­
Related
Data
Useful
for
Chemical
Risk
Screening"
(
Ref.
16).
EPA
agrees
that
there
are
many
ways
to
increase
the
accuracy,
validity,
and
reliability
of
the
data.
However,
in
developing
the
IURA
and
considering
various
alternatives,
EPA
maintained
a
balance
between
data
needs
for
exposure
screening
and
the
burden
associated
with
providing
the
information.
If
the
Agency
were
to
require
very
precise,
specific
reporting,
company
burden
would
increase
to
an
unacceptably
high
level.
Although
many
factors
can
affect
exposure
potential,
the
data
provided
by
the
submitters
will
provide
useful
baseline
information.

Commenters'
suggestions
implied
that
complete
information
about
exposures
including
use
of
personal
protective
equipment
and
engineering
controls
would
be
necessary
for
even
a
screening
level
analysis
of
potential
exposure.
However,
exposure
and
risk
analyses
performed
by
the
Agency
in
general
and
OPPT
in
particular
are
graduated
and
data­
driven.
Within
EPA,
more
accurate
and
reliable
reviews
are
desired
as
levels
of
concern
increase.
The
Agency
then
needs
increased
quantity
and
quality
of
data,
along
with
more
detailed
and
exacting
methodologies
of
risk
review.
Based
on
its
years
of
experience
assessing
chemical
risks
through
programs
such
as
the
New
Chemicals
Program,
the
Agency
believes
the
IURA
data
will
provide
information
adequate
to
perform
initial
exposure
screens
of
chemicals,
and
to
prioritize
and
make
basic
risk
management
decisions
about
those
chemicals
of
greatest
concern.
Those
decisions
then
can
prompt
more
detailed
assessments,
as
required.
Page
41
of
159
The
Agency
considered
the
data
accuracy
and
reliability
needed
for
screening
level
analyses
and
took
several
steps
to
ensure
that
the
data
to
be
collected
under
IURA
would
meet
those
needs.
Screening
level
data
need
not
be
absolutely
precise,
but
should
be
accurate
and
reliable
enough
to
make
usable
and
defensible
technical
assessments.
The
IURA
will
supply
information
the
Agency
does
not
currently
possess.
Without
this
information,
EPA
either
would
not
screen
these
chemicals,
or
would
screen
them
using
outdated
or
anecdotal
information,
or
would
make
estimates
using
modeling
data.
Personal
protective
equipment
is
discussed
in
section
B.
6.
b
of
this
document.

Comment
B.
1­
2:
EPA
is
requiring
submitters
to
provide
information
that
is
not
typically
tracked
in
the
format
that
EPA
is
requesting.
For
instance,
EPA
is
requiring
the
reporting
of
average
and
maximum
concentration
of
chemicals
in
formulation.
According
to
the
commenter,

this
information
is
difficult
to
obtain
because
many
process
changes
are
based
on
product
quality.

Therefore,
the
concentration
of
a
chemical
in
a
product
can
vary
wildly
and
would
be
difficult
to
estimate
with
any
precision.
Also,
commenters
stated
that
EPA's
requirement
that
submitters
provide
concentration
data
on
a
weight/
weight
basis
differs
from
industry
practice
which
typically
uses
a
weight/
volume
calculation
to
represent
concentration.
Therefore,
EPA's
requirement
would
be
an
additional
unnecessary
burden.

Source:
C1­
007,
C1­
014,
C1­
015,
C1­
018,
C1­
021,
C1­
023,
C1­
027,
C1­
032,
C1­
033,

C1­
068
Response
B.
1­
2:
EPA
had
proposed
that
submitters
report
the
both
the
average
and
maximum
concentrations
of
the
chemical
when
leaving
the
manufacturing
site.
EPA
has
eliminated
the
requirement
to
report
average
concentration
from
the
final
rule
in
response
to
commenters'
explanation
of
the
difficulty
of
determining
the
average
concentration.
However,

EPA
disagrees
with
the
claim
that
tracking
maximum
concentration
at
the
time
a
substance
leaves
the
submitter's
site
would
be
overly
burdensome.
EPA
is
requiring
submitters
to
provide
their
best
estimate
of
the
data
elements
in
the
IUR
form
to
the
extent
that
an
estimate
is
reasonably
ascertainable
(
in
the
case
of
data
elements
reported
on
Parts
I
and
II
of
Form
U)
or
is
readily
obtainable
(
in
the
case
of
data
elements
reported
on
Part
III
of
Form
U).
The
Agency
believes
that
submitters
have
sufficient
expertise
in
the
production
and
use
of
their
products
to
provide
reliable
estimates
of
the
IUR
data
elements,
including
maximum
concentration.
If
a
submitter
cannot
reasonably
ascertain
an
estimate
for
the
maximum
concentration
information
required
under
Page
42
of
159
section
710.32(
c)(
3)(
vii),
or
readily
obtain
an
estimate
for
the
maximum
concentration
information
required
under
section
710.32(
c)(
4)(
ii)(
D)
of
the
regulatory
text,
the
submitter
need
not
respond
to
the
data
element.

Concentration
is
an
important
variable
to
consider
when
estimating
the
magnitude
of
potential
exposures.
EPA
recognizes
that
the
concentration
of
an
IUR­
reportable
chemical
may
vary
from
shipment
to
shipment
when
leaving
a
submitter's
site
in
the
case
of
the
requirement
at
section
710.32(
c)(
3)(
vii),
or
from
product
to
product
within
a
commercial
and
consumer
product
category
in
the
case
of
the
requirement
at
section
710.32(
c)(
4)(
ii)(
D)
of
the
regulatory
text.

However,
the
Agency
does
not
intend
for
submitters
to
go
to
great
lengths
to
determine
what
concentration
ranges
to
select
for
IURA
reporting.
Instead,
EPA
is
simply
requiring
that
submitters
select
a
range
of
concentrations
from
a
list
of
given
ranges
(
less
than
1%
by
weight;
1­

30%
by
weight;
31­
60%
by
weight;
61
­
90%
by
weight,
and
greater
than
90%
by
weight)
to
indicate
the
maximum
concentration
of
an
IUR­
reportable
chemical
across
shipments
leaving
the
submitter's
site.
EPA
and
others
will
primarily
use
this
information
for
preliminary
risk
screening.

The
Agency
has
determined
that
reporting
of
concentration
data
in
ranges
will
be
sufficient
for
this
purpose,
and
indeed
has
some
advantages.
Information
presented
as
a
point
estimate
can
lead
the
user
to
infer
that
there
is
a
greater
precision
to
the
data
than
actually
exists,
while
information
presented
in
a
range
emphasizes
the
inherent
variability
in
the
information.
Since
the
maximum
concentration
of
a
chemical
at
a
site
can
change
over
time,
it
is
appropriate
to
collect
the
information
in
a
range.

Information
about
the
maximum
concentration
of
a
chemical
substance
present
at
processing
and
use
sites
is
frequently
used
in
chemical
risk
screening
in
the
review
of
Premanufacture
Notices
(
PMNs)
for
new
chemical
substances
required
by
Section
5
of
TSCA
and
can
be
used
in
screening
chemicals
on
the
TSCA
Inventory.
For
example,
EPA
has
developed
standard
methods
to
estimate
dermal
exposures
that
workers
may
experience
while
performing
common
industrial
operations
such
as
sampling
and
loading
chemicals
into
drums
[
See
Fehrenbacher,
M.
C.,
"
Dermal
Exposure
Assessments"
in
A
Strategy
for
Assessing
and
Managing
Occupational
Exposures,
J.
R.
Mulhausen
and
J.
Damiano,
eds.,
AIHA
Press,
Fairfax,
VA
(
1998).].
These
standard
methods
incorporate
maximum
concentration
information
to
arrive
at
an
upper
limit
in
exposure
estimates.
If
EPA
is
aware
that
a
chemical
is
processed
or
used
as
a
fraction
of
a
mixture
with
other
chemicals,
exposure
estimates
may
be
adjusted
accordingly.

Likewise,
a
chemical
that
is
a
component
of
a
mixture
exerts
a
lower
vapor
pressure
than
it
would
in
its
pure
form.
Because
higher
vapor
pressure
is
associated
with
higher
inhalation
exposure,
a
chemical's
concentration
in
a
liquid
mixture
impacts
the
exposure
assessment.
Page
43
of
159
Initially,
the
Agency
will
use
the
maximum
concentration
data
collected
under
the
IURA
to
screen
and
prioritize
chemicals
to
determine
whether
further
evaluation
is
necessary.
By
using
this
limited
set
of
exposure
and
use
data
for
relative
exposure
and
risk
ranking,
the
Agency
can
focus
testing
and
analysis
priorities
on
those
chemicals
with
the
greatest
potential
for
risk.

Without
this
information,
chemicals
will
be
evaluated
using
generic
assumptions
on
exposure
and
use,
which
could
lead
EPA
to
further
investigate
a
broader
set
of
chemicals
than
is
needed.

In
addition,
EPA
is
not
aware
of
information
or
data
that
indicates
a
prevalence
of
use
of
weight
/
volume
relative
to
weight/
weight.
If
weight/
volume
data
were
reported
under
the
IURA,

EPA
would
also
require
reporting
of
specific
gravity
of
the
mixture
in
order
to
utilize
the
reported
information
correctly.
Therefore,
for
ease
and
consistency
of
reporting
under
IURA,
EPA
has
chosen
weight/
weight
as
the
sole
basis
for
concentration
reporting.

Comment
B.
1­
3:
One
commenter
asked
whether
EPA
intends
for
the
sum
of
all
of
the
percent
production
volumes
reported
under
section
710.32(
c)(
4)(
i)(
D)
of
the
proposed
regulatory
text
or
the
sum
of
the
percent
production
volumes
reported
under
section
710.32(
c)(
4)(
ii)(
C)
of
the
proposed
regulatory
text
to
total
100
percent.
The
commenter
gave
as
an
example
a
case
where
if
there
are
20
or
more
uses
of
a
chemical,
and
only
the
top
10
uses
are
reported,
the
total
will
add
to
less
than
100
percent,
and
the
commenter
felt
that
in
such
a
case
the
database
would
likely
contain
significant
inconsistencies,
omissions,
and
errors.

Source:
C1­
033
Response
B.
1­
3:
EPA
understands
that
by
limiting
the
submitters'
estimates
of
percent
production
volume
attributable
to
each
of
only
the
top
10
industrial
function
categories
and
commercial
and
consumer
use
categories,
the
values
may
not
always
add
up
to
100
percent
of
the
submitter's
total
production
volume.
In
fact,
there
may
be
times
when
the
values
add
up
to
over
100
percent.
However,
this
will
not
significantly
affect
the
quality
of
the
data
submitted
and
will
not
result
in
inconsistencies
in
the
database.
Screening
level
estimates
are
intended
to
provide
order­
of­
magnitude
estimates
for
ranking
one
chemical
relative
to
another;
failure
to
account
for
a
small
percentage
of
a
chemical's
usage
will
likely
have
a
small
effect
on
exposure
estimates.
EPA
has
extensive
experience
with
the
type
of
data
to
be
collected
under
the
IURA
through
the
PMN
program
and
UEIP,
and
finds
that
industry
is
generally
able
to
provide
reasonable
exposure
and
use
data.
The
reasonableness
of
data
is
determined
using
a
combination
of
sources,
including
industry
contacts,
historical
data,
technical
references,
and
professional
judgment.
Page
44
of
159
2.
Double
Counting
of
Data
Comment
B.
2­
1:
Commenters
were
concerned
about
the
potential
for
"
double
counting"

of
information
collected
through
IURA.
They
pointed
out
that
a
single
customer
may
have
several
suppliers
and
that
each
supplier
would
be
required
to
predict
the
customer's
chemical
usage
and
worker
exposure,
leading
to
inflated
estimates
of
the
number
of
use
sites
and
the
number
of
potentially
exposed
workers.
One
commenter
pointed
out
that
this
problem
can
also
occur
within
a
site,
when
a
chemical
is
used
in
multiple
operations
throughout
a
plant
site.
The
same
worker
activities
will
be
reported
in
duplicate
when
multiple
operations
occur
at
one
site.

One
commenter
suggested
that
companies
rather
than
sites
report
downstream
use
information
as
a
way
to
minimize
the
double
counting.

Source:
C1­
007,
C1­
009,
C1­
011,
C1­
013,
C1­
016,
C1­
018,
C1­
021,
C1­
024,
C1­
027,

C1­
028,
C1­
033,
C1­
038,
C1­
055,
C1­
056,
C1­
060,
C1­
061
Response
B.
2­
1:
EPA
recognizes
that
the
potential
for
double
counting
exists
under
certain
scenarios,
but
believes
that
this
issue
is
not
as
great
as
suggested,
and
that
the
quality
of
the
data
that
will
be
collected
under
IURA
will
be
sufficient
for
the
purposes
for
which
EPA
and
other
IUR
information
users
require
it.
An
primary
purpose
of
the
IURA
data
is
to
aid
in
relative
exposure
and
risk
screening
of
IURA
chemicals,
not
to
generate
specific
exposure
values
for
use
in
detailed
risk
assessments.
Because
IURA
information
will
be
used
for
screening
purposes,

uncertainties
such
as
those
posed
by
the
potential
to
double
count
are
minor.
For
instance,
in
the
first
example
listed
about
in
the
submitter
comment,
the
number
of
user
sites
will
be
greater,
but
the
use
volume
per
site
will
be
less.
While
a
more
accurate
picture
would
be
to
decrease
the
number
of
use
sites
and
increase
the
use
volume
per
site,
EPA
believes
that
at
the
screening
level
this
distinction
is
relatively
minor
and
is
only
likely
to
occur
very
occasionally.
This
belief
is
founded
in
part
on
the
fact
that
the
majority
of
chemicals
reporting
to
past
IUR
collections
originate
from
a
single
site.

Within
a
site,
multiple
processing
or
use
activities
can
create
multiple
exposure
pathways.

EPA
is
interested
in
identifying
the
various
exposure
scenarios
and
obtaining
a
general
idea
of
the
magnitude
of
the
exposures
associated
with
those
pathways
than
in
precisely
measuring
those
exposures.
Because
of
this,
potential
double
counting
is
not
expected
to
dramatically
affect
the
quality
of
the
data
for
with
respect
to
the
purposes
to
which
the
data
will
be
put.

While
reporting
use
information
on
a
company
wide
basis
versus
a
site
specific
basis
may
Page
45
of
159
help
address
the
potential,
albeit
minor,
issue
of
double
counting,
EPA
has
other
reasons
for
preferring
site
specific
reporting.
For
instance,
site
location
is
used
in
conjunction
with
streamflow
data
from
the
U.
S.
Geological
Survey
to
assess
the
environmental
impact
of
sitespecific
releases
to
the
aquatic
environment.
Site­
specific
information
is
likewise
used
to
assess
the
magnitude
and
duration
of
exposure
of
workers
to
chemical
substances.
Additionally,

sitespecific
information
enables
EPA
to
assess
the
extent
to
which
a
change
in
manufacturing,

processing,
or
use
of
a
chemical
substance
changes
the
type
or
form
of
exposure
of
humans
or
the
environment.
Reporting
on
a
company­
wide
basis
for
a
company
that
has
a
variety
of
sites,
each
producing
one
or
more
IURA
reportable
chemicals,
would
result
in
a
less
accurate
and
informative
description
of
the
effect
of
chemical
manufacture
processing
and
use
on
the
environment.

Comment
B.
2­
2:
Commenters
stated
that
double
counting
occurs
when
the
production
volume
for
a
chemical
is
originally
reported
for
quantities
produced
at
the
manufacturing
site,

then
is
shipped
out
of
the
country,
and
then
imported
back
into
the
United
States.
This
results
in
an
artificially
inflated
production
volume.

Source:
C1­
023,
C1­
028,
C1­
056,
C1­
060
Response
B.
2­
2:
As
under
the
existing
IUR,
production
volume
amounts
will
continue
to
be
reported
on
a
per­
site
basis
under
the
IURA.
The
IUR
has
provided
EPA
with
a
general
understanding
of
who
manufactures
which
chemicals,
where
the
chemicals
are
manufactured
(
including
imported),
and
in
what
quantity,
over
the
course
of
a
given
year.
IUR
information
is
used
to
identify
potential
exposure
concerns.
Production
volume
associated
with
the
manufacturing
of
a
chemical
is
attributed
to
the
manufacturing
site,
with
potential
exposures
to
workers
and
others
attributed
to
the
manufacturing
site.
Production
volume
associated
with
the
import
of
a
chemical
is
likewise
attributable
to
the
importation
site,
with
potential
exposures
to
workers
and
others
attributable
to
the
importation
site.
These
are
two
different
exposures,
and
EPA
needs
to
collect
information
for
each
site.
While
the
overall
national
production
volume
of
the
chemical
which
is
manufactured,
exported,
and
imported
all
in
the
same
year
may
include
double
counting
of
the
same
volume
(
and
therefore
an
inflated
production
volume).
The
quantity
of
a
chemical
consumed
in
the
United
States
can
be
calculated
by
subtracting
exports
and
adding
imports
to
the
quantity
produced.

EPA
has
considered
ways
of
"
tagging"
information
that
covers
the
same
production
Page
46
of
159
volume
reported
in
two
different
places.
EPA
determined
that
tracking
individual
shipments
of
IUR­
reportable
chemicals
would
place
too
much
burden
on
industry.
Other
factors
affect
production
volume
levels
reported.
For
example,
the
Agency
is
aware
that
certain
chemical
manufacturers
have
taken
into
consideration
the
IUR
reporting
schedules
in
determining
whether/
when
to
manufacture
(
including
import)
an
IUR­
reportable
chemical.

Comment
B.
2­
3:
Several
commenters
suggested
that
the
argument
that
multiple
counting
is
not
significant
because
the
numbers
are
reported
in
ranges
is
not
logical
or
convincing.
The
commenters
suggest
that
EPA
consider
requiring
IUR
reporting
in
a
manner
similar
to
the
SIDS
Initial
Assessment
Reports
(
SIAR)
used
in
OECD's
SIDS
program,
which
would
eliminate
the
possibility
of
multiple
counting
as
data
from
all
manufacturers
are
aggregated
in
a
single
report.

Source:
C1­
031,
C1­
033,
C1­
061
Response
B.
2­
3:
EPA's
argument
that
range
reporting
reduces
the
importance
of
double
or
multiple
counting
is
flawed,
and
EPA
withdraws
that
argument.
EPA
agrees
that
range
reporting
may
not
have
a
significant
impact
in
reducing
double
counting.
However,
EPA
still
believes
that
double
counting
will
not
be
a
significant
problem
with
IURA
reporting.
The
fact
that,
based
on
past
IUR
reporting,
most
chemicals
are
reported
by
one
site
highlights
the
fact
that
the
possibility
of
multiple
counting
is
minor.
As
IURA
information
is
intended
for
use
in
screening
level
exercises,
the
small
incidence
of
multiple
counting
is
immaterial.
See
the
response
to
comment
B.
2­
1
for
further
discussion.

EPA
examined
the
idea
of
using
a
SIAR­
type
of
reporting
form,
which
is
used
by
OECD
for
SIDS
chemicals.
The
SIAR
form
aggregates
information
for
all
manufacturers,
thus
protecting
company­
specific
information.
However,
aggregation
would
eliminate
a
great
deal
of
flexibility
from
the
IURA
data
elements.
To
require
submitters
to
provide
data
in
an
aggregate
form
would
severely
limit
the
ultimate
utility
of
the
IURA
data
collection.
As
described
in
the
response
to
comment
B.
2­
1,
the
Agency
has
a
need
for
site
specific
information.
Additionally,

there
may
be
many
ways,
yet
unknown
to
EPA,
which
the
IURA
data
can
be
manipulated
and
analyzed
for
even
greater
utility
than
what
EPA
currently
envisions.
EPA
also
believes
it
is
infeasible
to
require
SIAR­
type
reporting
as
that
would
require
manufacturers
to
incur
greater
reporting
burden
by
aggregating
their
data
before
submitting
it
to
the
EPA
and
would
complicate
the
submission
of
CBI
information.
For
instance,
in
the
case
of
a
chemical
for
which
the
Agency
would
normally
received
submissions
from
several
manufacturers
or
importers,
those
submitters
Page
47
of
159
would
need
to
consolidate
information
into
one
report
prior
to
submission
to
EPA.
If
one
of
those
manufacturers
wished
to
maintain
confidentiality
for
their
information,
they
would
not
be
able
to
provide
their
information
to
the
others
for
consolidation
as
that
act
would
likely
cause
the
information
to
no
longer
qualify
for
CBI
protection.

3.
Site
and
Company
Identification
Comment
B.
3­
1:
EPA
should
include
a
'
not
applicable'
response
as
an
option
for
Facility
Identification
Number
(
FIN).
Commenters
state
that
some
facilities
have
not
been
assigned
a
number
while
other
facilities
have
more
than
one
FIN.
One
commenter
suggests
that
EPA
should
require
the
reporting
of
a
TRI
facility
identification
number
(
if
a
site
has
one)
because
this
would
not
create
unnecessary
burden
to
industry.
Commenters
stated
that
a
comprehensive
Facility
Registry
System
(
FRS)
would
simplify
identification
of
data
among
numerous
EPA
reporting
requirements.

Source:
C1­
031,
C1­
033,
C1­
047,
C1­
065,
C1­
068
Response
B.
3­
1:
EPA
agrees
that
use
of
a
comprehensive
facility
identification
number
would
simplify
the
collection
and
use
of
data
submitted
to
the
Agency
pursuant
to
multiple
program
reporting
requirements.
As
a
result,
EPA
is
now
taking
steps
to
institute
such
an
Agency
wide
numbering
system.
In
this
light,
reports
submitted
to
EPA
under
the
IUR
will
be
assigned
such
a
number
by
the
Agency
(
referred
to
generically
as
an
"
EPA
number").
Submitters
will
not
be
responsible
for
obtaining
this
number,
nor
for
filling
in
this
data
field
on
the
Form
U.
EPA
will
itself
make
number
assignments
either
directly
on
the
reporting
form
after
it
is
received
back
by
EPA
from
the
submitter,
or
prior
to
mailing
out
the
form
to
a
submitter.
As
a
result,
the
FRI
data
element
originally
present
in
the
proposed
regulatory
text
at
section
710.32(
c)(
2)(
ii)
has
been
eliminated
from
the
final
rule.

4.
Form
U,
Part
II
Data
Elements
­
Manufacturing
Information
a.
Production
volume
Comment
B.
4a­
1:
One
commenter
felt
that
simply
knowing
the
quantity
of
the
chemical
handled
annually
provides
little
insight
regarding
the
relative
risks
associated
with
a
manufacturing
process.
In
addition,
commenters
felt
that
the
amount
of
chemical
used
is
not
directly
related
to
Page
48
of
159
the
maximum
amount
present
in
a
site
at
any
given
time,
and
disparities
in
chemical
usage
between
sites
are
likely
to
occur
when
the
same
chemical
is
used
in
multiple
industries.

Source:
C1­
0017,
C1­
019,
C1­
033
Response
B.
4a­
1:
Knowing
the
quantity
of
a
chemical
produced
does
have
value
in
screening
potential
exposures
and
risks
associated
with
a
manufacturing
process
and
with
other
downstream
(
processing
and
use)
processes.
The
production
volume
of
a
chemical
substance
in
a
particular
application
can
be
used
with
other
exposure­
related
information
to
estimate
exposurerelated
parameters
for
particular
workplace
activities
that
can
lead
to
exposures.
For
example,

production
volume
and
chemical
concentration
information
can
be
used
to
estimate
the
total
volume
of
shipping
containers
needed
to
transport
a
formulation
containing
the
chemical.
For
a
semi­
volatile
chemical,
this
shipping
volume
may
be
used
to
estimate
releases
of
vapor
to
air
and
resulting
potential
doses
for
workers
by
inhalation.
The
production
volume
can
also
be
used
with
emission
factors
particular
to
an
application
to
estimate
releases
that
can
lead
to
off­
site
exposures.
But
because
the
volume
of
chemical
usage
alone
is
often
inadequate,
EPA
is
amending
the
IUR
to
collect
additional
information
needed
to
increase
confidence
in
the
screening
level
exposure
and
risk
assessment.

EPA
is
not
collecting
information
on
the
maximum
inventory
of
a
chemical
substance
present
at
a
facility
under
the
IURA.
Although
the
maximum
inventory
of
a
chemical
at
a
facility
is
useful
in
planning
for
emergencies,
the
amount
of
a
chemical
manufactured,
processed,

and
used
at
a
facility
is
of
greater
significance
when
estimating
occupational
and
environmental
risks.
EPA's
analysis
(
see
ref.
16)
showed
a
correlation
between
maximum
amount
present
onsite
and
throughput
volume;
this
correlation
has
been
used
to
develop
emission
factors
which
are
sometimes
used
to
develop
rough
estimates
of
annual
releases
in
the
Premanufacture
Notification
program
for
new
chemical
substances
when
throughput
volume
is
known.
Other
information
collection
rules
including
the
Toxics
Release
Inventory
collect
information
on
the
maximum
inventory
of
a
chemical
substance
at
a
facility.
The
additional
exposure
information
under
the
IURA
will
augment
other
data
(
such
as
EPA­
derived
emissions
data,
existing
IUR
production
volume
data,
etc.)
to
develop
screening
level
exposure
assessments.

EPA
agrees
that
when
a
chemical
substance
is
used
by
more
than
one
industry,
the
usage
rate
is
likely
to
vary
between
industries.
For
this
reason,
EPA
is
collecting
use
and
exposure
information
in
such
a
way
as
to
highlight
the
differences
in
chemical
use
among
different
industries.
Because
each
situation
will
present
a
different
exposure
scenario,
EPA
is
interested
in
Page
49
of
159
identifying
the
disparities
in
chemical
use
between
sites
and/
or
industries.

b.
Concentration
data
Comment
B.
4b­
1
:
One
commenter
expressed
concern
about
EPA's
proposal
that
submitters
report
concentration
data
in
ranges
because
EPA
does
not
specify
whether
it
would
require
manufacturers
(
including
importers)
to
do
specific
chemical
testing
or
statistical
analysis
to
report
concentration
data
or
whether
submitters
should
merely
estimate
concentrations.
The
commenter
found
it
unclear
whether
a
submitter
should
report
the
average
and
maximum
concentration
level
for
each
product
it
sells/
imports,
simply
estimate
the
total
average
concentration
of
all
units
sold/
imported,
or
record
each
shipment
and
statistically
determine
the
average
concentration
level.

Source:
C1­
033
Response
B.
4b­
1:
EPA
and
others
will
primarily
use
the
IURA
information
for
preliminary
exposure
and
risk
screening
purposes,
and
the
reporting
of
concentration
data
in
ranges
is
of
sufficient
precision
for
that
purpose.
Chemical
testing
or
statistical
analyses
will
not
be
necessary
to
either
make
the
required
estimates
or
to
calculate
actual
maximum
concentration
values.
The
concentration
data
reporting
requirements
under
IURA
are
chemical­
specific,
rather
than
product­
specific,
therefore
submitters
will
not
need
to
report
concentration
levels
for
each
product
sold/
imported.

For
the
maximum
concentration
information
required
under
section
710.52(
c)(
3)(
vii)
of
the
amended
regulatory
text,
submitters
must
provide
the
maximum
concentration
in
which
an
IUR­
reportable
chemical
is
found
at
the
time
the
chemical
substance
leaves
the
submitter's
site
(
i.
e.
out
of
all
the
shipments
that
leave
the
site).
Such
information
is
required
to
the
extent
that
it
(
or
an
estimate)
is
"
reasonably
ascertainable"
by
the
submitter.
EPA
is
not
requiring
the
submitter
to
report
average
concentrations
under
the
final
rule.
This
data
element,
which
EPA
had
proposed
adding,
has
been
eliminated
from
the
final
rule.
See
"
Instructions
for
2006
Inventory
Update
Rule
Reporting
Under
the
Toxics
Substances
Control
Act
(
TSCA)"
for
further
information
concerning
maximum
concentration
information
reporting
(
Ref
20).

Under
section
710.52(
c)(
4)(
ii)(
D)
of
the
amended
regulatory
text,
submitters
must
provide
the
maximum
concentration
of
each
reportable
chemical
likely
to
be
present
in
commercial
and
consumer
products
manufactured
(
including
imported)
at
sites
under
the
submitter's
control
and
at
Page
50
of
159
sites
where
the
submitter's
commercial
and
consumer
products
are
distributed
directly
or
indirectly.
Such
information
is
required
only
to
the
extent
that
it
(
or
an
estimate)
is
"
readily
obtainable"
by
the
submitter.
EPA
recognizes
that
concentration
data
may
vary
and
may
be
difficult
to
report
in
some
instances,
particularly
in
product
formulations.
EPA
is
not
requiring
the
reporting
of
concentrations
in
all
products
and
formulations
but
rather
only
one
maximum
concentration,
regardless
of
the
chemical
substance's
physical
form
or
product
formulation.

Because
concentration
information
will
be
reported
in
ranges,
and
not
as
individual
values,

this
information
should
be
known
to
or
reasonably
ascertainable
by
most
submitters
(
in
the
case
of
the
maximum
concentration
information
reported
under
section
710.52(
c)(
3)(
vii)
of
the
amended
regulatory
text)
or
readily
obtainable
by
most
submitters
(
in
the
case
of
the
maximum
concentration
information
reported
under
section
710.52(
c)(
4)(
ii)(
D)
of
the
amended
regulatory
text).
It
will
not
require
specific
chemical
testing
or
statistical
analysis
beyond
any
testing
or
analyses
already
done
by
the
submitter
as
part
of
normal
operations.
EPA
anticipates
that
chemical
importers
will
often
receive
maximum
concentration
information
from
their
suppliers
and
manufacturers
will
typically
obtain
this
information
from
samples
analyzed
for
quality
control.

c.
Physical
Form
Comment
B.
4c­
1
:
Several
commenters
suggested
the
need
for
variations
on
the
specifics
of
physical
form
reporting,
but
generally
agreed
with
reporting
the
physical
form
as
the
chemical
leaves
the
site
of
manufacture/
import.
For
example,
one
commenter
suggested
expanding
the
types
of
physical
forms
that
can
be
reported.
Other
commenters
recommended
that
EPA
allow
submitters
to
report
more
than
one
physical
form
for
each
reportable
substance,
because
a
substance
may
leave
a
site
in
more
than
one
physical
form.

Source:
C1­
021,
C1­
031,
C1­
033,
C1­
042,
C1­
047,
C1­
056
Response
B.
4c­
1:
EPA
agrees
that
multiple
physical
forms
should
be
reported
and
is
requiring
in
this
final
rule
that
submitters
report
all
physical
forms
of
a
substance
when
the
substance
leaves
the
site
of
manufacture/
import.
Reporting
on
all
physical
forms
in
the
IURA
will
lead
to
a
better
assessment
of
exposure
to
a
chemical
substance.
For
example,
processing
of
a
fine,
nonagglomerating
powder
could
result
in
occupational
exposure
by
inhalation
of
chemical
dust;
processing
of
the
same
chemical
as
a
liquid
solution
would
eliminate,
or
at
least
reduce,
the
inhalation
risk
(
the
liquid
could
become
an
aerosol
and
be
inhaled,
depending
on
the
processing
Page
51
of
159
activity).
By
combining
data
elements
on
the
physical
form
of
a
chemical
substance,
its
production
volume,
and
the
percentage
attributable
to
each
industrial
processing
or
use
activity,
a
screening
estimate
of
the
potential
exposure
associated
with
manufacturing
or
processing
of
a
chemical
substance
can
be
derived.
The
resulting
exposure
assessment
will
be
more
representative
and
less
conservative
than
if
the
physical
form
were
unknown.

EPA
does
not
agree
with
expanding
the
types
of
physical
forms
to
be
reported.
EPA's
experience
with
the
six
categories
proposed
by
EPA
(
see
section
710.32(
c)(
3)(
viii)
of
the
proposed
regulatory
text)
as
part
of
EPA's
exposure
screening
of
more
than
20,000
chemicals
in
its
New
Chemical's
Program
indicates
that
these
categories
will
be
adequate
for
risk
screening
purposes.
Additional
categories
would
not
improve
EPA's
or
others'
abilities
to
screen
chemicals
for
potential
exposure.

5.
Form
U,
Part
III
Data
Elements
­
Processing
and
Use
Information
a.
General
Downstream
Reporting
Comment
B.
5a­
1:
A
commenter
stated
the
collection
of
processing
and
use
information
is
overly
broad
and
unnecessarily
detailed.

Source:
C1­
032
Response
B.
5a­
1:
EPA
is
requiring
the
reporting
of
processing
and
use
information
to
assist
EPA
and
others
in
screening
potential
exposures
and
risks
resulting
from
industrial
chemical
operations
and
commercial
and
consumer
uses
of
chemical
substances.
EPA
considered
the
types
of
information
needed
for
screening­
level
exposure
and
risk
assessments
and
believes
the
information
to
be
collected
through
the
IURA
will
have
the
necessary
level
of
detail
and
substance
for
these
assessments.
The
specific
data
requirements
were
determined
using
the
Agency's
experience
with
a
variety
of
programs,
as
described
in
"
Inventory
Update
Rule
(
IUR)
Amendment
Technical
Support
Document:
Exposure­
Related
Data
Useful
for
Chemical
Risk
Screening"
(
ref.

14).
Additional
detail
regarding
the
use
of
processing
and
use
information
is
described
in
response
to
comments
A.
1­
1
and
A.
1­
2.

Comment
B.
5a­
2:
Commenters
stated
EPA
did
not
consider
the
logistics
and
issues
related
to
the
collection
of
downstream
information.
Commenters
stated
that
the
accuracy
and
Page
52
of
159
reliability
of
much
of
the
information
called
for
in
Part
III
of
amended
Form
U
would
be
highly
questionable
because
it
relates
to
facilities,
activities,
and
products
that
are
not
under
the
direct
or
indirect
control
of
the
company
submitting
the
Form
U.

Source:
C1­
007,
C1­
009,
C1­
011,
C1­
013,
C1­
015,
C1­
017,
C1­
018,
C1­
021,
C1­
024,

C1­
038,
C1­
042,
C1­
044,
C1­
048,
C1­
051,
C1­
055
Response
B.
5a­
2:
EPA
recognizes
that
submitters
may
not
always
have
detailed
information
about
how
the
chemical(
s)
they
make
are
used.
However,
EPA
believes
that
industry
has
a
greater
knowledge
than
EPA
about
its
own
operations
and
the
uses
of
chemicals
it
manufactures
and
sells.
In
addition,
based
on
our
experience
with
the
PMN
program,
many
stakeholder
meetings,
discussions
about
voluntary
risk
management
programs,
and
industry's
various
self­
regulation
initiatives,
the
Agency
believes
that
most
submitters
have
at
least
some
basic
information
about
downstream
uses,
including
the
information
that
would
be
reported
under
IURA.
EPA
believes
that
the
data
will
be
sufficiently
reliable
for
the
Agency
and
others
to
use
for
screening­
level
risk
assessments
and
prioritization.
EPA
has
extensive
experience
with
data
typical
of
IURA
through
its
PMN
program
and
UEIP,
and
believes
that
industry
is
generally
able
to
provide
accurate
processing
and
use
data.
The
Agency
has
received
thousands
of
PMN
submissions
over
the
past
several
years.
The
vast
majority
of
PMN
submissions
did
contain
some
level
of
exposure
information
in
processing
and
use
similar
to
those
required
under
the
IURA.

Comment
B.
5a­
3:
Commenters
suggested
that
a
"
no
data"
response
be
added
for
downstream
information
which
is
unknown.
The
proposal
stated
that
information
on
downstream
uses
must
only
be
reported
to
the
extent
it
is
readily
obtainable
but
then
goes
on
to
state
that
the
submitter
should
provide
estimates.
Another
commenter
stated
that
reporting
in
ranges
will
turn
the
downstream
reporting
into
a
guessing
game
if
the
information
is
not
readily
obtainable.

Commenters
are
concerned
about
providing
estimates
and
then
certifying
the
information
is
accurate.

Source:
C1­
007,
C1­
009,
C1­
011,
C1­
014,
C1­
015,
C1­
016,
C1­
017,
C1­
018,
C1­
020,

C1­
021,
C1­
023,
C1­
024,
C1­
027,
C1­
028,
C1­
030,
C1­
031,
C1­
032,
C1­
033,
C1­
037,

C1­
038,
C1­
044,
C1­
046,
C1­
051,
C1­
055,
C1­
068
Response
B.
5a­
3:
EPA
is
not
providing
an
"
unknown"
or
"
no
data"
response
on
the
form
Page
53
of
159
because
EPA
believes
that
submitters
often
possess
knowledge
concerning
the
downstream
use
of
chemicals
they
sell
to
their
customers,
even
though
the
submitters
do
not
control
their
customers'

sites.
EPA's
experience
with
over
30,000
PMNs
demonstrates
that
companies
have
some
knowledge
of
the
intermediate
and
ultimate
uses
of
their
products
and
therefore
EPA
believes
that
it
is
reasonable
to
assume
that
the
manufacturers
submitting
processing
and
use
information
would
be
aware
of
the
primary
uses
for
their
chemical.
Because
of
this
knowledge,
EPA
believes
the
submitter
will
also
be
able
to
provide
a
reasoned,
educated
estimate.
If
the
submitter
is
unable
to
do
so,
it
should
leave
a
blank
response.
Further
instruction
is
provided
in
the
final
rule's
guidance
document.

Reporting
in
ranges
will
lessen
the
reporting
burden
when
the
precise
quantities
of
a
chemical
directed
to
multiple
end
uses
are
not
known.
The
submitter
must
divide
the
amount
of
chemical
shipped
to
each
customer
among
the
known
uses
and
then
aggregate
these
estimates
to
obtain
an
estimate
of
the
amount
of
the
chemical
directed
to
each
use.
Although
this
may
result
in
some
uncertainty
in
the
data
reported,
an
estimate
made
in
good
faith
by
the
chemical
manufacturer
or
importer
is
preferable
to
no
estimate
at
all.

The
person
reporting
under
the
IUR
must
certify
that
to
the
best
of
her
knowledge
and
belief
that
all
information
reported
is
complete
and
accurate.
If
the
report
is
inaccurate
because
of
information
unknown
to
and
not
readily
attainable
by
the
person
reporting,
that
person
has,

nevertheless,
fulfilled
her
obligation
of
accuracy
and
completeness.

Comment
B.
5a­
4:
Several
commenters
stated
that
EPA
is
attempting
to
circumvent
the
"
reasonably
ascertainable"
standard
mandated
by
TSCA
by
lessening
the
requirement
to
"
readily
obtainable,"
which
is
not
what
is
required
by
the
statute.
Commenters
stated
that
because
the
data
required
are
not
"
reasonably
ascertainable,"
EPA's
goals
can
not
be
achieved
by
information
collected
using
the
"
readily
obtainable"
standard.

Source:
C1­
011,
C1­
014,
C1­
027,
C1­
031
Response
B.
5a­
4:
"
Known
to
or
reasonably
ascertainable
by"
is
the
current
standard
for
data
collection
under
which
the
IUR
operates
and
is
the
standard
authorized
by
TSCA
section
8(
a).
"
Known
to
or
reasonably
ascertainable
by"
means
all
information
in
a
person's
possession
or
control,
plus
all
information
that
a
reasonable
person
similarly
situated
might
be
expected
to
possess,
control,
or
know.
The
"
known
to
or
reasonably
ascertainable
by"
standard
is
applicable
to
chemical
manufacturing
by
the
submitter.
Page
54
of
159
"
Readily
obtainable"
is
a
lesser
standard
EPA
is
applying
to
the
provision
of
information
concerning
the
processing
and
use
of
chemicals
subject
to
the
IURA.
The
readily
obtainable
standard
is
less
inclusive
than
the
reasonably
ascertainable
standard
in
that
the
former
is
limited
to
information
known
or
available
to
management
or
supervisory
employees
of
the
submitter.

Readily
obtainable
does
not
require
additional
effort
to
collect
information
on
processing
or
use
of
chemicals
by
others
not
under
the
control
of
the
submitter.
Although
the
Agency
is
requiring
submitters
to
provide
only
information
in
their
possession,
EPA
believes
that
submitters
often
possess
knowledge
concerning
the
downstream
use
of
chemicals
sold
by
the
submitter
to
their
customers,
even
though
the
submitter
does
not
control
its
customers
sites.
EPA's
experience
with
over
30,000
PMNs
demonstrates
that
companies
have
some
knowledge
of
the
intermediate
and
ultimate
uses
of
their
products.

If
EPA
applied
the
"
known
to
or
reasonably
ascertainable
by"
standard
to
downstream
information
reporting,
manufacturers
would
be
required
to
report
these
data
and
would
be
required
to
go
to
greater
lengths
to
obtain
these
data
than
is
required
by
the
"
readily
obtainable"

standard.
Therefore,
EPA
believes
that
the
"
readily
obtainable"
standard
for
reporting
of
downstream
information
is
appropriate
and
will
provide
EPA
with
the
necessary
data
to
conduct
risk
screening.

Comment
B.
5a­
5:
Many
commenters
were
concerned
about
obtaining
downstream
information
from
customers.
One
commenter
stated
it
has
no
information
from
its
customer
companies
about
where
they
use
the
material,
or
if
they
use
it
at
more
than
one
site.
Commenters
said
that
such
information
is
difficult
to
obtain
because
most
customer
companies
are
unwilling
to
cooperate.
Commenters
stated
this
was
an
even
greater
issue
for
product
sold
through
brokers,

where
manufacturers
do
not
have
access
to
the
purchasers.
Commenters
stated
that
EPA
should
clarify
what
information
is
readily
obtainable
and
what
is
the
duty
of
manufacturer
to
contact
downstream
users.
One
commenter
stated
EPA
needs
to
clarify
the
reporting
obligation
of
toll
manufacturers.

Source:
C1­
009,
C1­
011,
C1­
013,
C1­
014,
C1­
015,
C1­
016,
C1­
017,
C1­
018,
C1­
021,

C1­
023,
C1­
024,
C1­
026,
C1­
027,
C1­
028,
C1­
031,
C1­
033,
C1­
037,
C1­
046,
C1­
047,

C1­
055,
C1­
068
Response
B.
5a­
5:
EPA
recognizes
that
submitters
may
not
always
have
detailed
information
about
how
the
chemical(
s)
they
make
are
used.
As
a
result,
submitters
will
only
be
Page
55
of
159
required
to
report
this
information
to
the
extent
it
is
"
readily
obtainable"
(
see
Unit
II.
F.
6.
a.
of
the
Final
Rule
Preamble).
In
addition,
based
on
its
experience
with
the
New
Chemicals
Program,
the
UEIP,
stakeholder
meetings,
discussions
with
industry
about
voluntary
risk
management
programs,
and
industry's
various
self­
regulation
initiatives,
EPA
believes
that
most
submitters
have
at
least
some
basic
information
about
the
downstream
uses
that
will
be
reported
under
IURA.
Submitters
need
not
report
the
number
of
downstream
facilities
processing
chemicals
they
manufacture
or
import
unless
the
amount
manufactured
and
imported
exceeds
300,000
pounds
at
a
single
site
in
the
reporting
year.
Manufacturers
and
importers
exceeding
this
threshold
generally
have
knowledge
of
their
customer's
operations
and
the
number
of
customer
sites
to
which
their
chemical
products
are
shipped
which
can
be
used
to
estimate
the
number
of
customer
processing
sites.
Reporting
in
ranges
will
lessen
the
burden
on
the
submitter
because
producers
and
importers
can
be
reasonably
expected
to
have
knowledge
of
the
scale
of
their
customers
operations.
If
definitive
information
is
not
readily
available,
the
person
reporting
must
use
the
best
information
readily
obtainable
but
need
not
contact
the
customer.
Additional
guidance
and
examples
for
completing
IURA
Form
U
will
be
provided
in
the
Technical
Guidance
Document.

The
reporting
obligation
for
toll
manufacturers
is
not
affected
by
the
IURA.
As
discussed
in
the
Agency's
Q&
A
document
for
the
IUR
(
currently
available
at
http://
www.
epa.
gov/
opptintr/
iur98/
tscaqa.
htm),
the
company
which
actually
manufactures
the
substance
is
the
company
which
is
required
to
report.

Comment
B.
5a­
6:
Commenters
suspect
that
their
customer's
information
is
sensitive
information,
and
requesting
that
information
may
jeopardize
their
customer
relationship.
One
commenter
stated
that
there
was
a
risk
of
potential
litigation
from
their
customers
due
to
the
downstream
IURA
reporting.

Source:
C1­
003,
C1­
011,
C1­
014,
C1­
016,
C1­
017,
C1­
018,
C1­
047,
C1­
055,
C1­
073
Response
B.
5a­
6:
EPA
does
not
believe
submitters
will
be
reporting
sensitive
customer
information
as
the
processing
and
use
information
will
be
reported
in
ranges,
will
be
agglomerated
information
from
individual
customers
and
other
downstream
users,
and
will
not
be
attributable
to
any
specific
processor
or
user.

Comment
B.
5a­
7:
A
commenter
requested
that
EPA
clarify
the
sentence
"
Persons
subject
to
this
paragraph
must
report
industrial
processing
and
use
information
for
each
reportable
Page
56
of
159
chemical
substance
at
sites
under
their
control
and
at
sites
that
receive
a
reportable
chemical
substance
from
the
submitter
directly
or
indirectly
(
including
through
a
broker/
distributor,
from
a
customer
of
the
submitter,
etc.)."
The
commenter
asked
if
the
"
person
subject
to
this
paragraph"

the
same
as
"
the
submitter"
and
if
"
sites
that
receive
a
reportable
substance
from
the
submitter"

are
the
sites
that
receive
the
substance
from
the
submitter's
site
or
from
any
of
the
submitter's
sites.

Source:
C1­
056
Response
B.
5a­
7:
The
paragraph
from
which
the
regulatory
text
is
quoted
was
proposed
as
40
CFR
710.32(
c)(
4).
This
paragraph
pertains
to
additional
information
that
must
be
reported
for
chemical
substances
manufactured
in
amounts
of
300,000
lbs.
or
more
in
a
reporting
year
at
a
single
site.
The
"
person
subject
to
this
paragraph"
is
the
submitter,
if
the
submitter
is
reporting
information
on
a
chemical
substances
whose
production
volume
exceeds
this
300,000
pound
threshold.

Reporting
under
the
IURA
is
required
for
each
chemical
manufactured
or
imported
at
a
single
site
in
quantities
that
exceed
the
reporting
threshold.
Because
reporting
is
by
site,
the
additional
information
required
by
40
CFR
710.52(
c)(
4)
should
include
data
only
on
processing
and
use
of
the
chemical
substances
manufactured
at
that
site.
If
a
firm
manufactures
the
same
chemical
substance
at
more
than
one
location,
the
downstream
information
should
pertain
only
to
the
chemical
substance
manufactured
at
the
site
for
which
the
report
is
prepared.

b.
Process
or
Use
Codes
Comment
B.
5b­
1:
One
commenter
stated
that
EPA
should
add
processing
through
distillation,
extracting,
or
refining
as
an
additional
processing
category.

Source:
C1­
024
Response
B.
5b­
1:
EPA
is
unable
to
add
the
suggested
processing
category
since
distillation,
extraction,
refining,
and
similar
activities
may
result
in
the
manufacture
of
a
chemical
substance.
For
instance,
extracting
a
chemical
from
a
mixture
of
chemicals
results
in
the
manufacture
of
a
chemical,
and,
in
that
instance,
is
not
considered
processing.
Page
57
of
159
c.
Industrial
Function
Categories
Comment
B.
5c­
1:
Commenters
expressed
concern
about
the
industrial
function
categories
(
IFCs)
to
be
reported
by
submitters
that
have
plant
sites
at
which
300,000
lbs.
or
more
of
a
reportable
chemical
substance
is
manufactured
(
including
imported).
One
commenter
was
concerned
about
the
application
of
the
IFCs
to
chemicals
with
multiple
industrial
uses.
Another
commenter
suggested
that
the
Agency
provide
submitters
with
a
"
free
response"
option
if
their
IFC
is
not
represented
on
Form
U
while
the
third
comment
stated
that
the
IFCs
selected
by
EPA
are
adequate.
Another
commenter
found
the
industrial
function
codes
to
be
extremely
broad.

Source:
C1­
024,
C1­
047,
C1­
068
Response
B.
5c­
1:
Submitters
are
required
to
report
up
to
ten
unique
combinations
of
processing
and
use
categories,
IFCs,
and
NAICS
codes
(
see
section
710.52(
c)(
4)(
i)(
C)
of
the
regulatory
text).
In
making
their
selection
from
among
the
IFC
codes,
submitters
must
determine
which
IFC
best
represents
the
specific
industrial
use
of
the
reportable
chemical
within
a
given
NAICS
code/
processing
and
use
category.
The
Agency
will
provide
examples
of
how
to
select
which
code
"
best
represents"
an
industrial
use
in
the
instruction
manual
that
will
be
available
to
all
submitters
(
see
section
710.59
of
the
regulatory
text).
Submitters
may
report
multiple
IFCs
for
the
same
NAICS
code,
or
multiple
NAICS
codes
for
each
IFC.
Unit
II.
F.
7.
of
the
final
rule
preamble
provides
further
information
on
reporting
industrial
processing
and
use
information.

The
set
of
IFCs
adopted
by
EPA
at
section
710.52(
c)(
4)(
i)(
C)
encompasses
the
vast
majority
of
uses
for
chemicals
subject
to
IUR
reporting.
EPA
did
not
include
all
IFCs
or,
as
one
commenter
suggested,
allow
the
submitter
to
supply
an
IFC
not
on
the
EPA
list
because
the
Agency
wishes
to
limit
the
number
of
scenarios
which
must
be
analyzed
for
risk
characterization.

By
aggregating
similar
uses
under
a
single
NAICS
and
a
single
IFC
code,
EPA
will
more
effectively
characterize
the
risk
associated
with
the
totality
of
the
production
of
each
chemical
substance,
especially
for
analysis
at
the
screening
level.
By
requiring
the
submitter
to
identify
the
appropriate
IFC
code
from
the
provided
list,
EPA
seeks
to
minimize
the
errors
that
could
occur
if
the
Agency,
rather
than
the
submitter,
attempted
to
aggregate
uses
other
than
those
identified
in
the
prescribed
list
of
IFCs.

Comment
B.
5c­
2:
One
commenter
stated
that
EPA
should
clearly
indicate
how
submitters
should
report
when
more
than
one
type
of
industrial
function
category
applies
to
a
given
Page
58
of
159
processing
or
use
activity.

Sources:
C1­
024
Response
B.
5c­
2:
Submitters
must
provide
industrial
processing
and
use
data
for
up
to
ten
categories
of
industrial
activity
(
by
NAICS
code).
The
Agency
expects
that
far
fewer
than
ten
categories
will
be
reported
for
most
chemicals.
For
instances
where
more
than
one
type
of
industrial
function
category
applies
to
a
given
industrial
activity/
NAICS
code
combination,
the
submitter
reports
that
combination
multiple
times,
along
with
the
associated
industrial
function
category.
Detailed
instructions
for
filling
out
Form
U
along
with
examples
will
be
provided
in
the
instruction
manual
that
will
be
made
available
to
all
submitters
(
see
section
710.59
of
the
regulatory
text
for
instructions
on
how
to
obtain
a
copy
of
this
document).

d.
Commercial
and
consumer
product
categories
Comment
B.
5d­
1:
Commenters
expressed
different
opinions
about
the
consumer/
commercial
use
categories
in
section
710.52(
c)(
4)(
ii)(
A)
of
the
regulatory
text
(
Part
III,

Section
II
of
the
Form
U).
One
commenter
felt
that
the
EPA
should
adopt
("
if
and
when
these
categories
need
to
be
delineated
as
part
of
any
voluntary
effort")
the
41
use
categories
described
in
the
European
Commission
Technical
Support
Document
(
EC's
TSD)
93/
67/
EEC
Part
III.

Another
commenter
stated
that
the
commercial
and
consumer
use
categories
proposed
appear
to
be
adequate.
A
third
commenter
suggested
that
the
"
C­
19
Other"
category
be
deleted
and
that
the
Agency
consider
requiring
the
respondent
to
identify
the
specific
use.

Source:
C1­
004,
C1­
065,
C1­
073
Response
B.
5d­
1:
EPA
is
not
changing
the
commercial
and
consumer
product
use
categories
at
this
time,
although
the
Agency
may
revisit
these
categories
in
the
future
should
a
need
arise
for
more
specific
commercial
and
consumer
use
information.
EPA
evaluated
the
EC's
categories
and
found
that
the
EC's
set
of
use
categories
results
in
a
more
complex
identification
system
than
the
one
that
will
be
used
under
the
IURA
because
it
blends
functional
use
information
with
end
use
information.
For
the
screening
level
purposes
of
IURA
data,
EPA
currently
believes
that
focusing
on
end
use
information
alone
for
commercial
and
consumer
uses
provides
the
necessary
level
of
detail
for
its
screening­
level
reviews.
EPA
additionally
believes
that
the
EC's
Page
59
of
159
scheme
for
commercial
and
consumer
reporting
would
be
overly
burdensome
(
55
EC
categories
vs.
19
IURA
categories)
and
does
not
describe
the
commercial
or
consumer
end
uses
in
a
way
that
meets
the
basic
needs
identified
by
EPA.
For
example,
a
chemical
that
is
used
as
a
propellant
would
be
listed
under
the
category
"
aerosol
propellants"
using
the
EC
system.
Such
a
listing
would
not
provide
the
Agency
with
the
information
it
needs,
about
the
type
of
commercial/
consumer
product
in
which
the
submitter
uses
the
propellant
(
e.
g.
paint,
a
lubricant,

etc.).
For
more
information
on
EPA's
commercial
and
consumer
category
analysis,
see
the
document
"
Inventory
Update
Rule
(
IUR)
Technical
Support
Document
Selection
of
Consumer
and
Commercial
End­
Use
Categories"
(
Final
Draft,
May
31,
1996)
(
Ref.
21).
EPA
will
provide
examples
of
the
types
of
products
that
fit
into
its
commercial
and
consumer
product
categories
in
the
instruction
manual
that
will
be
made
available
to
all
submitters
(
see
section
710.59
of
the
regulatory
text).

EPA
did
consider
requiring
submitters
to
identify
the
specific
use
of
the
product
as
suggested
by
the
commenter.
However,
the
Agency
decided
to
keep
the
"
C­
19
Other"
category
and
continue
to
require
submitters
to
choose
from
among
the
commercial
and
consumer
product
categories
provided
at
section
710.52(
c)(
4)(
ii)(
A)
of
the
regulatory
text
because
it
wishes
to
limit
the
number
of
scenarios
which
must
be
analyzed
for
risk
characterization.
Aggregating
similar
product
categories
will
enable
EPA
to
more
effectively
characterize
the
risk
associated
with
the
totality
of
the
use
of
each
chemical
substance.
By
requiring
the
submitter
to
identify
the
appropriate
product
categories
from
the
provided
list,
EPA
seeks
to
minimize
the
errors
that
could
occur
if
the
Agency,
rather
than
the
submitter,
attempted
to
aggregate
uses
other
than
those
identified
in
the
prescribed
list
of
product
categories.

Comment
B.
5d­
2:
Commenters
felt
that
the
EPA
should
clarify
that
pesticides,
drug
and
cosmetic
end
uses
need
not
be
reported
under
section
710.52(
c)(
4)
of
the
IURA
regulatory
text.

These
uses
fall
under
the
jurisdictions
of
other
Agencies/
Offices,
i.
e.,
the
Food
and
Drug
Administration
(
FDA),
EPA's
Office
of
Pesticide
Program
(
OPP),
FIFRA,
and
are
outside
the
scope
of
TSCA.
Other
commenters
suggested
EPA
provide
a
code
for
"
Use
not
regulated
by
TSCA,"
both
in
the
industrial
function
categories
(
section
710.52(
c)(
4)(
i)(
C)
of
the
regulatory
text)
and
in
the
commercial
and
consumer
product
categories
(
section
710.52(
c)(
4)(
ii)(
A)
of
the
regulatory
text).

Source:
C1­
018,
C1­
028,
C1­
031,
C1­
033,
C1­
056,
C1­
069,
C1­
073
Page
60
of
159
Response
B.
5d­
2:
EPA
agrees
that
non­
TSCA
substances
will
continue
to
be
exempt
from
reporting
under
IURA.
Such
substances
are
not
within
the
jurisdiction
of
TSCA.

Therefore,
under
IURA,
amounts
of
an
otherwise
IUR­
reportable
substance
that
are
intended
at
the
time
of
manufacture
or
import
to
be
used
for
non­
TSCA
purposes
(
e.
g.
as
a
pesticide,
as
a
drug)
will
not
have
to
be
reported.
This
was
also
the
case
under
the
IUR
in
the
past,
prior
to
these
amendments.

The
Agency
believes,
however,
that
it
does
have
the
authority
to
require
manufacturers
(
including
importers)
of
TSCA
chemicals
to
report
downstream
use
information,
for
both
TSCA
and
non­
TSCA
purposes
although
it
has
chosen
not
to
exercise
its
authority
at
this
time.

Under
IURA,
submitters
will
be
required
to
report
only
TSCA
uses
under
sections
710.52(
c)(
4)(
i)(
C)
and
(
c)(
4)(
ii)(
A)
of
the
regulatory
text
(
Form
U,
Part
III).
Descriptions
of
industrial
function
categories
have
been
clarified
to
reflect
the
fact
that
theyinclude
only
TSCA
uses.
For
example,
one
of
the
industrial
function
categories
is
called
"
Agricultural
chemicals
(
non­
pesticidal)."
The
consumer
and
commercial
product
categories
are
also
restricted
to
TSCA
uses.
For
example,
one
of
these
categories
is
"
Lawn
and
garden
products
(
non­
pesticidal)."
This
category
includes
chemicals
such
as
compressed
gasses
in
delivery
systems
for
many
pesticides
used
indoors
and
outdoors,
and
other
intermediates
and
inert
chemicals.
Additionally,
many
lawn
amendments
such
as
fertilizers
contain
chemicals
that
may
be
regulated
under
TSCA,
(
e.
g.,

surfactants).
See
the
instruction
manual
that
will
be
made
available
to
all
submitters
(
see
section
710.59
of
the
regulatory
text)
for
further
description
of
the
various
product
categories.

Comment
B.
5d­
3:
Commenters
stated
that
chemicals
used
in
articles
should
be
exempt
from
the
reporting
of
consumer
and
commercial
end­
use
information
(
i.
e.
Part
III.,
Section
II.
of
Form
U).
Commenters
believed
that
reporting
should
not
apply
to
products
which
incorporate
manufactured
chemicals
into
end
use
articles
at
the
site
of
manufacture.

Source:
C1­
007,
C1­
012,
C1­
013,
C1­
018
Response
B.
5d­
3:
EPA
disagrees
with
the
commenters'
statements
that
exposures
do
not
result
from
chemicals
in
articles.
Therefore,
EPA
is
not
exempting
manufacturers
of
chemicals
that
are
later
incorporated
into
articles
from
the
reporting
of
consumer
and
commercial
end­
use
information
at
this
time.
For
example,
potential
dermal
and
inhalation
exposures
can
result
from
chemicals
incorporated
into
products
in
the
commercial
and
consumer
product
category
"
fabrics,

textiles
and
apparel."
Specific
cases,
such
as
formaldehyde
from
pressed
wood
products
used
in
Page
61
of
159
mobile
homes,
show
that
potentially
harmful
exposures
can
occur
from
chemical
components
of
articles.

Comment
B.
5d­
4:
One
commenter
felt
that
in
the
case
of
consumer
products
in
particular,

it
is
unclear
whether
percent
production
data
and
maximum
concentration
data
in
Part
III.,

Section
II.
of
Form
U
(
the
consumer
and
commercial
information
section)
(
sections
710.52(
c)(
4)(
ii)(
C)
and
(
D)
of
the
regulatory
text)
would
add
any
material
information
to
the
production
volume
information
already
solicited
under
section
710.32(
c)(
3)(
iv)
of
the
regulatory
text.
The
commenter
stated
that
they
already
report
the
chemical
volume
manufactured
or
imported;
therefore,
there
is
no
need
to
report
it
again
with
the
consumer
product
information.

The
commenters
believe
that
expanding
the
IUR
requirements
to
include
consumer
and
commercial
information
creates
a
reporting
burden
without
serving
a
real
interest.
In
addition,
one
commenter
felt
that
reporting
the
maximum
concentration
of
a
chemical
in
commercial
and
consumer
products
"
will
create
an
exaggerated
impression
of
potential
exposure,"
especially
when
the
chemical
is
in
an
article
from
which
it
is
not
expected
to
be
released
during
use.
Two
commenters
recommended
dropping
the
maximum
concentration
data
element
from
section
710.52(
c)(
4)(
ii)(
D)
of
the
regulatory
text
to
reduce
the
amount
of
reporting
required.

Source:
C1­
007,
C1­
012,
C1­
018
Response
B.
5d­
4:
EPA
believes
that
percent
production
volume
and
maximum
concentration
information
for
chemicals
with
commercial
and
consumer
uses
will
be
extremely
useful
for
risk
screening
purposes.
Two
examples
of
cases
in
which
these
elements
could
be
used
are
as
follows:

1.
Large
volumes
of
a
chemical
are
reported
to
be
used
in
artists'
supplies,
in
products
specifically
intended
for
children,
and
at
a
significant
concentration
level.
This
IURA
information
would
help
EPA
determine
the
potential
exposure
to
children,
and
enable
EPA
to
evaluate
whether
the
development
of
toxicity
information
about
that
chemical
is
a
priority.
EPA
could
then
evaluate
and,
if
necessary,
manage
potential
risks
more
effectively.

2.
Reports
show
that
a
chemical
serves
as
an
absorbent
in
consumer
paper
products
such
as
diapers
and
training
pants
and
other
products
specifically
intended
for
use
by
children
or
Page
62
of
159
in
bladder
control
products
used
by
the
elderly,
and
that
concentrations
are
potentially
significant.
The
IURA
would
provide
EPA
with
additional
information,
such
as
the
fact
that
a
large
percentage
of
total
production
volume
(
of
an
absorbent)
is
dedicated
to
this
single
use
(
consumer
paper
products).
This
information
could
indicate
that
hazard
data
collection
or
development
should
be
a
priority
activity.
The
Agency
could
then
take
the
necessary
steps
to
reduce
the
risk
from
this
chemical
to
two
of
the
most
sensitive
population
groups­­
children
and
the
elderly.

EPA
is
aware
that
the
maximum
concentration
of
a
chemical
in
an
article
provides
an
upper
bound
on
the
concentration,
and
that
the
chemical
may
be
present
in
articles
at
lower
concentrations
as
well.
The
Agency
will
take
this
possibility
into
account
when
utilizing
the
maximum
concentration
information
it
collects
under
IURA.

6.
General
Data
Elements
Comments
a.
Workers
"
Reasonably
Likely
to
be
Exposed"
to
a
Chemical
Substance
Comment
B.
6a­
1:
Commenters
expressed
a
range
of
opinions
on
whether
EPA
should
adopt
OSHA's
definition
of
"
employee"
as
EPA's
definition
of
a
worker
who
is
"
reasonably
likely
to
be
exposed."
One
commenter
stated
that
OSHA's
definition
of
an
employee
under
its
hazard
communication
standard,
29
CFR
1910.1200(
c),
is
more
appropriate
for
use
in
identifying
persons
reasonably
likely
to
be
exposed
to
chemical
substances.
One
commenter
stated
that
the
Agency
should
broaden
its
definition
of
reasonably
likely
to
be
exposed
in
the
IURA
to
include
potential
accidental
or
possible
exposures
to
chemical
substances
which
workers
may
experience
in
the
course
of
their
employment.
Worker
exposures
in
the
"
real
world"
include
accidental
or
possible
exposures,
and
that
excluding
some
portion
of
those
worker
exposures,
as
EPA
proposed,
is
inappropriate.
Another
commenter
felt
that
persons
who
could
be
exposed
to
a
chemical
substance
in
foreseeable
emergencies
should
be
included
in
EPA's
new
definition,
while
other
commenters
felt
that
OSHA's
definition
is
"
overly
broad."
Yet
another
commenter
called
the
Agency's
definition
"
adequate."

Source:
C1­
007,
C1­
011,
C1­
016,
C1­
020,
C1­
028,
C1­
044,
C1­
047,
C1­
051,
C1­
055,

C1­
065,
C1­
068
Page
63
of
159
Response
B.
6a­
1:
The
OSHA
hazard
communication
standard
defines
"
employee"
as
a
worker
who
may
be
exposed
to
hazardous
chemicals
under
normal
operating
conditions
or
in
foreseeable
emergencies.
Workers
such
as
office
workers
or
bank
tellers
who
encounter
hazardous
chemicals
only
in
non­
routine,
isolated
instances
are
not
covered.
The
Standard
also
defines
"
exposure"
or
"
exposed"
as
the
subjection
of
an
employee
to
a
hazardous
chemical
in
the
course
of
employment
through
any
route
of
entry
(
inhalation,
ingestion,
skin
contact
or
absorption,
etc.)
and
includes
potential
(
e.
g.
accidental
or
possible)
exposure.
EPA
continues
to
believe
that
the
OSHA
definition
of
"
employee"
does
not
provide
a
more
appropriate
standard
than
the
one
proposed
and
finalized
in
the
IURA.
Whereas
OSHA
wanted
to
provide
all
workers
who
could
forseeably
be
exposed
to
a
chemical
substance
with
knowledge
of
the
potential
hazards
of
that
chemical,
EPA
is
seeking
to
specifically
identify
those
workers
routinely
exposed
to
chemical
substances
and
for
whom
engineering
controls
and
personal
protective
equipment
are
likely
to
provide
the
greatest
benefit.
The
cumulative
effect
of
small
doses
of
a
chemical
substances
over
a
long
period
of
time
is
a
greater
risk
to
workers
in
areas
where
chemicals
are
processed
than
the
unlikely
catastrophic
event
which
might
also
affect
workers
outside
rooms
where
chemical
processing
occurs.
The
definition
adopted
by
EPA
for
a
worker
"
reasonably
likely
to
be
exposed"
in
this
rule
will
target
those
individuals
routinely
exposed
to
chemical
substances
for
whom
chronic
risks
are
greatest.
This
definition
provides
more
useful
and
realistic
information
for
the
risk
screening
purposes
for
which
IURA
information
will
be
used.

Comment
B.
6a­
2:
A
commenter
does
not
understand
how
reporting
the
number
of
potentially
exposed
workers
will
aid
the
effort
to
protect
workers.
Other
commenters
stated
that
the
route
of
exposure
should
be
known
in
order
to
appropriately
assess
risk.

Source:
C1­
013,
C1­
020,
C1­
044
Response
B.
6a­
2:
Collecting
information
on
the
number
of
potentially
exposed
workers
will
enable
the
EPA
to
develop
screening
level
information
regarding
the
types
of
potential
exposures
and
the
size
of
the
exposed
population.
This
information
could
be
used
to
either
support
further
investigation
of
worker
protection
issues
or
to
allow
the
determination
that
no
further
investigation
is
warranted
at
that
time.

EPA
agrees
that
the
route
of
exposure
is
an
important
element
in
evaluating
risk.
The
information
collected
by
the
IURA
will
provide
preliminary
data
on
the
route
of
exposure
through
data
elements
such
as
the
Physical
Form
Code
(
see
section
710.52(
c)(
3)(
viii)
of
the
regulatory
Page
64
of
159
text)
and
the
Industrial
Function
Category
(
see
section
710.52(
c)(
4)(
i)(
C)
of
the
regulatory
text).

The
Agency
has
experience
in
determining
routes
of
exposure
based
on
these
types
of
data
elements.
Two
technical
documents
that
support
this
rule,
entitled
  
Inventory
Update
Rule
(
IUR)
Amendment
Technical
Support
Document:
Exposure­
Related
Data
Useful
for
Chemical
Risk
Screening,''
and
  
Preliminary
Assessment
Information
Rule
(
PAIR)
Database,

Manufacturing
Process
Type/
Release
Analysis
and
Number
of
Workers/
Production
Quantity
Analysis,''
describe
the
results
of
studies
that
demonstrate
that
information
regarding
the
industrial
sectors
where
a
chemical
substance
is
produced
and
used
and
information
regarding
the
function
that
a
chemical
substance
performs
within
industrial
processes
provide
indications
of
the
route,

magnitude,
and
concentration
of
potential
chemical
exposures
to
the
environment
and
to
humans.

Both
documents
can
be
found
in
the
public
record
for
this
rulemaking.

Comment
B.
6a­
3:
One
commenter
expressed
concern
that
EPA
may
use
IURA
exposurerelated
information
to
draw
conclusions
about
exposure
rates
for
the
population
at
large.

Source:
C1­
020
Response
B.
6a­
3:
The
goal
of
the
IURA
is
to
provide
a
database
of
exposure
related
information
which
can
be
used
for
screening
level
purposes
to
identify
chemicals
for
further
assessment,
as
well
as
chemicals
of
lesser
concern.
EPA
relies
on
this
type
of
screening
to
indicate
which
chemical
substances
may
pose
a
potential
risk
to
human
health
or
the
environment,

and
thus
warrant
a
more
detailed,
resource­
intensive
analysis.
For
example,
EPA
could
use
the
IURA
exposure­
related
information
to
identify
sensitive
and
unprotected
groups
and
inform
them
about
potential
health
effects
from
certain
chemical
exposures.
Therefore,
EPA
may
use
the
IURA
data
to
provide
an
indicator
of
general
population
exposure
concerns,
identifying
the
need
for
further
investigation.

Comment
B.
6a­
4:
Commenters
stated
that
the
highest
reporting
ranges
for
numbers
of
workers
reasonably
likely
to
be
exposed
are
too
broad,
and
that
narrower
ranges
would
provide
more
accurate
estimates
(
see
section
710.52(
c)(
3)(
vi)
of
the
regulatory
text).
Another
commenter
believes
that
the
reporting
burden
could
be
reduced
significantly
if
the
lowest
reporting
range
were
changed
from
"
Less
than
10
workers"
to
"
Less
than
50
workers."

Source:
C1­
021,
C1­
033,
C1­
051
Page
65
of
159
Response
B.
6a­
4:
EPA
selected
the
ranges
provided
in
the
IURA
based
on
the
expected
uses
of
the
information
for
basic
chemical
screening.
The
Agency
believes
that
these
ranges
offer
the
optimum
balance
considering
the
level
of
data
accuracy
that
is
needed
for
basic
screening­
level
exercises
and
the
amount
of
submitter
burden.
While
broader
ranges
may
further
reduce
the
submitter
burden,
the
ranges
would
be
too
broad
to
be
useful
for
screening
and,
while
narrow
ranges
would
likely
provide
more
accurate
estimates,
that
level
of
accuracy
is
not
likely
to
be
needed
for
the
anticipated
uses
of
the
information.
Additionally,
range
reporting
is
less
burdensome
for
the
submitter
than
calculating
specific
quantity
estimates.

Comment
B.
6a­
5:
Commenters
expressed
the
view
that
reporting
information
about
workers
reasonably
likely
to
be
exposed
to
a
reportable
substance
within
the
designated
ranges
(
see
section
710.52(
c)(
3)(
vi)
of
the
regulatory
text)
is
inherently
imprecise,
requiring
submitters
to
make
estimates
or
"
guess
about
employee
exposure."
Moreover,
one
commenter
felt
that
requiring
such
judgments
about
the
reasonable
likelihood
of
exposures
may
expose
submitters
to
significant
TSCA
liability
for
under­
reporting,
thereby
forcing
them
to
overestimate
exposures.

The
commenter
believes
that
these
inaccurate
figures
could
expose
submitters
to
negative
publicity
and
potential
tort
liability.
In
order
to
avoid
these
situations,
the
commenter
states
that
submitters
will
need
to
assert
and
substantiate
claims
for
CBI,
further
increasing
administrative
burdens.

Source:
C1­
015,
C1­
017,
C1­
027,
C1­
031
Response
B.
6a­
5:
Submitters
should
be
able
to
reasonably
ascertain
information
on
the
numbers
of
their
own
employees
who
are
"
reasonably
likely
to
be
exposed"
at
the
reporting
plant
site
(
with
respect
to
the
requirement
at
section
710.52(
c)(
3)(
vi)
of
the
regulatory
text),
and
should
be
able
to
readily
obtain
at
least
some
information
on
the
numbers
of
workers
who
are
"
reasonably
likely
to
be
exposed"
at
downstream
plant
sites
(
with
respect
to
the
requirement
at
section
710.52(
c)(
4)(
i)(
F)
of
the
regulatory
text).
Submitters
are
being
required
to
provide
the
information
in
ranges,
not
precise
numbers,
partly
due
to
the
fact
that
range
information
is
less
burdensome
to
compile
than
more
specific
information.
Although
range
information
is
less
precise
than
if
EPA
were
to
have
required
submitters
to
report
the
specific
number
of
workers
reasonably
likely
to
be
exposed
to
a
chemical,
the
Agency's
view
is
that
the
ranges
it
has
established
under
IURA
are
sufficient
to
provide
information
of
the
sort
that
can
be
used
in
basic,
Page
66
of
159
screening­
level
exposure
and
risk
determinations.

Claiming
CBI
solely
for
the
reasons
described
(
i.
e.,
to
avoid
negative
publicity
and
potential
civil
liability)
could
constitute
the
intentional
assertion
of
a
legally
invalid
claim.
The
criteria
which
the
commenter
identifies
are
not
recognized
as
criteria
justifying
confidential
protection.
The
substantive
criteria
required
to
be
met
by
claimants
of
confidential
information
are
found
at
40
CFR
2.208.

Comment
B.
6a­
6:
EPA
should
clarify
that
only
workers
employed
by
the
reporting
company
should
be
counted
among
the
workers
who
are
"
reasonably
likely
to
be
exposed."

Source:
C1­
011
Response
B.
6a­
6:
With
respect
to
the
requirement
at
section
710.52(
c)(
3)(
vi)
of
the
regulatory
text,
the
commenter
is
correct
that
only
workers
employed
by
the
reporting
site
would
be
counted.
With
respect
to
the
requirement
at
section
710.52(
c)(
4)(
i)(
F)
of
the
regulatory
text,

an
estimate
must
be
provided
of
the
number
of
workers
reasonably
likely
to
be
exposed
to
a
reportable
chemical
at
the
site(
s)
where
the
chemical
is
processed
or
used.
This
may
include
workers
at
the
reporting
site,
as
well
as
workers
at
other
sites,
whether
or
not
these
sites
are
owned
by
the
company
that
owns
the
reporting
site.

Comment
B.
6a­
7:
One
commenter
would
like
EPA
to
clarify
that
submitters
are
not
expected
to
perform
exposure
monitoring
or
measuring
to
develop
estimates
of
numbers
of
workers
reasonably
likely
to
be
exposed.

Source:
C1­
018
Response
B.
6a­
7:
The
IURA
does
not
require
submitters
to
conduct
any
new
exposure
monitoring
or
measuring
activities
to
help
them
develop
estimates
of
numbers
of
workers
reasonably
likely
to
be
exposed,
and
it
is
not
the
Agency's
intent
that
submitters
do
any
such
monitoring
or
measuring
for
this
purpose.
Submitters
should
develop
estimates
based
only
on
their
existing
knowledge
and
records
of
their
operations.

Comment
B.
6a­
8:
Commenters
requested
that
EPA
issue
guidance
for
submitters
under
the
IURA
to
help
them
interpret
the
regulation
and
develop
estimates
of
required
data
elements.
Page
67
of
159
One
commenter
asked
the
Agency
to
issue
the
guidance
document
concurrent
with
the
rulemaking
process,
not
after,
to
provide
opportunity
for
public
comment.

Source:
C1­
027,
C1­
028
Response
B.
6a­
8:
The
Agency
will
issue
an
instruction
manual,
called
"
Guidance
Document:
2002
Reporting
for
Updating
the
Chemical
Substances
Inventory
Database
Under
the
Toxic
Substances
Control
Act,"
to
assist
submitters
with
interpretation
of
the
rule
and
their
reporting.
The
document
will
be
available
from
the
EPA
website
(
www.
epa.
gov).
Although
EPA
is
not
required
to
request
public
comment
on
the
instruction
manual,
the
Agency
has
used
issues
and
ideas
raised
during
the
rulemaking
comment
period
to
develop
the
document.
For
each
reporting
cycle,
the
document
will
continue
to
be
enhanced
by
adding
additional
examples
or
explanations,
as
needed,
based
upon
comments
received
and
reporting
problems
identified.

Comment
B.
6a­
9:
Several
commenters
thought
that
EPA
should
define
a
minimum
frequency
and
duration
for
exposure
as
part
of
the
Agency's
definition
of
workers
"
reasonably
likely
to
be
exposed"
to
a
chemical
in
order
to
help
employers
determine
which
workers
need
to
be
included
in
estimates
associated
with
the
requirements
in
sections
710.52(
c)(
3)(
vi)
and
(
c)(
4)(
i)(
F)
of
the
regulatory
text.
One
commenter
suggested
that
EPA
should
establish
a
de
minimis
concentration
or
other
criterion
under
which
a
person
is
not
deemed
to
be
reasonably
likely
to
be
exposed.
The
commenter
also
stated
that
EPA
has
recognized
in
the
past
that
exposures
typically
occur
in
intermittent
bursts
and
spikes
and
as
such
these
occurrences
should
be
incorporated
into
the
EPA
definition
of
"
reasonably
likely
to
be
exposed."
The
commenter
adds
that
EPA
issued
a
report
on
this
topic
in
64
Federal
Register
69,530
(
Dec.
13,
1999).

Another
commenter
stated
that
EPA
should
provide
examples
of
activities
that
result
in/
do
not
result
in
a
worker's
being
qualified
as
someone
who
is
"
reasonably
likely
to
be
exposed"
to
help
clarify
the
definition
of
"
reasonably
likely
to
be
exposed."

Source:
C1­
007,
C1­
011,
C1­
013,
C1­
016,
C1­
017,
C1­
021,
C1­
028,
C1­
032,
C1­
055
Response
B.
6a­
9:
EPA
has
not
identified
a
de
minimis
concentration
level,
or
a
minimum
frequency
and
duration
for
exposure,
that
would
be
applicable
to
all
chemicals
reporting
under
the
IURA.
The
concentration
level
would
vary
depending
upon
the
specific
chemical,
the
physical
state
of
that
chemical,
and
the
route
of
exposure.
It
is
not
feasible
to
determine
the
appropriate
Page
68
of
159
level
for
each
chemical.

The
Agency
has
provided
examples
of
activities
which
may
lead
to
exposures
of
concern,

such
as
charging
reactor
vessels;
drumming;
bulk
loading;
cleaning
equipment;
maintenance
operations;
materials
handling
and
transfers;
and
analytical
operations.
Covered
exposures
include
exposures
through
any
route
of
entry
(
inhalation,
ingestion,
skin
contact
or
absorption,
etc.),
but
excludes
accidental
or
theoretical
exposures.

The
Agency's
current
methods
of
screening­
level
exposure
analysis
do
not
account
for
bursts
and
spikes
such
as
accidental
releases,
spills,
etc.
Current
risk
assessment
procedures
are
predicated
on
overall
daily
exposure
levels
and
emphasize
effects
resulting
from
continuous
exposure
over
a
lifetime.
Scientists
now
realize
that
exposures
are
more
likely
to
be
experienced
as
bursts
or
spikes,
or
intermittent
exposures
of
varying
levels.
EPA's
Risk
Assessment
Forum
is
beginning
to
examine
how
dose­
duration
relationships
are
or
can
be
incorporated
into
the
risk
assessment
process
for
less
than
life­
time
exposures.
As
part
of
this
effort,
the
Forum
and
the
Harvard
School
of
Public
Health
held
a
workshop
on
August
5­
6,
1998
to
discuss
the
current
understanding
of
dose­
duration
relationships,
the
approaches
that
can
be
used
in
their
modeling,

the
inclusion
of
these
relationships
in
risk
assessment,
and
future
efforts
in
this
area.
The
final
report,
Summary
of
the
U.
S.
EPA
Workshop
on
the
Relationship
Between
Exposure
Duration
and
Toxicity
(
EPA/
600/
R­
99/
081,
September
1999)
is
available
on
the
Agency
website
at
www.
epa.
gov/
ncea/
smdurto1.
htm.

At
the
initial
screening
level
of
analysis,
estimates
are
based
on
exposures
that
could
occur
during
activities
that
are
routine
in
nature.
Bursts
and
spikes
are
not
generally
included
at
this
level
of
analysis,
but
more
in­
depth
analyses
are
more
likely
to
include
them.
More
in­
depth
analyses
will
likely
require
information
beyond
that
provided
through
IURA.

In
its
definition
for
"
reasonably
likely
to
be
exposed,"
EPA
provides
examples
of
activities
that
are
likely
to
result
in
exposures
that
meet
the
definition
to
help
submitters
determine
their
need
for
reporting,
i.
e.
"
Such
exposures
would
normally
include,
but
would
not
be
limited
to,

activities
such
as
charging
reactor
vessels,
drumming,
bulk
loading,
cleaning
equipment,

maintenance
operations,
materials
handling
and
transfers,
and
analytical
operations."
(
See
section
710.43
of
the
regulatory
text).
Employees
reasonably
likely
to
be
exposed
to
a
chemical
are
those
who
regularly
and
routinely
monitor,
sample,
or
transfer
chemical
substances
or
clean
chemical
process
equipment.
Employees
who
do
not
work
near
the
location
where
chemicals
are
manufactured,
processed,
or
used
and
who
would
be
exposed
to
a
chemical
substance
only
in
the
unlikely
event
of
a
spill,
release,
or
accident
are
not
among
employees
reasonably
likely
to
be
exposed
to
the
chemical
substance.
Page
69
of
159
Comment
B.
6a­
10:
Commenters
stated
that,
while
they
would
be
able
to
estimate
the
number
of
workers
reasonably
likely
to
be
exposed
to
the
chemicals
they
manufacture
in
response
to
section
710.52(
c)(
3)(
vi)
of
the
regulatory
text,
they
have
no
way
of
knowing
how
many
customers'
employees
are
exposed
to
their
(
the
commenter's)
products
in
order
to
respond
to
section
710.52(
c)(
4)(
i)(
F)
of
the
regulatory
text.
Commenters
believed
that
their
customers
would
not
provide
the
needed
information,
and
that
it
would
be
extremely
time­
consuming
and
labor­
intensive
for
the
commenter
to
attempt
to
estimate
these
figures.
In
a
related
comment,
a
commenter
stated
that
worker
exposure
estimates
it
would
develop
for
its
customers
would
be
extremely
inaccurate.

Source:
C1­
015,
C1­
031,
C1­
068
Response
B.
6a­
10:
The
EPA
does
not
expect
nor
require
submitters
to
contact
their
customers
for
processing
and
use
information
in
order
to
respond
to
the
data
elements
in
section
710.52(
c)(
4)
of
the
regulatory
text.
Based
on
past
experience
(
e.
g.
the
New
Chemicals
program),

EPA
has
found
that
submitters
have
some
knowledge
of
processing
and
use
information
at
their
customers
sites.
EPA
is
requiring
that
submitters
provide
this
processing
and
use
information
to
the
extent
that
it
is
readily
obtainable
B
if
such
data
are
not
readily
obtainable
even
in
estimate
form,
a
submitter
is
not
required
to
respond
to
the
data
element.
In
the
case
of
number
of
workers,
submitters
must
indicate,
with
a
code
number/
letter,
in
which
range
their
customer
sites
fit.
The
ranges
are
sufficiently
wide
(
eg.,
25­
50
workers,
100­
500
workers)
not
to
require
submitters
to
develop
specific
numbers
of
workers
using
labor­
intensive
methods.

Submitters
are
not
required
to
gather
information
under
IURA
with
respect
to
chemicals
at
their
own
plant
sites
that
are
not
manufactured
at/
imported
into
their
own
plant
sites.

Submitters
are
only
responsible
for
reporting
information
associated
with
chemicals
that
they,

themselves,
manufacture
or
import
(
see
section
710.48
of
the
regulatory
text).
Therefore,
if
a
submitter
purchases
a
chemical
for
use
but
does
not
manufacture
or
import
the
chemical
itself,
the
submitter
has
no
IURA
obligations
with
respect
to
that
chemical.

b.
Personal
Protective
Equipment
Comment
B.
6b­
1:
A
number
of
commenters
expressed
the
opinion
that
EPA
should
not
collect
personal
protective
equipment
(
PPE)
information
for
the
purposes
of
risk
screening.
The
type
of
PPE
information
that
submitters
would
provide
would
be
analogous
to
MSDS
(
Material
Page
70
of
159
Safety
Data
Sheet)
data.
However,
the
commenters
could
support
the
collection
of
PPE
data
if
EPA
would
allow
submitters
to
use
PPE
as
a
way
to
submit
lower
estimates
for
various
IURA
data
elements
(
i.
e.,
lower
number
of
exposed
workers).
Furthermore,
commenters
stated
that
there
would
be
no
meaningful
way
to
differentiate
an
exposed
worker
from
a
worker
who
is
not
exposed
with
respect
to
PPE.

Source:
C1­
013,
C1­
016,
C1­
019,
C1­
032,
C1­
033,
C1­
047,
C1­
051,
C1­
055,
C1­
065,

C1­
068
Response
B.
6b­
1:
EPA
agrees
that
collecting
information
on
the
availability
of
PPE
is
not
critical
to
the
initial
risk
screening
process,
and
has
determined
that
this
data
element
should
not
be
added
to
IUR
as
part
of
this
rulemaking.
Because
EPA
cannot
ensure
that
protective
equipment
will
be
available
to
all
employees
and,
if
available,
will
be
used
properly
in
a
well
managed
hygiene
program,
the
risk
encountered
in
the
manufacture
(
including
import),

processing,
or
use
of
a
chemical
substance
is
initially
assessed
in
the
absence
of
PPE
information.

EPA
does
not
intend
to
use
PPE
information
to
lower
the
estimates
of
workers
reasonably
likely
to
be
exposed
to
a
chemical.

Comment
B.
6b­
2:
One
commenter
pointed
out
that
the
National
Institute
of
Safety
and
Health
(
NIOSH)
recommended
the
collection
of
PPE
information.
NIOSH
stated
that
it
is
willing
to
assist
in
the
development
of
a
PPE
usage
questionnaire
to
eliminate
any
duplication
of
NIOSH
information
collection
activities.

Source:
C1­
065
Response
B.
6b­
2:
EPA
appreciates
NIOSH's
offer
to
assist
in
the
development
of
PPE
usage
questions.
However,
for
the
reasons
stated
in
the
response
to
comment
B.
6b­
1,
EPA
does
not
intend
to
collect
information
on
the
availability
of
PPE.
EPA
may
work
with
NIOSH
in
the
future
if
it
decides
to
develop
PPE
information
for
use
in
post­
screening
assessment
activities.

c.
Metric
System
Reporting
Comment
B.
6c­
1:
Under
the
IUR,
data
are
currently
reported
using
the
English
system
of
measurement
units.
EPA
requested
comment
on
changing
reporting
requirements
to
substitute
Page
71
of
159
the
use
of
the
English
system
for
the
use
of
the
metric
system.
Two
commenters
suggested
that
EPA
convert
to
Metric
System
Units.
Another
commenter
requested
that
EPA
continue
requiring
the
use
of
the
English
System.
Commenters
also
suggested
giving
submitters
the
option
of
reporting
in
either
Metric
or
English
Units.

Source:
C1­
031,
C1­
033,
C1­
047
Response
B.
6c­
1:
EPA
has
decided,
for
now,
to
continue
to
require
the
use
of
the
English
system.
This
allows
the
IUR
database
to
remain
compatible
with
other
Agency
databases,

especially
TRI,
which
also
most
often
use
the
English
system.
EPA
believes
giving
submitters
the
option
of
reporting
using
either
the
English
or
metric
systems
of
units
would
create
confusion
and
increase
reporting
and
administrative
error.
EPA
may
revisit
this
issue
in
future
IUR
amendments.

d.
Use
volume
accuracy
and
reliability
Comment
B.
6d­
1:
Commenters
stated
that
the
accuracy
and
reliability
of
much
of
the
information
reported
in
Part
III
of
the
revised
Form
U
would
be
highly
questionable
since
it
relates
to
sites,
activities,
and
products
that
are
not
under
the
direct
or
indirect
control
of
the
reporting
company.

Source:
C1­
028,
C1­
033,
C1­
038
Response
B.
6d­
1:
EPA
recognizes
that
submitters
may
not
always
have
detailed
information
about
how
the
chemical(
s)
they
make
are
used.
However,
the
Agency
believes
that
most
submitters
have
at
least
some
basic
information
about
downstream
uses,
such
as
the
information
that
must
be
reported
under
IURA.
In
addition,
EPA
believes
that
the
data
will
be
of
sufficient
reliability
for
use
by
the
Agency
and
others
for
purposes
such
as
screening­
level
risk
assessments
and
prioritization.

C.
Reporting
Universe
Comments
1.
Inorganic
Chemicals
Page
72
of
159
a.
Removal
of
the
exemption
for
inorganic
chemical
substances
Comment
C.
1a­
1:
Several
commenters
supported
the
removal
of
the
inorganic
chemicals
exemption.
One
commenter
stated
that
the
Agency
should
never
have
exempted
inorganic
chemicals
from
IUR
reporting
in
the
first
place.

Source:
C1­
047,
C1­
051,
C1­
064,
C1­
065
Response
C.
1a­
1:
EPA
agrees
that
the
inorganic
chemical
substances
exemption
should
be
removed.

b.
Retention
of
the
exemption
for
inorganic
chemical
substances
Comment
C.
1b­
1:
A
number
of
commenters
stated
that
the
reporting
exemption
for
inorganic
substances
should
be
retained.
They
provided
the
following
statements
from
EPA's
proposed
rule
(
50
FR
9944,
9947,
March
12,
1985)
for
the
original
IUR
as
reasons
for
retaining
the
inorganic
exemption:
(
1)
the
hazard
potential
of
most
inorganic
chemicals
is
"
relatively
wellestablished
(
2)
it
was
unlikely
that
EPA
would
use
production
volume
for
performing
preliminary
screening
of
inorganic
chemicals
in
general,
and
(
3),
when
additional
data
were
needed,
EPA
could
use
the
authority
of
a
chemical­
specific
§
8(
a)
rule
to
collect
that
information.

Commenters
stated
that
EPA
has
failed
to
provide
a
well
reasoned
and
articulated
rationale
to
change
its
long­
standing
position
of
exempting
inorganics
from
the
IUR.

Source:
C1­
010,
C1­
011,
C1­
013,
C1­
014,
C1­
015,
C1­
016,
C1­
019,
C1­
020,
C1­
026,

C1­
027,
C1­
028,
C1­
031,
C1­
032,
C1­
033,
C1­
037,
C1­
038,
C1­
040,
C1­
041,
C1­
042,
C1­
043,

C1­
044,
C1­
045,
C1­
050,
C1­
055,
C1­
060,
C1­
061,
C1­
069
Response
C.
1b­
1:
EPA
is
removing
the
inorganic
chemical
exemption
to
update
the
TSCA
Inventory
as
required
by
TSCA
§
8
and
to
collect
use
and
exposure­
related
information
to
enable
EPA
to
screen
these
chemicals
for
potential
exposures
and
risks.
EPA
originally
devised
the
inorganic
chemical
exemption
because
it
believed
that
the
hazard
potential
of
many
inorganics
was
"
relatively
well­
established"
(
50
FR
9944,
9947,
March
12,
1985)
and
that
information
about
these
hazards
was
sufficient
to
prioritize
concerns
about
inorganic
chemicals,
even
without
substantive
exposure
data
or
formal
risk
assessments.
EPA
now
intends
to
increase
the
Page
73
of
159
consideration
given
to
exposure,
another
component
of
risk,
in
screening
chemicals
and
in
setting
priorities
for
risk
assessment
and
risk
management
activities
due
to
its
belief
that
chemical
hazard
information
alone
is
an
insufficient
basis
for
prioritization
for
these
purposes.
Additionally,
EPA's
need
for
data
has
changed;
the
Agency
is
now
evaluating
and
screening
chemicals
for
new
potential
health
effects
such
as
endocrine
disrupters
as
well
as
to
evaluate
potential
health
and
safety
risks
to
children.

In
the
past,
EPA
made
a
prioritization
decision
not
to
update
information
on
inorganic
chemicals;
however,
EPA
now
believes
that
updated
and
additional
information
is
necessary
to
make
informed
risk
management
decisions
on
inorganic
chemicals.
This
exposure
information
is
important
to
the
Agency's
intent
to
screen
risk,
thereby
increasing
the
importance
of
collecting
and
maintaining
an
exposure
database
for
these
chemicals.
Thus,
the
change
in
inorganic
reporting
reflects
a
change
in
the
emphasis
placed
on
exposure
in
EPA
risk
assessments
and
screening
activities.

EPA
relies
on
risk
screening
to
determine
which
chemical
substances
pose
a
potential
risk
to
human
health
or
the
environment,
and
thus
warrant
a
more
detailed,
resource­
intensive
analysis,
or
risk
assessment.
An
evaluation
of
potential
"
risk"
is
generally
based
on
a
combination
of
hazard
information
and
exposure
information.
To
the
extent
this
information
is
complete
and
current,
the
preliminary
determinations
are
more
accurate.
EPA
intends
to
increase
the
consideration
given
to
exposure
in
screening
chemicals
and
in
setting
priorities
for
risk
assessment
as
well
as
risk
management
activities,
because
chemical
hazard
information
alone
is
proving
increasingly
insufficient
for
prioritizing
risk.
Exposure
information,
such
as
that
expected
under
IURA
reporting,
is
important
to
the
Agency's
task
of
assessing
risk,
thereby
increasing
the
importance
of
collecting
and
maintaining
an
exposure
database
for
these
chemicals.
The
EPA
Science
Advisory
Board's
report
"
Reducing
Risk:
Setting
Priorities
and
Strategies
for
Environmental
Protection"
(
Ref.
12)
and
the
National
Academy
of
Public
Administration's
report
"
Setting
Priorities,
Getting
Results,
A
New
Direction
for
EPA"
(
Ref.
13)
recognize
that
EPA's
ability
to
set
priorities
through
risk
screening
and
to
allocate
its
limited
resources
has
been
significantly
impeded
by
a
lack
of
exposure
data.
The
manufacturing,
processing,
and
use
of
chemicals
on
the
TSCA
Inventory
result
in
a
wide
array
of
exposure
scenarios.
By
collecting
the
exposure­
related
data
included
in
the
IURA,
the
Agency
will
have
access
to
information
that
will
greatly
improve
EPA's
ability
to
identify,
through
risk
screening,
chemical
substances
that
could
pose
an
unreasonable
risk
to
human
health
or
to
the
environment
or
that
otherwise
warrant
further
investigation.

The
examples
provided
in
comment
C.
1b­
2,
below,
illustrate
how
important
it
is
to
have
Page
74
of
159
the
TSCA
Inventory
data
for
inorganic
chemicals
updated
in
the
same
way
that
organic
chemical
data
are
updated.
Additionally,
these
examples
illustrate
that
information
on
these
chemicals
does
not
exist
in
the
public
literature
and
why
a
chemical­
by­
chemical
updating
of
the
TSCA
Inventory
would
not
work.
Information
on
just
a
few
chemicals
would
not
satisfy
requests
such
as
those
for
the
HPV
Challenge
Program
or
for
ITC
purposes.

Comment
C.
1b­
2:
Commenters
stated
that
the
Agency
needs
to
demonstrate
specifically
how
the
data
on
inorganic
substances
will
be
used.
A
commenter
stated
that
there
is
no
indication
that
EPA
is
going
to
conduct
risk
screening
on
all
inorganics.
Some
commenters
stated
that
EPA
had
not
demonstrated
the
practical
utility
of
the
inorganic
exposure
information,
and
that
EPA
was
proposing
the
partial
exemption
only
to
get
future
use
and
exposure­
related
information.

Source:
C1­
011,
C1­
017,
C1­
019,
C1­
020,
C1­
027,
C1­
028,
C1­
033,
C1­
038,
C1­
040,

C1­
043,
C1­
044,
C1­
050,
C1­
055,
C1­
060
Response
C.
1b­
2:
EPA
will
use
this
information
in
the
same
way
as
it
will
use
the
exposure­
related
information
collected
on
organic
chemicals.
Although
EPA
may
not
develop
full
risk
assessments
for
all
inorganic
chemical
substances,
information
from
all
of
the
inorganic
chemicals
reported
through
the
IURA
will
be
used
to
conduct
exposure
and
risk
screening.
The
IURA
data
will
assist
EPA
in
prioritizing
its
resources
and
enabling
EPA
to
focus
on
those
chemicals,
including
inorganic
chemicals,
that
present
the
greatest
risk.
Information
collected
through
the
IURA
will
populate
an
exposure
database
containing
data
on
both
organic
and
inorganic
chemicals.
This
database
will
provide
information
to
a
wide
variety
of
programs,

including
TSCA
Existing
Chemicals;
Design
for
the
Environment
(
DfE)
(
see
http://
www.
epa.
gov/
opptintr/
dfe);
programs
in
other
Federal
agencies
such
as
CPSC,
OSHA,
and
NIOSH;
and
OECD
programs.
Additionally,
the
Agency
will
be
able
to
compare
chemicals
based
on
varying
potential
exposure
scenarios,
and
will
be
able
to
identify
chemicals
with
similarities
based
upon
manufacturing
and
use
characteristics.
For
example,
EPA
will
be
able
to
identify
chemicals
with
consumer
uses.
The
Agency
anticipates
that,
as
was
true
even
for
the
basic
production
data
reported
under
the
existing
IUR,
new
uses
of
IURA
data
by
EPA
and
by
others
will
continually
emerge
and
cannot
be
predicted.

EPA
documented
a
variety
of
instances
demonstrating
where
information
on
inorganic
chemicals
was
needed
to
support
the
Agency's
mission
and
was
not
available.
In
a
memo
to
OMB
(
April
20,
1999)
(
see
docket
OPPTS­
82053),
EPA
states:
Page
75
of
159
"
Federal,
State,
local,
and
tribal
governments
are
concerned
about
the
risks
these
[
inorganic]
compounds
may
pose
to
society
and
its
environment
in
contaminated
drinking
water,
ground
water,
sediment,
dredge
&
fill
sludge,
mine
tailings,
fish,
air,
hazardous
waste,
work
sites,
and
waste
streams.
Agencies
such
as
EPA,
OSHA,
NIOSH,
CPSC,

and
MSHA
need
information
to
identify
the
chemicals
which
potentially
pose
risks,
but
only
EPA
has
the
authority
to
obtain
data
of
the
type
found
on
the
TSCA
chemical
inventory.
Most
agencies
rely
on
toxicology
data
in
the
open
literature.
When
data
are
not
available
or
are
inadequate,
most
agencies
must
use
their
best
judgement;
this
often
results
in
the
use
of
conservative
estimates
that
may
put
an
additional
burden
on
the
regulated
community
required
to
comply.
In
other
cases,
when
there
are
inadequate
or
no
data
available,
they
may
not
have
sufficient
justification
for
taking
actions
that
would
be
justified
if
adequate
data
were
available.
Both
of
these
cases
result
in
inefficiencies
and
unnecessary
burdens.

Inorganic
compounds
are
also
the
subjects
for
management
decision­
making,
just
like
organic
chemicals.
Examples
of
decisions
include:
listing
and
delisting
decisions,
clean­
up
decisions,
decisions
setting
standards
for
hazardous
wastes,
permitting,
managing
accidental
releases,
etc.
EPA
would
use
the
inventory
information
to
set
priorities
for
developing
data,
including
supporting
findings
necessary
for
obtaining
test
data,

developing
risk
assessments
and
mitigating
risks
from
inorganic
chemical
substances."

EPA
provided
an
example
of
using
use
information
for
an
inorganic
chemical,
asbestos,
in
the
proposal
for
the
IURA.
In
the
OMB
memo,
EPA
presents
several
other
examples
identifying
instances
when
even
basic
production
information
for
inorganic
chemicals,
such
as
production
volume,
was
needed
and
was
not
available:

In
1996,
the
Agency
proposed
a
TSCA
§
4
test
rule
for
Hazardous
Air
Pollutant
(
HAPs)
chemicals.
The
proposal
included
three
inorganic
chemicals:
chlorine,
hydrogen
fluoride,
and
hydrochloric
acid.
These
are
all
very
high
production
volume
chemicals.

Even
for
these
very
high
production
chemicals,
EPA
had
problems
finding
the
necessary
information
(
on
production
volume
and
manufacturers)
and
had
to
make
a
number
of
assumptions
based
on
the
available
information.
This
affected
the
Agency's
ability
to
make
the
decisions
necessary
to
determine
the
impacts
the
HAPs
proposal
might
have
on
the
regulated
community.
Page
76
of
159
For
the
organic
chemicals
(
18
of
21
chemicals),
the
Agency
used
IUR
data
to
identify
producers
and
their
respective
production
volumes
for
assigning
test
costs
in
our
analysis.
For
the
inorganic
chemicals,
EPA
obtained
producer­
level
data
from
secondary
sources­­
Mannsville
or
Chemical
Marketing
Reporter
(
CMR).
In
estimating
test
costs
for
producers
identified
through
these
secondary
sources,
EPA
had
to
use
capacity
rather
than
production
volume
and
had
to
assume
that
production
would
be
proportional
to
capacity.

Past
experience
shows
that
capacity
is
a
poor
proxy
for
actual
production.
The
CMR
information
EPA
was
able
to
obtain
for
hydrochloric
acid
only
identified
manufacturers
with
a
combined
production
capacity
at
all
facilities
of
100
million
pounds
or
greater.

Data
on
an
estimated
23
producers
with
a
combined
capacity
of
920
million
pounds
was
not
available.

°
EPA
is
also
developing
a
test
rule
to
collect
toxicity
information
on
certain
inorganic
chemicals,
primarily
metals
such
as
antimony,
arsenic,
beryllium,
cadmium,

chromium,
cobalt,
lead,
manganese,
mercury,
nickel,
selenium,
tungsten
and
vanadium.

EPA
and
others
have
found
that
both
toxicity
and
exposure
information
is
incomplete
for
assessing
risks
associated
with
these
substances.
The
information
collected
through
an
amended
IUR,
including
certain
exposure­
related
information
concerning
the
processing
and
use
of
each
reportable
chemical
substance
at
sites
controlled
by
the
submitter
and
at
"
downstream"
sites
receiving
the
reportable
chemical
substance
either
directly
or
indirectly,
would
be
combined
with
toxicity
information,
including
the
information
collected
through
this
test
rule,
to
develop
priorities
based
on
potential
risk
concerns.

Specifically,
the
required
exposure­
related
information
would
include,
to
the
extent
the
information
is
readily
obtainable:
the
type
of
industrial
processing
or
use
at
each
site,

including
downstream
sites;
the
North
American
Industrial
Classification
System
("
NAICS")
codes
that
best
describe
the
relevant
industrial
activities;
the
"
industrial
functions"
of
each
chemical
substance
during
processing
or
use
for
each
NAICS
code
reported;
the
percentages
of
the
submitter's
production
volume
used
in
each
industrial
function
category;
the
number
of
sites
where
the
various
processing
and
use
operations
occur;
the
number
of
workers
reasonably
likely
to
be
exposed
to
the
chemical
substance
in
each
operation;
the
categories
of
commercial
and
consumer
uses
of
the
reportable
chemical
substance;
an
indication
of
the
presence
of
the
reportable
chemical
substance
in
consumer
products
intended
for
use
by
children;
the
percentages
of
the
submitter's
production
volume
associated
with
each
commercial
and
consumer
product
use
category;

and
the
maximum
concentration
of
the
reportable
chemical
substance
in
each
commercial
1The
ITC
is
an
independent
advisory
committee
to
the
EPA
Administrator
that
was
created
in
1976
under
§
4(
e)
of
the
Toxic
Substances
Control
Act
(
TSCA).
Sixteen
(
16)
U.
S.
Government
organizations
are
ITC
Members,
including
the
Agency
for
Toxic
Substances
and
Disease
Registry
(
ATSDR),
Council
on
Environmental
Quality
(
CEQ),
Consumer
Product
Safety
Commission
(
CPSC),
Department
of
Agriculture
(
USDA),
Department
of
Defense
(
DOD),
Food
and
Drug
Administration
(
FDA),
Department
of
the
Interior
(
DOI),
EPA,
Department
of
Commerce
(
DOC),
National
Cancer
Institute
(
NCI),
National
Institute
of
Environmental
Health
Sciences
(
NIEHS),
National
Institute
for
Occupational
Safety
and
Health
(
NIOSH),
National
Library
of
Medicine
(
NLM),
National
Science
Foundation
(
NSF),
National
Toxicology
Program
(
NTP)
and
Occupational
Safety
and
Health
Administration
(
OSHA).

Page
77
of
159
and
consumer
product
use
category.

°
The
Interagency
Testing
Committee
(
ITC),
comprised
of
representatives
from
16
U.
S.
Government
organizations11
(
including
the
EPA),
is
probably
the
most
consistent
and
largest
user
of
data
produced
from
the
IURs.
The
ITC's
dependence
on
production
(
and
import)
volume
data
and
trends
is
well
known
and
reflected
in
numerous
strategies
to
identify
chemicals
and
structurally­
related
classes
of
chemicals.
With
the
exception
of
antimony
compounds
and
organotins,
the
ITC
routinely
has
to
defer
recommending
large
structurally­
related
classes
of
inorganic
chemicals
for
testing
or
information
reporting
because
of
the
lack
of
reliable
production
volume
data.
A
recent
example
illustrates
how
the
lack
of
data
influences
which
chemicals
and
structurally­
related
classes
of
chemicals
the
ITC
recommends
for
testing
or
information
reporting.
The
ITC
recommendation
therefore
affects
which
chemicals
and
structurally­
related
classes
of
chemicals
are
then
assessed
for
exposure,
hazard
or
risk.

In
September
1991,
OSHA
presented
a
list
of
658
chemical
substances
and
mixtures
(
its
Z­
1­
A
Table
in
54
FR
2332­
2983)
to
the
ITC
to
assess
the
availability
of
dermal
absorption
data
and
the
need
for
testing
that
could
be
recommended
under
TSCA.

The
ITC
reviewed
the
list
and
determined
that
a
number
of
polymers,
pesticides,
complex
mixtures,
and
chlorofluorocarbons
(
CFCs)
are
not
suitable
candidates
for
consideration
because
they
are
not
suitable
for
testing,
they
are
regulated
under
other
Federal
authorities,
or
they
are
not
regulated
under
TSCA.
The
remaining
chemicals
were
divided
into
2
groups
based
on
production
volume:
greater
or
less
than
1
million
pounds,
based
on
the
1990
IUR
data.
All
inorganic
chemicals
and
structurally­
related
classes
of
inorganic
chemicals
were
assigned
to
the
"
less
than
1
million
pounds"
group
because
there
were
no
IUR
data.
The
ITC
recommended
80
chemicals
(
for
which
IUR
data
were
available)
for
dermal
absorption
testing
in
its
31st,
32nd
and
35th
Reports
to
the
EPA
Administrator.

Chemicals
which
had
no
IUR
data
(
including
all
of
the
inorganic
chemicals)
were
Page
78
of
159
eliminated
from
this
recommendation
solely
due
to
the
fact
that
IUR
data
did
not
exist.

Additional
discussion
of
uses
for
data
on
inorganic
substances
can
be
found
in
Unit
III.
A.
1.
of
the
preamble
for
the
IURA
final
rule,
the
preamble
to
the
proposal,
the
economic
analysis,
letters
to
OMB
(
placed
in
the
public
version
of
the
official
record
for
this
rulemaking),

and
in
the
report
"
EPA
Needs
Exposure­
Related
Data:
A
Discussion
of
the
Justification
for
Collecting
Exposure­
Related
Data
Through
the
IUR
Amendments."

Comment
C.
1b­
3:
Commenters
did
not
think
EPA's
proposed
rule
example
demonstrating
the
need
for
information
on
inorganic
chemicals
(
i.
e.
regarding
the
use
of
asbestos
in
building
materials)
justifies
lifting
the
exemption
for
these
chemicals
under
IURA.
Additionally,

a
commenter
pointed
out
that,
since
asbestos
has
been
subject
to
a
TSCA
§
6
rule,
it
was
not
previously
exempt
from
IUR
reporting
and
therefore
it
was
inappropriate
for
EPA
to
use
asbestos
as
an
example
for
mandating
IUR
reporting
for
all
inorganic
chemicals.

Source:
C1­
010,
C1­
011,
C1­
014,
C1­
015,
C1­
020,
C1­
032,
C1­
040,
C1­
042,
C1­
044,

C1­
055
Response
C.
1b­
3:
In
the
preamble
to
the
proposal
(
64
FR
46771,
August
26,
1999),
EPA
stated
that
the
Agency
is
increasing
the
"
consideration
given
to
exposure,
another
component
of
risk,
in
screening
chemicals
and
in
setting
priorities
for
risk
assessment
and
risk
management
activities
due
to
its
belief
that
chemical
hazard
information
alone
is
an
insufficient
basis
for
prioritization
for
these
purposes."
EPA
used
asbestos
as
an
example
of
an
inorganic
chemical
where
the
Agency
has
identified
a
need
for
downstream
use
information,
despite
the
fact
that
asbestos
is
a
well­
studied
and
regulated
chemical.
Asbestos
has
been
subject
to
basic
IUR
reporting
in
the
past,
due
to
the
fact
that,
as
an
inorganic
chemical
regulated
under
TSCA
§
6,
it
did
not
qualify
for
the
general
exemption
for
inorganic
chemicals.
The
fact
that
basic
IUR
data
have
been
provided
for
asbestos
in
the
past
does
not
make
this
chemical
a
poor
example
of
the
current
need
for
IURA
data
on
inorganic
chemicals,
however.
Additional
examples
of
the
need
for
both
basic
IUR
information
(
such
as
production
volume
information)
and
further
exposurerelated
information
(
such
as
the
processing
and
use
information
that
will
be
collected
under
IURA)
are
described
earlier
in
comments
A.
1­
1
and
A.
1­
2
and
were
provided
in
the
public
version
of
the
official
record.
Page
79
of
159
Comment
C.
1b­
4:
A
commenter
stated
that,
before
an
agency
can
reverse
a
settled
course
as
EPA
has
done
with
regards
to
its
treatment
of
inorganic
chemical
reporting
under
the
IUR,
it
must
consider
reasonable
alternatives
to
such
reversal
and
provide
a
reasoned
and
detailed
explanation
of
its
reasons
for
rejecting
those
alternatives.

Source:
C1­
038
Response
C.
1b­
4:
EPA
did
consider
alternatives
to
the
IURA
as
a
means
of
collecting
data
on
inorganic
chemicals,
and
as
a
means
of
collecting
exposure
data.
EPA
considered
using
publicly
available
data,
using
voluntary
surveys
to
collect
the
data,
using
PAIR
rules
to
collect
the
needed
data,
and
using
a
range
of
different
amendments
to
the
IUR
to
collect
the
data.

Discussions
of
these
alternatives
can
be
found
in
the
preamble
to
the
proposal
(
64
FR
46771,

August
26,
1999)
and
in
the
economic
analysis
for
the
proposal
("
Economic
Analysis
of
Proposed
Amendments
to
the
TSCA
§
8
Inventory
Update
Rule,"
ref.
22).
Further
discussions
are
found
in
the
preamble
to
the
final
rule
and
in
the
economic
analysis
for
the
final
rule
("
Revised
Economic
Analysis
for
the
Amended
Inventory
Update
Rule,"
ref.
23).

EPA
based
its
consideration
of
using
publicly
available
data
on
EPA's
experience
with
current
data
sources
and
a
review
of
existing
data
sources
to
determine
if
that
data
would
suffice
to
meet
EPA's
needs.
This
review
is
presented
in
"
A
Review
of
Existing
Exposure­
Related
Data
Sources
and
Approaches
to
Screening
Chemicals:
A
Response
to
CMA"
(
ref.
24).
Overall,
EPA
was
unable
to
identify
a
single
data
source,
or
a
combination
of
data
sources,
which
could
provide
the
information
EPA
would
collect
through
the
IURA.

As
discussed
in
the
preamble
to
the
proposed
rule,
EPA
had
conducted
a
voluntary
survey,
called
the
Use
and
Exposure
Information
Project
(
UEIP),
with
the
assistance
of
industry
partners
(
the
Chemical
Manufacturers
Association
(
CMA)
(
now
the
American
Chemistry
Council,

or
ACC),
the
Chemical
Specialty
Manufacturers
Association
(
CSMA),
the
Synthetic
Organic
Chemical
Manufacturers
Association
(
SOCMA),
and
the
American
Petroleum
Institute
(
API)).

The
UEIP
was
a
cooperative
effort
begun
in
the
fall
of
1992
between
government
and
industry
in
recognition
of
the
difficulties
encountered
in
obtaining
accurate
and
up­
to­
date
exposure
information
on
TSCA
chemicals.
Information
collected
by
EPA
under
the
UEIP
is
similar
to
that
being
requested
under
the
IURA
and
included
the
following:
production
volume,
site
location,

percentage
of
production
volume
for
a
given
use,
environmental
releases,
number
of
workers,

worker
activities,
monitoring
data,
and
industrial
and
consumer
uses.
EPA's
experience
with
UEIP
has
shown
that
the
types
of
information
requested
by
the
UEIP
can
be
used
to
prepare
Page
80
of
159
screening
level
exposure
assessments,
and
that
the
data
to
prepare
the
assessments
are
available
from
industry.
The
UEIP,
however,
provided
one­
time
reporting
of
information
by
a
subset
of
the
manufacturers
of
a
small
number
of
selected
high
production
volume
(
HPV)
chemicals.
Given
these
efforts,
the
limitations
of
the
data
available
from
past
and
current
information
collections
that
are
described
in
detail
in
the
proposal
(
64
FR
46772,
August
26,1999),
and
the
amount
of
time
it
would
take
otherwise
to
acquire
screening­
level
exposure
data
for
the
chemical
substances
on
the
Inventory,
EPA
believes
it
is
appropriate
to
develop
a
more
systematic
and
broadly
applied
approach
to
the
prioritization
process
by
requiring
that
new,
key,
additional
exposure­
related
information
be
reported
under
this
amended
rule
instead
of
collecting
the
information
through
a
voluntary
program.

EPA
also
determined
that
PAIR
was
not
a
sufficient
means
of
collecting
the
data
needed
to
satisfy
the
purposes
for
amending
the
IUR.
Further
discussion
of
PAIR
can
be
found
in
the
responses
to
comment
C.
1d­
4
below.

c.
Phasing
in
reporting
of
inorganic
chemical
substances
Comment
C.
1c­
1:
Commenters
supported
a
phased­
in
approach
to
full
reporting
requirements
for
inorganics,
stating
that
a
phased­
in
approach
would
give
affected
entities
time
to
get
familiar
with
the
IUR
requirements.
Another
commenter
suggested
using
a
tiered
approach,

beginning
with
partial
reporting
during
the
first
year
for
a
list
of
inorganics
for
which
the
Agency
has
specific
needs
or
concerns,
moving
to
full
reporting
for
those
inorganics
during
the
second
year
and
partial
reporting
for
the
remaining
inorganics.
One
commenter
affirmed
the
need
for
data
on
commercial
and
consumer
use
information
for
inorganic
chemicals
in
assessing
the
potential
risks
from
these
products
and
requested
the
EPA
require
full
reporting
from
the
beginning.

Source:
C1­
047,
C1­
051,
C1­
064,
C1­
065
Response
C.
1c­
1:
EPA
agrees
with
the
comments
supporting
a
phased­
in
approach
and
has
adopted
one
for
reporting
information
on
inorganic
chemicals.
Phasing
in
reporting
requirements
provides
new
submitters
with
an
opportunity
to
become
familiar
with
basic
IUR
reporting,
allows
EPA
to
become
familiar
with
the
current
inorganic
chemical
industry,
and
provides
basic
production
information
needed
for
programs
such
as
those
run
by
the
Interagency
Testing
Committee
(
ITC).
The
tiered
approach
would
not
accomplish
these
goals,
and
would
require
the
Agency
to
determine,
without
the
basic
information
needed
to
make
that
Page
81
of
159
determination,
which
inorganic
chemicals
are
of
most
interest.

Requiring
full
reporting
by
inorganic
chemical
manufacturers
after
the
initial
submission
period
(
in
which
only
basic
IUR
reporting
would
occur)
will
result
in
the
collection
of
information
needed
to
continue
efforts
begun
with
the
first
reporting
year
information,
such
as
providing
exposure
related
information
needed
to
put
HPV
Challenge
Program
hazard
information
into
context.
EPA's
primary
use
of
both
the
basic
data
collected
during
the
first
submission
period
and
the
additional
exposure
related
data
collected
during
subsequent
submission
periods
will
be
to
identify
priority
chemicals
for
more
detailed
information
gathering,
risk
assessment,
and
risk
management.
Screening
chemical
risks
generally
requires
a
combination
of
both
hazard
and
exposure
information.
The
absence
of
exposure
related
data,
beyond
even
the
basic
production
data
collected
during
the
first
submission
period
under
the
IURA,
would
severely
limit
EPA's
ability
to
conduct
efficient,
effective
risk
screening.

Comment
C.
1c­
2:
Some
commenters
suggested
EPA
review
the
information
collected
on
inorganic
chemicals
from
the
partial
exemption.
If
warranted,
EPA
could
then
collect
additional
information
on
these
chemicals
through
a
separate
IUR
amendment.
Additionally,
a
commenter
stated
that
full
reporting
for
inorganics
should
only
be
instituted
after
further
assessment
of
basic
reporting
information.
Another
commenter
suggested
the
Agency
demonstrate
the
benefits
of
the
processing
and
use
information
on
organic
chemical
substances
before
considering
inorganic
chemical
reporting.

Source:
C1­
003,
C1­
017,
C1­
043
Response
C.
1c­
2:
EPA
believes
that
there
is
no
compelling
rationale
for
treating
inorganic
chemicals
differently
than
organic
chemicals,
which
the
commenters
are
suggesting
by
stating
that
EPA
review
the
basic
manufacturing
information
before
extending
the
collection
to
processing
and
use
information,
or
by
demonstrating
the
benefits
of
processing
and
use
information
on
organic
chemicals
before
collecting
such
information
on
inorganic
chemicals.
EPA
proposed
a
partial
exemption
for
inorganics
for
two
basic
reasons.
First,
EPA
wanted
to
allow
the
inorganic
industry
to
become
familiar
with
reporting
under
the
IURA
before
requiring
full
reporting.

Second,
EPA
can
begin
work
on
issues
associated
with
inorganics
with
the
basic
manufacturing
information
that
will
be
collected
during
the
first
submission
period.
EPA
currently
does
not
have
access
to
this
type
of
information
on
inorganic
chemicals.
The
phased­
in
approach
being
used
for
Page
82
of
159
collected
inorganic
chemical
information
accomplishes
these
two
goals,
while
ensuring
that
the
Agency
and
others
will
have
needed
exposure­
related
information
on
inorganic
chemicals
in
a
more
timely
manner
than
would
be
possible
were
the
Agency
to
go
through
another
rulemaking
to
extend
the
collection
of
processing
and
use
information
to
inorganic
chemicals,
as
the
commenter
has
suggested.
Justification
for
collecting
the
additional
exposure
information
on
inorganic
chemicals
is
provided
in
the
response
to
comment
C.
1b­
3.

d.
Alternatives
for
reporting
of
inorganic
chemical
substances
Comment
C.
1d­
1:
EPA
should
focus
on
specific
inorganics
of
potential
concern,
based
upon
known
information
about
their
toxicity,
the
types
of
uses
that
may
be
of
potential
concern,

or
any
other
aspect
of
risk
that
may
already
be
known.
Elimination
of
the
exclusion
could
result
in
reporting
for
common
substances
such
as
water
and
sodium
hydroxide,
and
for
other
substances
for
which
IUR
reporting
would
have
no
value.
Commenters
stated
that
EPA
should
simply
list
the
CAS
numbers
of
the
inorganic
chemicals
for
which
it
requires
partial
reports
in
any
given
IUR
reporting
period,
or
promulgate
chemical­
specific
§
8(
a)
rules.
This
approach
would
allow
EPA
to
collect
data
for
those
inorganic
substances
for
which
it
actually
is
ready
to
perform
screening
and
prioritizing
(
i.
e.,
gather
data
on
a
case­
by­
case
basis).
Alternatively,
the
Agency
could
review
the
information
collected
on
inorganic
chemicals
from
the
partial
exemption
and
collect
additional
information
on
these
chemicals
by
specifically
listing
chemicals
for
future
IUR
collections.

Source:
C1­
011,
C1­
015,
C1­
017,
C1­
019,
C1­
020,
C1­
027,
C1­
028,
C1­
033,
C1­
038,

C1­
041,
C1­
043,
C1­
044,
C1­
060
Response
C.
1d­
1:
EPA
has
a
need
for
a
broad­
based
source
of
screening
level
use
and
exposure
information
on
inorganic
chemicals.
The
Agency
does
not
have
the
information
needed
to
determine
which
inorganic
chemicals
are
of
potential
concern.
In
fact,
one
of
the
primary
uses
of
the
IURA
information
is
to
determine
on
which
chemicals
EPA
and
others
should
be
focusing.

Data
collected
through
the
IURA
will
be
screened
to
determine
which
chemicals
potentially
have
exposures
of
concern
or,
when
combined
with
other
information
such
as
hazard
data,
to
determine
which
chemicals
potentially
have
risks
of
concern.
The
Agency
and
others
will
be
able
to
use
the
screening
results
to
help
focus
efforts
and
resources
by
identifying
those
chemicals
that
warrant
further
analysis,
as
well
as
setting
priorities
for
conducting
further
analyses,
including
Page
83
of
159
hazard
testing,
risk
assessment,
and
risk
management.
The
Agency
does
not
believe
that
hazard
is
an
appropriate
factor
for
limiting
the
collection
of
this
data.
Rather,
this
basic
information
on
exposure
and
use
will
provide
the
necessary
information
to
allow
the
Agency
to
consider
available
hazard
information
in
the
context
of
potential
risk.
Restricting
the
chemicals
for
which
data
are
collected
reduces
the
effectiveness
of
this
screening
tool
and
therefore
the
effectiveness
and
efficiency
of
various
risk
management
programs.
However,
EPA
does
believe
that
there
are
certain
chemicals
for
which
it
has
a
low
current
interest
in
the
processing
and
use
information
collected
through
the
IURA.
EPA
provides
a
specific
list
of
those
chemicals,
and
they
are
exempted
from
reporting
the
processing
and
use
information
[
see
710.46(
b)(
2)
of
the
regulatory
text].
As
interest
in
the
IURA
processing
and
use
information
for
a
specific
chemical
can
change,

this
list
of
chemicals
can
also
change;
a
list
revision
process
has
been
established
so
the
public
can
request
changes.
This
partial
exemption
and
the
list
revision
process
is
further
described
in
the
preamble
at
Unit
II.
F.
1.
d.
and
in
the
Instructions
Manual
(
Ref.
20).
The
development
of
the
initial
list
of
partially
exempt
chemicals
in
described
in
"
Methodology
Used
for
the
Initial
Selection
of
Chemicals
for
the
Inventory
Update
Rule
Amendments
(
IURA)
`
Low
Current
Interest'
Partial
Reporting
Exemption"
(
Ref.
25).

There
are
other
reasons
for
collecting
this
information
through
the
IURA.
After
the
first
few
collections
there
will
be
time
series
data
with
which
to
identify
trends.
Additionally,
this
information
is
unique
from
the
aspect
that
it
contains
CBI.
Although
it
may
appear
that
similar
data
is
available,
this
is
not
the
case.

Specifically
targeting
chemicals
undermines
many
of
EPA's
reasons
for
collecting
exposure
related
information
on
inorganic
chemicals.
Instead
of
having
a
database
of
information
that
allows
EPA
to
act
proactively,
identifying
areas
of
potential
concern
for
exposure
or
risk,
and
to
react
in
a
timely
manner
to
requests
and
demands
for
action
for
specific
concerns,
EPA
would
have
to
identify
which
chemicals
are
going
to
be
of
interest
for
the
future
­
up
to
eight
or
ten
years
before
the
information
is
needed.
Additionally,
EPA
would
not
have
a
baseline
of
information
to
track
the
progress
of
different
Agency
and
public
programs,
would
not
be
able
to
identify
trends
in
the
industry,
and
would
not
be
able
to
identify
future
issues
associated
with
inorganic
chemicals.

In
addition
to
the
partial
exemption
described
at
the
beginning
of
this
response,
EPA
has
focused
the
IUR
amendments
in
two
ways
that
affect
the
reporting
of
inorganic
chemicals.
First,

EPA
raised
the
reporting
threshold
from
10,000
lbs.
to
25,000
lbs.
Second,
EPA
instituted
a
second
reporting
threshold
of
300,000
lbs.
for
the
reporting
of
processing
and
use
information.

Naturally
occurring
chemicals,
defined
in
40
CFR
710.4(
b)(
1),
remain
exempt
from
reporting.
Page
84
of
159
EPA
disagrees
with
the
suggestion
to
use
the
first
year
reporting
data
to
choose
specific
chemicals
on
which
to
collect
processing
and
use
information.
In
addition
to
the
reasons
given
above,
the
Agency
found
that,
for
organic
chemicals
currently
reporting,
the
chemicals
change
about
30%
each
reporting
cycle.
This
turnover
in
substances
indicates
that
the
chemical
industry
is
dynamic
and
that
a
delay
of
four
years
in
gathering
information
on
chemicals
is
significant.

Since
the
Agency
is
collecting
this
information
to
prioritize
chemicals
using
a
relative
ranking
basis,
EPA
needs
to
compare
the
chemicals
and
therefore
needs
comparable
information
collected
at
the
same
time.
The
Agency
will
then
determine
which
chemicals
are
more
likely
to
pose
exposure
or
risk
concerns.

Comment
C.
1d­
2:
Commenters
suggested
using
a
hazard
or
exposure
level
for
establishing
which
inorganic
chemicals
would
be
subject
to
IURA
reporting.
A
commenter
stated
that
inorganics,
as
a
category,
have
limited
hazard
potential.
A
commenter
stated
that,
for
many
chemicals,
such
as
aluminas,
naturally
occurring
clays,
and
zeolites,
hazards
are
relatively
low.

Source:
C1­
019,
C1­
038
Response
C.
1d­
2:
The
Agency
disagrees
that
a
hazard
or
an
exposure
level
for
establishing
reporting
is
appropriate.
The
Agency
believes
that
hazards
are
not
well
established
for
all
inorganic
substances
and
disagrees
with
the
statement
that
inorganics
have
limited
hazard
potential.
Mercury
selenide
(
HgSe)
(
CASRN
20601­
83­
6)
and
gallium
arsenide
(
GaAs)(
CASRN
1303­
00­
0)
are
examples
of
inorganic
substances
that
could
possibly
harm
the
environment
due
to
either
hazard
potential
or
unknown
hazards.
Any
evaluation
of
potential
"
risk"
is
generally
based
on
a
combination
of
hazard
information
and
exposure
information;
choosing
just
one
as
the
criteria
for
reporting
would
not
provide
sufficient
information
to
satisfy
EPA's
expected
uses
of
this
information,
as
described
earlier
in
the
response
to
comment
C.
1b­
2.
EPA
relies
on
risk
screening
to
indicate
which
chemical
substances
pose
a
potential
risk
to
human
health
or
the
environment,
and
thus
warrant
a
more
detailed,
resource­
intensive
analysis.

Although
the
inherent
hazard
associated
with
a
chemical
substance
will
often
remain
the
same
over
time,
exposure
to
workers
and
affected
populations
can
change
significantly.
If
the
amount
of
a
chemical
substance
produced
increases
significantly,
releases
to
the
environment
and
human
exposures
would
also
be
expected
to
increase.
Conversely,
if
the
amount
produced
remains
constant,
environmental
releases
and
human
exposures
may
decline
as
engineering
controls
are
added
and
pollution
prevention
practices
are
implemented.
Although
the
hazard
Page
85
of
159
associated
with
a
chemical
generally
remains
constant,
the
risk
associated
with
the
manufacturing,

processing,
and
use
of
a
chemical
substance
will
change
as
exposure
increases
or
decreases.

Chemicals
that
present
low
hazard
may
still
pose
a
risk
if
they
have
high
exposures
or
involve
exposures
to
particularly
sensitive
subpopulations.

Naturally
occurring
chemical
substances,
both
organic
and
inorganic,
remain
exempt
from
reporting
under
the
IURA.
See
40
CFR
710.4(
b)(
1))
for
the
definition
of
naturally
occurring.

Comment
C.
1d­
3:
Commenters
stated
that
EPA
should
use
existing
information
for
inorganic
chemicals,
stating
that
the
data
(
especially
production
volume
data)
EPA
needs
to
conduct
screening­
level
risk
assessments
are
already
available
from
a
variety
of
sources.

Commenters
highlighted
the
U.
S.
Geological
Survey
(
USGS)
as
a
source
of
data.
Commenters
also
listed
the
following
potential
sources
of
information:
Toxics
Release
Inventory
(
TRI),
data
sources
maintained
by
the
Agency
for
Toxic
Substances
and
Disease
Registry
(
ATSDR)
and
the
National
Toxicology
Program
(
NTP),
EPCRA
Tier
II,
material
safety
data
sheets
(
MSDS),

Bureau
of
Mines,
Bureau
of
Labor
Statistics,
Census
of
Manufacturers,
and
the
International
Agency
for
Research
on
Cancer
(
IARC)
monographs.
The
Agency
should
fully
explore
all
sources
of
inorganic
chemical
information
before
collecting
more.

Source:
C1­
010,
C1­
016,
C1­
019,
C1­
032,
C1­
033,
C1­
038,
C1­
042,
C1­
043,
C1­
053,

C1­
055,
C1­
060,
C1­
067
Response
C.
1d­
3:
The
Agency
has
evaluated
data
sources
that
could
potentially
provide
the
accurate
and
up­
to­
date
information
it
needs,
including
the
data
sources
suggested
by
commenters.
These
data
sources
are
discussed
in
the
following
documents:
"
Inventory
Update
Rule
(
IUR)
Amendments
Technical
Support
Document:
Exposure
Related
Data
Useful
for
Chemical
Risk
Screening"
(
Ref.
16),
"
Economic
Analysis
of
Proposed
Amendments
to
the
TSCA
§
8
Inventory
Update
Rule"
(
Ref.
22)
and
"
A
Review
of
Existing
Exposure­
Related
Data
Sources
and
Approaches
to
Screening
Chemicals:
A
Response
to
CMA"(
Ref.
24).
EPA
believes
the
decision
not
to
utilize
an
alternate
data
source
as
a
replacement
for
amending
the
IUR
is
still
confirmed
by
the
Agency's
support
documents.

A
primary
consideration,
as
mandated
by
TSCA,
was
to
not
subject
industry
to
unnecessary
or
duplicative
reporting.
EPA
currently
does
not
have
access
to
the
exposure
information
sought
under
the
IURA.
Although
some
useful
exposure
related
data
exist
in
some
sources,
the
data
are
insufficient
typically
due
to
a
lack
of
currency
and
detail.
Without
the
Page
86
of
159
IURA,
EPA
has
difficulty
efficiently
screening
potential
risks
posed
by
a
large
number
of
chemicals
on
the
TSCA
Inventory.

Additionally,
EPA
reexamined
the
information
included
in
the
data
sources
specifically
mentioned
by
commenters
and
found
nothing
to
change
the
Agency's
conclusion
that
the
information
they
contain
would
not
fulfill
EPA's
purposes
for
adding
reporting
on
inorganic
chemical
manufacturing,
processing,
and
use
to
the
IUR.
Some
data
sources
pertained
to
naturally
occurring
substances
which
are
excluded
from
the
inventory
by
40
CFR
710.4(
b).
Many
of
the
remaining
data
sources
identified
by
commenters
pertained
to
metallic
alloys
or
studies
of
a
single
metal
species
and
did
not
include
information
on
the
multiplicity
of
pigments,
flocculating
agents,
oxidants,
photochromic
salts,
flame
retardants,
catalysts,
and
other
inorganic
compounds
for
which
data
is
sought
through
the
IURA.
In
some
cases,
the
data
sources
were
one­
time
collections
of
information
and
therefore
would
not
provide
current
information
on
the
inorganic
chemical
industries.
Others,
although
revised
from
time
to
time,
did
not
identify
the
chemicals
with
sufficient
specificity,
did
not
identify
the
manufacturing
site
or
a
technical
contact,
and/
or
did
not
provide
information
on
the
use
of
the
inorganic
chemical.
In
sum,
the
data
sources
identified
by
commenters
and
by
EPA
are
not
sufficient
to
provide
the
information
sought
through
the
IURA.
Additional
discussion
of
the
applicability
of
the
data
sources
is
found
in
"
Inorganic
Chemicals:
Sources
of
Information
Suggested
by
Commenters
to
the
Proposed
Inventory
Update
Rule
Amendments"
(
Ref.
26).

One
source
suggested
by
commenters
was
the
USGS
mineral
summaries.
The
USGS
Mineral
Commodity
Summaries
provide
annual
information
on
the
total
production
of
a
chemical,

in
thousands
of
metric
tons,
in
the
United
States.
This
information
is
presented
in
aggregate
and
it
is
not
broken
down
by
site;
in
contrast,
the
IURA
requires
this
information
for
each
site
required
to
report
under
the
rule.
Similarly,
the
USGS
Mineral
Industry
Surveys
provide
data
on
total
production,
imports,
and
consumption
of
each
chemical.
However,
this
information
is
also
presented
as
an
aggregate
and
would
not
be
of
use
for
site­
specific
information,
does
not
contain
specific
location
information,
does
not
indicate
a
tie­
in
to
any
parent
company,
and
does
not
contain
a
certification
of
accuracy
of
the
information.
Both
of
these
reports
provide
information
on
broad
chemical
categories
such
as
a
certain
metal
and
its
compounds.
In
such
a
USGS
category,
how
many
and
which
different
inorganic
chemicals
are
currently
manufactured
and
distributed
in
commerce
cannot
be
identified.
Users
of
these
sources
also
cannot
determine
if
the
USGS
reports
include
organic
substances
such
as
tetramethyl
lead
and
tetraethyl
lead
among
the
metal
compounds.
Additionally,
USGS
data
does
not
contain
the
other
exposure
information
collected
by
the
IURA,
including
certain
manufacturing,
processing,
or
use
information.
The
Page
87
of
159
USGS
data
varies
widely
from
chemical
to
chemical;
there
is
no
consistency
in
the
type
of
information
contained
in
these
summaries.
Therefore,
USGS
data
would
not
be
adequate
substitutes
for
IURA
reporting.
Production
volume
alone
provides
only
a
very
rough
idea
of
potential
exposure.

EPA
did
investigate
with
USGS
the
possibilities
of
collecting
IURA­
like
information
through
the
USGS
voluntary
reporting
process.
USGS
participated
in
this
investigation,
but
determined
that
using
USGS
to
collect
this
information
was
not
a
viable
option
due
to
the
wide
variation
in
data
collected,
the
differences
in
the
entities
from
whom
we
collect
information,
the
nature
of
a
voluntary
collection,
and
some
legal
challenges
associated
with
USGS
sharing
information
with
EPA.
(
Ref.
27)

EPA
disagrees
with
the
statement
that
available
public
information
is
sufficient
to
fulfill
EPA's
purposes
for
collecting
information
on
inorganic
chemicals
through
the
IURA.
EPA
is
in
a
unique
position
to
collect
this
data
using
TSCA.
TSCA
data
are
secured
by
regulation
directly
from
market
participants.
Market
participants,
the
regulated
community
entities,
are
required
to
provide
the
requested
information.
Sensitive
and
confidential
information
is
protected
by
statute
and
must
be
provided.
In
contrast,
other
information
collection
authorities
may
rely
on
surveys,

on
literature
searches,
or
on
the
voluntary
responses
of
entities
to
queries.
Some
information
may
be
sensitive
or
confidential
and
therefore
the
survey
participant
may
find
it
inappropriate
to
reveal
it.
Literature
searches
are
necessarily
limited
because
they
only
capture
information
actually
in
literature
and
that
literature
suffers
the
same
flaws
as
surveys,
queries,
etc.
In
short,
data
collected
under
the
IURA
is
more
reliable
than
the
data
available
from
other
sources.

Comment
C.
1d­
4:
Commenters
stated
that,
if
EPA
were
to
have
specific
concerns
for
substances
or
categories,
the
selective
use
of
TSCA
Preliminary
Assessment
Information
Reporting
(
PAIR)
(
40
CFR
part
712)
reporting
would
be
more
cost
effective
than
requiring
all
manufacturers
exceeding
a
production
trigger
to
report
production,
use,
and
exposure
information.
This
approach
would
allow
EPA
to
collect
data
for
those
inorganic
substances
for
which
it
actually
is
ready
to
perform
screening
and
prioritizing
(
i.
e.,
gather
data
on
a
case­
by­
case
basis).

Source:
C1­
011,
C1­
015,
C1­
017,
C1­
020,
C1­
027,
C1­
028,
C1­
033,
C1­
038,
C1­
041,

C1­
043,
C1­
044,
C1­
060
Response
C.
1d­
4:
While
the
Agency
agrees
that
PAIR
is
an
effective
and
useful
tool
for
Page
88
of
159
collecting
information
on
specific
chemicals
or
small
groups
of
chemicals,
chemical
specific
collections
of
data
will
not
fulfill
the
Agency's
reasons
for
collecting
the
IURA
inorganic
information
(
see
the
discussion
in
the
response
to
comment
C.
1b­
1).
Use
of
PAIR
in
this
manner
implies
that
EPA
should
continue
to
set
risk
screening
priorities
based
on
hazard
and
production
volume
alone,
or
in
response
to
requests
from
others.
As
discussed
in
the
document
entitled
"
A
Review
of
Existing
Exposure­
Related
Data
Sources
and
Approaches
to
Screening
Chemicals:
A
Response
To
CMA,"
(
Ref.
24)
this
approach
greatly
hinders
EPA's
ability
to
make
effective
and
efficient
risk
management
decisions.
The
response
to
comment
A.
3­
1
contains
a
further
discussion
of
reporting
under
PAIR.

e.
Specific
inorganic
chemical
substances
and
industries
Comment
C.
1e­
1:
Commenters
requested
that
EPA
clarify
whether
mining
is
considered
"
manufacturing"
under
TSCA.
They
argued
that
common
references
such
as
the
NAICS
system
and
a
dictionary
definition
indicate
that
the
term
manufacturing
does
not
include
mining
activities.

In
addition,
they
suggested
that
EPA
exclude
mined
materials
from
IUR
reporting
requirements,

arguing
that
the
category
for
naturally
occurring
substances
should
include
substances
that
are
produced
by
mining
operations.
According
to
one
commenter,
if
EPA
were
to
require
reporting
by
everyone
who
removes
more
than
25,000
pounds
of
material
from
the
ground,
this
would
result
in
a
huge
number
of
new
reporting
entities.
For
example,
one
large
truckload
of
sand,

rocks,
or
topsoil
weighs
well
over
the
production
volume
trigger.

Source:
C1­
008,
C1­
014,
C1­
053,
C1­
054,
C1­
067
Response
C.
1e­
1:
Mining,
such
as
extracting
metal
ore
or
minerals
from
their
natural
deposits
by
any
means,
including
the
secondary
recovery
of
metal
ore
from
reuse
or
other
storage
piles,
wastes,
or
rock
dumps,
or
from
mill
tailings
derived
from
the
mining,
cleaning,
or
concentration
of
metal
ores,
is
considered
"
manufacturing"
for
commercial
purposes
within
the
scope
of
TSCA.
However,
chemical
substances
which
are
naturally
occurring
and
which,
among
other
things,
are
(
i)
unprocessed
or
(
ii)
processed
only
by
manual,
mechanical,
or
gravitational
means
(
see
40
CFR
710.4(
b)(
1))
are
currently
excluded
from
IUR
reporting
and
would
continue
to
be
excluded
under
these
IUR
amendments.
For
example,
rocks,
ores,
and
minerals
would
not
be
IUR­
reportable
to
the
extent
they
are
manufactured
only
via
the
means
described
in
40
CFR
710.4(
b).
The
§
710.4(
b)
exclusion
is
a
process
specific
exclusion
rather
than
a
chemical
specific
Page
89
of
159
one,
therefore
persons
who
manufacture
a
substance
in
a
manner
other
than
as
specified
in
§
710.4(
b)
are
required
to
report
under
IUR
unless
they
or
the
substance
they
manufacture
are
otherwise
excluded.
As
a
result,
many
mined
materials
are
listed
on
the
TSCA
Inventory
because
at
least
some
of
the
time
they
are
produced
by
"
non­
natural"
means.

Comment
C.
1e­
2:
One
commenter
identified
multiple
counting
problems
for
mined
materials,
and
suggested
that
these
materials
would
be
reported
under
IURA
when
they
are
mined,
when
they
are
processed
or
manufactured
on
site,
and
when
they
are
remanufactured
due
to
recycling
efforts.

Source:
C1­
016,
C1­
026
Response
C.
1e­
2:
EPA
disagrees
that
there
is
such
a
multiple
counting
problem
for
mined
materials.
It
is
true
that,
to
the
extent
that
mined
materials
undergo
processes
that
result
in
the
materials
no
longer
being
considered
"
naturally
occurring"
(
see
40
CFR
710.4(
b)
and
40
CFR
710.46(
a)(
3)),
they
would
have
to
be
reported
under
IURA.
However,
with
respect
to
certain
"
remanufacturing
activities"
due
to
recycling
efforts,
these
are
often
considered
by
the
Agency
to
be
processing
rather
than
manufacturing
activities.
"
Process"
is
defined
in
40
CFR
710.3
as
the
preparation
of
a
chemical
substance
or
mixture,
after
its
manufacture,
for
distribution
in
commerce
(
1)
in
the
same
form
or
physical
state
as,
or
in
a
different
form
or
physical
state
from,

that
in
which
it
was
received
by
the
person
so
preparing
such
substance
or
mixture,
or
(
2)
as
part
of
a
mixture
or
article
containing
the
chemical
substance
or
mixture.
In
applying
this
definition
to
a
"
remanufacturing"
situation,
a
person
reclaiming
lead
from
batteries
by
operations
including
melting
down
the
lead
is
a
processor,
not
a
manufacturer.
Therefore,
the
reclaimed
lead
is
not
subject
to
the
IUR
reporting
requirements,
assuming
the
person
does
not
generate
new
amounts
of
lead
through
a
chemical
reaction
or
other
method
that
falls
outside
the
"
process"
definition.
If
any
lead
were
to
be
generated
via
chemical
reaction
or
other
non­
processing
method,
such
as
by
reducing
lead
salts,
that
lead
would
be
considered
to
have
been
manufactured
and
would
be
IURA
reportable.

Comment
C.
1e­
3:
Various
commenters
stated
that
either
metals
as
a
group,
or
various
specific
metals
such
as
zinc
and
copper,
should
be
granted
special
consideration
for
IURA
reporting.
Several
commenters
were
concerned
that
information
on
average
and
maximum
concentration
is
meaningless
for
the
metals,
since
they
will
have
close
to
100
percent
Page
90
of
159
concentrations
when
they
leave
the
manufacturing
site
and
when
they
are
present
in
consumer
or
commercial
products,
and
the
only
potential
exposure
will
be
dermal
(
not
inhalation
or
ingestion).

Additionally,
a
commenter
felt
that
in
the
case
of
metals,
workers
"
in
proximity"
to
or
handling
solid
metal
articles
should
not
be
considered
to
be
exposed
for
reporting
purposes
because
the
metal
is
in
a
form
in
which
neither
inhalation
nor
dermal
exposure
will
occur.
One
commenter
stated
chemicals
contained
in
"
articles"
should
be
exempted,
such
as
metals
used
in
coatings
or
alloys
in
steel
and
then
used
in
products
such
as
appliances
or
automobiles.

Source:
C1­
007,
C1­
014,
C1­
017,
C1­
021,
C1­
033,
C1­
038,
C1­
044,
C1­
054
Response
C.
1e­
3:
EPA
agrees
that
the
metals
present
some
unique
issues
regarding
exposure
potential.
However,
EPA
does
not
agree
that
the
information
on
the
concentration
of
metals
is
meaningless.
Not
all
products
with
metal
constituents
would
contain
a
single
metal,
or
would
have
metals
forming
100
percent
of
the
product.
For
example,
although
primary
cobalt
producers
might
manufacture
cobalt
strips
or
shot
(
pellets)
at
100%
concentration,
downstream
producers
of
pigments
and
paints
could
manufacture
products
of
which
cobalt
is
only
some
percentage
of
the
total
product,
and
present
in
a
form
(
such
as
a
paste
or
powder)
where
the
metal
could
be
released
during
processing
or
use,
and
to
which
workers
or
consumers
could
be
exposed.
Dermal
exposure
could
be
of
concern
for
certain
metals
such
as
nickel,
where
contact
dermatitis
can
occur
from
chronic
exposure.
For
other
metals,
such
as
antimony
and
beryllium,

inhalation
exposure
is
a
primary
concern
because
of
potential
effects
on
the
lungs.
Ingestion
exposure
is
of
concern
for
metals,
such
as
cadmium
and
chromium,
that
may
be
released
to
the
environment
and
enter
water
sources.
Although
EPA
is
requiring
the
reporting
of
maximum
concentration
information
under
IURA
for
metals,
the
Agency
has
eliminated
its
proposed
average
concentration
data
element
from
the
rule
(
see
).

Although
metals
may
be
initially
refined
so
as
to
be
as
pure
as
economically
achievable,

many
metals,
particularly
more
dense
metals
with
toxic
characteristics
in
the
body,
are
reacted
to
form
complex
chemical
substances.
Examples
include
pigments
containing
lead,
copper,

cadmium,
titanium,
and
chromium;
catalysts
containing
nickel,
manganese,
vanadium,
and
palladium;
and
electronic
and
semiconductor
materials
containing
lithium,
antimony,
arsenic,

indium,
and
gallium.
For
chemical
substances
in
which
the
amount
of
the
metal
may
be
only
a
few
percent,
the
concentration
of
the
metal
and
its
compounds
is
an
important
factor
is
assessing
the
toxicity
of
the
chemical
substance
and
its
dispersal
and
fate
in
the
environment.

EPA
has
exempted
chemicals
that
would
otherwise
be
subject
to
IUR
reporting
from
such
Page
91
of
159
reporting
where
they
are
imported
as
part
of
an
article
(
see
40
CFR
710.50(
b)).
Items
such
as
metal
ingots,
billets,
and
blooms,
however,
are
not
considered
articles
because
the
shape
in
which
they
are
manufactured
has
no
function
in
their
end
use,
i.
e.,
their
shape
is
not
maintained
as
an
essential
feature
in
the
finished
product
(
Ref.
28).

Comment
C.
1e­
4:
Commenters
stated
that
they
believed
reporting
on
metals
is
unnecessary
and
an
exemption
for
metals
and
metal
byproducts
should
be
retained.
Commenters
stated
that
ample
information
on
metals
production
and
exposure
potentials
is
already
available.

The
commenters
state
that
zinc
and
copper
can
be
found
in
dietary
supplements
and
therefore
cannot
be
harmful
to
human
health.
Some
of
these
commenters
suggested
sources
of
information
that
may
be
duplicative
of
the
information
that
would
be
collected
on
metals
under
IURA,
such
as
the
U.
S.
Geological
Survey
(
USGS)
or
various
trade
associations.
One
commenter
stated
that
the
hazard
potential
for
metals
is
well­
established
and
in
many
cases
concerns
about
exposure
have
already
been
addressed
by
federal
and
state
laws
and
regulations.

Source:
C1­
016,
C1­
017,
C1­
019,
C1­
038,
C1­
044,
C1­
060
Response
C.
1e­
4:
The
Agency
reviewed
a
number
of
sources
that
provide
information
about
metals
production
and
characteristics,
including
the
USGS
data
specifically
noted
by
commenters.
The
information
available
through
these
sources,
although
useful
for
depicting
global
mining
for
and
production
of
the
major
commercial
metals,
is
not
comparable
to
the
national
production
scale
and
domestic
exposures
data
that
would
be
provided
under
the
IURA.

The
response
to
comment
C.
1d­
3,
above,
provides
detail
concerning
EPA's
reexamination
of
the
data
sources
noted
by
the
commenters.
For
example,
many
commenters
specifically
mentioned
the
USGS
Mineral
Commodity
Summaries
(
http://
minerals.
usgs.
gov/
minerals/
pubs/
mcs/)
and
Mineral
Industry
Surveys
(
http://
minerals.
usgs.
gov/
minerals/
pubs/
commodity/
mis.
html).
The
USGS
Mineral
Commodity
Summaries
provide
annual
information
on
the
total
production
of
a
mineral,
in
thousands
of
metric
tons,
in
the
United
States.
This
information
is
presented
in
aggregate
and
it
is
not
broken
down
by
site;
in
contrast,
the
TSCA
Inventory
Update
Rule
gathers
this
information
for
each
site
required
to
report
under
the
Rule.
Similarly,
the
USGS
Mineral
Industry
Surveys
provide
data
on
total
production,
imports,
and
consumption
of
each
mineral.

However,
this
information
is
also
generally
presented
as
an
aggregate
and
does
not
provide
sitespecific
information,
does
not
contain
specific
location
information,
does
not
indicate
a
tie­
in
to
any
parent
company,
and
does
not
contain
a
certification
of
accuracy
of
the
information,
all
of
Page
92
of
159
which
will
be
provided
under
the
IURA.
Site­
specific
information
is
needed
in
order
to
determine
the
effect
of
manufacture
and
potential
releases
of
the
chemical
to
local
environments,
and
to
generate
screening
level
estimates
of
potential
exposures
to
workers.
Additionally,
site
specific
information
increases
the
flexibility
of
the
IURA
data
elements.
It
gives
the
Agency
the
freedom
to
aggregate
the
data
in
multiple
ways
to
suit
multiple
analytical
purposes,
thereby
significantly
increasing
the
utility
of
the
data.
The
USGS
sources
also
do
not
provide
information
on
specific
metal
substances,
such
as
inorganic
oxides,
halides,
or
sulfates.
As
described
in
the
response
to
comment
C.
1d­
3,
EPA
did
investigate
with
USGS
the
possibilities
of
collecting
IURA­
like
information
through
the
USGS
voluntary
reporting
process.
USGS
participated
in
this
investigation,
but
determined
that
using
USGS
to
collect
this
information
was
not
a
viable
option
due
to
the
wide
variation
in
data
collected,
the
differences
in
the
entities
from
whom
we
collect
information,
the
nature
of
a
voluntary
collection,
and
some
legal
challenges
associated
with
USGS
sharing
information
with
EPA.
(
Ref.
27)

Although
EPA
believes
that
the
hazard
potential
for
metals
is
relatively
well
established,

EPA
needs
exposure
information
to
screen
these
chemicals
for
potential
risk.
Risk
is
composed
of
both
hazard
and
exposure.
For
instance,
zinc,
copper,
and
other
metals
found
in
trace
amounts
in
dietary
supplements
are
not
inherently
safe
and
may
be
toxic
in
amounts
higher
than
the
FDA's
Recommended
Daily
Allowance.
As
a
result,
information
on
the
exposure
potential
associated
with
a
particular
metal
is
needed.
Likewise,
EPA
and
others
are
interested
in
the
effect
of
metals
on
the
environment,
and
not
just
the
direct
effect
on
human
health.

EPA
acknowledges
that
Federal
and
state
laws
address
some
exposure
issues
associated
with
metals.
However,
many
of
the
current
laws
address
very
specific
issues,
such
as
the
release
of
a
chemical
into
the
environment,
or
the
recycling
or
disposal
of
metal
or
metal­
containing
items
or
wastes.
The
IURA,
which
focuses
on
the
manufacturing,
processing
and
uses
of
metal
or
metal­
containing
products
in
commerce,
develops
a
reporting
system
for
obtaining
current
exposure­
related
information
that
can
improve,
augment,
or
validate
Agency
risk
assessment
or
risk
management
activities.
This
information
will
allow
EPA
and
other
interested
parties
to
identify
changes
in
use
patterns
or
areas
of
future
potential
concern,
and
to
measure
the
effectiveness
of
Agency
programs
which
stipulate
controls
on
metal
manufacture,
process,
and
use.
For
instance,
if
the
Agency
institutes
a
program
with
the
intent
of
reducing
the
use
of
a
certain
substance,
IURA
reporting
can
provide
data
to
determine
if
production
or
use
patterns
of
that
substance
are
changing.

Comment
C.
1e­
5:
A
commenter
stated
that
the
hazard
potential
of
aluminum
and
its
Page
93
of
159
related
compounds
continues
to
be
well­
established
and
ample
data
exist
on
its
health
and
safety.

OSHA
has
relied
on
available
data
to
perform
risk
assessments
and
make
risk
management
decisions,
therefore
enough
information
should
be
available
to
EPA
to
enable
it
to
screen
for
risk.

Non­
fibrous
aluminum
oxide
has
been
delisted
from
the
Toxic
Release
Inventory.
The
commenter
states
that
the
Agency's
proposal
to
require
IUR
reporting
for
non­
fibrous
aluminum
oxide
ignores
the
Agency's
previous
analysis
of
the
hazard
potential
of
this
substance.

Source:
C1­
044
Response
C.
1e­
5:
The
Agency
agrees
that
the
hazard
potentials
of
aluminum
and
its
related
compounds
have
been
well­
established,
with
substantive
health
and
safety
data
available.

However,
the
major
issues
surrounding
the
reporting
of
aluminum
and
related
products
under
the
IURA
concern
the
possible
exposure
profiles
of
those
chemicals
in
commerce,
as
well
as
the
examination
of
potential
risks
from
previously
unreported
uses
of
these
substances.
Chemicals
with
relatively
moderate
or
even
low
hazard
can
pose
harm
to
human
health
and/
or
the
environment
with
enough
exposure.

OSHA
is
primarily
concerned
with
occupational
health
risks
and
its
risk
assessments,

based
on
available
occupational
exposure
data
and
hazard
information,
focus
on
potential
risks
to
workers.
EPA's
risk
assessments
are
broader
in
scope
and
may
include
potential
risks
to
the
general
population
or
consumers
as
well
as
workers;
therefore,
additional
exposure­
related
data
are
needed
and
are
being
collected
via
IURA.
Similarly,
the
available
information
on
non­
fibrous
aluminum
oxide
would
be
augmented
by
IURA
reporting
regardless
of
any
change
or
lack
or
change
in
the
hazard
data,
because
possible
manufacturing,
processing,
and
use­
related
exposures
not
reflected
in
available
TRI
data
could
be
obtained.
TRI
listing
decisions
are
based
on
hazard
issues
and
not
on
exposure
issues.
Since
risk
is
a
combination
of
both
hazard
and
exposure
(
i.
e.,

low
hazard
and
high
exposure
may
lead
to
a
risk
level
of
concern),
a
decision
to
delist
a
chemical
from
TRI
does
not
mean
the
Agency
has
not
concern
for
potential
risks
associated
with
the
chemical.

Comment
C.
1e­
6:
Commenters
stated
that
lead
has
been
extensively
studied
and
its
hazard
potential
reviewed
on
a
continuing
basis
under
a
variety
of
Federal
programs,
all
providing
voluminous
data
readily
available
to
the
public.
EPA
has
already
conducted
and
completed
a
review
of
lead
in
the
environment
(
see
56
FR
22096
(
May
13,
1991))
and
has
investigated
leadbattery
recycling
issues.
Exposure
to
lead
is
also
covered
under
the
Clean
Air
Act,
the
Clean
Page
94
of
159
Water
Act,
the
Safe
Drinking
Water
Act,
the
Resource
Conservation
and
Recovery
Act,
and
the
Comprehensive
Environmental
Response,
Compensation,
and
Liability
Act.

Source:
C1­
042,
C1­
050
Response
C.
1e­
6:
EPA
acknowledges
that
lead
has
been
studied
extensively
and
that
lead
is
the
subject
of
various
Agency
and
other
programs.
These
studies
characterize
the
toxicity
of
lead,
and
a
variety
of
associated
programs
have
been
developed
to
address
lead
hazards.

However,
the
documents
and
program
areas
identified
by
commenters
generally
pertain
to
releases
of
lead
into
the
environment,
or
recycling/
disposal
of
lead­
containing
items
or
wastes.

The
IURA
focuses
on
the
manufacturing,
processing
and
use
of
lead­
containing
items
in
commerce.
The
cited
statutes,
notably
CWA,
CAA,
SDWA,
RCRA,
and
CERCLA,
generally
authorize
regulations
that
address
the
allowable
emissions,
contaminant
levels,
and
control
practices
for
lead
or
lead­
containing
wastes
and
contaminants.
In
contrast,
the
IURA
develops
a
reporting
system
for
obtaining
current
exposure­
related
information
that
can
improve,
augment,

or
validate
Agency
risk
assessment
or
risk
management
activities.
The
fact
that
lead
is
a
known
hazard
is
a
compelling
reason
to
track
its
future
use
and
manufacture.
This
information
will
allow
EPA
and
other
interested
parties
to
identify
any
changes
in
use
patterns
or
areas
of
future
potential
concern,
and
to
measure
the
effectiveness
of
Agency
programs
which
stipulate
controls
on
lead
manufacture,
import,
and
use.
For
instance,
if
the
Agency
institutes
a
program
with
the
intent
of
reducing
the
use
of
a
lead,
IURA
reporting
can
provide
data
to
determine
if
production
or
use
patterns
of
lead
are
changing.

Comment
C.
1e­
7:
A
commenter
stated
that
information
on
nickel
and
high
nickel
alloys
is
already
collected
by
the
USGS
and
the
TRI
program,
and
that
sufficient
information
to
conduct
risk
screening
and
priority
setting
for
nickel
are
available.
The
commenter
lists
the
following
documents
as
sources
of
information
on
Nickel:
Health
Assessment
Document
for
Nickel
and
Nickel
Compounds
(
EPA,
1986);
Toxicological
Profile
for
Nickel
and
associated
updates
(
ATSDR,
September
1997);
Toxicological
Review
of
Soluble
Nickel
Salts
(
Toxicology
Excellence
for
Risk
Assessment,
2000);
and
Occupational
Exposure
Limits
Criteria
Document
for
Nickel
and
Nickel
Compounds
(
European
Commission,
Dec
24,
1996).
The
commenter
also
states
that
the
Nickel
Development
Institute
(
NiDI),
the
major
industry
trade
association,

periodically
issues
data
on
intermediate
and
end­
use
applications
of
nickeland
that
ATSDR,
the
European
Commission,
and
others
have
profiled
the
primary
and
secondary
production
and
uses
Page
95
of
159
of
and
exposures
to
nickel.
Additionally,
EPA
has
used
these
data
to
develop
EPA's
Risk
Screening
Environmental
Indicator
(
RSEI)
values
in
OPPT.
The
commenter
states
that
these
RSEI
values
seem
to
be
exactly
what
the
Agency
is
seeking
through
the
IURA.

Source:
C1­
007
Response
C.
1e­
7:
EPA
agrees
that
the
sources
cited
by
commenters
contain
useful
information
on
the
hazards
of,
and
exposures
to
nickel.
The
Agency
disagrees
that
the
sources
cited
by
commenters
for
nickel
contain
sufficient
information
to
meet
Agency
risk
screening
needs,
especially
over
time.
The
major
goal
of
the
IURA
is
to
obtain
current
exposure­
related
information
involving
manufacturing,
processing
and
uses
of
chemicals
in
commerce.
Sample
information
on
nickel,
as
well
as
other
metals,
from
the
USGS,
ATSDR,
and
NiDI
has
been
reviewed,
and
is
either
relatively
general
or
does
not
provide
current
exposure
data.
For
instance,

the
1996
European
Commission
(
EC)
Occupational
Exposure
Limits
Criteria
Document
for
Nickel
and
Nickel
Compounds,
used
to
set
occupational
exposure
limits
for
nickel
and
nickel
compounds,
is
a
comprehensive
document
which
has
several
important
weaknesses
when
considered
in
light
of
the
IURA
data.
The
EC
report
lacks
the
U.
S.
site­
specific
data
necessary
for
EPA
screening
processes.
More
importantly,
this
report
will
gradually
become
out­
of­
date,
as
there
are
apparently
no
plans
to
update
it.
The
abstract
to
the
proceedings
of
the
Nickel­
Cobalt
97
International
Symposium,
also
provided
by
the
commenter,
states
that
nickel's
versatility
"
makes
it
indispensable
in
applications
as
diverse
as
food
preparation
and
handling,
architecture,

transportation,
oil
and
gas
production,
chemicals
processing,
potable
water
treatment,
gas
turbines,
and
environmental
protection.
The
longer
term
outlook
for
nickel
is
quite
buoyant."

The
summary
concludes
with
"
as
we
enter
the
twenty­
first
century,
nickel,
its
steels
and
alloys
should
continue
to
be
optimum
material
choices
for
service
in
tough
environments
and
critical
applications."
As
with
all
chemicals,
the
uses
of
nickel
are
likely
to
grow
and
change
in
the
future,
thereby
supporting
the
need
for
updated
information
on
the
uses
of
this
commercially
important
chemical.

Sources
such
as
the
EPA
and
ATSDR
documents
focus
on
nickel
hazards
rather
than
exposures,
unlike
the
IURA
data.
Although
such
information
can
be
useful
in
developing
RSEI
values,
these
values
do
not
fulfill
all
the
needs
expected
to
be
met
by
the
IURA.
(
See
http://
www.
epa.
gov/
opptintr/
rsei/
for
information
on
RSEI)
The
RSEI
project
primarily
uses
emissions
data,
such
as
from
TRI,
to
predict
screening­
level
human
health
and
ecological
risks
from
environmental
releases,
whereas
IURA
submissions
provide
site
specific,
exposure­
related
Page
96
of
159
data
on
chemical
manufacturing,
processing,
and
use.
The
IURA
data
might
be
useful
in
supplementing
the
RSEI
values,
rather
than
considering
these
values
as
substitutes
for
IURA
data.

The
IURA
involves
a
reporting
system
for
obtaining
current
exposure­
related
information
that
can
improve,
augment,
or
validate
Agency
risk
screening
or
risk
management
activities.

Because
nickel
is
a
known
hazard,
to
its
future
use
and
manufacture
should
be
monitored.

This
information
will
allow
EPA
and
other
interested
parties
to
identify
any
changes
in
use
patterns
or
areas
of
future
potential
concern,
and
to
measure
the
effectiveness
of
Agency
programs
which
regulate
nickel
manufacture,
import,
and
use.

Nickel
alloys
are
not
reportable
under
IUR
because
EPA
considers
alloys
to
be
nonreportable
mixtures.
While
manufacturers
of
individual
metals
and
metal
compounds
have
to
report
the
metal
manufactured,
manufacturers
of
alloys
may
not
need
to
report
alloys.
Further
discussion
of
reportability
of
inorganic
substances
is
found
in
Unit
II.
F.
1.
a.
of
the
final
rule
preamble.

Comment
C.
1e­
8:
A
commenter
representing
color
pigment
manufacturers,
who
used
to
make
products
such
as
ceramic
wares,
requested
that
EPA
explain
what
significant
hazard
the
Agency
has
established
for
ceramic
wares
and
related
products
in
the
marketplace.
The
commenter
stated
that
compounds
such
as
iron
oxides
and
complex
inorganic
color
pigments
are
extremely
safe
and
pose
no
risk
to
humans
or
the
environment.

Source:
C1­
026
Response
C.
1e­
8:
EPA
disagrees
with
the
comment
that
inorganic
color
pigments
pose
no
risk
to
humans
or
the
environment.
Some
of
the
inorganic
pigments
used
in
these
items
contain
heavy
metals.
Some,
for
example
lead
and
zinc
chromates,
are
possible
human
carcinogens.

Some,
such
as
calcium
carbonate,
kaolin,
titanium
oxide,
and
zinc,
could
present
respiratory
hazards.

Additionally,
the
International
Agency
for
Research
on
Cancer
(
IARC)
monograph
on
silica
and
silicates
(
i.
e.,
major
components
of
ceramic
ware)
indicates
that
dusts
formed
during
manufacturing,
processing
or
use
of
some
ceramic
ware
are
possible
human
carcinogens
through
inhalation
(
See
World
Health
Organization
(
WHO)
International
Agency
for
Research
on
Cancer
(
IARC)
Monographs
on
the
Evaluation
of
the
Carcinogenic
Risk
of
Chemicals
to
Humans.
Silica
and
Some
Silicates.
Volume
42,
(
1987)).
Page
97
of
159
Comment
C.
1e­
9:
A
commenter
suggested
that
collecting
IURA
information
on
the
large
number
of
salts
in
commerce
will
not
provide
any
additional
information
of
value.
Salts
are
especially
difficult
to
deal
with
in
mixtures
that
are
imported.
There
could
have
been
many
steps
in
the
processing
of
substances
that
would
lead
to
different
salts
being
formed,
for
example,

through
neutralization.
The
actual
salt
formed
may
be
inconsequential
to
the
properties
of
the
product.
For
example,
if
hydrochloric
acid
was
neutralized
using
sodium
hydroxide,
would
sodium
chloride
be
reported
or
the
acid
and
base
used
in
the
formulation?

Source:
C1­
061
Response
C.
1e­
9:
EPA
disagrees
that
information
on
salts
will
not
be
of
value.
the
Agency
believes
that
there
are
many
inorganic
substances,
including
salts,
for
which
the
hazards
are
not
well
established
and
where
exposure
pathways
are
not
well
understood.

Although
mixtures
as
defined
in
40
CFR
710.3
are
not
reportable
under
IUR,
the
chemical
substances
of
which
a
mixture
is
comprised
are
potentially
reportable.
If
you
manufacture
the
substances
as
part
of
a
mixture,
you
must
determine
for
each
substance
in
the
mixture
whether
the
production
volume
was
at
least
25,000
lbs.
Similarly,
if
you
import
a
mixture
you
must
determine
for
each
substance
in
the
mixture
whether
its
importation
volume
was
at
least
25,000
lbs.
Note
that
a
person
who
creates
a
mixture
by
combining
existing
substances
(
e.
g.
substances
that
the
person
purchased,
but
did
not
manufacture
themselves)
without
a
chemical
reaction
is
not
a
manufacturer
of
those
substances
and
therefore
does
not
report
those
substances
under
IUR.

If
an
acidic
or
basic
substance
is
deliberately
converted
to
a
salt
by
neutralization,
that
constitutes
manufacture
for
commercial
purposes
as
a
chemical
substance
per
se,
rather
than
processing.
The
resulting
salt
would
consequently
be
reportable
under
IUR.
For
instance,
a
company
that
manufactures
hydrochloric
acid
must
potentially
report
under
IUR,
assuming
the
amount
manufactured
is
25,000
lbs.
or
more,
etc.
If
the
same
company
subsequently
purchases
sodium
hydroxide
for
use
in
converting
the
hydrochloric
acid
into
a
salt
via
neutralization
(
which
involves
a
chemical
reaction),
the
company
would
also
potentially
be
subject
to
IUR
reporting
for
its
manufacture
of
the
salt
(
which
is
not
a
mixture).

Comment
C.
1e­
10:
One
commenter
stated
that
its
member
companies
would
continue
to
rely
on
40
CFR
710.26(
d)
(
710.46(
a)(
3)
of
the
new
regulatory
text),
the
exemption
for
naturally
occurring
substances,
as
the
basis
for
a
sodium
chloride
exemption
from
TSCA
IUR
requirements.
Page
98
of
159
Source:
C1­
008
Response
C.
1e­
10:
Sodium
chloride,
as
an
inorganic
material,
is
subject
to
reporting
except
for
that
volume
that
meets
the
requirements
of
the
definition
for
naturally
occurring
substances.
Chemical
substances
which
are
naturally
occurring
and
which,
among
other
things,

are
(
i)
unprocessed
or
(
ii)
processed
only
by
manual,
mechanical,
or
gravitational
means
(
see
40
CFR
710.4(
b)(
1))
are
currently
excluded
from
IUR
reporting
and
continue
to
be
excluded
under
IURA
(
see
40
CFR
710.46(
a)(
3)).
For
example,
rocks,
ores,
and
minerals
are
not
IUR­
reportable
to
the
extent
they
are
manufactured
only
via
the
means
described
in
40
CFR
710.4(
b).
The
§
710.4(
b)
exclusion
is
a
process
specific
exclusion
rather
than
a
chemical
or
industry
specific
one,

therefore
persons
who
manufacture
a
substance
in
a
manner
other
than
as
specified
in
§
710.4(
b)

are
required
to
report
under
IUR
unless
they
or
the
substance
they
manufacture
are
otherwise
excluded.
As
a
result,
sodium
chloride
is
listed
on
the
TSCA
Inventory
because
at
least
some
of
the
time
it
is
produced
by
other
than
manual,
mechanical,
or
gravitational
means.

Section
710.46(
a)(
3)
intentionally
exempts
from
IUR
reporting
any
chemical
substance
which
is
isolated/
removed
from
nature,
for
a
commercial
purpose,
by
any
means
listed
in
§
710.4(
b).
It
also
exempts
any
other
chemical
substance
derived
or
separated
from
the
substance
originally
removed
from
nature,
provided
such
derivation
involved
only
the
means
specified
in
§
710.4(
b).
For
example,
when
using
manual,
mechanical,
or
gravitational
processes
to
separate
one
or
more
substances
from
a
naturally­
occurring
mixture,
these
isolated
component
substances
are
also
considered
naturally­
occurring
and
excluded
from
reporting.
However,
any
substance
manufactured
from
a
naturally
occurring
precursor
substance
via
a
chemical
reaction
is
not
considered
naturally
occurring
and
therefore,
not
excluded
from
reporting
under
§
710.46(
a)(
3).

2.
Natural
Gas
Exemption
Comment
C.
2­
1:
Commenters
expressed
support
for
the
full
exemption
for
the
six
natural
gas
streams
listed
in
the
proposed
IURA.
These
commenters
recommended
adding
the
following
chemicals
to
the
list
of
those
being
fully
exempted:
fuel
oil#
2,
kerosene,
natural
gas
condensate,
liquefied
natural
gas,
alkanes
C4,
methane,
ethane,
propane,
normal
butane,
butane,

isobutane,
pentanes
plus,
pentane,
isopentane,
and
hexane.
The
commenters
stated
that
an
exemption
is
warranted
for
these
chemicals
because
DOE
already
requires
annual
and
monthly
reports
containing
the
same
information
as
requested
by
EPA.
Commenters
also
believe
that
an
exemption
is
warranted
for
these
chemicals
(
they
were
specifically
referring
to
ethane,
butane,
Page
99
of
159
propane,
and
methane)
as
they
are
similar
in
chemical
composition
to
the
six
exempt
streams,
their
chemical
structure
and
identity
remain
the
same
throughout
processing,
a
similar
amount
of
data
is
available
for
these
chemicals
as
for
the
exempt
six
chemicals,
and
these
chemicals
have
a
similar
number
of
TSCA
reports
filed
as
the
six
exempt
streams.

Source:
C1­
010,
C1­
015,
C1­
022,
C1­
027,
C1­
029,
C1­
040,
C1­
043,
C1­
048,
C1­
059
Response
C.
2­
1:
EPA
has
retained
the
natural
gas
exemption
as
proposed.
EPA
has
considered
the
issue
of
adding
the
other
chemicals
suggested.
The
Agency
did
not
include
methane,
ethane,
propane,
butane,
and
other
paraffinic
hydrocarbons
in
the
list
of
substances
excluded
from
IURA
reporting
because
they
are
not
just
isolated
components
of
natural
gas
but
are
also
chemical
substances
which
can
be
produced
from
other
source
materials,
chemical
process
streams,
feedstocks,
or
reactants.
Each
of
the
six
exempted
natural
gas
chemicals
is
a
UVCB
substance
where
the
name
reflects
the
source
(
natural
gas)
and
manufacturing
process
information.
"
UVCB"
is
a
category
defined
by
the
Agency
and
CAS
to
consist
of
substances
of
unknown
or
variable
composition,
complex
reaction
products,
or
biological
materials.
Since
a
UVCB
substance
is
not
considered
a
mixture
under
TSCA,
it
is
not
viewed
as
equivalent
to
a
blend
of
component
chemicals,
regardless
of
source.
Additionally,
there
are
no
other
sources
for
the
six
exempted
substances
and
their
chemical
idenities
are
specific
for
that
one
source
material,

natural
gas.
These
alkanes
have
significant
uses
in
chemical
manufacturing,
including
the
production
of
ammonia
and
methanol
from
synthesis
gas
derived
from
methane,
thermal
cracking
of
ethane/
propane
mixtures
to
produce
ethylene,
and
vapor­
phase
oxidation
of
n­
butane
to
produce
maleic
anhydride.
Although
they
are
less
toxic
than
other
classes
of
hydrocarbons,
these
alkanes
are
asphyxiants
and
higher
homologues
are
central
nervous
system
depressants.
In
addition,
liquid
alkanes
can
remove
oil
from
exposed
skin
and
can
cause
dermatitis
or
pneumonia.

In
any
case,
all
are
discrete
chemical
substances
for
which
processing
and
use
information
will
be
collected
by
the
IURA.

Through
EPA's
own
research
and
consultation
with
a
Department
of
Energy(
DOE)

representative,
the
Agency
determined
that
while
some
useful
information
for
these
chemicals
is
included
in
the
DOE/
Energy
Information
Administration's(
EIA)
survey
forms
64A,
810,
and
816,

the
information
available
in
those
reports
is
insufficient
for
exposure
or
risk
screening.
Chemical
substances
are
not
sufficiently
identified
in
the
DOE
reports
for
EPA
purposes.
For
example,
the
chemical
substances
are
identified
by
a
name
other
than
that
used
by
EPA,
are
identified
in
broad
categories,
and
are
not
identified
by
CAS
number.
DOE
reports
also
do
not
contain
information
Page
100
of
159
on
the
number
of
workers
that
are
reasonably
likely
to
be
exposed
to
the
chemicals
nor
information
on
maximum
concentration.
Downstream
processing
and
use
exposure
information
collected
through
the
amended
IUR
for
these
chemicals
will
be
valuable
to
EPA
and
others.

Liquefied
natural
gas,
which
is
a
form
of
natural
gas
(
CAS
#
8006­
61­
9),
is
covered
under
the
natural
gas
exemption.
Liquefied
natural
gas
is
natural
gas
that
has
been
liquefied
by
reducing
its
temperature
to
111
degrees
K
at
atmospheric
pressure.
It
remains
a
liquid
at
191
degrees
K,

when
the
atmospheric
pressure
is
4.64
MPa
(
or
673
psig).
EPA
considers
that
liquefied
natural
gas
is
the
same
chemical
substance
as
natural
gas.

The
fact
that
the
physical
state
of
a
substance
(
e.
g.
gas,
liquid)
is
different
from
the
original
state
of
that
already
reported
substance
does
not
cause
the
change
of
state
to
have
to
be
reported
under
IURA.
Thus,
a
person
manufacturing
liquefied
natural
gas
through
the
use
of
natural
gas
as
a
raw
material
is
considered
a
processor
of
a
chemical
substance
(
natural
gas)
and
should
not
report
liquefied
natural
gas
for
IUR
reporting.
In
addition,
as
a
result
of
the
new
natural
gas
exemption,
if
this
submitter
were
also
a
manufacturer
of
natural
gas,
it
would
no
longer
be
required
to
report
on
its
manufacture
of
natural
gas
because
that
chemical
is
fully
exempt
from
IUR
reporting.

Comment
C.
2­
2:
A
commenter
asked
why
natural
gas
is
not
already
exempt
from
IUR
reporting
under
the
exemption
for
naturally
occurring
substances,
i.
e.
what
purpose
does
the
separate
exemption
for
certain
forms
of
natural
gas
serve?

Source:
C1­
056
Response
C.
2­
2:
The
naturally
occurring
substances
exemption
covers
chemical
substances
which
are
naturally
occurring
and
which,
among
other
things,
are
(
i)
unprocessed
or
(
ii)
processed
only
by
manual,
mechanical,
or
gravitational
means
(
see
40
CFR
710.4(
b)(
1)).
The
exemption
doesn't
cover
substances
that
are
manufactured
by
means
other
than
those
described
above.
Natural
gas
is
only
naturally
occurring
when
it
meets
the
definition
of
naturally
occurring
substances
and
is
therefore
not
necessarily
exempt
from
reporting
under
the
current
IUR.
The
IURA's
exemption
for
certain
forms
of
natural
gas,
on
the
other
hand,
covers
substances
that
have
been
manufactured
by
means
other
than
those
described
in
the
naturally
occurring
substances
exemption.

Comment
C.
2­
3:
A
commenter
suggested
exempting
natural
gas
processing
plants
from
Page
101
of
159
IUR
reporting.

Source:
C1­
027
Response
C.
2­
3:
Because
of
its
wide
variation
in
composition,
natural
gas
obtained
at
the
wellhead
is
treated
for
safety,
economic,
or
system
and
material
compatibility
reasons.
Produced
gas
is
usually
saturated
with
water
which
is
removed
by
passing
over
liquid
or
solid
desiccants
to
preclude
condensation
and
corrosion
in
transmission
lines.
Poisonous
hydrogen
sulfide
is
removed
from
natural
gas
to
prevent
corrosion
in
transmission
lines
and
to
recover
elemental
sulfur;
common
processes
for
removal
include
adsorption
on
iron
sponge
and
extraction
by
ethanolamine
solutions.
Subsequent
to
separating
and
recovering
acid
gases
from
the
raw
natural
gas,
additional
processing
is
required
to
convert
the
hydrogen
sulfide
to
elemental
sulfur;
sulfur
production
from
natural
gas
exceeds
the
volume
produced
by
mining.
Natural
gas
processing
plants
are
not
simple
operations
in
which
the
constituents
of
natural
gas
are
separated
by
simple
physical
processes
but
often
are
complex
chemical
processing
facilities
at
which
chemical
substances
are
extracted
from
the
produced
gas
by
adsorption,
chemical
addition,
and
cryogenic
separation
with
further
refinement
of
chemical
substances
removed
from
natural
gas
to
produce
economic
products.
Because
of
the
potential
for
risk
posed
by
some
constituents
of
raw
natural
gas
and
the
potential
for
exposure
to
these
constituents
during
processing
and
chemical
transformation
into
economic
products,
natural
gas
processing
plants
have
not
been
exempted
from
IUR
reporting.

3.
Petroleum
Process
Streams
Comment
C.
3­
1:
A
commenter
stated
that
EPA
could
use
the
DOE
data
along
with
other
supplemental
information
sources
to
generate
the
type
of
petroleum
process
stream
information
that
the
IURA
proposed
to
collect.
Several
commenters
also
stated
that
the
proposed
IURA
reporting
would
be
duplicative
of
DOE
reporting
for
certain
chemicals,
particularly
fuel
oil
#
2
and
kerosene,
and
that
EPA
should
therefore
fully
exempt
them
from
reporting
under
IURA.
Several
persons
commented
that
there
is
no
need
to
collect
exposure
data
for
petroleum
process
stream
manufacturing
operations
because
physical
hazards
existing
at
many
sites
currently
necessitate
extensive
safety
precautions
that
limit
worker
exposure.
A
commenter
stated
that
concentration
data
(
both
average
and
maximum
concentration)
for
petroleum
streams
is
too
difficult
to
obtain.

Another
commenter
stated
processing
and
use
information
reported
in
Part
III
of
the
draft
Form
Page
102
of
159
U
is
not
relevant
to
petroleum
process
streams.
The
commenter
stated
that
"
many
of
these
are
site­
limited
(
i.
e.,
do
not
leave
the
refinery),
and
thus
the
data
in
proposed
Part
III
of
Form
U
would
not
be
relevant.
In
addition,
streams
that
do
leave
the
refinery
site
are
incorporated
into
products
for
which
exposure
controls
are
routine
and
required.
The
flammable
and/
or
combustible
nature
of
the
products
requires
special
containment
and
handling,
and
other
practices
designed
to
minimize
hazard
and
exposure.
The
Part
III
information,
which
does
not
account
for
any
of
these
practices
and
safeguards,
would
not
yield
useful
information
regarding
exposures
for
petroleum
products."

Source:
C1­
010,
C1­
027,
C1­
043,
C1­
047,
C1­
048
Response
C.
3­
1:
EPA
has
exempted
over
500
petroleum
processing
streams
from
reporting
the
processing
and
use
information
collected
in
Part
III
of
Form
U.
The
CAS
numbers
for
the
exempted
petroleum
processing
streams
are
listed
in
§
710.46(
b)(
1)
of
the
regulatory
text.

EPA
has
investigated
the
information
collection
conducted
by
DOE/
EIA
forms
64A,
810,

and
816
through
its
own
research
and
consultation
with
a
DOE
representative.
The
Agency
determined
that
chemical
substances
are
not
sufficiently
identified
for
EPA's
purposes
in
the
DOE
reports.
For
example,
many
of
the
chemical
substances
in
the
DOE
reports
are
identified
by
nomenclature
other
than
that
used
by
EPA,
are
identified
in
broad
categories,
and
are
not
identified
by
CAS
number.
Many
of
the
chemical
names
used
by
DOE
are
either
generic
or
represent
groups
of
chemicals.
For
example,
distillate
fuel
oil,
reported
on
EIA
Form
810,
may
refer
to
several
chemicals
on
the
TSCA
Inventory
such
as
Fuel
oil
#
2,
Fuel
oil
#
4,
or
Fuel
oil
#
6.

This
lack
of
specific
identifier
information
results
in
information
which
is
not
specific
to
a
chemical,
meaning
the
EPA
and
others
cannot
distinguish
which
information
collected
by
DOE
is
attributable
to
which
chemical.
Correct
identification
is
needed
to
attribute
the
appropriate
hazard
and
physical
and
chemical
properties
to
the
petroleum
stream.
The
DOE
information
also
lacks
important
exposure
components
and
identifiers
that
are
necessary
for
exposure
and
risk
screening
activities.
For
example,
the
DOE
information
does
not
contain
the
number
of
workers
reasonably
likely
to
be
exposed
to
a
chemical
or
the
maximum
concentration
of
the
chemical.
In
addition,
it
may
be
difficult
to
discern
from
the
DOE
data
if
a
petroleum
process
stream
is
used
as
a
solvent
in
a
consumer
product
or
as
a
combustible
fuel.
This
is
an
important
distinction
because
the
likelihood
of
exposure
to
a
petroleum
process
stream
depends
on
its
use.
These
data
are
needed
elements
that
will
fill
a
vital
data
gap
in
chemical
risk
screening.

Manufacturing
exposure
related
data
(
such
as
maximum
concentration,
number
of
Page
103
of
159
workers
reasonably
likely
to
be
exposed)
for
petroleum
process
stream
chemicals
are
needed
despite
workplace
safety
precautions
that
may
be
in
place
at
an
individual
site.
As
it
is
possible
that
methods
used
to
handle
and
store
petroleum
streams
diminish
exposure,
at
this
time
EPA
is
only
requiring
partial
IURA
reporting.
Partial
IURA
reporting
includes
site
location
and
production
volume
information
as
well
as
worker
exposure
information
that
will
enable
the
Agency
to
focus
on
those
industries
and
uses
of
chemicals
where
the
greatest
risk
exists.

Concentration
is
an
important
variable
to
consider
when
estimating
magnitude
of
potential
exposures.
EPA
is
not
requiring
reporting
of
average
concentration
and
is
requiring
reporting
of
maximum
concentration.
Maximum
concentration
information
is
used
in
screening
chemicals
on
the
TSCA
Inventory
and
in
the
review
of
Premanufacture
Notices
(
PMNs)
for
new
chemical
substances
required
by
§
5
of
TSCA.
EPA
does
not
intend
for
submitters
to
go
to
great
lengths
to
report
concentration
information
under
IURA.
Instead,
EPA
is
simply
requiring
that
submitters
select
a
range
of
concentrations
from
a
list
of
given
ranges
(
less
than
1%
by
weight;
1­
30%
by
weight;
31­
60%
by
weight;
61
­
90%
by
weight,
and
greater
that
90%
by
weight)
to
indicate
the
maximum
concentration
of
an
IUR­
reportable
chemical
in
shipments
leaving
the
submitter's
site.

4.
Other
Chemical
Categories
a.
High
Production
Volume
Chemicals
Comment
C.
4a­
1:
Industry
states
that
it
is
already
providing
EPA
with
sufficient
toxicity
data
via
the
HPV
Challenge
Program,
as
well
as
exposure
data
through
other
voluntary
programs
(
e.
g.
ICCA,
UEIP).
Providing
screening­
level
exposure­
related
information
via
the
IURA
would
be
duplicative
and
unnecessary.
Some
commenters
suggested
that
EPA
should
limit
the
IURA
reporting
requirements
to
HPV
chemicals
that
are
sponsored
by
industry
under
the
HPV
Challenge
Program,
while
others
suggested
that
EPA
should
limit
IURA
reporting
requirements
to
HPV
chemicals
not
sponsored
by
industry
under
the
HPV
Challenge
Program.
One
commenter
asked
why
the
voluntary
HPV
Challenge
Program
can't
be
modified
to
include
screening­
level
exposure­
related
information,
rather
than
collecting
this
information
via
IURA.
Another
commenter
suggested
reproposing
the
IURA
in
order
to
capture
those
high
production
volume
chemicals
for
which
HPV
Challenge
Program
participants
do
not
provide
a
risk
assessment.

Source:
C1­
010,
C1­
013,
C1­
017,
C1­
018,
C1­
019,
C1­
027,
C1­
028,
C1­
029,
C1­
031,

C1­
033,
C1­
037,
C1­
041,
C1­
046,
C1­
048,
C1­
060,
C1­
061,
C1­
073
Page
104
of
159
Response
C.
4a­
1:
The
Agency
recognizes
that
certain
voluntary
and
regulatory
efforts
to
collect
health
and
environmental
hazard
data
are
underway,
and
that
a
premier
effort
is
the
HPV
Challenge
Program.
However,
the
scope
and
expected
output
from
the
HPV
Challenge
Program
markedly
differ
from
those
anticipated
under
the
IURA.
The
HPV
Challenge
Program
centers
on
providing
hazard
data,
whereas
the
focus
of
IURA
is
on
gathering
exposure­
related
information
for
chemicals
in
a
wide
range
of
industrial
operations,
including
both
manufacturing
and
downstream
applications.
Adding
the
collection
of
IURA
exposure­
related
information
to
the
HPV
Challenge
Program
is
not
an
option
for
several
reasons.
First,
the
HPV
Challenge
is
limited
in
scope
to
only
the
chemicals
included
in
the
program,
thus
eliminating
information
from
other
chemicals.
Second,
the
HPV
program
is
a
one­
time
collection
of
information
and
is
therefore
an
effective
way
to
collect
hazard
data,
which
doesn't
change.
However,
exposure
does
change
as
uses
and
technology
changes
and,
therefore,
a
one­
time
collection
does
not
provide
the
needed
on­
going
information.
Third,
for
the
most
part
the
HPV
challenge
is
a
voluntary
program.
EPA
collected
exposure
information
in
a
voluntary
manner
through
the
UEIP.
As
described
in
the
response
to
comment
A.
3­
4,
the
Agency
found
that
a
voluntary
program
for
IURA
information
would
be
insufficient.

Similarly,
other
data
collection
efforts,
such
as
those
under
the
auspices
of
the
OECD
(
Organization
for
Economic
Cooperation
and
Development)
and
ICCA
(
International
Council
of
Chemical
Associations)
concentrate
on
the
development
of
hazard
assessments,
and
might
provide
only
a
very
small
fraction
of
the
exposure
related
data
called
for
under
IURA.
The
ICCA
and
OECD/
SIDS
(
Screening
Information
Data
Set)
programs
are
international
programs
designed
with
a
very
different
purpose
than
the
amendments
to
the
IUR.
The
goal
of
the
ICCA
Program
is
to
feed
chemical
cases
through
the
SIDS
Program.
The
SIDS
Program
develops
hazard
information
for
these
chemicals,
which
most
likely
does
not
change
from
year
to
year,
thus
supporting
a
one­
time
report.
However,
the
IURA
is
designed
to
provide
current
exposure
related
information
for
risk
screening
and
priority
setting.
EPA
therefore
maintains
that
its
data
reporting
requirements
under
the
IURA
are
justified.

The
effect
of
the
reporting
threshold
for
exposure
related
information
of
300,000
lb/
yr
is
to
ensure
that
the
majority
of
HPV
chemicals
will
report
processing
and
use
information
under
the
IURA,
thereby
limiting
the
information
collection
efforts
to
larger
volume
chemicals.

Additionally,
the
reporting
threshold
approach
is
taken
as
opposed
to
listed
specific
chemicals
since,
before
any
particular
reporting
cycle,
the
Agency
could
not
know
definitively
what
chemicals
are
HPV
substances.
This
is
because
production
volumes
can
vary
significantly,
Page
105
of
159
especially
over
a
four­
year
reporting
cycle,
and
it
is
not
uncommon
for
chemicals
to
rise
above
or
fall
below
the
HPV
threshold
each
reporting
cycle.

The
Agency
does
not
consider
it
appropriate
to
require
reporting
of
exposure
data
only
from
those
who
do
not
voluntarily
provide
exposure
information
through
the
HPV
Challenge
Program.
As
described
in
the
response
to
comment
A.
3­
4,
EPA's
experience
with
the
submission
of
exposure­
related
data
under
similar
voluntary
programs
(
e.
g.,
the
UEIP
voluntary
program)
is
that
EPA
cannot
predict
what
information
will
be
supplied.
Additionally,
information
submitted
through
the
IUR
is
collected
every
four
years,
while
information
collected
through
a
voluntary
program
such
as
the
HPV
Challenge
Program
is
generally
only
submitted
once.
Exposure
scenarios
change
over
time,
and
information
on
exposures
to
chemicals
needs
to
be
renewed
on
a
regular
basis.
A
change
in
exposure
information
could
affect
the
risk
associated
with
that
chemical.
Chemicals
that
present
low
hazard
may
still
pose
a
risk
if
they
are
produced
in
significant
amounts,
and
they
are
released
into
the
environment
at
high
volumes
and/
or
concentrations
and
result
in
exposures.

EPA
did
develop
a
partial
reporting
exemption
for
certain
chemical
substances
where
the
Agency
has
little
interest
in
the
IURA
processing
and
use
information
for
the
listed
substances.
In
compiling
the
initial
list,
EPA
included
chemicals
examined
through
the
HPV
Challenge
program,

where
the
Agency
determined
that
SIDS
type
hazard
information
was
not
of
interest
to
the
Agency.
Further
details
can
be
found
in
"
Methodology
Used
for
the
Initial
Selection
of
Chemicals
for
the
Inventory
Update
Rule
Amendments
(
IURA)
"
Low
Current
Interest"
Partial
Reporting
Exemption"
(
Ref.
25).

Comment
C.
4a­
2:
Procter
and
Gamble
commented
that
the
Soap
and
Detergent
Association
(
SDA)
intends
to
develop
exposure
and
risk
data
to
use
in
combination
with
the
information
collected
on
SDA
sponsored
chemicals
in
the
HPV
Challenge
Program.
The
SDA's
March
1999
HPV
Challenge
Program
commitment
letter
was
cited.

Source:
C1­
028
Response
C.
4a­
2:
EPA
commends
the
Soap
and
Detergent
Association
for
its
intent
to
develop
exposure
and
risk
data
to
be
used
in
conjunction
with
certain
of
the
HPV
Challenge
Program
data.
These
data
could
provide
a
valuable
source
of
exposure­
related
information
on
certain
types
of
chemicals.
However,
unlike
the
more­
limited,
one­
time
reporting
of
exposure
and
risk
data
that
may
occur
for
some
chemicals
under
the
HPV
Challenge
Program,
the
IURA
will
Page
106
of
159
gather
exposure­
related
information
for
a
large
number
of
chemicals
in
a
wide
range
of
industrial
operations,
including
both
manufacture
and
downstream
applications.

Comment
C.
4a­
3:
EPA
should
publish
a
list
of
chemicals
subject
to
the
new
Form
U
Part
III
(
processing
and
use
information)
reporting
in
advance
of
each
IUR
year.
HPV
determinations
could
be
based
on
data
gathered
in
the
prior
reporting
cycle
without
loss
of
data.

Source:
C1­
007,
C1­
016,
C1­
047
Response
C.
4a­
3:
To
do
as
the
commenter
suggested
would
result
in
an
5­
yr
gap
between
identifying
the
HPV
chemicals
and
actually
getting
exposure­
related
information
on
those
chemicals.
For
instance,
the
first
collection
of
data
will
occur
in
2006,
which
is
when
the
current
list
of
HPV
chemicals
would
be
identified.
The
next
reporting
would
occur
in
2010,
providing
information
which
the
Agency
would
be
able
to
use
starting
in
2011.
This
delay
in
obtaining
the
processing
and
use
information
would
not
provide
the
data
in
a
timely
manner,
thereby
undermining
the
Agency's
screening
efforts.
Information
collected
through
the
IURA
will
be
used
by
the
Agency
in
a
wide
variety
of
ways,
and
on
a
basically
daily
basis,
as
described
in
section
A.
1.
of
this
document.

Note
that
the
300,000
lbs.
per
site
year
threshold
for
the
reporting
of
processing
and
use
information
under
IURA
is
not
equivalent
to
the
1,000,000
lbs.
per
year
nationally
aggregated
threshold
for
determining
which
chemicals
are
HPV
for
a
given
IUR
reporting
year.

b.
Low
Priority
Chemicals
Comment
C.
4b­
1:
EPA
should
draft
a
list
of
chemicals
that
would
be
exempt
from
information
collection
under
IURA.
This
list
should
be
comprised
of
chemicals
that
have
been
previously
determined
to
be
of
`
low
risk'
or
chemicals
for
which
there
is
a
minimum
amount
of
existing
hazard/
exposure
data
(
e.
g.
OECD/
SIDS
chemicals).
Chemicals
that
may
qualify
for
this
proposed
`
low
risk'
exemption
may
be
chemicals
that
have
been
excluded
from
the
HPV
program
and/
or
chemicals
that
are
regulated
under
other
Federal
authority
(
e.
g.
FIFRA,
FDCA).

Commenters
also
stated
that
EPA
should
substantiate
the
collection
of
exposure
information
using
a
toxicity
screen,
thereby
allowing
EPA
to
prioritize
chemicals
based
on
toxicity.
One
commenter
stated
that
chemical
substances
such
as
foods,
food
additives
and
animal
feeds
are
of
such
low
hazard
that
the
risks
presented
by
those
chemicals
will
not
be
significant.
Other
commenters
Page
107
of
159
stated
that
EPA
should
continue
to
grant
full
exemptions
to
natural
gas
products,
polymers,
and
microorganisms,
and
should
exempt
other
substances,
such
as
carbon
dioxide
(
which
is
largely
naturally­
occurring)
and
other
commonly
used
fossil
fuels.

Source:
C1­
003,
C1­
010,
C1­
011,
C1­
015,
C1­
017,
C1­
018,
C1­
019,
C1­
024,
C1­
027,

C1­
028,
C1­
031,
C1­
032,
C1­
033,
C1­
043,
C1­
047,
C1­
059,
C1­
068
Response
C.
4b­
1:
The
Agency
has
a
need
for
a
broad­
based
database
of
exposure
information.
See
the
comment
response
in
section
A.
1
of
this
document
for
a
discussion
of
the
Agency's
and
other's
need
for
this
data.
Taking
out
chemicals
that
may
present
potential
risks
will
skew
the
results
of
the
screening
process,
providing
potentially
inaccurate
results
of
the
relative
exposure
or
risk
potentials
of
various
chemicals
and
exposure
scenarios.
However,
there
are
a
variety
of
exemptions
and
partial
exemptions
designed
to
better
focus
the
information
collection
on
those
chemicals
for
which
the
Agency
needs
or
has
current
interest
for
the
IURA
information.

EPA
has
created
exemptions
from
IURA
reporting
for
certain
chemicals,
in
addition
to
those
chemicals
already
exempt
under
current
IUR
requirements.
Since
its
inception,
the
IUR
has
exempted
from
reporting
chemical
groups
such
as
polymers.
Additionally,
amounts
of
a
chemical
manufactured
at
or
imported
into
a
site
for
a
purpose
covered
by
another
statute
(
e.
g.,
as
a
food
additive,
pesticide,
etc.)
have
never
been
subject
to
IUR,
and
are
not
subject
to
IURA.
Amounts
of
these
chemicals
that
are
manufactured
or
imported
for
TSCA
purposes
will
be
required
to
be
reported
under
the
IURA,
unless
subject
to
an
exemption.
Through
the
IURA,
EPA
has
created
an
exemption
for
natural
gas
substances
and
a
partial
exemption
for
multi­
chemical
petroleum
process
streams.
For
the
first
year
of
reporting,
inorganic
chemicals
are
also
partially
exempt.

As
discussed
in
the
IURA
proposal,
EPA
considered
developing
a
low
priority
exemption,

but
was
unable
to
develop
a
satisfactory
rationale
for
such
an
exemption.
Therefore,
EPA
requested
comment
on
the
criteria
the
Agency
might
use
to
establish
such
an
exemption
and
on
the
specific
chemicals
that
would
qualify
for
such
an
exemption
(
see
64
FR
46772,
46794).
EPA
received
a
variety
of
suggestions
for
additional
groups
of
chemicals
to
exempt.
However,
as
discussed
in
the
preamble
to
the
final
rule
and
in
specific
comment
summaries
in
this
document,

the
exemptions
were
either
too
limiting
(
i.
e.,
those
associated
with
HPV)
or
there
was
not
a
satisfactory
rationale
for
creating
the
exemption
that
clearly
describes
which
specific
chemicals
are
covered
by
the
exemption
in
such
a
way
that
distinguishes
these
chemicals
from
those
that
are
not
covered
by
the
exemption.
Page
108
of
159
EPA
developed
a
partial
exemption
for
specifically
listed
chemicals
for
which
the
Agency
has
a
low
interest
in
the
processing
and
use
information.
Based
upon
various
considerations
rather
than
criteria,
this
exemption
allows
the
Agency
to
better
target
the
IURA
to
collect
processing
and
use
information
for
those
chemical
substances
for
which
it
needs
the
information.

In
recognition
that
the
Agency's
information
needs
change
over
time,
the
list
of
partially
exempted
chemicals
can
be
changed.
A
petition
process
has
been
established
which
allows
the
public
to
provide
information
and
suggest
additions
or
deletions
from
the
list.
This
exemption
is
described
in
the
final
rule
preamble
in
Unit
II.
F.
1.
d.
and
in
the
regulatory
text
at
710.46(
b)(
2).

The
initial
list
of
chemicals
under
this
exemption
was
developed
following
the
procedure
in
"
Methodology
Used
for
the
Initial
Selection
of
Chemicals
for
the
Inventory
Update
Rule
Amendments
(
IURA)
"
Low
Current
Interest"
Partial
Reporting
Exemption"
(
Ref.
25).
The
IURA
exemptions
were
not
based
on
a
finding
of
low
hazard.
They
were
based
on
a
recognition
that
the
current
interest
in
IURA
information
on
these
substances
is
not
as
great
at
this
time.
The
Agency
disagrees
that
a
hazard
level
for
establishing
reporting
obligations
under
IURA
is
appropriate.
There
are
many
substances
for
which
the
hazards
are
not
well
established.

Furthermore,
EPA
does
not
believe
hazard
alone
is
an
appropriate
method
for
screening
risks
or
determining
priorities.
Although
the
hazard
associated
with
a
chemical
generally
remains
constant,
the
risk
associated
with
the
manufacturing,
processing,
and
use
of
a
chemical
substance
will
change
as
exposure
increases
or
decreases.
Chemicals
that
present
low
hazard
may
still
pose
a
risk
if
they
are
produced
in
significant
amounts
and
have
high
exposure
potential
or
are
released
into
the
environment
at
high
volumes
and/
or
concentrations,
or
involve
exposures
to
particularly
sensitive
subpopulations.

Comment
C.
4b­
2:
Several
commenters
stated
that
EPA
should
eliminate
low
priority
chemicals
from
reporting
exposure­
related
information.
According
to
these
commenters,
low
priority
chemicals
are
chemicals
that
EPA
has
already
determined
to
be
low
priority
through
the
TSCA
Existing
Chemicals
program,
the
HPV
Challenge
Program,
or
other
EPA
initiatives.

Collecting
data
on
these
chemicals
would
be
of
minimal
use
for
risk
screening
purposes.
A
commenter
stated
that
of
the
2000
substances
reviewed
through
EPA's
Risk
Management
(
RM)

process
within
the
TSCA
Existing
Chemicals
Program,
85%
required
no
risk
management
action.

This
benchmark
suggests
that
expanding
the
IURA
may
not
be
a
cost­
effective
approach
when
85%
of
the
substances
would
require
no
further
action
by
the
Agency,
due
to
either
low
hazard
or
low
exposure
potentials.
The
commenter
recommended
that
chemicals
considered
of
low
concern
via
the
Existing
Chemicals
Program
be
exempt
from
reporting
under
IURA.
Page
109
of
159
Source:
C1­
003,
C1­
011,
C1­
016,
C1­
024,
C1­
028,
C1­
032,
C1­
068
Response
C.
4b­
2:
EPA
agrees
that
there
are
chemicals
for
which
EPA
has
a
low
current
interest
in
the
IURA
processing
and
use
information.
As
described
in
response
C.
4b­
1,
EPA
developed
a
partial
exemption
for
specifically
listed
chemicals,
based
upon
considerations
listed
in
the
regulatory
text
at
710.46(
b)(
2)
and
described
in
the
preamble
in
Unit
II.
F.
1.
d.
The
Agency
developed
an
initial
list
of
chemicals
for
this
exemption
(
see
Ref.
25
for
further
discussion).
EPA
intends
to
examine
the
IURA
processing
and
use
information
needs
for
additional
chemicals
before
the
first
reporting
period
in
2006.

The
Agency
disagrees
that
low
concern
(
as
determined
by
previous
assessments
by
the
Existing
Chemicals
program)
existing
chemicals
should
be
uniformly
exempt
from
IURA
reporting,
for
a
number
of
reasons.
First,
historical
records
describing
outcomes
of
the
existing
chemical
review
process
(
or
"
completed
cases"
documents)
show
that
only
about
half
of
those
chemicals
subjected
to
review
were
actually
dropped
from
the
assessment
process
("
brought
to
closure")
after
initial
screening.
Of
those,
about
one­
third
were
removed
because
of
low
hazard/
exposure
determinations,
and
the
others
removed
due
to
action
by
another
agency,
low
risk
reduction
potential,
or
later
consideration
in
a
subsequent
review
process.
Therefore,
a
set
of
chemicals
possibly
exempt
because
of
low
hazard
or
exposure,
as
shown
by
initial
screens
in
the
Existing
Chemicals
Program,
is
actually
much
smaller
than
that
identified
by
the
commenter.

Many
of
the
chemicals
reviewed
through
the
Existing
Chemicals
program
were
examined
in
a
specific
context.
For
instance,
the
Agency
reviewed
chemicals
considered
to
be
paint
strippers
and
reviewed
the
chemicals
in
relation
to
each
other.
The
Agency
did
not
review
any
other
uses
of
the
chemicals
outside
of
paint
stripping;
any
finding
of
potential
risk
or
recommendation
for
further
action
was
based
on
the
use
of
the
chemicals
in
the
one
end
use.

EPA's
risk
assessment
activities
are
tiered
and
data
dependent;
as
new
data
are
available
for
those
chemicals
previously
screened
and
dismissed
as
low
hazard
and/
or
exposure,
those
concern
estimates
can
be
revised.
The
Agency's
screening
risk
estimates
are
largely
relative,
and
reflect
the
need
to
integrate
mission
with
available
resources.
Therefore,
exempting
low
concern
RM
chemicals
from
IURA
reporting
is
not
warranted
at
this
time.
However,
EPA
fully
intends
to
screen
data
for
all
chemicals
captured
by
the
IURA.
EPA
has
no
way
of
knowing
ahead
of
time
which
chemicals
will
require
risk
management
action,
which
is
why
the
data
EPA
will
be
collecting
via
the
IURA
are
necessary.
As
updated
exposure
information
becomes
available,

however,
individual
exemptions
on
a
case
by
case
basis
might
be
possible.
Page
110
of
159
Comment
C.
4b­
3:
A
commenter
stated
that
polymer­
encapsulated
substances
should
be
exempt
from
the
reporting
of
processing
and
use
information
under
the
IURA
because
they
are
low
exposure
chemicals.
Similarly,
one
commenter
stated
that
the
Agency's
treatment
of
such
substances
under
Significant
New
Use
Rules
(
SNURs)
implies
that
encapsulated
substances
are
of
little
concern.
The
commenter
indicated
that
SNUR
requirements
no
longer
apply
when
chemicals
are
secured
within
a
polymer
matrix.

Source:
C1­
046
Response
C.
4b­
3:
Formulated
products
that
are
made
when
a
polymer
and
other
nonreactive
additives
such
as
antioxidants,
colorants,
stabilizers,
etc.
are
mixed
without
a
chemical
reaction
are
considered
to
be
mixtures
under
TSCA.
Importers
of
these
products
are
not
required
to
report
under
IUR
with
respect
to
the
mixtures
themselves,
when
viewed
as
whole
entities.

However,
as
stated
in
a
note
in
40
CFR
710.4(
c)(
2),
although
IUR
reporting
for
mixtures
is
not
required,
IUR
reporting
is
required
for
chemical
substances
that
are
imported
as
part
of
a
mixture.

Thus,
each
component
in
a
mixture
is
itself
a
chemical
substance
reportable
under
the
IURA
if
it
is
imported
in
amounts
of
25,000
lbs.
or
more
by
a
site
in
a
year.
Importers,
like
all
other
TSCA
"
manufacturers,"
are
responsible
for
determining
whether
their
substances
are
subject
to
IUR
reporting
requirements.

The
commenter's
understanding
that
when
chemicals
are
secured
within
a
polymer
matrix,

the
SNUR
requirements
no
longer
apply,
is
inaccurate.
There
is
no
EPA
policy
in
40
CFR
part
721
stating
that
when
substances
are
encapsulated
in
a
polymer
matrix,
that
SNUR
requirements
no
longer
apply
to
them.
Although
chemicals
incorporated
into
a
polymer
matrix
are
not
subject
to
SNURs
in
certain
limited
circumstances,
for
example,
when
an
individual
SNUR
specifically
states
that
the
SNUR
requirements
do
not
apply
to
such
substances
(
see,
e.
g.,
40
CFR
721.8160(
a)),
such
chemicals
are
not
otherwise
generally
exempt
from
SNUR
requirements.
The
fact
that
a
substance
is
compounded
with
a
polymer
or
is
contained
or
encapsulated
in
a
polymer
does
not
necessarily
mean
that
the
substance
will
not
become
partially
or
readily
released
from
the
polymer,
and
such
releases
could
be
intentional.
The
Agency
believes
there
could
be
many
instances
of
significant
exposure
to
substances
that
have
been
compounded
with
or
encapsulated
in
polymers,
and
thus,
such
substances
should
not
be
generally
excluded
form
IUR
reporting.

Although
EPA
appreciates
the
difficulty
in
ascertaining
quantitative
production
information
from
manufacturers
outside
direct
U.
S.
jurisdiction,
exempting
IUR
reportable
components
encapsulated
in
a
polymer
matrix
from
IURA
is
not
warranted.
Not
all
polymers
are
Page
111
of
159
inviolable.
Additives
such
as
colorants
and
lubricants,
which
can
be
hazardous
to
human
health
or
the
environment,
can
leach
from
the
polymer
matrix,
resulting
in
subsequent
exposures.
Also,

additives
which
are
inherently
insoluble
in
the
polymer
may
migrate
to
the
surface
of
the
polymeric
material
and
be
released
over
time
from
the
polymer.
Under
IURA,
each
non­
exempted
mixture
component
is
reportable
if
imported
above
the
stated
thresholds.

Comment
C.
4b­
4:
Some
commenters
stated
that
low
exposure
chemicals,
such
as
closed
system
intermediates,
should
be
exempt
from
IURA
reporting.

Source:
C1­
046
Response
C.
4b­
4:
Closed
system
intermediates
are
chemical
substances
which,
if
transferred
from
the
reaction
vessel
in
which
they
are
created
to
enclosed
storage
or
to
subsequent
reaction
vessels,
such
transfer
is
done
by
means
of
enclosed
piping
and
pumping
networks.
The
intermediate
is
transformed
into
a
different
chemical
substance
in
a
subsequent
reaction
at
the
site
where
it
is
created.
Closed
system
intermediate
chemicals
are
exempt
from
IUR
reporting
under
40
CFR
710.50(
c)
only
if
they
are
non­
isolated
intermediates
as
defined
by
§
710.43
of
the
revised
regulatory
text,
which
states
that:

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

If
a
closed
system
intermediate
chemical
does
not
meet
this
definition,
then
it
is
NOT
exempt
from
IUR
reporting.
The
Agency
believes
that
intermediate
substances
contained
in
storage
tanks
or
other
enclosed
equipment
or
transfer
lines
could
possibly
have
enough
exposure
potential
to
generate
some
risk
concerns.

Comment
C.
4b­
5:
Commenters
provided
several
major
comments
regarding
fossil
fuel
combustion
byproducts.
In
general,
commenters
believed
these
byproducts
should
not
have
to
report
under
the
IURA.

Commenters
stated
that
fossil
fuel
combustion
byproducts
should
be
exempted
from
IUR
Page
112
of
159
reporting,
even
when
produced
in
high
volumes,
because
(
1)
these
chemicals
present
low
hazard
or
risk
when
created;
(
2)
byproducts
used
for
certain
commercial
purposes
other
than
use
as
fuel,

as
soil
amendments,
or
as
sources
of
other
commercial
products
have
previously
been
exempt
(
via
the
inorganics
exemption);
(
3)
fossil
fuel
combustion
byproducts
have
been
sufficiently
studied
for
beneficial
reuse;
and
(
4)
that
sufficient
data
is
already
provided
to
the
Agency
and
other
federal
organizations,
such
as
DOE.
Commenters
stated
that
enough
review
of
data
had
been
conducted
on
these
substances,
primarily
by
and
for
EPA's
Office
of
Solid
Waste
(
OSW),
to
allow
their
use
as
solid
waste
in
situations
where
exposures
were
possible
(
i.
e.,
with
soil
amendments
or
in
"
recycling"
as
road
building
materials).
For
example,
one
commenter
stated
that
information
on
coal
combustion
byproducts
is
already
available
through
DOE
reporting
and
the
Bevill
Amendment
Study
process
under
§
8002(
n)
of
the
Resource
Conservation
and
Recovery
Act
(
RCRA).
Commenters
argued
that
reporting
on
these
byproducts
under
IURA
would
be
duplicative
and
overly
burdensome,
especially
because
these
chemicals
are
considered
"
beneficially
used
in
an
environmentally
sound
manner"
by
OSW
(
Ref.
29).
Furthermore,

required
reporting
would
serve
as
a
disincentive
to
beneficially
reuse
the
byproducts.

One
commenter
stated
that
specific
examples
demonstrating
the
need
for
fossil
fuel
combustion
byproducts
information
should
be
given
to
justify
the
information
collection.
In
addition,
some
commenters
believe
EPA
offices
like
OPPT
and
OSW
must
coordinate
efforts
related
to
fossil
fuel
combustion
byproducts
within
each
office
as
well
as
between
offices
prior
to
undertaking
any
actions
under
TSCA.

Source:
C1­
030,
C1­
035,
C1­
043
Response
C.
4b­
5:
The
Agency
believes
that
even
if
a
chemical's
uses
and
hazards
have
been
fully
characterized,
beyond
"
basic
screening,"
EPA
needs
up­
to­
date
exposure­
related
information
for
that
chemical.
Although
a
chemical's
hazard
does
not
change
over
time,
the
amount
of
human
and/
or
environmental
exposure
may
change
greatly
over
time,
thereby
necessitating
cyclical
reporting
of
such
information
to
the
Agency.
A
change
in
exposure
information
could
affect
the
risk
associated
with
that
chemical.
A
low
hazard
chemical
would
also
be
low
risk
if
exposure
potential
is
low,
however
the
same
low
hazard
chemical
may
be
considered
higher
risk
if
exposure
potential
is
high.
Chemicals
that
present
low
hazard
may
still
pose
a
risk
if
they
are
produced
in
significant
amounts,
and
/
or
if
they
are
released
into
the
environment
at
high
volumes
and/
or
concentrations.

The
Agency
allows
under
IURA
exemptions
for
fossil
fuel
combustion
byproducts
that
Page
113
of
159
have
no
commercial
purpose
(
e.
g.,
are
simply
residuals
or
waste
streams
not
further
involved
in
the
manufacture
or
processing
of
another
chemical
product)
and
the
inorganic
exemption
has
been
removed.
EPA
has
determined
that
it
will
not
create
an
exemption
from
IUR
reporting
requirements
for
activities
other
than
those
described
in
40
CFR
710.50.
Under
subsection
(
c)
in
that
section,
manufacturers
(
including
importers)
of
chemicals
in
the
form
of
byproducts
that
are
used
for
commercial
purposes
other
than
those
described
as
follows
are
subject
to
IUR
reporting:

"
If
the
only
commercial
purpose
of
the
byproduct
is
for
use
by
public
or
private
organizations
that
(
1)
burn
it
as
a
fuel,
(
2)
dispose
of
it
as
a
waste,
including
a
landfill
or
for
enriching
soil,
or
(
3)
extract
component
chemical
substances
from
it
for
commercial
purposes.
(
This
exclusion
only
applies
to
the
byproduct;
it
does
not
apply
to
the
component
substances
extracted
from
the
byproduct.)
(
40
CFR
720.30(
g)).

For
example,
manufacturers
(
including
importers)
of
fossil
fuel
combustion
byproducts
that
are
disposed
of
for
commercial
purposes
as
a
waste
continue
to
be
exempt
from
IUR
reporting
with
respect
to
these
byproducts.

Manufacturers
(
including
importers)
of
fossil
fuel
combustion
byproducts
that
are
used
in
making
bridges,
roadways,
etc.,
however,
would
not
be
exempt
from
IUR
reporting.
EPA
has
decided
not
to
create
an
exemption
to
cover
these
latter
entities
for
a
number
of
reasons.
Review
of
the
recent
OSW
regulatory
determination
on
the
subject
of
fossil
fuel
combustion
byproducts,

(
FR
Vol.
65
No.
99,
May
22,
2000,
32214­
32237),
indicates
that
these
products
in
general
can
be
hazardous
to
human
health
and
the
environment.
OSW
has
decided,
however,
to
exempt
fossil
fuel
combustion
byproducts
from
regulation
as
hazardous
waste
when
they
are
"
beneficially
reused."
(
FR
Vol.
65
No.
99,
May
22,
2000,
pg.
32229).
While
OSW
was
not
able
to
identify
significant
risks
to
human
health
or
the
environment
associated
with
beneficial
uses
of
fossil
fuel
combustion
byproducts
based
on
available
data,
OSW
plans
to
assess
new
information
as
it
becomes
available.
The
IURA
will
be
instrumental
in
providing
production,
use,
and
exposure
data
for
reportable
fossil
fuel
combustion
byproducts,
to
enable
OSW
to
monitor
the
potential
risk
associated
with
these
chemical
substances.
Review
of
such
contemporary
data,
as
shared
between
OPPT
and
OSW,
will
allow
EPA
offices
to
better
coordinate
in
making
well­
informed
risk
management
decisions
by
constructing
realistic
screening
level
exposure
profiles
for
these
substances.
These
profiles
could
be
adjusted
as
the
production
dynamics
changed
between
reporting
cycles.
EPA
believes
the
importance
of
accurate
exposure
related
data
in
formulating
sound
risk
management
decisions
for
fossil
fuel
combustion
byproducts
justifies
the
associated
reporting
burden.
Further,
the
acknowledged
disincentive
to
continue
beneficial
reuse
because
of
the
associated
reporting
requirement
could
be
largely
offset
by
the
incentives
of
commercial
gain
Page
114
of
159
from
expanding
such
beneficial
reuse,
and
potential
uses
of
such
activities
in
community
relations
programs.

Comment
C.
4b­
6:
Some
commenters
stated
that
fertilizers
should
be
either
partially
or
fully
exempted
from
reporting
under
the
IURA
because
they
already
are
well­
characterized
and
generally
"
safe."
According
to
the
commenters,
ample
recent
hazard
and
exposure
data
from
studies
conducted
by
EPA's
Office
of
Solid
Waste
(
OSW)
indicate
that
fertilizers
generally
are
of
low
toxicity,
and
some
constituents
of
major
fertilizer
types
are
"
safe"
because
the
exposure
potentials
are
low.
Further,
recent
SIDS
program
studies
on
urea,
a
common
fertilizer,
described
the
chemical
to
be
"
of
low
priority"
as
regards
further
investigation,
thereby
implying
to
the
commenters
both
that
the
chemical
poses
little
hazard
to
human
health
and
the
environment,
and
that
adequate
risk
information
is
available.
One
commenter
suggested
that
the
following
substances,
listed
by
CAS
number,
be
included
in
the
fertilizer
exemption
list:
7664­
417
(
anhydrous
ammonia);
1336­
21­
6
(
aqua
ammonia);
6484­
52­
2
(
ammonium
nitrate);
7783­
20­
2
(
ammonium
sulfate);
7783­
18­
8
(
ammonium
thiosulfate);
12593­
60­
1
(
ammonium
phosphate
sulfate);
7783­
28­
0
(
diammoniurn
phosphate);
7722­
76­
1
(
monoammonium
phosphate);
7631­
99­

4
(
sodium
nitrate);
7757­
79­
1
(
potassium
nitrate);
7757­
79­
1/
763
1
99­
4
(
potassium
sodium
nitrate);
8011­
76­
5
(
single
superphosphate);
65996­
95­
4
(
granular
triple
superphosphate);
7447­

40­
7
(
potassium
chloride­),
14168­
73­
1
(
potassium
magnesium
sulfate);
7778­
80­
5
(
potassium
sulfate);
7778­
18­
9
(
calcium
sulfate);
7664­
38­
2
(
phosphoric
acid);
7697­
37­
2
(
nitric
acid);
and
7664­
93­
9
(
sulfuric
acid).

Source:
C1­
015,
C1­
035,
C1­
040
Response
C.
4b­
6:
Inorganic
fertilizers
compose
a
class
of
chemical
substances
that
have
been
exempt
from
the
IUR
in
the
past,
while
organic
chemicals
used
as
fertilizers
have
generally
been
subject
to
IUR
reporting.
EPA
does
not
believe
the
suggested
IURA
exemptions
for
fertilizers
and
fertilizer
materials
are
warranted
at
this
time.
Exposure
to
these
chemicals,

especially
to
children,
can
be
significant.
(
Children
are
likely
to
be
exposed
to
these
chemicals
on
raw
foods,
or
during
play.)
Therefore
the
Agency
feels
that
requiring
commercial/
consumer
use
information
under
the
IUR
amendments
for
fertilizers
containing
these
chemicals
is
necessary.
In
general,
the
Agency
finds
that
even
if
a
chemical's
uses
and
hazards
have
been
fully
characterized,

EPA
needs
up­
to­
date
exposure­
related
information
for
that
chemical.
Although
a
chemical's
toxicity
does
not
change
over
time,
the
amount
of
human
and/
or
environmental
exposure
may
Page
115
of
159
change
greatly
over
time.
A
change
in
exposure
information
could
affect
the
risk
associated
with
that
chemical.
A
low
hazard
chemical
would
typically
be
considered
to
be
low
risk
if
exposure
potential
is
low;
however,
the
same
low
hazard
chemical
may
be
considered
high
risk
if
exposure
potential
is
high.
For
example,
chemicals
that
present
low
hazard
may
still
pose
a
risk
if
they
are
produced
in
significant
amounts,
and/
or
if
they
are
released
into
the
environment
at
high
volumes
and/
or
concentrations.

The
Agency
does
not
agree
with
industry
comments
citing
a
1999
EPA
OSW
risk
evaluation
on
"
non­
nutritive"
elements
in
fertilizers
as
adequate
justification
for
classifying
these
substances
as
"
safe,"
and
therefore
eligible
for
exemption.
The
cited
report
addresses
trace
quantities
of
metal
contaminants
in
those
fertilizers
(
i.
e.,
the
non­
nutritive
elements),
not
the
fertilizers
themselves.
A
review
of
basic
hazard
identification
guides,
such
as
the
Merck
Index,

the
Condensed
Chemical
Dictionary,
and
Dangerous
Properties
of
Industrial
Materials,
shows
that
many
fertilizers
and
fertilizer
materials
including
those
cited
in
industry
comments,
such
as
anhydrous
ammonia,
potassium
sulfate,
and
urea,
can
cause
both
reversible
and
irreversible
adverse
health
effects
due
to
exposures
ranging
from
acute
to
chronic.
The
Agency
therefore
believes
it
appropriate
to
require
information
for
these
chemicals
under
the
IUR
amendments.

Even
if
a
chemical's
hazards
have
been
fully
characterized,
EPA
needs
up­
to­
date
exposure
information
to
adequately
screen
chemicals
for
possible
risks
to
human
health
and
the
environment.
Although
toxicity
of
a
chemical
generally
is
fixed
(
even
though,
for
example,
one
ionic
form
of
a
chemical
can
be
more
hazardous
than
another),
a
chemical's
exposure
profile
can
vary
greatly
over
time.
Human
and/
or
environmental
exposures
to
the
substance
can
at
one
time
be
minor,
but
at
another
time
be
a
major
concern.
Therefore,
chemicals
that
present
low
hazard
may
still
pose
a
risk
if
they
are
produced
in
significant
amounts,
or
if
they
are
released
into
the
environment
at
high
volumes
and/
or
concentrations.
Updated
exposure
information
would
improve
risk
evaluations
of
those
chemicals.

The
SIDS
dossier
for
urea,
a
common
fertilizer,
supports
the
conclusion
that
urea
is
"...
of
low
priority..."
in
the
context
of
the
SIDS
program.
However,
the
conclusions
expressed
in
the
dossier
are
based
on
information
inadequate
for
EPA
purposes.
Because
the
SIDS
program
is
designed
to
promote
international
cooperation
in
managing
chemicals
of
concern
to
all
member
nations,
SIDS
emphasizes
on
hazard
assessments
over
exposure
reviews
to
categorize
those
chemicals.
In
the
context
of
SIDS,
therefore,
urea
is
low
priority
because
its
hazards
are
well
known
and
are
of
modest
concern.
In
contrast,
the
IURA
is
designed
to
obtain
the
latest
exposure
data,
which
can
change
over
time
and
must
be
timely
to
be
most
useful.
The
SIDS
program
is
suspending
the
collection
of
detailed
exposure
information,
because
member
countries
Page
116
of
159
discovered
that
exposure
situations
from
one
country
to
the
next
were
too
variable
to
allow
useful
exchange
of
the
data.
Therefore,
any
exposure
information
collected
by
a
sponsor
country
typically
is
not
comparable
to
that
required
under
the
IURA.
For
example,
the
Urea
SIDS
Dossier
was
developed
by
Finland,
and
only
provides
U.
S.
production
and
use
data
on
a
national
scale,
which
would
be
unlikely
to
provide
the
specific
use
and
exposure
data
needed
for
a
U.
S.­

based
risk
assessment.

Comment
C.
4b­
7:
The
Agency
should
exempt
pesticides
from
reporting
under
the
IUR's
TSCA
authority,
and
should
exempt
those
substances
outside
its
purview,
including
drugs
and
cosmetics.

Source:
C1­
003,
C1­
015,
C1­
031,
C1­
043,
C1­
059
Response
C.
4b­
7:
The
original
IUR
did
not
include
non­
TSCA
chemicals
as
reportable.

Similarly,
in
the
IURA,
amounts
of
an
otherwise
IUR­
reportable
substance
that
are
intended
at
the
time
of
manufacture
or
import
to
be
used
for
non­
TSCA
purposes
(
e.
g.
as
a
pesticide,
as
a
drug)

do
not
have
to
be
reported.
For
example,
if
a
company
were
to
manufacture
100,000
lbs
of
an
IUR­
reportable
substance,
70,000
lbs
of
which
were
intended
at
the
time
of
manufacture
to
be
sold
as
a
food
additive,
and
30,000
lbs
of
which
were
intended
at
the
time
of
manufacture
to
be
used
for
a
TSCA
purpose,
only
30,000
lbs
of
the
substance
would
have
to
be
reported
under
IUR.

Further,
many
substances,
such
as
the
pesticide
"
active
ingredient"
pentachlorophenol
or
the
class
of
pesticidal
"
other
ingredients"
(
formerly
called
pesticide
inerts),
are
also
used
in
industrial/
commercial
applications
regulated
under
TSCA.
In
those
cases,
the
chemicals
would
be
reportable
under
the
IURA.

5.
Thresholds
Comment
C.
5­
1:
Commenters
agreed
with
raising
the
general
reporting
threshold
from
10,000
to
25,000
pounds.
A
commenter
stated
that
this
increased
threshold
is
sufficient
to
capture
major
production
sites.
One
commenter
stated
that
they
agreed
with
making
the
threshold
consistent
with
the
Toxic
Release
Inventory's
(
TRI)
threshold
and
that
they
recognize
that
a
lower
threshold
may
be
appropriate
for
the
limited
number
of
chemicals
that
are
persistent,

bioaccumulative,
and
toxic.
Commenters
stated
that
the
Agency
should
recognize
that
future
reductions
in
this
reporting
threshold
would
again
increase
the
IURA
reporting
burden.
Page
117
of
159
Source:
C1­
003,
C1­
010,
C1­
013,
C1­
014,
C1­
022,
C1­
027,
C1­
029,
C1­
031,
C1­
032,

C1­
033,
C1­
037,
C1­
041,
C1­
046,
C1­
047,
C1­
069,
C1­
073
Response
C.
5­
1:
EPA
increased
the
general
reporting
threshold
in
order
to
reduce
the
number
of
reports
filed,
thus
reducing
industry
burden.
The
new
reporting
threshold
does
not
represent
a
finding
of
low
exposure
or
low
risk.
The
Agency
does
recognize
that
reducing
the
reporting
threshold
in
the
future
could
increase
the
IURA
reporting
burden,
but
may
change
that
reporting
threshold
as
the
Agency's
needs
change.

Comment
C.
5­
2:
One
commenter
disagreed
with
raising
the
general
reporting
threshold
and
requested
that
it
be
maintained
at
10,000
pounds.
This
commenter
stated
that
the
new
25,000
lbs.
threshold
could
eliminate
some
reports
they
would
find
useful.
Also,
the
10,000
lbs.

threshold
could
provide
valuable
information
regarding
trends
in
the
use
of
chemicals
and
the
introduction
of
new
chemicals
that
may
replace
other
chemicals.

Source:
C1­
064
Response
C.
5­
2:
EPA
agrees
that
useful
information
may
be
eliminated
due
to
the
increased
threshold.
The
Agency
raised
the
reporting
threshold
in
order
to
mitigate
the
increased
burden
that
will
result
from
this
rule.
While
some
useful
data
will
be
forgone,
the
more
detailed
information
that
will
be
collected
will
improve
EPA's
and
others'
ability
to
assess
and
reduce
potential
chemical
risks.
EPA
may
lower
the
threshold
if
such
information
becomes
necessary
in
the
future.

Comment
C.
5­
3:
One
commenter
requested
that
the
Agency
raise
the
general
reporting
threshold
to
100,000
pounds.
The
commenter
felt
that
some
real
savings
could
be
generated
in
reducing
the
number
of
TSCA
IUR
reports
prepared
and
that
EPA
would
still
collect
sufficient
data
on
the
chemicals
widely
used
by
industry
in
order
to
update
the
TSCA
inventory.

Source:
C1­
011
Response
C.
5­
3:
EPA
disagrees
that
a
general
reporting
threshold
of
100,000
pounds
would
provide
sufficient
information
to
meet
the
Agency's
and
others'
needs
and
Congress'

intent.
EPA
has
been
charged
with
identifying
and
controlling
toxic
chemical
risks
to
human
Page
118
of
159
health
and
the
environment.
Raising
the
general
reporting
threshold
from
25,000
lbs.
to
100,000
lbs.
would
mean
that
EPA
would
receive
approximately
10,400
fewer
reports
on
2,600
fewer
chemicals
produced
in
volumes
of
25,000
to
100,000
pounds
at
the
site
level.
These
chemicals
and
reports
represent
a
substantial
portion
of
chemical
use
and
production
in
the
United
States.

By
forgoing
even
the
basic
information
required
of
partial
reporting,
EPA
would
be
completely
incapable
of
assessing
the
potential
risks
posed
by
this
large
portion
of
the
chemical
industry
and
would
be
unable
to
update
the
TSCA
Inventory,
as
required
under
TSCA.

Comment
C.
5­
4:
Commenters
agreed
with
adding
a
second
reporting
threshold
of
300,000
pounds
for
reporting
processing
and
use
information.

Source:
C1­
003,
C1­
013,
C1­
022
Response
C.
5­
4:
While
EPA
finalized
the
300,000
lbs.
threshold
for
processing
and
use
information,
the
Agency
also
recognizes
that
similar
exposure
information
on
lower
volume
chemicals
may
be
needed.
Because
of
this,
EPA
may
change
this
threshold
in
a
future
amendment,
or
may
collect
the
information
in
another
manner.

Comment
C.
5­
5:
Some
commenters
disagreed
with
EPA's
establishment
of
a
300,000
lbs.

threshold
for
reporting
processing
and
use
information
rather
than
the
100,000
lbs.
threshold
that
the
Agency
also
considered.
Commenters
believed
EPA's
rationale
of
reducing
paperwork
burdens
on
submitters
is
insufficient.
They
argue
that
establishing
a
100,000
lbs.
threshold
will
gather
useful
information
on
processing,
use,
and
worker
exposure
for
lower
production
volume
chemicals.
By
setting
the
bar
too
high,
EPA
will
be
ignoring
a
crucial
set
of
data
for
risk
screening
and
priority
setting
on
an
important
segment
of
chemical
users
and
exposed
workers.

Source:
C1­
051,
C1­
064,
C1­
065
Response
C.
5­
5:
EPA
agrees
that
raising
the
threshold
to
300,000
lbs.
does
omit
useful
information
on
chemicals
produced
below
that
threshold.
As
noted
by
EPA
on
page
46786
of
the
preamble
for
the
proposed
rule,
"...
information
concerning
lower
production
volume
chemical
substances
is
valuable,
especially
for
identifying
trends
and
additional
substitute
chemicals..."

The
300,000
lbs.
threshold
was
agreed
upon
during
interagency
review
as
a
way
to
limit
burden
while
still
collecting
data
on
almost
all
of
the
high
production
volume
(
HPV)
chemicals.
Page
119
of
159
Additionally,
EPA
believes
the
300,000
lbs.
threshold
strikes
an
appropriate
balance
between
the
Agency's
current
information
needs
and
the
burden
imposed
by
IURA.

Comment
C.
5­
6:
Several
commenters
suggested
alternative
threshold
levels
for
submitting
processing
and
use
information.
A
commenter
suggested
a
level
of
500,000
pounds
to
further
reduce
the
reporting
burden.
Another
commenter
stated
that
EPA
should
set
the
threshold
for
reporting
processing
and
use
information
at
1
million
pounds
or
more
per
year
on
a
company
(
versus
a
site)
basis,
given
that
EPA
stated
in
the
proposed
rule
(
pg.
46785)
that
EPA's
initial
focus
would
be
on
processing
and
use
information
associated
with
large
volume
chemical
substances.
The
commenter
claimed
that
chemicals
manufactured
at
greater
than
a
million
pounds
a
year
per
company
qualify
as
larger
volume
chemicals
and
should
be
higher
on
EPA's
priority
list
than
chemicals
produced
at
smaller
volumes.
The
Agency
would
be
able
to
focus
its
limited
resources
first
on
the
higher
volume
chemicals
while
it
develops
the
means
and
methods
necessary
to
assess
the
submitted
information
in
a
meaningful
and
timely
manner.
Another
commenter
stated
that
EPA
should
use
the
1,000,000
(
lb/
yr)
national
aggregate
production
volume
threshold
as
already
established
in
the
related
voluntary
HPV
Challenge
Program.
Having
the
same
threshold
criteria
would
enable
all
parties
to
focus
their
efforts
on
the
development
of
enhanced
exposure
and
effects/
property
data
for
a
single,
consistent
set
of
substances.
This
would
reduce
the
potential
for
confusion
in
users
of
the
data
and
significantly
reduce
unnecessary
burdens
to
chemical
manufacturers
and
importers.

Source:
C1­
013,
C1­
046,
C1­
047,
C1­
068
Response
C.
5­
6:
EPA
considered
a
range
of
reporting
thresholds
for
submitting
processing
and
use
information
and
selected
the
threshold
of
300,000
lbs.
While
higher
thresholds
do
reduce
the
burden,
they
also
reduce
the
information
submitted
through
IURA
­
information
that
has
already
been
reduced
by
the
selected
300,000
lbs.
threshold.

EPA
disagrees
with
setting
the
reporting
threshold
for
processing
and
use
information
at
either
a
company­
wide
or
a
national
production
level.
See
the
response
to
comments
B.
2­
1
and
B.
2­
3
for
further
discussion
of
these
alternate
reporting
designs.

EPA
determined
chemicals
eligible
for
the
HPV
Challenge
Program
based
on
aggregate,

nationwide
production
volumes
of
one
million
pounds
or
more,
based
on
1990
IUR
production
volume
data.
If
one
million
pounds
of
a
certain
chemical
are
manufactured
collectively,
in
a
given
Page
120
of
159
year,
by
all
manufacturers
(
including
importers)
throughout
the
United
States,
then
that
chemical
is
defined
as
an
HPV
chemical.
EPA
chose
the
300,000
pound
threshold
for
two
reasons:
1)
to
decrease
the
burden
associated
with
reporting
(
as
compared
to
the
100,000
pound
threshold)
and,

2)
to
ensure
that
information
is
collected
on
virtually
all
HPV
chemicals.
The
300,000
pound
threshold
captures
a
least
one
report
for
more
than
95%
of
the
HPV
chemicals
reported
to
the
1990
IUR,
the
collection
used
to
determine
the
initial
pool
of
HPV
Challenge
program
candidates.

The
production
volume
that
defines
chemicals
as
HPV
should
not
be
confused
with
the
reporting
threshold
for
processing
and
use
data
reporting
in
the
amended
IUR.
The
300,000
pound
IURA
threshold
is
for
the
amount
produced
at
a
single
site
and
is
not
an
aggregate,
industry
wide
production
number.
The
300,000
pounds
per
year
reporting
threshold
limits
the
chemicals
reporting
downstream
exposure­
related
data
to
approximately
4000
(
consistent
with
the
several
thousand
chemicals
suggested
by
GAO
in
it's
1995
report
  
EPA
Should
Focus
Its
Chemical
Use
Inventory
on
Suspected
Harmful
Substances,''
GAO/
RCED­
95­
165),
and
ensures
that
exposurerelated
data
will
be
reported
for
almost
all
HPV
chemicals
(
defined
by
national
aggregate
production).
Increasing
the
per
site
300,000
pound
threshold
to
either
500,000
or
1,000,000
pounds
would
drastically
undermine
the
Agency's
reasons
for
collecting
the
processing
and
use
exposure­
related
data
by
reducing
the
number
of
chemicals
for
which
information
is
submitted
and
by
eliminating
reporting
on
many
of
the
HPV
chemicals.
The
Agency
would
not
be
able
to
effectively
use
this
information
for
screening
level
assessments
as
intended.

Comment
C.
5­
7:
One
commenter
claims
the
effort
required
to
track
production
volume
for
each
reportable
chemical
for
any
single
company
site
is
very
burdensome,
and
of
limited
benefit.
"
Performing
this
work
to
prove
that
a
chemical
is
not
subject
to
reporting,
seems
redundant
and
outside
the
spirit
of
the
EPA's
intention
to
reduce
burden.
Some
enforcement
leeway
should
be
granted
to
those
companies
that
can
justify
a
non­
report
on
the
basis
of
"
theoretical"
volumes
less
than
25,000
pounds
per
year.
Where
companies
have
not
developed
computer
systems
to
fully
collect
the
final
volume
of
chemicals,
theoretical
calculations
based
on
previous
use,
future
use,
or
another
reasonable
determination
of
use
should
be
acceptable.
For
larger
companies,
this
justification
can
potentially
save
hundreds
of
hours
of
tracking."
Other
commenters
supported
eliminating
the
requirement
to
keep
volume
records
for
substances
that
fall
below
the
reporting
threshold.

Source:
C1­
010,
C1­
027,
C1­
028,
C1­
041
Page
121
of
159
Response
C.
5­
7:
The
Agency
has
removed
the
requirement
that
firms
not
submitting
IUR
reports
retain
production
volume
records
in
support
of
that
decision.
However,
the
Agency
believes
that
the
information
needed
to
determine
whether
reporting
is
required
is
part
of
normal
business
records.
EPA
recognizes
that
special
circumstances
may
exist,
and
therefore
production
volume
records
that
are
unavailable
may
not
meet
the
"
reasonably
ascertainable"
standard.
EPA
expects
such
instances
to
be
extremely
rare.

D.
Definitions
and
Clarification
Requests
1.
Inorganic
Chemical
Substance
Comment
D.
1­
1:
One
commenter
noted
that
the
definition
of
"
inorganic
chemical
substance"
in
the
proposed
regulatory
text
section
710.26(
a)
is
faulty.
It
seems
to
say
that
carbon,
graphite,
diamond,
carbon
dioxide,
carbon
monoxide,
the
various
carbides
and
other
materials
that
a
chemist
would
define
as
inorganic
are
actually
organic.
The
commenter
understood
that
this
definition
would
be
deleted
by
the
proposed
changes
and
suggested
that
EPA
be
careful
in
defining
organic
versus
inorganic
chemical
substances.

Source:
C1­
001
Response
D.
1­
1:
The
Agency
is
not
deleting
the
definition
of
inorganic
chemical
substances.
Under
IURA,
inorganic
substances
would
be
initially
subject
only
to
partial
reporting,

whereas
organic
substances,
unless
specifically
excluded
from
reporting
under
section
710.46
of
the
final
regulatory
text,
would
be
subject
to
full
IUR
reporting.
Therefore,
this
definition
of
inorganic
chemical
substance
will
be
needed
to
determine
whether
or
not
a
substance
would
be
subject
to
partial
or
full
IUR
reporting.

The
IURA
does
not
change
the
definition
of
inorganic
chemical
substances.
For
IURA
reporting
purposes,
inorganic
chemical
substances
will
continue
to
be
defined
as
any
chemical
substance
that
does
not
contain
a
carbon
atom,
or
contains
carbon
only
in
the
form
of
carbonato
[=
CO3],
cyano
[­
CN],
isocyano
[­
NC],
cyanato
[­
OCN],
or
isocyanato
[­
NCO],
groups,
or
the
chalcogen
analogues
of
these
groups
[
40
CFR
710.26(
a)].
Although
chemists
may
differ
on
their
classification,
the
Agency
has
also
chosen
to
also
exempt
carbon
black
[
CASRN
1333­
86­
4],

carbon
[
CASRN
7440­
44­
0],
graphite
[
CASRN:
7782­
42­
5],
and
charcoal
[
CASRN:
16291­
96­

6]
from
the
reporting
requirements
for
organic
chemicals
under
the
IUR;
they
will,
nevertheless,
Page
122
of
159
be
subject
to
the
reporting
requirements
for
inorganic
chemical
substances.
Carbides
are
considered
to
be
organic
chemical
substances.

Comment
D.
1­
2:
One
commenter
asked
that
EPA
clarify
that
process
and
use
information
is
required
only
for
organic
chemicals
by
adding
word
`
organic'
to
the
Part
III
Form
U
requirements.

Source:
C1­
056
Response
D.
1­
2:
For
the
first
reporting
period
following
promulgation
of
the
IURA,
EPA
is
requiring
only
partial
reporting
for
inorganic
substances
(
i.
e.,
inorganic
chemical
substances
would
not
be
subject
to
the
reporting
of
processing
and
use
information).
EPA
is
requiring
full
reporting
for
organic
substances,
based
upon
production
volume,
for
the
first
reporting
period
following
promulgation
of
the
IURA.
For
subsequent
reporting
periods,
manufacturers
(
including
importers)
of
inorganic
and
organic
substances
will
both
be
subject
to
the
processing
and
use
information
reporting
requirements,
to
the
extent
that
they
manufacture
(
including
import)
at
least
300,000
lbs.
of
a
substance.
EPA
has
clarified
this
in
the
preamble
for
the
final
IURA
and
in
the
instruction
manual.

2.
Chemical
Industry
Comment
D.
2­
1:
One
commenter
stated
that
the
Agency
focused
on
the
"
chemical
manufacturing
industry"
"
without
specific
consideration
of
its
data
needs
regarding
the
ancillary
production
of
byproduct
materials
from
other
industry
sectors
that
would
be
swept
into
IUR
reporting
as
the
result
of
its
broad
definition
of
manufacture
in
40
CFR
§
710.2"
of
the
proposed
regulatory
text.

Source:
C1­
043
Response
D.
2­
1:
EPA
listed
a
fairly
comprehensive
list
of
affected
industries
in
the
economic
analysis,
but
used
the
term
"
chemical
industry"
in
other
discussions.
EPA's
intention
was
to
use
the
term
"
chemical
industry"
to
represent
all
of
the
industries
reporting
under
this
rule.

EPA
fully
intends
for
any
company
meeting
the
reporting
requirements
of
the
rule
to
be
represented
by
the
term
"
chemical
industry,"
regardless
of
whether
the
company
fits
under
the
Page
123
of
159
NAICS
definition
of
the
term
"
chemical
industry"
or
under
a
different
industry.

Under
40
CFR
710.50(
c),
manufacturers
(
including
importers)
of
chemicals
in
the
form
of
byproducts
which
are
used
for
commercial
purposes
are
subject
to
IUR
reporting
unless
the
only
commercial
purpose
of
the
byproduct
is
for
use
by
public
or
private
organizations
that
(
1)
burn
it
as
a
fuel,
(
2)
dispose
of
it
as
a
waste,
including
in
a
landfill
or
for
enriching
soil,
or
(
3)
extract
component
chemical
substances
from
it
for
commercial
purposes.
(
This
exclusion
only
applies
to
the
byproduct;
it
does
not
apply
to
the
component
substances
extracted
from
the
byproduct.)
(
40
CFR
720.50(
g))

3.
Site
Comment
D.
3­
1:
One
commenter
was
confused
about
the
definition
of
a
"
site."
The
commenter
asked
how
the
report
should
be
completed
if
the
submitter
has
multiple
sites,
with
some
sites
manufacturing
more
than
300,000
lbs.,
and
other
sites,
less.

Source:
C1­
056
Response
D.
3­
1:
If
a
submitter
is
reporting
for
multiple
sites,
a
separate
submission
needs
to
be
completed
for
each
site.
The
processing
and
use
information
reported
on
Part
III
of
revised
Form
U
must
be
completed
for
each
reportable
chemical
at
each
individual
site
that
manufactures
or
imports
more
than
300,000
pounds
of
the
reportable
chemical.
Part
III
does
not
need
to
be
completed
for
individual
sites
that
manufacture
or
import
less
than
300,000
pounds
of
the
reportable
chemical.
The
reporting
requirements
for
individual
sites
have
been
clarified
in
the
preamble
for
the
final
IURA
and
in
the
instructions
manual.

4.
Importers
Comment
D.
4­
1:
One
commenter
felt
that
import
data
for
processed
or
formulated
substances
should
be
excluded
from
IUR
reporting.
The
commenter
believes
it
it
is
very
burdensome
because
"
every
formulated
product
(
including
perfumes)
must
be
broken
down
into
its
various
components
and
then
tallied
for
totals
to
determine
if
reporting
thresholds
are
met."

This
commenter
suggested
that
the
Agency
make
reporting
requirements
for
imported
chemical
substances
similar
to
requirements
for
manufactured
substances,
for
which
reporting
is
"
required
only
if
given
chemicals
are
used
and
released
at
a
specific
site."
Page
124
of
159
Source:
C1­
003,
C1­
028,
C1­
046,
C1­
061
Response
D.
4­
1:
Under
TSCA
section
3(
7),
importing
is
equivalent
to
manufacturing.

Congressional
intent
when
developing
TSCA
was
that
domestic
manufacturers
and
importers
be
treated
with
parity
(
H.
R.
Rep.
No.
94­
1341,
94th
Cong.,
2d
Sess.
12­
13).
As
a
result,
importers
are
treated
similarly
to
manufacturers
under
EPA's
TSCA
regulations.

These
IUR
amendments
specify
that
IUR
reporting
is
required
of
entities
that
manufacture
(
i.
e.
produce
or
import)
25,000
lbs.
or
more
of
an
IUR­
reportable
substance
at
a
site
in
a
year.

The
requirement
that
IUR
reporting
be
done
by
a
particular
entity,
whether
a
domestic
manufacturer
or
an
importer,
does
not
depend
on
that
entity's
use
or
release
of
a
substance.

Although
EPA
appreciates
the
difficulty
that
may
sometimes
be
associated
with
requesting
quantitative
production
information
from
foreign
manufacturers,
U.
S.
importers
are
required
to
seek
only
whatever
information
is
reasonably
ascertainable
to
estimate
import
quantities.

Comment
D.
4­
2:
Commenters
suggested
that
if
import
data
could
not
be
excluded
completely,
all
imported
mixtures/
formulated
products
should
be
excluded.
A
commenter
stated
that
"
for
companies
that
import
processed
materials,
it
is
meaningless
to
describe
manufacturing
characteristics
of
these
substances.
Many
are
mixtures
of
a
large
number
of
chemicals.
They
may
be
in
various
physical
forms
and
many
concentrations
and
no
worker
exposure
at
the
manufacturing
site
is
involved."

Source:
C1­
003,
C1­
028,
C1­
046,
C1­
061
Response
D.
4­
2:
Under
the
TSCA
regulations,
including
the
IURA,
importers
are
considered
to
have
manufactured
each
of
the
components
of
imported
mixtures.
However,

importers
are
only
required
to
complete
IURA
reports
if
they
import
at
least
25,000
lbs.
of
an
IURA­
reportable
substance
(
whether
as
a
component
of
a
mixture
or
otherwise)
in
a
year.
For
instance,
if
a
company
is
importing
100,000
lbs.
of
a
mixture
at
a
site,
the
submitter
must
report,

under
the
IURA,
any
components
accounting
for
25%
or
more
of
that
mixture.

Information
on
physical
forms
and
concentrations
of
imported
mixtures
are
important
for
screening
potential
exposures
for
downstream
sites
and
users
even
when
there
are
no
exposures
at
the
import
site.
The
multiple
physical
forms
and
concentrations
issues
have
been
covered
in
the
response
to
comment
B.
4c­
1.
Page
125
of
159
Comment
D.
4­
3:
One
commenter
asserted
that
processors
should
not
have
to
report
exposure
and
use
information.

Source:
C1­
003,
C1­
028,
C1­
061
Response
D.
4­
3:
Although
EPA
has
the
authority
under
TSCA
section
8(
a)
to
require
processors
to
report
under
IUR,
processors
have
never
been
subject
to
IUR
reporting
in
the
past,

and
will
not
be
subject
under
these
IUR
amendments
(
see
40
CFR
710.48).

Comment
D.
4­
4:
One
commenter
took
issue
with
EPA's
definition
of
plant
site
for
importers,
stating
that
in
the
proposed
IUR
amendments
(
at
46786
and
in
the
regulatory
text),

EPA
defines
the
plant
site
for
an
importer
as
"
the
site
of
the
operating
unit
within
the
importer's
organization
that
is
directly
responsible
for
importing
the
substance
and
that
controls
the
import
transaction,
and
may
in
some
cases
be
the
organization's
headquarters
office
in
the
United
States."
The
commenter
believes
that
requiring
an
importer
to
report
its
headquarters
office
as
its
plant
site
would
result
in
the
reporting
of
meaningless
site­
specific
information
by
the
importer.

In
addition,
the
commenter
stated
that
importers
should
not
be
required
to
comply
with
the
new
up­
front
substantiation
requirement
for
certain
confidential
business
information
(
CBI).

According
to
the
commenter,
in
many
cases
importers
are
product
formulators
whose
formulas
are
proprietary.
For
these
reasons,
the
commenter
believes
that
EPA
should
create
exceptions
for
importers
from
the
requirements
it
has
laid
out
in
the
proposed
IUR
amendments.

Source:
C1­
073
Response
D.
4­
4:
The
provision
referred
to
in
this
comment
has
been
present
in
the
IUR
regulations
since
1986,
and
EPA
does
not
intend
to
modify
it
in
the
current
rulemaking.

Provisions
which
identify
the
site
at
which
the
chemical
substance
is
imported
are
necessary
to
affix
the
responsibility
to
complete
and
submit
the
IUR
report.
In
1985,
when
the
provision
was
first
proposed,
EPA
had
suggested
that
the
importer
identify
its
company
headquarters
office
as
the
plant
site
responsible
for
IUR
reporting
(
50
FR
9944,
9952,
March
12,
1985).
However,

when
the
provision
was
finalized
in
1986
(
51
FR
21438,
21448,
June
12,
1986),
it
reflected
the
language
that
is
still
in
place
today
at
40
CFR
710.48(
c).

The
1986
final
rule
stated
that
for
importers
subject
to
IUR
reporting,
"[
IUR]
reports
would
be
made
by
the
site
which
actually
conducts
the
import
operation­­
either
the
specific
plant
Page
126
of
159
or
the
corporate
headquarters."
51
FR
21438,
21440.
The
Agency
also
stated
that
under
TSCA
"
an
importer
means
`*
*
*
any
person
who
imports
a
chemical
substance,
including
a
chemical
substance
as
part
of
a
mixture
or
article,
into
the
customs
territory
of
the
United
States,'
and
includes
`*
*
*
the
person
primarily
liable
for
the
payment
of
any
duties
on
the
merchandise*
*
*'.

.
.
.
[
C]
ertain
importers
must
report
by
the
United
States
headquarters
or
similar
central
office.

However,
if
a
plant
site
imports
a
substance
directly
from
a
foreign
supplier
and
is
`
primarily
liable
for
the
payment
of
any
duties'
on
that
substance,
the
plant
is
then
the
importer
of
that
substance.

In
that
case,
the
imported
substance
must
be
reported
directly
by
that
plant
site.
This
approach
allows
companies
to
report
consistent
with
the
conduct
of
their
importing."
51
FR
21438,
21441.

EPA
has
therefore
required
that
certain
importers
report
by
company
headquarters
office
while
others
report
by
individual
plant
site.
This
provision
further
ensures
that
IUR
information
reported
by
importers
is
meaningful.

The
Agency
does
not
agree
that
importers
should
be
exempt
from
the
new
up­
front
CBI
substantiation
requirements
for
plant
site
identity
information.
Although
EPA
understands
that
importers
may
at
times
wish
to
protect
these
data
as
CBI,
importers'
concerns
in
this
area
match
those
of
manufacturers
and
do
not
warrant
an
exemption
from
the
substantiation
requirements.

Indeed,
under
TSCA
section
3(
7),
manufacturers
and
importers
are
considered
to
be
equivalent;

therefore,
EPA
treats
them
similarly
under
its
TSCA
regulations,
including
the
IUR.

E.
Confidential
Business
Information
1.
General
CBI
Comment
E.
1­
1:
Commenters
stated
that
the
new
data
elements
raise
significant
CBI
concerns
and
that
the
proposed
IURA
can
be
expected
to
result
in
a
significant
increase
in
the
number
of
CBI
claims.

Source:
C1­
016,
C1­
032,
C1­
033,
C1­
047,
C1­
067
Response
E.
1­
1:
EPA
agrees
that
CBI
claims
will
likely
be
made
for
the
new
data
elements
that
are
being
added
by
the
IURA,
possibly
resulting
in
a
greater
number
of
CBI
claims
overall.
However,
the
Agency
has
taken
steps
to
enable
the
Agency
to
publicly
use
IURA
information.
For
instance,
EPA
is
requiring
reporting
for
most
of
the
new
data
elements
in
ranges,
a
reporting
method
the
Agency
believes
will
result
in
fewer
CBI
claims
compared
to
Page
127
of
159
reporting
discrete
numbers.

EPA
is
also
amending
the
IUR
to
include
a
new
requirement
to
provide
up­
front
substantiation
of
CBI
claims
for
plant
site
identity.
The
amendments
serve
to
ensure
that
claims
are
legitimate
by
requiring
submitters
to
perform
an
initial
evaluation
of
the
need
for
and
validity
of
a
CBI
claim
for
plant
site
identity,
an
essential
data
element.

Comment
E.
1­
2:
A
commenter
stated
that,
because
of
the
expected
increase
in
CBI
claims,
the
Agency
will
need
more
resources
to
handle
the
incoming
data.
Therefore,
the
commenter
anticipates
that
it
will
take
longer
for
the
Agency
to
make
the
information
available
to
Agency
personnel
and
stakeholders.

Source:
C1­
021
Response
E.
1­
2:
The
number
of
CBI
claims
does
not
affect
the
speed
with
which
the
Agency
will
be
able
to
process
the
IURA
information
and
make
it
available
to
the
public.
The
Agency
expects
to
have
sufficient
resources
to
process
the
incoming
data
and
the
expected
increase
in
the
number
of
electronic
submissions
will
facilitate
initial
data
capture
and
reconciliation
activities.
The
data
collected
through
the
IURA
will
be
transferred
directly
into
a
database
which
provides
the
ability
to
quickly
segregate
confidential
and
non­
confidential
submissions
and/
or
claims.

Comment
E.
1­
3:
Many
commenters
suggested
that
EPA
is
trying
to
discourage
legitimate
CBI
claims
by
making
their
assertion
overly
burdensome,
even
though
TSCA
provides
that
certain
submitted
information
may
be
claimed
confidential.
Included
in
this
issue
is
the
concern
that
imposing
unnecessary
additional
reporting
requirements
on
businesses
that
are
trying
to
protect
their
confidential
information
from
competitors,
including
those
overseas
who
are
not
regulated
by
the
EPA
and
therefore
don't
incur
the
expense
of
IURA
reporting,
puts
these
firms
at
a
competitive
disadvantage.

Source:
C1­
016,
C1­
047,
C1­
069
Response
E.
1­
3:
EPA
wishes
to
clarify
that
it
is
not
attempting
to
discourage
legitimate
confidentiality
claims.
Rather,
the
Agency
intends
to
encourage
only
appropriate
and
necessary
claims,
so
it
can
continue
protecting
legitimate
CBI
while
also
maximizing
the
amount
of
Page
128
of
159
information
available
for
public
use.
EPA
has
information
indicating
the
existence
of
inappropriate
or
no
longer
valid
CBI
claims.
For
instance,
when
EPA
selectively
challenged
CBI
claims
in
the
past,
many
of
these
claims
have
been
amended
by
the
companies
to
make
the
information
available
to
the
public.
Additionally,
OPPT's
Administrative
Record
00125,
which
contains
state
CBI
data
reviews,
published
articles,
industry
letters,
and
other
papers
discussing
CBI
issues,
provides
further
indication
that
inappropriate
or
no
longer
valid
CBI
claims
exist.
For
instance,
the
Georgia
Department
of
Natural
Resources
reported
in
a
1996
CBI
Data
Review
that
IUR
data
identified
as
confidential
were
available
in
other
non­
confidential
databases
(
Ref.
30).

The
Administrative
Record
is
in
the
same
location
as
the
Docket,
and
is
available
by
following
the
procedures
identified
in
Unit
II.
B.
2.
of
the
preamble
for
the
final
rule.

EPA
disagrees
with
the
assertion
that
the
IURA
requirements
make
the
assertion
of
legitimate
claims
overly
burdensome.
EPA
estimates
that,
every
four
years,
submitters
of
CBI
plant
site
identification
information
will
incur
a
burden
of
only
0.9
to
2.0
hours.
Burden
estimates
developed
in
the
Economic
Analysis
for
the
final
rule
are
discussed
in
the
Up­
Front
Substantiation
and
Reassertion
sections
of
this
portion
of
the
response
to
comments
document,
the
Economic
section
of
this
document
(
see
Sections
E.
2,
E.
3,
and
G.
1
of
this
document,
respectively).

Commenters
should
keep
in
mind
that
IUR
reporting
occurs
once
every
four
years,
not
annually,

and
that
information
protected
at
taxpayer
expense
qualifies
for
that
protection
by
meeting
the
minimum
legal
criteria.
EPA
believes
that
firms
that
comply
with
IURA
reporting
not
are
put
at
a
competitive
disadvantage
because
the
burdens
imposed
by
the
IURA
are
not
excessive.

a.
Protection
of
CBI
Comment
E.
1a­
1:
Commenters
expressed
concern
about
the
Agency's
ability
to
protect
CBI
from
inappropriate
release
and
stated
that,
under
Section
14
of
TSCA,
EPA
has
a
statutory
obligation
to
protect
from
improper
disclosure
information
properly
claimed
CBI.
Commenters
are
concerned
about
inappropriate
past
releases
of
information
claimed
as
CBI,
and
believe
that
IURA
will
"
unduly
foster
the
release
of
sensitive
and
proprietary
CBI."
They
would
like
to
see
the
Agency
take
steps
to
guarantee
greater
protection
of
CBI
data.

Source:
C1­
004,
C1­
011,
C1­
012,
C1­
016,
C1­
019,
C1­
033,
C1­
069
Response
E.
1a­
1:
EPA
is
continually
exploring
ways
to
better
protect
information
claimed
as
confidential,
including
soliciting
input
from
regulated
parties.
During
the
past
several
Page
129
of
159
years
the
Agency
has
committed
significant
resources
to
strengthening
its
CBI
management
procedures.
For
example,
the
Agency
is
revising
and
updating
its
TSCA
security
manual.
The
Agency
has
no
reason
to
believe
that
IURA
will
lead
to
an
increase
in
improper
releases
of
CBI.

To
the
contrary,
in
recent
years
administrative
incidents
have
been
dramatically
reduced,
and
the
Agency
is
continuing
its
efforts
to
protect
against
improper
disclosure.

Comment
E.
1a­
2:
A
commenter
is
concerned
that
the
Agency
is
compromising
the
safety
of
CBI
by
allowing
Federal
contractors
to
have
access
to
the
information.
This
commenter
also
expressed
concern
about
the
continued
protection
of
CBI
information
when
a
Federal
employee
leaves
and
takes
a
position
in
the
private
sector.

Source:
C1­
019
Response
E.
1a­
2:
EPA's
CBI
protection
procedures
extend
to
Federal
contractors,

exemployees
and
certain
others
who
may
legitimately
need
access
to
the
data.
TSCA
Section
14(
a)(
2)
provides
that
CBI
shall
be
disclosed
to
contractors
and
their
employees
if
EPA
determines
the
disclosure
is
necessary
for
the
satisfactory
performance
of
a
federal
contract
under
the
Act.
One
of
the
measures
EPA
employs
in
carrying
out
this
statutory
provision
requires
that
all
contractor
employees
sign
a
Confidentiality
Agreement
upon
relinquishing
TSCA
CBI
access
authority.
In
the
agreement,
contractor
employees
affirm
the
following:

"
I
agree
that
I
will
not
remove
any
copies
of
materials
containing
TSCA
CBI
from
the
premises
of
my
company
or
from
EPA
premises
upon
my
relinquishment
of
TSCA
CBI
access
authority.
I
further
agree
that
I
will
not
disclose
any
TSCA
CBI
to
any
person
after
my
relinquishment
of
TSCA
CBI
access
authority.

"
I
agree
that
as
a
contractor
employee
who
has
been
authorized
access
to
TSCA
CBI,

under
Section
14(
d)
of
TSCA
(
15
USC
2613(
d))
I
am
liable
for
a
possible
fine
of
up
to
$
5,000
and/
or
imprisonment
for
up
to
one
year
if
I
willfully
disclose
TSCA
CBI
to
any
person."

EPA
requires
federal
employees
who
terminate
their
employment
or
otherwise
relinquish
TSCA
CBI
access
authority
to
sign
an
agreement
containing
substantially
similar
language.

b.
Disclosing
customer
confidential
information
Page
130
of
159
Comment
E.
1b­
1:
Several
commenters
expressed
concern
that
their
customers
would
be
unwilling
to
provide
them
with
confidential
processing
and
use
data.
A
natural
gas
commenter
expressed
concern
that,
as
a
producer
of
chemical
feedstocks,
it
might
inadvertently
report
customer
data
and
not
claim
the
information
as
CBI,
while
its
customer
reports
the
same
data
to
EPA
under
IURA
and
does
claim
it
CBI.

Source:
C1­
028,
C1­
031,
C1­
033,
C1­
047,
C1­
048,
C1­
055
Response
E.
1b­
1:
EPA
does
not
believe
that
reporting
customer
data
will
be
a
significant
issue.
The
downstream
processing
and
use
information
that
some
submitters
will
be
required
to
provide
under
the
IURA
is
not
tied
to
customer
identities
or
to
the
identities
of
their
products.

Submitters
will
not
report
who
their
customers
are,
where
they
are
located,
or
what
or
how
much
they
produce
individually.
The
readily
obtainable
reporting
standard
for
processing
and
use
information
does
not
require
a
submitter
to
poll
customers
for
information,
therefore
the
submitter
need
not
ask
for
or
gather
CBI
from
customers.
In
addition,
CBI
claims
can
be
made
as
necessary
for
any
information
provided
on
Form
U.
Manufacturers
of
the
natural
gas
substances
described
in
section
710.46(
a)(
4)
of
the
regulatory
text
are
generally
fully
exempt
from
reporting
under
the
IURA,
so
this
commenter
will
not
be
subject
to
any
reporting
requirements
concerning
customer
data.

c.
Production
volume
ranges
Comment
E.
1c­
1:
Commenters
had
mixed
reactions
to
the
use
of
predetermined
production
volume
ranges
as
a
means
of
making
more
production
volume
information
available
to
the
public.
Some
commenters
believe
this
approach
will
be
successful,
while
others
stated
that
the
ranges
were
too
narrowly
drawn.
Commenters
stated
that
their
CBI
claims
would
likely
increase
because
the
production
volume
information
can
be
combined
with
new
exposure
data
to
reveal
confidential
information,
and
because
the
data
would
allow
competitors
to
predict
process
and
actual
production
volume
data
at
a
particular
site.

Source:
C1­
009,
C1­
023,
C1­
033,
C1­
041,
C1­
045,
C1­
047,
C1­
061,
C1­
073
Response
E.
1c­
1:
EPA
agrees
that
the
wider
the
reporting
ranges,
the
fewer
the
CBI
claims.
However,
EPA
has
set
the
reporting
ranges
to
provide
the
information
necessary
to
meet
Page
131
of
159
Agency
and
the
public's
needs
for
screening
level
data.
Moreover,
despite
these
comments,
the
Agency
has
determined
that
it
is
worthwhile
to
require
submitters
to
consider
whether
their
production
volumes,
within
the
original
Inventory
ranges,
warrant
protection
as
CBI.
Some
submitters
will
make
CBI
claims
for
both
the
specific
and
the
ranged
production
volume
information.
However,
EPA
believes
that
in
many
cases
submitters
will
allow
the
release
of
ranged
production
volume
information
without
fear
that
the
data
will
be
misused
by
competitors.

For
example,
in
a
1993
letter,
a
company
suggested
the
use
of
the
original
Inventory
production
volume
ranges
for
non­
confidential
reporting.
While
this
company
did
state
that
a
submitter
conceivably
could
be
able
to
justify
a
CBI
claim
for
a
range,
the
conclusion
was
that
many
companies
would
be
satisfied
with
reporting
in
these
ranges
non­
confidentially
(
Ref.
31).

These
conclusions
are
further
supported
by
EPA's
experience
with
the
original
Inventory,
where
only
35%
of
production
volume
values
reported
to
the
original
TSCA
Inventory
were
claimed
CBI,
compared
to
the
typical
claim
level
of
65%
for
production
volumes
under
the
IUR.

2.
Up­
Front
Substantiation
Comment
E.
2­
1:
Commenters
stated
that
the
proposed
up­
front
substantiation
requirement
for
plant
site
identity
information
is
not
authorized
under
TSCA.
Other
commenters
feel
that
requiring
up­
front
substantiation
for
each
piece
of
data
is
overly
burdensome
and
an
arbitrary
exercise
of
authority.
The
commenters
state
that
instead
of
up­
front
substantiation,

substantiation
should
be
required
only
if
a
request
for
public
disclosure
is
made.

Source:
C1­
009,
C1­
016,
C1­
026,
C1­
033,
C1­
038,
C1­
047,
C1­
060,
C1­
055,
C1­
069
Response
E.
2­
1:
Up­
front
substantiation
is
authorized
under
TSCA
Section
14(
c):
"
a
[
confidential]
designation
under
this
paragraph
shall
be
made
in
writing
and
in
such
manner
as
the
Administrator
may
prescribe."
Up­
front
substantiation
is
one
element
of
CBI
designation.
EPA
emphasizes
that
it
is
not
requiring
up­
front
substantiation
for
each
data
element.
The
Agency
has
been
and
is
continuing
to
require
up­
front
substantiation
of
chemical
identity
CBI
claims,
and
is
now
requiring
that
submitters
also
provide
up­
front
substantiation
of
CBI
claims
for
plant
site
identity.
No
other
data
elements
will
require
up­
front
substantiation
for
CBI
claims
made
under
IURA.

The
Agency
is
adding
the
up­
front
substantiation
requirement
for
plant
site
identity
because
EPA
has
observed
that,
on
occasion,
this
information
has
been
claimed
as
confidential
Page
132
of
159
even
though,
for
example,
it
was
revealed
(
without
CBI
claims)
in
TRI
public
filings,
under
sections
311,
312
and
313
of
the
Emergency
Planning
and
Community
Right­
to­
Know
Act
(
EPCRA),
42
U.
S.
C.
sections
11001
to
11050.
Such
CBI
claims
are
inappropriate
and
the
new
up­
front
substantiation
requirement
will
reduce
the
occurrence
of
such
claims.
Fewer
inappropriate
claims
will
allow
EPA
to
make
more
plant
site
information
available
to
other
Federal
agencies
and
the
public.

Up­
front
substantiation
of
CBI
claims
imposes
some
additional
burden,
although
this
burden
is
not
substantial.
EPA's
economic
analysis
for
this
rule
provides
an
estimate
of
0.9
to
2.0
hours
for
the
incremental
costs
of
providing
up­
front
CBI
substantiation
for
plant
site
identity
under
IURA.
(
See
the
Economic
Analysis
for
more
details).

Substantiation
of
all
CBI
claims
will
continue
to
be
required
when
a
challenge
to
the
claim
is
made
pursuant
to
a
request
for
public
disclosure,
as
is
current
practice.

Comment
E.
2­
2:
Several
commenters
feel
that
requiring
up­
front
substantiation
is
unnecessarily
burdensome.
One
commenter
suggests
simplifying
the
currently
detail­
oriented
11
question
report
with
only
two
questions:
(
1)
Are
the
specified
data
confidential?
and
(
2)
In
as
great
as
detail
as
possible,
explain
why
this
information
should
be
given
CBI
protection.
Another
commenter
stated
that
up­
front
substantiation
should
be
limited
to
a
certification
that
the
CBI
data
are
not
otherwise
available
and
that
the
submitter
undertakes
efforts
to
protect
the
data
from
disclosure.
This
commenter
feels
that
EPA
should
pursue
actions
against
individual
submitters
who
make
spurious
CBI
claims,
rather
than
impose
across­
the­
board
obstacles
and
costs
to
the
assertion
of
legitimate
claims.

Source:
C1­
016,
C1­
047
Response
E.
2­
2:
EPA
believes
that
requiring
responses
to
the
list
of
substantiation
questions
in
section
710.58
of
the
regulatory
text
is
necessary
to
ensure
that
certain
information
submitted
for
confidential
protection
qualifies
for
that
protection.
The
commenters'
proposed
questions,
while
providing
the
opportunity
for
a
submitter
to
express
its
business
reasons
and
preferences
regarding
the
information,
do
not
provide
all
of
the
necessary
information
to
definitively
evaluate
the
eligibility
of
the
information
for
confidential
treatment.
While
EPA
intends
to
take
action
against
individual
spurious
claims,
the
Agency
can
best
determine
whether
a
CBI
claim
of
chemical
or
plant
site
identification
is
valid
through
affirmative
substantiation
provided
by
submitters.
Page
133
of
159
3.
Reassertion
Comment
E.
3­
1:
Commenters
were
generally
negative
about
the
proposed
requirement
that
they
reassert
their
previous
IURA
CBI
claims.
Commenters
stated
that
the
reassertion
requirements
would
be
overly
burdensome,
unnecessary,
and
even
punitive.
Some
commenters
felt
that
the
requirements
would
weaken
protection
of
legitimate
CBI
by
inducing
some
submitters
feeling
overburdened
by
the
requirements
to
forego
reassertion
and
their
rights
to
CBI
protection.

Source:
C1­
003,
C1­
009,
C1­
010,
C1­
011,
C1­
012,
C1­
016,
C1­
018,
C1­
019,
C1­
032,

C1­
033,
C1­
038,
C1­
041,
C1­
047,
C1­
055,
C1­
060,
C1­
069,
C1­
073
Response
E.
3­
1:
EPA
did
not
propose
to
require
resubstantiation,
but
rather
reassertion
of
CBI.
A
number
of
commenters
appeared
to
use
the
terms
"
reassertion"
and
"
resubstantiation"

interchangeably.
However,
EPA
did
not
promulgate
the
reassertion
portion
of
the
proposal,
and
therefore
there
are
no
current
requirements
to
reassert
previous
CBI
claims.
The
decision
to
not
promulgate
reassertion
requirements
was
made
during
interagency
review,
in
order
to
reduce
the
burden
associated
with
these
amendments.

Submitters
must
remember
that
information
submitted
to
the
Agency
only
qualifies
for
confidential
treatment
when
it
meets
the
regulatory
criteria
established
under
40
CFR
Part
2.

Because
the
need
for
CBI
protections
for
a
given
piece
of
information
often
changes
over
time,

EPA
believes
submitters
must
periodically
review
the
circumstances
surrounding
their
information
and
determine
if
their
claims
continue
to
qualify.
EPA
does
not
view
this
process
as
either
unreasonable
or
unnecessary,
and
certainly
not
punitive.
Without
a
reassertion
requirement,
EPA
protects
indefinitely,
and
at
taxpayer
expense,
information
claimed
as
CBI
which
may
no
longer
qualify
for
such
protection.

EPA
believes
that
the
benefits
of
maintaining
only
claims
for
CBI
which
have
legal,

contemporaneous
merit,
and
clearing
all
other
information
for
public
release
outweigh
the
comparatively
minor
burden
of
completing
the
simple
reassertion
requirement.
If
a
submitter's
information
truly
qualifies
under
the
regulatory
standards
and
CBI
protection
remains
necessary,

then
it
is
logical
to
assume
a
submitter
will
take
whatever
required
action
necessary
to
protect
its
business
interests
rather
than
forego
protection.
EPA
takes
seriously
its
responsibility
under
TSCA
to
protect
CBI.
However,
information
is
CBI
only
if
submitters
can
verify
this
fact.
EPA
views
this
responsibility
on
the
part
of
the
regulated
community
to
be
ongoing.
Page
134
of
159
Comment
E.
3­
2:
A
number
of
commenters
objected
to
"
yearly
reassertion"
requirements
for
previous
CBI
claims.

Source:
C1­
019,
C1­
028,
C1­
032
Response
E.
3­
2:
The
commenters
are
incorrect
in
their
characterization
of
the
reassertion
requirement
as
a
yearly
effort.
In
fact,
IURA
data
are
collected,
and
previous
CBI
claims
would
have
needed
to
be
reasserted,
only
once
every
four
years,
not
on
an
annual
basis
as
the
commenters
state.

Comment
E.
3­
3:
Commenters
also
stated
that
EPA
does
not
have
the
authority
under
TSCA
to
require
reassertion.

Source:
C1­
010,
C1­
011,
C1­
018,
C1­
032,
C1­
033,
C1­
038,
C1­
055,
C1­
060
Response
E.
3­
3:
Section
14(
c)
of
TSCA
invests
the
Agency
with
the
authority
to
prescribe
the
manner
in
which
CBI
shall
be
designated.
In
proposing
these
amendments,
EPA
considered
initiating
a
quadrennial
reassertion
requirement
as
part
of
this
designation
process.

Comment
E.
3­
4:
Numerous
commenters
objected
strongly
to
the
proposed
requirement
that
submitters
affirmatively
reassert
their
CBI
claims,
and
that
failure
to
do
so
will
result
in
automatic
declassification
of
the
data.
Several
submitters
stated
that
if
a
chemical
is
not
reported
in
a
given
submission
period
because
it
was
not
manufactured
or
imported
during
that
reporting
year,
submitters
should
not
have
to
reassert
previous
CBI
claims.
The
submitters
felt
that
all
existing
CBI
claims
should
automatically
remain
in
effect
without
the
submitter
needing
to
take
any
action.

Other
commenters
stated
that
EPA
would
violate
the
law
by
releasing,
without
prior
written
notice
to
the
submitter,
CBI
which
had
not
been
reasserted.
Even
if
a
submitter
fails
to
reassert
a
CBI
claim,
commenters
contend
that
the
information
continues
to
be
"
designated"
CBI
and
protected
from
release
unless
EPA
provides
prior
notification
of
intent
to
disclose
it.
One
commenter
recommended
that
at
a
minimum,
if
a
submitter
does
not
reassert
a
claim,
the
Agency
should
first
contact
the
submitter
and
give
it
the
opportunity
to
supply
supporting
documentation
for
its
claim
before
the
claim
is
deemed
to
be
automatically
dropped
and
information
publicly
released.
Page
135
of
159
Commenters
also
recommended
that
CBI
be
declassified
only
upon
the
affirmative
and
voluntary
act
of
a
submitter,
such
as
indicating
on
the
Form
U
that
it
wishes
to
withdraw
a
claim,

and
not
by
default
for
failing
to
reassert.

Source:
C1­
003,
C1­
011,
C1­
024,
C1­
028,
C1­
029,
C1­
032,
C1­
033,
C1­
041,
C1­
047,

C1­
048,
C1­
055,
C1­
060,
C1­
069
Response
E.
3­
4:
The
Agency
agrees
that
EPA
is
required
to
provide
notification
of
intent
to
disclose
confidential
information.
Under
TSCA,
15
USC
Section
2613(
c),
"...
if
the
Administrator
proposes
to
release
for
inspection
data
which
has
been
designated
under
paragraph
(
1)(
A),
the
Administrator
shall
notify,
in
writing
and
by
certified
mail,
the
manufacturer,
processor,
or
distributor
in
commerce
who
submitted
such
data
of
the
intent
to
release
such
data."
The
IUR
amendments
were
to
include
a
periodic
reassertion
requirement
as
a
necessary
component
of
designating
IUR
information
as
confidential.
A
designation
of
CBI
under
IURA
would
have
been
effective
until
the
subsequent
reporting
period,
after
which,
if
not
re­
designated
(
i.
e.,
reasserted),
the
claim
would
have
been
considered
abandoned
or
withdrawn,

and
it
would
have
ceased
to
be
a
valid,
designated
claim
justifying
continued
CBI
protection.

While
EPA
did
not
promulgate
this
requirement,
it
believes
this
requirement
is
justified
because
the
Agency
cannot
know
whether
any
given
piece
of
formerly
submitted
CBI
still
qualifies
as
CBI
under
the
substantive
criteria
found
at
40
CFR
2.208,
as
judged
to
be
met
by
reviewing
a
claimant's
answers
to
the
questions
found
at
710.58
of
the
regulatory
text.
TSCA
does
not
require
EPA
to
protect
in
perpetuity
information
that
was
once
legitimately
claimed
as
CBI,
but
no
longer
warrants
CBI
protection.
Requiring
a
submitter
to
reassert
its
claim(
s)
every
four
years­­
including
reviewing
and
re­
evaluating
claims
made
on
prior
reports­­
is
consistent
with
this
legal
responsibility.

Furthermore,
submitters
are
free
at
any
time
to
notify
EPA
that
they
wish
to
withdraw
a
CBI
claim.
However,
EPA
believes
that
a
higher
number
of
previous
CBI
claims
which
no
longer
meet
the
criteria
will
be
withdrawn
under
an
affirmative
reassertion
program
than
under
a
voluntary
withdraw
plan
and,
while
the
Agency
is
not
promulgating
the
reassertion
requirement
at
this
time,
EPA
may
add
a
similar
requirement
in
the
future.

Comment
E.
3­
5:
Commenters
expressed
concern
that
the
proposed
reassertion
requirement
would
create
a
"
multiplier
effect"
that
would
require
submitters
to
review
all
prior
data
items
claimed
confidential
starting
in
2006.
In
the
case
where
a
data
element
has
lost
its
Page
136
of
159
confidential
status,
the
submitter
would
be
required
to
prepare
a
revised
report
to
reflect
the
change
in
status
of
some
of
the
data.
According
to
one
commenter,
this
would
create
increased
burdens
in
subsequent
years,
which
EPA
did
not
consider
in
its
analysis.
A
related
issue
was
raised
by
another
commenter,
who
was
concerned
that
the
five­
year
record
retention
requirement
would
lead
to
situations
where
a
submitter
who
needed
to
resubstantiate
an
answer
(
in
2010,
for
example)
made
in
a
claim
more
than
five
years
prior
(
ie.,
in
2002),
would
no
longer
have
the
necessary
records
to
support
the
resubstantiation.

Source:
C1­
021,
C1­
028,
C1­
033,
C1­
055,
C1­
061
Response
E.
3­
5:
EPA
disagrees
with
the
commenters
that
reassertion
will
have
a
multiplying
effect
on
burden.
The
nature
of
the
requirement
is
that
submitters
review
their
previous
CBI
claims
to
make
sure
they
are
still
valid
in
the
current
submission
period.
If
previous
claims
are
no
longer
valid
or
CBI
protection
is
no
longer
needed,
the
submitter
informs
the
Agency
in
the
reassertion
section
of
Form
U
in
the
current
submission
period.
The
submitter
should
need
to
go
back
only
to
the
previous
report
to
review
the
claim
and
be
able
to
reassert
it,
if
desired,
in
the
current
submission
period.
If
the
submitter
does
this
every
reporting
cycle,
then
each
report
will
be
based
on
updated
information
and
the
submitter
won't
have
to
go
back
more
than
one
reporting
cycle
to
verify
the
ongoing
validity
of
the
CBI
claim.
EPA
is
assuming
that
the
initial
claim
was
valid.
Therefore,
the
reassertion
process
should
entail
only
a
check
on
the
previous
report's
reassertion
that
the
information
initially
claimed
as
CBI
still
meets
the
legal
requirements
for
protection,
e.
g.,
that
the
information
was
not
made
public
during
the
prior
four
years.

The
same
holds
with
the
five
year
record
retention
requirement.
Each
submission
period's
report
should
be
based
on
updated
and
reverified
information.
If
either
a
portion
of
an
answer
or
an
entire
answer
to
a
substantiation
question
has
changed
from
its
original
answer,
the
submitter
should
have
only
to
go
back
one
submission
period
to
update
the
answer.

Comment
E.
3­
6:
By
proposing
the
IURA,
EPA
is
stating
that
the
value
of
CBI
automatically
diminishes
over
time.

Source:
C1­
016,
C1­
033,
C1­
073
Response
E.
3­
6:
EPA
does
not
assume
that
CBI
diminishes
over
time,
nor
is
any
less
Page
137
of
159
valuable
to
submitters
after
it
has
been
initially
reported.
EPA
recognizes
that
information
that
at
one
time
may
have
qualified
under
the
legal
requirements
as
CBI
may
no
longer
qualify,
or
the
circumstances
that
caused
the
information
to
be
claimed
as
CBI,
may
change
over
time.
Through
reassertion,
EPA
was
proposing
that
submitters
simply
reaffirm
that
the
CBI
designation
is
still
needed
and
is
still
legally
justified.
This
proposed
requirement
was
in
the
interest
of
maintaining
the
integrity
and
accuracy
of
the
CBI
files
on
which
EPA
expends
considerable
taxpayer
resources.

F.
Administrative
Comments
1.
Frequency
of
Reporting
Comment
F.
1­
1:
Several
commenters
stated
that
they
believe
one­
time
reporting
of
the
new
IURA
information
would
be
more
appropriate
than
recurring
reporting
for
the
intended
purposes
expressed
by
EPA.
In
general,
commenters
stated
that
EPA
could
use
tools
such
as
PAIR
to
identify
changes
in
a
particular
chemical's
exposure
or
use
profile
at
the
time
the
Agency
decides
to
do
a
risk
analysis.
A
few
commenters
stated
that
there
is
insufficient
change
in
the
chemical
industry
to
warrant
additional
reporting,
especially
for
higher
volume
chemicals.
Several
commenters
questioned
why
one­
time
data
collection
efforts
would
not
provide
useful
exposurerelated
data,
particularly
if
they
are
focused
on
a
subset
of
high
priority
chemicals.

Source:
C1­
009,
C1­
010,
C1­
011,
C1­
016,
C1­
018,
C1­
024,
C1­
027,
C1­
028,
C1­
033
Response
F.
1­
1:
EPA's
experience
with
past
IUR
reporting
demonstrates
that
the
chemical
industry
is
indeed
dynamic,
with
a
30%
change
in
chemicals
reporting
from
one
submission
period
to
the
next.
The
specific
chemicals
that
are
reported
or
not
reported
in
any
single
submission
period
change
at
a
variety
of
production
volumes;
this
change
is
by
no
means
limited
to
lower
production
volume
chemicals.
EPA
did
consider
one
time
reporting
for
the
processing
and
use
data
that
will
be
collected
under
these
amendments,
as
well
as
reporting
processing
and
use
data
every
other
reporting
cycle
(
once
every
8
years)
while
still
collecting
basic
IUR
data
(
i.
e.,
the
data
reported
on
partial
forms)
every
4
years.
However,
the
one
time
reporting
would
quickly
become
out
of
date.
Reporting
some
of
the
data
every
8
years
and
the
remaining
data
every
4
years
would
keep
the
processing
and
use
data
somewhat
updated,
but
would
be
difficult
and
confusing
to
administer,
both
for
the
submitter
and
for
the
Agency.
Page
138
of
159
EPA's
reasons
for
collecting
the
basic
IURA
data
include
providing
a
database
of
information
which
can
be
used
for
screening
level
purposes
and
to
identify
chemicals
for
further
assessment.
EPA
intends
to
use
other
data
sources
and
collection
tools,
as
appropriate,
once
a
chemical
has
been
identified
as
a
candidate
for
further
assessment.

2.
Calendar
year
reporting
Comment
F.
2­
1:
One
commenter
felt
that
the
requirement
to
report
data
on
a
calendar
year
basis
instead
of
a
company
fiscal
year
basis
would
increase
systems
development
needs
for
companies
who
report
their
volume
manufacturing
on
a
fiscal
year
basis
versus
a
calendar
year
basis
(
by
creating
the
need
for
a
second
tracking
system)
while
providing
no
additional
value
or
accuracy
in
the
reporting
of
manufacturing
data.
This
commenter
pointed
out
that
since
the
most
companies
can
differ
from
a
calendar
year
is
by
six
months
and
IUR
reporting
occurs
every
four
years
(
instead
of
every
year),
there
can
be
little
difference
in
the
data
with
a
six
month
time
frame
shift.
Other
commenters
supported
the
change
to
a
calendar
year
basis,
supporting
the
idea
of
having
a
consistent
timeframe
to
better
enable
linkages
with
other
databases.

Source:
C1­
014,
C1­
028,
C1­
065
Response
F.
2­
1:
EPA
has
retained
the
switch
to
the
calendar
year
basis
as
proposed.
By
moving
the
collection
to
a
calendar
year
basis,
the
IUR
data
collection
becomes
more
compatible
with
other
databases
such
as
the
Toxics
Release
Inventory
(
TRI).
This
compatibility
increases
the
utility
of
the
information
by
allowing
the
IUR
data
to
be
more
easily
combined
with
or
compared
to
information
from
other
collections.
It
is
EPA's
belief
that
most
companies
are
familiar
enough
with
their
production
volumes
that
this
provision
presents
no
special
challenge
that
are
unaccounted
for
in
the
burden
estimates
provided
by
survey
respondents,
as
described
in
the
economic
analysis.

3.
Form
U
comments
Comment
F.
3­
1:
Commenters
mentioned
that
the
existing
IUR
Form
U
allows
ten
chemicals
to
be
reported
on
each
form
(
with
an
unlimited
number
allowed
on
the
electronic
version),
and
that
each
form
requires
only
one
certification
with
one
signature
for
each
site,

regardless
of
the
number
of
chemicals
being
reported
by
that
site.
The
commenters
believed
that
Page
139
of
159
this
would
no
longer
be
the
case
when
using
the
revised
Form
U
and
urged
EPA
to
modify
Part
I
of
the
revised
Form
U
so
that
one
signature
will
cover
all
the
chemicals
reported
by
a
site.

Source:
C1­
031,
C1­
033,
C1­
061
Response
F.
3­
1:
The
certification
statement,
company
information,
and
plant
site
identification
reported
on
Part
I
of
the
revised
Form
U
will
cover
all
chemicals
reported
by
a
single
site.
Thus,
for
a
given
site,
submitters
will
only
have
to
fill
out
Part
I
of
the
revised
Form
U
once,
whereas
Parts
II
and
III
will
be
completed
for
each
individual
chemical
manufactured
(
including
imported)
at
that
site.

Comment
F.
3­
2:
A
commenter
objected
to
the
certification
that
"
all
information
entered
on
the
form
is
complete
and
accurate"
because
submitters
may
provide
estimates
where
specific
information
is
unavailable.
This
commenter
felt
that,
due
to
the
nature
of
estimated
information,

the
submitter
cannot
attest
to
the
accuracy
of
the
information.

Source:
C1­
0016
Response
F.
3­
2:
The
certification
attests
to
the
fact
that,
to
the
best
of
the
submitter's
knowledge,
the
information,
including
all
estimates,
is
accurate.
Although
it
is
true
that
all
estimates
are
inherently
imprecise
(
i.
e.
they
are
not
exact),
estimates
can
be
accurate
(
i.
e.
correct,

carefully
made).
Submitters
must
maintain
the
basis
for
their
estimates
as
part
of
their
overall
IUR
recordkeeping
(
see
40
CFR
710.57).

Comment
F.
3­
4:
In
section
710.32(
c)(
4)
and
(
5)
of
the
proposed
regulatory
text,
EPA
stated
that
certain
information
from
calendar
year
1999
would
be
reported
under
IURA.
The
year
1999
shouldn't
be
used
since
the
first
reporting
period
in
2002
is
based
on
data
from
2001,
not
1999.

Source:
C1­
056
Response
F.
3­
4:
EPA
agrees
that,
at
the
time
the
amendments
were
proposed,
the
first
reporting
year
after
the
promulgation
of
the
IURA
was
expected
to
be
2002,
based
on
2001
data.

However,
at
the
time
the
amendments
are
promulgated,
the
first
submission
period
will
occur
in
Page
140
of
159
2006,
based
on
2005
data.
EPA
has
modified
all
necessary
materials
to
reflect
this,
including
section
710.52
of
the
finalized
regulatory
text.

Comment
F.
3­
5:
One
commenter
pointed
out
there
is
an
error
in
Part
III
of
the
sample
version
of
Form
U
that
was
provided
in
the
proposed
rule.
The
directions
state
that
Part
III
should
be
completed
if
production
is
over
100,000
pounds,
rather
than
300,000
pounds.

Source:
C1­
027,
C1­
048
Response
F.
3­
5:
EPA
has
revised
Form
U
to
reflect
the
300,000
pound
production
threshold
established
for
completing
Part
III
of
Form
U.

Comment
F.
3­
6:
EPA
should
clarify
how
sites
located
in
more
than
one
county
should
report.

Source:
C1­
033
Response
F.
3­
6:
EPA
will
clarify
in
its
guidance
document
for
submitters
reporting
under
IURA
that,
where
a
site
is
located
in
more
than
one
county,
submitters
should
name
each
of
the
counties
in
which
the
site
is
located
in
response
to
section
710.52(
c)(
2)
of
the
regulatory
text.

G.
Economics
Comment
G­
1:
Commenters
disagreed
with
the
Agency's
characterization
of
the
economic
analysis
results
as
described
in
the
summary
and
introductory
sections
of
the
Economic
Analysis
of
Proposed
Amendments
to
the
TSCA
Section
8
Inventory
Update
Rule
(
March
1,
1999)

(
proposed
economic
analysis)
and
specifically
took
issue
on
the
following
four
points:

1)
"
On
page
S­
7...
EPA
inaccurately
characterizes
the
proposal
by
stating
that
`
most
of
these
reports
must
already
be
submitted
under
the
existing
IUR
requirements'
when
1,200
inorganic
chemicals
would
be
reportable
for
the
first
time."

2)
The
commenter
also
finds
misleading
"
the
Agency's
claim
that
`
companies
would
simply
be
providing
additional
information'
when
considerable
economic
burden
would
be
placed
on
manufacturers
and
importers
to
assemble
use
and
exposure
data
on
potentially
thousands
of
downstream
uses..."
and
continues
the
point
by
stating
that
"
On
page
S­
9
EPA
asserts
reporting
Page
141
of
159
processing
and
use
information
on
the
top
ten
NAICS
codes
will
cut
costs;
yet,
determining
the
top
ten,
perhaps
out
of
thousands,
could
take
considerable
effort..."

3)
"
On
page
S­
13
we
must
object
to
EPA's
characterization
of
its
decision
to
seek
use
and
exposure
information
at
the
300,000­
pound
level
as
a
burden
reduction
merely
because
it
could
have
proposed
its
collection
at
the
25,000­
pound
reporting
threshold..."

4)
"
On
page
II­
1
we
disagree
with
the
Agency's
theory
that
market
externalities
preclude
the
government
and
the
public
from
access
to
needed
information
on
risks
associated
with
chemicals.
Companies
wishing
to
stay
in
business
have
every
economic
incentive
not
to
use
chemicals
that
might
harm
their
employees
or
customers.
To
the
contrary,
more
and
more
companies
are
making
environmental
claims
about
their
products."

Source:
C1­
016,
C1­
073
Response
G­
1:
The
specific
comments
are
addressed
below:

1)
EPA
estimates
that
over
26,800
reports
will
be
filed
during
the
first
IURA
submission
period
(
i.
e.,
in
2006).
Of
these
26,800
reports,
about
4,500
are
expected
to
be
from
inorganic
chemical
manufacturers
reporting
for
the
first
time
on
approximately
1,200
inorganic
chemicals.

Roughly
82%
of
the
25,500
reports
are
required
under
the
current
IUR,
therefore
EPA's
statement
that
most
of
the
reports
must
already
be
filed
under
the
current
IUR
is
accurate.

2)
EPA
expects
submitters
to
report
information
on
a
wide
variety
of
downstream
uses.

However,
for
each
chemical
on
which
a
submitter
reports,
that
submitter
will
report
on
a
maximum
of
ten
industrial
uses.
Only
an
extremely
small
fraction
of
chemicals
are
likely
to
have
thousands
of
uses,
but
providing
the
top
ten
combinations
of
NAICS
codes
and
industrial
uses,
as
opposed
to
thousands,
will
entail
less
burden
than
listing
all
of
them.
EPA
surveyed
chemical
firms
to
estimate
the
burden
required
for
this
data
element
(
see
the
EA
for
the
final
rule).

3)
EPA
simply
meant
that
providing
a
partial
exemption
for
chemicals
below
300,000
lbs
is
a
concession
to
burden
reduction,
and
that
the
Agency
has
no
other
basis
for
creating
a
separate,
higher
threshold
for
the
reporting
of
processing
and
use
information.

4)
EPA
stands
by
its
statement
that
market
failures
(
including
externalities)
preclude
the
government
and
the
public
from
access
to
needed
information
on
risks
associated
with
chemicals.

This
discussion
is
presented
in
Section
2.2
of
the
EA
for
the
final
rule.
The
existence
of
certain
positive
incentives
and
environmental
claims
does
not
begin
to
address
the
fundamental
lack
of
data
on
chemical
risk
facing
the
public
and
EPA.
As
stated
throughout
all
documents
in
the
public
record
for
this
rule,
the
basic,
relatively
broad­
based
information
that
EPA
needs
to
assess
Page
142
of
159
potential
risks
stemming
from
chemical
production
and
use
is
simply
unavailable
in
the
marketplace.

1.
Burden
Comments
Comment
G.
1­
1:
Many
commenters
expressed
concern
about
the
burdens
that
would
be
imposed
by
the
IURA.
Some
felt
generally
that
the
Agency's
burden
estimates
in
the
Economic
Analysis
for
the
proposed
IURA
were
too
low.
Comments
that
provided
specific
criticisms
of
EPA's
economic
methodologies
are
addressed
below.

Source:
C1­
003,
C1­
010,
C1­
011,
C1­
015,
C1­
016,
C1­
017,
C1­
019,
C1­
020,
C1­
021,

C1­
023,
C1­
026,
C1­
027,
C1­
028,
C1­
031,
C1­
032,
C1­
033,
C1­
036,
C1­
037,
C1­
041,

C1­
048,
C1­
055,
C1­
061,
C1­
073
Response
G.
1­
1:
EPA
disagrees
with
the
comments
that
it
has
underestimated
reporting
burden.
Few
of
these
commenters
provided
any
evidence
as
to
why
they
felt
EPA
underestimated
burden,
and
none
provided
any
specific
analytical
basis
for
amending
the
estimates.
These
comments
generally
made
unsubstantiated
assertions
that
EPA
underestimated
burden.

EPA
surveyed
78
industry
respondents
to
determine
burden
estimates.
The
survey
instrument,
which
was
developed
in
1996,
differs
from
the
Form
U
as
it
appeared
at
the
time
of
proposal
and
as
it
appears
in
the
final
rule
docket.
These
differences
required
EPA
to
adjust
certain
survey
responses
to
fit
the
requirements
of
the
new
regulation.
In
response
to
these
comments
EPA
revised
the
burden
estimates
for
the
final
rule
by
instituting
more
conservative
assumptions
in
interpreting
the
survey
data.
This
adjustment
results
in
an
average
total
burden
(
incremental
plus
baseline)
for
preparation
and
submission
of
a
full
Form
U
of
92
to
105
hours
for
inorganic
chemicals
in
the
first
reporting
year,
and
86
to
96
hours
for
organic
chemicals.
The
methodology
is
explained
in
greater
detail
in
the
EA
for
the
final
rule.

There
are
two
important
factors
to
note
in
interpreting
the
burden
estimate.
First,
the
IUR
amendments
require
that
industry
report
only
"
reasonably
ascertainable"
information
for
most
data
elements,
and
"
readily
obtainable"
information
for
downstream
processing
and
use
information;

these
standards
for
reporting
information
were
developed
after
the
burden
survey
was
executed.

Thus,
the
survey
respondents
were
reporting
burden
estimates
for
a
higher
standard
of
information.
Second,
the
UEIP
program,
which
asked
respondents
to
report
chemical
information
very
similar
to
that
required
by
the
IUR,
also
asked
respondents
to
report
the
time
spent
of
the
Page
143
of
159
UEIP
form;
companies
reported
a
median
burden
per
chemical
report
of
8
hours,
with
a
mean
of
12
hours.
(
Ref.
32)

Throughout
the
development
of
these
amendments,
the
Agency
considered
its
need
for
the
information
along
with
industry's
burden
in
supplying
the
information.
EPA's
view
is
that
the
amendments
reach
an
appropriate
balance
between
these
considerations.

Comment
G.
1­
2:
Commenters
asserted
that
burdens
on
the
regulated
community
associated
with
IURA
will
not
decrease
over
time
as
EPA
claims
in
the
EA.
Commenters
claimed
that
the
four
year
time
lapse
between
reporting
periods
will
result
in
changes
to
product
lines
and
personnel
such
that
a
complete
reintroduction
to
reporting
will
be
necessary
in
each
reporting
cycle.

Source:
C1­
016,
C1­
033,
C1­
073
Response
G.
1­
2:
EPA
disagrees
with
the
comment
that
a
complete
reintroduction
to
reporting
will
be
necessary
in
each
reporting
cycleBsome
familiarity
with
reporting
is
anticipated
to
remain
from
cycle
to
cycle.
EPA
estimates
of
burden
decrease
over
time
for
two
reasons:
1)

rule
familiarization
is
expected
to
require
the
most
effort
in
the
first
reporting
period,
and
2)
the
information
reported
on
Form
U
is
expected
to
remain
similar
for
many
submitters
reporting
in
consecutive
periods.
EPA
agrees
that
rule
familiarization
will
occur
to
some
extent
in
each
reporting
cycle
after
the
first
year
of
reporting
due
to
the
four
years
between
reporting,
and
burden
levels
in
the
economic
analysis
reflect
that.
But
EPA
does
not
believe
that
the
IUR
Amendments
increase
that
burden
beyond
that
which
is
currently
experienced
under
the
existing
IUR,
despite
the
increased
complexity
of
the
Form
U
(
with
the
exception
of
inorganic
manufacturers).
Rule
familiarization
costs
only
encompass
becoming
familiar
with
rule
requirements,
and
do
not
include
any
activities
required
to
complete
the
revised
Form
U
or
otherwise
comply
with
the
IURA.
Nor
does
EPA
believe
that
subsequent
revised
Form
Us
will
be
as
difficult
to
prepare
as
the
initial
revised
Form
U.
Once
a
site
has
completed
a
Form
U,
that
site
will
be
required
to
keep
its
records
for
five
years,
which
will
facilitate
familiarization
and
form
completion
in
future
submission
periods,
and
it
is
extremely
unlikely
that
all
information
on
every
Form
U
will
be
entirely
different
in
each
submission
period.
EPA
has
recognized
that
some
information
will
vary
from
cycle
to
cycle,
and
has
incorporated
that
knowledge
into
its
estimates
of
future
year
costs.
See
Section
3
of
the
EA
for
the
final
rule
for
more
information.
Page
144
of
159
Comment
G.
1­
3:
Commenters
questioned
EPA's
estimate
that
only
1,200
inorganic
chemicals
will
require
reporting
under
this
proposal,
due
to
the
number
of
inorganic
substances
listed
on
the
inventory.
One
commenter
also
disagreed
with
EPA's
estimate
that
it
will
only
take
6
to
8
hours
to
complete
each
Form
U.
The
commenter
believes
that
it
will
take
at
least
twice
that
amount
of
time
for
the
completion
of
each
form.

Source:
C1­
020,
C1­
044
Response
G.
1­
3:
EPA
estimates
that,
in
addition
to
the
chemicals
that
are
already
reportable
under
the
current
IUR,
approximately
1,117
inorganic
chemicals
will
become
IUR
reportable
under
IURA.
EPA's
estimate
is
based
on
the
ratio
of
inorganic
to
organic
chemicals
in
the
CICIS
database.
(
The
CICIS
(
Chemicals
in
Commerce
Information
System)
database
maintained
by
EPA
contains
information
collected
by
the
Agency
on
chemicals
in
commerce
in
the
U.
S.
since
1977.)
Inorganic
chemicals
constitute
roughly
12%
of
CICIS,
so
EPA
assumed
they
would
account
for
the
same
proportion
of
chemicals
reporting
under
the
IURA,
or
1,117
discrete
chemicals
(
see
Appendix
C
of
the
EA
for
the
final
rule
for
more
detail).
This
figure
is
only
an
estimate,
as
current
production
data
on
inorganic
chemicals
are
currently
unavailable
to
the
Agency.
EPA
has
no
data
that
would
contradict
this
estimate,
nor
did
the
commenters
provide
evidence
or
a
specific
analytical
basis
that
EPA
could
use
for
amending
the
estimate.

The
commenter
obtained
the
6
to
8
hour
burden
figure
from
Regulatory
Assessment
Requirements
section
of
the
preamble
to
the
proposed
rule,
which
addresses
the
annual
burden
per
report
for
each
year
in
the
four
year
reporting
cycle
(
i.
e.,
the
total
burden
of
the
rule
divided
by
the
number
of
reports,
divided
by
the
four
years
in
a
reporting
cycle).
The
actual
burden
per
report
estimated
in
the
EA
for
proposed
rule
was
37
to
46
hours
for
a
full
report,
for
a
site
currently
reporting
under
IUR
(
see
Table
III­
12
in
the
EA
for
the
proposed
rule).
As
described
in
the
preamble
to
the
final
rule
and
the
Summary
section
of
the
EA,
EPA
has
increased
the
burden
estimates
for
the
final
rule
92
to
105
hours
for
a
full
report
(
see
Table
3­
2
in
the
EA
for
the
final
rule).

Comment
G.
1­
4:
Some
commenters
felt
that
the
revised
Form
U
represents
a
5­,
10­,
or
30­
fold
increase
in
burden
over
the
current
IUR
regulations.
For
example,
one
commenter
writes:

"
The
current
single
page
report
covering
up
to
ten
chemicals
will
be
replaced
by
a
three
page
document
for
each
reportable
chemical
also
at
each
site.
This
represents
a
paperwork
increase
factor
of
30..."
Page
145
of
159
Source:
C1­
010,
C1­
028,
C1­
041
Response
G.
1­
4:
EPA
disagrees
that
the
rule
results
in
such
a
significant
increase
in
burden.
Under
the
existing
IUR,
the
estimated
average
burden
for
a
site
to
submit
a
single
report
is
roughly
14
to
22
hours
per
reporting
cycle
(
including
compliance
determination,
rule
familiarization,
preparation
and
submission,
and
recordkeeping).
The
IURA
exempts
some
current
submitters,
adds
some
new
submitters,
and
would
result
in
an
increase
in
burden
for
the
average
report,
depending
on
production
volume
and
type
of
chemical,
of
between
roughly
19
and
117
hours,
in
the
first
year
(
see
Section
3
of
the
EA
for
the
final
rule).
The
number
of
pages
potentially
submitted
is
an
inappropriate
measure
of
the
burden
of
the
rule.
The
commenters
have
not
provided
a
reasonable
basis
for
their
assertions
about
burden
increase.
EPA
has
taken
a
number
of
steps
to
limit
reporting
burden,
including
raising
the
reporting
threshold
from
the
existing
level
of
10,000
pounds
to
25,000
pounds,
and
exempting
certain
natural
gas
chemicals
from
reporting.

Comment
G.
1­
5:
Several
commenters
claimed
that
CBI
up­
front
substantiation
and
reassertion
costs
are
underestimated.
For
example,
one
commenter
(
38)
writes:
"
The
proposed
rule
will
require
up
front
substantiation
of
each
CBI
parameter...
Furthermore,
the
requirement
that
all
previous
CBI
claims,
which...
may
involve
thousands
of
data
points,
must
be
reviewed
and
reasserted
each
year
is
unreasonable..."

Source:
C1­
016,
C1­
021,
C1­
026,
C1­
028,
C1­
033,
C1­
073
Response
G.
1­
5:
Up­
front
substantiation
is
only
being
instituted
for
one
new
data
element,
site
ID,
not
all
data
elements.
EPA
surveyed
submitters
to
determine
the
burden
associated
with
this
activity,
and
believes
that
its
estimates
are
reasonable.
Therefore,
the
Agency
disagrees
that
it
has
underestimated
the
increased
burden
of
up­
front
CBI
substantiation.

In
response
to
comments
received
on
the
proposed
rule,
and
concerns
presented
in
interagency
review,
EPA
has
removed
the
CBI
reassertion
requirement
from
the
Final
Rule.

Comment
G.
1­
6:
One
commenter
suggested
that
EPA
must
quantify
the
benefits
associated
with
IURA
or,
alternatively,
give
higher
priority
to
less
burdensome
options.

Source:
C1­
073
Page
146
of
159
Response
G.
1­
6:
EPA
is
required
under
Executive
Order
12866
to
describe
the
benefits
associated
with
its
rulemakings,
and
makes
every
reasonable
effort
to
quantify
these
benefits.
In
this
case
however,
the
benefits
of
the
IURA
information
collection
are
impossible
to
quantify
directly.
A
more
complete
discussion
of
the
economic
benefits
of
information
appears
in
Section
4
of
the
EA,
but
the
information
provided
through
the
IURA
will
reduce
the
costs
to
EPA,

industry,
and
the
public
of
making
decisions
about
chemical
risks,
and
will
improve
the
expected
outcome
of
those
decisions.
EPA
disagrees
that
the
proposal
is
overly
burdensome,
or
that
it
has
attempted
to
short­
circuit
CBI
protections.

Comment
G.
1­
7:
Two
commenters
suggest
that
in
the
economic
analysis
for
the
proposed
rule,
EPA
ignored
certain
company­
supplied
estimates
of
burden.
One
commenter
wrote:
"
we
find
no
statistical
reason
for
excluding
these
burden
estimates
and
conclude
that
the
burden
is
higher
than
indicated
in
the
Economic
Analysis..."

Source:
C1­
021,
C1­
061
Response
G.
1­
7:
In
developing
estimates
for
the
EA,
EPA
surveyed
81
respondents,
3
of
which
provided
burden
estimates
19,
35,
and
77
times
greater
than
the
average
for
medium
and
large
companies
(
17,
31,
and
69
standard
deviations
above
the
mean).
The
other
78
survey
responses
ranged
up
to
5.8
times
the
mean
and
4.4
standard
deviations
above
the
mean.
While
there
is
no
ironclad
rule
when
removing
outliers,
EPA
looked
for
a
significant
break
that
would
indicate
a
problem
with
the
responses.
Statistically,
these
outliers
are
significant
anomalies
that
could
have
serious
impacts
on
the
results
of
the
survey,
and
EPA
has
determined
these
three
responses
to
be
outside
reasonable
limits.
For
example,
one
respondent
estimated
it
would
take
12
hours
to
fill
out
its
address,
and
26
hours
to
fill
in
a
12­
character
ID
number.
Another
estimated
780
hours
to
find
the
consumer
uses
for
a
single
chemical.
And
the
third
estimated
902
hours
to
report
the
percentage
of
production
volume
of
a
single
chemical
that
go
to
consumer
uses.

EPA
has
no
knowledge
of
the
reasons
for
such
a
disparity
in
the
responses
of
these
firms,

but
possible
explanations
include:
1)
the
respondents
misunderstood
the
survey
(
for
example,
the
survey
respondents
may
have
been
unaware,
despite
the
instructions,
that
the
survey
applied
to
a
single
chemical,
not
to
all
chemicals
produced
at
a
site),
2)
EPA's
contractor
erred,
despite
strict
quality
control
measures,
in
reporting
survey
responses.
In
neither
of
these
cases
is
it
appropriate
for
EPA
to
include
such
responses.
Page
147
of
159
Comment
G.
1­
8:
EPA's
proposal
assumes
that
the
current
IUR
reporting
requirements
of
11
items
of
information
per
reportable
CASRN
will
explode
to
more
than
200
information
items
per
CASRN
under
the
amended
rule.
However,
the
current
IUR
requires
a
separate
"
line
item"
or
report
for
each
manufacturing
activity,
non­
site
limited
volume,
and
import
volume.
Thus,
IURA
would
result
in
over
600
information
items
potentially
being
reported,
compared
to
33
information
items
under
the
current
rule.

Source:
C1­
016,
C1­
026,
C1­
055
Response
G.
1­
8:
EPA
is
amending
the
IUR
to
provide
an
accurate
and
readily
available
source
of
basic
exposure­
related
information.
Industry's
reporting
burden
has
been
limited
as
much
as
possible
while
providing
EPA
with
information
necessary
to
screen
for
risks
to
human
health
and
the
environment.
The
maximum
number
of
data
elements
that
could
possibly
be
filled
in
on
the
revised
Form
U
for
an
IUR
chemical
is
roughly
233,
111
of
which
are
simply
check
boxes
for
claiming
CBI.
The
vast
majority
of
reports
will
contain
far
less
than
the
maximum
number
of
data
elements.

2.
Cost
comments
Comment
G.
2­
1:
Compliance
costs
for
chemicals
manufactured
in
amounts
below
the
25,000
lb./
yr.
production
volume
threshold
are
not
zero.
One
commenter
writes:
"
as
production
approaches
the
threshold,
tracking
costs
will
accrue
because
there
often
is
no
way
of
ascertaining
a
priori
whether
production
will
exceed
the
threshold.
This
position
is
verified
on
page
III­
11
[
of
the
Economic
Analysis
for
the
proposed
rule]
with
the
acknowledgment
in
the
footnote
of
the
existence
of
voluntary
below­
threshold
reports."

Source:
C1­
016,
C1­
073
Response
G.
2­
1:
Compliance
determination
(
the
act
of
determining
the
need
to
comply
with
a
regulation)
occurs
on
a
per­
site
basis,
so
that
the
economic
analysis
assumes
all
sites
that
report
to
the
IUR
incur
the
same
average
cost
for
determining
compliance,
regardless
of
the
number
of
chemicals
reported.
Some
small
number
of
firms
that
are
not
required
to
report
to
IUR
may
incur
some
negligible
costs
in
this
regard,
but
EPA
does
not
believe
the
costs
to
be
significant
as
compliance
determination
is
based
on
production
volume,
particularly
given
that
it
is
generally
Page
148
of
159
standard
procedure
for
a
business
to
be
aware
of
the
volumes
it
produces.
The
existence
of
voluntary
reporters
does
not
imply
that
below­
threshold
compliance
costs
are
non­
zero;
it
simply
indicates
that
some
firms
have
chosen
to
respond
to
the
IUR
when
not
required.
EPA
has
no
basis
for
including
costs
beyond
the
requirements
of
the
rule.
Additionally,
whereas
in
the
past
EPA
required
companies
to
retain
records
forming
the
basis
for
their
decision
not
to
report
in
a
given
year,
the
IURA
does
not
include
this
recordkeeping
requirement
for
non­
submitters.

Comment
G.
2­
2:
Burden
estimates
for
collecting
or
estimating
downstream
processing
and
use
data
were
too
low.

Source:
C1­
003,
C1­
011,
C1­
019,
C1­
021,
C1­
027,
C1­
028,
C1­
031,
C1­
037,
C1­
073
Response
G.
2­
2:
EPA
disagrees
that
its
burden
estimates
for
providing
downstream
processing
and
use
data
were
too
low.
EPA
surveyed
industry
respondents
to
determine
burden
estimates
for
downstream
processing
and
use
data,
which
total
79
to
86
hours
per
report.
It
is
EPA's
expectation
that
the
companies
that
will
file
IUR
reports
can
fairly
estimate
the
burdens
involved.
The
methodology
used
by
EPA
is
explained
in
greater
detail
in
the
EA
for
the
final
rule,

and
the
actual
survey
submissions
are
in
the
public
version
of
the
official
record
for
this
rulemaking.

There
are
two
important
factors
to
note
in
interpreting
the
burden
estimates
supplied
in
response
to
the
burden
survey.
First,
IURA
requires
that
industry
report
only
"
readily
obtainable"

downstream
processing
and
use
information;
this
information
standard
was
considered
after
the
burden
survey
was
executed.
Thus,
the
survey
respondents
were
reporting
burden
estimates
for
a
higher
standard
of
information.
Second,
the
UEIP
program,
which
asked
respondents
to
report
chemical
information
very
similar
to
that
required
by
IURA,
also
asked
respondents
to
report
the
time
spent
filling
out
the
UEIP
form;
companies
reported
a
median
burden
per
chemical
report
of
8
hours,
with
a
mean
of
12
hours.
No
commenters
provided
specific
analysis
as
to
how
EPA
has
underestimated
the
burden
of
providing
processing
and
use
data,
and
none
provided
any
basis
for
an
alternative
estimate.
Therefore,
EPA
has
concluded
that
its
estimates
are
reasonable.

Comment
G.
2­
3:
Commenters
asserted
that
EPA
would
be
unlikely
to
make
timely
use
of
the
volumes
of
processing
and
use
data
that
would
have
to
be
reported
and
collected
every
four
years
under
the
rule
as
proposed.
Commenters
pointed
out
that
EPA
projects
its
costs
under
the
reporting
program
would
only
be
$
525,000
in
the
first
reporting
year
and
$
275,000
in
subsequent
Page
149
of
159
reporting
years,
which
indicates
to
them
that
EPA
is
not
setting
aside
sufficient
funds
to
allow
for
timely
use
of
IURA
data.

Source:
C1­
016,
C1­
055
Response
G.
2­
3:
IURA
data
will
be
able
to
be
used
in
a
timely
manner.
The
data
will
be
in
a
database,
which
will
be
readily
searchable
or
downloadable
to
other
programs.
EPA
use
of
the
data
gathered
via
the
IURA
is
not
specifically
part
of
the
rulemaking
and
therefore
costs
associated
with
these
efforts
are
not
included
in
the
economic
analysis
for
the
proposed
rule.

EPA's
need
for,
and
expected
use
of,
the
IURA
data
are
documented
in
the
economic
analysis,
but
the
costs
indicated
by
the
commenter
are
solely
for
data
collection
and
management
activities
as
indicated
in
Section
4
of
the
EA.
Costs
arising
from
use
of
data
are
not
included
in
economic
analyses,
as
it
is
among
the
Agency's
primary
functions
to
use
available
data
in
the
course
of
fulfilling
its
mission.
And
it
is
important
to
note
that
IUR
data
are
currently
used
on
a
daily
basis
within
the
Agency,
and
provide
critical
information
to
a
wide
variety
of
programs.
Thus,
a
separate
budget
line­
item
for
IUR
data
use
would
fail
to
characterize
the
broad
range
of
situations
in
which
IUR
data
are,
and
will
continue
to
be,
crucial
to
EPA's
mission.
The
IURA
data
may
in
fact
save
the
Agency
resources,
because
the
reported
data
will
decrease
the
time
and
effort
required
to
estimate
chemical
use
and
exposure.
The
IURA
data
will
increase
the
quality
of
data
available
to
EPA,
improving
the
Agency's
ability
to
make
optimal
decisions
and
thus
saving
resources.

Comment
G.
2­
4:
EPA
projects
in
its
Economic
Analysis
of
the
proposed
rule
that
raising
the
10,000
lbs./
yr
reporting
threshold
to
25,000
lbs./
yr
will
eliminate
roughly
3,800
reports
for
1,535
chemicals
at
a
savings
of
$
21.3
to
$
25.8
million
in
the
first
year
alone.
One
commenter
doubts
that
these
savings
will
be
realized.
The
commenter
could
not
identify
a
single
instance
where
the
increase
in
the
reporting
threshold
to
25,000
lbs
would
eliminate
the
need
to
prepare
a
TSCA
IUR
report.
However,
they
suggested
that
perhaps
their
industry
(
forest
products)
is
unique
in
that
few,
if
any,
companies
will
benefit
from
the
increase
in
the
reporting
threshold.

Source:
C1­
011
Response
G.
2­
4:
EPA
received
roughly
3,800
IUR
reports
in
1994
for
chemicals
produced
in
quantities
between
10,000
and
25,000
pounds
per
site.
In
1998
IUR
data,
which
was
Page
150
of
159
unavailable
for
the
proposed
rule
but
was
used
in
the
EA
for
the
final
rule,
the
number
of
organic
chemicals
produced
in
volumes
between
10,000
and
25,000
pounds
was
roughly
3,100.
Under
the
rule
as
finalized,
reports
of
this
sort
will
not
have
to
be
filed,
generating
savings
similar
to
those
indicated
by
the
commenter.
EPA
cannot
comment
specifically
on
forest
product
companies.

Comment
G.
2­
5:
One
commenter
indicated
that
the
Economic
Analysis
does
not
explain
why
EPA
expects
to
save
$
21.3
to
$
25.8
million
in
the
first
reporting
cycle
from
raising
the
10,000
lbs.
reporting
threshold
to
25,000
lbs.,
but
the
Agency
projects
industry
to
only
incur
a
cost
of
$
5.1
to
$
8.5
million
in
the
first
reporting
cycle
by
removing
the
inorganic
exemption.
In
the
EA,
EPA
anticipates
that
industry
will
actually
end
up
submitting
4,500
new
reports
to
address
inorganics
while
subtracting
only
an
estimated
3,800
reports
for
raising
the
reporting
threshold.
In
short,
EPA
is
claiming
that
industry
"
saves"
$
6,789
per
report
on
the
one
hand
(
i.
e.,

by
raising
the
threshold),
but
on
the
other
hand
it
only
"
costs"
$
1,888
to
prepare
a
TSCA
report
for
an
inorganic
chemical.
It
appears
to
the
commenter
that
the
agency
is
either
overstating
its
savings
or
understating
the
costs
to
prepare
a
TSCA
IUR
report.

Source:
C1­
010
Response
G.
2­
5:
EPA
has
revised
the
estimated
savings
to
the
regulated
community
from
raising
the
10,000
lbs.
reporting
threshold
to
25,000
lbs.,
to
$
1.8
to$
2.9
million
per
reporting
cycle,
based
on
the
cost
of
an
IUR
report
under
the
existing
regulations.
The
re­
estimated
costs
of
removing
the
inorganic
exemption
are
$
6.4
to
$
9.9
million
in
the
first
year
(
when
inorganics
are
still
partially
exempt),
and
$
17.8
to
$
22.0
million
in
future
cycles.
See
table
S­
2
of
the
EA
for
the
final
rule.

Comment
G.
2­
6:
One
commenter
claimed
that
EPA
either
erred
or
was
obfuscating
at
several
points
in
the
economic
analysis.
"
For
example,
EPA
claims
that
roughly
7,700
reports
for
3,200
chemicals
will
be
'
eliminated'
from
the
requirement
of
reporting
processing
and
use
exposure
information
since
chemicals
produced
between
25,000
lbs.
and
300,000
lbs.
will
be
exempt
from
this
requirement.
However,
EPA
fails
to
acknowledge
that
the
vast
majority
of
the
processing
and
use
exposure
information
requirements
are
newly
proposed,
e.
g.,
exposure
information
on
downstream
customers...
Moreover,
EPA...
claims
cost
savings
of
$
16.6
million
to
$
18
million
for
the
elimination
of
supplying
process
and
use
exposure
information
on
certain
Page
151
of
159
petroleum
stream
chemicals
and
inorganics.
In
short,
EPA's
Economic
Analysis
appears
to
contain
erroneous
assumptions
or
calculations
that
distort
the
true
costs
of
the
proposed
rule
by
overstating
the
cost
savings
while
understating
the
actual
costs
to
prepare
the
reports."

Source:
C1­
011
Response
G.
2­
6:
The
figures
that
the
commenter
cites
are
comparisons
between
the
proposed
rule
and
options
in
which
all
submitters
are
required
to
report
the
full
revised
Form
U,

including
the
newly­
proposed
requirements.
None
of
the
calculations
cited
are
"
erroneous,"
but
a
careful
reading
of
the
EA
is
necessary
to
understand
the
context
in
which
figures
are
presented.

3.
Benefits
Comments
Comment
G.
3­
1:
Several
commenters
felt
the
costs
of
the
rule
outweigh
its
benefits,
which
are
not
quantified.
For
example,
one
commenter
writes:
"
the
IUR
amendment
as
now
proposed,

has
only
limited
benefit
to
the
public,
and
such
benefit
has
not
been
demonstrated
to
justify
the
anticipated
exorbitant
cost
and
burden
to
industry."

Source:
C1­
015,
C1­
016,
C1­
021,
C1­
028,
C1­
038,
C1­
073
Response
G.
3­
1:
EPA
disagrees
with
this
assertion.
As
stated
in
the
EA
for
the
final
rule,

the
benefits
from
this
rule
are
unquantifiable
on
a
monetary
scale.
Despite
this,
EPA
believes
that
the
benefits
of
increased
information
on
chemical
production
and
use
are
of
substantial
benefit
to
the
Agency,
and
critical
to
its
mandated
mission
to
reduce
chemical
risk.
Benefits
from
reductions
in
chemical
risk
are
spread
throughout
society.
Non­
EPA
users
of
the
data,
such
as
other
federal
agencies,
will
also
benefit
in
their
service
to
the
American
public.
EPA
has
enumerated
the
benefits
of
the
rule
in
more
detail
in
Section
5
of
the
EA.

Comment
G.
3­
2:
One
commenter
suggested
that
EPA
has
overestimated
the
benefits
of
the
rule.
Underlying
EPA's
economic
analysis
is
the
suggestion
that
the
market
does
not
provide
adequate
processing
and
use
information
on
existing
chemicals,
and
that
the
lack
of
information
requires
EPA
to
amend
the
IUR.
The
commenter
claims
that
the
economic
analysis
does
not
identify
any
non­
regulatory
alternatives,
and
fails
to
assess
the
relative
costs
and
benefits
of
an
alternative
approach.
The
commenter
also
maintains
that
it
is
not
possible
for
the
public
to
read
Page
152
of
159
EPA's
cost­
benefit
analysis
and
determine
why
the
proposed
option
is
superior
to
the
other
options,
and
feels
that
the
public
is
left
only
with
the
belief
that
the
Agency
"
feels"
the
proposed
option
is
the
most
cost­
effective.

Source:
C1­
033
Response
G.
3­
2:
EPA
recognizes
that
it
is
impossible
to
quantify
the
benefits
of
the
rule.

In
the
absence
of
hard
benefit
figures,
it
is
impossible
to
make
simple
comparisons.
Thus,
EPA
must
balance
the
needs
of
the
Agency
for
data
with
which
to
address
critical
environmental
risks,

with
the
burdens
of
obtaining
such
data.
In
doing
so,
the
uses
of
and
need
for
the
data
are
carefully
addressed
both
within
the
Agency,
and
during
interagency
review.
EPA
has
made
every
attempt
to
collect
only
the
information
necessary
to
meet
Agency
goals,
and
EPA
believes
the
final
rule
achieves
that
objective.

Non­
regulatory
alternatives
are
discussed
in
Section
2
of
the
EA
for
the
final
rule.
They
include
taking
no
direct
action
or
using
a
voluntary
approach.
Taking
no
action
and
attempting
to
rely
on
available
information
is
insufficient
(
see
A
Review
of
Existing
Exposure­
Related
Data
Sources
and
Approaches
to
Screening
Chemicals:
Response
to
CMA).
The
shortcomings
of
a
voluntary
program,
such
as
UEIP,
are
discussed
at
length
in
the
preamble
and
elsewhere
in
this
document.

Comment
G.
3­
3:
Several
commenters
described
the
environmental
benefits
of
their
energy
savings
programs
and
stated
it
is
counter­
productive
for
EPA
to
impose
burdens
that
divert
resources
away
from
energy
savings
efforts.
Commenters
stated
the
IURA
conflict
with
other
Agency
initiatives
that
include
reuse
conservation
goals.
One
commenter
went
on
to
state
that
"
under
a
revised
IUR,
cross­
industry
or
cross­
media,
including
the
environmental
benefits
associated
with
particular
uses
of
chemicals,
are
not
recognized
under
a
data
scheme
which
focuses
only
on
how
many
tons
of
a
chemical
were
used
in
the
past
year."

Source:
C1­
019,
C1­
035,
C1­
043
Response
G.
3­
3:
EPA
commends
industrial
groups
that
are
sponsoring
energy
savings
programs
and
that
have
reuse
conservation
goals.
EPA
recognizes
that
the
IURA
will
impose
a
slightly
increased
burden
on
industry.
However,
EPA
developed
the
IURA
to
provide
an
accurate
and
readily
available
source
of
basic
exposure­
related
information
for
about
4,000
of
the
76,000
Page
153
of
159
substances
listed
on
the
Inventory,
thus
limiting
industry's
reporting
burden
while
providing
EPA
with
information
necessary
to
screen
for
risks
to
human
health
and
the
environment.
EPA
disagrees
that
this
is
counter­
productive.
Although
IURA
will
not
collect
information
on
the
environmental
benefits
that
a
particular
reported
chemical
may
provide,
this
information
is
not
necessary
for
EPA
to
identify
and
screen
potential
exposures
and
risks
associated
with
TSCA
chemicals,
which
is
the
purpose
of
the
IURA.

4.
Small
Business
Analysis
Comments
Comment
G.
4­
1:
Several
commenters
argued
that
EPA's
analysis
of
the
impacts
of
the
IURA
on
small
businesses
was
insufficient
to
meet
the
requirements
of
the
Small
Business
Regulatory
Enforcement
Fairness
Act
(
SBREFA).

Source:
C1­
016,
C1­
016,
C1­
019,
C1­
073
Response
G.
4­
1:
EPA's
analysis
of
small
business
impacts
fully
complies
with
SBREFA.

For
rules
subject
to
the
Regulatory
Flexibility
Act,
which
was
amended
by
SBREFA,
the
Agency
is
required
to
undertake
specific
actions
(
such
as
preparing
an
initial
regulatory
flexibility
analysis
and
convening
a
small
business
advocacy
review
panel)
unless
it
certifies
that
the
rule
will
not
have
a
significant
impact
on
a
substantial
number
of
small
entities.
As
described
in
the
EA,
EPA
carefully
analyzed
the
impact
of
the
rule
on
small
entities.
(
The
Small
Business
Administration
participated
in
the
Interagency
review
for
the
proposed
and
final
rules,
and
its
input
was
incorporated
at
both
stages.)
For
both
the
proposed
and
final
rules,
EPA
certified
that
there
will
not
be
a
significant
impact
on
a
substantial
number
of
small
entities.
EPA
notes
that
it
has
done
and
will
continue
to
do
outreach
to
businesses,
including
small
businesses,
for
the
IURA.

It
is
also
important
to
note
three
facts:
1)
the
IUR
exempts
and
IURA
will
continue
to
exempt
small
businesses,
2)
the
Small
Business
Administration
reviewed
EPA's
small
entity
analysis,
and
3)
had
EPA
suspected
that
this
rule
might
have
a
significant
impact
on
a
substantial
number
of
small
entities,
the
Agency
would
have
investigated
the
matter
in
much
greater
detail.

Comment
G.
4­
2:
One
commenter
suggested
that
EPA's
economic
analysis
is
flawed,
as
it
uses
the
economic
profiles
from
organic
chemical
companies
to
predict
economic
impacts
on
sites
from
a
broad
range
of
affected
industries.
The
commenter
suggested
using
industry­
specific
economic
information
(
e.
g.,
profits)
in
the
analysis.
Page
154
of
159
Source:
C1­
036
Response
G.
4­
2:
The
portion
of
the
EA
to
which
the
commenter
refers
is
the
small
entity
analysis.
EPA's
small
entity
analysis
used
economic
data
from
all
firms
that
reported
under
the
IUR
in
1994,
which
represent
the
vast
majority
of
firms
that
will
be
required
to
report
under
IURA.
EPA
believes
that
it
makes
more
sense
to
use
available
data
on
IUR
sites
to
estimate
the
impacts
of
the
IURA
than
to
use
more
generalized
data
on
industry
as
a
whole.

EPA
uses
compliance
costs
as
a
percentage
of
annual
sales
as
an
indicator
of
the
severity
of
economic
impact;
the
type
of
profit
data
the
commenter
suggests
are
unavailable.
In
addition,

data
specific
to
inorganic
chemical
manufacturers
are
also
unavailable
to
EPA,
as
inorganic
chemicals
are
currently
exempt
from
IUR
reporting.
EPA
has
no
data
that
suggest
the
economic
profiles
of
inorganic
manufacturers
differ
significantly
from
those
of
organic
chemical
manufacturers.

5.
Executive
Order
12866
Comment
G.
5­
1:
One
commenter
claimed
that
the
IURA
is
inconsistent
with
Executive
Order
12866,
in
that
they
felt
the
proposed
rule
is
not
"
cost­
effective,"
and
the
same
commenter
also
mentioned
the
"
Administration's
program
on
Reinventing
Environmental
Regulation
(
March
16,
1995),
which
calls
for
environmental
protection
in
a
`
common
sense,
cost­
effective
manner'

and
a
reduction
in
`
existing
reporting
and
recordkeeping
burden
hours
by
25%.'"

Source:
C1­
016
Response
G.
5­
1:
Regarding
the
requirements
of
E.
O.
12866,
EPA
believes
that
IURA
represents
the
most
cost­
effective
method
of
collecting
the
data
necessary
to
begin
evaluating
risks
of
existing
chemicals
in
commerce.
The
screening
approach
enabled
by
the
IURA
will
allow
EPA
to
target
specific
situations
in
which
risks
may
be
unreasonable
without
necessitating
a
more
burdensome
chemical­
by­
chemical
review
of
existing
chemicals.
The
IURA
represents
the
least
burdensome
avenue
to
address
risks
from
chemicals
in
commerce.

The
25%
burden
reduction
target
contained
in
the
1995
Reinventing
Environmental
Information
Report
was
to
be
measured
across
the
Agency,
not
for
every
individual
regulation,

program,
or
Office
within
EPA.
Moreover,
the
commitment
was
to
reduce
the
burden
of
existing
regulations;
it
was
not
intended
to
bar
new
and
vital
collections
such
as
the
IURA.
Furthermore,
Page
155
of
159
EPA
has
reduced
burden
in
the
IURA
by
raising
the
reporting
threshold
from
10,000
pounds
to
25,000
pounds
and
adding
a
full
reporting
exemption
for
natural
gas,
reducing
the
number
of
reports
by
about
3,100
and
1,000,
respectively.
Additionally,
many
petroleum
process
streams
and
certain
specifically
listed
chemical
substances
are
exempt
from
reporting
processing
and
use
information.
Page
156
of
159
References
1.
USEPA,
"
IURA
Data
Use
Plan,"
OPPT/
EETD,
August
23,
2002.

2.
USEPA,
"
A
SAB
Report:
Improving
the
Use
Cluster
Scoring
System,
Recommendations
for
the
Use
Cluster
Scoring
System
Prepared
by
the
Environmental
Engineering
Committee,
"
Science
Advisory
Board,
SAB­
EEC­
95­
017,
September
1995.
Also
available
at
www.
epa.
gov/
sab/
pdf/
eec95017.
pdf.

3.
Memorandum
from
Sandra
Zavolta,
EPA
OPPT,
to
Heidi
King,
OIRA
OMB,
and
Kevin
Bromberg,
SBA,
regarding
the
proposed
IUR
Amendments
 
Additional
Information
Requested
04­
27­
1999;
Attachment
E:
RM1
Meeting
Summary
for
Methyl
Ethyl
Ketoxime
(
MEKO)
Summary
of
a
Risk
Management
1
(
RM1)
meeting
regarding
methyl
ethyl
ketoxime,
provided
to
the
Office
of
Management
and
Budget
and
the
Small
Business
Administration
to
show
how
exposure
and
use
information
can
affect
risk
management
decisions.
03­
19­
1997.

4.
Letter
from
Stephen
A.
Newell,
Occupational
Safety
and
Health
Administration,
to
Wardner
G.

Penberthy,
EPA,
October
15,
1996.

5.
Letter
from
Paul
A.
Schulte,
National
Institute
for
Occupational
Safety
and
Health,
to
Wardner
G.

Penberthy,
EPA,
October
8,
1996.

6.
Letter
from
Michael
A.
Babich,
U.
S.
Consumer
Product
Safety
Commission,
to
Wardner
G.

Penberthy,
EPA,
June
24,
1996.

7.
Letter
from
Robert
Franklin,
U.
S.
Consumer
Product
Safety
Commission,
to
EPA,
December
23,

1999.

8.
Letter
from
Paul
A.
Schulte,
Ph.
D.,
National
Institute
for
Occupational
Safety
&
Health,
to
EPA,

December
21,
1999.

9.
General
Accounting
Office,
"
Toxic
Chemicals:
Long­
Term
Coordinated
Strategy
Needed
to
Measure
Exposures
in
Humans,"
GAO/
HEHS­
00­
80,
May
2,
2000.

10.
Letter
from
Linda
Greer,
Ph.
D.,
Natural
Resources
Defense
Council,
to
Carol
Browner,
U.
S.
EPA,

February
12,
1999.

11.
USEPA,
  
EPA
Needs
Exposure­
Related
Data:
A
Discussion
of
the
Justification
for
Collecting
Exposure­
Related
Data
Through
the
IUR
Amendments,''
OPPT/
EETD/
EPAB,
1998.

12.
USEPA,
  
Reducing
Risk:
Setting
Priorities
and
Strategies
for
Environmental
Protection,''
Science
Advisory
Board,
(
SAB­
EC­
90­
021),
1990.

13.
National
Academy
of
Public
Administration,
  
Setting
Priorities,
Getting
Results
­
A
New
Direction
for
EPA,''
1995.

14.
Letter
to
James
Aidala,
EPA,
from
Sandra
Tirey,
CMA,
"
Tier
1
Exposure
Data
in
the
EPA
Voluntary
Children's
Safety
Program,"
Docket
Number
OPPTS­
00274,
March
24,
2000.

15.
Sandra
Tirey,
Inside
EPA's
Risk
Policy
Report,
Jan
24,
2000,
vol
7,
No
1.

16.
USEPA,
  
Inventory
Update
Rule
(
IUR)
Amendment
Technical
Support
Document:
Page
157
of
159
Exposure­
Related
Data
Useful
for
Chemical
Risk
Screening,''
Volumes
1
and
2,
OPPT,
July
19,
1996.

17.
General
Accounting
Office,
  
EPA
Should
Focus
Its
Chemical
Use
Inventory
on
Suspected
Harmful
Substances,''
GAO/
RCED­
95­
165,
July
7,
1995.

18.
E­
Mail
from
James
M.
Boiano,
NIOSH,
to
Susan
Sharkey,
OPPT/
EPA,
"
Status
of
NIOSH
NEWS"
October
24,
2002.

19.
USEPA,
"
U.
S.
Chemical
Production,
Use,
and
Exposure
Data:
A
Study
of
Existing
Information
Sources,"
OPPT,
Oct
1,
1997.

20.
USEPA,
"
Draft
Instructions
for
2006
Inventory
Update
Rule
Reporting
Under
the
Toxics
Substances
Control
Act
(
TSCA),"
OPPT,
August
2002.

21.
USEPA,
  
Inventory
Update
Rule
(
IUR)
Technical
Support
Document:
Selection
of
Consumer
and
Commercial
End­
Use
Categories,''
OPPT,
1996.

22.
USEPA,
  
Economic
Analysis
of
Proposed
Amendments
to
the
TSCA
Section
8
Inventory
Update
Rule,''
OPPT/
EETD/
EPAB,
March
1,
1999.

23.
USEPA,
"
Revised
Economic
Analysis
for
the
Amended
Inventory
Update
Rule,"
OPPT,
August
2000.
Date
will
need
to
be
updated
24.
USEPA,
  
A
Review
of
Existing
Exposure­
Related
Data
Sources
and
Approaches
to
Screening
Chemicals:
A
Response
to
CMA,''
OPPT,
March
1999.

25.
USEPA,
"
Methodology
Used
for
the
Initial
Selection
of
Chemicals
for
the
Inventory
Update
Rule
Amendments
(
IURA)
`
Low
Current
Interest'
Partial
Reporting
Exemption,"
OPPT,
July
24,
2002.

26.
USEPA,
"
Inorganic
Chemicals:
Sources
of
Information
Suggested
by
Commenters
to
the
Proposed
Inventory
Update
Rule
Amendments,"
OPPT,
June
2000.

27.
Letter
from
John
DeYoung,
Chief
Scientist,
U.
S.
Geological
Survey,
to
Mary
Ellen
Weber,
EPA,

July
25,
2002.

28.
USEPA,
"
Clarification
of
the
Interpretation
of
'
Article'
Under
TSCA,"
OTS,
October
1,
1985.

29.
USEPA,
"
Report
to
Congress:
Wastes
from
the
Combustion
of
Fossil
Fuels,"
OSW,
April
25,

2000,
available
at
http://
www.
epa.
gov/
epaoswer/
other/
fossil/
index.
htm.

30.
Confidential
Business
Information
Data
Review,
Georgia
Department
of
Natural
Resources,

Docket
entry
00125
B2a­
010
filed
June
19,
1996,
page
4.

31.
Letter
from
Mark
N.
Duvall,
Union
Carbide,
to
EPA,
  
Additional
Comments
of
Union
Carbide
Corporation
on
EPA's
Preliminary
Actions
to
Reform
TSCA
Confidential
Business
Information,
Docket
No.
OPPTS­
00125,''
August
31,
1993.

32.
USEPA.
1997b.
UEIP­
ICR
Database.
Summary
table.
Page
158
of
159
Appendix
1:
Docket
Commenter
Number
Cross
Reference
List
of
Legacy
Docket
to
E­
Docket
Each
comment
summary
is
followed
by
a
list
of
sources
used
to
compile
the
comment.
The
source
numbers
refer
to
the
legacy
docket
from
the
proposed
rule
(
Docket
#
82503).
The
Agency
now
has
an
EDocket
(
Docket
#
OPPT­
2002­
0054),
which
incorporated
the
legacy
docket
but
uses
a
new
numbering
system.
Below
is
a
table
providing
a
cross­
reference
between
the
two
docket
numbering
systems.

Legacy
Docket
E­
Docket
Legacy
Docket
E­
Docket
C1­
001
0148
C1­
041
0191
C1­
002
0159
C1­
042
0192
C1­
003
0150
C1­
043
0193­
0196
C1­
004
0151
C1­
044
0197­
0201
C1­
005
0152
C1­
045
0202
C1­
006
0153
C1­
046
0203
C1­
007
0154­
0156
C1­
047
0204
C1­
008
0157
C1­
048
0205­
0209
C1­
009
0158
C1­
049
0210
C1­
010
0159
C1­
050
0211
C1­
011
0160
C1­
051
0212
C1­
012
0161
C1­
052
0213
C1­
013
0162
C1­
053
0214
C1­
014
0163
C1­
054
0228
C1­
015
0164­
0165
C1­
055
0216
C1­
016
0166
C1­
056
0217
C1­
017
0167
C1­
057
0218
C1­
018
0168
C1­
058
0219
C1­
019
0169
C1­
059
0220
C1­
020
0170
C1­
060
0221
Page
159
of
159
C1­
021
0171
C1­
061
0222
C1­
022
0172
C1­
062
0223
C1­
023
0173
C1­
063
0224
C1­
024
0174
C1­
064
0225
C1­
025
0175
C1­
065
0226
C1­
026
0176
C1­
066
0227
C1­
027;
027(
1)
0177;
0231
C1­
067
0215
C1­
028
0178
C1­
068
0229
C1­
029
0179
C1­
069
0230
C1­
030
0180
C1­
070
0231
C1­
031
0181
C1­
071
0232
C1­
032
0182
C1­
072
0233
C1­
033
0183
C1­
073
0234
C1­
034
0184
C1­
035
0185
C1­
036
0186
C1­
037
0187
C1­
038
0188
C1­
039
0189
C1­
040
0190