Document ID: EPA-HQ-OPPT-2002-0025-0055
Agency: epa
Document Type: Notice
Title: Persistent Bioaccumulative Toxic (PBT) Chemicals; Lowering of Reporting Thresholds for Certain PBT Chemicals; Addition of Certain PBT Chemicals; Community Right-to-Know Toxic Chemical Reporting; Final Rule
Posted Date: 2002-10-18T04:00Z

federalregister
Friday
October
29,
l999
Part
VII
Environmental
Protection
Agency
40
CFR
Part
372
Persistent
Bioaccumulative
Toxic
(PBT)
Chemicals;
Final
Rule
58666
Federal
Register
/
Vol.
64,
No.
209
/
Friday,
October
29,
1999
/
Rules
and
Regulations
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
372
[OPPTS±
400132C;
FRL±
6389±
11]

RIN
2070±
AD09
Persistent
Bioaccumulative
Toxic
(PBT)
Chemicals;
Lowering
of
Reporting
Thresholds
for
Certain
PBT
Chemicals;
Addition
of
Certain
PBT
Chemicals;
Community
Right­
to­
Know
Toxic
Chemical
Reporting
AGENCY:
Environmental
Protection
Agency
(EPA).
ACTION:
Final
rule.

SUMMARY:
EPA
is
lowering
the
reporting
thresholds
for
certain
persistent
bioaccumulative
toxic
(PBT)
chemicals
that
are
subject
to
reporting
under
section
313
of
the
Emergency
Planning
and
Community
Right­
to­
Know
Act
of
1986
(EPCRA)
and
section
6607
of
the
Pollution
Prevention
Act
of
1990
(PPA).
EPA
is
also
adding
a
category
of
dioxin
and
dioxin­
like
compounds
to
the
EPCRA
section
313
list
of
toxic
chemicals
and
establishing
a
0.1
gram
reporting
threshold
for
the
category.
In
addition,
EPA
is
adding
certain
other
PBT
chemicals
to
the
EPCRA
section
313
list
of
toxic
chemicals
and
establishing
lower
reporting
thresholds
for
these
chemicals.
EPA
is
removing
the
fume
or
dust
qualifier
from
vanadium
and
adding
all
forms
of
vanadium
with
the
exception
of
vanadium
when
contained
in
alloys.
EPA
is
also
adding
vanadium
compounds
to
the
EPCRA
section
313
list
of
toxic
chemicals.
However,
EPA
is
not
lowering
the
reporting
thresholds
for
either
vanadium
or
vanadium
compounds.
EPA
is
taking
these
actions
pursuant
to
its
authority
under
EPCRA
section
313(
f)(
2)
to
revise
reporting
thresholds
and
pursuant
to
its
authority
to
add
chemicals
and
chemical
categories
that
meet
the
EPCRA
section
313(
d)(
2)
toxicity
criteria.
The
additions
of
these
chemicals
are
based
on
their
carcinogenicity
or
other
chronic
human
health
effects
and/
or
their
significant
adverse
effects
on
the
environment.
Today's
actions
also
include
modifications
to
certain
reporting
exemptions
and
requirements
for
those
toxic
chemicals
that
are
subject
to
the
lower
reporting
thresholds.
This
document
also
announces
the
effective
date
of
§
372.27
of
the
Code
of
Federal
Regulations,
which
contained
information
collection
requirements
and
which
was
originally
published
in
the
Federal
Register
on
November
30,
1994.
DATES:
40
CFR
372.27
became
effective
on
March
17,
1995,
when
the
Office
of
Management
and
Budget
approved
its
information
collection
requirements.
This
rule
shall
take
effect
on
December
31,
1999.
For
purposes
of
EPCRA
section
313(
d)(
4),
the
chemical
additions
shall
be
considered
made
as
of
November
30,
1999,
and
shall
apply
for
the
reporting
year
beginning
January
1,
2000.
FOR
FURTHER
INFORMATION
CONTACT:
For
technical
information
on
this
final
rule
contact:
Daniel
R.
Bushman,
Petitions
Coordinator,
Environmental
Protection
Agency,
Mail
Code
7408,
401
M
St.,
SW.,
Washington,
DC
20460;
telephone
number
202±
260±
3882,
e­
mail
address:
bushman.
daniel@
epa.
gov.
For
general
information
on
EPCRA
section
313,
contact
the
Emergency
Planning
and
Community
Right­
to­
Know
Hotline,
Environmental
Protection
Agency,
Mail
Code
5101,
401
M
St.,
SW.,
Washington,
DC
20460,
Toll
free:
1±
800±
535±
0202,
in
Virginia
and
Alaska:
703±
412±
9877
or
Toll
free
TDD:
1±
800±
553±
7672.

SUPPLEMENTARY
INFORMATION:

I.
General
Information
A.
Does
this
Action
Apply
to
Me?

You
may
be
affected
by
this
action
if
you
manufacture,
process,
or
otherwise
use
aldrin,
chlordane,
dioxin
and
certain
dioxin­
like
compounds,
heptachlor,
hexachlorobenzene,
isodrin,
mercury,
mercury
compounds,
methoxychlor,
octachlorostyrene,
pendimethalin,
pentachlorobenzene,
polychlorinated
biphenyls,
certain
polycyclic
aromatic
compounds,
tetrabromobisphenol
A,
toxaphene,
trifluralin,
and
vanadium
(except
alloys)
or
vanadium
compounds.
See
Table
1
in
Unit
V.
C.
for
a
more
detailed
listing.
Potentially
affected
categories
and
entities
may
include,
but
are
not
limited
to:

Category
Examples
of
Potentially
Affected
Entities
Industry
SIC
major
group
codes
10
(except
1011,
1081,
and
1094),
12
(except
1241),
or
20
through
39;
industry
codes
4911
(limited
to
facilities
that
combust
coal
and/
or
oil
for
the
purpose
of
generating
power
for
distribution
in
commerce);
4931
(limited
to
facilities
that
combust
coal
and/
or
oil
for
the
purpose
of
generating
power
for
distribution
in
commerce);
or
4939
(limited
to
facilities
that
combust
coal
and/
or
oil
for
the
purpose
of
generating
power
for
distribution
in
commerce);
or
4953
(limited
to
facilities
regulated
under
the
Resource
Conservation
and
Recovery
Act,
subtitle
C,
42
U.
S.
C.
section
6921
et
seq.),
or
5169,
or
5171,
or
7389
(limited
to
facilities
primarily
engaged
in
solvent
recovery
services
on
a
contract
or
fee
basis)

Federal
Government
Federal
facilities
This
table
is
not
intended
to
be
exhaustive,
but
rather
provides
a
guide
for
readers
regarding
entities
likely
to
be
affected
by
this
action.
Other
types
of
entities
not
listed
in
the
table
could
also
be
affected.
To
determine
whether
your
facility
would
be
affected
by
this
action,
you
should
carefully
examine
the
applicability
criteria
in
part
372,
subpart
B
of
Title
40
of
the
Code
of
Federal
Regulations.
If
you
have
questions
regarding
the
applicability
of
this
action
to
a
particular
entity,
consult
the
person
listed
in
the
``
FOR
FURTHER
INFORMATION
CONTACT''
section.

B.
How
Can
I
Get
Additional
Information
or
Copies
of
this
Document
or
Other
Support
Documents?

1.
Electronically.
You
may
obtain
electronic
copies
of
this
document
from
the
EPA
Internet
Home
Page
at
http://
www.
epa.
gov/.
On
the
Home
Page
select
``
Laws
and
Regulations''
and
then
look
up
the
entry
for
this
document
under
the
``
Federal
Register­­
Environmental
Documents.
''
You
can
also
go
directly
to
the
``
Federal
Register''
listings
at
http:/
/www.
epa.
gov/
fedrgstr/.
2.
In
person.
The
Agency
has
established
an
official
record
for
this
action
under
docket
control
number
OPPTS±
400132.
The
official
record
consists
of
the
documents
specifically
referenced
in
this
action,
any
public
comments
received
during
an
applicable
comment
period,
and
any
other
information
related
to
this
action,
including
any
information
claimed
as
confidential
business
information
(CBI).
This
official
record
includes
the
58667
Federal
Register
/
Vol.
64,
No.
209
/
Friday,
October
29,
1999
/
Rules
and
Regulations
documents
that
are
physically
located
in
the
docket,
as
well
as
the
documents
that
are
referenced
in
those
documents.
The
public
version
of
the
official
record
does
not
include
any
information
claimed
as
CBI.
The
public
version
of
the
official
record,
which
includes
printed,
paper
versions
of
any
electronic
comments
submitted
during
an
applicable
comment
period,
is
available
for
inspection
in
the
TSCA
Nonconfidential
Information
Center,
North
East
Mall
Rm.
B±
607,
Waterside
Mall,
401
M
St.,
SW.,
Washington,
DC.
The
Center
is
open
from
noon
to
4
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
telephone
number
for
the
Center
is
(202)
260±
7099.

II.
Statutory
Authority
EPA
is
finalizing
these
actions
under
sections
313(
d)(
1)
and
(2),
313(
f)(
2),
313(
g),
313(
h),
and
328
of
EPCRA,
42
U.
S.
C.
11023(
d)(
1)­(
2),
11023(
f)(
2),
11023(
g),
11023(
h)
and
11048;
PPA
section
6607,
42
U.
S.
C.
13106.
Section
313
of
EPCRA
requires
certain
facilities
manufacturing,
processing,
or
otherwise
using
a
listed
toxic
chemical
in
amounts
above
reporting
threshold
levels,
to
report
certain
facility
specific
information
about
such
chemicals,
including
the
annual
quantity
entering
each
environmental
medium.
These
reports
must
be
filed
by
July
1
of
each
year
for
the
previous
calendar
year.
Such
facilities
also
must
report
pollution
prevention
and
recycling
data
for
these
chemicals,
pursuant
to
section
6607
of
PPA.

A.
What
is
the
Authority
for
the
Addition
of
Chemicals?
Section
313
established
an
initial
list
of
toxic
chemicals
comprised
of
more
than
300
chemicals
and
20
chemical
categories.
Section
313(
d)
authorizes
EPA
to
add
or
delete
chemicals
from
the
list,
and
sets
forth
criteria
for
these
actions.
EPA
has
added
and
deleted
chemicals
from
the
original
statutory
list
on
the
basis
of
the
criteria
in
subparagraph
(A),
(B)
and/
or
(C)
of
subsection
(d)(
2)
of
EPCRA
section
313.
Under
section
313(
e)(
1),
any
person
may
petition
EPA
to
add
chemicals
to,
or
delete
chemicals
from,
the
list
on
the
grounds
that
it
does
or
does
not
meet
the
criteria
at
313(
d)(
2)(
A)
or
(B).
Pursuant
to
EPCRA
section
313(
e)(
1),
EPA
must
respond
to
petitions
within
180
days,
either
by
initiating
a
rulemaking
or
by
publishing
an
explanation
of
why
the
petition
is
denied.
EPCRA
section
313(
d)(
2)
states
that
a
chemical
may
be
added
to
the
list
if
any
of
the
three
listing
criteria
set
forth
there
are
met.
Therefore,
in
order
to
add
a
chemical,
EPA
must
find
that
at
least
one
criterion
is
met,
but
does
not
need
to
examine
whether
all
other
criteria
are
also
met.
EPA
has
published
a
statement
elaborating
its
interpretation
of
the
section
313(
d)(
2)
and
(3)
criteria
for
adding
and
deleting
chemicals
from
the
section
313
list
(at
59
FR
61432,
November
30,
1994)
(FRL±
4922±
2).

B.
What
is
the
Authority
for
the
Lowering
of
Reporting
Thresholds?

EPA
is
finalizing
these
actions
pursuant
to
its
authority
under
EPCRA
section
313(
f)(
2)
to
revise
reporting
thresholds.
EPCRA
section
313
establishes
default
reporting
thresholds,
which
are
set
forth
in
section
313(
f)(
1).
Section
313(
f)(
2),
however,
provides
that
EPA:

may
establish
a
threshold
amount
for
a
toxic
chemical
different
from
the
amount
established
by
paragraph
(1).
Such
revised
threshold
shall
obtain
reporting
on
a
substantial
majority
of
total
releases
of
the
chemical
at
all
facilities
subject
to
the
requirements
of
this
section.
The
amounts
established
by
EPA
may,
at
the
Administrator's
discretion,
be
based
on
classes
of
chemicals
or
categories
of
facilities.

This
provision
provides
EPA
with
broad,
but
not
unlimited,
authority
to
establish
thresholds
for
particular
chemicals,
classes
of
chemicals,
or
categories
of
facilities,
and
commits
to
EPA's
discretion
the
determination
that
a
different
threshold
is
warranted.
Congress
also
committed
the
determination
of
the
levels
at
which
to
establish
any
alternate
thresholds
to
EPA's
discretion,
requiring
only
that
any
``
revised
threshold
shall
obtain
reporting
on
a
substantial
majority
of
total
releases
of
the
chemical
at
all
facilities
subject
to
the
requirements''
of
section
313.
42
U.
S.
C.
11023(
f)(
2).
For
purposes
of
determining
what
constitutes
a
``
substantial
majority
of
total
releases,
''
EPA
interprets
the
language
in
section
313(
f)(
2),
``
facilities
subject
to
the
requirements
of
[section
313],
''
to
refer
to
those
facilities
that
fall
within
the
category
of
facilities
described
by
sections
313(
a)
and
(b),
i.
e.,
the
facilities
currently
reporting.
Subsection
(a)
lays
out
the
general
requirement
that
``
the
owner
or
operator
of
facilities
subject
to
the
requirements
of
this
section
shall''
file
a
report
under
EPCRA
section
313.
Subsection
(b)
then
defines
the
facilities
subject
to
the
requirements
of
this
section:

[t]
he
requirements
of
this
section
shall
apply
to
owners
and
operators
of
facilities
that
have
10
or
more
full­
time
employees
and
that
are
in
Standard
Industrial
Classification
Codes
20­
39,
.
.
.
and
that
manufactured,
processed,
or
otherwise
used
a
toxic
chemical
listed
under
subsection
(c)
of
this
section
in
excess
of
the
quantity
of
that
toxic
chemical
established
under
subsection
(f)
of
this
section
during
the
calendar
year
for
which
a
toxic
chemical
release
form
is
required
under
this
section.

Thus,
in
revising
the
reporting
thresholds,
EPA
must
ensure
that,
under
the
new
thresholds,
a
substantial
majority
of
releases
currently
being
reported
will
continue
to
be
reported.
No
further
prerequisites
for
exercising
this
authority
appears
in
the
statute.

C.
What
is
the
Authority
for
Modifications
to
Other
EPCRA
Section
313
Reporting
Requirements?

Today's
actions
also
include
modifications
to
certain
reporting
exemptions
and
requirements
for
those
toxic
chemicals
that
are
subject
to
the
lower
reporting
thresholds.
Congress
granted
EPA
rulemaking
authority
to
allow
the
Agency
to
fully
implement
the
statute.
EPCRA
section
328
provides
that
the
``
Administrator
may
prescribe
such
regulations
as
may
be
necessary
to
carry
out
this
chapter''
(28
U.
S.
C.
11048).

III.
Background
Information
A.
What
is
the
General
Background
for
this
Action?

Under
EPCRA
section
313,
Congress
set
the
initial
parameters
of
the
Toxic
Release
Inventory,
but
also
gave
EPA
clear
authority
to
modify
reporting
in
various
ways,
including
authority
to
change
the
toxic
chemicals
subject
to
reporting,
the
facilities
required
to
report,
and
the
threshold
quantities
that
trigger
reporting.
By
providing
this
authority,
Congress
recognized
that
the
TRI
program
would
need
to
evolve
to
meet
the
needs
of
a
better
informed
public
and
to
refine
existing
information.
EPA
has,
therefore,
undertaken
a
number
of
actions
to
expand
and
enhance
TRI.
These
actions
include
expanding
the
number
of
reportable
toxic
chemicals
by
adding
286
toxic
chemicals
and
chemical
categories
to
the
EPCRA
section
313
list
in
1994.
Further,
a
new
category
of
facilities
was
added
to
EPCRA
section
313
on
August
3,
1993,
through
Executive
Order
12856,
which
requires
Federal
facilities
meeting
threshold
requirements
to
file
annual
EPCRA
section
313
reports.
In
addition,
in
1997
EPA
expanded
the
number
of
private
sector
facilities
that
are
required
to
report
under
EPCRA
section
313
by
adding
seven
new
industrial
groups
to
the
list
of
covered
facilities.
At
the
same
time,
EPA
has
sought
to
reduce
the
burden
of
EPCRA
section
313
reporting
by
actions
such
as
delisting
chemicals
it
has
determined
do
not
meet
the
statutory
listing
criteria
and
establishing
58668
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/
Vol.
64,
No.
209
/
Friday,
October
29,
1999
/
Rules
and
Regulations
an
alternate
reporting
threshold
of
1
million
pounds
for
facilities
with
500
pounds
or
less
of
production­
related
releases
and
other
wastes.
Facilities
meeting
the
requirements
of
this
alternate
threshold
may
file
a
certification
statement
(Form
A)
instead
of
reporting
on
the
standard
EPCRA
section
313
form,
the
Form
R.
In
today's
actions,
EPA
is
finalizing
enhanced
reporting
requirements
that
focus
on
a
unique
group
of
toxic
chemicals.
These
toxic
chemicals
which
persist
and
bioaccumulate
in
the
environment
are
commonly
referred
to
as
persistent
bioaccumulative
toxic
chemicals
or
PBT
chemicals.
To
date,
with
the
exception
of
the
alternate
threshold
certification
on
Form
A,
EPA
has
not
altered
the
statutory
reporting
threshold
for
any
listed
chemicals.
However,
as
the
TRI
program
has
evolved
over
time
and
as
communities
identify
areas
of
special
concern,
thresholds
and
other
aspects
of
the
EPCRA
section
313
reporting
requirements
may
need
to
be
modified
to
assure
the
collection
and
dissemination
of
relevant,
topical
information
and
data.
Towards
that
end,
EPA
is
increasing
the
utility
of
TRI
to
the
public
by
adding
a
number
of
chemicals
to
the
section
313
list
of
toxic
chemicals
that
persist
and
bioaccumulate
in
the
environment
and
by
lowering
the
reporting
thresholds
for
a
number
of
toxic
chemicals
that
have
these
properties.
Toxic
chemicals
that
persist
and
bioaccumulate
are
of
particular
concern
because
they
remain
in
the
environment
for
significant
periods
of
time
and
concentrate
in
the
organisms
exposed
to
them.
EPA
believes
that
the
public
understands
that
these
PBT
chemicals
have
the
potential
to
cause
serious
human
health
and
environmental
effects
resulting
from
low
levels
of
release
and
exposure
(Refs.
75
and
76).
Lowering
the
reporting
thresholds
for
PBT
chemicals
will
ensure
that
the
public
has
important
information
on
the
quantities
of
these
chemicals
released
or
otherwise
managed
as
waste,
that
would
not
be
reported
under
the
10,000
and
25,000
pound/
year
thresholds
that
apply
to
other
toxic
chemicals.

B.
What
Outreach
Has
EPA
Conducted?
EPA
has
engaged
in
a
comprehensive
outreach
effort.
This
outreach
served
to
inform
interested
parties,
including
industry
groups
affected
by
the
rule,
state
regulatory
officials,
environmental
organizations,
labor
unions,
community
groups,
and
the
general
public
of
EPA's
intention
to
add
certain
PBT
chemicals
to
the
list
of
toxic
chemicals
under
EPCRA
section
313
and
lower
the
applicable
reporting
thresholds
for
a
subset
of
PBT
chemicals.
For
all
interested
parties,
EPA
held
three
public
meetings
(in
Chicago,
IL
(February
23,
1999);
San
Francisco,
CA
(March
5,
1999);
and
Washington,
DC
(February
16,
1999))
during
the
comment
period
for
the
proposal.
Participants
included
a
range
of
industry
representatives,
trade
associations
(representing
both
small
and
large
businesses),
law
firms
representing
industry
groups,
environmental
groups,
the
general
public,
plus
other
groups
and
organizations.
For
state
and
tribal
governments,
EPA
attended
the
regularly­
held
public
meetings
of
the
Forum
on
State
and
Tribal
Toxics
Action
(FOSTTA)
to
discuss
the
PBT
proposal.
EPA
also
received
substantial
public
comment
on
this
proposal,
to
which
EPA
is
responding
in
this
Final
Rule
and
the
Response
to
Comments
document
(Ref.
69).
In
response
to
the
strong
interest
by
the
public,
and
to
allow
more
individuals
and
groups
to
submit
their
comments,
EPA
extended
the
public
comment
period
to
April
7,
1999
(at
64
FR
9957,
March
1,
1999)
(FRL±
6066±
1).
Additional
information
regarding
EPA's
outreach
may
be
found
in
supporting
documents
included
in
the
public
version
of
the
official
record.

IV.
Summary
of
Proposal
A.
What
Chemicals
Did
EPA
Propose
to
Add
to
the
EPCRA
Section
313
List
of
Toxic
Chemicals?
In
an
initial
screening
of
PBT
chemicals
that
appear
on
the
list
of
chemicals
of
concern
in
the
various
chemical
initiatives,
EPA
identified
seven
chemicals
and
one
category
of
chemicals
that
persist
and
bioaccumulate
in
the
environment
but
that
were
not
on
the
list
of
EPCRA
section
313
toxic
chemicals.
Although
identification
of
these
chemicals
for
initial
consideration
prior
to
this
rulemaking
was
based
on
their
status
as
PBT
chemicals,
their
proposed
addition
in
this
rulemaking
was
based
solely
on
the
determination
that
they
meet
the
EPCRA
section
313(
d)(
2)
listing
criteria.
All
of
the
chemicals
proposed
for
addition
were
found
to
be
reasonably
anticipated
to
cause
serious
or
irreversible
chronic
human
health
effects
at
relatively
low
doses
or
ecotoxicity
at
relatively
low
concentrations,
and
thus
are
considered
to
have
moderately
high
to
high
chronic
toxicity
or
high
ecotoxicity.
The
chemicals
and
chemicals
categories
EPA
proposed
to
add
to
the
list
of
EPCRA
section
313
toxic
chemicals
include:
Dioxin
and
dioxin­
like
compounds
category,
benzo(
g,
h,
i)
perylene,
benzo(
j,
k)
fluorene
(fluoranthene),
3­
methylcholanthrene,
octachlorostyrene,
pentachlorobenzene,
tetrabromobisphenol
A
(TBBPA),
vanadium
(except
alloys)
and
vanadium
compounds.

B.
What
Persistence
and
Bioaccumulation
Issues
Did
EPA
Consider?
As
noted
above,
for
purposes
of
the
proposed
rule,
EPA
conducted
its
first,
limited
review
of
chemicals
for
their
persistence
and
bioaccumulation
properties
under
EPCRA
section
313.
EPA
first
established
criteria
to
be
used
under
section
313
for
determining
if
a
chemical
persists
or
bioaccumulates
in
the
environment.
These
criteria
were
then
applied
to
determine
whether
the
chemicals
included
in
the
review
have
the
potential
to
persist
and
bioaccumulate
in
the
environment.
The
initial
group
of
chemicals
reviewed
were
the
result
of
EPA's
screening
assessment
of
two
lists
of
persistent
and
bioaccumulative
chemicals:
(1)
The
Great
Lakes
Binational
Level
1
list
(Ref.
24);
and
(2)
chemicals
that
received
high
scores
for
persistence
and
bioaccumulation
in
the
initial
version
of
the
Waste
Minimization
Prioritization
Tool
(WMPT)
developed
by
EPA's
Office
of
Solid
Waste
(Ref.
74).
Finally,
included
in
this
initial
review
were
the
chemicals
included
in
the
dioxin
and
dioxin­
like
compounds
category
that
EPA
had
proposed
for
addition
to
the
section
313
list
in
1997
(at
62
FR
24887,
May
7,
1997)
(FRL±
5590±
1).
1.
Persistence.
A
chemical's
persistence
refers
to
the
length
of
time
the
chemical
can
exist
in
the
environment
before
being
destroyed
(i.
e.,
transformed)
by
natural
processes.
The
proposal
discussed
those
aspects
of
persistence
that
are
important
to
consider
in
determining
a
chemical's
persistence
in
the
environment
and
set
forth
the
criteria
that
EPA
used
for
determining
whether
a
chemical
is
persistent
for
purposes
of
reporting
under
EPCRA
section
313.
Numerous
organizations
and
internationally
negotiated
agreements
have
set
numerical
criteria
for
environmental
persistence,
many
of
which
have
been
developed
through
consensus
processes
(Ref.
68).
Of
those
reviewed,
the
criteria
for
persistence
in
water,
soil,
and
sediment
tend
to
cluster
around
two
half­
lifes,
1
to
2
months
and
6
months
while
the
persistence
criterion
for
air
was
either
a
half­
life
of
2
or
5
days.
A
half­
life
of
6
months
for
water,
soil,
and
sediment
and
half­
lifes
of
either
2
or
5
days
for
air
were
chosen
by
the
international
organizations
as
criteria
for
chemicals
that
are
being
banned
or
58669
Federal
Register
/
Vol.
64,
No.
209
/
Friday,
October
29,
1999
/
Rules
and
Regulations
severely
restricted.
However,
EPCRA
section
313
is
an
information
collection
and
dissemination
program.
EPA
believes
that
persistence
criteria
consistent
with
the
criteria
applied
to
chemicals
that
are
of
global
or
regional
(e.
g.,
Europe
and
the
Great
Lakes)
concern
and
that
are
targeted
for
ban,
restriction,
or
phase­
out
are
inappropriate
for
such
a
program.
Chemicals
that
meet
the
persistence
criteria
used
in
the
international
agreements
are
the
extremely
persistent
chemicals.
Applying
these
strict
criteria
to
EPCRA
section
313
would
result
in
a
very
narrow
list
of
chemicals
that
would
focus
on
only
extremely
persistent
chemicals.
This
is
inconsistent
with
one
of
the
fundamental
tenets
of
right­
toknow
which
is
to
provide
the
public
with
information
on
toxic
chemicals
that
have
the
potential
to
cause
adverse
effects
in
their
community.
Further,
persistence
criteria
of
half­
lifes
of
6
months
and
5
days
have
not
been
used
to
establish
whether
a
chemical
is
a
PBT
chemical
but
rather
whether
a
chemical
should
have
restrictions
on
its
uses.
The
Agency
stated
in
the
proposal
its
belief
that
half­
life
criteria
of
2
months
for
water,
sediment,
and
soil
and
2
days
for
air
will
include
a
better
representative
sample
of
chemicals
that
persist
in
the
environment.
Therefore,
EPA
used
a
half­
life
criterion
of
2
months
for
water,
sediment,
and
soil
and
a
half­
life
of
2
days
for
air
for
the
purposes
of
determining
under
EPCRA
section
313
whether
a
toxic
chemical
is
persistent
in
the
environment.
Under
these
criteria,
if
a
toxic
chemical
meets
any
one
of
the
media­
specific
criteria,
it
is
considered
to
be
persistent.
2.
Bioaccumulation.
Bioaccumulation
is
a
general
term
that
is
used
to
describe
the
process
by
which
organisms
may
accumulate
chemical
substances
in
their
bodies.
The
term
refers
to
both
uptake
of
chemicals
from
water
(bioconcentration)
and
from
ingested
food
and
sediment
residues.
The
discussions
and
data
on
bioaccumulation
in
the
proposed
rule
dealt
strictly
with
aquatic
organisms
because
most
of
the
bioaccumulation
data
are
from
aquatic
studies.
The
proposal
also
discussed,
in
detail,
those
aspects
of
determining
bioaccumulation
that
are
important
to
consider
in
assessing
whether
a
particular
chemical
will
bioaccumulate
in
the
environment.
A
chemical's
potential
to
bioaccumulate
can
be
quantified
by
measuring
or
predicting
a
chemical's
bioaccumulation
factor
(BAF)
or
a
chemical's
bioconcentration
factor
(BCF).
Sources
of
BAF
and
BCF
data
for
the
chemicals
included
in
the
proposed
rule
included
a
mixture
of
both
predicted
and
measured
BAF
and
BCF
values.
The
record
for
the
proposed
rule
includes
a
document
that
explains
the
origin
of
the
BAF
or
BCF
value
selected
for
each
PBT
chemical
(Ref.
71).
Most
data
were
retrieved
from
the
U.
S.
EPA's
AQUIRE
data
base
(Ref.
58)
and
the
Japanese
Chemicals
Inspection
and
Testing
Institute
(CITI)
data
base
(Ref.
18a).
As
with
persistence,
a
number
of
organizations
and
internationally
negotiated
agreements
have
set
numerical
criteria
for
bioaccumulation,
many
of
which
have
been
developed
through
a
consensus
processes.
Of
those
reviewed,
the
criteria
used
for
bioaccumulation
was
a
BAF/
BCF
numerical
value
of
either
5,000
or
1,000
or,
in
some
cases,
500.
The
bioaccumulation
criteria
chosen
by
the
international
organizations
as
criteria
for
chemicals
that
are
being
banned
or
severely
restricted
was
5,000.
However,
for
the
same
reasons
discussed
in
Unit
IV.
B.
1.,
EPA
stated
that
the
criteria
used
by
the
international
organizations
would
not
be
appropriate
for
purposes
of
EPCRA
section
313.
Therefore,
EPA
used
a
BAF/
BCF
numerical
criterion
of
1,000
for
determining
if
a
chemical
is
bioaccumulative
for
purposes
of
EPCRA
section
313.
3.
Persistence
and
bioaccumulation
data.
In
the
proposal,
EPA
presented
the
bioaccumulation
and
persistence
data
for
the
PBT
chemicals
being
considered.
More
detailed
discussions
of
the
sources
of
these
data
are
provided
in
the
support
documents
(Refs.
7
and
71).
When
considering
the
bioaccumulation
and
persistence
potential
of
chemical
categories,
EPA
reviewed
the
individual
bioaccumulation
and
persistence
data
for
the
category
members
and
determined
in
which
tier
the
entire
chemical
category
should
be
placed.
For
chemicals
that
had
half­
life
ranges
that
bracketed
the
persistence
tiers,
EPA
considered
the
types
of
studies
supporting
the
half­
life
ranges
and
determined
the
most
appropriate
tier
for
each
chemical.

C.
How
Did
EPA
Propose
to
Address
Dioxin
and
Dioxin­
Like
Compounds?
In
response
to
a
petition
from
Communities
For
A
Better
Environment,
EPA
issued
a
proposed
rule
(at
62
FR
24887)
to
add
a
category
of
dioxin
and
dioxin­
like
compounds
to
the
EPCRA
section
313
list
of
toxic
chemicals.
As
part
of
that
action,
EPA
proposed
to
move
11
co­
planar
polychlorinated
biphenyls
(PCBs)
from
their
listing
under
Chemicals
Abstract
Service
Registry
(CAS)
Number
1336±
36±
3
to
the
dioxin
and
dioxin­
like
compounds
category.
However,
since
PCBs
persist
and
bioaccumulate,
EPA
stated
its
belief
in
the
proposed
rule
that
PCBs
should
be
subject
to
lower
reporting
thresholds.
Thus
EPA
believed
there
was
no
need
to
move
the
11
co­
planar
PCBs
to
the
proposed
dioxin
and
dioxin­
like
compounds
category.
Therefore,
EPA
withdrew
its
original
proposal
to
modify
the
listing
for
PCBs
and
instead
proposed
to
lower
the
reporting
thresholds
for
the
current
PCB
listing
which
covers
all
PCBs
(at
64
FR
710).
Because
of
this
change,
the
proposed
dioxin
and
dioxin­
like
compounds
category
included
only
the
7
polychlorinated
dibenzo­
p­
dioxins
and
the
10
polychlorinated
dibenzofurans
identified
in
the
proposed
rule.
In
order
to
focus
reporting
on
those
facilities
that
actually
add
to
the
environmental
loading
of
the
dioxin
and
dioxin­
like
compounds
and
to
reduce
reporting
burden,
EPA
proposed
to
add
the
activity
qualifier
``
manufacture
only''
to
the
category.
This
qualifier
would
have
limited
reporting
to
those
dioxin
and
dioxin­
like
compounds
that
are
manufactured
at
the
facility,
including
those
coincidentally
manufactured.

D.
What
Proposed
Changes
to
Reporting
Requirements
for
PBT
Chemicals
Did
EPA
Consider?
1.
Changes
to
reporting
thresholds.
In
evaluating
potential
lower
reporting
thresholds
for
PBT
chemicals,
EPA
considered
not
only
their
persistence
and
bioaccumulation
and
the
purposes
of
EPCRA
section
313,
but
also
the
potential
burden
that
might
be
imposed
on
the
regulated
community.
Because
all
PBT
chemicals
persist
and
bioaccumulate
in
the
environment,
they
have
the
potential
to
pose
greater
exposure
to
humans
and
the
environment
over
a
longer
period
of
time
(Refs.
75
and
76).
The
nature
of
PBT
chemicals
indicates
that
small
quantities
of
such
chemicals
are
of
concern,
which
provides
strong
support
for
setting
lower
reporting
thresholds
than
the
current
section
313
thresholds
of
10,000
and
25,000
pounds.
For
determining
the
levels
at
which
reporting
thresholds
should
be
set
for
these
chemicals,
EPA
adopted
a
twotiered
approach.
EPA
made
a
distinction
between
persistent
bioaccumulative
toxic
chemicals
and
highly
persistent,
highly
bioaccumulative
toxic
chemicals
by
proposing
to
set
lower
reporting
thresholds
based
on
two
levels
of
persistence
and
bioaccumulation
potential.
EPA
proposed
to
set
a
manufacture,
process
and
otherwise
use
threshold
of
100
pounds
for
PBT
chemicals
and
a
threshold
of
10
pounds
for
that
subset
of
PBT
chemicals
that
are
highly
persistent
and
highly
58670
Federal
Register
/
Vol.
64,
No.
209
/
Friday,
October
29,
1999
/
Rules
and
Regulations
bioaccumulative
toxic
chemicals.
One
exception
to
this
is
the
reporting
threshold
for
the
dioxin
and
dioxin­
like
compounds
category,
see
the
discussion
in
Unit
IV.
D.
2.
In
determining
the
appropriate
reporting
thresholds
to
propose
for
PBT
chemicals,
EPA
started
with
the
premise
that
low
or
very
low
reporting
thresholds
may
be
appropriate
for
these
chemicals
based
on
their
persistence
and
bioaccumulation
potentials
only.
EPA
then
considered
the
burden
that
would
be
imposed
by
lower
reporting
thresholds
and
the
distribution
of
reporting
across
covered
facilities.
Considering
the
factors
described
above,
in
addition
to
the
purposes
of
EPCRA
section
313,
EPA
proposed
to
lower
the
manufacture,
process,
and
otherwise
use
thresholds
to
100
pounds
for
PBT
chemicals
and
to
10
pounds
for
that
subset
of
PBT
chemicals
that
are
highly
persistent
and
highly
bioaccumulative.
EPA
presented
the
proposed
section
313
reporting
thresholds
for
each
of
the
PBT
chemicals
considered.
For
purposes
of
section
313
reporting,
threshold
determinations
for
chemical
categories
are
based
on
the
total
of
all
toxic
chemicals
in
the
category
(see
40
CFR
372.25(
d)).
2.
Special
reporting
threshold
for
dioxin
and
dioxin­
like
compounds.
The
category
of
dioxin
and
dioxin­
like
compounds
are
highly
persistent
and
highly
bioaccumulative
toxic
chemicals.
However,
this
category
of
chemicals
poses
unique
problems
with
regard
to
setting
section
313
reporting
thresholds
because
these
chemicals
are
generally
produced
in
extremely
small
amounts
compared
to
other
section
313
chemicals.
In
response
to
EPA's
original
proposal
to
add
dioxin
and
dioxin­
like
compounds,
EPA
received
numerous
comments
suggesting
that
the
reporting
threshold
for
this
category
be
set
at
zero.
EPA
stated
its
belief
that
rather
than
setting
a
zero
reporting
threshold
it
would
be
better
to
set
a
very
low
threshold
that
provides
facilities
with
a
clear
indicator
of
when
they
are
required
to
report.
EPA
proposed
a
manufacture
threshold
of
0.1
gram
for
the
category.
EPA
expressed
its
intent
to
develop
reporting
guidance
for
industries
that
may
fall
within
this
reporting
category.
In
addition
to
the
proposed
lower
reporting
threshold
for
the
dioxin
and
dioxin­
like
compounds
category,
EPA
requested
comment
on
an
alternative
way
of
reporting
release
and
other
waste
management
data
for
this
category.
This
alternative
included
reporting
release
and
other
waste
management
data
for
the
dioxin
and
dioxin­
like
compounds
category
in
terms
of
grams
of
toxicity
equivalents
(TEQs).

E.
What
Other
Reporting
Issues
Did
EPA
Consider
for
PBT
Chemicals?
1.
De
minimis
exemption.
In
1988,
EPA
promulgated
the
de
minimis
exemption
because:
(1)
The
Agency
believed
that
facilities
newly
covered
by
EPCRA
section
313
would
have
limited
access
to
information
regarding
low
concentrations
of
toxic
chemicals
in
mixtures
that
are
imported,
processed,
otherwise
used
or
manufactured
as
impurities;
(2)
the
Agency
did
not
believe
that
these
low
concentrations
would
result
in
quantities
that
would
significantly
contribute
to
threshold
determinations
and
release
calculations
at
the
facility
(53
FR
4509,
February
16,
1988);
and
(3)
the
exemption
was
consistent
with
information
collected
by
the
Occupational
Safety
and
Health
Administration's
(OSHA)
Hazard
Communication
Standard
(HCS).
However,
given
that:
(1)
Covered
facilities
currently
have
several
sources
of
information
available
to
them
regarding
the
concentration
of
PBT
chemicals
in
mixtures;
(2)
even
minimal
releases
of
persistent
bioaccumulative
chemicals
may
result
in
significant
adverse
effects
and
can
reasonably
be
expected
to
significantly
contribute
to
exceeding
the
proposed
lower
thresholds;
and
(3)
the
concentration
levels
chosen,
in
part,
to
be
consistent
with
the
OSHA
HCS
are
inappropriately
high
for
PBT
chemicals,
EPA's
original
rationale
for
the
de
minimis
exemption
does
not
apply
to
PBT
chemicals.
EPA
therefore
proposed
to
eliminate
the
de
minimis
exemption
for
PBT
chemicals.
EPA
did
not
propose,
however,
to
modify
the
applicability
of
the
de
minimis
exemption
to
the
supplier
notification
requirements
(40
CFR
372.45(
d)(
1))
because
the
Agency
believed
there
was
sufficient
information
available.
2.
Use
of
the
alternative
threshold
and
Form
A.
EPA
stated
its
belief
that
use
of
the
existing
alternate
threshold
and
reportable
quantity
for
Form
A
would
be
inconsistent
with
the
intent
of
expanded
PBT
chemical
reporting.
The
general
information
provided
in
the
Form
A
on
the
quantities
of
the
chemical
that
the
facility
manages
as
waste
is
insufficient
for
conducting
analyses
on
PBT
chemicals
and
would
be
virtually
useless
for
communities
interested
in
assessing
risk
from
releases
and
other
waste
management
of
PBT
chemicals.
EPA,
therefore,
proposed
excluding
all
PBT
chemicals
from
the
alternate
threshold
of
1
million
pounds.
3.
Proposed
changes
to
the
use
of
range
reporting.
EPA
stated
its
belief
that
use
of
ranges
could
misrepresent
data
accuracy
for
PBT
chemicals
because
the
low
or
the
high
end
range
numbers
may
not
really
be
that
close
to
the
estimated
value,
even
taking
into
account
its
inherent
error
(i.
e.,
errors
in
measurements
and
developing
estimates).
EPA
believed
this
uncertainty
would
severely
limit
the
applicability
of
release
information
where
the
majority
of
releases,
particularly
for
PBT
chemicals,
are
expected
to
be
within
the
amounts
eligible
for
range
reporting.
Given
EPA's
belief
that
the
large
uncertainty
that
would
be
part
of
these
data
would
severely
limit
their
utility,
EPA
proposed
to
eliminate
range
reporting
for
PBT
chemicals.
4.
Proposed
changes
to
the
use
of
the
half­
pound
rule
and
whole
numbers.
EPA
currently
allows
facilities
to
report
whole
numbers
and
to
round
releases
of
0.5
pound
or
less
to
zero.
EPA
explained
its
concern
that
the
combination
of
requiring
the
reporting
of
whole
numbers
and
allowing
rounding
to
zero
would
result
in
a
significant
number
of
facilities
reporting
their
releases
of
some
PBT
chemicals
as
zero.
EPA,
therefore,
proposed
that
all
releases
or
other
waste
management
quantities
greater
than
1
¤10
of
a
pound
of
PBT
chemicals
(except
dioxins)
be
reported,
provided
that
the
appropriate
activity
threshold
has
been
exceeded.
For
the
category
of
dioxin
and
dioxin­
like
compounds,
which
have
a
proposed
reporting
threshold
of
0.1
gram,
EPA
proposed
that
facilities
report
all
releases
and
other
waste
management
activities
greater
than
100
micrograms
(ug)
(i.
e.,
0.0001
gram).
5.
Proposed
changes
to
other
EPCRA
section
313
reporting
requirements.
The
alkyl
lead
compounds
tetraethyl
lead
(CAS
No.
78±
00±
2)
and
tetramethyl
lead
(CAS
No.
75±
74±
1)
are
currently
reportable
under
the
EPCRA
section
313
category
listing
for
lead
compounds.
However,
these
two
chemicals
specifically
appear
on
the
Binational
Level
1
list
of
chemicals
that
have
been
identified
for
virtual
elimination
from
the
Great
Lakes
and
thus
are
of
special
concern.
EPA,
therefore,
proposed
that
separate
reports
be
filed
for
these
two
members
of
the
lead
compounds
category,
which
would
allow
better
tracking
of
these
specific
lead
compounds.
In
addition,
EPA
proposed
to
list
``
vanadium''
and
``
vanadium
compounds''
and
delete
the
EPCRA
section
313
listing
for
``
vanadium
(fume
or
dust).
''
Since
vanadium
without
the
fume
or
dust
qualifier
would
be
a
new
section
313
listing,
EPA
did
not
propose
to
include
additional
reporting
on
alloys
containing
vanadium.
In
the
proposal,
EPA
deferred
making
a
final
decision
on
58671
Federal
Register
/
Vol.
64,
No.
209
/
Friday,
October
29,
1999
/
Rules
and
Regulations
vanadium
contained
in
alloys
until
the
Agency
could
complete
a
scientific
review
of
issues
pertinent
to
some
alloys.
EPA
proposed
to
include
the
qualifier
``
except
when
contained
in
an
alloy''
in
the
vanadium
listing.
EPA
also
requested
comment
on
the
adequacy
of
existing
studies
for
determining
the
bioaccumulation
potential
of
cobalt
and
cobalt
compounds.

V.
Summary
of
the
Final
Rule
A.
Which
Chemicals
is
EPA
Adding
to
the
List
of
Toxic
Chemicals
Under
EPCRA
Section
313?

In
this
action,
EPA
is
adding
seven
chemicals
and
two
chemical
compound
categories
to
the
list
of
toxic
chemicals
subject
to
reporting
under
EPCRA
section
313.
These
chemicals
include:
benzo(
g,
h,
i)
perylene,
benzo(
j,
k)
fluorene
(fluoranthene),
3­
methylcholanthrene,
octochlorostyrene,
pentachlorobenzene,
TBBPA,
vanadium
(except
when
in
an
alloy),
vanadium
compounds,
and
a
category
consisting
of
17
specified
dioxin
and
dioxin­
like
compounds.
EPA
has
determined
that
each
of
these
chemicals
and
chemical
compound
categories
meets
the
listing
criteria
under
EPCRA
section
313(
d)(
2).
Two
of
these
chemicals,
3­
methylchloanthrene
and
benzo(
j,
k)
fluorene
(fluoranthene),
are
being
added
as
members
of
the
polycyclic
aromatic
compounds
(PACs)
category.
Vanadium,
with
the
qualifier
``
fume
or
dust,
''
has
been
on
the
list
of
toxic
chemicals
since
the
program's
inception
in
1987.
In
today's
action,
however,
the
Agency
is
removing
the
``
fume
or
dust''
qualifier
from
the
vanadium
listing.
However,
EPA
is
not
including
reporting
on
vanadium
when
contained
in
alloys.
EPA
is
finalizing
the
proposed
qualifier
``
except
when
contained
in
an
alloy''
to
the
vanadium
listing.
Therefore
all
elemental
vanadium,
unless
it
is
in
an
alloy,
is
now
reportable
under
EPCRA
section
313.
In
addition
to
modifying
the
qualifier,
EPA
is
also
adding
a
new
vanadium
compounds
category.
Thus,
all
chemical
compounds
that
contain
vanadium
are
reportable
under
this
listing.
Further,
EPA
is
finalizing
its
proposal
(62
FR
24887)
to
add
dioxins
and
16
dioxin­
like
compounds.
However,
the
Agency
is
modifying
the
qualifier
that
it
originally
included
with
this
listing.
In
the
PBT
proposed
rule,
EPA
proposed
to
add
the
dioxin
and
dioxin­
like
compounds
category
with
the
qualifier
``
manufacturing
only.
''
However,
based
on
comments
the
Agency
received,
EPA
is
changing
this
qualifier
to
include:
Manufacturing;
and
the
processing
or
otherwise
use
of
dioxin
and
dioxin­
like
compounds
if
the
dioxin
and
dioxin­
like
compounds
are
present
as
contaminants
in
a
chemical
and
if
they
were
created
during
the
manufacturing
of
that
chemical.

B.
Which
Chemicals
is
EPA
Including
as
PBT
Chemicals
Under
EPCRA
Section
313?

EPA
has
made
the
final
determination
that
18
of
the
chemicals
and
chemical
categories
proposed
meet
the
EPCRA
section
313
criteria
for
persistence
and
bioaccumulation.
Thus
EPA
is
lowering
the
reporting
threshold
for
all
of
these
toxic
chemicals.
These
chemicals
and
their
final
thresholds
are
listed
in
Table
1
below:

Table
1.Ð
Reporting
Thresholds
for
EPCRA
Section
313
Listed
PBT
Chemicals
Chemical
Name
or
Chemical
Category
Name
CASRN
Section
313
Reporting
Threshold
(in
pounds
unless
noted
otherwise

Aldrin
309­
00­
2
100
Benzo(
g,
h,
i)
perylene
191­
24­
2
10
Chlordane
57­
74­
9
10
Dioxin
and
dioxin­
like
compounds
category
(manufacturing;
and
the
processing
or
otherwise
use
of
dioxin
and
dioxin­
like
compounds
if
the
dioxin
and
dioxin­
like
compounds
are
present
as
contaminants
in
a
chemical
and
if
they
were
created
during
the
manufacturing
of
that
chemical)
NA
0.1
grams
Heptachlor
76­
44­
8
10
Hexachlorobenzene
118­
74­
1
10
Isodrin
465­
73­
6
10
Methoxychlor
72­
43­
5
100
Octachlorostyrene
29082­
74­
4
10
Pendimethalin
40487­
42­
1
100
Pentachlorobenzene
608­
93­
5
10
Polycyclic
aromatic
compounds
category
NA
100
Polychlorinated
biphenyl
(PCBs)
1336­
36­
3
10
Tetrabromobisphenol
A
79­
94­
7
100
Toxaphene
8001­
35­
2
10
Trifluralin
1582­
09­
8
100
Mercury
7439­
97­
6
10
58672
Federal
Register
/
Vol.
64,
No.
209
/
Friday,
October
29,
1999
/
Rules
and
Regulations
Table
1.Ð
Reporting
Thresholds
for
EPCRA
Section
313
Listed
PBT
ChemicalsÐ
Continued
Chemical
Name
or
Chemical
Category
Name
CASRN
Section
313
Reporting
Threshold
(in
pounds
unless
noted
otherwise

Mercury
compounds
NA
10
EPA
is
deferring
its
decision
for
two
chemicals
and
one
chemical
category.
Specifically,
EPA
is
deferring
a
determination
on
dicofol
while
the
Agency
continues
to
review
the
available
persistence
data.
EPA
is
also
deferring
its
decision
on
cobalt
and
cobalt
compounds
because
it
needs
to
further
investigate
the
bioaccumulative
potential
of
these
chemicals.

C.
What
Thresholds
Has
EPA
Established
for
PBT
chemicals?
EPA
is
finalizing
the
thresholds
it
proposed
for
PBT
chemicals
in
the
January
5,
1999
(64
FR
688)
Federal
Register.
Specifically,
EPA
is
finalizing
two
thresholds
based
on
the
chemicals'
potential
to
persist
and
bioaccumulate
in
the
environment.
The
two
levels
include
setting
section
313
manufacture,
process,
and
otherwise
use
thresholds
at
100
pounds
for
PBT
chemicals
and
at
10
pounds
for
that
subset
of
PBT
chemicals
that
are
highly
persistent
and
highly
bioaccumulative.
One
exception
is
the
dioxin
and
dioxin­
like
compounds
category.
The
dioxin
and
dioxin­
like
compounds
category
threshold
determination
required
special
consideration
because
these
highly
persistent
and
highly
bioaccumulative
compounds
are
manufactured
in
extremely
small
amounts
compared
to
other
section
313
chemicals.
In
order
to
capture
release
and
other
waste
management
data,
EPA
is
setting
the
threshold
for
the
dioxin
and
dioxin­
like
compound
category
at
0.1
gram.

D.
What
Exemptions
and
Other
Reporting
Issues
is
EPA
Addressing?
EPA
is
eliminating
the
de
minimis
exemption
for
the
PBT
chemicals
included
in
today's
final
rule.
However,
this
action
will
not
affect
the
applicability
of
the
de
minimis
exemption
to
the
supplier
notification
requirements
(40
CFR
372.45(
d)(
1)).
During
the
inter­
agency
review
process,
it
was
suggested
that
EPA
consider
constructing
an
exemption
for
facilities
in
SIC
code
5171,
i.
e.,
Petroleum
Bulk
Plants
and
Terminals.
Specifically,
it
was
suggested
that
EPA
exempt
the
processing
of
PBT
chemicals
in
petroleum
products.
Before
EPA
can
consider
this
exemption,
EPA
must
determine
that
these
facilities
process
and
release
and
otherwise
manage
as
waste
very
small
aggregate
quantities
of
PBT
chemicals.
The
Agency
is
soliciting
comments
and
information
on
this
suggestion,
particularly
any
information
that
could
provide
a
factual
basis
for
such
an
exemption.
Please
send
your
comments
to
the
person
listed
in
the
``
FOR
FURTHER
INFORMATION
CONTACT''
section
within
the
next
60
days.
EPA
will
evaluate
this
suggestion,
and
provide
a
response
within
approximately
180
days.
In
today's
action,
EPA
is
also
excluding
all
PBT
chemicals
from
eligibility
for
the
alternate
threshold
of
1
million
pounds
and
eliminating
for
PBT
chemicals
range
reporting
for
onsite
releases
and
transfers
off­
site
for
further
waste
management.
This
will
not
affect
the
applicability
of
the
range
reporting
of
the
maximum
amount
onsite
as
required
by
EPCRA
section
313(
g).
EPA
is
addressing
the
alkyl
lead
compounds,
tetraethyl
lead
(CAS
No.
78±
00±
2),
and
tetramethyl
lead
(CAS
No.
75±
74±
1),
in
a
separate
rulemaking
for
lead
and
lead
compounds
(64
FR
42222,
August
3,
1999)
(FRL±
6081±
4).
Therefore,
EPA
is
not
finalizing
any
action
with
respect
to
these
two
lead
compounds
in
today's
action.
EPA
proposed
to
require
reporting
of
all
releases
and
other
waste
management
quantities
greater
than
1
¤10
of
a
pound
of
PBT
chemicals
(except
dioxin),
provided
that
the
accuracy
in
the
underlying
data
on
which
the
estimate
is
based
supports
this
level
of
precision.
Also,
EPA
stated
that
releases
and
other
waste
management
quantities
would
continue
to
be
reported
to
two
significant
digits.
In
addition,
EPA
stated
that
for
quantities
of
10
pounds
or
greater,
only
whole
numbers
would
be
required
to
be
reported.
For
the
category
of
dioxin
and
dioxin­
like
compounds,
which
have
a
proposed
reporting
threshold
of
0.1
gram,
EPA
proposed
that
facilities
report
all
releases
and
other
waste
management
activities
greater
than
100
mg
(i.
e.,
0.0001
gram).
After
reviewing
all
the
comments
on
this
issue,
EPA
is
providing
additional
guidance
on
the
level
of
precision
at
which
facilities
should
report
their
releases
and
other
waste
management
quantities
of
PBT
chemicals.
Facilities
should
still
report
releases
and
other
waste
management
quantities
greater
than
0.1
pound
(except
dioxins)
provided
the
accuracy
and
the
underlying
data
on
which
the
estimate
is
based
supports
this
level
of
precision.
Rather
than
reporting
in
whole
numbers
and
to
two
significant
digits,
if
a
facility's
release
or
other
waste
management
estimates
support
reporting
an
amount
that
is
more
precise
than
whole
numbers
and
two
significant
digits,
then
the
facility
should
report
that
more
precise
amount.
The
Agency
believes
that,
particularly
for
PBT
chemicals,
facilities
may
be
able
to
calculate
their
estimates
of
releases
and
other
waste
management
quantities
to
1
¤10
of
a
pound
and
believes
that
such
guidance
is
consistent
with
the
reporting
requirements
of
sections
313(
g)
and
(h).

E.
What
is
the
Relationship
Between
This
Rule
and
the
Clean
Air
Act
Mercury
Information
Collection
Request?

Throughout
calendar
year
1999,
EPA
has
been
using
authority
under
section
114
of
the
Clean
Air
Act
to
require
all
coal­
fired
power
plants
over
25
mega
watts
to
submit
to
EPA
the
results
of
analyses
of
the
mercury
content
of
their
coal.
A
representative
sample
of
these
plants,
stratified
by
type
of
plant
and
type
of
coal
burned,
have
been
required
to
perform
stack
testing
to
determine
the
amount
(and
species)
of
mercury
emitted.
The
stack
testing
will
allow
EPA
to
develop
a
set
of
emissions
factors
that
can
be
applied
to
the
mercury
in
coal
analysis
to
generate
mercury
emissions
estimates
for
each
coal­
fired
plant.
EPA
does
not
intend
to
continue
to
require
plants
to
submit
either
the
coal
analysis
or
the
stack
testing
beyond
the
current
requirement.
Therefore
for
the
purpose
of
reporting
mercury
releases
to
the
TRI,
EPA
expects
coal­
fired
power
plants
that
do
not
have
monitoring
or
stack
test
data
for
the
reporting
year
to
use
the
emissions
factors
that
EPA
will
develop
and
make
available
to
the
public
in
the
summer
of
2000.
58673
Federal
Register
/
Vol.
64,
No.
209
/
Friday,
October
29,
1999
/
Rules
and
Regulations
VI.
Summary
of
Public
Comments
and
EPA
Responses
A.
What
Comments
Did
EPA
Receive
on
its
Statutory
Authority
to
Add
Chemicals
and
Lower
the
Reporting
Threshold
and
What
is
EPA's
Response?
Several
commenters
assert
that
EPCRA
section
313(
f)(
2)
only
grants
EPA
the
authority
to
raise
the
statutory
thresholds,
but
not
to
lower
them.
They
agree
that
the
substantial
majority
test
is
met
``
as
a
matter
of
logical
necessity''
when
EPA
lowers
the
reporting
threshold,
and
argue
that
this
makes
the
``
substantial
majority''
test
essentially
meaningless
when
thresholds
are
lowered.
They
argue
that
this
demonstrates
that
Congress
did
not
intend
for
EPA
to
lower
reporting
thresholds,
only
to
raise
them.
These
commenters
also
rely
on
the
language
of
other
provisions
of
EPCRA
section
313
to
support
their
argument
that
Congress
did
not
grant
EPA
authority
to
lower
thresholds.
They
rely
on
the
fact
that
section
313(
f)(
2)
does
not
provide
that
EPA
can
``
raise
or
lower''
thresholds,
unlike
section
313(
d),
under
which
EPA
can
``
add
or
delete''
chemicals
from
the
list,
and
section
313(
b),
under
which
EPA
can
``
add
or
delete''
industry
sectors.
In
addition,
the
commenters
argue
that
section
313(
f)(
2)
is
analogous
to
section
313(
l),
where,
despite
the
use
of
the
otherwise
neutral
term
``
modify,
''
Congress
clearly
meant
for
EPA
only
to
make
the
reporting
requirements
less
frequent
(i.
e.,
less
stringent).
Based
on
these
provisions,
they
also
argue
that,
where
Congress
intended
EPA
to
have
the
authority
to
both
expand
and
restrict
reporting,
the
statute
explicitly
provides
the
authority,
but
where
Congress
only
intended
to
authorize
EPA
to
reduce
the
reporting
burden,
it
provided
a
neutral
term,
and
then
restricted
it.
The
commenters
argue
that
in
section
313(
f)(
2),
Congress
qualified
EPA's
authority
with
a
substantial
majority
restriction
that
only
makes
sense
if
EPA
raises
the
thresholds.
EPA
disagrees
with
the
commenters'
interpretations.
Section
313(
f)(
2)
clearly
authorizes
EPA
to
lower
thresholds,
as
well
as
to
raise
them.
The
plain
language
of
this
provision
provides
that
``
the
Administrator
may
establish
a
threshold
different
from
the
amount
established
by
paragraph
(1).
''
It
clearly
does
not
state
that
the
Administrator
may
only
establish
a
higher
threshold
than
the
amount
established
by
paragraph
(1),
which
appears
to
be
the
commenters'
interpretation.
Moreover,
in
the
House
debate
on
the
conference
report,
Representative
Edgar,
one
of
EPCRA's
sponsors,
noted:
The
EPA
is
authorized
to
revise
these
thresholds,
but
only
if
such
revised
thresholds
obtain
reporting
on
a
substantial
majority
of
total
releases,
especially
if
such
revised
thresholds
raise
the
statutory
levels,.
.
.
(A
Legislative
History
of
the
Superfund
Amendments
and
Reauthorization
Act
of
1986,
Committee
Print,
vol.
6,
5315)
(emphasis
added).

The
clear
implication
of
this
statement
is
that
Congress
intended
EPA
to
have
the
authority
to
lower,
as
well
as
to
raise,
the
statutory
thresholds.
The
commenters'
interpretation
that
EPA
lacks
the
authority
to
lower
the
thresholds
conflicts
with
Congressional
intent
in
other
ways.
During
debate
on
the
Conference
Report,
Representative
Edgar
noted
that
``
This
act
is
intended
to
provide
a
comprehensive
view
of
toxic
chemical
exposure
and,
hopefully,
provide
a
basis
for
more
sensible
and
effective
local,
State,
and
national
policies.
''
Legislative
History
at
5316.
See,
also,
Legislative
History
at
5313
and
5338.
And
yet
without
the
authority
to
lower
the
thresholds,
EPA
cannot
ensure
that
this
objective
is
achieved.
For
example,
Congress
included
PCBs
on
the
original
list
of
EPCRA
section
313
chemicals,
thereby
indicating
an
intent
to
provide
the
public
with
a
``
comprehensive
view
of
exposure''
to
PCBs;
but
under
the
original
reporting
requirements,
EPA
only
received
6
reports.
Under
no
interpretation
can
six
reports
be
characterized
as
obtaining
``
a
comprehensive
view
of
toxic
chemical
exposure.
''
Legislative
History
at
5315.
EPA
also
disagrees
with
the
comment
that
the
Agency's
interpretation
has
rendered
this
provision
meaningless.
This
argument
is
based
on
a
logical
fallacy;
a
standard
need
not
constrain
agency
action
to
the
same
degree
in
all
circumstances
to
be
meaningful.
Congress
may
impose
a
standard
that
constrains
actions
to
varying
degrees
in
different
circumstances.
In
this
case,
the
Congressional
debate
on
this
provision
indicates
that
Congress
was
most
concerned
with
the
loss
of
publicly
available
information
that
may
result
from
raising
the
thresholds.
See,
e.
g.,
Legislative
History
at
5315­
16.
It
is
therefore
reasonable
to
assume
that
Congress
chose
to
impose
a
standard
that
presented
a
greater
constraint
on
the
Agency's
ability
to
raise
thresholds,
and
therefore
created
a
ceiling
beyond
which
the
Agency
was
not
authorized
to
modify
thresholds.
Further,
notwithstanding
the
fact
that
under
EPA's
interpretation
of
section
313(
f)(
2),
the
Agency
can
meet
the
statutory
standard
without
the
need
for
quantitative
support
when
it
lowers
the
threshold,
EPA
does
not
believe
that
Congress
has
granted
it
unfettered
discretion
to
establish
a
different
threshold.
As
discussed
at
length
in
Unit
VI.
E.,
Congress
provided
significant
guidance
in
other
provisions
of
the
statute
and
the
legislative
history,
to
guide
the
Agency's
exercise
of
discretion
under
this
provision.
Moreover,
as
noted
above,
the
substantial
majority
requirement
establishes
a
ceiling
beyond
which
the
Agency
is
not
authorized
to
modify
thresholds.
EPA
also
disagrees
with
the
commenters'
interpretation
of
other
provisions
of
EPCRA
section
313.
In
general,
Congress
established
the
basic
framework
of
right­
to­
know
reporting
in
EPCRA
section
313,
and
selectively
granted
EPA
carefully
qualified
authority
to
adjust
individual
parameters
as
appropriate.
For
example,
EPA
is
authorized
to
modify
the
chemicals
on
the
EPCRA
section
313
list,
the
SIC
codes
and
facilities
covered
by
section
313,
the
reporting
frequency,
and
the
reporting
thresholds,
but
each
grant
of
authority
is
constrained
to
varying
degrees
by
the
standards
contained
in
each
respective
provision.
As
the
commenters
have
correctly
noted,
where
Congress
intended
to
restrict
the
Agency's
authority
to
modify
the
original
requirements,
it
did
so
explicitly.
For
example
section
313(
l)
specifically
limits
EPA's
authority
to
modify
the
reporting
frequency:
``.
.
.but
the
Administrator
may
not
modify
the
frequency
to
be
any
more
often
than
annually.
''
Similarly
Congress
included
no
provision
authorizing
any
amendments
to
the
generally
applicable
employee
threshold.
It
is
therefore
reasonable
to
assume
that
had
Congress
intended
to
only
permit
EPA
to
raise
the
thresholds,
they
would
have
included
such
an
explicit
restriction
in
the
provision.
Moreover,
as
noted
earlier
in
this
unit,
the
little
legislative
history
that
exists
on
this
provision
indicates
that
Congress
intended
EPA
to
have
the
discretion
to
both
raise
and
lower
the
reporting
thresholds.
Further,
EPA
disagrees
with
the
commenters'
interpretation
that
Congress
relied
on
different
statutory
construction
to
indicate
its
decision
not
to
grant
the
Agency
authority
to
decrease
reporting
thresholds,
rather
than
relying
on
an
explicit
restriction
in
the
plain
language
of
the
statute.
EPA
is
aware
of
no
indication
of
such
Congressional
intent
in
the
legislative
history,
nor
have
the
commenters
cited
to
any.
More
to
the
point,
the
commenters'
interpretation
is
clearly
refuted
by
the
inclusion
in
section
313(
l)
of
an
explicit
restriction,
demonstrating
that
where
Congress
58674
Federal
Register
/
Vol.
64,
No.
209
/
Friday,
October
29,
1999
/
Rules
and
Regulations
intended
to
restrict
EPA's
authority,
it
did
so
explicitly.
One
commenter
argues
that
EPA
lacks
authority
to
lower
the
thresholds
based
on
a
comparison
of
the
language
in
EPCRA
sections
311
and
312
authorizing
EPA
to
revise
the
section
311
and
section
312
thresholds,
with
the
language
of
section
313(
f)(
2).
The
commenter
states
that
Congress
could
have
used
this
same
broad
and
simple
language
in
section
313,
and
argues
that
because
it
did
not,
but
instead
chose
to
impose
the
``
substantial
majority''
requirement,
this
demonstrates
that
Congress
did
not
intend
EPA
to
have
the
authority
to
lower
the
thresholds.
Instead,
the
commenter
argues,
Congress
was
concerned
with
reporting
burden
when
it
crafted
section
313,
and
so
declined
to
grant
EPA
authority
to
lower
the
thresholds.
EPA
disagrees.
There
is
no
significant
difference
between
the
language
in
sections
311,
312,
and
313
that
supports
the
commenter's
interpretation.
Unlike
section
313,
Congress
did
not
establish
thresholds
in
sections
311
and
312,
but
granted
the
Administrator
broad
discretion
to
determine
whether
a
threshold
was
even
appropriate;
at
what
level
to
establish
the
threshold;
and
to
modify
it
as
appropriate.
The
language
with
which
Congress
conferred
this
authority
provides
that
``
the
Administrator
may
establish
threshold
quantities.
.
.
.''
This
is
almost
identical
to
the
language
of
section
313(
f)(
2),
which
simply
provides
that
``
the
Administrator
may
establish
a
threshold
amount
for
a
toxic
chemical
different
from
the
amount
established
by
paragraph
(1).
''
The
commenter's
argument
turns
wholly
on
the
inclusion
of
the
``
substantial
majority''
requirement,
and
as
explained
above,
EPA
does
not
believe
that
this
standard
either
precludes
EPA
from
lowering
thresholds
or
demonstrates
Congressional
intent
to
do
so.
Several
commenters
challenged
EPA's
finding
that
its
alternate
thresholds
would
capture
a
substantial
majority
of
total
releases,
contending
that
the
Agency
had
impermissibly
relied
on
an
increase
in
the
number
of
reports
submitted.
The
commenters
assert
that
EPA
is
required
to
estimate
releases
at
these
facilities
and
determine,
on
a
percentage
basis,
whether
a
``
substantial
majority''
of
all
releases
of
each
chemical,
from
all
facilities
subject
to
EPCRA
section
313,
will
be
captured.
One
commenter
noted
that,
even
if
lowering
the
threshold
for
an
EPCRA
section
313
chemical
results
in
an
increase
in
the
number
of
reports
on
the
chemical,
this
does
not
necessarily
mean
that
the
additional
reports
will
capture
a
substantial
majority
of
the
total
releases
from
all
facilities
subject
to
EPCRA
section
313
reporting.
In
order
for
the
lower
threshold
to
meet
the
statutory
test,
the
threshold
must
result
in
capturing
at
least
two
thirds
of
all
releases
of
the
chemical
at
covered
facilities.
The
commenter
contended
that
the
number
of
reports
is
irrelevant
to
the
percentage
of
releases
captured
by
the
reports.
If
a
certain
chemical
were
present
at
only
one
facility
in
the
country
subject
to
EPCRA
section
313,
the
submission
of
one
report
on
the
chemical
accounting
for
at
least
66%
of
the
releases
from
that
facility
would
satisfy
the
``
substantial
majority''
test.
By
contrast,
if
a
lower
threshold
generated
1,000
new
reports
on
a
EPCRA
section
313
chemical,
the
``
substantial
majority''
test
would
not
be
met
if
those
reports
did
not
account
for
at
least
66%
of
the
total
releases
from
all
facilities
subject
to
EPCRA
section
313.
This
may
be
the
case,
for
example,
if
a
large
percentage
of
releases
of
the
EPCRA
section
313
chemical
occurred
at
facilities
otherwise
subject
to
EPCRA
section
313
that
do
not
meet
the
threshold
for
that
particular
chemical
that
triggers
the
obligation
to
report
the
releases.
EPA
disagrees
with
the
commenter's
interpretation.
As
noted
in
the
proposed
rule,
EPA
interprets
the
language
in
313(
f)(
2),
``
facilities
subject
to
the
requirements
of
[section
313],
''
to
refer
to
those
facilities
that
fall
within
the
category
of
facilities
described
by
sections
313(
a)
and
(b).
Subsection
(a)
lays
out
the
general
requirement
that
``
the
owner
or
operator
of
facilities
subject
to
the
requirements
of
this
section''
file
an
EPCRA
section
313
report.
Subsection
(b)
then
further
defines
the
facilities
subject
to
the
requirements
of
this
section:

[t]
he
requirements
of
this
section
shall
apply
to
owners
and
operators
of
facilities
that
have
10
or
more
full­
time
employees
and
that
are
in
Standard
Industrial
Classification
Codes
20­
39,
.
.
.
and
that
manufactured,
processed,
or
otherwise
used
a
toxic
chemical
listed
under
subsection
(c)
of
this
section
in
excess
of
the
quantity
of
that
toxic
chemical
established
under
subsection
(f)
of
this
section
during
the
calendar
year
for
which
a
toxic
chemical
release
form
is
required
under
this
section.

Thus,
to
be
subject
to
the
requirements,
a
facility
must
meet
all
three
of
the
requirements
laid
out
in
subsection
(b).
This
means
that
the
class
of
facilities
subject
to
reporting
under
section
313
will
vary
according
to
the
individual
chemical.
Moreover,
facilities
that
have
not
exceeded
a
threshold
for
a
particular
chemical
are
not
``
subject
to
the
requirements''
of
EPCRA
section
313
for
that
chemical.
To
determine
whether
a
particular
threshold,
either
higher
or
lower,
for
an
individual
chemical
meets
the
substantial
majority
test,
one
would
compare
the
total
national
aggregate
of
releases
of
the
chemical
by
covered
facilities
at
the
existing
thresholds
with
the
estimated
total
national
aggregate
of
releases
at
the
proposed
alternate
threshold,
and
determine
whether
a
substantial
majority
of
releases
reported
under
the
original
thresholds
would
be
reported.
Logically,
the
universe
of
facilities
subject
to
the
requirements
under
a
lower
threshold
will
always
be
either
equivalent
to,
or
greater,
than
the
universe
of
facilities
that
are
subject
to
the
requirements
under
the
existing
thresholds.
Moreover,
because
facilities
subject
to
the
requirements
of
section
313
must
report
``
the
annual
quantity
of
the
toxic
chemical
entering
each
environmental
medium,
''
EPA
can
meet
the
substantial
majority
standard
when
lowering
the
thresholds,
without
the
need
for
quantitative
support;
i.
e.,
facilities
that
report,
must
report
their
releases
and
other
waste
management
quantities.
In
this
instance,
the
number
of
reports
serves
as
an
adequate
surrogate
for
releases
because
essentially
all
releases
(and
other
waste
management
quantities)
will
be
reported
by
facilities
subject
to
the
requirements
of
this
section.
In
other
words,
facilities
``
subject
to
the
requirements
of
this
section''
are
those
that
must
file
EPCRA
section
313
reports.
Thus,
the
baseline
against
which
the
``
substantial
majority
of
total
releases''
is
measured
is
the
category
of
facilities
that
currently
submit
reports.
Consequently,
if
quantitative
support
for
its
finding
were
necessary,
EPA
would
be
justified
in
relying
on
the
number
of
reports
to
make
its
finding.
By
contrast,
although
it
is
not
clear
exactly
how
the
commenters
interpret
the
phrase
``
facilities
subject
to
the
requirements
of
this
section,
''
it
is
clear
that
they
do
so
without
reference
to
all
of
the
requirements
in
subsections
(a)
and
(b).
And
essentially,
any
interpretation
that
ignores
any
portion
of
subsection
(b),
results
in
an
interpretation
of
EPCRA
section
313(
f)(
2)
as
``
facilities
otherwise
or
potentially
subject
to
the
requirements
of
this
section.
''
This
is
inconsistent
with
the
plain
language
of
section
313(
f)(
2).
The
commenters
can
only
support
their
argument
that
EPA
has
not
met
the
``
substantial
majority''
test
by
assuming
that
all
facilities,
irrespective
of
whether
they
are
in
a
covered
SIC
code
or
they
exceed
the
existing
thresholds,
are
subject
to
EPCRA
section
58675
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/
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64,
No.
209
/
Friday,
October
29,
1999
/
Rules
and
Regulations
313,
and
that
EPA
must
ensure
that
it
captures
a
substantial
majority
of
releases
from
the
universe
of
those
facilities.
If
this
were
correct,
the
addition
of
certain
SIC
codes
could
be
a
prerequisite
to
lowering
thresholds
for
certain
chemicals.
Such
a
requirement
is
not
currently
included
in
section
313.
The
commenters
have
provided
no
support
in
either
the
statute
or
legislative
history
for
these
interpretations.
Nor
have
the
commenters
provided
any
support
for
the
interpretation
that
``
substantial
majority''
equates
to
a
particular
percentage,
such
as
66%.
Finally,
EPA
notes,
as
it
noted
in
the
proposed
rule,
that,
for
several
reasons,
it
does
not
believe
that
it
has
the
necessary
information
to
develop
even
reasonably
accurate
estimates
of
the
potential
releases
that
would
be
reported
at
an
average
facility
at
each
of
the
identified
options
for
a
lowered
threshold.
Specifically,
EPA
believes
that:
(1)
Sufficient
information
is
not
currently
available
for
these
chemicals,
and
(2)
there
is
insufficient
information
on
the
numerous
processes
employed
by
all
the
sectors
involved
to
calculate
a
comprehensive
release
estimate
for
each
sector.
While
there
are
some
data
available,
comprehensive
data
are
not
available
for
all
sectors
and
chemicals.
EPA
further
notes
that
none
of
the
commenters
provided
either
any
information
or
methodology
to
address
this
issue,
notwithstanding
EPA's
specific
request.
Two
commenters
rely
on
excerpts
from
the
debate
on
the
Conference
Report
with
respect
to
section
313(
f)(
2)
to
argue
that
EPA
is
only
authorized
to
revise
the
thresholds
if
EPA
presents
a
convincing
analysis
that
revisions
to
the
threshold
will
capture
a
substantial
majority
of
the
releases
while
also
ensuring
that
it
is
not
placing
undue
burdens
on
facilities
which
contribute
little
to
such
releases.
The
commenters
argue
that
EPA
has
not
satisfied
the
substantial
majority
requirement,
and
to
do
so,
must
conduct
a
more
thorough
assessment
of
the
burden
imposed
on
industry
focused
on
the
volume
of
releases
that
will
be
captured,
not
the
number
of
reports.
Another
commenter
compares
the
legislative
history
of
sections
311
and
312
with
313,
and
concludes
that
Congress
clearly
intended
EPA
to
factor
burden
into
section
313
threshold
questions.
EPA
disagrees.
Ultimately,
EPA
must
comply
with
the
statutory
language,
and
section
313(
f)(
2)
does
not
impose
any
requirement
on
the
Agency
to
rely
on
the
type
of
analyses
described
by
the
commenter.
In
addition,
the
commenters'
reliance
on
the
statements
made
during
the
Conference
Report
debate
are
misplaced.
The
commenter
only
quotes
part
of
Representative
Edgar's
statement;
the
full
quotation
indicates
only
that
EPA
must
present
a
convincing
case,
``
based
on
verifiable,
historical
data''
that
the
statutory
thresholds
warrant
revision.
As
discussed
below
in
Unit
VI.
E.,
EPA
believes
it
has
presented
a
convincing
case
that
the
thresholds
should
be
lowered
for
PBT
chemicals.
The
commenter
also
failed
to
include
the
portion
of
Representative
Edgar's
statement
explaining
that
a
convincing
case
was
particularly
necessary
if
the
effect
of
the
modification
was
to
raise
the
thresholds.
See,
Legislative
History
at
5315.
Nonetheless,
as
discussed
in
greater
detail
in
Unit
VI.
E.,
EPA
considered
the
burden
that
lower
thresholds
would
impose
on
industry
in
selecting
the
PBT
thresholds.
EPA
believes
that
the
levels
it
has
adopted
will
capture
significantly
more
information
about
PBT
chemicals
than
current
thresholds,
but
will
not
be
unduly
burdensome
on
industry.
In
addition,
as
discussed
in
the
Response
to
Comments
document
(Ref.
69),
EPA
believes
that
the
number
of
reports
filed
is
a
more
accurate
measure
of
burden
than
the
volume
of
releases.
A
commenter
alleges
that
EPA's
interpretation
of
section
313(
f)(
2)
contradicts
its
prior
statements
regarding
threshold
changes.
The
commenterstates
that
EPA
was
clear
in
the
original
EPCRA
section
313
rulemaking
that
the
statute
requires
a
substantial
majority
finding
supported
by
actual
data.
For
example,
in
the
June
1987
proposed
rule,
EPA
stated:
``
The
Agency
is
interested
in
data
that
would
support
the
necessary
finding
that
a
modified
threshold
would
still
generate
reporting
on
a
substantial
majority
of
total
releases,
as
the
statute
requires.
''
And
in
the
February
16,
1988
final
rule
promulgating
EPCRA
section
313
requirements,
EPA
stated
.
.
.the
first
few
years'
data
should
be
evaluated
to
determine
whether
modifications
of
the
threshold
would
meet
the
statutory
test
of
obtaining
reporting
on
a
substantial
majority
of
the
releases
(i.
e.,
pounds
released
per
year)
of
each
chemical
from
subject
facilities.
EPA
may
consider
changing
the
reporting
thresholds
based
on
several
years
of
data
collection.

The
commenter
also
notes
that
in
neither
the
proposed
nor
final
rule
establishing
EPCRA
section
313
requirements
did
EPA
specifically
assert
that
it
had
the
authority
to
lower
thresholds.
EPA
disagrees
that
its
statements
in
this
rulemaking
contradict
its
prior
statements
in
the
1988
rulemaking.
As
a
preliminary
matter,
EPA
has
never
denied
that
the
requirement
that
a
revised
threshold
obtain
reporting
on
a
substantial
majority
of
total
releases
applies
to
any
action
lowering
the
reporting
thresholds.
Specifically,
EPA's
discussion
in
the
1987
proposed
rule
was
in
the
context
of
a
response
to
proposals
from
the
Small
Business
Administration
(SBA)
that
the
Agency
raise
the
thresholds
to
capture
only
larger
facilities.
EPA's
statements
in
the
1988
final
rule
also
need
to
be
evaluated
with
SBA's
proposals
in
mind.
Moreover,
while
it
is
true
that
the
discussion
to
which
the
commenter
cited
did
not
distinguish
between
lowering
and
raising
the
thresholds
(it
was
intended
as
a
response
to
comments
on
both
sides
of
the
issue),
EPA
notes
that
the
majority
of
the
comment
summary
focuses
on
requests
to
raise
the
thresholds.
Finally,
while
it
is
true
that
EPA
did
not
specifically
assert
its
authority
to
lower
the
thresholds
in
either
rule,
neither
did
EPA
deny
that
EPCRA
section
313(
f)(
2)
grants
it
this
authority.
However,
it
is
worth
noting
that
in
the
final
rule,
EPA
responded
to
comments
from
environmental
and
public
interest
groups
requesting
that
the
Agency
lower
the
thresholds,
and
that
EPA
never
stated
or
implied
that
it
lacked
the
authority
to
lower
thresholds.
One
commenter
states
that
EPA's
authority
to
lower
reporting
thresholds
is
not
limitless.
The
commenter
argues
that
a
decision
to
lower
the
thresholds
must
be
tied
to
the
overall
purpose
of
the
Act,
namely,
to
inform
the
public
of
potential
health
risks
posed
by
the
presence
of
toxic
chemicals
released
to
the
environment
in
their
communities.
A
regulatory
decision
to
capture
more
reports
under
EPCRA
section
313
must
be
based
on
the
need
to
inform
the
public
of
health
risks
associated
with
the
releases
captured
in
those
reports.
Otherwise,
the
usefulness
of
the
TRI
data
base
begins
to
diminish.
EPA
needs
to
demonstrate
that
the
releases
of
the
PBTs
at
such
small
amounts
pose
a
meaningful
risk
to
the
public
health.
Another
commenter
asserts
that
EPA
is
relying
on
the
purposes
of
EPCRA
to
support
its
interpretation
of
section
313(
f),
and
argues
that,
although
section
313(
h)
does
describe
intended
uses
for
TRI
data,
section
313(
h)
itself
does
not
describe
the
purposes
or
intention
of
section
313.
The
commenter
instead
relies
on
several
provisions
of
section
313
and
argues
that
the
purpose
and
intention
of
Congress
to
make
information
available
to
the
public
was
balanced
by
concerns
about
the
potential
burden
of
the
TRI
program.
The
commenter
also
states
that
the
uses
58676
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/
Vol.
64,
No.
209
/
Friday,
October
29,
1999
/
Rules
and
Regulations
Congress
anticipated
for
TRI
data
do
not
outweigh
the
balance
that
Congress
intended
between
generating
information
and
minimizing
burden,
and
do
not
grant
EPA
blanket
authority
to
expand
the
reporting
requirements.
EPA
agrees
with
the
commenter
that
its
authority
to
lower
reporting
thresholds
is
not
limitless,
and
that
its
decision
to
lower
the
thresholds
must
be
tied
to
EPCRA's
overall
purposes.
However,
EPA
believes
that
Congress
granted
the
Agency
broad,
but
not
unfettered,
discretion
to
determine
when
it
is
appropriate
to
lower
thresholds,
and
to
determine
the
specific
thresholds
that
are
appropriate.
As
discussed
in
greater
detail
in
Unit
VI.
E.,
EPA
believes
that
its
decision
to
lower
the
thresholds,
and
the
thresholds
it
has
chosen,
reflect
these
principles.
However,
EPA
generally
disagrees
with
the
remainder
of
the
commenter's
conclusions.
As
discussed
in
more
detail
in
Unit
VI.
F.,
EPA
is
not
required
to
base
its
decisions
under
EPCRA
section
313
on
the
need
to
inform
the
public
of
health
risks
associated
with
reported
releases
and
other
waste
management
quantities.
And
as
discussed
elsewhere
in
this
preamble
and
the
Response
to
Comments
document
(Ref.
69),
EPA
believes
that
the
information
that
will
be
reported
as
a
result
of
this
rulemaking
will
provide
useful
information
to
the
public.
In
large
measure,
the
issues
raised
in
the
second
comment
closely
relate
to
the
specific
thresholds
and
EPA's
rationale
for
choosing
them,
and
this
issue
is
discussed
in
more
detail
in
Unit
VI.
E.
However,
to
the
extent
it
relates
to
EPA's
interpretation
of
section
313(
f)(
2),
some
response
is
also
provided
here.
As
a
preliminary
matter,
while
it
is
true
that
EPCRA
section
313
does
not
explicitly
identify
the
purposes
of
the
section,
the
Conference
Report
makes
clear
that
subsection
(h)
of
section
313:

Describes
the
intended
uses
of
the
toxic
chemical
release
forms
required
to
be
submitted
by
this
section
and
expresses
the
purposes
of
this
section.
The
information
collected
under
this
section
is
intended
to
inform
the
general
public
and
the
communities
surrounding
covered
facilities
about
releases
of
toxic
chemicals,
to
assist
in
research,
to
aid
in
development
of
regulations,
guidelines,
and
standards,
and
for
other
similar
purposes.
(Conference
Report
at
299).

Contrary
to
the
commenter's
assertion,
the
Agency
never
indicated
that
it
was
relying
on
section
313(
h)
to
expand
its
authority
under
section
313(
f)(
2).
Rather,
EPA
noted
that
it
was
relying
on
the
purposes
of
section
313
as
an
additional
source
of
Congressional
direction
to
guide
the
Agency's
exercise
of
discretion
under
this
provision.
EPA
relied
on
section
313(
h),
in
part,
because
the
Agency
believes
that
its
implementation
of
EPCRA
generally
should
be
guided
by
EPCRA
section
313's
purposes.
In
addition,
section
313(
h)
shares
certain
elements
with
the
Congressional
guidance
on
section
313(
f)(
2)
in
the
legislative
history.
As
discussed
in
greater
detail
in
Unit
VI.
E.,
EPA
has
distilled
those
common
elements,
and
relied
on
them
to
guide
its
discretion
in
establishing
the
specific
thresholds
under
section
313(
f)(
2).
EPA
also
disagrees
with
the
commenter's
assertion
that
the
purpose
of
EPCRA
is
to
achieve
a
balance
between
the
public's
right
to
information
about
their
potential
exposures
to
toxic
chemicals
and
the
reporting
burden
imposed
on
industry.
EPCRA
section
313(
f)(
2)
does
not
require
EPA
to
consider
burden
in
establishing
revised
thresholds.
Although
EPA
has
included
the
reporting
burdens
imposed
on
industry
as
one
consideration
in
determining
the
appropriate
thresholds,
the
Agency
is
also
mindful
that
the
authors
of
EPCRA,
while
sensitive
to
the
burdens
EPCRA
section
313
reporting
placed
on
industry,
never
intended
this
consideration
to
outweigh
the
public's
need
for
access
to
information
concerning
release
and
waste
management,
and
thus
their
potential
exposure
to
toxic
chemicals.
See,
e.
g.,
Legislative
History
at
5315±
16
and
5338±
39.
And
with
respect
to
the
assertion
that
the
general
purposes
of
section
313
are
to
balance
the
public's
right­
to­
know
about
toxic
chemical
releases
and
other
waste
management
in
their
communities
against
the
reporting
burdens
EPCRA
section
313
imposes,
EPA
notes
that
reporting
burden
is
not
included
anywhere
in
section
313(
h).
Nor
does
the
strong
policy
directive
underlying
EPA's
overall
implementation
of
EPCRA
section
313
support
such
an
interpretation.
Representative
Edgar,
one
of
the
bill's
primary
architects
noted:

The
heart
of
the
Federal
Right­
to­
Know
Program
is
its
reporting
requirements,
which
are
intended
to
provide
a
comprehensive
picture
of
the
community's
and
the
Nation's
exposure
to
toxic
chemicals.
As
the
Environmental
Protection
Agency,
the
States,
and
localities
implement
this
program,
they
should
be
guided
by
several
general
principles.
First,
Congress
recognizes
a
compelling
need
for
more
information
about
the
Nation's
exposure
to
toxic
chemicals.
Until
now,
the
success
of
such
regulatory
programs
such
as
the
Clean
Air
Act,
the
Resource
Conservation
and
Recovery
Act,
and
the
Clean
Water
Act
has
been
impossible
to
measure
because
no
broad­
based
national
information
has
been
compiled
to
indicate
increases
or
decreases
in
the
amounts
of
toxic
pollutants
entering
our
environment.
As
a
result,
the
reporting
provision
in
this
legislation
should
be
construed
expansively
to
require
the
collection
of
the
most
information
permitted
under
the
statutory
language.
Any
discretion
to
limit
the
amount
of
information
reported
should
be
exercised
only
for
compelling
reasons.
.
.
.
Legislative
History
at
5313.

Significantly,
Representative
Edgar
did
not
include
reporting
burden
as
one
of
the
general
principles
that
should
guide
the
Agency's
implementation
of
EPCRA
section
313.
Rather,
he
stated:

This
is
a
new
Federal
initiative,
and
I
recognize
the
desire
of
some
of
my
colleagues
to
move
ahead
cautiously
to
ensure
that
burdens
imposed
on
industry
are
not
excessive.
Frankly,
my
concerns
rest
with
the
families
that
live
in
the
shadows
of
these
chemical
and
manufacturing
plants.
I
have
put
myself
in
their
shoes
and
have
fought
for
a
program
that
looks
after
their
needs.
This
legislation
gets
us
well
on
the
path
to
the
full
disclosure
they
deserve.
Id
at
5316.

Nonetheless,
EPA
has
considered
the
legislative
history
on
section
313(
f)(
2),
including
the
excerpts
cited
by
the
commenter,
and
determined
it
would
be
reasonable
to
include
some
consideration
of
the
reporting
burdens
in
selecting
its
revised
thresholds.
The
degree
to
which
EPA
included
burden
in
its
selection
of
the
thresholds
established
in
this
rulemaking
is
discussed
at
length
in
Unit
VI.
E.
and
the
Response
to
Comments
document
(Ref.
69).
EPA
agrees
that
section
313(
h)
does
not
grant
EPA
unfettered
discretion
to
expand
EPCRA's
reporting
requirements;
as
noted
in
a
previous
response,
Congress
established
the
basic
parameters
of
the
EPCRA
section
313
reporting
requirements,
and
selectively
granted
EPA
carefully
qualified
authority
to
modify
certain
of
them.
In
this
action,
for
example,
EPA
is
only
affecting
the
activity
thresholds,
but
Congress
established
other
limitations
that
govern
whether
a
facility
is
subject
to
reporting.
For
example,
facilities
with
fewer
than
10
employees
are
not
subject
to
reporting
under
subsection
313(
b)(
1).

B.
What
Comments
Did
EPA
Receive
on
Persistence
Criteria,
Bioaccumulation
Criteria,
and
Toxicity
Criteria,
and
What
Are
EPA's
Responses?
1.
Comments
on
EPA's
general
approach.
Several
commenters
contend
that
only
chemicals
which
are
globally
recognized
as
persistent
bioaccumulative
toxic
chemicals
should
form
the
foundation
of
the
EPCRA
section
313
PBT
chemical
list
and
criteria.
The
application
of
the
criteria
in
this
manner
is
consistent
with
several
existing
international
agreements
and
58677
Federal
Register
/
Vol.
64,
No.
209
/
Friday,
October
29,
1999
/
Rules
and
Regulations
programs,
such
as
the
Great
Lakes
Binational
Strategy,
the
North
American
Commission
on
Environmental
Cooperation
(NACEC),
the
United
Nations
Economic
Commission
for
Europe's
(UNECE)
agreement
to
address
persistent
organic
pollutants
(POPs),
and
the
United
Nations
Environmental
Programme
(UNEP).
These
programs
have
prompted
widely
accepted
numerical
values
for
persistence
and
bioaccumulation
and
defined
parameters
for
assessing
toxicity.
These
criteria
have
also
been
adopted
with
U.
S.
support
and
leadership
and
the
commenters
contend
that
it
is
not
clear
why
EPA
is
now
taking
a
vastly
different
approach
to
identifying
PBT
criteria
in
the
proposed
rule.
The
commenters
suggest
that
EPA
conform
the
criteria
for
PBT
chemicals
on
EPCRA
section
313
with
the
criteria
and
chemicals
that
are
part
of
the
programs
being
implemented
by
the
NACEC,
UNECE,
and
UNEP.
By
doing
so,
EPA
would
harmonize
the
U.
S.
program
with
similar
international
programs
that
focus
on
a
narrow
set
of
PBT
chemicals.
EPA
believes
that
it
would
be
inappropriate
to
merely
adopt
the
criteria
and
list
of
chemicals
managed
under
the
international
programs
cited
because
the
purposes
of
the
TRI
program
are
different
than
the
purposes
of
the
cited
international
programs.
The
TRI
was
established
by
Congress
under
EPCRA
section
313
in
response
to
public
demand
for
information
on
toxic
chemicals
being
released
in
their
communities.
The
TRI
program
is
national
in
scope,
but
a
significant
part
of
its
overriding
goal
is
to
provide
information
on
releases
to
local
communities
so
that
they
can
determine
if
the
releases
result
in
potential
risks.
The
entire
concept
of
TRI,
and
indeed
other,
similar
Pollutant
Release
and
Transfer
Registries
(PRTRs)
since
established
in
several
nations,
is
founded
on
the
belief
that
the
public
has
the
right
to
know
about
chemical
use,
release,
and
other
waste
management
in
the
areas
in
which
they
live,
as
well
as
the
hazards
associated
with
these
chemicals.
This
emphasis
is
fundamentally
different
from
the
global
focus
of
the
UNEP
negotiation
and
its
concept
of
residual
risk.
It
is
EPA's
position
that
the
domestic,
communitybased
purposes
of
EPCRA
section
313
have
important
implications
with
regard
to
the
criteria
used
to
identify
toxic
chemicals
as
persistent
and/
or
bioaccumulative,
as
well
as
the
methods
and
models
used
to
evaluate
persistence
and/
or
bioaccumulation.
EPCRA
section
313
charges
EPA
with
collecting
and
disseminating
information
on
releases,
among
other
waste
management
data,
so
that
communities
can
estimate
local
exposure
and
local
risks.
One
intent
of
EPCRA
section
313
is
to
provide
information
to
the
public
so
that
they
can
take
an
active
role
in
determining
what
risks
resulting
from
toxic
chemical
releases
in
their
community
are
acceptable.
This
basic
local
empowerment
is
a
cornerstone
of
the
right­
to­
know
program.
EPCRA
section
313(
h)
states
that:

The
release
forms
required
under
this
section
are
intended
to
provide
information
to
the
Federal,
State,
and
local
governments
and
the
public,
including
citizens
of
communities
surrounding
covered
facilities.
The
release
form
shall
be
available,
consistent
with
section
11044(
a)
of
this
title,
to
inform
persons
about
releases
of
toxic
chemicals
to
the
environment;
to
assist
governmental
agencies,
researchers,
and
other
persons
in
the
conduct
of
research
and
data
gathering;
to
aid
in
the
development
of
appropriate
regulations,
guidelines,
and
standards;
and
for
other
similar
purposes.

EPCRA
section
313
establishes
an
information
collection
and
dissemination
program.
EPA
interprets
EPCRA
section
313(
g)(
2)
to
require
facilities
to
use
readily
available
information
to
prepare
each
chemicalspecific
EPCRA
section
313
report.
The
statute
does
not
require
that
the
facility
conduct
additional
monitoring
or
emissions
measurements
to
determine
these
quantities.
A
facility
must
only
use
readily
available
data
or
reasonable
estimation
methods
in
preparing
the
quantitative
information
it
reports.
The
purpose
of
EPCRA
section
313
is
not
to
ban
the
manufacture
or
use
of
a
chemical,
to
restrict
releases
of
the
chemical,
or
to
dictate
how
it
should
be
used
or
released.
As
a
result,
the
burden
and
control
EPCRA
section
313
imposes
is
significantly
less
than
that
imposed
by
a
statute
that
controls
the
manufacture,
use,
and/
or
release
of
a
chemical.
The
focus
of
EPCRA
section
313
is
not
equivalent
to
the
focus
of
a
statute
or
international
agreements
in
which
chemicals
are
to
be
banned,
phased­
out,
or
restricted.
In
contrast,
the
international
agreements
cited
by
the
commenters
are
intended
to
ban,
restrict,
or
phase­
out
the
manufacture,
use
and/
or
release
of
a
limited
set
of
persistent
organic
pollutants
and
certain
heavy
metals
that
are
highly
persistent
and
highly
bioaccumulative.
Descriptions
of
the
purposes
of
the
Protocol
on
Persistent
Organic
Pollutants
(POPs);
Convention
on
Long­
Range
Transboundary
Air
Pollution
(LRTAP),
UNECE,
UNEP
on
POPs,
North
American
Commission
for
Environmental
Cooperation's
Sound
Management
of
Chemicals
(NACEC
SMOC),
as
well
as
the
International
Council
of
Chemical
Associations'
(ICCA)
position
on
POPs
are
presented
below.
The
following
quotes
clearly
illustrate
that
the
intent
of
the
international
agreements
is
to
narrowly
focus
on
that
subset
of
toxic
chemicals
which
are
of
regional
(e.
g.,
North
America
and
Europe)
or
global
concern.

UNECE
LRTAP
The
ultimate
objective
is
to
eliminate
any
discharges,
emissions
and
losses
of
POPs.
The
Protocol
bans
the
production
and
use
of
some
products
outright
(aldrin,
chlordane,
chlordecone,
dieldrin,
endrin,
hexabromobiphenyl,
mirex
and
toxaphene).
Others
are
scheduled
for
elimination
at
a
later
stage
(DDT,
heptachlor,
hexachlorobenzene,
PCBs).
Finally,
the
Protocol
severely
restricts
the
use
of
DDT,
HCH
(including
lindane)
and
PCBs.
The
Protocol
includes
provisions
for
dealing
with
the
wastes
of
products
that
will
be
banned.
(The
1998
Aarhus
Protocol
on
Persistent
Organic
Pollutants
(POPs);
Convention
on
Long­
Range
Transboundary
Air
Pollution,
United
Nations
Economic
Commission
for
Europe
(UNECE)
at
http://
www.
unece.
org/
env/
lrtap)
(Ref.
54)

UNEP
International
action
to
protect
health
and
the
environment
through
measures
which
will
reduce
and/
or
eliminate
emissions
and
discharges
of
persistent
organic
pollutants,
including
the
development
of
an
international
legally
binding
instrument.
(Governing
Council
Decisions
20/
24,
1999;
United
Nations
Environmental
Programme
at
http://
irptc.
unep.
ch/
pops/
newlayout/
negotiations.
htm)
(Ref.
57)

NACEC
SMOC
NACEC
SMOC
has
developed
action
plans
for
PCBs,
DDT,
chlordane,
and
mercury.
The
action
plans
include
1)
for
PCBs
``
work
toward
the
virtual
elimination
of
PCBs
in
the
environment,
which
the
task
force
is
interpreting
as
no
measurable
release
to
the
environment'',
2)
for
DDT
``
gradual
reduction
of
DDT
use
for
malaria
control''
and
``
additional
reductions,
''
3)
for
chlordane
``
phase­
out
of
chlordane
use'',
and
4)
for
mercury
``
reduce
sources
of
anthropogenic
mercury
pollution.
''
The
longer­
term
goal
of
the
plan
is
to
reduce
the
presence
of
mercury
in
the
environment
to
achieve
naturally
occurring
levels.
''
(North
American
Cooperation
for
the
Sound
Management
of
Chemicals
(June
1998);
North
American
Commission
for
Environmental
Cooperation
at
http://
www.
cec.
org/
english/
profile/
coop/
PolluteÐ
f.
cfm?
format=
1)
(Ref.
40)

ICCA
ICCA
Position:
ICCA
member
associations
have
demonstrated
their
commitment
to
sound
chemicals
management,
and
to
the
goal
of
reducing
the
potential
human
health
and
environmental
risks
that
may
be
associated
with
POPs.
Many
POPs
are
already
subject
to
considerable
voluntary
risk
management
by
chemical
companies,
and
the
uses
of
most
substances
identified
as
POPs
has
been
discontinued
or
extremely
limited
58678
Federal
Register
/
Vol.
64,
No.
209
/
Friday,
October
29,
1999
/
Rules
and
Regulations
by
chemical
companies
within
the
countries
represented
by
ICCA
member
associations.
(International
Council
of
Chemical
Associations
(ICCA)
Briefing
Note
on
Persistent
Organic
Pollutants
(POPs)
(April
21,
1998)
at
http://
www.
icca­
chem.
org/
issues.
htm)
(Ref.
26)

In
addition,
as
directed
under
EPCRA
section
313(
h),
EPA
makes
the
TRI
data
available
to
various
groups,
including
international
organizations,
that,
in
turn,
use
the
information
to
decide
whether
to
ban,
restrict,
or
phase­
out
chemicals.
For
the
same
reasons,
EPA
also
disagrees
that
only
substances
globally
recognized
as
POPs
should
provide
the
basis
of
persistence
criteria
for
this
rulemaking.
POPs
are
organic
chemicals
whose
characteristics
of
persistence
in
the
environment,
accumulation
in
biological
organisms
and
toxicity
make
them
priority
pollutants
that
cause
significant
environmental
risks
to
humans
and
ecosystems.
The
substances
or
substance
categories
being
considered
for
implementation
of
global
controls
through
the
UNEP
negotiations
(UNEP/
GC.
18/
32,
1995:
aldrin,
chlordane,
DDT,
dieldrin,
endrin,
heptachlor,
mirex,
toxaphene,
hexachlorobenzene,
PCBs,
polychlorinated
dibenzo­
p­
dioxins
and
furans)
(Refs.
44
and
45)
were
selected
largely
because
they
or
their
degradation
products
pose
risks
that
may
occur
far
from
their
sites
of
initial
entry
into
the
environment.
The
UNEP
action
is
the
global
counterpart
to
similar,
regional
negotiations,
most
notably
the
UNECE
Convention
on
Long­
Range
Transboundary
Air
Pollution
(LRTAP)
(Ref.
54);
the
North
American
Free
Trade
Agreement
(NAFTA)
CEC
Initiative
on
the
Sound
Management
of
Chemicals
(Ref.
39);
and
the
bilateral
US/
Canada
agreement
to
control
discharge
or
release
of
POPs
in
the
Great
Lakes
basin
(Ref.
23).
A
central
theme
of
the
UNEP
action,
consistent
with
its
global
scope,
is
the
notion
of
residual
risk,
meaning
specifically
that
to
be
subject
to
the
negotiations,
it
is
not
sufficient
for
a
substance
to
pose
risks
within
a
nation
or
regionally,
rather
it
must
pose
risks
to
populations
and
nations
distant
from
release
sites.
2.
Comments
on
EPA's
individual
criteria.
The
same
commenters
state
that
EPA
should
use
the
international
criteria
being
applied
by
UNEP,
UNECE
LRTAP,
NACEC
SMOC,
for
persistence,
bioaccumulation,
and
toxicity.
Some
of
these
commenters
also
include
the
criteria
developed
by
CMA
(CMA,
PTB
Policy
Implementation
Guidance:
Product
Risk
Management
Guidance
for
PTBs
(February
1996)).
One
commenter
includes
the
criteria
developed
by
the
ICCA
for
POPs.
Another
commenter
states
that
there
is
no
reason
to
adopt
criteria
that
are
significantly
more
stringent
than
those
used
in
other
programs.
One
commenter
states
that
EPA
should
consider
the
degree
of
toxicity
and
focus
on
the
most
toxic
chemicals.
Some
commenters
state
that
EPA
should
couple
the
persistence
and
bioaccumulation
criteria
to
each
other.
They
believe
that
these
criteria
should
not
be
considered
independently.
The
numerical
criteria
presented
by
some
of
the
commenters
are
provided
below:

Table
2.Ð
Numerical
Persistence
and
Bioaccumulation
Criteria
Suggested
by
Commenters
CMA
PTB
Policy
NACEC
SMOC
UNECE
(LRTAP)
POPs
UNEP
POPs/
CEG
FRAMEWORK
Environment
Canada
Toxic
Substances
Management
Policy
(June
1995)
ICCA
Persistence
Half­
life
=
6
months
in
water
or
1
year
in
soil
Half­
life
>
=
2
days
air;
6
months
water/
soil;
or
1
year
sediment
Half­
life>
2
months
water
or
6
months
soils/
sediment;
or
otherwise
sufficiently
persistent
to
be
of
concern
Half­
life
>
[2
or
6]
months
soil/
sediment;
or
other
evidence
that
substance
is
sufficiently
persistent
to
be
of
concern
Half­
life
>
=
2
days
air;
6
months
water/
soil;
1
year
sediment
Half­
life
=
6
months
water,
1
year
soil
sediments
or
5
days
air
Bioaccumulation
BAF/
BCF
>
=
5,000
or
estimation
techniques
BAF/
BCF
>=
5,000
or
Log
Kow
>
=
5
BAF/
BCF
>
5,000
or
Log
Kow
>
5
or
factors
such
as
high
toxicity
BCF/
BAF
>
5,000
or
Log
Kow>
[4
or
5];
evidence
that
substance
with
significantly
lower
BCF/
BAF
is
of
concern,
e.
g.,
due
to
high
toxicity/
ecotoxicity;
or
monitoring
data
in
biota
indicating
sufficient
bioaccumulation
to
be
of
concern
Half­
life
>
2
months
water
or
6
months
soils/
sediment
(or
otherwise
sufficiently
persistent
to
be
of
concern)
BCF
>
5,000
or
log
Log
Kow
>
5
and
<7.5,
MW<
700
and
substance
is
not
metabolized
58679
Federal
Register
/
Vol.
64,
No.
209
/
Friday,
October
29,
1999
/
Rules
and
Regulations
Table
2.Ð
Numerical
Persistence
and
Bioaccumulation
Criteria
Suggested
by
CommentersÐ
Continued
CMA
PTB
Policy
NACEC
SMOC
UNECE
(LRTAP)
POPs
UNEP
POPs/
CEG
FRAMEWORK
Environment
Canada
Toxic
Substances
Management
Policy
(June
1995)
ICCA
Toxicity
Professional
judgment
in
evaluation
of
aquatic
toxicity,
wildlife
toxicity,
oral/
dermal/
inhalation
toxicity
(mammals
and
birds),
reproductive
toxicity,
neurological
toxicity;
carcinogenicity
mutagenicity
and/
or
teratogenicity
Acute
and
chronic
(including
toxicity
of
breakdown
products,
if
appropriate)
Potential
to
affect
human
health
and/
or
the
environment
adversely
Evidence
that
(chronic)
toxicity
or
ecotoxicity
data
indicate
a
potential
for
damage
to
human
health
or
the
environment
caused
by
the
substance
resulting
or
anticipated
from
long­
range
transport
CEPA
­
toxic
Expert
judgment
that
acute
aquatic
lethality,
subchronic
and
chronic
aquatic
toxicity,
acute
wildlife
toxicity,
oral/
dermal/
inhalation
toxicity
in
mammals
and
birds,
carcinogenicity
mutagenicity,
teratogenicity,
reproductive
toxicity,
neurological
toxicity,
and
immune
system
effects
must
be
demonstrated
or
expected
to
occur
at
the
concentrations
observed
in
the
environment
EPA
is
establishing
criteria
in
this
rulemaking
for
the
TRI
program
for
persistence
and
bioaccumulation.
EPCRA
section
313(
d)(
2)
already
provides
toxicity
criteria
for
the
TRI
program.
While
EPA
chose
in
this
rulemaking
to
focus
on
chemicals
that
are
toxic
and
persistent
and
bioaccumulative,
EPA
did
not
state
that
the
persistence
criterion
could
only
be
applied
in
conjunction
with
the
bioaccumulation
criterion
and
vice
versa.
EPA
has
not
tied
the
criteria
together
because
there
is
no
scientific
rationale
to
define
persistence
criteria
in
terms
of
both
bioaccumulation
and
persistence
and
to
define
bioaccumulation
both
in
terms
of
persistence
and
bioaccumulation.
As
illustrated
by
the
descriptions
of
persistence
and
bioaccumulation
provided
in
the
proposed
rule,
persistence
and
bioaccumulation
are
separate
chemical
and/
or
biological
processes.
They
are
not
by
definition
dependent
upon
the
other.

A
chemical's
persistence
refers
to
the
length
of
time
the
chemical
can
exist
in
the
environment
before
being
destroyed.
(at
64
FR
698)
and
Bioaccumulation
is
a
general
term
that
is
used
to
describe
the
process
by
which
organisms
may
accumulate
chemical
substances
in
their
bodies.
(at
64
FR
703)
A
chemical
is
not
considered
to
be
persistent
if
it
is
only
bioaccumulative.
For
example,
a
chemical
may
be
extremely
persistent
and
yet
not
bioaccumulate
appreciably.
For
example,
metals
cannot
be
destroyed
in
the
environment
and
thus
are
extremely
persistent.
Some
metals
bioaccumulate
appreciably
while
others
do
not.
However,
the
degree
to
which
a
metal
can
bioaccumulate
does
not
affect
the
metal's
persistence
in
the
environment.
The
connection
suggested
by
the
commenters
is
not
scientifically
justified.
Thus,
EPA
does
not
believe
that
persistence
criteria
can
be
applied
only
in
conjunction
with
the
bioaccumulation
criteria.
EPA
reiterates
that
in
this
rulemaking
the
Agency
chose
to
focus
on
those
toxic
chemicals
that
meet
both
the
persistence
and
bioaccumulation
criteria
proposed
for
EPCRA
section
313.
In
the
future,
the
Agency
may
focus
on
toxic
chemicals
that
are
either
persistent
or
bioaccumulative.
A
discussion
of
the
individual
criteria
is
presented
in
the
remainder
of
this
unit.
a.
Persistence.
EPA
proposed
persistence
criteria
for
the
TRI
program
of
half­
lifes
of
2
months
in
water,
soil,
and
sediment
and
2
days
in
air.
As
discussed
in
Unit
VI.
B.
1.,
EPA
disagrees
that
it
must
choose
persistence
criteria
for
EPCRA
section
313,
an
information
collection
and
dissemination
program,
consistent
with
the
international
criteria
being
applied
to
chemicals
that
are
of
global
or
regional
(e.
g.,
Europe
and
the
Great
Lakes)
concern
and
that
are
being
targeted
for
ban,
restriction,
or
phaseout
Chemicals
that
meet
the
persistence
criteria
used
in
the
international
agreements
are
extremely
persistent
chemicals.
Applying
these
criteria
to
EPCRA
section
313
would
result
in
a
very
narrow
list
of
chemicals
that
would
focus
on
only
extremely
persistent
chemicals.
This
is
inconsistent
with
both
the
purposes
of
EPCRA
section
313
and
with
EPA's
technical
judgment.
There
is
no
``
bright
line''
that
separates
what
is
persistent
from
what
is
not
persistent.
The
degree
of
persistence
is
a
continuum.
Chemicals
with
a
half­
life
of
2
to
6
months
are
not
non­
persistent.
They
are
less
than
chemicals
with
a
half­
life
of
greater
than
6
months.
The
degree
of
persistence
that
should
be
used
as
criteria
is
not
an
absolute
scientific
determination.
Rather
it
is
a
combination
of
science
and
policy.
As
discussed
in
the
proposed
rule
and
the
remainder
of
this
section,
organizations
have
generally
used
as
persistence
criteria
half­
lifes
of
2
months
and/
or
6
months
for
water,
soil,
and
sediment.
58680
Federal
Register
/
Vol.
64,
No.
209
/
Friday,
October
29,
1999
/
Rules
and
Regulations
The
determination
of
which
set
of
numerical
criteria
to
apply
will
depend
on
the
final
intent:
for
example,
providing
communities
with
information
on
persistent
chemicals
that
can
build
up
in
their
environment
versus
banning
the
manufacture
and
use
and
eliminating
releases
of
a
chemical
that
has
global
impacts.
For
EPCRA
section
313,
which
provides
information
on
toxic
chemicals
to
communities,
researchers,
and
governments,
the
criteria
should
be
in
keeping
with
both
science
and
the
intent
of
the
statute.
Long­
range
transport
(LRT)
and
residual
risk
are
relevant
domestically,
since
chemical
substances
may
be
transported
regionally
and
transcontinentally,
resulting
in
exposures
at
sites
distant
from
releases
but
still
within
U.
S.
borders.
Nevertheless,
as
a
general
rule,
the
closer
the
sources
and
receptor
are,
the
more
likely
it
is
that
released
material
will
reach
that
receptor.
The
12
UNEP
POPs
or
their
degradation
products
all
meet
or
exceed
the
half­
life
criterion
of
6
months
for
soil,
water,
or
sediment,
often
by
large
margins
(Refs.
44
and
45),
and
the
6
months
criterion
thus
acts
to
isolate
these
substances
for
international
attention
aimed
at
limiting
LRT.
But
a
shorter
half­
life
criterion
is
necessary
to
protect
communities
from
bioaccumulative
toxicants
derived
from
sources
closer
to
home,
since,
all
other
things
being
equal,
a
pollutant
reaches
nearby
populations
in
less
time
than
distant
ones.
An
article
by
Wania
and
Mackay
(Ref.
81)
is
often
cited
in
discussions
of
``
global
distillation''
of
relatively
mobile
POPs
such
as
hexachlorobenzene
and
lindane,
which
tend
to
have
inverted
concentration
profiles
such
that
concentrations
increase
with
distance
from
the
source
(i.
e.,
from
temperate
to
polar
regions)
rather
than
the
reverse.
What
may
be
less
obvious
is
that
the
converse
is
also
true;
namely,
that
less
volatile
substances
show
no
significant
latitudinal
dependence;
that
lowmobility
POPs
such
as
mirex
and
the
more
highly
chlorinated
PCBs
tend
to
undergo
rapid
deposition
and
retention
close
to
their
sources;
and
that
all
but
high
or
relatively
high
mobility
chemicals
are
expected
to
show
``
normal''
concentration
profiles,
such
that
concentrations
decline
with
distance
from
warmer
sources
to
colder
remote
regions
(Ref.
81).
A
recent
study
of
organochlorine
contaminants
in
sea
otters
illustrates
this
point.
Although
the
levels
of
total
DDTs
observed
were
not
considered
toxicologically
significant,
Bacon
et
al.
(Ref.
8)
found
the
highest
levels
in
California
sea
otters
(ca.
850
micrograms
per
kilogram
(mg/
kg))
but
much
lower
levels
in
Aleutian
otters
(40
mg/
kg)
and
southeast
Alaska
otters
(1
mg/
kg),
and
attributed
the
higher
levels
in
the
California
otters
to
extensive
DDT
use
and
production
in
this
region
from
the
1950s
to
the
1970s.
Even
UNEP's
Criteria
Expert
Group
(CEG),
which
is
charged
with
developing
criteria
and
procedures
for
addition
of
substances
beyond
the
original
12
POPs,
has
highlighted
the
importance
of
``
near­
field''
exposures:

In
warmer
climates
exposures
may
occur
closer
to
the
source;
e.
g.,
occupational
exposure
during
use,
or
local
exposure
caused
by
runoff
from
use
or
leaking
from
stockpiles.
Food,
such
as
fish,
may
be
a
major
route
of
intake
also
in
warmer
climates
[in
contrast
to
Arctic
and
sub­
Arctic
regions]
and
POPs
may
accumulate
in
the
food
chain
and
reach
high
levels
in
predatory
species
in
these
conditions.
(UNEP/
POPS/
INC/
CEG/
1/
2:
1998)
(Ref.
56)

An
additional
factor
that
argues
for
adopting
the
more
protective
persistence
criterion
is
the
need
for
communities
with
vulnerable
populations
to
have
access
to
data
on
release
and
other
waste
management
quantities.
Examples
of
such
populations
include
toddlers
who
play
in
contaminated
soil,
local
farmers
who
consume
their
own
produce,
and
subsistence
as
well
as
sport
fishers,
who
often
consume
large
quantities
of
what
they
catch.
The
relative
importance
of
any
of
these
pathways
depends
on
the
properties
of
the
substance,
rates
and
media
of
release
and
other
factors,
but
ingestion
of
bioaccumulating
substances
may
occur
by
all
of
these
routes.
The
Organization
for
Economic
Cooperation
and
Development
(OECD)
guidance
on
the
assessment
of
indirect
human
exposure
to
chemical
toxicants
is
consistent
with
EPA
policy,
and
states
that
in
the
case
of
local,
site­
specific
emissions,
one
or
more
of
these
subgroups
may
be
particularly
endangered
(Ref.
53).
From
a
scientific
perspective
there
is
no
one
best
persistence
criterion.
However,
it
is
simply
not
accurate
to
state
that
there
is
no
precedent
or
basis
for
using
a
persistence
criterion
of
2
months.
As
outlined
in
the
proposed
rule
(64
FR
701),
similar
values
have
been
proposed
by
several
authorities,
including
the
Ontario,
Canada
Ministry
of
Environment
and
Energy
(MOEE)
for
its
Candidate
Substances
List
for
Bans
or
Phaseouts
(Ref.
36);
the
Canadian
initiative
for
Accelerated
Reduction/
Elimination
of
Toxics
(ARET)
(Refs.
1
and
2);
the
International
Joint
Commission's
(IJC)
Great
Lakes
Water
Quality
Agreement
(GLWQA)
(Ref.
27);
and
the
UNECE's
LRTAP
Convention,
which
did
adopt
2
months
as
the
persistence
criterion
of
record
for
water
(Ref.
54).
In
each
of
these
programs
the
focus
was
on
persistent,
bioaccumulative
and
toxic
substances,
and
it
is
noteworthy
that
all
are
national
or
regional,
not
global,
in
scope.
Thus,
a
trend
exists
in
which
authorities
with
domestic
or
regional
mandates
to
take
action
to
reduce
risks
from
indirect
exposure
to
PBT
chemicals
have
recommended
half­
life
criteria
substantially
lower
than
6
months.
EPA's
Office
of
Water
maintains
a
Listing
of
Fish
and
Wildlife
Advisories
(LFWA)
for
the
U.
S.
and
territories,
which
listed
2,299
advisories
in
1997
(Ref.
29).
U.
S.
states
and
territories
and
Native
American
tribes
have
primary
responsibility
for
issuing
advisories
for
the
general
population,
which
include
recommendations
to
limit
or
avoid
consumption
of
certain
fish
and
wildlife
from
specific
water
bodies.
The
overwhelming
majority
of
the
advisories
are
for
well
recognized
PBT
chemicals
(chlordane,
mercury,
PCBs,
etc.),
but
many
less
familiar
substances
are
also
represented.
The
number
and
content
of
advisories
in
LFWA
clearly
indicate
that
toxicologically
significant
levels
of
chemical
contaminants,
specifically
PBT
chemicals,
are
often
found
in
fish
and
wildlife
that
are
caught
noncommercially
and
consumed
by
the
U.
S.
population.
It
is
generally
impossible
to
determine
the
exact
source(
s)
of
exposure
for
the
species
and
locations
included
in
any
given
advisory,
but
it
seems
highly
unlikely
that
the
majority
of
listed
contaminants
in
U.
S.
waters
could
be
derived
from
non­
U.
S.
(i.
e.,
geographically
distant)
sources.
The
LFWA
thus
lends
further
support
to
the
contention
that
concern
for
exposure
to
PBT
chemicals
is
not
limited
to
situations
where
the
exposure
results
primarily
from
LRT.
It
should
be
noted
that
the
fact
that
no
advisories
have
been
issued
for
a
particular
chemical
does
not
mean
that
it
does
not
persist.
Not
all
species
of
aquatic
organisms
are
tested
nor
are
all
water
bodies,
in
addition,
each
state
determines
what
it
will
use
as
the
level
of
concern
for
issuing
an
advisory.
A
series
of
Toxic
Substances
Control
Act
(TSCA)
section
5
Premanufacture
Notifications
(PMNs)
submitted
to
EPA
in
1990
also
illustrates
that
exposure
to
PBT
chemicals
is
not
limited
to
LRT
(Refs.
37
and
38),
and
also
demonstrates:
(i)
Why
EPA
believes
that
the
persistence
criterion
for
bioaccumulating
substances
in
soil,
water,
or
sediment
should
be
set
substantially
lower
than
6
months;
and
(ii)
that
for
purposes
of
EPCRA
section
313,
concern
for
potential
exposures
to
persistent
and
bioaccumulative
toxics
58681
Federal
Register
/
Vol.
64,
No.
209
/
Friday,
October
29,
1999
/
Rules
and
Regulations
must
extend
beyond
the
UNEP's
12
widely
acknowledged
POPs.
The
substances
in
question
were
alkylated
diphenyls
for
use
as
solvents,
and
for
which
EPA
expected
discharge
to
receiving
streams
and
rivers.
The
submitter
supplied
data
on
use
and
disposal,
aquatic
toxicity,
and
biodegradability.
The
submitted
environmental
fate
data
and
EPA
estimates
of
biodegradability
based
on
structural
analogs
suggested
that
halflifes
in
water
would
be
well
below
6
months,
but
not
necessarily
lower
than
2
months.
As
a
result
of
concerns
expressed
by
EPA,
use
was
limited
to
sites
where
resulting
water
concentrations
could
be
limited
to
1
microgram
per
liter
(mg/
L)
or
less;
concomitantly,
the
submitter
was
also
informed
of
EPA's
belief
that
a
potential
for
long­
term
risk
existed,
but
that
EPA
could
not
quantify
this
risk
since
assessments
typically
evaluated
releases
over
only
1
year.
In
1998,
results
of
monitoring
were
announced
by
the
State
EPA
and
revealed
that
the
alkylated
biphenyls
had
been
found
in
fish
fillets
and
sediment
samples
from
the
receiving
stream.
One
commenter
contends
that
the
persistence
criteria
of
half­
lifes
of
2
months
for
water,
soil,
and
sediment
and
2
days
for
air
may
not
be
sufficiently
protective
(i.
e.,
the
criteria
may
be
too
high).
EPA
disagrees
with
the
comment.
EPA
believes
that
it
should
adopt
criteria
that
focus
on
toxic
chemicals
that
will
build
up
in
the
environment,
while
at
the
same
time
not
limiting
the
list
of
persistent
toxic
chemicals
to
only
those
that
are
of
global
concern.
As
discussed
earlier
in
this
section,
EPA
believes
that
2
months
is
a
reasonable
half­
life
criterion
given
the
purposes
of
EPCRA
section
313.
EPA
believes
that
application
of
lower
criteria
would
include
so
many
substances
as
to
be
impractical.
Further,
given
the
uncertainties
that
often
exist
regarding
physical
properties
and
environmental
behavior
of
chemicals,
caution
is
especially
appropriate
for
substances
with
shorter
half­
lifes,
since
they
are
(all
other
things
being
equal)
less
likely
to
build
up
in
the
environment
than
more
persistent
substances.
EPA
believes
that
the
adoption
of
criteria
of
half­
lifes
of
2
months
in
water,
soil,
and
sediment
and
a
half­
life
of
2
days
in
air
allows
EPA
to
balance
the
need
to
provide
communities
and
other
data
users
with
information
on
toxic
chemicals
that
persist
in
their
environment
without
being
overly
inclusive
or
restrictive.
One
commenter
contends
that
a
halflife
criterion
for
air
of
2
days
should
be
considered
sufficient
in
and
of
itself
for
designating
substances
as
persistent.
EPA
agrees
with
the
comment.
EPA
made
the
following
statements
in
the
proposed
rule
regarding
the
2±
day
air
half­
life
criterion
and
its
use
in
the
determination
as
to
whether
a
chemical
was
a
PBT
under
EPCRA
section
313:

For
the
purposes
of
determining
whether
a
toxic
chemical
is
persistent
in
the
environment
under
section
313,
EPA
used
a
half­
life
criterion
of
2
months
for
water/
sediment
and
soil
and
a
half­
life
of
2
days
for
air.
Given
the
above
discussions,
EPA
believes
that,
for
purposes
of
reporting
under
section
313,
these
values
are
appropriate
for
determining
whether
a
toxic
chemical
is
persistent
in
the
environment
and
will
persist
long
enough
in
the
environment
to
bioaccumulate
or
be
transported
to
remote
locations.
Under
these
criteria,
if
a
toxic
chemical
meets
any
one
of
the
media
specific
criteria,
then
it
is
considered
to
be
persistent.
Thus
if
a
toxic
chemical's
half­
life
in
water
or
sediment
or
soil
is
equal
to
or
greater
than
2
months
or
greater
than
2
days
for
air
then
the
toxic
chemical
is
considered
to
be
persistent
for
purposes
of
section
313.
Note
that
when
considering
persistence
in
connection
with
the
potential
for
a
toxic
chemical
to
bioaccumulate,
meeting
the
air
half­
life
criteria
alone
would
not
be
sufficient,
since
a
chemical's
potential
to
bioaccumulate
is
usually
dependent
on
it
being
persistent
in
either
water,
sediment,
or
soil.
In
determining
whether
the
chemicals
in
this
proposal
were
persistent,
EPA
did
not
rely
solely
on
the
persistence
in
air.
(at
64
FR
702)

It
is
clear
from
the
discussion
above
that
EPA
agrees
with
the
commenter
that
when
considering
persistence
alone
an
air
half­
life
of
2
days
would
be
considered
sufficient
to
classify
a
chemical
as
persistent
under
EPCRA
section
313.
However,
for
the
reasons
explained
above,
if
a
chemical
only
meets
the
2±
day
air
half­
life
persistence
criteria,
EPA
does
not
believe
that
would
be
sufficient
for
classifying
a
chemical
as
a
PBT
under
EPCRA
section
313.
Some
commenters
contend
that
EPA's
two­
tiered
approach
to
the
persistence
criteria
is
confusing.
EPA
notes
that
it
proposed
only
one
set
of
persistence
criteria
for
EPCRA
section
313,
half­
lifes
of
2
months
or
greater
in
water,
soil,
and
sediment
and
2
days
in
air.
The
Agency
did
not
propose
to
use
half­
lifes
of
6
months
or
greater
in
water,
soil,
and
sediment
and
2
days
in
air
as
a
second
set
of
persistence
criteria
for
EPCRA
section
313.
However,
for
purposes
of
setting
reporting
thresholds
in
this
rulemaking,
the
Agency
did
choose
to
focus
on
the
subset
of
PBT
chemicals
that
have
halflifes
of
6
months
or
greater
in
water,
soil,
or
sediment
(and
BCF/
BAFs
greater
than
5,000)
by
proposing
a
10
pound
reporting
threshold.
For
the
reasons
given
above,
EPA
reaffirms
its
intention
to
use
a
half­
life
of
2
months
as
the
criterion
for
persistence
in
water,
soil,
and
sediment
and
a
half­
life
of
2
days
as
the
criterion
for
air
when
characterizing
a
chemical
as
persistent
for
purposes
of
EPCRA
section
313.
b.
Bioaccumulation.
EPA
proposed
as
bioaccumulation
criteria
for
the
TRI
program
bioaccumulation/
bioconcentration
factors
of
1,000.
As
discussed
in
Unit
VI.
B.
1.,
EPA
disagrees
that
it
must
choose
for
EPCRA
section
313,
bioaccumulation
criteria
consistent
with
the
international
criteria.
Applying
these
strict
criteria
to
EPCRA
section
313
would
result
in
a
very
narrow
list
of
chemicals
that
would
focus
on
only
extremely
bioaccumulative
chemicals.
This
is
inconsistent
with
the
purposes
of
EPCRA
section
313
and
with
EPA's
technical
judgment.
There
is
no
``
bright
line''
that
separates
what
is
bioaccumulative
from
what
is
not
bioaccumulative.
The
degree
of
bioaccumulation
is
a
continuum.
Chemicals
with
BCFs
or
BAFs
of
1,000
to
5,000
are
not
non­
bioaccumulative.
They
are
less
bioaccumulative
than
chemicals
with
BCFs
or
BAFs
greater
than
5,000.
The
degree
of
bioaccumulation
that
should
be
used
as
a
criterion
is
not
an
absolute
scientific
determination.
Rather
it
is
a
combination
of
science
and
policy.
As
discussed
in
the
proposed
rule
and
below,
organizations
have
generally
used
as
bioaccumulation
criteria
BAFs/
BCFs
of
1,000
and
5,000.
The
determination
of
which
numerical
criterion
to
apply
will
depend
on
the
final
intent:
for
example,
providing
communities
with
information
on
bioaccumulative
chemicals
that
can
accumulate
in
organisms
versus
banning
the
manufacture
and
use
and
eliminating
releases
of
a
chemical
that
has
global
impacts.
For
EPCRA
section
313
which
provides
information
on
toxic
chemicals
to
communities,
researchers,
and
governments,
the
criteria
should
be
in
keeping
with
both
the
Agency's
scientific
judgment
and
the
intent
of
the
statute.
From
a
scientific
perspective
there
is
no
one
bioaccumulation
criterion.
However,
it
is
simply
not
accurate
to
state
that
there
is
no
precedent
or
basis
for
using
a
bioaccumulation
criterion
of
1,000.
As
noted
in
the
proposed
rule,
for
a
number
of
years
EPA
scientists
and
programs
have
used
a
BCF
of
1,000
or
more
to
indicate
a
high
level
of
concern
for
bioaccumulation.
In
addition,
this
value
has
been
used
in
some
Canadian
projects,
many
dealing
with
the
Great
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/
Friday,
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29,
1999
/
Rules
and
Regulations
Lakes
basin.
Also,
Germany
proposed
a
BAF/
BCF
criterion
of
1,000
during
negotiation
of
the
LRTAP
Protocol.
Support
for
a
BAF
criterion
of
1,000
also
comes
from
the
Final
Water
Quality
Guidance
for
the
Great
Lakes
System
(FWQGGLS)
(60
FR
15366,
March
23,
1995)
(FRL±
5173±
7).
In
this
document,
EPA
stated
that
bioaccumulation
of
persistent
pollutants
is
a
serious
environmental
threat
to
the
Great
Lakes
Basin
Ecosystem
and
that
chemicals
identified
as
bioaccumulative
chemicals
of
concern
(BCCs)
(i.
e.,
with
BAF
values
greater
than
1,000)
would
receive
increased
attention
and
more
stringent
controls.
The
final
guidance
designated
as
BCCs
those
chemicals
with
human
health
BAFs
greater
than
1,000
that
were
derived
from
certain
fieldmeasured
BAFs.
One
commenter
believed
that
the
BAF
criteria
used
in
the
FWQGGLS
did
not
provide
support
for
the
use
of
a
BAF
of
1,000
since
a
more
strenuous
methodology
taking
more
factors
into
account
was
used.
However,
EPA
believes
that
this
does
provide
support
for
the
criteria
established
for
the
purposes
of
EPCRA
section
313
because,
although
the
underlying
technical
assessments
may
be
more
stringent,
the
bioaccumulation
level
of
concern
is
still
a
BAF
of
1,000.
Also,
as
noted
by
some
commenters,
EPA
has
proposed
to
use
a
BCF/
BAF
of
1,000
to
trigger
testing
under
TSCA
section
5(
e)
(63
FR
53417).
Specifically,
for
chemicals
subject
to
TSCA
section
5
that
have
a
BAF
of
1,000
or
greater
and
that
meet
certain
toxicity
and
persistence
criteria
(similar
to
the
EPCRA
section
313
persistence
criteria)
testing
would
be
``
triggered''
by
specific
production
limits.
While
the
manufacturer
of
the
chemical
would
be
allowed
to
commercialize
the
substance,
certain
controls
could
be
stipulated,
including
specific
limits
on
exposures,
releases,
or
uses.
EPA
notes
that
in
the
same
Federal
Register
document,
the
Agency
has
proposed
that
chemicals
that
have
a
bioaccumulation
factor
of
5,000
and
that
meet
certain
toxicity
and
persistence
criteria
(e.
g.,
half­
life
of
6
months
or
greater
in
soil)
be
placed
in
a
``
Ban
Pending
Testing,
''
bin.
Chemicals
meeting
these
criteria
could
be
subject
to
more
stringent
control
up
to
a
ban
on
commercial
production.
Not
only
is
there
precedent
for
the
use
a
BCF/
BAF
of
1,000,
but
EPA
believes
that
the
purposes
of
the
statute
argue
for
the
use
of
the
more
expansive
criterion.
Data
on
PBT
chemicals
are
the
type
of
information
that
will
be
of
particular
use
to
specific
communities
such
as
those
that
consist
of
subsistence
fishers.
Subsistence
fishers
(as
well
as
sports
fishers)
are
more
highly
exposed
to
PBT
chemicals
than
the
general
population.
Subsistence
fishers
consume
large
quantities
of
what
they
catch.
In
addition,
children
are
affected
by
lower
doses
of
certain
PBTs
than
are
adults.
Children
of
both
subsistence
fishers
and
sport
fishers
will
consume
larger
quantities
of
lake
food
and
seafood
than
children
in
other
communities.
As
discussed
in
Unit
VI.
B.
2.,
EPA's
Office
of
Water
maintains
a
Listing
of
Fish
and
Wildlife
Advisories
(LFWA)
for
the
U.
S.
and
its
territories,
which
listed
2,299
advisories
in
1997
(Ref.
29).
The
overwhelming
majority
of
the
advisories
are
for
well­
recognized
PBT
chemicals
(chlordane,
mercury,
PCBs,
etc.),
but
many
less
familiar
substances
are
also
represented.
The
number
and
content
of
advisories
in
LFWA
clearly
indicate
that
toxicologically
significant
levels
of
chemical
contaminants,
specifically
PBTs,
are
often
found
in
fish
and
wildlife
that
are
caught
noncommercially
and
consumed
by
the
U.
S.
population.
It
should
be
noted
that
the
fact
that
no
advisories
have
been
issued
for
a
particular
chemical
does
not
mean
that
the
chemical
does
not
bioaccumulate.
Not
all
species
of
aquatic
organisms
are
tested
nor
are
all
water
bodies.
In
addition,
each
state
determines
what
it
will
use
as
the
level
of
concern
for
issuing
an
advisory.
EPA
believes
that
it
would
be
inconsistent
with
the
intent
of
EPCRA
section
313
to
limit
the
information
on
bioaccumulative
toxic
chemicals
to
only
information
for
the
most
bioaccumulative.
One
commenter
contends
that
EPA
did
not
provide
scientific
justification
for
its
choice
of
the
bioaccumulation
criterion
of
a
BCF/
BAF
of
1,000.
The
commenter
states
the
EPA's
discussion
of
the
origin
of
the
1,000
BCF/
BAF
value
at
a
1976
meeting
sponsored
by
the
American
Society
of
Testing
and
Materials,
and
its
reaffirmation
in
1995
in
a
research
article
by
two
of
the
original
authors,
the
use
of
the
value
by
scientists
in
EPA's
Office
of
Research
and
Development's
Duluth
Laboratories,
by
EPA's
Office
of
Pollution
Prevention
and
Toxics
in
the
review
of
chemicals
under
TSCA
sections
4
and
5,
by
EPA's
Office
of
Water
in
the
Final
Water
Quality
Guidance
for
the
Great
Lakes
System,
and
the
use
by
other
authorities,
such
as
the
German
government,
to
identify
chemicals
of
high
concern
for
bioaccumulation
do
not
provide
a
technical
basis
for
choosing
a
value
of
1,000
as
a
criterion
for
bioaccumulation.
The
commenter
contends
that
a
criterion
of
5,000
is
scientifically
supportable
because
chemicals
with
a
BCF/
BAF
of
5,000
have
a
high
potential
to
biomagnify.
As
discussed
above,
there
is
no
scientifically
``
best''
bioaccumulation
criterion.
The
degree
of
bioaccumulation
is
a
continuum.
A
chemical
does
not
bioaccumulate
only
if
it
has
a
BCF
that
is
5,000
or
greater.
A
chemical
that
has
a
BCF
of
1,000
will
bioaccumulate,
specifically
the
chemical
will
be
present
in
an
organism
at
a
concentration
that
is
1,000
times
greater
than
its
concentration
in
the
surrounding
aqueous
environment.
Rather
the
choice
of
a
value
along
the
bioaccumulation
spectrum
is
based
to
a
large
degree
on
how
the
criterion
is
to
be
used,
e.
g.,
to
track
chemicals
entering
a
particular
environment,
or
to
restrict
the
use
of
chemicals,
etc.
As
such
the
choice
of
a
bioaccumulation
criterion
is
a
combination
of
science
and
policy.
The
commenter
did
not
provide
support
for
the
contention
that
5,000
was
scientifically
the
``
best''
bioaccumulation
criterion.
Specifically,
the
commenter
did
not
indicate
why
as
a
scientific
matter
a
BCF
of
5,000
was
preferable
to
a
BCF
of,
for
example
4,000
or
a
BCF
of
15,500.
While
the
commenter
did
note
that
chemicals
that
have
a
BCF
of
5,000
tend
to
have
a
high
potential
to
biomagnify,
the
commenter
did
not
indicate
in
what
way
this
factored
into
his
determination
that
a
BCF
of
5,000
is
the
scientifically
``
best''
bioaccumulation
criterion.
In
addition,
EPA
does
not
agree
that
a
BAF
or
BCF
of
5,000
indicates
that
a
chemical
will
be
more
likely
to
biomagnify
since
biomagnification
is
a
much
more
complex
process.
Biomagnification
is
not
a
separate
process
from
bioaccumulation
or
bioconcentration,
but
is
instead
a
specific
example
or
subset
of
both.
Biomagnification
has
been
defined
as:
The
result
of
the
processes
of
bioconcentration
and
bioaccumulation
by
which
tissue
concentrations
of
bioaccumulated
chemicals
increase
as
the
chemical
passes
up
through
two
or
more
trophic
levels
(Ref.
43).
The
difference
between
bioaccumulation
and
biomagnification
is
that
for
a
chemical
to
biomagnify
its
level
of
bioaccumulation
must
increase
as
it
moves
up
the
food
chain.
The
whole
concept
of
biomagnification
can
be
viewed
as
controversial
(Ref.
9)
and
biomagnification
has
been
studied
for
only
a
few
chemicals.
Most
importantly,
biomagnification
is
not
required
in
order
to
have
a
concern
for
chemicals
that
bioaccumulate.
This
is
because
bioaccumulation
in
even
one
species
can
have
a
serious
impact
on
that
species
or
any
other
species
that
feeds
on
it.
For
example,
if
a
chemical
only
bioaccumulates
in
fish
then
the
fish
will
58683
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/
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209
/
Friday,
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29,
1999
/
Rules
and
Regulations
be
exposed
to
higher
concentrations
of
the
chemical
as
will
anything
that
eats
the
fish.
Therefore,
EPA
believes
that
there
is
no
reason
to
establish
biomagnification
as
a
criterion
for
PBT
chemicals
since
bioaccumulation
is
of
more
than
sufficient
concern
in
and
of
itself.
None
of
the
other
commenters
who
believe
that
the
bioaccumulation
criterion
of
1,000
is
too
expansive
suggested
that
EPA
adopt
another
value,
other
than
the
5,000
value
used
in
international
agreements,
addressed
in
previous
responses
in
this
unit.
At
most,
several
commenters
took
issue
with
the
fact
that
the
EPCRA
section
313
bioaccumulation
criterion
(BCF/
BAF
of
1,000)
is
5
fold
less
than
the
international
bioaccumulation
criterion
of
a
BCF/
BAF
or
5,000.
Given
that
for
each
of
these
programs
the
focus
was
on
PBT
chemicals
that
are
of
global
concern,
EPA
believes
that
as
a
matter
of
public
policy,
it
is
more
appropriate
for
a
reporting
program
to
use
a
more
protective
criterion
than
that
used
in
international
agreements
that
seek
to
ban
or
severely
restrict
the
use
and/
or
release
of
chemicals.
One
commenter
believes
that
EPA
should
not
adopt
a
bioaccumulation
criterion
(BCF/
BAF
of
1,000)
for
EPCRA
section
313
that
is
more
stringent
than
the
criterion
for
a
Great
Lakes
BCCs
(a
human
health
BAF
of
1,000).
EPA
notes
that
BCCs
will
receive
stringent
controls
which
is
not
the
case
for
toxic
chemicals
identified
as
bioaccumulative
(and
persistent)
under
EPCRA
section
313.
Many
commenters
supported
the
proposed
bioaccumulation
criterion
of
a
BCF/
BAF
or
1,000.
However,
one
of
these
commenters
believes
that
1,000
should
be
the
criterion
only
if
the
BCF
or
BAF
is
a
measured
value.
If
the
BCF
is
an
estimated
value,
then
the
criterion
should
be
500.
EPA
believes
that
such
a
two­
tiered
approach
will
add
confusion.
Further,
estimated
or
predicted
BCFs
are
often
based
on
measured
data
and
equations
that
have
been
found
to
correlate
well
with
measured
data.
In
addition,
EPA
believes
that
a
BCF
of
500
is
overly
expansive.
EPA
believes
that
expanding
the
criteria
to
include
estimated
BCFs
of
500
would
label
so
many
chemicals
as
bioaccumulative
as
to
be
impractical.
EPA
believes
that
the
adoption
of
the
criterion
of
BCF/
BAF
of
1,000
allows
EPA
to
balance
the
need
to
provide
communities
with
information
on
toxic
chemicals
that
bioaccumulate
without
being
overly
inclusive
or
restrictive.
Some
commenters
contend
that
EPA's
two­
tiered
approach
to
the
bioaccumulation
criteria
is
confusing.
EPA
notes
that
it
proposed
only
one
bioaccumulation
criterion
for
EPCRA
section
313,
a
BCF/
BAF
of
1,000.
The
Agency
did
not
propose
to
use
a
BCF/
BAF
of
greater
5,000
as
a
second
bioaccumulation
criterion
for
EPCRA
section
313.
However,
for
purposes
of
setting
reporting
thresholds
in
this
rulemaking,
the
Agency
did
choose
to
focus
on
the
subset
of
PBT
chemicals
that
have
a
BCF/
BAF
greater
than
5,000
(and
half­
lifes
greater
than
6
months)
by
proposing
an
even
lower
reporting
threshold.
For
the
reasons
given
above,
EPA
reaffirms
its
intention
to
use
a
BCF/
BAF
of
1,000
as
the
criterion
for
characterizing
a
chemical
as
bioaccumulative
under
EPCRA
section
313.
c.
Toxicity.
A
number
of
commenters
contend
that
EPA
should
set
a
separate
toxicity
criteria
for
PBT
chemicals.
EPA
disagrees.
EPCRA
section
313
provides
toxicity
criteria
at
section
313(
d)(
2)
to
be
used
in
adding
a
chemical
to
or
deleting
a
chemical
from
the
EPCRA
section
313
list
of
toxic
chemicals.
These
criteria
are:

(A)
The
chemical
is
known
to
cause
or
can
reasonably
be
anticipated
to
cause
significant
adverse
acute
human
health
effects
at
concentration
levels
that
are
reasonably
likely
to
exist
beyond
facility
site
boundaries
as
a
result
of
continuous,
or
frequently
recurring,
releases.
(B)
The
chemical
is
known
to
cause
or
can
reasonably
be
anticipated
to
cause
in
humans
i)
cancer
or
teratogenic
effects,
or
(ii)
serious
or
irreversible
I)
reproductive
dysfunctions,
(II)
neurological
disorders,
(III)
heritable
genetic
mutations,
or
(IV)
other
chronic
health
effects.
(C)
The
chemical
is
known
to
cause
or
can
reasonably
be
anticipated
to
cause,
because
of
i)
its
toxicity,
(ii)
its
toxicity
and
persistence
in
the
environment,
or
(iii)
its
toxicity
and
tendency
to
bioaccumulate
in
the
environment,
a
significant
adverse
effect
on
the
environment
of
sufficient
seriousness,
in
the
judgment
of
the
Administrator,
to
warrant
reporting
under
this
section.

Given
that
Congress
has
provided
EPA
with
specific
toxicity
criteria,
and
that
listed
chemicals
are
statutorily
defined
as
``
toxic
chemicals,
''
the
Agency
does
not
believe
that
additional
``
toxicity''
criteria
would
be
appropriate.
One
reason
is
that
the
Agency
is
concerned
that
this
would
imply
that
TRI
data
on
the
toxic
chemicals
that
meet
the
statutory
toxicity
criteria
are
of
less
value
than
TRI
data
that
meet
both
the
statutory
toxicity
criteria
and
some
additional
toxicity
criteria
that
would
be
developed
by
EPA.
EPA
believes
that
bifurcating
the
list
with
an
additional,
non­
statutory
toxicity
criteria
would
be
inconsistent
with
the
intent
of
Congress.
In
addition,
it
is
worth
noting
that
some
of
the
toxicity
criteria
presented
by
the
commenters
are
fundamentally
consistent
with
the
toxicity
criteria
outlined
in
the
statute.
However,
EPA
notes
that
some
of
the
criteria
provided
by
the
commenters
are
risk
criteria
rather
than
hazard
criteria.
For
example,
see
ICCA
Briefing
Note
on
POPs
(April
21,
1998)
(Ref.
26).
As
discussed
at
length
in
the
final
rule
adding
286
chemicals
to
the
EPCRA
section
313
list
(59
FR
61432),
the
EPCRA
section
313(
d)(
2)(
B)
toxicity
criteria
(chronic
toxicity)
are
hazard
criteria,
not
risk
criteria.
The
EPCRA
section
313(
d)(
2)(
C)
criteria
are
primarily
hazard
based
with
only
a
limited
exposure
component.
To
impose
additional
toxicity
criteria
for
purposes
of
defining
a
PBT
or
a
PT
or
BT
chemical
based
on
risk
rather
than
hazard
would
be
inconsistent
with
EPCRA
section
313.
See,
e.
g.,
Legislative
History
at
5186.
Risk
assessment
may
be
appropriate
for
use
under
statutes
that
control
the
manufacture,
use
and/
or
release
of
a
chemical.
However,
EPCRA
section
313
is
an
information
collection
provision
that
is
fundamentally
different
from
other
environmental
statutes
that
control
or
restrict
chemical
activities.
For
these
reasons,
EPA
believes
that
it
is
inappropriate
to
add
toxicity
criteria,
beyond
the
criteria
provided
by
Congress
at
EPCRA
section
313(
d)(
2).
3.
Persistence
and
bioaccumulation
consideration
under
EPCRA
section
313(
d)(
2)(
C)(
ii)
and
(iii).
The
criteria
that
EPA
has
laid
out
in
this
rule
for
determining
if
a
chemical
is
a
persistent
and/
or
bioaccumulative
chemical
are
not
the
same
criteria
EPA
uses
when
conducting
assessments
for
listing
chemicals
pursuant
to
EPCRA
section
313(
d)(
2)(
C)(
ii)
and
(iii).
These
sections
of
EPCRA
allow
EPA
to
consider
whether
a
chemical
meets
the
listing
criteria
based
on
``
its
toxicity
and
persistence
in
the
environment''
or
``
its
toxicity
and
tendency
to
bioaccumulate
in
the
environment.
''
Including
consideration
of
persistence
and/
or
bioaccumulation
modifies
the
way
in
which
EPA
assesses
a
chemical's
toxicity
for
purposes
of
listing.
EPA
interprets
the
results
of
the
toxicity
data
in
light
of
a
chemical's
persistence
and/
or
bioaccumulation,
and
adjusts
its
concerns
for
the
chemical's
toxicity
in
accordance
with
the
degree
to
which
a
chemical
persists
or
bioaccumulates.
For
example,
standard
aquatic
toxicity
tests
provide
toxicity
results
in
time
frames
that
range
from
hours
to
a
few
weeks.
For
aquatic
toxicity
that
results
58684
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/
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64,
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209
/
Friday,
October
29,
1999
/
Rules
and
Regulations
from
such
short
exposure
times,
a
chemical
with
a
persistence
half­
life
of
even
2
weeks
will
result
in
a
greater
potential
for
exposure
and
therefore
increased
concern
for
the
concentration
at
which
toxicity
is
expressed.
In
this
case,
EPA
would
be
concerned
about
the
chemical's
persistence
at
levels
well
below
a
half­
life
of
2
months
or
more.
Because
EPA's
concern
under
these
provisions
is
with
the
interrelationship
between
two
chemical
properties
and
how
that
affects
whether
the
chemical
can
reasonably
be
anticipated
to
cause
a
significant
adverse
effect
on
the
environment,
EPA
believes
that
it
needs
to
be
able
to
consider
a
broader
range
of
values.
By
contrast,
the
persistence
and
bioaccumulation
criteria
established
in
today's
rulemaking
serve
a
different
purpose;
they
are
intended
to
operate
independent
of
a
chemical's
toxicity,
to
identify
a
fixed
class
of
chemicals.
EPA
has
provided
this
explanation
to
clarify
the
different
purposes
of
the
persistence
and
bioaccumulation
criteria
established
in
this
rule,
and
the
use
of
persistence
and
bioaccumulation
in
assessments
pursuant
to
EPCRA
section
313(
d)(
2)(
C)(
ii)
and
(iii).

C.
Criteria
as
they
Apply
to
Metals
Many
commenters
contend
that
the
persistence
criteria
proposed
by
EPA
were
developed
for
organic
chemicals
and
cannot
be
applied
to
metals,
or
if
applied,
are
not
useful
in
screening
for
hazard.
The
critical
parameter
in
determining
risk
is
bioavailability,
not
persistence.
This
has
been
recognized
by
international
organizations
of
which
EPA
is
a
member,
so
it
is
unclear
why
it
is
now
necessary
for
EPA
to
deviate
from
these
policies.
Metals
are
not
harmful
if
they
are
not
in
a
bioavailable
form.
Moreover,
metals
are
natural
components
of
the
earth's
crust
and
many
are
accumulated
by
living
organisms
because
they
are
essential
nutrients.
Two
of
the
commenters
state
that
because
persistence
is
defined
as
``
the
failure
of
a
substance
to
readily
biodegrade,
''
this
concept
has
no
relevance
for
metals.
EPA
disagrees.
The
scientific
literature
contains
many
definitions
of
persistence
which
vary
in
detail,
but
center
on
a
common
theme:
persistence
is
the
ability
of
a
chemical
substance
to
remain
in
a
particular
environment
in
an
unchanged
form.
This
definition
makes
no
mention
whatsoever
of
any
specific
processes
that
may
impact
a
substance's
environmental
fate,
such
as
biodegradation.
According
to
this
definition,
specific
metal
compounds
may
or
may
not
be
persistent
depending
on
the
form
of
the
metal
and
environmental
conditions,
but
the
elemental
metal
itself
obviously
meets
the
definition,
and
this
was
acknowledged
in
the
majority
of
comments
received.
That
elemental
metals
are
persistent
by
definition
is
widely
accepted.
While
they
may
take
different
oxidation
states
that
can
be
interconverted,
the
elemental
metal
itself
cannot
be
destroyed.
For
example,
chromium
(VI)
may
convert
to
chromium
(III).
Both
are
simply
different
forms
of
chromium.
All
elemental
metals
therefore
meet
the
2
months
half­
life
criterion
automatically.
Given
this,
it
is
obviously
false
to
assert,
as
did
the
majority
of
commenters
on
this
issue,
that
EPA's
proposed
persistence
criteria
cannot
be
applied
to
metals.
The
position
of
many
commenters
was
that
in
determining
whether
a
metal
or
metal
compound
may
actually
pose
a
risk
if
released
to
the
environment,
bioavailability
is
much
more
important
than
the
fact
that
a
substance
meets
the
formal
``
definition''
of
persistence.
EPA
agrees
that
bioavailability
is
important
in
determining
the
potential
for
the
metal
to
be
accumulated
in
organisms,
but
parent
metals
do
have
the
potential
to
become
available
from
metal
compounds
under
common
environmental
conditions.
Availability
of
the
metal
ion
may
be
the
result
of
biotic
or
abiotic
processes.
There
are
a
number
of
environmental
factors
which
EPA
considers
in
determining
the
availability
of
the
metal
ion.
These
include
hydrolysis,
pH
effects
on
solubility,
photolysis,
aerobic
and
anaerobic
transformations,
and
in
vivo
transformations.
As
outlined
in
the
remainder
of
this
section,
it
is
realistic
to
expect
that,
in
general,
metals
when
released
into
the
environment
can
encounter
conditions
in
which
they
are
available
at
levels
sufficient
to
exert
toxicity
and
bioaccumulate.
EPA
also
disagrees
with
the
commenters'
claims,
direct
or
implied,
that
metals
released
to
the
environment
as
a
result
of
human
activity
must
be
of
negligible
concern
because
they:
·
Cannot
be
converted
to
bioavailable
forms;
or
even
if
initially
bioavailable
are
rapidly
sequestered
in
such
a
way
that
subsequent
exposure
is
impossible;
or
·
If
bioavailable,
are
naturally
wholesome
and
good
because
organisms
need
them
to
function.
EPA
disagrees
with
this
simplistic
view.
Metals
can
enter
the
environment
in
bioavailable
forms
or
can
be
converted
in
the
environment
into
bioavailable
forms.
As
shown
below,
metals
and
metal
compounds
may
be
available
to
bioaccumulate
under
many
realistic
and
common
environmental
conditions.
The
commenters
are
correct
in
stating
that
metals
released
to
the
environment
from
anthropogenic
sources
are
affected
by
prevailing
environmental
conditions,
meaning
broadly
the
wide
variety
of
physical,
chemical
and
biological
processes
that
act
upon
them,
and
these
collectively
determine
the
form
in
which
the
metal
ultimately
exists.
According
to
Klein
(Ref.
28),
interconversion
of
inorganic
metal
compounds
can
be
quite
rapid,
especially
for
ionic
forms,
and
as
a
result
the
chemical
form
in
which
an
elemental
metal
is
released
may
not
be
the
predominant
form
post­
release.
Generally,
the
ionic
forms
of
inorganic
metals
are
the
most
available.
Availability
is
affected
by
many
factors
and
its
determination
is
complex.
For
metals
environmental
conditions
can
affect
their
availability.
A
detailed
scientific
discussion
of
the
environmental
fate
of
lead,
which
is
representative
of
other
metals,
and
that
is
illustrative
of
many
of
the
more
important
environmental
variables
that
affect
availability
is
provided
in
Refs.
14,
28,
30,
50,
66a,
72,
and
84.
See
also
the
preamble
to
EPA's
recent
proposal
to
lower
the
EPCRA
section
313
reporting
thresholds
for
lead
and
lead
compounds
(64
FR
42222).
The
same
basic
chemical
properties
and
environmental
variables
will
affect
the
degree
of
availability
of
a
metal
in
the
environment
regardless
of
the
specific
metal.
There
is
no
metal
that
is
unavailable
under
all
conditions.
EPA
recognizes
that
lead
and
lead
compounds
are
the
subject
of
an
EPA
proposal
under
EPCRA
section
313
(64
FR
42222).
The
inclusion
of
the
discussion
of
the
environmental
fate
of
lead
and
lead
compounds
does
not
predetermine
EPA's
decision
on
the
appropriate
thresholds
that
should
be
set
for
lead
and
lead
compounds.
That
determination
will
be
based
on
a
number
of
factors,
including
the
bioaccumulation
of
lead.
Microbial
transformations
in
soil,
water,
and
sediment
are
often
important
in
determining
the
overall
fate
of
metals
and
metal
compounds,
and
therefore
the
potential
for
formation
of
bioavailable
forms.
Metals
known
to
undergo
microbial
oxidation/
reduction
processes
include,
antimony,
arsenic,
iron,
mercury,
selenium,
and
tellurium
(Ref.
11).
Arsenic
microbiology
illustrates
the
importance
of
environmental
conditions
in
the
interconversion
of
inorganic
forms
of
arsenic.
Microbial
populations
in
activated
sludge
can
oxidize
arsenite
to
arsenate
under
aerobic
conditions,
but
under
anaerobic
conditions
such
as
often
predominate
in
sediments,
arsenate
can
be
reduced
to
arsenite
and
58685
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/
Vol.
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/
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29,
1999
/
Rules
and
Regulations
beyond.
Both
arsenites
and
arsenates
can
be
available
in
the
environment
(Ref.
11).
Microorganisms
can
reduce
mercury
in
the
form
of
mercuric
chloride
to
elemental
mercury,
and
are
also
capable
of
producing
elemental
mercury
from
organomercurials
such
as
phenylmercuric
acetate
and
methylmercuric
chloride.
Although
the
reduction
of
Hg
2¶
to
elemental
mercury
can
be
regarded
as
decreasing
availability,
the
elemental
mercury
formed
is
volatile
and
more
likely
to
enter
the
global
atmospheric
circulation.
Mercury
is
perhaps
better
known
for
its
potential
to
be
biomethylated
by
bacteria
in
the
environment
(Ref.
11).
Mercury
has
very
high
stability
constants
with
organic
ligands
and
can
form
true
organometallic
compounds
(Ref.
6).
As
indicated
by
Stumm
and
Morgan
(Ref.
49),
metals
and
metalloids
that
form
stable
alkyl
compounds
are
of
special
concern
because
they
may
be
volatile;
may
accumulate
in
cells;
and
are
toxic
to
the
central
nervous
system
of
higher
organisms.
Methylmercury
is
highly
bioaccumulative
and
is
by
far
the
best
studied
example
of
microbial
bioalkylation.
However,
methylation
of
arsenic
is
also
fairly
well­
characterized,
involves
the
replacement
of
substituent
oxygen
atoms
by
methyl
groups
(e.
g.,
arsenate
is
biomethylated
to
form
dimethylarsine),
and
is
important
in
the
transfer
of
arsenic
from
sediment
to
the
atmosphere
(Ref.
11).
Lead,
germanium,
selenium,
tellurium,
tin,
and
several
other
metals
can
also
be
biomethylated
(Ref.
49).
Many
of
the
commenters
noted
that
certain
metals
are
indeed
micronutrients
(e.
g.,
cobalt,
copper,
and
iron),
and
are
accumulated
precisely
because
they
are
required
for
certain
cellular
functions.
It
does
not
follow,
however,
that
any
amount
of
the
same
metal
is
acceptable
or
desirable.
Accumulation
of
essential
elements
is
usually
governed
by
homeostatic
mechanisms
that
control
uptake
(Ref.
28),
but
excessive
uptake
is
possible
and
can
be
toxic
to
an
organism.
For
example,
selenium
which
is
a
micronutrient
can
cause
selenosis
at
doses
as
low
as
0.023
milligrams
per
kilogram
per
day
(mg/
kg/
day).
Clinical
signs
of
selenosis
include
the
characteristic
``
garlic
odor''
of
excess
selenium
excretion
in
the
breath
and
urine,
thickened
and
brittle
nails,
hair
and
nail
loss,
lowered
hemoglobin
levels,
mottled
teeth,
skin
lesions,
and
central
nervous
system
(CNS)
abnormalities
(peripheral
anesthesia,
acroparesthesia,
and
pain
in
the
extremities)
(Ref.
61).
Similarly,
copper,
which
is
an
essential
nutrient,
at
high
doses
can
cause
vascular
injury
and
hemolytic
anemia.
It
should
also
be
noted
that
copper
exhibits
high
acute
and
chronic
toxicity
to
aquatic
organisms
that
results
in
the
death
of
the
organism
(61
FR
54381,
October
18,
1996)
(FRL±
5396±
9),
and
inhalation
of
hexavalent
chromium
is
known
to
cause
cancer
in
humans
(Ref.
60),
even
though
chromium
in
very
small
oral
doses
is
a
micronutrient
(Ref.
25).
Moreover,
the
commenters
freely
cite
Allen
(Ref.
4),
Chapman
(Ref.
18)
and
other
authors
to
the
effect
that
metals
are
accumulated
``
deliberately''
depending
on
the
physiological
needs
of
the
organism,
but
it
is
clear
that
this
applies
only
to
metals
that
are
essential
nutrients.
Metals
are
generally
taken
into
cells
by
nutrient
metal
transport
systems,
and
these
are
not
sufficiently
specific
to
completely
exclude
nonessential
metals,
some
of
which
may
be
toxic
and/
or
bioaccumulative.
In
this
situation
nutrient
metals
can
be
displaced
from
their
binding
sites
by
undesirable,
toxic
metals,
which
then
gain
access
to
the
cell
interior
with
concomitant
exclusion
of
the
essential
metal
(Ref.
49).
Toxic
metal
ions
are
then
free
to
react
with
critical
enzymes
or
otherwise
disrupt
cellular
functions
if
they
reach
certain
levels.
Often
this
toxicity
occurs
at
relatively
low
doses.
For
example,
inorganic
arsenic
is
a
known
human
carcinogen
and
causes
chronic
toxicity
at
doses
as
low
as
0.014
mg/
kg/
day
(Ref.
59).
Lead
has
no
known
biological
function
in
humans
but
is
readily
absorbed
and
has
been
shown
to
cause
various
toxic
effects.
For
example,
children
can
suffer
permanent
damage
from
lead
poisoning,
resulting
in
lowered
intelligence,
learning
disabilities,
hearing
loss,
reduced
attention
span,
and
behavioral
abnormalities
(Ref.
66).
EPA
concludes
that
under
many
environmental
conditions,
metals
and
metal
compounds
may
be
available
to
express
toxicity
and
to
bioaccumulate,
and
that
these
effects
are
not
necessarily
limited
to
metals
that
are
not
essential
nutrients.
It
is
appropriate,
therefore,
to
be
concerned
about
the
potential
adverse
effects,
and
one
step
in
this
direction
is
to
more
accurately
assess
emissions
from
anthropogenic
activities.
EPCRA
section
313
provides
that
opportunity.
Precedent
for
this
concern
exists
at
the
international
level
in
the
form
of
a
protocol
for
heavy
metals
under
the
UNECE
LRTAP,
which
is
currently
being
negotiated.
The
draft
protocol
expresses
concern
``.
.
.that
emissions
of
certain
heavy
metals
are
transported
across
national
boundaries
and
may
cause
damage
to
ecosystems.
.
.and
may
have
harmful
effects
on
human
health.
.
.,
''
and
specifically
advocates
assessing
and
controlling
emissions
caused
by
human
activities
(Ref.
54).
Several
commenters
raised
the
issue
of
EPA
participation
in
various
international
organizations,
claiming
that
any
attempt
to
apply
EPA's
proposed
persistence
and
bioaccumulation
criteria
and/
or
assessment
approach
to
metals
would
violate
the
policies
of
these
organizations,
whose
positions
EPA
has
previously
endorsed.
These
claims
are
false
because
the
commenters
either
misunderstand
or
misstate
the
aforementioned
policies.
The
main
focus
of
the
commenter's
attention
is
two
documents,
the
OECD's
Harmonized
Integrated
Hazard
Classification
System
for
Human
Health
and
Environmental
Effects
of
Chemical
Substances
(Ref.
41),
and
the
North
American
Agreement
on
Environmental
Cooperation
(NAAEC)
's
Process
for
Identifying
Candidate
Substances
for
Regional
Action
under
the
Sound
Management
of
Chemicals
Initiative
(Ref.
39).
A
report
from
a
joint
Canada/
European
Union
Technical
Workshop
on
metals
(Ref.
17)
was
also
cited
by
commenters
and
reached
similar
conclusions.
The
OECD
document's
pronouncements
on
metals
are
contained
in
paragraphs
22
and
23
of
that
document.
Paragraph
22
reads
as
follows:

For
inorganic
compounds
and
metals,
the
concept
of
degradability
as
applied
to
organic
compounds
has
limited
or
no
meaning.
Rather
the
substance
may
be
transformed
by
normal
environmental
processes
to
either
increase
or
decrease
the
bioavailability
of
the
toxic
species.
Equally,
the
use
of
bioaccumulation
data
should
be
treated
with
care.
Specific
guidance
will
be
[but
has
not
yet
been]
provided
on
how
these
data
for
such
materials
may
be
used
in
meeting
the
requirements
of
the
classification
criteria.
(Ref.
41)

By
``
degradability
as
applied
to
organic
compounds''
OECD
means
molecular
degradation,
most
often
by
microbial
degradation
and/
or
hydrolysis
or
other
abiotic
processes,
to
progressively
simpler
organic
chemical
structures,
leading
eventually
to
inorganic
substances
like
carbon
dioxide
and
water.
But,
note,
paragraph
22
does
not
in
any
way
suggest
that
metals
are
not
persistent.
Moreover,
it
does
not
suggest
that
OECD
hazard
classification
criteria
cannot
be
applied,
only
that
``
care''
(i.
e.,
professional
judgment)
is
required
in
the
interpretation
of
data
relative
to
the
classification
criteria.
In
fact,
EPA
agrees
that
bioavailability
is
important
in
determining
the
potential
for
the
metal
to
be
accumulated
in
organisms.
58686
Federal
Register
/
Vol.
64,
No.
209
/
Friday,
October
29,
1999
/
Rules
and
Regulations
The
Agency
has
analyzed
information
on
the
environmental
fate
of
metals,
and,
as
noted
above,
asserts
its
professional
judgment
that
the
parent
metals
do
have
the
potential
to
become
available
from
metal
compounds
under
commonly
encountered
environmental
conditions.
Therefore,
the
Agency's
treatment
of
metals
is
consistent
with
the
OECD's
intent.
The
same
holds
with
respect
to
NAAEC's
pronouncements
under
the
SMOC
(Ref.
39).
The
focus
of
NAAEC/
SMOC
(Ref.
39)
is
the
development
of
North
American
Regional
Action
Plans
(NARAPs)
for
substances
that
pose
significant
risk
to
human
health
and
the
environment
in
all
three
member
countries
(namely,
Mexico,
Canada,
and
the
United
States).
To
date,
NARAPs
have
been
established
for
DDT/
chlordane,
PCBs,
and
mercury
(note:
a
metal).
NAAEC/
SMOC
(Ref.
39)
acknowledges
the
persistence
of
metals,
but
highlights
the
role
of
expert
judgment
in
assessing
potential
bioavailability
of
metals
and
metal
compounds:

For
naturally
occurring
substances
such
as
metals
and
minerals,
the
Task
Force
understands
that
the
direct
application
of
the
persistence
and
bioaccumulation
criteria
proves
very
difficult.....
Organometals
can
behave
like
other
persistent
organic
pollutants
in
their
metallic
form,
and
as
certain
compounds,
metals
tend
to
be
infinitely
persistent
though
not
necessarily
in
a
form
that
is
bioavailable,
and
in
some
cases,
they
naturally
bioaccumulate
for
beneficial
purposes
in
organisms
(i.
e.,
essential
elements).
Expert
judgment
is
essential
for
a
meaningful
evaluation
of
these
substances.

Further,
an
earlier
section
of
the
document
(Ref.
39)
states,

It
is
understood
that
expert
scientific
judgment
plays
a
significant
role
in
acknowledging
and
addressing
the
difficulties
posed
by
quantitative
criteria
for
persistence
and
bioaccumulation,
particularly
in
relation
to
naturally­
occurring
substances
like
metals
and
minerals
where
the
potential
for
transformation
to
complexes
or
metallic
species
which
are
more
or
less
bioavailable,
are
emerging
as
important
considerations.

It
is
difficult
to
read
into
the
preceding
any
intention
to
exclude
metals
and
metal
compounds
from
consideration,
as
many
commenters
imply,
and
more
specifically,
to
declare
that
these
substances
have
no
potential
to
pose
risk
because
they
are
never
released
in
bioavailable
forms;
cannot
be
converted
to
bioavailable
forms
under
any
foreseeable
circumstances,
etc.
On
the
contrary,
it
is
clear
from
the
preceding
language
as
well
as
the
inclusion
of
mercury
among
the
NARAPs
developed
to
date
that
any
substance
judged
to
be
potentially
bioavailable
and
that
otherwise
meets
the
SMOC
criteria,
whether
organic
or
inorganic,
should
not
be
excluded
as
a
candidate
for
action.
As
outlined
above,
it
is
realistic
to
expect
that,
in
general,
released
metals
can
encounter
conditions
in
which
they
are
available
at
levels
sufficient
to
exert
toxicity
and
bioaccumulate.
Therefore,
the
Agency's
treatment
of
metals
is
consistent
with
international
policy
under
NAAEC/
SMOC
(Ref.
39).
Finally,
EPA
reminds
commenters
that
a
mechanism
already
exists
to
address
concerns
for
any
metal
compound
for
which
the
data
show
that
the
metal
cannot
become
available.
The
issue
of
bioavailability
was
addressed
previously
for
EPCRA
section
313
chemical
assessments
through
EPA's
policy
and
guidance
concerning
petitions
to
delist
individual
members
of
the
metal
compound
categories
listed
under
EPCRA
section
313
(56
FR
23703,
May
23,
1991).
This
policy
states
that
if
the
metal
in
a
metal
compound
cannot
become
available
as
a
result
of
biotic
or
abiotic
processes,
then
the
metal
will
not
be
available
to
express
its
toxicity,
and
by
extension,
to
bioaccumulate.
If
the
intact
metal
compound
is
not
toxic
and
the
metal
is
not
available
from
the
metal
compound,
then
such
a
chemical
is
a
potential
candidate
for
delisting.
EPA
has
received
fewer
than
10
petitions
to
delete
individual
metal
compounds
because
the
petitioner
contended
that
the
metal
portion
of
the
metal
compound
would
not
be
available
under
environmental
conditions
or
in
vivo.

D.
Multimedia
Modeling
One
commenter
contends
that
EPA
should
clarify
how
and
when
multimedia
models
will
be
used
in
the
evaluation
of
PBT
chemicals.
EPA
should
not
use
the
EQC
model
or
other
multimedia
models
as
the
sole
determinant
of
potential
risk.
If
exposure
and
use
information
is
available,
a
detailed
technical
evaluation
based
on
these
data
is
preferred
over
modeling
based
on
hypothetical
exposure
and
loading
scenarios.
The
purpose
of
this
rulemaking
is
to
lower
reporting
thresholds
for
certain
EPCRA
section
313
substances
that
are
being
designated
as
persistent
and
bioaccumulative,
and
to
list
several
additional
substances
that
meet
EPCRA
section
313
listing
criteria
and
are
also
persistent
and
bioaccumulative.
Although
neither
quantitative
risk
nor
exposure
assessments
have
been
performed,
nor
are
they
required
under
EPCRA,
designation
as
a
PBT
does
imply
the
existence
of
potential
risk.
However,
contrary
to
the
comment,
EPA
has
not
proposed
that
multimedia
models
be
used
as
the
sole
factor
in
determining
persistence.
As
clearly
stated
in
the
proposed
rule,
EPA
intends
to
use
such
modeling
``
as
an
additional
factor,
in
conjunction
with
reaction
halflifes
for
individual
media,
bioaccumulation/
bioconcentration
factors,
etc.,
in
justifying
[the]
actions
proposed.
''
In
the
proposed
rule
EPA
did
explain
in
a
general
way
(at
64
FR
703)
how
models
would
be
used
in
PBT
evaluation,
and
stated
that
results
of
multimedia
modeling
may
be
used
to
override
compartment
(medium)
specific
degradation
half­
lifes,
but
only
if
all
model
inputs
are
judged
sufficiently
accurate.
This
leaves
unspecified
what
specific
value(
s)
might
be
used
for
overall
environmental
persistence
criteria
(expressed
either
as
an
overall
residence
time
or
overall
halflife
To
date
no
international
scientific
or
regulatory
authority
has
proposed
any
such
criterion
for
POPs/
PBT
chemicals,
and
the
complex
relationship
between
compartment­
specific
and
overall
persistence
criteria
is
in
fact
a
major
topic
of
current
research.
One
commenter
raises
concerns
regarding
the
modification
EPA
made
to
the
EQC
III
model
that
deleted
advective
losses
and
sediment
burial.
EPA
modified
the
model
to
exclude
advective
losses
and
sediment
burial
because
if
these
processes
are
included
the
persistence
based
on
destruction
will
be
underestimated.
In
multimedia
modeling,
advection
can
be
viewed
as
the
flow
into
or
out
of
the
evaluative
environment
or
``
box.
''
These
include
processes
such
as
downstream
flow
in
surface
waters,
dispersion
downwind
in
air,
and
burial
in
sediments.
The
model
considers
these
non­
destructive
processes
to
result
in
loss
from
the
evaluative
environment
in
the
same
way
that
destruction
does.
However,
these
processes
simply
result
in
the
transport
of
a
chemical
to
another
part
of
the
environment
downwind
or
downstream
from
where
it
is
released,
or
its
deposition
into
sediments,
but
not
the
destruction
of
the
chemical.
The
persistence
of
a
chemical
calculated
when
the
model
is
run
considering
advective
losses
include
non­
destructive
transport
processes
which
remove
the
chemical
from
the
evaluative
environment.
For
example,
the
environmental
persistence
of
a
chemical
released
to
water
which
does
not
significantly
partition
to
sediments,
degrade,
or
volatilize
will
reflect
the
rate
at
which
the
water
to
which
it
is
released
flows
out
of
the
evaluative
environment.
In
this
example,
the
58687
Federal
Register
/
Vol.
64,
No.
209
/
Friday,
October
29,
1999
/
Rules
and
Regulations
relative
rate
of
non­
destructive
transport
out
of
the
evaluative
environment
may
be
more
rapid
than
the
processes
which
result
in
the
destruction
of
the
chemical.
Thus,
the
persistence
calculated
by
the
model
will
be
less
than
if
advective
transport
from
the
evaluative
environment
was
not
considered.
EPA
used
the
model
to
evaluate
persistence
based
on
destruction
in
a
multimedia
environment.
This
is
consistent
with
EPCRA
section
313
persistence
criteria
in
that
the
criteria
are
based
on
destruction,
not
transport
of
the
chemical.
The
Level
III
nonequilibrium
partitioning,
steady
state
mass
balance)
models
are
preferred
for
developing
qualitative
and
quantitative
predictions
of
chemical
distribution,
pathways,
and
relative
concentrations
(Ref.
16).
Level
III
models
can
also
be
used
to
assess
persistence
(Ref.
33).
At
steady
state
(level
III)
conditions
the
amount
of
chemical
is
unchanging
with
time
and
the
input
and
output
rates
for
a
compartment
are
equal.
The
overall
residence
time
of
the
chemical
is
the
mass
of
the
chemical
in
the
compartment
divided
by
the
input
or
output
rates.
This
represents
the
average
time
the
chemical
will
reside
in
the
compartment.
Output
may
be
by
reactions
that
result
in
the
destruction
of
the
chemical
or
by
advective
flow
(non­
destructive)
usually
in
air
or
water.
When
the
model
is
modified
to
eliminate
advective
flow,
the
persistence
of
a
chemical
based
on
the
rates
of
reactions
that
result
in
the
destruction
of
the
chemical
can
be
assessed.
Webster
et
al
(Ref.
82)
used
this
approach
in
evaluating
the
environmental
persistence
of
chemicals
using
a
multimedia
fate
model
and
noted
that
if
advective
loss
is
included,
the
residence
time
is
reduced
and
can
give
a
misleading
impression
of
a
short
persistence.
It
was
also
noted
that
these
advective
losses
``.
.
.merely
relocate
the
chemical;
they
do
not
destroy
it.
''
EPA
also
used
a
modified
version
of
the
EQC
level
III
model
as
a
tool
to
assist
on
the
characterization
of
the
persistence
of
the
chemicals
subject
to
this
rule.
In
this
version
of
the
model
only
irreversible
transformation
contributes
to
net
loss
of
a
chemical.
In
other
words,
the
model
was
modified
to
represent
a
``
closed
box''
in
which
the
effect
of
processes
that
serve
only
to
move
the
chemical
from
within
the
evaluative
environment
to
outside
of
it,
primarily
in
air
and
water
(advective
losses)
were
nullified.
Sediment
processes
responsible
for
transport
of
the
chemical
from
the
evaluative
environment
such
as
sediment
burial
were
similarly
treated.
The
intent
of
this
modification
was
to
make
sure
that
only
processes
responsible
for
the
destruction
of
the
chemical
were
considered
in
evaluating
its
persistence
in
a
multimedia
environment.
EPA
supports
the
use
of
level
III
multimedia
models
modified,
as
described,
for
their
ability
to
simultaneously
consider
reaction
rates
and
partitioning
so
as
to
give
a
reasonable
assessment
of
the
persistence
of
chemicals
in
the
multimedia
environment.
However,
EPA
notes
that
its
reliance
on
the
multimedia
modeling
was
limited.
As
discussed
in
the
proposed
rule
(at
64
FR
703)
and
in
Unit
VI.
B.
2.,
EPA
primarily
considered
mediaspecific
data
and
made
a
case­
by­
case
determination
about
the
persistence
of
each
chemical.

E.
Thresholds
The
issue
most
frequently
raised
by
commenters
was
the
Agency's
choice
of
thresholds
and
the
factors
that
EPA
considered
in
lowering
the
thresholds.
Many
commenters
contended
that
EPA
should
not
consider
burden
in
choosing
thresholds.
They
believe
that
EPA
should
set
a
threshold
of
10
pounds
for
PBT
chemicals
and
1
pound
for
that
subset
of
PBT
chemicals
that
are
both
highly
persistent
and
highly
bioaccumulative.
Some
commenters
believe
that
EPA
should
set
a
threshold
of
1
pound
for
all
chemicals
that
are
PBT
chemicals.
Numerous
commenters
believe
that
the
threshold
for
reporting
should
be
zero.
Other
commenters
believe
that
burden
should
have
been
a
greater
consideration
in
EPA's
choice
of
reporting
thresholds.
Many
of
these
commenters
believe
that
EPA
should
set
thresholds
based
on
some
percentage
of
releases
that
would
be
reported.
EPA
disagrees
with
these
commenters.
As
explained
in
the
proposal,
the
Agency
considered
a
number
of
factors
to
determine
the
appropriate
thresholds
that
should
be
established
for
these
chemicals.
EPA
relied
on
the
language
of
EPCRA
sections
313(
f)(
2)
and
(h),
and
the
legislative
history
to
elicit
the
following
principles
to
guide
its
exercise
of
discretion
in
lowering
the
thresholds,
and
in
selecting
the
specific
thresholds
for
PBT
chemicals:
(1)
The
purposes
of
EPCRA
section
313;
(2)
the
``
verifiable,
historical
data''
that
convinces
EPA
of
the
need
to
lower
the
thresholds;
(3)
the
chemical
properties
shared
by
the
members
of
the
class
of
toxic
chemicals
for
which
EPA
is
lowering
the
thresholds
i.
e.,
the
degree
of
persistence
and
bioaccumulation;
and
(4)
the
reporting
burden
imposed
by
revised
thresholds
to
the
extent
that
such
consideration
would
not
deny
the
public
significant
information
from
a
range
of
covered
industry
sectors.
Further,
EPA
believes
that
in
the
language
of
EPCRA
section
313,
and
its
legislative
history,
Congress
provided
direction
on
the
appropriate
weight
to
allocate
to
each
of
these
considerations
in
implementing
EPCRA
section
313(
f)(
2).
These
considerations
underlay
the
entire
process
by
which
EPA
determined
the
appropriate
thresholds.
But,
as
noted
below,
the
Agency's
choice
of
revised
thresholds
was
governed,
and
ultimately
constrained,
by
EPCRA
section
313's
overriding
purpose,
which
is
to
provide
government
agencies,
researchers,
and
local
communities,
with
a
comprehensive
picture
of
toxic
chemical
releases
and
potential
exposures
to
humans
and
ecosystems.
In
general,
EPA's
implementation
of
EPCRA
section
313
is
guided
by
the
statutory
purposes
described
by
EPCRA
section
313(
h),
which
provides:

The
release
forms
required
under
this
section
are
intended
to
provide
information
to
the
Federal,
State,
and
local
governments
and
the
public,
including
citizens
of
communities
surrounding
covered
facilities.
The
release
form
shall
be
available.
.
.to
inform
persons
about
releases
of
toxic
chemicals
to
the
environment;
to
assist
governmental
agencies,
researchers,
and
other
persons
in
the
conduct
of
research
and
data
gathering;
to
aid
in
the
development
of
appropriate
regulations,
guidelines,
and
standards;
and
for
other
similar
purposes.

In
addition
to
section
313(
h),
EPA
was
also
guided
by
several
statements
on
the
principles
intended
to
guide
EPA's
implementation
of
EPCRA
section
313
made
by
Representative
Edgar,
one
of
EPCRA
section
313's
principal
architects,
during
debate
on
the
Conference
Report.
See,
Legislative
History
at
5313±
16.
In
the
course
of
his
statement,
Representative
Edgar
also
articulated
EPCRA
section
313's
overriding
purpose,
which
is:

to
provide
a
comprehensive
view
of
toxic
chemical
exposure
and,
hopefully,
provide
a
basis
for
more
sensible
and
effective
local,
State,
and
national
policies.
Legislative
History
at
5316
(emphasis
added).

Based
on
the
existing
reporting
requirements,
the
Agency
believes
that
there
are
still
significant
gaps
in
the
picture
the
TRI
data
provides
local
communities,
government
agencies,
and
researchers.
One
of
the
most
significant
of
these
gaps
is
a
comprehensive
picture
of
the
releases
and
potential
exposure
of
PBT
chemicals
to
humans
and
the
environment.
Currently,
only
a
very
limited
picture
of
releases
and
other
waste
management
of
PBT
chemicals
is
available
from
the
TRI
data,
in
part,
as
a
result
of
the
current
thresholds.
For
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209
/
Friday,
October
29,
1999
/
Rules
and
Regulations
example,
under
the
current
reporting
thresholds,
in
1997,
EPA
received
only
29
reports
on
mercury
and
mercury
compounds,
and
6
reports
on
PCBs.
This
does
not
present
a
``
comprehensive
view
of
toxic
chemical
exposure.
''
In
addition,
information
on
the
releases
and
other
waste
management
of
PBT
chemicals
is
particularly
significant
because
these
chemicals
both
persist
and
bioaccumulate.
Individually,
each
of
these
attributes
has
the
potential
to
pose
increased
exposures
to
humans
and
the
environment.
Toxic
chemicals
possessing
both
attributes
have
the
potential
to
pose
significant
exposures
to
humans
and
ecosystems
over
a
longer
period
of
time;
even
small
amounts
of
PBT
chemicals
that
enter
the
environment
can
accumulate
to
elevated
concentrations
in
the
environment
and
in
organisms,
and
therefore
have
a
greater
potential
to
result
in
adverse
effects
on
human
health
and
the
environment.
As
a
first
step
in
addressing
the
significant
gap
of
information
on
PBT
chemical
releases
and
waste
management,
EPA
considered
whether
to
lower
the
reporting
thresholds
for
PBT
chemicals.
EPA
then
looked
to
section
313(
f)(
2)
for
further
guidance
on
how
to
proceed.
Since
lowering
the
thresholds
ensures
that
``
all
facilities
subject
to
the
requirements
of
[section
313]
''
will
continue
to
report,
the
requirement
in
section
313(
f)(
2)
that
a
revised
threshold
obtain
a
``
substantial
majority
of
total
releases
of
each
chemical
at
all
facilities
subject
to
the
requirements
of
this
section''
can
be
met
without
the
need
for
quantitative
support.
Consequently,
EPA
looked
to
other
sources
of
Congressional
direction
in
the
statute
and
legislative
history
to
guide
its
exercise
of
discretion
in
establishing
revised
thresholds.
Given
that
there
is
no
guidance
on
implementing
section
313(
f)(
2)
in
the
Conference
Report,
EPA
looked
to
the
debate
on
the
Conference
Report.
In
this
context,
Representative
Edgar,
stated:

It
is
also
important
to
clarify
the
intent
of
Congress
in
establishing
thresholds
for
reporting
under
this
section.
.
.
.These
thresholds
were
designed
to
obtain
reporting
on
both
a
substantial
majority
of
the
Nation's
toxic
chemical
releases
and
to
obtain
reporting
from
a
large
number
of
firms.
These
thresholds
reflect
Congress'
judgement
that
such
thresholds
appropriately
balance
the
need
for
information
against
the
burden
on
facilities
required
to
provide
such
information.
The
EPA
is
authorized
to
revise
these
thresholds,
but
only
if
such
revised
thresholds
continue
to
obtain
reporting
on
a
substantial
majority
of
total
releases.
Any
determination
by
the
EPA
regarding
the
ability
of
revised
thresholds
to
obtain
reporting
on
a
substantial
majority
of
releases,
especially
if
such
revised
thresholds
raise
the
statutory
levels,
must
be
based
on
verifiable,
historical
data
which
presents
a
convincing
case
that
the
statutory
levels
must
be
revised.
Legislative
History
at
5313
(emphasis
added).

And
during
the
House
debate,
Representative
Swift
noted
that
any
revised
threshold
``
should
be
designed
to
improve
the
usefulness
of
the
reports.
It
must
be
structured
to
obtain
reporting
on
a
substantial
majority
of
the
total
nationwide
releases
of
the
toxic
chemical
at
all
facilities
covered
by
section
313.
''
Id.
at
5338
(emphasis
added).

In
determining
how
to
structure
its
threshold
revisions,
and
particularly
how
it
would
improve
the
usefulness
of
the
reports,
EPA
also
consulted
EPCRA's
purposes,
laid
out
in
subsection
(h).
In
this
context,
EPA
also
considered
the
statements
made
by
Senator
Stafford
during
debate
on
the
Conference
Report:

This
section
also
requires
the
Administrator
to
computerize
the
data
reported
on
the
required
forms
and
to
make
these
data
public
by
various
means.
Successful
implementation
of
this
requirement
is
vital
to
the
basic
purpose
of
the
program.
The
data
should
be
managed
in
the
computer
in
such
a
way
as
to
allow
a
wide
variety
of
analyses.
For
example,
it
should
be
possible
to
retrieve
data,
not
only
about
individual
facilities,
but
also
aggregate
data
organized
by
type
of
chemical,
type
of
effect,
geographic
location,
company
name,
etc.
as
well
as
combinations
of
these
parameters.
.
.
.
Legislative
History
at
5186
(emphasis
added).

Based
on
this
Congressional
guidance,
EPA
reached
several
conclusions.
First,
ample
``
verifiable,
historical
data''
exists
to
support
EPA's
conclusions
that
PBT
chemicals
persist
for
long
periods
of
time
in
the
environment
and
bioaccumulate
in
organisms,
including
humans;
that
this
persistence
and
bioaccumulation
can
result
in
higher
exposures
to
humans
and
the
environment;
and
that
to
``
obtain
a
substantial
majority
of
the
Nation's
toxic
chemical
releases,
''
lower
thresholds
for
PBT
chemicals
are
warranted.
For
example,
PCBs
have
been
found
throughout
the
Great
Lakes
in
sediments,
water,
and
aquatic
organisms.
Multimedia
analyses
indicate
that
the
majority
(80±
90%)
of
human
exposure
to
chlorinated
organic
compounds,
such
as
PCBs
comes
from
the
food
pathway,
a
lesser
amount
(5±
10%)
from
air,
and
minute
amounts
(less
than
1%)
from
water.
Most
of
the
data
available
on
human
exposure
to
PCBs
in
the
Great
Lakes
come
from
the
analyses
of
contaminant
levels
in
drinking
water
and
sport
fish.
The
consumption
of
contaminated
sport
fish
and
wildlife
can
significantly
increase
human
exposure
to
the
Great
Lakes
critical
pollutants,
such
as
PCBs.
The
sport
fish
are
exposed
to
PCBs
by
consumption
of
sediments
and
through
water
(Ref.
76).
See
also
Refs.
75
and
77.
Further,
EPA
strongly
believes
that
increased
reporting
on
PBT
chemicals
will
improve
the
usefulness
of
the
data
on
these
chemicals.
There
are
currently
very
few
reports
for
some
of
the
PBT
chemicals,
such
as
mercury,
mercury
compounds
and
PCBs.
The
currently
available
data
provide
a
distorted
picture
of
potential
exposures
to
humans
and
the
environment,
because
at
the
current
thresholds
only
a
fraction
of
the
releases
from
facilities
otherwise
subject
to
EPCRA
section
313
are
reported.
This
limited
reporting
results
in
a
significant
underestimation
of
the
releases
from
the
industry
sectors
covered
by
EPCRA
section
313.
As
such,
the
current
data
are
of
limited
use
for
evaluating
the
potential
exposures
to
humans
and
the
environment
of
toxic
chemicals
that
persist
and
bioaccumulate.
Expanding
the
picture
of
releases,
and
therefore
potential
exposures,
will
increase
the
utility
of
all
the
TRI
data
on
these
chemicals.
See,
e.
g.,
Economic
Analysis,
Chapter
6.4
(Ref.
67).
On
these
bases,
EPA
determined
that
revising
the
thresholds
would
be
an
important
first
step
in
closing
the
information
gap
on
PBT
chemicals.
The
Agency
then
began
the
process
of
determining
the
appropriate
levels
at
which
to
establish
the
revised
thresholds.
For
a
number
of
technical
and
policy
reasons,
EPA
chose
an
approach
focused
on
two
classes
of
PBT
chemicals:
(1)
Toxic
chemicals
that
meet
the
EPCRA
section
313
persistence
and
bioaccumulation
criteria
discussed
in
Unit
VI.
B.,
i.
e.,
those
toxic
chemicals
that
have
half­
lifes
of
2
months
or
greater
in
water/
sediment
or
soil
and
that
have
bioaccumulation
or
bioconcentration
factors
of
1,000
and
(2)
the
subset
of
PBT
chemicals
that
are
highly
persistent
and
highly
bioaccumulative,
i.
e.,
those
toxic
chemicals
that
have
half­
lifes
of
6
months
or
greater
in
water/
sediment
or
soil
and
that
have
bioaccumulation
or
bioconcentration
factors
of
5,000
or
greater.
First,
for
the
most
persistent
and
bioaccumulative
toxic
chemicals
any
release
will
lead
to
elevated
concentrations
in
the
environment
and
in
organisms.
EPA
believes
that
such
highly
persistent
and
highly
bioaccumulative
toxic
chemicals
are
of
international,
as
well
as
national
concern,
because
of
the
extent
of
their
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64,
No.
209
/
Friday,
October
29,
1999
/
Rules
and
Regulations
persistence
and
bioaccumulation.
As
discussed
elsewhere
in
this
preamble,
these
facts
have
been
widely
recognized;
there
are
a
number
of
international
agreements
that
ban,
restrict,
or
phase
out
the
manufacture,
use
and/
or
release
of
highly
persistent
and
highly
bioaccumulative
toxic
chemicals.
Similarly,
toxic
chemicals
that
are
persistent
and
bioaccumulative
are
of
national,
regional,
and
local
concern.
As
discussed
elsewhere
in
this
preamble,
toxic
chemicals
that
are
persistent
and
bioaccumulative
present
a
significant
concern
to
many
local
communities
due
to
the
proximity
of
the
communities
to
industrial
sources.
All
other
things
being
equal,
a
pollutant
reaches
nearby
populations
in
less
time
than
distant
ones.
Thus,
toxic
chemicals
that
persist
and
bioaccumulate
can
pose
significant
exposures
to
communities
and
ecosystems
that
immediately
surround
industrial
sources
as
well
as
those
communities
that
are
subject
to
regional
transport.
Given
the
international
support
for
the
extreme
limitations
on
the
use
and
release
of
toxic
chemicals
that
are
highly
persistent
and
highly
bioaccumulative,
and
the
significant
exposures
that
persistent
and
bioaccumulative
toxic
chemicals
can
pose
to
both
local
communities
and
broader
regions
of
the
United
States
and
North
America,
EPA
believes
that
it
is
appropriate
to
lower
the
reporting
thresholds
for
both
(1)
Persistent
and
bioaccumulative
toxic
chemicals
and
(2)
for
highly
persistent
and
highly
bioaccumulative
toxic
chemicals.
In
addition,
EPA
believes
this
information
is
important
to
the
public,
government
agencies,
and
researchers;
for
example,
the
information
reported
by
facilities
under
the
lower
thresholds
will
help
these
groups
assess
the
loading
of
the
PBT
chemicals
in
both
local
and
regional
ecosystems,
e.
g.,
a
small
lake
or
river
or
a
larger
ecosystem
such
as
the
Great
Lakes
or
the
Chesapeake
Bay.
See
also,
Economic
Analysis
at
Chapter
6,
pages
32±
50
for
examples
of
other
uses
of
TRI
data
(Ref.
67).
Second,
EPA
considered
how
the
revised
thresholds
would
provide
the
information
on
PBT
chemicals
needed
to
assist
the
public
to
obtain
``
a
comprehensive
view
of
toxic
chemical
exposure,
''
as
well
as
to
assist
government
agencies,
researchers,
and
other
persons
to
conduct
research
and
to
establish
appropriate
regulations,
guidelines
and
standards,
in
accordance
with
the
directives
laid
out
in
subsection
(h).
EPA
determined
that
providing
greater
information
on
two
identifiable
classes
of
chemicals
best
achieved
these
ends.
It
is
consistent
with
the
actions
of
a
significant
number
of
the
groups
that
would
use
this
information;
for
example,
as
discussed
in
Unit
VI.
B.,
UNEP
is
in
the
process
of
negotiating
an
international
agreement
on
the
class
of
persistent
organic
pollutants
with
half­
lifes
of
6
months
and
BCF/
BAF
values
of
5,000.
See
also
Economic
Analysis
at
Chapter
6,
pages
46±
48
for
examples
of
how
TRI
data
will
be
used
(Ref.
67).
Moreover,
EPA
determined
that
data
on
members
within
the
same
class
are
more
easily
comparable;
the
members
of
the
classes
EPA
established
in
this
rulemaking
share
a
qualitatively
comparable
level
of
concern
based
on
their
potential
for
increased
exposure.
The
Agency
believed
that
creating
two
distinct
classes
of
comparable
chemicals
would
significantly
enhance
the
ability
of
researchers,
government
agencies,
and
other
similar
persons,
to
use
the
reports.
Establishing
distinct
classes
of
comparable
chemicals
normalizes
the
subsequent
years'
data,
providing
a
baseline
against
which
data
users
can
ascertain
trends
over
time.
Consequently
researchers
can
more
easily
distinguish,
and
therefore
track,
the
releases
and
other
waste
management
of
highly
PBT
chemicals,
to
evaluate
the
efficacy
and
progress
of
the
policy
strategies
intended
to
address
the
risks
of
PBT
chemicals,
such
as
the
Binational
Great
Lakes
Water
Quality
Initiative.
Finally,
administrative
convenience
argued
for
establishing
a
limited
number
of
alternate
thresholds.
As
a
practical
matter,
it
would
be
burdensome
for
both
the
Agency
and
the
regulated
community
to
track
a
variety
of
individual
thresholds
for
separate
chemicals.
In
addition,
because
this
was
only
the
Agency's
initial
rulemaking
to
lower
thresholds
for
certain
PBT
chemicals,
EPA
intended
that
the
revised
thresholds
establish
a
set
of
categories
that
would
be
generally
applicable
to
future
designated
PBT
chemicals.
All
of
these
considerations
led
the
Agency
to
conclude
that
it
should
establish
two
sets
of
revised
thresholds
based
on
two
classes
of
PBT
chemicals.
Thus,
having
concluded
it
was
appropriate
to
focus
the
rulemaking
on
two
classes
of
chemicals,
persistent
and
bioaccumulative
toxic
chemicals
and
that
subset
of
PBT
chemicals
that
are
highly
persistent
and
highly
bioaccumulative,
EPA
began
the
process
of
determining
the
specific
thresholds
that
would
achieve
the
purposes
of
subsections
(f)(
2)
and
(h).
The
intrinsic
properties
of
PBT
chemicals
argue
for
very
low
thresholds.
The
subset
of
PBT
chemicals
that
are
highly
persistent
and
highly
bioaccumulative
warrant,
in
the
absence
of
other
considerations,
a
threshold
approaching
zero.
Any
release
of
these
toxic
chemicals
is
of
global
concern
because
they
can
persist
for
long
periods
of
time,
can
maintain
their
identity
even
after
undergoing
long
range
transport,
and
can
bioaccumulate
to
a
significant
degree.
As
discussed
above,
and
at
length
in
Unit
VI.
B.,
the
potential
impacts
that
can
result
from
any
release
of
toxic
chemicals
that
are
highly
persistent
and
highly
bioaccumulative
have
been
widely
recognized.
There
are
a
number
of
international
agreements
that
ban,
restrict,
or
phase
out
the
manufacture,
use
and/
or
release
of
the
most
persistent
and
bioaccumulative
toxic
chemicals.
However,
EPA
believes
that
a
zero
threshold
would
be
impractical.
Attempting
to
require
facilities
to
determine
if
they
manufacture,
process,
or
otherwise
use
any
amount
whatsoever
of
these
chemicals
would
be
extremely
burdensome
and
perhaps
technically
impossible.
Without
an
actual
numerical
threshold,
many
facilities
might
report
some
amount
of
these
chemicals
in
a
misguided
attempt
to
assure
compliance.
This
could
lead
to
misleading
and
inaccurate
data
on
the
actual
sources
of
these
chemicals.
EPA
believes
that
rather
than
setting
a
zero
reporting
threshold
it
would
be
better
to
set
a
very
low
threshold
that
provides
facilities
with
a
clear
indicator
of
when
they
are
required
to
report.
In
general
for
purposes
of
EPCRA
section
313,
1
pound
is
the
practical
equivalent
of
zero
for
these
chemicals.
EPA
explained
these
considerations
in
the
proposed
rule
(64
FR
712)
and
has
received
no
information
from
commenters
that
convinces
the
Agency
to
pursue
a
different
approach.
EPA
then
considered
the
relative
degree
of
persistence
and
bioaccumulation
between
the
two
classes
of
chemicals.
EPA
wanted
to
establish
two
sets
of
revised
thresholds
with
the
same
approximate
relationship
to
each
other,
as
the
relative
exposure
potentials
of
PBT
chemicals
to
that
subset
of
highly
persistent
and
highly
bioaccumulative
PBT
chemicals.
Simply
stated,
chemicals
with
half­
lifes
of
6
months
or
greater
and
a
BAF/
BCF
of
5,000
or
greater
have
a
higher
exposure
potential
than
chemicals
with
half­
lifes
of
2
months
or
greater
and
a
BAF/
BCF
of
1,000
or
greater.
However,
although,
as
discussed
below,
EPA
could
establish
a
qualitative
relationship,
the
Agency
could
not
reliably
quantify
the
relative
exposure
potential
across
the
board
for
all
of
the
members
of
both
classes.
Therefore,
in
attempting
to
translate
the
qualitative
exposure
potential
of
PBT
58690
Federal
Register
/
Vol.
64,
No.
209
/
Friday,
October
29,
1999
/
Rules
and
Regulations
chemicals
to
that
subset
of
PBT
chemicals
that
are
highly
persistent
and
highly
bioaccumulative
into
a
qualitative
threshold
relationship,
EPA
considered
both
the
attributes
of
these
chemicals
and
factors
specific
to
thresholds.
The
manufacture,
process,
and
otherwise
use
thresholds
are
not
equivalent
to
release
thresholds
although,
in
many
cases,
the
quantity
manufactured
or
otherwise
used
will
be
very
similar
to
the
quantity
released.
Thus,
even
if
EPA
were
able
to
quantify
the
relative
exposure
potential
of
PBT
chemicals
and
that
subset
of
PBT
chemicals
that
are
highly
persistent
and
highly
bioaccumulative,
based
on
their
degrees
of
persistence
and
bioaccumulation,
and
their
interrelationship,
the
Agency
would
not
rely
solely
on
this
to
select
a
quantitative
threshold
relationship
between
these
two
classes
of
chemicals
because:
(1)
The
manufacturing,
processing,
and
otherwise
use
thresholds
are
not
equivalent
to
release
thresholds,
and
(2)
the
quantity
released,
not
the
quantity
manufactured,
processed
or
otherwise
used,
is
a
critical
factor
in
determining
exposure.
Nonetheless,
EPA
believes
that
the
relative
reporting
thresholds
should
be
based
to
some
extent
upon
the
qualitative
differential
between
the
potential
exposures
that
may
result
from
releases
of
PBT
chemicals
and
that
subset
of
PBT
chemicals
that
are
highly
persistent
and
highly
bioaccumulative.
There
is
not
a
direct
quantifiable
relationship
between
the
potential
exposures
that
can
result
from
equivalent
releases
of
a
toxic
chemical
that
persists
in
the
environment
with
a
half­
life
of
6
months
and
that
has
a
bioaccumulation
factor
of
5,000
and
releases
of
a
toxic
chemical
that
persists
in
the
environment
with
a
half­
life
of
2
months
and
that
has
a
bioaccumulation
factor
of
1,000.
The
potential
exposure
to
humans
and
the
environment
will
depend
upon
a
number
of
factors,
including
release
patterns,
environment
variables
such
as
soil
type,
surface
water
chemistry,
the
types
and
distribution
of
flora
and
fauna,
and
fish
consumption
patterns.
However,
EPA
did
consider
the
relative
differences
in
the
potential
exposures
between
these
two
classes.
For
example,
after
1
year,
there
will
be
more
than
15
times
as
much
of
a
highly
persistent
chemical
that
remains
in
the
environment
than
of
a
persistent
chemical,
all
other
things
being
equal.
Similarly,
fish
will
accumulate
more
than
5
times
as
much
of
the
highly
bioaccumulative
chemical
than
of
the
bioaccumulative
chemical,
all
other
things
being
equal.
While
EPA
believes
that
it
can
qualitatively
describe
the
relative
relationship
of
highly
persistent
chemicals
to
persistent
chemicals
and
the
relative
relationship
of
highly
bioaccumulative
chemicals
to
bioaccumulative
chemicals,
the
Agency
cannot
at
the
present
time,
define
the
relative
relationship
of
persistence
and
bioaccumulation
between
the
two
classes
of
chemicals.
This
is
in
large
part
due
to
the
many
variables
that
must
be
considered
in
determining
the
potential
exposures
both
due
to
the
interaction
of
these
chemical
attributes
and
the
large
number
of
environmental
factors
that
must
be
considered
when
evaluating
persistence
and
bioaccumulation
together.
Although
EPA
could
not
develop
an
exact
quantitative
threshold
relationship
between
the
two
classes
of
chemicals,
the
Agency
did
consider
the
factors
discussed
above
and
did
rely
to
some
extent
on
the
numerical
relationships
between
the
highly
persistent
and
persistent
chemicals
and
the
highly
bioaccumulative
and
bioaccumulative
chemicals.
Therefore,
given
that:
(1)
Highly
bioaccumulative
toxic
chemicals
will
accumulate
approximately
5
times
greater
than
bioaccumulative
toxic
chemicals,
(2)
highly
persistent
toxic
chemicals
will
remain
in
the
environment
after
1
year,
at
a
level
about
15
times
greater
than
persistent
toxic
chemicals,
(3)
the
fact
that
the
EPCRA
section
313
reporting
thresholds
are
not
release
thresholds
but
that
in
some
instances
the
quantities
manufactured
or
otherwise
used
will
be
very
similar
to
the
quantity
released,
and
(4)
toxic
chemicals
that
persist
in
the
environment
with
half­
lifes
of
2
months
and
bioaccumulation
factors
of
1,000
or
greater
can
be
of
both
local
and
regional
concern,
EPA
believes
that
the
threshold
for
PBT
chemicals
should
be
a
factor
of
10
greater
than
the
threshold
for
that
subset
of
PBT
chemicals
that
are
highly
persistent
and
highly
bioaccumulative.
EPA
believes
that
this
ratio
balances
the
uncertainties
and
factors,
including
numerical
factors,
that
the
Agency
considered.
Therefore,
based
on
the
chemicals'
intrinsic
characteristics,
EPA
would
establish
thresholds
of
1
pound
for
that
subset
of
PBT
chemicals
that
are
highly
persistent
and
highly
bioaccumulative
and
10
pounds
for
PBT
chemicals.
However,
the
legislative
history
of
section
313(
f)(
2)
indicates
that
in
establishing
the
original
thresholds,
Congress
recognized
the
burden
imposed
on
the
regulated
community.
Lowering
thresholds
necessarily
will
increase
that
burden.
Therefore,
EPA
determined
it
would
be
reasonable
to
include
some
consideration
of
reporting
burden
in
selecting
thresholds
for
PBT
chemicals.
But
EPA
accorded
less
weight
to
burden
than
to
the
other
considerations
discussed
above.
First,
neither
section
313(
f)(
2),
section
313(
h),
nor
any
other
provision
of
EPCRA
requires
EPA
to
consider
burden.
Second,
EPA
was
mindful
of
the
fact
that
in
several
places
in
the
legislative
history
Congress
made
clear
it
never
intended
impacts
on
reporting
facilities
to
outweigh
the
public's
right­
to­
know
about
their
potential
exposures
to
toxic
chemicals.
For
example,
although
Representative
Edgar
recognized
that
Congress
had
considered
burden
in
establishing
the
statutory
thresholds,
he
did
not
include
reporting
burden
as
one
of
the
general
principles
that
should
guide
the
Agency's
implementation
of
EPCRA
section
313
as
a
whole.
Rather,
he
stated:

This
is
a
new
Federal
initiative,
and
I
recognize
the
desire
of
some
of
my
colleagues
to
move
ahead
cautiously
to
ensure
that
burdens
imposed
on
industry
are
not
excessive.
Frankly,
my
concern
rest
with
the
families
that
live
in
the
shadows
of
these
chemical
and
manufacturing
plants.
I
have
put
myself
in
their
shoes
and
have
fought
for
a
program
that
looks
after
their
needs.
This
legislation
gets
us
well
on
the
path
to
the
full
disclosure
they
deserve.
Legislative
History
at
5316.
See
also,
Legislative
History
at
5185±
86
(Senate
debate
on
the
Conference
Report).
As
noted
in
Unit
VI.
A,
one
of
the
major
pieces
of
Congressional
guidance
on
the
establishment
of
alternate
thresholds
was
to
obtain
a
comprehensive
picture
of
``
total
nationwide
releases
of
the
toxic
chemical
at
all
facilities
covered
by
section
313.
''
This
language,
plus
other
Congressional
directives
on
implementing
section
313
generally,
such
as
section
313(
h),
reflect
an
interest
in
obtaining
information
from
a
broadly
representative
range
of
sources.
Consequently,
EPA
determined
that
the
Agency
should
consider
burden
only
to
the
extent
that
it
would
not
deny
the
public
significant
information
from
a
range
of
covered
industry
sectors.
Therefore,
EPA
estimated
the
number
of
reports
that
would
be
submitted
by
each
industry
sector
for
four
groups
of
thresholds,
1
and
10
pounds,
10
and
100
pounds,
100
and
1,000
pounds,
and
1,000
pounds
for
both
classes
of
chemicals.
These
options
were
selected
for
the
following
reasons.
EPA
needed
a
reasonable
but
finite
number
of
options
to
evaluate,
and
the
options
described
above
represent
a
reasonable
picture
of
the
entire
range
of
potential
revised
thresholds.
Data
limitations
on
the
manufacturing,
processing,
and
otherwise
use
of
PBT
chemicals
in
the
numerous
industries,
processes,
and
uses
covered
by
EPCRA
section
313
58691
Federal
Register
/
Vol.
64,
No.
209
/
Friday,
October
29,
1999
/
Rules
and
Regulations
constrained
EPA's
ability
to
make
meaningful
and
reliable
distinctions
between
threshold
options
that
are
less
than
an
order
of
magnitude
apart.
For
example,
while
EPA
believes
it
can
reliably
estimate
the
difference
in
the
number
of
reports
from
a
10
pound
reporting
threshold
and
a
100
pound
reporting
threshold,
EPA
believes
that
the
data
are
insufficient
to
allow
it
to
make
a
meaningful
and
reliable
distinction
in
estimates
of
options
that
are
closer
than
an
order
of
magnitude
such
as
35
pounds
and
50
pounds.
EPA
explained
its
data
limitations
in
the
proposal,
and
commenters
provided
no
information
that
would
allow
the
Agency
to
increase
the
resolution
of
its
analysis.
Consequently,
for
the
final
rule,
EPA
analyzed
options
that
were
orders
of
magnitude
apart
from
the
two
thresholds
identified
through
its
technical
review:
1
pound
for
highly
persistent
and
highly
bioaccumulative
chemicals,
and
10
pounds
for
persistent
and
bioaccumulative
chemicals.
Based
on
information
provided
in
the
economic
analysis
for
this
rulemaking,
at
the
technical
reporting
thresholds
EPA
would
obtain
information
from
a
broad
range
of
facilities
(Ref.
67a).
The
analysis
showed
that
at
a
threshold
of
1
pound,
the
public
would
obtain
information
from
all
industry
sectors
that
are
currently
subject
to
EPCRA
section
313,
and
that
have
been
identified
as
manufacturing,
processing,
or
otherwise
using
those
highly
persistent
highly
bioaccumulative
toxic
chemicals
that
are
part
of
this
rulemaking
(except
dioxin
and
dioxinlike
compounds
which
are
discussed
below).
At
a
threshold
of
10
pounds,
the
public
would
obtain
information
from
all
industry
sectors
that
are
currently
subject
to
EPCRA
section
313,
and
that
have
been
identified
as
manufacturing,
processing,
or
otherwise
using
those
PBT
chemicals
that
are
part
of
this
rulemaking.
At
the
technical
reporting
thresholds,
the
estimated
costs
of
the
additional
reports
filed
would
have
totaled
$355
million
in
the
first
year,
and
$193
million
in
subsequent
years
(Ref.
67).
EPA
considered
these
costs,
even
though
it
cannot
quantify
the
value
of
the
information
obtained
or
lost
at
the
various
thresholds,
and
cannot
quantify
the
relationship
between
the
reporting
costs
and
the
value
of
the
information
reported,
or
lost,
at
a
particular
threshold.
At
thresholds
of
10
pounds
for
highly
persistent
and
highly
bioaccumulative
chemicals
and
100
pounds
for
persistent
and
bioaccumulative
chemicals,
EPA
is
still
able
to
obtain
a
significant
amount
of
information
on
both
classes
of
PBT
chemicals
from
a
wide
range
of
industry
sectors
and
sources.
For
example,
no
reporting
on
TBBPA
would
be
lost
from
any
sources
or
industry
sectors
at
100
pounds,
and
some
information
on
octachlorostyrene
would
be
potentially
lost
from
only
one
industry
sector,
pesticide
manufacturing
facilities.
At
these
thresholds,
EPA
does,
however,
lose
information
significant
to
local
communities;
for
example,
EPA
loses
considerable
reporting
on
mercury
and
mercury
compounds
at
10
pounds,
but
the
loss
of
information
is
localized
in
a
limited
number
of
industry
sectors,
and
the
public
will
still
obtain
some
reporting
from
all
of
the
currently
covered
industry
sectors
(Ref.
67a).
For
this
threshold
option,
EPA
estimated
the
total
burden
at
these
thresholds
to
be
$191
million
for
the
first
year,
and
$105
million
for
subsequent
years
(Ref.
67).
At
thresholds
of
100
and
1,000
pounds
and
higher,
EPA's
analysis
indicated
that
the
public,
government
agencies,
and
researchers
would
lose
information
on
many
of
the
PBT
chemicals
from
certain
industry
sectors
and
sources.
For
example,
at
a
threshold
of
100
pounds
for
toxic
chemicals
that
are
highly
persistent
and
highly
bioaccumulative,
the
Agency
would
not
obtain
reporting
on
mercury
and
mercury
compounds
generated
in
boilers
in
the
manufacturing
sector
or
information
on
octachlorostyrene
from
the
primary
metal
industries
(Ref.
67a).
However,
at
these
thresholds,
EPA
estimated
the
total
first
year
costs
to
be
$99
million
and
$55
million
in
subsequent
years
(Ref.
67).
These
analyses
led
EPA
to
several
conclusions.
First,
thresholds
of
10
pounds
for
highly
persistent
and
highly
bioaccumulative
chemicals
and
100
pounds
for
persistent
and
bioaccumulative
chemicals,
achieve
a
significant
reduction
in
reporting
burden.
Second,
at
these
thresholds
EPA
obtains
information
from
a
broad
distribution
of
industry
sectors.
Although
EPA
also
loses
information
significant
to
local
communities
at
these
thresholds,
it
maintains
the
overall
distribution
of
reporting
from
a
broad
range
of
industry
sectors
nationally.
EPA
could
have
attempted
to
compensate
for
the
community­
level
loss
of
information
on
individual
members
of
the
classes
of
PBT
chemicals
(i.
e.,
by
establishing
separate
thresholds
of
1
pound
or
10
pounds
for
individual
chemicals),
but
only
by
failing
to
take
reporting
burden
into
account
for
those
individual
chemicals.
As
explained
previously,
the
availability
of
the
data
limited
EPA's
ability
to
distinguish
meaningfully
between
thresholds
separated
by
less
than
an
order
of
magnitude.
In
addition,
establishing
separate
thresholds
would
sacrifice
many
of
the
benefits
of
receiving
information
from
comparable
facilities
using
comparable
chemicals,
discussed
earlier
in
this
unit.
Thus
greater
information
for
local
communities
would
be
achieved
at
the
expense
of
the
increased
utility
of
the
reports
for
other
purposes
established
under
EPCRA
section
313(
h)­­
e.
g.,
assisting
governmental
agencies,
researchers,
agencies
and
other
persons
in
the
conduct
of
research
and
data
gathering;
and
aiding
in
the
development
of
appropriate
regulations,
guidelines,
and
standards.
EPA
believes
that,
to
be
consistent
with
the
overriding
policy
directive
in
subsection
(h),
it
must
achieve
a
balance
between
improving
the
utility
of
the
reports
for
all
of
the
groups
that
rely
on
TRI
data.
Finally,
as
noted
earlier
in
this
Unit,
administrative
convenience
argues
against
the
establishment
of
individual
thresholds.
Among
other
issues,
it
would
be
burdensome
on
both
EPA
and
the
regulated
community
to
track
a
variety
of
separate
thresholds.
Moreover,
EPA
intends
the
revised
thresholds
established
in
this
rulemaking
for
the
two
classes
of
PBT
chemicals
to
be
generally
applicable
to
future
members
of
the
two
classes;
absent
a
strong
technical
or
policy
concern
to
the
contrary,
it
would
ultimately
be
inconsistent
with
the
purposes
of
EPCRA
section
313
for
chemicals
that
share
such
common
characteristics
to
have
vastly
different
thresholds.
Therefore,
EPA
believes
its
selection
of
thresholds
of
100
pounds
for
PBT
chemicals
and
10
pounds
for
that
subset
of
PBT
chemicals
that
are
highly
persistent
and
highly
bioaccumulative,
balances
the
purposes
of
EPCRA
section
313
and
the
Agency's
desire
to
provide
a
comprehensive
picture
on
releases
and
potential
exposures
of
PBT
chemicals,
while
factoring
in
an
appropriate
degree
of
the
consequent
impact
on
the
regulated
community.
Dioxin
and
dioxin­
like
compounds
are
highly
persistent
and
highly
bioaccumulative
toxic
chemicals.
As
discussed
above,
toxic
chemicals
that
are
highly
persistent
and
highly
bioaccumulative
warrant,
in
the
absence
of
other
considerations,
a
threshold
approaching
zero.
But,
for
the
reasons
discussed
previously
in
this
section,
EPA
does
not
believe
that
a
zero
threshold
would
be
practical.
However,
because
the
dioxin
and
dioxin­
like
compounds
are
manufactured
in
extremely
small
amounts,
EPA
needed
to
select
a
threshold
lower
than
that
for
the
other
highly
persistent
and
highly
58692
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/
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64,
No.
209
/
Friday,
October
29,
1999
/
Rules
and
Regulations
bioaccumulative
chemicals
in
order
to
obtain
any
reporting.
In
choosing
reporting
thresholds
for
these
chemicals,
the
Agency
considered
the
extent
of
the
information
on
dioxin
and
dioxin­
like
compounds
that
would
be
made
available
to
the
public,
government
agencies
and
researchers.
EPA
considered
whether
this
level
of
information
would
provide
them
with
``
a
comprehensive
view
of
toxic
chemical
exposure,
''
given
the
attributes
of
dioxin
and
dioxin­
like
compounds,
and
with
``
broad­
based
national
information.
''
At
a
threshold
of
0.1
gram,
the
public
would
obtain
information
from
all
industry
sectors
that
are
subject
to
EPCRA
section
313
and
that
have
been
identified
in
the
Inventory
of
Sources
of
Dioxin
in
the
United
States
(Ref.
3).
EPA
does
not
believe
that
a
higher
threshold,
i.
e.,
1.0
grams,
would
provide
the
public
with
broad­
based
national
information
because
there
would
be
no
information
on
the
manufacture
and
release
and
other
waste
management
of
certain
sectors.
For
example,
at
a
higher
threshold,
EPA
anticipates
that
there
would
be
no
reporting
from
hazardous
waste
incinerators,
pulp
mills,
non
high
ferrous
foundry
industries,
and
secondary
lead
smelters
(Ref.
67a).
At
thresholds
lower
than
0.1
gram,
there
is
greater
coverage
within
certain
industry
sectors,
with
a
concomitant
significant
increase
in
burden.
EPA
believes
its
selection
of
a
threshold
of
0.1
gram
for
dioxin
and
dioxin­
like
compounds
balances
the
purposes
of
EPCRA
section
313
and
the
Agency's
desire
to
provide
a
comprehensive
picture
on
releases
and
exposures
of
dioxin
and
dioxin­
like
compounds
while
factoring
in
an
appropriate
degree
of
the
resultant
impact
on
the
regulated
community.

F.
What
Comments
Did
EPA
Receive
on
Exposure
and
Risk
Considerations
and
What
Are
EPA's
Responses?
One
of
the
most
significant
issues
raised
by
commenters
relates
to
the
Agency's
lack
of
consideration
of
quantitative
risk
in
modifying
the
section
313(
f)
reporting
thresholds.
Specifically,
a
number
of
commenters
believe
that
EPA
should
use
quantitative
risk
as
a
criterion
in
determining
whether
to
lower
the
reporting
thresholds
and
in
choosing
a
particular
reporting
threshold
for
each
PBT
chemical.
The
commenters
contend
that
EPA
should
conduct
risk
assessments
and
make
a
formal
determination
that
at
a
particular
threshold
releases
of
the
PBT
chemical
pose
a
risk
before
lowering
the
reporting
threshold.
While
the
majority
of
commenters
who
commented
on
the
issue
believe
that
EPA
should
make
a
risk
determination
before
modifying
the
reporting
thresholds,
the
rationale
for
their
conclusions
varied.
Some
commenters
state
that
a
risk
determination
is
required
by
EPCRA
because
the
intent
of
EPCRA
is
to
provide
information
to
the
public
of
potential
risks
posed
by
the
presence
of
toxic
chemicals
released
to
the
environment
in
their
communities.
Some
commenters
state
that
in
addition
to
addressing
the
substantial
majority
test,
EPCRA
section
313(
f)(
2)
requires
EPA
to
use
the
degree
of
risk
that
releases
will
pose
to
communities
as
a
determinant
in
choosing
new
thresholds.
Other
commenters
state
that
consideration
of
risk
is
a
required
component
of
any
action
under
EPCRA
section
313.
In
support
of
this
position,
one
of
the
commenters
cites
two
D.
C.
Circuit
Court
decisions.
Other
commenters
contend
that
it
would
be
good
public
policy
to
choose
a
threshold
based
on
risks.
Some
commenters
contend
that
EPA
should
lower
the
reporting
thresholds
only
for
those
chemicals
that
present
the
highest
risks
to
the
public.
One
commenter,
however,
believes
that
the
Agency
should
not
consider
the
degree
of
risk
in
making
a
determination
to
lower
the
reporting
thresholds
for
PBT
chemicals
because
the
consideration
of
risk
in
past
actions
taken
by
EPA
under
other
environmental
statutes
have
not
resulted
in
a
decrease
of
human
health
or
environmental
risks
due
to
PBT
chemicals.
The
commenter
states
that
the
increasing
number
of
fish
advisories
and
the
lingering
and,
in
some
cases,
increasing
levels
of
PBT
chemicals
in
the
environment
and
in
fish,
wildlife,
and
human
tissue
demonstrates
the
magnitude
of
the
failure
of
the
``
risk
management
strategy.
''
EPA
disagrees
with
the
commenters'
assertion
that
evidence
of
risk
is
required
prior
to
lowering
the
threshold
for
any
EPCRA
section
313
chemical.
Section
313(
f)(
2)
addresses
revisions
to
the
reporting
thresholds.
It
does
not
require
EPA
to
establish,
prior
to
the
lowering
of
reporting
thresholds,
that
releases
at
a
particular
threshold
will
result
in
specific
quantitative
risks.
That
section
expressly
provides
that
the
Administrator
may
establish
a
threshold
amount
for
a
toxic
chemical
different
from
the
25,000
pound
threshold
for
manufacturing
and
processing
activities
and
the
10,000
pound
threshold
for
otherwise
use
activities.
The
only
prerequisite
for
revising
the
reporting
threshold
for
a
toxic
chemical
is
that
the
revised
threshold
obtain
reporting
on
a
substantial
majority
of
total
releases
of
the
chemical
at
all
facilities
subject
to
the
requirements
of
EPCRA
section
313.
As
discussed
in
Units
II.
B.
and
VI.
A.,
EPA
believes
that
it
has
satisfied
the
requirements
of
EPCRA
section
313(
f)(
2)
without
the
need
for
quantitative
support.
EPA
believes
that
the
commenters
attribute
a
purpose
to
EPCRA
that
is
inconsistent
with
that
clearly
intended
by
Congress.
Specifically,
Congress
stated
in
EPCRA
section
313(
h)
that:

The
release
forms
required
under
this
section
are
intended
to
provide
information
to
the
Federal,
State,
and
local
governments
and
the
public,
including
citizens
of
communities
surrounding
covered
facilities.
The
release
form
shall
be
available,.
.
.to
inform
persons
about
releases
of
toxic
chemicals
to
the
environment;
to
assist
government
agencies,
researchers,
and
other
persons
in
the
conduct
of
research
and
data
gathering;
to
aid
in
the
development
of
appropriate
regulations,
guidelines,
and
standards;
and
for
other
similar
purposes.
42
U.
S.
C.
section
11023(
h).

Neither
EPCRA
section
313(
h)
nor
its
legislative
history
directs
EPA
to
limit
the
collection
of
information
on
releases
to
those
releases
that,
from
the
Federal
government's
perspective,
pose
significant
local
human
and
environmental
exposure
and
human
health
and
environmental
risks.
See,
e.
g.,
Legislative
History
at
5186.
Federal
and
local
perspectives
on
what
may
be
an
acceptable
risk
are
likely
to
be
very
different.
The
roles
of
local
government
and
the
Federal
government
differ
significantly
in
terms
of
ensuring
environmental
quality.
In
passing
EPCRA,
Congress
determined
that
it
is
for
the
public
to
take
the
information
reported
on
the
use
and
releases
and
other
waste
management
of
toxic
chemicals,
and
to
determine
whether
these
releases
result
in
potential
risks
that
the
community
determines
warrant
further
action
given
other
factors,
such
as
economic
and
environmental
conditions,
or
particularly
vulnerable
human
or
ecological
populations.
Congress
did
not
intend
the
Federal
government
to
consider
these
specific
local
factors
prior
to
determining
whether
certain
information
should
be
made
public
or
prior
to
determining
whether
a
different
threshold
should
be
established
for
one
or
more
toxic
chemicals.
The
intent
of
EPCRA
section
313
is
to
move
the
determination
of
what
risks
are
acceptable
from
EPA
to
the
communities
in
which
the
releases
occur.
This
basic
local
empowerment
is
a
cornerstone
of
the
right­
to­
know
program.
EPCRA
section
313
establishes
an
information
collection
and
dissemination
program.
The
burden
it
imposes
is
significantly
less
than
the
58693
Federal
Register
/
Vol.
64,
No.
209
/
Friday,
October
29,
1999
/
Rules
and
Regulations
burden
imposed
by
a
statute
which
controls
the
manufacture,
use,
and/
or
disposal
of
a
chemical.
EPCRA
section
313
requires
that
a
facility
use
readily
available
data,
or
if
such
data
are
not
available,
reasonable
estimates
to
prepare
each
chemical­
specific
report.
The
statute
does
not
require
that
the
facility
conduct
monitoring
or
emissions
measurements
to
determine
these
quantities.
This
is
in
contrast
to
other
environmental
statutes
that
may
require
a
facility
to
monitor
releases,
change
its
manufacturing
process,
install
a
specific
waste
treatment
technology,
or
dispose
of
wastes
in
a
certain
manner.
As
such,
the
Agency
believes
that
as
a
matter
of
policy
the
standard
that
must
be
met
to
require
information
pursuant
to
EPCRA
section
313
is
less
than
that
required
to
regulate
a
chemical
under
a
statute
such
as
the
Clean
Air
Act.
See,
e.
g.,
Legislative
History
at
5186.
Further,
contrary
to
assertions
by
some
commenters,
EPCRA
section
313
does
not
require
the
collection
of
quantitative
risk
data
nor
does
the
statute
require
that
risk
data
be
disseminated
to
the
public.
Rather
TRI
data
provide
communities
with
information
on
releases
and
other
waste
management
quantities.
TRI
data
cannot,
in
themselves,
provide
information
on
quantitative
risks
to
individual
communities.
A
determination
of
the
potential
risk
that
a
chemical
release
may
pose
is
dependent
upon
a
number
of
factors,
including
the
toxicity
of
the
chemical,
the
physical
chemical
properties
of
the
chemical,
the
specific
media
to
which
the
chemical
is
released,
and
sitespecific
information
that
will
determine
the
estimated
exposures.
While
TRI
data
are
not
in
themselves
measures
of
risk,
they
are
an
important
input
that
local
communities
can
use
along
with
the
factors
described
in
this
section
to
determine
potential
risks
to
themselves,
their
children,
their
communities,
and
their
environment
that
may
result
from
releases
of
toxic
chemicals.
EPA's
decision
to
lower
the
reporting
threshold
for
PBT
chemicals
is
rationally
related
to
the
EPCRA
section
313
goals
of
informing
communities,
assisting
research
and
data
gathering,
and
aiding
the
development
of
regulations
and
guidelines.
Because
PBT
chemicals
persist
in
the
environment
for
a
significant
period
of
time
and
bioaccumulate
in
animal
tissues,
PBT
chemicals
have
the
potential
to
be
pervasive
in
the
environment,
in
the
food
chain,
and
often
in
humans.
In
short,
for
PBT
chemicals,
releases
and
other
waste
management
activities
for
relatively
small
amounts
of
PBT
chemicals
are
of
concern.
Accordingly,
pursuant
to
the
intended
purposes
of
EPCRA,
even
relatively
small
releases
and
other
waste
management
activities
for
PBT
chemicals
need
to
be
reported
in
order
to
inform
communities,
assist
those
engaged
in
research
and
data
gathering,
and
to
aid
the
development
of
regulations
and
guidelines.
Lowered
reporting
thresholds
for
PBT
chemicals
are
needed
to
obtain
reporting
on
these
relatively
small
releases
and
other
waste
management
activities
for
PBT
chemicals.
Consequently,
EPA
believes
that
including
consideration
of
the
quantitative
risk
in
establishing
the
thresholds
would
be
poor
public
policy
that
would
be
inconsistent
with
the
overall
principles
of
EPCRA.
Finally,
the
reference
by
one
of
the
commenters
to
two
D.
C.
Circuit
Court
decisions
is
misplaced.
In
support
of
its
position
that
EPA
must
undertake
a
risk
assessment
of
any
toxic
chemical
it
is
considering
for
lower
reporting
thresholds,
the
commenter
cites
American
Petroleum
Institute
v.
Costle,
665
F.
2d
1176,
1187
(D.
C.
Cir.
1981),
cert.
denied,
455
U.
S.
1034
(1982),
and
Milwaukee
Metropolitan
Sewerage
District
v.
EPA,
40
F.
3d
392
(D.
C.
Cir.
1994).
Neither
case
cited
by
the
commenter
addresses
EPCRA.
Nor
do
these
cases
establish
a
generally
applicable
principle
of
law
that
risk
assessments
are
required
prior
to
any
government
action.
In
Milwaukee
Metropolitan
Sewerage
the
court
reviewed
standards
adopted
by
EPA
in
a
Clean
Water
Act
regulation.
In
American
Petroleum
Institute
the
court
reviewed
the
primary
and
secondary
national
ambient
air
quality
standards
for
ozone
promulgated
by
EPA
under
the
Clean
Air
Act.
Both
the
Clean
Air
Act
and
the
Clean
Water
Act
have
no
bearing
on
EPCRA
section
313.
Unlike
the
statutes
at
issue
in
the
cases
cited
by
the
commenter,
consideration
of
risk
is
not
a
requirement
of
section
313(
f)(
2)
for
modifying
the
reporting
thresholds
for
EPCRA
section
313
listed
chemicals,
and,
in
fact,
the
consideration
of
risk
is
generally
not
required
for
any
rulemaking
under
section
313.
Troy
Corporation
v.
EPA,
120
F.
3d
277
(D.
C.
Cir.
1997).
Some
commenters
further
state
that
in
proposing
to
change
EPCRA
section
313
reporting
thresholds,
EPA
has
not
addressed
any
of
the
factors
the
Agency
mentioned
when
it
originally
promulgated
EPCRA
section
313
regulations.
In
the
February
16,
1988
final
rule,
EPA
stated:

EPA
may
consider
a
number
of
factors
for
threshold
modification
including
exposure
factors
such
as
population
density,
the
distance
of
population
from
covered
facilities,
and
the
types
of
releases.
Threshold
modifications
could
also
take
into
account
the
relative
potency
of
the
chemical
or
class
of
chemicals
and
effects
of
concern.
(53
FR
4508).

In
this
statement,
the
commenters
contend
that
EPA
correctly
mentions
factors
that
relate
to
risk
(i.
e.,
exposure
and
relative
toxicity).
The
current
proposal
to
change
reporting
thresholds
under
EPCRA
section
313
fails
to
address
these
factors.
As
is
clearly
evident
in
the
quote
from
the
February
16,
1988
final
rule,
EPA
stated
that
these
were
things
that
it
``
may
consider''
or
that
could
be
taken
into
account.
These
statements
do
not
require
that
the
possible
factors
mentioned
above
be
a
basis
for
any
change
in
the
reporting
thresholds
nor
do
they
preclude
the
consideration
of
factors
such
as
the
persistence
and/
or
bioaccumulation
of
toxic
chemicals
in
modifying
the
reporting
thresholds.
This
statement
was
not
a
commitment
that
EPA
would
consider
risk
in
any
decision
to
modify
reporting
thresholds.
It
merely
provided
examples
of
things
that
the
Agency
may
consider.
As
explained
in
previous
responses,
EPA
does
not
believe
that
it
would
be
good
public
policy
to
consider
factors
related
to
quantitative
risk
with
respect
to
establishing
thresholds
for
PBT
chemicals.
Given
the
degree
of
persistence
and
bioaccumulation
that
these
toxic
chemicals
exhibit,
EPA
believes
that
the
value
of
this
information
to
the
public
outweighs
the
policy
considerations
presented
in
favor
of
considering
risk
factors
in
establishing
revised
thresholds.
Any
other
decision
would
be
inconsistent
with
the
legislative
intent
underlying
EPCRA
section
313.
Finally,
EPA
notes
that
this
decision
is
consistent
with
the
approach
adopted
in
modifying
the
thresholds
to
establish
a
1
million
pound
manufacture,
process,
or
otherwise
use
threshold
for
facilities
that
have
500
pounds
or
less
of
production­
related
waste
(59
FR
61488,
November
30,
1994)
(FRL±
4920±
5).
Any
decision
to
include
risk
considerations
in
establishing
modified
thresholds
under
section
313(
f)(
2)
would
compel
the
Agency
to
re­
examine
the
thresholds
established
for
facilities
with
less
than
500
pounds
of
production­
related
waste.
Several
commenters
contend
that
a
chemical's
degree
of
persistence
and
bioaccumulation
are
unrelated
to
the
chemical's
exposure
potential.
They
disagree
that
persistence
and
bioaccumulation
are
necessarily
indicators
of
exposure
or
exposure
potential.
As
an
example,
the
commenter
states
that
many
of
the
compounds
EPA
is
targeting
are
highly
lipophilic,
non­
water
soluble
58694
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64,
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209
/
Friday,
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29,
1999
/
Rules
and
Regulations
compounds,
and
the
greatest
potential
for
bioaccumulative
effects
is
through
uptake
from
the
water
column.
EPA
should
evaluate
how
these
compounds
partition
in
the
environment.
Those
that
are
not
bioavailable
have
limited
exposure
potential,
and
therefore
limited
risk.
Thus,
the
commenter
believes
that
EPA
must
consider
exposure
in
conjunction
with
persistence
and
bioaccumulation.
EPA
disagrees
with
the
commenters.
All
other
things
being
equal,
the
chemical
with
a
higher
degree
of
persistence
and
bioaccumulation
will
have
a
greater
exposure
potential
than
the
chemical
with
a
lower
degree
of
persistence
and
bioaccumulation.
For
example,
all
other
things
being
equal,
a
chemical
that
has
a
half­
life
in
water
of
4
months
will
have
a
higher
exposure
potential
to
aquatic
organisms
than
a
chemical
with
a
half­
life
in
water
of
1
month.
Fifty
percent
of
the
first
chemical
will
remain
in
the
water
after
4
months
while
only
12.5%
of
the
second
chemical
will
remain
in
the
water
after
4
months.
After
4
months,
aquatic
organisms
will
be
exposed
to
4
times
more
of
the
first
chemical
than
the
second
chemical.
Clearly
the
chemical
with
the
greater
persistence
has
the
higher
exposure
potential.
EPA
does
not
believe
that
the
commenter's
example
supports
their
contention
that
persistence
and
bioaccumulation
are
unrelated
to
exposure
potential.
As
EPA
understands
the
commenter's
example,
chemicals
that
have
the
greatest
bioaccumulation
potential
will
not
be
bioavailable
in
water
because
they
are
highly
lipophilic
and
non­
water
soluble.
Thus,
because
they
are
not
bioavailable
in
water,
they
cannot
bioaccumulate
in
aquatic
organisms.
A
well­
studied
example
that
clearly
contradicts
the
commenter's
claim
is
the
bioaccumulation
of
polychorinated
biphenyls
(PCBs)
in
the
Great
Lakes.
PCBs
have
BAFs
as
high
as
141,000,000
(Table
1,
at
64
FR
707±
8)
and
very,
very
low
water
solubility.
PCBs
have
been
found
throughout
the
Great
Lakes
in
sediments,
water,
and
aquatic
organisms.
Multimedia
analyses
indicate
that
the
majority
(80±
90%)
of
human
exposure
to
chlorinated
organic
compounds,
such
as
PCBs
comes
from
the
food
pathway,
a
lesser
amount
(5±
10%)
from
air,
and
minute
amounts
(less
than
1%)
from
water.
Most
of
the
data
available
on
human
exposure
to
toxic
substances
in
the
Great
Lakes
come
from
the
analyses
of
contaminant
levels
in
drinking
water
and
sport
fish.
The
consumption
of
contaminated
sport
fish
and
wildlife
can
significantly
increase
human
exposure
to
the
Great
Lakes
critical
pollutants.
The
sport
fish
are
exposed
to
PCBs
by
consumption
of
sediments
and
in
water,
from
which
they
bioaccumulate
the
PCBs
(Ref.
62).
Some
commenters
contend
that
EPCRA
requires
that
EPA
consider
the
risks
that
a
chemical
may
pose
when
making
determinations
to
add
a
chemical
to
the
EPCRA
section
313
list
of
toxic
chemicals.
In
support
of
this
position,
one
commenter
cites
two
D.
C.
Circuit
Court
decisions.
As
discussed
in
detail
in
the
final
rule
adding
286
chemicals
to
EPCRA
section
313
(59
FR
61432),
EPA
disagrees
with
commenters
that
the
Agency
must
include
a
risk
assessment
component
to
EPCRA
section
313
determinations.
While
the
Agency
believes
that
there
are
limited
circumstances
where
it
may
be
appropriate
to
consider
risk
in
making
listing
determinations,
e.
g.,
acute
human
health
effects,
EPA
does
not
believe
that
the
intent
of
EPCRA,
the
EPCRA
section
313
toxicity
criteria,
or
the
legislative
history
support
the
contention
that
risk
assessment
is
a
required
component
of
all
EPCRA
section
313
listing
determinations.
The
EPCRA
section
313
toxicity
criteria
require
that
exposure
and
risk
factors
be
considered
only
when
determining
if
the
toxic
chemical
should
be
listed
on
EPCRA
section
313
based
on
its
acute
human
health
effects,
but
even
then
in
only
a
very
limited
manner.
The
statute
mandates
that
EPA
consider
whether
``
a
chemical
is
known
to
cause
or
can
reasonably
be
anticipated
to
cause
significant
adverse
acute
human
health
effects
at
concentration
levels
that
are
reasonably
likely
to
exist
beyond
facility
site
boundaries.
''
EPA
has,
and
will
continue
to
look
at
exposures
reasonably
likely
to
exist
beyond
facility
site
boundaries
when
making
a
listing
determination
pursuant
to
EPCRA
section
313(
d)(
2)(
A).
However,
EPA
notes
that
none
of
the
toxic
chemicals
added
in
today's
action
were
added
pursuant
to
paragraph
(A)
of
that
section.
The
statute
is
silent
on
the
issue
of
exposure
considerations
for
the
section
313(
d)(
2)(
B)
and
(C)
criteria.
The
language
of
section
313
does
not
prohibit
EPA
from
considering
exposure
factors
when
making
a
finding
under
either
section
313(
d)(
2)(
B)
or
section
313(
d)(
2)(
C).
However,
the
language
of
sections
313(
d)(
2)(
B)
and
(C)
does
not
require
the
type
of
exposure
assessment
and/
or
risk
assessment
argued
by
the
commenters.
EPA
believes
that
it
has
the
discretion
under
both
section
313(
d)(
2)(
B)
and
section
313(
d)(
2)(
C)
to
consider,
where
appropriate,
those
exposure
factors
that
may
call
into
question
the
validity
of
listing
of
any
specific
chemical
on
EPCRA
section
313.
EPA
believes
that
its
position
regarding
the
limited
use
of
risk
in
listing
decisions
is
consistent
with
the
purpose
and
legislative
history
of
EPCRA
section
313,
as
illustrated
in
the
following
passage
from
the
Conference
report:

The
Administrator,
in
determining
to
list
a
chemical
under
any
of
the
above
criteria,
may,
but
is
not
required
to,
conduct
new
studies
or
risk
assessments
or
perform
sitespecific
analyses
to
establish
actual
ambient
concentrations
or
to
document
adverse
effects
at
any
particular
location.
(H.
Rep.
99­
962,
99th
Cong.,
2nd
Sess.,
p.
295
(October
3,
1986)).
See
also
Legislative
History
at
5186.

This
passage
indicates
that
Congress
did
not
intend
to
require
EPA
to
conduct
new
studies,
such
as
exposure
studies,
or
to
perform
risk
assessments.
Therefore,
Congress
did
not
consider
these
activities
to
be
mandatory
components
of
all
section
313
decisions.
EPA
believes
that
this
statement
combined
with
the
plain
language
of
the
statutory
criteria
clearly
indicate
that
Congress
intended
that
the
decision
of
whether
and
how
to
consider
exposure
under
EPCRA
section
313(
d)(
2)(
B)
and
(C)
should
be
left
to
the
Agency's
discretion.
EPA
has
carefully
considered
when
and
how
to
use
exposure
to
fully
implement
the
right­
to­
know
provisions
of
EPCRA.
The
Agency
believes
that
exposure
should
be
considered
only
in
very
limited
circumstances
when
adding
a
chemical
to
EPCRA
section
313(
d)(
2)(
B)
or
(C).
The
Agency's
interpretation
of
the
section
313(
d)(
2)
and
(d)(
3)
criteria
for
modifying
the
section
313
list
of
toxic
chemicals
is
discussed
in
the
final
rule
adding
286
chemicals
to
EPCRA
section
313
(at
59
FR
61440±
2).
And
in
fact,
EPA's
interpretation
was
upheld
by
the
D.
C.
Circuit
in
Troy
v.
EPA,
120
F.
3d
277.
The
addition
of
chemicals
pursuant
to
EPCRA
section
313(
d)(
2)(
B)
and
(C)
in
today's
rulemaking
is
consistent
with
this
interpretation.
The
intent
of
EPCRA
section
313
is
to
move
the
determination
of
which
risks
are
acceptable
from
EPA
to
the
communities
in
which
the
releases
occur.
This
basic,
local
empowerment
is
a
cornerstone
of
the
right­
to­
know
program.
EPCRA
section
313
establishes
an
information
collection
and
dissemination
program.
It
provides
the
public
with
information
that
can
be
used
with
other
site­
specific
factors
to
determine
if
releases
into
their
communities
result
in
risks
that
the
community
determines
warrant
further
action
given
other
factors,
such
as
economic
and
environmental
58695
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/
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209
/
Friday,
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29,
1999
/
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Regulations
conditions,
or
particularly
vulnerable
human
or
ecological
populations.
In
addition,
the
reference
by
one
of
the
commenters
to
two
D.
C.
Circuit
Court
decisions
is
misplaced.
In
support
of
its
position
that
EPA
must
undertake
a
risk
assessment
of
any
toxic
chemical
it
is
considering
to
add
to
EPCRA
section
313,
the
commenter
cites
American
Petroleum
Institute
v.
Costle,
665
F.
2d
1176,
1187
(D.
C.
Cir,
1981),
cert.
denied,
455
U.
S.
1034
(1982),
and
Milwaukee
Metropolitan
Sewerage
District
v.
EPA,
40
F.
3d
392
(D.
C.
Cir.
1994).
As
discussed
in
a
previous
response
in
this
unit,
neither
case
cited
by
the
commenter
addresses
EPCRA.
In
addition,
since
both
cases
were
decided
prior
to
Troy,
by
the
same
court,
that
decided
the
specific
issue
raised
by
the
commenter,
nothing
in
the
two
earlier
cases
cited
by
the
commenter
can
overrule
that
decision.

G.
Which
Chemicals
is
EPA
Adding
to
the
List
of
EPCRA
Section
313
Toxic
Chemicals?
EPA
is
adding
the
following
chemicals
to
the
EPCRA
section
313
list
of
toxic
chemicals:
dioxin
and
dioxinlike
compounds,
benzo(
g,
h,
i)
perylene,
benzo(
j,
k)
fluorene
(fluoranthene),
3­
methylcholanthrene,
octachlorostyrene,
pentachlorobenzene,
tetrabromobisphenol
A,
vanadium
(except
alloys)
and
vanadium
compounds.
EPA
conducted
a
hazard
assessment
on
each
chemical
being
added
to
the
EPCRA
section
313
list
of
toxic
chemicals
today.
This
assessment
was
separate
and
independent
from
the
review
conducted
to
determine
each
chemical's
persistence
and
bioaccumulation
potential,
although
EPA
considered
some
of
the
same
data
in
certain
of
its
hazard
assessments.
EPA
finds
that
each
chemical
being
added
today
meets
the
criteria
for
chronic
human
toxicity
and/
or
environmental
toxicity,
as
set
forth
at
EPCRA
sections
313(
d)(
2)(
B)
and
(C).
A
summary
discussion
of
the
basis
for
listing
each
of
these
chemicals
as
well
as
other
related
issue
are
presented
in
the
remainder
of
this
unit.
A
more
extensive
discussion
of
these
issues
is
included
in
the
Response
to
Comments
document
(Ref.
69)
and
supporting
documents.
1.
Dioxin
and
dioxin­
like
compounds
category.
There
were
a
number
of
comments
received
on
the
addition
of
the
dioxin
and
dioxin­
like
compounds
category
and
these
are
addressed
in
detail
in
the
Response
to
Comments
document
(Ref.
69).
Most
of
the
comments
on
the
toxicity
data
that
EPA
presented
in
support
of
the
addition
of
the
category
concern
the
dioxin­
like
compounds
since
most
commenters
seemed
to
agree
that
2,3,7,8­
tetrachlorodibenzo­
p­
dioxin
(dioxin
or
2,3,7,8­
TCDD)
meets
the
criteria
for
listing
under
EPCRA
section
313(
d)(
2)(
B).
A
number
of
commenters
did
not
believe
that
there
was
sufficient
information
to
add
any
of
the
dioxinlike
compounds
while
several
commenters
argue
that
the
data
on
the
octa­
and
heptachlorodibenzo­
p­
dioxins
in
particular
were
not
sufficient.
Commenters
also
argue
that
reliance
on
established
toxicity
equivalence
factors
(TEFs)
does
not
provide
sufficient
support
for
determining
that
the
dioxinlike
compounds
meet
the
EPCRA
section
313(
d)(
2)(
B)
criteria.
EPA
disagrees
with
the
commenters
that
contend
that
there
are
not
sufficient
data
to
add
the
dioxin­
like
compounds
pursuant
to
EPCRA
section
313(
d)(
2)(
B).
2,3,7,8­
TCDD
is
generally
recognized
as
one
of
the
most
studied
toxic
compounds
found
in
the
environment.
To
require
the
degree
of
documentation
supporting
toxicological
classification
of
2,3,7,8
­TCDD
as
a
necessary
criterion
for
determining
that
other
dioxin­
like
compounds
exhibit
dioxin­
like
toxicity
or
for
listing
under
EPCRA
section
313
is
an
arbitrary
and
unrealistic
criteria.
As
discussed
in
more
detail
in
the
Response
to
Comments
document
(Ref.
69),
a
more
scientifically
supportable
set
of
criteria
for
determining
if
compounds
exhibit
dioxin­
like
toxicity
was
proposed
by
the
World
Health
Organization
European
Centre
for
Environmental
Health
(WHO­
ECEH)
and
the
International
Programme
on
Chemical
Safety
(IPCS)
consultation
group.
These
criteria
include:
(1)
A
compound
must
show
a
structural
relationship
to
TCDD;
(2)
a
compound
must
bind
to
the
Ah
receptor;
(3)
a
compound
must
elicit
Ah
receptormediated
biochemical
and
toxic
responses;
and
(4)
a
compound
must
be
persistent
and
accumulate
in
the
food
chain.
Each
of
the
2,3,7,8
substitute
dioxins
and
furans
included
in
the
dioxin
TEQ
approach
meet
these
criteria
(Ref.
3).
The
commenters
often
quoted
from
the
EPA
Science
Advisory
Board
(SAB)
review
of
EPA's
draft
dioxin
reassessment,
to
help
support
the
claim
that
dioxin­
like
compounds
other
than
2,3,7,8­
TCDD
should
not
be
included
in
the
toxic
release
inventory.
The
SAB
report
is
a
complex
document
containing
a
number
of
contrasting
observations.
Care
must
be
taken
to
accurately
capture
the
SAB's
concerns.
For
example,
in
their
Executive
Summary,
the
SAB
concluded
that,
``
The
use
of
the
TEFs
as
a
basis
for
developing
an
overall
index
of
public
health
risk
is
clearly
justified'';
they
caution,
however,
``
that
practical
application
depends
on
the
reliability
of
the
TEFs
and
the
availability
of
representative
and
reliable
data.
''
In
their
summary
conclusions,
the
SAB
stated:

The
document
(EPA
Draft
Reassessment)
represents
a
departure
from
the
earlier
EPA
risk
assessment
for
dioxin,
which
dealt
primarily
with
2,3,7,8­
TCDD.
In
addressing
a
broad
range
of
dioxin­
like
compounds
having
the
common
property
of
binding
to
the
Ah
receptor
and
producing
related
responses
in
cells
and
whole
animals,
it
creates
opportunities
for
a
holistic
assessment
of
the
cumulative
impacts
of
these
broadly
distributed
anthropogenic
pollutants.
Thus,
while
the
environmental
concentrations
of
each
compound
alone
may
be
too
low
to
produce
effects
of
concern,
the
combined
exposure
may
be
producing
effects
that
warrant
concern.
The
use
of
the
concept
of
TEFs
and
the
concentrations
of
the
compounds
in
foods
and
environmental
media
to
produce
an
overall
index
of
public
health
risk
is
clearly
justifiable.

The
character
and
thrust
of
these
statements
made
by
the
SAB
are
significantly
different
from
those
selectively
chosen
by
many
of
the
commenters
opposing
the
addition
of
some
or
all
of
the
dioxin­
like
compounds.
The
apparent
contradiction
between
these
broad
concluding
statements
by
the
SAB
and
those
cited
by
several
commenters
is
due,
in
part,
to
commenters
confusing
the
SAB
criticisms
of
the
text
of
the
draft
reassessment
with
statements
about
the
general
state
of
scientific
knowledge.
The
SAB
clearly
felt
that
EPA
needed
to
do
a
more
rigorous
job
of
discriminating
between
the
inferences
it
drew
about
the
toxicity
of
2,3,7,8­
TCDD,
other
2,3,7,8
substitute
dioxins
and
furans,
and
dioxin­
like
PCBs.
Many
of
the
comments
cited
were
intended
to
help
EPA
generate
a
more
rigorous
scientific
discussion
in
its
final
reassessment
document
rather
than
to
represent
substantive
conclusions
reached
by
the
SAB
on
the
nature
of
dioxin
toxicology.
Fully
taking
these
concerns
into
consideration
it
was
still
the
SAB's
overall
judgment,
as
stated
above,
that
``
the
use
of
the
TEFs
as
a
basis
for
developing
an
overall
index
of
public
health
risk
is
clearly
justified.
''
Some
commenters
argue
that
there
are
qualitative
differences
in
the
toxicity
of
the
different
2,3,7,8­
substituted
isomers
of
polychlorinated
dioxins
(PCDDs)
and
furans
(PCDFs).
Specifically,
there
are
structural
differences
between
the
more
toxic,
lower
chlorinated
isomeric
PCDDs
and
PCDFs
and
the
higher
chlorinated
cogeners
to
the
extent
that
the
octa­
and
hepta­
PCDDs
and
PCDFs
should
not
be
added
to
the
list
of
EPCRA
section
313
58696
Federal
Register
/
Vol.
64,
No.
209
/
Friday,
October
29,
1999
/
Rules
and
Regulations
toxic
chemicals.
These
arguments
are
not
valid
for
several
reasons.
First,
there
are
data
from
subchronic
studies
for
both
octa­
and
hepta­
PCDDS
and
PCDFs
which
demonstrate
dioxin­
like
effects
(Refs.
19,
21,
79,
and
80).
The
new
WHO
TEFs
are
based
on
these
subchronic
studies
(Ref.
78).
While
short­
term
studies
indicate
limited
dioxin­
like
effects
of
these
chemicals,
these
contrasting
results
are
readily
explained
by
the
structural
differences
between
the
octa­
and
hepta­
PCDDS
and
PCDFs
compared
to
the
lower
chlorinated
PCDDs
and
PCDFs.
The
relative
potency
of
the
dioxin­
like
compounds
is
related
to
both
their
ability
to
bind
to
the
Ah
receptor
and
their
pharmacokinetic
properties
(Ref.
20).
The
water
solubility
of
PCDDs
and
PCDFs
decrease
with
increasing
chlorine
substitution.
Hence
the
octa­
and
hepta­
PCDDS
and
PCDFs
are
significantly
less
soluble
in
aqueous
solutions
compared
to
the
lower
chlorinated
PCDDs
and
PCDFs.
These
solubility
problems
limit
the
amount
of
chemical
that
can
be
absorbed
in
high
dose
acute
toxicity
studies.
The
lack
of
effect
observed
in
the
high
dose
acute
studies
is
consistent
with
the
limited
aqueous
solubility
of
these
compounds.
However,
low
dose
subchronic
studies
allow
the
chemicals
to
be
better
absorbed
and
bioaccumulate
to
concentrations
which
produce
biochemical
and
toxic
effects
(Refs.
19,
21,
79,
and
80).
Once
again
this
is
consistent
with
the
evidence
of
dioxinlike
effects
of
these
chemicals
observed
in
the
low­
dose
subchronic
studies.
Although
not
legally
required
to
determine
that
a
chemical
meets
the
listing
criteria
under
EPCRA
section
313(
d)(
2)(
B),
it
should
be
noted
that
human
exposure
to
octa­
and
heptaPCDDs
and
PCDFs
are
subchronic
low
dose
exposures,
similar
to
the
experimental
studies
which
demonstrate
dioxin­
like
effects
of
these
chemicals
(Refs.
19,
21,
79,
and
80).
While
there
are
structural
differences
between
the
octa­
and
hepta­
PCDDs
and
PCDFs
compared
to
the
lower
chlorinated
PCDDs
and
PCDFs,
these
differences
result
in
quantitative
not
qualitative
differences
in
the
toxicity
of
these
chemicals.
The
quantitative
differences
are
demonstrated
by
the
lower
potency
of
the
octa­
and
heptacongeners
compared
to
TCDD.
In
addition,
the
TEFs
reflect
these
quantitative
differences
by
assigning
lower
TEF
values
to
the
octa­
and
heptaPCDDS
and
PCDFs.
While
there
is
limited
evidence
that
the
shape
of
the
dose­
response
curve
for
induction
of
CYP1A1
activity
in
vitro
for
octachlorodibenzo­
p­
dioxin
(OCDD)
is
different
from
TCDD,
in
vivo
evidence
indicates
that
the
dose
response
for
CYP1A1
induction
by
octachlorodibenzofuran
(OCDF)
in
three
tissues
is
equivalent
to
TCDD
(Ref.
20).
However,
it
should
be
noted
that
these
are
quantitative
not
qualitative
differences.
Commenters
also
argue
that
octa­
and
hepta­
PCDDs
and
PCDFs
should
not
be
listed
because
``
there
is
a
growing
consensus
in
the
scientific
community
that
the
potential
risks
posed
by
dioxins
are
largely
driven
by
a
limited
number
of
dioxin
and
dioxin­
like
compounds
(tetra­,
penta­,
and
hexa­
PCDDs
and
PCDFs
and
certain
coplanar
PCBs).
''
It
is
important
to
remember
that,
as
discussed
in
Unit
VI.
F.,
EPCRA
section
313
is
primarily
a
hazard­
based
rather
than
a
risk­
based
statute.
The
``
growing
consensus''
on
dioxin
toxicity
is
probably
best
captured
by
the
revised
TEFs
recently
established
by
the
WHO
(Ref.
78).
In
this
review
the
scientific
evidence
for
ascribing
values
of
relative
toxicity
to
octa­
and
hepta­
PCDDs
and
PCDFs
was
specifically
reviewed,
as
evidenced
by
the
lowering
of
the
TEF
for
OCDD
and
OCDF
by
a
factor
of
10.
In
the
course
of
the
deliberations
by
the
WHO
panel
of
internationally
distinguished
scientists,
there
was
the
opportunity
to
remove
both
octa­
and
hepta­
PCDDs
and
PCDFs
from
the
TEF
listings.
However,
the
WHO
panel
concluded
that
the
best
scientific
interpretation
of
the
data
available
was
to
leave
hepta­
PCDDs
and
PCDFs
unchanged
and
reduce
but
not
eliminate
OCDD
from
TEQ
calculations.
Even
with
this
reduced
toxicity,
OCDD
and
OCDF
clearly
meet
the
listing
criteria
of
EPCRA
section
313(
d)(
2)(
B).
EPA
disagrees
with
the
commenters
that
contend
that
TEFs
are
not
adequate
support
for
listing
chemicals
under
EPCRA
section
313.
The
development
of
TEFs
has
been
a
rigorous
scientific
effort
involving
a
number
of
international
panels
of
scientific
experts
and
has
involved
the
careful
review
of
all
relevant
scientific
literature.
EPA
believes
that
the
development
and
review
processes
used
for
the
generation
of
the
TEFs
was
sound
and
represents
a
reasoned
and
reliable
judgment
on
the
dioxin
toxicity
of
each
of
the
17
dioxin
and
dioxin­
like
compounds.
The
Response
to
Comments
document
(Ref.
69)
includes
an
extensive
discussion
of
the
history
of
the
development
of
dioxin
TEFs
which
demonstrates
why
EPA
believes
that
the
TEFs
are
well
supported
scientifically
and
consequently
have
been
openly
adopted
by
the
international
scientific
and
regulatory
community.
In
addition,
as
EPA
has
previously
explained
(59
FR
61432),
the
Agency
believes
that
EPCRA
section
313
allows
a
chemical
category
to
be
added
to
the
list,
where
EPA
identifies
the
toxic
effects
of
concern
for
at
least
one
member
of
the
category
and
then
shows
why
those
effects
can
reasonably
be
expected
to
be
caused
by
all
other
members
of
the
category.
Here,
individual
toxicity
data
are
not
available
for
all
members
of
the
category;
however,
there
is
sufficient
information
to
conclude
based
on
generally
accepted
scientific
principles,
that
all
of
these
chemicals
are
highly
toxic
based
on
structural
and
physical/
chemical
property
similarities
to
those
members
of
the
category
for
which
data
are
available.
Thus,
EPA
reaffirms
that
there
is
sufficient
evidence
for
adding
dioxin
and
dioxin­
like
compounds
on
EPCRA
section
313
pursuant
to
EPCRA
section
313(
d)(
2)(
B)
based
on
the
available
cancer
and
other
serious
chronic
health
effects
data
for
these
compounds.
Therefore,
EPA
is
finalizing
the
listing
of
dioxin
and
dioxin­
like
compounds
on
the
EPCRA
section
313
list.
a.
Manufacturing
only
qualifier
for
dioxins
and
dioxin­
like
compound
category.
Comments
were
mixed
with
regard
to
EPA's
proposal
to
add
a
manufacture
only
qualifier
to
the
dioxin
and
dioxin­
like
compounds
category.
Some
commenters
agree
with
EPA's
statements
in
the
proposed
rule
concerning
the
burden
reduction
aspects
of
the
qualifier
and
the
fact
that
as
a
result,
the
dioxin
reporting
would
focus
on
facilities
that
manufacture
dioxin
and
dioxin­
like
compounds
rather
than
those
that
process
or
otherwise
use
raw
materials
containing
dioxin
and
dioxin­
like
compounds
that
have
accumulated
in
those
raw
materials.
Some
commenters
state
that
the
qualifier
would
avoid
duplicative
testing
and
administrative
costs
among
many
processing
and
using
industries
which
do
not
necessarily
discharge
dioxins
or
furans
into
the
environment.
Some
commenters
state
that
all
releases
of
dioxin
and
dioxin­
like
compounds
must
be
reported,
not
just
those
resulting
from
the
manufacture
of
these
chemicals.
Other
commenters
note
that
a
significant
gap
is
created
by
the
manufacture
only
qualifier
because
it
would
exclude
the
processing
and
otherwise
use
of
chemicals
than
contain
dioxin
and
dioxin­
like
compounds
as
a
result
of
the
processes
used
to
manufacture
them.
Commenters
specifically
cite
pentachlorophenol
as
an
example
of
a
chemical
that
is
contaminated
with
dioxin
and
dioxinlike
compounds
from
its
manufacturing
process.
Commenters
state
that
the
processing
and
use
of
such
chemicals
58697
Federal
Register
/
Vol.
64,
No.
209
/
Friday,
October
29,
1999
/
Rules
and
Regulations
result
in
the
release
of
dioxin
and
dioxin­
like
compounds
that
would
go
unreported
under
the
manufacture
only
qualifier.
One
commenter
states
that
if
the
qualifier
is
finalized
the
commenter
would
like
to
see
language
that
requires
facilities
to
report
if
the
background
levels
of
dioxin
are
modified,
concentrated,
or
somehow
added
to
in
the
manufacturing
process.
Another
commenter
states
that
if
the
Agency
wants
to
exempt
animal
sources
of
dioxin,
such
as
dioxin
contained
in
meat
and
other
animal
products,
it
should
craft
the
rule
to
do
so
and
not
cut
out
other
significant
sources
of
dioxin
in
the
environment
by
exempting
all
facilities
that
process
material
containing
dioxin.
EPA
believes
that
in
order
to
obtain
any
reporting
on
dioxin
and
dioxin­
like
compounds
a
very
low
threshold
is
required,
which
is
several
orders
of
magnitude
lower
than
the
thresholds
for
other
PBT
chemicals.
At
such
a
low
reporting
threshold
it
is
estimated
that
thousands
of
reports
could
potentially
be
filed
by
facilities,
mainly
food
processing
facilities,
due
to
the
amount
of
dioxins
in
the
raw
materials
they
process.
The
dioxins
found
in
the
meat
and
dairy
products
that
food
processors
handle
have
been
previously
released,
circulated
in
the
environment,
and
bioaccumulated
in
animals;
thus
these
are
not
additional
loadings
to
the
environment
but
loadings
that
have
already
occurred
and
cycled
through
the
environment
due
to
the
persistence
and
bioaccumulative
properties
of
these
compounds.
The
unique
combination
of
very
low
thresholds,
the
number
of
food
processors
that
would
be
required
to
file,
and
the
fact
that
they
would
be
filing
because
of
the
bioaccumulation
of
previously
released
material,
led
EPA
to
add
the
manufacture
only
qualifier
to
the
dioxins
category.
The
qualifier
was
added
in
response
to
the
unique
set
of
conditions
that
apply
to
the
reporting
of
dioxin
and
dioxin­
like
compounds.
The
manufacture
only
qualifier
was
added
to
reduce
reporting
burden
on
facilities,
mainly
in
the
food
processing
industry,
that
results
from
the
unique
combination
of
circumstances
related
to
the
reporting
for
these
chemicals
and
to
focus
on
those
activities
that
add
to
the
loading
of
dioxins
in
the
environment
rather
than
on
activities
dealing
with
previously
released
and
bioaccumulated
chemicals.
However,
EPA
acknowledges
that
the
commenters
who
noted
that
the
processing
and
otherwise
use
of
chemicals
contaminated
with
dioxin
and
dioxin­
like
compounds
as
a
result
of
their
manufacturing
process,
are
correct
that
these
would
be
newly
created
and
thus
any
releases
of
dioxin
and
dioxin­
like
compounds
that
are
due
to
the
processing
and
otherwise
use
of
such
chemicals
would
be
new
loadings
on
the
environment.
In
addition,
EPA
agrees,
and
has
never
stated
otherwise,
that
the
processing
or
use
of
chemicals
contaminated
with
dioxin
and
dioxinlike
compounds
could
result
in
the
release
of
these
chemicals
to
the
environment.
Given
the
fact
that
the
manufacture
of
certain
chemicals
also
results
in
the
manufacture
of
dioxin
and
dioxin­
like
compounds
that
remain
with
those
chemicals
as
impurities,
EPA
believes
that
releases
and
other
waste
management
quantities
for
the
dioxin
and
dioxin­
like
compounds
found
as
impurities
with
those
chemicals
should
be
reported
under
the
dioxin
and
dioxin­
like
compounds
category.
Thus,
EPA's
original
proposal
would
have
created
an
exemption
that
was
too
broad.
Consequently,
EPA
is
modifying
the
qualifier
to
read
as
follows:

Dioxin
and
dioxin­
like
compounds
(Manufacturing;
and
the
processing
or
otherwise
use
of
dioxin
and
dioxin­
like
compounds
if
the
dioxin
and
dioxin­
like
compounds
are
present
as
contaminants
in
a
chemical
and
if
they
were
created
during
the
manufacturing
of
that
chemical)

EPA
believes
that
narrowing
its
proposal
in
this
fashion
is
consistent
with
EPA's
intention
to
focus
on
new
loadings
to
the
environment
for
dioxin
and
dioxin­
like
compounds.
One
commenter
states
that
the
activity
qualifier
for
dioxin
and
dioxin­
like
compounds
is
intended
to
minimize
the
burden
of
reporting
on
naturallyoccurring
constituents
of
raw
materials
and
that
this
qualifier
would
be
consistent
with
the
PBT
criteria
set
forth
by
Canada's
Department
of
the
Environment
in
their
Toxic
Substances
Management
Policy.
The
commenter
states
that
the
Canadian
policy
requires
a
chemical
to
be
``
predominantly
anthropogenic''
to
be
considered
a
PBT
chemical.
The
commenter
states
that
EPA's
assumption
that
these
compounds
are
ubiquitous
in
raw
materials
may
be
incorrect.
The
commenter
further
states
that
these
compounds
may
be
formed
in
combustion
processes
due
to
the
ubiquitous
presence
of
precursor
chemicals
in
coal,
such
as
natural
hydrocarbons
and
chlorine.
The
commenter
argues
that
it
is
not
reasonable
to
expect
the
hydrocarbon
nor
the
chlorine
to
be
removed
from
the
raw
material
prior
to
combustion.
Thus,
the
``
incidental
manufacture''
of
extremely
minute
amounts
of
these
chemicals
may
be
unavoidable.
EPA
disagrees
that
the
sole
basis
for
its
qualifier
was
to
minimize
the
burden
of
reporting.
The
qualifier
was
added
in
response
to
the
unique
set
of
conditions
that
apply
to
the
reporting
of
dioxin
and
dioxin­
like
compounds.
As
noted
above,
EPA
was,
and
remains,
concerned
that,
because
dioxin
is
ubiquitous
in
the
environment,
the
reporting
be
focused
on
those
facilities
that
actually
add
to
the
environmental
loading
of
these
chemicals.
EPA
did
not
state
that
dioxin
and
dioxin­
like
compounds
would
be
ubiquitous
in
all
raw
material
and
did
not
intend
to
imply
that
all
raw
materials
contain
these
compounds.
EPA
stated
that
these
compounds
are
ubiquitous
in
the
environment
and,
thus,
facilities
that
process
raw
materials
containing
these
compounds
might
have
to
report
because
of
the
very
low
reporting
threshold
necessary
to
obtain
reports
from
any
sources,
including
those
facilities
that
coincidentally
manufacture
them.
In
addition,
although
the
qualifier
may
be
consistent
with
Canada's
Toxic
Substances
Management
Policy,
EPA
has
not
proposed
any
requirement
that
a
chemical
must
be
``
predominantly
anthropogenic''
to
be
considered
a
PBT
chemical
under
EPCRA
section
313.
The
commenter
is
correct
that
dioxin
and
dioxin­
like
compounds
may
be
manufactured
in
combustion
processes
due
to
the
``
ubiquitous
presence
of
precursor
chemicals''
and
that
such
``
incidental
manufacture''
may
be
unavoidable.
However,
the
mere
presence
of
the
dioxin
precursors
will
not
guarantee
dioxin
production.
There
are
well
documented
conditions
that
favor
the
formation
of
dioxins
during
combustion,
and
in
some
cases
it
may
be
possible
to
stringently
control
fuel
composition,
flow
times,
temperature,
and
other
conditions
in
order
to
substantially
reduce
or
even
eliminate
the
incidental
manufacture
of
dioxins
during
combustion
processes.
b.
Withdrawal
of
the
proposal
to
include
dioxin­
like
PCBs
in
the
dioxin
category.
Several
commenters
support
EPA's
decision
to
withdraw
the
proposal
to
modify
the
current
PCB
listing
and
move
the
11
co­
planar
PCBs
to
the
proposed
dioxin
and
dioxin­
like
compounds
category
and
retain
the
coplanar
PCBs
as
part
of
the
current
PCB
listing.
Two
commenters
support
EPA's
decision
to
leave
co­
planar
PCBs
out
of
the
dioxin
and
dioxin­
like
compounds
category
since
the
structure,
metabolism,
gene
regulation,
and
toxicities
of
PCBs
are
substantially
different
from
those
of
2,3,7,8­
tetrachlorodibenzo­
p­
dioxin.
One
commenter
takes
exception
to
the
use
of
the
term
``
dioxin­
like''
as
a
way
of
describing
PCBs
and
other
chlorinated
58698
Federal
Register
/
Vol.
64,
No.
209
/
Friday,
October
29,
1999
/
Rules
and
Regulations
compounds
and
agrees
that
the
PCBs
should
be
kept
out
of
the
``
dioxin­
like''
class.
Other
commenters
also
argue
that
PCBs
are
more
appropriately
classified
as
PCBs,
not
dioxin­
like
compounds.
One
commenter
contends
that
since
these
chemicals
are
no
longer
allowed
to
be
distributed
in
commerce,
maintaining
a
separate
EPCRA
section
313
chemical
category
for
these
chemicals
will
streamline
data
management.
This
approach
will
also
enable
EPCRA
section
313
reporting
for
this
category
of
chemicals
to
be
more
consistent
with
existing
data
already
collected
for
the
purposes
of
complying
with
TSCA.
Further
the
commenter
asserts
that
approach
is
also
consistent
with
EPA's
Reinvention
Policy
and
will
enable
``
one­
stop''
reporting.
Another
commenter
asserts
that
it
is
unclear
just
how
many
grams
of
dioxinlike
compounds
would
be
excluded
from
this
reporting
since
there
are
conflicting
Agency
proposals
at
work:
the
first
is
a
much
lower
threshold
for
dioxins.
The
second
includes
only
dioxins
manufactured
on
site.
Since
PCBs
are
not
generally
manufactured
on
site,
these
11
dioxin­
like
compounds
would
not
be
reported
under
the
proposal
if
they
were
included
as
dioxins.
On
the
other
hand,
if
all
dioxins
(manufactured,
processed,
and
otherwise
used)
are
included
in
the
EPCRA
section
313
threshold
determination,
these
11
PCBs
could
make
the
difference
between
a
facility's
reporting
or
not
reporting
dioxins.
If
the
dioxin
threshold
remains
as
proposed,
then
the
11
PCBs
should
remain
with
the
PCB
category.
Further
the
commenter
argues
that
if
the
threshold
is
expanded
to
include
sources
other
than
those
that
manufacture
dioxin
onsite
then
the
PCBs
should
be
part
of
the
dioxin­
like
compounds
category.
If
EPA
does
not
modify
the
dioxin
threshold
to
include
all
dioxin
uses,
the
11
dioxinlike
PCBs
should
remain
with
the
PCB
category.
While
EPA
agrees
with
the
commenters
that
the
co­
planar
PCBs
should
remain
as
part
of
the
current
PCB
listing,
the
Agency
does
not
agree
with
all
of
the
reasons
the
commenters
have
presented.
As
EPA
stated
in
the
proposed
rule:

.
.
.EPA
has
determined
that
all
PCBs
persist
and
bioaccumulate.
Since
PCBs
persist
and
bioaccumulate,
EPA
believes
that
they
should
be
subject
to
lower
reporting
thresholds,
and
thus
there
is
no
need
to
move
the
11
co­
planar
PCBs
to
the
proposed
dioxin
and
dioxin­
like
compounds
category.
Therefore,
EPA
has
decided
to
withdraw
its
proposal
to
modify
the
current
listing
for
PCBs
and
instead
proposes
to
lower
the
reporting
thresholds
for
the
current
PCB
listing
which
covers
all
PCBs.
EPA
believes
that,
since
all
PCBs
persist
and
bioaccumulate,
it
is
appropriate
to
lower
the
reporting
threshold
for
this
class
of
chemicals
and
that
this
proposal
is
less
burdensome
than
requiring
separate
reporting
on
the
dioxin­
like
PCBs
as
part
of
the
proposed
dioxin
and
dioxin­
like
compounds
category
(at
64
FR
710).

EPA
did
not
base
its
decision
on
a
determination
that
co­
planar
PCBs
were
not
``
dioxin­
like''
and
keeping
them
under
the
current
PCB
listing
should
not
be
interpreted
as
such
a
determination.
Also,
since
EPA
is
not
expanding
the
qualifier
for
the
dioxin
and
dioxin­
like
compounds
category
to
include
all
processing
and
otherwise
use
activities,
the
amounts
of
co­
planar
PCBs
that
might
be
reportable
under
the
category
would
not
be
expected
to
contribute
significantly
to
threshold
determinations
for
the
category
at
most
facilities.
Four
commenters
specifically
do
not
support
EPA's
decision
to
withdraw
the
proposal
to
modify
the
current
PCB
listing.
Commenters
assert
that
the
aggregation
of
dioxin­
like
PCBs
together
with
other
PCBs
will
fail
to
provide
reporting
of
useful
information
on
dioxin­
like
PCBs.
The
commenters
either
contend
that
the
PCBs
should
be
included
in
the
dioxin­
like
compounds
category
or
the
PCBs
and
all
dioxin­
like
compounds
should
be
reported
separately.
One
commenter
argues
that
the
aggregate
reporting
of
dioxin­
like
PCBs
and
other
PCBs
fails
to
provide
any
information
on
the
release
of
dioxin­
like
PCBs
to
meet
the
research,
regulatory,
or
public
information
goals
of
EPA's
proposal.
This
commenter
raises
several
points.
The
commenter
contends
that
specifically,
even
if
some
facilities
releasing
dioxin­
like
PCBs
reported
these
releases
as
a
portion
of
their
total
PCBs
production
of
10
pounds
annually
or
greater,
information
on
dioxin­
like
PCBs
releases
would
still
be
unobtainable.
The
commenter
asserts
that
aside
from
the
food
chain,
where
some
dioxin­
like
PCBs
tend
to
concentrate
disproportionately,
available
measurements
indicate
that
these
dioxin
compounds
are
only
a
small
portion
of
the
mass
of
all
PCB
compounds.
The
commenter
further
argues
that
some
of
these
dioxin
compounds
such
as
PCB­
126
are
far
more
toxic
than
other
dioxin­
like
and
non
dioxin­
like
PCBs.
Thus,
the
commenter
asserts
that
in
addition
to
all
of
the
problems
of
dioxin­
like
chemical
aggregate
reporting,
one
would
not
know
what,
if
any,
portion
of
the
total
PCBs
reported
were
dioxin­
like.
The
commenter
contends
that
the
dioxinlike
co­
planar
PCBs
also
should
be
reported
individually
so
that
a
TEQ
for
all
28
dioxin
and
dioxin­
like
compounds
can
be
calculated.
Another
commenter
argues
that
based
on
information
about
current
body
burdens
of
co­
planar
PCBs,
they
compose
as
much
or
an
even
greater
percentage
of
one's
overall
exposure
than
the
17
dioxin
and
dioxin­
like
compounds.
This
commenter
cites
an
EPA
document
that
stated
that:
``[
e]
stimates
of
exposure
to
dioxin­
like
CDDs
and
CDFs
based
on
dietary
intake
are
in
the
range
of
1­
3
pg
TEQ/
kg/
day.
Estimates
based
on
the
contribution
of
dioxin­
like
PCBs
to
toxicity
equivalents
raise
the
total
to
3­
6
pg
TEQ/
kg/
day.
''
Some
commenters
contend
that
reporting
the
co­
planar
PCBs
differently
from
the
17
dioxin
and
dioxin­
like
compounds
would
make
any
assessment
of
the
overall
release
and
potential
health
impact
of
these
types
of
compounds
difficult.
One
commenter
argues
that
PCBs
are
currently
contaminating
sediments
and
industrial
sites
nationally
and
have
ruined
fish
as
a
natural
resource
for
human
consumption
across
the
nation
and
that
the
distinction
between
dioxin­
like
PCBs
and
dioxin­
like
compounds
made
under
this
rule
is
a
distinction
without
a
difference.
This
commenter
urges
EPA
to
include
all
dioxin­
like
compounds,
including
PCBs,
in
the
dioxin­
like
compounds
category
and
to
require
strict
accounting
from
all
sources
which
release
these
compounds
and
which
manufacture
them,
incidentally
or
by
design.
One
commenter
contends
that
the
failure
to
report
dioxin­
like
PCBs
as
a
distinct
entity
separate
from
other
PBT
chemicals
may
hold
back
information
on
a
significant
portion
of
the
total
dioxin­
like
hazard
from
releases
by
facilities
that
report
under
EPCRA
section
313,
even
if
all
dioxin
and
furan
releases
were
reported.
The
commenter
argues
that
environmental
exposure
measurements,
such
as
those
from
fish
in
San
Francisco
Bay
and
from
human
tissues
nationally,
indicate
that
dioxinlike
PCBs
contribute
a
very
significant
portion
of
the
total
toxicity
hazard
from
exposure
to
all
dioxin­
like
chemicals.
The
commenter
also
asserts
that
PCB
releases
might
in
some
cases
represent
an
inadequately
measured
yet
significant
portion
of
the
ongoing
dioxin
release
hazard.
If,
for
example,
PCB­
126
comprises
even
1
¤10
of
the
PCBs
release
measured
from
San
Francisco
Bay
Area
sources,
it
would
contribute
substantially
to
total
dioxin­
like
toxicity
emission
from
some
of
these
facilities.
The
commenter
contends
that
the
failure
to
provide
release
information
on
dioxin­
like
PCBs
under
EPA's
proposal
58699
Federal
Register
/
Vol.
64,
No.
209
/
Friday,
October
29,
1999
/
Rules
and
Regulations
may
result
in
failure
to
inform
the
public
about
a
significant
portion
of
the
total
dioxin
toxicity
that
is
still
released.
EPA
agrees
that
PCBs
are
toxic
chemicals
of
concern
that
have
caused
significant
contamination
of
the
environment
and
that
co­
planar
PCBs
may
have
dioxin­
like
health
effects.
However,
this
does
not,
in
itself,
create
a
requirement
that
the
co­
planar
PCBs
must
be
moved
from
their
current
PCB
listing
to
the
dioxin
and
dioxin­
like
compounds
category.
EPA
does
not
believe
that
the
co­
planar
PCBs
must
be
reported
separately
from
the
non
coplanar
PCBs
because
they
may
be
more
toxic
than
other
PCBs.
In
general,
chemical
categories
consist
of
chemicals
that
vary
in
their
level
of
toxicity
but
this
variability
alone
does
not
mean
that
release
information
must
be
reported
separately
for
each
chemical
in
the
category.
EPA
believes
that
all
PCBs
are
of
concern
and
that
leaving
the
coplanar
PCBs
under
the
current
PCB
listing
will
still
provide
the
public
with
useful
and
important
information.
In
deciding
not
to
move
the
co­
planar
PCBs
to
the
dioxin
category,
EPA
also
considered
any
potential
additional
burden
associated
with
splitting
the
reporting
for
PCBs
into
two
different
listings,
as
well
as
the
fact
that
facilities
are
not
likely
to
be
able
to
determine
quantities
of
the
specific
co­
planar
PCBs
in
question.
Specifically,
EPA
considered
the
lack
of
readily
available
estimation
techniques
for
determining
quantities
of
co­
planar
PCBs,
as
opposed
to
other
PBT
chemicals
and
the
PCB
listing
as
a
whole
(co­
planar
PCBs
will
be
included
in
the
estimation
of
PCBs).
EPA
determined
that
since
all
PCBs
are
of
concern
and
since
the
reporting
threshold
for
all
of
the
PCBs
under
the
PCB
listing
would
be
lowered
substantially,
that
requiring
separate
reporting
on
the
co­
planar
PCBs
was
not
warranted.
One
commenter
contends
that
the
failure
to
report
dioxin­
like
PCBs
would
fail
to
provide
information
on
that
subgroup
of
dioxin­
like
compounds
for
which
there
is
the
greatest
need
for
additional
information.
The
commenter
argues
that
EPA's
evaluation
of
the
emission
of
dioxin­
like
chemicals
nationwide
shows
that
there
is
less
information
on
releases
of
dioxin­
like
PCBs
than
there
is
for
other
dioxin
compounds.
The
commenter
asserts
that
similarly,
their
survey
of
source
information
in
the
San
Francisco
Bay
Area
shows
that,
despite
many
measurements
of
dioxin
and
furan
releases,
and
despite
a
handful
of
source
measurements
confirming
PCBs,
there
are
few
or
no
source
measurements
for
dioxin­
like
PCBs.
The
commenter
argues
that
the
information
on
releases
from
facilities
is
even
less
available
for
the
dioxin­
like
PCBs
than
it
is
for
the
other
dioxin­
like
chemicals
and
that
EPA's
analysis
in
the
proposed
rule
fails
to
consider
adequately
this
extreme
need
for
source
release
information.
EPA
agrees
that
there
is
far
less
information
available
on
co­
planar
PCBs
than
for
dioxin
and
other
dioxin­
like
compounds.
Much
less
testing
and
analysis
has
been
conducted
for
these
chemicals.
This
would
pose
an
additional
problem
for
reporting
on
the
co­
planar
PCBs
separately
from
the
other
PCBs.
EPA
considered
the
ability
to
estimate
quantities
of
specific
coplanar
PCBs
and
determined
that
there
is
a
lack
of
readily
available
estimation
techniques
for
co­
planar
PCBs.
In
fact,
at
this
time,
the
Agency
would
not
be
able
to
provide
guidance
for
making
a
reasonable
estimate
of
quantities
of
coplanar
PCBs
that
may
be
manufactured
in
certain
processes.
In
addition,
EPCRA
section
313
does
not
require
any
additional
monitoring
beyond
that
required
by
other
provisions
of
law
so
listing
the
co­
planar
PCBs
separately
would
not
mean
that
additional
source
measurements
would
be
developed.
Thus,
listing
under
EPCRA
section
313
will
not
require
the
development
of
additional
monitoring
data
that
could
be
used
to
make
reasonable
estimations
of
thresholds
or
releases
and
other
waste
management
quantities.
Given
the
lack
of
information
available
for
estimating
quantities
of
co­
planar
PCBs
and
the
potential
additional
burden
associated
with
splitting
the
reporting
for
PCBs
into
two
different
listings,
EPA
decided
to
leave
the
co­
planar
PCBs
under
the
current
PCB
listing.
One
commenter
asserts
that
the
burden
on
industrial
producers
of
dioxin­
like
PCBs
is
not
an
appropriate
reason
for
excluding
dioxin­
like
PCBs
from
the
dioxin
and
dioxin­
like
compounds
category
because
this
will
not
meet
EPCRA's
right­
to­
know
goal
for
dioxin­
like
PCBs.
The
commenter
contends
that
EPA's
cost
analysis
does
not
address
dioxin­
like
PCBs
specifically
and
thus,
EPA's
rationale
in
Unit
VI.
of
the
preamble
of
the
proposed
rule
(64
FR
688)
that
``
this
proposal
is
less
burdensome
than
requiring
separate
reporting
on
the
dioxin­
like
PCBs''
is
not
based
on
any
cost
analysis
in
EPA's
proposal.
The
commenter
argues
further
that
in
any
case,
aggregate
reporting
of
dioxin­
like
PCBs
with
a
10
pound
threshold
will
fail
to
obtain
the
required
reporting
on
a
substantial
majority
of
dioxin­
like
PCBs
or
to
provide
needed
information
about
dioxin­
like
PCB
releases
and
therefore,
EPA's
perceptions
regarding
reporting
burden
cannot
properly
outweigh
the
public's
need
for
the
information
which
is
denied
under
EPA's
new
proposal.
The
commenter
refers
to
the
proposal
to
retain
dioxin­
like
PCBs
under
the
PCB
listing
as
the
``
less
than
10
pounds
exemption.
''
The
commenter
asserts
that
existing
evidence
demonstrates
that
many
dioxin
producing
processes
such
as
waste
incinerators,
oil­
fired
boilers,
and
other
processes
also
produce
potentially
significant
amounts
of
PCBs
which
are
released
to
the
environment
from
these
facilities.
The
commenter
argues
that
this
evidence
suggests
that
at
least
some
facilities
reporting
under
EPCRA
section
313
are
likely
to
be
releasing
dioxin­
like
PCBs
as
a
portion
of
these
PCB
releases.
The
commenter
contends
that
the
evidence
also
suggests
that
most
or
all
releases
of
dioxin­
like
PCBs
at
these
facilities
may
be
associated
with
total
annual
PCB
production
of
less
than
10
pounds
per
facility
and
thus,
EPA
may
not
meet
the
requirement
that
a
substantial
majority
of
dioxin­
like
PCBs
be
reported
under
this
exemption.
Reporting
burden
was
not
the
sole
or
even
most
important
factor
in
EPA's
decision
not
to
move
the
co­
planar
PCBs
to
the
dioxin
and
dioxin­
like
compounds
category.
In
reaching
its
final
decision,
EPA
considered
the
fact
that
additional
information
would
be
collected
on
all
PCBs
by
lowering
the
threshold
for
the
PCB
listing
and
that
the
additional
information
that
would
be
collected
was
sufficient
for
EPCRA
section
313
purposes,
as
well
as
less
burdensome.
Even
in
its
proposal
EPA
did
not
conclude
that
reporting
burden
alone
outweighed
the
public's
right­
toknow
about
chemical
releases.
As
stated
in
other
responses
to
this
issue,
EPA
is
also
concerned
about
the
ability
to
estimate
quantities
of
specific
co­
planar
PCBs
since
there
is
a
lack
of
readily
available
estimation
techniques
for
coplanar
PCBs.
It
is
correct
that
EPA
did
not
attempt
to
quantify
the
reduction
in
burden
that
would
result
from
not
including
the
co­
planar
PCBs
in
the
dioxin
and
dioxin­
like
compounds
category.
However,
EPA
believes
that
it
would
be
inherently
less
burdensome
since
facilities
would
not
have
to
attempt
to
determine
if
they
can
estimate
co­
planar
PCBs
separately
and
filing
one
form
would
obviously
be
easier
and
less
confusing
than
attempting
to
track
and
adjust
the
amounts
that
must
be
applied
to
two
different
listings
and
filing
two
reports.
With
regard
to
the
issue
of
obtaining
reporting
on
a
substantial
majority
of
``
dioxin­
like
PCB''
releases,
as
stated
in
EPCRA
section
313(
f)(
2),
the
58700
Federal
Register
/
Vol.
64,
No.
209
/
Friday,
October
29,
1999
/
Rules
and
Regulations
determination
of
whether
a
revised
threshold
meets
the
``
substantial
majority''
standard
is
measured
against
the
``
total
releases
of
the
chemical
at
all
facilities
subject
to
the
requirements
of
this
section.
''
As
EPA
stated
in
the
proposed
rule:

For
purposes
of
determining
what
constitutes
a
``
substantial
majority
of
total
releases'',
EPA
interprets
``
facilities
subject
to
the
requirements''
of
section
313
as
the
facilities
currently
reporting,
...
(at
64
FR
689).

Currently,
facilities
required
to
report
on
PCBs
must
report
on
all
PCBs,
not
just
the
co­
planar
PCBs
or
any
other
individual
PCBs.
The
current
listing
includes
all
PCBs.
Consequently
EPA
does
not
believe
that
the
requirements
of
section
313(
f)(
2)
function
as
an
impediment
to
its
decision
to
withdraw
its
proposal
to
include
the
co­
planar
PCBs
in
the
dioxin
and
dioxin­
like
compounds
category.
As
discussed
in
Units
II.
B.
and
VI.
A.,
EPA
believes
that
it
has
satisfied
the
requirements
of
EPCRA
section
313(
f)(
2),
without
the
need
for
quantitative
support.
c.
Listing
dioxin
and
dioxin­
like
compounds
as
a
category
versus
individual
listing
of
each
chemical.
Some
commenters
contend
that
reporting
dioxin
and
dioxin­
like
compounds
as
one
category
would
not
provide
useful
information
and
asked
that
the
individual
compounds
be
reported.
One
commenter
recommends
that
reporting
on
individual
chemical
species
should
be
required
when
the
information
is
available.
One
commenter
who
supports
the
individual
reporting
of
all
of
the
dioxin
and
dioxinlike
compounds,
states
that
the
amounts
of
individual
dioxin
compounds
released
from
facilities
is
part
of
the
important
public
information
needed
to
assist
research
and
policy
development.
The
commenter
claims
that
reporting
as
a
category
will
not
provide
the
public
with
the
information
to
assess
the
relative
hazards
of
releases
since
one
dioxin­
like
compound
can
have
a
relative
hazard
several
orders
of
magnitude
less
than
2,3,7,8­
tetrachlorodibenzo­
p­
dioxin.
This
commenter
also
states
that
different
sources
often
emit
a
different
mix
of
dioxin
compounds
and
that
this
information
is
widely
used
to
trace
dioxin
contamination
to
specific
root
causes.
The
commenter
states
that
the
relative
amounts
of
the
many
different
dioxin­
like
chemicals
in
a
sample
are
compared
to
create
a
``
profile''
which
might
match
the
profile
created
by
emission
from
a
particular
source.
The
commenter
did
not
support
the
reporting
of
the
category
based
on
toxic
equivalents
(TEQs)
but
thought
it
important
for
the
users
of
the
data
to
be
able
to
determine
TEQs.
Some
other
commenters
make
the
same
general
argument
that
individual
isomer
reporting
is
needed
to
facilitate
risk
characterization
including
transport
and
fate
of
the
different
isomers.
Some
commenters
contend
that
certain
dioxin­
like
compounds
such
as
octachlorodibenzo­
p­
dioxin
and
octachlorodibenzofuran
should
not
be
reported
since
they
are
ubiquitous
in
the
environment
and
are
the
least
toxic
under
the
toxic
equivalent
factors
(TEFs).
One
commenter
states
that
EPA
should
require
reporting
only
for
the
most
toxic
congeners:
the
tetra­,
penta
and
hexa­
congeners
and
not
the
heptaand
octa­
congeners
which
are
less
toxic
and
less
relevant
from
a
risk
standpoint.
Other
commenters
state
that
only
2,3,7,8­
tetrachlorodibenzo­
p­
dioxin
should
be
reported.
Some
commenters
contend
that
reporting
for
these
compounds
should
not
be
required
at
the
same
reporting
threshold
as
the
other
dioxin
and
dioxin­
like
compounds.
Most
commenters
who
would
like
to
exclude
certain
dioxinlike
compounds
did
not
indicate
that
they
wanted
individual
reporting
of
the
remaining
compounds.
Some
commenters
support
the
reporting
of
dioxin
and
dioxin­
like
compounds
as
a
category,
as
EPA
proposed.
One
commenter
states
that
if
reporting
is
not
limited
to
just
2,3,7,8­
tetrachlorodibenzo­
p­
dioxin,
then
the
commeter
supports
EPA's
proposal
to
limit
the
category
to
only
the
7
dioxins
and
10
furans
listed
in
the
proposed
rule.
After
consideration
of
all
of
the
comments
on
this
issue,
EPA
has
decided
that
the
best
way
to
report
on
dioxin
and
dioxin­
like
compounds
is
to
report
them
as
a
category.
This
is
consistent
with
the
way
EPA
has
addressed
other
groups
of
chemicals
that
share
the
same
toxic
effect
and
in
this
case
are
also
generated
as
complex
mixtures.
As
discussed
in
Units
VI.
G.
1.
d.
and
e.,
reporting
as
a
category
and
based
on
TEQs
would
not
provide
users
of
the
data
with
information
on
which
compounds
contribute
the
most
to
the
TEQ
total.
In
addition,
requiring
facilities
to
report
each
compound
individually
would
impose
an
additional
burden
on
the
industries
that
will
be
required
to
report.
However,
EPA
agrees
that
being
able
to
determine
the
amounts
of
the
individual
dioxin
and
dioxin­
like
compounds
would
make
the
data
more
useful.
Therefore
EPA
will
add
a
section
to
the
Form
R
that
will
require
the
reporting
facility
to
provide
the
distribution
of
dioxin
and
each
dioxin­
like
compound
for
the
total
quantity
that
the
facility
is
reporting.
If
a
facility
has
information
on
the
distribution
of
the
dioxin
and
dioxinlike
compounds,
the
facility
must
report
either
the
distribution
that
best
represents
the
distribution
of
the
total
quantity
of
dioxin
and
dioxin­
like
compounds
released
to
all
media
from
the
facility;
or
its
one
best
mediaspecific
distribution.
This
information
is
only
required
if
it
is
available
from
the
data
used
to
calculate
thresholds,
releases,
and
other
waste
management
quantities,
no
additional
analysis
is
required.
As
with
all
other
reporting
under
EPCRA
section
313,
this
information
will
only
be
required
if
the
facility
has
information
that
can
be
used
to
make
a
reasonable
estimate
of
the
distribution
from
the
available
data.
With
the
distribution
of
congeners
reported
on
each
Form
R,
the
user
of
the
data
can
determine
the
grams
of
dioxin
and
each
individual
dioxin­
like
compound
that
makes
up
the
total
quantity
reported
on
the
Form
R.
Under
this
reporting
mechanism,
all
of
the
information
that
the
commenters
have
stated
is
important
to
determining
the
significance
of
quantities
reported
under
this
category
will
be
provided
to
the
public
but
the
reporting
facilities
will
still
only
have
to
file
one
report.
Any
of
the
other
possible
options,
such
as
reporting
in
terms
of
TEQs
or
reporting
each
individual
compound
separately,
either
do
not
provide
all
of
the
information
the
commenters
would
like
to
have,
or
impose
too
great
an
additional
reporting
burden
without
providing
the
public
with
significant
additional
information.
d.
Using
mass
versus
TEQs
for
reporting
releases
and
other
waste
management
quantities.
Most
of
the
commenters
on
this
issue
suggest
that
EPA
should
require
that
release
and
other
waste
management
data
for
the
dioxin
and
dioxin­
like
compounds
category
be
reported
in
terms
of
TEQs
rather
than
in
terms
of
absolute
grams.
The
following
list
is
a
summary
of
the
various
reasons
provided
by
the
commenters
in
support
of
reporting
dioxin
and
dioxin­
like
compounds
in
terms
of
TEQs:
(1)
All
dioxin
data
reported
under
other
EPA
programs
as
well
as
other
Federal
and
state
regulatory
programs
are
reported
in
terms
of
toxicity
equivalents;
(2)
the
public
is
familiar
with
dioxin
data
reported
in
terms
of
TEQs
and
reporting
in
other
units
would
cause
confusion
and
be
misleading;
(3)
TEQs
provide
more
meaningful
information
than
total
weights
since
they
take
into
account
the
relative
toxicities
of
the
various
dioxinVerDate
58701
Federal
Register
/
Vol.
64,
No.
209
/
Friday,
October
29,
1999
/
Rules
and
Regulations
like
compounds;
(4)
facilities
that
report
under
other
regulatory
programs
are
likely
to
rely
upon
TEQ
data
that
they
already
have;
(5)
use
of
absolute
mass
may
cause
misleading
comparisons
between
grams
and
grams
TEQ;
(6)
releases
reported
in
absolute
mass
make
it
difficult
to
assess
the
impacts
these
compounds
may
have
on
the
environment
due
to
the
differences
in
their
toxicities;
and
(7)
reports
based
on
TEQs
would
provide
far
more
useful
information
about
potential
community
risks
than
reports
based
on
the
total
mass
of
compounds
in
the
category
since
more
risk
information
would
be
provided.
One
commenter
argues
that
EPA's
justification
for
adding
the
category
is
based
on
assumptions
about
the
toxicity
of
the
other
dioxin­
like
compounds
relative
to
dioxin
itself
and
that
given
these
assumptions
the
reporting
of
TEQs
makes
sense.
The
commenter
states
that
under
current
TEQ
schemes,
these
dioxin­
like
compounds
are
all
less
toxic
than
dioxin,
as
much
as
1,000
times
less,
and
that
facilities
should
not
simply
sum
emissions
on
the
Form
R
for
compounds
with
such
drastically
different
toxicities.
One
commenter
suggests
that
EPA
require
the
reporting
of
both
grams
and
TEQs
and
if
not
both,
then
just
grams.
This
commenter
asserts
that
if
only
grams
are
reported,
the
data
will
be
somewhat
difficult
to
interpret
without
any
further
information,
but
if
only
TEQs
are
required
to
be
reported,
then
there
are
uncertainties
about
what
and
how
much
is
discharged.
Another
commenter
states
that
if
EPA
is
going
to
require
dioxin
reporting
as
a
group
and
not
by
specific
chemicals,
TEQ
reporting
is
an
unnecessary
complication.
The
commenter
states
that
the
TEFs
used
to
formulate
the
TEQs
are
constantly
reviewed
and
changed,
which
would
necessitate
EPA
review
and
possible
reissuance
of
new
TEFs
each
year.
The
commenter
argues
that
this
would
make
previous
years'
TRI
data
impossible
to
compare
once
the
changes
were
made.
While
EPA
recognizes
that
TEQs
are
a
common
way
of
expressing
quantities
of
dioxin­
like
compounds,
EPA
does
not
believe
that
reporting
in
these
units
would
be
the
best
or
most
appropriate
way
to
report
for
the
dioxin
and
dioxinlike
compounds
category
under
EPCRA
section
313.
Although
some
commenters
believe
that
TEQ
reporting
should
be
used
since
not
all
of
the
dioxin­
like
compounds
are
as
toxic
as
dioxin
itself,
EPA
has
determined
that
all
of
the
dioxin­
like
compounds
meet
the
listing
criteria
of
EPCRA
section
313.
Since
all
of
these
compounds
meet
the
listing
criteria,
the
actual
mass
of
each
member
of
the
category
should
be
reported.
To
do
otherwise
would
deny
the
public
information
on
the
actual
quantities
of
toxic
chemicals
entering
the
environment.
It
would
also
be
inconsistent
with
all
other
reporting
of
EPCRA
section
313
toxic
chemicals
since
none
of
them
are
reported
based
on
relative
toxicities.
In
addition,
this
would
be
inconsistent
with
EPCRA
section
313(
g)(
1)(
C)(
iv)
which
requires
that
``
the
annual
quantity
of
the
toxic
chemical
entering
each
environmental
medium''
be
reported.
Some
of
the
commenters
state
that
TEQs
should
be
used
because
they
provide
more
risk
information
to
the
public
than
just
reporting
mass.
While
TEQs
do
provide
information
on
relative
toxicity,
EPA
does
not
believe
that
increasing
the
amount
of
risk
information
is
a
basis
for
changing
the
EPCRA
section
313
method
for
reporting
from
mass­
based
to
relative
toxicitybased
As
discussed
in
Unit
VI.
F.,
EPCRA
section
313
is
not
a
risk­
based
program,
and
reporting
is
not
intended
to
communicate
information
about
relative
risks.
Rather
it
provides
local
communities
with
data
on
release
and
other
waste
management
quantities
on
listed
toxic
chemicals,
so
that
they
may
use
the
data
in
conjunction
with
information
on
chemical
properties
(e.
g.,
persistence
and
bioaccumulation)
and
site­
specific
information
to
determine
if
releases
present
a
potential
risk.
It
is
also
not
clear,
as
some
commenters
state,
that
the
public
is
more
familiar
with
dioxin
data
reported
in
terms
of
TEQs
or
that
they
will
understand
TEQs
any
better
than
grams.
EPA
does
not
believe
that
the
fact
that
other
programs
require
reporting
in
TEQs
and
that
facilities
will
already
have
TEQ
information
is
a
significant
reason
to
require
TEQ
reporting
under
EPCRA
section
313.
Since
the
first
piece
of
information
that
is
required
to
determine
TEQs
is
the
grams
of
dioxin
and
each
dioxin­
like
compound,
these
facilities
should
already
have
the
grambased
information
they
would
need.
In
addition,
as
stated
above,
EPCRA
section
313
reporting
serves
the
purposes
of
EPCRA
section
313;
other
programs,
e.
g.,
the
CWA,
are
risk­
based
command
and
control
programs.
Several
commenters
also
disagree
with
the
concerns
that
EPA
raised
in
the
proposed
rule,
which
were:

.
.
.there
are
three
significant
disadvantages
to
reporting
in
TEQs.
First,
revisions
in
TEF
factors
for
individual
dioxin­
like
compounds
in
future
years
would
require
changes
to
the
calculations
in
the
reported
release
and
other
waste
management
quantities,
thus
making
year
to
year
comparisons
more
difficult,
unless
the
particular
dioxin­
like
compounds
are
identified.
Second,
some
facilities
may
not
be
able
to
report
in
TEQs,
since,
although
they
may
be
able
to
estimate
a
mass
quantity
for
the
category
as
a
whole,
they
may
not
have
enough
information
to
estimate
the
relative
distribution
of
all
category
members.
Third,
TEQ
reporting
would
be
different
from
all
other
TRI
reporting,
which
is
mass­
based,
and
may
cause
additional
confusion.
(at
64
FR
712­
713)

Some
commenters
contend
that
EPA's
first
concern
is
not
valid
since
the
EPCRA
section
313
reporting
requirements
have
been
changed
several
times
in
the
past
in
spite
of
difficulties
in
comparing
future
reports
to
past
performance.
Two
commenters
state
that
this
same
logic
could
be
applied
to
the
use
of
AP±
42
factors
which
EPA
acknowledges
have
been
revised
and
refined
over
the
years,
and
that
this
also
diminishes
the
value
of
year­
to­
year
reporting
comparisons.
One
commenter
suggests
that
EPA
could
minimize
any
confusion
that
might
be
caused
by
a
subsequent
change
in
one
or
more
TEFs
by
each
year
specifically
publishing
or
cross
referencing
the
TEFs
that
must
be
used
for
that
reporting
period.
One
commenter
contends
that
EPA's
second
and
third
concerns
appeared
weak
in
light
of
the
much
greater
risk
information
provided
by
a
TEQ
approach.
Some
commenters
contend
that
EPA's
third
concern
is
not
valid
since
the
reporting
requirement
being
proposed
for
dioxin
and
dioxin­
like
compounds
is
different
whether
TEQs
are
used
or
not.
One
commenter
states
that
the
third
concern
is
clearly
dwarfed
by
the
confusion
that
would
ensue
if
all
dioxin­
like
compounds
were
reported
as
equivalent,
when
the
hazards
vary
by
a
factor
of
500.
One
commenter
states
that
reporting
dioxin
on
a
TEQ
basis
will
cause
more
rather
than
less
confusion
if
the
public
mistakenly
compares
data
in
grams
with
data
presented
in
grams
TEQ.
Some
commenters
agreed
with
the
concerns
EPA
expressed
in
the
preamble.
One
commenter
states
that
it
agreed
with
these
concerns
but
that
the
concern
about
year­
to­
year
comparisons
being
more
difficult
also
applies
to
the
reporting
of
a
single
mass
value
for
the
entire
category.
The
commenter
contends
that
since
the
amounts
of
the
individual
dioxin­
like
compounds
would
not
be
known,
if
TEFs
change,
one
cannot
adjust
previously
reported
values
to
reflect
the
changes
in
TEFs.
This
commenter
suggests
that
in
order
to
make
the
information
reported
of
greatest
use,
the
mass
of
dioxin
and
each
of
the
dioxin­
like
compounds
should
be
reported
once
a
TEQ
threshold
is
exceeded.
One
commenter
argues
that
while
TEQs
are
a
valid
and
scientifically
58702
Federal
Register
/
Vol.
64,
No.
209
/
Friday,
October
29,
1999
/
Rules
and
Regulations
sound
metric
for
reporting
the
likely
health
hazard
of
a
compound,
that
was
not
the
intended
purpose
of
the
EPCRA
section
313
reporting
requirement.
The
commenter
claims
that
reporting
dioxin
and
dioxin­
like
compounds
in
TEQs
will
cause
confusion,
since
all
other
reporting
under
EPCRA
is
done
in
terms
of
mass
and
does
not
take
toxicity
into
account.
EPA
believes,
as
do
some
of
the
commenters,
that
the
concerns
that
were
expressed
in
the
proposed
rule
for
reporting
dioxin
and
dioxin­
like
compounds
in
terms
of
TEQs
under
EPCRA
section
313
are
valid.
EPA
disagrees
with
those
commenters
who
claim
that
since
other
changes
in
reporting
have
occurred,
such
as
revisions
to
AP­
42
emission
factors,
there
should
be
no
concern
for
the
changes
that
might
occur
in
TEFs
and
the
resulting
TEQs.
The
fact
that
certain
changes
have
occurred
in
reporting
requirements
or
methods
of
estimation
and
that
those
changes
may
make
certain
year­
to­
year
comparisons
more
difficult
does
not
reduce
the
concern
for
knowingly
selecting
reporting
units,
based
on
relative
toxicity
as
opposed
to
emission
factors,
that
have
changed
in
the
past
and
may
well
change
in
the
future.
Also,
EPA
would
be
required
to
choose
a
particular
set
of
TEFs
(i.
e.,
as
of
1999)
and
would
need
to
amend
them
by
rulemaking
each
time
the
TEFs
were
revised.
Changes
in
TEFs
and
the
resulting
TEQs
would
be
unlike
any
of
the
past
changes
in
EPCRA
section
313
reporting
since
none
of
these
reporting
changes
were
related
to
the
relative
toxicity
of
chemicals
that
meet
the
listing
criteria
of
EPCRA
section
313.
The
cross
referencing
or
publishing
of
the
TEFs
that
must
be
used
for
each
reporting
period
would
still
not
allow
year­
to­
year
comparisons
since
without
knowing
a
facility's
distribution
of
each
of
the
category
members
the
TEQ
cannot
be
recalculated.
EPA's
concerns
that
some
facilities
may
not
be
able
to
report
in
terms
of
TEQs
are
also
valid.
Although
most
facilities
that
will
be
able
to
make
reasonable
estimations
for
the
dioxin
and
dioxin­
like
compounds
category
should
be
able
to
report
in
terms
of
TEQs,
there
may
be
some
that
can
only
report
in
actual
mass
units
and
they
should
not
be
exempt
from
reporting.
EPA
is
also
still
concerned
that
TEQs
would
be
different
than
other
EPCRA
section
313
reporting
units,
since
they
are
not
based
on
absolute
mass,
and
that
this
could
cause
confusion.
EPA
does
not
agree
with
the
commenters
that
state
that
this
does
not
matter
since
the
reporting
for
the
dioxin
and
dioxin­
like
compounds
category
is
going
to
be
different
anyway.
The
only
real
reporting
difference
for
the
dioxin
and
dioxin­
like
compounds
category
is
that
the
reporting
units
are
in
grams
rather
than
pounds.
To
determine
the
amounts
in
pounds
all
that
one
would
have
to
do
is
multiply
the
grams
by
0.002204.
However,
TEQ
reporting
would
be
much
different
since
in
order
to
understand
the
reported
value
one
would
need
to
understand
the
basis
for
TEFs,
what
they
are,
how
they
relate
to
dioxin,
and
how
TEQs
are
calculated
from
the
individual
TEFs.
This
obviously
requires
more
knowledge
on
the
part
of
the
data
user
than
simply
understanding
different
units
of
mass
and
does
have
the
potential
to
cause
some
confusion.
One
commenter
contends
that
neither
total
mass
nor
TEQ
reporting
provides
sufficient
information
on
reduction
in
potential
exposure
and
risk.
The
commenter
asserts
that
it
is
possible
that
a
facility
could
reduce
its
dioxin
TEQ
while
releasing
a
greater
mass
of
dioxinlike
compounds,
but
neither
total
mass
nor
TEQ
reporting
would
really
provide
a
good
picture
of
what
a
facility
was
doing.
The
commenter
suggests
that
if
EPA
wants
to
provide
TEQ
information
to
the
public,
it
should
also
require
facilities
to
report
dioxins
by
individual
chemical,
rather
than
as
a
group.
Another
commenter
that
favors
the
reporting
of
dioxin
and
dioxin­
like
compounds
as
individual
chemicals
claims
that
reporting
as
a
category
but
in
TEQs
would
still
fail
to
reveal
the
amounts
of
individual
dioxin
compounds
released.
The
commenter
argues
that
this
alternative
would
provide
no
information
on
individual
compounds
for
use
in
tracing
dioxin
source
profiles.
The
commenter
contends
that
reporting
in
TEQs
would
provide
better
information
on
the
relative
toxicity
hazard
based
upon
today's
toxicity
information
but
that
information
on
the
relative
toxicity
of
the
many
dioxin­
like
chemicals
is
improving
and
thus
toxicity
factors
for
some
of
these
compounds
will
change
in
the
future.
The
commenter
claims
that
in
future
years
the
Inventory
would
have
to
choose
between
keeping
the
old
toxicity
calculation
(and
becoming
irrelevant
in
comparison
with
other
research
data),
or
changing
the
toxicity
calculation
(and
becoming
irrelevant
for
tracking
changes
in
dioxin
release
rates
over
time).
The
commenter
contends
that
the
need
to
aid
research
and
policy
development
based
on
current
science
and
the
need
to
track
release
rates
over
time
are
fundamental
to
the
Inventory's
purpose
and
that
this
alternative
must
be
rejected
as
just
another
ill­
advised
aggregate
reporting
scheme.
The
commenter
recommends
that
EPA
require
the
reporting
of
dioxin
and
dioxin­
like
compounds
in
the
way
these
compounds
are
measured
and
analyzed
by
scientists
and
government
agencies,
as
individual
chemicals,
and
consider
an
additional
service
by
EPA
to
calculate
and
report
dioxin
toxicity
as
TEQ
for
the
year­
to­
year
data
using
the
most
recent
toxicity
information
which
becomes
available.
Several
commenters
make
the
point
that
for
dioxin
and
dioxin­
like
compounds
neither
reporting
total
mass
nor
reporting
in
terms
of
TEQs
provides
sufficient
information
on
potential
exposures
and
risks,
and
that
neither
would
allow
for
the
tracing
of
dioxin
source
profiles.
EPA
agrees
that
neither
approach
would
provide
all
of
the
data
that
the
commenters
would
like
to
have
reported
and
that
being
able
to
determine
TEQs
would
provide
additional
useful
information.
A
common
solution
to
the
TEQ
issue
that
the
commenters
suggest,
was
to
report
dioxin
and
each
individual
dioxin­
like
compound
separately
rather
than
as
a
category.
However,
EPA
believes
that
this
approach
would
be
overly
burdensome
and
unnecessary
to
get
the
kind
of
data
that
would
be
the
most
useful.
As
discussed
in
the
previous
section
of
this
unit,
many
other
commenters
requested
that
dioxin
and
dioxin­
like
compounds
be
reported
separately
rather
than
as
a
category.
After
consideration
of
all
of
the
comments
on
this
issue,
EPA
has
determined
that
the
best
way
to
report
for
the
dioxin
and
dioxin­
like
compounds
category
is
to
report
in
terms
of
absolute
grams
for
the
entire
category.
This
is
consistent
with
all
other
reporting
under
EPCRA
section
313
and
will
provide
the
most
consistent
information
from
year­
toyear
However,
EPA
agrees
with
most
of
the
commenters
that
being
able
to
determine
TEQs
from
the
reported
data
and
being
able
to
determine
which
individual
chemicals
are
include
in
a
facilities
report
would
make
the
data
more
useful
to
the
public.
Therefore,
as
discussed
in
the
previous
section
of
this
unit,
EPA
will
add
a
section
to
the
Form
R
that
will
require
the
reporting
facility
to
provide
the
distribution
of
dioxin
and
each
dioxin­
like
compound
for
the
total
quantity
that
the
facility
is
reporting.
If
a
facility
has
information
on
the
distribution
of
the
dioxin
and
dioxinlike
compounds,
the
facility
must
report
either
the
distribution
that
best
represents
the
distribution
of
the
total
quantity
of
dioxin
and
dioxin­
like
compounds
released
to
all
media
from
the
facility;
or
its
one
best
mediaVerDate
58703
Federal
Register
/
Vol.
64,
No.
209
/
Friday,
October
29,
1999
/
Rules
and
Regulations
specific
distribution.
This
information
is
only
required
if
it
is
available
from
the
data
used
to
calculate
thresholds,
releases,
and
other
waste
management
quantities,
no
additional
analysis
is
required.
As
with
all
other
reporting
under
EPCRA
section
313,
this
information
will
only
be
required
if
the
facility
has
information
that
can
be
used
to
make
a
reasonable
estimate
of
the
distribution
from
the
available
data.
With
the
distribution
of
the
individual
members
of
the
category
reported
on
each
Form
R,
the
user
of
the
data
can
determine
the
grams
TEQ
that
correspond
to
the
absolute
grams
reported
and
can
adjust
the
grams
TEQ
as
TEF
values
change
over
time.
Under
this
reporting
mechanism,
all
of
the
information
that
the
commenters
state
is
important
to
determining
the
significance
of
quantities
reported
for
this
category
will
be
provided
to
the
public
on
one
Form
R.
This
way
all
parties
can
express
the
data
in
whichever
format
they
believe
is
best,
and
since
the
first
thing
that
must
be
determined
under
any
reporting
method
is
the
mass
of
each
member
of
the
category,
there
should
be
little,
if
any,
additional
burden
associated
with
including
the
distribution.
e.
Using
TEQs
as
the
basis
for
reporting
thresholds.
All
of
the
commenters
on
this
issue
requested
that
the
reporting
threshold
for
the
dioxin
and
dioxin­
like
compounds
be
set
in
terms
of
TEQs.
Most
of
the
commenters
indicate
that
the
reasons
they
support
a
TEQ­
based
threshold
were
the
same
as
the
reasons
they
support
reporting
release
and
other
waste
management
quantities
in
terms
of
TEQs
(see
the
first
paragraph
of
the
preceding
section
of
this
unit).
Two
commenters
argue
that
since
EPA
proposed
to
use
TEQs
for
reporting
release
and
other
waste
management
quantities,
that
not
basing
the
reporting
threshold
on
TEQs
would
be
inconsistent.
The
commenters
contend
that
a
facility
may
trigger
reporting
by
having
emissions
that
exceed
the
threshold
(in
terms
of
absolute
weight)
but
have
no
significant
reporting
quantity
(in
terms
of
TEQ
equivalent
weight)
and,
therefore,
no
significant
health
risk.
The
commenters
recommend
the
use
of
a
consistent
approach
where
TEQs
are
used
for
both
threshold
determinations
and
release
and
other
waste
management
quantities.
The
commenters
state
that
such
an
approach
would
be
consistent
with
the
health
risk
rationale
for
EPCRA
reporting,
yet
not
rely
on
site­
specific
risk
approaches
that
may
evolve
over
time.
Another
commenter
had
similar
concerns
suggesting
that
it
would
be
extremely
burdensome
and
unnecessarily
complex
to
have
thresholds
based
on
absolute
grams
and
release
and
other
waste
management
quantities
reported
in
TEQs
and
recommends
that
EPA
should
use
TEQs
for
both.
One
commenter
claims
that
it
may
ease
the
reporting
burden
somewhat
to
base
the
EPCRA
section
313
reporting
threshold
on
a
TEQ
basis
rather
than
attempting
to
develop
mass­
based
estimates.
Another
commenter
contends
that
in
order
to
determine
the
sum
of
the
mass
of
the
17
dioxin
and
dioxin­
like
compounds,
one
already
will
have
determined
the
mass
of
each
compound
individually
and
that
with
data
reported
by
compound,
a
TEQ
can
easily
be
calculated.
The
commenter
also
suggests
that
there
are
short­
term
screening
bioassays
for
determining
the
TEQ
of
a
sample
that
are
less
expensive,
more
sensitive,
and
can
be
done
more
rapidly
than
traditional
analytical
chemistry
methods.
The
commenter
states
that
rather
than
facilities
trying
to
guess
what
their
releases
may
be,
in
an
attempt
to
avoid
spending
money
on
expensive
analytical
chemistry
methods,
if
the
reporting
threshold
were
based
on
TEQs,
a
facility
can
readily
and
more
inexpensively
screen
its
releases.
The
commenter
argues
that
having
a
reporting
threshold
based
on
TEQ
is
more
representative
of
potential
health
risks
and
recommends
that
EPA
consider
using
some
amount
of
TEQs
as
the
reporting
threshold.
Another
commenter
suggests
that
one
option
would
be
to
report
releases
of
each
dioxin­
like
compound
if
the
total,
in
TEQ,
exceeds
some
chosen
threshold.
One
commenter
that
suggests
that
TEQs
should
be
used
for
thresholds,
notes
that
reporting
dioxin
on
a
mass
basis
is
quite
different
from
reporting
on
a
TEQ
basis.
The
commenter
asserts
that
since
some
of
the
dioxin­
like
compounds
have
TEFs
of
0.001
then
the
0.1
gram
threshold
could
require
facilities
that
produce
0.0001
gram
TEQ
of
dioxin
to
report.
The
commenter
claims
that
when
compared
to
the
estimate
that
there
are
2,973
grams
TEQ
of
U.
S.
dioxin
emissions
such
amounts
are
insignificant
and
meaningless.
The
commenter
maintains
that
using
TEQs
instead
of
the
mass
of
each
compound
for
determining
whether
an
EPCRA
reporting
threshold
for
dioxin
and
dioxin­
like
compounds
is
exceeded
would
not
deprive
EPA
or
the
public
of
information
regarding
meaningful
releases
of
dioxin.
The
commenter
also
recommends
that
whatever
units
EPA
decides
to
use
should
be
the
same
for
thresholds
and
for
release
and
other
waste
management
quantities.
One
commenter
suggests
that
EPA
should
require
sources
to
use
toxicity
factors
in
calculating
the
manufacturing
threshold
for
dioxin
and
dioxin­
like
compounds
to
avoid
triggering
the
threshold
based
solely
on
non­
detection.
The
commenter
states
that
the
17
dioxin­
like
compounds
to
which
the
0.1
gram
proposed
reporting
threshold
would
apply
vary
in
toxicity
by
a
factor
of
1,000
but
that
EPA
does
not
take
this
variation
in
toxicity
into
consideration
for
the
purpose
of
determining
the
manufacturing
threshold.
EPA
did
not
propose
to
use
TEQs
as
the
units
of
measurement
for
the
EPCRA
section
313
reporting
threshold
for
dioxin
and
dioxin­
like
compounds.
EPA
has
the
same
concerns
for
using
TEQs
for
EPCRA
section
313
thresholds
as
it
does
for
reporting
releases
and
other
waste
management
quantities
in
terms
of
TEQs,
and
most
of
the
issues
raised
here
have
been
addressed
in
the
preceding
section
of
this
unit.
Most
importantly,
since
EPA
has
determined
that
each
of
the
dioxin­
like
compounds
meets
the
listing
criteria
of
EPCRA
section
313,
the
actual
mass
of
each
member
of
the
category
should
be
included
in
threshold
determinations.
Also,
the
fact
that
the
TEFs
and
thus
the
TEQs
can
change
over
time,
is
even
more
important
for
thresholds
since
TEF
changes
would
in
effect
change
the
threshold,
because
for
example,
the
same
mass
quantity
that
would
have
exceeded
the
threshold
before
the
change
may
not
exceed
the
threshold
after
the
change.
As
one
of
the
commenters
pointed
out,
using
TEQs
as
the
units
for
the
reporting
threshold
is
much
different
than
using
actual
mass.
The
commenter
showed
how
a
0.1
gram
threshold
for
a
dioxin­
like
compound
with
a
TEF
of
0.001
would
be
equivalent
to
a
0.0001
gram
TEQ
threshold.
The
opposite
of
this
is
that
if
the
0.1
gram
threshold
were
in
units
of
TEQ,
then
for
dioxinlike
compounds
with
a
0.001
TEF,
it
would
take
100
grams
to
reach
the
reporting
threshold.
Using
TEQs
as
the
units
for
the
reporting
threshold
would
thus
be
equivalent
to
establishing
separate
thresholds
for
each
member
of
the
dioxin
and
dioxin­
like
compounds
category
based
on
their
relative
toxicity.
EPA
does
not
believe
that
any
of
the
reporting
requirements
of
EPCRA
section
313
should
be
based
on
relative
toxicities
since,
as
discussed
in
Unit
VI.
F.,
EPCRA
section
313
is
not
a
riskbased
program
and
reporting
is
not
intended
to
communicate
information
about
the
Federal
government's
risk
determinations
for
individual
chemicals.
Rather
it
provides
local
communities
with
data
on
release
and
58704
Federal
Register
/
Vol.
64,
No.
209
/
Friday,
October
29,
1999
/
Rules
and
Regulations
other
waste
management
quantities
on
listed
toxic
chemicals,
so
that
they
may
use
the
data
in
conjunction
with
information
on
chemical
properties
(e.
g.
persistence
and
bioaccumulation)
and
site­
specific
information
to
determine
if
releases
present
a
potential
risk.
Several
commenters
express
concern
about
consistency
between
the
units
of
measurement
for
the
threshold
for
the
dioxin
and
dioxin­
like
compounds
category
and
the
units
of
measurement
used
to
report
releases
and
other
waste
management
quantities.
While
EPA
is
not
adopting
the
use
of
TEQ
as
some
commenters
requested,
EPA
is
being
consistent
since
absolute
gram
quantities
will
be
used
for
both
thresholds
and
the
reporting
of
releases
and
other
waste
management
quantities.
EPA
does
not
agree
with
those
commenters
who
state
that
the
information
collected
under
a
0.1
gram
threshold
would,
in
some
cases,
represent
such
a
small
portion
of
the
estimated
national
amount
of
dioxin
TEQs
that
the
data
would
not
be
useful.
On
a
facility­
by­
facility
basis,
the
amounts
reported
may
be
a
small
percentage
of
the
national
total,
but
that
does
not
mean
that
it
will
not
be
useful
or
meaningful
to
the
public.
One
of
the
purposes
of
EPCRA
section
313
is
to
provide
information
to
communities
about
releases
into
their
community.
A
small
percentage
of
national
releases
may
pose
potential
risks
to
local
communities.
Further,
even
information
that
shows
little
or
no
releases
helps
communities
to
understand
what
risks
may
be
or
may
not
be
present
in
their
communities
and
helps
government
agencies
to
target
resources.
In
addition,
since
not
all
of
the
sources
of
dioxin
and
dioxin­
like
compounds
will
be
reporting
under
EPCRA
section
313,
the
amount
reported
will
be
a
larger
portion
of
the
total
amount
reported
under
EPCRA
section
313
than
it
will
be
on
a
national
basis.
The
issue
of
how
many
sources
of
dioxin
and
dioxin­
like
compounds
are
captured
by
EPCRA
section
313
are
addressed
in
the
Response
to
Comments
document
(Ref.
69)
for
this
rulemaking.
EPA
does
not
agree
that
reporting
in
terms
of
TEQs
would
necessarily
be
less
burdensome.
As
one
commenter
states,
in
order
to
determine
the
sum
of
the
mass
of
the
17
dioxin
and
dioxin­
like
compounds,
one
already
will
have
determined
the
mass
of
each
compounds
individually
and
that
with
data
reported
by
compound,
a
TEQ
can
easily
be
calculated.
Since
the
TEQs
are
calculated
from
the
relative
amounts
of
dioxin
and
each
dioxin­
like
compound
that
is
present,
it
is
an
additional
step
to
present
the
data
in
terms
of
TEQs
and
therefore
it
should
not
be
less
burdensome.
f.
Reporting
guidance
for
dioxin
and
dioxin­
like
compounds.
A
number
of
commenters
requested
that
EPA
develop
reporting
guidance
for
the
dioxin
and
dioxin­
like
compounds
category.
EPA
agrees
that
guidance
should
be
provided
to
assist
facilities
in
determining
threshold
and
release
quantities
for
the
dioxin
and
dioxin­
like
compounds
category.
As
EPA
stated
in
the
proposed
rule:

EPA
intends
to
develop
reporting
guidance
for
industries
that
may
fall
within
this
reporting
category.
The
guidance
developed
will
be
consistent
with
the
methods
and
procedures
that
EPA
has
developed
for
determining
if
dioxin
and
dioxin­
like
compounds
are
present
in
various
industrial
processes,
including
Method
23
(Ref.
77)
developed
for
electric
utilities.
In
developing
the
reporting
guidance
for
the
dioxin
and
dioxin­
like
compounds
category
EPA
will
work
with
interested
parties
to
provide
the
best
possible
guidance
for
reporting
facilities
(at
64
FR
712).

EPA
will
provide
a
guidance
document
to
assist
certain
facilities
in
making
thresholds
and
release
determinations
for
the
dioxin
and
dioxin­
like
compounds
category.
The
guidance
document
will
be
consistent
with
EPA
established
methods
of
measuring
or
estimating
quantities
of
dioxin
and
dioxin­
like
compounds,
including
Method
23.
2.
Benzo(
g,
h,
i)
perylene
(CAS
No.
191­
24­
2)
(Ref.
70).
EPA
proposed
to
add
benzo(
g,
h,
i)
perylene
to
EPCRA
section
313
pursuant
to
EPCRA
section
313
(d)(
2)(
C).
One
commenter
states
that
EPA
should
not
add
benzo(
g,
h,
i)
perylene
to
the
EPCRA
section
313
list
of
toxic
chemicals
because
there
are
insufficient
data
to
support
the
EPCRA
section
313(
d)(
2)(
C)
determination.
The
commenter
states
that
EPA
used
predicted
aquatic
toxicity
values
based
on
quantitative
structure
activity
relationship
(QSAR)
analysis
but
did
not
provide
any
toxicity
data.
The
commenter
contends
that
EPA
did
not
provide
any
evidence
to
support
the
statement
that
aquatic
QSAR
equations
show
a
high
correlation
between
predicted
and
measured
toxicity
values,
and
did
not
provide
any
other
information
to
support
use
of
QSAR
for
this
type
of
chemical.
EPA
disagrees
with
the
commenter's
statements.
EPA
provided
the
following
discussion
in
the
proposed
rule:

Three
of
the
chemicals
being
proposed
for
listing
(benzo(
g,
h,
i)
perylene,
3­
methylcholanthene,
and
octachlorostyrene)
have
been
found
to
meet
the
EPCRA
section
313(
d)(
2)(
C)
criteria
for
ecotoxicity
based
on
predicted
aquatic
toxicity
values
generated
from
quantitative
structure
activity
relationship
(QSAR)
equations
and
other
predictive
techniques.
As
previously
stated
(58
FR
63500,
December
1,
1993),
EPA
believes
that,
where
no
or
insufficient
actual
measured
aquatic
toxicity
data
exist
upon
which
to
base
a
decision,
toxicity
predictions
generated
by
QSARs
and
other
predictive
techniques
may
constitute
sufficient
evidence
that
a
chemical
meets
the
section
313
listing
criteria.
EPA's
authority
to
use
such
predictive
techniques
derives
from
section
313(
d)(
2)
of
the
statute,
which
states
that
EPA
shall
base
its
listing
determinations
on,
inter
alia,
``
generally
accepted
scientific
principles.
''
EPA
believes
that
the
aquatic
QSAR
equations
that
are
in
widespread
use
and
show
a
high
correlation
between
predicted
and
measured
aquatic
toxicity
values
can
be
considered
to
be
''generally
accepted
scientific
principles''
and
can
appropriately
form
the
basis
of
a
listing
determination
(Ref.
70).
(at
64
FR
693)

EPA
believes
that
QSAR
data
is
valid
predicted
aquatic
toxicity
data
and
the
fact
that
no
actual
toxicity
studies
were
provided
does
not
mean
that
the
available
data
were
insufficient
to
determine
that
benzo(
g,
h,
i)
perylene
met
the
listing
criteria
of
EPCRA
section
313(
d)(
2)(
C).
In
addition,
EPA
did
provide
support
for
the
statement
that
aquatic
QSAR
equations
are
in
widespread
use
and
show
a
high
correlation
between
predicted
and
measured
aquatic
toxicity
values.
The
docket
for
the
proposed
rule
contained
a
document
titled
``
SAR/
QSAR
in
the
Office
of
Pollution
Prevention
and
Toxics''
In:
Environmental
Toxicology
and
Risk
Assessment:
2nd
Volume,
STP
1216.
One
of
the
articles
in
this
reference
was
titled
Validation
of
Structure
Activity
Relationships
Used
By
the
USEPA's
Office
of
Pollution
Prevention
and
Toxics
for
the
Environmental
Hazard
Assessment
of
Industrial
Chemical.
This
includes
the
methods
of
SAR
for
the
class
of
neutral
organic
chemicals
which,
as
discussed
in
the
support
document,
was
used
for
benzo(
g,
h,
i)
perylene
since
it
is
a
neutral
organic
chemical.
Thus,
EPA
did
provide
support
for
its
conclusions
about
QSAR
analysis
and
for
the
use
of
QSAR
for
benzo(
g,
h,
i)
perylene.
This
commenter
also
states
that
EPA
uses
an
estimated
Log
Kow
in
its
aquatic
toxicity
prediction
and
argues
that
Log
Kow
is
an
inaccurate
predictor
for
many
chemicals
particularly
if
it
is
estimated
rather
than
measured.
The
commenter
contends
that
EPA's
basis
for
the
listing
of
benzo(
g,
h,
i)
perylene
is
a
prediction
based
upon
a
prediction,
with
no
actual
data
and
that
this
is
not
a
sufficient
basis
for
listing
under
EPCRA
section
313
and
it
does
not
meet
the
statutory
requirements
for
listing
that
a
chemical
is
``
known
to
cause
or
can
reasonably
be
58705
Federal
Register
/
Vol.
64,
No.
209
/
Friday,
October
29,
1999
/
Rules
and
Regulations
anticipated
to
cause''
a
significant
adverse
effect.
EPA
disagrees
with
the
commenter's
conclusions.
The
majority
of
the
SAR
calculations
in
the
ECOSAR
Class
Program
are
based
upon
the
octanol/
water
partition
coefficient
(Kow
or
Log
P)
since
there
is
a
correlation
between
Log
P
and
toxicity.
Using
the
measured
aquatic
toxicity
values
and
estimated
Log
P
values,
regression
equations
can
be
developed
for
a
class
of
chemicals.
Toxicity
values
for
a
chemical
within
that
class
may
then
be
calculated
by
inserting
the
estimated
Kow
into
the
class
regression
equation
and
correcting
the
resultant
value
for
the
molecular
weight
of
the
compound.
The
ecological
assessment
guidelines
for
predicting
the
toxicity
of
chemicals
with
limited
measured
aquatic
toxicity
data
have
been
used
for
over
a
decade
(Ref.
35).
The
commenter
has
not
provided
the
Agency
with
any
concrete
information
or
data
indicating
that
this
approach
either
is
not
a
generally
accepted
scientific
approach
or
is
unreliable,
and
the
Agency
finds
no
reasonable
basis
to
change
these
techniques
at
this
time.
In
addition,
the
commenter
did
not
provide
any
data
to
indicate
that
the
predicted
Log
Kow
for
benzo(
g,
h,
i)
perylene
was
inaccurate.
This
commenter
also
contends
that
EPA's
failure
to
consider
exposure
in
this
proposed
rule
is
particularly
important
for
benzo(
g,
h,
i)
perylene.
The
commenter
argues
that
given
the
properties
of
benzo(
g,
h,
i)
perylene,
any
release
into
water
will
result
in
the
vast
majority
(more
than
99%)
of
the
compound
being
partitioned
to
sediment
or
adsorbed
onto
suspended
particulates
and
organics
in
the
water
column
and
thus
the
potential
for
this
chemical
to
be
in
a
toxic
form
and
pose
risk
in
natural
systems
is
low.
EPA
disagrees
with
the
commenters'
contention
that
EPA
should
consider
exposure
in
its
determination
that
benzo(
g,
h,
i)
perylene
meets
the
EPCRA
section
313(
d)(
2)(
C)
listing
criteria.
As
discussed
in
Unit
VI.
F.,
EPA
is
only
required
to
consider
exposure
under
a
limited
set
of
circumstances.
In
the
final
chemical
expansion
rule
(59
FR
61432),
EPA
further
explained
its
policy
on
the
use
of
exposure
considerations
under
EPCRA
section
313(
d)(
2)(
C)
and
the
fact
that
the
Agency
does
not
consider
exposure
for
chemicals
that
are
highly
ecotoxic.
As
EPA
explained
in
the
final
rule:

The
Agency
believes
that
exposure
considerations
are
not
appropriate
in
making
determinations
(1)
under
section
313(
d)(
2)(
B)
for
chemicals
that
exhibit
moderately
high
to
high
human
toxicity
(These
terms,
which
do
not
directly
correlate
to
the
numerical
screening
values
reflected
in
the
Draft
Hazard
Assessment
Guidelines,
are
defined
in
unit
II.)
based
on
a
hazard
assessment,
and
(2)
under
section
313(
d)(
2)(
C)
for
chemicals
that
are
highly
ecotoxic
or
induce
wellestablished
adverse
environmental
effects
(at
59
FR
61441).

Although
EPA
does
not
believe
that
it
would
be
appropriate
to
consider
exposure,
EPA
also
disagrees
with
the
commenter's
characterization
of
the
fate
of
benzo(
g,
h,
i)
perylene.
Environmental
fate
models
show
that
the
chemical
will
only
partition
about
60%
to
the
sediment.
Also,
the
Agency
cannot
rely
on
the
environment
to
serve
as
a
sink
for
this
chemical.
Other
environmental
conditions
such
as
turbidity,
biological
activity,
or
the
chemical
activity
in
water
could
cause
redistribution
of
the
chemical
into
the
water
column
again.
Based
upon
QSAR
equations
and
other
predictive
techniques,
EPA
has
concluded
that
benzo(
g,
h,
i)
perylene
is
toxic.
It
has
the
potential
to
kill
fish,
daphnia,
and
algae,
among
other
adverse
effects,
based
on
chemical
and/
or
biological
interactions.
Benzo(
g,
h,
i)
perylene
can
cause
these
toxic
effects
at
relatively
low
concentrations.
The
predicted
aquatic
toxicity
values
for
benzo(
g,
h,
i)
perylene,
based
upon
QSAR
analysis
using
the
equation
for
neutral
organics
and
an
estimated
Log
Kow
of
6.7,
included
calculated
values
of
0.030
milligrams
per
liter
(mg/
L)
for
the
fish
96±
hour
LC50
(i.
e.,
the
concentration
that
is
lethal
to
50%
of
test
organisms)
and
0.0002
mg/
L
for
fish
chronic
toxicity;
0.012
mg/
L
for
daphnia
48±
hour
LC50
and
0.027
mg/
L
for
the
daphnid
16±
day
chronic
LC50;
and
0.03
mg/
L
for
the
algae
96±
hour
EC50
(i.
e.,
the
concentration
that
is
effective
in
producing
a
sublethal
response
in
50%
of
tests
organisms)
with
an
algal
chronic
toxicity
of
0.012
mg/
L.
Benzo(
g,
h,
i)
perylene
can
cause
its
toxic
effects
at
relatively
low
concentrations,
therefore
EPA
considers
it
to
be
highly
toxic.
Since
benzo(
g,
h,
i)
perylene
is
toxic
at
relatively
low
concentrations
EPA
believes
that
it
causes
or
can
reasonably
be
anticipated
to
cause
a
significant
adverse
effect
on
the
environment.
In
addition,
because
of
the
nature
of
the
potential
significant
adverse
effects,
e.
g.,
fish,
daphnia,
and
algae
kills,
and
the
impacts
such
effects
can
have
on
ecological
communities
and
ecosystems,
EPA
has
determined
that
they
are
of
sufficient
seriousness
to
warrant
reporting.
EPA
reaffirms
that
there
is
sufficient
evidence
for
listing
benzo(
g,
h,
i)
perylene
on
the
EPCRA
section
313
list
of
toxic
chemicals
pursuant
to
EPCRA
section
313(
d)(
2)(
C)(
i)
based
on
the
available
ecotoxicity
information
for
this
chemical.
Therefore,
EPA
is
finalizing
the
addition
of
benzo(
g,
h,
i)
perylene
on
the
EPCRA
section
313
list.
3.
Benzo(
j,
k)
fluorene
(fluoranthene)
(CAS
No.
206±
44±
0)
(Ref
70).
EPA
proposed
to
add
fluoranthene
to
EPCRA
section
313
pursuant
to
EPCRA
sections
313
(d)(
2)(
B)
and
(C).
EPA
received
no
comments
specific
to
the
carcinogenicity
data
that
EPA
presented
in
the
proposed
rule
in
support
of
the
addition
of
fluoranthene
to
the
EPCRA
section
313
list
of
toxic
chemicals.
Thus,
EPA
reaffirms
that
there
is
sufficient
evidence
for
adding
fluoranthene
to
this
list
of
EPCRA
section
313
toxic
chemicals
pursuant
to
EPCRA
section
313(
d)(
2)(
B)
based
on
the
available
carcinogenicity
data
for
this
chemical.
One
commenter
argues
that
EPA
should
refrain
from
listing
fluoranthene
pending
additional
assessment
of
the
data.
The
commenter
contends
that
EPA's
reported
toxicity
values
for
fluoranthene
span
a
range
of
about
two
orders
of
magnitude
and
that
for
such
a
wide
range,
it
is
necessary
to
evaluate
potential
exposure
to
determine
which
scenarios,
and
therefore
which
types
of
data,
are
most
relevant
to
this
compound
following
a
release.
The
commenter
argues
that
fluoranthene
is
a
highly
lipophilic
compound
that
will
bind
primarily
to
sediment
and
suspended
organics,
so
it
is
not
clear
whether
the
reported
toxicity
values
on
which
EPA
relies
for
the
listing
are
applicable
to
this
compound
in
the
environment.
EPA
assumes
the
commenter
was
referring
to
data
used
to
support
EPA's
proposal
to
list
fluoranthene
pursuant
to
EPCRA
section
313(
d)(
2)(
C).
As
discussed
in
Unit
VI.
F.,
EPA
does
not
believe
that
it
is
appropriate
to
consider
exposure
for
chemicals
that
are
highly
ecotoxic
as
the
data
for
fluoranthene
clearly
shows
it
is.
However,
even
if
EPA
were
to
consider
exposure,
the
commenter
provided
no
data
to
support
the
assumption
that
fluoranthene
will
bind
primarily
to
sediments
and
suspended
organics,
and
EPA
believes
that
fluoranthene
will
partition
to
water
as
well
as
sediment.
While
the
ecotoxicity
data
for
fluoranthene
does
range
over
about
two
orders
of
magnitude
that
does
not,
in
itself,
form
a
basis
for
conducting
an
exposure
assessment.
There
are
data
that
clearly
show
that
fluoranthene
is
highly
ecotoxic.
Thus,
an
exposure
assessment
is
not
required.
While
it
does
not
impact
EPA's
assessment,
EPA
notes
that
of
the
ecotoxicity
values
presented
in
the
proposed
rule,
9
were
within
the
same
order
of
magnitude,
4
58706
Federal
Register
/
Vol.
64,
No.
209
/
Friday,
October
29,
1999
/
Rules
and
Regulations
were
one
order
of
magnitude
higher,
and
2
were
two
orders
of
magnitude
higher.
Thus,
60%
are
within
the
same
order
of
magnitude
and
87%
are
within
one
order
of
magnitude.
EPA
does
not
believe
that
this
represents
a
very
wide
distribution
as
the
commenter
implies.
Based
on
the
available
toxicity
data,
EPA
has
concluded
that
fluoranthene
is
toxic.
It
has
the
potential
to
kill
mysid
shrimp,
a
variety
of
freshwater
benthic
species
and
various
saltwater
species
and
it
can
also
cause
other
adverse
effects
on
fish
and
mysids,
based
on
chemical
and/
or
biological
interactions.
Fluoranthene
can
cause
these
toxic
effects
at
relatively
low
concentrations.
Ecotoxicity
values
for
fluoranthene
include
a
calculated
96±
hour
LC50
of
0.04
mg/
L
for
mysid
shrimp.
Using
standard
acute
toxicity
tests,
fluoranthene
has
been
tested
in
12
freshwater
species
from
11
genera.
For
freshwater
benthic
species,
the
acute
96±
hour
LC50
calculated
values
are
0.032
mg/
L
for
an
amphipod
(Gammarus
minus),
0.070
mg/
L
for
a
hydra
(Hydra
americana),
0.17
mg/
L
for
an
annelid
(Lumbriculus
variegatus),
and
0.17
mg/
L
for
a
snail
(Physella
virgata).
For
saltwater
species,
the
96±
hour
LC50
values
are
0.051
mg/
L
for
a
mysid
(Mysidopsis
bahia),
0.066
mg/
L
for
an
amphipod
(Ampelisca
abdita),
0.14
mg/
L
for
a
grass
shrimp
(Palaemonetes
pugio),
and
0.50
mg/
L
for
an
annelid
(Neanthes
arenaceodentata).
Fathead
minnows
exposed
to
fluoranthene
at
a
concentration
of
0.0217
mg/
L
for
28
days
in
a
chronic
early
life­
stage
test
showed
a
reduction
of
67%
in
survival
and
a
50.2%
reduction
in
growth
relative
to
the
controls.
In
a
28±
day
chronic
study,
mysids
exposed
to
0.021
mg/
L
of
fluoranthene
showed
a
26.7%
reduction
in
survival
and
a
91.7%
reduction
in
reproduction;
at
0.043
mg/
L
all
mysids
died.
In
a
31±
day
study,
mysids
showed
a
reduction
of
30%
in
survival,
12%
in
growth,
and
100%
in
reproduction
relative
to
controls
at
a
concentration
of
0.018
mg/
L
of
fluoranthene.
Fluoranthene
can
cause
its
toxic
effects
at
these
relatively
low
concentrations,
therefore
EPA
considers
it
to
be
highly
toxic.
Since
fluoranthene
is
toxic
at
relatively
low
concentrations,
EPA
believes
that
it
causes
or
can
reasonably
be
anticipated
to
cause
a
significant
adverse
effect
on
the
environment.
In
addition,
because
of
the
nature
of
the
potential
significant
adverse
effects,
e.
g.,
kills
of
mysid
shrimp,
a
variety
of
freshwater
benthic
species,
and
various
saltwater
species,
and
the
impacts
such
effects
can
have
on
ecological
communities
and
ecosystems,
EPA
has
determined
that
they
are
of
sufficient
seriousness
to
warrant
reporting.
Thus,
EPA
reaffirms
that
there
is
sufficient
evidence
for
adding
fluoranthene
on
the
EPCRA
section
313
list
of
toxic
chemicals
pursuant
to
EPCRA
section
313(
d)(
2)(
C)(
i)
based
on
the
available
ecotoxicity
information
for
this
chemical.
Therefore,
EPA
is
finalizing
the
listing
of
fluoranthene
on
the
EPCRA
section
313
list.
4.
3­
Methylcholanthrene
(CAS
No.
56±
49±
5)
(Ref.
70).
EPA
proposed
to
add
3­
methylcholanthrene
to
EPCRA
section
313
pursuant
to
EPCRA
sections
313(
d)(
2)(
B)
and
(C).
EPA
received
no
comments
on
the
carcinogenicity
data
that
EPA
presented
in
the
proposed
rule
in
support
of
the
addition
of
3­
methylcholanthrene
to
the
EPCRA
section
313
list
of
toxic
chemicals.
Thus,
EPA
reaffirms
that
there
is
sufficient
evidence
for
adding
3­
methylcholanthrene
to
the
list
of
EPCRA
section
313
toxic
chemicals
pursuant
to
EPCRA
section
313(
d)(
2)(
B)
based
on
the
available
carcinogenicity
data
for
this
chemical.
No
comments
were
received
concerning
the
ecotoxicity
data
that
EPA
presented
for
3­
methylcholanthrene
in
the
proposed
rule.
Based
upon
quantitative
structure
activity
relationship
(QSAR)
equations
and
other
predictive
techniques,
EPA
has
concluded
that
3­
methylcholanthrene
is
toxic.
It
has
the
potential
to
kill
fish
and
daphnia
as
well
as
cause
other
adverse
effects
on
fish,
daphnia,
and
algae
based
on
chemical
and/
or
biological
interactions.
3­
Methylcholanthrene
can
cause
these
toxic
effects
at
relatively
low
concentrations.
The
predicted
aquatic
toxicity
values
for
3­
methylcholanthrene,
based
on
QSAR
analysis
using
the
equation
for
neutral
organics
and
an
estimated
Log
Kow
of
7.05,
include
a
calculated
fish
96±
hour
LC50
of
0.009
mg/
L
and
a
chronic
fish
toxicity
value
of
0.003
mg/
L,
a
daphnia
48±
hour
LC50
of
0.005
mg/
L
and
a
16±
day
chronic
LC50
of
0.015
mg/
L,
and
an
algae
96±
hour
EC50
of
0.0105
mg/
L
with
a
calculated
chronic
toxicity
value
of
0.014
mg/
L.
3­
Methylcholanthrene
can
cause
its
toxic
effects
at
these
relatively
low
concentrations;
therefore,
EPA
considers
it
to
be
highly
toxic.
Since
3­
methylcholanthrene
is
toxic
at
relatively
low
concentrations,
EPA
believes
that
it
causes
or
can
reasonably
be
anticipated
to
cause
a
significant
adverse
effect
on
the
environment.
In
addition,
because
of
the
nature
of
the
potential
significant
adverse
effects,
e.
g.,
fish
and
daphnia
kills,
and
the
impacts
such
effects
can
have
on
ecological
communities
and
ecosystems,
EPA
has
determined
that
they
are
of
sufficient
seriousness
to
warrant
reporting.
Thus,
EPA
reaffirms
that
there
is
sufficient
evidence
for
listing
3­
methylcholanthrene
on
the
EPCRA
section
313
list
of
toxic
chemicals
pursuant
to
EPCRA
section
313(
d)(
2)(
C)(
i)
based
on
the
available
ecotoxicity
information
for
this
chemical.
Therefore,
EPA
is
finalizing
the
listing
of
3­
methylcholanthrene
on
the
EPCRA
section
313
list.
5.
Octachlorostyrene
(CAS
No.
29082±
74±
4)
(Ref.
70).
EPA
proposed
to
add
octachlorostyrene
to
EPCRA
section
313
pursuant
to
EPCRA
sections
313(
d)(
2)(
B)
and
(C).
One
commenter
argues
that
octachlorostyrene
(OCS)
should
not
be
included
in
the
EPCRA
section
313
PBT
chemicals
list.
The
commenter
contends
that
OCS
was
included
as
a
PBT
chemical
simply
because
it
appears
on
several
lists
of
persistent
and
bioaccumulative
chemicals
and
not
based
on
a
thorough
evaluation
of
its
toxicity.
The
commenter
argues
that
there
is
limited
toxicity
data
for
OCS
and
cited
two
statements
that
were
in
EPA's
support
document
for
the
addition
of
OCS
and
the
other
chemicals
being
added
in
this
rulemaking.
The
two
statements
the
commenter
cited
were:

The
health
hazard
data
which
support
TRI
listing
are
very
limited.
Human
health
data
were
not
located.
(Ref.
70
p.
48)

EPA
disagrees
with
the
commenters'
conclusions.
The
commenter
did
not
comment
on
the
actual
toxicity
data
that
EPA
provided
as
the
basis
for
listing
OCS
pursuant
to
EPCRA
section
313(
d)(
2)(
B).
Rather
the
commenter
takes
two
statements
that
were
contained
in
the
support
document
out
of
context
to
support
their
apparent
contention
that
there
are
insufficient
data
to
list
OCS
under
EPCRA
section
313(
d)(
2)(
B).
The
fact
that
the
commenter
has
taken
these
statements
out
of
context
is
demonstrated
by
the
content
of
the
rest
of
the
paragraph
that
contained
the
statements
the
commenter
cited:

Laboratory
studies
on
rats
suggest
OCS
may
have
acute
and
chronic
effects
on
the
liver,
kidneys,
and
thyroid.
In
a
long­
term
study
(one
year)
of
rats
a
LOAEL
of
0.31
mg/
kg/
day
was
determined
based
on
significant
histological
effects
on
these
organs.
(Ref.
70)

The
statements
the
commenter
cited
only
acknowledged
that
there
was
not
a
vast
amount
of
toxicity
data
for
OCS
and
specifically,
that
there
were
no
human
studies;
they
do
not
support
the
commenters'
conclusion
that
OCS
does
not
meet
listing
criteria
of
EPCRA
58707
Federal
Register
/
Vol.
64,
No.
209
/
Friday,
October
29,
1999
/
Rules
and
Regulations
section
313(
d)(
2)(
B).
In
addition,
these
statements
were
from
the
summary
section
of
the
discussion
on
OCS,
more
detailed
discussion
of
the
toxicity
data
for
OCS
was
contained
in
the
other
sections
on
OCS
toxicity
but
the
commenter
provided
no
comments
on
this
information.
EPA
reaffirms
that
there
is
sufficient
evidence
for
adding
OCS
to
the
EPCRA
section
313
list
of
toxic
chemicals
pursuant
to
EPCRA
section
313(
d)(
2)(
B)
based
on
the
available
hepatic,
nephric,
and
thyroid
toxicity
data
for
this
chemical.
The
same
commenter
also
claims
that
the
toxicity
comparisons
to
hexachlorobenzene
are
not
supported
and
that
no
references
or
rationale
are
provided
to
support
basing
the
aquatic
toxicity
of
OCS
on
that
of
hexachlorobenzene.
As
with
the
human
health
data,
the
commenter
argues
that
there
are
limited
environmental
toxicity
data
for
OCS
and
cited
some
statements
that
were
in
EPA's
support
document.
The
statements
the
commenter
cited
were:

So
far
as
is
known,
after
a
search
of
former
EEB
chemical
files,
the
ecological
hazard
of
OCS
has
never
been
formally
reviewed
under
TSCA
section
4
or
in
the
OPPT
Risk
Management
(RM)
process.
OCS
was
briefly
reviewed
for
aquatic
toxicity
in
August
1986,
as
part
of
an
OTS
(now
OPPT)
chemical
scoring
project.
Thus,
available
information
on
OCS
is
very
limited.
(Ref.
70,
p.
52)

EPA
disagrees
with
the
commenter's
conclusions.
The
commenter
has
not
commented
on
the
actual
toxicity
data
but
rather
states
that
the
data
are
limited
and
that
hexachlorobenzene
is
not
an
appropriate
analogue
for
predicting
the
aquatic
toxicity
data
for
OCS.
The
statements
the
commenter
cited
only
acknowledged
that
there
was
not
a
vast
amount
of
toxicity
data
for
OCS,
they
do
not
support
the
commenter's
conclusion
that
OCS
does
not
meet
the
listing
criteria
of
EPCRA
section
313(
d)(
2)(
C).
Contrary
to
the
commenter's
statement,
EPA
did
provide
a
reference
to
the
use
of
hexachlorobenzene
as
an
appropriate
analogue
for
OCS.
As
EPA
stated
in
the
same
section
of
the
support
document
the
commenter
cited:

OCS
is
one
of
7
compounds
in
this
chemical
class
(chlorinated
styrenes)
with
the
generic
formula
C8H8­
xClx,
where
x
equals
8
for
OCS.
This
class
is
analogous
to
the
chlorinated
benzenes;
for
example
hexachlorobenzene
(HCB),
is
considered
to
be
an
appropriate
analogue
chemical
for
OCS
(2).
(Ref.
70,
page
52).

The
reference
EPA
cited
is
a
previous
EPA
analysis
of
this
class
of
chemicals
that
also
used
hexachlorobenzene
as
an
appropriate
analogue
for
OCS.
EPA
believes
that
since
OCS
and
hexachlorobenzene
are
both
highly
chlorinated
derivatives
of
benzene
they
can
reasonably
be
anticipated
to
have
similar
toxicities.
However,
in
addition
to
aquatic
toxicity
data
on
hexachlorobenzene,
EPA
provided
the
results
of
a
QSAR
analysis
of
OCS,
using
a
measured
Log
Kow
of
7.7,
that
gave
a
predicted
14±
day
LC50
value
of
6
mg/
L
for
guppies.
Based
upon
QSAR
equations
and
analogue
data,
EPA
has
concluded
that
OCS
is
toxic.
It
has
the
potential
to
kill
fish
and
inhibit
photosynthesis
in
algae,
among
other
adverse
effects,
based
on
chemical
and/
or
biological
interactions.
OCS
can
cause
these
toxic
effects
at
relatively
low
concentrations.
The
predicted
aquatic
toxicity
value
for
OCS,
based
upon
QSAR
analysis
using
a
measured
Log
Kow
of
7.7,
is
an
estimated
14±
day
LC50
of
6
mg/
L
for
guppies.
Based
on
the
chemical
analogue
hexachlorobenzene,
OCS
can
reasonably
be
anticipated
to
inhibit
photosynthesis
in
algae
at
a
concentration
of
30
mg/
L
and
have
a
calculated
subchronic
EC50
value
of
16
mg/
L
for
daphnids.
OCS
can
cause
its
toxic
effects
at
these
relatively
low
concentrations;
therefore,
EPA
considers
it
to
be
highly
toxic.
Since
OCS
is
toxic
at
relatively
low
concentrations,
EPA
believes
that
it
causes
or
can
reasonably
be
anticipated
to
cause
a
significant
adverse
effect
on
the
environment.
In
addition,
because
of
the
nature
of
the
potential
significant
adverse
effects,
e.
g.,
fish
kills,
and
inhibition
of
photosynthesis
in
algae
and
the
impacts
such
effects
can
have
on
ecological
communities
and
ecosystems,
EPA
has
determined
that
they
are
of
sufficient
seriousness
to
warrant
reporting.
EPA
reaffirms
that
there
is
sufficient
evidence
for
listing
OCS
on
the
EPCRA
section
313
list
of
toxic
chemicals
pursuant
to
EPCRA
section
313(
d)(
2)(
C)(
i)
based
on
the
available
ecotoxicity
information
for
this
chemical.
Therefore,
EPA
is
finalizing
the
addition
of
OCS
on
the
EPCRA
section
313
list.
6.
Pentachlorobenzene
(CAS
No.
609±
93±
5)
(Ref.
70).
EPA
proposed
to
add
pentachlorobenzene
to
EPCRA
section
313
pursuant
to
EPCRA
sections
313(
d)(
2)(
B)
and
(C).
No
comments
were
received
concerning
the
human
health
toxicity
data
that
EPA
presented
in
the
proposed
rule.
Thus,
EPA
reaffirms
that
there
is
sufficient
evidence
for
adding
pentachlorobenzene
on
EPCRA
section
313
pursuant
to
EPCRA
section
313(
d)(
2)(
B)
based
on
the
available
hepatic,
nephric,
hematological,
and
developmental
toxicity
data
for
this
chemical.
No
comments
were
received
concerning
the
ecotoxicity
data
that
EPA
presented
for
pentachlorobenzene
in
the
proposed
rule.
Based
on
the
available
toxicity
data,
EPA
has
concluded
that
pentachlorobenzene
is
toxic.
It
has
the
potential
to
kill
fish
and
mysid
shrimp
as
well
as
cause
other
adverse
effects
on
algae
and
daphnia,
based
on
chemical
and/
or
biological
interactions.
Pentachlorobenzene
can
cause
these
toxic
effects
at
relatively
low
concentrations.
Aquatic
acute
toxicity
calculated
values
for
pentachlorobenzene
include
a
sheepshead
minnow
96±
hour
LC50
of
0.83
mg/
L,
bluegill
sunfish
96±
hour
LC50s
of
0.25
mg/
L
and
0.3
mg/
L,
a
guppy
96±
hour
LC50
of
0.54
mg/
L,
and
a
mysid
shrimp
96±
hour
LC50
of
0.16
mg/
L.
Because
pentachlorobenzene
can
cause
these
toxic
effects
at
these
relatively
low
concentrations,
EPA
considers
it
to
be
highly
toxic.
Additional
acute
toxicity
calculated
values
include
algae
96±
hour
EC50s
of
1.98
mg/
L
and
6.78
mg/
L,
and
daphnia
48±
hour
EC50s
of
1.3
mg/
L
and
5.28
mg/
L.
Considering
pentachlorobenzene's
persistence
and
bioaccumulation
potential
pentachlorobenzene
is
considered
highly
toxic
to
aquatic
organism
at
these
higher
concentrations.
As
discussed
above,
pentachlorobenzene
is
highly
toxic.
Because
pentachlorobenzene
is
highly
toxic
at
relatively
low
concentrations,
EPA
believes
that
it
causes
or
can
reasonably
be
anticipated
to
cause
a
significant
adverse
effect
on
the
environment.
In
addition,
because
of
the
nature
of
the
potential
significant
adverse
effects,
e.
g.,
fish
and
mysid
shrimp
kills
as
well
as
other
adverse
effects
on
algae
and
daphnia,
and
the
impacts
such
effects
can
have
on
ecological
communities
and
ecosystems,
EPA
has
determined
that
they
are
of
sufficient
seriousness
to
warrant
reporting.
Thus,
EPA
reaffirms
that
there
is
sufficient
evidence
for
adding
pentachlorobenzene
on
the
EPCRA
section
313
list
of
toxic
chemicals
pursuant
to
EPCRA
section
313(
d)(
2)(
C)(
i),
(ii),
and
(iii)
based
on
the
available
ecotoxicity
information
for
this
chemical.
Therefore,
EPA
is
finalizing
the
listing
of
pentachlorobenzene
on
the
EPCRA
section
313
list.
7.
Tetrabromobisphenol
A
(CAS
No.
79±
94±
7)
(Ref.
70).
EPA
proposed
to
add
TBBPA
to
EPCRA
section
313
pursuant
to
EPCRA
sections
313(
d)(
2)(
B)
and
(C).
One
commenter
claims
that
the
study
cited
by
EPA
in
support
of
its
58708
Federal
Register
/
Vol.
64,
No.
209
/
Friday,
October
29,
1999
/
Rules
and
Regulations
conclusion
that
TBBPA
meets
the
EPCRA
section
313(
d)(
2)(
B)
criteria
for
listing
based
on
developmental
toxicity
was
not
a
study
on
TBBPA.
The
study
in
question
was
submitted
to
EPA
by
ICI
Americas
Inc.
with
a
cover
letter
identifying
Saytex
111,
the
product
tested,
as
being
TBBPA.
The
product
was
identified
as
TBBPA
by
both
name
and
CAS
number.
EPA
has
determined
that
the
product
tested
was
not
TBBPA
as
claimed
by
the
submitter
but
has
been
unable
to
determine
why
it
was
misidentified
by
the
submitter.
ICI
Americas
is
now
Zeneca
at
the
Delaware
location
that
submitted
the
study.
A
Zeneca
staff
member
researched
the
submission
and
found
that
the
report
was
originally
from
Ethyl
Corporation
and
that
no
other
report
on
TBBPA
was
submitted
to
EPA
on
that
date.
Without
the
misidentified
developmental
study,
no
adequate
toxicology
studies
or
other
data
were
located
by
EPA
that
support
the
addition
of
TBBPA
pursuant
to
EPCRA
section
313(
d)(
2)(
B).
Thus,
EPA
is
not
adding
TBBPA
based
on
concerns
for
developmental
toxicity
or
any
other
human
health
effects.
The
same
commenter
provides
comments
on
the
persistence
and
bioaccumulation
of
TBBPA
and
contends
that
there
are
insufficient
data
to
conclude
that
TBBPA
meets
the
listing
criteria
of
EPCRA
section
313(
d)(
2)(
C)(
ii)
and
313(
d)(
2)(
C)(
iii).
These
two
sections
deal
with
EPA's
authority
to
add
a
chemical
based
on
its
``
toxicity
and
persistence
in
the
environment''
and
its
``
toxicity
and
tendency
to
bioaccumulate
in
the
environment''
respectively.
However,
the
commenter
does
not
contend
that
TBBPA
does
not
meet
the
listing
criteria
of
EPCRA
section
313(
d)(
2)(
C)(
i)
which
addresses
EPA's
authority
to
add
a
chemical
based
on
its
``
toxicity''
without
consideration
of
persistence
and
bioaccumulation.
EPA
believes
that
TBBPA
is
persistent
and
bioaccumulative
as
discussed
in
Unit
VI.
H.
However,
EPA
did
not
propose
to
add
TBBPA
to
the
EPCRA
section
313
list
of
toxic
chemicals
based
on
its
persistence
or
bioaccumulation
data,
and
neither
of
these
properties
were
mentioned
in
the
toxicity
discussion
of
TBBPA
in
the
proposed
rule.
Rather,
EPA
based
its
listing
decision
on
the
ecotoxicity
data
alone
which
indicated
that
TBBPA
was
highly
toxic
even
without
consideration
of
persistence
or
bioaccumulation.
Based
the
available
toxicity
data,
EPA
has
concluded
that
TBBPA
is
toxic.
It
has
the
potential
to
kill
fish,
daphnid,
and
mysid
shrimp,
among
other
adverse
effects,
based
on
chemical
and/
or
biological
interactions.
TBBPA
can
cause
these
toxic
effects
at
relatively
low
concentrations.
Aquatic
acute
toxicity
calculated
values
for
TBBPA
include
a
fathead
minnow
96±
hour
LC50
of
0.54
mg/
L,
a
rainbow
trout
96±
hour
LC50
of
0.40
mg/
L,
a
bluegill
sunfish
96±
hour
LC50
of
0.51
mg/
L,
and
a
daphnid
48±
hour
LC50
of
0.96
mg/
L;
mysid
shrimp
96±
hour
LC50
values
ranged
from
0.86
to
1.2
mg/
L
depending
on
the
age
of
the
shrimp.
Aquatic
chronic
toxicity
calculated
values
from
a
daphnia
21±
day
study
resulted
in
a
Maximum
Acceptable
Toxicant
Concentration
(MATC)
that
was
between
0.30
and
0.98
mg/
L
(geometric
mean
0.54
mg/
L)
based
on
a
significant
reduction
in
reproduction
rates;
a
fathead
minnow
35±
day
study
resulted
in
a
MATC
that
was
calculated
to
be
between
0.16
and
0.31
mg/
L
(geometric
mean
0.22
mg/
L)
based
on
adverse
effects
on
embryo
and
larval
survival.
TBBPA
can
cause
its
toxic
effects
at
these
relatively
low
concentrations;
therefore,
EPA
considers
it
to
be
highly
toxic.
Since
TBBPA
is
toxic
at
relatively
low
concentrations,
EPA
believes
that
it
causes
or
can
reasonably
be
anticipated
to
cause
a
significant
adverse
effect
on
the
environment.
In
addition,
because
of
the
nature
of
the
potential
significant
adverse
effects,
e.
g.,
fish,
daphnid,
and
mysid
shrimp
kills,
and
the
impacts
such
effects
can
have
on
ecological
communities
and
ecosystems,
EPA
has
determined
that
they
are
of
sufficient
seriousness
to
warrant
reporting.
EPA
reaffirms
that
there
is
sufficient
evidence
for
listing
TBBPA
on
the
EPCRA
section
313
list
of
toxic
chemicals
pursuant
to
EPCRA
section
313(
d)(
2)(
C)(
i)
based
on
the
available
ecotoxicity
information
for
this
chemical.
Therefore,
EPA
is
finalizing
the
addition
of
TBBPA
on
the
EPCRA
section
313
list.
8.
Vanadium
and
vanadium
compounds.
EPA
proposed
to
add
vanadium
and
vanadium
compounds
to
EPCRA
section
313
pursuant
to
EPCRA
sections
313(
d)(
2)(
C).
One
commenter
cited
the
following
statement
from
the
proposed
rule,
``
However,
very
few
toxicity
tests
have
been
conducted
with
invertebrates.
''
The
commenter
argues
that,
beyond
vanadium
pentoxide,
the
Agency
appears
to
have
very
little
toxicity
data
on
vanadium
compounds.
The
commenter
contends
that
the
paucity
of
toxicity
data
on
many
different
forms
of
vanadium
compounds
in
the
proposal,
as
well
as
in
the
literature,
does
not
appear
to
support
the
Agency's
belief
that
``
the
evidence
is
sufficient
to
list
vanadium
and
vanadium
compounds
on
EPCRA
section
313
pursuant
to
EPCRA
section
313(
d)(
2)(
C)
based
on
the
available
ecotoxicity
information
on
vanadium
and
vanadium
compounds''
(at
64
FR
698).
EPA
disagrees
with
the
commenters'
conclusions.
Although
there
is
limited
information
on
vanadium's
toxicity
on
invertebrates,
data
that
were
available
for
invertebrates
shows
that
vanadium
is
toxic
to
these
species.
Furthermore,
EPA's
assessment
of
vanadium's
toxicity
included
algae
and
vertebrates,
and
showed
that
the
chemical
is
highly
toxic
to
aquatic
organisms.
The
data
on
vanadium
are
not
limited
to
vanadium
pentoxide,
the
ecological
data
provided
in
the
proposed
rule
for
vanadium
evaluates
vanadium
toxicity
based
on
data
for
other
vanadium
compounds
including:
sodium
metavanadate,
sodium
orthovanadate,
vanadyl
sulfate,
and
ammonium
vanadate.
In
assessing
the
ecological
toxicity
of
vanadium
and
vanadium
compounds,
EPA
evaluated
the
parent
metal
(vanadium)
and
determined
that
it
is
highly
toxic
to
some
aquatic
species
and
anticipated
to
cause
a
significant
adverse
effect
on
the
environment
of
sufficient
seriousness
to
warrant
reporting.
Thus,
vanadium,
the
parent
metal
in
vanadium
compounds,
is
the
concern,
not
the
other
components
of
each
vanadium
compound.
Many
metals
are
tested
in
the
salt
form
because
these
forms
are
readily
soluble
in
aqueous
solutions.
The
toxicity
data
for
vanadium
shows
that
the
metal
is
highly
toxic
(aquatic
toxicity
<
1
mg/
L)
to
the
most
sensitive
species.
This
evaluation
of
vanadium's
toxicity
is
acceptable
according
to
traditional
guidelines
for
the
assessment
of
toxic
substances
as
conducted
by
the
Agency
for
over
2
decades.
In
addition,
when
consideration
is
given
to
vanadium's
persistence
it
is
also
considered
highly
toxic
at
higher
concentrations.
Three
commenters
contend
that
since
most
vanadium
compounds
are
practically
insoluble,
they
consequently
have
very
low
bioavailability,
and
thus
it
is
likely
that
they
could
qualify
for
delisting.
The
commenters
argue
that
the
delisting
process
is
extremely
cumbersome,
time­
consuming
and
costly.
One
of
these
commenters
contends
that
it
is
inappropriate
to
list
all
of
vanadium
compounds
based
on
aquatic
toxicity
of
the
few
compounds
cited
in
the
proposed
rule.
The
bioavailability
of
metals
such
as
vanadium
was
also
raised
as
an
issue
at
the
public
meetings
held
for
this
rulemaking.
It
was
suggested
that
the
parent
metal
will
not
be
bioavailable
from
certain
metal
compounds
that
may
be
released
into
the
environment
and
that
therefore
the
compounds
cannot
be
58709
Federal
Register
/
Vol.
64,
No.
209
/
Friday,
October
29,
1999
/
Rules
and
Regulations
properly
characterized
as
a
PBT
chemicals.
EPA
disagrees
with
these
comments.
First,
it
should
be
noted
that
EPA
has
not
addressed
whether
vanadium
and
vanadium
compounds
can
properly
be
classified
as
PBT
chemicals
in
this
rulemaking.
The
sole
issue,
therefore,
is
whether
vanadium
and
vanadium
compounds
meet
the
EPCRA
section
313(
d)(
2)(
C)
listing
criteria.
EPA's
analysis
of
the
environmental
fate
of
vanadium
and
vanadium
compounds
shows
that
under
many
environmental
conditions
vanadium
will
be
available
and
thus
is
able
to
express
its
toxicity.
The
commenters
have
not
provided
EPA
with
any
data
or
acceptable
scientific
studies
indicating
that
vanadium
in
any
particular
compound
will
not
become
available
in
the
environment.
In
fact,
at
least
one
commenter
appears
to
indicate
that
these
vanadium
compounds
may
merely
have
low
solubility.
In
these
compounds,
the
parent
metal
vanadium
can
become
available.
While
water
soluble
vanadium
compounds
would
obviously
provide
vanadium
in
an
immediately
bioavailable
form,
solubility
is
not
the
only
factor
to
consider
in
determining
the
bioavailability
of
vanadium
from
a
vanadium
compound.
In
addition
to
solubility,
processes
such
as:
hydrolysis
at
various
pHs;
solubilization
in
the
environment
at
various
pHs;
photolysis;
aerobic
transformations
(both
abiotic
and
biotic);
anaerobic
transformation
(both
abiotic
and
biotic);
and
bioavailability
when
the
compounds
are
ingested
(solubilization
in
and/
or
absorption
from
the
gastrointestinal
tract
and
solubilization
in
various
organs)
need
to
be
considered.
In
Unit
VI.
C.,
EPA
discusses
in
detail
the
persistence
and
bioavailability
of
metals
in
general.
The
issue
of
bioavailability
has
been
addressed
for
EPCRA
section
313
chemical
assessments
through
EPA's
policy
and
guidance
concerning
petitions
to
delist
individual
members
of
the
metal
compound
categories
on
the
EPCRA
section
313
toxic
chemical
list
(56
FR
23703).
This
policy
states
that
if
the
metal
in
a
metal
compound
cannot
become
available
as
a
result
of
biotic
or
abiotic
processes
then
the
metal
will
not
be
available
to
express
its
toxicity.
If
the
intact
metal
compound
is
not
toxic
and
the
metal
is
not
available
from
the
metal
compound
then
such
a
chemical
is
a
potential
candidate
for
delisting.
One
commenter
argued
that
the
lowest
toxicity
value
cited
by
EPA
for
a
marine
algal
species
was
for
Dunaliella
marina
with
a
9±
day
LC50
of
0.5
mg/
L
but
that
EPA
omitted
a
study
which
tested
the
same
species
and
reported
no
significant
adverse
effects
at
a
concentration
of
50
mg/
L.
EPA
believes
that
the
study
that
reported
the
9±
day
LC50
of
0.5
parts
per
million
(ppm)
on
Dunaliella
marina,
is
accurate
and
was
acceptably
conducted
within
the
guidelines
for
ecological
assessments
of
hazardous
chemicals.
This
study
shows
the
most
sensitive
species'
response
to
the
chemical.
There
are
differences
in
the
two
studies
that
could
explain
the
range
of
toxicity
between
the
two.
They
are:
(1)
Differences
in
the
exposure
times,
(2)
the
species
used
in
the
experiments,
and
(3)
the
form
of
vanadium
that
was
exposed
to
the
organisms.
The
exposure
time
in
the
study
EPA
cited
reported
a
9±
day
LC50
of
0.5
mg/
L.
However,
the
study
the
commenter
cites
did
not
report
an
LC50
duration.
Also,
the
species
for
the
study
EPA
cited
reported
the
test
species
to
be
Dunaliella
marina
(salina),
but
the
study
the
commenter
cited
only
reported
the
genus
name
for
this
organism.
Furthermore,
the
study
EPA
cited
reported
the
form
of
vanadium
as
sodium
vanadate,
but
the
study
the
commenter
cites
only
reported
using
the
vanadium
compound
without
reporting
the
specific
salt
form.
It
is
clear
that
any
one
of
the
three
factors
mentioned,
or
some
combination
of
these
factors,
likely
accounts
for
the
variation
in
toxicity
between
the
two
studies.
One
commenter
argues
that
a
study,
omitted
in
EPA's
review
of
vanadium
toxicity,
on
nine
algal
species
showed
no
significant
reduction
in
productivity
(as
measured
by
chlorophyll
synthesis)
at
vanadium
concentrations
in
excess
of
10
mg/
L.
The
commenter
also
contends
that
the
authors
of
the
study
also
demonstrated
that
phosphate
concentrations
were
critical
in
the
toxicity
of
vanadium
to
algae.
The
Agency
has
not
neglected
to
review
the
study
cited
by
the
commenter.
However,
EPA
interprets
the
study
cited
by
the
commenter
as
describing
the
competition
uptake
between
vanadium
and
phosphorus
in
an
algal
medium
containing
two
different
kinds
of
phosphorus
concentrations
(i.
e.,
phosphorus
deficient
and
phosphorus
sufficient).
Also,
this
study
was
performed
only
on
freshwater
algae
and
one
form
of
vanadium
(orthovanadate)
which
only
exists
in
a
pH
range
of
3
to
6.
This
study
did
report
a
moderately
high
toxicity
value
for
Scenedesmus
acutus
between
5
and
177
M,
which
continues
to
support
EPA's
findings
that
vanadium
is
toxic
to
algae.
Furthermore,
EPA
is
aware
that
there
are
studies
that
were
not
included
in
the
assessment
that
showed
that
the
chemical
was
more
toxic
than
the
values
reported
in
EPA's
assessment.
However,
each
study
was
carefully
reviewed
based
on
EPA's
extensive
evaluation
process
which
reviews
studies
for
conformance
with
generally
accepted
scientific
standards
and
tests.
The
studies
that
were
reported
in
EPA's
assessment
used
generally
accepted,
validated
scientific
methods
for
evaluating
aquatic
toxicity.
The
toxicity
values
that
were
reported
in
the
ecological
assessment
of
vanadium
toxicity
were
from
well­
conducted
studies.
One
commenter
argues
that
it
appears
from
a
review
of
the
data
that
the
contention
that
vanadium
is
highly
toxic
to
algae
has
no
basis.
The
commenter
contends
that
with
the
exception
of
one
study
on
a
single
species,
Ceratium
hirundinella,
none
of
the
studies
on
freshwater
algae
showed
significant
toxicity
at
concentrations
below
10
mg/
L.
The
commenter
states
that
the
lowest
level
of
toxicity
reported
for
a
marine
species
(Dunaliella
marina)
was
an
LC50
of
0.5
mg/
L,
but
that
there
is
conflicting
evidence
that
the
threshold
of
toxicity
for
this
species
may
be
higher
than
50
mg/
L.
The
commenter
concludes
that
there
appears
to
be
little
evidence
that
vanadium
is
a
highly
toxic
agent
to
algae.
The
commenter
also
argues
that
evaluating
the
toxicity
of
a
compound
based
on
the
response
of
individual
algal
species
can
be
misleading.
The
commenter
contends
that
algae
never
exist
within
either
marine
or
freshwater
environments
as
monocultures,
but
rather
as
dynamic
mixed
populations.
The
commenter
concludes
that
unless
a
compound
can
be
shown
to
have
a
broad
effect
over
an
entire
assemblage
or
over
numerous
species
of
either
freshwater
or
marine
species,
it
is
not
likely
to
have
a
significant
effect
within
the
natural
environment.
EPA's
assessment
on
algae
toxicity
shows
that
vanadium
is
highly
toxic
based
on
the
most
sensitive
species'
response
to
the
chemical.
There
is
no
conflict
in
the
threshold
of
toxicity
of
Dunaliella
marina.
As
stated
above,
there
are
three
factors
that
most
probably
account
for
the
differences
between
the
study
EPA
cited
and
the
study
the
commenter
cites.
After
careful
review
of
the
available
data,
it
is
EPA's
professional
judgment
that
the
study
EPA
cited
provides
accurate
and
valid
data.
Algae
studies
have
been
included
in
ecological
risk
assessments
for
over
2
decades.
Several
guidelines
on
different
species
have
been
written
to
show
that
these
genera
are
important
in
the
environment
and
show
sensitivity
in
how
chemicals
affect
the
biota.
EPA
58710
Federal
Register
/
Vol.
64,
No.
209
/
Friday,
October
29,
1999
/
Rules
and
Regulations
agrees
that
algae
usually
do
not
exist
in
monocultures
in
the
marine
or
freshwater
environment.
However,
testing
monocultures
species
is
the
most
accurate
method
to
determine
whether
a
chemical
is
directly
harmful
to
that
species.
Therefore,
if
a
compound
is
highly
toxic
to
a
particular
species
of
algae
or
any
species,
its
effects
can
be
extrapolated
to
represent
other
species
exposed
to
that
chemical.
This
evaluation
process
has
been
used
by
the
Agency
and
accepted
by
OECD
for
over
two
decades,
and
used
on
thousands
of
chemicals.
Vanadium's
toxicity
ranges
from
highly
toxic
to
moderately
toxic
for
algae
in
EPA's
assessment.
It
is
reasonable
from
the
evidence
in
EPA's
assessment
of
vanadium
that
the
species
that
is
the
most
sensitive
to
the
chemical
can
represent
the
toxicity
for
all
other
species
based
on
this
narrow
range.
EPA's
final
evaluation
of
any
chemical's
toxicity
is
based
on
the
most
sensitive
species'
response.
One
commenter
contends
that
the
study
EPA
cited
that
reported
the
144±
hour
LC50
of
0.4
and
0.5
mg/
L
for
vanadyl
sulfate
(VOSO4)
and
ammonium
metavanadate
(NH4VO3),
respectively,
were
actually
values
for
VOSO4
and
sodium
metavanadate
(NaVO3)
respectively.
The
commenter
contends
that
the
144±
hour
LC50
for
NH4VO3
was
l.
5
mg/
L.
The
commenter
also
argues
that
EPA
neglected
to
report
from
the
same
study
a
144±
hour
LC50
of
1.1
mg/
L
for
vanadate
pentoxide
(V2O5)
for
this
species.
The
commenter
also
contends
that
the
findings
of
144±
hour
LC50s
of
2.5
to
8.1
mg/
L
in
goldfish
(Carassius
auratus)
for
the
same
four
vanadium
species
were
also
omitted.
The
comment
concerning
the
vanadium
compounds
for
the
144±
hour
LC50s
of
0.4
and
0.5
mg/
L
is
correct.
EPA
inadvertently
cited
to
the
incorrect
compound
in
the
study.
The
correct
vanadium
compounds
will
be
reflected
in
an
update
to
the
support
document.
However,
sodium
metavanadate,
is
still
a
vanadium
compound
and
the
study
therefore
continues
to
support
EPA's
findings
that
vanadium
is
highly
toxic
to
fish.
The
other
values
of
2.5
and
8.1
mg/
L
merely
provide
further
support
for
EPA's
finding
that
the
vanadium
is
moderately
toxic
to
fish.
However,
considering
vanadium's
persistence
in
the
environment,
EPA
believes
that
it
is
highly
toxic
at
concentrations
between
1
and
10
mg/
L.
Thus
the
goldfish
values
provide
further
support
to
EPA's
finding
that
vanadium
is
highly
toxic
to
some
aquatic
organisms.
One
commenter
contends
that
in
assessing
the
toxicity
of
vanadium
to
fish,
EPA
neglected
to
review
the
following
studies:
(1)
Hamilton
and
Buhl
(1997),
who
reported
a
96±
hour
LC50
for
the
flannelmouth
sucker
(Catostomus
latipinnis)
of
11.7
mg/
L;
(2)
Taylor
et
al.
(1985),
who
reported
a
96±
hour
LC50
for
English
sole
(Limanda
limanda)
of
26.8
mg/
L;
(3)
Ernst
and
Garside
(1987),
who
reported
a
96±
hour
LC50
for
the
brook
trout
(Salvelinus
fontinaliis)
alevins
of
24
mg/
L
and
for
yearlings
of
7±
15
mg/
L
(the
authors
also
reported
that
the
method
by
which
stock
solutions
are
formulated
could
have
a
dramatic
effect
on
the
toxicity
of
vanadium
through
its
effects
on
the
polymeric
form
of
the
metal
in
the
test
study);
and
(4)
Hamilton
and
Buhl
(1990),
who
reported
a
96±
hour
LC50
for
chinook
salmon
(Oncorhynchus
tshawytscha)
fry
of
16.5
mg/
L.
EPA
undertook
an
exhaustive
review
of
vanadium
toxicity.
The
studies
the
commenter
has
listed
show
that
vanadium
compounds
are
moderately
toxic
to
fish,
which
further
support
EPA's
findings
on
the
toxicity
of
vanadium.
EPA's
review
of
the
studies
cited
in
the
proposed
rule
are
not
contradicted
or
undermined
by
the
studies
provided
by
the
commenter,
and
continue
to
support
the
Agency's
conclusion
that
vanadium
and
vanadium
compounds
are
highly
toxic
to
some
aquatic
species.
One
commenter
states
that
the
background
document
to
support
EPA's
proposal
to
list
vanadium
and
vanadium
compounds
indicates
that
the
proposed
listing
is
based
on
data
for
five
vanadium
compounds:
vanadium
pentoxide,
sodium
metavanadate,
sodium
orthovanadate,
vanadyl
sulfate,
and
ammonium
vanadate.
The
commenter
contends
that
EPA
may
consider
listing
under
EPCRA
section
313
for
the
individual
compounds
for
which
the
Agency
has
data,
but
EPA
is
not
justified
in
listing
a
broad
``
vanadium
and
vanadium
compounds''
category
based
on
data
for
only
five
compounds.
The
commenter
suggests
that
EPA
consider
individual
listings
for
these
compounds,
or
a
category
consisting
only
of
the
compounds
for
which
the
Agency
has
data.
EPA
disagrees
with
the
commenter's
characterization
of
the
Agency's
assessment
of
vanadium
and
vanadium
compounds.
In
assessing
the
ecological
toxicity
of
vanadium
and
vanadium
compounds,
EPA
evaluated
the
parent
metal
(vanadium)
and
determined
that
it
is
highly
toxic
to
some
aquatic
organisms
and
can
reasonably
be
anticipated
to
cause
a
significant
adverse
effect
on
the
environment
of
sufficient
seriousness
to
warrant
reporting
pursuant
to
EPCRA
section
313(
d)(
2)(
C).
Thus,
vanadium,
the
parent
metal
in
vanadium
compounds,
is
the
concern,
not
the
other
components
of
each
compound.
Many
metals
are
tested
in
the
salt
form
because
they
are
readily
soluble
in
aqueous
solutions.
The
toxicity
data
for
vanadium
shows
that
the
metal
is
highly
toxic
(aquatic
toxicity
<
1
mg/
L)
to
the
most
sensitive
species.
In
addition,
because
vanadium
is
persistent,
EPA
considers
any
toxicity
values
between
1
and
10
mg/
L
as
indicating
high
ecotoxicity.
This
evaluation
of
vanadium's
toxicity
is
acceptable
according
to
traditional
guidelines
for
the
assessment
of
toxic
substances
conducted
by
the
Agency
for
over
two
decades.
EPA
has
also
provided
sufficient
basis
for
the
inclusion
of
all
vanadium
compounds
in
the
category.
As
EPA
stated
in
the
1994
chemical
expansion
final
rule:

The
Agency
believes
it
satisfies
the
statutory
criteria
to
add
a
category
to
the
list
by
identifying
the
toxic
effect
of
concern
for
at
least
one
member
of
the
category
and
then
showing
why
that
effect
may
reasonably
be
expected
to
be
caused
by
all
other
members
of
the
category.
(at
59
FR
61442)
See
also,
Troy,
supra
at
277.

EPA
developed
a
hazard
assessment
for
vanadium
which
reviewed
the
toxicity
data
for
several
vanadium
compounds.
The
assessment
indicated
that
the
vanadium
from
these
compounds
is
highly
toxic
to
aquatic
organisms.
Since
it
is
the
vanadium
from
these
compounds
that
is
highly
toxic
rather
than
the
intact
chemical
compound,
EPA
believes
that
all
chemicals
that
are
a
source
of
vanadium
meet
the
EPCRA
section
313(
d)(
2)(
C)
listing
criteria.
Thus,
EPA
has
established
the
toxic
effect
of
concern,
the
chemical
species
that
causes
the
effect,
and
the
basis
for
why
it
may
reasonably
be
expected
that
all
members
of
the
vanadium
compounds
category
can
cause
the
effects
of
concern.
Based
on
the
available
toxicity
data,
EPA
has
concluded
that
vanadium
and
vanadium
compounds
are
toxic.
They
have
the
potential
to
kill
fish,
algae,
and
invertebrates
as
well
as
causing
a
range
of
other
adverse
effects
on
fish,
algae,
and
invertebrates,
based
on
chemical
and/
or
biological
interactions.
Vanadium
and
vanadium
compounds
can
cause
these
toxic
effects
at
relatively
low
concentrations.
Toxicity
data
for
vanadium
and
vanadium
compounds
include
for
algae,
a
9±
day
LC50
of
0.5
mg/
L,
a
15±
day
LC50
of
0.5
mg/
L,
inhibition
of
growth
at
0.1
ppm,
adverse
effects
on
cell
division
at
3
ppb,
20
ppb,
and
0.5
ppm;
and
for
fish,
a
96±
hour
LC50
of
0.62
ppm,
and
growth
and
survival
depression
of
larvae
at
0.17
ppm.
Because
vanadium
and
vanadium
58711
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/
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209
/
Friday,
October
29,
1999
/
Rules
and
Regulations
compounds
can
cause
these
toxic
effects
at
these
relatively
low
concentrations,
EPA
considers
these
chemicals
to
be
highly
toxic.
Additional
toxicity
values
include
for
algae,
9±
day
LC50s
of
2
and
3
ppm,
and
a
15±
day
LC50
of
2
mg/
L;
for
invertebrates,
a
9±
day
LC50
of
10
ppm;
and
for
fish,
96±
hour
LC50s
of
6.4
ppm,
10
ppm,
and
7
mg/
L,
an
LC50
of
5.6
mg/
L,
an
11±
day
LC50
of
1.99
mg/
L,
14±
day
LC50s
from
1.95
to
4.34
mg/
L,
and
7±
day
LC50s
from
1.9
to
6.0
ppm.
Considering
vanadium's
persistence,
vanadium
and
vanadium
compounds
are
considered
highly
toxic
to
aquatic
organism
at
these
higher
concentrations.
As
discussed
above,
vanadium
and
vanadium
compounds
are
highly
toxic.
Because
vanadium
and
vanadium
compounds
are
toxic
at
relatively
low
concentrations,
EPA
believes
that
they
cause
or
can
reasonably
be
anticipated
to
cause
a
significant
adverse
effect
on
the
environment.
In
addition,
because
of
the
nature
of
the
potential
significant
adverse
effects,
e.
g.,
fish,
algae,
and
invertebrate
kills
as
well
as
a
range
of
other
adverse
effects
on
fish,
algae,
and
invertebrates,
and
the
impacts
such
effects
can
have
on
ecological
communities
and
ecosystems,
EPA
has
determined
that
they
are
of
sufficient
seriousness
to
warrant
reporting.
Thus,
EPA
reaffirms
that
there
is
sufficient
evidence
for
adding
vanadium
and
vanadium
compounds
on
the
EPCRA
section
313
list
of
toxic
chemicals
pursuant
to
EPCRA
section
313(
d)(
2)(
C)(
i)
and
(ii),
based
on
the
available
ecotoxicity
information
for
vanadium
and
vanadium
compounds.
Therefore,
EPA
is
finalizing
the
listing
of
vanadium
and
vanadium
compounds
on
the
EPCRA
section
313
list.
a.
Reporting
limitation
of
alloys.
A
number
of
commenters
support
EPA's
proposed
determination
to
defer
the
reporting
of
vanadium
when
contained
in
alloys
(64
FR
717).
Many
commenters
also
suggest
that
the
Agency
adopt
a
reporting
limitation
for
the
other
metals
such
as
chromium,
copper,
manganese,
and
nickel
which
are
commonly
found
in
alloys.
The
commenters
assert
that
alloys
have
significantly
different
bioavailability,
bioaccumulation,
and
toxicity
characteristics
than
other
forms
of
metals,
and
thus
should
be
treated
separately.
The
commenters
argue
that
alloys
are
inherently
more
stable
than
unalloyed
materials,
do
not
enter
the
environment
as
readily
as
unalloyed
materials
and
hence
do
not
interact
as
greatly
with
organisms,
and
should
be
considered
safer
from
an
environmental
and
human
health
perspective.
The
commenters
suggested
that
alloys
should
be
treated
separately
not
only
for
threshold
changes,
but
also
for
EPCRA
section
313
listings
in
general
and
recommend
excluding
alloys
from
general
EPCRA
section
313
listings
for
metals.
One
commenter
states
in
regard
to
the
reporting
of
metals
in
alloys
that
it
makes
little
or
no
sense
to
require
the
reporting
of
such
``
useless''
information,
since
the
information
does
not
serve
the
purpose
of
informing
the
community.
The
commenter
contends
that
not
adding
vanadium
when
contained
in
alloys
would
help
to
achieve
EPCRA
section
313's
underlying
purpose,
i.
e.,
to
provide
the
public
with
meaningful
information,
while
at
the
same
time
reducing
the
burden
on
reporting
facilities.
Another
commenter
argues
that
the
proposed
alloys
exemption
correctly
recognizes
that
metals
in
alloys
are
not
generally
available
for
exposure
or
for
toxic
effects.
The
commenter
argues
that
expansion
of
the
exemption
would
improve
the
TRI
data
base
by
reporting
only
releases
that
may
pose
risks
to
human
health
and
the
environment,
thereby
providing
the
public
with
more
meaningful
data.
Two
commenters
state
that
the
definition
of
vanadium
alloys
should
include
``
fused
alloy
slag''
in
the
qualifier
as
well.
The
commenters
contend
that
the
state
of
the
vanadium
in
a
ferroalloy
form
is
one
of
intimate
chemical
combination
on
the
atomic
level,
not
a
simple
mixture
of
individual
components
and
it
is
inherently
stable
and
cannot
be
dissociated
by
ordinary
means.
The
commenters
argue
that
likewise,
the
fused
alloy
slag
formed
represents
an
intimate
chemical
combination
of
materials
as
a
result
of
the
smelting
operation.
The
commenters
assert
that
these
elemental
materials
may
include
various
components
such
as
gangue
or
ore,
ash
of
fuel,
refractory
lining,
or
other
stable
oxides
with
the
ultimate
characterization
resting
upon
the
chemical
stability
of
the
resultant
fused
alloy
bearing
slag.
Thus,
the
commenters
argue,
vanadium
contained
in
either
alloy
or
alloy
slag
form
is
fused
in
a
stable
compound
and
therefore,
no
releases
of
vanadium
into
the
environment
would
occur
from
either
substance.
The
commenters
state
that
the
true
environmental
issue
to
consider
in
the
formulation
of
an
activity
qualifier
is
the
leachability
of
the
material
in
that
state,
and
since
in
both
of
the
aforementioned
cases
the
vanadium
is
in
a
stable
compound,
leaching
would
not
be
expected.
The
commenters
assert
that
without
allowing
an
exemption
for
fused
alloy
slag,
large
volumes
of
steelmaking
and
ferroalloy
slag
will
unnecessarily
fall
under
this
reporting
requirement.
The
commenters
request
that
EPA
reconsider
its
position
and
expand
the
definition
of
alloy
to
include
both
vanadium
alloys
and
vanadium
alloy
slags.
EPA
agrees
with
those
commenters
that
support
EPA's
belief
that
it
would
be
inappropriate,
at
this
time,
to
change
the
status
quo
regarding
reporting
vanadium
when
contained
in
an
alloy.
As
EPA
stated
in
the
proposed
rule,
the
Agency
is
reviewing
the
issue
of
whether
there
should
be
any
changes
to
the
reporting
requirements
for
metals
contained
in
alloys.
In
the
proposed
rule,
EPA
did
not
state,
and
did
not
intend
to
imply,
that
EPA
considers
alloys
to
be
``
safe,
''
or
as
some
commenters
suggested,
that
EPA
had
``
correctly''
recognized
that
metals
in
alloys
are
not
generally
available
for
exposure
or
to
express
their
toxic
effects.
EPA
has
not
completed
its
review
of
the
alloys
issue
and
has
made
no
conclusions
regarding
whether
there
should
or
should
not
be
any
type
of
limitation
or
exemption
for
any
metals
contained
in
alloys.
EPA's
proposal
merely
recognized
that
while
this
issue
was
under
review,
it
would
not
be
appropriate
to
add
alloy
forms
of
vanadium.
The
commenters
contend
that
alloys
have
significantly
different
bioavailability,
bioaccumulation,
toxicity
characteristics
than
other
forms
of
metals
and
are
inherently
more
stable
than
unalloyed
materials
and
do
not
enter
the
environment
as
readily
as
unalloyed
materials.
EPA
believes
that
the
issue
with
alloys
is
primarily
bioavailability,
i.
e.,
do
the
metals
contained
in
alloys
become
available.
This
issue
is
the
focus
of
EPA's
current
review.
At
this
point
in
time,
while
EPA
is
in
the
process
of
a
scientific
review
of
the
issues
pertinent
to
alloys,
the
Agency
is
not
prepared
to
make
a
final
determination
on
whether
vanadium
in
vanadium
alloys
meet
the
EPCRA
section
313(
d)(
2)
toxicity
criteria.
The
commenters
did
not
provide
any
data
to
support
their
contention.
The
Agency
does
not
believe
that
a
metal
compound
in
a
slag
necessarily
will
be
environmentally
unavailable;
rather,
the
Agency's
experience
with
a
previous
EPCRA
section
313(
d)
review
of
manganese
slags,
indicates
that
at
least
in
some
cases
the
metal
will
be
available
(60
FR
44000,
August
24,
1995)
(FRL±
4954±
6).
Some
commenters
suggested
that
EPA
create
an
alloys
reporting
limitation
for
all
metals
contained
in
alloys.
However,
as
EPA
has
stated,
the
review
of
whether
any
kind
of
exemption
or
reporting
limitation
should
be
granted
for
certain
metals
in
alloys
is
still
under
review
and
until
the
Agency
has
thoroughly
reviewed
the
available
data,
EPA
is
not
58712
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/
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209
/
Friday,
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29,
1999
/
Rules
and
Regulations
prepared
to
extend
the
reporting
limitation
to
any
other
metals.
For
example,
EPA
is
not
lowering
the
reporting
threshold
for
cobalt
and
cobalt
compounds,
and
therefore
the
Agency
is
taking
no
action
with
respect
to
a
reporting
limitation
for
cobalt
when
contained
in
alloys.
One
commenter
asserts
that
for
reasons
of
consistency­­
which
helps
ensure
data
quality­­
with
existing
EPCRA
section
313
metal
compound
categories,
they
oppose
adding
the
qualifier
``
except
when
contained
in
an
alloy''
in
any
new
listing
for
vanadium.
EPA
has
not
completed
its
review
of
the
alloys
issue
and
has
made
no
conclusions
regarding
whether
there
should
be
any
type
of
general
limitation
or
exemption
for
any
metals
contained
in
alloys.
EPA
merely
recognized
that
while
this
issue
was
under
review
it
would
not
be
appropriate
to
increase
the
reporting
requirements
for
those
facilities
that
would
otherwise
submit
reports
for
vanadium
contained
in
alloys.
Therefore,
as
discussed
earlier
in
this
section,
EPA
has
expanded
the
EPCRA
section
313
listing
for
vanadium
by
removing
the
``
fume
or
dust''
qualifier
for
vanadium,
but
has
not
added
the
alloy
forms
of
vanadium.
Until
EPA
has
the
opportunity
to
fully
evaluate
the
available
data,
the
Agency
is
not
prepared
to
make
a
final
determination
whether
vanadium
contained
in
alloys
meets
the
EPCRA
section
313(
d)(
2)
listing
criteria
and
should
therefore
be
added.
EPA
believes
that
consistency,
in
this
context,
does
not
provide
a
sufficient
basis
to
require
reporting
of
vanadium
contained
in
alloys.

H.
Persistence
and
Bioaccumulation
The
persistence
and
bioaccumulation
data
for
the
PBT
chemicals
covered
by
this
final
rule
are
listed
in
Table
3.
A
discussion
of
these
data
follows
Table
3.

Table
3.Ð
Persistence
and
Bioaccumulation
Data
Chemical
Category/
Chemical
Name
CASRN
BCF
BAF
Air
Half­
life
Surface
Water
Halflife
Soil
Half­
life
Dioxin/
Dioxin­
Like
Compounds
Polychlorinated
dibenzo­
p­
dioxins
1,2,3,4,6,7,8­
heptachlorodibenzo­
p­
dioxin
35822±
46±
9
1,466
12.2±
4.2
hrs
~20
yrs
1,2,3,4,7,8­
hexachlorodibenzo­
p­
dioxin
39227±
28±
6
5,176
12.4±
2.7
hrs
~20
yrs
1,2,3,6,7,8­
hexachlorodibenzo­
p­
dioxin
57653±
85±
7
3,981
12.4±
2.7
hrs
~20
yrs
1,2,3,7,8,9­
hexachlorodibenzo­
p­
dioxin
19408±
74±
3
1,426
12.4±
2.7
hrs
~20
yrs
1,2,3,4,6,7,8,9­
octachlorodibenzo­
p­
dioxin
3268±
87±
9
2,239
20.4±
4.8
hrs
~20
yrs
1,2,3,7,8­
pentachlorodibenzo­
p­
dioxin
40321±
76±
4
10,890
14.8±
2.0
hrs
~20
yrs
2,3,7,8­
tetrachlorodibenzo­
p­
dioxin
1746±
01±
6
5,755
9.6±
1.2
hrs
20±
1.5
yrs
Polychlorinated
dibenzofurans
1,2,3,4,6,7,8­
heptachlorodibenzofuran
67562±
39±
4
3,545
25.0±
4.3
hrs
~20
yrs
1,2,3,4,7,8,9­
heptachlorodibenzofuran
55673±
89±
7
3,545
25.0±
4.3
hrs
~20
yrs
1,2,3,4,7,8­
hexachlorodibenzofuran
70648±
26±
9
3,586
13.3±
3
hrs
~20
yrs
1,2,3,6,7,8­
hexachlorodibenzofuran
57117±
44±
9
3,586
13.3±
3
hrs
~20
yrs
1,2,3,7,8,9­
hexachlorodibenzofuran
72918±
21±
9
10,300
13.3±
3
hrs
~20
yrs
2,3,4,6,7,8­
hexachlorodibenzofuran
60851±
34±
5
3,586
13.3±
3
hrs
~20
yrs
1,2,3,4,6,7,8,9­
octachlorodibenzofuran
39001±
02±
0
1,259
29.4±
13.7
hrs
~20
yrs
1,2,3,7,8­
pentachlorodibenzofuran
57117±
41±
6
33,750
11.6±
1.2
hrs
~20
yrs
2,3,4,7,8­
pentachlorodibenzofuran
57117±
31±
4
42,500
11.6±
1.2
hrs
~20
yrs
2,3,7,8­
tetrachlorodibenzofuran
51207±
31±
9
2,042
11.5±
2.1
hrs
~20
yrs
Pesticides
Aldrin
309±
00±
2
3,715
10
hrs±
1
hr
24
days
1
9
yrs±
291
days
Chlordane
57±
74±
9
11,050
>6,000,000
2
5
days±
12
hrs
239
days
8­
0.4
yrs
Heptachlor
76±
44±
8
19,953
10.5
hrs±
1
hr
129.4±
23.1
hrs
4
yrs±
8
days
Isodrin
465±
73±
6
20,180
10
hrs±
1
hr
5
yrs±
180
days
Methoxychlor
72±
43±
5
8,128
12
hrs±
1
hr
15.2±
5
days
136±
81
days
Pendimethalin
40487±
42±
1
1,944
21±
2
hrs
1300±
54
days
Toxaphene
8001±
35±
2
34,050
16
days±
19
hrs
5
yrs±
1
yr
11±
1
yrs
Trifluralin
1582±
09±
8
5,674
3.2±
0.42
hrs
36.5±
4.5
days
1
394±
99
days
Polycyclic
Aromatic
Compounds
58713
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Register
/
Vol.
64,
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209
/
Friday,
October
29,
1999
/
Rules
and
Regulations
Table
3.Ð
Persistence
and
Bioaccumulation
DataÐ
Continued
Chemical
Category/
Chemical
Name
CASRN
BCF
BAF
Air
Half­
life
Surface
Water
Halflife
Soil
Half­
life
Benzo(
a)
pyrene
50±
32±
8
912
2.4
hrs
17.3±
5.4
yrs
14.6
yrs±
151
days
Benzo(
b)
fluoranthene
205±
99±
2
5,631
1.4
days±
3.4
hrs
³100
days
14.2
yrs±
87
days
Benzo(
r,
s,
t)
pentaphene
189±
55±
9
26,280
13
hrs±
1
hr
371±
232
days
Benzo(
a)
anthracene
56±
55±
3
800
13
hrs±
1
hr
3­
1.2
yrs
2.0
yrs±
240
days
7,12­
Dimethylbenz(
a)
anthracene
57±
97±
6
5,834
4±
0.4
hrs
6
yrs±
1
yr
28±
20
days
Dibenzo(
a,
h)
anthracene
53±
70±
3
31,440
13
hrs±
1
hr
³100
days
2
yrs±
240
days
3­
Methylcholanthrene
56±
49±
5
17,510
3±
0.3
hrs
3.8±
1.7
yrs
7H­
Dibenzo(
c,
g)
carbazole
194±
59±
2
16,900
23±
2
hrs
>160
days
Benzo(
k)
fluoranthene
207±
08±
9
10,090
12
hrs±
1
hr
11
yrs±
139
days
Benzo(
j)
fluoranthene
205±
82±
3
10,090
12
hrs±
1
hr
10.5
yrs
Dibenzo(
a,
e)
pyrene
192±
65±
4
6,875
13
hrs±
1
hr
371±
232
days
Dibenzo(
a,
h)
pyrene
189±
64±
4
26,280
13
hrs±
1
hr
371±
232
days
Indeno(
1,2,3­
cd)
pyrene
193±
39±
5
28,620
7.6±
0.34
hrs
730±
58
days
Dibenz(
a,
h)
acridine
226±
36±
8
3,500
13
hrs±
1
hr
>160
days
Dibenz(
a,
j)
acridine
224±
42±
0
18,470
23±
2
hrs
>160
days
Benzo(
g,
h,
i)
perylene
191±
24±
2
25,420
10.0±
0.31
hrs
³100
days
1.8
yrs±
173
days
Dibenzo(
a,
e)
fluoranthene
5385±
75±
1
26,280
10
hrs±
1
hr
371±
232
days
3
5­
Methylchrysene
3697±
24±
3
9,388
5±
0.5
hrs
3.8
yrs±
79
days
4
2.7
yrs±
255
days
4
Dibenzo(
a,
l)
pyrene
191±
30±
0
6,875
13
hrs±
1
hr
371±
232
days
Benzo(
a)
phenanthrene
218±
01±
9
800
13
hrs±
1
hr
3.8
yrs±
79
days
2.7
yrs±
255
days
1­
Nitropyrene
5522±
43±
0
908
4
days±
10
hrs
44
yrs±
16
yrs
Benzo(
j,
k)
fluorene
(fluoranthene)
206±
44±
0
5,100
20±
2
hrs
13
yrs±
110
days
Metals/
Metal
Compounds
Mercury
5
and
Mercury
compounds
7439±
97±
6
7,000­
36,000
see
footnote
5
see
footnote
5
see
footnote
5
Polychlorinated
Biphenyl
(PCBs)
1336±
36±
3
>200,000
2,6
2,3,3¢,
4,4¢,
5,5¢­
heptachlorobiphenyl
39635±
31±
9
4,922
191±
19
days
>56
days
>5±
3.92
yrs
2,3,3¢,
4,4¢,
5­
hexachlorobiphenyl
38380±
08±
4
37,590
127±
13
days
>56
days
>5±
3.42
yrs
2,3,3¢,
4,4¢,
5¢­
hexachlorobiphenyl
69782±
90±
7
37,590
114±
11
days
>56
days
>5±
3.42
yrs
58714
Federal
Register
/
Vol.
64,
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209
/
Friday,
October
29,
1999
/
Rules
and
Regulations
Table
3.Ð
Persistence
and
Bioaccumulation
DataÐ
Continued
Chemical
Category/
Chemical
Name
CASRN
BCF
BAF
Air
Half­
life
Surface
Water
Halflife
Soil
Half­
life
2,3¢,
4,4¢,
5,5¢­
hexachlorobiphenyl
52663±
72±
6
37,590
114±
11
days
>56
days
>5±
3.42
yrs
3,3¢,
4,4¢,
5,5¢­
hexachlorobiphenyl
32774±
16±
6
73,840
88±
9
days
>56
days
>5±
3.42
yrs
2,3,3¢,
4,4¢­
pentachlorobiphenyl
32598±
14±
4
196,900
>134,000,000
2
80­
8
days
>56
days
7.25±
0.91
yrs
2,3,4,4¢,
5­
pentachlorobiphenyl
74472±
37±
0
196,900
67±
7
days
>56
days
7.25±
0.91
yrs
2,3¢,
4,4¢,
5­
pentachlorobiphenyl
31508±
00±
6
184,300
>141,000,000
2
80±
8
days
>56
days
7.25±
0.91
yrs
2¢,
3,4,4¢,
5­
pentachlorobiphenyl
65510±
44±
3
196,900
50±
5
days
>56
days
7.25±
0.91
yrs
3,3¢,
4,4¢,
5­
pentachlorobiphenyl
57465±
28±
8
196,900
57±
6
days
>56
days
7.25±
0.91
yrs
3,3¢,
4,4¢­
tetrachlorobiphenyl
32598±
13±
3
105,900
37±
4
days
>98
days
4.83±
0.91
yrs
Other
Chemicals
Hexachlorobenzene
118±
74±
1
29,600­
66,000
>2,500,000
2
1,582±
158
days
5.7±
2.7
yrs
Octachlorostyrene
29082±
74±
4
33,113
>117,000,000
2
10
hrs±
1
hr
5.7±
2.7
yrs7
Pentachlorobenzene
608±
93±
5
8,318
>640,000
2
460±
46
days
194
days±
>22
yrs
Tetrabromobisphenol
A
79±
94±
7
780;
1,200;
3,200
9
days±
1
day
84±
48
days
44±
179
days
1
The
reported
half­
life
data
for
water
are
suspected
to
include
significant
removal
from
the
medium
by
processes
other
than
degradation
(e.
g.,
volatilization).
2
Values
are
for
Piscivorous
Fish.
3
Since
data
could
not
be
found
for
this
chemical,
the
data
for
the
dibenzopyrenes
(192±
65±
4;
189±
64±
0;
191±
30±
0),
which
are
structural
analogues
was
used.
4
Since
data
could
not
be
found
for
this
chemical,
the
data
for
benzo(
a)
phenanthrene
(218±
01±
9),
a
structural
analogue
was
used.
5
The
bioaccumulation
potential
for
the
parent
metals
is
assumed
to
be
equivalent
to
the
associated
metal
compounds
since
in
the
environment
the
parent
metals
may
be
converted
to
a
metal
compound.
Since
metals
are
not
destroyed
in
the
environment
they
persist
longer
than
6
months.
6
Lowest
value
reported
for
a
dichlorinated
PCB.
7
Since
no
data
could
be
found
for
this
chemical,
the
data
for
the
structural
analogues
hexachlorobenzene
(118±
74±
1)
and
pentachlorobenzene
(608±
93±
5)
was
used.

1.
PersistenceÐ
a.
Dioxin
and
dioxinlike
compounds.
In
the
proposal,
EPA
preliminarily
determined
that
dioxin
and
dioxin­
like
compounds
have
persistence
half­
life
values
in
soil
that
ranged
from
1.5
years
to
more
than
20
with
all
but
one
chemical
having
a
soil
half­
life
of
more
than
20
years.
EPA
has
reviewed
information
and
all
comments
received
on
dioxin
and
dioxin­
like
compounds'
persistence
characteristics.
Taking
into
account
this
information,
as
indicated
in
Table
3,
EPA
finds
that
dioxin
and
dioxin­
like
compounds
persist
in
the
environment
with
halflives
of
2
months
or
greater
and
therefore
meet
the
persistence
criterion
established
in
this
rulemaking.
A
complete
discussion
of
EPA's
findings
on
this
chemical
category
can
be
found
in
EPA's
Response
to
Comments
document
for
this
rulemaking
(Ref.
69)
and/
or
in
EPA's
support
documents
for
this
rulemaking
(Ref.
7).
In
addition,
dioxin
and
dioxin­
like
compounds
persist
in
the
environment
with
a
halflife
of
greater
than
6
months
making
it
highly
persistent.
This,
plus
other
factors,
supports
EPA's
decision
to
lower
the
threshold
to
0.1
gram.
b.
Aldrin.
In
the
proposal,
EPA
preliminarily
determined
that
aldrin
has
persistence
half­
life
values
in
soil
of
291
days
to
9
years
and
a
persistence
halflife
value
in
water
of
24
days.
EPA
has
reviewed
information
and
all
comments
received
on
aldrin's
persistence
characteristics.
Taking
into
account
this
information,
as
indicated
in
Table
3,
EPA
finds
that
aldrin
persists
in
the
environment
with
a
half­
life
of
2
months
or
greater
and
therefore
meets
the
persistence
criterion
established
in
this
rulemaking.
A
complete
discussion
of
EPA's
findings
on
this
chemical
can
be
found
in
EPA's
Response
to
Comments
document
for
this
rulemaking
(Ref.
69)
and/
or
in
EPA's
support
documents
for
this
rulemaking
(Ref.
7).
c.
Chlordane.
In
the
proposal,
EPA
preliminarily
determined
that
chlordane
has
persistence
half­
life
values
in
soil
of
0.4±
8
years
and
a
persistence
half­
life
value
in
water
of
239
days.
EPA
has
reviewed
information
and
all
comments
received
on
chlordane's
persistence
characteristics.
Taking
into
account
this
information,
as
indicated
in
Table
3,
EPA
finds
that
chlordane
persists
in
the
environment
with
a
half­
life
of
2
months
or
greater
and
therefore
meets
the
persistence
criterion
established
in
this
rulemaking.
A
complete
discussion
of
EPA's
findings
on
this
chemical
can
be
found
in
EPA's
Response
to
Comments
document
for
this
rulemaking
(Ref.
69)
58715
Federal
Register
/
Vol.
64,
No.
209
/
Friday,
October
29,
1999
/
Rules
and
Regulations
and/
or
in
EPA's
support
documents
for
this
rulemaking
(Ref.
7).
In
addition,
chlordane
persists
in
the
environment
with
a
half­
life
of
greater
than
6
months
which
supports
EPA's
decision
to
lower
the
threshold
to
10
pounds.
d.
Heptachlor.
In
the
proposal,
EPA
preliminarily
determined
that
heptachlor
has
persistence
half­
life
values
in
soil
of
8
days
to
4
years
and
a
persistence
half­
life
value
in
water
of
23.1±
129.4
hours.
EPA
has
reviewed
information
and
all
comments
received
on
heptachlor's
persistence
characteristics.
Taking
into
account
this
information,
as
indicated
in
Table
3,
EPA
finds
that
heptachlor
persists
in
the
environment
with
a
half­
life
of
2
months
or
greater
and
therefore
meets
the
persistence
criterion
established
in
this
rulemaking.
A
complete
discussion
of
EPA's
findings
on
this
chemical
can
be
found
in
EPA's
Response
to
Comments
document
for
this
rulemaking
(Ref.
69)
and/
or
in
EPA's
support
documents
for
this
rulemaking
(Ref.
7).
In
addition,
heptachlor
persists
in
the
environment
with
a
half­
life
of
greater
than
6
months
which
supports
EPA's
decision
to
lower
the
threshold
to
10
pounds.
e.
Isodrin.
In
the
proposal,
EPA
preliminarily
determined
that
isodrin
has
persistence
half­
life
values
in
soil
of
180
days
to
5
years.
EPA
has
reviewed
information
and
all
comments
received
on
isodrin's
persistence
characteristics.
Taking
into
account
this
information,
as
indicated
in
Table
3,
EPA
finds
that
isodrin
persists
in
the
environment
with
a
half­
life
of
2
months
or
greater
and
therefore
meets
the
persistence
criterion
established
in
this
rulemaking.
A
complete
discussion
of
EPA's
findings
on
this
chemical
can
be
found
in
EPA's
Response
to
Comments
document
for
this
rulemaking
(Ref.
69)
and/
or
in
EPA's
support
documents
for
this
rulemaking
(Ref.
7).
In
addition,
isodrin
persists
in
the
environment
with
a
halflife
of
greater
than
6
months
which
supports
EPA's
decision
to
lower
the
threshold
to
10
pounds.
f.
Methoxychlor.
In
the
proposal,
EPA
preliminarily
determined
that
methoxychlor
has
persistence
half­
life
values
in
soil
of
81
to
136
days
and
a
persistence
half­
life
value
in
water
of
5
to
15.2
days.
EPA
has
reviewed
information
and
all
comments
received
on
methoxychlor's
persistence
characteristics.
Taking
into
account
this
information,
as
indicated
in
Table
3,
EPA
finds
that
methoxychlor
persists
in
the
environment
with
a
half­
life
of
2
months
or
greater
and
therefore
meets
the
persistence
criterion
established
in
this
rulemaking.
A
complete
discussion
of
EPA's
findings
on
this
chemical
can
be
found
in
EPA's
Response
to
Comments
document
for
this
rulemaking
(Ref.
69)
and/
or
in
EPA's
support
documents
for
this
rulemaking
(Ref.
7).
g.
Pendimethalin.
In
the
proposal,
EPA
preliminarily
determined
that
pendimethalin
has
a
persistence
halflife
value
in
soil
of
54
to
1,300
days.
EPA
received
several
significant
comments
addressing
pendimethalin's
persistence
potential
which
are
addressed
below.
EPA
has
reviewed
information
and
all
comments
received
on
pendimethalin's
persistence
characteristics.
Taking
into
account
this
information,
as
indicated
in
Table
3,
EPA
finds
that
pendimethalin
persists
in
the
environment
with
a
half­
life
of
2
months
or
greater
and
therefore
meets
the
persistence
criterion
established
in
this
rulemaking.
A
complete
discussion
of
EPA's
findings
on
this
chemical
can
be
found
in
EPA's
Response
to
Comments
document
for
this
rulemaking
(Ref.
69)
and/
or
in
EPA's
support
documents
for
this
rulemaking
(Ref.
7).
One
commenter
contends
that
EPA
has
miscategorized
pendimethalin
as
a
PBT
chemical
based
on
limited
screening
data
which
conflicts
with
conclusions
reached
by
EPA
in
its
risk
assessment
under
the
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(FIFRA).
The
commenter
believes
that
the
characterization
of
pendimethalin
is
inaccurate
and
will
lead
to
misplaced
effort
and
misplaced
focus
on
listed
chemicals,
and
that
there
will
be
no
benefit
to
the
public
or
the
environment
in
lowering
the
reporting
threshold
for
pendimethalin.
EPA
disagrees
with
the
commenter.
EPA
did
not
base
its
determination
that
pendimethalin
meets
the
EPCRA
section
313
persistence
criteria,
nor
that
pendimethalin
is
highly
persistent
on
``
screening''
data.
EPA's
conclusion
that
pendimethalin
persists
with
a
half­
life
greater
than
6
months
is
based
on
a
well­
conducted
study
in
which
pendimethalin
degrades
in
soil
with
a
half­
life
of
1,322
days.
Further,
even
if
these
data
were
discounted,
there
are
numerous
data
submitted
in
support
of
reregistration
of
pendimethalin
under
FIFRA
that
provide
strong
evidence
that
pendimethalin
meets
the
EPCRA
section
313
persistence
criteria,
i.
e.,
a
half­
life
greater
than
2
months.
A
more
detailed
discussion
of
these
data
is
presented
in
the
following
responses.
Contrary
to
the
assertion
by
the
commenter,
the
categorization
of
pendimethalin
as
a
PBT
chemical
as
described
in
the
proposed
rule
is
not
in
conflict
with
the
conclusions
reached
by
EPA
during
the
FIFRA
assessment.
In
addition,
EPA
disagrees
that
there
will
be
no
benefits
to
the
public
or
the
environment
from
lowering
the
thresholds
for
pendimethalin.
EPA
believes
that
pendimethalin,
like
all
PBT
chemicals,
is
of
special
concern
because
it
has
the
potential
to
cause
adverse
effects
even
when
released
to
the
environment
in
small
quantities
because
it
can
bioaccumulate
in
organisms
to
levels
much
greater
than
those
present
in
the
environment.
EPA
believes
that
lowering
the
reporting
threshold
for
pendimethalin
will
provide
information
to
the
public
that
will
increase
their
awareness
of
low
levels
of
releases
to
the
environment
which
have
the
potential
to
concentrate
in
organisms
and
cause
adverse
effects,
which
is
fully
consistent
with
the
purposes
of
EPCRA
section
313.
The
commenter
states
that
EPA
has
ignored
bioavailability
in
designating
pendimethalin
as
a
PBT
chemical
and
argues
that
the
true
bioaccumulation
potential
for
pendimethalin
is
greatly
overestimated
based
on
the
results
of
the
standard
laboratory
fish
bioconcentration
study.
The
commenter
asserts
that
when
data
on
bioavailability,
degradation,
and
depuration
are
all
considered,
the
``
real
world''
bioconcentration
potential
for
pendimethalin
is
low
and,
therefore
pendimethalin
should
not
be
mischaracterized
as
a
PBT
chemical.
The
bioavailability
data
the
commenter
refers
to
was
not
specifically
identified.
Bioavailability
of
a
chemical
will
vary
from
environment
to
environment
and
soil
type
to
soil
type.
Caution
must
be
taken,
however,
not
to
draw
the
erroneous
conclusion
that
because
a
chemical
has
been
shown
to
have
a
high
affinity
to
sorb
to
sediments
in
aquatic
environments
that
it
will
not
be
available
for
uptake
by
aquatic
organisms.
Examples
like
the
PCBs
(see
Unit
VI.
F.
for
a
further
discussion
on
this
issue)
indicate
that
although
some
of
these
compounds
have
sorption
coefficients
much
greater
than
pendimethalin,
they
are
still
widely
found
in
the
tissues
of
aquatic
organisms
in
contaminated
waters.
Further,
it
would
be
erroneous
to
state
that
pendimethalin
is
not
bioavailable
because
if
it
were
not
bioavailable
it
could
not
function
as
an
herbicide.
The
commenter
claims
that
using
EPA's
own
criteria
(half­
lifes
longer
than
2
months
in
water,
sediment,
or
soil,
or
a
half­
life
longer
than
2
days
in
air)
pendimethalin
cannot
be
classified
as
persistent.
Rather
the
commenter
contends
that
pendimethalin
has
``
low''
or
``
low
to
moderate''
persistence.
The
commenter
is
incorrect.
The
Agency
has
set
persistence
criteria
of
half­
lifes
for
soil,
sediment,
and
water
58716
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Register
/
Vol.
64,
No.
209
/
Friday,
October
29,
1999
/
Rules
and
Regulations
greater
than
2
months
and
a
half­
life
in
air
of
greater
than
2
days.
Chemicals
meeting
these
criteria
are
considered
persistent
for
purposes
of
EPCRA
section
313.
There
are,
in
fact,
no
qualifiers
such
as
``
low,
''
``
moderate,
''
or
``
high''
associated
with
the
persistence
criteria.
The
commenter's
characterization
of
the
persistence
of
pendimethalin
as
``
low''
or
``
low
to
moderate''
is
thus
not
particularly
relevant.
It
appears,
based
on
the
comments,
that
the
commenter
defines
low
to
moderate
persistence
as
a
halflife
of
greater
than
2
days
in
air
and
greater
than
2
months
in
soil,
sediment,
or
water.
If
this
is
the
case,
then
the
commenter
in
fact
concurs
with
EPA's
assessment
of
pendimethalin
as
persistent
(half­
life
greater
than
2
months
in
soil
or
water
and
greater
than
2
days
in
air).
If
the
commenter,
instead,
meant
that
pendimethalin
has
half­
lifes
of
less
than
2
months
in
soil
or
water,
and
2
days
in
air,
EPA
notes
that
the
commenter
has
failed
to
provide
data
to
support
that
assertion,
and
that
EPA's
review
of
the
data
support
the
Agency's
conclusion.
A
commenter
cites
numerous
laboratory
and
field
dissipation
studies
in
support
of
the
claim
that
pendimethalin
does
not
meet
the
persistence
criteria.
EPA
disagrees
that
the
degree
of
persistence
of
pendimethalin
can
be
characterized
by
the
field
dissipation
studies
cited
by
the
commenter.
Field
dissipation
studies
are
not
equivalent
to
the
studies
which
measure
the
half­
life
for
destruction
of
a
chemical
in
a
specific
medium
(i.
e.,
soil,
water,
or
air).
Field
dissipation
studies
are
designed
to
measure
the
rate
or
extent
of
chemical
loss
from
the
medium
after
application
of
the
chemical.
The
processes
by
which
the
chemical
is
lost
may
include
not
only
those
that
result
in
destruction
of
the
chemical,
but
those
which
only
transport
the
chemical
from
one
medium
to
another
such
as
volatilization.
The
studies
cited
by
the
commenter
measure
the
dissipation
of
pendimethalin
from
soil.
For
a
relatively
volatile
chemical
such
as
pendimethalin,
field
dissipation
studies
are
of
limited
use
in
assessing
persistence
because
an
unknown
amount
of
pendimethalin
will
be
transported
from
soil
to
air,
resulting
in
a
measured
loss
from
that
medium,
but
not
destruction.
Thus,
the
field
dissipation
studies
cited
by
the
commenter
will
underestimate
the
persistence
of
pendimethalin
in
soil.
The
commenter
cites
several
laboratory
experiments
on
the
degradation
of
pendimethalin
in
soil
to
support
the
argument
that
pendimethalin
does
not
meet
the
persistence
criteria.
For
example,
they
state
that
laboratory
aerobic
soil
degradation
studies
have
been
conducted
in
which
pendimethalin
was
applied
to
soil
grab
samples
and
incubated
under
controlled
conditions.
Pendimethalin
degraded
in
laboratory
soil
studies
with
half­
lifes
ranging
from
31
to
1,322
days.
In
the
Reregistration
Eligibility
Decision
(RED)
for
Pendimethalin
(Ref
63)
document,
EPA
explained
that
172
days
was
used
instead
of
1,322
days
because:

The
half­
lifes
for
aerobic
soil
metabolism
ranged
from
42­
563
days
in
the
literature
studies
referenced
below
with
a
guideline
study
reporting
a
half­
life
of
1,322
days
for
a
total
of
27
total
observations.
Because
of
the
range
of
half­
life
values,
statistical
analyses
of
the
available
data
were
performed.
The
mean,
median,
and
modal
half­
lifes
are
126,
122,
and
122
days,
respectively,
with
a
standard
deviation
of
66
days
(n=
24).
The
half­
life
values
of
409,
563,
and
1,322
days
were
not
included
in
the
final
statistical
analyses
because
they
were
greater
than
three
standard
deviations
from
the
mean.
Based
on
soils
and
crops
that
are
normally
treated
with
pendimethalin,
the
reviewer
assumed
that
temperatures
would
likely
range
from
20±
30
°C
and
soil
moisture
contents
from
50­
75%
Field
Capacity
(FC).
The
range
of
observed
half­
lifes
in
the
above
experimental
conditions
was
72±
172
days.

The
commenter
contends
that
the
1,322±
day
half­
life
value
is
assumed
to
be
an
outlier
(Ref.
5),
the
range
was
31
to
172
days.
Thus,
it
is
claimed
that
laboratory
studies
also
indicate
that
pendimethalin
has
a
low
to
moderate
persistence
according
to
the
EPCRA
section
313
persistence
criteria.
EPA
believes
that
the
guideline
study
that
reported
a
half­
life
of
1,322
days
represents
an
accurate
and
representative
value
for
the
assessment
of
the
persistence
of
pendimethalin
in
the
environment.
In
situations
where
multiple
values
for
half­
lifes
are
submitted
under
FIFRA
to
EPA's
Office
of
Pesticide
Program
(OPP),
statistical
analysis
may
be
conducted
to
determine
mean
values
and
standard
deviations.
The
analysis
permits
the
use
of
a
value
for
exposure
assessment
modeling
that
takes
into
account
the
variability
in
data,
and
allows
the
exclusion
of
values
more
than
three
standard
deviations
outside
the
mean
as
``
outliers.
''
The
designation
as
an
outlier
does
not
invalidate
the
study,
and
in
fact,
EPA
maintains
that
even
a
study
designated
as
an
``
outlier,
''
if
valid,
gives
useful
half­
life
information.
In
their
assessment
of
the
persistence
of
chemicals
in
soils,
OPP
focuses
on
studies
using
soil
types,
soil
moisture
contents,
and
temperatures
consistent
with
the
field
application
of
the
chemical
in
its
intended
use.
In
the
OPP
review
of
the
studies,
the
reviewer
assumed
that
in
the
field
application
of
the
chemical,
temperatures
would
likely
range
from
20­
30
°C
and
that
soil
moisture
would
range
from
50
to
75%
field
capacity.
The
consideration
of
data
from
studies
conducted
under
these
conditions
resulted
in
a
half­
life
range
of
72
to
172
days
for
pendimethalin.
It
should
be
noted
that
even
after
the
elimination
of
outliers
and
consideration
of
studies
relevant
to
normal
field
application,
the
entire
halflife
range
is
above
2
months,
clearly
meeting
the
criteria
for
persistence
in
soil,
i.
e.,
a
half­
life
of
2
months.
The
releases
of
pendimethalin
subject
to
EPCRA
section
313
reporting,
in
many
cases,
will
not
be
to
agricultural
soils
under
typical
application
scenarios.
EPA,
therefore,
contends
that
even
though
some
soil
half­
life
values
were
not
considered
by
OPP,
either
because
they
were
derived
using
studies
that
did
not
represent
the
desired
field
conditions,
or
because
they
were
labeled
as
statistical
outliers,
the
study
conditions
still
represent
realistic
scenarios
for
releases
reported
under
EPCRA
section
313
and
are
valid
for
use
in
the
determination
of
persistence.
The
commenter
cites
studies
conducted
using
flooded
soils
to
support
the
argument
that
pendimethalin
does
not
meet
the
persistence
criteria.
The
commenter
asserts
that
the
studies
involved
the
use
of
pendimethalin
spiked
into
soil
grab
samples
covered
with
a
shallow
layer
of
water
and
incubated
in
the
laboratory
under
controlled
conditions.
In
laboratory
flooded
soil
studies,
pendimethalin
degradation
half­
lifes
ranged
from
seven
to
104
days
with
the
majority
of
studies
giving
half­
lifes
of
less
than
2
months.
Degradation
of
pendimethalin
was
more
rapid
in
flooded
soils
than
in
nonflooded
soils
in
most
instances.
The
commenter
asserts
that
these
results
demonstrate
that
pendimethalin
has
a
low
to
moderate
persistence
in
flooded
soils
according
to
the
EPCRA
section
313
persistence
criteria.
EPA
agrees
that
the
reported
degradation
half­
lifes
in
laboratory
flooded
soils
studies
range
from
7
to
104
days.
The
studies
were
reviewed
for
quality
and
preferred
methodologies.
Of
the
studies
that
are
of
acceptable
quality,
EPA
chose
the
highest
value
(most
protective)
of
the
range
to
determine
if
the
chemical
meets
the
EPCRA
section
313
persistence
criteria.
In
this
case,
the
value
of
104
days
would
be
used
to
characterize
pendimethalin
as
persistent
in
flooded
soils.
However,
58717
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Register
/
Vol.
64,
No.
209
/
Friday,
October
29,
1999
/
Rules
and
Regulations
there
is
not
a
separate
persistence
criterion
for
flooded
soils,
nor
are
data
on
flooded
soils
preferable
to
other
soil
data.
EPA
notes
that
other
soil
studies,
as
discussed
above
in
this
section,
indicate
a
half­
life
of
1,322
days
in
soils.
The
commenter
states
that
while
pendimethalin
is
stable
to
hydrolysis,
it
will
degrade
in
natural
water
and
water/
sediment
systems
under
laboratory
conditions
with
degradation
half­
lifes
ranging
from
4
to
22
days.
Photodegradation
is
also
rapid
with
half­
lifes
of
approximately
3.5
days.
The
commenter
concludes
that
these
results
indicate
that
pendimethalin
has
a
low
persistence
in
both
water
and
its
underlying
sediment
according
to
the
EPCRA
section
313
persistence
criteria.
Two
of
the
aerobic
aquatic
degradation
studies
cited
by
the
commenter
were
not
provided
to
the
Agency
or
are
not
publicly
available,
(i.
e.,
they
are
internal
American
Cyanamid
studies).
It
is
unclear
from
the
summary
provided
whether
the
cited
studies
measured
destruction
of
pendimethalin
or
its
loss
from
the
medium
by
non­
destructive
water
to
air
transport
processes.
If
the
latter
is
the
case,
the
``
dissipation
half­
lifes''
cited
cannot
be
used
to
characterize
persistence.
EPA
agrees
that
if
the
halflifes
reported
for
aerobic
aquatic
degradation
represent
half­
lifes
for
destruction
of
the
chemical,
they
do
not
meet
the
criteria
for
persistence
in
water.
However,
as
noted,
the
full
studies
were
not
available
for
review
and
as
such,
EPA
cannot
assume
that
the
studies
followed
destruction
of
pendimethalin,
or
that
the
studies
meet
the
quality
criteria
outlined
in
this
rule.
The
commenter
cites
a
half­
life
range
of
6
to
22
days
derived
from
an
anaerobic
aquatic
degradation
study
to
support
the
argument
that
pendimethalin
has
a
low
persistence
in
both
water
and
its
underlying
sediment
according
to
the
EPCRA
section
313
persistence
criteria.
EPA
agrees
that
the
persistence
half­
life
values
cited
by
the
commenter
do
not
meet
the
EPCRA
section
313
persistence
criteria,
but
points
out
that
additional
data
submitted
in
support
of
the
reregistration
of
pendimethalin
indicated
that
half­
lifes
in
aquatic
environments
could
be
longer.
OPP
used
flooded
soil
degradation
studies
to
assess
the
persistence
of
pendimethalin
under
anaerobic
aquatic
conditions.
Half­
lifes
in
these
studies
ranged
from
6
to
105
days.
In
its
discussion
of
the
potential
impact
of
pendimethalin
on
water
resources,
OPP
in
the
RED
notes
that
pendimethalin
has
an
anaerobic
aquatic
metabolism
half­
life
of
60
days.
EPA
believes
that
after
review
of
the
available
data
on
its
persistence
in
water
pendimethalin
meets
the
EPCRA
section
313
persistence
criteria.
EPA
agrees
that
rapid
aqueous
photodegradation
under
laboratory
studies
has
been
reported
for
pendimethalin.
However,
the
photolysis
screening
tests
used
are
designed
to
allow
the
determination
of
rates
of
photolysis
at
shallow
depths
in
pure
water
as
a
function
of
lattitude
and
season.
EPA
believes
that
the
environmental
relevence
of
these
tests
should
be
considered
in
their
use
to
determine
persistence,
and
that
the
results
are
most
applicable
to
shallow,
clear
waters.
EPA
believes
that
the
application
of
the
results
beyond
these
environments
is
tenuous
due
to
the
attenuation
of
light
by
suspended
matter
and
increasing
depth
in
the
aquatic
environment.
EPA
believes
that
pendimethalin's
tendency
to
sorb
to
soil
and
sediments
may
result,
under
some
circumstances,
in
its
deposition
in
benthic
environments
beyond
the
effects
of
aqueous
photolysis.
Therefore,
EPA
does
not
believe
that
the
half­
life
for
pendimethalin
in
water
should
be
based
on
aqueous
photolysis.
The
commenter
claims
pendimethalin
will
not
persist
in
air
according
to
the
EPCRA
section
313
persistence
criteria
for
air
since
it
has
a
half­
life
of
less
than
2
days.
The
commenter
discusses
the
estimation
of
pendimethalin's
atmospheric
half­
life
and
a
study
on
its
photodegradation
in
air.
The
commenter
cites
the
results
of
a
calculation
according
to
the
method
of
Atkinson
performed
to
determine
the
rate
constant
for
reaction
of
pendimethalin
with
OH
radicals
in
the
gas
phase
(Ref
42).
A
tropospheric
half­
life
of
3.4
hours
was
calculated
using
the
method.
The
photolysis
of
pendimethalin
was
investigated
by
Bossan,
et
al.,
1995
(Ref.
15),
who
reported
on
the
photoreactivity
of
pendimethalin
on
airborne
fly
ash
and
kaolin
using
simulated
sunlight.
Approximately
70%
of
applied
pendimethalin
degraded
within
30
minutes
when
adsorbed
to
fly
ash
but
little
degradation
was
observed
after
100
minutes
when
pendimethalin
was
bound
to
kaolin.
EPA
agrees
that
pendimethalin
does
not
meet
the
persistence
half­
life
criteria
for
air
of
greater
than
2
days,
but
because
it
meets
the
persistence
criteria
for
soil
and
water,
this
does
not
affect
EPA's
conclusion.
As
noted
in
the
proposed
final
rule
(at
64
FR
702),
a
chemical
need
only
meet
one
of
the
media­
specific
criteria
to
be
considered
persistent.
The
commenter
cites
EPA's
pendimethalin
RED
document
and
cites
its
conclusion
in
support
of
the
argument
that
pendimethalin
does
not
meet
the
persistence
criteria.
The
commenter
describes
the
RED
conclusions
as
follows:

Pendimethalin
dissipates
in
the
environment
by
binding
to
soil,
microbiallymediated
metabolism
and
volatilization.
It
is
essentially
immobile
in
soil.
Based
on
laboratory
studies
and
limited
field
study
information,
pendimethalin
is
slightly
to
moderately
persistent
in
aerobic
soil
environments.
Persistence
decreases
with
increased
temperature,
increased
moisture
and
decreased
soil
organic
carbon.

EPA
disagrees
with
the
commenters'
suggestion
that
the
OPP
RED
for
pendimethalin
concludes
that
it
does
not
meet
the
EPCRA
313
persistence
criteria.
As
stated
in
an
earlier
response,
``
moderate''
persistence
has
no
relevance
in
the
context
of
the
proposed
rule.
A
chemical
is
considered
persistent
if
it
has
half­
lifes
of
2
days
in
air
or
2
months
in
soil,
sediment,
or
water,
respectively.
The
commenter
implies
that
OPP
has
concluded
that
pendimethalin
does
not
meet
the
persistence
criteria
by
selectively
citing
the
OPP
RED
while
failing
to
acknowledge
other
information
OPP
discussed
in
the
document
confirming
the
persistence
of
pendimethalin.
OPP
did
not
make
any
formal
summary
conclusions
regarding
the
overall
environmental
persistence
of
pendimethalin.
The
commenter
has
selectively
cited
from
the
RED
by
taking
a
few
comments
out
of
context
while
ignoring
additional
findings
which
demonstrate
that
pendimethalin
meets
the
persistence
criteria.
The
first
statement
cited
by
the
commenter
addresses
dissipation
in
the
environment.
Two
of
the
three
processes
(soil
binding
and
volatilization)
responsible
for
dissipation
do
not
result
in
the
destruction
of
the
chemical
and
cannot
be
directly
related
to
persistence.
Volatilization
results
in
the
relocation
of
the
chemical
to
the
atmosphere.
Binding
to
soil
does
not
destroy
pendimethalin
and
under
some
soil
conditions
has
been
shown
to
increase
persistence.
While
microbial
metabolism
of
pendimethalin
can
result
in
its
destruction,
it
has
been
shown
to
be
a
slow
process
under
many
environmental
conditions.
The
commenter
cites
OPP's
qualitative
description
of
the
persistence
of
pendimethalin
in
aerobic
soil
environments
as
slight
to
moderate.
This
does
not
serve
as,
nor
did
OPP
intend
for
this
statement
to
represent,
a
quantitative
description
of
pendimethalin's
persistence
in
soil.
OPP
does
not
attempt
to
relate
this
characterization
to
a
numeric
range
of
persistence
values
in
the
RED,
and
the
58718
Federal
Register
/
Vol.
64,
No.
209
/
Friday,
October
29,
1999
/
Rules
and
Regulations
commenter
does
not
provide
a
rationale
for
concluding
that
OPP's
language
indicates
that
pendimethalin
does
not
meet
the
EPCRA
section
313
persistence
criteria.
The
final
sentence
of
the
citation
points
out
factors
that
decrease
persistence,
but
a
more
detailed
reading
of
the
RED
on
the
subject
of
pendimethalin
persistence
in
aerobic
soils
reveals
that
its
persistence
increases
as
temperature
and
soil
moisture
decrease,
and
soil
organic
carbon
increase.
The
commenter
performed
a
Level
III
EQC
Multimedia
Modeling
assessment
for
pendimethalin
assuming
``
best
case,
reasonable
case,
and
worst
case''
scenarios.
The
calculated
overall
environmental
persistence
was
determined
for
pendimethalin
to
be
5
days,
58
days,
and
142
days
under
the
``
best,
reasonable,
and
worst
case''
scenarios,
respectively.
The
results
of
the
multimedia
model
indicated
that
pendimethalin
will
have
a
persistence
in
the
environment
of
less
than
2
months,
assuming
a
reasonable
case
scenario.
The
commenter
claims
that
multimedia
modeling
results
indicate
that
pendimethalin
will
not
be
persistent
according
to
the
EPCRA
section
313
persistence
criteria.
The
commenter
notes
that
the
values
it
calculated
using
the
EQC
model
are
much
lower
than
the
30
days
and
487
days
calculated
for
EPA
(Ref.
51)
assuming
best
case
and
worst
case
scenarios.
The
commenter
alleges
that
EPA
assumed
that
half­
lifes
in
soil,
sediment
and
water
were
identical,
54
days
and
1,322
days,
respectively
(Ref.
7).
The
data
presented
above,
however,
indicate
that
these
were
erroneous
assumptions.
The
half­
lifes
for
pendimethalin
dissipation
in
water,
soil,
and
sediment
are
not
identical,
and
the
1,322
day
half­
life
is
an
outlier.
The
commenter
concludes
that
pendimethalin
will
have
a
low
to
moderate
persistence
whether
found
in
the
air,
water,
soil,
or
sediment
compartments
of
the
environment.
The
commenter
asserts
that
this
is
supported
by
field
and
laboratory
degradation
studies,
multimedia
modeling,
and
EPA's
FIFRA
registration
environmental
assessment
of
pendimethalin.
Therefore,
pendimethalin
should
not
be
classified
as
persistent
for
purposes
of
inclusion
on
the
EPCRA
section
313
list
of
PBT
chemicals.
EPA
disagrees
that
pendimethalin
will
have
low
persistence
in
the
environment
whether
laboratory
and
field
studies
or
multimedia
modeling
are
considered.
Multimedia
mass
balance
models
offer
the
most
convenient
means
to
estimate
overall
environmental
persistence
from
information
on
sources
and
loadings,
chemical
properties
and
transformation
processes,
and
intermedia
partitioning.
For
the
chemicals
included
in
the
proposed
rule,
EPA
used
a
modified
version
of
the
EQC
model
(Ref.
33)
to
estimate
overall
environmental
persistence.
Overall
persistence
estimated
in
this
way
is
used
as
an
additional
factor,
in
conjunction
with
reaction
half­
lifes
for
individual
media,
bioaccumulation/
bioconcentration
factors,
in
justifying
the
determination
made
by
EPA
in
this
rule.
The
EQC
model
is
based
on
the
fugacity
approach
first
delineated
by
Mackay
(Ref.
31)
and
subsequently
applied
to
numerous
environmental
processes
(Ref.
32).
It
uses
an
``
evaluative
environment''
in
which
environmental
parameters
such
as
bulk
compartment
dimensions
and
volumes
(e.
g.,
total
area,
volume
of
soil
and
sediment,
etc.)
are
standardized,
so
that
overall
persistence
for
chemicals
with
different
properties
and
rates
of
transformation
may
be
compared
on
an
equal
basis
(Ref.
15).
EPA
used
a
version
of
the
EQC
level
III
model
(Ref.
33)
which
was
modified
to
focus
on
net
losses
by
deleting
model
terms
for
advective
losses
(movement
out
of
the
evaluative
environment
of
air
and
water
potentially
containing
a
chemical)
and
sediment
burial
(Ref.
82).
In
this
version
of
the
model
only
irreversible
transformation
contributes
to
net
loss
of
a
chemical.
The
overall
persistence
obtained
from
this
model
is
calculated
as
the
total
amount
in
the
evaluative
environment
when
steady
state
is
achieved,
divided
by
the
total
loss
rate.
The
results
thus
obtained
are
neither
an
overall
environmental
half­
life
nor
a
compartment
(or
transformation)
specific
half­
life;
rather
they
are
equivalent
to
an
environmental
residence
time.
When
only
irreversible
transformation
contributes
to
net
loss­

i.
e.,
under
the
conditions
of
this
version
of
the
EQC
model­­
overall
environmental
persistence
times
can
be
converted
to
half­
lifes
by
multiplying
the
former
by
ln
2
(i.
e.,
0.693).
The
overall
half­
life
calculated
in
this
way
is
for
dissipation
in
the
environment
as
a
whole
and
cannot
be
related
directly
to
any
individual
compartment.
The
commenter
selected
mediaspecific
environmental
half­
lifes
for
use
as
input
to
the
EQC
model.
The
values
were
characterized
as
``
best,
''
``
reasonable''
and
``
worst''
case.
No
justification
was
given
for
this
classification.
It
appeared
that
the
shortest
half­
lives
were
categorized
as
``
best
case.
''
Based
on
the
information
provided
by
the
commenter,
it
was
not
always
possible
to
determine
whether
the
half­
lifes
for
soil
or
water
selected
by
the
commenter
for
use
as
input
to
the
EQC
model
were
for
destruction
of
chemical,
or
its
dissipation
from
the
medium.
As
noted
previously,
dissipation
half­
lifes
do
not
necessarily
represent
destruction
of
the
chemical
since
non­
destructive
transport
processes
such
as
volatilization
can
be
responsible
for
loss
from
the
medium.
Their
use
in
multimedia
modeling
could
potentially
underestimate
overall
environmental
persistence.
This
is
particularly
important
since
the
modified
EQC
model
predicted
that
greater
than
90%
of
the
pendimethalin
would
partition
to
soil
at
steady
state.
If
a
soil
half­
life
based
on
loss
from
soil
by
nondestructive
processes
was
used
rather
than
one
based
on
the
destruction
of
pendimethalin,
its
persistence
would
have
been
underestimated.
In
its
modeling
of
the
overall
environmental
persistence
of
pendimethalin
EPA
used
the
highest,
lowest
and
mean
values
for
the
ranges
of
media­
specific
half­
lifes
from
valid
studies
as
inputs
to
the
modified
EQC
model,
not
the
highest
and
lowest
as
stated
by
the
commenter.
These
included
a
half­
life
for
pendimethalin
in
soil
of
1,322
days.
EPA
determined
that
the
study
was
properly
conducted
and
chose
the
half­
life
value
of
1,322
days
for
soil
because
it
represented
the
most
environmentally
protective
half­
life
derived
from
a
valid
study.
The
calculated
overall
environmental
persistence
half­
lifes
were
1
month,
8
months,
and
16
months
based
on
the
highest,
mean,
and
lowest
half­
lifes,
respectively.
For
chemicals
in
this
rulemaking,
EPA
considered
the
multimedia
modeling
EQC
results
in
characterizing
persistence
in
the
overall
environment.
EPA
only
intended
to
use
multimedia
modeling
results
to
override
the
medium­
specific
persistence
data
in
limited
circumstances,
e.
g.,
only
if
all
model
inputs
are
judged
to
be
accurate
(and,
as
noted
above,
the
commenter's
inputs
cannot
be
determined
to
be
accurate).
But
even
if
EPA
were
to
use
the
EQC
model
to
assess
persistence,
pendimethalin
would
be
considered
persistent
because,
with
the
EPA
inputs
described
above,
EQC
overall
environmental
persistence
half­
lifes
were
calculated
to
be
greater
than
6
months
using
the
mean
and
maximum
air,
soil,
and
water
half­
lifes
calculated.
In
response
to
this
comment
(even
though
it
was
unclear
whether
the
commenter
was
basing
its
assertion
on
degradation
data
or
dissipation
data),
EPA
conducted
a
new
EQC
assessment
for
pendimethalin
using
the
same
halfVerDate
58719
Federal
Register
/
Vol.
64,
No.
209
/
Friday,
October
29,
1999
/
Rules
and
Regulations
life
inputs
selected
by
the
commenter.
The
calculated
overall
environmental
persistence
half­
life
was
greater
than
2
months
using
the
longest
half­
lifes
provided
by
the
commenter
for
air,
soil,
water,
and
sediment.
These
results
support
EPA's
assertion
that
the
persistence
of
pendimethalin
in
the
environment
meets
the
EPCRA
section
313
persistence
criteria.
The
commenter
argues
that
the
scientifically­
based
risk
assessments
conducted
on
pendimethalin
as
a
part
of
the
pesticide
registration
process
should
not
be
ignored,
and
that
EPA
should
review
pesticide
PBT
chemical
classifications
with
EPA
registration
information
to
ensure
an
accurate
analysis
has
been
performed.
The
commenter
notes
that
EPA
has
determined
through
the
review
of
a
complete
set
of
studies
that
this
material
used
at
an
approximate
rate
of
1.0
to
2.0
pounds
of
active
ingredient
per
acre
does
not
present
an
unreasonable
risk
to
human
health
or
the
environment,
that
low
levels
of
pendimethalin
in
manufacturing
wastewater
releases
do
not
pose
an
unacceptable
risk
to
the
environment,
and
that
reported
EPCRA
section
313
air
releases
do
not
pose
a
significant
risk
to
human
health
or
the
environment.
The
commenter
concludes
that
based
on
the
weight
of
evidence
it
is
clear
that
releases
of
pendimethalin
from
manufacturing
do
not
pose
a
significant
threat
to
human
health
and
the
environment
and
that
pendimethalin
should
not
be
branded
as
having
a
high
potential
for
harm
as
indicated
by
the
proposed
listing
as
a
PBT
chemical
and
lowering
of
the
reporting
threshold.
EPA
disagrees
that
the
risk
assessments
cited
by
the
commenter
are
relevant
to
the
characterization
of
pendimethalin
as
a
PBT
chemical.
The
characterization
of
chemicals
as
PBT
chemicals
for
the
purpose
of
this
rule
are
based
on
intrinsic
physical­
chemical
properties.
Risk
is
not
an
intrinsic
property
of
a
substance,
but
rather
the
result
of
the
combination
of
intrinsic
hazard
(toxicity)
a
substance
possesses
and
the
exposure
to
a
target
organism
under
a
defined
set
of
circumstances.
It
is
possible
for
a
substance
to
present
a
risk
under
one
set
of
exposure
conditions,
but
not
another.
In
contrast,
a
substance
characterized
as
a
PBT
chemical
will
remain
a
PBT
chemical,
regardless
of
the
exposure
to
it
or
its
levels
in
the
environment.
(See
Unit
VI.
C.)
Toxic
chemicals
that
persist
and
bioaccumulate
are
of
particular
concern
because
they
remain
in
the
environment
for
significant
periods
of
time
and
concentrate
in
the
organisms
exposed
to
them.
Furthermore,
these
PBT
chemicals
can
have
serious
human
health
and
environmental
effects
resulting
from
low
levels
of
release
and
exposure.
EPA
believes
that
the
substances
subject
to
this
rule
have
been
characterized
as
PBT
chemicals
using
scientifically
sound
indicators
based
on
the
intrinsic
properties
of
the
substances.
The
PBT
characterization
is
independent
of
the
risk
the
substance
may
pose
under
a
given
set
of
circumstances.
These
substances
have
been
characterized
as
persistent,
bioaccumulative
and
toxic
and,
therefore,
meet
the
criteria
for
lowered
reporting
thresholds.
Further,
FIFRA
requires
the
Agency
to
determine
that
pesticidal
uses
of
a
chemical
do
not
cause
``
unreasonable
adverse
effects
on
the
environment,
''
which
is
defined
in
FIFRA
section
2(
bb)
as
``
any
unreasonable
risk
to
man
or
the
environment
taking
into
account
the
economic,
social,
and
environmental
costs
and
benefits
of
the
use
of
pesticides''
(7
U.
S.
C.
section
136(
bb)).
FIFRA
is
a
regulatory
statute,
and
the
impacts
of
regulation
can
be
immediate
and
direct
(e.
g.,
banning
of
a
chemical),
and
as
such
EPA
examines
not
only
the
hazards
presented
by
the
chemical,
but
also
the
specific
exposure
scenarios,
and
weighs
the
risks
against
the
benefits
of
the
chemical.
The
``
unreasonable
adverse
effects''
determination
under
FIFRA
is
specific
to
the
intentional
use
of
the
chemical
as
a
pesticide
and
does
not
address
other
uses
or
releases
of
the
chemical
that
may
result
from
manufacture,
processing,
or
other
use.
Furthermore,
a
determination
under
FIFRA
that
the
use
of
a
chemical
will
not
result
in
an
``
unreasonable
adverse
effect''
is
not
a
determination
that
the
chemical
is
not
hazardous
or
persistent
or
that
the
use
of
the
chemical
is
without
risk,
but
merely
that
the
benefits
of
agricultural
use
as
a
pesticide
outweigh
its
risks
as
an
agricultural
pesticide
or
that
the
pesticide
chemical
residues
on
food
or
feed
meet
the
standards
of
section
408
of
the
Federal
Food,
Drug,
and
Cosmetic
Act.
EPCRA
section
313
was
not
enacted
to
serve
the
same
purpose
as
FIFRA.
Listing
on
EPCRA
section
313
provides
communities
with
some
of
the
information
required
to
determine
what
risks
may
result
from
the
manufacture,
processing,
and
use
of
a
chemical,
and
to
allow
local
communities
to
determine
for
themselves
whether
such
risks
are
acceptable,
information
not
provided
under
FIFRA.
h.
Toxaphene.
In
the
proposal,
EPA
preliminarily
determined
that
toxaphene
has
persistence
half­
life
values
in
soil
of
1
to
11
years
and
a
persistence
half­
life
value
in
water
of
1
to
5
years.
EPA
has
reviewed
information
and
all
comments
received
on
toxaphene's
persistence
characteristics.
Taking
into
account
this
information,
as
indicated
in
Table
3,
EPA
finds
that
toxaphene
persists
in
the
environment
with
a
half­
life
of
2
months
or
greater
and
therefore
meets
the
persistence
criterion
established
in
this
rulemaking.
A
complete
discussion
of
EPA's
findings
on
this
chemical
can
be
found
in
EPA's
Response
to
Comments
document
for
this
rulemaking
(Ref.
69)
and/
or
in
EPA's
support
documents
for
this
rulemaking.
(Ref.
7).
In
addition,
toxaphene
persists
in
the
environment
with
a
half­
life
of
greater
than
6
months
which
supports
EPA's
decision
to
lower
the
threshold
to
10
pounds.
i.
Trifluralin.
In
the
proposal,
EPA
preliminarily
determined
that
trifluralin
has
persistence
half­
life
values
in
soil
of
99
to
394
days
and
a
persistence
halflife
value
in
water
of
5
to
37
days.
EPA
has
reviewed
information
and
all
comments
received
on
trifluralin's
persistence
characteristics.
Taking
into
account
this
information,
as
indicated
in
Table
3,
EPA
finds
that
trifluralin
persists
in
the
environment
with
a
halflife
of
2
months
or
greater
and
therefore
meets
the
persistence
criterion
established
in
this
rulemaking.
A
complete
discussion
of
EPA's
findings
on
this
chemical
can
be
found
in
EPA's
Response
to
Comments
document
for
this
rulemaking
(Ref.
69)
and/
or
in
EPA's
support
documents
for
this
rulemaking
(Ref.
7).
j.
Polycyclic
aromatic
compounds.
In
the
proposal,
EPA
preliminarily
determined
that
PACs
have
persistence
half­
life
values
in
soil
that
ranged
from
20
days
to
13
years.
All
but
a
few
had
half­
lifes
well
in
excess
of
6
months.
These
chemicals
had
persistence
halflife
values
in
water
that
ranged
from
79
days
to
44
years.
EPA
received
one
significant
comment
addressing
the
persistence
potential
of
PACs,
which
is
discussed
below.
EPA
has
reviewed
information
and
all
comments
received
on
PACs'
persistence
characteristics.
Taking
into
account
this
information,
as
indicated
in
Table
3,
EPA
finds
that
PACs
persist
in
the
environment
with
half­
lives
of
2
months
or
greater
and
therefore
meet
the
persistence
criterion
established
in
this
rulemaking.
A
complete
discussion
of
EPA's
findings
on
this
chemical
category
can
be
found
in
EPA's
Response
to
Comments
document
for
this
rulemaking
(Ref.
69)
and/
or
in
EPA's
support
documents
for
this
rulemaking
(Ref.
7).
One
commenter
contends
that
EPA
has
incorrectly
ignored
biotreatment
58720
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/
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209
/
Friday,
October
29,
1999
/
Rules
and
Regulations
studies
in
evaluating
persistence
for
PACs.
EPA
has
also
ignored
a
large
body
of
recent
research
on
sequestration
and
other
phenomena
that
collectively
act
to
reduce
the
bioavailability
of
soil
contaminants,
such
as
PACs.
Biotreatment
studies
include
activated
sludge
or
other
wastewater
treatment
studies.
As
EPA
stated
in
the
proposed
rule
(at
64
FR
700),
the
reason
for
excluding
such
studies
is
that
wastewater
treatment
in
general
and
activated
sludge
in
particular
represent
conditions
that
are
far
removed
from
ambient
(surface)
waters,
soils,
and
sediments.
Data
on
environmental
fate
and
persistence
of
substances
in
wastewater
and
activated
sludge
normally
cannot
be
extrapolated
to
the
other
conditions.
The
commenter
seems
most
concerned
about
land
biotreatment
(bioremediation)
studies,
but
in
fact
goes
well
beyond
the
concept
of
treatability,
appearing
to
infer
that
EPA
has
ignored
all
biodegradation
studies
of
PACs.
However,
this
is
incorrect
because
all
mixed­
culture
biodegradation
studies
other
than
activated
sludge
tests­­
i.
e.,
field
tests
as
well
as
lab
studies
that
used
authentic
soil,
water
and/
or
sediment
grab
samples­­
were
considered
in
determining
persistence
for
all
of
the
listed
substances.
The
commenter
also
discusses
recent
research
indicating
that
bioavailability
of
a
substance
may
decline
with
time
of
incubation
in
soil,
and
suggests
that
EPA
should
include
``
reasonable
bioavailability
factors''
in
its
determination
of
persistence.
As
an
example
of
why
this
is
relevant,
there
has
been
a
concern
that
Superfund
site
remediation
actions
may
be
mistargeted
if
they
are
based
on
residues
released
from
the
soils
by
vigorous
extraction
procedures,
since
chemical
substances
in
soil
may
become
nonbioavailable
yet
still
be
extractable
for
analytical
purposes.
Additionally,
bioremediation
may
fail
to
destroy
all
of
a
substance
that
such
analysis
shows
is
present,
if
some
portion
is
sequestered
in
a
nonbioavailable
state.
Further,
the
commenter
contends
that
chemicals
(including
many
PACs)
are
not
bioavailable
if
the
bioavailability
is
considerably
less
than
100%.
The
commenter
does
further
specify
a
numerical
bioavailability
criteria.
The
commenter
over­
generalizes
from
the
research
findings,
using
selective
citation
and
quotation
from
the
literature
to
give
the
impression
that
all
is
now
known
and
any
substance
released
to
soil
is
as
good
as
gone
toxicologically
speaking.
Other
reports
can
be
quoted
to
the
effect
that
the
many
factors
determining
bioavailability,
sequestration,
etc.
are
far
from
completely
resolved,
and
deserve
much
further
research.
Moreover,
sequestration
does
not
necessarily
imply
non­
bioavailability.
For
example,
in
a
study
of
PAC
sequestration
and
bioremediation,
Tang
et
al.
(Ref.
51a)
state
that:

The
results
of
the
present
study
suggest
that
extensive
biodegradation
by
microorganisms
does
not
necessarily
remove
all
of
the
fraction
of
an
aged
compound
that
is
bioavailable
since
some
uptake
by
worms
occurred
even
after
the
laboratory­
scale
bioremediation.
.
.
.it
is
also
possible
that
a
portion
of
a
compound
that
is
sequestered
is
available
to
different
degrees
to
dissimilar
organisms.
.
.
.It
may
be
that
the
mass
of
material
that
becomes
sequestered
should
be
considered
as
existing
in
two
forms.
One
form
may
be
unavailable
to
all
organisms
because
it
is
physically
remote
and
thus
inaccessible.
The
second
form
may
be
differentially
available,
and
its
assimilation,
toxicity,
and/
or
biodegradation
may
depend
on
the
properties
of
the
species
and
its
ability
to
mobilize
the
molecules
from
this
nonremote
location.
[There
is]
danger
if
it
is
assumed
that
the
disappearance
of
lethality
denotes
the
absence
of
bioavailability....
The
point
is
reinforced
by
the
case
of
DDT,
which
is
sequestered
in
soil
(13)
and
whose
lethality
to
insects
totally
disappears
as
a
result
of
such
sequestration
(5),
yet
a
portion
of
that
insecticide
was
still
assimilated
by
earthworms
introduced
into
soil
that
was
treated
in
the
field
with
DDT
more
than
40
years
before
the
bioassay
was
performed.
.
.
.(
emphasis
added)

And
in
a
similar
paper
on
DDT
and
dieldrin,
Robertson
and
Alexander
(Ref.
43a)
state
that:

The
significance
of
soil
properties
in
controlling
sequestration
is
evident
in
the
early
observation
that
the
degree
of
sequestration
of
lindane
after
22
months
was
greatest
in
a
muck,
intermediate
in
extent
in
a
loam,
and
least
in
a
sandy
loam
(11).
Thus,
soil
properties
must
be
considered
in
attempting
to
predict
the
bioavailability
of
persistent
compounds.
It
is
also
evident
from
the
data
presented
herein
that
the
bioavailability
of
a
sequestered
toxicant
varies
with
the
exposed
species.
Thus,
the
declines
in
toxicity
of
aged
DDT
and
dieldrin
to
the
three
test
insects
were
quite
different;
whereas
the
lethality
of
the
sequestered
compound
to
one
species
had
almost
disappeared,
it
still
was
effective
against
a
second.
(emphasis
added)

The
conclusion
is
manifest:
it
is
that
although
chemical
substances
released
to
soil
may
become
sequestered
over
time,
it
cannot
be
assumed
that
this
process
necessarily
leads
to
nonbioavailability
even
when
the
time
horizon
is
years.
Site­
and
speciesspecific
factors,
as
well
as
substance
properties,
are
important
in
determining
bioavailability.
Therefore,
it
is
appropriate
to
be
concerned
about
the
bioavailability
in
soil
and
sediment
of
PACs
and
other
substances
that
meet
the
PBT
criteria
established
for
this
rulemaking.
Further,
there
is
no
scientific
reason
why
a
chemical
can
only
be
considered
bioavailable
if
its
bioavailability
approaches
100%.
The
degree
of
bioavailability
will
vary
depending
upon
the
environmental
conditions.
In
addition,
as
noted
above
the
degree
of
bioavailability
will
also
be
species
dependent.
Therefore,
EPA
believes
that
the
commenter's
approach
is
overly
simplistic.
k.
Benzo(
g,
h,
i)
perylene.
In
the
proposal,
EPA
preliminarily
determined
that
benzo(
g,
h,
i)
perylene
has
persistence
half­
life
values
in
soil
of
173
days
to
1.8
years
and
persistence
halflife
values
in
water
of
greater
than
100
days.
EPA
has
reviewed
information
and
all
comments
received
on
benzo(
g,
h,
i)
perylene's
persistence
characteristics.
Taking
into
account
this
information,
as
indicated
in
Table
3,
EPA
finds
that
benzo(
g,
h,
i)
perylene
persists
in
the
environment
with
a
halflife
of
2
months
or
greater
and
therefore
meets
the
persistence
criterion
established
in
this
rulemaking.
A
complete
discussion
of
EPA's
findings
on
this
chemical
can
be
found
in
EPA's
Response
to
Comments
document
for
this
rulemaking
(Ref.
69)
and/
or
in
EPA's
support
documents
for
this
rulemaking.
(Ref.
7).
In
addition,
benzo(
g,
h,
i)
perylene
persists
in
the
environment
with
a
half­
life
of
greater
than
6
months
which
supports
EPA's
decision
to
lower
the
threshold
to
10
pounds.
1.
Mercury
and
mercury
compounds.
Because
metals
may
convert
to
different
oxidation
states
but
can
never
be
destroyed,
all
metals
meet
the
6
months
half­
life
criterion
automatically.
EPA
received
a
few
significant
comments
addressing
mercury
and
mercury
compounds'
persistence.
These
are
discussed
below.
EPA
has
reviewed
information
and
all
comments
received
on
mercury
and
mercury
compounds'
persistence
characteristics.
Taking
into
account
this
information,
as
indicated
in
Table
3,
EPA
finds
that
mercury
and
mercury
compounds
persist
in
the
environment
with
half­
lives
of
2
months
or
greater
and
therefore
meet
the
persistence
criterion
established
in
this
rulemaking.
A
complete
discussion
of
EPA's
findings
on
this
chemical
category
can
be
found
in
EPA's
Response
to
Comments
document
for
this
rulemaking
(Ref.
69)
and
in
EPA's
support
documents
for
this
rulemaking
(Ref.
7).
In
addition,
mercury
and
mercury
compounds
persist
in
the
environment
with
a
half­
life
of
greater
58721
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Register
/
Vol.
64,
No.
209
/
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October
29,
1999
/
Rules
and
Regulations
than
6
months
which
supports
EPA's
decision
to
lower
the
threshold
to
10
pounds.
One
commenter
asserts
that
EPA
should
not
classify
all
forms
of
mercury
as
persistent.
The
commenter
agrees
that
Hg
(0)
is
properly
characterized
as
persistent.
However,
the
commenter
contends
that
EPA
is
incorrect
in
characterizing
Hg
(II)
as
persistent
because
it
is
removed
rapidly
from
the
atmosphere
via
wet
and
dry
deposition.
EPA
believes
that
the
commenter
confuses
residence
time
with
half­
life;
these
terms
do
not
represent
equivalent
processes.
There
is
a
distinction
between
atmospheric
``
half­
life,
''
which
is
the
amount
of
time
necessary
for
half
of
the
chemical
present
to
be
destroyed
in
the
medium,
and
atmospheric
``
residence
time''
which
is
the
length
of
time
a
chemical
resides
in
a
particular
environmental
medium.
For
the
purposes
of
this
rule
``
half­
life''
includes
only
irreversible
chemical
transformations
resulting
in
the
destruction
of
chemical
whereas
``
residence
time''
includes
factors
such
as
transport
of
the
substance
to
another
medium,
for
example,
wet
and
dry
deposition,
sorption,
complexation
or
sequestration;
and
reversible
changes
in
speciation
(i.
e.,
oxidation
reduction
reactions).
EPA
agrees
that
Hg
(0)
has
an
average
``
residence
time''
in
the
atmosphere
of
about
1
year
and
that
Hg
(II)
may
be
deposited
relatively
quickly
by
wet
and
dry
deposition
processes,
leading
to
a
``
residence
time''
of
hours
to
months
(Ref.
42a).
But
the
shorter
residence
times
noted
for
Hg
(II)
are
due
to
physical
transport
from
the
medium,
rather
than
irreversible
transformations
resulting
in
the
destruction
of
chemical.
Hg
(0)
released
to
the
atmosphere
is
rapidly
converted
to
Hg
(II)
through
ozone­
mediated
oxidation.
However,
this
is
not
an
irreversible
reaction,
nor
does
it
result
in
the
destruction
of
the
substance
since
the
Hg
(II)
produced
from
oxidation
of
Hg
(0)
by
ozone
can
be
reduced
back
to
Hg
(0)
by
sulfite
(Ref.
28a).
The
persistence
of
mercury
will
not
be
mitigated
simply
by
redox
reactions
of
Hg
(0)
to
and
from
Hg
(II).
Whether
as
Hg
(0)
or
as
Hg
(II),
mercury
persists
in
the
environment.
Environmental
processes
may
cause
it
to
change
oxidation
states
or
to
be
transported
from
one
environmental
medium
to
another;
however,
these
processes
will
not
destroy
it.
EPA
agrees
that
the
report
cited
provides
reasonable
estimates
of
the
fraction
of
mercury
emissions
from
each
source
category
that
is
likely
to
be
in
the
form
of
Hg
(II)
versus
the
fraction
as
Hg
(0).
However,
this
information
is
not
relevant
to
the
assessment
of
the
persistence
of
mercury
and
mercury
compounds
because
persistence
considers
destruction
only.
m.
Polychlorinated
biphenyls.
In
the
proposal,
EPA
preliminarily
determined
that
polychlorinated
biphenyls
(PCBs)
have
persistence
half­
life
values
in
soil
that
ranged
from
1
to
7
years
and
persistence
half­
life
values
in
water
that
ranged
from
56
to
98
days.
EPA
has
reviewed
information
and
all
comments
received
on
PCBs'
persistence
characteristics.
Taking
into
account
this
information,
as
indicated
in
Table
3,
EPA
finds
that
PCBs
persist
in
the
environment
with
half­
lifes
of
2
months
or
greater
and
therefore
meet
the
persistence
criterion
established
in
this
rulemaking.
A
complete
discussion
of
EPA's
findings
on
this
chemical
listing
can
be
found
in
EPA's
Response
to
Comments
document
for
this
rulemaking
(Ref.
69)
and/
or
in
EPA's
support
documents
for
this
rulemaking
(Ref.
7).
In
addition,
all
of
the
PCBs
persist
in
the
environment
with
a
halflife
of
greater
than
6
months
which
supports
EPA's
decision
to
lower
the
threshold
to
10
pounds.
n.
Hexachlorobenzene.
In
the
proposal,
EPA
preliminarily
determined
that
hexachlorobenzene
has
persistence
half­
life
values
in
soil
of
3
to
6
years.
EPA
has
reviewed
information
and
all
comments
received
on
hexachlorobenzene's
persistence
characteristics.
Taking
into
account
this
information,
as
indicated
in
Table
3,
EPA
finds
that
hexachlorobenzene
persists
in
the
environment
with
a
halflife
of
2
months
or
greater
and
therefore
meets
the
persistence
criterion
established
in
this
rulemaking.
A
complete
discussion
of
EPA's
findings
on
this
chemical
can
be
found
in
EPA's
Response
to
Comments
document
for
this
rulemaking
(Ref.
69)
and
in
EPA's
support
documents
for
this
rulemaking
(Ref.
7).
In
addition,
hexachlorobenzene
persists
in
the
environment
with
a
halflife
of
greater
than
6
months
which
supports
EPA's
decision
to
lower
the
threshold
to
10
pounds.
o.
Octachlorostyrene.
In
the
proposal,
EPA
preliminarily
determined
that
OCS
has
persistence
half­
life
values
in
soil
of
3
to
6
years.
EPA
received
one
significant
comment
addressing
OCS's
persistence
potential
which
is
discussed
below.
EPA
has
reviewed
information
and
all
comments
received
on
OCS's
persistence
characteristics.
Taking
into
account
this
information,
as
indicated
in
Table
3,
EPA
finds
that
OCS
persists
in
the
environment
with
a
half­
life
of
2
months
or
greater
and
therefore
meets
the
persistence
criterion
established
in
this
rulemaking.
A
complete
discussion
of
EPA's
findings
on
this
chemical
can
be
found
in
EPA's
Response
to
Comments
document
for
this
rulemaking
(Ref.
69)
and/
or
in
EPA's
support
documents
for
this
rulemaking
(Ref.
7).
In
addition,
OCS
persists
in
the
environment
with
a
half­
life
of
greater
than
6
months
which
supports
EPA's
decision
to
lower
the
threshold
to
10
pounds.
One
commenter
believes
that
OCS
should
not
be
considered
to
be
a
PBT
chemical.
The
commenter
admits
that
OCS
has
the
potential
to
bioaccumulate
and
may
theoretically
persist
in
the
environment,
but
cites
falling
environmental
levels
of
OCS
and
the
lack
of
evidence
of
human
and
environmental
toxicity
as
justification
for
why
OCS
should
not
be
considered
to
be
a
persistent,
bioaccumulative
and
toxic
chemical.
The
commenters
contend
that
pentachlorobenzene
and
hexachlorobenzene
are
not
good
analogs
for
OCS.
EPA
disagrees.
As
discussed
in
Unit
VI.
G.,
EPA
believes
that
OCS
meets
the
EPCRA
section
313
toxicity
criteria.
Further,
EPA
believes
that
OCS
is
highly
persistent.
No
measured
half­
life
data
for
soil
or
water
that
met
the
standards
for
data
acceptability
could
be
located
for
octachlorostyrene
(CAS
No.
29082±
74±
4).
Therefore,
EPA
used
half­
lifes
for
the
structural
analogs
pentachlorobenzene
(CAS
No.
608±
93±
5)
and
hexachlorobenzene
(CAS
No.
118±
74±
1)
for
estimating
half­
lifes
for
OCS.
EPA
believes
that
pentachlorobenzene
and
hexachlorobenzene
are
good
analogs
for
OCS
because
they,
like
OCS,
are
highly
chlorinated
benzene
derivatives,
which
are
structurally
very
similar.
By
analogy,
OCS
is
expected
to
have
a
half­
life
in
soil
of
greater
than
6
months
and
greater
than
2
days
in
air
(Ref.
7).
These
halflifes
are
sufficient
to
designate
OCS
as
persistent
using
the
criteria
described
in
the
proposed
rule.
EPA
believes
that
its
use
of
analog
data
is
scientifically
supportable
because
like
OCS
both
analogs
are
highly
chlorinated
monocyclic
aromatics.
EPA
believes
that
the
degree
of
toxicity
as
well
as
the
degree
of
persistence
and
bioaccumulation
are
inherent
to
a
chemical.
The
absolute
level
of
a
chemical
in
the
environment
does
not
affect
its
degree
of
persistence,
bioaccumulation,
or
whether
or
not
it
has
been
shown
to
cause
adverse
effects
to
aquatic
organisms.
The
absolute
level
in
the
environment
is
a
factor
of
both
how
much
is
entering
the
environment
and
the
persistence
of
the
chemical
in
the
environment.
The
degree
to
which
a
chemical
is
present
in
aquatic
organisms
is
not
only
a
measure
of
the
BAF,
but
also
inputs
into
the
environment
and
58722
Federal
Register
/
Vol.
64,
No.
209
/
Friday,
October
29,
1999
/
Rules
and
Regulations
persistence.
The
assertions
made
by
the
commenter
do
not
support
their
contentions
concerning
the
toxicity,
persistence,
or
bioaccumulation
of
OCS.
p.
Pentachlorobenzene.
In
the
proposal,
EPA
preliminarily
determined
that
pentachlorobenzene
has
persistence
half­
life
values
in
soil
of
194
days
to
more
than
22
years.
EPA
received
no
significant
comments
addressing
pentachlorobenzene's
persistence
potential.
EPA
has
reviewed
information
and
all
comments
on
pentachlorobenzene's
persistence
characteristics.
Taking
into
account
this
information,
as
indicated
in
Table
3,
EPA
finds
that
pentachlorobenzene
persists
in
the
environment
with
a
halflife
of
2
months
or
greater
and
therefore
meets
the
persistence
criterion
established
in
this
rulemaking.
A
complete
discussion
of
EPA's
findings
on
this
chemical
can
be
found
in
EPA's
Response
to
Comments
document
for
this
rulemaking
(Ref.
69)
and/
or
in
EPA's
support
documents
for
this
rulemaking
(Ref.
7).
In
addition,
pentachlorobenzene
persist
in
the
environment
with
a
half­
life
of
greater
than
6
months
which
supports
EPA's
decision
to
lower
the
threshold
to
10
pounds.
q.
Tetrabromobisphenol
A.
In
the
proposal,
EPA
preliminarily
determined
that
TBBPA
has
persistence
half­
life
values
in
soil
of
44
to
179
days
and
persistence
half­
life
values
in
water
of
48
to
84
days.
EPA
received
several
significant
comments
addressing
TBBPA's
persistence
and
discusses
them
below.
EPA
has
reviewed
information
and
all
comments
received
on
TBBPA's
persistence
characteristics.
Taking
into
account
this
information,
as
indicated
in
Table
3,
EPA
finds
that
TBBPA
persists
in
the
environment
with
a
half­
life
of
2
months
or
greater
and
therefore
meets
the
persistence
criterion
established
in
this
rulemaking.
A
complete
discussion
of
EPA's
findings
on
this
chemical
can
be
found
in
EPA's
Response
to
Comments
document
for
this
rulemaking
(Ref.
69)
and/
or
in
EPA's
support
documents
for
this
rulemaking
(Ref.
7).
One
commenter
states
that
EPA's
determination
that
TBBPA
is
persistent
in
the
environment
appears
to
be
based
upon
a
model
which
uses
default
data,
that
it
is
difficult
to
interpret
EPA's
methodology
for
applying
its
EQC
Model
Output
for
Toxics
Release
Inventory
PBT
Rule
Chemicals,
and
it
therefore
is
not
clear
how
EPA
arrived
at
the
conclusion
that
TBBPA
is
persistent.
EPA
disagrees
that
it
is
unclear
how
the
EQC
model
was
used
in
the
assessment
of
chemical
persistence
and
that
EPA
used
only
default
data.
EPA
provided
discussion
on
the
conduct
of
the
multimedia
modeling
in
the
document
titled
EQC
Model
Output
for
Toxics
Release
Inventory
PBT
Rule
Chemicals
(Ref.
33).
EPA
used
chemicalspecific
input
data
(i.
e.,
half­
lifes
in
air,
soil,
water,
and
sediment
and
chemical
properties)
where
available
in
all
multimedia
modeling
runs.
No
default
data
were
used
in
lieu
of
chemicalspecific
inputs.
All
chemical­
specific
inputs
for
each
chemical
were
listed
in
this
document.
Further,
EPA
explained
its
use
of
the
modified
EQC
model
not
only
in
the
support
document
identified
earlier,
but
also
in
the
preamble
to
the
proposed
rule.
In
its
description
of
the
modeling
EPA
stated:

Multimedia
mass
balance
models
offer
the
most
convenient
means
to
estimate
overall
environmental
persistence
from
information
on
sources
and
loadings,
chemical
properties
and
transformation
processes,
and
intermedia
partitioning.
For
the
chemicals
included
in
this
proposed
rule
EPA
used
the
[modified]
EQC
model.
.
.to
estimate
overall
environmental
persistence.
Overall
persistence
estimated
in
this
way
is
used
as
an
additional
factor,
in
conjunction
with
reaction
half­
lifes
for
individual
media,
bioaccumulation/
bioconcentration
factors,
etc.,
in
justifying
actions
proposed
in
this
rule.

The
EQC
model
is
based
on
the
fugacity
approach
first
delineated
by
Mackay
(Ref.
31)
and
subsequently
applied
to
numerous
environmental
processes
(Ref.
32).
It
uses
an
``
evaluative
environment''
in
which
environmental
parameters
such
as
bulk
compartment
dimensions
and
volumes
(e.
g.,
total
area,
volume
of
soil
and
sediment)
are
standardized,
so
that
overall
persistence
for
chemicals
with
different
properties
and
rates
of
transformation
may
be
compared
on
an
equal
basis
(Ref.
15).
EPA
used
a
version
of
the
EQC
level
III
model
(Ref.
33)
which
was
modified
to
focus
on
net
losses
by
deleting
model
terms
for
advective
losses
(movement
out
of
the
evaluative
environment
of
air
and
water
potentially
containing
a
chemical)
and
sediment
burial
(Ref.
82).
In
this
version
of
the
model
only
irreversible
transformation
contributes
to
net
loss
of
a
chemical.
The
overall
persistence
obtained
from
this
model
is
calculated
as
the
total
amount
in
the
evaluative
environment
when
steady
state
is
achieved,
divided
by
the
total
loss
rate.
The
results
thus
obtained
are
neither
an
overall
environmental
half­
life
nor
a
compartment
(or
transformation)
specific
half­
life;
rather
they
are
equivalent
to
an
environmental
residence
time.
When
only
irreversible
transformation
contributes
to
net
loss­

i.
e.,
under
the
conditions
of
this
version
of
the
EQC
model­­
overall
environmental
persistence
times
can
be
converted
to
half­
lifes
by
multiplying
the
former
by
ln
2
(i.
e.,
0.693).
The
overall
half­
life
calculated
in
this
way
is
for
dissipation
in
the
environment
as
a
whole
and
cannot
be
related
directly
to
any
individual
compartment.
In
the
analysis
EPA
used
the
highest,
lowest
and
mean
values
for
the
ranges
of
half­
lifes
for
soil,
air,
and
water
as
inputs
to
the
model.
These
half­
lifes
were
collected
from
the
literature
from
scientifically
sound
studies
and
were
subject
to
data
quality
standards.
The
overall
environmental
persistence
halflife
for
TBBPA
calculated
based
on
the
EQC
model
was
greater
than
2
months
but
less
than
6
months
using
the
longest
half­
lifes
for
air,
soil,
water,
and
sediment.
These
results
support
EPA's
assertion
that
the
persistence
of
TBBPA
in
the
environment
will
meet
the
EPCRA
section
313
persistence
criteria.
The
commenter
believes
that
TBBPA
does
not
meet
the
persistence
criteria
for
air.
To
support
this
contention
the
commenter
refers
to
a
study
cited
in
a
World
Health
Organization
(WHO)
document
(Ref.
83).
Specifically
the
commenter
cites
photodegradation
studies
that
demonstrated
that
the
halflife
of
TBBPA
absorbed
onto
silica
gel
exposed
to
ultraviolet
(UV)
radiation
was
0.12
day
in
air.
In
addition,
the
commenter
contends
that
studies
of
the
photolysis
of
TBBPA
in
the
presence
of
UV
light
and
hydroxyl
radicals
show
that
TBBPA
was
totally
degraded
within
5
to
6
days
with
an
estimated
33±
hour
half­
life.
The
commenter
did
not
provide
these
studies
or
provide
references
to
the
original
studies.
Further,
the
same
commenter
cites
WHO
EHC
172
(Ref.
83)
for
data
on
photodegradation
to
support
the
claim
that
TBBPA
does
not
meet
the
persistence
criteria
for
air.
A
review
of
the
citation
provided
by
the
commenter
reveals
that
it
is
a
secondary
reference
taken
from
unpublished
data
from
Bayer
(Ref.
10).
EPA
was
unable
to
review
the
full
unpublished
study
to
determine
the
quality
of
the
data,
only
the
summary
found
in
the
WHO
document
was
available.
In
the
WHO
summary
of
the
Bayer
study
TBBPA
adsorbed
onto
silica
gel
and
was
exposed
to
ultraviolet
irradiation
at
the
254
nanometer
(nm)
wavelength.
Eight
metabolites
were
detected
and
a
half­
life
value
of
0.12
days
obtained.
WHO
noted
that
``[
i]
t
is
difficult
to
derive
environmental
conclusions
from
the
results
of
these
experiments.
''
EPA
believes
that
the
environmental
relevance
of
the
test
results
is
doubtful.
58723
Federal
Register
/
Vol.
64,
No.
209
/
Friday,
October
29,
1999
/
Rules
and
Regulations
While
the
experiment
may
demonstrate
the
potential
for
TBBPA
to
undergo
photodegradation
under
laboratory
conditions,
the
experimental
conditions,
to
the
extent
they
could
be
determined
from
the
short
summary
provided,
were
not
environmentally
relevant.
In
order
for
a
molecule
to
undergo
photochemical
change
it
must
absorb
light.
It
is
well
known
that
only
the
transitions
corresponding
to
ultraviolet/
visible
light
absorption
are
inherently
energetic
enough
to
lead
to
chemical
reactions.
The
wavelengths
of
importance
for
photochemical
transformations
is
thus
ultraviolet/
visible
light
with
a
wavelength
of
110
750
nm.
When
environmental
photochemistry
at
or
near
the
earth's
surface
is
considered,
the
wavelengths
of
light
of
importance
are
further
narrowed
because
the
stratospheric
ozone
layer
effectively
prevents
UV
irradiation
of
less
than
290
nm
from
reaching
the
earth's
surface.
Thus,
only
the
light
of
the
290­
750
nm
wavelength
absorbed
by
a
molecule
can
potentially
lead
to
photochemical
changes
of
that
molecule
in
the
environment
near
the
earth's
surface.
EPA
believes
that
because
the
subject
study
utilized
UV
irradiation
at
the
254
nm
wavelength,
a
wavelength
that
does
not
reach
the
earth's
surface
due
to
mitigation
by
stratospheric
ozone,
the
half­
life
derived
is
not
relevant
and,
therefore,
cannot
be
used
to
determine
the
persistence
of
TBBPA
in
air.
The
commenter
also
refers
to
studies
of
the
photolysis
of
TBBPA
in
the
presence
of
UV
light
and
hydroxyl
radicals
in
which
TBBPA
was
shown
to
totally
degrade
within
5
to
6
days
with
an
estimated
33±
hour
half­
life.
No
additional
information
or
references
were
provided
to
enable
EPA
to
evaluate
these
findings
for
use
in
the
characterization
of
the
atmospheric
halflife
TBBPA.
The
commenter
contends
that
TBBPA's
molecular
structure
makes
it
inherently
biodegradable.
The
hydroxyl
moiety
on
the
TBBPA
molecule
can
be
readily
transformed
by
organisms
in
the
environment.
The
parent
TBBPA
molecule
is
no
longer
present
once
this
biotransformation
takes
place.
Therefore,
based
on
TBBPA's
structure
alone,
the
Agency
should
consider
TBBPA
as
unlikely
to
be
environmentally
persistent.
EPA
disagrees
with
the
statement
that
based
on
structure
alone,
the
Agency
should
consider
TBBPA
as
unlikely
to
be
environmentally
persistent.
While
EPA
generally
believes
that
measured
values
from
well
conducted
studies
are
preferable
to
structure
activity
relationships
(SAR)
as
an
indicator
of
persistence,
the
Agency
believes
that
it
is
possible
to
make
some
general
statements
about
the
biodegradability
of
TBBPA
based
on
its
structure.
Current
knowledge
of
structure
biodegradability
relationships
suggests
that
the
presence
of
multiple
bromines
on
an
aromatic
molecule
adversely
effects
biodegradation.
In
fact,
when
the
biodegradability
of
TBBPA
is
assessed
with
EPA
structure
activity
relationship
tools
for
predicting
biodegradation
from
structure
(Refs.
46
and
47),
the
presence
of
multiple
aromatic
bromines,
a
carbon
with
four
single
bonds,
and
the
molecular
weight
of
TBBPA
are
all
structural
features
that
reduce
biodegradability.
Therefore,
even
if
EPA
were
to
base
its
assessment
of
the
persistence
of
TBBPA
on
its
molecular
structure,
the
Agency
would
conclude
that
it
is
not
readily
biodegradable.
The
commenter
contends
that
TBBPA
will
not
meet
the
persistence
criteria
for
water,
soil,
and
sediment
because
TBBPA
will
biodegrade
in
these
media.
The
commenter
cites
the
results
of
several
biodegradation
studies
as
demonstrating
that
TBBPA
is
not
persistent
in
these
media.
The
commenter
states
that
even
though
degradation
studies
have
shown
that
TBBPA
is
not
``
readily
biodegradable''
(i.
e.,
TBBPA
is
not
mineralized
to
a
significant
extent
by
sewage
sludge
within
28
days)
there
are
studies
that
indicate
it
is
not
persistent.
Specifically,
in
studies
submitted
to
EPA
in
1989,
TBBPA
has
been
shown
to
be
subject
to
biodegradation
both
in
soil
and
sediment
under
aerobic
or
anaerobic
conditions;
TBBPA's
estimated
half­
life
derived
from
these
studies
is
50
days.
In
studies
submitted
by
the
Brominated
Flame
Retardants
Industry
Panel
to
EPA,
TBBPA
also
was
shown
to
undergo
degradation
in
a
sediment/
water
system
with
an
estimated
half­
life
of
48
to
84
days.
(These
data
were
reported
under
the
Agency's
TSCA
Section
4
test
rule.)
The
commenter
argues
that
these
data
demonstrate
that
TBBPA
does
not
meet
most
widely
(and
internationally)
accepted
criteria
for
persistence
in
soil
or
sediments
(See
Unit
VI.
B.)
Therefore,
TBBPA
should
not
be
considered
to
be
persistent
for
purposes
of
EPCRA
Section
313.
The
commenter
cites
additional
research
conducted
on
the
biodegradation
of
TBBPA
under
aerobic
and
anaerobic
conditions
in
soil
(Refs.
47)
and
asserts
that
the
data
indicate
that
``
TBBPA
does
not
meet
the
most
widely
and
internationally
accepted
criteria.
''
EPA
discusses
its
assessment
of
the
Springborn
soil
biodegradation
studies
elsewhere
in
the
Response
to
Comments
document
(Ref.
69).
As
explained
earlier,
the
international
persistence
criteria
are
not
relevant
to
the
classification
of
persistence
under
the
criteria
adopted
by
the
Agency,
and
EPA
disagrees
that
TBBPA
should
not
be
considered
persistent
because
it
does
not
meet
the
``
most
widely
(and
internationally)
accepted''
criteria.
(See
Unit
VI.
B.)
The
commenter
makes
the
argument
that
TBBPA
has
been
shown
to
be
subject
to
biodegradation
in
soil
and
sediment
under
aerobic
and
anaerobic
conditions
with
``
estimated''
half­
lifes
of
50
days.
Although
the
commenter
derived
a
biodegradation
half­
life,
the
method
used
to
do
so
and
the
validity
of
the
value
could
not
be
determined
because
no
supporting
information
was
provided.
EPA
questions
the
validity
of
the
50±
day
half­
lifes
estimated
by
the
commenter
on
those
grounds.
The
commenter
refers
to
two
soil
grab
sample
studies
and
a
sediment/
water
microbial
system
study.
These
studies
investigated
the
biodegradation
of
TBBPA
in
three
different
soil
types
in
the
presence
(aerobic)
and
absence
(anaerobic)
of
oxygen,
and
the
biodegradation
of
TBBPA
in
a
system
containing
sediment
and
river
water
in
the
presence
of
oxygen.
In
the
aerobic
soil
studies
less
than
6%
ultimate
biodegradation
(complete
biodegradation
to
CO2)
was
observed
over
the
64±
day
test
period.
The
major
portion
of
TBBPA
remained
in
the
soil.
Analysis
showed
after
64
days
74
to
82%
TBBPA
remained
in
a
Massachusetts
sandy
loam
soil,
36
to
40%
remained
in
an
Arkansas
silt
loam,
and
41
to
43%
remained
in
a
California
clay
loam
soil.
Over
the
course
of
the
experiments,
TBBPA
either
remained
in
soil
undegraded,
underwent
minor
structural
changes
(primary
biodegradation),
or
to
a
very
small
extent
(<
6%),
underwent
complete
biodegradation
to
CO2.
Individual
values
for
evolved
CO2
in
each
soil
type
over
time
were
not
reported
and
biodegradation
half­
life
values
were
not
calculated.
If
it
is
assumed
in
the
absence
of
values
for
CO2
evolution
at
sampling
times
spaced
evenly
over
the
test
period
reported
data,
that
TBBPA
underwent
a
steady
rate
of
degradation
over
the
duration
of
the
experiments,
approximate
half­
lifes
of
44
to
179
days
can
be
estimated
(Ref.
7).
Biodegradation
half­
lifes
from
the
aerobic
soil
biodegradation
experiments
can
be
approximated.
The
half­
life
is
defined
as
the
amount
of
time
necessary
for
the
destruction
of
half
of
the
chemical
present
in
the
medium.
Given
that
the
duration
of
the
soil
biodegradation
test
is
64
days
(equivalent
to
greater
than
2
months),
a
58724
Federal
Register
/
Vol.
64,
No.
209
/
Friday,
October
29,
1999
/
Rules
and
Regulations
chemical
that
undergoes
less
than
50%
biodegradation
by
the
end
of
the
test
period
would
have
a
half­
life
of
greater
than
2
months
and
meet
the
EPCRA
313
persistence
criteria
for
soil.
In
one
of
the
soils
in
which
TBBPA
was
tested
(a
Massachusetts
sandy
loam
soil)
74
to
82%
of
the
original
TBBPA
applied
remained
in
the
soil
unchanged
at
the
end
of
the
64±
day
test
period.
Thus,
in
this
study,
TBBPA
was
shown
to
have
a
half­
life
in
soil
of
greater
than
2
months
since
less
than
50%
degradation
of
TBBPA
occurred
in
64
days.
The
biodegradation
of
TBBPA
in
the
same
three
soils
as
above
under
anaerobic
conditions
in
a
64±
day
test
has
also
been
studied.
The
results
showed
that
44
to
57%
of
the
TBBPA
applied
to
soil
remained
undegraded
in
the
Massachusetts
sandy
loam
soil
after
a
64±
day
test
period,
53±
65%
in
an
Arkansas
silt
loam
soil,
and
90%
in
a
California
clay
loam
soil.
Less
than
50%
destruction
of
the
test
chemical
occurred
over
a
64±
day
(>
2
month)
test
period
in
all
soils
tested.
Thus,
in
this
study,
TBBPA
was
shown
to
have
a
halflife
in
soil
of
greater
than
2
months
since
less
than
50%
degradation
of
TBBPA
occurred
in
64
days.
Aerobic
sediment
water
microbial
test
systems
containing
natural
sediments
and
river
water
were
used
to
measure
degradation
half­
lifes
for
TBBPA
in
56±
day
experiments.
Half­
lifes
calculated
for
the
biodegradation
of
TBBPA
ranged
from
48
to
84
days.
Researchers
found
an
apparent
correlation
between
halflifes
and
TBBPA
concentration,
and
half­
lifes
and
microbial
concentrations.
Thus,
in
this
study,
TBBPA
was
shown
to
have
a
half­
life
in
sediment
water
systems
of
greater
than
2
months
when
either
the
larger
value
or
the
mean
of
the
two
values
is
considered.
Further,
the
commenter
claims
that
abiotic
degradation
of
TBBPA
in
water
also
is
expected.
The
calculated
half­
life
of
decomposition
of
TBBPA
by
UV
radiation
in
water
was
10.2
days
in
spring,
6.6
in
summer,
25.9
in
autumn,
and
80.7
days
in
winter.
Therefore,
TBBPA
is
not
expected
to
be
persistent
in
water.
No
other
information
was
provided.
The
commenter
cites
WHO
EHC
172
(Ref.
83)
for
data
on
photodegradation
to
support
the
claim
that
TBBPA
does
not
meet
the
persistence
criteria
for
water.
In
its
review
of
the
literature
to
evaluate
the
persistence
of
TBBPA,
EPA
found
no
information
on
its
photodegradation
in
water.
A
review
of
the
citation
provided
by
the
commenter
reveals
that
it
is
a
secondary
reference
taken
from
an
unpublished
study
from
Bayer
(Ref.
10).
EPA
was
unable
to
review
the
full
unpublished
study
to
determine
the
quality
of
the
data.
Only
the
summary
found
in
the
WHO
document
was
available.
The
Bayer
study
on
photodegradation
in
water
yielded
calculated
half­
lifes
ranging
from
6.6
days
to
80.7
days
with
the
longest
halflife
calculated
during
the
winter,
when
solar
irradiation
is
least
intense
and
the
shortest
half­
life
occurring
in
the
summer,
when
the
solar
irradiation
is
most
intense.
The
commenter
did
not
include
the
fact
that
the
effect
of
cloud
cover
lengthened
the
calculated
half­
life
by
a
factor
of
2.
Water
depth
was
also
found
to
influence
the
direct
photodegradation
of
TBBPA.
At
the
surface
of
a
water
body,
solar
irradiation
is
fairly
uniform;
however,
as
depth
increases,
both
the
water
itself
and
materials
in
it
can
attenuate
the
transmission
of
solar
energy
through
the
water
column.
Irradiance
has
been
shown
to
decrease
by
greater
than
90%
for
both
ultraviolet
and
visible
light
at
a
depth
of
5
meters
in
a
eutrophic
lake
(Ref.
52).
EPA
disagrees
with
the
commenter's
conclusion
that
TBBPA
photodegradation
in
water
will
be
sufficiently
rapid
that
it
will
not
meet
the
persistence
criteria.
Based
on
the
study
cited
by
the
commenter
which
includes
an
80±
day
(
>
2
month)
halflife
for
photodegradation
of
TBBPA
in
winter,
and
the
mitigating
effects
of
water
depth
and
cloud
cover
on
rates
of
photodegradation,
EPA
believes
that
a
half­
life
of
greater
than
2
months
in
water
is
supported.
EPA,
therefore
asserts
that
based
on
these
findings,
TBBPA
meets
the
EPCRA
section
313
persistence
criteria
of
greater
than
2
months
in
soil
and
water.
2.
BioaccumulationÐ
a.
Dioxin
and
dioxin­
like
compounds.
In
the
proposal,
EPA
preliminarily
determined
that
dioxin
and
dioxin­
like
compounds
have
BCF
values
that
range
from
1,259±
42,500
with
6
chemicals
over
5,000
and
6
chemicals
between
3,500
and
5,000.
EPA
has
reviewed
information
and
all
comments
received
on
dioxin
and
dioxin­
like
compounds'
bioaccumulation
characteristics.
As
indicated
in
Table
3,
EPA
finds
that
dioxin
and
dioxin­
like
compounds
bioaccumulate
in
the
environment
with
BAF/
BCF
values
greater
than
1,000
and
therefore
meet
the
bioaccumulation
criterion
established
in
this
rulemaking.
A
complete
discussion
of
EPA's
findings
on
this
chemical
category
can
be
found
in
EPA's
Response
to
Comments
document
for
this
rulemaking
(Ref.
69)
and/
or
in
EPA's
support
documents
for
this
rulemaking
(Ref.
71).
In
addition,
most
of
the
members
of
the
dioxin
and
dioxin­
like
compounds
category
bioaccumulate
in
the
environment
with
a
value
close
to,
or
well
above,
5,000,
which
supports
EPA's
decision
to
lower
the
threshold
to
0.1
gram.
b.
Aldrin.
In
the
proposal,
EPA
preliminarily
determined
that
aldrin
has
a
BCF
value
of
3,715.
EPA
has
reviewed
information
and
all
comments
received
on
aldrin's
bioaccumulation
characteristics.
Taking
into
account
this
information,
as
indicated
in
Table
3,
EPA
finds
that
aldrin
bioaccumulates
in
the
environment
with
a
BAF/
BCF
value
greater
than
1,000
and
therefore
meets
the
bioaccumulation
criterion
established
in
this
rulemaking.
A
complete
discussion
of
EPA's
findings
on
this
chemical
can
be
found
in
EPA's
Response
to
Comments
document
for
this
rulemaking
(Ref.
69)
and/
or
in
EPA's
support
documents
for
this
rulemaking
(Ref.
71).
c.
Chlordane.
In
the
proposal,
EPA
preliminarily
determined
that
chlordane
has
a
BCF
value
of
11,050.
EPA
has
reviewed
information
and
all
comments
received
on
chlordane's
bioaccumulation
characteristics.
Taking
into
account
this
information,
as
indicated
in
Table
3,
EPA
finds
that
chlordane
bioaccumulates
in
the
environment
with
a
BAF/
BCF
value
greater
than
1,000
and
therefore
meets
the
bioaccumulation
criterion
established
in
this
rulemaking.
A
complete
discussion
of
EPA's
findings
on
this
chemical
can
be
found
in
EPA's
Response
to
Comments
document
for
this
rulemaking
(Ref.
69)
and/
or
in
EPA's
support
documents
for
this
rulemaking
(Ref.
71).
In
addition,
chlordane
bioaccumulates
in
the
environment
with
a
BCF
value
greater
than
5,000
which
supports
EPA's
decision
to
lower
the
threshold
to
10
pounds.
d.
Heptachlor.
In
the
proposal,
EPA
preliminarily
determined
that
heptachlor
has
a
BCF
value
of
19,953.
EPA
has
reviewed
information
and
all
comments
received
on
heptachlor's
bioaccumulation
characteristics.
Taking
into
account
this
information,
as
indicated
in
Table
3,
EPA
finds
that
heptachlor
bioaccumulates
in
the
environment
with
a
BAF/
BCF
value
greater
than
1,000
and
therefore
meets
the
bioaccumulation
criterion
established
in
this
rulemaking.
A
complete
discussion
of
EPA's
findings
on
this
chemical
can
be
found
in
EPA's
Response
to
Comments
document
for
this
rulemaking
(Ref.
69)
and
in
EPA's
support
documents
for
this
rulemaking
(Ref.
71).
In
addition,
heptachlor
bioaccumulates
in
the
environment
with
a
BAF/
BCF
value
greater
than
5,000
which
supports
EPA's
decision
to
lower
the
threshold
to
10
pounds.
58725
Federal
Register
/
Vol.
64,
No.
209
/
Friday,
October
29,
1999
/
Rules
and
Regulations
e.
Isodrin.
In
the
proposal,
EPA
preliminarily
determined
that
isodrin
has
a
BCF
value
of
20,180.
EPA
has
reviewed
information
and
all
comments
received
on
isodrin's
bioaccumulation
characteristics.
Taking
into
account
this
information,
as
indicated
in
Table
3,
EPA
finds
that
isodrin
bioaccumulates
in
the
environment
with
a
BAF/
BCF
value
greater
than1,000
and
therefore
meets
the
bioaccumulation
criterion
established
in
this
rulemaking.
A
complete
discussion
of
EPA's
findings
on
this
chemical
can
be
found
in
EPA's
Response
to
Comments
document
for
this
rulemaking
(Ref.
69)
and/
or
in
EPA's
support
documents
for
this
rulemaking
(Ref.
71).
In
addition,
isodrin
bioaccumulates
in
the
environment
with
a
BAF/
BCF
value
greater
than
5,000
which
supports
EPA's
decision
to
lower
the
threshold
to
10
pounds.
f.
Methoxychlor.
In
the
proposal,
EPA
preliminarily
determined
that
methoxychlor
has
a
BCF
value
of
8,128.
EPA
has
reviewed
information
and
all
comments
received
on
methoxychlor's
bioaccumulation
characteristics.
Taking
into
account
this
information,
as
indicated
in
Table
3,
EPA
finds
that
methoxychlor
bioaccumulates
in
the
environment
with
a
BAF/
BCF
value
greater
than
1,000
and
therefore
meets
the
bioaccumulation
criterion
established
in
this
rulemaking.
A
complete
discussion
of
EPA's
findings
on
this
chemical
can
be
found
in
EPA's
Response
to
Comments
document
for
this
rulemaking
(Ref.
69)
and/
or
in
EPA's
support
documents
for
this
rulemaking
(Ref.
71).
g.
Pendimethalin.
In
the
proposal,
EPA
preliminarily
determined
that
pendimethalin
has
a
BCF
value
of
1,944.
EPA
has
reviewed
information
and
all
comments
received
on
pendimethalin's
bioaccumulation
characteristics.
Taking
into
account
this
information,
as
indicated
in
Table
3,
EPA
finds
that
pendimethalin
bioaccumulates
in
the
environment
with
a
BAF/
BCF
value
greater
than
1,000
and
therefore
meets
the
bioaccumulation
criterion
established
in
this
rulemaking.
A
complete
discussion
of
EPA's
findings
on
this
chemical
can
be
found
in
EPA's
Response
to
Comments
document
for
this
rulemaking
(Ref.
69)
and/
or
in
EPA's
support
documents
for
this
rulemaking
(Ref.
71).
h.
Toxaphene.
In
the
proposal,
EPA
preliminarily
determined
that
toxaphene
has
a
BCF
value
of
34,050.
EPA
has
reviewed
information
and
all
comments
received
on
toxaphene's
bioaccumulation
characteristics.
Taking
into
account
this
information,
as
indicated
in
Table
3,
EPA
finds
that
toxaphene
bioaccumulates
in
the
environment
with
a
BAF/
BCF
value
greater
than
1,000
and
therefore
meets
the
bioaccumulation
criterion
established
in
this
rulemaking.
A
complete
discussion
of
EPA's
findings
on
this
chemical
can
be
found
in
EPA's
Response
to
Comments
document
for
this
rulemaking
(Ref.
69)
and/
or
in
EPA's
support
documents
for
this
rulemaking
(Ref.
71).
In
addition,
toxaphene
bioaccumulates
in
the
environment
with
a
BAF/
BCF
value
greater
than
5,000
which
supports
EPA's
decision
to
lower
the
threshold
to
10
pounds.
i.
Trifluralin.
In
the
proposal,
EPA
preliminarily
determined
that
trifluralin
has
a
BCF
value
of
5,674.
EPA
has
reviewed
information
and
all
comments
received
on
trifluralin's
bioaccumulation
characteristics.
Taking
into
account
this
information,
as
indicated
in
Table
3,
EPA
finds
that
trifluralin
bioaccumulates
in
the
environment
with
a
BAF/
BCF
value
greater
than
1,000
and
therefore
meets
the
bioaccumulation
criterion.
A
complete
discussion
of
EPA's
findings
on
this
chemical
can
be
found
in
EPA's
Response
to
Comments
document
for
this
rulemaking
(Ref.
69)
and/
or
in
EPA's
support
documents
for
this
rulemaking
(Ref.
71).
j.
Polycyclic
aromatic
compounds.
In
the
proposal,
EPA
preliminarily
determined
that
PACs
have
BCF
values
that
ranged
from
800
to
31,440
with
16
of
the
21
members
of
the
category
having
BCF
values
greater
than
5,000.
EPA
received
several
comments
concerning
the
PACs
category
listing
and
the
bioaccumulation
data
which
are
addressed
below.
EPA
has
reviewed
information
and
all
comments
received
on
PACs'
bioaccumulation
characteristics.
Taking
into
account
this
information,
as
indicated
in
Table
3,
EPA
finds
that
PACs
bioaccumulate
in
the
environment
with
BAF/
BCF
values
greater
than
1,000
and
therefore
meet
the
bioaccumulation
criterion
established
in
this
rulemaking.
A
complete
discussion
of
EPA's
findings
on
this
chemical
category
can
be
found
in
EPA's
Response
to
Comments
document
for
this
rulemaking
(Ref.
69)
and/
or
in
EPA's
support
documents
for
this
rulemaking
(Ref.
71).
Three
of
the
commenters
support
the
retention
of
a
single
PACs
category
while
one
commenter
believes
that
splitting
the
category
into
two
categories
would
be
the
most
appropriate
option.
Additional
specific
comments
were
as
follows.
One
commenter
stated
that
PACs
are
typically
found
as
mixtures
in
incoming
natural
organic
raw
materials,
such
as
coal
and
that
it
would
be
difficult
to
separate
information
into
two
reporting
categories.
Another
commenter
stated
that
reporting
as
one
category
is
also
more
consistent
with
the
Great
Lakes
Binational
Toxics
Strategy
Level
2
listing
for
these
chemicals.
A
commenter
stated
that
the
alternate
proposal
to
create
two
PAC
categories
would
be
unnecessarily
burdensome
for
the
regulated
community
since
reporting
facilities
would
be
required
to
speciate
their
PAC
releases,
and,
if
chemicals
from
both
categories
exceeded
reporting
thresholds,
file
two
Form
R
reports,
instead
of
one.
One
commenter
stated
that
use
of
a
single
PACs
category
will
simplify
the
reporting
requirements;
thus,
it
will
reduce
reporting
burden.
Several
commenters
stated
that
according
to
the
proposed
rule,
16
of
the
21
members
of
the
category
had
BCF
values
greater
than
5,000
and
that
one
proposal
would
regard
the
entire
PACs
category
to
be
highly
persistent
and
bioaccumulative,
regardless
of
each
individual
PAC's
actual
persistence
and
bioaccumulative
properties.
Several
commenters
stated
that
they
believed
that
splitting
the
category
into
two
categories
would
be
the
most
appropriate
course.
Another
commenter
stated
that
no
chemical
should
be
added
to
the
highly
persistent/
bioaccumulative
category
when
it
does
not
fit
the
criteria
and
that
in
order
to
gain
the
most
accurate
information,
two
separate
categories
would
be
the
superior
solution.
The
commenter
stated
that
lowering
the
reporting
threshold
for
the
PACs
category
to
10
pounds
is
unjustified
considering
that,
according
to
EPA
data,
many
of
the
individual
PACs
within
the
category
do
not
meet
the
PBT
criteria.
EPA
considered
splitting
the
PACs
category
into
two
or
three
categories
or
listings,
but
EPA
believes,
as
do
most
of
the
commenters,
that
the
most
appropriate
option
is
to
retain
a
single
PACs
category.
The
PACs
category
was
created
because
the
members
of
the
category
are
chemically
and
structurally
very
similar,
share
the
same
toxicological
effect
(carcinogenicity),
and
typically
are
produced,
released,
and
otherwise
managed
as
waste
as
complex
mixtures
rather
than
individual
chemicals.
As
such
it
would
be
more
difficult
to
estimate
releases
if
the
category
were
split
into
two
or
three
categories
based
on
the
currently
available
bioaccumulation
data.
These
reasons
support
retaining
a
single
PACs
category.
EPA
agrees
with
those
commenters
that
stated
that
the
retention
of
a
single
PACs
category
would
be
the
simpler
and
less
burdensome
option.
EPA
also
58726
Federal
Register
/
Vol.
64,
No.
209
/
Friday,
October
29,
1999
/
Rules
and
Regulations
recognizes
that,
based
on
currently
available
information,
not
all
members
of
the
PACs
category
meet
the
highly
persistence
and
highly
bioaccumulative
criteria.
Of
the
21
chemicals
in
the
PACs
category
proposed
for
a
lower
threshold,
5
have
BCF
values
that
nominally
do
not
meet
the
highly
bioaccumulative
criteria,
while
the
rest
exceed
the
highly
bioaccumulative
criteria.
Given
the
structural
similarities
of
the
members
of
this
category
and
the
higher
bioaccumulation
values
for
16
of
the
21
PACs,
the
5
BCF
values
below
5,000
may
underestimate,
to
some
extent,
the
bioaccumulation
potential
of
these
compounds.
For
purposes
of
this
rulemaking,
EPA
is
classifying
the
PACs
category
as
persistent
and
bioaccumulative
rather
than
highly
persistent
and
highly
bioaccumulative.
Thus,
the
PACs
category
will
have
a
reporting
threshold
of
100
pounds.
However,
the
Agency
will
continue
to
assess
the
bioaccumulation
potential
of
this
category
and
specifically
whether
the
lower
bioaccumulation
values
for
5
members
of
the
category
are
appropriate.
k.
Benzo(
g,
h,
i)
perylene.
In
the
proposal,
EPA
preliminarily
determined
that
benzo(
g,
h,
i)
perylene
has
a
BCF
value
of
25,420.
EPA
has
reviewed
information
and
all
comments
received
on
benzo(
g,
h,
i)
perylene's
bioaccumulation
characteristics.
Taking
into
account
this
information,
as
indicated
in
Table
3,
EPA
finds
that
benzo(
g,
h,
i)
perylene
bioaccumulates
in
the
environment
with
a
BAF/
BCF
value
greater
than
1,000
and
therefore
meets
the
bioaccumulation
criterion
established
in
this
rulemaking.
A
complete
discussion
of
EPA's
findings
on
this
chemical
can
be
found
in
EPA's
Response
to
Comments
document
for
this
rulemaking
(Ref.
69)
and/
or
in
EPA's
support
documents
for
this
rulemaking
(Ref.
71).
In
addition,
benzo(
g,
h,
i)
perylene
bioaccumulates
in
the
environment
with
a
BCF
value
greater
than
5,000
which
supports
EPA's
decision
to
lower
the
threshold
to
10
pounds.
l.
Mercury
and
mercury
compounds.
In
the
proposal,
EPA
preliminarily
determined
that
mercury
and
mercury
compounds
have
BCF
values
that
ranged
from
7,000
to
36,000.
EPA
has
reviewed
information
and
all
comments
received
on
mercury
and
mercury
compounds'
bioaccumulation
characteristics.
Taking
into
account
this
information,
as
indicated
in
Table
3,
EPA
finds
that
mercury
and
mercury
compounds
bioaccumulate
in
the
environment
with
BAF/
BCF
values
greater
than
1,000
and
therefore
meet
the
bioaccumulation
criterion
established
in
this
rulemaking.
A
complete
discussion
of
EPA's
findings
on
this
chemical
category
can
be
found
in
EPA's
Response
to
Comments
document
for
this
rulemaking
(Ref.
69)
and/
or
in
EPA's
support
documents
for
this
rulemaking
(Ref.
71).
In
addition,
mercury
and
mercury
compounds
bioaccumulate
in
the
environment
with
a
value
above
5,000,
which
supports
EPA's
decision
to
lower
the
threshold
to
10
pounds.
m.
Polychlorinated
biphenyls.
In
the
proposal,
EPA
preliminarily
determined
that
PCBs
have
BCF
values
that
ranged
from
4,922
to
196,900.
All
of
the
PCBs,
except
one,
had
BCF
values
far
exceeding
5,000.
The
one
exception,
2,3,3',
4,4',
5,5'
heptachlorobiphenyl,
had
a
BCF
value
of
4,922.
EPA
has
reviewed
information
and
all
comments
received
on
PCBs'
bioaccumulation
characteristics.
Taking
into
account
this
information,
as
indicated
in
Table
3,
EPA
finds
that
PCBs
bioaccumulate
in
the
environment
with
BAF/
BCF
values
greater
than
1,000
and
therefore
meet
the
bioaccumulation
criterion
established
in
this
rulemaking.
A
complete
discussion
of
EPA's
findings
on
this
chemical
listing
can
be
found
in
EPA's
Response
to
Comments
document
for
this
rulemaking
(Ref.
69)
and/
or
in
EPA's
support
documents
for
this
rulemaking
(Ref.
71).
In
addition,
with
one
exception,
all
of
the
PCBs
listed
bioaccumulate
in
the
environment
with
a
value
far
exceeding
5,000,
which
supports
EPA's
decision
to
lower
the
threshold
to
10
pounds.
n.
Hexachlorobenzene.
In
the
proposal,
EPA
preliminarily
determined
that
hexachlorobenzene
has
a
BCF
value
of
29,600
to
66,000.
EPA
has
reviewed
information
and
all
comments
received
on
hexachlorobenzene's
bioaccumulation
characteristics.
Taking
into
account
this
information,
as
indicated
in
Table
3,
EPA
finds
that
hexachlorobenzene
bioaccumulates
in
the
environment
with
a
BAF/
BCF
value
greater
than
1,000
and
therefore
meets
the
bioaccumulation
criterion
established
in
this
rulemaking.
A
complete
discussion
of
EPA's
findings
on
this
chemical
can
be
found
in
EPA's
Response
to
Comments
document
for
this
rulemaking
(Ref.
69)
and/
or
in
EPA's
support
documents
for
this
rulemaking
(Ref.
71).
In
addition,
hexachlorobenzene
bioaccumulates
in
the
environment
with
a
BAF/
BCF
value
greater
than
5,000
which
supports
EPA's
decision
to
lower
the
threshold
to
10
pounds.
o.
Octochlorostyrene.
In
the
proposal,
EPA
preliminarily
determined
that
OCS
has
a
BCF
value
of
33,113.
EPA
received
one
significant
comment
addressing
OCS's
bioaccumulation
potential
which
is
discussed
below.
EPA
has
reviewed
this
comment
and
information
on
OCS's
bioaccumulation
characteristics.
Taking
into
account
this
information,
as
indicated
in
Table
3,
EPA
finds
that
OCS
bioaccumulates
in
the
environment
with
a
BAF/
BCF
value
greater
than
1,000
and
therefore
meets
the
bioaccumulation
criterion
established
in
this
rulemaking.
A
complete
discussion
of
EPA's
findings
on
this
chemical
can
be
found
in
EPA's
Response
to
Comments
document
for
this
rulemaking
(Ref.
69)
and/
or
in
EPA's
support
documents
for
this
rulemaking.
(Ref.
71).
In
addition,
OCS
bioaccumulates
in
the
environment
with
a
BAF/
BCF
value
greater
than
5,000
which
supports
EPA's
decision
to
lower
the
threshold
to
10
pounds.
One
commenter
argued
that
OCS
should
not
be
included
in
the
EPCRA
section
313
PBT
chemicals
list.
The
commenter
contends
that
OCS
was
included
as
a
PBT
chemical
simply
because
it
appears
on
several
lists
of
persistent
and
bioaccumulative
chemicals
and
not
based
on
a
thorough
evaluation
of
its
bioaccumulation.
The
commenter
states
that
OCS
has
the
potential
to
bioaccumulate,
but
nonetheless,
OCS
levels
in
fish
and
aquatic
species
in
the
Great
Lakes
continue
to
decline.
The
commenter
provides
a
report
on
the
Great
Lakes
region
and
argues
that
OCS
should
not
be
considered
a
PBT
chemical
since
environmental
concentration
data
show
OCS
levels
in
the
environment
are
decreasing
at
a
rate
of
8%
to
30%
per
year.
EPA
disagrees
with
the
commenter's
conclusions.
The
commenter
does
not
dispute
the
bioaccumulation
values
EPA
presented
in
the
proposed
rule.
Rather
the
commenter
agrees
that
OCS
has
the
potential
to
bioaccumulate
but
contends
that
since
environmental
concentrations
are
declining
in
the
Great
Lakes
region
OCS
should
not
be
considered
a
PBT
chemical.
The
fact
that
OCS
levels
in
the
Great
Lakes
region
may
be
declining
is
not
a
basis
for
concluding
that
OCS
is
not
a
PBT
chemical
or
that
it
cannot
bioaccumulate.
There
are
a
number
of
reasons
that
could
explain
a
decrease
in
environmental
concentrations
of
OCS
but
they
do
not
change
the
fact
that
OCS
has
been
shown
to
be
highly
bioaccumulative.
OCS
was
included
as
a
PBT
chemical
because
it
meets
the
EPCRA
section
313
criterion
for
bioaccumulation
laid
out
in
the
proposed
rule,
not
simply
because
it
has
appeared
on
several
other
lists
of
PBT
chemicals.
p.
Pentachlorobenzene.
In
the
proposal,
EPA
preliminarily
determined
58727
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Register
/
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64,
No.
209
/
Friday,
October
29,
1999
/
Rules
and
Regulations
that
pentachlorobenzene
has
a
BCF
value
of
8,318.
EPA
has
reviewed
information
and
all
comments
received
on
pentachlorobenzene's
bioaccumulation
characteristics.
Taking
into
account
this
information,
as
indicated
in
Table
3,
EPA
finds
that
pentachlorobenzene
bioaccumulates
in
the
environment
with
a
BAF/
BCF
value
greater
than
1,000
and
therefore
meets
the
bioaccumulation
criterion
established
in
this
rulemaking.
A
complete
discussion
of
EPA's
findings
on
this
chemical
can
be
found
in
EPA's
Response
to
Comments
document
for
this
rulemaking
(Ref.
69)
and/
or
in
EPA's
support
documents
for
this
rulemaking
(Ref.
71).
In
addition,
pentachlorobenzene
bioaccumulates
in
the
environment
with
a
BAF/
BCF
value
greater
than
5,000
which
supports
EPA's
decision
to
lower
the
threshold
to
10
pounds.
q.
Tetrabromobisphenol
A.
In
the
proposal,
EPA
preliminarily
determined
that
TBBPA
was
found
to
have
BCF
values
of
780;
1,200;
and
3,200.
EPA
received
one
significant
comment
addressing
TBBPA's
bioaccumulation
which
is
discussed
below.
EPA
has
reviewed
the
comments
and
information
on
TBBPA's
bioaccumulation
characteristics.
Taking
into
account
this
information,
as
indicated
in
Table
3,
EPA
finds
that
TBBPA
bioaccumulates
in
the
environment
with
a
BAF/
BCF
value
greater
than
1,000
and
therefore
meets
the
bioaccumulation
criterion
established
in
this
rulemaking.
A
complete
discussion
of
EPA's
findings
on
this
chemical
can
be
found
in
EPA's
Response
to
Comments
document
for
this
rulemaking
(Ref.
69)
and/
or
in
EPA's
support
documents
for
this
rulemaking
(Ref.
71).
One
commenter
contends
that
the
available
data
on
TBBPA
do
not
support
its
classification
as
a
PBT
chemical.
The
commenter
argues
that
the
oyster
BCF
value
of
780
does
not
support
the
proposed
criterion
of
1,000.
The
commenter
also
notes
that
EPA
fails
to
consider
that
TBBPA
is
not
retained
in
the
body
once
dosing
stops
in
a
BCF
test
and
that
TBBPA
is
rapidly
eliminated.
The
commenter
states
that
rapid
elimination
limits
any
potential
for
biomagnification.
The
commenter
notes
that
only
the
highest
chironomid
BCF
value
(3,200)
was
cited
by
EPA
and
not
the
fact
that
this
is
from
a
range
of
650±
3,200.
EPA
believes
that
the
available
data
do
support
classification
of
TBBPA
as
a
PBT
chemical.
Measured
BCF
values
of
780,
1,200,
and
3,200
were
obtained
from
TSCA
section
4
tests
with
oysters,
fish
and
chironomids,
respectively.
The
measured
BCF
values
of
1,200
and
3,200
for
fish
and
chironomids
respectively,
clearly
satisfy
the
EPCRA
section
313
bioaccumulatioin
criterion
of
1,000.
EPA
is
aware
that
TBBPA
will
be
eliminated
from
the
body
eventually
once
exposure
to
the
chemical
is
halted;
however,
continuous
or
intermittent
exposures
of
TBBPA
to
organisms
may
result
in
significant
tissue
residues
depending
on
the
exposure
or
release
scenarios.
The
issue
of
biomagnification
of
TBBPA
is
not
relevant
to
determining
if
TBBPA
is
a
PBT
chemical.
As
discussed
in
Unit
VI.
B.
3.,
biomagnification
is
not
required
in
order
to
have
a
concern
for
chemicals
that
bioaccumulate.
The
highest
chironomid
BCF
value
was
listed
because
it
is
considered
as
a
worst
case
indication
of
bioaccumulation
in
sediment­
dwelling
invertebrates.

I.
Exemptions
and
Other
Reporting
Requirements
1.
De
minimis
exemption.
Many
of
the
commenters
assert
that
the
initial
reasons
for
adopting
the
de
minimis
exemption
are
still
valid
and
that
this
exemption
should
be
maintained
for
PBT
chemicals.
Specifically,
several
commenters
contend
that
the
de
minimis
exemption
was
initially
adopted
to
alleviate
undue
burden
on
reporting
facilities
and
that
the
elimination
of
this
exemption
for
PBT
chemicals
will
significantly
increase
the
reporting
burden
for
this
rulemaking.
EPA
disagrees
with
the
commenters'
contention
that
the
initial
reasons
for
adopting
the
de
minimis
exemption
are
valid
for
PBT
chemicals.
As
originally
explained
in
the
1988
final
rule
implementing
the
reporting
provisions
of
EPCRA
section
313,
reiterated
in
the
1997
final
rule
adding
seven
new
industry
sectors,
and
discussed
in
the
proposal
to
this
final
rule,
EPA
promulgated
the
de
minimis
exemption
for
several
reasons,
of
which
burden
was
only
one.
In
addition
to
burden
reduction,
EPA
promulgated
the
de
minimis
exemption
because:
(1)
The
Agency
believed
that
facilities
newly
covered
by
EPCRA
section
313
would
have
limited
access
to
information
regarding
low
concentrations
of
toxic
chemicals
in
mixtures
that
are
imported,
processed,
otherwise
used
or
manufactured
as
impurities;
(2)
the
Agency
did
not
believe
that
these
low
concentrations
would
result
in
quantities
that
would
significantly
contribute
to
threshold
determinations
and
release
calculations
at
the
facility
(53
FR
4509);
and
(3)
the
exemption
was
consistent
with
information
collected
under
the
Occupational
Safety
and
Health
Administration's
(OSHA)
Hazard
Communication
Standard
(HCS).
If
EPA
had
adopted
the
exemption
only
to
reduce
burden,
the
exemption
would
have
covered
all
uses
of
de
minimis
quantities
of
the
toxic
chemical
in
mixtures.
The
exemption,
however,
includes
only
limited
uses
of
the
toxic
chemical
in
mixtures
(i.
e.,
importing,
processing,
otherwise
use,
and
manufacturing
impurities)
that
were
roughly
tailored
to
whether
EPA
expected
that
facilities
were
reasonably
likely
to
have
information
that
would
allow
them
to
determine
thresholds
and
make
release
calculations.
The
purpose
of
the
PBT
rulemaking,
however,
is
different
from
past
rulemakings
in
that
it
is
intended
to
capture
information
on
significantly
smaller
quantities
of
releases
and
other
waste
management
associated
with
these
chemicals.
Most
of
the
PBT
chemicals
addressed
in
this
rule
have
been
shown
to
cause
adverse
effects
at
concentrations
far
less
than
the
de
minimis
levels.
For
example,
dioxins
have
been
shown
to
cause
adverse
effects
at
levels
in
the
parts
per
trillion.
In
addition,
after
10
years
of
experience
with
the
program,
the
Agency
believes
there
are
many
sources
of
information
in
addition
to
material
safety
data
sheets
(MSDSs),
readily
available
to
reporters
to
use
in
making
EPCRA
section
313
determinations.
Some
of
these
sources
of
information
include
EPA
guidance
documents
(e.
g.,
EPCRA
Section
313
Industry
Guidance:
Electricity
Generating
Facilities
(EPA
745±
B±
99±
003))
and
trade
association
guidance
documents
(e.
g.,
National
Council
of
the
Paper
Industry
for
Air
and
Stream
Improvement
(NCASI)
Technical
Bulletins
and
NCASI's
Handbook
of
Chemical
Specific
Information
for
SARA
Title
III
Section
313
Form
R
Reporting).
In
addition,
relevant
information
has
become
much
more
accessible
to
covered
facilities
over
the
past
10
years.
For
example,
although
the
United
States
Geological
Survey's
U.
S.
Coal
Quality
Database
has
been
in
existence
since
the
mid
1970s,
only
more
recently
has
it
been
made
available
on
the
Internet.
(http://
energy.
er.
usgs.
gov/
products/
databases/
UScoal/
index.
htm).
Further,
the
Agency
believes
that
it
underestimated
how
much
information
covered
facilities
had
available
to
them
in
1988
regarding
small
concentrations
of
toxic
chemicals
in
mixtures.
Therefore,
given
that:
(1)
Covered
facilities
have
several
sources
of
information
available
to
them
regarding
the
concentration
of
PBT
chemicals
in
mixtures;
(2)
even
minimal
releases
of
persistent
bioaccumulative
chemicals
may
result
in
significant
adverse
effects
and
these
small
58728
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Vol.
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209
/
Friday,
October
29,
1999
/
Rules
and
Regulations
quantities
can
reasonably
be
expected
to
significantly
contribute
to
the
lower
thresholds;
and
(3)
the
concentration
levels
originally
chosen,
in
part,
to
be
consistent
with
the
OSHA
HCS
are
inappropriately
high
for
PBT
chemicals,
EPA
believes
that
the
reasons
for
the
de
minimis
exemption
that
the
Agency
held
for
previous
rulemakings
do
not
apply
to
PBT
chemicals.
A
few
commenters
assert
that
reviewing
each
MSDS,
when
a
facility
may
have
many
MSDSs
for
mixtures
used
on­
site,
to
see
if
it
includes
trace
quantities
of
PBT
chemicals
will
be
very
time
consuming.
They
contend
that
they
do
not
have
the
manpower
to
track
products
on
an
individual
basis
looking
for
trace
quantities
of
PBT
chemicals
and
that
these
activities
will
be
very
burdensome.
EPA
disagrees
that
eliminating
the
de
minimis
exemption
for
PBT
chemicals
will
greatly
increase
burden
under
EPCRA
section
313.
Covered
facilities
are
not
required
to
report
on
toxic
chemicals
in
mixtures
and
trade
name
products
for
which
they
have
no
concentration
information
or
such
information
that
is
not
reasonably
known.
However,
if
facilities
do
have
information
concerning
the
concentration
of
PBT
chemicals
in
mixtures,
such
as
on
MSDSs,
EPA
does
not
believe
it
is
more
burdensome
for
facilities
to
identify
and
evaluate
process
streams
containing
relatively
small
quantities
of
PBT
chemicals
than
for
larger
quantities
of
chemicals.
Although
some
burden
is
associated
with
the
identification
and
evaluation
of
process
streams,
EPA
disagrees
that
the
elimination
of
the
de
minimis
exemption
would
vastly
increase
the
extent
of
this
required
effort.
Covered
facilities
will
need
to
identify
and
evaluate
process
streams
when
considering
a
PBT
chemical
in
concentrations
below
the
de
minimis
level
in
the
same
manner
they
already
do
for
toxic
chemicals
found
in
process
streams
in
concentrations
above
the
de
minimis
level.
The
additional
burden
can
be
attributed
to
resources
spent
considering
and
reporting
on
information
they
currently
are
allowed
to
disregard.
Further,
as
explained
above,
EPA
adopted
the
de
minimis
exemption
for
several
reasons,
of
which
burden
reduction
was
only
one,
and
EPA
does
not
believe
that
these
original
reasons
apply
to
this
PBT
rulemaking.
Some
commenters
assert
that
it
is
unrealistic
for
EPA
to
assume
that
industry
will
report
only
on
what
they
know
without
making
an
effort
to
fill
the
data
gaps
and
that
enforcement
actions
could
arise
from
reports
based
on
only
what
is
known
to
a
facility.
EPA
disagrees,
however,
because
covered
facilities
are
expected
to
have
reasonable
knowledge
of
the
toxic
chemicals
present
at
their
site
and
need
only
document
their
considerations
concerning
threshold
determinations
and
release
and
other
waste
management
calculations.
As
stated
in
EPCRA
section
313(
g)(
2):

[i]
n
order
to
provide
the
information
required
under
this
section,
the
owner
or
operator
of
a
facility
may
use
readily
available
data
(including
monitoring
data)
collected
pursuant
to
other
provisions
of
law,
or,
where
such
data
are
not
readily
available,
reasonable
estimates
of
the
amounts
involved.
Nothing
in
this
section
requires
the
monitoring
or
measurement
of
the
quantities,
concentration,
or
frequency
of
any
toxic
chemical
released
into
the
environment
beyond
that
monitoring
and
measurement
required
under
other
provisions
of
law
or
regulation.
.
.
.
(emphasis
added)

Further,
as
stated
previously,
covered
facilities
are
not
required
to
report
on
toxic
chemicals
in
mixtures
and
trade
name
products
for
which
they
have
no
concentration
information,
or
for
which
such
information
is
not
readily
available.
Therefore,
it
is
unlikely
that
facilities
will
have
additional
enforcement
concerns.
Several
commenters
argue
that
the
need
to
be
consistent
with
the
OSHA
HCS
that
EPA
cited
in
the
1988
final
rule
continues
to
be
relevant
with
regards
to
collecting
information
on
very
small
quantities.
EPA
disagrees
that
the
need
to
be
consistent
with
OSHA
to
reduce
burden
is
sufficient
to
justify
retaining
the
de
minimis
exemption
for
PBT
chemicals.
EPA
is
not
required
to
be
consistent
with
the
OSHA
HCS.
In
1988,
EPA
chose
to
be
consistent
with
the
OSHA
HCS
as
part
of
its
rationale
for
the
exemption,
because
the
Agency
expected
facilities
to
be
familiar
with
these
levels
and
thought
that
covered
facilities
might
only
have
access
to
MSDSs
for
information
on
the
content
and
percentage
composition
of
toxic
chemicals
in
mixtures.
(See
53
FR
4509)
However,
EPA
has
never
instructed
facilities
to
stop
looking
if
information
concerning
a
toxic
chemical
is
not
on
an
MSDS.
Rather,
EPA
has
consistently
instructed
facilities
to
use
their
best
readily
available
data
in
determining
compliance
with
EPCRA
section
313.
As
EPA
explained
earlier,
given
10
years
of
experience
with
the
program,
the
Agency
believes
that
facilities
may
have
other
sources
of
information,
in
addition
to
MSDSs,
available
to
them.
Therefore,
if
a
facility
has
better
information
regarding
the
concentration
of
a
toxic
chemical
in
a
mixture,
for
example,
that
the
chemical
is
above
the
de
minimis
level,
the
facility
should
be
using
that
information
to
comply
with
EPCRA
section
313.
Further,
EPA
is
consistent
in
some
respects
because
under
the
OSHA
HCS,
if
an
employer
has
reason
to
believe
that
a
permissible
exposure
limit
for
a
component
may
be
exceeded
under
the
mixture's
normal
circumstances
of
use,
the
HCS
also
requires
employers
to
list
chemicals
that
are
below
the
1.0%
and
0.1%
thresholds.
Therefore,
OSHA
adopted
exceptions
to
the
1.0%
and
0.1%
limits
under
the
HCS.
Similarly,
PBT
chemicals
are
different
from
other
toxic
chemicals
in
that
they
may
pose
a
more
significant
concern
to
the
environment
in
much
smaller
quantities
than
other
toxic
chemicals.
Furthermore,
as
explained
in
other
responses
in
this
unit,
EPA
believes
the
remainder
of
its
rationale
for
the
de
minimis
exemption
is
not
applicable
to
PBT
chemicals.
For
example,
contrary
to
the
commenter's
statement,
the
small
concentrations
subject
to
the
de
minimis
exemption
are
not
necessarily
small
quantities
and
may
contribute
significantly
to
exceeding
the
lowered
reporting
thresholds.
Some
commenters
argue
that
the
Agency
has
not
justified
why
the
exemption
will
result
in
increased
health
risk
to
the
public
or
the
environment.
One
commenter
specifically
argues
that
given
the
extremely
low
levels
of
these
PBT
chemicals
in
coal,
the
risk
to
the
general
public
from
these
releases,
which
they
believe
is
the
original
purpose
of
the
legislation,
is
not
apparent.
Another
commenter
asserts
that
EPA
must
demonstrate
that
the
removal
of
the
exemption
for
specific
PBT
chemicals
will
have
a
public
health
or
environmental
benefit.
Yet
another
commenter
argues
that
the
concentration
of
toxic
chemicals
contained
in
mixtures
is
irrelevant
to
public
health
concerns
when
the
compounds
of
concern
remain
chemically
bound
within
benign
compounds.
EPA
strongly
disagrees
with
those
commenters
who
indicated
that
EPA
must
consider
risk
to
the
general
public
when
determining
whether
to
eliminate
the
de
minimis
exemption.
A
primary
purpose
of
the
TRI
program
is
to
provide
data
on
the
releases
(and
other
waste
management
activities)
of
listed
toxic
chemicals
to
communities
so
that
they
may
use
these
data
in
conjunction
with
toxicity
information
for
the
chemical
and
site­
specific
information
to
determine
if
releases
present
a
potential
risk.
They
can
also
use
TRI
data
in
other
ways.
For
example,
an
individual
can
use
TRI
data
as
a
factor
58729
Federal
Register
/
Vol.
64,
No.
209
/
Friday,
October
29,
1999
/
Rules
and
Regulations
in
choosing
a
neighborhood
in
which
to
live.
The
purpose
of
TRI,
however,
is
not
to
make
a
national
determination
of
risk,
nor
did
EPA
consider
risk
in
its
original
adoption
of
the
de
minimis
exemption
under
EPCRA
section
313.
Moreover,
as
previously
explained,
EPA
originally
promulgated
the
de
minimis
exemption
based
on
several
considerations
that
are
inapplicable
to
PBT
chemicals.
Where,
as
here,
the
rationale
and
factual
bases
underlying
an
exemption
no
longer
exist
with
respect
to
a
particular
class,
the
Agency
believes
it
cannot
justify
retaining
the
exemption
for
that
class.
Further,
the
Agency
has
received
no
information
from
any
commenters
that
contradicts
the
Agency's
factual
and
legal
conclusions,
or
that
would
otherwise
present
a
basis
for
retention
of
the
de
minimis
exemption.
EPA
also
disagrees
with
the
comment
that
because
there
are
very
low
levels
of
PBT
chemicals
(e.
g.,
mercury)
in
coal
that
the
risk
to
the
general
public
is
not
apparent.
EPA
believes
that
the
commenter
misunderstands
the
concept
of
risk.
Because
a
chemical
is
in
a
low
concentration
in
coal
does
not
in
itself
control
the
level
of
risk
that
can
result
when
coal
is
combusted.
For
example,
mercury
compounds
are
found
in
very
low
concentrations
in
coal.
When
coal
is
combusted,
mercury
compounds
are
either
converted
into
mercury
chloride
or
reduced
to
elemental
mercury.
Some
of
the
mercury/
mercury
chloride
is
released
to
air
and
some
remains
in
the
bottom
ash.
The
concentration
of
the
mercury/
mercury
chloride
in
the
air
wastestream
will
not
be
the
same
as
the
concentration
originally
present
in
the
coal.
Once
the
mercury/
mercury
chloride
is
released,
it
will
be
carried
varying
distances
before
it
is
deposited.
Mercury
can
be
transported
over
large
distances,
while
mercury
chloride
may
be
deposited
relatively
rapidly
by
wet
and
dry
deposition
processes.
The
amount
of
mercury
in
a
community
or
ecosystem
will
depend
upon
sources
both
local
and
distant.
Once
mercury
has
been
deposited,
it
will
bioaccumulate
in
organisms
and
will
also
persist
in
the
environment
as
a
sink
for
exposure
and
bioaccumulation.
The
amount
of
mercury
that
a
human,
animal,
or
plant
will
be
exposed
to
is
related
more
closely
to
exposure
pathways
and
the
quantity
that
is
present
in
an
ecosystem
rather
than
the
concentration
in
the
coal
that
is
combusted.
Thus,
EPA
believes
that
the
commenter
is
incorrect.
One
commenter
asserts
that
the
elimination
of
the
de
minimis
thresholds
would
not
yield
meaningful
additional
information.
The
commenter
argues
that
the
proposed
rule
vastly
overstates
the
significance
of
TRI
data
and
therefore
incorrectly
concludes
that
the
de
minimis
thresholds
would
``
deprive
communities
of
important
information
on
PBT
chemicals''
(at
64
FR
714).
Instead,
the
commenter
contends,
TRI
data
only
provide
a
snapshot
view
of
releases
from
the
chemical
industry
and
the
few
other
industry
sectors
subject
to
TRI
reporting
and
that
many
potential
release
sources
are
not
subject
to
TRI
reporting.
The
commenter
argues
that
these
sources
overwhelm
the
limited
additional
information
that
will
be
reported
by
eliminating
the
de
minimis
exemption.
EPA
disagrees
that
the
proposed
rule
vastly
overstates
the
significance
of
the
TRI
data.
The
public,
all
levels
of
government,
and
the
regulated
community
have
come
to
rely
on
TRI
data
in
improving
decision­
making,
measuring
pollution
prevention,
and
understanding
the
environmental
and
health
consequences
of
toxic
chemical
releases
and
other
waste
management
activities.
Although
the
Toxics
Release
Inventory
does
not
contain
a
complete
inventory
of
every
release,
EPA
believes
it
does
provide
one
of
the
most
comprehensive
and
accessible
sources
of
release
and
other
waste
management
information
available.
EPA
also
disagrees
with
the
commenter's
assertion
that
the
data
base
only
contains
information
from
the
chemical
industry
and
a
few
others.
In
fact,
all
20
manufacturing
industry
groups
as
well
as
an
additional
7
other
industries
including
metal
and
coal
mining
facilities
and
hazardous
waste
management
facilities
are
subject
to
EPCRA
section
313.
Further,
with
the
addition
of
these
7
newly
covered
industries,
EPA
expects
over
27,500
facilities
to
submit
over
110,000
reports
on
more
than
630
toxic
chemicals
to
the
TRI
for
the
1998
reporting
year.
Currently
no
other
sources
of
information
can
provide
releases
and
information
on
other
waste
management
quantities
and
qualitative
source
reduction
data
with
the
scope,
level
of
detail,
and
chemical
coverage
as
data
currently
included
in
TRI.
Further,
as
EPA
has
previously
explained,
PBT
chemicals
can
remain
in
the
environment
for
a
significant
amount
of
time
and
can
bioaccumulate
in
animal
tissues.
Even
relatively
small
releases
of
such
chemicals
have
the
potential
to
accumulate
over
time
and
cause
significant
adverse
impacts
on
human
health
and
the
environment.
Therefore,
EPA
believes
it
is
particularly
important
to
gather
and
disseminate
to
the
public
relevant
information
on
even
relatively
small
amounts
of
releases
and
other
waste
management
of
PBT
chemicals.
Under
the
10,000
and
25,000
pound/
year
reporting
thresholds,
a
significant
amount
of
the
releases
and
other
waste
management
activities
involving
PBT
chemicals
are
not
being
captured
and
thus
the
public
does
not
have
the
information
needed
to
determine
if
these
chemicals
are
present
in
their
communities
at
levels
that
may
pose
a
significant
risk.
Several
commenters
argue
that
the
de
minimis
exemption
already
does
not
apply
to
the
manufacture
of
a
toxic
chemical
unless
the
toxic
chemical
is
manufactured
as
an
impurity
or
is
imported.
Therefore,
any
incidental
manufacturing
of
a
PBT
chemical
as
a
by­
product
would
not
be
eligible
for
the
de
minimis
exemption
and
would
be
subject
to
reporting.
Thus,
they
argue,
the
elimination
of
the
exemption
will
provide
little
additional
information
and
will
not
provide
added
value.
The
commenters
are
correct
in
stating
that
there
are
instances
where
PBT
chemicals
are
manufactured
as
byproducts
and
would,
therefore,
not
be
affected
by
the
elimination
of
the
de
minimis
exemption.
However,
as
EPA
explained
in
the
PBT
proposal,
there
are
also
many
instances
where
a
PBT
chemical
may
exist
in
a
mixture
or
trade
name
product
at
a
concentration
below
the
1%
or
0.1%
de
minimis
limit
but
where
the
processing
or
otherwise
use
of
the
PBT
chemical
in
that
mixture
would
otherwise
contribute
significantly
to
or
in
itself
exceed
the
reporting
thresholds
(at
64
FR
714).
For
example,
mercury
can
be
found
at
very
low
concentrations
in
steel.
A
resmelting
facility
could
process
and
release
more
than
100
pounds
of
mercury
a
year
from
its
resmelting
activities.
However,
although
this
total
quantity
is
greater
than
the
10
pound
proposed
threshold
for
mercury,
if
the
concentration
of
mercury
in
the
steel
is
less
than
the
de
minimis
limit,
none
of
the
mercury
would
be
reportable
if
the
de
minimis
level
is
retained
for
PBT
chemicals.
Releases
and
other
waste
management
associated
with
these
exempt
activities
would
be
absent
from
the
TRI
data
base.
Because
even
minimal
releases
of
PBT
chemicals
may
result
in
elevated
concentrations
in
the
environment
or
in
an
organism
and
can
have
the
potential
to
cause
an
adverse
effect,
EPA
believes
that
all
releases
of
these
chemicals
are
of
concern
and
that
such
information
is
significant
and
of
value
to
the
public.
a.
Readily
available
data.
Some
commenters
assert
that
the
elimination
of
the
de
minimis
exemption
will
conflict
with
the
condition
that
reporters
obtain
data
from
readily
58730
Federal
Register
/
Vol.
64,
No.
209
/
Friday,
October
29,
1999
/
Rules
and
Regulations
available
sources.
They
argue
that
because
concentrations
below
1%
(and
0.1%
for
carcinogens)
are
not
required
on
MSDSs,
reporters
will
no
longer
be
able
to
use
MSDSs
to
screen
for
products
containing
PBT
chemicals
below
these
concentrations.
They
further
contend
that
AP­
42
guidance,
Air
CHIEF
CD­
ROM,
TANKS,
CHEMDAT8
and
WATER8
would
provide
additional
assistance
in
estimating
the
amount
of
a
PBT
coincidentally
manufactured
in
wastestreams
or
released;
however,
these
tools
will
not
help
quantify
the
amount
of
chemical
in
materials
which
are
distributed
in
commerce
or
used
as
feedstock.
They
assert
that
there
are
no
other
consistent
sources
of
information
on
whether
a
product
contains
a
PBT
chemical
below
de
minimis
levels.
They
also
assert
that
the
elimination
of
the
de
minimis
exemption
will
cause
additional
burden
for
the
regulated
community
because
covered
facilities
will
struggle
with
how
to
comply
in
the
absence
of
information.
The
Agency
believes
that
since
reporting
first
began
in
1988,
new
sources
of
information
have
become
available
to
covered
facilities
to
use
to
determine
concentrations
of
toxic
chemicals
in
mixtures.
In
addition
to
the
data
bases
and
information
sources
cited
by
the
commenter,
EPA
believes
there
are
other
sources
of
data
that
can
and
should
be
used
in
making
threshold
determinations
and
release
and
other
waste
management
calculations
for
PBT
chemicals.
Examples
of
these
sources
of
information
include
EPA
guidance
documents
(e.
g.,
EPCRA
Section
313
Industry
Guidance:
Electricity
Generating
Facilities
(EPA
745±
B±
99±
003))
and
trade
association
guidance
documents
(e.
g.,
National
Council
of
the
Paper
Industry
for
Air
and
Stream
Improvement
(NCASI)
Technical
Bulletins
and
NCASI's
Handbook
of
Chemical
Specific
Information
for
SARA
Title
III
Section
313
Form
R
Reporting).
In
addition,
relevant
information
has
become
much
more
accessible
to
covered
facilities
over
the
past
10
years.
For
example,
the
United
States
Geological
Survey's
U.
S.
Coal
Quality
Database
has
been
in
existence
since
the
mid
1970s,
but
only
more
recently
has
it
been
made
available
on
the
Internet.
(http://
energy.
er.
usgs.
gov/
products/
databases/
UScoal/
index.
htm)
EPA
believes
that
these
tools,
in
addition
to
the
ones
cited
by
the
commenter,
will
help
covered
facilities
quantify
the
amount
of
chemical
in
materials
which
are
distributed
in
commerce
or
used
as
feedstock
and
will
allow
covered
facilities
to
make
reasonable
calculations
to
comply
with
EPCRA
section
313.
Further,
the
Agency
believes
that
it
underestimated
how
much
information
covered
facilities
had
available
to
them
in
1988
regarding
small
concentrations
of
toxic
chemicals
in
mixtures.
Therefore,
EPA
believes
that
facilities
have
sufficient
information
to
make
threshold
determinations
and
release
and
other
waste
management
calculations
for
PBT
chemicals
below
de
minimis
concentrations.
However,
as
EPA
explained
above,
if
a
covered
facility
has
no
information,
including
no
reasonable
estimates
or
other
reasonably
known
information,
on
the
concentration
of
the
toxic
chemical
in
the
mixture,
they
need
not
consider
the
chemical
in
that
mixture
for
threshold
determinations
and
release
and
other
waste
management
calculations
(at
53
FR
4511).
Therefore
if
the
only
source
of
information
on
a
toxic
chemical
in
a
mixture
is
from
an
MSDS,
and
the
MSDS
does
not
indicate
if
the
chemical
is
contained
in
the
mixture,
the
facility
is
not
required
to
consider
the
toxic
chemical
towards
threshold
determinations
or
release
and
other
waste
management
calculations.
Because
some
facilities
covered
under
EPCRA
section
313
have
more
extensive
information
available
to
them
than
they
did
in
1988,
or
EPA
underestimated
how
much
information
they
had
available
in
1988,
and
because
these
facilities
are
not
required
to
report
if
they
have
no
information
on
the
concentration
of
the
toxic
chemical,
the
Agency
believes
that
in
these
cases
retention
of
the
de
minimis
exemption
would
allow
facilities
to
avoid
reporting
when
information
is
available
to
them
that
would
otherwise
permit
them
to
report.
Some
commenters
assert
that
facilities
will
have
to
begin
monitoring
for
trace
quantities
of
chemicals
in
mixtures
if
the
de
minimis
exemption
is
eliminated
for
PBT
chemicals.
One
commenter
argues
that
the
only
way
facilities
would
be
able
to
estimate
the
levels
of
dioxin
in
combustion
products
and
wastewater
treatment
``
would
be
to
undertake
the
costly
burden
of
monitoring
what
comes
off
at
a
series
of
concentrations
and
temperatures.
''
Another
commenter
asserts
that
if
the
de
minimis
level
is
eliminated,
industry
would
be
subject
to
increased
enforcement
action
because
exhaustive
testing
may
be
insufficient
to
detect
the
chemicals.
EPA
disagrees
with
the
commenters
because,
as
stated
previously,
EPCRA
section
313(
g)(
2)
limits
monitoring
requirements
under
EPCRA
section
313.
Under
this
section,
facilities
are
not
required
to
perform
any
additional
monitoring
or
analysis
of
production,
process
or
use
other
than
that
already
collected
under
other
requirements.
However,
if
a
facility
is
required
to
monitor
toxic
chemicals
under
another
statute,
this
data
must
be
considered
in
determining
thresholds
and
release
and
other
waste
management
calculations
under
EPCRA
section
313.
EPCRA
section
313(
g)(
2)
requires
that
facilities
use
readily
available
data,
or
in
absence
of
such
data,
facilities
are
required
to
use
reasonable
estimates.
If
no
monitoring
data
are
available,
the
facility
should
use
other
readily
available
information
in
making
threshold
determinations
and
release
and
other
waste
management
calculations.
Further,
if
the
facility
believes
that
it
has
other,
more
representative
data
than
its
monitoring
data,
the
facility
should
use
that
information
instead.
As
to
specifically
tracking
PBT
chemicals
in
wastewater,
the
commenter
does
not
specify
whether
the
toxic
chemicals
discussed
in
the
comment
are
manufactured
as
byproducts
are
processed,
or
otherwise
used.
As
discussed
above,
the
de
minimis
exemption
does
not
apply
to
toxic
chemicals
manufactured
as
byproducts
Therefore,
if
PBT
chemicals
are
coincidentally
manufactured
during
on­
site
wastewater
treatment,
covered
facilities
would
be
required
to
consider
those
PBT
toxic
chemicals
for
threshold
determinations
and
release
and
other
waste
management
calculations
even
if
the
de
minimis
exemption
were
retained
for
PBT
chemicals.
Similarly,
PBT
chemicals
manufactured
as
a
result
of
burning
fuel
would
not
be
exempt
even
if
the
de
minimis
exemption
were
retained
because
manufactured
byproducts
are
not
eligible
for
this
exemption.
PBT
chemicals
in
below
de
minimis
concentrations
in
mixtures
that
are
imported,
processed,
or
otherwise
used
will
be
affected
by
the
elimination
of
the
de
minimis
exemption.
Covered
facilities
will
need
to
consider
these
quantities
towards
threshold
determinations
and
release
and
other
waste
management
calculations.
These
calculations
would
include
the
amounts
contained
in
combustion
by­
products
and
wastewater
treatment
units.
Additional
monitoring
of
these
quantities,
however,
would
not
be
required
under
EPCRA
section
313.
Finally,
EPA
has
limited
the
dioxin
listing
with
the
qualifier
``
manufacturing;
and
the
processing
or
otherwise
use
of
dioxin
and
dioxin­
like
compounds
if
the
dioxin
and
dioxin­
like
compounds
are
present
as
contaminants
in
a
chemical
and
if
they
were
created
58731
Federal
Register
/
Vol.
64,
No.
209
/
Friday,
October
29,
1999
/
Rules
and
Regulations
during
the
manufacturing
of
that
chemical.
''
Therefore,
not
all
processing
or
otherwise
use
activities
of
the
dioxin
and
dioxin­
like
compounds
category
must
be
considered
towards
a
facility's
threshold
determinations.
Some
commenters
assert
that
EPA
should
maintain
the
de
minimis
exemption
for
PBT
chemicals
present
as
impurities.
They
argue
that
information
on
PBT
chemicals
present
as
impurities
is
not
readily
available
and
that
obtaining
the
relevant
data,
conducting
the
initial
reviews
to
determine
what
information
is
available,
and
identifying
data
gaps
would
impose
a
huge
burden
on
industry.
They
argue
that
even
developing
estimates
with
any
accuracy
entails
a
significant
amount
of
time.
In
the
instance
of
impurities,
they
assert
that
the
absence
of
data
and
the
difficulty
in
developing
estimates
will
result
in
a
heavy
burden
with
little
information
of
value
being
reported.
These
commenters
believe
that
the
elimination
of
the
de
minimis
level
is
a
requirement
to
provide
new
data
when
utilizing
the
de
minimis
exemption.
EPA
disagrees
with
these
commenters.
Although
there
are
burdens
associated
with
obtaining
relevant
data,
determining
available
information
and
identifying
data
gaps,
EPA
disagrees
that
the
elimination
of
the
de
minimis
exemption
for
PBT
chemicals
present
as
impurities
would
vastly
increase
the
extent
of
this
required
effort.
From
the
comment,
it
is
unclear
why
requiring
facilities
to
identify
and
evaluate
process
streams
containing
small
quantities
of
PBT
chemicals
as
impurities
is
more
burdensome
than
for
larger
quantities
of
these
chemicals
manufactured,
processed,
or
otherwise
used
at
a
covered
facility
in
excess
of
the
activity
thresholds.
For
example,
a
facility
monitors
for
chemical
A
at
a
concentration
of
greater
than
0.001%
and
monitors
for
chemical
B
at
a
concentration
of
greater
than
1.5%.
The
monitoring
is
done
for
the
same
wastestream
and
the
same
frequency.
There
is
no
differential
in
effort
or
burden.
Currently,
the
only
difference
is
that
facilities
can
ignore
available
data
when
utilizing
the
de
minimis
exemption.
One
commenter
asserts
that
the
de
minimis
exemption
should
be
retained
for
PBT
chemicals
present
at
mining
facilities.
The
commenter
argues
that
the
burden
upon
the
mining
industry
is
even
greater
in
the
context
of
the
low
thresholds
proposed
for
PBT
chemicals.
Further,
the
commenter
asserts
that
although
EPCRA
does
not
require
covered
facilities
to
conduct
tests
concerning
the
amount
of
listed
chemicals
processed,
most
reporters
rely
upon
their
knowledge
of
their
manufacturing
processes
and
raw
materials
to
produce
meaningful
data
for
EPCRA
section
313
reporting
purposes.
The
commenter
contends
that
this
is
not
true
of
the
mining
industry.
Due
to
the
volume
of
materials
moved
in
the
extraction
process
and
the
heterogeneous
nature
of
the
materials
mined,
process
knowledge
often
is
inadequate
to
produce
a
meaningful
picture
of
the
minute
levels
of
PBT
chemicals
that
may
be
present
in
mining
operations.
The
commenter
asserts
that
inadequate
process
knowledge
combined
with
the
enormous
expense
of
constantly
testing
the
processed
materials
makes
the
elimination
of
the
de
minimis
exemption
for
PBT
chemicals
unworkable
as
applied
to
mining
operations.
EPA
disagrees
with
the
commenter.
As
the
commenter
points
out,
under
EPCRA
section
313(
g)(
2),
facilities
are
not
required
to
perform
any
additional
monitoring
or
analysis
of
production,
process,
or
use
other
than
that
already
collected
under
other
statutory
or
regulatory
requirements.
Therefore,
there
should
be
no
added
cost
due
to
testing
to
comply
with
EPCRA
section
313.
However,
EPA
believes
that
in
many
cases
mining
facilities
have
the
information
needed
to
make
reasonable
estimates
regarding
small
concentrations
of
PBT
chemicals
in
the
ores
mined.
In
addition,
as
EPA
explained
in
the
1988
final
rule,
if
a
covered
facility
has
no
information
on
the
concentration
of
the
toxic
chemical
in
the
mixture,
including
no
reasonable
estimates,
the
facility
need
not
consider
the
chemical
in
that
mixture
for
threshold
determinations
and
release
and
other
waste
management
calculations.
If
a
mining
facility
does
have
information
regarding
the
concentration
of
a
toxic
chemical
in
a
mixture
or
trade
name
product,
the
facility
must
consider
all
non­
exempted
sources
of
the
chemical
for
threshold
determinations.
If
an
activity
threshold
is
exceeded
for
the
chemical,
the
facility
must
then
calculate
release
and
other
waste
management
quantities.
Covered
mining
facilities
will
need
to
identify
and
evaluate
process
streams
when
considering
a
PBT
chemical
in
concentrations
below
the
de
minimis
level
just
as
they
already
do
for
toxic
chemicals
found
in
process
streams
in
concentrations
above
the
de
minimis
level.
Therefore,
given
that
covered
facilities:
(1)
Are
not
required
to
perform
additional
monitoring;
(2)
are
not
required
to
consider
concentrations
of
toxic
chemicals
for
which
they
have
no
information;
and
(3)
need
only
consider
readily
available
data,
EPA
disagrees
that
identifying
and
evaluating
mining
activities
involving
mixtures
containing
less
than
1.0%
or
0.1%
concentrations
of
PBT
chemicals
will
be
more
burdensome
than
for
larger
quantities
of
these
chemicals
manufactured,
processed,
or
otherwise
used
at
a
mining
facility
in
excess
of
the
activity
thresholds.
b.
Alternate
de
minimis
level.
Several
commenters
argue
that
in
lieu
of
eliminating
the
de
minimis
exemption
for
PBT
chemicals,
it
would
make
more
sense
to
change
the
level
for
the
de
minimis
exemption
for
these
chemicals.
Some
commenters
argue
that
a
more
appropriate
approach
would
be
to
compare
the
current
thresholds
and
the
current
de
minimis
levels
and
use
the
same
ratio
to
create
a
new
de
minimis
level
for
the
lowered
PBT
chemical
thresholds.
Therefore,
they
argue,
the
existing
level
is
1%
for
a
threshold
of
10,000
pounds,
so
an
analogous
reduction
of
the
de
minimis
level
would
be
0.01%
for
the
new
proposed
threshold
of
100
pounds
and
0.001%
for
the
new
proposed
threshold
of
10
pounds
per
year
and
1
ppb
for
dioxins.
One
commenter
argues
that
the
current
de
minimis
level
of
0.1%
for
known
or
suspected
carcinogens
is
not
appropriate
for
dioxins.
They
suggest
that
EPA
lower
the
de
minimis
exemption
for
dioxins
proportionally
to
the
lower
reporting
threshold
EPA
sets
in
the
final
rule.
They
assert
that
a
reporting
threshold
for
dioxins
of
0.002
pound
TEQ
(not
the
threshold
in
the
PBT
proposal
nor
the
one
that
EPA
is
finalizing
today),
is
approximately
seven
orders
of
magnitude
less
than
the
current
10,000
pound
threshold.
Therefore,
they
argue,
the
0.1%
de
minimis
exemption
should
be
lowered
proportionally
to
1
x
10
­8
%.
This
translates
to
a
concentration
of
100
parts
per
trillion.
EPA
disagrees
with
these
commenters.
As
explained
previously,
EPA
adopted
the
de
minimis
exemption
for
several
reasons
including
the
desire
to
be
consistent
with
information
mandated
by
the
OSHA
HCS.
This
OSHA
standard
requires
the
listing
of
hazardous
chemicals
on
MSDSs
but
allows
chemical
suppliers
to
omit
from
the
MSDSs
hazardous
chemicals
that
are
below
certain
concentrations:
Specifically,
levels
of
0.1%
for
OSHA
carcinogens
and
1.0%
for
other
hazardous
chemicals.
However,
the
rationale
for
the
OSHA
HCS
de
minimis
exemption
is
not
relevant
to
PBT
chemicals
and
therefore,
is
insufficient
by
itself
to
support
an
alternative
de
minimis
exemption
for
PBT
chemicals.
58732
Federal
Register
/
Vol.
64,
No.
209
/
Friday,
October
29,
1999
/
Rules
and
Regulations
As
explained
in
the
1983
final
rule,
OSHA
chose
the
1.0%
concentration
limit
based
on
comments
that
this
level
seemed
to
be
sufficiently
protective
of
workers
and
was
considered
to
be
reasonable
by
a
number
of
commenters
(48
FR
53280,
at
53290,
November
25,
1983).
OSHA
was
also
persuaded
by
comments
that
in
some
instances
the
1.0%
cut­
off
levels
may
not
be
protective
enough
with
respect
to
certain
health
hazards
and
adopted
the
0.1%
level
for
carcinogens
(at
48
FR
53292).
Specifically,
PBT
chemicals
are
of
concern
because
they
persist
and
bioaccumulate
in
the
environment.
Persistence
and
bioaccumulation
were
not
considered
as
a
part
of
the
OSHA
rulemaking.
In
addition,
as
explained
in
other
responses
in
this
unit,
EPA's
original
rationale
for
this
exemption
is
inapplicable
to
PBT
chemials,
and
the
commenters
have
provided
no
alternate
rationale
to
support
an
exemption
based
on
extrapolating
new
de
minimis
levels
from
the
proposed
thresholds.
Therefore,
given
the
different
intents
between
the
OSHA
HCS
and
EPCRA
section
313,
EPA
does
not
believe
that
creating
alternative
de
minimis
levels
for
PBT
chemicals
based
on
a
ratio
between
the
lowered
threshold
and
the
OSHA
HCS
levels
is
appropriate.
Several
commenters
support
EPA's
elimination
of
the
de
minimis
exemption
for
PBT
chemicals.
They
assert
that
retention
of
the
de
minimis
exemption
would
undermine
the
changes
to
the
reporting
threshold
and
would
allow
an
unnecessary
loophole
from
reporting.
They
assert
that
the
rule
does
not
require
any
additional
testing
for
impurities
and
that
the
only
additional
reporting
would
be
for
those
facilities
that
use
sufficient
quantities
of
mixtures
or
trade
name
products
containing
PBT
chemicals
as
impurities.
One
commenter
asserts
that
one
of
the
original
reasons
for
the
de
minimis
exemption
levels,
that
it
was
based
on
OSHA
HCS
thresholds
of
1.0%
for
hazardous
chemicals
in
mixtures
and
0.1%
for
carcinogens
in
mixtures,
does
not
apply
to
raw
materials
that
are
not
manufactured
chemicals,
such
as
crude
oil,
coal,
and
mining
inputs.
EPA
agrees
with
these
commenters
and
is
eliminating
the
de
minimis
exemption
for
PBT
chemicals
addressed
in
today's
rule.
As
discussed
above,
the
reasons
EPA
indicated
for
originally
adopting
the
de
minimis
exemption
are
not
applicable
to
PBT
chemicals.
In
addition,
EPA
has
received
no
compelling
arguments
from
commenters
to
extend
the
de
minimis
exemption
to
PBT
chemicals.
Because
the
purpose
of
today's
rulemaking
is
different
from
past
rulemakings
in
that
it
is
intended
to
capture
information
on
significantly
smaller
quantities
of
releases
and
other
waste
management
associated
with
these
chemicals,
the
de
minimis
exemption
could
significantly
limit
the
amount
of
reporting
on
PBT
chemicals.
Therefore,
given
that:
(1)
Covered
facilities
have
several
sources
of
information
available
to
them
regarding
the
concentration
of
PBT
chemicals
in
mixtures;
(2)
even
minimal
releases
of
persistent
bioaccumulative
chemicals
may
result
in
significant
adverse
effects
and
can
reasonably
be
expected
to
significantly
contribute
to
the
proposed
lower
thresholds;
and
(3)
the
concentration
levels
chosen,
in
part,
to
be
consistent
with
the
OSHA
HCS
are
inappropriately
high
for
PBT
chemicals,
EPA
believes
that
the
reasons
for
the
de
minimis
exemption
that
the
Agency
held
for
previous
rulemakings
do
not
apply
to
PBT
chemicals.
EPA
is
therefore
eliminating
the
de
minimis
exemption
for
PBT
chemicals.
c.
Supplier
notification.
Several
commenters
were
confused
by
EPA's
failure
to
modify
the
de
minimis
exemption
for
PBT
chemicals
under
the
supplier
notification
requirements.
As
explained
in
the
PBT
proposal,
the
Agency
believes
that
covered
facilities
have
sufficient
information
available
to
them
on
PBT
chemicals.
The
requirement
of
additional
information
under
the
supplier
notification
requirements
would
result
in
redundancies.
Commenters
that
correctly
understood
EPA's
inaction
on
this
topic
support
the
retention
of
the
de
minimis
exemption
for
purposes
of
Subpart
C
Supplier
Notification
Requirements
under
40
CFR
372.45(
d)(
1).
EPA
agrees
with
these
commenters
and
has
therefore
taken
no
action
on
the
supplier
notification
requirements
for
PBT
chemicals.
2.
Other
exemptions.
Although
the
Agency
received
several
comments
regarding
the
existing
exemptions,
EPA
is
not
modifying
any
of
these
exemptions
in
this
rule.
Any
changes
to
these
exemptions
would
require
additional
rulemaking,
and
any
comments
submitted
to
EPA
during
this
rulemaking
will
be
considered
as
part
of
EPA's
evaluation
of
these
exemptions.
3.
Use
of
alternate
threshold
and
Form
A.
One
issue
that
commenters
raise
relates
to
EPA's
proposal
to
exclude
all
PBT
chemicals
from
the
alternate
threshold
of
1
million
pounds
for
PBT
chemicals.
Several
commenters
argue
that
EPA
should
retain
the
alternate
threshold
of
1
million
pounds
for
PBT
chemicals.
EPA
disagrees.
As
stated
in
detail
in
the
proposal,
EPA
believes
that
use
of
the
existing
alternate
threshold
and
reportable
quantity
for
Form
A
would
be
inconsistent
with
the
intent
of
expanded
PBT
chemical
reporting.
The
general
information
provided
on
the
Form
A,
on
the
quantities
of
the
chemical
that
the
facility
manages
as
waste
is
insufficient
for
conducting
meaningful
analyses
on
PBT
chemicals.
A
commenter
states
that
because
PACs
in
fuel
are
destroyed
during
combustion,
EPA
should
retain
the
alternate
threshold
or
provide
a
new
alternate
threshold.
First,
the
commenter
did
not
provide
any
information
to
support
the
contention
that
PACs
in
fuel
are
destroyed
during
combustion.
And,
to
the
contrary,
EPA
believes
that,
even
if
some
or
all
of
the
PACs
in
fuel
are
destroyed
during
combustion,
additional
PACs
may
be
created
during
the
combustion
process.
Consequently,
absent
any
information
to
support
the
basis
for
such
an
option,
or
the
need
for
an
alternate
threshold,
EPA
does
not
believe
it
would
be
appropriate
at
this
time
to
provide
a
new
alternate
Form
A
threshold.
Although
EPA
solicited
comments
on
this
issue
in
the
proposal,
at
this
time,
the
Agency
believes
that
it
is
appropriate
to
collect
and
analyze
several
years
worth
of
data
at
the
lowered
thresholds
before
EPA
considers
developing
a
new
alternate
threshold
and
reportable
quantity
appropriate
for
PBT
chemicals.
In
addition,
the
commenter
also
appears
to
be
raising
a
broader
issue
than
just
the
destruction
of
PACs
during
combustion.
The
commenter
implies
that
when
a
facility
estimates
its
releases
to
be
zero,
the
facility
should
be
eligible
to
use
the
Form
A.
However,
the
commenter
appears
to
misunderstand
how
to
calculate
the
amounts
required
to
determine
eligibility
for
the
Form
A.
Facilities
may
use
the
Form
A
provided
that
they
do
not
exceed
500
pounds
for
the
total
annual
reportable
amount
for
a
chemical,
and
that
their
amounts
manufactured
or
processed
or
otherwise
used
do
not
exceed
1
million
pounds.
The
annual
reportable
amount
is
equal
to
the
combined
total
quantities
released
at
the
facility,
treated
at
the
facility,
recovered
at
the
facility
as
a
result
of
recycle
operations,
combusted
for
the
purpose
of
energy
recovery
at
the
facility,
and
amounts
transferred
from
the
facility
to
off­
site
locations
for
the
purpose
of
recycle,
energy
recovery,
treatment,
and/
or
disposal.
The
commenter
only
appears
to
consider
their
releases
as
reportable
amounts
and
does
not
appear
to
consider
quantities
generated
from
their
other
waste
management
activities
as
reportable
amounts.
This
additional
waste
management
information
on
PBT
chemicals
is
very
important
to
58733
Federal
Register
/
Vol.
64,
No.
209
/
Friday,
October
29,
1999
/
Rules
and
Regulations
communities
because
it
helps
them
understand
the
quantities
of
EPCRA
section
313
chemicals
that
are
being
transported
through
their
communities,
the
destination
of
these
EPCRA
section
313
chemicals,
as
well
as
the
reported
waste
management
activity
at
the
receiving
facility.
In
conclusion,
EPA
has
not
proposed
to
disregard
this
waste
management
information
in
calculating
the
annual
reportable
amount,
therefore
the
commenter's
approach
is
not
consistent
with
current
reporting
under
Form
A
or
appropriate
as
an
approach
for
reporting
on
PBT
chemicals.
The
commenter
also
states
that
the
alternate
threshold
should
be
retained
in
order
to
ensure
that
only
meaningful
amounts
of
substances
are
reported
under
EPCRA
section
313.
EPA
disagrees
that
retention
of
the
alternate
threshold
would
ensure
that
only
meaningful
information
is
reported
under
EPCRA
section
313.
The
500
pound
waste
eligibility
could
be
interpreted
by
some
data
users,
as
a
worst
case,
to
mean
that
greater
than
500
pounds
of
the
chemical
has
been
released
into
the
environment
(i.
e.,
500
pounds
of
production­
related
waste
as
release
and
some
quantity
of
catastrophic
release).
Other
data
users
may
assume
that
the
facility
had
no
catastrophic
releases
and
all
of
the
toxic
chemical
in
waste
was
managed
in
a
manner
other
than
as
a
release,
e.
g.,
the
toxic
chemical
in
waste
was
recycled.
For
PBT
chemicals
where
any
release
is
a
concern,
an
uncertainty
level
of
500
pounds
may
result
in
data
that
is
virtually
unusable.
As
a
result,
EPA
does
not
agree
with
the
commenter
that
the
alternate
threshold
will
ensure
that
only
meaningful
amounts
of
substances
will
be
reported
under
EPCRA
section
313.
In
addition,
the
commenter
argues
elimination
of
the
alternate
threshold
for
PBT
chemicals
will
cause
reporting
burdens
to
increase
while
failing
to
provide
for
the
collection
of
substantial
additional
release
information.
EPA's
economic
analysis
used
reporting
costs
for
the
Form
R
to
estimate
the
costs
to
those
facilities
that
would
not
be
able
to
use
the
alternate
threshold.
The
economic
analysis
also
evaluated
the
benefits
of
the
collection
of
additional
release
and
other
waste
management
of
PBT
chemicals
(Ref.
67).
The
commenter
does
not
dispute
those
estimates.
As
a
result,
EPA
sees
no
compelling
argument
to
revise
its
decision
to
exclude
all
PBT
chemicals
from
the
alternate
threshold
of
1
million
pounds.
A
number
of
commenters
argue
that
EPA
should
eliminate
the
alternate
threshold
of
1
million
pounds
for
all
PBT
chemicals
on
the
EPCRA
section
313
list.
One
commenter
asserts
that
in
light
of
the
relatively
small
quantities
of
concern
for
PBT
chemicals,
particularly
those
with
no
deliberate
commercial
manufacture,
it
makes
little
sense
to
retain
the
Form
A.
The
commenter
further
states
that
it
believes
that
a
modified
Form
A
would
be
inappropriate
due
to
the
concern
over
releases
of
these
chemicals
at
low
levels.
Another
commenter
adds
that
the
Form
A
is
clearly
inappropriate
for
chemicals
that
will
now
have
thresholds
significantly
lower
than
the
500
pound
waste
generation
level.
The
commenter
further
contends
that
it
is
not
appropriate
for
EPA
to
set
a
new
Form
A
threshold
for
PBT
chemicals,
given
the
need
to
collect
more
information
on
these
substances.
EPA
agrees
with
the
commenters
that
all
PBT
chemicals
should
be
excluded
from
the
alternate
threshold
of
1
million
pounds.
As
stated
in
detail
in
the
proposal,
EPA
believes
that
use
of
the
existing
alternate
threshold
and
reportable
quantity
for
Form
A
would
be
inconsistent
with
the
intent
of
expanded
PBT
chemical
reporting
(at
64
FR
715±
716).
The
general
information
provided
in
the
Form
A
on
the
quantities
of
the
chemical
that
the
facility
manages
as
waste
is
insufficient
for
conducting
meaningful
analyses
on
PBT
chemicals.
EPA
also
agrees
that
a
new
alternate
threshold
for
PBT
chemicals
would
be
inappropriate
due
to
the
concern
over
releases
and
other
waste
management
of
these
chemicals
at
low
levels.
As
stated
in
the
proposal,
even
small
quantities
of
persistent
bioaccumulative
chemicals
may
cause
elevated
concentrations
in
the
environment
and
organisms
that
may
cause
significant
adverse
effects.
Given
the
persistent
and
bioaccumulative
nature
of
these
chemicals
and
the
need
for
the
public
to
have
information
about
smaller
amounts
of
these
PBT
chemicals,
EPA
believes
it
would
be
inappropriate
at
this
time
to
allow
an
option
that
would
exclude
significant
information
on
some
releases
and
other
waste
management
of
these
chemicals.
In
response
to
EPA's
proposal
to
exclude
all
PBT
chemicals
from
the
alternate
threshold
of
1
million
pounds,
one
commenter
argues
that
EPA
should
consider
establishing
a
new
alternate
reporting
threshold
for
these
chemicals.
The
commenter
states
that,
at
a
minimum,
an
alternate
reporting
threshold
of
10
to
100
pounds
would
be
consistent
with
the
throughputreporting
threshold
proposed
for
all
PBT
chemicals
except
dioxins.
The
commenter
further
states
that
the
SBA's
analysis
suggests
significant
reductions
in
burden
associated
with
alternate
reporting
thresholds
of
50
pounds
for
PBT
chemicals.
The
commenter
states
that,
based
on
an
SBA
study
commissioned
of
petroleum
bulk
plants,
which
it
estimates
will
be
the
largest
group
of
reporters
under
this
proposal,
it
finds
that
most
of
the
reports
avoided
by
this
alternate
threshold
would
reflect
zero
releases.
EPA
disagrees
with
the
comment
suggesting
that
a
new
alternate
threshold
be
established
for
PBT
chemicals.
As
stated
in
the
proposal,
even
small
quantities
of
persistent
bioaccumulative
chemicals
may
cause
elevated
concentrations
in
the
environment
and
organisms
that
may
cause
significant
adverse
effects.
Given
the
persistent
and
bioaccumulative
nature
of
these
chemicals
and
the
need
for
the
public
to
have
information
about
smaller
amounts
of
these
PBT
chemicals,
EPA
believes
it
would
be
inappropriate
at
this
time
to
allow
an
option
that
would
exclude
significant
information
on
some
releases
and
other
waste
management
of
these
chemicals.
The
general
information
provided
in
the
Form
A
on
the
quantities
of
the
chemical
that
the
facility
manages
as
waste
is
insufficient
for
conducting
meaningful
analyses
on
PBT
chemicals.
Therefore,
EPA
does
not
agree
that
a
new
alternate
threshold
for
PBT
chemicals
should
be
established.
The
commenter
also
suggests
that
reporting
burdens
will
increase
while
failing
to
provide
for
the
collection
of
substantial
additional
release
information.
EPA's
economic
analysis
used
reporting
costs
for
the
Form
R
to
estimate
the
costs
to
those
facilities
that
would
not
be
able
to
use
the
alternate
threshold.
The
economic
analysis
also
evaluated
the
benefits
of
the
collection
of
additional
release
and
other
waste
management
of
PBT
chemicals
(Ref.
67).
The
commenter
does
not
dispute
those
estimates.
As
a
result,
EPA
sees
no
compelling
argument
to
revise
its
decision
to
exclude
all
PBT
chemicals
from
the
alternate
threshold
of
1
million
pounds.
4.
Data
precision
issuesÐ
a.
Use
of
significant
digits,
half
pound
and
whole
numbers.
EPA
proposed
to
require
reporting
of
all
releases
and
other
waste
management
quantities
of
PBT
chemicals
(except
dioxin)
that
are
greater
than
1
¤10
of
a
pound,
provided
that
the
accuracy
in
the
underlying
data
on
which
the
estimate
is
based
supports
this
level
of
precision.
EPA
further
stated
that
releases
and
other
waste
management
quantities
would
continue
to
be
reported
to
two
significant
digits.
In
addition,
EPA
stated
that
for
quantities
of
10
pounds
or
greater,
only
58734
Federal
Register
/
Vol.
64,
No.
209
/
Friday,
October
29,
1999
/
Rules
and
Regulations
whole
numbers
would
be
required
to
be
reported.
For
the
category
of
dioxin
and
dioxin­
like
compounds,
which
have
a
proposed
reporting
threshold
of
0.1
gram,
EPA
proposed
that
facilities
report
all
releases
and
other
waste
management
activities
greater
than
100
mg
(i.
e.,
0.0001
gram).
After
reviewing
all
comments
on
this
issue,
EPA
is
providing
the
following
guidance
on
the
level
of
precision
covered
facilities
should
use
to
report
their
releases
and
other
waste
management
quantities
of
PBT
chemicals.
Facilities
should
continue
to
report
releases
and
other
waste
management
amounts
greater
than
1
¤10
of
a
pound
(except
dioxin),
at
a
level
of
precision
supported
by
the
accuracy
of
the
underlying
data
and
the
estimation
techniques
on
which
the
estimate
is
based.
This
approach
is
consistent
with
the
statutory
reporting
requirements
when
estimating
reportable
amounts.
The
statute
requires
facilities
to,
among
other
things,
report
``[
t]
he
annual
quantity
of
the
toxic
chemical
entering
each
environmental
medium.
''
(42
U.
S.
C.
11023(
g)(
1)(
C)(
iv)).
To
determine
this
``
annual
quantity,
''
the
statute
directs
facilities
to
use
readily
available
data
(including
monitoring
data).
When
such
data
are
not
readily
available,
the
statute
directs
facilities
to
use
reasonable
estimates.
(42
U.
S.
C.
11023(
g)(
2)).
However,
while
the
statute
allows
for
some
level
of
imprecision
regarding
reportable
amounts,
it
does
not
create
an
exemption
or
exception
that
would
allow
facilities
to
report
less
precisely
than
provided
for
by
their
data
or
estimation
techniques.
Therefore,
facilities
should
report
PBT
chemicals
as
precisely
as
their
estimation
techniques
or
readily
available
data
allow.
If
a
facility's
release
or
other
management
calculations
support
reporting
an
amount
that
is
more
precise
than
two
significant
digits,
then
the
facility
should
report
that
more
precise
amount.
b.
Use
of
range
reporting.
In
the
preamble
to
the
proposed
rule,
EPA
requested
comments
on
its
proposal
to
eliminate
the
use
of
range
reporting
in
Form
Rs
for
PBT
chemicals.
Commenters
disagree
with
the
proposal
for
a
number
of
reasons
outlined
below.
Commenters
argue
that
applying
different
reporting
conventions
for
PBT
chemicals
would
complicate
EPCRA
section
313
reporting,
cause
compliance
difficulty,
and
introduce
data
inconsistencies
(i.
e.,
ranges
for
some
chemicals
but
not
for
others).
Commenters
also
argue
that
eliminating
the
use
of
range
reporting
for
PBT
chemicals
has
the
potential
to
mislead
the
public
and
divert
attention
from
actual
risks.
EPA
disagrees
that
the
elimination
of
the
use
of
range
reporting
for
PBT
chemicals
will
cause
insurmountable
obstacles
to
EPCRA
section
313
reporting
and
cause
compliance
difficulties
and
data
inconsistencies.
There
are
already
many
different
industries
that
report
to
EPA
for
643
chemicals.
EPA
provides
numerous
guidance
documents
and
training
opportunities
to
reporting
industries.
With
the
finalization
of
the
PBT
rule,
EPA
will
provide
updated
guidance
documents,
will
prepare
and
provide,
in
those
cases
where
it
is
appropriate,
chemical­
specific
guidance
documents,
and
will
continue
to
offer
training
in
order
to
assist
facilities
in
reporting
under
EPCRA
section
313.
EPA
also
believes
that
the
Agency
will
be
able
to
adequately
explain
to
the
public
the
different
reporting
requirements
for
PBT
chemicals
so
that
they
are
put
in
context
of
other
TRI
data.
EPA
currently
does
this
for
other
types
of
chemicals
on
the
EPCRA
section
313
list
such
as
metals
and
pesticides.
Additionally,
EPA
believes
that
the
elimination
of
range
reporting
is
a
critical
part
of
this
rulemaking,
of
which
the
ultimate
intent
is
to
provide
useful
information
on
PBT
chemicals
to
assist
communities
in
determining
if
PBT
chemicals
are
present
in
their
communities
at
levels
that
may
pose
an
unacceptable
risk.
This
information
on
PBT
chemicals
can
also
be
used
by
government
agencies
and
others
to
identify
problems,
set
priorities,
and
take
appropriate
steps
to
reduce
any
potential
risks
to
human
health
and
the
environment.
Consequently,
the
information
collected
about
these
PBT
chemicals
will
inform
the
public
rather
than
mislead
the
public
and
will
actually
assist
the
public
in
determining
the
risk
of
PBT
chemicals
in
their
communities.
Commenters
also
argue
that
reporting
numerical
values
for
PBT
chemicals
assumes
a
level
of
accuracy
that
generally
does
not
exist
in
the
measurement
of
releases.
In
addition,
commenters
state
that
estimating
numerical
values
would
require
the
use
of
material
balances,
which
are
difficult
to
apply
and
essentially
inaccurate
for
chemicals
used
in
low
concentrations.
Commenters
contend
that,
especially
where
reports
are
estimates,
ranges
may
in
fact
provide
more
information
than
point
estimates.
Commenters
argue
that,
for
these
reasons,
elimination
of
range
reporting
will
result
in
inaccurate
estimates.
Commenters
also
state
that
eliminating
the
use
of
range
reporting
for
PBT
chemicals
would
give
the
false
impression
of
precise
data,
where
uncertainty
inherently
exists.
As
stated
in
the
proposal,
EPA
believes
that
the
use
of
ranges
could
misrepresent
data
accuracy
because
the
low
or
the
high
end
range
numbers
may
not
really
be
that
close
to
the
estimated
value,
even
taking
into
account
its
inherent
error
(i.
e.,
error
in
measurements
and
developing
estimates)
(at
64
FR
716).
The
user
of
the
data
must
make
a
determination
on
whether
to
use
the
low
end
of
the
range,
the
mid­
point,
or
the
upper
end.
For
example,
a
release
of
501
pounds
could
be
misinterpreted
as
999
pounds
if
reported
as
a
range
of
500±
999.
This
represents
nearly
a
100%
error.
This
uncertainty
severely
limits
the
applicability
of
release
information
where
the
majority
of
releases,
particularly
for
PBT
chemicals,
are
expected
to
be
within
the
amounts
eligible
for
range
reporting.
The
utility
of
these
data
would
be
severely
limited
given
the
uncertainty
associated
with
data
reported
using
ranges.
Therefore,
due
to
this
uncertainty,
EPA
believes
that
facilities
should
report
numerical
values,
not
ranges,
for
PBT
chemicals.
In
addition,
EPA
believes
that
the
information
available
to
the
typical
EPCRA
section
313
reporter
is
generally
greater
and/
or
more
accessible
than
it
was
10
years
ago.
Because
of
this
improved
information
availability,
EPA
believes
that
many
facilities
will
be
able
to
accurately
estimate
releases
and
offsite
transfers
for
further
waste
management
of
PBT
chemicals
in
quantities
of
less
than
1,000
pounds
without
the
use
of
range
codes.
Although
it
may
be
true
that
some
facilities
will
be
better
able
to
make
those
estimates
than
others,
EPA
does
not
believe
this
justifies
not
collecting
the
more
specific
and
useful
information
from
those
facilities
that
can
provide
it.
Further,
the
Form
R
and
Instructions
and
annual
TRI
data
release
provide
information
on
the
methods
used
to
generate
information
reported
and
characterize
many
of
the
limitations
that
may
apply
to
the
data.
This
aids
the
data
user
in
understanding
the
overall
nature
of
the
information
available
under
EPCRA
section
313.
Facilities
are
required,
for
each
release
or
transfer
amount,
to
indicate
on
the
the
principal
method
used
to
determine
the
amount
of
release
reported.
There
are
codes
which
allow
the
facility
to
indicate
whether
the
estimate
is
based
on
monitoring
data,
mass
balance
calculations,
published
emission
factors,
or
other
approaches
such
as
engineering
calculations
or
best
engineering
judgment.
By
looking
at
the
58735
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Register
/
Vol.
64,
No.
209
/
Friday,
October
29,
1999
/
Rules
and
Regulations
information
provided
through
the
use
of
these
codes,
users
of
the
data
can
gain
an
understanding
of
the
degree
of
accuracy
or
uncertainty
in
any
particular
number
reported
by
a
facility.
Thus,
EPA
believes
that
false
impressions
will
not
be
communicated
to
the
data
user
about
the
accuracy
of
the
information
filed.
Finally,
EPCRA
permits
facilities
to
use
reasonable
estimates
in
the
absence
of
readily
available
data
to
calculate
reportable
amounts.
Compliance
with
EPCRA
section
313
does
not
require
that
additional
monitoring
or
sampling
be
done.
Thus,
the
statute
contemplates
some
level
of
imprecision
in
the
data
that
may
be
filed,
yet,
by
authorizing
reporting
based
on
reasonable
estimates,
affirms
the
community
right­
to­
know
purposes
relative
to
information
based
on
such
reasonable
estimates.
Reporting
releases
of
low
volumes
of
PBT
chemicals
based
on
such
reasonable
estimates
is
no
different
than
reporting
on
other
toxic
chemicals
based
on
the
same
kind
of
information.
The
TRI
data
that
has
been
reported
since
1987
is
a
blend
of
estimates
based
on
monitoring
data,
mass
balance
calculations,
published
emissions
factors,
and
engineering
calculations
or
engineering
judgment.
The
commenters
contend
that
eliminating
the
use
of
range
reporting
for
PBT
chemicals
would
be
extremely
burdensome
to
facilities.
EPA
explained
in
the
proposal
that
the
original
intent
of
providing
the
range
reporting
option
was
primarily
as
a
burden
reducing
measure
focused
on
small
businesses.
In
past
expansion
activities,
EPA
has
tried
to
retain
burden
reducing
options
wherever
feasible.
However,
EPA
does
not
expect
the
elimination
of
range
reporting
to
significantly
affect
the
unit
cost
of
reporting
because
many
facilities
that
could
use
range
reporting
are
not
choosing
to
do
so.
An
analysis
of
the
1997
data
reported
under
EPCRA
section
313
reveals
that
the
number
of
instances
in
which
a
range
code
was
used
for
reporting
quantities
in
sections
5
and
6
of
the
Form
R
was
37,168.
These
37,168
instances
included
7,605,305
pounds
of
releases
and
transfers
using
the
median
of
the
range
code
reported.
However,
there
were
66,842
instances
in
which
range
reporting
could
have
been
used
(i.
e.,
the
amounts
reported
where
below
1,000
pounds),
but
the
reporting
facility
chose
instead
to
report
a
number
rather
than
a
range.
These
66,842
instances
included
13,662,758
pounds
of
releases
and
transfers.
Thus,
in
64%
of
the
instances
where
range
reporting
could
have
been
used
facilities
reported
a
number
instead.
The
fact
that
in
a
majority
of
the
instances
in
which
range
reporting
could
have
been
used
facilities
opted
to
report
specific
numbers
would
appear
to
indicate
that
the
elimination
of
range
reporting
for
PBT
chemicals
is
unlikely
to
impose
any
significant
additional
burden
on
facilities.
Therefore,
EPA
does
not
expect
the
elimination
of
range
reporting
to
have
any
significant
effect
on
unit
reporting
costs.
Commenters
also
argue
that
the
elimination
of
the
use
of
range
reporting
for
PBT
chemicals
could
result
in
an
increase
in
the
threat
to
confidential
information
and
a
possible
increase
in
trade
secret
claims.
Commenters
maintain
that
Congress
considered
the
need
to
protect
trade
secret
information
in
the
discussion
of
reporting
chemical
use
and
presence
in
ranges
for
EPCRA
section
313:

The
conference
substitute
provides
for
reporting
categories
of
use
and
ranges
of
chemicals
present
because
the
exact
use
of
an
identified
chemical
at
a
facility
or
the
exact
amount
present
may
disclose
secret
processes.
In
some
circumstances,
this
information
may
need
to
be
reported
in
terms
of
broad
43
categories
of
use
or
amount
ranges.
.
.
.
(H.
R.
Report
No.
99±
962,
298)

However,
EPA
believes
that
the
conference
report
language
cited
by
the
commenter
clearly
refers
only
to
the
use
of
range
reporting
for
the
data
element
entitled
``
maximum
amount
of
the
toxic
chemical
on­
site
at
any
time
during
the
calendar
year.
''
EPA
is
not
precluding
range
reporting
for
maximum
amounts
on­
site.
Contrary
to
the
notion
expressed
by
the
commenter,
Congress
did
not
expressly
direct
EPA
to
allow
range
reporting
for
the
reporting
of
releases
and
transfers
off­
site
for
further
waste
management.
Additionally,
in
the
statute,
Congress
provided
the
only
means
and
mechanism
for
facilities
to
protect
confidential
business
information
(CBI)
through
the
statute's
trade
secret
provisions.
If
the
commenter
believes
that
any
report
filed
might
reveal
confidential
information
as
to
the
identity
of
the
chemical,
the
commenter
may
choose
to
file
a
CBI
claim
by
following
the
procedures
as
outlined
in
40
CFR
part
350.
In
addition,
the
statute
is
clear
that
trade
secret
claims
may
only
be
made
for
the
identity
of
the
chemical.
Therefore,
EPA
believes
that
Congress
adequately
provided
procedures
for
the
protection
of
CBI
and
that
a
possible
increase
in
CBI
claims
does
not
outweigh
the
need
for
increased
information
on
releases
and
other
waste
management
of
PBT
chemicals.
See,
Legislative
History
at
5185.
Commenters
also
argue
that
eliminating
the
use
of
range
reporting
for
PBT
chemicals
will
not
result
in
the
collection
of
substantial
additional
release
information.
EPA
disagrees.
The
issue
of
range
reporting
is
closely
tied
to
the
lowering
of
the
reporting
thresholds
for
PBT
chemicals.
As
EPA
noted
in
the
proposal,

Since
PBT
chemicals
can
remain
in
the
environment
for
a
significant
amount
of
time
and
can
bioaccumulate
in
animal
tissues,
even
relatively
small
releases
of
such
chemicals
from
individual
facilities
have
the
potential
to
accumulate
over
time
to
higher
levels
and
cause
significant
adverse
impacts
on
human
health
and
the
environment.

EPA
also
noted
in
the
proposal
that,

Under
current
reporting
thresholds,
a
significant
amount
of
the
releases
and
other
waste
management
activities
involving
PBT
chemicals
are
not
being
captured
and
thus
the
public
does
not
have
the
information
needed
to
determine
if
PBT
chemicals
are
present
in
their
communities
and
at
levels
that
may
pose
a
significant
risk.

Therefore,
by
the
lowering
of
reporting
thresholds,
EPA
will
receive
important
information
on
the
quantities
of
PBT
chemicals
being
released
or
otherwise
managed
as
waste.
Given
the
lowering
of
the
reporting
thresholds,
continued
use
of
ranges
could
misrepresent
data
accuracy
because
the
low
or
the
high
end
range
numbers
may
not
really
be
that
close
to
the
estimated
value,
even
taking
into
account
any
inherent
error
(i.
e.,
errors
in
measurements
and
developing
estimates).
The
user
of
the
data
must
make
a
determination
on
whether
to
use
the
low
end
of
the
range,
the
mid­
point,
or
the
upper
end.
For
example,
a
release
of
501
pounds
could
be
misinterpreted
as
999
pounds
if
reported
as
a
range
of
500±
999.
This
represents
a
nearly
100%
error.
This
uncertainty
severely
limits
the
applicability
of
release
information
where
the
majority
of
releases,
particularly
for
PBT
chemicals,
are
expected
to
be
within
the
amounts
eligible
for
range
reporting.
Given
that
the
large
uncertainty
would
be
part
of
these
data
and
would
severely
limit
their
utility,
EPA
has
concluded
that
facilities
must
report
numerical
values,
not
ranges,
for
PBT
chemicals.
In
addition
to
the
above
comments,
several
commenters
recommend
the
use
of
multiple
ranges
rather
than
total
elimination
of
ranges
just
for
PBT
chemicals.
One
commenter
generally
agrees
with
EPA's
position
that
reporting
ranges
``
B''
(11
to
499
pounds)
and
``
C''
(500
to
999
pounds),
as
they
currently
exist,
may
be
too
broad
to
provide
meaningful
information
for
PBT
chemicals.
Because
the
proposal
does
not
impose
any
new
obligation
to
measure
or
test
beyond
what
is
currently
required,
however,
the
commenter
believes
it
is
still
58736
Federal
Register
/
Vol.
64,
No.
209
/
Friday,
October
29,
1999
/
Rules
and
Regulations
appropriate
to
retain
the
``
A''
reporting
range
of
1
to
10
pounds
for
PBT
chemicals.
The
commenter
contends
that
the
use
of
a
specific
number
conveys
a
sense
of
precision
that
may
not
actually
exist.
The
commenter
argues
that
the
retention
of
the
``
A''
reporting
range
in
its
current
form,
coupled
with
the
new
reporting
range
of
``
greater
than
zero,
but
less
than
1
pound,
''
will
provide
meaningful
and
valuable
information
to
the
public
on
PBT
chemical
transfers
or
releases.
Another
commenter
agrees
with
the
purpose
underlying
the
EPA's
proposal
to
prohibit
the
use
of
range
reporting
for
PBT
chemicals
and
believes
the
ranges
authorized
under
the
current
rules
are
too
broad
to
be
useful
for
PBT
chemicals.
However,
the
commenter
believes
that
EPA
should
recognize
that
reporting
in
ranges
is
often
necessary
because
uncertainty
makes
the
selection
of
a
single
number
arbitrary.
Another
commenter
argues
that
EPA
should
retain
range
reporting
for
PBT
chemicals,
even
if
the
ranges
are
lower
than
those
allowed
for
non­
PBT
chemicals.
The
commenter
further
contends
that
they
believe
that
range
reporting
helps
to
correct
some
of
the
error
introduced
to
EPCRA
section
313
reporting
through
the
use
of
estimates.
EPA
disagrees
that
the
Agency
should
retain
the
``
A''
reporting
range
of
1
to
10
pounds
for
PBT
chemicals
or
that
the
Agency
should
retain
some
form
of
range
reporting
for
PBT
chemicals.
As
stated
in
the
proposal,
EPA
believes
that
the
use
of
ranges
could
misrepresent
data
accuracy
because
the
low
or
the
high
end
range
numbers
may
not
really
be
that
close
to
the
estimated
value,
even
taking
into
account
its
inherent
error
(i.
e.,
error
in
measurements
and
developing
estimates).
The
user
of
the
data
must
make
a
determination
on
whether
to
use
the
low
end
of
the
range,
the
mid­
point,
or
the
upper
end.
For
example,
a
release
of
501
pounds
could
be
misinterpreted
as
999
pounds
if
reported
as
a
range
of
500±
999.
This
represents
a
nearly
100%
error.
Even
with
a
lower
range
such
as
1
to
10
pounds,
the
uncertainty
associated
with
range
reporting
could
severely
limit
the
applicability
of
release
information
for
PBT
chemicals.
Numerical
values
are
particularly
important
since
PBT
chemicals
can
remain
in
the
environment
for
a
significant
amount
of
time
and
can
bioaccumulate
in
animal
tissues.
This
means
that
even
relatively
small
releases
of
such
chemicals
from
individual
facilities
have
the
potential
to
accumulate
over
time
to
higher
levels
and
cause
adverse
impacts
on
the
environment
and
organisms.
The
utility
of
these
data
would
be
limited
given
the
uncertainty
associated
with
data
reported
using
ranges.
Therefore,
due
to
this
uncertainty,
EPA
is
requiring
that
facilities
report
numerical
values,
not
ranges,
for
PBT
chemicals.
In
addition,
EPA
believes
that
the
information
available
to
the
typical
EPCRA
section
313
reporter
is
generally
greater
and
more
accessible
than
it
was
10
years
ago.
Because
of
this
improved
information
availability,
EPA
believes
that
facilities
will
be
able
to
accurately
estimate
releases
and
off­
site
transfers
for
further
waste
management
of
PBT
chemicals
in
quantities
of
less
than
1,000
pounds
without
the
use
of
range
codes.
Although
it
may
be
true
that
some
facilities
will
be
better
able
to
make
those
estimates
than
others,
EPA
does
not
believe
this
justifies
not
collecting
the
more
specific
and
useful
information
from
those
facilities
that
can
provide
it.
Further,
in
the
Form
R,
facilities
are
required,
for
each
release
or
transfer
amount,
to
indicate
the
principal
method
used
to
determine
the
amount
of
release
reported.
There
are
codes
which
allow
the
facility
to
indicate
whether
the
estimate
is
based
on
monitoring
data,
mass
balance
calculations,
published
emission
factors,
or
other
approaches
such
as
engineering
calculations
or
best
engineering
judgment.
By
looking
at
the
information
provided
through
the
use
of
these
codes,
users
of
the
data
can
gain
an
understanding
of
the
degree
of
accuracy
or
uncertainty
in
any
particular
number
reported
by
a
facility.
Thus,
EPA
does
not
believe
that
false
impressions
will
be
communicated
to
the
data
user
about
the
accuracy
of
the
information
filed.
Finally,
as
noted
earlier
EPCRA
permits
facilities
to
use
reasonable
estimates
in
the
absence
of
readily
available
data
to
calculate
reportable
amounts.
EPCRA
does
not
require
that
additional
monitoring
or
sampling
be
done
in
order
to
report.
Thus,
the
statute
contemplates
some
level
of
imprecision
in
the
data
that
may
be
filed,
yet,
by
authorizing
reporting
based
on
reasonable
estimates,
affirms
the
community
right­
to­
know
purposes
relative
to
information
based
on
such
reasonable
estimates.
A
number
of
commenters
agreed
with
EPA's
proposal
that
range
reporting
be
eliminated
for
all
PBT
chemicals
on
the
EPCRA
section
313
list.
The
commenters
agreed
with
EPA's
belief
that
the
use
of
ranges
could
misrepresent
data
accuracy
and
significantly
impact
the
usefulness
of
the
data.
J.
Other
Issues
1.
Placing
reported
data
into
context.
Several
commenters
make
the
same
general
comment
that
EPCRA
section
313
does
not
capture
all
sources
of
PBT
chemical
releases
and
therefore
will
not
provide
a
complete
or
accurate
picture
of
the
releases
of
these
chemicals.
Commenters
criticize
the
proposal
for
not
putting
the
PBT
releases
from
EPCRA
section
313
covered
facilities
into
context,
in
terms
of
either
risk
or
the
amount
of
PBT
releases
expected
from
non­
covered
facilities
or
sources.
EPA
disagrees
with
the
implication
by
several
commenters
that
simply
because
EPCRA
section
313
may
not
capture
all
the
sources
of
releases
of
PBT
chemicals
EPA
should
not
attempt
to
capture
more
information
from
the
facilities
that
do
report
under
EPCRA
section
313.
This
comment
has
been
voiced
in
every
major
rulemaking
under
EPCRA
section
313
but,
as
EPA
has
stated
in
the
past,
this
is
not
an
argument
that
EPA
believes
should
restrict
any
efforts
to
collect
additional
data
under
EPCRA
section
313.
The
mere
fact
that
for
some
chemicals
significant
release
sources
are
not
captured
does
not
in
any
way
diminish
the
importance
of
the
information
that
can
be
provided
by
those
facilities
that
are
required
to
report
under
EPCRA
section
313.
There
is
currently
no
one
single
reporting
requirement
that
captures
all
of
the
releases
of
PBT
chemicals
and
makes
that
information
available
to
the
public.
For
those
chemicals
that
do
have
large
release
sources
not
captured
under
EPCRA
section
313,
EPA
will
use
all
available
data
to
aid
its
actions
and
those
of
other
international
and
national
organizations
and
the
public
in
efforts
to
address
concerns
on
PBT
chemicals.
For
example,
all
data
will
be
considered
to
aid
EPA's
PBT
strategy
or
other
EPA
PBT
related
programs;
EPA
will
not
rely
solely
on
the
data
collected
under
EPCRA
section
313.
In
addition,
if
there
are
significant
sources
of
PBT
chemicals
that
are
not
reported
under
EPCRA
section
313,
EPA
will
attempt
to
let
the
public
know
that
some
sources
are
not
captured.
In
fact,
in
the
most
recent
TRI
data
release
documents,
EPA
has
been
providing
information
to
the
pubic
on
other
sources
of
releases
for
certain
EPCRA
section
313
chemicals.
In
addition,
EPA
will
continue
to
improve
and
augment
public
information
materials
so
that
users
of
the
data
will
have
information
available
to
put
in
context
the
releases
and
other
waste
management
of
PBT
chemicals
by
industries
reporting
under
EPCRA
section
313
versus
those
industries
that
do
not
report
under
EPCRA
section
313.
58737
Federal
Register
/
Vol.
64,
No.
209
/
Friday,
October
29,
1999
/
Rules
and
Regulations
In
fact,
rather
than
an
argument
against
lowering
the
reporting
thresholds
for
PBT
chemicals,
EPA
believes
that
the
argument
the
commenters
are
making
is
one
that
supports
expanding
the
types
of
facilities
that
should
be
required
to
report
under
EPCRA
section
313
and
not
an
argument
that
supports
denying
the
public
the
right­
to­
know
about
PBT
chemical
releases
from
EPCRA
section
313
covered
facilities.
Some
commenters
stated
that
since
EPA
did
not
use
exposure
or
risk
considerations,
the
data
on
PBT
chemical
releases
will
be
misleading
to
the
public
by
indicating
risks
where
none
exist.
EPCRA
section
313
is
not
a
risk­
based
reporting
system,
and,
as
discussed
in
Unit
VI.
F.,
EPA
believes
that
a
risk­
based
approach
to
EPCRA
section
313
reporting
is
at
odds
with
the
overriding
policy
of
EPCRA
section
313,
which
is
to
get
information
about
the
use,
disposition,
and
management
of
toxic
chemicals
into
the
public
domain,
enabling
the
users
of
this
information
to
evaluate
the
information
and
draw
their
own
conclusions
about
risk.
The
intent
of
EPCRA
section
313
is
to
move
the
determination
of
which
risks
are
acceptable
from
EPA
to
the
communities
in
which
the
releases
occur.
This
basic,
local
empowerment
is
a
cornerstone
of
the
right­
to­
know
program.
In
addition,
EPA
will
continue
to
improve
its
annual
public
data
release
as
well
as
its
outreach
and
education
efforts
to
assist
users
in
understanding
the
data.
Consequently,
EPA
disagrees
with
the
commenters
that
the
information
reported
on
releases
and
other
waste
management
of
PBT
chemicals
will
be
misleading
to
the
public.
Another
commenter
states
that
the
quantities
of
PBT
chemicals
reported
in
the
TRI
will
be
far
smaller
than
the
quantities
of
other
chemicals
which
pose
far
less
significant
health
risks.
The
commenter
is
concerned
that
the
small
quantities
could
lead
members
of
the
public
to
overlook
the
data
on
PBT
chemicals.
Therefore,
the
commenter
argues
that
EPA
should
present
PBT
data
in
a
way
that
draws
the
public's
attention
to
it.
The
commenter
states
that
it
sees
a
danger
that
without
sufficient
education
and
guidance,
the
public
may
either
overestimate
or
underestimate
the
health
risks
from
PBT
chemicals.
The
commenter
believes
that
EPA
should
make
a
commitment
to
ensuring
that
the
public
is
given
the
necessary
education
and
guidance.
EPA
understands
that
the
quantities
of
PBT
chemicals
may
be
reported
in
smaller
quantities
than
other
chemicals
under
EPCRA
section
313
and
that
these
quantities
have
the
potential
to
be
overlooked.
EPA
is
also
sensitive
to
the
issue
that
data
on
PBT
chemicals
must
be
presented
clearly
to
assist
data
users
in
understanding
how
the
information
on
PBT
chemicals
is
different
from
that
reported
on
other
chemicals
under
EPCRA
section
313.
EPA
will
continue
to
improve
its
annual
public
data
release
as
well
as
its
outreach
and
education
efforts
to
assist
users
in
understanding
the
data.
Despite
the
concerns
voiced
by
the
commenters,
EPA
still
believes
that
it
is
important
to
collect
and
disseminate
this
information
so
that
communities
can
use
the
information
with
other
site­
specific
factors
to
determine
if
releases
into
their
communities
result
in
risks
that
the
community
determines
warrant
further
action
given
other
factors,
such
as
economic
and
environmental
conditions,
or
particularly
vulnerable
human
or
ecological
populations.
Another
commenter
expresses
concern
that
release
numbers
for
PBT
chemical
will
not
be
comparable
to
those
for
other
chemicals
with
higher
reporting
thresholds
or
to
releases
of
the
PBT
chemical
in
previous
years.
The
commenter
adds
that
the
lower
thresholds
may
mislead
the
public
into
thinking
that
releases
are
rising
or
that
a
new
chemical
has
been
introduced
at
a
facility.
EPA
understands
the
commenter's
concern
but
does
not
believe
this
is
a
justification
for
not
collecting
additional
information
about
PBT
chemicals.
EPA
believes
that
it
will
be
able
to
adequately
explain
to
the
public
the
different
reporting
requirements
for
PBT
chemicals
so
that
they
are
put
in
context
of
other
TRI
data.
EPA
will
make
clear
which
PBT
chemicals
were
reportable
prior
to
the
finalization
of
this
rule
and
what
the
reporting
threshold
was
for
these
chemicals.
Finally,
EPA
will
continue
to
improve
its
annual
public
data
release
as
well
as
its
outreach
and
education
efforts
to
assist
users
in
understanding
the
data.
2.
Manufacture
only
qualifier
for
chemicals
other
than
dioxin.
Many
commenters
request
that
EPA
add
a
``
manufacture
only''
qualifier
to
all
PBT
chemicals,
not
just
the
dioxin
and
dioxin­
like
compounds
category.
The
commenters
assert
that
the
addition
of
the
manufacture
only
qualifier
to
all
PBT
chemicals
would
greatly
reduce
the
burden
of
the
rule.
Some
commenters
suggest
that
at
a
minimum
the
manufacture
only
qualifier
should
apply
to
polychlorinated
biphenyls
(PCBs),
since
EPA's
rationale
for
applying
the
qualifier
to
dioxin
and
dioxin­
like
compounds
is
equally
applicable
to
PCBs.
One
commenter
contends
that
EPA's
statement
that
the
manufacture
qualifier
is
appropriate
for
chemicals
that
are
``
ubiquitous
in
the
environment''
because
otherwise
many
facilities
would
be
required
to
report
simply
due
to
background
levels
in
raw
materials
applies
to
PCBs
as
well.
Some
commenters
suggest
that
unintentionally
manufactured
byproducts
such
as
hexachlorobenzene
and
octachlorostyrene
should
also
have
the
manufacture
only
qualifier.
Some
commenters
argue
that
the
burden
of
the
rule
could
be
significantly
reduced
if
EPA
focused
the
reporting
effort
on
the
manufacturing
sector,
which
should
help
concentrate
EPA's
pollution
prevention
efforts
on
the
sector
most
likely
to
be
able
to
make
reductions.
Some
commenters
contend
that
the
primary
source
for
PBT
chemicals
within
the
EPCRA
section
313
reporting
sectors
is
from
manufacturing,
and
these
are
the
sources
that
should
be
focused
on
for
tracking
PBT
chemicals.
Some
commenters
assert
that
EPA
has
acknowledged
that
many
chemicals
identified
as
persistent
and
bioaccumulative
are
not
imported,
processed,
or
otherwise
used,
but
are
manufactured
as
by­
products
(at
64
FR
715).
Some
commenters
assert
that
they
agree
that
manufacturing
is
the
primary
source
for
environmental
loading
of
PBT
chemicals
from
EPCRA
section
313
facilities,
and
thus
the
effort
for
reporting
should
be
concentrated
on
the
sources
where
PBT
chemicals
are
generated
and
data
can
be
gathered.
Some
commenters
argue
that
concentration
on
the
manufacturing
of
PBT
chemicals
provides
an
efficient
focus
for
meaningful
pollution
prevention
efforts.
Some
commenters
assert
that
they
are
concerned
that
data
from
importing,
processing,
or
otherwise
use
of
PBT
chemicals
will
be
inaccurate
and
misleading
since
processors
and
users
may
not
have
the
resources
to
conduct
the
analyses
required
to
provide
accurate
estimates.
One
commenter
contends
that
the
fear
of
enforcement
might
motivate
those
importing,
processing,
or
otherwise
using
PBT
chemicals
to
report
``
some
amount''
and
that
such
information
is
likely
to
be
inaccurate,
and
will
not
accurately
reflect
the
true
level
of
concern.
Some
commenters
assert
that
instead
of
requiring
reports
from
the
many
sources
where
effective
emissions
reductions
may
not
be
possible,
that
the
addition
of
a
manufacture
only
activity
qualifier
for
all
PBT
chemicals
will
provide
the
public
with
the
most
accurate
information
on
PBT
chemical
emissions
and
the
best
opportunity
to
monitor
EPCRA
section
313­
related
58738
Federal
Register
/
Vol.
64,
No.
209
/
Friday,
October
29,
1999
/
Rules
and
Regulations
environmental
loading
of
these
chemicals.
EPA
believes
that
in
order
to
obtain
any
reporting
on
dioxin
and
dioxin­
like
compounds
a
very
low
threshold
is
required,
which
is
several
orders
of
magnitude
lower
than
the
thresholds
for
other
PBT
chemicals.
At
such
a
low
reporting
threshold
it
is
estimated
that
thousands
of
reports
could
potentially
be
filed
by
facilities,
mainly
food
processing
facilities,
due
to
the
amount
of
dioxins
in
the
raw
materials
they
process.
The
dioxins
found
in
the
meat
and
dairy
products
that
food
processors
handle
have
been
previously
released,
circulated
in
the
environment,
and
bioaccumulated
in
animals,
thus
these
are
not
additional
loadings
to
the
environment
but
loadings
that
have
already
occurred
and
cycled
through
the
environment
due
to
the
persistence
and
bioaccumulative
properties
of
these
compounds.
The
unique
combination
of
very
low
thresholds,
the
number
of
food
processors
that
would
be
required
to
file,
and
the
fact
that
they
would
be
filing
because
of
the
bioaccumulation
of
previously
released
material
led
EPA
to
propose
to
add
only
dioxin
and
dioxinlike
compounds
that
are
manufactured.
EPA
is
finalizing
the
addition
of
dioxin
with
a
revised
qualifier
in
response
to
the
unique
set
of
conditions
that
apply
to
the
reporting
of
dioxin
and
dioxinlike
compounds.
EPA
proposed
and
is
finalizing
the
addition
of
dioxin
with
a
qualifier
to
reduce
reporting
burden
on
facilities,
mainly
in
the
food
processing
industry,
that
results
from
the
unique
combination
of
circumstances
related
to
the
reporting
for
these
chemicals
and
to
focus
on
those
activities
that
add
to
the
loading
of
dioxins
in
the
environment
rather
than
on
activities
dealing
with
previously
released
and
bioaccumulated
chemicals.
EPA
did
not
conclude
and
does
not
believe
that
the
manufacturing
activity
is
the
only
important
source
of
PBT
chemical
releases
to
the
environment
and
believes
that
other
activities
such
as
processing
or
use
can
result
in
significant
releases
of
PBT
chemicals,
including
chemicals
released
to
the
environment
for
the
first
time.
As
discussed
in
Unit
VI.
G.,
EPA
has
modified
the
dioxin
qualifier
to
reflect
this.
The
unique
combination
of
circumstances
that
exists
for
dioxin
and
dioxin­
like
compounds
does
not
exists
for
any
of
the
other
PBT
chemicals
being
added
by
this
rule.
EPA
did
not
conclude
that
the
manufacture
qualifier
is
generally
appropriate
for
other
chemicals
that
are
being
added
and
that
are
``
ubiquitous
in
the
environment.
''
The
full
statement
in
the
proposal
was
``
These
dioxin
and
dioxin­
like
compounds
are
ubiquitous
in
the
environment
and
thus
under
the
very
low
reporting
thresholds
necessary
to
get
reports
from
any
sources
(see
discussion
in
Unit
VII.
A.
2.),
facilities
that
process
raw
materials
would
be
required
to
report
simply
because
the
raw
material
contains
background
levels
of
these
chemicals''
(at
64
FR
710).
Clearly
EPA
made
this
statement
in
the
context
of
the
``
very
low
reporting
thresholds
necessary
to
get
reports
[for
the
dioxin
and
dioxin­
like
compounds
category]
from
any
sources.
''
This
statement
is
consistent
with
the
unique
combination
of
circumstances
that
exists
for
dioxin
and
dioxin­
like
compounds
and
was
not
intended
to
apply
to
all
PBT
chemicals.
Neither
did
EPA
conclude
that
the
manufacturing
activity
is
the
activity
for
which
facilities
would
be
most
likely
to
be
able
to
make
reductions
or
that
EPA's
pollution
prevention
efforts
should
focus
solely
on
the
manufacturing
of
PBT
chemicals.
Commenters
provided
no
basis
for
such
a
conclusion
and
EPA
believes
that
processors
and
users
of
PBT
chemicals
also
have
the
opportunity
to
make
effective
emissions
reductions
by
using
less
of
a
PBT
chemical,
by
not
using
materials
that
contain
PBT
chemicals
as
contaminants,
etc.
In
addition,
the
purposes
of
reporting
under
EPCRA
section
313
are
not
limited
to
the
collection
of
information
from
sources
where
effective
reductions
in
release
and
other
waste
management
quantities
are
possible.
Data
collected
under
EPCRA
section
313
can
serve
a
variety
of
information
purposes
that
do
not
depend
on
how
easy
it
is
for
the
source
to
achieve
reduction
in
releases
and
other
waste
management.
The
commenter
statement
that
EPA
has
acknowledged
that
many
chemicals
identified
as
persistent
and
bioaccumulative
are
not
imported,
processed,
or
otherwise
used,
but
are
manufactured
as
by­
products,
is
incorrect.
The
actual
statement
was:
``[
m]
any
of
the
chemicals
identified
as
persistent
and
bioaccumulative
in
today's
action
are
not
imported,
processed,
or
otherwise
used
but
are
manufactured
as
by­
products''
(at
64
FR
715).
As
the
words
``
today's
action''
clearly
demonstrate,
this
statement
was
not
a
broad
statement
about
all
PBT
chemicals
but
simply
an
acknowledgment
that
many
of
the
PBT
chemicals
in
the
proposed
rule
were
byproducts
In
addition,
this
statement
was
made
in
the
context
of
the
discussion
on
the
de
minimis
exemption
about
how
removing
the
exemption
for
PBT
chemicals
would
affect
the
chemicals
in
the
proposed
rule;
it
was
not
a
statement
made
in
connection
with
the
discussion
on
the
manufacture
only
qualifier.
EPA
also
did
not
state
that
manufacturing
is
the
primary
source
for
environmental
loading
of
PBT
chemicals
from
facilities
covered
under
EPCRA
section
313.
The
discussion
on
the
loading
of
chemicals
in
the
environment
from
manufacturing
was
in
relation
to
the
reporting
of
dioxin
which,
as
discussed
above,
presents
a
unique
combination
of
circumstances
that
EPA
considered
to
determine
how
to
focus
its
listing
decision
and
does
not
apply
to
all
PBT
chemicals.
EPA
disagrees
with
the
statements
that
data
from
facilities
that
import,
process,
or
otherwise
use
PBT
chemicals
will
be
inaccurate
and
misleading
or
that
such
facilities
will
report
some
quantity
out
of
fear
of
enforcement
and
that
such
information
is
likely
to
be
inaccurate,
and
will
not
accurately
reflect
the
true
level
of
concern.
EPA
believes
that
facilities
that
import,
process,
or
otherwise
use
PBT
chemicals
will
be
just
as
able
to
report
as
facilities
that
manufacture
PBT
chemicals.
It
is
no
more
difficult
to
do
calculations
regarding
small
numbers
than
it
is
to
do
calculations
on
larger
numbers,
so
if
a
facility
that
imports,
processes,
or
otherwise
uses
PBT
chemicals
has
information
that
allows
them
to
make
a
reasonable
estimation
of
quantities
then
they
should
be
just
as
able
to
report
as
any
manufacturing
facility
would
be
able
to
report
on
small
quantities
manufactured
as
by­
products.
If
facilities
that
import,
process,
or
otherwise
use
PBT
chemicals
do
not
have
data
available
that
allows
them
to
make
a
reasonable
estimation
of
quantities
then
they
are
not
required
to
report.
As
for
fear
of
enforcement,
EPA
can
take
enforcement
actions
both
for
under
reporting
and
over
reporting
so
facilities
should
not
report
an
amount
of
a
PBT
chemical
in
order
to
avoid
an
enforcement
action.
EPA
does
not
believe
that
the
unique
combination
of
circumstances
that
exists
for
dioxin
and
dioxin­
like
compounds
exists
for
any
of
the
other
PBT
chemicals
being
added
by
this
rule
nor
does
EPA
believe
that
reduced
burden
or
any
of
the
other
reasons
suggested
by
the
commenters
provide
a
sufficient
reason
to
focus
on
manufacturing
activity
only
for
the
other
PBT
chemicals
in
this
rule.
Therefore,
EPA
does
not
believe
that
it
is
appropriate
to
add
a
manufacture
only
qualifier
to
any
of
the
other
PBT
chemicals
in
this
rule.
3.
Waste
management
issues.
Some
commenters
contend
that
because
activities
such
as
recycling,
approved
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/
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1999
/
Rules
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Regulations
waste
disposal,
and
treatment
are
incorporated
into
reported
volumes,
the
EPCRA
section
313
reported
releases
will
be
substantial
overestimates
of
the
actual
quantities
released
to
the
ambient
environment.
They
further
argue
that
although
this
information
may
be
useful
to
source
reduction
efforts,
merging
of
reporting
requirements
under
section
313
of
EPCRA
and
section
6607
of
PPA
has
resulted
in
information
which
is
misleading
to
the
public's
desire
to
know
the
actual
exposures
that
are
occurring.
Another
commenter
asserts
that
by
requiring
electricity
generating
facilities
to
report
transfers
off­
site
for
treatment
and
disposal
of
PCBs
from
transformers,
EPA
has
established
a
disincentive
to
properly
dispose
of
PCB
transformers
and
remove
them
from
use
because
most
PCB
wastes
transferred
to
off­
site
facilities
are
destroyed
in
regulated
units
which
destroy
at
least
99.9999%
of
the
PCBs.
They
are
concerned
that
because
the
casual
reader
may
conclude
additional
releases
of
PCBs
to
the
environment
have
occurred,
companies
would
have
a
disincentive
to
voluntarily
remove
PCBs.
The
commenters
are
incorrect
in
stating
that
EPCRA
section
313
release
quantities
include
recycling
and
treatment
amounts.
Under
EPCRA
section
313,
if
a
chemical
activity
threshold
is
met
for
the
chemical,
covered
facilities
are
required
to
report
the
quantity
of
the
toxic
chemical
entering
each
environmental
medium;
this
includes
``
releases.
''
The
definition
of
release
pursuant
to
EPCRA
section
329(
8)
means:

any
spilling,
leaking,
pumping,
pouring,
emitting,
emptying,
discharging,
injecting,
escaping,
leaching,
dumping,
or
disposing
into
the
environment
(including
the
abandonment
or
discarding
of
barrels,
containers,
and
other
closed
receptacles)
of
any
hazardous
chemical,
extremely
hazardous
substance,
or
toxic
chemical.

There
is
no
language
in
this
definition,
any
other
provision
of
EPCRA,
or
in
the
regulations
promulgated
pursuant
to
EPCRA
section
313,
that
limit
this
definition
to
ambient
releases
to
the
environment
which
may
result
in
public
exposure.
In
fact
the
definition
specifically
includes
disposing
of
toxic
chemicals
as
well
as
the
abandonment
of
closed
receptacles.
In
addition,
neither
the
statute
nor
the
regulations
limit
this
definition
to
on­
site
releases.
Therefore,
the
statutory
definition
of
release
under
EPCRA
section
313
is
significantly
broader
than
the
commenter
seems
to
believe.
In
addition
to
release
reporting,
under
section
6607(
b)(
1)
of
the
PPA,
if
a
covered
facility
meets
the
reporting
thresholds
under
EPCRA
section
313,
the
facility
is
required
to
report
the
``
quantity
of
the
chemical
entering
any
wastestream
(or
otherwise
released
to
the
environment).
.
.
.''
This
quantity
includes
amounts
of
the
toxic
chemical
released,
treated,
and
recycled.
However,
this
quantity
does
not
include:
[t]
he
amount
of
any
toxic
chemical
released
into
the
environment
which
resulted
from
a
catastrophic
event,
remedial
action,
or
other
one
time
event,
and
is
not
associated
with
production
processes
during
the
reporting
year.
(PPA
6607
(b)(
7))
(emphasis
added)
Therefore,
the
quantity
of
the
toxic
chemical
entering
the
wastestream
as
collected
under
section
6607(
b)(
1)
of
the
PPA,
is
the
amount
of
the
toxic
chemical
in
production
related
waste.
Covered
facilities
currently
report
the
amount
of
the
toxic
chemical
in
production
related
waste
as
quantities
of
the
toxic
chemical
released,
treated,
combusted
for
energy
recovery
and
recycled.
These
quantities
are
collected
as
separate
data
elements
in
section
8
of
the
Form
R.
Further,
facilities
report
the
ultimate
disposition
of
toxic
chemicals
in
waste
such
that
these
quantities
(i.
e.,
amounts
released,
treated,
combusted
for
energy
recovery,
and
recycled)
are
mutually
exclusive.
Collectively,
then,
these
quantities
are
the
amount
entering
the
waste
stream
or
the
quantity
of
the
toxic
chemical
in
production
related
waste.
For
example,
a
covered
facility
transfers
1,000,000
pounds
of
PCBs
to
an
incinerator
for
treatment.
The
covered
facility
knows
that
999,999
pounds
are
destroyed
in
the
incinerator
and
the
remaining
1
pound
is
disposed
in
a
landfill.
The
facility
reports
999,999
pounds
as
transferred
off­
site
for
treatment
and
1
pound
as
transferred
off­
site
for
disposal.
These
two
quantities
are
reported
as
separate
data
elements
on
the
Form
R.
The
quantity
reported
as
disposed
off­
site
is
considered
released
because,
as
explained
previously,
disposal
is
a
type
of
release.
The
entire
quantity
(1,000,000
pounds)
is
the
amount
of
production
related
waste.
Once
collected,
EPA
presents
the
TRI
data
to
the
public
in
a
number
of
formats.
In
its
annual
data
release
documents,
EPA
highlights
different
aspects
of
the
quantities
of
toxic
chemicals
released
and
otherwise
managed
as
waste.
For
example,
EPA
presents
total
on­
site
releases
and,
as
subsets,
presents
the
quantities
released
to
air,
surface
water,
underground
injection
and
on­
site
land
releases.
(See
1997
Toxics
Release
Inventory
(EPA
745±
R±
99±
003)
Figure
2­
3
``
TRI
On­
site
Releases'')
EPA
also
presents
the
quantity
of
total
releases
in
the
public
data
release.
As
discussed
earlier,
under
EPCRA
section
313,
release
quantities
are
not
limited
to
quantities
released
to
the
ambient
environment.
Therefore,
total
releases,
as
presented
in
the
public
data
release
include
both
on
and
off­
site
releases
as
well
as
a
variety
of
disposal
methods.
For
example,
in
Table
2­
20A
of
the
1997
public
data
release,
EPA
presents
TRI
on­
site
and
off­
site
releases
by
chemical
and
type
of
release
(e.
g.,
air
emissions,
underground
injection,
etc.)
(1997
Toxics
Release
Inventory;
EPA
745±
R±
99±
003).
In
addition
to
TRI
release
data,
EPA
presents
production
related
waste
quantities
in
the
public
data
release.
Because
production
related
waste
includes
releases,
EPA
includes
release
quantities
with
other
waste
management
quantities.
However,
in
this
document,
the
Agency
generally
distinguishes
quantities
of
the
toxic
chemical
released
from
other
types
of
waste
management.
EPA
does
not
count
the
quantities
of
toxic
chemicals
treated,
combusted
for
energy
recovery
or
recycled
as
quantities
released.
(See,
for
example,
1997
Toxics
Release
Inventory
(EPA
745­
R­
99­
003)
Table
2­
20A
``
TRI
On­
site
and
Off­
site
Releases,
by
Chemical,
1997''
and
Table
2­
20B
``
TRI
Chemicals
in
Waste,
by
Chemical,
1997'')
Further,
EPA
does
not
believe
that
the
TRI
program
provides
a
disincentive
for
the
proper
and
safe
handling
of
PCBs
in
transformers
managed
as
waste.
As
explained
earlier,
covered
facilities
are
required
under
EPCRA
section
313
and
section
6607
of
the
PPA
to
report
quantities
of
toxic
chemicals
released
or
otherwise
managed
as
waste
if
they
meet
a
chemical
activity
threshold.
Quantities
of
toxic
chemicals
sent
offsite
for
treatment
are
described
as
such.
These
transfers
are
not
included
as
releases.
In
addition,
EPA
disagrees
that
quantities
of
PCBs
sent
off­
site
for
treatment
will
be
misunderstood
by
the
public
because
these
quantities
are
accurately
represented
in
the
TRI
data
base
and
in
the
public
data
release
as
a
separate
type
of
waste
management.
Another
commenter
asserts
that
the
proposed
rule
will
not
encourage
waste
minimization
because
facilities
will
not
be
able
to
modify
process
designs
to
accomodate
such
minimization
simply
on
the
basis
of
data
generated
from
guidance
documents
or
reasonable
estimates.
The
commenter
asserts
that
although
industry
has
made
substantial
minimization
gains,
the
technology
is
not
available
to
treat
or
remove
chemicals
of
concern
from
manufactured
products
or
waste
(prior
to
generation)
at
such
low
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/
Rules
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Regulations
concentrations
and
that
any
future
improvements
will
be
enormously
expensive
due
to
the
low
concentrations
that
would
likely
be
involved.
EPA
disagrees
with
the
commenter.
In
the
preamble
to
the
proposed
rule,
EPA
did
not
assert
that
covered
facilities
will
begin
performing
waste
minimization
activities
as
a
direct
result
of
this
rulemaking.
Rather,
the
Agency
stated
that
the
PBT
chemical
rulemaking
will
provide
data
on
PBT
chemicals
to
EPA,
industry,
and
the
public.
For
example,
several
EPA
offices
have
ongoing
projects
and
programs
that
deal
with
issues
concerning
PBT
chemicals.
EPA
has
established
the
PBT
planning
group
which
is
a
coordinating
body
consisting
of
representatives
from
various
program
offices
throughout
EPA
that
are
dealing
with
PBT
chemicals.
This
group
has
developed
a
strategy
to
reduce
pollution
from
PBT
chemicals
through
the
application
of
regulatory
and
nonregulatory
authorities,
with
a
strong
emphasis
on
pollution
prevention.
The
availability
of
that
data,
in
turn,
can
allow
all
parties
to
identify
and
track
releases
of
PBT
chemicals
and
monitor
the
progress
of
the
programs
designed
to
reduce
the
amount
of
PBT
chemicals
entering
the
environment.
The
data
will
also
allow
EPA
and
others
to
design
prevention
strategies
that
are
focused
and
effective.
In
addition,
EPA
disagrees
with
the
commenter's
last
assertion
concerning
the
available
technology
and
its
costs.
Although
there
are
some
processes
that
might
not,
at
present,
be
amenable
to
source
reduction
in
terms
of
PBT
chemicals,
some
processes
may
be.
For
example,
it
may
be
possible
to
stringently
control
fuel
composition,
flow
times,
temperature,
and
other
conditions
in
order
to
substantially
reduce
or
even
eliminate
the
incidental
manufacture
of
dioxins
during
combustion
processes.
Therefore,
EPA
continues
to
believe
that
in
some
cases,
opportunities
for
pollution
prevention
will
present
themselves
resulting
from
information
reported
under
EPCRA
section
313
and
section
6607
of
the
PPA.
4.
Modulated
reporting
thresholds.
The
majority
of
commenters
contend
that
modulating
thresholds
for
reporting
so
that
lower
reporting
thresholds
are
used
every
other
year
(with
current
thresholds
used
in
alternate
years)
would
introduce
confusion
for
the
regulated
community
and
data
users
and
would
not
significantly
reduce
burden.
Further
it
could
discourage
facilities
from
establishing
common
standard
procedures
for
data
collection.
Modulation
will
also
result
in
data
gaps,
undermining
data
consistency
and
tracking.
Many
commenters
believe
that
annual
reporting
is
a
fundamental
attribute
of
TRI.
EPA
agrees
that
modulating
the
reporting
thresholds
would
introduce
confusion
for
both
the
regulated
community
and
data
users.
For
data
users,
EPA
believes
that
modulating
the
reporting
thresholds
would
limit
the
usefulness
of
the
TRI
data
because
there
would
be
poor
data
consistency
and
poorer
data
quality.
For
the
regulated
community,
EPA
believes
that
the
burden
reduction
would
not
be
significant
and
would
possibly
be
offset
by
the
confusion
that
would
be
introduced
by
different
thresholds
in
alternate
years.

VII.
What
Were
the
Results
of
EPA's
Economic
Analysis?
EPA
has
prepared
an
economic
analysis
of
the
impact
of
this
action,
which
is
contained
in
a
document
entitled
Economic
Analysis
of
the
Final
Rule
to
Modify
Reporting
of
Persistent
Bioaccumulative
Toxic
Chemicals
under
EPCRA
Section
313
(Ref.
67).
This
document
is
available
in
the
public
docket
for
this
rulemaking.
The
analysis
assesses
the
costs,
benefits,
and
associated
impacts
of
the
rule,
including
potential
effects
on
small
entities.
The
major
findings
of
the
analysis
are
briefly
summarized
here.

A.
What
is
the
Need
for
the
Rule?
Federal
regulations
exist,
in
part,
to
address
significant
market
failures.
Markets
fail
to
achieve
socially
efficient
outcomes
when
differences
exist
between
market
values
and
social
values.
Two
causes
of
market
failure
are
externalities
and
information
asymmetries.
In
the
case
of
negative
externalities,
the
actions
of
one
economic
entity
impose
costs
on
parties
that
are
``
external''
to
any
market
transaction.
For
example,
a
facility
may
release
toxic
chemicals
without
accounting
for
the
consequences
to
other
parties,
such
as
the
surrounding
community,
and
the
prices
of
that
facility's
goods
or
services
thus
will
fail
to
reflect
those
costs.
The
market
may
also
fail
to
efficiently
allocate
resources
in
cases
where
consumers
lack
information.
For
example,
where
information
is
insufficient
regarding
toxic
releases,
individuals'
choices
regarding
where
to
live
and
work
may
not
be
the
same
as
if
they
had
more
complete
information.
Since
firms
ordinarily
have
little
or
no
incentive
to
provide
information
on
their
releases
and
other
waste
management
activities
involving
toxic
chemicals,
the
market
fails
to
allocate
society's
resources
in
the
most
efficient
manner.
This
rule
is
intended
to
address
the
market
failures
arising
from
private
choices
about
PBT
chemicals
that
have
societal
costs,
and
the
market
failures
created
by
the
limited
information
available
to
the
public
about
the
release
and
other
waste
management
activities
involving
PBT
chemicals.
Through
the
collection
and
distribution
of
facilityspecific
data
on
toxic
chemicals,
TRI
overcomes
firms'
lack
of
incentive
to
provide
certain
information,
and
thereby
serves
to
inform
the
public
of
releases
and
other
waste
management
of
PBT
chemicals.
This
information
enables
individuals
to
make
choices
that
enhance
their
overall
well­
being.
Choices
made
by
a
more
informed
public,
including
consumers,
corporate
lenders,
and
communities,
may
lead
firms
to
internalize
into
their
business
decisions
at
least
some
of
the
costs
to
society
relating
to
their
releases
and
other
waste
management
activities
involving
PBT
chemicals.
In
addition,
by
helping
to
identify
areas
of
concern,
set
priorities
and
monitor
trends,
TRI
data
can
also
be
used
to
make
more
informed
decisions
regarding
the
design
of
more
efficient
regulations
and
voluntary
programs,
which
also
moves
society
towards
an
optimal
allocation
of
resources.
If
EPA
were
not
to
take
this
action
adding
certain
PBT
chemicals
to
EPCRA
section
313
and
lowering
reporting
thresholds,
the
market
failure
(and
the
associated
social
costs)
resulting
from
the
limited
information
on
the
release
and
other
waste
management
of
PBT
chemicals
would
continue.
EPA
believes
that
today's
action
will
improve
the
scope
of
multi­
media
data
on
the
release
and
other
waste
management
of
PBT
chemicals.
This,
in
turn,
will
provide
information
to
the
public,
empower
communities
to
play
a
meaningful
role
in
environmental
decision­
making,
and
improve
the
quality
of
environmental
decisionmaking
by
government
officials.
In
addition,
this
action
will
serve
to
generate
information
that
reporting
facilities
themselves
may
find
useful
in
such
areas
as
highlighting
opportunities
to
reduce
chemical
use
or
release
or
other
waste
management
and
thereby
lower
costs
of
production
and/
or
waste
management.
EPA
believes
that
these
are
sound
rationales
for
adding
chemicals
to
the
EPCRA
section
313
list
of
toxic
chemicals
and
lowering
reporting
thresholds
for
PBT
chemicals.

B.
What
Are
the
Costs
Associated
With
This
Rule?
This
action
will
result
in
the
expenditure
of
resources
that,
in
the
absence
of
the
regulation,
could
be
used
58741
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209
/
Friday,
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29,
1999
/
Rules
and
Regulations
for
other
purposes.
The
cost
of
the
rule
is
the
value
of
these
resources
in
their
best
alternative
use.
Most
of
the
costs
of
the
rule
result
from
requirements
on
industry.
Approximately
11,300
facilities
are
expected
to
submit
approximately
20,000
additional
Form
R
reports
annually.
The
estimated
composition
of
this
reporting,
by
chemical,
is
shown
in
Table
4.

Table
4.Ð
Summary
of
Chemical
Reporting
as
Estimated
for
Proposed
and
Final
Rules
Chemical
or
Chemical
Category
Estimated
Number
of
Reports
(Annual)

Proposed
Rule
Final
Rule
Alkyl
lead
(tetraethyl
lead
and
tetramethyl
lead)
134
N/
A
Benzo(
g,
h,
i)
perylene
353
909
Dioxin
and
dioxin­
like
compounds
category
1,863
1,475
Hexachlorobenzene
778
778
Mercury;
mercury
compounds
category
5,230
5,346
Octachlorostyrene
230
230
Pentachlorobenzene
707
707
Pesticides
(aldrin,
chlordane,
heptachlor,
isodrin,
methoxychlor,
pendimethalin,
toxaphene,
trifluralin)
264
264
Polycyclic
aromatic
compounds
(PACs)
category
4,699
7,166
Polychlorinated
biphenyls
(PCBs)
2,267
2,310
Tetrabromobisphenol
A
150
150
Vanadium;
vanadium
compounds
category
654
655
Total
17,329
19,990
Table
5
displays
the
industry
costs
for
this
action
based
on
the
estimated
number
of
facilities
affected
and
the
estimated
number
of
additional
reports.
Aggregate
industry
costs
in
the
first
year
for
the
rule
are
estimated
to
be
$145
million;
in
subsequent
years
they
are
estimated
to
be
$80
million
per
year.
Industry
costs
are
lower
after
the
first
year
because
facilities
will
be
familiar
with
the
reporting
requirements,
and
many
will
be
able
to
update
or
modify
information
from
the
previous
year's
report.
EPA
is
expected
to
expend
$2.0
million
in
the
first
year,
and
$1.6
million
in
subsequent
years
as
a
result
of
the
rule.

Table
5.Ð
Summary
of
Reporting
and
Associated
Costs
as
Estimated
for
Proposed
and
Final
Rules
Proposed
Rule
Final
Rule
Number
of
new
facilities
2,600
3,114
Total
number
of
facilities
9,515
11,257
Number
of
Form
Rs
submitted
17,329
19,990
First
year
industry
costs
$126
million
$145
million
Subsequent
year
industry
costs
$70
million
$80
million
EPA
costs
$1.4
million
$1.6
million
The
estimated
cost
of
the
final
rule
differs
from
the
estimated
cost
of
the
proposed
rule
as
shown
in
Table
5.
There
are
six
major
reasons
for
this
change.
First,
EPA
received
new
data
during
the
comment
period
on
the
concentrations
of
PACs
and
benzo(
g,
h,
i)
perylene
in
distillate
fuel
oil.
Since
approximately
18,000
manufacturing
facilities
subject
to
EPCRA
313
reporting
use
distillate
fuel
oil,
this
change
had
a
significant
positive
effect
on
the
estimated
number
of
reports
for
PACs
and
benzo(
g,
h,
i)
perylene
as
shown
in
Table
4.
Second,
the
methodology
for
estimating
reporting
from
facilities
in
SIC
5171
(Bulk
Petroleum
Stations
and
Terminals)
was
revised
to
account
for
the
mix
of
products
containing
PBT
chemicals
that
are
processed
at
these
facilities.
This
revision
also
had
a
positive
effect
on
the
estimated
number
of
reports.
Third,
because
facility­
level
dioxin
emission
factors
for
coal­
and
oilburning
manufacturing
facilities
have
not
been
developed,
the
estimated
number
of
reporting
facilities
was
reduced.
Fourth,
the
reporting
qualifier
for
dioxin
was
changed
from
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209
/
Friday,
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1999
/
Rules
and
Regulations
``
manufacture
only''
to
``
manufacturing;
and
the
processing
or
otherwise
use
of
dioxin
and
dioxin­
like
compounds
if
the
dioxin
and
dioxin­
like
compounds
are
present
as
contaminants
in
a
chemical
and
if
they
were
created
during
the
manufacturing
of
that
chemical''
in
the
final
rule.
This
resulted
in
additional
expected
reporting
from
facilities
that
process
or
otherwise
use
chemicals
with
dioxin
impurities.
Fifth,
the
Agency
is
not
lowering
EPCRA
section
313
reporting
thresholds
for
alkyl
leads
as
part
of
this
rulemaking.
Therefore,
no
additional
EPCRA
section
313
reporting
on
alkyl
leads
is
expected
at
this
time.
Sixth,
the
threshold
for
the
PACs
category
was
changed
from
10
pounds
in
the
proposed
rule
to
100
pounds
in
the
final
rule.

C.
What
Are
the
Benefits
of
This
Rule?
In
enacting
EPCRA
and
PPA,
Congress
recognized
the
significant
benefits
of
providing
the
public
with
information
on
toxic
chemical
releases
and
other
waste
management
practices.
EPCRA
section
313
has
empowered
the
Federal
government,
State
governments,
industry,
environmental
groups,
and
the
general
public
to
fully
participate
in
an
informed
dialogue
about
the
environmental
impacts
of
toxic
chemicals
in
the
United
States.
EPCRA
section
313's
publicly
available
data
base
provides
quantitative
information
on
toxic
chemical
releases
and
other
waste
management
practices.
Since
the
TRI
program's
inception
in
1987,
the
public,
government,
and
the
regulated
community
have
had
the
ability
to
understand
the
magnitude
of
chemical
releases
in
the
United
States,
and
to
assess
the
need
to
reduce
the
uses,
releases
and
other
waste
management
of
toxic
chemicals.
TRI
enables
all
interested
parties
to
establish
credible
baselines,
to
set
realistic
goals
for
environmental
progress
over
time,
and
to
measure
progress
in
meeting
these
goals
over
time.
The
TRI
program
is
a
neutral
yardstick
by
which
progress
can
be
measured
by
all
stakeholders.
The
information
reported
under
EPCRA
section
313
increases
knowledge
of
the
amount
of
toxic
chemicals
released
and
waste
management
practices,
and
thus
aids
in
the
evaluation
of
the
potential
pathways
of
exposure,
improves
scientific
understanding
of
the
health
and
environmental
risks
of
toxic
chemicals;
allows
the
public
to
make
informed
decisions
on
where
to
work
and
live;
enhances
the
ability
of
corporate
leaders
and
purchasers
to
more
accurately
gauge
a
facility's
potential
environmental
liabilities;
provides
reporting
facilities
with
information
that
can
be
used
to
save
money
as
well
as
reduce
emissions;
and
assists
Federal,
State,
and
local
authorities
in
making
better
decisions
on
acceptable
levels
of
toxic
chemicals
in
the
environment.
There
are
two
types
of
benefits
associated
with
EPCRA
section
313
reporting,
those
resulting
from
the
actions
required
by
the
rule
(such
as
reporting
and
recordkeeping),
and
those
derived
from
follow­
on
activities
that
are
not
required
by
the
rule.
Benefits
of
activities
required
by
the
rule
include
the
value
of
improved
knowledge
about
the
release
and
waste
management
of
toxic
chemicals,
which
leads
to
improvements
in
understanding,
awareness,
and
decision­
making.
It
is
expected
that
this
rule
will
generate
such
benefits
by
providing
readily
accessible
information
that
otherwise
would
not
be
available
to
the
public.
The
rule
will
benefit
ongoing
research
efforts
to
understand
the
risks
posed
by
PBT
chemicals
and
to
evaluate
policy
strategies
that
address
the
risks.
The
second
type
of
benefits
derive
from
changes
in
behavior
that
may
result
from
the
information
reported
under
EPCRA
section
313.
These
changes
in
behavior,
including
reductions
in
releases
of
and
changes
in
the
waste
management
practices
for
toxic
chemicals
may
yield
health
and
environmental
benefits.
These
changes
in
behavior
come
at
some
cost,
and
the
net
benefits
of
the
follow­
on
activities
are
the
difference
between
the
benefits
of
decreased
chemical
releases
and
transfers
and
the
costs
of
the
actions
needed
to
achieve
the
decreases.
Because
the
state
of
knowledge
about
the
economics
of
information
is
not
highly
developed,
EPA
has
not
attempted
to
quantify
the
benefits
of
adding
chemicals
to
EPCRA
section
313
or
changing
reporting
thresholds.
Furthermore,
because
of
the
inherent
uncertainty
in
the
subsequent
chain
of
events,
EPA
has
also
not
attempted
to
predict
the
changes
in
behavior
that
result
from
the
information,
or
the
resultant
net
benefits
(i.
e.,
the
difference
between
benefits
and
costs).
EPA
does
not
believe
that
there
are
adequate
methodologies
to
make
reasonable
monetary
estimates
of
either
the
benefits
of
the
activities
required
by
the
rule,
or
the
follow­
on
activities.
The
economic
analysis
of
the
rule,
however,
does
provide
illustrative
examples
of
how
the
rule
will
improve
the
availability
of
information
on
PBT
chemicals
(Ref.
67).
A
number
of
commenters
asserted
that
information
on
the
magnitude
of
PBT
chemical
releases
that
would
be
reported
as
a
result
of
this
rule
is
required
for
EPA
and
commenters
to
evaluate
the
benefit
of
EPA's
proposed
alternatives.
EPA
disagrees
with
these
commenters
for
the
following
reasons.
Existing
data
do
not
support
estimates
of
releases
to
multiple
environmental
media
from
the
full
range
of
facilities
that
may
be
affected
by
the
rule
because
most
of
the
data
required
for
the
analysis
would
only
be
available
after
the
rule
is
in
place.
For
most
PBT
chemicals
and
industry
sectors,
up­
todate
multi­
media
release
and
other
waste
management
estimates
for
affected
facilities
do
not
exist.
Even
where
release
estimates
are
available
for
an
industry
sector,
most
are
derived
from
national
activity
levels
rather
than
from
facility­
level
information.
To
the
extent
that
release
estimates
are
available,
they
tend
to
cover
only
a
single
medium
such
as
air.
EPA
does
not
believe
that
there
is
sufficient
information
to
make
reasonable
predictions
of
the
multi­
media
releases
and
other
waste
management
information
that
will
be
reported
as
a
result
of
EPCRA
section
313
rulemakings.
Some
commenters
note
that
EPA
has
estimated
releases
of
certain
PBT
chemicals
in
recent
reports
such
as
the
Mercury
Study
Report
to
Congress
(Ref.
65)
and
the
Inventory
of
Source
of
Dioxin
in
the
United
States
(Ref.
73).
In
fact,
EPA
reported
the
results
of
these
reports
in
its
economic
analysis
for
this
proposal.
These
studies
do
not
provide
community­
or
facility­
level
release
estimates.
The
estimates
in
these
studies
are
derived
using
a
``
top­
down''
methodology
in
which
emission
factors
are
applied
to
activity
levels
for
entire
industries.
While
having
an
estimate
of
multi­
media
PBT
releases
for
a
specific
industry
sector
is
a
first
step,
other
information
would
also
be
required
to
estimate
the
releases
that
would
be
reported
as
a
result
of
each
proposed
alternative.
Assuming
that
multi­
media
release
estimates
were
available
for
an
entire
industry
sector,
these
releases
would
still
have
to
be
divided
among
individual
facilities
according
to
some
currently
unknown
distribution.
In
addition,
there
is
the
complication
that
EPCRA
section
313
reporting
thresholds
are
based
on
chemical
throughput
(manufacture,
process,
or
use)
rather
than
chemical
release.
The
relationship
between
a
chemical
throughput
that
triggers
the
submission
of
a
report,
and
the
releases
reported
will
vary
in
some
currently
unknown
manner
among
industries,
as
well
as
among
facilities
within
an
industry.
Therefore,
EPA
does
not
believe
that
there
is
sufficient
information
to
make
reliable
release
estimates
for
this
rule,
when
considering
all
the
affected
chemicals
and
industries.
The
58743
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Register
/
Vol.
64,
No.
209
/
Friday,
October
29,
1999
/
Rules
and
Regulations
uncertainties
in
the
estimated
values
that
go
into
such
a
calculation
make
predictions
of
facility
level
reporting
extremely
imprecise.
Historical
attempts
to
estimate
the
releases
expected
to
be
reported
under
EPCRA
section
313
would
have
been
imprecise
to
the
point
of
being
misleading,
particularly
in
respect
to
estimates
of
releases
per
report
or
per
facility
(which
some
commenters
have
suggested
that
EPA
should
make).
Further
information
on
the
feasibility
of
ex
ante
release
estimates
is
available
in
the
Response
to
Comments
document
(Ref.
69).
Aside
from
the
general
issue
of
uncertainty
in
the
estimates
of
aggregate
releases,
predictions
of
releases
per
facility
or
per
report
(or
dollars
of
reporting
cost
per
pound
of
releases
reported)
are
likely
to
be
misleading
due
to
the
biases
built
into
the
estimates.
The
predicted
number
of
reports
(and
thus
costs)
is
generally
an
overestimate,
since
EPA's
economic
analyses
use
conservative
estimates
to
avoid
underestimating
true
costs.
On
the
other
hand,
predictions
of
releases
will
tend
to
underestimate
emissions,
because
while
there
may
be
information
available
on
releases
of
some
chemicals
from
some
sectors,
such
estimates
will
not
include
other
sources
where
releases
are
not
identified
until
more
detailed
data
(such
as
TRI
data)
are
collected.
Combining
the
two
sets
of
estimates
compounds
the
problem.
Since
estimated
pounds
of
releases
are
underestimated
and
reports
are
overestimated,
pounds
per
report
would
be
biased
significantly
downward.
Likewise,
estimates
of
dollars
of
reporting
cost
per
pound
of
releases
(which
varies
as
the
inverse
of
pounds
per
report)
would
be
biased
significantly
upward.
EPA
notes
that
there
were
various
reports
and
studies
about
air
emissions
of
toxic
chemicals
prior
to
EPCRA
section
313,
but
the
collection
of
facility­
level
data
provided
significant
new
information
on
releases
as
well
as
other
waste
management.
EPA
cannot
predict,
at
this
stage,
the
quantity
of
releases
and
other
waste
management
that
will
be
reported
as
the
result
of
this
action
any
more
accurately
than
it
could
have
predicted
when
it
proposed
the
original
EPCRA
section
313
rule.
Aside
from
the
issue
of
whether
EPA
can
predict
releases
and
other
waste
management
quantities
prior
to
TRI
reporting,
EPA
notes
that
pounds
of
releases
(even
if
known)
are
not
a
reasonable
proxy
for
the
benefits
of
the
information
being
provided.
This
is
because
the
benefits
of
an
informational
regulation
are
not
a
linear
function
of
the
magnitude
of
the
information
being
reported.
EPA
disagrees
with
the
implicit
assumption
by
commenters
that
the
benefits
of
information
from
different
facilities
is
strictly
and
systematically
related
to
the
quantity
reported
as
being
released.
Calculations
such
as
the
commenters
have
suggested
presume
that
the
benefit
to
the
public
of
knowing
about
a
release
of
20,000
pounds
is
twice
as
large
as
the
benefit
of
knowing
about
a
release
of
10,000
pounds;
and
that
the
benefit
of
knowing
about
a
40,000
pound
release
is
twice
the
benefit
of
knowing
about
a
20,000
pound
release
and
four
times
the
benefit
of
knowing
about
a
10,000
pound
release.
EPA
does
not
believe
this
characterization
to
be
accurate.
One
of
the
central
purposes
of
TRI
data
is
to
inform
the
public
about
releases
and
other
waste
management
of
EPCRA
section
313
listed
toxic
chemicals
in
their
community
so
that
the
public
can
form
its
own
conclusions
about
risks.
The
amount
of
releases
and
waste
management
quantities
that
a
community
may
find
relevant
or
useful
will
vary
depending
on
numerous
factors
specific
to
that
community,
such
as
the
toxicity
of
the
various
chemicals,
potential
exposure
to
these
toxic
chemicals,
and
the
number
of
other
facilities
in
the
area
that
release
EPCRA
section
313
listed
toxic
chemicals.
Section
313(
h)
of
EPCRA
states
that
the
data
are
``
to
inform
persons
about
releases
of
toxic
chemicals
to
the
environment;
to
assist
governmental
agencies,
researchers,
and
other
persons
in
the
conduct
of
research
and
data
gathering;
to
aid
in
the
development
of
appropriate
regulations,
guidelines,
and
standards;
and
for
other
similar
purposes''
(See
Unit
VI.
E.
for
a
more
detailed
discussion
on
the
purposes
of
EPCRA
section
313).
Pounds
of
releases
reported
does
not
measure
how
the
data
perform
these
functions,
and
thus
is
not
a
measure
of
benefits.
Finally,
EPA
notes
that
commenters
on
this
rule
did
not
provide
information
on
approaches
or
methodologies
for
estimating
releases
and/
or
throughput,
or
on
estimating
releases
from
throughput
data,
for
the
spectrum
of
industries,
chemicals,
and
facilities
covered
by
the
rule.
Instead,
some
commenters
submitted
data
from
EPA
studies
(that
EPA
had
already
reviewed
in
the
context
of
this
rule
and
used
as
references
for
the
economic
analysis
of
the
proposed
rule)
for
very
narrow
slices
of
the
regulated
universe
(for
example,
estimated
mercury
releases
from
electric
utilities
or
estimated
dioxin
releases
from
the
vinyl
industry).
EPA
considered
these
data
and
determined
that
they
are
not
sufficient
to
predict
the
releases
and/
or
throughput
that
will
be
reported
as
a
result
of
this
rule.
Other
commenters
simply
stated
that
EPA
should
consider
releases
without
referencing
any
data.
None
of
the
commenters
suggested
new
methodologies
or
approaches,
or
provided
information
from
any
sources
that
EPA
had
not
already
reviewed
and
considered.
As
a
result,
EPA
continues
to
conclude
that
while
there
are
data
available
to
estimate
national
releases
for
some
chemicals
for
some
sectors,
comprehensive,
reliable
data
for
all
sectors
and
chemicals
are
unavailable,
resulting
in
an
incomplete
data
set.
Furthermore,
as
stated
previously,
the
quantity
of
releases
reported
are
not
a
measure
of
the
benefits
of
the
rule.
EPA
does
not
believe
that
inaccurate
or
incomplete
estimates
of
releases
would
aid
the
decision­
making
process
for
the
rule.
Therefore,
EPA
has
not
estimated
the
releases
that
would
be
reported
as
a
result
of
the
rule.

D.
What
are
the
Potential
Impacts
on
Small
Entities?
In
accordance
with
the
Regulatory
Flexibility
Act
(RFA)
and
the
Agency's
longstanding
policy
of
always
considering
whether
there
may
be
a
potential
for
adverse
impacts
on
small
entities,
the
Agency
has
evaluated
the
potential
impacts
of
this
rule
on
small
entities.
The
Agency's
analysis
of
potentially
adverse
economic
impacts
is
included
in
the
Economic
Analysis
for
this
rule
(Ref.
67).
The
following
is
a
brief
overview
of
EPA's
findings.
1.
Overall
methodology.
This
rule
may
affect
both
small
businesses
and
small
governments.
For
the
purpose
of
its
analysis
for
the
rule,
EPA
defined
a
small
business
using
the
small
business
size
standards
established
by
the
Small
Business
Administration
(SBA)
at
13
CFR
part
121.
EPA
defined
small
governments
using
the
RFA
definition
of
jurisdictions
with
a
population
of
less
than
50,000.
No
small
organizations
are
expected
to
be
affected
by
the
rule.
Only
those
small
entities
that
are
expected
to
submit
at
least
one
report
are
considered
to
be
affected
for
the
purpose
of
the
small
entity
analysis,
although
EPA
recognizes
that
other
small
entities
will
conduct
compliance
determinations
under
lower
thresholds.
The
number
of
affected
entities
will
be
smaller
than
the
number
of
affected
facilities,
because
many
entities
operate
more
than
one
facility.
Impacts
were
calculated
for
both
the
first
year
of
reporting
and
subsequent
years.
First
year
costs
are
typically
higher
than
continuing
costs
because
firms
must
familiarize
themselves
with
the
requirements.
Once
firms
have
become
familiar
with
how
the
reporting
58744
Federal
Register
/
Vol.
64,
No.
209
/
Friday,
October
29,
1999
/
Rules
and
Regulations
requirements
apply
to
their
operations,
costs
fall.
EPA
believes
that
subsequent
year
impacts
present
the
best
measure
to
judge
the
impact
on
small
entities
because
these
continuing
costs
are
more
representative
of
the
costs
firms
face
to
comply
with
the
rule.
EPA
analyzed
the
potential
cost
impact
of
the
rule
on
small
businesses
and
governments
for
the
manufacturing
sector
and
in
each
of
the
recently
added
industry
sectors
separately
in
order
to
obtain
the
most
accurate
assessment
for
each.
EPA
then
aggregated
the
analyses
for
the
purpose
of
determining
whether
it
could
certify
that
the
rule
will
not,
if
promulgated,
have
a
``
significant
economic
impact
on
a
substantial
number
of
small
entities.
''
RFA
section
605(
b)
provides
an
exemption
from
the
requirement
to
prepare
a
regulatory
flexibility
analysis
for
a
rule
where
an
agency
makes
and
supports
the
certification
statement
quoted
above.
EPA
believes
that
the
statutory
test
for
certifying
a
rule
and
the
statutory
consequences
of
not
certifying
a
rule
all
indicate
that
certification
determinations
may
be
based
on
an
aggregated
analysis
of
the
rule's
impact
on
all
of
the
small
entities
subject
to
it.
2.
Small
businesses.
EPA
used
annual
compliance
costs
as
a
percentage
of
annual
company
sales
to
assess
the
potential
impacts
on
small
businesses
of
this
rule.
EPA
believes
that
this
is
a
good
measure
of
a
firm's
ability
to
afford
the
costs
attributable
to
a
regulatory
requirement,
because
comparing
compliance
costs
to
revenues
provides
a
reasonable
indication
of
the
magnitude
of
the
regulatory
burden
relative
to
a
commonly
available
measure
of
a
company's
business
volume.
Where
regulatory
costs
represent
a
small
fraction
of
a
typical
firm's
revenue
(for
example,
less
than
1%,
but
not
greater
than
3%),
EPA
believes
that
the
financial
impacts
of
the
regulation
may
be
considered
not
significant.
As
discussed
above,
EPA
also
believes
that
it
is
appropriate
to
apply
this
measure
to
subsequent
year
impacts.
Based
on
its
estimates
of
additional
reporting
as
a
result
of
the
rule,
the
Agency
estimates
that
approximately
6,300
businesses
will
be
affected
by
the
rule,
and
that
approximately
4,400
of
these
businesses
are
classified
as
small
based
on
the
applicable
SBA
size
standards.
For
the
first
reporting
year,
EPA
estimates
that
approximately
17
small
businesses
may
bear
compliance
costs
between
1%
and
3%
of
revenues,
and
that
no
small
businesses
will
bear
costs
greater
than
3%.
In
subsequent
years,
EPA
estimates
that
approximately
5
small
businesses
may
bear
compliance
costs
between
1%
and
3%
of
revenues,
and
that
no
small
businesses
will
bear
costs
greater
than
3%.
As
stated
above,
EPA
believes
that
subsequent­
year
impacts
are
the
appropriate
measure
of
small
business
impacts.
3.
Small
governments.
To
assess
the
potential
impacts
on
small
governments,
EPA
used
annual
compliance
costs
as
a
percentage
of
annual
government
revenues
to
measure
potential
impacts.
Similar
to
the
methodology
for
small
businesses,
this
measure
was
used
because
EPA
believes
it
provides
a
reasonable
indication
of
the
magnitude
of
the
regulatory
burden
relative
to
a
government's
ability
to
pay
for
the
costs,
and
is
based
on
readily
available
data.
EPA
estimates
that
39
municipalities
operate
49
publicly
owned
electric
utility
facilities.
Of
these
facilities,
44
are
expected
to
file
additional
reports
as
a
result
of
this
action.
Of
these
affected
facilities,
15
are
operated
by
15
small
governments
(i.
e.,
those
with
populations
under
50,000).
It
is
estimated
that
none
of
these
small
governments
will
bear
annual
costs
greater
than
1%
of
annual
government
revenues.
4.
All
small
entities.
As
discussed
above,
approximately
5
small
businesses
are
expected
to
bear
annual
costs
between
1%
and
3%
of
annual
revenues
after
the
first
year
of
reporting.
None
of
the
affected
small
governments
are
estimated
to
bear
annual
costs
greater
than
1%
of
annual
revenues.
No
small
organizations
are
expected
to
be
affected
by
the
rule.
Thus,
the
total
number
of
small
entities
with
impacts
above
1%
of
revenues
does
not
change
when
the
results
are
aggregated
for
all
small
entities
(i.
e.,
small
businesses,
small
governments,
and
small
organizations).

VIII.
What
are
the
References
for
this
Action?
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Reduction/
Elimination
of
Toxics
(ARET)
Secretariat.
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1994.
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2.
Accelerated
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Soil.
Environ.
Sci.
Technol.
11:
1202±
1207.

IX.
Which
Regulatory
Assessment
Requirements
Apply
to
This
Action?

A.
What
is
the
Determination
under
Executive
Order
12866
Under
Executive
Order
12866,
entitled
Regulatory
Planning
and
Review
(58
FR
51735,
October
4,
1993),
this
is
an
economically
``
significant
regulatory
action''
because
it
is
likely
to
have
an
annual
effect
of
$100
million
or
more.
This
action
was
submitted
to
the
Office
of
Management
and
Budget
(OMB)
for
review,
and
any
substantive
comments
or
changes
made
during
that
review
have
been
documented
in
the
public
version
of
the
official
record.
EPA
has
prepared
an
economic
analysis
of
the
impact
of
this
action,
which
is
contained
in
a
document
entitled
Economic
Analysis
of
the
Final
Rule
to
Modify
Reporting
of
Persistent
Bioaccumulative
Toxic
Chemicals
under
EPCRA
Section
313
(Ref.
67).
This
document
is
available
as
a
part
of
the
public
version
of
the
official
record
for
this
action
(instructions
for
accessing
this
document
are
contained
in
Unit
I.
B.)
and
is
discussed
in
Unit
VII.

B.
What
is
the
Determination
under
the
Regulatory
Flexibility
Act?

Pursuant
to
section
605(
b)
of
the
Regulatory
Flexibility
Act
(RFA)
(5
U.
S.
C.
601
et
seq.),
the
EPA
Administrator
hereby
certifies
that
this
final
rule
will
not
have
a
significant
economic
impact
on
a
substantial
number
of
small
entities.
The
factual
basis
for
this
determination
is
presented
in
the
small
entity
impact
analysis
prepared
as
part
of
the
Economic
Analysis
for
this
final
rule
(Ref.
67),
which
is
also
discussed
in
detail
in
Unit
VII.
and
contained
in
the
public
version
of
the
official
record
for
this
rule.
The
following
is
a
brief
summary
of
the
Agency's
factual
basis
for
this
certification.
For
the
purpose
of
analyzing
potential
impacts
on
small
entities,
EPA
used
the
RFA
definition
of
small
entities
in
section
601(
6)
of
the
RFA.
Under
this
section,
small
entities
include
small
governments,
small
non­
profit
organizations,
and
small
businesses.
No
small
organizations
are
expected
to
be
affected
by
this
final
rule.
EPA
defined
small
governments
using
the
RFA
definition
of
jurisdictions
with
a
population
of
less
than
50,000,
and
defined
a
small
business
using
the
small
business
size
standards
established
by
the
Small
Business
Administration
(SBA),
which
are
generally
based
on
the
number
of
employees
or
annual
sales/
revenue
a
business
in
a
particular
industrial
sector
has.
Based
on
EPA's
economic
analysis,
approximately
11,300
facilities
are
expected
to
submit
approximately
20,000
additional
Form
R
reports
annually.
Of
these
facilities,
approximately
3,100
are
expected
to
file
TRI
reports
for
the
first
time
as
a
result
of
today's
action.
EPA
estimates
that
the
cost
for
collecting
this
information
averages
$5,079
per
Form
R
in
the
first
reporting
year,
and
$3,557
in
subsequent
years.
EPA
estimates
that
there
are
15
small
governments
that
may
be
affected
by
the
rule
(i.
e.,
EPA
analysis
estimates
that
these
entities
may
have
to
file
one
or
more
reports
under
the
final
rule).
EPA
estimates
that
none
of
these
small
governments
will
bear
annual
costs
greater
than
1%
of
annual
government
revenues.
EPA
estimates
that
5
small
businesses
of
the
approximately
4,400
small
businesses
potentially
affected
by
the
rule
will
experience
annual
compliance
costs
between
1%
and
3%
of
annual
sales
after
the
first
year
of
reporting.
Given
the
relatively
small
estimated
impacts
on
small
entities,
EPA
believes
that
the
rule
will
not
have
a
significant
economic
impact
on
a
substantial
number
of
small
entities.
This
determination
is
for
the
entire
population
of
small
entities
potentially
affected
by
this
rule,
since
the
test
for
certification
is
whether
the
rule
as
a
whole
has
a
significant
economic
impact
on
a
substantial
number
of
small
entities.
Notwithstanding
the
Agency's
certification
of
this
rule
under
section
605(
b)
of
the
RFA,
EPA
remains
committed
to
minimizing
real
impacts
58748
Federal
Register
/
Vol.
64,
No.
209
/
Friday,
October
29,
1999
/
Rules
and
Regulations
on
small
entities
where
this
does
not
unacceptably
compromise
the
informational
benefits
of
the
rule.
Although
not
required,
EPA
intends
to
prepare
guidance
for
reporting
on
dioxin
that
will
assist
facilities
in
determining
their
compliance
needs
and
in
properly
completing
the
form,
which
will
help
ensure
that
small
entities
receive
assistance
to
ease
their
burden
of
compliance.
EPA
has
prepared
such
documents
for
current
reporters
and
has
received
positive
feedback
on
their
utility
from
the
targeted
facilities.
In
addition,
the
Agency
is
always
interested
in
any
comments
regarding
the
economic
impacts
that
this
regulatory
action
would
impose
on
small
entities,
particularly
suggestions
for
minimizing
that
impact.
Such
comments
may
be
submitted
to
the
Agency
at
any
time,
to
the
address
listed
in
Unit
I.
B.
Information
relating
to
this
determination
has
been
provided
to
the
Chief
Counsel
for
Advocacy
of
the
Small
Business
Administration,
and
is
included
in
the
public
version
of
the
official
record
for
this
rulemaking.

C.
What
is
the
Determination
under
the
Paperwork
Reduction
Act?
The
information
collection
requirements
contained
in
this
final
rule
have
been
submitted
to
OMB
under
the
Paperwork
Reduction
Act
(PRA),
44
U.
S.
C.
3501
et
seq.,
and
in
accordance
with
the
procedures
at
5
CFR
1320.11.
OMB
has
approved
the
existing
reporting
and
recordkeeping
requirements
EPA
Toxic
Chemical
Release
Inventory
Form
R
(EPA
Form
No.
9350­
1),
supplier
notification,
and
petitions
under
OMB
Control
No.
2070±
0093
(EPA
ICR
No.
1363).
An
Information
Collection
Request
(ICR)
document
has
been
prepared
by
EPA
(EPA
ICR
No.
1363.10)
to
amend
the
existing
ICR
to
include
the
burden
associated
with
the
lower
reporting
thresholds,
and
a
copy
may
be
obtained
from
Sandy
Farmer,
Office
of
Information
Collections
(OIC);
U.
S.
Environmental
Protection
Agency
(2137),
401
M
St.,
SW.,
Washington,
DC
20460,
by
calling
(202)
260±
2740,
or
electronically
by
sending
an
e­
mail
message
to
``
farmer.
sandy@
epa.
gov.
''
An
electronic
copy
has
also
been
posted
with
this
Federal
Register
document
on
EPA's
Homepage
with
other
information
related
to
this
action
as
described
in
Unit
I.
B.,
and
may
also
be
downloaded
from
the
Internet
at
http://
www.
epa.
gov.
icr/.
An
Agency
may
not
conduct
or
sponsor,
and
a
person
is
not
required
to
respond
to
a
collection
of
information
subject
to
OMB
approval
under
the
PRA
unless
it
displays
a
currently
valid
OMB
control
number.
The
OMB
control
numbers
for
EPA's
regulations,
after
initial
publication
in
the
Federal
Register,
are
maintained
in
a
list
at
40
CFR
part
9.
The
information
requirements
contained
in
this
final
rule
are
not
effective
until
OMB
approves
them.
EPCRA
section
313
requires
owners
or
operators
of
certain
facilities
manufacturing,
processing,
or
otherwise
using
any
of
over
600
listed
toxic
chemicals
and
chemical
categories
in
excess
of
the
applicable
threshold
quantities,
and
meeting
certain
requirements
(i.
e.,
at
least
10
Full
Time
Employees
or
the
equivalent),
to
report
environmental
on­
site
releases
and
transfers
off­
site
for
release
and
treatment.
Under
section
6607
of
the
PPA,
facilities
must
also
provide
information
on
the
quantities
of
the
toxic
chemicals
in
certain
waste
streams,
and
the
efforts
made
to
manage
those
waste
quantities.
The
regulations
codifying
the
EPCRA
section
313
reporting
requirements
appear
at
40
CFR
part
372.
Respondents
may
designate
the
specific
chemical
identity
of
a
substance
as
a
trade
secret,
pursuant
to
EPCRA
section
322
(42
U.
S.
C.
11042).
Regulations
codifying
the
trade
secret
provisions
can
be
found
at
40
CFR
part
350.
Under
the
final
rule,
all
facilities
reporting
under
EPCRA
section
313
on
PBT
chemicals
would
have
to
use
the
Form
R
(EPA
Form
No.
9350­
1),
which
is
currently
approved
by
OMB.
For
Form
R,
EPA
estimates
the
industry
reporting
burden
for
collecting
this
information
(including
recordkeeping)
to
average
74
hours
per
report
in
the
first
year,
at
an
estimated
cost
of
$5,079
per
Form
R.
In
subsequent
years,
the
burden
is
estimated
to
average
52.1
hours
per
report,
at
an
estimated
cost
of
$3,557
per
Form
R.
These
estimates
include
the
time
needed
to
review
instructions;
search
existing
data
sources;
gather
and
maintain
the
data
needed;
complete
and
review
the
collection
of
information;
and
transmit
or
otherwise
disclose
the
information.
The
actual
burden
on
any
specific
facility
may
be
different
from
this
estimate
depending
on
the
complexity
of
the
facility's
operations
and
the
profile
of
the
releases
at
the
facility.
This
final
rule
is
estimated
to
result
in
reports
from
11,300
respondents.
Of
these,
3,100
facilities
are
estimated
to
be
reporting
under
EPCRA
section
313
for
the
first
time
as
a
result
of
the
rule,
while
8,200
are
currently
reporting
facilities
that
will
be
submitting
additional
reports.
These
facilities
will
submit
an
estimated
additional
20,000
Form
Rs.
This
rule
therefore
results
in
an
estimated
total
burden
of
2.1
million
hours
in
the
first
year,
and
1.2
million
hours
in
subsequent
years,
at
a
total
estimated
industry
cost
of
$145
million
in
the
first
year
and
$80
million
in
subsequent
years.
The
existing
ICR
will
be
amended
to
include
an
additional
annual
burden
of
1.5
million
hours
(annual
average
burden
for
the
first
3
years
of
ICR
approval).
Under
the
PRA,
``
burden''
means
the
total
time,
effort,
or
financial
resources
expended
by
persons
to
generate,
maintain,
retain,
or
disclose
or
provide
information
to
or
for
a
Federal
agency.
This
includes,
where
applicable,
the
time
needed
to
review
instructions;
develop,
acquire,
install,
and
utilize
technology
and
systems
for
the
purposes
of
collecting,
validating,
and
verifying
information,
processing
and
maintaining
information,
and
disclosing
and
providing
information;
adjust
the
existing
ways
to
comply
with
any
previously
applicable
instructions
and
requirements;
train
personnel
to
be
able
to
respond
to
a
collection
of
information;
search
data
sources;
complete
and
review
the
collection
of
information;
and
transmit
or
otherwise
disclose
the
information.
EPA's
burden
estimates
for
the
rule
take
into
account
all
of
the
above
elements,
considering
that
under
section
313,
no
additional
measurement
or
monitoring
may
be
imposed
for
purposes
of
reporting.

D.
What
are
the
Determinations
under
the
Unfunded
Mandates
Reform
Act
and
Executive
Orders
12875
and
13084?
Pursuant
to
Title
II
of
the
Unfunded
Mandates
Reform
Act
of
1995
(UMRA)
(Public
Law
104±
4),
EPA
has
determined
that
this
action
contains
a
Federal
mandate
that
may
result
in
expenditures
of
$100
million
or
more
for
the
private
sector
in
any
1
year,
but
that
it
will
not
result
in
such
expenditures
for
State,
local,
and
tribal
governments,
in
the
aggregate.
Accordingly,
EPA
has
prepared
a
written
statement
for
this
rule
pursuant
to
section
202
of
UMRA,
and
that
statement
is
available
in
the
public
version
of
the
official
record
for
this
rulemaking
(Ref.
71a).
The
costs
associated
with
this
action
are
estimated
in
the
economic
analysis
prepared
for
this
rule
(Ref.
67),
which
is
also
included
in
the
public
version
of
the
official
record
and
summarized
in
Unit
VII.
The
following
is
a
brief
summary
of
the
UMRA
statement
for
the
rule.
This
rule
is
being
promulgated
pursuant
to
sections
313(
d)(
1)
and
(2),
313(
f)(
2),
313(
g),
313(
h),
and
328
of
EPCRA,
42
U.
S.
C.
11023(
d)(
1)±(
2),
11023(
f)(
2),
11023(
g),
11023(
h)
and
58749
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Register
/
Vol.
64,
No.
209
/
Friday,
October
29,
1999
/
Rules
and
Regulations
11048;
PPA
section
6607,
42
U.
S.
C.
13106.
The
economic
analysis
contains
an
analysis
of
the
benefits
and
costs
of
this
rule,
which
estimates
that
the
total
industry
costs
of
the
rule
will
be
$145
million
in
the
first
year
and
$80
million
per
year
thereafter,
and
concludes
that
the
benefits
will
be
significant
but
cannot
be
assigned
a
dollar
value
due
to
the
lack
of
adequate
methodologies.
EPA
believes
that
the
benefits
provided
by
the
information
to
be
reported
under
this
rule
will
significantly
outweigh
the
costs
imposed
by
today's
action.
The
benefits
of
the
information
will
in
turn
have
positive
effects
on
health,
safety,
and
the
natural
environment
through
the
behavioral
changes
that
may
result
from
that
information.
EPA
has
not
identified
any
Federal
financial
resources
that
are
available
to
cover
the
costs
of
this
rule.
As
set
forth
in
the
economic
analysis,
EPA
has
estimated
the
future
industry
compliance
costs
(after
the
first
year)
of
this
rule
to
be
$80
million
annually.
Of
those
entities
affected
by
today's
action,
EPA
has
not
identified
any
disproportionate
budgetary
impact
on
any
particular
region,
government,
or
community,
or
on
any
segment
of
the
private
sector.
Based
on
the
economic
analysis,
EPA
has
concluded
that
it
is
highly
unlikely
that
this
rule
will
have
an
appreciable
effect
on
the
national
economy.
EPA
has
determined
that
it
is
not
required
to
develop
a
small
government
agency
plan
as
specified
by
section
203
of
UMRA
or
to
conduct
prior
consultation
with
State,
local,
or
tribal
governments
under
section
204
of
UMRA,
because
the
rule
will
not
significantly
or
uniquely
affect
small
governments
and
does
not
contain
a
significant
Federal
intergovernmental
mandate.
Finally,
EPA
believes
this
rule
complies
with
section
205(
a)
of
UMRA.
The
objective
of
this
rule
is
to
expand
the
public
benefits
of
the
TRI
program
by
exercising
EPA's
discretionary
authority
to
add
chemicals
to
the
program
and
to
lower
reporting
thresholds,
thereby
increasing
the
amount
of
information
available
to
the
public
regarding
the
use,
management,
and
disposition
of
PBT
chemicals
and
enabling
a
more
comprehensive
view
of
PBT
chemical
exposures.
In
making
additional
information
available
through
TRI,
the
Agency
increases
the
utility
of
TRI
data
as
an
effective
tool
for
empowering
local
communities,
the
public
sector,
industry,
other
agencies,
and
State
and
local
governments
to
better
evaluate
risks
to
public
health
and
the
environment.
As
described
in
Unit
IV.
D.,
EPA
considered
burden
in
the
threshold
selection.
Existing
burden­
reducing
measures
(e.
g.,
the
laboratory
exemption
and
the
otherwise
use
exemptions,
which
include
the
routine
janitorial
or
facility
grounds
maintenance
exemption,
motor
vehicle
maintenance
exemption,
structural
component
exemption,
intake
air
and
water
exemption
and
the
personal
use
exemption)
will
continue
to
apply
to
the
facilities
that
file
new
reports
as
a
result
of
this
rule.
EPA
also
will
be
assisting
small
entities
subject
to
the
rule,
by
such
means
as
providing
meetings,
training,
and
compliance
guides
in
the
future,
which
also
will
ease
the
burdens
of
compliance.
Many
steps
have
been
and
will
be
taken
to
further
reduce
the
burden
associated
with
this
rule,
and
to
EPA's
knowledge
there
is
no
available
alternative
to
the
rule
that
would
obtain
the
equivalent
information
in
a
less
burdensome
manner.
For
all
of
these
reasons,
EPA
believes
the
rule
complies
with
UMRA
section
205(
a).
In
addition,
today's
rule
does
not
create
an
unfunded
Federal
mandate
on
State,
local
or
tribal
governments,
nor
does
it
significantly
or
uniquely
affect
the
communities
of
Indian
tribal
governments.
Accordingly,
the
requirements
of
section
1(
a)
of
Executive
Order
12875,
entitled
Enhancing
the
Intergovernmental
Partnership
(58
FR
58093,
October
28,
1993),
and
section
3(
b)
of
Executive
Order
13084,
entitled
Consultation
and
Coordination
with
Indian
Tribal
Governments
(63
FR
27655,
May
19,
1998),
do
not
apply
to
this
proposed
rule.

E.
What
are
the
Determinations
under
Executive
Orders
12898
and
13045?
Pursuant
to
Executive
Order
12898,
entitled
Federal
Actions
to
Address
Environmental
Justice
in
Minority
Populations
and
Low­
Income
Populations
(59
FR
7629,
February
16,
1994),
the
Agency
must
consider
environmental
justice
related
issues
with
regard
to
the
potential
impacts
of
this
action
on
environmental
and
health
conditions
in
low­
income
populations
and
minority
populations.
Pursuant
to
Executive
Order
13045,
entitled
Protection
of
Children
from
Environmental
Health
Risks
and
Safety
Risks
(62
FR
19885,
April
23,
1997),
if
an
action
is
economically
significant
under
Executive
Order
12866,
the
Agency
must,
to
the
extent
permitted
by
law
and
consistent
with
the
Agency's
mission,
identify
and
assess
the
environmental
health
risks
and
safety
risks
that
may
disproportionately
affect
children.
By
lowering
the
section
313
reporting
thresholds
for
PBT
chemicals,
EPA
will
provide
communities
across
the
United
States
(including
low­
income
populations
and
minority
populations)
with
access
to
data
that
may
assist
them
in
lowering
exposures
and
consequently
reducing
chemical
risks
for
themselves
and
their
children.
This
information
can
also
be
used
by
government
agencies
and
others
to
identify
potential
problems,
set
priorities,
and
take
appropriate
steps
to
reduce
any
potential
risks
to
human
health
and
the
environment.
Therefore,
the
informational
benefits
of
the
rule
will
have
a
positive
impact
on
the
human
health
and
environmental
impacts
of
minority
populations,
low­
income
populations,
and
children.

F.
What
are
the
Determinations
under
Executive
Orders
13132
and
12612?

On
August
4,
1999,
President
Clinton
issued
a
new
executive
order
on
federalism,
Executive
Order
13132,
entitled
Federalism
(64
FR
43255,
August
10,
1999),
which
will
take
effect
on
November
2,
1999.
In
the
interim,
the
current
Executive
Order
12612,
entitled
Federalism
(52
FR
41685,
October
30,
1987)
still
applies.
This
action
is
expected
to
have
a
limited
impact
on
municipal
governments
which
operate
electric
utilities.
EPA
estimates
that
39
municipalities
operate
49
publicly
owned
electric
utility
facilities.
Of
these
facilities,
44
are
expected
to
file
additional
reports
as
a
result
of
this
action.
Therefore
EPA
concludes
that
this
rule
will
not
have
a
substantial
direct
effect
on
States,
on
the
relationship
between
the
national
government
and
the
States,
or
on
the
distribution
of
power
and
responsibilities
among
the
various
levels
of
government,
as
specified
in
Executive
Order
12612.

G.
What
are
the
Determinations
under
the
National
Technology
Transfer
and
Advancement
Act?

Section
12(
d)
of
the
National
Technology
Transfer
and
Advancement
Act
of
1995
(NTTAA)
(15
U.
S.
C.
272
note)
directs
EPA
to
use
voluntary
consensus
standards
in
its
regulatory
activities
unless
doing
so
would
be
inconsistent
with
applicable
law
or
impractical.
Voluntary
consensus
standards
are
technical
standards
(e.
g.,
materials
specifications,
test
methods,
sampling
procedures,
etc.)
that
are
developed
or
adopted
by
voluntary
consensus
standards
bodies.
The
NTTAA
directs
EPA
to
provide
Congress,
through
OMB,
explanations
when
the
Agency
decides
not
to
use
58750
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/
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/
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29,
1999
/
Rules
and
Regulations
available
and
applicable
voluntary
consensus
standards.
This
action
does
not
involve
technical
standards,
nor
did
EPA
consider
the
use
of
any
voluntary
consensus
standards.
In
general,
EPCRA
does
not
prescribe
technical
standards
to
be
used
for
threshold
determinations
or
completion
of
EPCRA
section
313
reports.
EPCRA
section
313(
g)(
2)
states
that
``
In
order
to
provide
the
information
required
under
this
section,
the
owner
or
operator
of
a
facility
may
use
readily
available
data
(including
monitoring
data)
collected
pursuant
to
other
provisions
of
law,
or,
where
such
data
are
not
readily
available,
reasonable
estimates
of
the
amounts
involved.
Nothing
in
this
section
requires
the
monitoring
or
measurement
of
the
quantities,
concentration,
or
frequency
of
any
toxic
chemical
released
into
the
environment
beyond
that
monitoring
and
measurement
required
under
other
provisions
of
law
or
regulation.
''

H.
What
are
the
Determinations
under
the
Congressional
Review
Act?
The
Congressional
Review
Act,
5
U.
S.
C.
801
et
seq.,
as
added
by
the
Small
Business
Regulatory
Enforcement
Fairness
Act
of
1996,
generally
provides
that
before
a
rule
may
take
effect,
the
agency
promulgating
the
rule
must
submit
a
rule
report,
which
includes
a
copy
of
the
rule,
to
each
House
of
the
Congress
and
to
the
Comptroller
General
of
the
United
States.
EPA
will
submit
a
report
containing
this
rule
and
other
required
information
to
the
U.
S.
Senate,
the
U.
S.
House
of
Representatives,
and
the
Comptroller
General
of
the
United
States
prior
to
publication
of
the
rule
in
the
Federal
Register.
A
major
rule
cannot
take
effect
until
60
days
after
it
is
published
in
the
Federal
Register.
This
action
is
a
``
major
rule''
as
defined
by
5
U.
S.
C.
804(
2).
This
rule
will
be
effective
December
31,
1999.

List
of
Subjects
in
40
CFR
Part
372
Environmental
protection,
Community
right­
to­
know,
Hazardous
substances,
Intergovernmental
relations,
Reporting
and
recordkeeping
requirements,
Superfund.

Dated:
October
25,
1999.
Carol
M.
Browner,
Administrator.

Therefore,
40
CFR
part
372
is
amended
as
follows:

PART
372Ð[
AMENDED]

1.
The
authority
citation
for
part
372
continues
to
read
as
follows:

Authority:
42
U.
S.
C.
11023
and
11048.

§
372.22
[Amended]

2.
In
§
372.22(
c),
remove
the
phrase
``§
372.25
or
§
372.27.
''
and
add
in
its
place
``§
372.25,
§
372.27,
or
§
372.28.
''.
§
372.25
[Amended]

3.
Section
372.25
is
amended
as
follows:
i.
In
the
introductory
text
of
§
372.25,
remove
the
first
clause
``
Except
as
provided
in
§
372.27,
''
and
add
in
its
place
``
Except
as
provided
in
§§
372.27
and
372.28,
''.
ii.
In
paragraphs
(f),
(g),
and
(h),
remove
the
reference
``§
372.25''
and
add
in
its
place
``§
372.25,
§
372.27,
or
§
372.28''.
4.
In
§
372.27,
add
a
new
paragraph
(e)
to
read
as
follows:

§
372.27
Alternate
threshold
and
certification.

*
*
*
*
*
(e)
The
provisions
of
this
section
do
not
apply
to
any
chemicals
listed
in
§
372.28.
5.
Add
a
new
§
372.28
to
subpart
B
to
read
as
follows:

§
372.28
Lower
thresholds
for
chemicals
of
special
concern.

(a)
Notwithstanding
§
372.25
or
§
372.27,
for
the
toxic
chemicals
set
forth
in
this
section,
the
threshold
amounts
for
manufacturing
(including
importing),
processing,
and
otherwise
using
such
toxic
chemicals
are
as
set
forth
in
this
section.
(1)
Chemical
listing
in
alphabetic
order.

Chemical
name
CAS
No.
Reporting
threshold
Aldrin
.......................................................................................
00309±
00±
2
100
Benzo(
g,
h,
i)
perylene
...............................................................
00191±
24±
2
10
Chlordane
................................................................................
00057±
74±
9
10
Heptachlor
...............................................................................
00076±
44±
8
10
Hexachlorobenzene
................................................................
00118±
74±
1
10
Isodrin
......................................................................................
00465±
73±
6
10
Mercury
...................................................................................
07439±
97±
6
10
Methoxychlor
...........................................................................
00072±
43±
5
100
Octachlorostyrene
...................................................................
29082±
74±
4
10
Pendimethalin
..........................................................................
40487±
42±
1
100
Pentachlorobenzene
...............................................................
00608±
93±
5
10
Polychlorinated
biphenyl
(PCBs)
............................................
01336±
36±
3
10
Tetrabromobisphenol
A
...........................................................
00079±
94±
7
100
Toxaphene
..............................................................................
08001±
35±
2
10
Trifluralin
..................................................................................
01582±
09±
8
100
(2)
Chemical
categories
in
alphabetic
order.

Category
name
Reporting
threshold
Dioxin
and
dioxin­
like
compounds
(Manufacturing;
and
the
processing
or
otherwise
use
of
dioxin
and
dioxinlike
compounds
if
the
dioxin
and
dioxin­
like
compounds
are
present
as
contaminants
in
a
chemical
and
if
they
were
created
during
the
manufacturing
of
that
chemical)
(This
category
includes
only
those
chemicals
listed
below).
0.1
grams
67562±
39±
4
1,2,3,4,6,7,8­
Heptachlorodibenzofuran
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1999
/
Rules
and
Regulations
Category
name
Reporting
threshold
55673±
89±
7
1,2,3,4,7,8,9­
Heptachlorodibenzofuran
70648±
26±
9
1,2,3,4,7,8­
Hexachlorodibenzofuran
57117±
44±
9
1,2,3,6,7,8­
Hexachlorodibenzofuran
72918±
21±
9
1,2,3,7,8,9­
Hexachlorodibenzofuran
60851±
34±
5
2,3,4,6,7,8­
Hexachlorodibenzofuran
39227±
28±
6
1,2,3,4,7,8­
Hexachlorodibenzo­
p­
dioxin
57653±
85±
7
1,2,3,6,7,8­
Hexachlorodibenzo­
p­
dioxin
19408±
74±
3
1,2,3,7,8,9­
Hexachlorodibenzo­
p­
dioxin
35822±
46±
9
1,2,3,4,6,7,8­
Heptachlorodibenzo­
p­
dioxin
39001±
02±
0
1,2,3,4,6,7,8,9­
Octachlorodibenzofuran
03268±
87±
9
1,2,3,4,6,7,8,9­
Octachlorodibenzo­
p­
dioxin
57117±
41±
6
1,2,3,7,8­
Pentachlorodibenzofuran
57117±
31±
4
2,3,4,7,8­
Pentachlorodibenzofuran
40321±
76±
4
1,2,3,7,8­
Pentachlorodibenzo­
p­
dioxin
51207±
31±
9
2,3,7,8­
Tetrachlorodibenzofuran
01746±
01±
6
2,3,7,8
Tetrachlorodibenzo­
p­
dioxin
Mercury
compounds
10
Polycyclic
aromatic
compounds
(PACs)
(This
category
includes
only
those
chemicals
listed
below).
100
00056±
55±
3
Benz(
a)
anthracene
00205±
99±
2
Benzo(
b)
fluoranthene
00205±
82±
3
Benzo(
j)
fluoranthene
00207±
08±
9
Benzo(
k)
fluoranthene
00206±
44±
0
Benzo(
j,
k)
fluorene
00189±
55±
9
Benzo(
r,
s,
t)
pentaphene
00218±
01±
9
Benzo(
a)
phenanthrene
00050±
32±
8
Benzo(
a)
pyrene
00226±
36±
8
Dibenz(
a,
h)
acridine
00224±
42±
0
Dibenz(
a,
j)
acridine
00053±
70±
3
Dibenzo(
a,
h)
anthracene
00194±
59±
2
7H­
Dibenzo(
c,
g)
carbazole
05385±
75±
1
Dibenzo(
a,
e)
fluoranthene
00192±
65±
4
Dibenzo(
a,
e)
pyrene
00189±
64±
0
Dibenzo(
a,
h)
pyrene
00191±
30±
0
Dibenzo(
a,
l)
pyrene
00057±
97±
6
7,12­
Dimethylbenz(
a)
anthracene
00193±
39±
5
Indeno[
1,2,3­
cd]
pyrene
00056±
49±
5
3­
Methylcholanthrene
03697±
24±
3
5­
Methylchrysene
05522±
43±
0
1­
Nitropyrene
(b)
The
threshold
determination
provisions
under
§
372.25(
c)
through
(h)
and
the
exemptions
under
§
372.38(
b)
through
(h)
are
applicable
to
the
toxic
chemicals
listed
in
paragraph
(a)
of
this
section.

§
372.30
[Amended]

6.
Section
372.30
is
amended
as
follows:
i.
In
paragraph
(a),
remove
the
phrase
``
in
§
372.25
at''
and
add
in
its
place
``
in
§
372.25,
§
372.27,
or
§
372.28
at''.
ii.
In
paragraphs
(b)(
1),
the
introductory
text
of
(b)(
3),
(b)(
3)(
i),
and
(b)(
3)(
iv),
remove
the
reference
``§
372.25''
and
add
in
its
place
``§
372.25,
§
372.27,
or
§
372.28''.
§
372.38
[Amended]

7.
Section
372.38
is
amended
as
follows:
i.
In
paragraph
(a),
add
the
following
sentence
at
the
end
of
the
paragraph
to
read
as
follows:
``
This
exemption
does
not
apply
to
toxic
chemicals
listed
in
§
372.28,
except
for
purposes
of
§
372.45(
d)(
1).
''.
ii.
In
paragraphs
(b),
(c)
introductory
text,
(d)
introductory
text,
and
(f),
remove
the
reference
``§
372.25''
and
add
in
its
place
``§
372.25,
§
372.27,
or
§
372.28''.
iii.
In
paragraphs
(g)
and
(h),
remove
the
phrase
``§
372.25
or
§
372.27''
and
add
in
its
place
``§
372.25,
§
372.27,
or
§
372.28''.
8.
Section
372.65
is
amended
as
follows:
i.
In
the
table
in
paragraph
(a),
revise
the
entry
for
``
Vanadium''
and
alphabetically
add
four
chemicals.
ii.
In
the
table
in
paragraph
(b),
revise
the
CAS
no.
entry
``
7440±
62±
2''
and
add
four
chemicals
in
numerical
CAS
no.
sequence.
iii.
In
the
table
in
paragraph
(c),
alphabetically
add
two
categories,
``
dioxin
and
dioxin­
like
compounds''
and
``
vanadium'',
and
alphabetically
add
two
chemicals,
``
benzo(
j,
k)
fluorene''
and
``
3­
methylcholanthrene'',
under
the
polycyclic
aromatic
compounds
(PACs)
category.
The
revisions
and
additions
read
as
follows:

§
372.65
Chemicals
and
chemical
categories
to
which
the
part
applies.

*
*
*
*
*
(a)
*
*
*
58752
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/
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1999
/
Rules
and
Regulations
Chemical
name
CAS
No.
Effective
date
*
*
*
*
*
*
*
Benzo(
g,
h,
i)
perylene
00191±
24±
2
1/
00
*
*
*
*
*
*
*
Octachlorostyrene
29082±
74±
4
1/
00
*
*
*
*
*
*
*
Pentachlorobenzene
00608±
93±
5
1/
00
*
*
*
*
*
*
*
Tetrabromobisphenol
A
00079±
94±
7
1/
00
*
*
*
*
*
*
*
Vanadium
(except
when
contained
in
an
alloy)
7440±
62±
2
1/
00
*
*
*
*
*
*
*

(b)
*
*
*

CAS
No.
Chemical
name
Effective
date
*
*
*
*
*
*
*
7440±
62±
2
Vanadium
(except
when
contained
in
an
alloy)
1/
00
*
*
*
*
*
*
*
00079±
94±
7
Tetrabromobisphenol
A
1/
00
00191±
24±
2
Benzo(
g,
h,
i)
perylene
1/
00
00608±
93±
5
Pentachlorobenzene
1/
00
*
*
*
*
*
*
*
29082±
74±
4
Octachlorostyrene
1/
00
*
*
*
*
*
*
*

(c)
*
*
*

Category
name
Effective
date
*
*
*
*
*
*
*
Dioxin
and
dioxin­
like
compounds
(Manufacturing;
and
the
processing
or
otherwise
use
of
dioxin
and
dioxin­
like
compounds
if
the
dioxin
and
dioxin­
like
compounds
are
present
as
contaminants
in
a
chemical
and
if
they
were
created
during
the
manufacturing
of
that
chemical)
(This
category
includes
only
those
chemicals
listed
below)
1/
00
67562±
39±
4
1,2,3,4,6,7,8­
Heptachlorodibenzofuran
55673±
89±
7
1,2,3,4,7,8,9­
Heptachlorodibenzofuran
70648±
26±
9
1,2,3,4,7,8­
Hexachlorodibenzofuran
57117±
44±
9
1,2,3,6,7,8­
Hexachlorodibenzofuran
72918±
21±
9
1,2,3,7,8,9­
Hexachlorodibenzofuran
60851±
34±
5
2,3,4,6,7,8­
Hexachlorodibenzofuran
39227±
28±
6
1,2,3,4,7,8­
Hexachlorodibenzo­
p­
dioxin
57653±
85±
7
1,2,3,6,7,8­
Hexachlorodibenzo­
p­
dioxin
19408±
74±
3
1,2,3,7,8,9­
Hexachlorodibenzo­
p­
dioxin
35822±
46±
9
1,2,3,4,6,7,8­
Heptachlorodibenzo­
p­
dioxin
39001±
02±
0
1,2,3,4,6,7,8,9­
Octachlorodibenzofuran
03268±
87±
9
1,2,3,4,6,7,8,9­
Octachlorodibenzo­
p­
dioxin
57117±
41±
6
1,2,3,7,8­
Pentachlorodibenzofuran
57117±
31±
4
2,3,4,7,8­
Pentachlorodibenzofuran
40321±
76±
4
1,2,3,7,8­
Pentachlorodibenzo­
p­
dioxin
51207±
31±
9
2,3,7,8­
Tetrachlorodibenzofuran
01746±
01±
6
2,3,7,8­
Tetrachlorodibenzo­
p­
dioxin
58753
Federal
Register
/
Vol.
64,
No.
209
/
Friday,
October
29,
1999
/
Rules
and
Regulations
Category
name
Effective
date
*
*
*
*
*
*
*
Polycyclic
aromatic
compounds
(PACs):
This
category
includes
only
those
chemicals
listed
below).

*
*
*
*
*
*
*
00206±
44±
0
Benzo(
j,
k)
fluorene
1/
00
*
*
*
*
*
*
*
00056±
49±
5
3­
Methylcholanthrene
1/
00
*
*
*
*
*
*
*
Vanadium
compounds
1/
00
9.
In
§
372.85,
revise
the
introductory
text
of
paragraph
(b)(
15)(
i),
add
a
new
paragraph
(b)(
15)(
ii),
and
revise
paragraphs
(b)(
16)(
i)(
B)
and
(b)(
16)(
ii)(
B)
to
read
as
follows:

§
372.85
Toxic
chemical
release
reporting
form
and
instructions.
*
*
*
*
*
(b)
*
*
*
(15)
*
*
*
(i)
An
estimate
of
total
releases
in
pounds
(except
for
dioxin
and
dioxinlike
compounds,
which
shall
be
reported
in
grams)
per
year
(releases
of
less
than
1,000
pounds
per
year
may
be
indicated
in
ranges,
except
for
chemicals
set
forth
in
§
372.28)
from
the
facility
plus
an
indication
of
the
basis
of
estimate
for
the
following:
*
*
*
*
*
(ii)
Report
a
distribution
of
the
chemicals
included
in
the
dioxin
and
dioxin­
like
compounds
category.
Such
distribution
shall
either
represent
the
distribution
of
the
total
quantity
of
dioxin
and
dioxin­
like
compounds
released
to
all
media
from
the
facility;
or
its
one
best
media­
specific
distribution.
(16)
*
*
*
(i)
*
*
*
(B)
An
estimate
of
the
amount
of
the
chemical
transferred
in
pounds
(except
for
dioxin
and
dioxin­
like
compounds,
which
shall
be
reported
in
grams)
per
year
(transfers
of
less
than
1,000
pounds
per
year
may
be
indicated
as
a
range,
except
for
chemicals
set
forth
in
§
372.28)
and
an
indication
of
the
basis
of
the
estimate.
*
*
*
*
*
(ii)
*
*
*
(B)
An
estimate
of
the
amount
of
the
chemical
in
waste
transferred
in
pounds
(except
for
dioxin
and
dioxin­
like
compounds,
which
shall
be
reported
in
grams)
per
year
(transfers
of
less
than
1,000
pounds
may
be
indicated
in
ranges,
except
for
chemicals
set
forth
in
§
372.28)
to
each
off­
site
location,
and
an
indication
of
the
basis
for
the
estimate
and
an
indication
of
the
type
of
treatment
or
disposal
used.
*
*
*
*
*

[FR
Doc.
99±
28169
Filed
10±
28±
99;
8:
45
am]

BILLING
CODE
6560±
50±
F