6560­
50­
P
U.
S.
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
63
[
OAR­
2005­
0155;
FRL­
]

RIN
2060­
AK18
National
Perchloroethylene
Air
Emission
Standards
for
Dry
Cleaning
Facilities
AGENCY:
Environmental
Protection
Agency
(
EPA).

ACTION:
Proposed
rule.

SUMMARY:
The
EPA
is
proposing
revised
standards
to
limit
emissions
of
perchloroethylene
(
PCE)
from
existing
and
new
dry
cleaning
facilities.
In
1993,
EPA
promulgated
technology­
based
emission
standards
to
control
emissions
of
PCE
from
dry
cleaning
facilities.
As
required
by
section
112(
d)(
6)
of
the
Clean
Air
Act
(
CAA),
EPA
has
reviewed
the
standards
and
is
proposing
revisions
to
take
into
account
new
developments
in
production
practices,
processes,
and
control
technologies.
In
addition,
pursuant
to
CAA
section
112(
f),
EPA
has
evaluated
the
remaining
risk
to
public
health
and
the
environment
following
implementation
of
the
technology­
based
rule
and
is
proposing
more
stringent
standards
in
order
to
protect
public
health
with
an
ample
margin
of
safety.
The
proposed
standards
are
expected
to
provide
further
reductions
of
PCE
beyond
the
1993
national
emission
standards
for
hazardous
air
pollutants
(
NESHAP),

based
on
application
of
equipment
and
work
practice
2
standards.

DATES:
Comments.
Comments
must
be
received
on
or
before
[
INSERT
DATE
60
DAYS
AFTER
DATE
OF
PUBLICATION
OF
THE
PROPOSED
RULE
IN
THE
FEDERAL
REGISTER].

Public
Hearing.
If
anyone
contacts
EPA
requesting
to
speak
at
a
public
hearing
by
[
INSERT
DATE
15
DAYS
AFTER
DATE
OF
PUBLICATION
OF
THE
PROPOSED
RULE
IN
THE
FEDERAL
REGISTER],
a
public
hearing
will
be
held
on
[
INSERT
DATE
30
DAYS
AFTER
DATE
OF
PUBLICATION
OF
THE
PROPOSED
RULE
IN
THE
FEDERAL
REGISTER],
and
if
that
date
falls
on
a
weekend,
the
hearing
will
be
held
the
next
business
day.
Under
the
Paperwork
Reduction
Act,
comments
on
the
information
collection
provisions
must
be
received
by
OMB
on
or
before
[
INSERT
DATE
30
DAYS
AFTER
DATE
OF
PUBLICATION
OF
THE
PROPOSED
RULE
IN
THE
FEDERAL
REGISTER].

ADDRESSES:
Comments.
Submit
your
comments,
identified
by
Docket
ID
No.
OAR­
2005­
0155,
by
one
of
the
following
methods:

°
www.
regulations.
gov.
Follow
the
on­
line
instructions
for
submitting
comments.

°
Agency
Web
site:
http://
www.
epa.
gov/
edocket.

EDOCKET,
EPA's
electronic
public
docket
and
comment
system,
will
be
replaced
by
an
enhanced
Federal­
wide
electronic
docket
management
and
3
comment
system
located
at
www.
regulations.
gov.

When
that
occurs,
you
will
be
redirected
to
that
site
to
access
the
docket
and
submit
comments.

Follow
the
on­
line
instructions
for
submitting
comments.

°
E­
mail:
a­
and­
r­
Docket@
epa.
gov,
Attention
Docket
ID
No.
OAR­
2005­
0155.

°
Fax:
(
202)
566­
1741,
Attention
Docket
ID
No.
OAR­

2005­
0155.

°
Mail:
U.
S.
Postal
Service,
send
comments
to:
EPA
Docket
Center
(
6102T),
Attention
Docket
ID
No.

OAR
2005­
0155,
1200
Pennsylvania
Avenue,
NW,

Washington,
DC
20460.
Please
include
a
total
of
two
copies.
In
addition,
please
mail
a
copy
of
your
comments
on
the
information
collection
provisions
to
the
Office
of
Information
and
Regulatory
Affairs,
Office
of
Management
and
Budget
(
OMB),
Attn:
Desk
Officer
for
EPA,
725
17th
St.,
NW,
Washington,
DC
20503.

°
Hand
Delivery:
In
person
or
by
courier,
deliver
your
comments
to:
EPA
Docket
Center
(
6102T),

Attention
Docket
ID
No.
OAR­
2005­
0155,
1301
Constitution
Avenue,
NW,
EPA
West
Building,
Room
B­
108,
Washington,
DC
20004.
Such
deliveries
are
only
accepted
during
the
Docket's
normal
hours
of
4
operation,
and
special
arrangements
should
be
made
for
deliveries
of
boxed
information.
Please
include
a
total
of
two
copies.

Instructions:
Direct
your
comments
to
Docket
ID
No.
OAR­

2005­
0155.
EPA's
policy
is
that
all
comments
received
will
be
included
in
the
public
docket
without
change
and
may
be
made
available
online
at
www.
regulations.
gov,
including
any
personal
information
provided,
unless
the
comment
includes
information
claimed
to
be
confidential
business
information
(
CBI)
or
other
information
whose
disclosure
is
restricted
by
statute.
Do
not
submit
information
that
you
consider
to
be
CBI
or
otherwise
protected
through
www.
regulations.
gov
or
e­
mail.
Send
or
deliver
information
identified
as
CBI
to
only
the
following
address:
Mr.
Roberto
Morales,
OAQPS
Document
Control
Officer,
EPA
(
C404­
02),
Attention
Docket
ID
No.
OAR
2005­
0155,
Research
Triangle
Park,
NC
27711.

Clearly
mark
the
part
or
all
of
the
information
that
you
claim
to
be
CBI.
The
www.
regulations.
gov
website
is
an
"
anonymous
access"
system,
which
means
EPA
will
not
know
your
identity
or
contact
information
unless
you
provide
it
in
the
body
of
your
comment.
If
you
send
an
e­
mail
comment
directly
to
EPA
without
going
through
www.
regulations.
gov,

your
e­
mail
address
will
be
automatically
captured
and
included
as
part
of
the
comment
that
is
placed
in
the
public
docket
and
made
available
on
the
Internet.
If
you
submit
an
5
electronic
comment,
EPA
recommends
that
you
include
your
name
and
other
contact
information
in
the
body
of
your
comment
and
with
any
disk
or
CD­
ROM
you
submit.
If
EPA
cannot
read
your
comment
due
to
technical
difficulties
and
cannot
contact
you
for
clarification,
EPA
may
not
be
able
to
consider
your
comment.
Electronic
files
should
avoid
the
use
of
special
characters,
any
form
of
encryption,
and
be
free
of
any
defects
or
viruses.
For
additional
information
about
EPA's
public
docket
visit
the
EPA
Docket
Center
homepage
at
http://
www.
epa.
gov/
epahome/
dockets.
htm
or
see
the
Federal
Register
of
May
31,
2002
(
67
FR
38102).

Docket.
All
documents
in
the
docket
are
listed
in
the
www.
regulations.
gov
index.
Although
listed
in
the
index,

some
information
is
not
publicly
available,
e.
g.,
CBI
or
other
information
whose
disclosure
is
restricted
by
statute.

Certain
other
material,
such
as
copyrighted
material,
will
be
publicly
available
only
in
hard
copy.
Publicly
available
docket
materials
are
available
either
electronically
in
www.
regulations.
gov
or
in
hard
copy
at
the
EPA
Docket
Center,
Docket
ID
No.
OAR
2005­
0155,
EPA
West
Building,
Room
B­
102,
1301
Constitution
Ave.,
NW,
Washington,
DC.
The
EPA
Docket
Center
Public
Reading
Room
is
open
from
8:
30
a.
m.
to
4:
30
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.

The
telephone
number
for
the
Public
Reading
Room
is
(
202)

566­
1744,
and
the
telephone
number
for
the
EPA
Docket
Center
6
is
(
202)
566­
1742.
A
reasonable
fee
may
be
charged
for
copying
docket
materials.

Public
Hearing:
If
a
public
hearing
is
held,
it
will
begin
at
10:
00
a.
m.
and
will
be
held
at
EPA's
campus
at
109
T.
W.

Alexander
Drive,
Research
Triangle
Park,
NC,
or
at
an
alternate
facility
nearby.
Persons
interested
in
presenting
oral
testimony
or
inquiring
as
to
whether
a
public
hearing
is
to
be
held
should
contact
Ms.
Janet
Eck,
Coatings
and
Consumer
Products
Group,
Emission
Standards
Division,
EPA
(
C539­
03),
Research
Triangle
Park,
NC
27711,
telephone
(
919)

541­
7946.,
at
least
2
days
in
advance
of
the
hearing.
If
no
one
contacts
Ms.
Eck
in
advance
of
the
hearing
with
a
request
to
present
oral
testimony
at
the
hearing,
we
will
cancel
the
hearing.

FOR
FURTHER
INFORMATION
CONTACT:
For
questions
about
the
proposed
rule,
contact
Ms.
Rhea
Jones,
EPA,
Office
of
Air
Quality
Planning
and
Standards,
Emission
Standards
Division,

Coatings
and
Consumer
Products
Group
(
C539­
03),
Research
Triangle
Park,
NC
27711;
telephone
number
(
919)
541­
2940;

fax
number
(
919)
541­
5689;
e­
mail
address:

jones.
rhea@
epa.
gov.
For
questions
on
the
residual
risk
analysis,
contact
Mr.
Neal
Fann,
EPA,
Office
of
Air
Quality
Planning
and
Standards,
Emission
Standards
Division,
Risk
and
Exposure
Assessment
Group
(
C404­
01),
Research
Triangle
7
Park,
NC
27711;
telephone
number
(
919)
541­
0209;
fax
number
(
919)
541­
0840;
e­
mail
address:
fann.
neal@
epa.
gov.

SUPPLEMENTARY
INFORMATION:

Regulated
Entities.
Categories
and
entities
potentially
regulated
by
the
proposed
rule
are
industrial
and
commercial
PCE
dry
cleaners.
The
proposed
rule
affects
the
following
categories
of
sources:

Category
NAICS1
Code
Examples
of
Potentially
Regulated
Entities
Coin­
operated
Laundries
and
Dry
Cleaners
Dry
Cleaning
and
Laundry
Services
(
except
coin­
operated)

Industrial
Launderers
812310
812320
812332
Dry­
to­
dry
machines
Transfer
machines
Dry­
to­
dry
machines
Transfer
machines
Dry­
to­
dry
machines
Transfer
machines
1
North
American
Industry
Classification
System.

This
table
is
not
intended
to
be
exhaustive,
but
rather
provides
a
guide
for
readers
regarding
entities
likely
to
be
regulated
by
the
proposed
rule.
To
determine
whether
your
facility
is
regulated
by
the
proposed
rule,
you
should
examine
the
applicability
criteria
in
40
CFR
63.320
of
subpart
M
(
1993
Dry
Cleaning
NESHAP).
If
you
have
any
questions
regarding
the
applicability
of
the
proposed
rule
to
a
particular
entity,
contact
the
person
listed
in
the
preceding
FOR
FURTHER
INFORMATION
CONTACT
section.

Submitting
CBI.
Do
not
submit
information
which
you
claim
8
to
be
CBI
to
EPA
through
EDOCKET,
regulations.
gov,
or
email
Clearly
mark
the
part
or
all
of
the
information
that
you
claim
to
be
CBI.
For
CBI
information
in
a
disk
or
CD
ROM
that
you
mail
to
EPA,
mark
the
outside
of
the
disk
or
CD
ROM
as
CBI
and
then
identify
electronically
within
the
disk
or
CD
ROM
the
specific
information
that
is
claimed
as
CBI.

In
addition
to
one
complete
version
of
the
comment
that
includes
information
claimed
as
CBI,
a
copy
of
the
comment
that
does
not
contain
the
information
claimed
as
CBI
must
be
submitted
for
inclusion
in
the
public
docket.
Information
marked
as
CBI
will
not
be
disclosed
except
in
accordance
with
procedures
set
forth
in
40
CFR
part
2.

If
you
have
any
questions
about
CBI
or
the
procedures
for
claiming
CBI,
please
consult
either
of
the
persons
identified
in
the
FOR
FURTHER
INFORMATION
CONTACT
section.

Worldwide
Web
(
WWW).
In
addition
to
being
available
in
the
docket,
an
electronic
copy
of
the
proposed
rule
is
also
available
on
the
WWW.
Following
the
Administrator's
signature,
a
copy
of
the
proposed
rule
will
be
posted
on
EPA's
Technology
Transfer
Network
(
TTN)
policy
and
guidance
page
for
newly
proposed
or
promulgated
rules
at
http://
www.
epa.
gov/
ttn/
oarpg.
The
TTN
provides
information
and
technology
exchange
in
various
areas
of
air
pollution
control.
9
Outline.
The
information
presented
in
this
preamble
is
organized
as
follows:

I.
Background
A.
What
is
the
statutory
authority
for
regulating
hazardous
air
pollutants
(
HAP)?
B.
What
are
PCE
dry
cleaning
facilities?
C.
What
are
the
health
effects
of
PCE?
D.
What
does
the
1993
NESHAP
require?
II.
Summary
of
Proposed
Rule
A.
What
are
the
proposed
requirements
for
major
sources?
B.
What
are
the
proposed
requirements
for
area
sources?
C.
What
are
the
proposed
requirements
for
transfer
machines
at
major
and
area
sources?
III.
Rationale
for
the
Proposed
Rule
A.
What
is
our
approach
for
developing
residual
risk
standards?
B.
How
did
we
estimate
residual
risk?
C.
What
are
the
residual
risks
from
major
sources?
D.
What
are
the
options
for
reducing
risk,
their
costs,
and
risk
reduction
impacts
for
major
sources?
E.
What
is
our
proposed
decision
on
acceptable
risk
and
ample
margin
of
safety
for
major
sources?
F.
What
are
the
risks
from
typical
area
sources?
G.
What
are
the
options
for
reducing
risk,
their
costs,
and
risk
reduction
impacts
for
typical
area
sources?
H.
What
is
our
proposal
for
addressing
the
remaining
emissions
for
typical
area
sources?
I.
What
are
the
risks
from
co­
residential
area
sources?
J.
What
is
our
proposed
decision
on
co­
residential
area
sources?
K.
What
determination
is
EPA
proposing
pursuant
to
review
of
the
1993
Dry
Cleaning
NESHAP
under
CAA
section
112(
d)(
6)?
L.
What
additional
changes
are
we
making
to
the
1993
Dry
Cleaning
NESHAP?
IV.
Solicitation
of
Public
Comments
A.
Additional
Requirements
for
Highest
Risk
Facilities
B.
Requirement
for
PCE
Sensor
and
Lockout
as
New
Source
MACT
for
Major
Sources
C.
Alternative
Performance­
based
Standard
for
Existing
Major
Sources
D.
Environmental
Impacts
of
PCE
Emissions
E.
Additional
Time
for
Complying
with
Provisions
for
Transfer
Machines
V.
Statutory
and
Executive
Order
Reviews
A.
Executive
Order
12866:
Regulatory
Planning
and
Review
B.
Paperwork
Reduction
Act
10
C.
Regulatory
Flexibility
Act
D.
Unfunded
Mandates
Reform
Act
E.
Executive
Order
13132:
Federalism
F.
Executive
Order
13175:
Consultation
and
Coordination
with
Indian
Tribal
Governments
G.
Executive
Order
13045:
Protection
of
Children
from
Environmental
Health
and
Safety
Risks
H.
Executive
Order
13211:
Actions
Concerning
Regulations
That
Significantly
Affect
Energy
Supply,
Distribution,
or
Use
I.
National
Technology
Transfer
Advancement
Act
I.
Background
A.
What
is
the
statutory
authority
for
regulating
hazardous
air
pollutants
(
HAP)?

Section
112
of
the
CAA
establishes
a
two­
stage
regulatory
process
to
address
emissions
of
hazardous
air
pollutants
(
HAP)
from
stationary
sources.
In
the
first
stage,
after
EPA
has
identified
categories
of
sources
emitting
one
or
more
of
the
HAP
listed
in
the
CAA,
section
112(
d)
calls
for
us
to
promulgate
national
technology­
based
emission
standards
for
sources
within
those
categories
that
emit
or
have
the
potential
to
emit
any
single
HAP
at
a
rate
of
10
tons
or
more
per
year
or
any
combination
of
HAP
at
a
rate
of
25
tons
or
more
per
year
(
known
as
major
sources),

as
well
as
for
certain
area
sources
emitting
less
than
those
amounts.
These
technology­
based
standards
must
reflect
the
maximum
reductions
of
HAP
achievable
(
after
considering
cost,
energy
requirements,
and
non­
air
health
and
environmental
impacts)
and
are
commonly
referred
to
as
11
maximum
achievable
control
technology
(
MACT)
standards.

For
area
sources,
CAA
section
112(
d)(
5)
provides
that
the
standards
may
reflect
generally
available
control
technology
or
management
practices
in
lieu
of
MACT,
and
are
commonly
referred
to
as
generally
available
control
technology
(
GACT)
standards.
We
published
MACT
and
GACT
standards
for
PCE
dry
cleaning
facilities
on
September
22,

1993
at
58
FR
49376.
The
EPA
is
then
required,
pursuant
to
section
112
(
d)(
6),
to
review
these
technology­
based
standards
and
to
revise
them
"
as
necessary,
taking
into
account
developments
in
practices,
processes
and
control
technologies,"
no
less
frequently
than
every
8
years.

The
second
stage
in
standard­
setting
is
described
in
section
112(
f)
of
the
CAA.
This
provision
requires,
first,

that
EPA
prepare
a
Report
to
Congress
discussing
(
among
other
things)
methods
of
calculating
risk
posed
(
or
potentially
posed)
by
sources
after
implementation
of
the
MACT
standards,
the
public
health
significance
of
those
risks,
the
means
and
costs
of
controlling
them,
actual
health
effects
to
persons
in
proximity
to
emitting
sources,

and
recommendations
as
to
legislation
regarding
such
remaining
risk.
The
EPA
prepared
and
submitted
this
report
(
Residual
Risk
Report
to
Congress,
EPA­
453/
R­
99­
001)
in
March
1999.
The
Congress
did
not
act
on
any
of
the
recommendations
in
the
report,
thereby
triggering
the
second
12
stage
of
the
standard­
setting
process,
the
residual
risk
phase.

Section
112(
f)(
2)
of
the
CAA
requires
us
to
determine
for
each
section
112(
d)
source
category
whether
the
MACT
standards
protect
public
health
with
an
ample
margin
of
safety.
If
the
MACT
standards
for
HAP
"
classified
as
a
known,
probable,
or
possible
human
carcinogen
do
not
reduce
lifetime
excess
cancer
risks
to
the
individual
most
exposed
to
emissions
from
a
source
in
the
category
or
subcategory
to
less
than
1­
in­
1­
million,"
EPA
must
promulgate
residual
risk
standards
for
the
source
category
(
or
subcategory)
as
necessary
to
protect
public
health
with
an
ample
margin
of
safety.
The
EPA
must
also
adopt
more
stringent
standards
if
required
to
prevent
an
adverse
environmental
effect
(
defined
in
section
112(
a)(
7)
as
"
any
significant
and
widespread
adverse
effect
*
*
*
to
wildlife,
aquatic
life,
or
natural
resources
*
*
*."),
but
must
consider
cost,
energy,
safety,

and
other
relevant
factors
in
doing
so.

B.
What
are
PCE
dry
cleaning
facilities?

Dry
cleaners
use
PCE
in
a
dry
cleaning
machine
to
clean
all
types
of
garments,
including
clothes,
gloves,
leather
garments,
blankets,
and
absorbent
materials.
There
are
approximately
28,000
PCE
dry
cleaning
facilities
in
the
United
States.
Of
the
28,000
dry
cleaners,
15
of
the
facilities
are
major
sources
and
the
remaining
are
area
13
sources.
Major
source
PCE
dry
cleaners
are
those
that
emit
10
tons
or
more
of
PCE
per
year
upon
the
compliance
date
of
the
1993
Dry
Cleaning
NESHAP.
The
1993
Dry
Cleaning
NESHAP
defines
this
as
facilities
that
purchase
more
than
2,100
gallons
(
gal)
of
PCE
per
year
(
1,800
gal
per
year
if
the
facility
uses
transfer
machines).
Area
sources
are
typically
the
common
neighborhood
dry
cleaner.
Area
sources
were
divided
into
large
or
small
in
the
1993
Dry
Cleaning
NESHAP,
with
large
area
sources
defined
as
those
facilities
that
use
between
140
to
2,100
gal
of
PCE
per
year
(
or
140
to
1,800
gal
per
year
if
the
facility
uses
transfer
machines).

Small
area
sources
use
less
than
140
gal
per
year.
Some
area
sources
are
collocated
in
the
same
building
with
residences.
In
the
1993
Dry
Cleaning
NESHAP
we
did
not
specifically
discuss
these
sources,
but
in
this
notice
we
refer
to
them
as
co­
residential
dry
cleaners.
A
coresidential
dry
cleaning
facility
is
located
in
a
building
in
which
people
reside.
Co­
residential
facilities
are
located
primarily
in
urban
areas.

In
general,
PCE
dry
cleaning
facilities
can
be
classified
into
three
types:
commercial,
industrial,
and
leather.
Commercial
facilities
typically
clean
household
items
such
as
suits,
dresses,
coats,
pants,
comforters,

curtains,
and
formalwear.
Industrial
dry
cleaners
clean
heavily­
stained
articles
such
as
work
gloves,
uniforms,
14
mechanics'
overalls,
mops,
and
shop
rags.
Leather
cleaners
mostly
clean
household
leather
products
like
jackets
and
other
leather
clothing.
The
15
major
sources
include
eight
industrial
facilities,
five
commercial
facilities,
and
two
leather
facilities.
The
five
commercial
facilities
are
each
the
central
plant
for
a
chain
of
retail
storefronts.
We
do
not
expect
any
new
source
facilities
constructed
in
the
future
to
be
major
sources.
Based
on
the
low
emission
rates
of
current
PCE
dry
cleaning
machines
and
the
typical
business
models
used
in
the
industrial
and
commercial
dry
cleaning
sectors,
it
is
unlikely
that
any
new
sources
that
are
constructed
will
emit
PCE
at
major
levels,
or
that
any
existing
area
sources
will
become
major
sources
due
to
business
growth.

Dry
cleaning
machines
can
be
classified
into
two
types:

transfer
and
dry­
to­
dry.
Similar
to
residential
washing
machines
and
dryers,
transfer
machines
have
a
unit
for
washing/
extracting
and
another
unit
for
drying.
Following
the
wash
cycle,
PCE­
laden
articles
are
manually
transferred
from
the
washer/
extractor
to
the
dryer.
The
transfer
of
wet
fabrics
is
the
predominant
source
of
PCE
emissions
in
these
systems.
Dry­
to­
dry
machines
wash,
extract,
and
dry
the
articles
in
the
same
drum
in
a
single
machine,
so
the
articles
enter
and
exit
the
machine
dry.
Because
the
transfer
step
is
eliminated,
dry­
to­
dry
machines
have
much
15
lower
emissions
than
transfer
machines.

New
transfer
machines
are
effectively
prohibited
at
major
and
area
sources
due
to
the
1993
Dry
Cleaning
NESHAP
requirement
that
new
dry
cleaning
systems
eliminate
any
emissions
of
PCE
while
transferring
articles
from
the
washer
to
the
dryer.
Therefore,
transfer
machines
are
no
longer
sold.
Existing
transfer
machines
are
becoming
an
increasingly
smaller
segment
of
the
dry
cleaning
population
as
these
machines
reach
the
end
of
their
useful
lives
and
are
replaced
by
dry­
to­
dry
machines.
There
are
approximately
200
transfer
machines
currently
being
used,

all
at
area
sources.

The
primary
sources
of
PCE
emissions
from
dry­
to­
dry
machines
are
the
drying
cycle
and
fugitive
emissions
from
the
dry
cleaning
equipment
(
including
equipment
used
to
recycle
PCE
and
dispose
of
PCE­
laden
waste).
Machines
are
designed
to
be
either
vented
or
non­
vented
during
the
drying
cycle.
Approximately
200
dry
cleaners
(
1
percent)
use
vented
machines,
and
the
remaining
facilities
use
the
lowerpolluting
non­
vented
machines.
(
The
1993
Dry
Cleaning
NESHAP
prohibits
new
dry
cleaning
machines
at
major
and
area
sources
that
vent
to
the
atmosphere
while
the
dry
cleaning
drum
is
rotating.)
In
vented
machines,
the
majority
of
emissions
from
the
drying
cycle
are
vented
outside
the
building.
In
non­
vented
machines,
dryer
emissions
are
16
released
when
the
door
is
opened
to
remove
garments.

Currently,
the
largest
sources
of
emissions
from
dry
cleaning
are
from
equipment
leaks,
which
come
from
leaking
valves
and
seals,
and
the
loading
and
unloading
of
garments.

C.
What
are
the
health
effects
of
PCE?

The
main
health
effects
of
PCE
are
neurological,
liver,

and
kidney
damage
following
acute
(
short­
term)
and
chronic
(
long­
term)
inhalation
exposure.
Animal
studies
have
reported
an
increased
incidence
of
liver
cancer
in
mice
via
inhalation,
kidney
cancer
and
mononuclear
cell
leukemia
in
rats.
PCE
was
considered
to
be
a
"
probable
carcinogen"

(
Group
B)
when
assessed
under
the
previous
1986
Guidelines
by
the
EPA
Science
Advisory
Board.
See
the
risk
characterization
memorandum
in
the
public
docket
for
additional
information
regarding
the
health
effects
of
PCE.

D.
What
does
the
1993
NESHAP
require?

The
1993
NESHAP
prescribes
a
combination
of
equipment,

work
practices,
and
operational
requirements.
The
requirements
for
process
controls
are
summarized
in
table
1
of
this
preamble.
The
1993
Dry
Cleaning
NESHAP
defines
major
and
area
sources
based
on
the
annual
PCE
purchases
for
all
machines
at
a
facility.
The
consumption
criterion
(
which
affects
the
amount
of
PCE
purchased)
varies
depending
on
whether
the
facility
has
dry­
to­
dry
machines
only,

transfer
machines
only,
or
a
combination
of
both.
The
17
affected
source
is
each
individual
dry
cleaning
system.

Table
1.
Summary
of
the
1993
Dry
Cleaning
NESHAP
Process
Controls
Sources
Annual
PCE
Purchased
New1
(
after
12/
9/
91)
Existing2
Major
Sources
Dry­
to­
dry
ONLY
>
2,100
gal/
yr
Transfer
ONLY
>
1,800
gal/
yr
Dry­
to­
dry
AND
Transfer
>
1,800
gal/
yr
Dry­
to­
dry
machines
with
a
refrigerated
condenser,
AND
carbon
adsorber
operated
immediately
before
or
as
the
door
is
opened.
Dry­
to­
dry
machines:
must
have
refrigerated
condenser3.

Transfer
machines:
must
be
enclosed
in
a
room
exhausting
to
a
dedicated
carbon
adsorber.
Large
Area
Sources
Dry­
to­
dry
ONLY
140
to
2,100
gal/
yr
Transfer
ONLY
200
to
1,800
gal/
yr
Dry­
to­
dry
AND
Transfer
140
to
1,800
gal/
yr
Dry­
to­
dry
machines
with
a
refrigerated
condenser.
Dry­
to­
dry
machines:
must
have
a
refrigerated
condenser3.

Transfer
machines:
No
controls
required.

Small
Area
Sources
Dry­
to­
dry
ONLY
<
140
gal/
yr
Transfer
ONLY
<
200
gal/
yr
Dry­
to­
dry
AND
Transfer
<
140
gal/
yr
Same
as
large
area
sources.
No
controls
required.

1
No
new
transfer
machines
are
allowed
after
9/
23/
93.
2
Compliance
date
=
9/
23/
96.
3
Alternatively,
carbon
adsorber
is
allowed
only
if
installed
before
9/
22/
93.

In
addition,
all
sources
must
comply
with
certain
operating
requirements,
including
recording
PCE
purchases,
18
storing
PCE
and
PCE­
containing
waste
in
non­
leaking
containers,
and
inspecting
for
perceptible
leaks.
Owners
or
operators
are
required
to
operate
and
maintain
the
control
equipment
according
to
procedures
specified
in
the
1993
Dry
Cleaning
NESHAP
and
to
use
pollution
prevention
procedures,

such
as
good
operation
and
maintenance,
for
both
dry
cleaning
machines
and
auxiliary
equipment
(
such
as
filter,

muck
cookers,
stills,
and
solvent
tanks)
to
prevent
liquid
and
vapor
leaks
of
PCE
from
these
sources.

II.
Summary
of
Proposed
Rule
A.
What
are
the
proposed
requirements
for
major
sources?

Under
the
proposed
revisions,
the
requirements
for
all
new
and
existing
major
sources
would
be
the
same.
The
proposed
revisions
would
require
the
implementation
of
an
enhanced
leak
detection
and
repair
(
LDAR)
program
and
the
use
of
dry­
to­
dry
machines
that
do
not
vent
to
the
atmosphere
(
closed­
loop)
during
any
phase
of
the
dry
cleaning
cycle.
A
refrigerated
condenser
and
a
secondary
carbon
adsorber
would
be
required
control
equipment
for
all
machines.
The
secondary
carbon
adsorber
would
control
the
PCE
emissions
during
the
final
stage
of
the
dry
cleaning
cycle
immediately
before
and
as
the
drum
door
is
opened.

Under
the
enhanced
LDAR
program,
the
facility
owner
or
operator
would
have
to
use
a
PCE
gas
analyzer
19
(
photoionization
detector,
flameionization
detector,
or
infrared
analyzer)
and
perform
leak
checks
according
to
EPA
Method
21
on
a
monthly
basis.
The
facility
owner
or
operator
would
also
be
required
to
continue
the
weekly
perceptible
leak
check
according
to
the
requirements
of
the
1993
Dry
Cleaning
NESHAP.

B.
What
are
the
proposed
requirements
for
area
sources?

For
existing
area
sources
(
large
and
small),
the
proposed
revisions
would
require
implementation
of
an
enhanced
LDAR
program
and
a
prohibition
on
the
use
of
existing
transfer
machines.
All
other
existing
area
source
standards
would
remain
the
same
as
in
the
1993
Dry
Cleaning
NESHAP.

For
new
area
sources
(
large
and
small),
the
proposed
rule
would
require
implementation
of
an
enhanced
LDAR
program
and
use
of
a
non­
vented
dry­
to­
dry
machine
with
a
refrigerated
condenser
and
secondary
carbon
adsorber.
In
addition,
the
proposed
rule
would
prohibit
the
use
of
new
PCE
machines
in
co­
residential
dry
cleaning
facilities.

The
enhanced
LDAR
program
for
area
sources
would
require
facilities
to
use
a
halogenated
leak
detector
(
instead
of
a
more
costly
gas
analyzer
proposed
for
major
sources)
to
perform
leak
checks
on
a
monthly
basis.
The
facility
would
also
be
required
to
continue
to
inspect
for
perceptible
leaks
biweekly
for
small
area
sources
and
weekly
20
for
large
area
sources
according
to
the
requirements
of
the
1993
Dry
Cleaning
NESHAP.

C.
What
are
the
proposed
requirements
for
transfer
machines
at
major
and
area
sources?

The
proposed
rule
would
effectively
prohibit
the
use
of
all
existing
transfer
machines
90
days
from
the
effective
date
of
the
final
rule
by
requiring
owners
or
operators
to
eliminate
any
PCE
emissions
from
clothing
transfer
between
the
washer
and
dryer.
Similarly,
the
installation
of
new
transfer
machines
was
prohibited
by
the
1993
Dry
Cleaning
NESHAP.
We
estimate
that
about
200
transfer
machines
remain
in
use
within
the
population
of
28,000
dry
cleaning
machines
located
at
area
sources
(
estimated
one
PCE
dry
cleaning
machine
per
facility
with
approximately
28,000
facilities).

Most
of
these
machines
will
be
at
or
near
the
end
of
their
useful
economic
life
by
the
time
final
rule
requirements
are
promulgated.
The
typical
life
of
a
dry
cleaning
machine
is
10
to
15
years.
By
the
end
of
2006,
the
newest
transfer
machines
in
the
industry
will
be
13
years
old.

III.
Rationale
for
the
Proposed
Rule
A.
What
is
our
approach
for
developing
residual
risk
standards?

Following
our
initial
determination
that
the
individual
most
exposed
to
emissions
from
the
category
considered
21
1
This
reading
is
confirmed
by
the
Legislative
History
to
CAA
section
112(
f);
see,
e.
g.,
"
A
Legislative
History
of
the
Clean
Air
Act
Amendments
of
1990,"
vol.
1,
page
877
(
Senate
Debate
on
Conference
Report).

2
Legislative
History,
vol.
1,
p.
877,
stating
that:
".
.
.
the
managers
intend
that
the
Administrator
shall
exceeds
a
1­
in­
1
million
individual
cancer
risk,
our
approach
to
developing
residual
risk
standards
is
based
on
a
two­
step
determination
of
acceptable
risk
and
ample
margin
of
safety.
The
first
step,
consideration
of
acceptable
risk,
is
only
a
starting
point
for
the
analysis
that
determines
the
final
standards.
The
second
step
determines
an
ample
margin
of
safety,
which
is
the
level
at
which
the
standards
are
set.

The
terms
"
individual
most
exposed,"
"
acceptable
level,"
and
"
ample
margin
of
safety"
are
not
specifically
defined
in
the
CAA.
However,
CAA
section
112(
f)(
2)(
B)

refers
positively
to
the
interpretation
of
these
terms
in
our
1989
rulemaking
(
54
FR
38044,
September
14,
1989),

"
National
Emission
Standards
for
Hazardous
Air
Pollutants:

Benzene
Emissions
from
Maleic
Anhydride
Plants,

Ethylbenzene/
Styrene
Plants,
Benzene
Storage
Vessels,

Benzene
Equipment
Leaks,
and
Coke
By­
Product
Recovery
Plants
(
Benzene
NESHAP),"
essentially
directing
us
to
use
the
interpretation
set
out
in
that
notice
1
or
to
utilize
approaches
affording
at
least
the
same
level
of
protection
2
.
22
interpret
this
requirement
[
to
establish
standards
reflecting
an
ample
margin
of
safety]
in
a
manner
no
less
protective
of
the
most
exposed
individual
than
the
policy
set
forth
in
the
Administrator's
benzene
regulations
.
.
.."

3
Residual
Risk
Report
to
Congress.
March
1999.
EPA­
453/
R­
99­
001,
page
ES­
11.

4
Id.
We
likewise
notified
Congress
in
the
Residual
Risk
Report
that
we
intended
to
utilize
the
Benzene
NESHAP
approach
in
making
CAA
section
112(
f)
residual
risk
determinations
3
.

In
the
Benzene
NESHAP
(
54
FR
38044,
September
14,

1989),
we
stated
as
an
overall
objective:

.
.
.
in
protecting
public
health
with
an
ample
margin
of
safety,
we
strive
to
provide
maximum
feasible
protection
against
risks
to
health
from
hazardous
air
pollutants
by
(
1)
protecting
the
greatest
number
of
persons
possible
to
an
individual
lifetime
risk
level
no
higher
than
approximately
1
in
1
million;
and
(
2)
limiting
to
no
higher
than
approximately
1
in
10
thousand
[
i.
e.,
100
in
1
million]
the
estimated
risk
that
a
person
living
near
a
facility
would
have
if
he
or
she
were
exposed
to
the
maximum
pollutant
concentrations
for
70
years.

As
explained
more
fully
in
our
Residual
Risk
Report,

these
goals
are
not
"
rigid
line[
s]
of
acceptability,"
but
rather
broad
objectives
to
be
weighed
"
with
a
series
of
other
health
measures
and
factors
4
."

B.
How
did
we
estimate
residual
risk?

The
"
Residual
Risk
Report
to
Congress"
(
EPA­
453/
R­
99­
23
5
Additional
details
are
provided
in
the
risk
characterization
memorandum
in
the
rulemaking
docket.

6
Residual
Risk
Report
to
Congress,
pp.
B 
18
and
B 
22.
The
approach
used
to
assess
the
risks
associated
with
standards
for
the
dry
cleaning
industry
are
consistent
with
the
technical
approach
and
policies
described
in
the
Report
to
Congress.
001)
provides
the
general
framework
for
conducting
risk
assessments
to
support
decisions
made
under
the
residual
risk
program.
The
report
acknowledged
that
each
risk
assessment
design
would
have
some
common
elements,
including
a
problem
formulation
phase,
an
analysis
phase,
and
the
risk
characterization
phase.
The
risk
assessment
for
PCE
dry
cleaners
used
both
site­
specific
data
for
many
modeling
parameters
and
population
characteristics
derived
from
census
data,
as
well
as
default
assumptions
for
exposure
parameters 
some
of
which
were
assumed
to
be
health
protective
(
e.
g.,
exposure
frequency
and
exposure
duration,

70­
year
constant
emission
rates)
5
,
6
.
To
estimate
the
cancer
risk
and
non­
cancer
hazard
for
major
source
facilities,
we
performed
refined
modeling
for
a
subset
of
major
source
facilities
we
determined
were
representative
of
all
major
sources,
including
industrial
cleaners,
commercial
cleaners,

and
leather
cleaners.
Facilities
within
each
of
these
three
specializations
tend
to
be
homogenous
with
respect
to
factors
that
affect
the
emissions,
pollutant
dispersion,
and
population
size
in
the
modeling
radius,
allowing
us
to
24
7
USEPA.
2005.
Guidelines
for
Carcinogen
Risk
Assessment.
EPA/
650/
P­
03/
001B.
Risk
Assessment
Forum,
Washington,
DC.

8
March
9,
1988
letter
to
Lee
Thomas,
Administrator,
U.
S.
Environmental
Protection
Agency,
from
Norton
Nelson,
Chair,
Executive
Committee
of
EPA
Science
Advisory
Board.
extrapolate
risks
from
facilities
modeled
to
those
that
were
not
modeled.
We
used
a
combination
of
modeling
and
monitoring
approaches
to
analyze
risks
for
area
sources.

See
the
risk
characterization
memorandum
in
the
public
docket
for
a
complete
discussion
of
the
major
and
area
source
risk
assessment.

1.
How
did
we
estimate
the
atmospheric
dispersion
of
PCE
emitted
from
major
and
area
sources?

We
used
the
Industrial
Source
Complex
Short­
term
model,

version
3
(
ISCST­
3)
to
estimate
the
dispersion
of
PCE
from
facilities
to
receptor
locations.
For
a
complete
description
of
the
dispersion
modeling,
please
see
the
risk
characterization
memorandum.

2.
How
did
we
assess
public
health
risk
associated
with
PCE
emitted
from
PCE
dry
cleaners?

PCE
has
been
associated
with
a
variety
of
health
effects,
including
cancer.
Although
PCE
has
not
yet
been
reassessed
under
the
Agency's
recently
revised
Guidelines
for
Cancer
Risk
Assessment
7
,
it
was
considered
to
be
a
"
probable
carcinogen"
(
Group
B)
8
when
assessed
under
the
25
9
USDHHS.
1989.
Report
on
Carcinogens,
Fifth
Edition;
U.
S.
Department
of
Health
and
Human
Services,
Public
Health
Service,
National
Toxicology
Program.

10
IARC.
1995.
Monographs
on
the
evaluation
of
carcinogenic
risks
to
humans.
Volume
63.
Dry
Cleaning,
Some
Chlorinated
Solvents
and
Other
Industrial
Chemicals.
ISBN
9283212630.
Geneva,
Switzerland.
previous
1986
Guidelines
by
the
EPA
Science
Advisory
Board.

Since
that
time,
the
United
States
Department
of
Health
and
Human
Services
has
concluded
that
PCE
is
"
reasonably
anticipated
to
be
a
human
carcinogen
9
,"
and
the
International
Agency
for
Research
on
Cancer
has
concluded
that
PCE
is
"
probably
carcinogenic
to
humans
10
."

In
our
assessment
of
public
health
risk
associated
with
PCE
emitted
from
PCE
dry
cleaners,
we
considered
risks
of
cancer
and
other
health
effects.
Cancer
risks
associated
with
inhalation
exposure
were
assessed
using
lifetime
cancer
risk
estimates.
The
noncancer
risks
were
characterized
through
the
use
of
hazard
quotient
(
HQ)
and
hazard
index
(
HI)
estimates.
An
HQ
is
calculated
as
the
ratio
of
the
exposure
concentration
of
a
pollutant
to
its
health­
based
non­
cancer
threshold.

In
this
assessment,
values
that
are
below
1.0
are
not
likely
to
be
associated
with
adverse
health
effects.
An
HI
is
the
sum
of
HQ
for
pollutants
that
target
the
same
organ
or
system.
For
dry
cleaners,
PCE
is
the
only
HAP
emitted,

therefore,
HI
and
HQ
are
the
same.
26
11
USEPA.
1998.
Cleaner
Technologies
Substitutes
Assessment:
Professional
Fabricare
Processes.
EPA
744­
B­
98­
001.
U.
S.
Environmental
Protection
Agency,
Office
of
Pollution
Prevention
and
Toxics,
Washington,
DC.

12
USEPA.
1996.
Addendum
to
the
Health
Assessment
Document
for
Tetrachloroethylene
(
Perchloroethylene),
Updated
Carcinogenicity
Assessment
for
Tetrachloroethylene
(
Perchloroethylene,
PERC,
PCE).
EPA/
600/
8­
82/
005FA.
External
Review
Draft.
U.
S.
Environmental
Protection
Agency,
Office
of
Health
and
Environmental
Assessment,
Washington,
DC.

13
CDHS.
1991.
Health
Effects
of
Tetrachloroethylene
(
PCE).
California
Department
of
Health
Services
(
subsequently
CalEPA,
Office
of
Environmental
Health
Hazard
Assessment),
Berkeley,
CA.

14
H.
J.
Clewell,
P.
R.
Gentry,
J.
E.
Kester,
and
M.
E.
Andersen.
2005.
Evaluation
of
physiologically
based
pharmacokinetic
perchloroethylene.
Several
sources
were
considered
for
cancer
and
noncancer
dose­
response
assessment
information.
In
a
1998
assessment
of
PCE
cancer
risks
associated
with
dry
cleaners,

EPA's
Office
of
Prevention,
Pesticides,
and
Toxic
Substances
(
OPPTS)
derived
and
used
a
lifetime
inhalation
unit
risk
estimate
(
URE)
of
7.1
x
10­
7
per
microgram
per
cubic
meter
(
ug/
m3)
11
.
This
reflected
an
update
of
the
URE
of
5.8
x
10­
7
per
ug/
m3
that
was
derived
by
EPA
in
the
1980s
12
.
The
PCE
cancer
dose­
response
assessments
developed
by
others
include
a
lifetime
URE
of
5.9
x
10­
6
per
ug/
m3
developed
by
the
California
Environmental
Protection
Agency
(
CalEPA)
13
,

and
a
lifetime
URE
of
3.8
x
10­
7
per
ug/
m3
developed
by
Clewell
and
others
14
.
27
15
JISA
(
Japan
Industrial
Safety
Association).
1993.
Carcinogenicity
Study
of
Tetrachloroethylene
by
Inhalation
in
Rats
and
Mice.
Data
No.
3­
1.
Available
from:
EPA­
IRIS
Information
Desk.

16
NTP.
1986.
NTP
technical
report
on
the
toxicology
and
carcinogenesis
of
tetrachloroethylene
(
perchloroethylene)
(
CAS
No.
127­
18­
4)
in
F344/
N
rats
and
B6C3F1
mice
(
inhalation
studies).
National
Toxicology
Program,
Research
Triangle
Park,
NC.
NTP
TR
311,
NIH
Publication
No.
86­
2567.
August
1986.
We
are
currently
reevaluating
the
available
information
on
health
effects
of
PCE,
including
cancer,
as
part
of
a
hazard
and
dose­
response
assessment
for
the
Agency's
Integrated
Risk
Information
System
(
IRIS).
The
cancer
component
of
this
evaluation
is
being
conducted
in
accordance
with
the
2005
Guidelines
for
Carcinogen
Risk
Assessment.
Data
have
become
available
from
the
Japanese
Industrial
Safety
Association
(
1993)
that
includes
rodent
inhalation
studies
with
a
cancer
bio­
assay
which
was
not
considered
by
the
sources
above
15
.
The
document
describing
the
evaluation
is
expected
to
be
released
for
external
scientific
peer
review
and
public
comment.
The
projected
schedule
for
completion
of
the
IRIS
assessment
is
available
at
http://
cfpub.
epa.
gov/
iristrac/
index.
cfm.

While
all
of
the
available
lifetime
URE
are
based
on
the
same
animal
bioassay
16
(
1986),
there
are
several
factors
contributing
to
the
differences
in
magnitude
among
them.

One
significant
contributing
factor
is
characterization
of
28
17
USEPA.
March
1999.
Residual
Risk
Report
to
Congress.
Office
of
Air
Quality
Planning
and
Standards,
Research
Triangle
Park,
NC
27711.
EPA­
453/
R­
99­
001;
available
at
http://
www.
epa.
gov/
ttn/
oarpg/
t3/
meta/
m8690.
html.
human
metabolism
of
PCE.
This
is
an
area
in
which
widely
diverging
quantitative
estimates
have
been
published,
and
their
use
leads
to
notable
differences
in
human
cancer
doseresponse
value
derived
from
animal
data,
illustrated
to
some
extent
by
the
range
of
values
presented
above.

As
an
interim
approach
in
lieu
of
the
completed
IRIS
assessment,
we
used
two
dose­
response
values
to
characterize
cancer
risk.
These
two
values
were
chosen
to
represent
the
best
available
peer­
reviewed
science.
As
we
have
stated
previously,
we
will
not
be
relying
exclusively
on
IRIS
values,
but
will
be
considering
all
credible
and
readily
available
assessments
17
.
We
used
the
CalEPA
URE
(
5.9
x
10­
6
per
ug/
m3)
and
the
estimate
developed
by
OPPTS
(
7.1
x
10­
7
per
ug/
m3).
Both
are
derived
with
consideration
of
findings
of
liver
tumors
in
mouse
laboratory
bioassays,
with
the
OPPTS
value
additionally
considering
laboratory
findings
of
mononuclear
cell
leukemia
in
rats,
and
both
have
received
public
comment
and
scientific
peer
review
by
external
panels.
Dose­
response
modeling
performed
in
both
assessments
involved
use
of
metabolized
doses
with
different
estimates
of
human
PCE
metabolism
contributing
to
29
18
ATSDR.
1997.
Toxicological
Profile
for
Tetrachloroethylene.
Department
of
Health
and
Human
Services,
Public
Health
Services,
Agnecy
for
Toxic
Substances
and
Disease
Registry,
Atlanta,
Georgia.

19
V.
Vu.
1997.
Memorandum
titled
"
Provisional
RfC
for
perchloroethylene"
From
Vanessa
Vu,
Acting
Director,
Health
and
Environmental
Review
Division,
to
William
Waugh,
Acting
Directory,
Chemical
Screening
and
Risk
Assessment
Division,
OPPT,
USEPA.
As
cited
in
OPPTS
1998.
Cleaner
Technologies
Substitutes
Assessment:
Professional
Fabricare
Processes.
EPA­
744­
B­
98­
001.
USEPA,
Office
of
Pollution
Prevention
and
Toxics,
Washington,
DC.
differences
in
the
resulting
URE.

Effects
other
than
cancer
associated
with
long­
term
inhalation
of
PCE
in
worker
or
animal
studies
include
neurotoxicity,
liver
and
kidney
damage,
and,
at
higher
levels,
developmental
effects.
To
characterize
noncancer
hazard
in
lieu
of
the
completed
IRIS
assessment,
we
used
the
Agency
for
Toxic
Substances
and
Disease
Registry's
(
ATSDR)

Minimum
Risk
Level
(
MRL)
(
270
ug/
m3)
18
.
This
value
is
based
on
a
study
of
neurological
effects
in
workers
in
dry
cleaning
shops,
and
is
derived
in
a
manner
similar
to
EPA's
method
for
derivation
of
reference
concentrations
(
Rfc),
and
with
scientific
and
public
review.
The
ATSDR
MRL
is
quite
similar
to
the
provisional
RfC
(
170
ug/
m3)
derived
by
OPPTS
in
1997
based
on
a
study
of
kidney
effects
in
workers
in
dry
cleaning
shops
19
that
reported
effects
at
similar
exposure
concentrations
than
those
elsewhere
reported
associated
with
neurological
effects.
The
OPPTS
value
was
termed
a
30
20
USEPA.
2004.
Summary
report
of
the
peer
review
workshop
on
the
neurotoxicity
of
tetrachloroethylene
(
perchloroethylene)
discussion
paper.
National
Center
for
Environmental
Assessment,
Washington,
DC;
EPA­
600­
R­
04­
041.
Available
online
at
http://
www.
epa.
gov/
ncea.
provisional
RfC
because
it
was
derived
by
a
single
EPA
program
office
with
limited
cross­
office
review.
This
value
is
based
on
a
study
of
neurological
effects
in
workers
in
dry
cleaning
shops.
Since
that
time,
more
recent
studies
have
been
published,
particularly
with
regard
to
more
sensitive
neurological
effects
at
lower
exposures
20
.
We
are
reviewing
these
and
all
of
the
available
information
on
the
noncancer
health
effects
of
PCE
as
part
of
the
IRIS
assessment.

The
proposed
rule
is
based
on
both
the
risk
estimates
derived
using
both
the
CalEPA
cancer
dose­
response
values
and
the
ATSDR
noncancer
MRL.
The
CalEPA
cancer
doseresponse
value
is
higher
than
the
value
derived
by
OPPTS,

leading
to
higher
cancer
risk
estimates.
Given
our
uncertainty
regarding
the
pending
IRIS
dose­
response
values,

we
have
considered
the
range
of
available
potencies
with
which
to
calculate
inhalation
cancer
risk.
We
calculate
cancer
risk
using
both
values,
but
propose
to
use
the
CalEPA
value.
We
request
comment
on
both
this
approach
of
using
the
more
health
protective
end
of
the
dose­
response
range
and
our
selection
of
dose­
response
values.
Based
on
the
31
findings
and
status
of
the
IRIS
assessment
at
the
time
of
promulgation,
we
may
reassess
our
estimates
of
cancer
risk
and
noncancer
hazard.
The
Agency
is
aware
that
some
stakeholders
have
suggested
that
we
defer
certain
action
pending
completion
of
the
IRIS
assessment
for
PCE.
In
today's
notice,
we
request
comment
on
our
proposal
to
use
the
available
CalEPA
and
OPPTS
potency
values,
and
we
request
comments
on
whether
we
should
defer
further
development
of
the
risk
assessment
and
any
rulemakings
under
section
112(
f)(
2)
for
area
sources
pending
completion
of
the
IRIS
assessment
for
PCE.

3.
How
did
we
assess
environmental
impacts
of
major
sources
and
typical
area
sources?

The
chemical
properties
of
PCE
suggest
that
once
it
is
emitted
into
the
atmosphere
as
a
vapor,
it
is
not
likely
to
partition
significantly
into
soil,
water,
or
sediment.

Based
on
fugacity
modeling,
we
estimate
that
99.8
percent
of
ambient
PCE
remains
in
the
atmosphere,
with
the
remainder
partitioning
into
water
(
0.17
percent),
and
soil
(
0.05
percent).
Thus,
PCE
emitted
from
major
stationary
sources
is
not
likely
to
pose
a
significant
ecological
risk
due
to
any
exposure
pathway
other
than
inhalation.

Further,
to
assess
the
potential
inhalation
risk
to
mammals
from
PCE
inhalation,
we
compared
the
minimum
lowest
observable
adverse
effect
level
(
LOAEL)
for
rats
with
the
32
highest
level
of
modeled
ambient
concentration
from
PCE
cleaners;
the
rat
LOAEL
for
PCE
can
be
found
in
the
ATSDR
toxicological
profile
that
documents
the
development
of
the
MRL
(
http://
www.
atsdr.
cdc.
gov/
toxprofiles/
tp18.
html).
The
lowest
rat
LOAEL
(
9
parts
per
million
(
ppm),
or
60
mg/
m3)
is
about
2,000
times
higher
than
the
highest
modeled
postcontrol
ambient
concentrations
from
major
stationary
sources.

This
large
margin
of
exposure
leads
us
to
conclude
that
risks
to
mammals
from
PCE
inhalation
are
likely
insignificant,
obviating
the
need
to
further
quantify
ecological
risks
to
any
degree.

In
the
atmosphere,
PCE
is
known
to
degrade
into
many
compounds,
including
trichloroacetic
acid
(
TCAA).
TCAA
is
a
persistent,
known
phytotoxin,
which
has
been
discontinued
as
a
herbicide.
Atmospheric
transformation
of
PCE
to
TCAA
is
the
subject
of
great
debate,
with
potential
conversion
efficiencies
estimated
to
be
on
the
order
of
5
to
15
percent.
However,
there
are
very
few
data
quantifying
TCAA
concentrations
in
the
air,
precipitation,
water,
soil,
or
sediment
in
the
United
States.
This
scarcity
of
data
makes
it
difficult
to
determine
whether
there
is
any
potential
for
adverse
ecological
impacts
on
plant
life
from
PCE
emissions
from
dry
cleaners
due
to
conversion
to
TCAA.
While
we
have
no
direct
evidence
that
this
will
present
a
significant
33
ecological
risk,
we
nonetheless
invite
public
comment
and
solicit
additional
scientific
information
on
this
issue.

Since
our
results
showed
no
screening
level
ecological
effects,
we
do
not
believe
that
there
is
any
potential
for
an
effect
on
threatened
or
endangered
species
or
on
their
critical
habitat
within
the
meaning
of
50
CFR
402.14(
a).

Because
of
these
results,
we
concluded
a
consultation
with
the
Fish
and
Wildlife
Service
is
not
necessary.

C.
What
are
the
residual
risks
from
major
sources?

Table
2
of
this
preamble
summarizes
the
estimated
risks
remaining
for
the
seven
modeled
major
source
facilities
after
compliance
with
MACT.
In
performing
residual
risk
assessments
under
the
CAA
section
112(
f)(
2),
EPA
believes
it
may
evaluate
potential
risk
based
on
consideration
of
both
emission
levels
allowed
under
the
MACT
standard
and
actual
emissions
levels
achieved
in
compliance
with
MACT.
See,

e.
g.,
70
FR
19992,
19998
(
April
15,
2005).
Generally,

allowable
emissions
are
the
maximum
levels
sources
could
emit
and
still
comply
with
existing
standards.
It
is
also
reasonable
that
we
consider
actual
emissions
when
available,

as
a
factor
in
both
steps
of
the
residual
risk
determination,
to
avoid
unrealistic
inflation
of
risk
levels
or
where
other
factors
suggest
basing
the
evaluation
soley
on
allowables
is
not
appropriate.
Essentially,
the
existing
dry
cleaning
MACT
standard
is
comprised
of
equipment
34
standards
and
various
work
practices.
Compliance
with
the
existing
MACT
standard
is
demonstrated
by
use
of
the
required
equipment
and
implementation
of
the
required
work
practices,
and
there
are
no
numeric
emissions
levels
to
model.
Therefore,
the
seven
facilities
were
modeled
using
actual
2000­
2002
emissions
and
are
representative
of
the
emissions
from
major
sources.
We
conclude
that
the
sampled
facilities
represent
characteristics
of
the
major
source
facility
population,
including
commercial,
industrial,
and
leather
facilities.
The
risk
analysis
shows
that
each
of
the
seven
modeled
facilities
poses
a
cancer
risk
of
1­
in­
1
million
or
greater.
The
highest
maximum
individual
cancer
risk
(
MIR)
is
between
300­
in­
1
million
and
2,400­
in­
1
million.
The
MIR
is
the
lifetime
risk
of
developing
cancer
for
the
individual
facing
the
highest
estimated
exposure
over
a
70­
year
lifetime.
Five
of
the
modeled
facilities
pose
a
risk
greater
than
100­
in­
1
million
(
the
presumptive
unacceptable
risk
level),
and
about
550
people
are
exposed
at
this
level.
One
facility
has
a
HQ
of
greater
than
1.0.

As
described
below
in
section
III.
E,
we
expect
a
continuing
decline
in
PCE
emissions
even
in
the
absence
of
additional
Federal
regulation.
These
baseline
risk
estimates
do
not
reflect
such
a
trend,
therefore;
baseline
risks
are
likely
to
be
overestimated.
35
Table
2.
Major
Source
Baseline
Risk
Estimates
for
Modeled
Facilities
after
Application
of
1993
Dry
Cleaning
NESHAP,
Based
on
70­
year
Exposure
Duration1
Parameter
MACT
Level
(
OPPTS
URE)
MACT
Level
(
CalEPA
URE)

MIR
from
facility
with
highest
risk
300­
in­
1
million
2,400­
in­
1
million
Maximum
HQ
from
facility
with
highest
risk
based
on
ATSDR
MRL
2
2
Population
at
risk
across
all
modeled
facilities
(
modeled
to
10
kilometers
(
km):

>
1­
in­
1
million
16,000
175,000
>
10­
in­
1
million
800
12,500
>
100­
in­
1
million
10
550
Total
population
exposed
3,300,000
3,300,000
1
In
this
table,
all
risk
and
population
estimates
are
rounded.

To
account
for
the
fact
that
individuals
may
move
through
areas
(
microenvironments)
of
differing
concentrations
during
their
daily
activities,
EPA
conducted
an
exposure
variability
analysis
in
which
it
used
the
Total
Risk
Integration
Methodology
Exposure
model
(
TRIM.
Expo,
also
known
as
the
Air
Pollutant
Exposure
Model
3,
or
APEX3).
The
TRIM.
Expo
model
uses
a
personal
profile
approach
in
which
it
stochastically
simulates
exposures
for
individuals
of
differing
demographic
characteristics
and
associated
daily
activity
patterns.
The
model
output
provides
a
distribution
of
exposure
estimates
which
are
intended
to
be
36
21
Note
that
the
ISCST­
3
modeling
results
do
not
match
earlier
risk
estimates
due
to
the
fact
that
EPA
used
an
earlier
set
of
ISCST­
3
modeling
results
for
the
TRIM.
Expo
analysis.
The
original
ISCST­
3
results
are
retained
here
so
that
the
comparison
with
TRIM.
Expo
will
be
consistent.
representative
of
the
study
population
with
respect
to
their
demographically
based
behavior,
in
terms
of
the
microenvironments
through
which
they
move
during
a
day
and
throughout
a
year
(
see
http://
www.
epa.
gov/
ttn/
fera
for
more
information
regarding
the
model).
To
estimate
cancer
risk,

EPA
assumes
that
this
1­
year
exposure
scenario
continues
for
70
years.
Table
3
contrasts
ISCST­
3
and
TRIM.
Expo
estimates
of
population
risk
for
the
worst­
case
facility,
using
the
CalEPA
URE;
this
example
is
illustrative
only
21
.

Table
3.
Comparison
of
ISCST­
3
Exposure
Estimates
with
Activity­
patterned/
day,
lifetime
exposure
(
ISCST­
3+
Trim.
Expo)

Model
Total
Population
at
Cancer
Risk
>
100­
in­
1
million
>
10­
in­
1
million
>
1­
in­
1
million
ISCST­
3
900
14,000
75,000
TRIM.
Expo
400
9,000
80,000
TRIM.
Expo
provides
a
more
central
tendency
estimate
of
risk
by
accounting
for
variability
in
personal
exposure.

The
table
above
shows
a
smaller
number
of
individuals
exposed
at
the
higher
levels
of
cancer
risk
and
a
slightly
larger
number
of
individuals
exposed
at
a
cancer
risk
of
at
37
22
Risk
estimates
derived
using
maximum
exposure
concentration.
least
1­
in­
1
million.
While
we
performed
this
analysis
for
the
worst­
case
facility,
it
is
reasonable
to
infer
that
the
risk
distribution
above
would
be
similar
to
the
remainder
of
the
major
source
facilities.
One
limitation
of
this
analysis
is
that
we
assume
continuous
70­
year
exposure
when
calculating
cancer
risk,
and
some
individuals
are
likely
to
move
away
from
the
facility.
However,
given
the
large
number
of
area
source
dry
cleaners
nation
wide,
and
the
consequent
ubiquity
of
PCE
exposure,
it
is
unlikely
that
the
PCE
exposure
of
individuals
moving
out
of
the
TRIM.
Expo
study
area
would
fall
to
zero.

For
illustrative
purposes,
below
we
provide
estimates
of
individual
inhalation
cancer
risk
based
on
different
assumptions
regarding
exposure
duration.
In
contrast
to
the
TRIM.
Expo
estimates
above,
the
risk
estimates
below
do
not
account
for
personal
activity
patterns
and
assume
that
individuals
receive
continuous
exposure
for
the
duration
noted.

Table
4.
Estimates
of
Individual
Inhalation
Cancer
Risk
Based
on
Different
Exposure
Durations
Estimated
Lifetime
Cancer
Risk
Assumed
Exposure
Duration
22
70
50
30
20
10
38
Risk
per
Million
(
CalEPA)
2,400
1,700
1,030
700
340
Risk
per
Million
(
OPPTS)
300
210
130
90
40
D.
What
are
the
options
for
reducing
risk,
their
costs,
and
risk
reduction
impacts
for
major
sources?

We
evaluated
several
methods
for
reducing
risks.
These
methods
include
enhanced
LDAR
and
three
emission
control
technologies.

Enhanced
LDAR.
Enhanced
LDAR
would
require
the
facility
owner
or
operator
to
use
a
portable
PCE
gas
analyzer
to
perform
leak
checks
on
a
monthly
basis.
Two
major
sources
and
several
State
and
local
agencies
currently
use
a
photoionization
detector,
one
type
of
gas
analyzer,

for
leak
inspections.
The
detection
probe
is
moved
slowly
along
the
equipment
part,
and
if
PCE
is
detected,
the
device
gives
a
concentration
reading
of
the
leak.
The
proposed
leak
definition
is
a
concentration
of
25
ppm.
Portable
gas
analyzers
cost
about
$
3,300
and
have
a
10­
year
life
expectancy.
The
facility
would
be
required
to
continue
to
perform
the
weekly
perceptible
leak
checks
as
required
by
the
1993
Dry
Cleaning
NESHAP.
A
nominal
amount
of
additional
labor
would
be
required
as
a
result
of
the
proposed
requirement
to
use
a
gas
analyzer.
We
estimated
1
hour
of
labor
per
machine
per
month
to
perform
the
leak
39
inspection.
The
estimated
total
capital
cost
to
the
industry
to
establish
an
enhanced
LDAR
program
is
$
40,000,

with
a
annual
cost
savings
of
$
390,000.
The
cost
savings
is
due
to
reduced
PCE
consumption.

Control
Technologies.
Three
types
of
emission
control
technologies
can
be
used
to
reduce
emissions
from
dry
cleaning
machines.
The
first
two
are
a
refrigerated
condenser
and
a
secondary
carbon
adsorber.
The
third
technology
is
a
PCE
sensor
and
lockout.
By
using
the
first
two
control
technologies
together,
and
by
operating
them
properly,
a
significant
amount
of
PCE
can
be
recovered.

Refrigerated
condensers
are
the
most
effective
method
for
reducing
PCE
from
the
drying
cycle.
They
are
used
to
condense
PCE
vapor
for
reuse.
By
operating
at
lower
temperatures
than
water­
cooled
condensers,
refrigerated
condensers
recover
more
PCE
from
the
drying
air
and
reduce
emissions.
By
the
end
of
the
cool­
down
cycle,
refrigerated
condensers
can
reduce
PCE
concentrations
in
the
drum
to
between
2,000
and
8,600
ppm.
Refrigerated
condensers
require
relatively
little
maintenance,
needing
only
to
have
their
refrigerant
recharged
and
to
have
lint
removed
from
the
coils
(
yearly
or
even
less
frequently).

A
secondary
carbon
adsorber
controls
the
PCE
emissions
during
the
final
stage
of
the
dry
cleaning
cycle
just
prior
to
the
drum
door
opening.
A
carbon
adsorber
removes
organic
40
compounds
from
air
by
adsorption
onto
a
bed
of
activated
carbon
as
the
air
passes
over
the
bed.
Carbon
adsorbers
have
a
PCE
removal
efficiency
of
95
percent
or
greater.

Properly
designed
and
operated
secondary
adsorbers
have
been
shown
to
reduce
the
PCE
concentration
in
the
drum
from
several
thousand
ppm
to
less
than
100
ppm,
and
in
some
cases,
to
less
than
10
ppm.
Most
new
dry
cleaning
machines
sold
today
are
equipped
with
secondary
carbon
adsorbers.

Carbon
adsorbers
require
periodic
desorption
to
recover
PCE
and
maintain
their
peak
PCE
collection
efficiency.

The
technologies
currently
in
use
by
major
and
area
source
dry
cleaners
include
vented
dry­
to­
dry
machines
with
water­
cooled
condensers
and
carbon
adsorbers,
non­
vented
(
closed­
loop)
dry­
to­
dry
machines
with
refrigerated
condensers,
non­
vented
dry­
to­
dry
machines
with
refrigerated
condensers
and
secondary
carbon
adsorbers
and
transfer
machines.
To
meet
a
standard
requiring
a
refrigerated
condenser
and
secondary
carbon
adsorber,
existing
dry
cleaning
machines
without
this
control
could
be
retrofitted,

or
new
replacement
machines
could
be
purchased
depending
on
the
remaining
useful
life
of
each
existing
machine.
The
costs
to
add
control
technologies
range
from
$
13,000
to
$
40,000
per
machine,
depending
on
the
size
of
the
existing
machine
and
the
level
of
control
of
the
machine.
Machine
replacement
costs
are
approximately
$
900
to
$
1,000
per
pound
41
of
capacity.
Additional
analysis
of
costs
can
be
found
in
the
Background
Information
Document
in
the
public
docket.

A
PCE
sensor
is
the
third
control
technology
used
in
machines
with
a
secondary
carbon
adsorber.
The
sensor
controls
the
carbon
adsorption
cycle
to
achieve
a
set
PCE
concentration
in
the
drum.
This
device
uses
a
single­
beam
infrared
photometer
to
measure
the
concentration
of
PCE
in
the
drum,
and
prolongs
the
carbon
adsorption
cycle
until
the
concentration
set
point
is
achieved.
An
interlock
(
lock­
out)
ensures
that
the
PCE
set­
point
has
been
attained
before
the
machine
door
can
be
opened.

Regulatory
Options.
We
considered
three
options
for
reducing
risk
from
major
source
dry
cleaners.
Option
I
would
require
all
major
sources
to
use
an
enhanced
LDAR
program
and
have
dry­
to­
dry
machines
with
a
refrigerated
condenser
and
a
secondary
carbon
adsorber.
Option
II
would
require
a
PCE
sensor
and
lock­
out
in
addition
to
the
Option
I
controls.
Option
III
would
require
no
PCE
emissions
from
major
sources
(
a
ban
on
the
use
of
PCE).

Table
5
of
this
preamble
shows
the
costs
and
risk
estimates
for
each
regulatory
option.
The
population
risk
estimates
were
extrapolated
from
the
seven
modeled
facilities
to
all
15
major
source
facilities.
The
cost
estimates
are
also
for
all
15
major
source
facilities.
42
23
Modeled
to
10
km.
Table
5.
Risk
Estimates
and
Costs
of
Control
Options
for
Major
Sources
Based
on
70­
year
Exposure
Duration1
Parameter
MACT
Level
Option
I
Option
II
Option
III
MIR
from
facility
with
highest
risk
(
CalEPA
URE)
2,400­
in­
1
million
270­
in­
1
million
150­
in­
1
million
NA2
MIR
from
facility
with
highest
risk
(
OPPTS
URE)
300­
in­
1
million
30­
in­
1
million
20­
in­
1
million
NA
Maximum
HQ
from
facility
with
highest
risk
2
0.2
0.1
NA
Population
at
risk
across
all
facilities
23
(
population
risk
range
represents
difference
between
OPPTS
and
CalEPA
URE):

>
1­
in­
1
million
35,000
to
375,000
2,000
to
55,000
1,000
to
26,000
NA
>
10­
in­
1
million
2,000
to
27,000
20
to
1,800
10
to
900
NA
>
100­
in­
1
million
10
to
1,200
0
to
13
0
to
6
NA
Total
population
exposed
(
within
10
km)
9,300,000
NA
Capital
Cost
($
1000)
­
830
5,700
8,200
Annualized
Cost
($
1000)
­
(
220)
420
Not
Estimated
43
Emission
Reduction
(
tons
per
year
(
tpy))
­
209
249
(
40
incremental
293
(
44
incremental

1
In
this
table,
risk
estimates
are
based
on
both
OPPTS
and
the
CalEPA
URE.
All
risk
and
population
estimates
are
rounded.
2
NA
=
not
applicable.
Under
Option
III,
risk
from
PCE
would
be
eliminated,
however,
potential
risks
from
alternative
solvents
were
not
analyzed.

E.
What
is
our
proposed
decision
on
acceptable
risk
and
ample
margin
of
safety
for
major
sources?

Section
112(
f)(
2)(
A)
of
the
CAA
states
that
if
the
MACT
standards
for
a
source
emitting
a:

...
known,
probable,
or
possible
human
carcinogen
do
not
reduce
lifetime
excess
cancer
risks
to
the
individual
most
exposed
to
emissions
from
a
source
in
the
category...
to
less
than
one
in
one
million,
the
Administrator
shall
promulgate
[
residual
risk]
standards...
for
such
source
category.

The
residual
risk
to
the
individual
most
exposed
to
emissions
from
PCE
dry
cleaners
is
estimated
at
1­
in­
1
million
or
greater
at
each
major
source
dry
cleaner
modeled.

Major
source
dry
cleaners
subject
to
the
proposed
rule
emit
a
possible
to
probable
human
carcinogen,
and,
as
shown
in
table
3
of
this
preamble,
we
estimate
that
the
MIR
associated
with
the
1993
Dry
Cleaning
NESHAP
limits
is
between
300­
in­
1
million
and
2,400­
in­
1
million.
Therefore,

we
believe
a
residual
risk
standard
is
necessary.

In
the
1989
Benzene
NESHAP,
the
first
step
of
the
44
residual
risk
decision
framework
is
the
determination
of
acceptable
risk
(
i.
e.,
are
the
estimated
risks
due
to
emissions
from
these
facilities
"
acceptable").
This
determination
is
based
on
health
considerations
only,

without
consideration
of
costs.
The
determination
of
what
represents
an
"
acceptable"
risk
level
is
based
on
a
judgment
of
"
what
risks
are
acceptable
in
the
world
in
which
we
live"

(
54
FR
38045,
1987,
quoting
the
Vinyl
Chloride
decision
at
DC
Circuit
Courts
Decision
in
NRDC
vs.
EPA,
824
F.
2d
at
1165)
recognizing
that
our
world
is
not
risk­
free.

In
the
1989
Benzene
NESHAP,
we
stated
that
a
MIR
of
approximately
100­
in­
1
million
should
ordinarily
be
the
upper
end
of
the
range
of
acceptable
risks
associated
with
an
individual
source
of
pollution.
We
characterized
the
MIR
as
"
the
estimated
risk
that
a
person
living
near
a
facility
would
have
if
he
or
she
were
exposed
to
the
maximum
pollutant
concentrations
for
70
years."
We
explained
that
this
measure
of
risk
"
is
an
estimate
of
the
upper
bound
of
risk
based
on
conservative
assumptions,
such
as
continuous
exposure
for
24
hours
per
day
for
70
years."
We
acknowledge
that
the
MIR
"
does
not
necessarily
reflect
the
true
risk,

but
displays
a
conservative
risk
level
which
is
an
upper
bound
that
is
unlikely
to
be
exceeded."

Understanding
that
there
are
both
benefits
and
limitations
to
using
MIR
as
a
metric
for
determining
45
acceptability,
we
acknowledged
in
the
1989
Benzene
NESHAP
that
"
consideration
of
maximum
individual
risk.
.
.
must
take
into
account
the
strengths
and
weaknesses
of
this
measure
of
risk."
Consequently,
the
presumptive
risk
level
of
100­
in­
1
million
provides
a
benchmark
for
judging
the
acceptability
of
MIR,
but
does
not
constitute
a
rigid
line
for
making
that
determination.
In
establishing
a
presumption
for
the
acceptability
of
maximum
risk,
rather
than
a
rigid
line
for
acceptability,
we
explained
in
the
1989
Benzene
NESHAP
that
risk
levels
should
also
be
weighed
with
a
series
of
other
health
measures
and
factors,
including
the
following:

°
The
numbers
of
persons
exposed
within
each
individual
lifetime
risk
range
and
associated
incidence
within,

typically,
a
50
km
(
about
30
miles)
exposure
radius
around
facilities.

°
The
science
policy
assumptions
and
estimation
uncertainties
associated
with
the
risk
measures.

°
Weight
of
the
scientific
evidence
for
human
health
effects.

°
Other
quantified
or
unquantified
health
effects.

°
The
overall
incidence
of
cancer
or
other
serious
health
effects
within
the
exposed
population.

In
some
cases,
these
health
measures
and
factors
taken
together
may
provide
a
more
realistic
description
of
the
magnitude
of
risk
in
the
exposed
population
than
that
46
provided
by
MIR
alone.

Based
on
use
of
the
criteria
identified
above,
we
judge
the
level
of
risk
resulting
from
regulatory
option
I
to
be
acceptable
for
this
source
category
(
table
3
of
this
preamble).
This
option
requires
dry
cleaning
machines
at
all
major
sources
to
have
an
enhanced
LDAR
program
and
closed­
loop,
dry­
to­
dry
machines
with
refrigerated
condensers
and
secondary
carbon
adsorbers.
The
calculated
MIR
is
between
30­
in­
1
million
and
270­
in­
1
million.
While
the
upper­
end
of
this
risk
range
is
greater
than
the
presumptively
acceptable
level
of
MIR
under
the
1989
Benzene
NESHAP
formulation
(
100­
in­
1
million),
we
also
considered
other
factors
in
making
our
determination
of
acceptability,

as
directed
by
the
1989
Benzene
NESHAP.
The
principal
factors
that
influenced
our
decision
were
that
nearly
all
of
the
population
living
within
10
km
of
each
facility
receive
cancer
risk
at
less
than
1­
in­
1
million.
Considering
the
very
small
number
of
individuals
that
are
estimated
to
receive
greater
than
100­
in­
1
million
cancer
risk
coupled
with
the
exposure
and
dose­
response
assessment
methodology
that
was
conservatively
health
protective,
it
is
likely
that
no
actual
persons
are
exposed
at
risk
levels
above
100­
in­
1
million.
Among
the
exposed
population
of
9.3
million
individuals,
a
maximum
of
between
0
and
13
people
are
estimated
to
receive
risks
of
more
than
100­
in­
1
million.
47
Under
option
I,
the
exposure
to
maximum
exposed
individuals
would
be
reduced
from
between
300­
in­
1
million
to
2,400­
in­
1
million
to
between
30­
in­
1
million
and
270­
in­
1
million.

Total
combined
cancer
incidence
would
be
between
0.002
and
0.003
cases
per
year
for
all
seven
major
source
facilities
that
were
modeled.
In
addition,
no
significant
non­
cancer
health
effects
are
predicted.
The
maximum
HQ
would
be
reduced
from
2
to
0.2,
and
no
adverse
ecological
impacts
are
predicted
under
option
I.
In
addition,
we
expect
that
PCE
usage
will
continue
to
drop
as
has
been
the
trend
over
the
past
10
years.
This
trend
has
been
caused
by
the
greater
use
of
alternative
solvents,
older
machines
at
the
end
of
their
useful
lives
being
replaced
with
newer,
lower
emitting
dry­
to­
dry
machines
with
refrigerated
condensers
and
secondary
carbon
adsorbers,
and
State
and
industry
programs
that
improve
machine
efficiency
and
reduce
PCE
consumption.

All
of
these
factors
will
cause
risks
to
continue
to
decrease
in
the
future
in
the
absence
of
further
Federal
regulatory
requirements.
Therefore,
we
have
determined
that
the
risks
associated
with
regulatory
option
I
are
acceptable
after
considering
MIR,
the
population
exposed
at
different
risk
levels,
the
projected
absence
of
noncancer
effects
and
adverse
ecological
effects,
and
the
projected
decline
in
PCE
usage.

While
not
relevant
for
determining
the
acceptable
risk
48
level,
the
national
capital
costs
of
regulatory
option
I
are
$
830,000
and
annualized
cost
savings
of
$
220,000.
Most
facilities
would
recognize
a
cost
savings
primarily
from
implementing
the
enhanced
LDAR
program.
Leak
detection
and
repair
is
a
pollution
prevention
approach
where
reduced
emissions
translate
into
less
PCE
consumption
and
reduced
operating
costs
because
facilities
would
need
to
purchase
less
PCE.
The
capital
costs
for
individual
facilities
would
range
from
$
0
to
$
313,000,
with
a
median
cost
of
$
51,000.

Annualized
costs
would
range
from
a
cost
savings
of
$
106,000
per
year
to
a
cost
of
$
22,000
per
year.

The
second
step
in
the
residual
risk
decision
framework
is
the
determination
of
standards
that
are
equal
to
or
lower
than
the
acceptable
risk
level
and
that
protect
public
health
with
an
ample
margin
of
safety.
In
making
this
determination,
we
considered
the
estimate
of
health
risk
and
other
health
information
along
with
additional
factors
relating
to
the
appropriate
level
of
control,
including
costs
and
economic
impacts
of
controls,
technological
feasibility,
uncertainties,
and
other
relevant
factors,

consistent
with
the
approach
of
the
1989
Benzene
NESHAP.

We
evaluated
regulatory
option
II
as
the
first
level
of
control
more
stringent
than
the
acceptable
risk
level
for
this
source
category.
Our
analysis
showed
a
relatively
small
incremental
risk
reduction
beyond
that
achieved
by
49
option
I.
Under
option
I,
one
of
the
seven
modeled
facilities
would
pose
risks
greater
than
100­
in­
1
million
using
the
CalEPA
URE
and
no
facility
would
pose
risks
greater
than
100­
in­
1
million
using
the
OPPTS
URE.
Under
option
II,
this
facility
would
still
have
risks
above
100­

in­
1
million
using
the
CalEPA
URE
only.
For
the
other
six
modeled
facilities,
the
risks
would
remain
in
the
range
of
10­
in­
1
million
under
option
II
using
the
CalEPA
URE
and
risks
would
drop
below
the
range
of
10­
in­
1
million
for
three
of
seven
facilities
using
the
OPPTS
URE.

The
national
capital
cost
for
option
II
(
all
15
major
sources)
is
$
5.7
million
with
an
annualized
cost
of
$
420,000.
These
costs
include
retrofitting
PCE
sensors
and
lockout
systems
on
machines
that
were
manufactured
in
1998
or
later,
and
the
costs
of
replacing
machines
installed
before
1998,
which
cannot
reliably
meet
the
same
level
of
emission
reduction
with
a
PCE
sensor.

Overall,
option
II
has
high
costs
considering
the
relatively
low
risk
reduction
for
most
of
the
major
sources.

These
costs
do
not
achieve
a
significant
risk
reduction
for
most
sources.
Consequently,
we
determined
that
requiring
the
addition
of
a
PCE
sensor
and
lock­
out
was
not
a
reasonable
or
economically
feasible
option
for
all
major
sources.

We
also
evaluated
regulatory
option
III,
a
ban
on
PCE
50
use,
as
a
level
of
control
more
stringent
than
the
acceptable
risk
level
for
this
source
category.
This
would
completely
eliminate
risk
from
PCE
for
the
population
around
the
15
major
source
facilities
by
essentially
eliminating
the
sources
of
PCE.
The
costs
to
eliminate
PCE
usage
at
major
sources
would
require
a
capital
cost
to
the
industry
of
approximately
$
8.2
million.
This
estimate
was
based
on
the
total
cost
of
replacing
all
PCE
machines
with
machines
using
an
alternative
solvent
(
not
an
incremental
cost
of
a
new
PCE
machine
versus
a
new
alternative
solvent
machine).

Alternative
solvents
currently
being
used
in
the
industry
include
cyclic
siloxanes,
liquid
carbon
dioxide,

wetcleaning,
and
synthetic
hydrocarbon.
There
are
some
uncertainties
that
these
solvents
do
not
have
the
cleaning
power
(
kB
value)
of
PCE
for
the
heavy
soiled
or
greasy
garments
like
leather
work
gloves
and
aprons
which
are
the
typical
garments
cleaned
by
industrial
major
sources.
There
are
some
fabrics
that
cannot
be
cleaned
in
the
alternative
solvents.
There
are
also
some
uncertainties
about
whether
the
waste
from
alternative
solvent
systems
would
be
classified
as
hazardous.
Alternative
solvents
have
a
role
in
the
industry,
and
are
being
used
for
certain
cleaning
applications.
However,
there
is
not
enough
experience
to
determine
that
these
technologies
are
sufficiently
demonstrated
for
all
applications
such
that
PCE
should
be
51
eliminated
from
the
marketplace.
Therefore,
we
have
determined
that
regulatory
option
III
is
not
a
viable
option
at
this
time
considering
cost,
economic
impacts,
technical
feasibility,
and
uncertainties.

Based
on
the
information
analyzed
for
the
three
options,
we
are
proposing
that
option
I
provides
an
ample
margin
of
safety
to
protect
public
health
for
major
sources
in
the
dry
cleaning
industry.

F.
What
are
the
risks
from
typical
area
sources?

We
are
not
mandated
to
develop
residual
risk
standards
for
area
sources
regulated
by
GACT.
Under
our
discretion,

we
have
developed
estimates
of
the
remaining
risk
for
these
sources.
In
estimating
the
inhalation
cancer
risk
that
area
sources
pose,
we
considered
the
risks
from
facilities
co­
located
with
residences
(
co­
residential
area
sources)

separately
from
those
located
in
all
other
settings
(
typical
area
sources).

To
assess
risks
from
area
sources,
we
first
analyzed
readily
available
data.
The
1999
National
Air
Toxics
Assessment
(
NATA)
provides
census
tract
level
estimates
of
cancer
risk
and
noncancer
hazard
across
the
United
States
for
a
subset
of
the
188
HAP.
Using
this
assessment,
we
were
able
to
generate
a
course­
scale
estimate
of
population
risk
for
PCE
area
source
dry
cleaners
by
scaling
the
NATA
cancer
for
PCE
by
the
relative
contribution
of
area
source
cleaners
52
to
PCE
emissions.
See
table
6
below
for
a
summary
of
the
NATA­
derived
estimated
risks
for
area
source
cleaners.

Table
6.
Estimated
NATA­
Derived
Population
Cancer
Risk
for
PCE
Area
Source
Dry
Cleaners
Dose­
Response
Value
Estimated
Cancer
Risk
at
Least:

100­
in­
1
million
10­
in­
1
million
1­
in­
1
million
OPPTS
0
0
960,000
CalEPA
0
400,000
56,000,000
This
assessment
provides
a
screening­
level
estimate
of
PCE
risk
to
the
general
population.

Next,
we
performed
a
"
model
facility"
assessment.
In
this
modeling
scenario,
we
used
information
regarding
typical
facility
size
and
dispersion
parameters
and
average
and
upper­
end
emissions
of
a
facility
meeting
the
1993
Dry
Cleaning
NESHAP
to
create
a
set
of
"
model
facilities."
See
the
risk
characterization
memorandum
in
the
public
docket
for
a
complete
description
of
the
two
modeling
methodologies.
Table
7
of
this
preamble
summarizes
the
cancer
and
noncancer
risk
for
typical
area
sources
(
excluding
transfer
machines).

Table
7.
Estimated
Incremental
Lifetime
Individual
Cancer
Risk
and
Non­
Cancer
Hazard
for
Typical
Area
Sources
Using
a
Range
of
Emissions
and
Worst­
Case
Dispersion
Modeling
Risk
Estimate
Model
Facility
Emissions
Average
(
0.5
tons)
99th
percentile
(
4
tons)
Maximum
(
8
tons)
53
MIR
(
OPPTS
URE)
2­
in­
1
million
20­
in­
1
million
30­
in­
1
million
MIR
(
CalEPA
URE)
15­
in­
1
million
120­
in­
1
million
220­
in­
1
million
Noncancer
HQ1
0.001
0.07
0.1
1
HQ
estimates
have
been
rounded.

G.
What
are
the
options
for
reducing
risk,
their
costs,
and
risk
reduction
impacts
for
typical
area
sources?

We
evaluated
three
control
measures
to
reduce
risks
from
typical
area
sources.
These
measures
are
an
enhanced
LDAR
program
for
area
sources,
elimination
of
emissions
from
existing
transfer
machines,
and
the
use
of
a
refrigerated
condenser
and
secondary
carbon
adsorber
(
same
control
technologies
described
above
for
major
sources).
These
control
measures
have
been
commercially
demonstrated
at
area
source
dry
cleaners
in
the
United
States.
The
three
control
measures
were
used
to
develop
two
regulatory
options
to
reduce
risk.

The
enhanced
LDAR
program
for
area
sources
would
require
the
use
of
a
halogenated
leak
detector
instead
of
a
gas
analyzer,
which
is
being
proposed
for
major
sources.

The
cost
of
a
halogenated
leak
detector
($
250)
is
significantly
less
than
a
gas
analyzer
($
3,300).
A
gas
analyzer
is
a
more
accurate
device
that
provides
a
quantitative
reading
of
PCE
concentration.
This
device
can
be
particularly
useful
in
pinpointing
leaks
at
major
sources
54
that
have
high
background
concentrations
of
PCE.
The
halogenated
leak
detector
is
a
non­
quantitative
device
that
provides
an
audible
or
visual
display
when
it
detects
a
leak
above
25
ppm.
We
have
concluded
that
a
halogenated
leak
detector
is
sufficient
for
detecting
leaks
at
area
source
dry
cleaners
and
will
provide
a
significant
improvement
in
reducing
emissions
compared
to
the
current
requirement
to
inspect
for
perceptible
leaks
only.

Transfer
machines
have
substantially
higher
emissions
than
dry­
to­
dry
machines.
The
1993
Dry
Cleaning
NESHAP
effectively
bans
new
transfer
machines,
but
existing
machines
were
grandfathered.
In
1993,
we
determined
that
the
capital
costs
required
to
replace
all
transfer
machines
would
have
created
an
adverse
economic
impact
on
a
substantial
portion
of
the
industry,
especially
small
businesses
that
had
recently
purchased
new
transfer
machines.
We
estimate
that
about
200
transfer
machines
remain
in
use
within
the
population
of
28,000
dry
cleaning
machines
located
at
area
sources
(
estimated
one
PCE
dry
cleaning
machine
per
facility
with
approximately
28,000
facilities).
Most
of
these
machines
will
be
at
or
near
the
end
of
their
useful
economic
life
by
the
time
final
rule
requirements
are
promulgated.
The
typical
life
of
a
dry
cleaning
machine
is
10
to
15
years.
By
the
end
of
2006,
the
newest
transfer
machines
in
the
industry
will
be
13
years
55
old.
Replacing
these
machines
with
new
machines
meeting
the
requirements
for
new
sources
under
the
proposed
amendments
would
reduce
PCE
emissions
substantially.

We
developed
two
regulatory
options
to
evaluate
area
source
risk
reductions.
Option
I
would
require
enhanced
LDAR
and
eliminate
emissions
from
existing
transfer
machines
by
requiring
that
they
be
replaced
with
new
machines.
This
option
would
apply
to
both
large
and
small
area
sources.

Option
II
would
require
all
area
sources
to
use
a
refrigerated
condenser
and
secondary
carbon
adsorber
in
addition
to
option
I.
Table
8
of
this
preamble
summarizes
the
cancer
and
noncancer
risks
from
these
control
options.

Table
8.
Estimated
Maximum1
Cancer
Risk
and
Noncancer
Hazard
for
Typical
Area
Sources
Risk
Metric
Control
Option
1993
NESHAP
Option
I
­
LDAR
Option
II
­
LDAR
+
Secondary
Controls
Estimated
Lifetime
Cancer
Risk
(
OPPTS
URE)
30­
in­
1
million
20­
in­
1
million
15­
in­
1
million
Estimated
Lifetime
Cancer
Risk
(
CalEPA
URE)
220­
in­
1
million
175­
in­
1
million
110­
in­
1
million
Noncancer
HQ
0.1
0.1
0.1
Capital
Cost
($
1,000,000)
­
$
12.4
$
85.7
Annualized
Cost
­
($
2.7)
$
7.9
56
($
1,000,000)
Emission
Reduction
(
tpy)
­
3,236
5,749
1
Assumes
a
facility
using
a
dry­
to­
dry
machine
with
a
refrigerated
condenser
emitting
8
tons
of
PCE
a
year
(
highest
known
emitting
dry­
to­
dry
machine).
Risks
from
transfer
machines
are
not
included
in
the
tables.
The
costs
and
risk
estimates
in
this
table
do
not
consider
the
impacts
of
future
trends
of
declining
PCE
usage.

H.
What
is
our
proposal
for
addressing
the
remaining
emissions
for
typical
area
sources?

We
are
considering
adopting
a
residual
risk
decision
process
for
area
sources
which
is
based
on
that
used
for
major
sources.
This
involves
first
determining
an
acceptable
level
of
risk
to
the
public
and
then
determining
an
ample
margin
of
safety
to
protect
public
health,

considering
costs
and
economic
impacts
of
controls,

technological
feasibility,
uncertainties,
and
other
relevant
factors.
We
request
comments
on
this
approach
for
area
sources.

AS
part
of
this
rulemaking,
we
have
determined
that
exposure
to
emissions
under
the
1993
Dry
Cleaning
NESHAP
constitutes
an
acceptable
level
of
risk
for
typical
area
sources.
Currently,
we
estimate
that
more
than
98
percent
of
28,000
existing
dry
cleaners
use
a
dry­
to­
dry
machine
with
a
refrigerated
condenser
to
comply
with
the
1993
Dry
57
Cleaning
NESHAP
or
State
emission
standards.
Using
the
most
health
protective
modeling
assumptions
for
meteorology
and
location,
the
model
facility
analysis
indicated
that
the
highest
known
emitting
area
source
would
pose
cancer
risks
of
between
30­
in­
1
million
and
220­
in­
1
million.
The
risk
from
the
vast
majority
of
area
sources
would
be
substantially
less.
For
example,
cancer
risk
for
the
typical
area
source,
which
emits
approximately
0.5
ton
of
PCE
per
year,
is
estimated
at
between
4­
in­
1
million
and
15­

in­
1
million.
In
addition,
the
assessment
showed
no
significant
acute
health
effects
(
HQ
of
1.0
for
the
highest
emitting
area
source
facility).
Considering
the
relatively
low
level
of
risk
posed
by
the
great
majority
of
area
sources,
the
projected
absence
of
significant
noncancer
and
ecological
effects,
and
the
projected
decline
in
PCE
usage,

we
believe
that
the
1993
Dry
Cleaning
NESHAP
level
of
control
results
in
an
acceptable
level
of
risk
to
the
public.

Replacing
transfer
machines
with
new
dry­
to­
dry
equipment
would
reduce
risks
from
the
potentially
highest­
emitting
sources.
Under
either
option
I
or
II,

transfer
machines
would
be
replaced
with
dry­
to­
dry
machines
with
a
refrigerated
condenser
and
a
secondary
carbon
adsorber
(
i.
e.,
the
proposed
new
source
requirements
for
area
sources,
which
are
discussed
below).
58
For
dry­
to­
dry
machines,
equipment
leaks
are
the
largest
source
of
emissions,
particularly
from
older
dry
cleaning
machines.
While
the
perceptible
leaks
program
under
the
1993
Dry
Cleaning
NESHAP
may
prevent
major
leaks,

a
substantial
emission
reduction
can
be
achieved
by
earlier
leak
detection
using
an
instrument
like
a
halogenated
hydrocarbon
leak
detector.

Therefore,
to
protect
public
health
with
an
ample
margin
of
safety,
we
are
proposing
to
eliminate
the
use
of
transfer
machines
and
require
an
enhanced
LDAR
program
for
dry­
to­
dry
machines
(
option
I).
This
option
would
reduce
PCE
emissions
by
3,200
tpy
and
reduce
risks
to
the
public
from
between
30­
in­
1
million
and
220­
in­
1
million
to
between
20­
in­
1
million
and
175­
in­
1
million.

Option
I
would
require
total
capital
costs
of
$
12
million.
The
enhanced
LDAR
program
would
cost
about
$
5
million.
About
20,000
facilities
would
be
required
to
purchase
a
halogenated
hydrocarbon
detector
at
a
cost
of
$
250
each.
About
200
facilities
would
be
required
to
replace
their
existing
transfer
machines
with
dry­
to­
dry
machines
with
refrigerated
condensers
and
carbon
adsorber
at
a
cost
of
about
$
36,000
each
for
a
total
industry
cost
of
$
7.3
million.
Annually,
option
I
is
expected
to
result
in
a
cost
savings
to
industry
of
about
$
2.7
million
per
year.

Cost
saving
would
be
realized
because
both
replacement
of
59
transfer
machines
and
enhanced
LDAR
will
reduce
annual
PCE
consumption.
The
reduction
in
annual
PCE
consumption
at
the
200
businesses
that
would
replace
transfer
machines
is
more
than
sufficient
to
offset
the
annualized
cost
of
the
new
equipment.
In
particular,
we
believe
most
of
the
transfer
machines
are
at
the
end
of
their
useful
life
and
it
would
be
economically
beneficial
for
the
facilities
to
replace
the
transfer
machines
with
dry­
to­
dry
machines.
Thus,
we
believe
the
economic
impacts
to
the
affected
businesses
and
facilities
are
negligible.
Finally,
these
costs
and
risk
estimates
do
not
consider
the
impacts
of
future
trends
of
declining
PCE
usage.

We
are
not
proposing
the
option
of
requiring
existing
area
sources
to
install
secondary
carbon
adsorbers
(
option
II).
Secondary
carbon
adsorbers
would
reduce
maximum
risks
at
the
highest
risk
area
sources
from
between
20­
in­
1
million
and
175­
in­
1
million
under
option
I
to
between
15­

in­
1
million
and
110­
in­
1
million
under
option
II.
Under
option
II,
about
7,500
facilities
would
be
required
to
raise
capital
to
install
carbon
adsorbers
(
27
percent
of
the
industry).
For
these
sources,
the
capital
costs
for
compliance
would
be
about
$
85
million
with
an
annualized
cost
of
about
$
8
million.
The
capital
cost
for
individual
facilities
would
range
from
$
4,000
to
$
45,000.
A
majority
of
sources
that
would
be
affected
by
option
II
are
small
60
businesses.
For
these
small
businesses,
the
annualized
costs
would
average
from
10
to
20
percent
of
sales,
and
this
amount
is
much
higher
than
the
average
profit
per
unit
of
sales
that
small
dry
cleaners
normally
experience
(
1
to
3
percent).
This
cost
would
lead
to
a
high
number
of
small
businesses
owning
affected
facilities
that
will
likely
close
due
to
the
lack
of
available
capital
for
the
needed
investment
in
carbon
adsorbers.
Therefore,
we
are
not
proposing
to
require
a
secondary
carbon
adsorber
on
existing
area
sources,
because
the
risk
reduction
would
be
relatively
minor
and
the
costs
would
impose
adverse
economic
impacts
on
a
number
of
small
businesses.

I.
What
are
the
risks
from
co­
residential
area
sources?

Residents
living
in
the
same
building
with
a
dry
cleaner
may
receive
significantly
higher
exposures
to
PCE
than
people
not
living
above
or
in
the
same
building
as
a
dry
cleaner.
We
estimate
there
are
approximately
1,300
co­
residential
dry
cleaning
facilities
in
the
United
States.

Residents
in
these
buildings
can
receive
elevated
PCE
concentrations
because
PCE
vapor
travels
through
the
building
walls
and
up
elevator
and
pipe
shafts
into
residences.
Emissions
of
PCE
also
can
enter
from
the
ambient
air
into
residences
via
open
windows.
Even
after
the
dry
cleaner
closes,
PCE
absorbed
onto
surfaces
can
continue
to
be
emitted
throughout
the
day
and
night.
To
61
assess
potential
risks,
we
used
indoor
air
monitoring
data
collected
by
the
New
York
Department
of
Health
and
the
New
York
State
Department
of
Environmental
Conservation
(
NYSDEC)

between
2001­
2003
as
part
of
an
epidemiological
study
examining
neurological
endpoints.
In
considering
the
New
York
data,
it
should
be
recognized
that
the
data
resulted
from
an
epidemiological
study,
and
dry
cleaner
building
and
apartment
inclusion
and
exclusion
criteria
influenced
buildings
that
were
ultimately
sampled.
Also,
certain
buildings
were
identified
in
order
to
potentially
increase
the
likelihood
of
finding
apartments
with
elevated
PCE
levels.
Data
collected
during
this
period
indicate
that
resident
exposures
ranged
from
a
geometric
mean
of
33
ug/
m3
to
a
maximum
of
5,000
ug/
m3.
The
New
York
Department
of
Health
collected
these
data
during
the
final
implementation
of
title
6
NYCRR
Part
232
rules,
which
require
the
use
of
a
refrigerated
condenser
and
secondary
carbon
adsorber,
and
a
vapor
barrier
or
room
enclosure
around
co­
residential
dry
cleaning
machines.
We
extrapolated
these
24­
hour
samples
to
lifetime
exposure
to
estimate
inhalation
cancer
risk
and
noncancer
hazard.
For
a
full
description
of
the
methodology
that
we
used,
see
the
risk
characterization
memorandum
in
the
public
docket.
Table
9
of
this
preamble
summarizes
the
inhalation
cancer
risk
and
noncancer
hazard
of
co­
residential
area
sources.
62
Table
9.
Estimated
Incremental
Lifetime
Individual
Cancer
Risk
and
Noncancer
Hazard
for
Co­
residential
Area
Sources
Using
a
Range
of
Monitored
Exposures
Risk
Metric3
Distribution
of
Monitored
Exposure
Lower
5th
Percentile2
Median
Geometric
Mean
Upper
95th
Percentile
Maximum
Estimated
Lifetime
Cancer
Risk
(
OPPTS
URE)
4­
in­
1
million
10­
in­
1
million
20­
in­
1
million
500­
in­
1
million
4,000­
in­
1
million
Estimated
Lifetime
Cancer
Risk
(
CalEPA
URE)
30­
in­
1
million
50­
in­
1
million
200­
in­
1
million
4,000­
in­
1
million
30,000­
in­
1
million
Noncancer
HQ1
0.02
0.06
0.1
3
20
1
HQ
estimates
have
been
rounded.
2
The
lowest
5th
percentile
of
exposure
is
equal
to
the
nondetect
limit
of
the
monitors,
which
is
5ug/
m3.
3
These
estimates
reflect
only
facilities
in
full
compliance
with
Title
6
NYCRR
Part
232.

To
better
characterize
inhalation
cancer
risk
among
residents
of
apartments
co­
located
with
area
source
cleaners,
we
performed
a
sensitivity
analysis
in
which
we
varied
the
assumed
exposure
duration.
Table
10
illustrates
the
results
from
this
analysis.

Table
10.
Estimated
High­
End
Cancer
Risks
for
Residents
of
Co­
located
Apartments:
Exposure
Duration
Sensitivity
63
24
Cancer
risk
estimates
derived
using
95th
percentile
PCE
exposures
for
monitoring
data
from
facilities
in
full
compliance
with
NYSDEC
requirements.
Analysis
24
Estimated
Lifetime
Cancer
Risk
Assumed
Exposure
Duration
70
years
50
years
30
years
20
years
10
years
Risk
per
million
(
CalEPA
URE)
4,000
3,000
2,000
1,000
600
Risk
per
million
(
OPPTS
URE)
500
400
200
100
80
HQ
7
5
3
2
1
Inhalation
cancer
risk
estimates
using
the
95th
percentile
exposure
level
range
from
a
maximum
of
between
4,000
and
500­
in­
1
million,
assuming
70­
year
exposure
to
between
600
and
80­
in­
1
million
assuming
10­
year
exposure.

The
PCE
exposure
concentrations
presented
in
table
11
of
this
preamble
show
the
potential
risk
levels
that
co­
residential
sources
may
pose.
The
MIR
was
predicted
at
between
4,000­
in­
1
million
and
30,000­
in­
1
million,
which
is
higher
than
the
maximum
risk
at
both
major
sources
and
typical
area
sources.
This
table
suggests
that
maximum
coresidential
area
source
risks
are
about
13
times
higher
than
the
maximum
major
source
risks
and
about
140
times
higher
than
the
maximum
typical
area
source
risk.
64
25
Estimate
range
represents
difference
between
estimated
risk
using
OPPTS
and
CalEPA
URE.
Table
11.
Comparison
of
PCE
Exposure
Concentrations
by
Type
of
Facility
25
Facility
Coresidential
area
source
Typical
Area
Source
Major
Source
Maximum
Exposure
Concentration
(
ug/
m3)
5,0001
37
405
Geometric
Mean
Exposure
Concentration
(
ug/
m3)
33
1
1.3
Maximum
Inhalation
Risk
(
per
million)
3,000
to
30,0002
30
to
220
300
to
2,400
Maximum
Noncancer
HQ
20
0.1
2
Geometric
Mean
Noncancer
HQ
0.1
0.004
0.004
1
New
York
Department
of
Health
monitoring
data.
2
Inhalation
cancer
risks
were
extrapolated
from
24­
hour
monitoring
data,
assuming
continuous
exposure
for
70
years
at
the
maximum
monitored
concentration.

J.
What
is
our
proposed
decision
on
co­
residential
area
sources?

We
are
proposing
not
to
allow
any
new
co­
residential
machines
that
emit
PCE.
Our
proposal
is
based
on
the
highend
estimated
MIR
of
between
4,000­
in­
1
million
and
30,000­

in­
1
million,
and
on
our
conclusion
that
risks
from
new
coresidential
sources
should
be
substantially
reduced.
These
65
risk
estimates
are
based
on
monitored
concentrations
taken
from
apartments
above
co­
residential
dry
cleaners
with
the
level
of
equipment
control
required
by
NYSDEC
in
their
title
6
NYCRR
Part
232
rules
(
e.
g.,
a
refrigerated
condenser
and
secondary
carbon
adsorber,
and
a
vapor
barrier
or
room
enclosure).
We
request
comment
on
whether
a
control
option
for
new
sources
similar
to
Title
6
NYCRR
Part
232
rules
would
substantially
reduce
the
risks
from
new
co­
residential
sources.

The
most
stringent
possible
control
option
with
the
greatest
risk
reduction
is
a
prohibition
of
new
co­
residential
sources.
This
option
would
eliminate
PCE
risks
for
new
sources
and
require
that
any
new
dry
cleaning
machines
located
in
a
residential
building
would
have
to
use
an
alternative
cleaning
solvent.
We
believe
the
owner/
operator
can
choose
from
several
types
of
alternative
solvent
dry
cleaning
systems
to
use
in
a
residential
building.

The
national
capital
costs
of
this
regulatory
option
are
$
8.6
million,
and
the
annualized
costs
are
approximately
$
950,000.
These
cost
estimates
are
based
on
the
assumption
that
existing
facilities
will
replace
PCE
machines
that
have
reached
the
end
of
their
useful
lives
(~
15
years)
and
are
estimated
for
facilities
affected
within
the
first
5
years
after
the
final
rule
takes
effect.
These
costs
reflect
the
66
incremental
cost
between
replacing
existing
machines
with
PCE
machines
with
refrigerated
condensers
and
carbon
adsorbers,
and
replacing
them
with
machines
using
hydrocarbon
solvents.
This
analysis
includes
costs
for
all
affected
facilities,
such
as
the
cost
incurred
to
install
fire
protection
sprinklers
required
by
most
applicable
fire
codes
to
operate
a
hydrocarbon
technology,
that
would
not
be
necessary
with
other
options.
Cost
estimates
would
be
much
lower
if
facilities
using
this
option
have
sprinkler
systems
in
place,
or
if
they
choose
a
less
costly
alternative
garment
cleaning
option
utilizing
non­
flammable
solvents,
or
conducting
dry
cleaning
operations
off­
site
from
the
coresidential
facility.
We
estimate
that
this
control
option
may,
after
about
15
years,
result
in
the
elimination
of
cancer
risks
from
all
co­
residential
sources.
This
means
that
maximum
individual
risk
levels
due
to
these
sources
would
decline
from
between
30,000­
and
4,000­
in­
1
million
to
0;
average
individual
risk
would
decline
from
between
1,000­

and
200­
in­
1
million
to
0;
and
annual
incidence
would
decline
from
between
2.2
and
0.3
cases
per
year
to
0.
These
risk
reduction
estimates
for
all
co­
residential
dry
cleaners
are
subject
to
a
number
of
limitations,
the
greatest
of
which
are
likely:
(
1)
the
degree
to
which
the
small
sampled
subset
of
co­
residential
dry
cleaners
(
16)
is
representative
of
the
full
set
(
about
1,300)
of
all
co­
residential
dry
67
cleaners;
(
2)
our
uncertainty
of
the
size
of
the
affected
population;
and
(
3)
the
possible
range
of
cancer
potency
factors
used
in
our
analysis,
which
is
reflected
in
the
ranges
of
the
risk
metrics
reported
above.

We
request
comment,
as
an
alternative
approach,
on
the
adoption
of
the
NYSDEC
title
6
NYCRR
Part
232
rules
(
or
similar
standards)
as
the
basis
for
control
standards
for
new
sources,
instead
of
prohibition
on
any
new
coresidential
machines
that
emit
PCE.
We
request
data
on
the
emission
levels,
exposure,
risks,
and
costs
of
meeting
the
level
of
control
required
by
NYSDEC
and
for
any
other
control
options
for
co­
residential
sources
that
may
substantially
reduce
risks
from
new
sources
(
e.
g.,
periodic
gasket
replacement
in
lieu
of
inspections).

Finally,
we
also
recognize
that
a
proposal
to
prohibit
new
co­
residential
sources
could
encourage
continued
operation
of
existing
co­
residential
PCE
machines
beyond
their
useful
lives
rather
than
replacement
with
new
machines.
We
request
comment
on
a
sunset
provision,
where,

after
some
period
of
time
that
reflects
the
typical
lifetime
of
a
dry
cleaning
machine,
existing
co­
residential
sources
would
have
to
be
replaced
with
new
machines
that
do
not
emit
PCE.

We
are
proposing
the
alternative
of
no
additional
control
requirements
for
existing
co­
residential
dry
68
cleaners
at
this
time
beyond
the
proposed
requirements
for
existing
area
sources.
However,
we
also
request
comment
on
the
appropriateness
of
adopting
other
alternatives
such
as
the
NYSDEC
title
6
NYCRR
Part
232
rules
for
existing
coresidential
facilities
in
the
final
rule.

In
particular,
we
are
continuing
to
analyze
the
potential
health
risks
at
co­
residential
sources
and
the
range
of
options
to
reduce
these
risks.
Options
under
consideration
range
from
voluntary
initiatives
to
regulatory
action.
About
1,100
of
the
estimated
1,300
co­
residential
sources
are
located
in
New
York
and
California.
These
sources
are
controlled
with
the
technology
equivalent
to
the
requirements
of
the
1993
Dry
Cleaning
NESHAP
for
new
major
sources;
plus,
the
facilities
in
New
York
have
installed
room
enclosures
to
reduce
exposure
from
residual
emissions.

In
addition,
under
the
proposed
requirements,
all
co­
residential
sources
would
be
required
to
adopt
an
enhanced
LDAR
program
and
all
transfer
machines
would
be
eliminated.

At
this
time
we
have
limited
data
on
co­
residential
sources
outside
of
New
York
and
California.
We
do
not
know
how
representative
the
dataset
is
of
all
facilities
in
New
York
City.
We
do
not
know
how
many
people
are
exposed
at
other
sources
and
if
the
exposure
and
risk
levels
in
other
parts
of
the
United
States
are
similar
to
those
in
New
York
69
City
buildings.
We
have
little
information
on
the
distribution
of
PCE
concentrations,
the
number
of
persons
living
in
co­
residential
buildings,
or
the
number
of
persons
exposed
to
various
PCE
concentration
levels.
Based
on
the
New
York
monitoring
data,
we
know
the
level
of
PCE
concentrations
can
vary
substantially
within
co­
residential
buildings.
While
we
believe
that
the
dataset
used
for
this
risk
assessment
represents
a
high­
quality
set
of
measurements
which
is
appropriate
for
estimating
risks,
we
are
also
aware
that
the
dataset
may
contain
a
selection
bias
due
to
the
fact
that
the
study
from
which
the
data
were
taken
was
an
epidemiological
study
aimed
at
identifying
high
exposures
within
minority
and
economically­
disadvantaged
populations.
Moreover,
we
are
also
aware
that
variable
attention
to
work
practices,
difficulties
in
achieving
compliance
with
newly­
installed
equipment,
and
poor
ventilation
in
sampled
apartments
may
also
have
increased
the
measured
concentration
values
relative
to
the
remaining
population
of
apartments
co­
located
with
area
source
dry
cleaners.
Thus,
we
specifically
request
comment
on
the
appropriateness
of
using
this
dataset
to
develop
a
risk
assessment
which
represents
the
population
of
co­
residential
facilities.
We
also
request
any
additional
data
that
might
be
used
to
characterize
these
risks.

If
a
long­
term
time
series
dataset
of
concentration
70
measurements
were
available,
we
would
estimate
chronic
exposure
based
on
it
to
take
into
account
the
true
temporal
variability
of
exposures.
However,
we
do
not
have
such
a
dataset.
Instead,
we
base
our
exposure
and
risk
estimates
on
snapshot
data
available,
recognizing
that
an
extrapolation
from
short­
term
monitoring
values
can
lead
to
an
upward
bias
of
the
high­
end
chronic
exposures
and
risks
and
a
downward
bias
of
the
low­
end
chronic
exposures
and
risks.
We
request
comment
on
ways
to
minimize
these
biases.

In
evaluating
the
potential
impact
of
NYSDEC
requirements,
our
analysis
focused
on
those
facilities
which
were
deemed
to
be
in
compliance
with
the
NYSDEC
part
232
regulations.
However,
it
is
not
always
clear
from
the
available
data
what
the
exact
compliance
status
of
the
facilities
were
at
the
time
that
measurements
were
taken.

For
example,
we
note
that
the
highest
measured
exposure
level
(
5,000
ug/
m3),
which
is
associated
with
a
facility
that
was
reported
to
be
in
full
compliance
with
the
NYSDEC
regulations
at
the
time
of
the
measurements,
has
been
called
into
question
by
industry
stakeholders
based
on
evidence
that
the
facility
was
inspected
and
found
to
be
out
of
compliance
(
due
to
equipment
operation
problems)

approximately
2
months
after
the
measurements
were
taken.

These
problems
were
remedied
and
compliance
was
certified
a
week
later.
This
uncertainty
in
exact
compliance
status
71
leads
to
an
uncertainty
in
whether
the
measured
concentration
values
actually
reflect
a
level
of
control
consistent
with
implementation
of
the
NYSDEC
requirements.

Thus,
we
request
comment
on
whether
and
to
what
extent
temporal
variability
or
compliance
problems
among
the
facilities
located
in
buildings
with
the
sampled
apartments
may
have
biased
the
sampled
measurements
high
or
low
and
influenced
the
results
of
the
risk
assessment.

While
we
are
not
proposing
additional
controls
for
existing
co­
residential
area
sources
at
this
time,
given
the
high
risk
levels
estimated
at
existing
co­
residential
facilities,
we
are
very
concerned
about
potential
health
risks
posed
by
PCE
dry
cleaners
that
are
located
inside
residential
buildings.
For
this
reason,
we
request
comment
on
the
adoption
of
the
level
of
control
required
by
NYSDEC
as
the
basis
of
control
standards
for
existing
sources.

We
do
not
believe
that
the
proposed
requirements
for
area
sources
pose
more
than
a
minimal
burden,
however,
we
specifically
ask
for
comment
on
methods
by
which
EPA
could
focus
the
additional
regulatory
requirements
being
proposed
by
this
rule
to
only
those
area
sources
which
pose
significant
risks
to
human
health.
For
example,
we
seek
comments
on
whether
there
could
be
a
methodology
by
which
facilities
could
conduct
site
specific
risk
assessments
to
demonstrate
that
their
PCE
emissions
pose
cancer
risk
levels
72
that
are
less
than
1­
in­
1
million,
with
a
HI
of
less
than
1,

and
with
no
acute
human
health
risks
or
adverse
environmental
effects,
and
thereby
avoid
the
additional
requirements
that
would
otherwise
apply
under
the
proposed
rule
revisions.
Comments
should
address
whether
such
an
approach
is
feasible
(
for
example,
if
facilities
would
be
able
to
conduct
these
risk
assessments),
the
legal
authority
for
such
an
approach,
the
methodology
sources
would
use
for
conducting
risk
assessments,
the
specific
criteria
by
which
potential
"
low­
risk"
sources
would
be
evaluated,
the
mechanism
for
evaluating
and
determining
whether
source
risk
assessments
meet
those
criteria,
how
the
process
would
be
implemented
by
Federal
and/
or
State
and
local
agencies,
how
it
would
be
enforced
(
for
example,
through
a
permitting
program
or
other
regulatory
structure
to
ensure
that
any
sources
found
to
be
"
low­
risk"
remain
so),
and
what
would
be
the
consequences
if
and
when
a
source,
for
whatever
reason,

is
found
to
no
longer
qualify
as
a
"
low­
risk"
source.

K.
What
determination
is
EPA
proposing
pursuant
to
review
of
the
1993
Dry
Cleaning
NESHAP
under
CAA
section
112(
d)(
6)?

Section
112(
d)(
6)
of
the
CAA
requires
us
to
review
and
revise
MACT
standards,
as
necessary,
every
8
years,
taking
into
account
developments
in
practices,
processes,
and
control
technologies
that
have
occurred
during
that
time.

If
we
find
relevant
changes,
we
may
revise
the
MACT
73
standards
and
develop
additional
standards.
We
do
not
interpret
CAA
section
112(
d)(
6)
as
requiring
another
analysis
of
MACT
floors
for
existing
and
new
sources.

For
major
sources,
we
considered
as
a
MACT
alternative
the
same
options
considered
above
for
residual
risk
(
table
5
of
this
preamble).
The
use
of
a
PCE
sensor/
lock
system
(
option
II
on
table
5
of
this
preamble)
is
an
option
more
stringent
than
the
level
of
control
that
we
are
proposing
to
protect
the
public
from
residual
risks
with
an
ample
margin
of
safety.
The
system
would
reduce
emissions
by
40
tpy.

Total
capital
costs
are
estimated
to
be
$
5.7
million
for
the
15
major
sources
with
an
annualized
cost
of
$
420,000.

Additional
analysis
of
costs
can
be
found
in
the
Background
Information
Document
in
the
public
docket.
The
incremental
cost­
effectiveness
of
the
option
is
$
17,000
per
ton
of
PCE
removed
(
overall,
considering
all
15
facilities).

Consequently,
we
propose
that
requiring
enhanced
LDAR
and
a
refrigerated
condenser/
secondary
carbon
adsorber
would
meet
the
requirements
for
CAA
section
112(
d)(
6).

Section
112(
d)(
6)
of
the
CAA
also
requires
that
we
review
and,
if
necessary,
revise
the
technology­
based
standards
for
area
sources.
The
1993
Dry
Cleaning
NESHAP
for
area
sources
was
based
on
the
use
of
generally
available
control
technology.
The
options
selected
for
evaluating
GACT
are
the
same
two
options
that
we
discussed
above;
74
enhanced
LDAR
and
eliminating
transfer
machines
(
option
I
on
table
8
of
this
preamble),
and
the
use
of
secondary
carbon
adsorbers
(
option
II
on
table
8
of
this
preamble).
Option
I
would
reduce
emissions
by
an
estimated
3,200
tpy
and
would
result
in
a
net
cost
savings
to
area
sources.
Option
II
would
reduce
emissions
by
an
additional
3,000
tpy.
However,

as
explained
above,
retrofitting
a
secondary
carbon
adsorber
would
not
be
cost­
effective
for
many
existing
area
source
dry
cleaners.
Consequently,
we
propose
that
requiring
enhanced
LDAR
and
eliminating
transfer
machines
would
meet
the
requirements
for
CAA
section
112(
d)(
6).

For
new
machines
located
at
area
source
dry
cleaners,

we
are
proposing
the
use
of
refrigerated
condensers,

secondary
carbon
adsorbers,
and
enhanced
LDAR.
Requiring
the
use
of
secondary
carbon
adsorbers
on
new
machines
will
not
impose
any
significant
new
costs
to
the
industry,

because
the
majority
of
new
machines
today
are
sold
with
secondary
carbon
adsorbers.
Vented
machines,
water­
cooled
condensers,
and
transfer
machines
are
no
longer
sold.
Many
area
source
dry
cleaners
are
buying
this
latest
technology
(
dry­
to­
dry
machine
with
refrigerated
condenser
and
secondary
carbon
adsorber)
because
they
are
easier
to
operate,
use
less
PCE,
and
produce
less
hazardous
waste.
In
addition,
several
States
require
the
use
of
this
technology.

A
machine
manufacturer
stated
that
70
percent
of
the
new
PCE
75
machines
sold
in
the
year
2000
were
dry­
to­
dry
machines
with
refrigerated
condenser
and
secondary
carbon
adsorbers,
and
by
2003
nearly
all
of
the
PCE
machines
sold
would
have
this
technology.
New
York
and,
beginning
in
2007,
California,

will
require
this
technology
for
all
existing
major
and
area
sources.
Due
to
the
vast
number
of
area
sources
compared
to
major
sources,
the
majority
of
the
new
PCE
machines
are
purchased
by
area
sources
to
replace
older
technology
machines.
Therefore,
we
are
proposing
the
use
of
dry­
to­
dry
machines
with
refrigerated
condensers
and
secondary
carbon
adsorbers
for
new
machines
at
area
sources
to
meet
the
requirements
for
CAA
section
112(
d)(
6).

For
co­
residential
sources,
the
most
stringent
standards
currently
in
place
are
those
enforced
by
NYSDEC.

They
require
that
dry
cleaning
machines
have
refrigerated
condensers
and
secondary
carbon
adsorbers,
and
that
equipment
be
housed
inside
a
vapor
barrier
with
general
ventilation
to
the
outside
air
for
both
new
and
existing
facilities.
Facilities
must
conduct
weekly
leak
inspections
using
a
leak
detection
device
such
as
a
halogenated
hydrocarbon
detector.
Facilities
are
required
to
obtain
annual
third
party
inspections,
and
must
make
available
the
most
recent
inspection
report
to
interested
individuals
for
their
review.
The
NYSDEC
also
requires
that
the
facility
owner
and/
or
manager
and
the
dry
cleaning
machine
operator
76
be
certified
by
an
organization
that
offers
a
training
program
approved
by
the
State
agency.
In
some
cases,
these
and
related
requirements
have
been
effective
in
reducing
exposure
levels;
the
mean
exposure
has
dropped
by
tenfold
since
1997
(
McDermott,
et.
al.,
2005).
However,
as
described
earlier,
a
monitoring
study
in
New
York
City
suggests
that
risk
levels
after
implementation
of
these
standards
may
remain
relatively
high.
We
are
considering,

as
an
alternative
approach,
adoption
of
the
NYSDEC
Part
232
(
or
similar)
regulations
(
see
docket
for
details)
for
new
and
existing
co­
residential
sources.
By
adopting
the
NYSDEC
standards
for
existing
co­
residential
sources,
this
alternative
would
reduce
exposures
more
than
the
option
to
require
enhanced
LDAR.
This
alternative
approach
eliminates
the
continued
use
of
equipment
without
secondary
carbon
adsorbers;
this
contrasts
with
the
option
discussed
under
section
J
above,
which
prohibits
the
use
of
new
PCE
machines
and
may
give
facilities
the
incentive
to
prolong
the
use
of
existing
machines
rather
than
purchase
newer,
lower
emitting
PCE
machines.
Most
co­
residential
facilities
meet
the
New
York
standards
(
of
the
1,300
co­
residential
facilities
nationwide,
approximately
900
are
in
New
York),
but
several
hundred
facilities
across
the
country
would
need
to
upgrade
their
equipment
to
comply
with
this
alternative
approach.

With
respect
to
new
facilities,
this
alternative
approach
77
would
allow
new
facilities
to
use
PCE
only
if
they
also
use
equipment
with
refrigerated
condensers
and
secondary
carbon
adsorbers
housed
in
a
vapor
barrier.
We
request
comment
on
whether
the
NYSDEC
standards
meet
the
requirements
of
CAA
section
112(
d)(
6)
for
co­
residential
facilities.

We
recognize
that
developing
residual
risk
standards
for
area
sources
is
discretionary
under
the
CAA,
and
that
emission
reductions
can
be
achieved
through
more
stringent
additional
standards
under
the
required
technology
review
for
area
sources
under
CAA
section
112(
d)(
6).
We
request
comment
on
the
appropriateness
of
regulating
co­
residential
and
other
area
sources
under
section
112(
d)(
6)
and
not
exercising
our
discretion
to
regulate
under
the
section
112(
f)
risk
authority.
Under
the
section
112(
d)(
6)

authority,
we
would
consider
the
NYSDEC
level
of
regulatory
control
and
other
control
options
discussed
in
this
proposal.

L.
What
additional
changes
are
we
making
to
the
1993
Dry
Cleaning
NESHAP?

In
40
CFR
63.322(
e),
we
are
deleting
the
term
"
diverter
valve,"
but
retaining
the
requirement
to
prevent
air
drawn
into
the
door
of
the
dry
cleaning
machine
from
passing
through
the
refrigerated
condenser.
We
are
proposing
this
change
because
some
newer
machines
accomplish
this
objective
without
a
diverter
valve.
This
change
does
not
subject
78
sources
to
any
new
requirements
and
does
not
change
the
requirement
for
machines
with
diverter
valves.

In
40
CFR
63.322(
m)
and
40
CFR
63.324(
d),
we
are
changing
"
perceptible
leaks"
to
"
leaks"
because
the
requirements
now
apply
to
both
the
monthly
inspection
for
vapor
leaks,
which
would
require
the
use
of
a
leak
detection
instrument,
as
well
as
the
weekly
or
biweekly
inspections
for
perceptible
leaks.
This
harmonizing
change
would
not
change
the
nature
of
existing
inspection
requirements.
To
support
the
proposed
requirements
for
monthly
vapor
leak
inspection,
we
have
proposed
to
add
definitions
of
"
vapor
leak,"
"
PCE
gas
analyzer,"
and
"
halogenated
hydrocarbon
detector."

The
40
CFR
63.323(
b)
would
be
revised
to
add
PCE
gas
analyzers
as
an
acceptable
monitoring
instrument
in
addition
to
colorimetric
tubes.
Major
sources
would
need
a
PCE
gas
analyzer
for
enhanced
leak
detection
and
repair.
This
analyzer
could
also
be
used
for
monitoring
a
carbon
adsorber.
Also,
the
phrase
"
or
removal
of
the
activated
carbon"
would
be
added
to
clarify
that
any
major
source
required
to
use
a
carbon
adsorber
is
required
to
monitor
the
adsorber
exhaust
weekly
for
PCE.
Previously,
this
requirement
was
unclear
for
sources
that
disposed
of
the
carbon
instead
of
desorbing
it.

IV.
Solicitation
of
Public
Comments
79
We
request
comments
on
all
aspects
of
the
proposed
amendments.
We
are
also
considering
additional
rule
amendments
and
specifically
solicit
comments
on
these
potential
amendments.
The
additional
amendments
are
described
in
the
following
sections.
All
significant
comments
received
will
be
considered
in
the
development
and
selection
of
the
final
amendments.

A.
Additional
Requirements
for
Highest
Risk
Facilities
For
one
of
the
modeled
major
source
facilities,
the
estimated
emissions
after
installing
controls
required
by
the
proposed
rule
would
pose
a
MIR
greater
than
100­
in­
1
million
using
the
CalEPA
URE.
An
alternative
approach
we
are
considering
is
establishing
more
stringent
requirements
for
this
source.
We
would
like
information
about
whether
such
an
approach
would
be
appropriate
and
what
would
be
a
suitable
regulatory
basis
for
creating
a
separate
class
for
this
major
source.
We
are
considering
requiring
this
facility
to
install
a
PCE
sensor
and
lockout
on
each
dry
cleaning
machine.

Under
the
proposed
rule,
this
facility
would
be
required
to
install
a
refrigerated
condenser
and
secondary
carbon
adsorber.
Most
dry
cleaning
machines
with
secondary
carbon
adsorbers
sold
in
this
country
since
1998
are
equipped
with
a
lockout
that
prevents
the
drum
from
being
opened
until
the
completion
of
the
timed
adsorption
cycle.
80
These
machines
have
been
demonstrated
to
achieve
a
concentration
inside
the
drum
of
less
than
300
ppm
without
a
PCE
sensor.
The
addition
of
a
sensor
ensures
that
this
target
concentration
will
be
met
for
every
load,
thereby
preventing
episodes
of
high
emissions
caused
by
operator
error
or
machine
malfunction.

The
PCE
sensor
and
lockout
system
originally
was
developed
to
meet
the
2.
BImSchV
German
Emission
Control
Law,
which
requires
a
PCE
concentration
in
the
dry
cleaning
machine
drum
of
less
than
2
grams
per
cubic
meter
(~
300
ppm)

at
the
end
of
the
drying
cycle.
Dry
cleaning
machines
equipped
with
PCE
sensors
are
widely
used
in
Germany
and
are
available
in
the
United
States.
However,
there
is
limited
experience
with
this
technology
in
the
United
States.
We
are
aware
of
only
two
commercial
dry
cleaners
in
the
United
States
and
one
industrial
dry
cleaner
in
Canada
that
use
a
PCE
sensor.
Because
of
the
limited
United
States
experience,
we
do
not
have
emission
test
data
to
evaluate
the
performance
of
this
system
relative
to
machines
with
a
timed
lockout
system,
particularly
with
industrial
articles
such
as
work
gloves.
The
emissions
reductions
that
we
used
to
evaluate
the
PCE
sensor
and
lockout
system
were
based
on
estimates
of
solvent
mileage
(
pounds
garments
cleaned
per
gal
of
PCE
used)
compared
to
machines
with
a
refrigerated
condenser
and
secondary
carbon
adsorber.
The
estimated
81
mileage
of
the
various
dry
cleaning
systems
was
obtained
from
engineering
judgment
by
several
industry
experts.

Facilities
using
a
PCE
sensor
and
lockout
system
could
possibly
observe
a
wide
range
of
emission
reduction
potential.
For
example,
facilities
that
use
good
maintenance
procedures
and
follow
manufacturers
specifications
would
achieve
lower
emission
reductions
than
facilities
with
poor
maintenance
procedures.
This
control
technology
ensures
optimal
operation
of
the
carbon
adsorber
by
preventing
the
door
from
being
opened
until
the
PCE
concentration
in
the
drum
is
less
than
300
ppm
at
the
end
of
the
drying
cycle.
Facilities
with
good
maintenance
procedures
will
have
fewer
high
emission
episodes
caused
by
premature
termination
of
the
drying
cycle.

We
solicit
comments
on
the
appropriateness
of
requiring
greater
emission
reduction
at
the
highest
risk
source,
the
performance
of
the
PCE
sensor
and
lockout
system
and
its
effectiveness
in
reducing
risks
from
this
source,
and
the
basis
for
creating
a
separate
class
for
this
major
source
dry
cleaner.
We
also
request
information
on
the
feasibility,
cost,
and
amount
of
emission
reduction
that
could
be
achieved
at
this
source
through
other
techniques,

such
as
the
use
of
alternative
solvents
or
other
approaches.

B.
Requirement
for
PCE
Sensor
and
Lockout
as
New
Source
MACT
for
Major
Sources
82
We
are
considering
making
PCE
sensor
and
lockout
controls
a
requirement
for
new
machines
installed
at
major
sources.
The
decision
to
select
option
I
instead
of
this
control
option
for
major
sources
was
based
on
the
relatively
small
emission
reduction
estimated
to
result
from
the
installation
of
PCE
sensor
and
lockout
controls.
We
would
like
additional
data
on
the
amount
of
PCE
reduction
achieved
by
these
controls
in
both
industrial
and
commercial
applications,
and
about
how
site­
specific
factors
influence
the
reduction
achieved.

C.
Alternative
Performance­
based
Standard
for
Existing
Major
Sources
We
are
considering
establishing
an
alternative
performance­
based
standard
for
existing
major
sources.
The
alternative
standard
would
be
a
facility­
wide
PCE
use
limitation
(
e.
g.,
gal
PCE
per
year,
solvent
mileage
or
other
metrics),
which
would
be
determined
as
a
percent
reduction
of
actual
PCE
use
from
a
baseline
year.
If
adopted,
a
source
could
elect
to
comply
with
either
the
proposed
process
vent
controls
(
i.
e.,
closed
loop
machine
with
refrigerated
condenser
and
secondary
carbon
adsorber)
or
the
performance­
based
alternative.
Facilities
that
use
the
performance­
based
alternative
still
would
be
required
to
comply
with
the
operating
controls
(
i.
e.,
enhanced
leak
detection
and
repair,
etc.)
in
the
proposed
rule.
83
The
alternative
standard
would
provide
more
flexibility
in
choosing
the
method
of
reducing
emissions.
This
flexibility
provides
the
opportunity
to
decrease
compliance
costs,
reduce
recordkeeping,
and
simplify
compliance
and
enforcement.
We
anticipate
that
any
facility
selecting
this
alternative
would
reduce
emissions
by
replacing
some
machines
with
alternative
solvent
machines
and
continuing
to
operate
some
PCE
machines
without
secondary
controls.

Additional
emission
reductions
could
also
be
achieved
by
more
aggressive
maintenance
and
leak
detection
programs.

The
performance­
based
alternative
we
are
considering
would
limit
annual
PCE
consumption
on
a
facility­
wide
basis.

Usage
of
PCE
correlates
directly
with
PCE
emissions.
The
limit
would
be
based
on
the
average
fraction
of
emissions
reduced
by
the
control
technology
requirement
for
the
different
types
of
affected
sources.
For
the
three
major
source
industrial
facilities
that
would
be
required
to
make
equipment
changes
to
comply
with
the
proposed
rule,
the
average
estimated
facility­
wide
emission
reduction,

including
enhanced
leak
detection
and
repair,
would
be
76
percent.
For
the
four
affected
major
source
commercial
facilities,
the
average
estimated
total
emission
facility­
wide
reduction
would
be
67
percent.
These
reductions
are
relative
to
estimated
emissions
from
these
facilities
in
2002.
Therefore,
we
envision
that
facilities
84
that
clean
industrial
articles
such
as
work
gloves
would
be
required
to
reduce
PCE
usage
by
at
least
76
percent.
For
facilities
that
do
not
clean
work
gloves
or
shop
rags,
we
envision
a
PCE
reduction
of
67
percent.
For
a
description
of
how
the
emission
reduction
percentages
were
estimated,

refer
to
the
Background
Information
Document
in
the
public
docket.
The
baseline
year
for
determining
the
PCE
usage
limit
would
be
2002.
Annual
PCE
usage
would
be
calculated
based
on
the
amount
of
PCE
purchased
during
the
calendar
year,
adjusted
for
the
PCE
in
use
and
storage
at
the
beginning
and
end
of
the
calendar
year.

If
the
performance
alternative
is
selected,
the
required
PCE
usage
percent
reduction
levels
will
be
prescribed
in
the
final
rule.
The
percent
reductions
would
be
selected
to
be
equivalent
to
the
emission
reductions
achieved
by
the
technology
based
MACT
requirements
and
the
residual
risk
requirements
adopted
in
the
final
rule.

The
performance­
based
alternative
would
apply
only
to
existing
major
sources.
New
major
sources
are
not
eligible
for
these
performance­
based
alternative
standards
because
no
baseline
PCE
data
exists
for
determining
a
required
emission
reduction
level.
This
alternative
also
would
not
be
practicable
for
area
sources
because
the
proposed
rule
has
no
process
vent
requirements
for
existing
area
sources.
The
only
requirements
for
existing
area
sources
are
the
ban
on
85
transfer
machines,
enhanced
LDAR,
and
the
operating
requirements.
Moreover,
most
area
sources
operate
only
one
dry
cleaning
machine.

We
solicit
comments
on
whether
such
an
approach
would
be
appropriate
for
major
sources.
We
would
also
like
comments
from
affected
sources
regarding
the
likelihood
that
they
would
select
this
alternative
standard.
In
addition,

we
welcome
comments
on
other
options
for
a
performance­
based
alternative.
Please
include
in
your
comments
how
the
option
ensures
equivalent
emission
reductions
to
the
proposed
equipment
standards
and
how
the
option
could
be
enforced,

including
any
recordkeeping
needed.

D.
Environmental
Impacts
of
PCE
Emissions
As
discussed
above,
due
to
the
large
margin
of
exposures
relative
to
known
thresholds,
risks
to
mammals
from
PCE
inhalation
are
likely
insignificant.
Also,
the
scarcity
of
data
makes
it
difficult
to
identify
any
potential
for
adverse
ecological
impacts
to
plant
life
from
PCE
emissions
from
dry
cleaners
due
to
conversion
to
TCAA.

While
we
have
no
direct
evidence
that
this
will
present
a
significant
ecological
risk,
we
nonetheless,
invite
public
comment
and
solicit
additional
scientific
information
on
this
issue.

E.
Additional
Time
for
Complying
with
Provisions
for
Transfer
Machines
86
As
discussed
in
section
III.
H
of
this
preamble,
we
are
proposing
to
eliminate
the
use
of
transfer
machines.
Per
section
112(
f)
of
the
CAA,
sources
have
90
days
to
comply
with
health
based
standards.
However,
we
are
soliciting
comment
on
what
additional
time
beyond
the
90­
day
compliance
period,
if
any,
might
be
necessary
for
area
sources
to
replace
existing
transfer
machines
with
dry­
to­
dry
machines,

and
on
whether,
if
EPA
were
to
grant
area
sources
replacing
transfer
machines
additional
compliance
time
in
the
final
rule,
any
further
steps
should
be
taken
by
these
area
sources
before
achieving
compliance
to
assure
that
the
health
of
persons
will
be
protected
from
imminent
endangerment,
consistent
with
section
112(
f)(
4)(
B)
of
the
CAA.

V.
Statutory
and
Executive
Order
Reviews
A.
Executive
Order
12866,
Regulatory
Planning
and
Review
Under
Executive
Order
12866
(
58
FR
51735,
October
4,

1993),
EPA
must
determine
whether
the
regulatory
action
is
"
significant"
and,
therefore,
subject
to
OMB
review
and
the
requirements
of
the
Executive
Order.
The
Executive
Order
defines
"
significant
regulatory
action"
as
one
that
is
likely
to
result
in
a
rule
that
may:

(
1)
Have
an
annual
effect
on
the
economy
of
$
100
million
or
more,
or
adversely
affect
in
a
material
way
the
economy,
a
sector
of
the
economy,
productivity,
competition,
87
jobs,
the
environment,
public
health
or
safety,
or
State,

local,
or
tribal
governments
or
communities;

(
2)
create
a
serious
inconsistency
or
otherwise
interfere
with
an
action
taken
or
planned
by
another
agency;

(
3)
materially
alter
the
budgetary
impact
of
entitlements,
grants,
user
fees,
or
loan
programs
or
the
rights
and
obligations
of
recipients
thereof;
or
(
4)
raise
novel
legal
or
policy
issues
arising
out
of
legal
mandates,
the
President's
priorities,
or
the
principles
set
forth
in
the
Executive
Order.

Pursuant
to
the
terms
of
Executive
Order
12866,
OMB
has
determined
that
it
considers
this
proposed
rule
a
"
significant
regulatory
action"
within
the
meaning
of
the
Executive
Order.
The
EPA
has
submitted
this
action
to
OMB
for
review.
Changes
made
in
response
to
OMB
suggestions
or
recommendations
will
be
documented
in
the
public
record.

B.
Paperwork
Reduction
Act
The
information
collection
requirements
in
this
proposed
rule
have
been
submitted
for
approval
to
the
OMB
under
the
Paperwork
Reduction
Act,
44
U.
S.
C.
3501,
et
seq.

The
Information
Collection
Request
(
ICR)
document
prepared
by
EPA
has
been
assigned
EPA
ICR
number
1415.06
and
OMB
Control
Number
2060­
0234.

The
2005
proposed
revisions
to
the
Dry
Cleaning
NESHAP
contain
recordkeeping
and
reporting
requirements
beyond
the
88
recordkeeping
and
reporting
requirements
that
were
promulgated
on
September
22,
1993.
Owners
or
operators
will
continue
to
keep
records
and
submit
required
reports
to
us
or
the
delegated
State
regulatory
authority.
Notifications,

reports,
and
records
are
essential
in
determining
compliance
and
are
required,
in
general,
of
all
sources
subject
to
the
1993
Dry
Cleaning
NESHAP.
Owners
or
operators
subject
to
the
1993
Dry
Cleaning
NESHAP
continue
to
maintain
records
and
retain
them
for
at
least
5
years
following
the
date
of
such
measurements,
reports,
and
records.
Information
collection
requirements
that
were
promulgated
on
September
22,
1993
in
the
Dry
Cleaning
NESHAP
prior
to
the
2005
proposed
amendments,
as
well
the
NESHAP
General
Provisions
(
40
CFR
part
63,
subpart
A),
which
are
mandatory
for
all
owners
or
operators
subject
to
national
emission
standards,

are
documented
in
EPA
ICR
No.
1415.05.

The
information
collection
requirements
described
here
are
only
those
notification,
recordkeeping,
and
reporting
requirements
that
are
contained
in
the
2005
proposed
revisions
to
the
Dry
Cleaning
NESHAP.
To
comply
with
the
2005
proposed
revisions
to
the
1993
Dry
Cleaning
NESHAP,

owners
or
operators
of
dry
cleaning
facilities
would
read
instructions
to
determine
how
they
would
be
affected.
All
sources
would
begin
an
enhanced
leak
detection
and
repair
program
that
requires
a
handheld
portable
monitor.
Major
89
source
facilities
would
purchase
a
PCE
gas
analyzer
and
area
sources
would
purchase
a
halogenated
hydrocarbon
leak
detector.
Owners
and
operators
would
incur
the
capital/
startup
cost
of
purchasing
the
monitors,
plus
ongoing
annual
operation
and
maintenance
costs.
The
total
capital/
startup
cost
for
this
ICR
is
$
5,049,000.
Annual
operation
and
maintenance
cost
would
be
$
552,825.

Owners
and
operators
of
major
and
area
sources
would
conduct
enhanced
leak
detection
and
repair
and
keep
monthly
records
of
enhanced
leak
detection
and
repair
events.

Approximately
28,000
existing
area
sources
and
15
existing
major
sources
are
subject
to
the
proposed
rule
and
are
subject
to
the
1993
Dry
Cleaning
NESHAP.
We
estimate
that
an
average
of
2,330
new
area
sources
per
year
will
become
subject
to
the
regulation
in
the
next
3
years,
but
that
the
overall
number
of
facilities
will
remain
constant
as
the
new
owners
will
take
over
old
existing
facilities.

No
new
major
sources
are
expected.
The
estimated
annual
labor
cost
for
major
and
area
sources
to
comply
with
the
2005
proposed
rule
is
approximately
$
3.9
million.

The
recordkeeping
and
reporting
requirements
are
specifically
authorized
by
CAA
section
114
(
42
U.
S.
C.
7414).

All
information
submitted
to
us
pursuant
to
the
recordkeeping
and
reporting
requirements
for
which
a
claim
of
confidentiality
is
made
is
safeguarded
according
to
our
90
policies
set
forth
in
40
CFR
part
2,
subpart
B.

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
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.

An
agency
may
not
conduct
or
sponsor,
and
a
person
is
not
required
to
respond
to
a
collection
of
information
unless
it
displays
a
currently
valid
OMB
control
number.

The
OMB
control
numbers
for
EPA's
regulations
in
40
CFR
are
listed
in
40
CFR
part
9.

To
comment
on
EPA's
need
for
this
information,
the
accuracy
of
the
provided
burden
estimates,
and
any
suggested
methods
for
minimizing
respondent
burden,
including
the
use
of
automated
collection
techniques,
EPA
has
established
a
public
docket
for
the
proposed
rule,
which
includes
this
91
ICR,
under
Docket
ID
No.
OAR­
2005­
0155.
Submit
any
comments
related
to
the
ICR
for
the
proposed
rule
to
EPA
and
OMB.

See
the
ADDRESSES
section
at
the
beginning
of
today's
notice
for
where
to
submit
comments
to
EPA.
Send
comments
to
OMB
at
the
Office
of
Information
and
Regulatory
Affairs,
OMB,

725
17th
Street,
NW,
Washington,
DC
20503,
Attention:
Desk
Office
for
EPA.
Since
OMB
is
required
to
make
a
decision
concerning
the
ICR
between
30
and
60
days
after
[
INSERT
DATE
OF
PUBLICATION
OF
THE
PROPOSED
RULE
IN
THE
FEDERAL
REGISTER],
a
comment
to
OMB
is
best
assured
of
having
its
full
effect
if
OMB
receives
it
by
[
INSERT
DATE
30
DAYS
AFTER
DATE
OF
PUBLICATION
OF
THE
PROPOSED
RULE
IN
THE
FEDERAL
REGISTER].
The
final
rule
will
respond
to
any
OMB
or
public
comments
on
the
information
collection
requirements
contained
in
the
proposed
rule.

C.
Regulatory
Flexibility
Act
The
Regulatory
Flexibility
Act
(
RFA)
generally
requires
an
agency
to
prepare
a
regulatory
flexibility
analysis
of
any
rule
subject
to
notice
and
comment
rulemaking
requirements
under
the
Administrative
Procedure
Act
or
any
other
statute
unless
the
agency
certifies
that
the
rule
will
not
have
a
significant
economic
impact
on
a
substantial
number
of
small
entities.
Small
entities
include
small
businesses,
small
organizations,
and
small
governmental
jurisdictions.
92
For
the
purposes
of
assessing
the
impacts
of
today's
proposed
rule
on
small
entities,
small
entity
is
defined
as:

(
1)
a
small
business
based
on
the
following
Small
Business
Administration
(
SBA)
size
standards,
which
are
based
on
annual
sales
receipts:
NAICS
812310
 
Coin­
Operated
Laundries
and
Dry
Cleaners­$
6.0
million;
NAICS
812320
 
Dry
Cleaning
and
Laundry
Services
(
Except
Coin­
Operated)­$
4.0
million;
NAICS
812332
 
Industrial
Launderers­$
12.0
million;

(
2)
a
small
governmental
jurisdiction
that
is
a
government
of
a
city,
county,
town,
school
district
or
special
district
with
a
population
of
less
than
50,000;
and
(
3)
a
small
organization
that
is
any
not­
for­
profit
enterprise
which
is
independently
owned
and
operated
and
is
not
dominant
in
its
field.
Under
these
definitions,
over
99
percent
of
commercial
dry
cleaning
firms
are
small.
For
more
information,
refer
to
http://
www.
sba.
gov/
size/
sizetable2002.
html.
The
economic
impacts
of
the
regulatory
alternatives
were
analyzed
based
on
consumption
of
PCE,
but
are
described
in
terms
of
comparing
the
compliance
costs
to
dry
cleaning
revenues
at
affected
firms.
For
more
detail,
see
the
current
Economic
Impact
Analysis
in
the
public
docket.

After
considering
the
economic
impacts
of
today's
proposed
rule
on
small
entities,
I
certify
that
the
proposed
rule
will
not
have
a
significant
economic
impact
on
a
93
substantial
number
of
small
entities.
This
certification
is
based
on
the
economic
impact
of
the
proposed
rule
to
affected
small
entities
in
the
entire
PCE
dry
cleaning
source
category.
Over
98
percent
of
the
approximately
20,000
small
entities
directly
regulated
by
the
proposed
rule,
including
both
major
and
area
sources,
are
expected
to
have
costs
of
less
than
1
percent
of
sales.
The
cost
impacts
for
all
regulated
small
entities
range
from
cost
savings
to
less
than
1.2
percent
of
sales.
The
small
entities
directly
regulated
by
the
proposed
rule
are
dry
cleaning
businesses
within
the
NAICS
codes
812310,
812320,

and
812332.
We
have
determined
that
all
of
the
major
sources
affected
by
the
proposed
rule
are
owned
by
businesses
within
NAICS
812332.
The
proposed
rule
is
expected
to
affect
14
ultimate
parent
businesses
that
would
be
regulated
as
major
sources.
Eight
of
the
parent
businesses
are
small
according
to
the
SBA
small
business
size
standard.
None
of
the
eight
firms
would
have
an
annualized
cost
of
more
than
1
percent
of
sales
associated
with
meeting
the
requirements
for
major
sources
(
option
I
noted
earlier
in
this
preamble).
Also,
no
other
adverse
impacts
are
expected
to
these
affected
small
businesses.

We
have
determined
that
virtually
all
of
the
affected
small
businesses
that
own
area
source
dry
cleaners
are
in
NAICS
812320.
Small
businesses
complying
with
the
proposed
94
area
source
requirements
(
area
source
option
I
described
earlier
in
this
preamble)
are
expected
to
have
the
following
impacts.
The
one­
time
cost
of
$
250
for
purchasing
a
halogenated
hydrocarbon
detector
is
less
than
0.10
percent
of
the
average
annual
revenues
for
dry
cleaning
businesses
in
NAICS
812320,
and
there
are
minimal
annualized
costs
associated
with
a
detector's
use.
Of
the
nearly
200
small
businesses
that
would
have
to
replace
their
transfer
machines,
most
of
these
businesses
would
experience
an
annual
cost
savings
and
the
others
would
have
compliance
costs
of
less
than
1.2
percent
of
sales.

Cost
impacts
associated
with
the
proposed
decision
for
major
sources
are
presented
in
Section
III.
E
of
this
preamble.
These
impacts
are
also
presented
for
area
sources
in
Section
III.
H,
and
for
co­
residential
sources
in
Section
III.
J.
These
impacts
are
detailed
in
the
BID
in
the
public
docket
as
memos
5
through
7.
For
more
information
on
the
small
entity
economic
impacts
associated
with
the
proposed
decisions
for
dry
cleaners
affected
by
today's
action,

please
refer
to
the
Economic
Impact
and
Small
Business
Analyses
in
the
public
docket.

Although
the
proposed
rule
would
not
have
a
significant
economic
impact
on
a
substantial
number
of
small
entities,

we
nonetheless
tried
to
reduce
the
impact
of
the
proposed
rule
on
small
entities.
When
developing
the
revised
95
standards,
we
took
special
steps
to
ensure
that
the
burdens
imposed
on
small
entities
were
minimal.
We
conducted
several
meetings
with
industry
trade
associations
to
discuss
regulatory
options
and
the
corresponding
burden
on
industry,

such
as
recordkeeping
and
reporting.

Following
publication
of
the
proposed
rule,
copies
of
the
Federal
Register
notice
and,
in
some
cases,
background
documents,
will
be
publically
available
to
all
industries,

organizations,
and
trade
associations
that
have
had
input
during
the
regulation
development,
as
well
as
State
and
local
agencies.
We
continue
to
be
interested
in
the
potential
impacts
of
the
proposed
rule
on
small
entities
and
welcome
comments
on
issues
related
to
such
impacts.

D.
Unfunded
Mandates
Reform
Act
Title
II
of
the
Unfunded
Mandates
Reform
Act
of
1995
(
UMRA),
Public
Law
104­
4,
establishes
requirements
for
Federal
agencies
to
assess
the
effects
of
their
regulatory
actions
on
State,
local,
and
tribal
governments
and
the
private
sector.
Under
section
202
of
the
UMRA,
EPA
generally
must
prepare
a
written
statement,
including
a
cost­
benefit
analysis,
for
proposed
and
final
rules
with
"
Federal
mandates"
that
may
result
in
expenditures
to
State,

local,
and
tribal
governments,
in
the
aggregate,
or
to
the
private
sector,
of
$
100
million
or
more
in
any
1
year.

Before
promulgating
an
EPA
rule
for
which
a
written
96
statement
is
needed,
section
205
of
the
UMRA
generally
requires
EPA
to
identify
and
consider
a
reasonable
number
of
regulatory
alternatives
and
adopt
the
least
costly,
most
cost­
effective,
or
least
burdensome
alternative
that
achieves
the
objectives
of
the
rule.
The
provisions
of
section
205
do
not
apply
when
they
are
inconsistent
with
applicable
law.
Moreover,
section
205
allows
EPA
to
adopt
an
alternative
other
than
the
least
costly,
most
cost­
effective,
or
least
burdensome
alternative
if
the
Administrator
publishes
with
the
final
rule
an
explanation
why
that
alternative
was
not
adopted.
Before
EPA
establish
any
regulatory
requirements
that
may
significantly
or
uniquely
affect
small
governments,
including
tribal
governments,
it
must
have
developed
under
section
203
of
the
UMRA
a
small
government
agency
plan.
The
plan
must
provide
for
notifying
potentially
affected
small
governments,

enabling
officials
of
affected
small
governments
to
have
meaningful
and
timely
input
in
the
development
of
EPA
regulatory
proposals
with
significant
Federal
intergovernmental
mandates,
and
informing,
educating,
and
advising
small
governments
on
compliance
with
the
regulatory
requirements.

Today's
proposed
rule
contains
no
Federal
mandates
(
under
the
regulatory
provisions
of
title
II
of
the
UMBR)

for
State,
local,
or
tribal
governments
or
the
private
97
sector.
We
have
determined
that
the
proposed
rule
does
not
contain
a
Federal
mandate
that
may
result
in
expenditures
of
$
100
million
or
more
for
State,
local,
and
tribal
governments,
in
the
aggregate,
or
to
the
private
sector
in
any
1
year.
No
costs
are
attributable
to
the
proposed
rule.

Thus,
the
proposed
rule
is
not
subject
to
the
requirements
of
sections
202
and
205
of
the
UMRA.

EPA
has
determined
that
today's
proposed
rule
contains
no
regulatory
requirements
that
might
significantly
or
uniquely
affect
small
governments
because
it
contains
no
requirements
that
apply
to
such
governments
or
impose
obligations
upon
them.
Therefore,
the
proposed
rule
is
not
subject
to
section
203
of
the
UMRA.

E.
Executive
Order
13132,
Federalism
Executive
Order
13132
(
64
FR
43255,
August
10,
1999)

requires
EPA
to
develop
an
accountable
process
to
ensure
"
meaningful
and
timely
input
by
State
and
local
officials
in
the
development
of
regulatory
policies
that
have
federalism
implications."
"
Policies
that
have
federalism
implications"

is
defined
in
the
Executive
Order
to
include
regulations
that
have
"
substantial
direct
effects
on
the
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."

The
proposed
rule
does
not
have
federalism
98
implications.
It
will
not
have
substantial
direct
effects
on
the
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
13132.
None
of
the
affected
dry
cleaning
facilities
are
owned
or
operated
by
State
governments.
Thus,
Executive
Order
13132
does
not
apply
to
the
proposed
rule.
In
the
spirit
of
Executive
Order
13132,

and
consistent
with
EPA
policy
to
promote
communications
between
EPA
and
State
and
local
governments,
EPA
specifically
solicits
comment
on
the
proposed
rule
from
State
and
local
officials.

F.
Executive
Order
13175,
Consultation
and
Coordination
with
Indian
Tribal
Governments
Executive
Order
13175
(
65
FR
67249,
November
9,
2000)

requires
EPA
to
develop
an
accountable
process
to
ensure
"
meaningful
and
timely
input
by
tribal
officials
in
the
development
of
regulatory
policies
that
have
tribal
implications."
The
proposed
rule
does
not
have
tribal
implications
as
specified
in
Executive
Order
13175.
It
will
not
have
substantial
direct
effects
on
tribal
governments,

on
the
relationship
between
the
Federal
government
and
Indian
tribes,
or
on
the
distribution
of
power
and
responsibilities
between
the
Federal
government
and
Indian
tribes.
No
tribal
governments
own
dry
cleaning
facilities
99
subject
to
the
MACT
standards
for
dry
cleaning
facilities.

Thus,
Executive
Order
13175
does
not
apply
to
the
proposed
rule.
EPA
specifically
solicits
additional
comment
on
this
proposed
rule
from
tribal
officials.

G.
Executive
Order
13045,
Protection
of
Children
from
Environmental
Health
and
Safety
Risks
Executive
Order
13045
(
62
FR
19885,
April
23,
1997)

applies
to
any
rule
that:
(
1)
Is
determined
to
be
"
economically
significant"
as
defined
under
Executive
Order
12866,
and
(
2)
concerns
an
environmental
health
or
safety
risk
that
EPA
has
reason
to
believe
may
have
a
disproportionate
effect
on
children.
If
the
regulatory
action
meets
both
criteria,
the
Agency
must
evaluate
the
environmental
health
or
safety
risk
of
the
planned
rule
on
children,
and
explain
why
the
planned
regulation
is
preferable
to
other
potentially
effective
and
reasonably
feasible
alternatives
considered
by
the
Agency.

The
proposed
rule
is
not
subject
to
the
Executive
Order
because
it
is
not
economically
significant
as
defined
in
Executive
Order
12866,
and
because
the
Agency
does
not
have
reason
to
believe
the
environmental
health
or
safety
risks
addressed
by
this
action
present
a
disproportionate
risk
to
children.
This
conclusion
is
based
on
our
assessment
of
the
information
on
PCE
effects
on
human
health
and
exposures
associated
with
dry
cleaner
operations.
100
H.
Executive
Order
13211,
Actions
Concerning
Regulations
That
Significantly
Affect
Energy
Supply,
Distribution,
or
Use
The
proposed
rule
is
not
a
"
significant
energy
action"

as
defined
in
Executive
Order
13211
(
66
FR
28355,
May
22,

2001)
because
it
is
not
likely
to
have
a
significant
adverse
effect
on
the
supply,
distribution,
or
use
of
energy.

The
proposed
rule
would
have
a
negligible
impact
on
energy
consumption
because
less
than
1
percent
of
the
industry
would
have
to
install
additional
emission
control
equipment
to
comply.
The
cost
of
energy
distribution
should
not
be
affected
by
the
proposed
rule
at
all
since
the
standards
do
not
affect
energy
distribution
facilities.
We
also
expect
that
there
would
be
no
impact
on
the
import
of
foreign
energy
supplies,
and
no
other
adverse
outcomes
are
expected
to
occur
with
regards
to
energy
supplies.
Further,

we
have
concluded
that
the
proposed
rule
is
not
likely
to
have
any
significant
adverse
energy
effects.

I.
National
Technology
Transfer
Advancement
Act
Section
112(
d)
of
the
National
Technology
Transfer
and
Advancement
Act
(
NTTAA)
of
1995
(
Public
Law
No.
104­
113,

12(
d)
(
15
U.
S.
C.
272
note),
directs
EPA
to
use
voluntary
consensus
standards
(
VCS)
in
its
regulatory
activities
unless
to
do
so
would
be
inconsistent
with
applicable
law
or
otherwise
impractical.
VCS
are
technical
standards
(
e.
g.,
Perchloroethylene
Emissions
From
Dry
Cleaning
Facilities ­
page
101
of
112
materials
specifications,
test
methods,
sampling
procedures,

and
business
practices)
that
are
developed
or
adopted
by
VCS
bodies.
The
NTTAA
directs
EPA
to
provide
Congress,
through
OMB,
explanations
when
the
Agency
decides
not
to
use
available
and
applicable
VCS.

The
proposed
rule
does
not
involve
technical
standards.

Therefore,
EPA
is
not
considering
the
use
of
any
VCS.

List
of
Subjects
in
40
CFR
Part
63
Environmental
Protection,
Air
pollution
control,
Hazardous
substances,
Reporting
and
Recordkeeping
requirements.

Dated:

Stephen
L.
Johnson,
Administrator.
102
For
the
reasons
stated
in
the
preamble,
title
40,
chapter
I
of
the
Code
of
Federal
Regulations
is
proposed
to
be
amended
as
follows:

PART
63­­[
AMENDED]

1.
The
authority
citation
for
part
63
continues
to
read
as
follows:

Authority:
42
U.
S.
C.
7401,
et
seq.

Subpart
M ­[
AMENDED]

2.
Section
63.320
is
amended
by
revising
paragraphs
(
b),

(
c),
(
d),
and
(
e)
to
read
as
follows:

§
63.320
Applicability.

*
*
*
*
*

(
b)
The
compliance
date
for
a
new
dry
cleaning
system
depends
on
the
date
that
construction
or
reconstruction
commences.

(
1)
Each
dry
cleaning
system
that
commences
construction
or
reconstruction
on
or
after
December
9,
1991
and
before
[
INSERT
THE
DATE
OF
PUBLICATION
OF
THE
PROPOSED
RULE
IN
THE
FEDERAL
REGISTER],
shall
be
in
compliance
with
the
provisions
of
this
subpart
except
§
63.322(
o)
beginning
on
September
22,
1993
or
immediately
upon
startup,
whichever
is
later,
except
for
dry
cleaning
systems
complying
with
section
112(
i)(
2)
of
the
Clean
Air
Act;
and
shall
be
in
compliance
with
the
provisions
of
§
63.322(
o)
beginning
on
[
90
DAYS
AFTER
DATE
FINAL
RULE
IS
PUBLISHED
IN
THE
FEDERAL
103
REGISTER]
or
immediately
upon
startup,
whichever
is
later,

except
as
provided
by
§
63.6(
b)(
4).

(
2)
Each
dry
cleaning
system
that
commences
construction
or
reconstruction
on
or
after
[
INSERT
DATE
OF
PUBLICATION
OF
THE
PROPOSED
RULE
IN
THE
FEDERAL
REGISTER]

and
before
[
DATE
FINAL
RULE
IS
PUBLISHED
IN
THE
FEDERAL
REGISTER],
shall
be
in
compliance
with
the
provisions
of
this
subpart
except
§
63.322(
o)
immediately
upon
startup,
and
shall
be
in
compliance
with
the
provisions
of
§
63.322(
o)

beginning
on
[
DATE
FINAL
RULE
IS
PUBLISHED
IN
THE
FEDERAL
REGISTER]
or
immediately
upon
startup,
whichever
is
later.

(
3)
Each
dry
cleaning
system
that
commences
construction
or
reconstruction
on
or
after
[
DATE
FINAL
RULE
IS
PUBLISHED
IN
THE
FEDERAL
REGISTER],
shall
be
in
compliance
with
provisions
of
this
subpart,
including
§
63.322(
o)
immediately
upon
startup.

(
c)
Each
dry
cleaning
system
that
commenced
construction
or
reconstruction
before
December
9,
1991,
and
each
new
transfer
machine
system
and
its
ancillary
equipment
that
commenced
construction
or
reconstruction
on
or
after
December
9,
1991
and
before
September
22,
1993,
shall
comply
with
§
§
63.322(
c),
(
d),
(
i),
(
j),
(
k),
(
l),
and
(
m);

63.323(
d);
and
63.324(
a),
(
b),
(
d)(
1),
(
d)(
2),
(
d)(
3),

(
d)(
4),
and
(
e)
beginning
on
December
20,
1993,
and
shall
comply
with
other
provisions
of
this
subpart
except
104
§
63.322(
o)
by
September
23,
1996;
and
shall
comply
with
§
63.322(
o)
by
[
DATE
90
DAYS
AFTER
DATE
FINAL
RULE
IS
PUBLISHED
IN
THE
FEDERAL
REGISTER].

(
d)
Each
existing
dry­
to­
dry
machine
and
its
ancillary
equipment
located
in
a
dry
cleaning
facility
that
includes
only
dry­
to­
dry
machines,
and
each
existing
transfer
machine
system
and
its
ancillary
equipment,
and
each
new
transfer
machine
system
and
its
ancillary
equipment
installed
between
December
9,
1991
and
September
22,
1993,
as
well
as
each
existing
dry­
to­
dry
machine
and
its
ancillary
equipment,

located
in
a
dry
cleaning
facility
that
includes
both
transfer
machine
system(
s)
and
dry­
to­
dry
machine(
s)
is
exempt
from
§
§
63.322,
63.323,
and
63.324,
except
paragraphs
63.322(
c),
(
d),
(
i),
(
j),
(
k),
(
l),
(
m),
(
o)(
1),
and
(
o)(
4);

63.323(
d);
and
63.324
(
a),
(
b),
(
d)(
1),
(
d)(
2),
(
d)(
3),

(
d)(
4),
and
(
e)
if
the
total
perchloroethylene
consumption
of
the
dry
cleaning
facility
is
less
than
530
liters
(
140
gallons)
per
year.
Consumption
is
determined
according
to
§
63.323(
d).

(
e)
Each
existing
transfer
machine
system
and
its
ancillary
equipment,
and
each
new
transfer
machine
system
and
its
ancillary
equipment
installed
between
December
9,

1991
and
September
22,
1993,
located
in
a
dry
cleaning
facility
that
includes
only
transfer
machine
system(
s),
is
exempt
from
§
§
63.322,
63.323,
and
63.324,
except
paragraphs
105
63.322(
c),
(
d),
(
i),
(
j),
(
k),
(
l),
(
m),
(
o)(
1),
and
(
o)(
4),

63.323(
d),
and
63.324
(
a),
(
b),
(
d)(
1),
(
d)(
2),
(
d)(
3),

(
d)(
4),
and
(
e)
if
the
perchloroethylene
consumption
of
the
dry
cleaning
facility
is
less
than
760
liters
(
200
gallons)

per
year.
Consumption
is
determined
according
to
§
63.323(
d).

*
*
*
*
*

3.
Section
63.321
is
amended
by
revising
the
definition
of
filter,
and
adding
definitions
for
halogenated
hydrocarbon
detector,
perchloroethylene
gas
analyzer,
residence,
and
vapor
leak
to
read
as
follows:

§
63.321
Definitions.

*
*
*
*
*

Filter
means
a
porous
device
through
which
perchloroethylene
is
passed
to
remove
contaminants
in
suspension.
Examples
include,
but
are
not
limited
to,
lint
filter,
button
trap,
cartridge
filter,
tubular
filter,

regenerative
filter,
prefilter,
polishing
filter,
and
spin
disc
filter.

Halogenated
hydrocarbon
detector
means
a
portable
device
capable
of
detecting
vapor
concentrations
of
perchloroethylene
of
25
parts
per
million
by
volume
and
indicating
a
concentration
of
25
parts
per
million
by
volume
or
greater
by
emitting
an
audible
or
visual
signal
that
varies
as
the
concentration
changes.
106
*
*
*
*
*

Perchloroethylene
gas
analyzer
means
a
flame
ionization
detector,
photoionization
detector,
or
infrared
analyzer
capable
of
detecting
vapor
concentrations
of
perchloroethylene
of
25
parts
per
million
by
volume.

*
*
*
*
*

Residence
means
any
dwelling
or
housing
in
which
people
reside
excluding
short­
term
housing
that
is
occupied
by
the
same
person
for
a
period
of
less
than
180
days
(
such
as
a
hotel
room).

*
*
*
*
*

Vapor
leak
means
a
perchloroethylene
vapor
concentration
exceeding
25
parts
per
million
by
volume
(
50
parts
per
million
by
volume
as
methane)
as
indicated
by
a
halogenated
hydrocarbon
detector
or
perchloroethylene
gas
analyzer.

*
*
*
*
*

4.
Section
63.322
is
amended
by
revising
paragraphs
(
e)(
3),

(
k),
and
(
m),
and
adding
paragraph
(
o)
to
read
as
follows:

§
63.322
Standards.

*
*
*
*
*

(
e)
*
*
*

(
3)
Shall
prevent
air
drawn
into
the
dry
cleaning
machine
when
the
door
of
the
machine
is
open
from
passing
through
the
refrigerated
condenser.
107
*
*
*
*
*

(
k)
The
owner
or
operator
of
a
dry
cleaning
system
shall
inspect
the
system
weekly
for
perceptible
leaks
while
the
dry
cleaning
system
is
operating.
Inspection
with
a
halogenated
hydrocarbon
detector
or
perchloroethylene
gas
analyzer
also
fulfills
the
requirement
for
inspection
for
perceptible
leaks.
The
following
components
shall
be
inspected:

*
*
*
*
*

(
m)
The
owner
or
operator
of
a
dry
cleaning
system
shall
repair
all
leaks
detected
under
paragraph
(
k)
or
(
o)(
1)
of
this
section
within
24
hours.
If
repair
parts
must
be
ordered,
either
a
written
or
verbal
order
for
those
parts
shall
be
initiated
within
2
working
days
of
detecting
such
a
leak.
Such
repair
parts
shall
be
installed
within
5
working
days
after
receipt.

*
*
*
*
*

(
o)
Additional
requirements:

(
1)
The
owner
or
operator
of
a
dry
cleaning
system
shall
inspect
the
components
listed
in
paragraph
(
k)
of
this
section
for
vapor
leaks
monthly
while
the
component
is
in
operation.

(
i)
Area
sources
shall
conduct
the
inspections
using
a
halogenated
hydrocarbon
detector
or
perchloroethylene
gas
analyzer
that
is
operated
according
to
the
manufacturer's
108
instructions.
The
operator
shall
place
the
probe
inlet
at
the
surface
of
each
component
interface
where
leakage
could
occur
and
move
it
slowly
along
the
interface
periphery.

(
ii)
Major
sources
shall
conduct
the
inspections
using
a
perchloroethylene
gas
analyzer
operated
according
to
EPA
Method
21.

(
2)
The
owner
or
operator
of
a
dry
cleaning
system
at
any
major
source
shall
route
the
air­
perchloroethylene
gasvapor
stream
contained
within
each
dry
cleaning
machine
through
a
refrigerated
condenser
and
shall
pass
the
airperchloroethylene
gas­
vapor
stream
from
inside
the
dry
cleaning
machine
drum
through
a
carbon
adsorber
or
equivalent
control
device
immediately
before
or
as
the
door
of
the
dry
cleaning
machine
is
opened.
The
carbon
adsorber
must
be
desorbed
in
accordance
with
manufacturer's
instructions.

(
3)
The
owner
or
operator
of
each
dry
cleaning
system
installed
after
[
INSERT
THE
DATE
OF
PUBLICATION
OF
THE
PROPOSED
RULE
IN
THE
FEDERAL
REGISTER]
at
an
area
source
shall
route
the
air­
perchloroethylene
gas­
vapor
stream
contained
within
each
dry
cleaning
machine
through
a
refrigerated
condenser
and
pass
the
air­
perchloroethylene
gas­
vapor
stream
from
inside
the
dry
cleaning
machine
drum
through
a
carbon
adsorber
or
equivalent
control
device
immediately
before
the
door
of
the
dry
cleaning
machine
is
109
opened.
The
carbon
adsorber
must
be
desorbed
in
accordance
with
manufacturer's
instructions.

(
4)
The
owner
or
operator
of
any
dry
cleaning
system
shall
eliminate
any
emission
of
perchloroethylene
during
the
transfer
of
articles
between
the
washer
and
the
dryer(
s)
or
reclaimer(
s).

(
5)
The
owner
or
operator
shall
eliminate
any
emission
of
perchloroethylene
from
any
dry
cleaning
system
that
is
installed
after
[
INSERT
DATE
OF
PUBLICATION
OF
THE
PROPOSED
RULE
IN
THE
FEDERAL
REGISTER]
and
that
is
located
in
a
building
with
a
residence.

5.
Section
63.323
is
amended
by
revising
paragraphs
(
b)

introductory
text,
(
b)(
1),
(
b)(
2),
and
(
c)
to
read
as
follows:

§
63.323
Test
methods
and
monitoring.

*
*
*
*
*

(
b)
When
a
carbon
adsorber
is
used
to
comply
with
§
63.322(
a)(
2)
or
exhaust
is
passed
through
a
carbon
adsorber
immediately
upon
machine
door
opening
to
comply
with
§
63.322(
b)(
3)
or
§
63.323(
o)(
2),
the
owner
or
operator
shall
measure
the
concentration
of
perchloroethylene
in
the
exhaust
of
the
carbon
adsorber
weekly
with
a
colorimetric
detector
tube
or
perchloroethylene
gas
analyzer.
The
measurement
shall
be
taken
while
the
dry
cleaning
machine
is
venting
to
that
carbon
adsorber
at
the
end
of
the
last
dry
110
cleaning
cycle
prior
to
desorption
of
that
carbon
adsorber
or
removal
of
the
activated
carbon
to
determine
that
the
perchloroethylene
concentration
in
the
exhaust
is
equal
to
or
less
than
100
parts
per
million
by
volume.
The
owner
or
operator
shall:

(
1)
Use
a
colorimetric
detector
tube
or
perchloroethylene
gas
analyzer
designed
to
measure
a
concentration
of
100
parts
per
million
by
volume
of
perchloroethylene
in
air
to
an
accuracy
of
±
25
parts
per
million
by
volume;
and
(
2)
Use
the
colorimetric
detector
tube
or
perchloroethylene
gas
analyzer
according
to
the
manufacturer's
instructions;
and
*
*
*
*
*

(
c)
If
the
air­
perchloroethylene
gas
vapor
stream
is
passed
through
a
carbon
adsorber
prior
to
machine
door
opening
to
comply
with
§
63.322(
b)(
3)
or
§
63.323(
o)(
2),
the
owner
or
operator
of
an
affected
facility
shall
measure
the
concentration
of
perchloroethylene
in
the
dry
cleaning
machine
drum
at
the
end
of
the
dry
cleaning
cycle
weekly
with
a
colorimetric
detector
tube
or
perchloroethylene
gas
analyzer
to
determine
that
the
perchloroethylene
concentration
is
equal
to
or
less
than
300
parts
per
million
by
volume.
The
owner
or
operator
shall:

(
1)
Use
a
colorimetric
detector
tube
or
111
perchloroethylene
gas
analyzer
designed
to
measure
a
concentration
of
300
parts
per
million
by
volume
of
perchloroethylene
in
air
to
an
accuracy
of
±
75
parts
per
million
by
volume;
and
(
2)
Use
the
colorimetric
detector
tube
or
perchloroethylene
gas
analyzer
according
to
the
manufacturer's
instructions;
and
(
3)
Conduct
the
weekly
monitoring
by
inserting
the
colorimetric
detector
or
perchloroethylene
gas
analyzer
tube
into
the
open
space
above
the
articles
at
the
rear
of
the
dry
cleaning
machine
drum
immediately
upon
opening
the
dry
cleaning
machine
door.

*
*
*
*
*

6.
Section
63.324
is
amended
by
revising
paragraphs
(
d)(
3),

(
d)(
5),
and
(
d)(
6)
to
read
as
follows:

§
63.324
Reporting
and
recordkeeping
requirements.

*
*
*
*
*

(
d)
*
*
*

(
3)
The
dates
when
the
dry
cleaning
system
components
are
inspected
for
leaks,
as
specified
in
§
63.322(
k),
(
l),
or
(
o)(
1),
and
the
name
or
location
of
dry
cleaning
system
components
where
leaks
are
detected;

*
*
*
*
*

(
5)
The
date
and
temperature
sensor
monitoring
results,
as
specified
in
§
63.323
if
a
refrigerated
condenser
112
is
used
to
comply
with
§
63.322(
a)
or
(
b);
and
(
6)
The
date
and
monitoring
results,
as
specified
in
§
63.323,
if
a
carbon
adsorber
is
used
to
comply
with
§
63.322(
a)(
2),
(
b)(
3),
or
(
o)(
2).

*
*
*
*
*
