WordPerfect
Document
Compare
Summary
Original
document:
G:\
BEACHES\
BEACh
Act
Promulgation\
Final
Rule\
Final
Rule
DRAFT
11­
04
ombreview.
wpd
Revised
document:
G:\
BEACHES\
BEACh
Act
Promulgation\
Final
Rule\
Final
Rule
DRAFT
11­
07
2200.
wpd
Deletions
are
shown
with
the
following
attributes
and
color:
Strikeout,
Blue
RGB(
0,0,255).
Deleted
text
is
shown
as
full
text.
Insertions
are
shown
with
the
following
attributes
and
color:
Double
Underline,
Redline,
Red
RGB(
255,0,0).
Moved
blocks
are
marked
in
the
new
location,
and
only
referenced
in
the
old
location.
Moved
block
marks
are
shown
in
the
following
color:
Orange
RGB(
255,200,0).

The
document
was
marked
with
132
Deletions,
168
Insertions,
1
Move.
Page
2
of
102
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
131
[
OW­
2004­
0010;
FRL­
XXXX­
X]

[
RIN
2040­
AE63]

Water
Quality
Standards
for
Coastal
and
Great
Lakes
Recreation
Waters
AGENCY:
Environmental
Protection
Agency.

ACTION:
Final
Rule.

SUMMARY:
The
Environmental
Protection
Agency
(
EPA)
is
promulgating
water
quality
criteria
for
bacteria
for
coastal
recreation
waters
in
specific
States
and
Territories.
The
States
and
Territories
covered
by
this
promulgation
do
not
have
water
quality
standards
for
bacteria
that
comply
with
the
requirements
of
section
303(
i)(
1)(
A)
of
the
Clean
Water
Act.
Under
these
circumstances,
the
Act
requires
EPA
to
promptly
propose
such
standards
and
to
promulgate
such
standards
not
later
than
90
days
after
proposal.
The
criteria
promulgated
today
apply
to
coastal
and
Great
Lakes
waters
that
specific
States
and
Territories
have
designated
for
swimming,

bathing,
surfing,
or
similar
water
contact
activities
and
for
which
the
State
or
Territory
does
not
have
in
place
EPA­
approved
bacteria
criteria
that
are
as
protective
of
human
health
as
EPA's
1986
recommended
bacteria
criteria.
Through
this
promulgation,
the
Federally
designated
water
quality
criteria
will
be
added
to
the
States'
and
Territories'
water
quality
criteria
applicable
to
coastal
recreation
waters.

DATES:
This
final
rule
is
effective
[
INSERT
DATE
30
DAYS
AFTER
DATE
OF
PUBLICATION].
Page
3
of
102
ADDRESSES:
EPA
has
established
a
docket
for
this
action
under
DOCKET
ID
No.
OW­
2004­

0010.
All
documents
in
the
docket
are
listed
in
the
EDOCKET
index
at
http://
www.
epa.
gov/
edocket.
Although
listed
in
the
index,
some
information
is
not
publicly
available,
i.
e.,
Confidential
Business
Information
(
CBI)
or
other
information
whose
disclosure
is
restricted
by
statute.
Certain
other
material,
such
as
copyrighted
material,
is
not
placed
on
the
Internet
and
will
be
publicly
available
only
in
hard
copy
form.
Publicly
available
docket
materials
are
available
either
electronically
in
EDOCKET
or
in
hard
copy
at
the
Water
Quality
Standards
for
Coastal
and
Great
Lakes
Recreation
Waters
Docket,
EPA/
DC,
EPA
West,
Room
B102,
1301
Constitution
Ave.,
NW,
Washington,
DC
20460.
The
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
Water
Quality
Standards
for
Coastal
and
Great
Lakes
Recreation
Water
Docket
is
(
202)
566­
2422.

FOR
FURTHER
INFORMATION
CONTACT:
For
information
concerning
today's
rulemaking,
contact
Lars
Wilcut,
Standards
and
Health
Protection
Division,
Office
of
Science
and
Technology
(
4305
T),
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW,

Washington,
DC
20460;
telephone
number:
202­
566­
0447;
fax
number:
202­
566­
0409;
e­
mail
address:
wilcut.
lars@
epa.
gov.

SUPPLEMENTARY
INFORMATION:

Table
of
Contents
I.
General
Information
A.
Does
this
Action
Apply
to
Me?
Page
4
of
102
B.
How
Can
I
Get
Copies
of
This
Document
and
Other
Related
Information?

II.
Background
A.
Statutory
and
Regulatory
Background
1.
Clean
Water
Act
2.
BEACH
Act
of
2000
B.
1986
Ambient
Water
Quality
Criteria
for
Bacteria
III.
EPA's
Proposed
Rule
and
Solicitation
of
Comment
A.
July
2004
Proposed
Rule
B.
Public
Comments
IV.
Criteria
That
EPA
is
Promulgating
Today
A.
Scope
of
the
Rule
B.
Criteria
for
Pathogen
Indicators
1.
Selection
of
Pathogen
Indicator
2.
Bacteria
Criteria
Values
3.
Use
of
the
Single
Sample
Maximum
4.
Intensity
of
Use
Categories
of
Coastal
Recreation
Waters
5.
Intrastate
vs.
Interstate
Determinations
of
Use
Intensity
6.
State
Calculation
of
Site­
Specific
Single
Sample
Maximums
7.
Addressing
Non­
Human
Sources
of
Bacteria
Page
5
of
102
C.
Applicability
of
Today's
Rule
1.
Applies
in
Addition
to
Any
State/
Territorial
Criteria
2.
Role
of
State/
Territorial
General
Rules
of
Applicability
D.
Compliance
Schedules
V.
EPA
Review
of
State
and
Territorial
Standards
A.
How
Did
EPA
Decide
Which
States
and
Territories
to
Include
in
Today's
Rule?

B.
Which
States
and
Territories
are
Included
in
Today's
Rule?

C.
Under
What
Conditions
Will
States
and
Territories
Be
Removed
from
Today's
Rule?

VI.
Response
to
Additional
Significant
Public
Comments
A.
1986
Bacteria
Criteria
B.
Economics
C.
Analytical
Methods
D.
Effective
Date
VII.
Alternative
Regulatory
Approaches
and
Implementation
Mechanisms
VIII.
Economic
Analysis
A.
Identifying
Affected
Facilities
B.
Method
for
Estimating
Potential
Compliance
Costs
C.
Results
IX.
Statutory
and
Executive
Order
Reviews
Page
6
of
102
A.
Executive
Order
12866:
Regulatory
Planning
and
Review
B.
Paperwork
Reduction
Act
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
that
Significantly
Affect
Energy
Supply,
Distribution,

or
Use
I.
National
Technology
Transfer
and
Advancement
Act
J.
Congressional
Review
Act
I.
General
Information
A.
Does
this
Action
Apply
to
Me?

State
and
Territorial
agencies
responsible
for
adopting
and
implementing
water
quality
standards
in
the
States
and
Territories
identified
in
40
CFR
131.41
are
the
entities
most
directly
affected
by
today's
rule.
People
concerned
with
water
quality
in
coastal
and
Great
Lakes
States
may
be
interested
in
this
rulemaking.
Facilities
discharging
pollutants
to
certain
waters
of
the
United
States
in
coastal
and
Great
Lakes
States
could
be
affected
by
this
rulemaking
because
Page
7
of
102
water
quality
standards
are
used
in
determining
water
quality­
based
National
Pollutant
Discharge
Elimination
System
permit
limits.
In
addition,
beach
managers
and
businesses
in
beach
areas
could
also
be
indirectly
affected
by
this
rulemaking
because
water
quality
standards
are
used
in
making
decisions
regarding
beach
advisories
and
closures.
Categories
and
entities
that
may
be
affected
include:

Category
Examples
of
potentially
affected
entities
Industry
Industries
discharging
pollutants
to
the
waters
of
the
States
and
Territories
identified
in
40
CFR
131.41.

Municipalities
Publicly­
owned
treatment
works
or
municipal
wet
weather
discharges
(
such
as
combined
sewer
overflows)
that
discharge
pollutants
to
the
waters
of
the
States
and
Territories
identified
in
40
CFR
131.41.

Other
Beach
owners
and
managers,
beach
goers.

States
identified
in
40
CFR
131.41.

This
table
is
not
intended
to
be
exhaustive,
but
rather
provides
a
guide
for
readers
regarding
entities
likely
to
be
affected
by
this
action.
This
table
lists
the
types
of
entities
that
EPA
is
now
aware
could
potentially
be
affected
by
this
action.
Other
types
of
entities
not
listed
in
the
table
could
also
be
affected.
To
determine
whether
your
facility
may
be
affected
by
this
action,

you
should
carefully
examine
the
language
in
40
CFR
131.41
of
today's
final
rule.
If
you
have
questions
regarding
the
applicability
of
this
action
to
a
particular
entity,
consult
the
person
listed
in
the
preceding
"
FOR
FURTHER
INFORMATION
CONTACT"
section.
Page
8
of
102
B.
How
Can
I
Get
Copies
of
This
Document
and
Other
Related
Information?

1.
Docket.
EPA
has
established
an
official
public
docket
for
this
action
under
Docket
ID
No.
OW­
2004­
0010.
The
official
public
docket
consists
of
the
documents
specifically
referenced
in
this
action,
any
public
comments
received,
and
other
information
related
to
this
action.

Although
a
part
of
the
official
docket,
the
public
docket
does
not
include
Confidential
Business
Information
(
CBI)
or
other
information
the
disclosure
of
which
is
restricted
by
statute.
The
official
public
docket
is
the
collection
of
materials
that
is
available
for
public
viewing
at
the
Water
Quality
Standards
for
Coastal
and
Great
Lakes
Recreation
Waters
Docket,
EPA/
DC,
EPA
West,

Room
B102,
1301
Constitution
Ave.,
NW,
Washington,
DC.
The
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
Water
Quality
Standards
for
Coastal
and
Great
Lakes
Recreation
Waters
Docket
is
(
202)
566­
2422.

Docket
copying
costs
are
as
follows:
the
first
266
pages
are
free,
additional
copying
incurs
a
$
25
administrative
fee,
and
each
additional
page
is
$
0.15.

2.
Electronic
Access.
You
may
access
this
Federal
Register
document
electronically
through
the
EPA
Internet
under
the
"
Federal
Register"
listings
at
http://
www.
epa.
gov/
fedrgstr/.

An
electronic
version
of
the
public
docket
is
available
through
EPA's
electronic
public
docket
and
comment
system,
EDOCKET.
You
may
use
EDOCKET
at
http://
www.
epa.
gov/
edocket/
to
view
public
comments,
access
the
index
listing
of
the
contents
of
the
official
public
docket,
and
to
access
those
documents
in
the
public
docket
that
are
available
electronically.
Although
not
all
docket
materials
may
be
available
electronically,
you
may
still
access
any
of
the
publicly
available
docket
materials
through
the
docket
facility
identified
in
Page
9
of
102
Section
I.
B.
Once
in
the
system,
select
"
search,"
then
key
in
the
appropriate
docket
identification
number.

II.
Background
A.
Statutory
and
Regulatory
Background
1.
Clean
Water
Act
Section
303
(
33
U.
S.
C.
1313)
of
the
Clean
Water
Act
directs
States,
Territories,
and
authorized
Tribes,
with
oversight
by
EPA,
to
adopt
water
quality
standards
to
protect
the
public
health
and
welfare,
enhance
the
quality
of
water
and
serve
the
purposes
of
the
Clean
Water
Act.

Under
section
303,
States,
Territories,
and
authorized
Tribes
are
to
develop
water
quality
standards
for
navigable
waters
of
the
United
States
within
the
State,
Territory,
or
authorized
Tribe.
Section
303(
c)
provides
that
water
quality
standards
shall
include
the
designated
use
or
uses
for
the
waters
and
water
quality
criteria
necessary
to
protect
those
uses.
Section
303(
c)(
2)(
A)
of
the
Clean
Water
Act
specifies
the
uses
that
States,
Territories,
and
authorized
Tribes
should
consider
in
establishing
new
or
revised
water
quality
standards.
These
uses
are
public
water
supplies,
propagation
of
fish
and
wildlife,
recreational
purposes,
agricultural,

industrial,
and
other
purposes,
and
navigation.
States,
Territories,
and
authorized
Tribes
must
review
their
water
quality
standards
at
least
once
every
three
years
and,
if
appropriate,
revise
or
adopt
new
standards.
States,
Territories,
and
authorized
Tribes
must
submit
the
results
of
this
triennial
review
to
EPA,
and
EPA
must
approve
or
disapprove
any
new
or
revised
standards.

Section
303(
c)
of
the
Clean
Water
Act
authorizes
the
EPA
Administrator
to
promulgate
water
quality
standards
to
supersede
State,
Territorial,
or
authorized
Tribal
standards
that
have
been
disapproved
or
in
any
case
where
the
Administrator
determines
that
a
new
or
revised
Page
10
of
102
standard
is
needed
to
meet
the
Clean
Water
Act's
requirements.
EPA
regulations
implementing
Clean
Water
Act
section
303(
c)
are
published
at
40
CFR
Part
131.
Under
these
rules,
the
minimum
elements
that
States,
Territories,
or
authorized
Tribes
must
incorporate
in
their
water
quality
standards
include:
use
designations
for
all
water
bodies
in
the
State,
Territory,
or
authorized
Tribe,
water
quality
criteria
sufficient
to
protect
those
use
designations,
and
an
antidegradation
policy
(
see
40
CFR
131.6).
Section
303(
c)(
4)
requires
the
EPA
Administrator
to
promulgate
any
new
or
revised
water
quality
standard
not
later
than
90
days
after
publishing
a
proposed
Federal
standard
unless
prior
to
this
deadline,
the
State,
Territory
or
authorized
Tribe
has
adopted
a
water
quality
standard
that
the
Administrator
determines
to
be
in
accordance
with
the
Clean
Water
Act.

2.
The
BEACH
Act
of
2000
The
Beaches
Environmental
Assessment
and
Coastal
Health
(
BEACH)
Act
of
2000
amended
the
Clean
Water
Act
in
part
by
adding
section
303(
i).
Section
303(
i)(
1)(
A)
requires
that
not
later
than
April
10,
2004,
"
each
State
having
coastal
recreation
waters
shall
adopt
and
submit
to
the
Administrator
water
quality
criteria
and
standards
for
the
coastal
recreation
waters
of
the
State
for
those
pathogens
and
pathogen
indicators
for
which
the
Administrator
has
published
criteria
under
section
304(
a)."
EPA's
Ambient
Water
Quality
Criteria
for
Bacteria
­
1986
(
EPA
440/
5­
84­
002,
January
1986)
(
the
1986
bacteria
criteria
document)
is
the
relevant
criteria
document
published
by
the
Administrator
under
Clean
Water
Act
section
304(
a).

Section
303(
i)(
2)(
A)
requires
that,
"[
i]
f
a
State
fails
to
adopt
water
quality
criteria
and
standards
in
accordance
with
[
section
303(
i)(
1)(
A)]
that
are
as
protective
of
human
health
as
the
criteria
for
pathogens
and
pathogen
indicators
for
coastal
recreation
waters
published
by
the
Page
11
of
102
Administrator,
the
Administrator
shall
promptly
propose
regulations
for
the
State
setting
forth
revised
or
new
water
quality
standards
for
pathogens
and
pathogen
indicators
described
in
[
section
303(
i)(
1)(
A)]
for
coastal
recreation
waters
of
the
State."

The
BEACH
Act
also
added
section
502(
21)(
A)
to
the
Clean
Water
Act,
which
defines
"
coastal
recreation
waters"
as
"(
i)
the
Great
Lakes;
and
(
ii)
marine
coastal
waters
(
including
coastal
estuaries)
that
are
designated
under
section
303(
c)
by
a
State
for
use
for
swimming,

bathing,
surfing,
or
similar
water
contact
activities."
Section
502(
21)(
B)
explicitly
excludes
from
the
definition
of
coastal
recreation
waters
"
inland
waters;
or
.
.
.
waters
upstream
of
the
mouth
of
a
river
or
stream
having
an
unimpaired
natural
connection
with
the
open
sea."

B.
1986
Ambient
Water
Quality
Criteria
for
Bacteria
In
1986,
EPA
published
Ambient
Water
Quality
Criteria
for
Bacteria
 
1986.
This
document
contains
EPA's
current
recommended
water
quality
criteria
for
bacteria
to
protect
people
from
gastrointestinal
illness
in
recreational
waters,
i.
e.,
waters
designated
for
primary
contact
recreation
or
similar
full
body
contact
uses.
States
and
Territories
typically
define
primary
contact
recreation
to
encompass
recreational
activities
that
could
be
expected
to
result
in
the
ingestion
of,
or
immersion
in,
water,
such
as
swimming,
water
skiing,
surfing,
kayaking,
or
any
other
recreational
activity
where
ingestion
of,
or
immersion
in,
the
water
is
likely.
The
main
route
of
exposure
to
illness­
causing
organisms
during
recreation
in
water
is
through
accidental
ingestion
of
fecally
contaminated
water
while
engaging
in
these
activities.

EPA
based
its
1986
water
quality
criteria
for
bacteria
on
levels
of
indicator
bacteria,

namely
Escherichia
coli
(
E.
coli)
and
enterococci,
which
demonstrate
the
presence
of
pathogens
in
fecal
pollution
that
can
cause
acute
gastrointestinal
illness.
Public
health
agencies
have
long
used
Page
12
of
102
indicator
organisms
such
as
these
to
protect
people
from
illnesses
that
they
may
contract
from
engaging
in
recreational
activities
in
surface
waters
contaminated
by
fecal
pollution.
These
organisms
generally
do
not
cause
illness
directly,
but
have
demonstrated
characteristics
that
make
them
good
indicators
of
fecal
contamination
and
thus
the
potential
presence
of
pathogens
capable
of
causing
human
illnesses
such
as
gastroenteritis.
Gastroenteritis
describes
a
variety
of
diseases
that
affect
the
gastrointestinal
tract
and
are
rarely
life­
threatening.
Symptoms
of
the
illness
include
nausea,
vomiting,
stomachache,
diarrhea,
headache,
and
fever.
Prior
to
its
publication
of
the
1986
bacteria
criteria
document,
EPA
recommended
the
use
of
fecal
coliforms
as
an
indicator
organism
to
protect
people
from
gastrointestinal
illness
in
recreational
waters.
The
previously
recommended
numeric
criteria
for
fecal
coliform
were
a
geometric
mean
of
200/
100
ml,
with
no
more
than
10%
of
the
total
samples
taken
during
any
30­
day
period
exceeding
400/
100
ml.

However,
EPA
conducted
epidemiological
studies
and
evaluated
the
use
of
several
organisms
as
indicators,
including
fecal
coliforms,
E.
coli,
and
enterococci.
EPA
subsequently
recommended
the
use
of
E.
coli
or
enterococci
for
fresh
recreational
waters
and
enterococci
for
marine
recreational
waters
because
levels
of
these
organisms
more
accurately
predict
acute
gastrointestinal
illness
than
levels
of
fecal
coliforms.
On
page
5,
EPA's
1986
bacteria
criteria
document
states:
"[
E]
nterococci
showed
the
strongest
relationship
to
gastroenteritis.
E.
coli
was
a
very
poor
second
and
all
of
the
other
indicators,
including
total
coliforms
and
fecal
coliforms
showed
very
weak
correlations
to
gastroenteritis."

In
EPA's
epidemiological
studies,
E.
coli
and
enterococci
exhibited
the
strongest
correlation
to
swimming­
associated
gastroenteritis,
the
former
in
freshwaters
only
and
the
latter
in
both
fresh
and
marine
waters
(
1986
bacteria
criteria
document;
Health
Effects
Criteria
for
Fresh
Page
13
of
102
Recreational
Waters,
EPA
600/
1­
84­
004,
August
1984;
Health
Effects
Criteria
for
Marine
Recreational
Waters,
EPA
600/
1­
80­
031,
August
1983).
In
marine
waters,
the
stronger
correlation
may
be
due
to
enterococci's
ability
to
survive
longer
than
coliforms,
similar
to
the
pathogens
of
concern.
In
addition,
fecal
coliforms
are
sometimes
detected
where
fecal
contamination
is
absent,
possibly
resulting
in
inaccurate
assessments
of
recreational
safety.
For
example,
Klebsiella
spp.,
a
bacterial
organism
that
is
part
of
the
fecal
coliform
group
but
which
is
generally
not
harmful
to
humans
and
does
not
occur
with
fecal
contamination,
is
often
present
in
pulp
and
paper
and
textile
mill
effluents
(
Archibald,
F.,
Water
Qual.
Res.
J.
Canada
35(
1):
1­
22,

2000;
Dufour,
Journal
WPCF,
48:
872­
879,
1976)
.

Table
1
contains
the
water
quality
criteria
values
for
the
protection
of
primary
contact
recreation
that
EPA
recommended
in
the
1986
bacteria
criteria
document.
EPA
developed
these
values
based
on
the
concentrations
of
E.
coli
and
enterococci
from
EPA­
sponsored
epidemiological
studies
that
roughly
correlated
to
the
estimated
illness
rate
associated
with
EPA's
previously
recommended
fecal
coliform
criteria.
EPA
estimated
this
illness
rate
to
be
approximately
0.8%
of
swimmers
exposed
in
freshwater
and
1.9%
of
swimmers
exposed
in
marine
waters.
EPA's
1986
bacteria
criteria
document
indicates
the
illness
rates
are
"
only
approximate"
and
that
the
Agency
based
the
1986
values
that
appear
in
Table
1
on
these
approximations.
The
illness
rates
fall
below
the
point
where
epidemiological
data
exhibited
a
statistically
significant
difference
between
illness
of
swimmers
compared
to
that
of
non­
swimmers
at
the
beaches
EPA
studied.
The
1986
bacteria
criteria
document
provides
geometric
mean
densities
as
well
as
four
different
single
sample
maximum
values
(
representing
values
below
which
an
increasing
percentage
of
single
values
are
expected
to
fall
if
the
mean
(
average)
of
all
samples
Page
14
of
102
equals
the
geometric
mean
criterion).
The
higher
the
single
sample
maximum,
the
lower
the
confidenceprobability
that
a
single
sample
exceeding
that
value
iswould
occur
as
part
of
the
normal
random
variability
of
samples
around
the
geometric
mean.
Single
sample
maximums
are
water
quality
assessment
tools
that
provide
a
sense
of
when
a
single
value
that
comes
from
a
waterbody
may
be
part
of
a
bacterial
density
with
a
geometric
mean
concentration
higher
than
that
specified
by
the
water
quality
criteria.
For
instance,
if
the
geometric
mean
concentration
in
the
water
at
a
marine
beach
is
35/
100
ml,
then
there
is
an
18%
probability
that
the
concentration
of
enterococci
in
a
single
sample
would
be
over
158/
100
ml.
In
this
case,
o
One
could
thus
consider
a
single
sample
with
this
value
to
be
indicative
of
bacterial
densities
with
a
geometric
mean
above
35/
100
ml,
but
there
would
be
an
18%
a
non­
trivial
chance
of
being
wrong
in
this
determination.
Statisticians
say
this
conclusion
can
be
drawn
"
with
82%
confidence."

The
1986
bacteria
criteria
document
includes,
for
each
geometric
mean,
a
table
of
four
single
sample
maximum
values
that
are
appropriate
for
different
levels
of
beach
usage.
In
general,
where
a
given
area
has
a
greater
potential
for
more
people
to
be
exposed,
that
area
may
warrants
a
higher
degree
of
protectiveness
(
i.
e.,
a
lower
single
sample
maximum).
The
1986
bacteria
criteria
document
categorizes
the
levels
of
beach
usage
corresponding
to
the
four
single
sample
maximums
as
follows:
"
designated
bathing
beach"
for
the
75%
(
most
protective)

confidence
level,
"
moderate
use
for
bathing"
for
the
82%
confidence
level,
"
light
use
for
bathing"

for
the
90%
confidence
level,
and
"
infrequent
use
for
bathing"
for
the
95%
confidence
level.

Note
that
the
lowest
confidence
level
corresponds
to
the
highest
level
of
protection
because
it
leads
to
a
more
precautionary
judgment
to
treat
the
waterbody
as
exceeding
the
mean
criterion,

even
though
there
is
less
statistical
confidence
that
this
is
the
case.
EPA
assigned
the
lowest
Page
15
of
102
single
sample
maximum
to
designated
bathing
beach
areas
because
a
high
degree
of
caution
should
be
used
to
evaluate
the
status
of
such
areas,
giving
greater
weight
to
a
measured
single
value
above
the
geometric
mean,
even
though
the
statistical
significance
of
this
single
measurement
may
be
weak.
MEPA
believes
this
is
appropriate
because
more
people
are
likely
to
become
ill
at
heavily
used
areas
if
they
exceed
the
criteria.
The
1986
bacteria
criteria
document
described
bathing
beach
areas
as
those
areas
that
are
"
frequently
lifeguard
protected,
provide
parking
and
other
public
access
and
are
heavily
used
by
the
public."
The
document
does
not
specifically
describe
in
greater
detail
the
potential
use
frequency
differences
of
"
moderate,"

"
lightly
used,"
and
"
infrequently
used"
full
body
contact
recreation
waters.

Table
1:
1986
Criteria
for
Indicators
for
Bacteriological
Densities
Acceptable
Swimming
Associated
Gastroenteritis
Rate
per
1000
swimmers
Steady
State
Geometric
Mean
Indicator
Density
Single
Sample
Maximum
Allowable
Density(
4)(
5)

Designated
Beach
Area
(
upper
75%
C.
L.)
Moderate
Full
Body
Contact
Recreation
(
upper
82%
C.
L.)
Lightly
Used
Full
Body
Contact
Recreation
(
upper
90%
C.
L.)
Infrequently
Used
Full
Body
Contact
Recreation
(
upper
95%
C.
L.)

Freshwater
Enterococci
8
33/
100
ml(
1)
61
78
107
151
E.
coli
8
126/
100
ml(
2)
235
298
409
575
Marine
Water
Enterococci
19
35/
100
ml(
3)
104
158
276
501
Notes:

(
1)
Calculated
to
nearest
whole
number
using
equation:
(
mean
enterococci
density)
=
antilog10
((
illness
rate/
1000
people
+
6.28)
/
9.40).

(
2)
Calculated
to
nearest
whole
number
using
equation:
(
mean
E.
coli
density)
=
antilog10
((
illness
rate/
1000
people
+
11.74)
/
9.40).

(
3)
Calculated
to
nearest
whole
number
using
equation:
(
mean
enterococci
density)
=
antilog10
((
illness
rate/
1000
people
­
0.20)
/
12.17).

(
4)
Single
sample
limit
=
antilog10
(
log10
indicator
geometric
mean
density/
100
ml
+
(
factor
determined
from
areas
under
the
normal
probability
curve
for
the
assumed
level
of
probability
*
log10
standard
deviation)).

The
appropriate
factors
for
the
indicated
one
sided
confidence
levels
are:
Page
16
of
102
75%
C.
L.
­
.675
82%
C.
L.
­
.935
90%
C.
L.
­
1.28
95%
C.
L.
­
1.65.

(
5)
Based
on
the
observed
log
standard
deviations
during
the
EPA
studies:
0.4
for
freshwater
E.
coli
and
enterococci;
and
0.7
for
marine
water
enterococci.
Each
jurisdiction
shouldmay
establish
its
own
standard
deviation
for
its
conditions
which
would
then
vary
the
single
sample
limit.

III.
EPA's
Proposed
Rule
and
Solicitation
of
Comment
A.
July
2004
Proposed
Rule
On
July
9,
2004,
EPA
published
a
proposal
entitled
"
Water
Quality
Standards
for
Coastal
and
Great
Lakes
Recreation
Waters"
(
see
69
FR
41720).
At
that
time,
EPA
proposed
to
promulgate
E.
coli
and
enterococci
standards
for
coastal
recreation
waters
in
States
that
had
not
adopted
water
quality
standards
for
those
waters
that
are
as
protective
of
human
health
as
EPA's
1986
bacteria
criteria.

EPA
proposed
a
geometric
mean
of
126/
100
ml
for
E.
coli
in
fresh
coastal
recreation
waters
and
a
geometric
mean
of
35/
100
ml
for
enterococci
in
marine
coastal
recreation
waters.

EPA
also
proposed
four
different
single
sample
maximums
in
both
fresh
and
marine
coastal
recreation
waters.
Each
single
sample
maximum
was
assigned
to
a
category
of
coastal
recreation
water
based
on
intensity
of
use.
EPA
proposed
to
interpret
the
single
sample
maximums
as
maximum
values
that
would
not
be
allowed
to
be
exceeded,
but
requested
comment
on
various
other
interpretations.
EPA
did
not
propose
particular
waters
to
which
a
specific
single
sample
maximum
would
apply;
rather,
EPA
proposed
that
States
and
Territories
would
determine
which
single
sample
maximum
would
apply
to
each
of
its
coastal
recreation
waters.
The
criteria
values
for
fresh
and
marine
coastal
recreation
waters
are
the
same
values
that
are
found
in
the
1986
1In
the
case
of
Washington
State,
EPA
has
determined
that
a
fecal
coliform
standard
of
14/
100
ml
for
marine
waters
is
"
as
protective
as"
EPA's
1986
bacteria
criteria.
(
See
section
V.
A.
1
of
this
preamble.)

Page
17
of
102
bacteria
criteria
document.

EPA
did
not
include
coastal
or
Great
Lakes
States
and
Territories
in
the
proposed
rule
if
their
current
standards
met
each
of
five
criteria:
the
standards
are
based
on
EPA's
1986
recommended
pathogen
indicators;
the
standards
are
derived
from
a
scientifically­
defensible
methodology
linked
quantitatively
to
an
acceptable
risk
level
under
Clean
Water
Act
section
303(
i);
the
standards
include
appropriate
single
sample
maximums;
the
standards
do
not
address
fecal
contamination
from
non­
human
sources
in
a
way
inconsistent
with
the
1986
bacteria
criteria;

and
EPA
approved
the
standards.
If
a
State
or
Territory
met
all
five
criteria,
EPA
proposed
to
not
include
that
State
or
Territory
in
the
rule.

1
B.
Public
Comments
The
comment
period
for
this
rule
closed
on
August
9,
2004.
EPA
received
55
comments
on
the
proposed
rule
from
a
variety
of
sources,
including
academic
associations,
environmental
groups,
municipal
wastewater
associations,
industry,
State
agencies,
local
governments,
and
private
citizens.
Most
of
the
comments
focused
on
the
following
issues:
choice
of
pathogen
indicator,
promulgation
of
a
geometric
mean
and
four
single
sample
maximums
for
the
indicators,

use
of
the
single
sample
maximum,
intensity
of
use
categories
of
coastal
recreation
waters,

intrastate
vs.
interstate
determinations
of
use
intensity,
State
calculation
of
site­
specific
single
sample
maximums,
and
addressing
non­
human
sources
of
bacteria.
This
preamble
includes
a
general
summary
of
public
comments
in
the
discussions
of
the
various
issues
addressed
here.
Page
18
of
102
EPA
has
prepared
a
"
Comment
Response
Document"
that
includes
responses
to
comments
submitted
on
the
proposed
rule,
which
is
in
the
docket
for
today's
rule.

IV.
Criteria
That
EPA
is
Promulgating
Today
A.
Scope
of
the
Rule
EPA
is
promulgating
the
rule
to
apply,
as
proposed,
to
Great
Lakes
and
marine
coastal
recreation
waters
(
including
coastal
estuaries)
designated
by
a
State
or
Territory
under
Clean
Water
Act
303(
c)
for
swimming,
bathing,
surfing,
or
similar
water
contact
activities.
As
explained
in
the
preamble
to
the
proposed
rule
(
69
FR
41723),
the
requirements
of
the
BEACH
Act
are
limited
to
"
coastal
recreation
waters,"
which
are
defined
in
Clean
Water
Act
section
502(
21)
as
the
Great
Lakes
and
marine
coastal
recreation
waters
(
including
coastal
estuaries)
that
are
designated
under
Clean
Water
Act
section
303(
c)
by
a
State
for
use
for
swimming,
bathing,

surfing,
or
similar
water
contact
activities.
The
definition
explicitly
excludes
"
inland
waters
or
waters
upstream
of
the
mouth
of
a
river
or
stream
having
an
unimpaired
natural
connection
with
the
open
sea."
EPA
interprets
Clean
Water
Act
section
502(
21)
to
apply
only
to
those
Great
Lakes
waters
that
are
designated
for
swimming,
bathing,
surfing,
or
similar
water
contact
activities,
consistent
with
the
purpose
of
the
BEACH
Act
to
protect
the
public
from
the
health
risks
associated
with
swimming
in
polluted
water.

The
BEACH
Act
clearly
envisioned
and
intended
that
States,
Territories,
and
authorized
Tribes
with
coastal
recreation
waters
adopt
into
their
water
quality
standards
bacteria
criteria
as
protective
of
human
health
as
EPA's
1986
bacteria
criteria.
Under
EPA's
water
quality
standards
regulations
at
40
CFR
Part
131,
States,
Territories,
and
authorized
Tribes
have
broad
discretion
to
designate
specific
uses
to
specific
waters.
They
are
not
required
to
designate
all
waters
for
Page
19
of
102
swimming,
bathing,
surfing,
or
similar
water
contact
activities
(
i.
e.,
primary
contact
recreation),
as
long
as
they
have
conducted
a
use
attainability
analysis
that
supports
the
decision
that
full
attainment
ofcomplied
with
the
requirements
of
the
Clean
Water
Act
section
101(
a)
uses
("
fishable/
swimmable")
is
not
feasible
for
those
waters
(
40
CFR
131.10(
g))
and
EPA's
implementing
regulations
for
designating
uses.
Today's
rule
applies
only
to
those
waters
designated
by
a
State
or
Territory
for
swimming,
bathing,
surfing,
or
similar
water
contact
activities,
not
to
waters
designated
for
uses
that
only
involve
incidental
contact.
However,
States,

Territories,
and
authorized
Tribes
are
to
continue
to
work
towards
the
goal
of
achieving
full
attainment
of
Clean
Water
Act
section
101(
a)
uses
("
fishable/
swimmable")
in
waters
that
do
not
currently
attain
such
uses.
Further,
any
waters
with
designated
uses
that
do
not
include
the
uses
specified
in
Clean
Water
Act
section
101(
a)(
2)
must
be
re­
examined
every
three
years
to
determine
if
any
new
information
has
become
available
(
40
CFR
131.20(
a)).
If
such
new
information
indicates
that
the
uses
specified
in
Clean
Water
Act
section
101(
a)(
2)
are
attainable,

the
State,
Territory,
or
authorized
Tribe
is
required
to
revise
its
water
quality
standards
accordingly.
EPA
expects
States,
Territories,
and
authorized
Tribes
to
continue
this
process
and
revise
their
water
quality
standards
where
appropriate.
States,
Territories,
and
authorized
Tribes
may
remove
a
designated
use
that
is
not
an
existing
use
if
it
conducts
a
use
attainability
analysis
to
demonstrate
that
the
designated
use
is
not
attainable
(
40
CFR
131.10(
g)).

EPA
received
few
comments
on
the
scope
of
the
rule.
One
commenter
suggested
that
the
rule
should
not
apply
to
State
waters
outside
of
the
areas
where
swimming
normally
occurs,
citing
as
an
example
Hawaii's
water
quality
standards,
which
are
consistent
with
EPA's
1986
bacteria
criteria
but
apply
only
to
those
swimming
waters
within
300
meters
of
shore.
This
commenter
Page
20
of
102
also
suggested
that
the
criteria
should
only
have
to
apply
at
depths
of
less
than
150
feet.
EPA
does
not
find
these
comments
persuasive
in
light
of
the
clear
language
of
Clean
Water
Act
sections
303(
i)
and
502(
21),
which
together
require
the
adoption
of
criteria
for
all
of
the
coastal
or
Great
Lakes
waters
designated
by
the
State
for
use
for
swimming,
bathing,
surfing,
or
similar
water
contact
activities
even
if,
as
a
factual
matter,
the
waters
designated
for
swimming
are
not
frequently
or
typically
used
for
swimming.

One
commenter
expressed
concern
that
the
rule
could
establish
a
binding
precedent
for
EPA's
review
of
pathogen
criteria
for
inland
waters
that
do
not
fall
within
the
definition
of
a
coastal
recreation
water.
As
discussed
above,
section
303(
i)
of
the
Clean
Water
Act
does
not
apply
to
inland
waters
other
than
the
Great
Lakes
because
such
waters
are
explicitly
excluded
from
the
definition
of
"
coastal
recreation
waters"
in
section
502(
21)
of
the
Clean
Water
Act.
For
all
other
waters
(
i.
e.,
waters
that
are
not
coastal
recreation
waters),
section
303(
c)
of
the
Clean
Water
Act
and
EPA's
implementing
regulations
at
40
CFR
Part
131
require
States,
Territories,

and
authorized
Tribes
to
adopt
criteria
that
are
scientifically
defensible
and
sufficient
to
protect
the
designated
uses
of
those
waters.
When
EPA
reviews
a
State's,
Territory's
or
authorized
Tribe's
new
or
revised
water
quality
standards,
EPA
applies
its
regulations
at
40
CFR
131.5
and
131.6.
EPA's
decision
on
future
State
or
Territorial
submissions
will
be
based
on
the
information
supporting
those
submissions.
EPA's
decisions
in
today's
rule
should
not
be
considered
as
binding
on
States
and
Territories
adopting
bacteria
criteria
for
inland
waters
other
than
the
Great
Lakes.

B.
Criteria
for
Pathogen
Indicators
1.
Selection
of
Pathogen
Indicator
Page
21
of
102
For
States
and
Territories
covered
by
today's
rule,
EPA
is
promulgating
water
quality
criteria
using
the
pathogen
indicators
of
enterococci
for
marine
waters
and
both
enterococci
and
E.
coli
for
freshwaters.
EPA
interprets
Clean
Water
Act
section
303(
i)(
1)(
A)
to
require
States
and
Territories
to
adopt
and
submit
water
quality
criteria
for
enterococci
in
marine
waters
and
either
enterococci
or
E.
coli
in
fresh
waters
because
it
requires
States
and
Territories
to
submit
criteria
"
for
the
pathogens
and
pathogen
indicators
for
which
the
Administrator
has
published
criteria
under
section
304(
a)."
EPA's
1986
bacteria
criteria
document
is
the
relevant
Clean
Water
Act
section
304(
a)
criteria
referred
to
in
Clean
Water
Act
section
303(
i)(
1)(
A).
It
recommends
the
use
of
enterococci
in
marine
waters
and
E
coli
or
enterococci
in
fresh
waters
for
the
protection
of
primary
contact
recreation.
Clean
Water
Act
section
303(
i)(
2)(
A)
requires
EPA
to
promptly
propose
regulations
for
the
State
setting
forth
revised
or
new
water
quality
standards
for
pathogens
and
pathogen
indicators
described
in
Clean
Water
Act
section
303(
i)(
1)(
A)
for
coastal
recreation
waters
of
the
State
for
those
States
that
fail
to
adopt
criteria
that
are
as
protective
of
human
health
as
the
criteria
referenced
in
section
303(
i)(
1)(
A).

In
the
proposal
(
69
FR
41727),
EPA
proposed
to
adopt
only
E.
coli
for
freshwaters
because
most
of
the
States
and
Territories
that
had
adopted
or
were
in
the
process
of
adopting
the
1986
bacteria
criteria
had
chosen
to
use
E.
coli
instead
of
enterococci.
However,
EPA
also
solicited
comment
on
whether
to
promulgate
criteria
based
on
both
indicators
for
freshwater
and
to
allow
States
and
Territories
to
choose
which
indicator
to
apply
to
its
coastal
recreation
waters
at
the
time
of
implementation.
EPA
received
comments
from
the
New
York
Department
of
Environmental
Conservation
(
DEC)
and
the
Pennsylvania
Department
of
Environmental
Protection
(
DEP)
requesting
EPA
to
do
so.
Both
of
these
State
agencies
have
responsibility
for
Page
22
of
102
promulgating
State
water
quality
standards.
New
York
DEC
explained
that
the
New
York
Department
of
Health
had
recently
adopted
regulations
adding
both
E.
coli
and
enterococci
as
the
criteria
for
its
freshwater
bathing
beaches,
and
that
the
New
York
DEC
was
in
the
process
of
deciding
which
of
the
two
indicators
it
would
adopt
for
its
water
quality
standards
in
the
Great
Lakes.
Consequently,
New
York
DEC
requested
that
EPA's
final
rule
include
values
for
both
indicators
and
to
allow
the
State
to
select
either
at
the
time
of
implementation.
Pennsylvania
DEP
explained
that
the
Pennsylvania
Department
of
Health
had
adopted
E.
coli
criteria
for
public
bathing
beaches,
but
also
requested
that
EPA
promulgate
a
final
rule
allowing
Great
Lakes
States
to
choose
either
E.
coli
or
enterococci
criteria
at
the
time
of
implementation.
Pennsylvania
DEP
offered
no
reason
for
its
request.
None
of
the
other
States
included
in
the
proposal
with
fresh
coastal
recreation
waters
commented
on
this
aspect
of
the
proposal.

As
requested
by
these
States,
EPA
is
promulgating
criteria
for
both
indicators
and
allowing
New
York
and
Pennsylvania
determine
which
indicator
to
apply
for
each
waterbody.

EPA
also
determined
that
it
is
reasonable
to
extend
this
flexibility
to
all
of
the
Great
Lakes
States
covered
by
this
rule.
Accordingly,
EPA
has
added
the
freshwater
criteria
values
for
enterococci
to
the
table
in
40
CFR
131.41(
c)(
1)
as
well
as
a
footnote
to
the
table
explicitly
recognizing
that
the
State
willmay
decide
which
indicator,
E.
coli
or
enterococci,
will
be
the
applicable
criterion
for
its
freshwater
coastal
recreation
water
(
i.
e.,
which
criteria
apply
to
the
Great
Lakes
waters
within
the
State's
jurisdiction).
In
the
eventUntil
a
State
does
not
make
a
decision
which
criteria
is
applicable
in
its
waterss
that
determination,
E.
coli
will
be
the
applicable
criteriaindicator.

EPA
is
providing
this
flexibility
to
all
Great
Lakes
States
in
the
rule
because
the
Great
Lakes
States
have
a
history
of
cooperating
to
protect
the
Great
Lakes
resource,
and
may
find
a
Page
23
of
102
need
to
agree
on
a
consistent
pathogen
indicator
for
the
Great
Lakes.
Because
both
the
E.
coli
and
enterococci
freshwater
criteria
in
the
1986
bacteria
criteria
have
the
same
illness
rate
they
provide
equal
protection
against
acute
gastrointestinal
illness.
In
light
of
these
considerations,

EPA
does
not
want
to
create
a
barrier
to
this
cooperation
by
promulgating
only
one
of
the
two
freshwater
criteria
in
some
Great
Lakes
States
and
both
indicators
in
other
Great
Lakes
States.

2.
Bacteria
Criteria
Values
EPA
is
promulgating
a
geometric
mean
of
35/
100
ml
for
enterococci
in
marine
coastal
recreation
waters
and
four
different
single
sample
maximums,
which
vary
for
marine
coastal
recreation
waters
based
on
intensity
of
use
as
shown
in
Table
2.
These
are
the
same
values
as
in
the
1986
bacteria
criteria
document
and
in
the
proposed
rule.

Table
2.
Ambient
Marine
Water
Quality
Criteria
for
Bacteria
A
Indicator
B
Geometric
mean
C
Single
Sample
Maximum
(
per
100
ml)

C1
Designated
bathing
beach
(
75%
confidence
level)
C2
Moderate
use
coastal
recreation
waters
(
82%
confidence
level)
C3
Light
use
coastal
recreation
waters
(
90%
confidence
level)
C4
Infrequent
use
coastal
recreation
waters
(
95%
confidence
level)

Enterococci
35/
100
mla
104b
158b
276b
501b
Footnotes
to
table
in
paragraph
(
c)(
2):

a.
This
value
is
for
use
with
analytical
methods
1106.1
or
1600
or
any
equivalent
method
that
measures
viable
bacteria.

b.
Calculated
using
the
following:
single
sample
maximum
=
geometric
mean
*
10^(
confidence
level
factor
*
log
standard
deviation),
where
the
confidence
level
factor
is:
75%:
0.68;
82%:
0.94;
90%:
1.28;
95%:
1.65.
The
log
standard
deviation
from
EPA's
epidemiological
studies
is
0.7.

For
fresh
coastal
recreation
waters,
EPA
is
also
promulgating
a
geometric
mean
of
126/
100
ml
for
E.
coli
and
a
geometric
mean
of
33/
100
ml
for
enterococci
with
four
different
single
sample
maximums,
which
vary
based
on
intensity
of
use.
As
described
above,
only
one
of
Page
24
of
102
the
criteria
for
one
of
these
indicators
will
apply
in
freshwaters
at
the
choice
of
the
State.
These
values
are
shown
in
Table
3,
and
are
the
same
values
as
in
the
1986
bacteria
criteria
document.

For
E.
coli,
these
values
are
the
same
as
those
that
EPA
proposed.
EPA
is
also
promulgating
criteria
for
enterococci
in
freshwater
based
on
the
request
of
two
Great
Lakes
States
and
used
the
values
from
the
1986
bacteria
criteria
document
for
these
enterococci
criteria.

Table
3.
Ambient
Freshwater
Quality
Criteria
for
Bacteria
A
Indicatord
B
Geometric
mean
C
Single
Sample
Maximum
(
per
100
ml)

C1
Designated
bathing
beach
(
75%

confidence
level)
C2
Moderate
use
coastal
recreation
waters
(
82%

confidence
level)
C3
Light
use
coastal
recreation
waters
(
90%
confidence
level)
C4
Infrequent
use
coastal
recreation
waters
(
95%

confidence
level)

E.
coli
126/
100
mla
235b
298b
409b
575b
Enterococci
33/
100
mlc
61b
78b
107b
151b
Footnotes
to
table
in
paragraph
(
c)(
1):

a.
This
value
is
for
use
with
analytical
methods
1103.1,
1603,
or
1604
or
any
equivalent
method
that
measures
viable
bacteria.

b.
Calculated
using
the
following:
single
sample
maximum
=
geometric
mean
*
10^(
confidence
level
factor
*
log
standard
deviation),
where
the
confidence
level
factor
is:
75%:
0.68;
82%:
0.94;
90%:
1.28;
95%:
1.65.
The
log
standard
deviation
from
EPA's
epidemiological
studies
is
0.4.

c.
This
value
is
for
use
with
analytical
methods
1106.1
or
1600
or
any
equivalent
method
that
measures
viable
bacteria.

d.
The
State
willmay
determine
which
of
these
indicators
applies
to
its
fresh
coastal
recreation
waters.
Until
a
State
makes
that
determination,
E.
coli
will
be
the
applicable
indicator.

In
proposed
40
CFR
131.41(
c),
EPA
included
footnotes
to
the
geometric
mean
values
for
E.
coli
and
enterococci
stating
that
"[
t]
his
value
is
for
use
with
[
specified]
analytical
methods
.
.
.

or
any
equivalent
viable
method."
The
specified
methods
are
based
on
measurement
of
viable
bacteria.
New
analytical
methods
that
rely
on
genetic
material
for
measurement
may
yield
Page
25
of
102
different
results
that
are
not
appropriately
calibrated
to
the
numeric
criteria
in
today's
rule.
To
address
this
concern,
EPA
is
identifying,
as
in
the
proposal,
the
specific
methods
that
must
be
used
to
apply
the
bacteria
criteria.

In
today's
rule,
EPA
is
also
making
two
minor
changes
to
this
aspect
of
the
proposal.

First,
EPA
had
incorrectly
identified
the
analytical
methods
for
enterococci
as
being
for
E.
coli
and
the
analytical
methods
for
E.
coli
as
being
for
enterococci,
and
is
correcting
this
technical
error
in
the
footnotes
in
the
final
rule.
Second,
EPA
has
revised
the
footnotes
to
explain
more
clearly
what
the
methods
are.
The
footnotes
state:
"
This
value
is
for
use
with
[
specific
methods]

or
any
equivalent
method
that
measures
viable
bacteria."

EPA
notes
that
today's
rule
does
not
specify
the
duration
over
which
the
geometric
mean
is
calculated.
The
criteria
in
the
tables
at
40
CFR
131.41(
c)
are
identical
to
those
in
table
4
of
the
1986
bacteria
criteria
document,
which
does
not
specify
the
duration
for
computing
the
geometric
mean.
The
1986
bacteria
criteria
document
discusses
the
duration
over
which
the
mean
is
calculated
in
two
places.
The
first
is
in
the
discussion
of
the
basis
for
the
criteria
(
page
six).

Here,
EPA
calculated
the
geometric
mean
bacteria
density
over
a
summer
swimming
season
(
recreation
season).
The
second
place
is
in
the
summary
of
the
criteria
(
page
16)
where
EPA
stated
that
"[
b]
ased
on
a
statistically
sufficient
number
of
samples
(
generally
not
less
than
5
samples
equally
spaced
over
a
30­
day
period),
the
geometric
mean
...."
EPA
considers
this
statement
in
the
1986
bacteria
criteria
document
to
provide
guidance
on
how
a
regulatory
agency
could
compute
the
geometric
mean,
and
not
as
a
definition
of
the
specific
period
over
which
the
mean
must
be
computed.
For
the
geometric
mean
to
be
only
computed
over
a
30­
day
period
would
mean
that
regulatory
agencies
would
need
to
sample
more
than
once
a
month,
which
is
Page
26
of
102
contrary
to
the
guidance
on
monitoring
provided
in
the
1986
bacteria
criteria
document.
EPA
expects
from
current
practice
by
States
and
Territories
that
they
will
compute
the
geometric
mean
on
either
a
monthly
or
recreation
season
basis.

EPA
is
not
specifying
in
the
final
rule
how
the
averaging
period
for
the
geometric
must
be
applied.
EPA
recommends
that
the
averaging
period
be
applied
as
a
"
rolling"
or
"
running"

average.
EPA
expects
that
most
States
will
in
fact
apply
the
averaging
period
as
a
rolling
average;
however,
EPA
also
recognizes
that
it
would
be
technically
appropriate
to
apply
the
averaging
period
on
a
set
basis
such
as
monthly
or
recreation
season.
EPA
therefore
has
concluded
that
it
is
appropriate
to
allow
the
States
to
exercise
discretion
in
deciding
how
to
apply
the
averaging
period
for
the
geometric
mean.

3.
Use
of
the
Single
Sample
Maximum
EPA
is
promulgating
the
single
sample
maximum
values
that
it
proposed
without
change,

but
is
clarifying
its
expectations
with
regard
to
how
these
values
could
be
used
in
the
context
of
beach
notification
and
closure
decisions,
and
in
the
context
of
the
implementation
of
other
Clean
Water
Act
programs.
EPA
expects
that
the
single
sample
maximum
values
would
be
used
for
making
beach
notification
and
closure
decisions.
EPA
recognizes,
however,
that
States
and
Territories
may
also
use
criteria
in
their
water
quality
standards
for
other
purposes
under
the
Clean
Water
Act
in
order
to
protect
and
improve
water
quality.
Other
than
in
the
beach
notification
and
closure
decision
context,
the
geometric
mean
is
the
more
relevant
value
for
ensuring
that
appropriate
actions
are
taken
to
protect
and
improve
water
quality
because
it
is
a
more
reliable
measure,
being
less
subject
to
random
variation,
and
more
directly
linked
to
the
underlying
studies
on
which
the
1986
bacteria
criteria
were
based.
Nevertheless,
the
single
Page
27
of
102
sample
maximum
can
play
a
role
in
identifying
potential
pollution
episodes,
especially
in
waters
that
are
prone
to
short­
term
spikes
in
bacteria
concentrations,
e.
g.,
waters
that
may
be
affected
by
a
combined
sewer
overflow
outfall.
Having
identified
that
a
water
is
prone
to
short­
term
spikes
in
bacteria
concentrations
due
to
pollution
episodes,
States
and
Territories
have
significant
flexibility
in
how
they
address
those
episodes
consistent
with
the
Clean
Water
Act
and
implementing
regulations.
(
Note
that
additional
guidance
on
making
water
quality
standard
attainment
status
determinations
may
be
found
in
EPA's
guidance
to
States
on
integrated
reporting
of
water
quality
for
sections
303(
d)
and
305(
b)
purposes.)

EPA
received
considerable
comment
on
this
topic.
Some
comments
addressed
the
issue
of
whether
the
single
sample
maximum
should
be
part
of
the
criteria
that
applies
in
all
applications,
including
beach
closure,
waterbody
assessment,
Total
Maximum
Daily
Load
establishment,
and
National
Pollutant
Discharge
Elimination
System
permitting
decisions,
or
instead
was
only
designed
for
beach
notification
and
closure
decisions.
Most
commenters
expressed
their
interpretation
of
the
1986
bacteria
criteria
document
as
discussing
the
single
sample
maximum
only
in
the
context
of
making
beach
decisions
based
on
limited
data.
Several
of
these
commenters
argue
that
the
geometric
mean
criterion
was
included
in
the
1986
bacteria
criteria
document
for
protection
against
acute
gastrointestinal
illness
in
other
contexts,
and
that
the
single
sample
maximum
was
included
as
a
tool
to
implement
the
criteria
in
beach
monitoring
situations,
and
therefore,
was
not
necessary
to
provide
protection
in
other
contexts.
Other
commenters
asserted
that
the
single
sample
maximum
should
be
used
for
all
Clean
Water
Act
purposes.

EPA
notes
that
the
1986
bacteria
criteria
document
clearly
identifies
the
single
sample
Page
28
of
102
maximum
values
as
part
of
the
criteria,
in
addition
to
the
geometric
mean
values.
Therefore,

consistent
with
section
303(
i)(
2)(
A)
of
the
Clean
Water
Act,
EPA
is
promulgating
them
today.

EPA
recognizes
that
the
single
sample
maximum
discussion
in
the
1986
bacteria
criteria
document
refers
only
to
beach
monitoring,
and
does
not
discuss
how
or
whether
the
single
sample
maximum
should
be
implemented
for
other
Clean
Water
Act
applications,
such
as
establishing
Total
Maximum
Daily
Loads
or
National
Pollutant
Discharge
Elimination
System
permit
limitations.

EPA
agrees
that
the
single
sample
maximum
values
in
the
criteria
are
best
used
for
making
beach
notification
and
closure
decisions.
However,
as
noted
above,
they
may,
but
need
not,
also
play
a
role
in
implementing
other
Clean
Water
Act
programs.
Except
in
the
beach
notification
and
closure
context,
EPA
expects
that
States
will
determine
how
to
use
the
single
sample
maximum
criteria
in
the
context
of
their
broader
programs
implementing
the
Clean
Water
Act.

For
beach
monitoring
and
beach
notification
and
closure
decisions,
beach
managers
frequently
need
to
make
beach
decisions
based
on
one
or
very
few
data
points.
Thus,
having
a
trigger
level
for
a
single
sample
value
enables
beach
managers
to
make
an
immediate
decision
for
the
protection
of
public
health
at
beaches.
The
beach
manager
will
frequently
not
be
able
to
obtain
sufficient
samples
to
compute
a
geometric
mean
for
the
purposes
of
making
a
decision
to
close
a
beach
or
issue
a
beach
advisory.
Of
the
2,823
beaches
reporting
information
to
EPA
in
2002,
65%
reported
that
pathogen
levels
were
monitored
at
least
once
per
week
(
EPA's
Beach
Watch
Program:
2002
Swimming
Season,
EPA
823­
F­
03­
007,
May
2003,

http://
www.
epa.
gov/
waterscience/
beaches/
beachwatch2003­
newformat.
pdf).
This
means
that
at
35%
of
the
beaches,
the
beach
managers
had
fewer
than
four
samples
each
month
for
making
decisions
to
open
or
close
the
beach
and
in
many
cases
only
had
one
sample
in
any
week.
Page
29
of
102
Furthermore,
beach
management
programs
need
to
be
able
to
respond
rapidly
to
short­
term
changes
in
water
quality.
Because
a
geometric
mean
provides
information
pertaining
to
water
quality
that
looks
backwards
in
time,
it
is
not
necessarily
useful
in
determining
whether
a
beach
is
safe
for
swimming
on
a
particular
day.

EPA's
National
Beach
Guidance
and
Required
Performance
Criteria
for
Grants
(
EPA­
823­

B­
02­
004,
June
2002)
requires
States
and
Territories
receiving
Clean
Water
Act
section
406
implementation
grants
to
either
immediately
issue
a
public
notification
or,
if
there
are
reasons
to
doubt
the
accuracy
of
the
first
sample,
resample
when
any
sample
surpasses
a
water
quality
standard
at
beaches.
Although
this
requirement
pertains
only
to
the
States
and
Territories
receiving
these
grants,
given
that
the
States
and
Territories
covered
by
this
rule
receive
Clean
Water
Act
section
406
implementation
grants,
it
reflects
the
actions
that
States
and
Territories
will
be
expected
to
take
when
a
sample
shows
an
exceedance
of
the
applicable
single
sample
maximum
in
today's
rule.
(
EPA
notes
that
all
35
eligible
coastal
States
and
Territories
received
grants
in
2003,
and
most
have
received
these
grants
in
2004.)
In
other
words,
States
and
Territories
will
use
a
single
sample
maximum
to
trigger
a
notification
or
closure
action
at
beaches;

whether
the
action
taken
is
an
advisory
or
a
closure
depends
on
the
decision
rules
established
by
the
State,
Territory
or
local
beach
management
authority,
although
the
National
Beach
Guidance
and
Required
Performance
Criteria
for
Grants
requires
the
State
or
Territory
to
provide
a
notification
of
the
exceedance.
Using
a
single
sample
maximum
is
especially
important
for
beaches
that
are
infrequently
monitored
or
prone
to
short­
term
spikes
in
bacteria
concentrations,

e.
g.,
waters
that
may
be
affected
by
combined
sewer
overflow
outfalls.
Thus,
consistent
with
the
1986
bacteria
criteria
document,
EPA
expects
that
States
and
Territories
would
apply
the
single
Page
30
of
102
sample
maximums
for
making
beach
notification
decisions
as
values
that
if
exceeded
would
trigger
a
notification
or
closure
action
at
the
beach.

Numerous
commenters
said
that
application
of
the
single
sample
maximum
values
in
the
criteria
as
never­
to­
be­
surpassed
limitations
in
other
contexts
could
lead
to
consequences
which
were
not
contemplated
in
the
1986
bacteria
criteria
document,
including,
for
example,
Total
Maximum
Daily
Loads
and
National
Pollutant
Discharge
Elimination
System
permit
limitations
which
might
be
technologically
and
economically
unattainable
at
a
particular
location.
EPA
agrees
that
the
1986
bacteria
criteria
document
did
not
discuss
using
the
single
sample
maximum
as
a
never­
to­
be­
surpassed
value
for
all
implementation
applications
under
the
Clean
Water
Act.

In
developing
the
1986
bacteria
criteria
document,
EPA
derived
single
sample
maximums
as
upper
percentiles
of
the
frequency
distributions
around
the
geometric
mean.
The
1986
bacteria
criteria
document
recognizes
that
in
using
the
single
sample
maximum,
there
will
be
instances
where
the
concentration
of
bacteria
in
one
or
more
individual
samples
will
be
higher
than
the
acceptable
geometric
mean
concentration.
This
is
to
be
expected
when
dealing
with
water
quality
criteria
expressed
as
average
concentrations
over
specified
lengthsa
period
of
time.
IFor
example,

in
a
waterbody
with
a
30­
day
average
concentration
exactly
at
the
water
quality
criterion,
it
can
be
expected
that
approximately
half
of
the
samples
collected
will
have
a
concentration
above
the
criterion
concentration
(
e.
g.,
126/
100
ml
for
E.
coli),
while
the
other
half
of
the
samples
will
have
lower
concentrations.
Thus,
that
the
value
of
one
sample
is
greater
than
the
numerical
value
of
the
geometric
mean
criterion,
or
even
the
numerical
value
of
the
single
sample
maximum,
does
not
necessarily
indicate
that
the
geometric
mean
criterion
has
actually
been
exceeded.
Furthermore,

the
single
sample
maximum
values
in
the
1986
bacteria
criteria
document
were
not
developed
as
Page
31
of
102
acute
criteria;
rather,
they
were
developed
as
a
statistical
construction
to
allow
decision
makers
to
make
informed
decisions
to
open
or
close
beaches
based
on
small
data
sets.
This
does
not
mean
single
sample
maximums
serve
no
purpose
outside
of
beach
notification
decisions.
For
example,

they
may
give
States
and
Territories
the
ability
to
make
waterbody
assessments
where
they
have
limited
data
for
a
waterbody.
However,
the
single
sample
maximums
were
not
designed
to
provide
a
further
reduction
in
the
design
illness
level
provided
for
by
the
geometric
mean
criterion.
Application
outside
of
the
statistical
construct
for
which
they
were
designed
(
i.
e.,
any
individual
sample
being
compared
only
to
the
single
sample
maximum,
and
not
also
being
evaluated
as
one
of
the
samples
used
to
calculate
a
geometric
mean),
could
result
in
a
decreased
level
of
protection
against
acute
gastrointestinal
illness
than
is
provided
for
by
the
geometric
mean
criterion.

Based
on
the
derivation
of
the
single
sample
maximums
as
percentiles
of
a
distribution
around
the
geometric
mean,
using
the
single
sample
maximums
as
values
not
to
be
surpassed
for
all
Clean
Water
Act
applications,
even
when
the
data
set
is
large,
could
impart
a
level
of
protection
much
more
stringent
than
intended
by
the
1986
bacteria
criteria
document.
For
example,
in
marine
waters
the
geometric
mean
criterion
for
enterococci
is
35/
100
ml,
and
the
single
sample
maximum
is
104/
100
ml
at
designated
bathing
beach
waters
based
on
the
75th
percentile
of
the
distribution
of
individual
values
around
the
mean.
If
that
single
sample
maximum
were
used
as
a
value­
not­
to­
be­
surpassed,
it
would
become
a
maximum
value
and
all
other
values
in
the
statistical
distribution
of
individual
measurements
would
have
to
be
less
than
the
maximum.

EPA
typically
uses
the
99th
percentile
of
a
distribution
to
derive
regulatory
maximums.
For
instance,
aAssuming
a
waterbody
had
the
same
standard
deviation
in
concentrations
of
bacteria
Page
32
of
102
employed
in
deriving
the
single
sample
maximums
(
e.
g.,
0.7
for
marine
waters),
the
waterbody
geometric
mean
needed
to
keep
the
waterbody
concentration
below
104/
100
ml
99%
of
the
time
would
be
2/
100
ml.
This
would
be
far
more
stringent
than
the
level
of
protection
provided
by
the
actual
geometric
mean
criterion
for
enterococci
of
35/
100
ml.
Therefore,
EPA
recognizesintends
that
States
and
Territories
haveshould
retain
the
discretion
to
apply
theseuse
single
sample
maximum
values
as
they
deem
appropriate
in
the
context
of
Clean
Water
Act
implementation
programs
other
than
beach
notification
and
closure,
consistent
with
the
Clean
Water
Act
and
its
implementing
regulations.

EPA
expectsThe
final
rule
does
not
constrain
States
and
Territories
will
exercise
flexibility
asin
how
they
applyuse
the
single
sample
maximum
values
in
the
context
of
Clean
Water
Act
implementation
programs
such
as
Total
Maximum
Daily
Loads
and
National
Pollutant
Discharge
Elimination
System
permit
requirements,
as
long
as
the
geometric
mean
criteria
for
E.
coli
and
enterococci
are
met.
EPA's
expectation
that
The
flexibility
afforded
to
States
and
Territories
will
exercise
flexibility
in
applying
the
single
sample
maximum
values
in
the
National
Pollutant
Discharge
Elimination
System
permitting
program
does
not
mean
that
all
National
Pollutant
Discharge
Elimination
System
permits
will
not
have
maximum
daily
or
seven­
day
average
permit
limits
for
bacteria
are
inappropriate
for
National
Pollutant
Discharge
Elimination
System
permits.

EPA
notes
that
maximum
daily
and
7­
day
average
effluent
limits
can
be
calculated
based
on
30­

day
average
conditions
and
an
understanding
of
effluent
variability.
See
Section
5.4.4
of
EPA's
Technical
Support
Document
for
Water
Quality­
based
Toxics
Control
(
EPA­
505­
2­
90­
001,

March
1991).
(
These
procedures
are
based
on
statistical
methodologies
similar
to
those
employed
in
deriving
the
single
sample
maximums
in
the
1986
water
quality
criteria
for
bacteria.)
Page
33
of
102
EPA's
recommendation
that
the
single
sample
maximum
values
in
the
1986
bacteria
criteria
document
should
be
used
primarily
for
making
beach
notification
and
closure
decisions
does
not
constrain
States'
use
of
maximum
daily
permit
limits
in
accordance
with
current
State
permitting
procedures.

EPA
received
a
few
comments
about
the
specific
use
of
single
sample
maximums
in
making
waterbody
assessment
decisions,
for
example,
in
the
development
of
Clean
Water
Act
section
305(
b)
reports
or
developing
section
303(
d)
lists.
One
commenter
stated
that
the
single
sample
maximum
should
not
be
used
solely
as
the
means
for
deciding
if
a
waterbody
was
impaired.
Another
commenter
stated
that
one
sample
should
not
be
used
to
characterize
a
waterbody.
Yet
another
commenter
suggested
that
the
single
sample
maximum
only
be
used
when
there
were
insufficient
data
to
compute
a
geometric
mean.

In
general,
EPA
agrees
with
these
comments.
As
discussed
above,
EPA
recognizes
the
utility
of
single
sample
maximums
where
there
are
insufficient
data
(
generally
fewer
than
five
samples
over
a
given
period)
to
compute
a
geometric
mean
for
the
purposes
of
assessing
waterbodies,
and
expects
that
States
and
Territories
will
use
single
sample
maximums
in
these
instances.
While
it
is
far
preferable
for
States
and
Territories
to
obtain
more
robust
data
for
making
decisions
about
waterbody
impairments
(
the
1986
bacteria
criteria
document
implicitly
recommends
determining
the
geometric
mean
using
generally
not
less
than
5
samples
equally
spaced
over
a
30­
day
period),
EPA
recognizes
that
in
some
instances
States
and
Territories
will
have
limited
data
and
may
decide
to
use
the
single
sample
maximums
or
other
similarly
derived
statistical
constructs
for
making
waterbody
impairment
decisions.

4.
Intensity
of
Use
Categories
of
Coastal
Recreation
Waters
Page
34
of
102
EPA
is
promulgating
the
same
single
sample
maximumintensity
of
use
categories
of
coastal
recreation
waters
as
in
the
proposal,
specifically,
the
four
categories
of
waters
with
a
corresponding
single
sample
maximum
as
described
in
the
1986
bacteria
criteria
document.
Only
one
single
sample
maximum
applies
to
each
category
of
coastal
recreation
water:
designated
bathing
beach
waters,
moderate
use
coastal
recreation
waters,
light
use
coastal
recreation
waters,

and
infrequent
use
coastal
recreation
waters.
EPA
is
also
promulgating
the
definitions
of
the
categories
as
proposed.
By
providing
definitions
for
the
four
categories,
EPA
provides
clear
guidance
to
States
and
Territories
and
information
for
the
public
to
identify
the
category
in
which
each
coastal
recreation
water
belongs
based
on
its
intensity
of
use
for
primary
contact
recreation.

EPA
does
not
have
sufficient
information
regarding
frequency
of
use
of
each
specific
coastal
recreation
water
covered
by
this
rule
to
list
all
those
waters
in
the
rule
according
to
the
four
categories
defined
in
40
CFR
131.41(
b).
Therefore,
EPA
does
not
list
individual
coastal
recreation
waters
by
intensity
of
use
category.
EPA
recommends
that
States
and
Territories
evaluate
existing
use
information
and
identify
which
individual
coastal
recreation
waters
belong
to
each
category
and
make
this
information
publicly
available
(
e.
g.,
on
a
State's
or
Territory's
website).
As
explained
in
the
preamble
to
the
proposed
rule
(
69
FR
41726),
States
and
Territories
could
use
their
existing
beach
tiering
process
for
BEACH
Act
implementation
grants
as
a
source
of
information
for
determining
frequency
in
categorizing
a
coastal
recreation
water
for
purposes
of
determining
the
applicable
single
sample
maximum.

Today's
rule
does
not
require
that
States
and
Territories
apply
the
definitions
at
40
CFR
131.41(
b)
such
that
the
State
or
Territory
finds
at
least
one
water
for
each
of
the
four
categories
of
waters.
A
State
or
Territory
could,
at
its
discretion,
apply
the
single
sample
maximum
for
Page
35
of
102
designated
bathing
beaches
(
the
lowest
single
sample
maximum)
to
all
its
coastal
recreation
waters
because
this
approach
would
be
more
protective
of
human
health
than
the
structure
for
single
sample
maximums
in
40
CFR
131.41(
b)
and
(
c).
Thus,
a
State
or
Territory
that
had
commented
that
it
preferred
that
EPA
promulgate
only
one
category
of
waters
could
exercise
its
discretion
and
apply
the
single
sample
maximum
for
designated
bathing
beaches
to
all
of
its
waters.
Alternatively,
a
State
or
Territory
may
choose
to
place
their
coastal
recreation
waters
in
only
two
of
the
four
single
sample
maximum
categories,
such
as
the
75%
confidence
level
single
sample
maximum
for
designated
bathing
beaches
and
the
95%
confidence
level
single
sample
maximum
for
all
other
coastal
recreation
waters,
if
the
recreational
usage
of
the
waters
matches
the
definitions
at
40
CFR
131.41(
b).
This
approach
would
be
appropriate
if
the
State
or
Territory
determined
that
the
"
infrequent
use"
definition
was
the
most
appropriate
categorization
for
its
coastal
recreation
waters
that
were
not
identified
as
designated
bathing
beaches.
Although
the
rule
does
not
explicitly
require
thespecify
which
State
waters
belong
in
which
use
of
any
particular
single
sample
maximumcategory,
the
definitions
in
the
rule
must
be
applied
in
orderused
to
determine
which
single
sample
maximum
would
apply
into
any
particular
Clean
Water
Act
action.

Although
the
rule
does
not
list
specific
waters
to
which
the
single
sample
applies,
the
determination
can
be
made
using
the
regulatory
definitions
when
Clean
Water
Act
actions
are
taken.
For
example,
a
State
or
Territory
would
use
the
75%
confidence
level
single
sample
maximum
when
developing
Total
Maximum
Daily
Loads
for,
or
issuing
permits
to
facilities
discharging
into,
coastal
recreation
waters
that
meet
the
definition
of
designated
bathing
beach
waters.
Similarly,
a
State
or
Territory
would
use
a
single
sample
maximum
that
is
no
less
stringent
than
the
95%
confidence
level
when
developing
Total
Maximum
Daily
Loads
for,
or
Page
36
of
102
issuing
permits
to
facilities
discharging
into,
coastal
recreation
waters
that
meet
the
definition
of
infrequent
use
coastal
recreation
waters.
As
States
and
Territories
develop
Total
Maximum
Daily
Loads
and
issue
permits
consistent
with
the
single
sample
maximums,
the
public
would
have
the
opportunity
to
review
and
comment
on
the
application
of
the
single
sample
maximums
as
part
of
the
Total
Maximum
Daily
Load
and
permitting
processes.
EPA
would
use
its
oversight
authority
under
Clean
Water
Act
section
402(
d)
to
ensure
that
States
and
Territories
apply
the
appropriate
single
sample
maximums
when
conducting
these
types
of
activities.

coastal
recreation
water.

A
number
of
comments
requested
that
EPA
promulgate
only
the
75%
confidence
level
criterion
for
all
coastal
recreation
waters
because
having
only
one
single
sample
maximum
would
provide
for
consistency
in
all
coastal
recreation
waters,
and
provide
the
same
level
(
and
highest
level)
of
protection
to
all
users
of
coastal
recreation
waters,
no
matter
what
the
use
intensity
of
that
particular
water
might
be.

EPA
declines
to
take
this
approach
in
today's
rule.
EPA
acknowledges
the
reasons
expressed
in
the
comments.
If
EPA
was
to
take
the
approach
suggested
by
these
comments,
EPA
would
promulgate
the
lowest
single
sample
maximum
value
for
all
coastal
recreation
waters.

ThisHowever,
EPA
believes
this
would
be
more
restrictive
than
what
is
necessary
to
ensure
that
the
promulgated
water
quality
criteria
are
as
protective
of
human
health
as
the
1986
bacteria
criteria
document,
which
provides
single
sample
maximums
for
four
categories
of
waters.
Thus,

such
an
approach
would
unnecessarily
restrict
the
flexibility
of
States
and
Territories
to
determine
when
to
impose
standards
more
protective
than
EPA's
1986
bacteria
criteria.
EPA
normally
defers
to
a
State's
or
Territory's
decision
on
what
criteria
apply
to
protect
a
designated
use
Page
37
of
102
subject
to
the
State
or
Territory
providing
information
to
show
that
the
water
quality
criteria
are
sufficient
to
protect
the
designated
uses,
and
for
coastal
recreation
waters,
that
the
water
quality
criteria
are
as
protective
of
human
health
as
the
criteria
for
the
pathogen
or
pathogen
indicators
that
EPA
has
published.
EPA
does
not
consider
the
benefits
of
identical
standards
in
the
States
and
Territories
covered
by
this
rule
to
outweigh
the
negative
effects
of
unnecessarily
constraining
the
flexibility
that
the
Clean
Water
Act
and
EPA's
rules
give
States
and
Territories
in
establishing
water
quality
standards,
particularly
because
there
is
somealready
variation
in
the
single
sample
maximums
in
use
among
States
and
Territories
that
are
not
covered
by
today's
rule.

5.
Intrastate
vs.
Interstate
Determinations
of
Use
Intensity
In
today's
final
rule,
as
in
the
proposal,
single
sample
maximums
apply
to
categories
of
waters
based
on
intensity
of
use.
These
categories
are
based
on
intrastate
comparisons
of
frequency
of
use
(
i.
e.,
relative
to
the
other
waters
within
that
State
or
Territory).
Using
this
approach,
a
State
or
Territory
will
identify
its
designated
bathing
beach
waters
first
and
then
evaluate
all
other
waters
in
comparison
to
those
waters.
However,
today's
rule
does
not
require
that
a
State
or
Territory
use
all
four
categories
of
intensity
of
use.
Rather,
EPA
expects
that
States
and
Territories
will
first
identify
portions
of
waters
as
designated
bathing
beaches
based
on
heavy
use,
the
factors
listed
in
40
CFR
131.41(
b)(
2)
and
then
categorize
the
remaining
waters
based
on
their
intensity
of
use
relative
to
those
beaches.
In
interpreting
the
phrase
"
heavily
used,"

EPA
expects
States
will
make
reasonable
judgments
about
the
level
of
use
at
a
given
beach.
EPA
does
not
intend
that
States
should
exclude
heavily
used
waters
from
the
designated
bathing
beach
category
merely
because
they
can
identify
other
beaches,
either
within
the
State
or
in
other
States,

that
are
more
heavily
used.
Page
38
of
102
While
several
commenters
supported
intrastate
comparison
of
intensity
of
use,
others
suggested
using
an
interstate
comparison
of
intensity
of
use
because
beach
use
varies
significantly
across
States
and
Territories.
While
EPA
recognizes
that
beach
use
intensity
varies
significantly
across
the
nation,
EPA
also
does
not
agree
that
interstate
comparisons
are
the
best
approach
for
categorizing
use
intensity.
An
interstate
approach
could
result
in
some
States
or
Territories
comparing
their
beaches
only
to
the
most
heavily
used
beaches
in
the
nation
and
determining
that
they
have
no
beaches
warranting
protection
at
the
75
%
confidence
level.
Rather,
States
and
Territories
will
need
to
evaluate
the
intensity
of
use
of
their
own
beaches,
independent
of
beaches
in
the
rest
of
the
nation,
and
assign
the
beaches
to
categories
based
on
the
definitions
provided
in
40
CFR
131.41(
b).
This
does
not
mean
that
there
is
any
minimum
number
or
percentage
of
beaches
that
must
be
placed
in
the
designated
bathing
beach
category.
Rather,
States
should
identify
those
beaches,
if
any,
in
the
State
which
satisfy
the
criteria
for
this
category
and
then
assign
the
remaining
waters
to
one
or
more
of
the
lower
intensity
of
use
categories
as
appropriate.

Intrastate
comparison
of
use
will
allow
States
and
Territories
the
flexibility
to
provide
the
level
of
protection
that
is
appropriate
to
visitors
to
beaches
with
different
intensities
of
use.

In
today's
rule,
EPA
is
also
making
a
minor
change
to
this
aspect
of
the
proposed
rule.

The
Agency
added
text
to
the
definition
of
"
designated
bathing
beach"
in
40
CFR
131.41(
b)(
2)
to
provide
expressly
that
the
determination
of
"
heavy
use"
is
based
on
a
comparisonn
evaluation
of
use
within
the
State,
which
is
consistent
with
the
above
discussion.

6.
State
Calculation
of
Site­
Specific
Single
Sample
Maximums
EPA
is
promulgating,
as
proposed,
default
single
sample
maximums
based
on
the
75,
82,

90,
and
95%
confidence
levels,
along
with
the
equation
to
calculate
site­
specific
single
sample
Page
39
of
102
maximums.
EPA
calculated
the
values
for
the
single
sample
maximums
in
tables
2
and
3
using
the
standard
deviations
observed
during
the
EPA
epidemiological
studies.
The
Agency
recognizes
that
standard
deviations
observed
in
EPA's
epidemiological
studies
may
not
coincide
with
that
for
a
particular
waterbody.
States
and
Territories
may
decide
to
collect
data
to
calculate
site­
specific
standard
deviations.
To
compute
the
site­
specific
log
standard
deviation
in
a
statistically
meaningful
way
as
explained
in
the
preamble
to
the
proposed
rule
(
69
FR
41727),
today's
rule
requires
that
the
States
and
Territories
collect
at
least
30
samples
in
a
single
recreation
season
(
see
40
CFR
131.41(
c)(
3)).
If
this
requirement
is
met,
the
State
or
Territory
may
use
the
resulting
site­
specific
standard
deviation
to
calculate
a
corresponding
single
sample
maximum.

EPA
considers
that
the
calculation
of
site­
specific
single
sample
maximums
as
specified
in
40
CFR
131.41(
c)(
3)
provides
enough
detail
on
the
calculation
that
States
and
Territories
can
implement
the
provision
of
the
rule
without
needing
to
adopt
it
as
a
site­
specific
water
quality
criterion.
As
a
result,
States
and
Territories
do
not
need
EPA
review
and
approval
under
40
CFR
Part
131
in
their
application
of
40
CFR
131.41(
c)(
3).

All
commenters
that
addressed
this
issue
supported
EPA's
proposal
to
require
30
samples
to
derive
a
site­
specific
standard
deviation;
however,
one
commenter
stated
that
States
and
Territories
should
be
allowed
to
collect
the
samples
over
two
recreation
seasons
if
there
were
not
significant
differences
in
bacteria
concentrations
over
the
two­
year
period.
The
commenter
explained
that
States
and
Territories
may
find
it
difficult
to
collect
30
samples
in
one
recreation
season.
EPA
recognizes
the
difficulty
in
collecting
the
required
number
of
samples
over
a
single
recreation
season,
but
the
Agency
has
nonetheless
concluded
that
collecting
this
data
during
a
single
season
is
necessary
in
order
to
capture
the
variability
inherent
in
bacteria
concentrations
at
Page
40
of
102
a
site
over
the
period
of
a
single
season
without
introducing
additional
variability
from
extreme
weather
conditions
such
as
drought
or
El
Niño
conditions.
Using
30
samples
over
more
than
one
recreation
season
could
affect
the
outcome
of
the
single
sample
maximum
such
that
it
may
not
be
as
protective
of
human
health
as
EPA's
1986
bacteria
criteria.

7.
Addressing
Non­
Human
Sources
of
Bacteria
EPA
is
adopting
the
approach
preferred
in
the
proposal
for
addressing
non­
human
sources
of
bacteria.
In
today's
rule,
EPA
added
footnote
"
e"
to
40
CFR
131.41(
c)(
1)
and
footnote
"
c"
to
40
CFR
131.41(
c)(
2)
to
describe
this
approach
for
addressing
non­
human
sources
of
bacteria.

The
footnotes
state:
"
These
values
apply
to
[
E.
coli
or
enterococci]
regardless
of
origin
unless
a
sanitary
survey
shows
that
sources
of
the
indicator
bacteria
are
non­
human
and
an
epidemiological
study
shows
that
the
indicator
densities
are
not
indicative
of
a
human
health
risk."
Specifically,

States
and
Territories
must
apply
the
E.
coli
and
enterococci
criteria
to
all
coastal
recreation
waters.
If,
however,
sanitary
surveys
and
epidemiological
studies
show
the
sources
of
the
indicator
bacteria
to
be
non­
human
and
the
indicator
densities
do
not
indicate
a
human
health
risk,

then
it
is
reasonable
for
the
State
or
Territory
to
not
consider
those
sources
of
fecal
contamination
in
determining
whether
the
standard
is
being
attained.
This
is
the
approach
taken
in
the
1986
bacteria
criteria
document.
It
would
be
reasonable
for
a
State
or
Territory
to
use
existing
epidemiological
studies
rather
than
conduct
new
or
independent
epidemiological
studies
for
every
waterbody
if
it
is
scientifically
appropriate
to
do
so.

EPA
also
anticipates
that
a
State
or
Territory
that
has
conducted
a
sanitary
survey
and
an
epidemiological
study
to
show
that
the
sources
of
the
indicator
bacteria
in
a
waterbody
are
nonhuman
and
that
the
indicator
densities
do
not
indicate
a
health
risk
to
those
swimming
in
the
Page
41
of
102
waters,
will
apply
the
criteria
in
today's
rule
where
a
change
in
circumstances
affecting
the
waterbody
makes
it
appropriate
to
do
so.
For
example,
the
criteria
would
apply
to
a
waterbody
in
which
there
is
a
subsequent
sewer
line
break
or
other
later
occurrence
that
results
in
the
introduction
in
the
waterbody
of
bacteria
that
is
a
human
health
risk
to
those
using
the
waters
for
primary
contact
recreation.

EPA
is
promulgating
this
approach
because
Clean
Water
Act
section
303(
i)(
2)(
A)
requires
EPA
to
propose
criteria
which
are
"
as
protective
of
human
health
as"
EPA's
1986
bacteria
criteria
in
cases
where
a
State
or
Territory
has
failed
to
do
so.
While
EPA's
scientific
understanding
of
pathogens
and
pathogen
indicators
has
evolved
since
1986,
data
characterizing
the
public
health
risk
associated
with
non­
human
sources
is
still
too
limited
for
the
Agency
to
promulgate
another
approach.

Almost
half
of
the
commenters
addressed
some
or
all
of
the
approaches
to
exempting
nonhuman
sources
of
fecal
contamination
described
in
the
proposed
rule
(
69
FR
41729­
41731).

Several
commenters
expressed
support
for
EPA's
preferred
approach.
EPA
agrees
that
the
criteria
should
apply
unless
sanitary
surveys
and
epidemiological
studies
show
the
sources
of
the
indicator
bacteria
to
be
non­
human
and
that
the
indicator
densities
are
not
indicative
of
a
human
health
risk.
This
is
the
approach
taken
in
the
1986
bacteria
criteria
document.

Some
commenters
expressed
a
preference
for
not
allowing
any
exclusion
of
non­
human
sources
from
the
criteria.
They
emphasized
the
significance
of
the
human
health
risk
associated
with
any
type
of
fecal
contamination
and
asserted
that
this
approach
would
be
most
protective
of
human
health.
EPA
does
not
agree
that
this
approach
is
necessary
for
States
to
adopt
if
an
epidemiological
study
demonstrates
that
non­
human
sources
do
not
pose
a
risk
to
human
health
at
Page
42
of
102
a
given
waterbody.

Several
commenters
supported
a
non­
human
source
exclusion
based
on
sanitary
surveys
only.
In
general,
these
commenters
expressed
concern
about
the
cost
of
epidemiological
studies,

especially
in
areas
where
evidence
of
human
fecal
contamination
was
absent.
EPA
has
found
the
scientific
understanding
of
the
human
health
risks
associated
with
non­
human
sources
of
fecal
contamination
is
still
too
incomplete
to
promulgate
this
option.
In
the
proposed
rule
(
69
FR
41730­
41731),
EPA
cited
several
instances
where
studies
have
attributed
disease
outbreaks
to
non­
human
sources
of
fecal
contamination.
Given
the
potential
human
health
risk
from
nonhuman
sources
of
fecal
contamination,
EPA
concludes
that
this
option
would
not
be
as
protective
of
human
health
as
the
1986
bacteria
criteria.

Some
commenters
supported
exclusion
of
bacteria
from
wildlife
sources
from
the
criteria
because
wildlife
sources
may
pose
less
of
a
risk
to
human
health
than
human
sources
or
domestic
animal
and
livestock
sources.
Other
commenters
raised
issues
with
the
reliability
of
current
bacteria
source
tracking
methods
that
may
be
needed
to
support
this
exclusion.
EPA
finds
the
scientific
understanding
of
the
human
health
risks
associated
with
wildlife
sources
of
fecal
contamination
and
source
tracking
methods
still
too
incomplete
to
support
promulgation
of
this
option.
Once
again,
EPA
concludes
that
this
option
is
not
as
protective
as
the
1986
bacteria
criteria.

Many
commenters
expressed
the
need
for
more
research
on
non­
human
sources.

Commenters
emphasized
two
major
areas
of
needed
research:
research
on
bacterial
source
tracking
methods
to
better
distinguish
between
different
types
of
bacteria
contamination
and
research
on
the
health
risks
associated
with
different
types
of
non­
human
fecal
contamination.
Page
43
of
102
EPA
expects
to
conduct
research
in
thisthese
areas
as
time
and
resources
allow.
EPA
also
encourages
others
to
continue
to
conduct
research
in
thisthese
areas.

C.
Applicability
of
Today's
Rule
1.
Applies
in
Addition
to
Any
State/
Territorial
Criteria
EPA
is
promulgating
the
rule
as
proposed
with
respect
to
the
interaction
of
today's
criteria
with
existing
State
and
Territorial
water
quality
criteria.
Under
today's
rule,
the
promulgated
criteria
do
not
replace
existing
bacteria
criteria
for
coastal
recreation
waters
already
adopted
by
States
and
Territories
(
and
for
those
adopted
after
May
30,
2000,
approved
by
EPA).

For
States
and
Territories
included
in
today's
rule,
permitting
under
the
National
Pollutant
Discharge
Elimination
System,
as
well
as
monitoring
and
assessment
based
on
applicableRather,

today's
promulgated
criteria
apply
for
Clean
Water
Act
water
quality
standards,
would
need
to
be
based
on
the
applicable
standards
for
bacteria
in
the
final
rule,
purposes
in
addition
to
any
other
applicable
standards
for
bacteria
previously
adopted
by
theexisting
State
or
TerritoryTerritorial
criteria
already
applicable
to
protect
uses
other
than
primary
contact
recreationthose
waters.
This
will
ensure
that,
where
commercial
shellfishing
and
primary
contact
recreation
occur
in
the
same
coastal
recreation
waters,
both
uses
will
be
adequately
protected
by
existing
State
and
Territorial
standards
(
which
generally
still
use
fecal
coliform)
and
the
new
standards
for
either
E.
coli
or
enterococci.
States
and
Territories
may
also
continue
to
use
existing
criteria
for
fecal
coliform
to
supplement
the
new
indicators
for
the
purposes
of
waterbody
assessment
and
other
purposes
where
ambient
data
are
needed.
The
dual
sets
of
bacteria
criteria
also
will
enable
regulatory
decisions
and
actions
to
continue
while
collecting
data
for
the
newly
adopted
E.
coli
or
enterococci
criteria.
For
States
and
Territories
included
in
today's
rule,
EPA
expects
that
States
Page
44
of
102
and
Territories
will
be
actively
collecting
data
on
E.
coli
and/
or
enterococci
and
working
to
incorporate
E.
coli
and/
or
enterococci
water
quality
criteria
into
their
water
quality
programs,

e.
g.,
National
Pollutant
Discharge
Elimination
System,
Clean
Water
Act
section
305(
b),
and
Clean
Water
Act
section
303(
d)
programs.
As
they
accomplish
this,
States
and
Territories
may
phase
out
their
use
of
fecal
coliform
as
a
supplemental
indicator
to
protect
primary
contact
recreation,

provided
this
does
not
result
in
less
protective
determinations.
While
EPA
cannot
remove
or
revise
existing
State
or
Territorial
standards,
EPA
believes
that
it
would
not
be
an
efficient
use
of
resources
for
States
and
Territories
to
base
Clean
Water
Act
actions
related
to
protection
of
primary
contact
recreation
on
both
fecal
coliform
and
the
new,
preferred
indicators
if
the
fecal
coliform
criteria
do
not
provide
any
additional
protection..
However,
if
States
believe
their
existing
standards
are
as
protective
as
the
criteria
in
today's
rule,
they
may
submit
data
to
EPA
to
support
this
determination,
and
if
EPA
then
determines
that
the
State
standards
are
at
least
as
protective
as
the
criteria
in
today's
rule,
EPA
will
withdraw
the
Federal
criteria
for
that
State.

(
See
section
V.
C.)
States
and
Territories
are
also
encouraged
to
expeditiously
revise
their
water
quality
standards
to
remove
fecal
coliform
criteria
thatas
an
indicator
for
primary
contact
recreation
where
it
haves
been
replaced
by
the
new
indicators
in
their
implementation
of
the
Clean
Water
Act.
Today's
rule
also
provides
in
40
CFR
131.41(
d)(
1)
that
new
EPA­
approved
bacteria
criteria
in
State
or
Territorial
water
quality
standards
arebecome
the
effective
Clean
Water
Act
criteria
upon
their
approval,
replacing
the
criteria
in
today's
rule.

EPA
received
very
few
comments
on
this
topic.
All
commenters
addressing
this
topic
supported
EPA's
proposal
that
once
EPA
approves
a
State's
or
Territory's
standards
as
being
as
protective
of
human
health
as
EPA's
1986
bacteria
criteria,
the
EPA­
approved
bacteria
criteria
in
Page
45
of
102
State
or
Territorial
water
quality
standards
would
become
effective
for
Clean
Water
Act
purposes
and
EPA's
promulgated
criteria
would
no
longer
apply.
EPA
will
still
remove
the
State
or
Territory
from
40
CFR
131.41,
but
any
delay
in
that
process
would
not
delay
the
approved
State
criteria
from
becoming
the
sole
applicable
criteria
for
Clean
Water
Act
purposes.

2.
Role
of
State/
Territorial
General
Rules
of
Applicability
Today's
rule,
like
the
proposal,
makes
today's
criteria
subject
to
States'
and
Territories'

general
rules
of
applicability
in
the
same
way
and
to
the
same
extent
as
are
other
Federallyadopted
or
State­
adopted
numeric
criteria.
EPA
received
a
few
comments
on
this
topic
and
these
generally
pertained
to
mixing
zones.
One
commenter
suggested
that
the
final
rule
prohibit
the
use
of
mixing
zones
to
comply
with
today's
criteria.
The
commenter
said
that
the
use
of
mixing
zones
would
not
be
as
protective
of
human
health
as
the
1986
bacteria
criteria.
Another
commenter
supported
allowing
States
to
apply
their
existing
mixing
zone
provisions.

EPA
appreciates
the
concerns
of
commenters
regarding
human
health
risks
of
exposure
to
fecal
contamination
within
mixing
zones.
However,
EPA
has
determined
that
the
Agency's
existing
guidance
provides
sufficient
direction
to
permitting
authorities
as
they
implement
State
or
Territorial
mixing
zone
policies.
EPA's
Water
Quality
Standards
Handbook:
Second
Edition
(
EPA­
823­
B­
94­
005a,
August
1994)
as
well
as
EPA's
Technical
Support
Document
for
Water
Quality
Based
Toxics
Control
(
EPA­
505­
2­
90­
001,
March
1991)
advise
against
the
use
of
mixing
zones
where
the
location
may
pose
a
significant
health
risk.
These
documents
stress
the
importance
of
determining
the
appropriate
placement
and
size
of
mixing
zones
depending
on
the
potential
effects
to
human
health
and
the
environment.
As
a
result,
EPA
is
not
prohibiting
the
application
of
mixing
zones
in
the
final
rule
in
cases
where
they
would
be
allowed
under
existing
Page
46
of
102
State
and
Territorial
programs.

D.
Compliance
Schedules
Where
a
State
or
Territory
does
not
have
a
regulation
that
is
in
effect
for
Clean
Water
Act
purposes
authorizing
compliance
schedules
for
water
quality­
based
effluent
limits,
EPA
proposed
to
authorize,
but
not
require,
the
permit
issuing
authority
to
include
compliance
schedules
in
permits
under
appropriate
circumstances.
EPA
also
proposed
that
if
a
State
or
Territory
has
a
regulation
in
effect
authorizing
compliance
schedules
for
Clean
Water
Act
purposes
then
that
compliance
schedule
regulation
could
be
used
in
implementing
the
water
quality
standards
in
this
rule;
it
would
not
be
affected
by
the
final
rule.
Because
EPA
recognizes
that
a
State
or
Territory
without
a
regulation
authorizing
compliance
schedules
may
not
want
such
a
regulation,
in
the
preamble
to
the
proposed
rule,
EPA
asked
such
States
to
notify
EPA
prior
to
promulgation.
No
State
or
Territory
notified
EPA
that
it
does
not
want
the
ability
to
use
the
compliance
schedule
provision
in
today's
rule.
Therefore,
EPA
is
not
including
in
today's
final
rule
any
regulatory
text
identifying
those
States
or
Territories
that
do
not
want
a
compliance
schedule
provision
for
their
standards.

EPA
received
several
comments
in
support
of
the
allowance
for
compliance
schedules.

One
commenter
requested
that
EPA
remove
the
requirement
that
a
permittee
request
a
compliance
schedule;
this
commenter
believed
that
the
permitting
authority
could
determine
whether
the
permittee
needed
time
to
comply
with
the
new
effluent
limitation
based
on
the
criterion.
EPA
disagrees
that
it
needs
to
make
this
change
because
the
rule
does
not
impose
a
requirement
for
a
request.
The
rule
at
40
CFR
131.41(
f)(
3)
provides
permittees
with
the
opportunity
to
request
a
compliance
schedule
where
the
permittee
reasonably
believes
it
will
be
Page
47
of
102
infeasible
to
immediately
achieve
the
new
limitation,
but
it
does
not
require
them
to
do
so.
The
permitting
authority
also
has
the
discretion
to
suggest
the
need
for
compliance
schedules
as
part
of
the
permit
even
if
the
permittee
does
not
initiate
a
request
for
one.

One
commenter
supported
the
definition
of
a
new
pathogen
discharger.
Another
commenter
requested
clarification
that
the
definition
does
not
apply
to
relocated
combined
sewer
overflow
outfalls.
EPA
agrees
that
the
definition
does
not
apply
to
relocated
combined
sewer
overflow
outfalls.
The
rule
at
40
CFR
131.41(
f)(
2)
does
not
allowauthorize
compliance
schedules
for
new
pathogen
dischargers
because
EPA
recognizes
that
a
new
discharger
could
design
and
build
a
new
treatment
system,
which
will
meet
the
new
water
quality­
based
requirements
more
efficiently
(
69
FR
41736).
However,
a
relocated
combined
sewer
overflow
outfall
is
not
a
new
discharge,
rather
it
is
an
existing
discharge
being
released
at
an
alternate
location.
The
relocating
of
the
outfall
does
not
necessarily
provide
an
opportunity
for
the
discharger
to
apply
additional
controls
or
reduce
pathogen
loads
to
the
extent
anticipated
for
a
new
pathogen
discharger.

EPA's
Combined
Sewer
Overflow
Control
Policy,
published
on
April
11,
1994,
recommends
that
Long
Term
Control
Plans
consider
relocating
overflow
away
from
sensitive
areas
wherever
physically
possible
and
economically
achievable
(
59
FR
18688,
18692).
In
today's
final
rule,
EPA
has
added
text
to
the
definition
of
a
"
new
pathogen
discharger"
in
40
CFR
131.41(
b)(
6)
to
provide
expressly
that
"[
i]
t
does
not
include
relocation
of
existing
combined
sewer
overflow
outfalls."

Many
commenters
addressed
the
length
of
the
compliance
schedule.
Some
commenters
supported
capping
the
length
of
the
compliance
schedule
at
five
years,
while
one
commenter
suggested
that
three
years
should
be
sufficient.
Other
commenters
suggested
that
compliance
Page
48
of
102
schedules
longer
than
five
years
may
be
necessary,
or
that
the
rule
should
not
specify
the
length
of
a
compliance
schedule,
but
rather
allow
the
permitting
authority
to
exercise
discretion
in
determining
how
much
time
is
necessary
for
each
discharger.
Finally,
several
commenters
noted
that
combined
sewer
overflow
systems
may
need
compliance
schedules
longer
than
five
years,
and
that
the
compliance
schedule
provision
of
the
rule
should
be
consistent
with
EPA's
Combined
Sewer
Overflow
Control
Policy
and
the
requirements
of
Clean
Water
Act
section
402(
q).

EPA
has
determined
that
five
years
is
a
reasonable
limit
on
the
length
of
a
compliance
schedule
within
a
National
Pollutant
Discharge
Elimination
System
permit.
EPA
expects
that
most
continuous
dischargers
will
look
to
optimize
their
existing
disinfection
treatment,
and
that
five
years
is
sufficient
time
to
do
so.
As
discussed
in
section
VIII,
EPA
believes
that
experiences
from
facilities
with
bacteria
effluent
limits
that
are
currently
meeting
the
E.
coli
and
enterococci
criteria,
as
well
as
the
current
fecal
coliform
criteria,
suggest
that
disinfection
processes
can
be
upgraded
or
adjusted
to
produce
the
levels
of
bacteria
necessary
for
compliance
with
the
rule.

EPA
has
used
five
years
for
compliance
schedules
where
permittees
were
expected
to
design,

construct,
and
operate
new
treatment
processes,
and
not
just
optimize
their
current
treatment.

(
See
40
CFR
131.38(
e)(
6)
and
40
CFR132
Appendix
F,
Procedure
9.
B.
1.)

EPA
does
not
regard
the
five­
year
cap
on
compliance
schedules
as
inconsistent
with
either
EPA's
Combined
Sewer
Overflow
Control
Policy
or
Clean
Water
Act
section
402(
q).
Section
402(
q)
requires
that
an
National
Pollutant
Discharge
Elimination
System
permits
conform
to
EPA's
Combined
Sewer
Overflow
Control
Policy
published
on
April
11,
1994
(
59
FR
18688).

EPA's
Combined
Sewer
Overflow
Control
Policy
recommends
that
permittees
develop
a
construction
and
financing
schedule
for
implementation
of
combined
sewer
overflow
controls
(
59
Page
49
of
102
FR18694).
The
Combined
Sewer
Overflow
Control
Policy
recommends
that
permitting
(
and
water
quality
standards
setting)
authorities
include,
in
an
appropriate
enforceable
mechanism,

compliance
dates,
on
the
soonest
practicable
schedule,
for
requirements
to
implement
Long
Term
Control
Plans
(
59
FR18696).
In
addition,
permits
need
to
include
water
quality­
based
effluent
limits
requiring
compliance
by
no
later
than
the
date
allowed
under
the
water
quality
standards
that
apply.
The
Combined
Sewer
Overflow
Control
Policy
itself
does
not
require
compliance
schedules
in
water
quality
standards
(
or
otherwise
constrain
the
authority
of
water
quality
standard
setting
agencies).
Finally,
the
Combined
Sewer
Overflow
Control
Policy
recommends,

in
cases
where
water
quality
standards
do
not
allow
compliance
schedules
and
the
permittee
cannot,
on
the
effective
date
of
the
permit,
comply
with
effluent
limitations
established
in
the
permit,
that
the
compliance
schedule
be
placed
in
a
judicial
order
for
major
permittees
(
59
FR18697).
EPA
recognizes
that
combined
sewer
overflow
systems
often
need
more
thatn
five
years
to
meet
the
requirements
of
the
Clean
Water
Act.
In
these
situations,
the
permitting
authority
can
provide
sufficient
time
for
the
combined
sewer
overflow
system
to
comply
by
using
the
enforceable
mechanisms
identified
in
the
Combined
Sewer
Overflow
Control
Policy.

Finally,
in
today's
final
rule,
EPA
is
making
two
corrections
to
the
proposed
rule
at
40
CFR
131.41(
f)(
3)­(
4)
to
refer
to
paragraph
(
c)
as
the
paragraph
containing
the
water
quality
criteria
for
bacteria.

V.
EPA
Review
of
State
and
Territorial
Standards
A.
How
Did
EPA
Decide
Which
States
and
Territories
to
Include
in
Today's
Rule?

EPA
evaluated
the
water
quality
standards
for
bacteria
for
all
35
coastal
States
and
Territories
with
coastal
recreation
waters
to
determine
whether
the
water
quality
standards
for
Page
50
of
102
such
waters
are
as
protective
of
human
health
as
the
1986
bacteria
criteria
document,
as
required
by
Clean
Water
Act
section
303(
i)(
1)(
A).
If
a
State's
or
Territory's
approved
water
quality
standards
for
bacteria
for
coastal
recreation
waters
are
as
protective
of
human
health
as
the
1986
bacteria
criteria
as
of
the
signature
date
of
today's
rule,
EPA
is
not
including
the
State
or
Territory
in
the
promulgated
rule.

EPA
described
the
five
considerations
used
to
evaluate
the
State
and
Territorial
water
quality
standards
in
detail
in
the
proposed
rule
(
69
FR
41728­
41731).
Today,
EPA
uses
the
same
five
considerations
to
evaluate
State
and
Territorial
water
quality
standards
for
inclusion
in
the
final
rule.
The
following
five
sections
summarize
the
considerations.

1.
Are
the
standards
based
on
EPA's
recommended
indicators
of
E.
coli
and
enterococci
as
pathogen
indicators
for
freshwaters
and
enterococci
for
marine
waters?

As
discussed
in
section
IV.
B.
1
of
the
preamble
to
today's
rule,
EPA
is
promulgating
water
quality
criteria
for
E.
coli
and
enterococci
for
use
as
standards
for
State
and
Territorial
coastal
and
Great
Lakes
recreation
waters.
These
are
the
indicator
bacteria
for
which
EPA
published
criteria
in
the
1986
bacteria
criteria
document.

EPA
received
a
number
of
comments
asserting
that
a
fecal
coliform
water
quality
criterion
of
14/
100
ml
for
the
protection
of
a
shellfishing
use
should
generally
be
as
protective
of
human
health
as
the
enterococci
criterion
of
35/
100
ml.
Some
of
these
commenters
referenced
the
statement
in
the
1986
bacteria
criteria
document
that
EPA
selected
the
value
of
the
enterococci
criterion
to
be
no
more
protective
of
human
health
than
the
then
current
fecal
coliform
criterion
of
200/
100
ml
for
recreation
protection
in
support
of
their
argument
that
if
there
is
equal
protection
between
the
1986
bacteria
criteria
and
a
fecal
coliform
value
of
200/
100
ml,
then
a
fecal
coliform
Page
51
of
102
value
of
14/
100
ml
should
be
even
more
protective
of
human
health
than
an
enterococci
value
of
35/
100
ml
for
marine
waters.
EPA
disagrees
with
this
argument.
that
this
statement
in
the
1986
bacteria
criteria
document
provides
a
basis
for
determining
that
a
fecal
coliform
criterion
of
14/
100
ml
is
"
as
protective
as"
an
enterococci
criterion
of
35/
100
ml.
EPA
explicitly
acknowledged
in
the
1986
bacteria
criteria
document
that
these
illness
rates
for
fecal
coliform
were
only
approximations,
but
were
the
best
available
estimates.
(
The
fecal
coliform
criteria
were
developed
long
before
EPA
calculated
the
corresponding
estimated
illness
rates.)
EPA
used
these
estimated
illness
rates
for
one
purpose:
to
select
illness
rates
for
the
enterococci
and
E.
coli
criteria
in
marine
and
fresh
waters
that
would
be
least
likely
to
cause
a
change
in
the
stringency
of
the
water
quality
standards
for
bacteria.
However,
that
discussion
in
the
1986
bacteria
criteria
document
must
be
considered
along
with
the
purpose
of
the
1986
bacteria
criteria
document:
to
recommend
that
States
replace
their
fecal
coliform
criteria
for
recreation
with
enterococci
or
E.

coli
criteria
because
studies
showed
almost
nolow
correlation
between
fecal
coliform
densities
and
illness
rates.
In
EPA's
view,
it
would
not
be
reasonable
to
rely
on
the
equivocal
discussion
regarding
the
after­
the­
fact
approximation
of
an
illness
rate
for
fecal
coliform
in
light
of
the
unequivocal
conclusion
of
the
entire
document:
that
the
fecal
coliform
criteria
for
recreation
is
not
a
reliable
indicator
of
illness
to
swimmers.

One
commenter,
the
Washington
Department
of
Ecology,
supplied
EPA
with
recentlycollected
ambient
water
monitoring
data
for
both
fecal
coliform
and
enterococci,
and
suggestedstated
that
the
data
for
enterococci
and
fecal
coliform,
when
compared
to
each
other,

show
that,
in
Washington
State
coastal
recreation
waters,
when
fecal
coliform
concentrations
were
at
14/
100
ml
or
less
(
a
level
substantially
below
the
200/
100
ml
level
that
EPA
Page
52
of
102
recommended
prior
to
1986),
the
enterococci
concentrations
were
almost
always
at
35/
100
ml
or
less.
The
State
currently
has
a
fecal
coliform
criterion
of
14/
100
ml
as
a
geometric
mean
and
43/
100
ml
as
a
value
not
to
be
exceeded
more
than
10%
of
the
time
for
its
Class
AA
and
A
waters,
which
for
marine
waters
are
the
only
classes
with
primary
recreation
uses.
The
data
submitted
to
EPA
are
from
37
locations
in
the
King
County
area
of
the
Puget
Sound
for
the
years
1995
through
2004,
155
locations
in
the
Kitsap
County
area
of
the
Puget
Sound
and
its
embayments
for
early
1997,
and
36
locations
across
the
Puget
Sound,
Strait
of
Juan
Ddel
Fuca,

and
two
Pacific
Ocean
embayments
from
November
2000
through
July
2001.

EPA
reviewed
the
data
provided
by
the
Washington
Department
of
Ecology.
EPA
analyzed
the
data
that
were
collected
from
stations
located
close
to
shore
and
within
the
upper
two
meters
of
depth,
because
these
are
the
areas
where
people
most
frequently
swim.
EPA
also
excluded
data
that
the
State
identified
as
invalid.
From
these
data,
there
are
3535
samples
with
both
fecal
coliform
and
enterococci
bacterial
counts.
From
these
samples,
EPA
calculated
241
summertime
geometric
means
for
both
fecal
coliform
and
enterococci
for
the
data
from
King
County.
EPA
could
not
calculate
summertime
geometric
means
for
the
other
locations
because
there
were
insufficient
data
in
these
data
sets
to
do
so.

These
geometric
mean
calculations
show
that,
for
King
County,
the
attainment
of
the
State's
current
fecal
coliform
geometric
mean
criterion
of
14/
100
ml
always
assures
attainment
of
the
Federalan
enterococci
geometric
mean
of
35/
100
ml.
Further,
there
were
67
of
191
relevant
occasions
(
35%
of
the
time)
when
use
of
the
State's
fecal
coliform
geometric
mean
criterion
would
bewas
exceeded
but
the
Federal
geometric
mean
enterococci
criterion
wouldwas
not.

The
data
also
show
that
attainment
of
the
State's
current
fecal
coliform
criterion
also
Page
53
of
102
attainsensures
attainment
of
the
Federal
enterococci
criterion
expressed
as
the
75th
percentile
single
sample
maximum
criterion
(
104/
100
ml)
in
99%
of
the
samples
collected
at
all
locations
in
Washington.
Of
2194
relevant
data
points,
the
State's
upper
bound
fecal
coliform
criterion
of
43/
100
ml
assures
attainment
of
the
Federal
enterococci
75th
percentile
single
sample
maximum
criterion
on
2166
occasions.
Finally,
there
were
570
of
2736
relevant
occasions
(
21%
of
the
samples)
when
use
of
the
State's
fecal
coliform
criterion
could
be
used
to
close
a
beach
or
issue
an
advisory
but
the
Federal
enterococci
criterion
(
expressed
as
a
single
sample
maximum)
would
not
support
closure
or
an
advisory.
Based
on
this
analysis,
EPA
agrees
that
the
data
provided
by
the
State
of
Washington
for
the
Puget
Sound,
Strait
of
Juan
Ddel
Fuca,
and
the
Pacific
Ocean
embayments
shows
that
use
of
the
State's
14/
100
ml
fecal
coliform
criterion
is
as
protective
of
human
health
as
the
1986
bacteria
criteria
for
the
State
of
Washington.

In
the
proposed
rule,
EPA
solicited
comment
on
its
interpretation
that
Clean
Water
Act
section
303(
i)
requires
States
and
Territories
to
adopt
criteria
for
E.
coli
or
enterococci
to
comply
with
the
provisions
of
that
section.
Section
303(
i)(
1)(
A)
requires
that
States
and
Territories
submit
criteria
"...
for
the
pathogens
and
pathogen
indicators
for
which
the
Administrator
has
published
criteria
under
section
304(
a)."
EPA's
Ambient
Water
Quality
Criteria
for
Bacteria­

1986
is
considered
to
be
the
Clean
Water
Act
section
304(
a)
criteria
referred
to
in
Clean
Water
Act
section
303(
i)(
1)(
A).
The
Ambient
Water
Quality
Criteria
for
Bacteria
­
1986
strongly
recommended
the
use
of
E.
coli
and
enterococci
as
pathogen
indicators
for
fresh
waters
and
strongly
recommended
enterococci
for
marine
waters.

Clean
Water
Act
section
303(
i)(
2)(
A)
requires
EPA
to
propose
water
quality
standards
regulations
for
a
State
"[
i]
f
a
State
fails
to
adopt
water
quality
criteria
and
standards
.
.
.
that
are
Page
54
of
102
as
protective
of
human
health
as
the
criteria
for
pathogens
and
pathogen
indicators
for
coastal
recreation
waters
published
by
the
Administrator
.
.
.
"
(
emphasis
added).
EPA
solicited
comment
on
whether
section
303(
i)(
2)(
A)
could
be
read
to
require
that
EPA
need
only
promulgate
for
a
State
or
Territory
if
the
State
or
Territory
failed
to
adopt
any
criteria
(
not
necessarily
E.
coli
or
enterococci)
that
were
as
protective
of
human
health
as
EPA's
1986
bacteria
criteria.
In
other
words,
EPA
solicited
comment
on
whether
it
was
required
to
promulgate
E.
coli
or
enterococci
under
section
303(
i)(
2)(
A)
in
situations
where
a
State
or
Territory
adopted
a
low
fecal
coliform
criterion
for
protection
of
primary
contact
recreation
that
was
demonstrated
to
provide
protection
equal
to
the
protection
provided
by
EPA's
1986
bacteria
criteria.
EPA
has
reconsidered
its
interpretation
and
believes
that
there
is
some
ambiguity
in
section
303(
i)(
2)(
A)
and
that
given
this
ambiguity
that
it
should
interpret
section
303(
i)(
2)(
A)
in
this
manner
because
it
makes
public
policy
senseas
allowing
EPA
to
approve
standards
based
on
other
indicators
provided
they
are
as
protective
as
EPA's
1986
bacteria
criteria
because
this
approach
is
most
consistent
with
the
purposes
of
the
Clean
Water
Act.
Thus,
EPA
is
taking
the
position
that
EPA
is
not
required
to
promulgate
E.
coli
or
enterococci
criteria
if
a
State
demonstrates
that
other
criteria,
based
on
other
bacteria
indicators,
are
as
protective
of
human
health
as
EPA's
1986
bacteria
criteria.
That
is,
if
a
State
or
Territory
adopts
criteria,
even
though
they
are
not
for
E.
coli
or
enterococci,
if
those
criteriathat
are
demonstrated
to
be
as
protective
of
human
health
as
EPA's
1986
bacteria
criteria,
section
303(
i)(
2)(
A)
does
not
require
EPA
to
promulgate
criteria
for
E.
coli
or
enterococci.
Promulgation
of
criteria
for
E.
coli
or
enterococci
in
that
situation
would
not
provide
any
greater
level
of
public
health
protection.
Protection
of
public
health
was
Congress's
primary
intent
in
enacting
the
BEACH
Act.
Therefore,
if
a
State
or
Territory
can
show
that
in
waters
in
which
the
State
or
Territory
intends
to
protect
primary
contact
recreation
uses
with
its
Page
55
of
102
criteria
for
fecal
coliform,
that
such
uses
will
be
protected
at
a
level
equal
to
or
greater
than
the
protection
provided
by
EPA's
1986
bacteria
criteria
for
enterococci
and
E.
coli,
EPA
does
not
believe
Congress
intended
that
EPA
needs
to
promulgate
water
quality
criteria
for
pathogens
or
pathogen
indicators
for
those
waters
in
that
State
or
Territory
where
this
has
been
demonstrated.

The
facts
presented
by
the
Washington
Department
of
Ecology
highlight
the
reasonableness
of
this
interpretation.

In
addition,
EPA
considers
it
to
be
an
appropriate
exercise
of
Federal
discretion
to
take
this
approach
with
Washington
State.
Congress
intended
through
Clean
Water
Act
section
303(
c)

to
give
States
the
paramount
role
in
weighing
any
available
credible
information
for
establishing
water
quality
standards
that
are
protective
of
the
designated
uses
of
their
waters.
Congress
maintained
this
same
approach
in
Clean
Water
Act
section
303(
i)
by
giving
States
the
responsibility
to
adopt
water
quality
standards
for
protecting
human
health,
with
EPA's
role
being
to
promulgate
standards
for
those
States
that
had
not
adopted
standards
as
protective
of
human
health
as
the
1986
bacteria
criteria.
This
interpretation
is
supported
by
the
legislative
history
of
Clean
Water
Act
section
303(
i).
For
example,
S.
Rep.
No.
106­
366
states
in
the
section­

bysection
analysis
of
the
Act:

These
provisions
are
consistent
with
the
applicable
requirements
of
the
Clean
Water
Act
and
specifically
section
303(
c)
and
the
regulations
implementing
that
section.
States
must
incorporate
into
their
water
quality
standards,
water
quality
criteria
for
pathogens
and
pathogen
indicators
that
are
at
least
as
protective
of
human
health
as
criteria
EPA
publishes
under
section
304(
a).
The
State's
criteria
may
be
as
protective
as
those
of
EPA
without
being
numerically
equivalent.
However,
if
a
State
adopts
criteria
differing
from
those
published
by
EPA,
the
State
has
a
duty
to
defend
the
criteria
from
a
scientific
perspective.
EPA's
approval
or
disapproval
of
the
criteria
is
based
upon
the
information
provided
by
the
State.
(
S.
Rep.
No.
106­
366,
at
4
(
2000)).

EPA
believes
that
this
language
demonstrates
Congress's
intent
that
section
303(
i)
be
interpreted
Page
56
of
102
within
the
broader
context
of
section
303,
and
that
section
303(
i)
not
be
interpreted
to
preclude
a
State's
adopting
alternative
criteria
from
those
published
by
EPA
under
section
304(
a),
provided
that
the
State
demonstrates
(
and
EPA
agrees)
that
the
alternative
criteria
are
as
protective
of
human
health
as
EPA's
published
criteria.

H.
Rep.
No.
106­
98
has
similar
language
in
its
section­
by­
section
analysis
as
follows:

The
Committee
intends
that
the
legal
standard
for
determining
when
a
State
water
quality
standard
is
consistent
with
the
applicable
requirements
of
the
Clean
Water
Act
be
governed
by
the
existing
requirements
of
section
303(
c)
of
the
Clean
Water
Act,
and
the
regulations
implementing
that
section.
This
standard
has
been
interpreted
to
mean
that
State
water
quality
criteria
must
be
at
least
as
protective
of
human
health
as
EPA's
water
quality
criteria.
Thus,
a
State
must
incorporate
into
its
water
quality
standards
water
quality
criteria
for
pathogens
and
pathogen
indicators
that
are
at
least
as
protective
as
criteria
that
EPA
has
published
under
section
304(
a),
including
EPA's
1986
criteria
for
enterococcus
and
Escherichia
coli.
(
H.
Rep.
No.
106­
98,
at
8
(
1999)).

Here
again,
EPA
believes
Congress
is
clarifying
its
intent
that
State
criteria
to
be
approvable
under
section
303(
i),
must
be
at
least
as
protective
as
EPA's
1986
bacteria
criteria,
but
not
necessarily
the
same
as
the
1986
criteria.

With
respect
to
the
State
of
Washington,
EPA
looked
at
the
process
that
the
State
took
in
reviewing
its
fecal
coliform
standards
for
protecting
recreation
uses
in
marine
waters.
The
State
did
this
as
part
of
its
triennial
review
of
water
quality
standards.
The
State
undertook
a
multi­
year
process
starting
in
the
summer
of
1996
and
finishing
in
2003.
In
this
period,
the
State
convened
a
multi­
stakeholder
technical
workgroup
to
examine
the
technical
merits
of
the
State's
bacteria
criteria,
and
documented
the
technical
and
policy
issues
evaluated
by
the
work­
group
and
its
predecessor
(
see
http://
www.
ecy.
wa.
gov/
pubs/
0010072.
pdf).
The
State
used
this
information
to
focus
discussions
with
numerous
advisory
panels
both
internal
and
external
to
the
Washington
Department
of
Ecology.
The
State
held
a
formal
60­
day
public
review
and
comment
period
on
Page
57
of
102
proposed
revisions
to
its
water
quality
standards
(
including
adoption
of
EPA's
recommended
enterococci
criteria
for
Class
AA
and
Class
A
marine
waters),
and
as
part
of
the
public
notification
process,
directly
mailed
out
approximately
3320
announcements,
550
email
announcements,
and
621
CDs
to
potential
interested
citizens,
regulated
businesses,
governmental
officials,
and
every
city,
county,
and
Tribe
in
the
State.
The
State
conducted
eight
public
workshops
and
hearings
regarding
proposed
changes
to
its
standards
at
locations
across
the
State.

Finally,
the
State
made
all
documents
available
to
the
public
at
its
website
at
http://
www.
ecy.
wa.
gov/
programs/
wq/
swqs/
supporting_
docs/
supporting_
docs.
html.

Based
on
the
input
from
the
various
stakeholders
in
the
State
and
the
paired
monitoring
data
for
fecal
coliform
and
enterococci,
the
State
concluded
that
its
fecal
coliform
criteria
for
marine
waters
is
protective
of
the
recreation
use
in
these
waters,
and
also
is
at
least
as
protective
of
human
health
as
EPA's
1986
bacteria
criteria.
Many
stakeholders
in
Washington
share
this
conclusion,
as
expressed
in
the
public
comments
by
many
stakeholders
on
the
State's
proposed
water
quality
standards
(
see
http://
www.
ecy.
wa.
gov/
programs/
wq/
swqs/
supporting_
docs/
public_
comments.
html)
and
comments
by
a
Puget
Sound
public
interest
group
and
a
Northern
Pacific
Ocean
shellfish
group
on
EPA's
proposed
rule.
Given
this
conclusion,
the
State
and
some
stakeholders
were
concerned
that
the
State
adoption
of
the
enterococci
standard
and
the
attendant
new
monitoring
that
this
would
entail
would
limit
the
State's
ability
to
monitor
as
comprehensively
for
fecal
coliform
as
it
does
currently
and
thus
provide
the
maximum
assurance
that
its
waters
are
meeting
its
protective
14/
100
ml
fecal
coliform
standard.
However,
this
rule
does
not
require
monitoring.

As
discussed
previously
in
section
V.
A.
1
of
theis
preamble,
EPA
reviewed
the
State's
data
Page
58
of
102
and
determined
that
it
shows
that
the
State's
fecal
coliform
criterion
is
as
protective
as
the
1986
bacteria
criteria.
Accordingly,
EPA
considers
it
appropriate
and
consistent
with
Congressional
intent
to
exclude
Washington
from
today's
Federal
promulgation
because
the
State
has
fully
met
its
obligations
under
the
Clean
Water
Act
using
a
full
and
open
public
process
and
is
ensuring
protection
of
human
health
in
the
coastal
recreation
waters
of
Washington.

EPA
considers
its
analysis
of
the
data
provided
by
the
State
of
Washington
to
only
be
relevant
to
the
State's
waters.
EPA
does
not
agree
that
the
Washington
data
show
that
use
of
a
fecal
coliform
criterion
of
14/
100
ml
is
as
protective
of
human
health
as
the
1986
bacteria
criteria
for
any
other
coastal
recreation
waters
in
the
United
States
because
the
conditions
of
these
waters
inthe
Washington
State
waters
may
differ
from
thatwaters
of
other
watersStates.
The
relationship
between
fecal
coliform
and
enterococci
in
the
data
provided
by
the
Washington
Department
of
Ecology
is
an
empirical
relationship,
and
reflects
the
conditions
of
the
water
from
which
the
samples
were
collected.
EPA
cannot
determine
how
representative
iswithout
water­
specific
data
the
extent
to
which
the
Washington
State
waters
where
the
samples
were
collected
compared
toare
representative
of
other
waters
in
other
parts
of
the
United
States.
The
Washington
data
reflect
the
pathogen
sources
in
that
area,
the
local
rainfall
which
has
an
effect
on
pathogen
loadings,
the
tidal
flushing
in
the
waters,
and
the
temperature
of
the
waters.
No
other
comments
received
by
EPA
identified
the
type
and
amount
of
information
that
would
demonstrate
fecal
coliform
(
or
any
other
pathogen
indicator)
in
any
other
State
or
Territory
isFurther,
as
noted
above,
the
legislative
history
indicates
that
any
State
wishing
to
adopt
criteria
other
than
those
in
the
1986
bacteria
criteria
document,
"
has
a
duty
to
defend
the
criteria
from
a
scientific
perspective"
and
specifically
to
demonstrate
that
they
are
as
protective
of
human
health
as
Page
59
of
102
theEPA's
1986
bacteria
criteria.

No
other
comments
received
by
EPA
included
the
type
and
amount
of
information
that
EPA
views
as
necessary
to
demonstrate
that
fecal
coliform
criteria
(
or
any
other
pathogen
indicator)
in
any
other
State
or
Territory
are
as
protective
of
human
health
as
the
1986
bacteria
criteria.
However,
if
following
promulgation
of
this
rule,
some
other
State
or
Territory
provides
data
to
EPA
sufficient
to
make
this
demonstration,
EPA
will
approve
such
other
criteria
as
meeting
the
requirements
of
section
303(
i)
and
withdraw
today's
Federal
criteria
from
that
State's
coastal
recreation
waters.
EPA
cautions,
however,
that
given
the
focus
of
the
BEACH
Act
on
the
specific
indicators
in
EPA's
1986
bacteria
criteria
document,
there
is
a
substantial
burden
of
proof
for
States
wishing
to
adopt
criteria
based
on
alternative
indicators.
EPA
believes
that
both
the
process
and
quantity
of
information
and
data
provided
by
Washington
State
in
making
this
determination
may
provide
guidance
to
any
other
State
that
wished
to
make
a
similar
showing.

2.
Are
the
standards
for
E.
coli
and
enterococci
derived
from
a
scientifically­
defensible
methodology
that
links
them
quantitatively
to
an
acceptable
risk
level
under
Clean
Water
Act
section
303(
i)?

As
discussed
in
section
IV.
B.
2
of
the
preamble
to
today's
rule,
EPA
is
promulgating
water
quality
criteria
that
correspond
to
an
illness
rate
of
0.8%
for
swimmers
in
freshwater
and
1.9%
for
swimmers
in
marine
waters.
In
deciding
which
States
and
Territories
have
already
adopted
water
quality
criteria
as
protective
of
human
health
as
these
criteria,
EPA
considered
an
illness
rate
of
1.0%
of
swimmers
to
be
as
protective
as
the
1986
bacteria
criteria
in
determining
whether
to
include
a
State
or
Territory
in
the
rule.
EPA
explained
its
reasons
for
this
consideration
in
the
proposed
rule
(
69
FR
41724­
41725).
EPA
would
consider
State
or
Territorial
bacterial
criteria
Page
60
of
102
for
fresh
coastal
recreation
waters
to
not
be
as
protective
of
human
health
if
the
risk
level
of
the
criteria
was
above
1.0%.

Some
commenters
addressed
this
topic.
Of
these,
a
majority
agreed
with
EPA
that
a
1.0%

illness
rate
in
swimmers
in
freshwater
is
as
protective
of
human
health
as
the
1986
bacteria
criteria
for
different
reasons.
One
commenter
said
that
a
1.0%
illness
rate
would
result
in
only
a
small
increase
in
risk
of
illness
and
that
would
still
be
below
the
risk
of
illness
in
marine
waters.

Another
commenter
stated
that
the
difference
between
0.8%
and
1.0%
was
well
within
the
inherent
variability
in
the
criteria.
One
commenter
expressed
support
for
the
1.0%
risk
level
but
only
if
EPA
had
examined
and
analyzed
all
available
updated
epidemiological
data
in
identifying
an
acceptable
risk
level.
As
explained
in
the
proposal
(
69
FR
41724­
41725),
EPA
conducted
an
external
peer
review
of
EPA's
analysis
of
the
epidemiological
data
from
EPA's
bacteriological
studies
on
which
the
1986
bacteria
criteria
document
is
based.

Of
the
commenters
who
did
not
agree
that
the
1.0%
illness
rate
was
as
protective
of
human
health
of
the
1986
bacteria
criteria,
most
argued
that
there
is
no
logical
reason
to
allow
for
different
acceptable
illness
rates
in
marine
and
freshwater.
One
commenter
said
that
the
increase
from
0.8%
to
1.0%
in
freshwater
would
increase
the
incidence
of
gastrointestinal
illness
by
25%.

Three
commenters
believed
that
the
illness
rate
for
freshwater
should
be
0.8%,
while
one
commenter
felt
that
EPA
should
promulgate
additional
geometric
mean
and
single
sample
maximum
values
relative
to
other
risk
levels.
EPA
disagrees
that
it
should
only
consider
an
illness
rate
of
0.8%
to
be
as
protective
of
human
health
as
the
1986
bacteria
criteria
document.
To
do
so
would
suggest
that
there
is
significant
uncertainty
in
the
incremental
health
protection
provided
by
small
changes
in
the
stringency
of
the
criteria
below
the
1.0%
level.
More
importantly,
aAs
Page
61
of
102
explained
in
the
proposal,
EPA
does
not
see
any
a
priori
reason
to
require
a
greater
level
of
protection
for
freshwaters
than
for
marine
waters,
which
account
for
the
vast
majority
of
swimming
days
in
coastal
recreation
waters
subject
to
section
303(
i)
of
the
Clean
Water
Act.
See
the
proposed
rule
(
69
FR
41724)
for
further
discussion
of
EPA's
reasoning.

3.
Do
the
standards
include
appropriate
single
sample
maximums
for
all
coastal
recreation
waters?

As
discussed
in
sections
IV.
B.
3
and
IV.
B.
4
of
the
preamble
to
today's
rule,
EPA
is
promulgating
water
quality
criteria
that
include
separate
single
sample
maximums
for
four
categories
of
waters
based
on
intensity
of
use,
which
allows
the
State
or
Territory
to
assign
waters
to
the
four
use
intensity
categories.
In
determining
whether
existing
State
or
Territorial
water
quality
standards
for
coastal
recreation
waters
are
as
protective
of
human
health
as
EPA's
1986
bacteria
criteria,
EPA
determined
whether
the
water
quality
standards
include
a
single
sample
maximum
for
all
coastal
recreation
waters
and
if
designated
bathing
beaches
have
a
single
sample
maximum
based
on
at
least
the
75%
confidence
level.
EPA
considers
this
approach
to
be
as
protective
as
the
1986
bacteria
criteria
and
also
consistent
with
the
criteria
as
discussed
in
section
IV.
B
of
the
preamble
to
today's
rule.
EPA
included
in
the
rule
any
State
or
Territory
that
does
not
cover
all
coastal
recreation
waters
with
a
single
sample
maximum
and
that
for
designated
bathing
beaches
does
not
have
a
single
sample
maximum
based
on
at
least
the
75%
confidence
level.
EPA
does
not
expect
a
State
or
Territory
to
use
all
four
of
the
use
categories
identified
in
the
criteria
document
for
its
standards
to
be
at
least
as
protective
as
the
1986
bacteria
criteria.

For
example,
a
State
that
applied
the
75%
confidence
based
maximum
to
all
waters
would
clearly
be
as
protective
as
the
1986
bacteria
criteria,
even
though
it
would
only
have
a
single
use
Page
62
of
102
category.

Most
commenters
agreed
with
this
approach.
Those
that
disagreed
with
it
commented
that
the
single
sample
maximum
should
not
be
a
part
of
the
water
quality
criteria
but
rather
available
for
use
as
an
implementation
tool
for
monitoring
at
beaches.
EPA
addressed
these
comments
in
sections
IV.
B.
3
and
IV.
B.
4
of
today's
preamble.

EPA
notes
that
all
of
the
35
coastal
and
Great
Lakes
States
and
Territories
have
identified
coastal
recreation
waters
where
there
are
beaches
or
similar
points
of
access
(
National
List
of
Beaches,
EPA­
823­
R­
04­
004,
69
FR
24597,
May
4,
2004).
Also,
all
35
of
these
States
and
Territories
have
received
Clean
Water
Act
section
406
grants
since
2002
for
monitoring
and
notification
of
beach
advisories
or
closures
at
beaches
adjacent
to
coastal
recreation
waters.

Today's
rule
specifies
that
the
highest
use
category
with
a
single
sample
maximum
based
on
the
75%
confidence
level
applies
to
all
beaches
meeting
the
definition
of
designated
bathing
beaches
in
40
CFR
131.41(
b)(
2)
(".
.
.
coastal
recreation
waters
that,
during
the
recreation
season
are
heavily­
used
(
based
upon
a
comparison
an
evaluation
of
use
within
the
State)
and
may
have:
a
lifeguard,
bathhouse
facilities,
or
public
parking
for
beach
access")
with
a
single
sample
maximum
based
on
the
75%
confidence
level,
and
that
the
other
use
categories
apply
to
lower
use
waters
accordingly.
Based
on
the
applications
for
Clean
Water
Act
section
406
grants,
EPA
expects
that
many
coastal
and
Great
Lakes
States
will
have
at
least
some
beaches
in
the
higher
use
categories.

4.
Do
the
standards
exempt
fecal
contamination
from
non­
human
sources?

For
the
reasons
discussed
in
section
IV.
B.
7
of
the
preamble
to
today's
rule,
EPA
is
promulgating
the
exemption
for
non­
human
sources
expressed
in
the
1986
bacteria
criteria
document.
EPA
is
including
in
today's
rule
those
States
and
Territories
for
which
the
criteria
Page
63
of
102
include
exemptions
for
non­
human
sources
that
are
inconsistent
with
the
exemption
provision
in
the
criteria
document,
as
promulgated
in
today's
final
rule.
EPA
addressed
comments
on
this
issue
in
section
IV.
B.
7
of
the
preamble
to
this
rule.

5.
Has
EPA
approved
the
standards?

Under
section
303(
i)(
1)(
A)
of
the
Clean
Water
Act,
States
and
Territories
must
adopt
water
quality
standards
as
protective
of
human
health
as
EPA's
1986
bacteria
criteria.
Moreover,

under
40
CFR
131.21,
EPA
must
approve
State
or
Territorial
water
quality
standards
adopted
after
May
30,
2000,
in
order
for
those
standards
to
be
in
effect
for
Clean
Water
Act
purposes.

Therefore,
EPA
must
have
approved
State
and
Territorial
standards
for
enterococci
or
E.
coli
adopted
after
May
30,
2000,
as
consistent
with
Clean
Water
Act
section
303(
i)
in
order
for
EPA
to
exclude
the
State
or
Territory
from
the
final
rule.
State
and
Territorial
standards
adopted
prior
to
May
30,
2000,
that
are
consistent
with
Clean
Water
Act
section
303(
i)
are
in
effect
for
Clean
Water
Act
purposes
even
without
explicit
EPA
approval.

B.
Which
States
and
Territories
are
Included
in
Today's
Rule?

The
proposed
rule
contains
a
State­
by­
State
summary
of
the
status
of
each
State
or
Territory
(
69
FR
41731­
41735).
EPA
did
not
include
any
Tribes
in
the
proposal
because
although
there
are
Federally­
recognized
Tribes
located
next
to
either
coastal
or
Great
Lakes
waters,
none
of
those
Tribes
have
coastal
recreation
waters
as
defined
in
40
CFR
131.41(
b)(
1).

(
See
69
FR
41735.)

Today,
EPA
is
promulgating
a
rule
that
is
identical
with
respect
to
the
water
quality
criteria
values
to
what
EPA
proposed.
While
there
were
some
changes
in
other
provisions
of
the
rule,
none
of
these
affected
EPA's
determination
with
regard
to
specific
States.
Therefore,
EPA
Page
64
of
102
is
not
excluding
any
other
States
from
the
final
rule
based
on
changes
in
the
provisions
of
the
final
rule.

Table
4
contains
a
summary
of
the
status
of
each
of
the
35
States
and
Territories
under
today's
rule.
EPA
considered
three
possible
reasons
for
a
change
in
a
State's
or
Territory's
status
from
that
described
in
the
proposal:
1)
since
the
publication
of
the
proposed
rule,
the
State
or
Territory
may
have
adopted
(
and
EPA
approved)
water
quality
standards
that
are
as
protective
of
human
health
as
the
1986
bacteria
criteria;
2)
the
State's
or
Territory's
water
quality
standards
may
now
be
viewed
as
being
as
protective
of
human
health
in
light
of
EPA's
final
decision
with
respect
to
the
application
of
the
single
sample
maximum
in
the
final
rule;
and
3)
new
information
submitted
following
publication
of
the
proposal
may
have
caused
EPA
to
reassess
its
previous
determination.
During
the
period
between
publication
of
the
proposal
and
the
final
rule,
four
States
 
Delaware,
Hawaii,
Maryland,
and
South
Carolina
 
and
the
Commonwealth
of
the
Northern
Mariana
Islands
adopted
revised
water
quality
criteria
for
pathogens.
In
addition,
the
State
of
Washington
provided
information
forthat
caused
EPA
to
consider
to
determinereassess
its
determination
as
to
whether
the
State's
fecal
coliform
criterion
of
14/
100
ml
is
as
protective
of
human
health
as
the
1986
bacteria
criteria.
Below,
EPA
describes
the
status
of
these
States
and
Territory
and
provides
an
update
on
the
status
of
several
other
States
working
to
adopt
water
quality
standards,
as
described
in
the
preamble
to
the
proposed
rule.

Table
4:
Categorization
of
35
States/
Territories
With
Coastal
Recreation
Waters
Not
Subject
to
40
CFR
131.41
Subject
to
40
CFR
131.41
Alabama
Alaska
American
Samoa
California
Connecticut
Florida
Guam
Delaware
(
1)
Georgia
Page
65
of
102
DelawareGuam
Hawaii
Indiana
Illinois
Michigan
Louisiana
New
Hampshire
Maine
New
Jersey
Maryland
Northern
Mariana
Islands
(
1)
Massachusetts
South
Carolina
(
1)
Minnesota
Texas
Mississippi
Virginia
New
York
Washington
(
1)
North
Carolina
Ohio
Oregon
Pennsylvania
Puerto
Rico
Rhode
Island
Virgin
Islands
Wisconsin
(
1)
These
States
were
removed
from
40
CFR
131.41
following
publication
of
the
proposed
rule.

Commonwealth
of
the
Northern
Mariana
Islands
The
Attorney
General
for
the
Commonwealth
of
the
Northern
Mariana
Islands
certified
the
adoption
of
revisions
to
their
water
quality
standards
on
September
30,
2004.
These
revisions
add
single
sample
maximum
standards
of
104/
100
ml
for
Class
AA
waters
and
276/
100
ml
for
Class
A
waters
in
the
Commonwealth
of
the
Northern
Mariana
Islands.
Along
with
the
bacteria
standards
that
Commonwealth
of
the
Northern
Mariana
Islands
adopted
and
EPA
approved
in
1997,
the
revised
standards
will
fully
satisfy
the
requirements
of
the
Clean
Water
Act.
On
October
28,
2004,
EPA
approved
the
revised
standards
and
the
Commonwealth
of
the
Northern
Mariana
Islands
is
not
included
in
the
rule.

Delaware
On
September
17,
2004,
Delaware
submitted
to
EPA
newly
adopted
criteria
for
all
its
coastal
recreation
waters.
The
State's
criteria
specify
a
geometric
mean
of
35/
100
ml
and
a
single
Page
66
of
102
sample
maximum
of
104/
100
ml
for
enterococci
for
all
primary
contact
recreation
marine
waters.

Delaware's
regulations
also
limit
the
application
of
the
criteria
when
the
bacteria
comes
from
wildlife
sources.
The
State
has
submitted
documentation
to
EPA
in
support
of
its
source
tracking
methodology
for
bacteria,
together
with
epidemiological
work
on
illness
rates
from
bacteria
of
wildlife
origin.
The
State
uses
the
source
information
to
apply
a
factor
to
bacteria
from
wildlife
sources
that
accounts
for
illness
risk
from
such
bacteria.
EPA
reviewed
the
submitted
criteria
in
accordance
with
this
rule
and
on
[
DATE]
November
4,
2004,
approved
the
specific
numeric
criteria
as
meeting
the
requirements
of
both
sections
303(
c)
and
303(
i)
of
the
Clean
Water
Act.

EPA
is
discussing
the
State's
methodology
for
source
tracking
with
the
State
and
is
reviewing
it
to
determine
whether
it
meets
the
requirements
of
the
Clean
Water
Act
and
this
rule.
Until
EPA
approves
this
limitation,
for
purposes
of
the
Clean
Water
Act,
Delaware's
bacteria
criteria
for
primary
contact
recreation
apply
to
enterococci
bacteria
regardless
of
the
source.
As
a
result,

Delaware
is
not
included
in
today's
rule.

Hawaii
On
September
21,
2004,
Hawaii
adopted
bacteria
criteria
for
its
coastal
estuaries,
and
a
single
sample
maximum
for
coastal
waters
within
300
meters
(
1000
feet)
of
the
shore.
The
criteria
are
for
enterococci
and
have
a
geometric
mean
of
33/
100
ml
and
a
single
sample
maximum
of
89/
100
ml
in
coastal
estuaries.
These
newly
adopted
criteria
also
contain
a
single
sample
maximum
of
100/
100
ml
in
coastal
waters
within
300
meters
from
shore
to
complement
the
existing
geometric
mean
for
coastal
waters.
On
October
28,
2004,
EPA
approved
these
criteria.
However,
Hawaii
still
has
no
numeric
criteria
protecting
State
waters
beyond
300
meters
from
shore,
although
these
waters
are
designated
for
recreation
in
the
State's
water
quality
Page
67
of
102
standards.
Therefore,
EPA
is
including
Hawaii
in
this
rule
but
only
for
the
lack
of
criteria
in
State
waters
beyond
300
meters
from
shore.

Maryland
On
July
5,
2004,
Maryland
adopted
new
criteria
for
all
its
coastal
recreation
waters.

These
criteria
specify
a
geometric
mean
of
35/
100
ml
enterococci
for
all
recreation
waters
and
at
least
a
single
sample
maximum
of
104/
100
ml
for
those
waters
that
are
designated
natural
bathing
areas
under
the
State
regulations.
EPA
is
reviewing
these
criteria
in
accordance
with
this
rule
and
is
consulting
with
the
State
regarding
the
intent
and
meaning
of
the
State
regulations.
EPA
and
Maryland
have
not
concluded
discussions
of
the
applicability
of
the
State
criteria.
Because
Maryland
does
not
yet
have
approved
criteria,
EPA
is
including
Maryland
in
this
rule.
If
EPA
determines
that
Maryland's
standards
comply
with
Clean
Water
Act
303(
i),
they
will
become
immediately
effective
for
Clean
Water
Act
purposes,
as
specified
in
40
CFR
131.41(
d)(
1).

South
Carolina
On
June
25,
2004,
South
Carolina
adopted
criteria
for
all
of
its
coastal
recreation
waters
consistent
with
EPA's
1986
bacteria
criteria.
The
criteria
are
for
enterococci
and
have
a
geometric
mean
of
35/
100
ml,
a
single
sample
maximum
of
104/
100ml
for
coastal
waters
designated
by
South
Carolina
as
Classes
SFH
(
Shellfish
Harvesting)
and
SA,
and
a
single
sample
maximum
of
501/
100ml
for
coastal
waters
designated
by
South
Carolina
as
Class
SB.
However,

the
South
Carolina
water
quality
standard
delays
the
applicability
of
the
enterococci
criteria
for
permit
effluent
limits
until
such
time
that
EPA
publishes
analytical
methods
for
enterococci
in
effluents.
On
October
7,
2004,
EPA
disapproved
part
of
the
South
Carolina
standards
and
approved
the
remainder
of
the
standards
that
pertain
to
pathogens
and
pathogen
indicators.
EPA
Page
68
of
102
considers
the
approved
water
quality
standards
to
be
as
protective
of
human
health
as
EPA's
1986
bacteria
criteria,
and
South
Carolina
is
not
included
in
the
rule.

Washington
The
Washington
Department
of
Ecology
submitted
data
consisting
of
paired
samples
of
fecal
coliform
and
enterococci
measurements
collected
in
Puget
Sound,
the
Strait
of
Juan
Ddel
Fuca,
and
the
Pacific
Ocean
embayments.
The
Department
of
Ecology
considers
this
information
as
sufficient
to
demonstrate
that
use
of
the
State's
fecal
coliform
criterion
of
14/
100
ml
ensures
that
enterococci
concentrations
are
below
the
1986
bacteria
criteria,
and
requested
that
EPA
consider
the
State's
fecal
coliform
criterion
to
be
as
protective
of
human
health
as
the
1986
bacteria
criteria.
As
discussed
in
section
V.
A.
1
of
the
preamble,
EPA
reviewed
these
data
and
has
determined
that
the
Washington
fecal
coliform
criterion
of
14/
100
ml
is
as
protective
of
human
health
as
the
1986
bacteria
criteria.
The
Washington
fecal
coliform
criterion
applies
to
all
marine
waters
with
primary
contact
recreation
use,
and
thus
applies
to
all
coastal
recreation
waters.

Therefore,
Washington
is
not
included
in
the
rule.

Text
Was
Moved
From
Here:
1
Maine
EPA
is
also
making
a
minor
change
with
respect
to
including
Maine
in
today's
final
rule.

As
explained
in
the
preamble
to
the
proposal
(
69
FR
41733),
EPA
intended
to
exclude
Maine's
Class
SA
waters
from
coverage
under
the
rule;
however,
EPA
failed
to
list
Maine's
Class
SA
waters
as
excluded
in
the
regulatory
text
of
40
CFR
131.41(
e)(
2).
EPA
has
corrected
this
Page
69
of
102
omission
in
today's
final
rule.

Text
Moved
Here:
1
Other
States
EPA
identified
two
other
States
or
Territories
that,
at
the
time
of
proposal,
intended
to
adopt
EPA's
1986
bacteria
criteria
by
September
30,
2004.
These
were
Illinois
and
the
Virgin
Islands.
However,
neither
Illinois
nor
the
Virgin
Islands
adopted
the
criteria
and
received
EPA
approval
as
of
the
signature
of
today's
rule.

End
Of
Moved
Text
C.
Under
What
Conditions
Will
States
and
Territories
Be
Removed
from
Today's
Rule?

State
and
Territorial
standards
for
bacteria
approved
by
EPA
pursuant
to
Clean
Water
Act
sections
303(
c)
and
303(
i)
will
be
in
effect
for
Clean
Water
Act
purposes,
and
the
Federal
criteria
for
40
CFR
131.41
will
no
longer
apply.
EPA
recognizes
that
once
it
approves
the
water
quality
standards
of
the
State
or
Territory,
the
Code
of
Federal
Regulations
will
still
include
a
reference
to
the
State
in
40
CFR
131.41
until
EPA
formally
withdraws
the
State
or
Territory
from
the
Federal
rule,
and
thereby
the
Code
of
Federal
Regulations.
However,
the
State
and
Territorial
standards
for
bacteria
approved
by
EPA
pursuant
to
Clean
Water
Act
sections
303(
c)
and
303(
i)

will
be
in
effect
for
Clean
Water
Act
purposes
(
and
not
the
Federal
criteria
at
40
CFR
131.41)

between
the
time
EPA
approves
the
State
standards
and
formal
withdrawal
of
the
State
or
Territory
from
the
rule.
Page
70
of
102
A
State
or
Territory
may
adopt
and
submit
partial
water
quality
standards
for
EPA's
review
and
approval
under
today's
rule.
EPA
envisions
two
types
of
partial
water
quality
standards
submittals
with
different
results.
If
a
State
adopts
and
submits
water
quality
standards
that
meet
all
the
requirements
discussed
in
today's
rule
but
the
standards
apply
only
to
a
portion
of
the
State's
coastal
recreation
waters,
EPA
expects
to
approve
the
State
standards
for
the
coastal
recreation
waters
to
which
they
apply,
and
today's
Federal
standards
would
continue
to
apply
to
all
coastal
recreation
waters
that
are
not
addressed
in
the
submittal.
The
combination
of
the
approved
State
and
Federal
standards
serve
to
meet
the
requirements
of
Clean
Water
Act
section
303(
i).
If
a
State
adopts
and
submits
standards
for
all
of
its
coastal
recreation
waters
but
the
standards
do
not
satisfy
all
of
the
considerations
described
in
today's
rule
as
necessary
for
EPA
to
make
a
determination
that
the
State
standards
are
as
protective
of
human
health
as
the
1986
bacteria
criteria,
EPA
expects
to
disapprove
the
entire
the
submittal
and
today's
Federal
standards
would
continue
to
apply
to
the
State's
coastal
recreation
waters.
For
example,
a
State
maymight
adopt
water
quality
standards
that
contain
only
a
geometric
mean
for
marine
waters
of
35/
100
ml
for
enterococci
and
not
a
single
sample
maximum
provision.
This
would
not
be
sufficient
to
satisfy
section
303(
i).
EPA
anticipates
that
it
would
be
administratively
unworkable
to
approve
State
standards
in
piecemeal
fashion
and
to
supplement
piecemeal
State
standards
with
components
of
today's
rule,
as
in
the
example
of
a
State
that
hasadopts
a
State
geometric
mean
andbut
must
still
retain
a
Federal
single
sample
maximum
for
its
coastal
recreation
waters.

VI.
Response
to
Additional
Significant
Public
Comments
EPA
has
prepared
a
Comment
Response
Document,
which
addresses
the
comments
that
EPA
received
and
is
included
in
the
docket
for
today's
rule.
Below,
EPA
provides
a
summary
of
Page
71
of
102
its
responses
to
four
additional
categories
of
significant
comments.

A.
1986
Bacteria
Criteria
Some
commenters
raised
concerns
about
EPA's
1986
bacteria
criteria.
The
bulk
of
the
comments
questioned
the
reliability
of
the
studies
on
which
EPA
based
the
criteria.
Some
remarked
that
the
studies
evaluated
in
the
criteria
document
did
not
appropriately
select
test
sites
because
the
test
sites
were
all
located
on
the
East
Coast
and
therefore
may
not
represent
conditions
on
the
West
Coast;
the
test
sites
had
only
one
source
of
pollution
(
human);
and
no
control
sites
were
used.
In
addition,
commenters
characterized
the
data
as
anecdotal
rather
than
clinical
in
nature
(
e.
g.,
blood
and
stool
samples)
and
suggested
that
the
studies
did
not
ensure
that
the
reported
illnesses
were
due
to
pathogens
relating
to
bathing
in
the
water.
Others
questioned
EPA's
chosen
risk
levels.
One
commenter
suggested
other
possible
indicators.
Others
commented
on
the
lack
of
EPA
follow­
up
epidemiological
studies
since
1986.

EPA
acknowledges
these
comments,
but
notes
that
Clean
Water
Act
section
303(
i)

requires
States
and
Territories
with
coastal
recreation
waters
to
adopt
water
quality
criteria
for
bacteria
as
protective
of
human
health
as
the
criteria
published
by
EPA
under
Clean
Water
Act
section
304(
a).
Section
303(
i)
was
added
to
the
Clean
Water
Act
in
2000
by
the
BEACH
Act.

At
the
time
the
BEACH
Act
was
enacted,
the
current
Clean
Water
Act
section
304(
a)
criteria
were
EPA's
1986
bacteria
criteria
because
that
isthese
are
EPA's
only
currently
recommended
bacteria
criteria
for
protection
of
primary
contact
recreation
waters.
The
legislative
history
makes
it
clear
that
Congress
recognized
that
EPA's
1986
bacteria
criteria
have
flaws,
but
also
that
Congress
wanted
States
to
adopt
standards
based
on
them
by
April
10,
2004,
despite
those
flaws,

presumably
because
Congress
thought
the
1986
bacteria
criteria
are
better
than
what
it
Page
72
of
102
characterized
as
"
outdated"
criteria
used
by
some
States.
(
See
H.
Rep.
No.
106­
98,
at
6
(
1999);

see
generally
S.
Rep.
No.
106­
366
(
2000)
and
H.
Rep.
No.
106­
98.)

EPA
had
reviewed
its
original
studies
supporting
its
recommended
1986
water
quality
criteria
for
bacteria
and
the
literature
on
human
health
research
conducted
since
EPA
completed
the
original
studies
of
health
effects
associated
with
swimming
in
marine
and
freshwater,
as
discussed
in
on
pages
10­
13
of
the
Implementation
Guidance
for
Ambient
Water
Quality
Criteria
for
Bacteria
(
EPA­
823­
B­
02­
003,
May
2002
Draft)
.
Based
on
these
reviews,
EPA
has
confirmed
that
the
1986
EPA
recommended
water
quality
criteria
for
bacteria
are
protective
of
human
health
against
acute
gastrointestinal
illness.

The
epidemiological
studies
used
to
develop
the
criteria
were
themselves
peer
reviewed.

The
marine
studies
were
peer
reviewed
in
the
Journal
of
the
American
Public
Health
Association.

EPA's
Office
of
Research
and
Development
reviewed
the
freshwater
studies.
The
Harvard
School
of
Public
Health
evaluated
the
epidemiology
test
protocol
for
both
fresh
and
marine
studies,
and
the
University
of
Pittsburgh
Center
for
Excellence
provided
an
independent
review
of
the
results
of
the
epidemiology
studies.
Finally,
the
1986
bacteria
criteria
were
reviewed
by
the
public
when
EPA
published
a
Federal
Register
notice
concerning
the
criteria
(
49
FR
21987,
May
24,
1984).

While
Congress
directed
in
Clean
Water
Act
section
303(
i)
that,
by
April
9,
2004,
States
and
Territories
adopt
criteria
as
protective
as
EPA's
current
criteria,
Congress
also
recognized
that
"
EPA's
1986
criteria
need
to
be
updated
to
improve
the
scientific
basis
for
identifying
pathogens
in
coastal
waters."
S.
Rep.
No.
106­
366,
at
2.
To
address
this
concern,
Congress
amended
Clean
Water
Act
section
304(
a)
to
require
EPA
to
"
publish
[
within
five
years
of
Page
73
of
102
enactment
of
the
BEACH
Act]
new
or
revised
water
quality
criteria
for
pathogens
and
pathogen
indicators
(
including
a
revised
list
of
testing
methods,
as
appropriate),
based
on
the
results
of
the
studies
conducted
.
.
.
for
the
purpose
of
protecting
human
health
in
coastal
recreation
waters."

See
Clean
Water
Act
section
304(
a)(
9).
Thus,
while
Congress
recognized
that
the
1986
bacteria
criteria
need
improvement,
Congress
still
required
States
and
Territories
to
adopt
water
quality
standards
as
protective
of
human
health
as
the
1986
bacteria
criteria.
EPA
is
currently
conducting
epidemiological
studies
on
potential
health
risks
resulting
from
exposure
to
pathogens
or
pathogen
indicators
in
coastal
recreation
waters,
as
required
under
this
section
of
the
Clean
Water
Act.
Once
EPA
publishes
these
new
criteria,
EPA
expects
that
States
and
Territories
will
begin
to
adopt
water
quality
standards
as
protective
of
human
health
as
the
new
criteria
for
coastal
and
Great
Lakes
recreation
waters,
as
required
by
Clean
Water
Act
section
303(
i)(
1)(
B).

B.
Economics
Some
commenters
noted
that,
if
the
rule
imposes
single
sample
maximums
as
"
not­
to­

beexceeded
values,
the
geometric
mean
component
of
the
criteria
would
be
significantly
different
from
the
geometric
mean
values
in
most
State
current
fecal
coliform
bacteria
criteria
for
recreation.
For
fecal
coliform
criteria
to
protect
recreational
uses,
most
State
criteria
include
a
geometric
mean
value
and
a
threshold
value
not
to
be
exceeded
in
more
than
10%
of
the
samples.

Some
commenters
state
that
there
will
be
a
substantially
largesubstantial
cost
difference
to
regulated
entities
if
the
rule
imposes
single
sample
maximums
for
E.
coli
or
enterococci
as
"

notto
be
exceeded"
values,
noting
that
EPA's
economic
analysis
in
the
proposal
does
not
address
the
cost
of
controlling
discharges
from
combined
sewer
overflows,
sanitary
sewer
overflows,
and
municipal
separate
storm
sewer
systems
to
meet
such
single
sample
maximums,
and
that
EPA's
Page
74
of
102
cost
estimates
for
controlling
these
sources
in
other
regulatory
and
policy
actions
are
not
based
on
a
single
sample
maximum
as
a
never­
to­
be
exceeded
criterion
for
Clean
Water
Act
purposes.

Today's
rule
does
not
treat
single
sample
maximums
as
a
requirement
that
may
never
be
exceeded
in
all
instances.
Single
sample
maximums
are
values
that
indicate,
with
a
certain
degree
of
confidence,
that
a
waterbody
may
exceed
the
geometric
mean.
The
State
can
collect
additional
data
on
a
receiving
water
if
it
believes
that
the
violation
of
the
single
sample
maximum
does
not
indicate
violation
of
the
geometric
mean,
as
described
in
the
preamble
to
today's
rule.

For
its
economic
analysis,
EPA
evaluated
the
potential
controls
for
publicly
owned
treatment
plants
and
industrial
facilities
likely
to
discharge
bacteria
to
meet
permit
limits
based
on
the
single
sample
maximums
as
never­
to­
be
exceeded
values
to
provide
a
conservatively
high
estimate
of
cost.
In
reality,
States
and
Territories
have
flexibility
in
implementing
the
criteria
in
National
Pollutant
Discharge
Elimination
System
permits.
EPA
also
assumed
that
none
of
the
States
covered
by
the
rule
had
adopted
E.
coli
or
enterococci
as
the
applicable
water
quality
standard
whereas
several
of
the
States
in
today's
rule
have
water
quality
standards
for
E.
coli
or
enterococci
already
in
place
for
some
of
their
coastal
recreation
waters.
This
also
led
to
a
higher
estimate
of
cost
than
may
actually
be
incurred.
EPA
addresses
discharges
of
bacteria
from
municipal
separate
storm
sewers,
combined
sewer
overflows,
sanitary
sewer
overflows,
and
nonpoint
sources
(
e.
g.,
agriculture)
to
coastal
waters
in
existing
regulations
and
policies,
and
has
tallied
potential
control
costs
to
comply
with
those
regulations
and
policies
as
part
of
analyses
for
those
actions.
In
general,
the
best
management
practices
or
treatment
controls
for
wet
weather
discharges
that
are
designed
to
meet
fecal
coliform
standards
in
a
waterbody
are
also
the
best
management
practices
or
treatment
controls
used
to
address
E.
coli
and
enterococci.
Because
of
Page
75
of
102
the
substantial
variability
in
bacterial
indicators
and
the
site­
specific
effectiveness
of
control
measures,
EPA
is
not
able
to
determine
at
this
time
if
additional
measures
will
ultimately
be
necessary
to
meet
criteria
based
on
the
new
indicators.
Compliance
with
pathogen
standards
is
best
achieved
through
an
adaptive
management
approach
based
on
cost­
effective
management
practices
and
control
measures
coupled
with
on­
going
monitoring
and
revision
of
control
plans
as
necessary.

C.
Analytical
Methods
EPA
received
a
few
comments
on
the
topic
of
analytical
methods.
One
commenter
expressed
concern
that
EPA
has
not
published
EPA­
approved
analytical
methods
for
measuring
enterococci
and
E.
coli
in
effluent.
EPA
recognizes
that
it
has
not
yet
published
analytical
methods
for
measuring
enterococci
and
E.
coli
in
effluents.
EPA
published
its
methods
for
measuring
enterococci
and
E.
coli
in
ambient
waters
on
July
21,
2003,
and
is
now
in
the
process
of
proposing
methods
for
measuring
these
pathogen
indicators
in
effluent.
EPA
has
completed
its
inter­
laboratory
study
of
method
1600
for
enterococci
and
method
1603
for
E.
coli
in
secondary
treated
effluents,
and
has
determined
that
the
variability
found
in
this
study
support
publication
of
a
proposed
method
for
effluents.
EPA
is
moving
expeditiously
to
promulgate
these
methods.

Three
commenters
noted
that
the
inter­
laboratory
study
for
enterococci
and
E.
coli
methods
discussed
above
did
not
address
pulp
and
paper
effluents,
and
that
these
effluents
are
suspected
of
containing
E.
coli
and
enterococci
independent
of
fecal
matter.
As
a
result,
the
commenters
suggest
that
EPA
complete
validation
studies
of
enterococci
and
E.
coli
methods
for
pulp
and
paper
effluents
before
requiring
States
to
implement
the
criteria
in
National
Pollutant
Discharge
Elimination
System
permits
for
pulp
and
paper
facilities.
EPA
disagrees
that
it
must
Page
76
of
102
complete
additional
validation
studies
before
States
use
the
criteria
for
permits.
EPA
has
completed
its
inter­
laboratory
validation
for
EPA
Methods
1600
and
1603
for
effluents,
and
is
in
the
process
of
proposing
these
methods.
In
addition,
EPA
is
currently
completing
its
interlaboratory
validation
for
EPA
Methods
1103.1
and
1106.1
in
effluents,
and
intends
to
propose
them
after
the
validation
process
is
completed.
EPA
did
not
specifically
use
pulp
and
paper
effluent
matrices
in
the
study.
EPA
method
validation
studies
typically
include
several
representative
matrices
and
are
not
intended
to
include
every
potential
effluent
matrix
to
which
a
method
may
be
applicable.
In
addition,
EPA
notes
that
its
National
Pollutant
Discharge
Elimination
System
regulations
do
not
require
that
compliance
monitoring
for
National
Pollutant
Discharge
Elimination
System
permits
be
based
on
EPA­
approved
methods.
40
CFR
122.41(
j)(
4)

provides
that
monitoring
results
must
be
conducted
according
to
test
procedures
approved
under
40
CFR
Part
136
unless
other
test
procedures
have
been
specified
in
the
permit.
States
implementing
the
criteria
in
National
Pollutant
Discharge
Elimination
System
permits
may
thus
specify
some
other
analytical
method
that
the
permittee
is
to
use
for
compliance
monitoring.
Of
course,
any
such
method
must
be
scientifically
defensible,
which
usually
means
that
it
has
been
tested
and
verified
by
some
other
recognized
standard
setting
or
method
development
body.

Permittees
who
believe
that
a
particular
method
is
not
appropriate
or
reliable
for
their
effluent
may
present
documentation
of
this
concern
to
the
permitting
authority
for
consideration
in
determining
compliance
monitoring
requirements.

D.
Effective
Date
Section
553
of
the
Administrative
Procedure
Act
provides
that
a
substantive
rule
shall
be
published
not
less
than
30
days
before
its
effective
date,
except
under
certain
circumstances.
EPA
Page
77
of
102
is
promulgating
today's
rule
with
an
effective
date
of
30
days
after
publication
in
the
Federal
Register
in
order
to
make
the
water
quality
criteria
effective
as
soon
as
possible
and
available
for
use
in
assessing
beach
safety
and
for
other
Clean
Water
Act
purposes.
This
will
serve
to
protect
human
health
at
coastal
recreation
waters.

EPA
received
two
comments
on
this
issue.
One
commenter
requested
that
EPA
delay
promulgating
the
rule
until
July
2005
and
another
commenter
suggested
that
EPA
delay
the
effective
date
for
90
days
so
that
a
State
could
complete
its
own
promulgation
of
water
quality
standards
based
on
the
1986
bacteria
criteria.
EPA
disagrees
that
it
should
allow
more
than
30
days
because
this
would
delay
the
time
at
which
States
and
Territories
will
begin
using
today's
water
quality
criteria
to
govern
decisions
about
opening
and
closing
beaches
and
for
other
Clean
Water
Act
purposes.
EPA
understands
the
interest
of
the
commenters
in
having
their
State
standards
serve
as
the
effective
standards
for
Clean
Water
Act
purposes.
If
a
State
adopts,
and
EPA
approves,
standards
satisfying
Clean
Water
Act
section
303(
i)
shortly
after
the
effective
date
of
this
rule,
the
State
criteria
will
immediately
replace
the
criteria
in
today's
rule
for
Clean
Water
Act
purposes
within
the
State,
consistent
with
40
CFR
131.41(
d)(
i).
EPA
does
not
expect
that
a
short
window
during
which
Federal
standards
are
in
effect
will
unduly
disrupt
on­
going
State
water
quality
standards
programs.
Therefore,
EPA
is
making
the
rule
effective
30
days
after
publication
in
the
Federal
Register.

VII.
Alternative
Regulatory
Approaches
and
Implementation
Mechanisms
States
and
Territories
have
considerable
discretion
in
designating
uses.
A
State
or
Territory
may
find
that
changes
in
use
designations
are
warranted.
EPA
will
review
any
new
or
revised
use
designations
adopted
by
States
or
Territories
for
coastal
recreation
waters
covered
by
Page
78
of
102
this
rule
to
determine
if
the
standards
meet
the
requirements
of
the
Clean
Water
Act
and
implementing
regulations.
In
adopting
recreation
uses,
the
States
and
Territories
may
wish
to
consider
additional
categories
of
recreation
uses.
If
States
and
Territories
change
the
designated
use
of
a
waterbody
consistent
with
Clean
Water
Act
section
303(
c)
and
the
regulations
at
40
CFR
Part
131,
such
that
they
are
no
longer
designated
for
swimming,
bathing,
surfing,
or
similar
water
contact
activities,
then
the
waterbody
would
not
be
covered
by
the
Clean
Water
Act
definition
of
"
coastal
recreation
waters"
or
this
rule.

EPA
reminds
the
States
and
Territories
that
they
must
conduct
use
attainability
analyses
as
required
by
40
CFR
131.10(
g)
when
adopting
water
quality
standards
that
do
not
include
the
uses
specified
in
Clean
Water
Act
section
101(
a)(
2)
or
with
subcategories
of
the
designated
uses
specified
in
Clean
Water
Act
section
101(
a)(
2)
that
require
less
stringent
criteria
(
see
40
CFR
131.10(
j)),
than
those
currently
in
effect.

VIII.
Economic
Analysis
These
water
quality
standards
may
serve
as
a
basis
for
development
of
National
Pollutant
Discharge
Elimination
System
permit
limits.
Many
of
the
affected
jurisdictions
(
i.
e.,
States
and
Territories)
are
the
National
Pollutant
Discharge
Elimination
System
permitting
authorities,
which
retain
considerable
discretion
in
implementing
standards.
EPA
evaluated
the
potential
costs
to
National
Pollutant
Discharge
Elimination
System
dischargers
in
affected
jurisdictions
associated
with
State
and
Territorial
implementation
of
today's
standards.
This
analysis
is
documented
in
``
Economic
Analysis
for
Final
Water
Quality
Standards
for
Coastal
Recreation
Waters,''
which
can
be
found
in
the
record
for
this
rulemaking.

Any
National
Pollutant
Discharge
Elimination
System­
permitted
facility
that
discharges
to
Page
79
of
102
waterbodies
affected
by
this
rule
could
potentially
incur
compliance
costs.
The
types
of
affected
facilities
may
include
industrial
facilities
and
publicly
owned
treatment
works
(
POTWs)
discharging
sanitary
wastewater
to
surface
waters
(
i.
e.,
point
sources).
In
addition,
EPA
addresses
discharges
of
bacteria
from
municipal
separate
storm
sewer
systems,
combined
sewer
overflows,
and
sanitary
sewer
overflows
to
coastal
waters
in
existing
regulations
and
policies,
and
has
tallied
potential
control
costs
as
part
of
the
analyses
for
those
actions.
EPA
expects
that
States
and
municipalities
will
continue
to
use
the
same
types
of
controls
to
come
into
compliance
with
the
revised
criteria
as
are
currently
used
for
compliance
with
existing
regulations
and
policies.
Available
evidence
suggests
that
if
discharges
are
controlled
in
such
a
way
that
fecal
coliform
criteria
are
met,
it
is
likely
that
enterococci
and
E.
coli
criteria
would
also
be
met,
and
there
would
not
be
an
increase
in
impaired
waters,
resulting
in
additional
Total
Maximum
Daily
Loads,
though
not
enough
is
known
about
the
relationship
between
sources,
controls,
and
the
various
indicators
to
conclude
this
with
any
certainty
at
this
time.
EPA
did
not
evaluate
the
costs
of
this
rule
to
Concentrated
Animal
Feeding
Operations
because
the
regulations
for
Concentrated
Animal
Feeding
Operations
prohibit
discharges
except
in
unusual
circumstances
(
i.
e.,
very
large
storms)
and
therefore
those
entities
are
unlikely
to
incur
any
additional
costs
as
a
result
of
today's
rule.
EPA
did
not
evaluate
the
potential
for
costs
to
nonpoint
sources,
such
as
agricultural
runoff.
Finally,
EPA
did
not
attempt
to
quantify
the
potential
benefits
of
the
rule.

EPA
recognizes
that
a
State
or
Territory
may
decide
to
require
controls
for
nonpoint
sources
(
e.
g.,
agricultural
runoff).
However,
it
is
difficult
to
model
and
evaluate
the
potential
costs
impacts
of
this
rule
to
those
sources
because
they
are
intermittent,
highly
variable,
and
occur
under
different
hydrologic
or
climatic
conditions
than
continuous
discharges
from
industrial
and
municipal
Page
80
of
102
facilities,
which
EPA
evaluates
under
critical
low
flow
or
drought
conditions.
Also,
data
on
instream
and
discharge
levels
of
bacteria
after
States
have
implemented
controls
to
meet
current
water
quality
standards
based
on
fecal
coliform
are
not
available.
Therefore,
trying
to
determine
which
sources
would
not
achieve
standards
based
on
E.
coli
or
enterococci
after
complying
with
existing
regulations
and
policies
may
not
be
possible,
and
would
be
extremely
time
and
resource
intensive.
Finally,
it
is
likely
that
controls
needed
to
meet
existing
criteria
(
assumed
for
the
purpose
of
costing
to
be
fecal
coliform
for
all
States
covered
by
the
rule)
would
also
address
water
quality
problems
indicated
by
criteria
for
E.
coli
or
enterococci.

A.
Identifying
Affected
Facilities
EPA
identified
approximately
734
point
source
facilities
that
may
be
affected
by
the
rule.
Of
these
potentially
affected
facilities,
306
are
classified
as
major
dischargers,
and
428
are
minor
dischargers.
EPA
did
not
include
general
permit
facilities
in
its
analysis
because
data
for
such
facilities
are
extremely
limited,
and
flows
are
usually
negligible.
Furthermore,
EPA
could
not
determine
if
any
of
these
facilities
with
general
permits
actually
discharge
to
the
affected
water
bodies
because
facility
location
information
is
not
available
in
EPA's
Permit
Compliance
System
database.

Of
the
facilities
located
in
jurisdictions
included
in
the
rule,
EPA
evaluated
that
subset
of
facilities
with
individual
permits
that
discharge
within
two
miles
of
coastal
waters
or
the
Great
Lakes
may
be
affected.
EPA
identified
these
facilities
by
relating
facility
information
to
the
potentially
affected
waters
using
Geographic
Information
System
software.
EPA
also
assumed
that
only
wastewater
treatment
plants
or
facilities
with
similar
effluent
characteristics
(
i.
e.,
facilities
having
the
potential
to
discharge
bacteria
in
the
form
of
fecal
matter)
may
be
affected.
For
those
Page
81
of
102
facilities
for
which
latitude/
longitude
data
are
not
included
in
the
Permit
Compliance
System,
EPA
included
only
facilities
for
which
the
receiving
waterbody
name
in
the
Permit
Compliance
System
indicates
a
coastal
water
(
e.
g.,
Pacific
Ocean,
Lake
Erie).
Table
5
summarizes
these
potentially
affected
facilities
by
type
and
category.

Table
5.
Potentially
Affected
Facilities1
Category
Number
of
Facilities
Total
Major2
Minor
Municipal
Other3
Coastal
242
233
100
575
Great
Lakes
64
75
20
159
Total
306
308
120
734
1.
Facilities
from
States
and
Territories
included
in
the
rule
that
discharge
within
two
miles
of
coastal
waters
or
the
Great
Lakes.

2.
No
major
industrial
facilities
are
affected
by
the
rule.
However,
4
other
facilities
(
SIC
codes
9711
and
9999)
are
included
because
their
names
indicate
that
they
are
wastewater
treatment
plants.

3.
Includes
the
following
standard
industrial
classifications:
eating
places
(
5812),
drinking
places
(
5813),
operators
of
nonresidential
buildings
(
6512),
operators
of
apartment
buildings
(
6513),
operators
of
dwellings
other
than
apartment
buildings
(
6514),
operators
of
residential
mobile
home
sites
(
6515),
hotels
and
motels
(
7011),
recreational
vehicle
parks
and
campsites
(
7033),
organization
hotels
and
lodging
houses
(
7041),
physical
fitness
facilities
(
7991),

amusement
and
recreation
services
(
7999),
skilled
nursing
care
facilities
(
8051),
general
medical
and
surgical
hospitals
(
8062),
elementary
and
secondary
schools
(
8211),
colleges,
universities,
and
professional
schools
(
8221),

civic,
social,
and
fraternal
associations
(
8641),
private
households
(
8811).
Also
includes
the
following
SICs
if
the
facility
name
suggests
that
they
may
discharge
sanitary
waste:
operative
builders
(
1531),
sanitary
services,
not
elsewhere
classified
(
4959),
real
estate
agents
and
managers
(
6531),
business
associations
(
8611),
religious
organizations
(
8661),
services
not
elsewhere
classified
(
8999),
air
and
water
resource
and
solid
waste
management
(
9511),
national
security
(
9711),
and
nonclassifiable
establishments
(
9999).
Page
82
of
102
B.
Method
for
Estimating
Potential
Compliance
Costs
To
estimate
costs,
EPA
evaluated
the
15
major
municipal
facilities
with
design
flows
greater
than
120
mgd,
thus
ensuring
that
the
facilities
with
the
potential
for
the
largest
costs
would
be
evaluated.
For
the
remaining
facilities,
EPA
evaluated
a
sample
of
facilities
to
represent
discharger
type
and
category.

The
Permit
Compliance
System
does
not
contain
E.
coli
or
enterococci
effluent
data
for
any
of
the
sample
facilities.
Therefore,
to
evaluate
potential
costs
associated
with
the
E.
coli
criteria,

EPA
assumed
that
100%
of
the
fecal
coliform
measured
at
the
sample
facilities
is
E.
coli
because
E.

coli
is
a
type
of
fecal
coliform.
EPA
assumed
that
all
potentially
affected
facilities
need
effluent
limits
that
are
required
to
meet
both
the
applicable
geometric
mean
and
single
sample
maximum
values
promulgated
in
today's
rule.
Based
on
the
last
3
years
of
data,
EPA
thus
estimated
that
facilities
with
average
monthly
effluent
levels
exceeding
a
geometric
mean
of
126/
100
ml,
or
maximum
daily
levels
exceeding
235/
100
ml,
would
most
likely
need
treatment
controls
to
meet
potential
permit
limits
based
on
today's
rule.

Enterococci
are
fecal
bacteria
in
the
fecal
streptococcus
group,
and
their
relationship
to
fecal
coliform
bacteria
is
uncertain.
Therefore,
for
coastal
facilities,
EPA
used
data
and
information
in
the
literature
regarding
the
ratio
of
fecal
coliform
to
enterococci
in
untreated
sewage,
and
the
inactivation
of
both
of
these
bacteria
at
minimum
disinfection
levels,
to
identify
the
concentrations
of
fecal
coliform
(
as
related
to
enterococci)
that
may
indicate
a
need
for
controls.
Data
in
the
literature
indicate
that
the
ratio
of
fecal
coliform
to
fecal
streptococcus
in
untreated
sewage
ranges
from
about
4
to
28.
EPA
used
the
most
conservative
(
i.
e.,
erring
on
the
side
of
overestimating
costs)
ratio
of
4
(
i.
e.,
fecal
coliform
levels
are
4
times
fecal
streptococcus
levels)
to
estimate
the
Page
83
of
102
fecal
coliform
levels
at
which
facilities
would
need
treatment
to
comply
with
the
enterococci
criteria.
A
ratio
of
4
translates
to
fecal
coliform
levels
of
140
fecal
coliform
per
100
ml
(
4

35
=

140/
100
ml);
however,
for
consistency
with
the
Great
Lakes
analysis,
EPA
estimated
costs
based
on
meeting
a
more
stringent
value
of
126
fecal
coliform
per
100
ml.
In
addition,
EPA
assumed
that
coastal
facilities
with
maximum
fecal
coliform
effluent
values
exceeding
235
colonies
per
100
ml
would
need
treatment
controls
(
even
though
235
/
4
=
59,
which
is
more
stringent
than
the
single
sample
maximum
value
of
104
in
the
final
rule).

Experiences
from
four
facilities
currently
having
effluent
limitations
to
meet
E.
coli
and
enterococci
criteria,
as
well
as
the
current
fecal
coliform
criteria,
suggest
that
chlorination
processes
can
be
upgraded
or
adjusted
to
treat
the
levels
of
bacteria
necessary
for
compliance
with
effluent
limitations
based
on
today's
rule.
Therefore,
EPA
estimated
that
optimization
of
existing
disinfection
processes
would
enable
the
sample
facilities
to
comply
with
the
rule.
Process
optimization
usually
involves
process
analysis
and
process
modifications,
and
EPA's
cost
estimates
include
both
capital
and
operating
and
maintenance
costs.

C.
Results
Based
on
the
results
for
the
15
facilities
with
flows
greater
than
120
mgd,
and
extrapolating
the
sample
results
to
the
remaining
potentially
affected
facilities,
EPA
estimated
a
total
annual
cost
of
approximately
$
20
million
($
13
million
for
coastal
facilities,
and
$
7
million
for
Great
Lakes
facilities).
EPA
estimates
that
approximately
70
major
and
20
minor
permittees
could
incur
control
costs
as
a
result
of
permit
modifications
to
include
limits
based
on
the
criteria
in
today's
rule.

IX.
Statutory
and
Executive
Order
Reviews
A.
Executive
Order
12866:
Regulatory
Planning
and
Review
Page
84
of
102
Under
Executive
Order
12866,
(
58
FR
51735,
October
4,
1993),
the
Agency
must
determine
whether
the
regulatory
action
is
"
significant"
and
therefore
subject
to
Office
of
Management
and
Budget
(
OMB)
review
and
the
requirements
of
the
Executive
Order.
The
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,
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,
it
has
been
determined
that
this
rule
is
a
"
significant
regulatory
action"
because
the
rule
raises
novel
policy
issues
arising
out
of
the
BEACH
Act.
action."
As
such,
this
action
was
submitted
to
OMB
for
review.
Changes
made
in
response
to
OMB
suggestions
or
recommendations
are
documented
in
the
public
record.

B.
Paperwork
Reduction
Act
This
action
does
not
impose
an
information
collection
burden
under
the
provisions
of
the
Paperwork
Reduction
Act
(
44
U.
S.
C.
3501
et
seq.).
It
does
not
include
any
information
collection,

reporting,
or
record­
keeping
requirements.
Page
85
of
102
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.

C.
Regulatory
Flexibility
Act
The
Regulatory
Flexibility
Act
(
RFA),
as
amended
by
the
Small
Business
Regulatory
Enforcement
Fairness
Act
of
1996
(
SBREFA),
5
U.
S.
C.
601
et
seq.,
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.

For
purposes
of
assessing
the
impacts
of
today's
rule
on
small
entities,
small
entity
is
defined
as:
(
1)
a
small
business
according
to
RFA
default
definitions
for
small
business
(
based
on
Small
Business
Administration
size
standards);
(
2)
a
small
governmental
jurisdiction
that
is
a
government
Page
86
of
102
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.

After
considering
the
economic
impacts
of
today's
rule
on
small
entities,
I
certify
that
this
action
will
not
have
a
significant
economic
impact
on
a
substantial
number
of
small
entities.
As
discussed
below,
these
water
quality
standards
do
not
directly
apply
to
any
discharger,
including
small
entities.

Clean
Water
Act
section
303(
i)(
2)(
A)
requires
that
if
a
State
or
Territory
fails
to
adopt
water
quality
criteria
and
standards
in
accordance
with
paragraph
(
1)(
A)
that
are
as
protective
of
human
health
as
the
criteria
for
pathogen
indicators
for
coastal
recreation
waters
published
by
the
Administrator,
the
Administrator
shall
promptly
propose
regulations
for
the
State
or
Territory
setting
forth
revised
or
new
water
quality
standards
for
pathogen
indicators
described
in
paragraph
(
1)(
A)
for
coastal
recreation
waters
of
the
State
or
Territory.
These
State
standards
(
or
EPApromulgated
standards)
are
implemented
through
various
water
quality
control
programs
including
the
National
Pollutant
Discharge
Elimination
System
program,
which
limits
discharges
to
navigable
waters
except
in
compliance
with
a
National
Pollutant
Discharge
Elimination
System
permit.
The
Clean
Water
Act
requires
that
all
National
Pollutant
Discharge
Elimination
System
permits
include
any
limits
on
discharges
that
are
necessary
to
meet
applicable
water
quality
standards.

In
cases
in
which
a
discharger
(
including
a
small
entity)
is
discharging
pathogens
into
waters
subject
to
these
standards,
the
permitting
authority
will
need
to
determine
whether
the
discharge
is
or
may
be
discharged
at
a
level
which
will
cause,
contribute
to,
or
have
the
reasonable
potential
to
cause
an
exceedance
of
the
applicable
water
quality
standard.
In
making
that
determination,
the
Page
87
of
102
permitting
authority
would
need
to
consider
the
factors
listed
in
40
CFR
122.44(
d)(
1)(
ii).
Whether
a
permitting
authority
will
need
to
require
a
water
quality­
based
effluent
limit
depends
on
the
analysis
of
these
factors,
which
will
vary
based
on
the
specific
facts
of
each
permit
decision.
Based
on
that
analysis,
if
the
permitting
authority
finds
that
the
discharger
causes,
contributes
to,
or
has
the
reasonable
potential
to
cause
an
exceedance
of
the
applicable
water
quality
standard,
after
the
application
of
any
required
technology­
based
effluent
limits,
then
the
permitting
authority
will
need
to
impose
a
water
quality­
based
effluent
limit
to
meet
the
applicable
water
quality
standard.
(
See
Clean
Water
Act
section
301(
b)(
1)(
C);
40
CFR
122.44(
d).)
Therefore,
as
a
practical
matter,

today's
rule
may
or
may
not
necessitate
a
change
in
the
permit,
depending
on
the
specific
circumstances.
While
the
Clean
Water
Act
and
its
implementing
regulations
may
trigger
the
need
for
new
or
revised
discharge
limits
based
on
the
water
quality
standards
in
today's
rule
to
be
placed
on
small
entities
in
some
cases,
the
standards
themselves
do
not
directly
apply
to
any
discharger,

including
small
entities.

Although
not
required
by
the
Regulatory
Flexibility
Act,
EPA
conducted
a
screening
analysis
to
evaluate
the
potential
for
today's
rule
to
have
a
significant
impact
on
a
substantial
number
of
small
entities,
as
part
of
its
general
practice
to
assess
and
reduce
burden
on
small
entities
wherever
possible.
The
screening
analysis,
which
is
included
in
the
docket
for
today's
rule,
In
the
"
Economic
Analysis
for
Final
Water
Quality
Standards
for
Coastal
Recreation
Waters,"
EPA
presents
an
analysis
which
supports
a
conclusion
that
today''
s
rule
will
not
have
a
significant
impactlikely
affect
only
a
substantial
number
offew
small
entities.
EPA
identified
the
universe
of
National
Pollutant
Discharge
Elimination
System­
permitted
entities
that
are
small
in
size.
EPA
evaluated
the
severity
of
potential
economic
impacts
on
those
small
entities
by
comparing
their
Page
88
of
102
estimated
compliance
costs
to
revenues,
sales,
or
household
income,
depending
on
the
type
of
entity.
EPA
observed
that
only
one
small
government
(
a
major
facility)
may
incur
annual
costs
that
equal
or
exceed
1%
and
3%
of
annual
revenues.
For
small
businesses,
the
impact
ratio
exceeds
1%

for
two
facilities,
and
3%
for
only
one.
Thus,
given
the
few
facilities
for
which
impact
ratios
exceed
1%
and
3%,
the
combined
results
for
small
governments
and
businesses
support
a
conclusion
that
there
will
not
be
a
significant
impact
on
a
substantial
number
of
small
entities.(
See
the
docket
for
today's
rule.)

D.
Unfunded
Mandates
Reform
Act
Title
II
of
the
Unfunded
Mandates
Reform
Act
of
1995
(
UMRA),
P.
L.
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.
The
definition
of
"
State"
for
the
purposes
of
the
Unfunded
Mandates
Reform
Act
includes
"
a
territory
or
possession
of
the
United
States."
Under
section
202
of
the
Unfunded
Mandates
Reform
Act,
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
one
year.
Before
promulgating
an
EPA
rule
for
which
a
written
statement
is
needed,
section
205
of
the
Unfunded
Mandates
Reform
Act
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
Page
89
of
102
explanation
of
why
that
alternative
was
not
adopted.
Before
EPA
establishes
any
regulatory
requirements
that
may
significantly
or
uniquely
affect
small
governments,
including
Tribal
governments,
it
must
have
developed
under
section
203
of
the
Unfunded
Mandates
Reform
Act
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
rule
contains
no
Federal
mandates
(
under
the
regulatory
provisions
of
Title
II
of
the
Unfunded
Mandates
Reform
Act)
that
may
result
in
expenditures
to
State,
local
and
Tribal
governments,
or
the
private
sector,
in
the
aggregate
of
$
100
million
or
more
in
any
one
year.

Therefore,
this
rule
is
not
subject
to
the
requirements
of
sections
202
and
205
of
the
Unfunded
Mandates
Reform
Act.

EPA
has
determined
that
this
rule
contains
no
regulatory
requirements
that
might
significantly
or
uniquely
affect
small
governments.
Thus,
this
rule
is
not
subject
to
the
requirements
of
section
203
of
the
Unfunded
Mandates
Reform
Act.

E.
Executive
Order
13132:
Federalism
Executive
Order
13132,
entitled
"
Federalism"
(
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
Page
90
of
102
the
States,
or
on
the
distribution
of
power
and
responsibilities
among
the
various
levels
of
government."

This
final
rule
does
not
have
Federalism
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.
EPA's
authority
and
responsibility
to
promulgate
Federal
water
quality
standards
when
State
standards
do
not
meet
the
requirements
of
the
Clean
Water
Act
is
well
established
and
has
been
used
on
various
occasions
in
the
past.
The
final
rule
does
not
substantially
affect
the
relationship
of
EPA
and
the
States
and
Territories,
or
the
distribution
of
power
or
responsibilities
between
EPA
and
the
various
levels
of
government.
The
final
rule
does
not
alter
the
States'
or
Territories'
considerable
discretion
in
implementing
these
water
quality
standards.

Further,
this
rule
does
not
preclude
the
States
and
Territories
from
adopting
water
quality
standards
that
meet
the
requirements
of
the
Clean
Water
Act,
either
before
or
after
promulgation
of
the
final
rule,
thus
eliminating
the
need
for
Federal
standards.
Thus,
Executive
Order
13132
does
not
apply
to
this
rule.

Although
Executive
Order
13132
does
not
apply
to
this
rule,
in
the
spirit
of
Executive
Order
13132
and
consistent
with
EPA's
policy
to
promote
communication
between
EPA
and
State
and
local
governments,
EPA
did
consult
with
representatives
of
the
States
and
Territories
subject
to
Clean
Water
Act
section
303(
i)
in
developing
this
rule.
Prior
to
this
rulemaking
action,
EPA
had
numerous
phone
calls,
meetings
and
exchanges
of
written
correspondence
with
the
States
to
discuss
EPA's
concerns
with
the
States'
bacteria
criteria,
compliance
with
the
BEACH
Act,
and
the
Federal
rulemaking
process.
In
June
2000,
EPA
and
the
Association
of
State
and
Interstate
Water
Pollution
Page
91
of
102
Control
Administrators
(
ASIWPCA)
established
a
State/
EPA
Work
Group
on
Water
Quality
Standards,
composed
of
selected
senior
State
and
EPA
managers,
to
provide
input
to
EPA
on
water
quality
standards
issues.
The
group
has
met
approximately
three
times
per
year
since
then,

beginning
with
a
meeting
in
September
2000.
At
every
meeting
the
group
has
discussed
the
scientific,
programmatic,
and
policy
aspects
of
bacteria
criteria
for
both
coastal
and
non­
coastal
recreation
waters,
and
has
provided
useful
input
to
EPA
on
these
topics.
Members
of
this
group,

together
with
other
interested
State
participants,
have
also
served
as
an
ad­
hoc
work
group
since
2001
to
assist
EPA
in
developing
draft
detailed
scientific
and
policy
guidance
(
Implementation
Guidance
for
Ambient
Water
Quality
Criteria
for
Bacteria
(
EPA­
823­
B­
02­
003,
May
2002
Draft))

concerning
adoption
and
implementation
of
EPA's
recommended
criteria
for
bacteria.
Today's
final
rule
reflects
State
and
Territorial
input,
and
EPA
has
responded
to
State
and
Territorial
comment
on
various
topics
in
the
preamble
to
today's
rule
and
in
the
Comment
Response
Document,
which
is
part
of
the
record
for
this
rule.

F.
Executive
Order
13175:
Consultation
and
Coordination
with
Indian
Tribal
Governments
Executive
Order
13175,
entitled
"
Consultation
and
Coordination
with
Indian
Tribal
Governments"
(
65
FR
67249,
November
6,
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."

This
final
rule
does
not
have
Tribal
implications.
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,
as
specified
in
Executive
Order
13175.
There
are
four
authorized
Indian
Tribes
with
coastal
or
Great
Page
92
of
102
Lakes
waters;
however,
they
have
not
yet
adopted
water
quality
standards,
and
therefore,
have
no
designated
coastal
recreation
waters
within
their
jurisdiction.
These
Tribes
are
therefore
not
subject
to
today's
rule.
Thus,
Executive
Order
13175
does
not
apply
to
this
rule.

EPA
has
contacted
those
Tribes
identified
as
having
coastal
or
Great
Lakes
waters
to
inform
them
of
the
potential
future
impact
this
could
have
on
Tribal
waters.

G.
Executive
Order
13045:
Protection
of
Children
from
Environmental
Health
Risks
and
Safety
Risks
Executive
Order
13045:
"
Protection
of
Children
from
Environmental
Health
Risks
and
Safety
Risks"
(
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
effects
of
the
rule
on
children,
and
explain
why
the
regulation
is
preferable
to
other
potentially
effective
and
reasonably
feasible
alternatives
considered
by
the
Agency.

This
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.
As
explained
in
section
II.
B
of
the
preamble
to
today's
rule,
EPA
developed
the
water
quality
criteria
promulgated
in
today's
rule
based
on
concentrations
of
E.
coli
and
enterococci
from
EPA­
sponsored
epidemiological
studies
reflecting
all
reported
illnesses,
including
those
of
children.

In
the
marine
and
freshwater
studies,
the
range
of
the
number
of
children
under
age
10
was
between
Page
93
of
102
15%
and
25%
of
the
total
study
population.
Children
in
the
age
range
10
to
19
years
old
made
up
a
slightly
higher
percentage
of
the
study
population.
During
the
studies,
information
on
gastroenteritis,
respiratory
symptoms,
and
other
symptoms
were
collected
for
all
participants,

including
children.
EPA
designed
the
1986
bacteria
criteria
to
protect
all
age
groups.

H.
Executive
Order
13211:
Actions
that
Significantly
Affect
Energy
Supply,
Distribution,
or
Use
This
rule
is
not
a
"
significant
energy
action"
as
defined
in
Executive
Order
13211,
"
Actions
Concerning
Regulations
That
Significantly
Affect
Energy
Supply,
Distribution,
or
Use"
(
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.
EPA
estimates
that
compliance
with
the
final
rule
will
create
a
negligible
increase
in
nationwide
energy
consumption
for
point
source
facilities
discharging
to
coastal
recreation
waters
in
affected
States.
In
section
VIII,
EPA
presented
its
estimated
incremental
costs
to
permitted
facilities
as
a
result
of
the
final
rule.
Some
of
these
costs
include
energy
use
associated
with
increased
maintenance
of
disinfection
tanks.
EPA
estimates
that
the
increased
energy
use
from
these
activities
would
be
about
99,000
kilowatt
hours.
Net
production
by
electric
power
generation
facilities
in
the
United
States
in
2002
was
3,858,452
million
kilowatt
hours
(
Energy
Information
Administration,
Department
of
Energy,

http://
www.
eia.
doe.
gov/
neic/
quickfacts/
quickelectric.
htm).
EPA
estimates
that
the
additional
energy
requirements
of
EPA's
rule
are
insignificant
(
i.
e.,
0.000003%
of
national
energy
generation).

I.
National
Technology
Transfer
and
Advancement
Act
As
noted
in
the
proposal,
section
12(
d)
of
the
National
Technology
Transfer
and
Advancement
Act
of
1995
("
NTTAA"),
Pub.
L.
104­
113,
section
12(
d)
(
15
U.
S.
C.
272
note)

directs
EPA
to
use
voluntary
consensus
standards
in
its
regulatory
activities
unless
to
do
so
would
Page
94
of
102
be
inconsistent
with
applicable
law
or
otherwise
impractical.
Voluntary
consensus
standards
are
technical
standards
(
e.
g.,
materials
specifications,
test
methods,
sampling
procedures,
and
business
practices)
that
are
developed
or
adopted
by
voluntary
consensus
standards
bodies.
The
NTTAA
directs
EPA
to
provide
Congress,
through
OMB,
explanations
when
the
Agency
decides
not
to
use
available
and
applicable
voluntary
consensus
standards.

While
ambient
water
quality
criteria
may
be
considered
technical
standards,
EPA
is
not
aware
of
any
voluntary
consensus
standards
relating
to
bacteria
criteria
to
protect
human
health
and
none
were
brought
to
our
attention
in
comments
on
the
proposed
rule.
Furthermore,
even
if
there
were
such
voluntary
consensus
standards,
the
BEACH
Act
specifically
directs
EPA
to
promulgate
Federal
standards
based
on
its
own
bacteria
criteria,
in
accordance
with
Clean
Water
Act
section
304(
a),
in
cases
where
States
fail
to
do
so.
Therefore,
EPA
is
not
considering
the
use
of
any
voluntary
consensus
standards.

J.
Congressional
Review
Act
The
Congressional
Review
Act,
5
U.
S.
C.
801
et
seq.,
as
added
by
the
Small
Business
Regulatory
Enforcement
Fairness
Act
of
1996,
generally
provides
that
before
a
rule
may
take
effect,

the
agency
promulgating
the
rule
must
submit
a
rule
report,
which
includes
a
copy
of
the
rule,
to
each
House
of
the
Congress
and
to
the
Comptroller
General
of
the
United
States.
EPA
will
submit
a
report
containing
this
rule
and
other
required
information
to
the
U.
S.
Senate,
the
U.
S.
House
of
Representatives,
and
the
Comptroller
General
of
the
United
States
prior
to
publication
of
the
rule
in
the
Federal
Register.
A
"
major
rule"
cannot
take
effect
until
60
days
after
it
is
published
in
the
Federal
Register.
This
action
is
not
a
"
major
rule"
as
defined
by
5
U.
S.
C.
804(
2).
This
rule
will
be
effective
[
INSERT
DATE
30
DAYS
AFTER
PUBLICATION
IN
THE
FEDERAL
REGISTER].
Page
95
of
102
List
of
Subjects
in
40
CFR
Part
131
Environmental
protection,
Intergovernmental
relations,
Reporting
and
recordkeeping
requirements,

Water
pollution
control.
Water
Quality
Standards
for
Coastal
and
Great
Lakes
Recreation
Waters
page
96
of
102
Page
96
of
102
Dated:

Michael
O.
Leavitt,

Administrator.

For
the
reasons
set
out
in
the
preamble,
40
CFR
part
131
is
amended
as
follows:

PART
131­­
WATER
QUALITY
STANDARDS
1.
The
authority
citation
for
part
131
continues
to
read
as
follows:

Authority:
33
U.
S.
C.
1251
et
seq.

Subpart
D
­­
[
Amended]

2.
Section
131.41
is
added
to
Subpart
D
to
read
as
follows:

§
131.41
Bacteriological
criteria
for
those
states
not
complying
with
Clean
Water
Act
section
303(
i)(
1)(
A).

(
a)
Scope.
This
section
is
a
promulgation
of
the
Clean
Water
Act
section
304(
a)
criteria
for
bacteria
for
coastal
recreation
waters
in
specific
States.
It
is
not
a
general
promulgation
of
the
Clean
Water
Act
section
304(
a)
criteria
for
bacteria.
This
section
also
contains
a
compliance
schedule
provision.

(
b)
Definitions.
(
1)
Coastal
Recreation
Waters
are
the
Great
Lakes
and
marine
coastal
waters
(
including
coastal
estuaries)
that
are
designated
under
section
303(
c)
of
the
Clean
Water
Act
for
use
for
swimming,
bathing,
surfing,
or
similar
water
contact
activities.
Coastal
recreation
waters
do
not
Page
97
of
102
include
inland
waters
or
waters
upstream
from
the
mouth
of
a
river
or
stream
having
an
unimpaired
natural
connection
with
the
open
sea.

(
2)
Designated
bathing
beach
waters
are
those
coastal
recreation
waters
that,
during
the
recreation
season,
are
heavily­
used
(
based
upon
a
comparisonn
evaluation
of
use
within
the
State)
and
may
have:
a
lifeguard,
bathhouse
facilities,
or
public
parking
for
beach
access.
States
may
include
any
other
waters
in
this
category
even
if
the
waters
do
not
meet
these
criteria.

(
3)
Moderate
use
coastal
recreation
waters
are
those
coastal
recreation
waters
that
are
not
designated
bathing
beach
waters
but
typically,
during
the
recreation
season,
are
used
by
at
least
half
of
the
number
of
people
as
at
typical
designated
bathing
beach
waters
within
the
State.
States
may
also
include
light
use
or
infrequent
use
coastal
recreation
waters
in
this
category.

(
4)
Light
use
coastal
recreation
waters
are
those
coastal
recreation
waters
that
are
not
designated
bathing
beach
waters
but
typically,
during
the
recreation
season,
are
used
by
less
than
half
of
the
number
of
people
as
at
typical
designated
bathing
beach
waters
within
the
State,
but
are
more
than
infrequently
used.
States
may
also
include
infrequent
use
coastal
recreation
waters
in
this
category.

(
5)
Infrequent
use
coastal
recreation
waters
are
those
coastal
recreation
waters
that
are
rarely
or
occasionally
used.

(
6)
New
pathogen
discharger
for
the
purposes
of
this
section
means
any
building,
structure,
facility,

or
installation
from
which
there
is
or
may
be
a
discharge
of
pathogens,
the
construction
of
which
commenced
on
or
after
[
INSERT
DATE
30
DAYS
AFTER
DATE
OF
PUBLICATION].
It
does
not
include
relocation
of
existing
combined
sewer
overflow
outfalls.

(
7)
Existing
pathogen
discharger
for
the
purposes
of
this
section
means
any
discharger
that
is
not
a
new
pathogen
discharger.
Page
98
of
102
(
c)
EPA's
section
304(
a)
ambient
water
quality
criteria
for
bacteria.

(
1)
Freshwaters:

A
Indicatord
B
Geometric
Mean
C
Single
Sample
Maximum
(
per
100
ml)

C1
Designated
bathing
beach
(
75%

confidence
level)
C2
Moderate
use
coastal
recreation
waters
(
82%

confidence
level)
C3
Light
use
coastal
recreation
waters
(
90%
confidence
level)
C4
Infrequent
use
coastal
recreation
waters
(
95%

confidence
level)

E.
colie
126/
100
mla
235b
298b
409b
575b
Enterococcie
33/
100
mlc
61b
78b
107b
151b
Footnotes
to
table
in
paragraph
(
c)(
1):

a.
This
value
is
for
use
with
analytical
methods
1103.1,
1603,
or
1604
or
any
equivalent
method
that
measures
viable
bacteria.

b.
Calculated
using
the
following:
single
sample
maximum
=
geometric
mean
*
10^(
confidence
level
factor
*
log
standard
deviation),
where
the
confidence
level
factor
is:
75%:
0.68;
82%:
0.94;
90%:

1.28;
95%:
1.65.
The
log
standard
deviation
from
EPA's
epidemiological
studies
is
0.4.

c.
This
value
is
for
use
with
analytical
methods
1106.1
or
1600
or
any
equivalent
method
that
measures
viable
bacteria.

d.
The
State
willmay
determine
which
of
these
indicators
applies
to
its
freshwater
coastal
recreation
waters.
Until
a
State
makes
that
determination,
E.
coli
will
be
the
applicable
indicator.

e.
These
values
apply
to
E.
coli
or
enterococci
regardless
of
origin
unless
a
sanitary
survey
shows
that
sources
of
the
indicator
bacteria
are
non­
human
and
an
epidemiological
study
shows
that
the
indicator
densities
are
not
indicative
of
a
human
health
risk.

(
2)
Marine
waters:
Page
99
of
102
A
Indicator
B
Geometric
Mean
C
Single
Sample
Maximum
(
per
100
ml)

C1
Designated
bathing
beach
(
75%

confidence
level)
C2
Moderate
use
coastal
recreation
waters
(
82%

confidence
level)
C3
Light
use
coastal
recreation
waters
(
90%
confidence
level)
C4
Infrequent
use
coastal
recreation
waters
(
95%

confidence
level)

Enterococcic
35/
100
mla
104b
158b
276b
501b
Footnotes
to
table
in
paragraph
(
c)(
2):

a.
This
value
is
for
use
with
analytical
methods
1106.1
or
1600
or
any
equivalent
method
that
measures
viable
bacteria.

b.
Calculated
using
the
following:
single
sample
maximum
=
geometric
mean
*
10^(
confidence
level
factor
*
log
standard
deviation),
where
the
confidence
level
factor
is:
75%:
0.68;
82%:
0.94;
90%:

1.28;
95%:
1.65.
The
log
standard
deviation
from
EPA's
epidemiological
studies
is
0.7.

c.
These
values
apply
to
enterococci
regardless
of
origin
unless
a
sanitary
survey
shows
that
sources
of
the
indicator
bacteria
are
non­
human
and
an
epidemiological
study
shows
that
the
indicator
densities
are
not
indicative
of
a
human
health
risk.

(
3)
As
an
alternative
to
the
single
sample
maximum
in
paragraph
(
c)(
1)
or
(
c)(
2)
of
this
section,

States
may
use
a
site­
specific
log
standard
deviation
to
calculate
a
single
sample
maximum
for
individual
coastal
recreation
waters,
but
must
use
at
least
30
samples
from
a
single
recreation
season
to
do
so.

(
d)
Applicability.
(
1)
The
criteria
in
paragraph
(
c)
of
this
section
apply
to
the
coastal
recreation
waters
of
the
States
identified
in
paragraph
(
e)
of
this
section
and
apply
concurrently
with
any
ambient
recreational
water
criteria
adopted
by
the
State,
except
for
those
coastal
recreation
waters
where
State
regulations
determined
by
EPA
to
meet
the
requirements
of
Clean
Water
Act
section
Page
100
of
102
303(
i)
apply,
in
which
case
the
State's
criteria
for
those
coastal
recreation
waters
will
apply
and
not
the
criteria
in
paragraph
(
c)
of
this
section.

(
2)
The
criteria
established
in
this
section
are
subject
to
the
State's
general
rules
of
applicability
in
the
same
way
and
to
the
same
extent
as
are
other
Federally­
adopted
and
State­
adopted
numeric
criteria
when
applied
to
the
same
use
classifications.

(
e)
Applicability
to
specific
jurisdictions.
(
1)
The
criteria
in
paragraph
(
c)(
1)
of
this
section
apply
to
fresh
coastal
recreation
waters
of
the
following
States:
Illinois,
Minnesota,
New
York,
Ohio,

Pennsylvania,
Wisconsin.

(
2)
The
criteria
in
paragraph
(
c)(
2)
of
this
section
apply
to
marine
coastal
recreation
waters
of
the
following
States:
Alaska,
California
(
except
for
coastal
recreation
waters
within
the
jurisdiction
of
Regional
Board
4),
Florida,
Georgia,
Hawaii
(
except
for
coastal
recreation
waters
within
300
meters
of
the
shoreline),
Louisiana,
Maine
(
except
for
SA
waters
and
SB
and
SC
waters
with
human
sources
of
fecal
contamination),
Maryland,
Massachusetts,
Mississippi,
New
York,
North
Carolina,
Oregon,
Puerto
Rico
(
except
for
waters
classified
by
Puerto
Rico
as
intensely
used
for
primary
contact
recreation
and
for
those
waters
included
in
§
131.40),
Rhode
Island,
United
States
Virgin
Islands.

(
f)
Schedules
of
compliance.
(
1)
Paragraph
(
f)
applies
to
any
State
that
does
not
have
a
regulation
in
effect
for
Clean
Water
Act
purposes
that
authorizes
compliance
schedules
for
National
Pollutant
Discharge
Elimination
System
permit
limitations
needed
to
meet
the
criteria
in
paragraph
(
c)
of
this
section.
All
dischargers
shall
promptly
comply
with
any
new
or
more
restrictive
water
quality­
based
effluent
limitations
based
on
the
water
quality
criteria
set
forth
in
this
section.

(
2)
When
a
permit
issued
on
or
after
[
INSERT
DATE
30
DAYS
AFTER
DATE
OF
Page
101
of
102
PUBLICATION]
to
a
new
pathogen
discharger
as
defined
in
paragraph
(
b)
of
this
section
contains
water
quality­
based
effluent
limitations
based
on
water
quality
criteria
set
forth
in
paragraph
(
c)
of
this
section,
the
permittee
shall
comply
with
such
water
quality­
based
effluent
limitations
upon
the
commencement
of
the
discharge.

(
3)
Where
an
existing
pathogen
discharger
reasonably
believes
that
it
will
be
infeasible
to
comply
immediately
with
a
new
or
more
restrictive
water
quality­
based
effluent
limitations
based
on
the
water
quality
criteria
set
forth
in
paragraph
(
c)
of
this
section,
the
discharger
may
request
approval
from
the
permit
issuing
authority
for
a
schedule
of
compliance.

(
4)
A
compliance
schedule
for
an
existing
pathogen
discharger
shall
require
compliance
with
water
quality­
based
effluent
limitations
based
on
water
quality
criteria
set
forth
in
paragraph
(
c)
of
this
section
as
soon
as
possible,
taking
into
account
the
dischargers'discharger's
ability
to
achieve
compliance
with
such
water
quality­
based
effluent
limitations.

(
5)
If
the
schedule
of
compliance
for
an
existing
pathogen
discharger
exceeds
one
year
from
the
date
of
permit
issuance,
reissuance
or
modification,
the
schedule
shall
set
forth
interim
requirements
and
dates
for
their
achievement.
The
period
between
dates
of
completion
for
each
requirement
may
not
exceed
one
year.

If
the
time
necessary
for
completion
of
any
requirement
is
more
than
one
year
and
the
requirement
is
not
readily
divisible
into
stages
for
completion,
the
permit
shall
require,
at
a
minimum,
specified
dates
for
annual
submission
of
progress
reports
on
the
status
of
interim
requirements.

(
6)
In
no
event
shall
the
permit
issuing
authority
approve
a
schedule
of
compliance
for
an
existing
pathogen
discharge
which
exceeds
five
years
from
the
date
of
permit
issuance,
reissuance,
or
modification,
whichever
is
sooner.
Page
102
of
102
(
7)
If
a
schedule
of
compliance
exceeds
the
term
of
a
permit,
interim
permit
limits
effective
during
the
permit
shall
be
included
in
the
permit
and
addressed
in
the
permit's
fact
sheet
or
statement
of
basis.
The
administrative
record
for
the
permit
shall
reflect
final
permit
limits
and
final
compliance
dates.
Final
compliance
dates
for
final
permit
limits,
which
do
not
occur
during
the
term
of
the
permit,
must
occur
within
five
years
from
the
date
of
issuance,
reissuance
or
modification
of
the
permit
which
initiates
the
compliance
schedule.
