Document ID: EPA-HQ-ORD-2003-0009-0001
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2003-07-29T04:00Z

Page
1
SECTION
1.

A.
SUPPORTING
STATEMENT
1.
IDENTIFICATION
OF
THE
INFORMATION
COLLECTION
1(
a)
TITLE
Health
Effects
of
Microbial
Pathogens
in
Recreational
Waters.

1(
b)
ABSTRACT
This
study
will
be
conducted,
and
the
information
collected,
by
the
Epidemiology
and
Biomarkers
Branch,
Human
Studies
Division,
National
Health
and
Environmental
Effects
Research
Laboratory,

Office
of
Research
and
Development,
U.
S.
Environmental
Protection
Agency
(
EPA).
Participation
of
adults
and
children
in
this
collection
of
information
is
strictly
voluntary.

This
information
is
being
collected
as
part
of
a
research
program
consistent
with
the
Section
3(
a)

(
v)
(
1)
of
the
Beaches
Environmental
Assessment
and
Coastal
Health
Act
of
2000
and
the
strategic
plan
for
EPA's
Office
of
Research
and
Development
(
ORD)
and
the
Office
of
Water
entitled
"
Action
Plan
for
Beaches
and
Recreational
Water.
The
Beaches
Act
and
ORD's
strategic
plan
have
identified
research
on
effects
of
microbial
pathogens
in
recreational
waters
as
a
high­
priority
research
area
with
particular
emphasis
on
developing
new
water
quality
indicator
guidelines
for
recreational
waters.
EPA
has
broad
legislative
authority
to
establish
water
quality
criteria
and
to
conduct
research
to
support
these
criteria.
This
data
collection
is
for
a
series
of
epidemiological
studies
to
evaluate
exposure
to
and
effects
of
microbial
pathogens
in
marine
and
fresh
(
Great
Lakes)
recreational
waters
as
part
of
EPA's
research
program
on
exposure
and
health
effects
of
microbial
pathogens
in
recreational
waters.

The
results
of
these
health
effects
studies
will
be
used
to
document
human
health
effects
associated
with
recreational
water
use
and
correlate
these
health
effects
with
ongoing
EPA
studies
to
identify
a
new
generation
of
indicators
for
detection
of
human
pathogens
in
recreational
water
and
appropriate,

effective,
and
expeditious
testing
methods
for
these
indicators
(
addressed
separately
under
Section
3(
a)

(
v)
(
2
&
3)
of
the
Beaches
Environmental
Assessment
and
Coastal
Health
Act
of
2000).
The
epidemiological
results
will
be
used
to
develop
mathematical
relationships
that
will
generate
of
new
national
water
quality
guidelines
and
appropriate
monitoring
guidelines.

The
beaches
will
be
selected
based
on
the
potential
number
of
beach
goers,
water
quality
parameters,
and
potential
sources
of
microbial
pathogens
in
the
water
(
domestic
sewage
vs
animals).

These
studies
will
place
the
emphasis
on
beaches
that
have
identified
point
source
contamination
(
e.
g.,

sewage
treatment
plants).
Families
at
selected
beaches
will
be
interviewed
on
the
beach
about
a
variety
of
exposures
including
those
to
recreational
water
(
Appendix
D).
Four
to
seven
days
later
families
will
Page
2
be
contacted
by
telephone
and
interviewed
over
the
phone
on
the
occurrence
of
selected
symptomatology
since
swimming
at
the
beach
(
Appendix
E).
During
the
first
year,
another
telephone
follow­
up
interview
will
be
conducted
10­
14
days
following
the
initial
beach
interview
to
determine
the
extent
of
illness
occurring
as
a
result
of
longer
incubation
period
pathogens
(
Appendix
F).
In
addition,

selected
groups
of
children
(
boy
and
girl
scouts,
church
groups,
camps)
who
are
making
day
trips
to
selected
beaches
for
recreation
will
be
asked
to
participate
in
a
special
study
to
identify
specific
microbial
pathogens.
Concurrently,
recreational
waters
will
be
monitored
with
a
selection
of
water
quality
indicators
developed
under
a
separate
EPA
research
effort.
The
epidemiologic
information
will
be
collected
electronically
and
stored
in
a
computerized
database.

The
questionnaire
health
data
will
be
compared
with
routinely
collected
water
quality
measurements.
The
information
collected
by
this
study
will
be
used
to
estimate
the
relationship
between
new
water
quality
indicators
and
health
effects.
The
analysis
will
focus
on
determining
whether
water
quality
parameters
are
associated
with
increased
prevalence
of
swimming­
related
health
effects.

The
estimated
annual
respondent
burden
for
this
study
is
5000
hours
and
$
73,606.
The
estimated
annual
agency
cost
for
conducting
this
study
is
11,102
hours
and
$
712,298.
This
study
requires
no
maintenance
of
records
by
the
respondents.

2.
NEED
FOR
AND
USE
OF
THE
INFORMATION
COLLECTION
2(
a)
NEED
/
AUTHORITY
FOR
THE
INFORMATION
COLLECTION
The
information
is
being
collected
as
a
part
of
a
research
program
to
identify
and
evaluate
exposure
to
and
effects
of
microbial
contaminants
of
recreational
water
as
part
of
the
U.
S.
Environmental
Protection
Agency's
research
program
on
exposure
and
health
effects
of
microbial
pathogens
in
recreational
waters.
The
Beaches
Act
of
2000
specifically
authorizes
such
studies
(
Appendix
A).

These
studies
will
provide
information
on
the
ability
of
water
quality
indicators
to
predict
health
effects
associated
with
recreational
exposures.
These
studies
will
also
provide
information
on
the
level
of
gastrointestinal
disease
and
other
related
illnesses
(
skin,
ear,
eye,
urinary
tract,
and
respiratory
infections)
in
adults
and
children
that
are
associated
with
marine
and
fresh
water
(
Great
Lakes)

recreational
exposures.

2(
b)
PRACTICAL
UTILITY
/
USERS
OF
THE
DATA
The
EPA's
Office
of
Research
and
Development,
the
Office
of
Water
and
the
Centers
for
Disease
Control
and
Prevention
will
use
the
information.
EPA
investigators
will
present
the
results
of
this
program
in
a
series
of
meetings
for
identified
stakeholders,
local
and
state
public
health
officials,
and
EPA
regional
scientists.
EPA
investigators
also
will
present
the
study
results
at
scientific
conferences
Page
3
and
will
prepare
one
or
more
scientific
papers
for
peer­
reviewed
publications.

These
peer­
reviewed
scientific
publications
may
be
used
by
EPA's
Office
of
Water
to
develop
water
quality
criteria
or
guidelines.
Every
attempt
will
be
made
to
identify
a
wide
range
of
marine
and
fresh
(
Great
Lakes)
water
beaches
so
the
sites
will
be
as
representative
as
is
technically
feasible.
Information
from
the
studies
may
be
useful
to
local
and
state
public
health
officials
in
the
design
and
implementation
of
a
beach
monitoring
and
closure
program.

3.
NONDUPLICATION,
CONSULTATIONS,
AND
OTHER
COLLECTION
CRITERIA.

3(
a)
NONDUPLICATION
The
questionnaires
do
not
duplicate
any
existing
information.
While
this
study
closely
follows
the
design
and
conduct
of
several
previous
studies
(
see
Appendix
G),
there
are
no
health
effects
studies
that
have
evaluated
swimming
related
illness
and
correlated
it
with
the
current
proposed
set
of
microbial
pathogen
indicators.

3(
b)
FEDERAL
REGISTER
NOTICE
This
is
the
second
announcement
of
a
public
comment
period
for
this
ICR.
The
first
Federal
Register
notice,
published
on
February
15,
2002
(
67
FR
7150).
See
Appendix
B
for
Text
copy
of
the
Federal
Register
notice.
Federal
Register
1
Online
via
GPO
Access
(
wais.
access.
gpo.
gov)
also
provides
a
copy.
Three
responses
to
the
Federal
Register
Notice
1
posting,
"
Health
Effects
of
Microbial
Pathogens
in
Recreational
Waters,"
were
received
by
April
16,
2002.
The
comments
are
summarized
and
addressed
below.
The
full
text
of
these
comment
can
be
found
in
Appendix
C.

The
beaches
selected
should
include
those
having
non­
point
sources
of
contamination
(
including
domestic
and
wildlife
contamination)
and
include
non­
beach
recreational
waters?

These
views
are
certainly
legitimate
and
have
support
from
the
scientific
community
and
from
the
EPA.

Although
the
addition
of
a
non­
point
source
or
a
non­
beach
study
would
certainly
provide
useful
information,
at
this
time
they
are
not
specifically
funded
by
the
current
legislation
of
the
Beaches
Environmental
Assessment
and
Coastal
Act
of
2000
(
Appendix
A).
EPA
has
interpreted
the
BEACH
Act
requirement
("
an
assessment
a
of
potential
human
health
risks
resulting
from
exposure
to
pathogens
in
coastal
recreation
waters,
including
non­
gastrointestinal
effects.")
to
mean
that
the
epidemiologic
studies
referenced
in
the
Federal
Register
should
identify
health
effects
of
swimming
in
coastal
beach
areas
(
Great
Lakes
and
marine
beaches)
where
the
study
can
access
and
interview
large
numbers
of
people
an
measure
subsequent
health
effects.
Although
all
types
of
contamination
are
of
importance,

the
coastal
water
requirement,
limited
funding,
and
EPA's
authority
to
regulate
point
sources
of
contamination
have
made
point
source
contaminated
beaches
(
known
and
well­
characterized
Page
4
contamination)
the
priority
study
sites.
However,
EPA
laboratories
are
aggressively
pursuing
new
methodologies
designed
to
differentiate
between
human
and
non­
human
sources
of
contamination.

Does
this
proposed
study
duplicate
previous
EPA
studies?

The
proposed
study
does
not
duplicate
prior
EPA
studies.
This
data
collection
is
for
a
series
of
epidemiological
studies
to
evaluate
exposure
to
and
effects
of
microbial
pathogens
in
marine
and
fresh
(
Great
Lakes)
recreational
waters
as
part
of
EPA's
research
program
on
exposure
and
health
effects
of
microbial
pathogens
in
recreational
waters.
The
results
of
these
health
effects
studies
will
be
used
to
document
human
health
effects
associated
with
recreational
water
use
and
correlate
these
health
effects
with
ongoing
EPA
studies
to
identify
a
new
generation
of
indicators
for
detection
of
human
pathogens
in
recreational
water
and
appropriate,
effective,
and
expeditious
testing
methods
for
these
indicators
(
addressed
separately
under
Section
3(
a)
(
v)
(
2
&
3)
of
the
Beaches
Environmental
Assessment
and
Coastal
Health
Act
of
2000).
No
prior
studies
have
attempted
to
correlate
health
effects
with
these
new
indicators
or
the
methods
utilized.
The
results
will
be
used
to
develop
mathematical
relationships
that
will
be
used
for
the
generation
of
new
national
water
quality
guidelines
and
appropriate
monitoring
guidelines.

The
ICR
should
specify
specific
indicators
and
methods
to
be
used.

The
purpose
of
the
ICR
was
to
announce
plans
for,
and
receive
comments
on,
the
health
effects
studies
that
will
focus
on
exposure
and
health
effects
of
swimmers
in
coastal
recreational
areas.
Its
purpose
was
epidemiologic
in
nature
and
was
not
intended
to
cover
the
EPA's
ongoing
National
Exposure
Research
Laboratory's
(
NERL)
program
to
develop
new
methods
and
indicators
for
recreational
water.

Because
there
are
other
potentially
reliable
indicators
other
that
the
accepted
standards
(
E.
coli,

enterococcus),
EPA
will
utilize
a
variety
of
new
indicators
and
methods
(
including
specific
chemical
indicators)
as
well
as
including
the
standard
E.
coli
and
enterococcus
testing.
These
studies
will
not
be
restricted
to
previously
approved
standards.
The
Beach
Act
of
2000
also
requires
other
action
beyond
the
epidemiologic
studies
referenced
in
this
ICR.
Other
goals
of
the
BEACH
Act
that
are
not
included
in
this
ICR
submission
include:
1)
provide
effective
microbial
indicators
for
testing
of
beach
water
quality,
2)
develop
rapid
protocols
for
monitoring
microbial
indicators
in
beach
waters,
and
3)

give
guidance
to
states
on
how
to
apply
these
new
criteria
to
recreational
waters.
EPA
will
strive
to
include
a
diverse
group
of
candidate
indicators
and
different
methodologies
(
candidate
rapid
tests
that
give
results
in
several
hours
will
be
included)
in
order
to
meet
partner
needs
for
a
new
generation
of
recreational
water
monitoring
guidelines.
At
this
time,
indicators
of
fecal
contamination
and
potential
agents
of
gastroenteritis
will
be
the
focus.
This
epidemiologic
study
will
also
gather
information
on
Page
5
non­
enteric
illness
that
may
give
some
insight
into
the
potential
for
development
of
indicators
for
nonenteric
illness.

It
is
difficult
to
evaluate
the
burden
of
this
study
based
on
the
Federal
Register
posting.

More
detail
has
been
added
to
the
revised
ICR,
which
can
be
requested,
and
the
Respondent
Burden
table
has
been
revised.

Data
analysis:
Will
the
data
be
analyzed
in
the
same
way
that
prior
EPA
studies
were
analyzed?

Since
the
completion
of
the
studies
by
Dufour
and
Cabelli,
developments
in
statistical
theory
and
the
availability
of
statistical
software
enable
the
investigation
of
other
approaches
to
analysis
in
order
to
obtain
the
best
possible
fit
and
shortest
prediction
intervals.
It
is
the
EPA's
intention
to
use
methods
that
do
clearly
depict
uncertainty
around
the
indicator
density
and
their
relationships
to
illness.

Model
fitting
analyses
performed
in
the
original
EPA
studies
by
Dufour
(
1984)
and
Cabelli
et
al.

(
1982)
were
based
on
grouped
data
using
least
squares
regression.
Developments
in
statistical
theory
and
in
the
availability
of
statistical
software
in
the
ensuing
years
will,
in
addition,
enable
the
investigation
of
other
approaches
to
analysis
in
order
to
obtain
the
best
possible
fit
and
shortest
prediction
intervals.

The
analysis
of
this
multilevel
study
will
be
conducted
in
two
stages.
In
the
first
stage,
the
adjusted
prevalence
of
the
health
outcome
of
interest
is
estimated
for
swimmers
and
non­
swimmers.
The
symptom
rate
as
a
difference
between
the
two
groups
is
calculated.
This
rate
difference
value
is
used
to
develop
a
statistical
relationship
with
water
quality
indicators.
In
the
second
stage
of
the
analysis,

the
uncertainty
of
the
beach
specific
estimates
of
illness
rates
for
swimmers
and
for
the
rate
difference
between
swimmers
and
non­
swimmers
will
be
evaluated
by
considering
linear
and
nonlinear
statistical
models
that
will
consider
adjustment
for
potential
confounders
such
as
age,
beach,
gender,
and
race.

Analyses
will
be
conducted
by
comparing
gastrointestinal
symptoms
and
illness
to
water
quality
parameters.
Regression
analysis
will
be
conducted
in
a
similar
manner
as
in
previous
studies
and
will
use
a
two­
step
analysis
to
correct
for
beach
variability.
In
the
first
step,
swimming
associated
illnessspecific
adjusted
logits
of
symptom
prevalence
will
be
calculated
from
a
logistic
regression
model
for
the
gastrointestinal
symptoms
of
interest
controlling
for
age,
sex,
family
size,
socioeconomic
status,
and
other
potential
confounders
(
other
recreational
exposures).
In
the
second
step,
these
beach­
specific
adjusted
logits
will
be
regressed
against
the
beach­
specific
water
pollutant
concentrations.

Water
quality
indicator
concentrations
for
each
methodology
would
be
entered
as
continuous
variables
into
the
model.
Water
pollution
concentrations
would
be
based
on
actual
measurements
at
Page
6
each
beach.
Direct
measurements
of
water
quality
pollution
concentration
at
all
beaches
will
be
conducted.
It
is
expected
the
monitoring
scheme
may
allow
the
development
of
models
to
consider
upper
and
lower
bound
parameters
for
inclusion
in
the
model.

Our
experience
with
the
new
water
quality
indicators
is,
to
date,
limited.
Current
assumptions
are
that
they
will
be
at
a
minimum
as
good
as,
if
not
better,
than
current
EPA
or
state
indicators
(
e.
g.,

enterococci,
E.
coli,
and
fecal
coliforms).

3(
c)
CONSULTATIONS
The
following
people
have
been
consulted:

Michael
Beach,
Epidemiologist,
CDC,
National
Center
for
Infectious
Diseases
Abdel
el­
Shaawari,
National
Water
Research
Institute,
Canada
Center
for
Inland
Waters,

Burlington,
Canada
David
Parkhurst,
Indiana
University,
School
of
Public
and
Environmental
Affairs,
Bloomington,

IN
Richard
O.
Gilbert,
Private
Consultant,
Rockville,
MD
Paul
Succop,
University
of
Cincinnati,
Cincinnati,
OH
Public
Meetings:
The
proposed
studies
have
been
publicly
discussed
at
the
following
meetings:

East
Coast
Regional
Beach
Conference
­
October
18­
19,
1999
West
Coast
Regional
Beach
Conference
­
August,
1999
Great
Lakes
Beach
Conference
­
February
5,
2000
The
response
from
these
individuals
and
organizations
has
been
favorable.

3(
d)
EFFECTS
OF
LESS
FREQUENT
COLLECTION
The
questionnaire
information
will
be
collected
only
once
during
the
summer
from
a
family.
This
factor,
therefore,
does
not
apply
to
this
study.

3(
e)
GENERAL
GUIDELINES
We
have
adhered
to
all
of
OMB's
general
guidelines.

3(
f)
CONFIDENTIALITY
We
will
adhere
to
all
standard
steps
to
maintain
confidentiality.
These
include
the
exclusion
of
personal
identifiers
from
the
database
following
completion
of
the
phone
interviews
and
storage
of
hard
copies
in
locked
files.
Contractor
involvement
will
be
monitored
by
requiring
hard
and/
or
electronic
copies
to
be
stored
at
EPA
after
the
contractor
has
completed
data
processing.
The
contractor
has
agreed
to
observe
the
rules
of
confidentiality
regarding
the
health
information
provided
by
individuals
and
their
families.
Page
7
3(
g)
SENSITIVE
QUESTIONS
No
questions
of
a
sensitive
nature
will
be
required.

4.
THE
RESPONDENTS
AND
THE
INFORMATION
REQUESTED
4(
a)
RESPONDENTS
/
SIC
CODES
This
study
will
be
conducted
among
families
who
are
at
the
selected
beaches
around
the
country.

Based
on
previous
studies,
it
is
anticipated
about
4500
families
will
be
enrolled
from
all
sites
in
a
single
recreational
season.

Children
constitute
a
susceptible
subpopulation
due
to
the
immaturity
of
their
immune
system
and
their
lack
of
lifetime
exposure
experience.
Pregnant
women
also
constitute
a
susceptible
subpopulation
for
severe
disease
due
to
dehydration
associated
with
gastroenteritis.

4(
b)
INFORMATION
REQUESTED
(
i)
Data
Items:

Each
questionnaire
will
ask
a
single
adult
member
of
the
family
to
provide
the
information
listed
for
all
members
of
the
family.
The
questionnaires
can
be
found
in
Appendix
D,
E
and
F.
The
requested
information
includes
questions
specific
to
past
illnesses,
recreational
experience,
other
risk
information
and
general
household
characteristics.

This
study
will
use
water
quality
monitoring
data
and
meteorologic
data
that
will
be
routinely
collected
by
EPA
and
EPA
contractors
under
separate
EPA
research
efforts.

There
are
no
maintenance
of
records
by
respondents
required
for
this
study.

(
ii)
Respondent
Activities
The
representative
member
of
the
family
will
be
given
a
brochure
describing
the
study's
risks
and
benefits
and
will
be
asked
for
verbal
consent
to
enroll
them
in
the
study.
The
families
will
be
interviewed
on
the
beach
and
then
will
be
followed
via
telephone
interview
4
to
7
days
later.
In
the
first
year,
a
second
follow­
up
10
to
14
days
after
the
initial
beach
visit
will
also
be
attempted.
The
utility
of
a
second
interview
will
be
reviewed
after
the
first
year
for
possible
deletion.

5.
THE
INFORMATION
COLLECTED
­­
AGENCY
ACTIVITIES,
COLLECTION
METHODOLOGY,
AND
INFORMATION
MANAGEMENT
5(
a)
AGENCY
ACTIVITIES
EPA's
Epidemiology
and
Biomarkers
Branch
and
an
EPA
contractor
will
be
responsible
for
administering
the
questionnaire,
answering
respondent
questions,
reviewing
respondent
answers,

developing
and
maintaining
the
database,
analyzing
the
data
and
storing
and
reviewing
the
data.

5(
b)
COLLECTION
METHODOLOGY
AND
MANAGEMENT
Page
8
The
initial
interview
questionnaire
that
contains
family
demographics
and
usual
beach
activities
will
be
collected
using
computer
assisted
technology
(
CATI)
that
contains
the
questionnaire
(
Appendix
D).

The
water
quality
measurements
will
be
collected
by
EPA's
National
Exposure
Research
Laboratory
under
a
separate
ongoing
EPA
research
project.
The
water
quality
parameters
will
include
real
time
measurement
of
fecal
indicators
(
e.
g.,
enterococci,
E.
coli,
chemical
indicators)
and/
or
measurement
of
fecal
indicators
and/
or
microbial
pathogens
with
methods
that
give
answers
in
two
hours
or
less.
Beach
monitoring
sites
will
be
selected
to
support
a
regulatory
program
and
are
located
in
areas
representative
of
geographic
differences
and
a
range
of
exposures
associated
with
point
source
fecal
contamination
of
recreational
waters.
These
sites
are
intended
to
support
an
epidemiological
study
and
therefore
have
been
designed
to
provide
sufficient
information
on
the
gradient
of
exposures
to
fecal
contamination
found
in
recreational
waters.
No
additional
burden
will
be
placed
on
the
local
water
pollution
agencies
in
the
selected
areas.

All
data
will
be
reviewed
for
unusual
or
unacceptable
values.
The
CATI
questionnaire
data
will
be
verified
through
the
daily
data
verification
programs.
Statistical
data
will
be
maintained
in
electronic
format
using
the
Statistical
Analysis
System
(
SAS).
We
will
control
access
to
the
data
in
accordance
with
Federal
privacy
regulations
and
OMB
Circular
A­
110.

5(
c)
IMPACT
ON
SMALL
BUSINESSES
OR
OTHER
SMALL
ENTITIES
The
procedures
for
beach
interview
and
follow­
up
telephone
interviews,
have
been
designed
to
minimize
the
burden
to
the
families
who
agree
to
participate
in
the
study.

5(
d)
COLLECTION
SCHEDULE
The
timeline
for
this
study
is
to
(
a)
conduct
pilot
studies
the
summer
of
2002,
(
b)
conduct
full
scale
studies
the
summers
of
2003,
2004
and
2005,
and
(
c)
collect
water
quality
measurements
at
the
beaches
concurrently
with
beach
interviews.
Preliminary
data
sets
will
be
delivered
by
the
end
of
December
for
each
recreational
season.
These
preliminary
data
sets
will
be
extensively
reviewed
for
quality
assurance
prior
to
any
analysis.

6.
ESTIMATING
THE
BURDEN
AND
COST
OF
THE
COLLECTION
6(
a).
ESTIMATING
RESPONDENT
BURDEN
Interview
&
Telephone
Follow­
up:
Based
on
consultation
with
the
individuals
listed
in
Section
3(
c),

and
our
experience
with
similar
types
of
information
collection,
we
estimate
that
each
family
will
spend
an
average
of
30
minutes
completing
the
beach
interview
and
will
require
no
record
keeping.
This
includes
the
time
for
reviewing
the
information
pamphlet
and
answering
the
questions.
We
estimate
that
each
family
will
spend
an
average
of
30
minutes
completing
the
first
home
telephone
interview
and
Page
9
20
minutes
completing
the
second
home
telephone
interview.
The
telephone
inteviews
will
require
no
record
keeping.

TABLE
1.
ESTIMATED
ANNUAL
RESPONDENT
BURDEN
Type
of
Respondent
Respondent
Activities
Estimated
Number
of
Respondents
Burden
Hours
Frequency
Annual
Reporting
Burden
Annual
Cost
X
14.72
Parent
Beach
Interview
4500
0.50
hr.
1
2250
hr
$
33,120
a
Parent
Complete
home
interview
I
(
80%)
3600
0.50
hr.
1
1800
hr
$
26,496
a
Parent
Complete
home
Interview
II
(
80%)
2880
0.33
hr.
1
950
hr
$
13,990
a
Totals
5,000
hr
$
73,606
a
$
14.72/
hour
(
average
hourly
wage)

ANNUAL
REPORTING
BURDEN:
5,000
hours
ANNUAL
RESPONDENT
COST:
$
73,606
NO
ANNUAL
RECORD
KEEPING
BURDEN
6(
b)
ESTIMATING
RESPONDENT
COSTS
Beach
Interview:
The
wage
estimate
for
the
parental
respondent
is
based
on
the
average
salary
for
women
who
work
full
time
reported
by
the
US
Bureau
of
Labor
and
Statistics
Employment
Cost
Trends
(
March
1999)
at
$
14.72
per
hour.
Given
the
0.50
hour
burden,
the
respondent
cost
for
each
family
is
$
7.36.
Home
Telephone
Interview
I:
The
wage
estimate
for
the
parental
respondent
is
based
on
average
salary
for
women
who
work
full
time
reported
by
the
US
bureau
of
Labor
and
Statistics
employment
Cost
Trends
(
March
1999)
at
$
14.72
per
hour.
Given
the
0.50
hour
burden,
the
respondent
cost
for
each
family
is
$
7.36.
Home
Telephone
Interview
II:
The
wage
estimate
for
the
parental
respondent
is
based
on
average
salary
for
women
who
work
full
time
reported
by
the
US
bureau
of
Labor
and
Statistics
employment
Cost
Trends
(
March
1999)
at
$
14.72
per
hour.
Given
the
0.33
hour
burden,
the
respondent
cost
for
each
family
is
$
4.85.
NO
CAPITAL
COSTS
ARE
INVOLVED.

NO
O&
M
COSTS
ARE
INVOLVED.
Page
10
6(
c)
ESTIMATING
AGENCY
BURDEN
AND
COST
TABLE
2.
AGENCY
COST
ANNUAL
BURDEN
Burden
Hours
Cost
($)

AGENCY
ACTIVITIES
Contractor
EPA
Freq
Total
Hours
Contractor
$
66/
hr
EPA
$
49/
hr
Prepare
and
format
questionnaires
60.00
80.00
1
140.00
$
3,960
$
3,920
Prepare
computers
120.00
8.00
1
128.00
$
7,920
$
392
Plan
logistics
&
coordination
40.00
40.00
8
640.00
$
21,120
$
15,680
Recruit
and
interview
on
beach
480.00
60.00
8
4320.00
$
253,440
$
23,520
Telephone
interview
I
160.00
0.00
8
1280.00
$
84,480
$
0
Telephone
interview
II
160.00
0.00
8
1280.00
$
84,480
$
0
Prepare
statistical
data
sets
and
reports
160.00
0.00
1
160.00
$
10,560
$
0
Collect/
analyze
water
quality
data
240.00
8.00
8
1984.00
$
126,720
$
3,136
IRB
package
preparation
&
submission
40.00
10.00
1
50.00
$
2,640
$
490
Quality
Assurance
&
Quality
Control
40.00
10.00
8
400.00
$
21,120
$
3,920
Convert
data
to
electronic
form
10.00
0.00
8
80.00
$
5,280
$
0
Perform
statistical
analysis
480.00
160.00
1
640.00
$
31,680
$
7,840
11102.00
$
653,400
$
58,898
AGENCY
TOTAL
ANNUAL
BURDEN:
11,102
hours
AGENCY
TOTAL
ANNUAL
COST:
$
653,400
+$
58,898
=$
712,298
These
agency
burden
estimates
were
based
on
our
prior
experience
in
developing
and
gathering
information
for
research
purposes.
The
agency
costs
have
been
based
on
a
GS­
13(
6)
for
the
primary
investigator
and
include
benefits.
The
contractor
costs
are
based
on
a
composite
cost
given
the
people
needed
to
conduct
this
study.

Estimated
annualized
hours
and
costs
could
be
over
estimated
by
33%.

6(
d)
ESTIMATING
THE
RESPONDENT
UNIVERSE
AND
TOTAL
BURDEN
AND
COSTS
Based
on
previous
studies
conducted
in
the
1970s
and
1980s,
we
estimate
that
the
respondent
universe
for
each
recreational
water
season
is
4500
families
for
the
beach
interview,
3600
telephone
interview
follow­
up
and
2880
for
the
second
telephone
follow­
up
(
assuming
80%
completion
rates).
Thus
the
total
estimated
respondent
burden
for
this
study
is
5,000
hours
from
4500
families
and
$
73,606.

6(
e)
BOTTOM
LINE
BURDEN
HOURS
AND
COSTS
/
BURDEN
TABLES
The
estimated
respondent
burden
for
this
study
is
5,000
hours
and
$
73,606.
The
estimated
agency
cost
for
Page
11
conducting
this
study
is
11,102
hours
and
$
712,298.

6(
f)
BURDEN
STATEMENTS
Beach
Interview:
Parental
reporting
burden
for
this
collection
of
information
is
estimated
to
average
30
minutes
and
will
require
no
record
keeping.
This
includes
the
time
for
reviewing
the
informational
brochure,

obtaining
verbal
consent,
and
answering
the
questions.

Telephone
Interview
Follow­
up:
The
respondent's
reporting
burden
for
this
collection
of
information
is
estimated
to
average
30
minutes
per
family.
This
includes
times
for
reviewing
information
collected
on
the
beach
and
answering
questions.

Telephone
Interview
Follow­
up
II:
The
respondent's
reporting
burden
for
this
collection
of
information
is
estimated
to
average
20
minutes
per
family.
This
includes
times
for
reviewing
information
collected
on
the
first
telephone
interview
and
answering
questions.

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
are
listed
in
40
CFR
Part
9
and
48
CFR
Chapter
15.

Send
comments
on
the
Agency's
need
for
this
information,
the
accuracy
of
the
provided
burden
estimates,

and
any
suggested
methods
for
minimizing
respondent
burden,
including
through
the
use
of
automated
collection
techniques
to
the
Director,
Collection
Strategies
Division,
U.
S.
Environmental
Protection
Agency
(
2822T),
1200
Pennsylvania
Ave.,
NW,
Washington,
D.
C.
20460;
and
to
the
Office
of
Information
and
Regulatory
Affairs,

Office
of
Management
and
Budget,
725
17th
Street,
NW,
Washington,
DC
20503,
Attention:
Desk
Officer
for
EPA.
Include
the
EPA
ICR
number
2081.01
and
OMB
control
number
in
any
correspondence.
Page
12
B.
STATISTICAL
APPROACH
1.
SURVEY
OBJECTIVES,
KEY
VARIABLES,
AND
OTHER
PRELIMINARIES
1(
a)
SURVEY
OBJECTIVES
The
objective
of
the
study
is
to
conduct
health
effects
studies
to
evaluate
exposure
to
microorganisms
in
recreational
waters
and
their
subsequent
health
effects.
The
beaches
will
be
chosen
to
consider
a
range
of
exposures
and
will
primarily
consider
fecal
contamination
from
point
sources
(
e.
g.,
sewage
treatment
plants).

For
the
first
year,
preliminary
pilot
work
will
be
done
at
a
single
beach.
Subsequent
years
of
study
will
evaluate
three
or
four
beaches.
Current
estimates
are
that
a
minimum
of
three
marine
beaches
will
be
evaluated
and
a
minimum
of
six
fresh
water
beaches
will
be
evaluated.
The
results
of
these
health
effects
studies
will
be
used
to
document
human
health
effects
associated
with
recreational
water
use
and
correlate
these
health
effects
with
ongoing
EPA
studies
to
identify
a
new
generation
of
indicators
for
detection
of
human
pathogens
in
recreational
water
and
appropriate,
effective,
and
expeditious
testing
methods
for
these
indicators
(
addressed
separately
under
Section
3(
a)
(
v)
(
2
&
3)
of
the
Beaches
Environmental
Assessment
and
Coastal
Health
Act
of
2000).
The
results
will
be
used
to
develop
mathematical
relationships
that
will
be
used
for
the
generation
of
new
national
water
quality
guidelines
and
appropriate
monitoring
guidelines.

1(
b)
KEY
VARIABLES
The
beach
interview
will
collect
the
standard
demographic
variables
of
age,
race
and
gender.
The
survey
will
collect
the
health
information
mentioned
below
in
Section
B.
2
(
d)
Questionnaire
Design
.
Questionnaires
can
be
found
in
Appendices
D,
E,
F.

1(
c)
STATISTICAL
APPROACH
The
health
status
of
the
study
population
will
be
evaluated
along
with
the
water
quality
in
the
local
beach
area
in
which
they
will
be
visiting.
Statistical
associations
between
health
effects
and
water
quality
parameters
will
be
calculated.
The
targeted
population
will
be
families
with
children
approximately
age
2
to
10.
The
sampling
base
may
change
for
each
beach
depending
on
size.
The
families
will
be
identified
as
such
by
the
beach
interviewers.
A
single
respondent
that
is
an
adult
member
of
the
household
(
e.
g.,
mother)
will
be
asked
to
participate
in
the
study.

The
proposed
data
collection
is
designed
as
a
multilevel
analytic
study
(
also
called
semi­
ecological
or
semiindividual
using
both
ecological
level
information
on
environmental
exposures
and
individual
level
information
on
health
status
and
potential
confounders.
The
multilevel
design
has
particular
utility
whenever
a
common
environmental
exposure
is
shared
by
individuals
clustered
within
a
geographic
area.
The
questionnaire
obtains
individual
level
information
on
health
status
and
potential
confounders,
such
as
age,
sex,
race,
Hispanic
status,

housing
characteristics,
family
characteristics
and
behaviors,
and
other
variables.
Environmental
exposures
are
to
be
independently
measured
for
each
beach­
based
cluster.
Page
13
1(
d)
FEASIBILITY
Obstacles:
Based
on
previous
experience
with
beach
studies,
the
major
problem
has
been
non­
response
primarily
related
to
catching
families
just
prior
to
leaving
the
beach
area.
This
is
usually
improved
by
providing
a
minimal
incentive
to
participate
such
as
a
beach
ball,
cooler,
or
tote
bag.

Sufficient
funds:
This
study
has
been
budgeted
with
sufficient
funds
for
the
first
year
of
pilot
work.

Remaining
years
of
funding
have
been
requested
and
is
pending
the
budget
process.
In
the
event
a
dramatic
cut
in
the
beaches
research
program
were
to
take
place,
the
study
could
be
downsized
to
fewer
beaches.

Time
line:
The
beach
studies
will
be
completed
by
the
end
of
September
of
the
appropriate
recreational
season.
Processing
of
recreational
season
data
sets
will
be
completed
by
December
of
the
same
calendar
year.

2.
SURVEY
DESIGN
2(
a)
Target
Population
and
Coverage
The
target
population
for
this
study
will
be
families
with
children
ages
2
to
10
exposed
to
various
levels
of
water
pollutants
from
point
sources
at
fresh
(
Great
Lakes)
and
marine
beaches
in
the
continental
United
States.

2(
b)
Sample
Design
(
i)
Sampling
frame.

The
sampling
frame
will
be
families
on
the
beach
currently
being
monitored.
The
beaches
that
will
be
monitored
must
have
historical
data
suggesting
the
appropriate
population
size
to
support
sampling
families.
It
is
estimated
80­
125
families
per
weekend
per
site
will
be
needed.

(
ii)
Sample
size.

The
sample
size
for
this
study
is
constrained
by
the
numbers
of
families
visiting
the
beach
under
consideration.
From
earlier
studies,
we
estimate
that
this
sample
size
will
provide
90%
power
to
detect,
with
95%

confidence,
the
expected
association
between
water
quality
indicators
and
associated
gastrointestinal
health
effects.

(
iii)
Stratification
variables.

The
primary
variables
used
for
stratification
will
be
demographic
variables.
Additional
stratification
may
be
assessed
by
beach,
by
level
of
water
exposure,
and
by
level
of
water
quality
indicator
if
the
data
is
robust
enough
for
such
analysis.
Our
experience
to
date
is
limited
with
the
new
water
quality
indicators.
Current
assumptions
are
that
they
will
be
at
a
minimum
as
good
as,
if
not
better,
than
current
EPA
or
state
indicators
(
e.
g.,
enterococci,
E.
coli,
and
fecal
coliforms).

(
iv)
Sampling
method.

A
complete
sample
of
all
eligible
families
for
each
day
and
beach
under
study
will
be
attempted.

(
v)
Multi­
stage
sampling.

Not
applicable.

2(
c)
PRECISION
REQUIREMENTS
Page
14
(
i)
Precision
targets.

The
survey
is
designed
to
show,
with
80%
confidence,
the
statistical
relationship
associated
specifically
with
a
water
quality
indicator.

(
ii)
Non­
sampling
error.

Most
health
and
epidemiology
studies
are
concerned
with
errors
resulting
from
the
misclassification
of
both
disease
and
exposure.
Exposure
misclassification
will
be
minimized
by
collecting
water
quality
measurements
on
new
indicators.
The
precision
or
predictability
of
the
new
indicators
is
estimated
to
be
at
least
as
good
as
the
previous
indicators.
There
is
some
concern
over
misclassification
of
gastrointestinal
symptoms
and
illness
since
we
are
relying
on
self­
reporting.
The
standard
practice
to
account
for
this
potential
error
has
been
to
weigh,
or
place
the
reporting
of
symptoms,
in
categories
of
credibility.
Groups
of
symptoms
reported
together
are
more
credible,
and
symptoms
that
require
a
person
to
alter
their
normal
routine
(
stay
home,
stay
in
bed
or
seek
medical
care)
are
the
most
credible.
Although
some
parents
may
fail
to
fully
report
gastrointestinal
symptoms
and
illness
among
their
children,
the
propensity
to
report
should
not
be
associated
with
the
exposures
of
interest.
Parental
under­
reporting
of
gastrointestinal
conditions
that
are
not
associated
with
the
exposures
of
interest
(

nondifferential
misclassification)
will
reduce
the
statistical
power
of
the
study,
and
bias
the
observed
association
of
interest
towards
the
null
(
no
difference)
and
therefore
increase
the
variance
in
the
modeled
relationship
between
illness
and
water
quality
indicator.

Confounding
of
the
association
of
interest
is
always
an
important
issue
in
observational
studies.

Any
determinant
of
the
health
outcome
of
interest
that
is
non­
causally
associated
with
the
exposure
of
interest
may
confound
the
association
under
study.
Since
the
children
in
this
study
have
not
been
randomly
assigned
to
differing
recreational
water
exposures,
differences
in
the
distribution
of
various
independent
determinants
of
gastrointestinal
disease,
across
the
study
area,
may
be
potential
confounders.
As
detailed
below,
a
substantial
portion
of
the
questionnaire
is
devoted
to
the
determination
of
information
on
potential
confounders.

2(
d)
QUESTIONNAIRE
DESIGN
The
two
data
collection
instruments
in
this
study
each
serve
a
unique
purpose.
The
first
is
the
beach
interview
which
establishes
eligibility
to
participate
in
the
study,
recreational
habits
at
the
beach,
and
background
demographic
information.
The
telephone
interview
is
to
verify
key
pieces
of
information
in
the
beach
interview,

obtain
symptom
and
illness
information
and
determine
other
exposures
that
may
confound
the
association
(
e.
g.,

other
recreational
exposures).
Copies
of
the
beach
interview
and
the
two
telephone
follow­
up
surveys
are
included
in
Appendix
D,
E,
and
F,
respectively.
The
interview
forms
may
be
modified
based
on
piloting
and
use
during
the
2002
season.

The
personal
identifying
information
in
the
beach
interview
(
name,
address,
phone
number,
time
to
call
for
follow­
up)
are
required
to
ensure
efficient
follow­
up.
This
information
will
be
recorded
electronically
since
the
interview
will
be
done
using
Computer
Assisted
Technology
Application
(
CATI)
and
hence
allows
for
preserving
Page
15
confidentiality
through
limited
access
data
files.
The
personal
identifying
information
will
not
become
part
of
the
statistical
data
base.

For
each
member
of
the
family
it
is
important
to
determine
the
members
of
the
family,
their
age,
sex
,
ethnic
status,
race
and
recreational
and
beach
activities.
These
variables
are
all
potential
confounders
of
the
association
of
interest.
The
information
on
the
beach
visit
date
and
the
participant
birth
dates
will
allow
us
to
check
the
direct
parental
report
of
all
family
member
ages.
Previous
work
has
suggested
little
association
between
gastrointestinal
illness
and
race
or
ethnicity,
however
these
studies
will
be
collecting
information
on
non­
gastrointestinal
illness
(
e.
g.,
urinary
tract,
skin,
respiratory,
eye
and
ear)
associated
with
recreational
water
exposures
and
there
has
been
some
reporting
of
racial
differences
associated
with
those
illnesses.

The
telephone
follow­
up
requests
information
about
several
common
gastrointestinal,
urinary
tract,

respiratory,
eye,
ear
and
skin
conditions
(
diarrhea,
vomiting,
respiratory
problems,
runny
nose,
ear
infections
and
skin
infections).

The
questions
in
the
current
household
members
section
are
all
related
to
potential
confounders.
Number
of
rooms
per
household
is
an
indicator
of
socioeconomic
status.

Style
of
questions
Most
questions
have
forced
choice
between
multiple
responses
or
two
choices
(
Yes,
No).
The
number
of
free
form
questions
are
limited
to
facilitate
the
CATI
process.

Purpose
of
questions
The
outcomes
of
interest
are
determined
by
questions
on
common
gastrointestinal,
urinary
tract,
respiratory,

eye,
ear
and
skin
conditions.

Potential
confounders
include
age,
sex,
ethnic
status
and
race
;
severe
preexisting
health
conditions
of
participants;
and
socioeconomic
status
as
indicated
by
the
family's
residence,
or
family
size.
We
also
examine,

as
potential
confounders,
other
recreational
exposures,
eating
out,
contact
with
animals,
children
in
diapers
and
other
ill
individuals.

3.
PRETESTS
AND
PILOT
TESTS
The
beach
interview
is
based
on
previous
questionnaires
used
in
the
studies
conducted
by
EPA
in
the
1970s
and
1980s.
In
addition,
the
questions
have
been
compared
to
and
when
possible
modifications
made
to
be
compatible
with
the
Centers
for
Disease
Control,
National
Center
for
Infectious
Diseases
FoodNet
survey.
In
addition,
similar
questions
have
been
used
in
drinking
water
studies
(
ref
Payment
1,
Payment
2,
Calderon,

Colford).
Respiratory
symptoms
have
been
adapted
from
the
Epidemiology
Standardization
Project
of
the
American
Thoracic
Society
and
the
Division
of
Lung
Diseases.
The
questionnaire
will
be
evaluated
after
the
beach
trials
in
2002.
Modifications
may
be
made
based
on
that
experience.
It
is
anticipated
that
most
of
the
modifications
will
come
in
the
area
of
questions
on
non­
gastrointestinal
illnesses
and
symptoms.

4.
COLLECTION
METHODS
AND
FOLLOW­
UP
Page
16
4(
a)
COLLECTION
METHODS
An
informational
meeting
will
be
held
at
each
beach
site
to
explain
the
study.
It
will
include
EPA
regional
scientist(
s),
identified
state
officials,
the
local
public
health
officer
(
if
the
beach
is
not
federal
or
state
managed),

and
other
interested
persons.
After
the
meeting,
a
letter
of
endorsement
will
be
requested
from
the
party
charged
with
managing
the
recreational
site.
In
the
stakeholder
meetings
held
by
EPA,
many
potential
beaches
have
expressed
an
interest
in
having
their
beaches
chosen
for
study.

Beach
interviews
will
be
done
on
Friday,
Saturday,
Sunday,
and
Mondays
during
the
recreational
season
(
June
to
mid
September
depending
on
the
geographic
location).
Trained
interviewers
will
be
deployed
on
the
beach
and
will
visually
identify
families
eligible
to
participate.
Interviews
will
begin
late
morning
to
late
afternoon
to
try
and
catch
families
just
prior
to
their
leaving
the
beach
for
the
day.
Other
types
of
recruitment
such
as
partial
recruitment
on
the
beach
and
then
having
the
family
stop
by
an
interview
center
near
the
parking
area
at
the
beach
will
be
considered
in
the
first
year.

Four
to
seven
days
from
leaving
the
beach,
families
will
be
recontacted
by
telephone
at
the
agreed
upon
time.
Health
status
and
confirmation
of
recreational
and
other
potential
exposures
will
be
obtained
over
the
phone.
An
additional
follow­
up
will
be
attempted
10­
14
days
after
visiting
the
beach.
This
second
interview
will
be
evaluated
the
first
year
as
to
efficiency
and
value
of
information.
This
second
follow­
up
is
based
on
discussions
with
CDC
and
based
on
acknowledgment
of
microbial
pathogens
that
have
incubation
periods
longer
than
the
four
to
seven
days
used
for
the
first
telephone
interview
(
e.
g.,
Cryptosporidum
has
a
mean
incubation
period
of
7
days).

4(
b)
SURVEY
RESPONSE
AND
FOLLOW­
UP
Response
rates
to
the
beach
interview
have
historically
ranged
from
60
to
80%
among
those
families
eligible.

The
follow­
up
response
rate
is
estimated
to
average
80%
for
the
whole
study.
Similar
studies
in
the
United
Kingdom,
Hong
Kong
and
Canada
have
had
similar
response
rates
using
a
similar
study
design
and
methodology.

5.
ANALYZING
AND
REPORTING
SURVEY
RESULTS
5(
a)
DATA
PREPARATION
The
completed
interviews
will
verify
that
data
submitted
is
internally
consistent,
as
entered.
The
CATI
program
will
flag
missing
items
prior
to
terminating
the
interview
and
will
also
flag
erroneous
responses
as
well
to
allow
the
interviewer
to
obtain
the
correct
information
while
interviewing
the
family.
The
CATI
system
will
also
eliminate
errors
associated
with
data
entry.

5(
b)
ANALYSIS
The
analysis
of
a
multilevel
study
is
conducted
in
two
stages.
In
the
first
stage,
the
adjusted
prevalence
of
the
health
outcome
of
interest
is
estimated
for
swimmers
and
non­
swimmers.
The
symptom
rate
as
a
difference
between
the
two
groups
is
calculated.
This
rate
difference
value
is
used
to
develop
a
statistical
relationship
with
Page
17
water
quality
indicators.
In
the
second
stage
of
the
analysis,
the
uncertainty
of
the
beach­
specific
estimates
of
illness
rates
for
swimmers
and
for
the
rate
difference
between
swimmers
and
non­
swimmers
will
be
evaluated
by
considering
linear
and
nonlinear
statistical
models
that
will
consider
adjustment
for
potential
confounders
such
as
age,
beach,
gender
and
race.

Analyses
will
be
conducted
by
comparing
gastrointestinal
symptoms
and
illness
to
water
quality
parameters.
Regression
analysis
will
be
conducted
in
a
similar
manner
as
in
previous
studies
and
will
use
a
twostep
analysis
to
correct
for
beach
variability.
In
the
first
step,
swimming
associated
illness­
specific
adjusted
logits
of
symptom
prevalence
will
be
calculated
from
a
logistic
regression
model
for
the
gastrointestinal
symptoms
of
interest
controlling
for
age,
sex,
other
potential
confounders
(
other
recreational
exposures)
and
family
size.
In
the
second
step,
these
beach­
specific
adjusted
logits
will
be
regressed
against
the
beach­
specific
water
pollutant
concentrations.

Water
quality
indicator
concentrations
for
each
methodology
would
be
entered
as
continuous
variables
into
the
model.
Water
pollution
concentrations
would
be
based
on
actual
measurements
at
each
beach.
Direct
measurements
of
water
quality
pollution
concentrations
at
all
beaches
will
be
conducted.
It
is
expected
the
monitoring
scheme
may
allow
the
development
of
models
to
consider
upper
and
lower
bound
parameters
for
inclusion
in
the
model.

In
our
subsequent
publications,
we
will
explicitly
report
the
results
for
associations
between
health
characteristics
and
(
a)
the
directly
measured
concentrations
for
all
beaches
and
(
b)
the
modeled
concentrations
as
a
summary
for
all
marine
beaches
together
and
all
fresh
water
beaches
together.
This
will
allow
an
assessment
of
the
role
of
the
modeling
of
water
quality
indicator
concentrations
on
our
results.

5(
c)
REPORTING
RESULTS
A
report
on
each
of
the
beaches
water
quality
monitoring
data
will
be
developed
and
available
to
the
managers
of
the
beach,
as
well
as
appropriate
state
authorities
if
the
beach
is
not
a
state
managed
beach.
At
the
completion
of
the
entire
program,
an
overall
report
will
be
produced
that
synthesizes
all
the
information.
An
EPA
report
will
be
produced
for
Agency
and
public
use.
A
manuscript
for
each
recreational
season
will
be
submitted
for
publication
in
a
peer­
reviewed
scientific
journal.
Page
18
APPENDIX
A:
Clean
Water
Act
Beaches
Environmental
Assessment
and
Coastal
Health
Act
of
2000
(
Public
Law
106­
284
 
October
10,
2000)

TITLE
42
­
PUBLIC
HEALTH
CHAPTER
85
­
FEDERAL
WATER
POLLUTION
CONTROL
ACT
Section
303.
Revisions
to
water
quality
criteria
(
a)
STUDIES
CONCERNING
PATHOGEN
INDICATORS
IN
COASTAL
RECREATION
WATERS.
­

Section
104
of
the
Federal
Water
Pollution
Control
Act
(
33
U.
S.
C.
1254)
is
amended
by
adding
at
the
end
the
following:

(
v)
STUDIES
CONCERNING
PATHOGEN
INDICATORS
IN
COASTAL
RECREATION
WATERS.
 
Not
later
than
18
months
after
the
date
of
the
enactment
of
this
subsection,
after
consultation
and
in
cooperation
with
appropriate
Federal,
State,
tribal,
and
local
officials
(
including
local
health
officials),
the
Administrator
shall
initiate,
an,
not
later
than
3
years
after
the
date
of
the
enactment
of
this
subsection,
shall
complete,
in
cooperation
with
the
heads
of
other
Federal
agencies,
studies
to
provide
additional
information
for
use
in
developing:

(
1)
an
assessment
of
potential
human
health
risks
resulting
from
exposure
to
pathogens
in
coastal
recreation
waters,
including
nongastrointestinal
effects;

(
2)
appropriate
and
effective
indicators
for
improving
detection
in
a
timely
manner
in
coastal
recreation
waters
of
the
presence
of
pathogens
that
are
harmful
to
human
health;

(
3)
appropriate,
accurate,
expeditious,
and
cost­
effective
methods
(
including
predictive
models)
for
detecting
in
a
timely
manner
in
coastal
recreation
waters
the
presence
of
pathogens
that
are
harmful
to
human
health;
and
(
4)
guidance
for
State
application
of
criteria
for
pathogens
and
pathogen
indicators
to
be
published
under
Section
304(
a)(
9)
to
account
for
the
diversity
of
geographic
and
aquatic
conditions.
Page
19
APPENDIX
B:
Federal
Register
1
[
Federal
Register:
February
15,
2002
(
Volume
67,
Number
32)]

[
Notices]

[
Page
7150­
7151]

From
the
Federal
Register
Online
via
GPO
Access
[
wais.
access.
gpo.
gov]

[
DOCID:
fr15fe02­
68]

=======================================================================

­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

ENVIRONMENTAL
PROTECTION
AGENCY
[
FRL­
7146­
6]

Office
of
Research
and
Development;
Agency
Information
Collection
Activities:
Proposed
Collection;
Comment
Request;
Health
Effects
of
Microbial
Pathogens
in
Recreational
Waters
AGENCY:
Environmental
Protection
Agency
(
EPA).

ACTION:
Notice.

­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

SUMMARY:
In
compliance
with
the
Paperwork
Reduction
Act
(
44
U.
S.
C.
3501
et
seq.),
this
notice
announces
that
the
EPA
is
planning
to
submit
the
following
Information
Collection
Request
(
ICR)
to
the
Office
of
Management
and
Budget
(
OMB).

TITLE:
Health
Effects
of
Microbial
Pathogens
in
Recreational
Waters.

Before
submitting
the
ICR
to
OMB
for
review
and
approval,
the
EPA
is
soliciting
comments
on
specific
aspects
of
the
proposed
information
collection
as
described
below.

DATES:
Comments
must
be
submitted
on
or
before
April
16,
2002.

ADDRESSES:
Public
comments
should
be
submitted
to:
Dr.
Rebecca
L.

Calderon,
US
EPA
(
M
D
58­
C),
Research
Triangle
Park,
NC
27711.

FOR
FURTHER
INFORMATION
CONTACT:
Interested
persons
may
obtain
a
copy
of
the
ICR
without
charge
by
contacting:
Dr.
Rebecca
L.
Calderon,
(
919)

966­
0617,
FAX:
(
919)
966­
0655,
E­
mail:

calderon.
rebecca@
epamail.
epa.
gov,
or
by
mailing
a
request
to
the
address
above.
Page
20
SUPPLEMENTARY
INFORMATION:

Affected
entities:
Entities
potentially
affected
by
this
action
are
families
frequenting
fresh
and
marine
water
beaches
in
the
continental
United
States.

Title:
Health
Effects
of
Microbial
Pathogens
in
Recreational
Waters.

Abstract:
This
study
will
be
conducted,
and
the
information
collected,
by
the
Epidemiology
and
Biomarkers
Branch,
Human
Studies
Division,
National
Health
and
Environmental
Effects
Research
Laboratory,
Office
of
Research
and
Development,
U.
S.
Environmental
Protection
Agency
(
EPA).
Participation
of
adults
and
children
in
this
collection
of
information
is
strictly
voluntary.

This
information
is
being
collected
as
part
of
a
research
program
consistent
with
the
Sec.
3(
a)(
v)(
1)
of
the
Beaches
Environmental
Assessment
and
Coastal
Health
Act
of
2000
and
the
strategic
[[
Page
7151]]

plan
for
EPA's
Office
of
Research
and
Development
(
ORD)
and
the
Office
of
Water
entitled
  
Action
Plan
for
Beaches
and
Recreational
Water.''

The
Beaches
Act
and
ORD's
strategic
plan
has
identified
research
on
effects
of
microbial
pathogens
in
recreational
waters
as
a
high­

priority
research
area
with
particular
emphasis
on
developing
new
water
quality
indicator
guidelines
for
recreational
waters.
The
EPA
has
broad
legislative
authority
to
establish
water
quality
criteria
and
to
conduct
research
to
support
these
criteria.
This
data
collection
is
for
a
series
of
epidemiological
studies
to
evaluate
exposure
to
and
effects
of
microbial
pathogens
in
marine
and
fresh
recreational
waters
as
part
of
the
EPA's
research
program
on
exposure
and
health
effects
of
microbial
pathogens
in
recreational
waters.
The
research
plan
includes
piloting
the
collection
of
both
recreational
information
and
water
quality
information
during
the
summer
months
of
2002.
Multiple
sites
with
refined
study
design
will
be
conducted
in
2003,
2004
and
2005.
The
information
collected
by
this
study
program
will
be
used
to
estimate
the
relationship
between
water
quality
indicators
and
health
effects.

The
questionnaire
health
data
will
be
compared
with
routinely
collected
water
quality
measurements.
The
analysis
will
focus
on
determining
whether
any
water
quality
parameters
are
associated
with
increased
prevalence
of
swimming­
related
health
effects.

Burden
Statement
Burden
means
the
total
time,
effort,
or
financial
resources
Page
21
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.

Table
1.­­
Estimated
Annual
Respondent
Burden
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

Estimated
Annual
Type
of
respondent
Respondent
number
of
Burden
Frequency
reporting
Annual
cost
activities
respondents
hours
burden
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

Parent.........................
Beach
Interview...
1500
0.40
1
600
\
a\
$
8,832
Parent.........................
Complete
home
1200
0.33
1
396
\
a\
5,830
interview
I
(
80%).

Parent.........................
Complete
home
960
0.17
1
163
2,400
interview
II
(
80%).

­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

Totals.....................
..................
...........
.........
.........
1,159
hr
17,062
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

\
a\
$
14.72/
hour
(
average
hourly
wage).

There
are
no
direct
respondent
costs
for
this
data
collection.

No
Annual
Record
Keeping
Burden
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
are
listed
in
40
CFR
part
9
and
48
CFR
chapter
15.

The
EPA
would
like
to
solicit
comments
to:

(
i)
Evaluate
whether
the
proposed
collection
of
information
is
necessary
for
the
proper
performance
of
the
functions
of
the
agency,

including
whether
the
information
will
have
practical
utility;

(
ii)
Evaluate
the
accuracy
of
the
agency's
estimate
of
the
burden
of
the
proposed
collection
of
information,
including
the
validity
of
the
methodology
and
assumptions
used;
Page
22
(
iii)
Enhance
the
quality,
utility,
and
clarity
of
the
information
to
be
collected;
and
(
iv)
Minimize
the
burden
of
the
collection
of
information
on
those
who
are
to
respond,
including
through
the
use
of
appropriate
automated
electronic,
mechanical,
or
other
technological
collection
techniques
or
other
forms
of
information
technology,
e.
g.,
permitting
electronic
submission
of
responses.

Dated:
February
4,
2002.

Linda
Birnbaum,

Director,
Human
Studies
Division,
National
Health
&
Environmental
Effects
Research
Laboratory,
Office
of
Research
and
Development.

[
FR
Doc.
02­
3771
Filed
2­
14­
02;
8:
45
am]

BILLING
CODE
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P
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February
15,
2002
11:
03:
33
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Day­
15/
w3771.
htm
Page
23
APPENDIX
C:
Comments
and
Response
to
Federal
Register
I
Rebecca
Calderone
US
Environmental
Protection
Agency
RE:
Health
Effects
of
Microbial
Pathogens
in
Recreational
Waters
April
12,
2002
Dear
Ms.
Calderone
The
has
reviewed
a
document
entitled
"
Health
Effects
of
Microbial
Pathogens
in
Recreational
Waters.
We
wholeheartedly
support
the
this
study
and
are
pleased
to
note
that
health
outcomes
such
as
skin,
eye
and
ear
infections
in
addition
to
gastrointestinal
issues,
will
be
included.
We
do,
however,
have
some
concerns
that
need
to
be
addressed
in
the
protocol.

It
appears
that
this
study
will
only
be
conducted
at
beaches
with
known
point
sources
of
pollution.
It
is
important
that
studies
also
be
conducted
at
beaches
with
non­
point
sources,
especially
where
the
contamination
is
of
non­
human
origin.

The
protocol
states
that
the
"
water
quality
parameters
will
include
real
time
measurement
of
fecal
indicators
(
e.
g.
enterococci)
and
or
measurement
of
fecal
indicators
and/
or
microbial
pathogens
with
methods
that
give
answers
in
two
hours
or
less."
The
organisms
that
will
be
reviewed
should
be
specified
within
the
protocol.
In
addition,
we
are
unaware
of
any
testing
for
those
indicators
commonly
associated
with
bathing
water
quality
that
will
provide
results
within
two
hours
that
are
presently
approved.

Thank
you
for
your
consideration
Page
24
April
16,
2002
Dr.
Rebecca
L.
Calderon
U.
S.
Environmental
Protection
Agency
(
M
D
58­
C)
Research
Triangle
Park,
NC
27711
SUBJECT:
Comments:
EPA's
Health
Effects
of
Microbial
Pathogens
in
Recreational
Waters;
Federal
Register:
February
15,
2002
(
Volume
67,
Number
32)

Dear
Dr.
Calderon:

The
appreciates
the
opportunity
to
comment
on
EPA's
Agency
Information
Collection
Activities:
Proposed
Collection:
Health
Effects
of
Microbial
Pathogens
in
Recreational
Waters,
February
15,
2002.

EPA
has
solicited
comments
regarding
the
collection
of
information
that
will
be
required
by
the
proposed
study.
The
following
areas
were
identified:
(
i)
Evaluate
whether
the
proposed
collection
of
information
is
necessary
for
the
proper
performance
of
the
functions
of
the
agency,
including
whether
the
information
will
have
practical
utility;
(
ii)
Evaluate
the
accuracy
of
the
agency's
estimate
of
the
burden
of
the
proposed
collection
of
information,
including
the
validity
of
the
methods
and
assumptions
used;
(
iii)
Enhance
the
quality,
utility,
and
clarity
of
the
information
to
be
collected;
and
(
iv)
Minimize
the
burden
of
the
collection
of
information
on
those
who
are
to
respond,
including
through
the
use
of
appropriate
automated...
technology.

The
supports
these
additional
efforts
to
study
the
epidemiology
of
swimmer
associated
illnesses
in
recreational
waters.
Our
responses
to
the
items
listed
above
are
as
follows:
(
i)
We
believe
that
the
collection
of
the
information
in
the
proposed
study
is
necessary
for
the
proper
performance
of
the
Agency's
functions,
particularly
in
light
of
the
recent
passage
of
PL
106­
284
 
The
BEACH
ACT
of
2000.
Additional
comments
regarding
the
proposed
study
will
follow
the
Department's
comments
on
items
(
i­
iv).
(
ii)
Based
on
the
information
presented,
it
is
difficult
to
evaluate
the
burden
of
the
proposed
collection
without
additional
information
on
the
scope
of
the
study
and
any
modification
to
the
study
that
may
occur.
(
iii)
The
quality,
utility
and
clarity
of
the
information
provided
will
directly
depend
on
the
exact
scope
of
work
defined
in
the
study.
Please
see
the
comments
following
response
(
iv).
(
iv)
We
have
no
suggestion
on
how
to
minimize
the
burden
of
the
collection
of
information
on
those
who
are
to
respond.

Although
the
proposed
study
was
not
addressed
in
any
detail
in
this
announcement,
we
offer
the
following
concerns
and
issues
for
your
consideration
in
developing
the
final
scope
of
work
for
this
extremely
important
study.
The
has
been
actively
participating
in
the
development
of
EPA's
Implementation
Guidance
for
Ambient
Water
Quality
Criteria
for
Bacteria
and
the
National
Beach
Guidance
and
Grant
Performance
Criteria
for
Recreational
Waters.
During
recent
discussions
at
each
of
these
workgroups,
it
was
indicated
that
your
study
would
address
areas
much
broader
than
the
designated
bathing
beach
areas,
specifically
areas
where
either
bathing
was
relatively
infrequent
or
areas
where
only
non­
anthropogenic
sources
of
fecal
pollution
potentially
exist.
Based
on
the
information
in
the
current
notice,
the
scope
of
the
study
implies
that
this
effort
will
only
address
the
designated
bathing
beach
areas
during
multiple
summer
seasons.

Bathing
beaches
are
a
small
subset
of
all
recreational
waters.
There
is
a
need
to
know
the
relative
risk
of
exposure
to
indicators
from
human
sources,
domestic
animal
sources,
and
wildlife
sources.
Health
impacts
have
been
documented
for
each
of
these
sources
and
may
play
a
significant
role
is
how
we
ultimately
define
public
health
protection.
We
encourage
you
to
expand
the
scope
of
this
study
to
include
areas
with
a
variety
of
impacts
at
both
Page
25
beach
and
non­
beach
areas.

One
issue
not
addressed
in
the
previous
studies
used
as
the
basis
of
the
1986
criteria
was
the
certainty
of
the
source
of
the
indicators.
It
was
mentioned
that
the
polluted
waters
were
know
to
be
under
the
influence
of
human
associated
pollution,
but
the
characteristics
of
the
discharge
(
e.
g.,
the
size
of
the
municipal
WWTP,
the
flow
volumes,
treatment
level
and
time
in
transit)
were
not
identified.
In
order
to
use
data
for
predictive
impacts
and
levels
of
protection,
there
needs
to
be
some
measure
of
certainty
about
the
source
of
the
indicator
and
thus
the
potential
source
and
presence
of
the
pathogen.

The
1986
criteria
dropped
fecal
coliform
in
favor
of
E.
coli
as
an
indicator.
However,
the
fecal
coliform
indicator
included
Klebsiella
which
is
an
opportunistic
pathogen
causing
respiratory
illness.
The
exclusion
of
Klebsiella
as
a
cause
of
gastrointestional
illness
fit
the
model
of
the
1986
criteria
but
it
overlooks
a
potential
source
of
illness
to
immuno­
compromised
bathers.
We
encourage
you
to
include
Klebsiella
sp.
in
the
proposed
study,
particularly
if
a
recreational
water
is
under
the
influence
of
pulp
and
paper
mill
discharge.

We
encourage
you
to
also
address
non­
human
sources
of
the
indicator
and
the
potential
health
effects
that
may
result.
The
study
should
look
at
more
than
gastrointestinal
illness
effects.
Perhaps
indicators
from
different
sources
contribute
to
different
illnesses
in
humans,
not
all
of
them
gastrointestinal.
In
order
to
be
protective,
the
list
of
indicators
may
need
to
be
expanded.
This
study
could
offer
an
excellent
opportunity
to
evaluate
this
need.

We
have
concerns
about
how
the
data
were
averaged
in
the
studies
by
Dufour
and
Cabelli
to
derive
the
1986
ambient
water
quality
criteria.
The
data
for
fresh
water
beaches
were
averaged
by
season
resulting
in
a
single
point
representing
the
geometric
mean
of
all
indicator
data
collected
at
a
specific
beach
for
an
entire
season
and
the
average
number
of
illnesses
per
1000
bathers
for
the
entire
season.
These
nine
seasonal
points
were
plotted
to
establish
an
indicator
density
to
illness
relationship.
The
plot
fails
to
represent
the
true
variability
of
the
daily
test
results.
Similar
data
analyses
were
performed
on
the
saltwater
beaches
data,
but
not
on
a
seasonal
basis.
We
encourage
you
to
analyze
the
data
collected
in
your
studies
in
a
manner
that
clearly
depicts
the
uncertainty
around
the
indicator
density
to
illness
relationships.

We
appreciate
this
opportunity
to
comment
on
the
Health
Effects
of
Microbial
Pathogens
in
Recreational
Waters.
If
you
wish
to
discuss
these
comments
further
or
require
additional
information,
please
contact
either
of
us
at
the
following
telephone
numbers:
Page
26
RE:
Health
Effects
of
Microbial
Pathogens
in
Recreational
Waters
We
have
the
following
comments
on
the
ICR
for
the
above
referenced
document.
The
main
point
may
be
that
we
are
unsure
of
what
EPA's
objective
is.
Since
EPA
often
has
stated
that
the
work
of
Cabelli
and
Dufour
has
been
supported
by
the
findings
of
many
other
studies,
it
seems
that
another
confirmatory
investigation
is
not
needed.
On
the
other
hand,
if
it
is
to
test
new
indicators
(
biological
or
chemical)
that
have
a
much
quicker
turnaround
time,
then
there
may
be
merit
in
repeating
the
earlier
work
assuming
the
results
do
not
conflict
with
the
previous
findings.
The
latter
outcome
will
cause
confusion
and
lead
to
requests
for
more
definitive
investigations,
which
is
fine
for
such
a
result
will
tell
us
that
we
do
need
more
information.
At
the
same
time,
this
will
work
only
if
those
studies
are
forthcoming.

More
detailed
comments:
The
proposal
raises
several
general
questions.
The
first
is,
given
the
work
of
Cabelli
and
Dufour,
would
not
a
study
assessing
the
health
risk
from
non­
point
sources
provide
a
better
return
for
the
efforts
than
what
appears
to
be
a
refinement
of
existing
work?
One
would
like
to
know
how
many
bathing
waters
are
affected
by
only
non
point
sources
of
bacterial
contamination.
These
could
represent
a
far
greater
percentage
of
the
swimming
beaches
or
bather­
days
than
those
areas
affected
by
wastewater
from
human
sources
and
thus
be
of
greater
import
from
a
public
health
point
of
view.
Few
beaches
in
Massachusetts,
especially
fresh
water
ones,
have
known
impacts
from
sources
of
human
sewage.

The
rates
of
affliction
for
outcomes
such
as
eye
infections
would
seem
likely
to
be
even
more
prevalent
than
for
gastroenteritis
given
the
general
exposure
upon
immersion
in
bathing
water.
The
public
may
find
the
current
risk
levels
for
enteritis
associated
with
EPA's
proposed
criteria
unpalatable
and
essentially
work
towards
closing
beaches
affected
by
human
sewage
or
removing
the
sources.
While
this
is
desirable,
it
leaves
open
the
question
of
what
risk
is
associated
with
animal
sources,
which
likely
cannot
be
eliminated.
This
again
argues
for
orienting
the
study
towards
non
point
sources
with
some
capability
of
being
able
to
distinguish
between
human
and
other
origins
of
the
indicators.

Having
said
this,
it
is
not
clear
if
assessing
the
new
outcomes
but
including
the
already
studied
gastroenteritis,
is
the
object
or
are
the
more
rapid
tests
for
indicators
the
primary
object
for
assessment.
The
question
of
whether
tests
already
accepted
by
EPA
or
as
standard
methods
are
to
be
used.
Also,
only
enterococci
and
fecal
coliform
are
mentioned.
Why
is
fecal
coliform
included
and
what
about
E.
coli?
It
is
not
clear
if
chemical
indicators,
e.
g.,
caffeine,
caprostanol,
are
being
considered
as
well.
If
so,
they
should
be
identified.
OMB
Control
No.:
2080­
XXXX
Expiration
date
XX/
XX/
XX
27
APPENDIX
D:
Beach
Interview
BEACH
INTERVIEW
Site
ID
______

Friday
_______
Saturday
_______
Sunday______
Monday
_________
Date:__­__­____
Time:
_________

1.
Are
you
leaving
the
beach
in
the
next
30
minutes?

2.
Have
you
been
interviewed
before
by
us
this
summer?
Yes_____
No_____
When?

3.
Would
you
be
willing
to
participate
in
a
study
on
illnesses
associated
with
recreation
at
the
beach?

Yes
(
give
brochure
with
consent
form,
inform
about
2
follow­
up
calls)
No
(
Terminate
Interview)

4.
How
many
members
in
your
party
are
at
the
beach
today?
_________

5.
What
time
did
you
and
your
party
arrive
at
the
beach
today?

6.
Are
there
any
children
in
your
family
at
the
beach
today
between
2
and
10
years
of
age?
Yes
(
continue)
No
(
Terminate
Interview)

7.
We
are
interested
in
whether
or
not
anyone
who
is
at
the
beach
with
you
today
becomes
ill
in
the
next
few
weeks
with
stomach
trouble,
respiratory
illness,
sore
throat
or
cough,
eye
or
ear
infection
or
skin
problems.
Could
you
please
give
me
your
complete
address
and
telephone
number
so
we
can
get
in
touch
with
you
next
week
and
then
again
for
the
following
week?

Yes
(
Go
to
8)
No
If
no,
is
it
for
one
of
the
following
reasons:
1.
Too
busy
2.
No
longer
interested
3.
Will
not
be
available
4.
Other
reason_______________
5.
Didn't
specify
8.
Permanent
home
address
Name:_________________________________________________________
Address:_______________________________________________________
City:____________________
Zip_________________
Home
Phone
_____________
Cell/
other
phone_________________
Set
appointment
time
for
phone
call____________

Are
you
here
on
vacation
(
vacation
home,
rental
property,
etc.)?

If
yes,
Will
you
be
at
home
or
still
on
vacation
during
the
next
week
or
the
week
after.
28
If
they
won't
be
home
in
time
for
first
follow­
up
call.

Can
I
please
have
the
address
of
your
vacation
residence
so
that
we
may
contact
you
there?

Name:_________________________________________________________
Address:_______________________________________________________
City:____________________
Zip_________________
Home
Phone
_____________
Other
phone_________________
Set
appointment
time
for
phone
call____________

9.
List
members
of
family
at
beachRelationship
Date
of
Birth
Gender
Race
Ethnicity
10.
Will
all
these
people
at
the
beach
with
you
today
also
be
living
with
you
at
the
address(
es)
above
during
the
next
two
weeks:
(
List
Persons)
Yes
No
11.
List
members
of
family
not
at
beach
Relationship
Date
of
Birth
Gender
RaceEthnicity
[
For
family
members
under
age
4
ask
if
still
in
diapers?]

12.
Have
any
of
these
family
members
been
ill
in
the
past
3
days
with:

A.
Diarrhea
or
loose
bowels
(
three
or
more
loose
stools
in
a
24
hour
period)?
B.
Throwing
up
or
vomiting?
C.
Sore
throat
or
Cough?
D.
Earache,
ear
infection
or
runny
ears?
E.
Eye
infection?
F.
Rash,
skin
infection
or
itchy
skin?
G.
Skin
or
sun
burn?

12a.
Do
you
suffer
from
any
of
the
following
chronic,
long­
term
conditions?.
A.
Gastrointestinal
(
Crohn's
disease,
irritable
bowel
syndrome)
B.
Allergies
C.
Skin
problems
(
psoriasis,
eczema)

[
Repeat
for
all
members
of
family
at
beach]

13.
How
many
times
do
you
usually
come
to
the
beach
each
summer
(
Memorial
Day
to
Labor
Day)

14.
What
distance
is
it
from
this
beach
to
your
home
or
the
place
you
are
currently
staying?

15.
During
the
past
two
weeks,
did
(
person)
go
bathing
or
swimming
anywhere
B
at
this
or
some
other
beach,
pool
or
lake?

Yes
(
continue)
No
(
Go
to
question
16)

15a.
Who
was
that?
15b.
Did
they
swim
in
the
past
week
(
between
Monday
and
Friday).

15c.
Did
(
person)
actually
get
their
head
or
face
wet?

[
Repeat
for
all
members
of
family
at
beach]
29
I
would
now
like
to
ask
you
about
how
much
you
were
in
the
water
and
the
types
of
activities
you
participated
in
on
today's
trip.

[
Repeat
questions
16­
17
for
all
members
of
family
going
in
water]

16.
Did
(
person)
go
into
the
water
at
all
today?

Yes
(
ask
17)
No
(
Go
to
18)

17a.
Did
(
person)
wade
in
or
play
in
the
water
Yes
(
continue),
No
(
Go
to
18)

get
water
in
face
Yes
(
continue),
No
(
Go
to
17c)

immerse
body
(
not
necessarily
head)
in
water
put
face
in
water
or
submerse
head
in
water
Yes
(
continue),
No
(
Go
to
17c)

get
water
in
mouth
Yes
(
continue),
No
(
Go
to
17c)
Did
you
swallow
the
water
How
much
do
you
estimate
you
swallowed
17b.
Did
(
person)
gag
or
cough
after
swallowing
or
getting
water
in
their
mouth?

17c.
What
part
of
the
beach
did
(
person)
swim
in?
Indicate
all
areas
on
map
(
preassign
area
designations
for
each
beach)

17d.
did
you
avoid
swimming
in
certain
areas?

17e.
Did
(
person)
swim
in
any
shallow
non­
circulating
water
in
temporary
pools
on
sandbars
or
at
low
tide
17f.
Was
(
person)
in
the
water
at
the
following
times
today:

Time
1
Yes
No
Time
2
Yes
No
Time
3
Yes
No
Time
4
Yes
No
17g.
What
total
time
did
(
person)
stay
in
the
water?
_____________(
hours)
or
_____________(
minutes).
We
are
only
interested
in
time
actually
in
the
water,
not
the
total
time
at
the
beach.

18.
What
would
(
person)
estimate
their
total
time
in
direct
sunlight
was?
_____
hours
or
_____
minutes.
This
does
not
include
being
indoors
or
under
umbrellas,
etc.

19.
Did
(
person)
cut
themselves
today
or
have
an
open
cut
when
they
came?

20.
Did
(
person)
engage
in
any
of
the
following
activities
while
at
the
beach
today?
body
surfing,
swimming,
surfing,
boogie
boarding,
snorkeling,
scuba
diving,
rafting,
sea
shell
collection,
digging
in
and/
or
building
with
sand,
crabbing,
playing
with
seaweed
We
would
now
like
to
ask
a
few
questions
about
things
that
may
help
protect
swimmers
from
becoming
ill.
30
21.
Did
(
person)
wear
ear
plugs
while
in
the
water?

22.
Did
(
person)
wear
nose
plugs
while
in
the
water?

23.
Did
(
person)
wear
eye
goggles
or
use
a
face
mask
while
you
were
in
the
water?

24.
Did
(
person)
use
a
wet
suit
while
in
the
water?

25.
Did
(
person)
wear
suntan
lotion?

26.
Did
(
person)
wear
insect
repellant?

27.
Did
(
person)
take
a
cleansing
shower
before
leaving
the
beach?

[
The
following
information
is
recorded
based
on
visual
appearance.]

For
(
person)
check
one
of
the
following:
1.
Head
and
suit
wet
2.
Head
wet
3.
Suit
wet
4.
Neither
wet
5.
Dressed
6.
Not
present
28.
Did
you
and
your
family
consume
food
while
at
the
beach
today?

Was
the
food:
Brought
from
home?
Yes
No
Purchased
from
a
vender
at
the
beach?
Yes
No
Purchased
from
a
vender
outside
the
beach?
Yes
No
29.
In
the
last
48
hours
has
anyone
done
the
following:
Come
into
contact
with
an
unfamiliar
animal
(
give
example)?
Come
into
contact
with
someone
who
is
sick
with
diarrhea
or
vomiting?
Specify
type
of
illness
Consumed
raw
shell
fish?

Thank
you
for
your
help.
You
can
contact
us
regarding
information
about
the
study
at
the
toll
free
number
in
the
booklet.

Following
are
entered
by
the
interviewer:
How
cooperative
was
this
family?
1.
Very
2.
Somewhat
3.
Not
at
all
Burden
Statement:
The
annual
public
reporting
and
recordkeeping
burden
for
this
collection
of
information
is
estimated
to
average
about
a
half
hour
per
response.
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;
31
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.

Interview
&
Telephone
Follow­
ups:
Based
on
consultation
with
the
individuals
listed
in
Section
3(
c)
of
the
ICR,
and
our
experience
with
similar
types
of
information
collection,
we
estimate
that
each
family
will
spend
an
average
of
30
minutes
completing
the
beach
interview
and
will
require
no
record
keeping.
This
includes
the
time
for
reviewing
the
information
pamphlet
and
answering
the
questions.
We
estimate
that
each
family
will
spend
an
average
of
30
minutes
completing
the
first
home
telephone
interview
and
20
minutes
completing
the
second
home
telephone
interview.
The
telephone
interviews
will
require
no
record
keeping.

Send
comments
on
the
Agency's
need
for
this
information,
the
accuracy
of
the
provided
burden
estimates,
and
any
suggested
methods
for
minimizing
respondent
burden,
including
through
the
use
of
automated
collection
techniques
to
the
Director,
Collection
Strategies
Division,
U.
S.
Environmental
Protection
Agency
(
2822T),
1200
Pennsylvania
Ave.,
NW,
Washington,
D.
C.
20460.
Include
the
EPA
ICR
number
2081.01
in
any
correspondence.
Do
not
send
the
completed
survey
to
this
address.
OMB
Control
No.:
2080­
XXXX
Expiration
date
XX/
XX/
XX
Page
32
APPENDIX
E:
Telephone
Interview
I
Telephone
Interview
First
follow­
up
(
4­
7
days)

Is
this
person
(
primary
respondent
from
beach
interview)?

Yes
(
continue)

No
(
reschedule
or
continue)

Were
you
at
the
beach
on
(
give
date)
with
(
primary
respondent)?

Yes
­
Continue
No
­
Please
ask
(
primary
respondent)
to
call
this
number
at
their
earliest
convenience.
TERMINATE
INTERVIEW
I'm
going
to
ask
questions
about
any
swimming
you've
done
and
illnesses
you've
experienced
in
the
last
week
for
the
following
people:
List
person(
s)

1.
Have
you
or
any
of
the
listed
people
gone
bathing
or
swimming
anywhere
since
being
interviewed
at
(
Name
beach)?

Yes:
Same
beach?

Different
beach?
If
yes
have
them
specify:
Lake?
River?
Ocean?

Water
park?

Public
pool?

Private
pool?

Wading
pool?

Other?
Specify__________________

Did
(
person)
actually
get
their
face
wet?

Which
days
did
person
go
to
beach?
Mon
Tues
Wed
Thurs
Fri
Sat
Sun
2.
I'm
going
to
go
through
a
list
of
symptoms,
please
let
me
know
if
any
of
the
above
listed
people
have
had
them.

A.
Stomach
ache
or
abdominal
cramping
Starting
on
what
day?

Lasting
how
many
days?
_____
Still
experiencing
symptom
____

B.
Diarrhea
or
loose
bowels?
(
3
or
more
loose
or
watery
stools
in
a
24
hour
period)

Starting
on
what
day?

Maximum
number
of
bouts/
episodes
per
day?

Lasting
how
many
days?
_____
Still
experiencing
symptom
____
Page
33
C.
Nausea
Starting
on
what
day?

Lasting
how
many
days?
_____
Still
experiencing
symptom
____

D.
Throwing
up
or
vomiting?

Starting
on
what
day?

How
many
times
or
episodes
the
first
day?

Lasting
how
many
days?
_____
Still
experiencing
symptom
____

E.
Fever
Starting
on
what
day?

Measured?
(
Give
exact
measure)

Perceived?

Lasting
how
many
days?
_____
Still
experiencing
symptom
____

F.
Head
ache
lasting
more
than
a
few
hours?

Starting
on
what
day?

Lasting
how
many
days?
_____
Still
experiencing
symptom
____

G.
Sore
throat?

Starting
on
what
day?

Lasting
how
many
days?
_____
Still
experiencing
symptom
____

H.
Bad
Cough?

Starting
on
what
day?

Lasting
how
many
days?
_____
Still
experiencing
symptom
____

I.
Cold?

Starting
on
what
day?

Lasting
how
many
days?
_____
Still
experiencing
symptom
____

J.
Runny
or
stuffy
nose?

Starting
on
what
day?

Lasting
how
many
days?
_____
Still
experiencing
symptom
____

K.
Earache,
outer
ear
infection
or
runny
ears?
(
Note
not
inner
ear
infections)

Starting
on
what
day?

Lasting
how
many
days?
_____
Still
experiencing
symptom
____

L.
Watery
or
itchy
eyes?

Starting
on
what
day?

Lasting
how
many
days?
_____
Still
experiencing
symptom
____

If
Yes
to
G
thru
L:
Where
any
of
these
symptoms
related
to
allergies?
Yes
No.

Which
symptoms?

M.
Eye
infection?
Page
34
Starting
on
what
day?

Lasting
how
many
days?
_____
Still
experiencing
symptom
____

N.
Infected
cut?

Starting
on
what
day?

Lasting
how
many
days?
_____
Still
experiencing
symptom
____

O.
Rash
,
itchy
or
other
skin
infection?

Starting
on
what
day?

Lasting
how
many
days?
_____
Still
experiencing
symptom
____

P.
Skin
or
sun
burn?

List
parts
of
body:

Q.
Urinary
tract
infection:

Lasting
how
many
days?
_____
Still
experiencing
symptom
____

3.
If
Yes
to
any
did
they:

A.
Stay
at
home?

How
many
days?

B.
Stay
in
bed?

C.
Seek
medical
help?

Visit
a
physician
or
other
health
care
provider?

Visit
an
emergency
room?

Require
hospitalization
for
more
than
24
hours?

D.
Did
(
person)
take
any
medications
for
the
symptoms?

If
yes,
what
medications?

List:_____________________

This
completes
our
telephone
interview?
We
will
call
again
in
a
week
for
the
last
telephone
interview.
Will
you
still
be
at
this
telephone
number
next
week
when
we
call?
What
would
be
a
good
time
to
call?

Schedule
time:______________

Burden
Statement:
The
annual
public
reporting
and
recordkeeping
burden
for
this
collection
of
information
is
estimated
to
average
about
a
half
hour
per
response.
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.
Interview
&
Telephone
Follow­
ups:
Based
on
consultation
with
the
individuals
listed
in
Section
3(
c)
of
the
ICR,
and
our
experience
with
similar
types
of
information
collection,
we
estimate
that
each
family
will
spend
an
average
of
30
minutes
completing
the
beach
interview
and
will
require
no
record
keeping.
Page
35
This
includes
the
time
for
reviewing
the
information
pamphlet
and
answering
the
questions.
We
estimate
that
each
family
will
spend
an
average
of
30
minutes
completing
the
first
home
telephone
interview
and
20
minutes
completing
the
second
home
telephone
interview.
The
telephone
interviews
will
require
no
record
keeping.

Send
comments
on
the
Agency's
need
for
this
information,
the
accuracy
of
the
provided
burden
estimates,
and
any
suggested
methods
for
minimizing
respondent
burden,
including
through
the
use
of
automated
collection
techniques
to
the
Director,
Collection
Strategies
Division,
U.
S.
Environmental
Protection
Agency
(
2822T),
1200
Pennsylvania
Ave.,
NW,
Washington,
D.
C.
20460.
Include
the
EPA
ICR
number
2081.01
in
any
correspondence.
Do
not
send
the
completed
survey
to
this
address.
OMB
Control
No.:
2080­
XXXX
Expiration
date
XX/
XX/
XX
Page
36
APPENDIX
F:
Telephone
Interview
II
Telephone
Interview
Second
follow­
up
(
10­
14
days)

Is
this
person
(
primary
respondent
from
beach
interview)?

Yes
(
continue)

No
(
reschedule
or
continue)

Were
you
at
the
beach
on
(
give
date)
with
(
primary
respondent)?

Yes
­
Continue
No
­
Please
ask
(
primary
respondent)
to
call
this
number
at
their
earliest
convenience.
TERMINATE
INTERVIEW
I'm
going
to
ask
questions
about
any
swimming
you've
done
and
illnesses
you've
experienced
in
the
last
week
SINCE
THE
LAST
PHONE
CALL
ON
(
give
date)
for
the
following
people:
List
person(
s)

1.
Have
you
or
any
of
the
listed
people
gone
bathing
or
swimming
anywhere
since
we
last
called?

Yes:
Same
beach
(
name
original
beach)?

Different
beach?
If
yes
have
them
specify:
Lake?
River?
Ocean?

Waterpark?

Public
pool?

Private
pool?

Wading
pool?

Other?
Specify__________________

Did
(
person)
actually
get
their
face
wet?

Which
days
did
person
go
to
beach?
Mon
Tues
Wed
Thurs
Fri
Sat
Sun
Mon
Tues
Wed
Thurs
Fri
Sat
Sun
2.
At
the
previous
telephone
interview
you
reported
that
__________
had
been
ill
with
___________.
Is
that
person(
s)

still
ill?

3.
I'm
going
to
go
through
a
list
of
symptoms,
please
let
me
know
if
any
of
the
above
listed
people
have
had
them
since
the
last
phone
call
on
(
repeat
date
and
time).

A.
Stomach
ache
and/
or
abdominal
cramping?

Starting
on
what
day?

Lasting
how
many
days?
_____
Still
experiencing
symptom
____
Page
37
B.
Diarrhea
or
loose
bowels?
(
3
or
more
loose
or
watery
stools
in
a
24
hour
period)

Starting
on
what
day?

Maximum
number
of
bouts/
episodes
per
day?

Lasting
how
many
days?
_____
Still
experiencing
symptom
____

C.
Nausea
Starting
on
what
day?

Lasting
how
many
days?
_____
Still
experiencing
symptom
____

D.
Throwing
up
or
vomiting?

Starting
on
what
day?

How
many
times
or
episodes
the
first
day?

Lasting
how
many
days?
_____
Still
experiencing
symptom
____

E.
Fever
Starting
on
what
day?

Measured?
(
Give
exact
measure)

Perceived?

Lasting
how
many
days?
_____
Still
experiencing
symptom
____

F.
Head
ache
lasting
more
than
a
few
hours?

Starting
on
what
day?

Lasting
how
many
days?
_____
Still
experiencing
symptom
____

G.
Sore
throat?

Starting
on
what
day?

Lasting
how
many
days?
_____
Still
experiencing
symptom
____

H.
Bad
Cough?

Starting
on
what
day?

Lasting
how
many
days?
_____
Still
experiencing
symptom
____

I.
Cold?

Starting
on
what
day?

Lasting
how
many
days?
_____
Still
experiencing
symptom
____

J.
Runny
or
stuffy
nose?

Starting
on
what
day?

Lasting
how
many
days?
_____
Still
experiencing
symptom
____

K.
Earache,
outer
ear
infection
or
runny
ears?
(
Do
not
include
inner
ear
infections)

Starting
on
what
day?

Lasting
how
many
days?
_____
Still
experiencing
symptom
____

L.
Watery
or
itchy
eyes?

Starting
on
what
day?
Page
38
Lasting
how
many
days?
_____
Still
experiencing
symptom
____

If
Yes
to
G
thru
L:
Where
any
of
these
symptoms
related
to
allergies?
Yes
No.

Which
symptoms?

M.
Eye
infection?

Starting
on
what
day?

Lasting
how
many
days?
_____
Still
experiencing
symptom
____

N.
Infected
cut?

Starting
on
what
day?

Lasting
how
many
days?
_____
Still
experiencing
symptom
____

O.
Rash
or
itchy
skin?

Starting
on
what
day?

Lasting
how
many
days?
_____
Still
experiencing
symptom
____

P.
Skin
and/
or
sun
burn?

List
parts
of
body:

Q.
Urinary
tract
infections:

Lasting
how
many
days?
_____
Still
experiencing
symptom
____

3.
If
Yes
to
any
did
they:

A.
Stay
at
home?

How
many
days?

B.
Stay
in
bed?

C.
Seek
medical
help?

Visit
a
physician
or
other
health
care
provider?

Visit
an
emergency
room?

Require
hospitalization
for
more
than
24
hours?

D.
Did
(
person)
take
any
medications
for
the
symptoms?

If
yes
what
medications?

List:_____________________

Burden
Statement:
The
annual
public
reporting
and
recordkeeping
burden
for
this
collection
of
information
is
estimated
to
average
about
a
half
hour
per
response.
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.
Page
39
Interview
&
Telephone
Follow­
ups:
Based
on
consultation
with
the
individuals
listed
in
Section
3(
c)
of
the
ICR,
and
our
experience
with
similar
types
of
information
collection,
we
estimate
that
each
family
will
spend
an
average
of
30
minutes
completing
the
beach
interview
and
will
require
no
record
keeping.
This
includes
the
time
for
reviewing
the
information
pamphlet
and
answering
the
questions.
We
estimate
that
each
family
will
spend
an
average
of
30
minutes
completing
the
first
home
telephone
interview
and
20
minutes
completing
the
second
home
telephone
interview.
The
telephone
interviews
will
require
no
record
keeping.

Send
comments
on
the
Agency's
need
for
this
information,
the
accuracy
of
the
provided
burden
estimates,
and
any
suggested
methods
for
minimizing
respondent
burden,
including
through
the
use
of
automated
collection
techniques
to
the
Director,
Collection
Strategies
Division,
U.
S.
Environmental
Protection
Agency
(
2822T),
1200
Pennsylvania
Ave.,
NW,
Washington,
D.
C.
20460.
Include
the
EPA
ICR
number
2081.01
in
any
correspondence.
Do
not
send
the
completed
survey
to
this
address.
Page
40
APPENDIX
G
References
Cabelli
VJ
"
Health
Effects
Criteria
for
Marine
Recreational
Waters"
EPA­
600/
1­
80­
031.
August
1983.

Calderon
RL,
Mood
EW
and
Dufour
AP.
"
Health
Effects
and
Nonpoint
Sources
of
Pollution",
Int.
J.
Environ.
Hlth
1:
21­
31,
1991.

Colford
JM,
Rees
JR,
Wade
TJ,
Khalakdina
A,
Hilton
JF,
Ergas
IJ,
Burns
S,
Benker
A,
Ma
C,
Bowen
C,
Mills
DC,
Vugia
DJ,
Juranek
DD,
and
Levy
DA.
"
Participant
Blinding
and
Gastrointestinal
Illness
in
a
Randomized,
Controlled
Trial
of
an
In­
Home
Drinking
Water
Intervention"
Emerging
Infectious
Diseases
8:
(
1)
2001.

Dufour
AP.
"
Health
Effects
Criteria
for
Fresh
Recreational
Waters"
EPA­
600/
1­
84­
004.
August
1984.

Payment
P,
Siemiatycki
J,
Richardson
L.
et
al.
A
Prospective
Epidemiological
Study
of
Gastrointestinal
Health
Effects
due
to
the
Consumption
of
Drinking
Water.
Intl
J
Environ.
Hlth
Res.
7:
5­
31,
1997.

Payment
P,
Richardson
L,
Siemiatycki
J,
et
al.
A
Randomized
Trial
to
Evaluate
the
Risk
of
Gastrointestinal
Disease
due
to
Consumption
of
Drinking
Water
Meeting
Current
Microbiological
Standards.
Amer.
J.
Pub.
Hlth
81:
703­
708
,
1991.