1
SECTION
1.
A.
SUPPORTING
STATEMENT
1.
IDENTIFICATION
OF
THE
INFORMATION
COLLECTION
1(
a)
TITLE:
Evaluation
of
the
burden
of
waterborne
disease
within
communities
in
the
United
States.

1(
b)
ABSTRACT:
The
proposed
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,
US
EPA.
Participation
in
this
collection
of
information
is
strictly
voluntary.
The
Branch
will
conduct
a
feasibility
study
of
water
utilities
and
health
studies
of
individuals
served
by
targeted
drinking
water
utilities.

Feasibility
Studies
Drinking
water
utilities
serving
populations
greater
than
15,000
will
be
asked
to
provide
information
on
the
utility
and
results
of
monitoring
activities.
The
information
will
be
used
to
assess
the
feasibility
of
conducting
an
environmental
health
study
to
evaluate
the
burden
of
water­
borne
disease
in
the
community
it
serves.
A
utility
representative
will
be
interviewed
to
gather
information
on:
miles
of
distribution
pipe,
storage
capacity,
quantity
of
source
water,
the
availability
of
the
previous
year=
s
monitoring
records,
and
the
utilities
willingness
to
participate.
The
water
utility
will
provide
annual
reports
describing
the
monthly
mean
and
range
for:
water
temperature,
turbidity,
particle
counts,
pH,
color,
total
and
fecal
coliforms,
heterotrophic
plate
count,
total
organic
carbon,
chlorine
residual
(
free
and
total),
total
organic
halides,
total
trihalomethanes,
viruses,
Giardia,
and
Cryptosporidium.

The
information
collected
is
for
research
purposes
only
and
could
be
used
by
other
laboratories
in
the
Office
of
Research
and
Development
such
as
the
National
Risk
Management
Laboratory
(
Cincinnati)
and
the
National
Exposure
Research
Laboratory
(
Cincinnati).
The
information
will
be
converted
to
electronic
form
and
stored
in
a
computerized
database.
Administering
this
questionnaire
will
involve
approximately
400
utilities
at
a
cost
of
$
45,302.

Environmental
Health
Studies:

If
the
feasibility
studies
determine
that
we
can
proceed
with
the
Environmental
Health
Studies,
approximately
1000
households
will
be
randomly
selected
from
each
community.
Eligibility
for
households
to
participate
will
include
residence
of
one
or
more
children
between
the
ages
of
two
and
ten
years
as
children
are
the
most
sensitive
population
for
illnesses
of
interest.
Demographic
information
and
a
short
health
history
will
be
requested
from
household
members
at
the
beginning
of
each
study.
A
representative
from
each
household
will
be
asked
to
fill
out
a
monthly
health
questionnaire
for
each
family
member
for
a
total
of
12
months.
The
monthly
health
information
requested
includes
a
symptom
diary
for
upper
respiratory
illness,
gastrointestinal
illness,
fever,
and
severity
of
illness.
Care
will
be
taken
to
maintain
participant
confidentiality.
The
information
will
be
used
to
estimate
the
burden
of
waterborne
disease
in
communities
within
the
United
States
(
US).
Health
data
obtained
from
the
household
diaries
will
be
compared
with
the
corresponding
monitoring
data
at
the
water
utility
to
determine
whether
any
increase
in
symptoms
is
associated
with
water
quality
parameters.
2
The
information
is
being
collected
as
part
of
a
research
program
to
support
the
Office
of
Water
in
estimating
the
burden
of
waterborne
disease
in
the
US
as
mandated
under
the
Safe
Drinking
Water
Act
Amendments
of
1996,
section
1458
(
Appendix
A).
These
studies
will
also
provide
information
on
the
level
of
disease
associated
with
microorganisms
found
in
the
drinking
water.
The
information
could
potentially
be
used
by
other
laboratories
in
the
Office
of
Research
and
Development
such
as
the
National
Risk
Management
Laboratory
(
Cincinnati)
and
the
National
Exposure
Research
Laboratory
(
Cincinnati).
The
information
may
also
be
used
in
comparison
analyses
by
scientists
in
government
or
academia
who
are
conducting
similar
types
of
studies.
There
is
no
maintenance
of
records
required
under
this
ICR.
The
information
will
be
converted
to
electronic
form
and
stored
in
a
computerized
database.
The
estimated
costs
for
administering
this
questionnaire
is
$
721,734.

2.
NEED
FOR
AND
USE
OF
THE
DATA
COLLECTION
2(
a)
NEED
/
AUTHORITY
FOR
THE
DATA
COLLECTION
The
information
is
being
collected
as
part
of
a
research
program
to
support
the
Office
of
Water
in
estimating
the
burden
of
waterborne
disease
in
the
U.
S.
as
mandated
under
the
Safe
Drinking
Water
Act
Amendments
of
1996,
section
1458.
These
studies
will
provide
information
on
currently
regulated
microorganisms
(
total
coliforms)
and
on
microorganisms
identified
for
possible
regulation
(
Giardia,
Cryptosporidium,
and
enteroviruses).
These
studies
will
also
provide
information
on
the
level
of
disease
associated
with
drinking
water
quality.

2(
b)
USE
/
USERS
OF
THE
DATA
Feasibility
Study:

Water
utility
monitoring
data
collected
during
the
feasibility
phase
will
determine
appropriate
sites
to
conduct
the
environmental
health
studies
and
assess
the
willingness
of
the
utilities
to
participate.
Appropriate
sites
cannot
be
definitively
identified
without
the
information
requested
since
selection
will
be
based
on
water
quality,
size,
and
willingness
to
cooperate.
The
information
will
be
used
by
the
Epidemiology
and
Biomarkers
Branch,
Human
Studies
Division,
National
Health
and
Environmental
Effects
Research
Laboratory,
Office
of
Research
and
Development.
The
information
could
potentially
be
used
by
other
laboratories
in
the
Office
of
Research
and
Development
such
as
the
National
Risk
Management
Laboratory
(
Cincinnati)
and
the
National
Exposure
Research
Laboratory
(
Cincinnati).
The
information
may
also
be
used
in
comparison
analyses
by
scientists
in
government
or
academia
who
are
conducting
similar
types
of
studies.

Environmental
Health
Studies:

Health
data
obtained
from
the
household
symptom
diaries
will
be
compared
with
the
corresponding
monitoring
data
at
the
water
utility
to
determine
whether
any
increase
in
symptoms
is
associated
with
higher
levels
of
contaminants.
Overall
illness
will
be
measured.
Specific
relationships
between
microorganisms
and
disease
may
be
developed
by
linking
microorganisms
found
in
the
water
with
those
found
in
symptomatic
people.
The
results
of
the
studies
will
be
used
by
the
Office
of
Science
and
Technology
in
the
Office
of
Water,
and
the
Office
of
Research
and
Development
in
developing
risk
assessments
associated
with
microorganisms
found
in
drinking
water.
The
information
may
be
used
by
the
Office
of
Drinking
Water
and
3
Ground
Water
to
set
MCLs,
mandate
"
Best
Available
Technology"
for
microorganisms
in
drinking
water
and/
or
to
evaluate
the
benefit
of
the
Surface
Water
Treatment
Rule.
The
information
may
also
be
used
in
comparison
analyses
by
scientists
in
government
or
academia
who
are
conducting
similar
types
of
studies.

3.
NONDUPLICATION,
CONSULTATIONS,
AND
OTHER
COLLECTION
CRITERIA.

3(
a)
NONDUPLICATION
Feasibility
Study:
Some
of
the
information
requested
has
been
collected
by
the
American
Water
Works
Association.
This
information,
however,
was
collected
only
for
their
members.
Not
all
utilities
are
members.
Some
states
also
require
the
utilities
to
report
monitoring
information,
but
the
requirements
vary
from
state
to
state.

Environmental
Health
Studies:
These
studies
represent
a
continuation
of
work
initiated
in
1995,
however,
study
populations,
potential
exposures,
and
health
effects
will
differ.

3(
b)
The
first
Federal
Register
Notice
of
renewal
was
published
on
February
5,
1998.

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

Gunther
Craun,
President,
Global
Consulting
for
Environmental
Health,
703­
639­
2094.

Peter
Karalekas,
Jr.,
Consulting
Environmental
Engineer,
413­
583­
8179.

Floyd
Frost,
Epidemiologist
and
Director,
Southwest
Center
for
Managed
Care
Research,
505­
262­
3471
Environmental
Health
Studies:
Since
this
approach
has
been
used
before,
no
additional
consultations
have
been
initiated.

Public
Meetings:
The
proposed
studies
have
been
publicly
discussed
at
the
following
meetings:

California/
Nevada
American
Water
Works
Association
Meeting,
April,
1993.
Meeting
with
the
American
Water
Works
Association
Research
Foundation.
State
Drinking
Water
Administrators,
October
,1996.
EPA/
CDC
Workshop
on
Waterborne
Disease,
March
1997.

The
response
from
these
organizations
has
been
favorable.

3(
d)
EFFECTS
OF
LESS
FREQUENT
COLLECTION
Feasibility
Study:
The
information
will
be
collected
once
during
the
feasibility
study.
This
factor,
therefore,
does
not
apply
for
this
phase
of
the
study.

Environmental
Health
Studies:
Studies
have
shown
and
our
own
experience
indicate
that
less
frequent
4
collection
of
data
leads
to
loss
of
memory
and,
therefore,
incomplete
reporting.
Optimal
recording
is
on
a
two
week
basis.
We
have
chosen
monthly
reporting
to
ease
the
burden
of
reporting.

3(
e)
GENERAL
GUIDELINES
Feasibility
Study:
All
general
guidelines
are
adhered
to.

Environmental
Health
Studies:
All
general
guidelines
except
the
quarterly
provision
are
adhered
to.
The
more
frequent
request
is
due
to
the
nature
of
the
study
and
described
in
d.
above.

3(
f)
CONFIDENTIALITY
I)
Confidentiality:
For
both
the
Feasibility
Study
and
the
Environmental
Health
Studies,
all
standard
steps
to
maintain
confidentiality
will
be
adhered
to.
These
include
the
removal
of
personal
identifiers
from
the
database,
storage
of
hard
copies
in
a
locked
file,
and
disposing
of
hard
copies
one
year
after
completion
of
the
study.
Contractor
involvement
will
be
monitored
by
requiring
hard
copies
to
be
stored
at
EPA
after
the
contractor
has
completed
the
electronic
conversion.
The
contractor
has
agreed
to
observe
the
rules
of
confidentiality
regarding
the
health
information
to
be
provided
by
individuals
and
their
families.

3(
g)
SENSITIVE
QUESTIONS:
No
questions
of
a
sensitive
nature
will
be
required
in
either
survey.

4.
THE
RESPONDENTS
AND
THE
INFORMATION
REQUESTED
4(
a)
RESPONDENTS
/
SIC
CODES
Feasibility
Study:

The
Epidemiology
and
Biomarkers
Branch
will
collect
monitoring
information
from
water
utilities
serving
greater
than
15,000
households
(
SIC
=
4941
water
supply).
Utilities
will
be
selected
for
the
Environmental
Health
Studies
based
on
water
criteria
and
willingness
of
the
utility
and
the
served
communities
to
participate.

Environmental
Health
Studies:

The
Epidemiology
and
Biomarkers
Branch
will
conduct
health
studies
of
individuals
served
by
the
targeted
drinking
water
utilities.
Approximately
1000
households
will
be
selected
randomly
for
each
study.
The
actual
number
of
households
per
community
may
vary
depending
on
the
size
of
the
community
and
the
quality
of
the
drinking
water
source.
The
sampling
base
may
vary
depending
on
the
size
of
the
community.
Eligibility
for
households
to
participate
will
include
residence
of
one
or
more
children
between
the
ages
of
two
and
ten
years.
Children
are
the
most
sensitive
population
for
illnesses
of
interest
(
respiratory
and
gastrointestinal
infections).
Targeting
them
for
participation
increases
the
sensitivity
of
the
studies.
We
expect
that
each
household
has,
on
the
average
2.2
members
for
a
total
of
approximately
2200
individuals
responding
in
each
study.

4(
b)
INFORMATION
REQUESTED
5
(
I)
Data
Items:

Feasibility
Study:

Each
utility
contacted
will
be
requested
to
provide
the
information
listed
below,
if
available,
unless
they
serve
populations
of
less
than
15,000.
No
new
data
will
be
required
from
any
of
the
water
utilities
at
this
time.
The
questionnaire
for
this
phase
can
be
found
in
Appendix
B.

The
requested
information
include:

­
contact
time
for
disinfection
process
­
miles
of
distribution
pipe
­
storage
capacity
of
distribution
system
­
source
water
quantity
­
average
monthly
water
temperatures
for
one
year
­
source
water
storage
capacity,
flow
rate,
depth
­
one
year's
report
on
monthly
mean
and
range
for
the
following
water
quality
parameters;
turbidity,
particles,
pH,
color,
total
coliforms,
fecal
coliforms,
heterotrophic
plate
count,
total
organic
carbon,
viruses,
Giardia,
Cryptosporidia,
total
organic
halides,
total
trihalomethanes.
­
existence
of
historical
monitoring
records
­
willingness
to
participate
The
water
utilities
will
be
offered
the
opportunity
to
provide
an
Annual
Report
instead
of
completing
the
questionnaire
if
the
data
are
available
in
the
report.

There
are
no
maintenance
of
records
required
under
this
ICR.

Environmental
Health
Studies:

Information
on
age,
sex,
racial
composition
and
underlying
conditions
(
diabetes,
chronic
heart
disease)
will
be
requested
of
each
household
member
at
the
onset
of
the
study.
Then
one
member
of
the
household
will
be
asked
to
complete
the
section
of
the
monthly
checklist
for
every
member
of
the
household
concerning
respiratory
and
gastrointestinal
symptoms
experienced
during
the
month.
The
checklist
will
be
completed
for
the
12
month
time
period
of
the
study.
The
information
requested
during
this
phase
is
listed
below.
The
health
diary
can
be
found
in
Appendix
C.

The
monthly
checklist
will
request
information
on
the
occurrence
of
the
following
symptoms:

­
headache,
fever,
cold,
flu,
vomiting,
nausea,
diarrhea.
­
duration
of
symptoms
­
severity
of
illness
as
measured
by
'
stay
at
home',
'
stay
in
bed'
and
'
seek
medical
care'.

(
ii)
Respondent
Activities
Feasibility
Study
The
respondent
at
each
utility
will
be
required
to
do
the
following:
(
CBP=
Common
Business
Practice)
6
­
read
questionnaire
instructions
[
CBP]
­
create
information
by
analyzing
samples
and
measuring
supplies
­
gather
information
from
existing
company
records
[
CBP]
­
process
and
review
information
for
accuracy
and
appropriateness
­
complete
written
forms
­
return
questionnaire
as
directed
Environmental
Health
Study
The
household
respondents
will
need
to
do
the
following:
­
read
questionnaire
instructions
­
consult
with
other
family
members
as
to
occurrence
of
illness
­
record
information
as
it
occurs
­
return
questionnaire
on
a
monthly
basis
5.
THE
INFORMATION
COLLECTED­­
AGENCY
ACTIVITIES,
COLLECTION
METHODOLOGY,
AND
INFORMATION
MANAGEMENT
5(
a)
AGENCY
ACTIVITIES
The
agency
will
be
responsible
for
the
following
activities
for
both
the
Feasibility
and
the
Environmental
Health
Study:

Feasibility
Study:

­
administer
questionnaire
­
develop
and
maintain
database
­
answer
respondent
questions
and
administer
the
telephone
interview
if
necessary.
­
review
respondent
submissions
­
convert
data
to
electronic
form
­
store
and
review
the
data
Environmental
Health
Study:

­
administer
questionnaire
­
develop
and
maintain
database
­
answer
respondent
questions
­
review
respondent
submissions
­
convert
data
to
electronic
form
­
store
and
review
the
data
5(
b)
COLLECTION
METHODOLOGY
AND
MANAGEMENT
7
Feasibility
Study:

The
information
to
be
collected
during
the
feasibility
study
can
be
found
in
the
attached
questionnaire
in
Appendix
B.
The
questionnaire
has
been
used
successfully
in
the
previous
ICR.
The
majority
of
the
questions
are
standard
parameters
descriptive
of
drinking
water
utilities.
No
additional
burden
is
placed
on
the
utility
by
requesting
data
on
monitoring
results
since
the
monitoring
activities
are
required
by
the
Safe
Drinking
Water
Act.

The
data
will
be
reviewed
for
unusual
or
unacceptable
values.
The
utility
may
be
recontacted
to
clarify
some
responses.
Reported
monitoring
values
that
exceed
the
MCL
will
be
checked
with
the
Safe
Drinking
Water
Information
System
for
validity.
The
data
will
be
converted
to
an
electronic
format
through
data
entry
and
will
be
submitted
to
a
100%
verification.
The
data
will
then
be
stored
in
a
database
on
an
IBM
compatible
computer
for
further
analysis.
It
is
not
anticipated
that
the
public
will
request
the
data
since
it
is
collected
for
research
purposes
only.
Access,
however,
will
be
available
in
the
form
of
a
report
that
summarizes
findings
across
all
surveyed
utilities.

Steps
taken
to
minimize
time
in
completing
the
questionnaire
include
allowing
the
utility
to
include
an
annual
report
or
summary
of
monitoring
data
generated
by
their
system.
This
will
decrease
their
time
burden
and
reduce
the
possibility
of
error
associated
with
transferring
results
from
one
media
to
another.

Environmental
Health
Studies:
The
health
diary
used
for
these
studies
is
a
modified
version
of
one
previously
used.
It
has
been
pretested
extensively
in
other
studies.
Its
time
and
cost
burden
are
well
known.
The
time
burden
required
of
each
individual
has
been
minimized
as
only
illnesses
listed
on
the
questionnaire
require
reporting.
These
illnesses
occur
up
to
eight
times
per
year
in
younger
children
and
as
infrequently
as
twice
a
year
in
adults.
The
data
collected
via
health
diaries
will
be
entered
into
a
computer
database.
Occasional
telephone
calls
will
be
made
to
verify
the
accuracy
of
the
information.
Given
the
repetitiveness
of
the
reporting,
the
same
database
structure
can
be
used
from
month
to
month
to
minimize
input
error.
The
data
will
be
converted
to
an
electronic
format
through
data
entry
and
will
be
submitted
to
a
100%
verification.
The
data
will
then
be
stored
in
a
database
on
an
IBM
compatible
computer
for
further
analysis.
It
is
not
anticipated
that
the
public
will
request
the
data
since
it
is
collected
for
research
purposes
only.
Access,
however,
will
be
available
in
the
form
of
a
report
that
summarizes
findings
across
all
surveyed
participants.

5(
c)
SMALL
ENTITY
FLEXIBILITY
Feasibility
Study:
Small
entities,
defined
as
water
utilities
serving
less
than
15,000
people
will
not
be
asked
to
fill
out
the
questionnaire.

Environmental
Health
Studies:
This
question
does
not
apply
to
individuals
since
individuals
are
all
equal.

5(
d)
COLLECTION
SCHEDULE
Feasibility
Study:
Data
collection
for
the
Feasibility
Study
will
be
a
one­
time
collection
for
the
purpose
of
determining
possible
sites
to
conduct
environmental
health
studies.
8
Environmental
Health
Studies:
The
health
diary
will
be
returned
to
the
study
center
once
a
month,
for
12
months
in
each
study.
The
expected
time
table
for
recording
health
checklists
is
unknown
as
it
depends
on
adequate
subject
recruitment
in
each
area
served
by
selected
utilities
and
will
be
unique
for
each
of
the
communities
to
be
studied.
The
exact
time
frame
for
each
utility
may
vary
depending
on
the
season
of
the
year
and
number
of
households
participating.

Timeline:
these
collections
should
be
completed
in
time
for
the
second
phase
of
the
Enhanced
Surface
Water
Treatment
Rule
scheduled
for
promulgation
in
2002.

6(
a).
ESTIMATING
RESPONDENT
BURDEN
TABLE
1.
Feasibility
Study:

Feasibility
Study:
Respondent
Activities
Burden
Hours
Freq
Costs
($)
@
$
31.00/
hr
1.
Read
questionnaire
instructions
0.10
1
3.10
2.
Gather
information
1.00
1
31.00
3.
Complete
questionnaire
1.00
1
31.00
4.
Return
questionnaire
as
requested
0.10
1
3.10
TOTAL
2.20
68.20
ANNUAL
REPORTING
BURDEN:
Hr.
total
(
2.20)
x
No.
of
Respondents
(
400)
=
880
hrs
ANNUAL
COST:
Cost
total
($
68.20)
x
No.
of
Respondents
(
400)
=
$
27,280.00
NO
ANNUAL
RECORDKEEPING
BURDEN
The
burden
estimates
for
the
Feasibility
Study
are
based
on
consultation
with
the
individuals
listed
in
3(
c)
and
our
experience
with
similar
types
of
information
collection.

TABLE
2.
Environmental
Health
Study:

Respondent
Activities
Burden
Hours
Freq
Total
Costs
($)
@
$
10.00/
hr
hr
1.
Read
questionnaire
instruction
0.10
12
1.20
12.00
2.
Gather
information
from
family
members
0.25
12
3.00
30.00
3.
Record
information
biweekly
0.10
24
2.40
24.00
4.
Return
questionnaire
monthly
0.05
12
0.60
6.00
TOTAL
0.50
7.20
72.00
ANNUAL
REPORTING
BURDEN:
Hr.
total
(
7.2)
x
No.
of
Respondents
(
1000)
=
7,200
hrs
ANNUAL
COST:
Cost
total
($
72.00)
x
No.
of
Respondents
(
1000)
=
$
72,000.00
NO
ANNUAL
RECORDKEEPING
BURDEN
9
The
burden
estimates
for
the
Environmental
Health
Studies
are
based
on
previous
experience
with
this
type
of
questionnaire.

6(
b)
ESTIMATING
RESPONDENT
COSTS
The
Feasibility
Study
average
wage
for
the
utility
respondent
is
taken
from
consultation
with
the
American
Water
Works
Association
information
on
wages
and
salaries.
Their
1979
"
Survey
of
Water
Utility
Salaries,
Wages
and
Employee
Benefits",
was
consulted.
They
reported
an
average
hourly
wage
of
$
12.31
for
a
managerial/
supervisor
position.
After
adjusting
for
inflation
and
including
benefits,
a
base
pay
of
$
31.00/
hr
is
used.
We
have
assumed
a
manager
would
respond
to
the
questionnaire.
This
may
vary
depending
on
the
size
of
the
utility,
however
a
manager
for
a
small
utility
may
approximate
the
same
wage
rate
as
a
technical
person
in
a
large
utility.

The
Environmental
Health
Study
wage
estimate
for
the
household
respondent
is
based
on
the
average
salary
for
women
who
work
full
time
(
the
primary
respondent)
reported
by
the
US
Census
Bureau
(
1990)
at
a
salary
of
$
19,822
per
year
or
$
10.00
($
9.53)
per
hour.
All
numbers
have
been
rounded.

6(
c)
ESTIMATING
AGENCY
BURDEN
AND
COST
Worksheet
2.
Annual
Agency
Burden/
Cost
Estimates
TABLE
3.
Feasibility
Study:

AGENCY
Activities
Burden
Hours
Freq
Total
Costs
($)
Cont
EPA
hours
Cont
EPA
$
54.00/
hr
$
49.00/
hr
1.
Administer
questionnaire
40
0.25
1
40.25
2,160
12
2.
Set
up
and
maintain
the
database
80
10
1
90
4,320
490
3.
Answer
questions,
contact
respondent
0.25
0.25
400
200
5,400
4,900
4.
Review
respondent
submissions
0.5
0.25
400
300
10,800
4,900
5.
Convert
data
to
electronic
form
0.5
0
400
200
10,800
0
6.
Store
and
review
data
10
20
1
30
540
980
TOTAL
131.25
30.75
1203
860.25
34,020
11,282
AGENCY
TOTAL
ANNUAL
BURDEN:
860.25
hrs
AGENCY
TOTAL
ANNUAL
COST:
$
34,020
+
$
11,282
=
$
45,302
10
TABLE
4.
Environmental
Health
Study:
___________________________________________________________________________________
AGENCY
Activities
Burden
Hours
Freq
Total
Costs
($)
Cont.
EPA
hours
Cont.
EPA
$
54.00/
hr
$
49.00/
hr
1.
Administer
questionnaire
40
3
12
516
25,920
1,764
2.
Set
up
and
maintain
the
database
80
10
1
90
4,320
490
3.
Answer
questions,
contact
respondents
0.25
0.50
1,000
750
13,500
24,500
4.
Review
respondent
submissions
0.5
0.25
12,000
9000
324,000
147,000
5.
Convert
data
to
electronic
form
0.25
0
12,000
3000
162,000
0
6.
Store
data
10
20
12
360
6,480
11,760
TOTAL
131
33.75
4,313
13,716
536,220
185,514
AGENCY
TOTAL
ANNUAL
BURDEN:
13,716
hrs
AGENCY
TOTAL
ANNUAL
COST:
($
536,220
+
$
185,514)
=
$
721,734
___________________________________________________________________________________

We
based
our
burden
estimates
on
our
prior
experience
in
developing,
gathering
information
for
research
purposes.
The
agency
costs
have
been
based
on
a
GS­
13(
6)
for
the
primary
investigator
and
calculated
to
include
benefits.
The
contractor
costs
are
based
on
a
composite
cost
given
the
team
of
people
needed
to
conduct
this
study.
Estimated
annualized
hours
and
costs
for
the
Environmental
Health
Study
could
be
over
estimated
by
33%.

6(
d)
ESTIMATING
THE
RESPONDENT
UNIVERSE
AND
TOTAL
BURDEN
COSTS
The
respondents,
burdens
and
costs
are
different
between
types
of
studies.
See
Tables
5
and
6
for
a
breakdown
of
burden
hours
and
costs.

6(
e)
BOTTOM
LINE
BURDEN
HOURS
AND
COSTS
/
BURDEN
TABLES
TABLE
5.
AGGREGATE
RESPONDENT
COSTS
Burden
Hours
$
Costs
#
1
Feasibility
880
27,280
#
2
Environmental
Health
7,200
72,000
TOTAL
8,080
99,280
______________________________________________________________________________
11
TABLE
6.
AGGREGATE
AGENCY
BURDEN
/
COSTS
Burden
Hours
$
Costs
#
1
Feasibility
860.25
45,302
#
2
Environmental
Health
13,716
721,734
TOTAL
14,576.25
767,036
______________________________________________________________________________

6(
f)
REASONS
FOR
CHANGE
IN
BURDEN
There
has
been
a
change
in
the
respondent
burden
calculation
for
this
ICR
renewal.
In
the
environmental
health
study,
the
time
required
to
complete
the
health
diary
checklist
has
been
estimated
to
require
6
minutes
(
0.1
hours)
versus
15
minutes
(
0.25
hours)
this
adjustment
has
been
made
as
we
have
gained
more
field
experience
with
this
instrument.
The
number
of
months
respondents
will
provide
information
has
changed
from
9
to
12
months
as
we
would
like
a
full
year
of
health
data
to
evaluate
seasonal
effects
on
health
endpoints.

6(
g)
BURDEN
STATEMENT
Feasibility
Study:
Public
reporting
burden
for
this
collection
of
information
is
estimated
to
average
2.20
hours
per
response,
and
will
require
no
recordkeeping.
This
includes
the
time
for
reviewing
instructions,
compiling
relevant
data,
reviewing
the
data
for
accuracy,
filling
out
the
form
and
returning
the
form.

Environmental
Health
Studies:
The
reporting
burden
for
this
collection
of
information
is
estimated
to
average
7.20
hours
per
person
per
year.
This
includes
times
for
reviewing
instructions,
obtaining
the
information
from
other
family
members,
recording
that
information,
returning
the
health
diary
over
a
12
month
period
of
the
study.

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,
OPPE
Regulatory
Information
Division,
U.
S.
Environmental
Protection
Agency
(
2137),
401
M
St.,
S.
W.,
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
and
OMB
control
number
in
any
correspondence.

B.
STATISTICAL
ASPECTS
Feasibility
Study:
No
statistical
analyses
are
involved
during
this
study
since
selection
of
participating
utilities
will
be
based
on
water
quality
criteria
and
willingness
to
participate.

Environmental
Health
Studies:
The
following
sections
relate
to
the
proposed
environmental
health
studies
12
that
will
be
conducted
upon
completion
of
the
feasibility
study.
The
remaining
section
refers
to
the
Environmental
Health
Studies
only.

1(
a)
SURVEY
OBJECTIVES
The
objective
of
the
Environmental
Health
Studies
is
to
determine
the
burden
of
enteric
illness
in
U.
S.
communities
attributable
to
drinking
water.

1(
b)
KEY
VARIABLES
Information
will
be
collected
on
the
standard
demographic
variables
of
age,
race
and
gender.
The
survey
will
collect
the
health
information
mentioned
above
in
4(
b)
I:
"
Data
Items".
The
rate
of
illness
does
not
vary
much
between
the
sexes
or
by
race.
Age
is
a
significant
variable
when
considering
acute
gastroenteritis
and
upper
respiratory
infections.
Children
under
ten
years
of
age
and
adults
over
65
years
of
age
have
the
highest
rates
of
disease
(
6
episodes
per
person
per
year).
The
overall
rate
is
two
episodes
per
person
per
year.

1(
c)
STATISTICAL
APPROACH
The
health
status
of
the
study
population
will
be
evaluated
along
with
the
physical
and
microbial
quality
of
their
water.
Statistical
associations
between
health
effects
and
water
quality
parameters
will
be
calculated.
The
targeted
population
will
be
families
with
children
between
the
age
of
two
and
10
years
old.
The
sampling
base
may
change
for
each
community
depending
on
size.
A
central
group
of
people
will
be
identified
from
elementary
school
rosters,
health
maintenance
organization
patient
lists,
or
utility
customer
lists.
A
random
sample
of
that
population
will
be
selected
and
asked
to
participate.
The
study
group
will
be
contacted
to
establish
the
link
with
the
organization,
do
the
random
sampling
and
establish
the
study
population.

1(
d)
FEASIBILITY
Obstacles:
Based
on
previous
experience
with
health
diaries,
the
major
problem
has
been
completion
of
reporting.
This
is
usually
improved
by
occasional
home
visits
to
pick
up
the
diary
or
a
telephone
call
or
post
card
to
remind
the
respondent
of
the
need
to
be
complete
in
reporting
the
symptoms
listed.

Sufficient
funds:
This
study
has
been
budgeted
with
sufficient
funds
from
a
long
standing
program.
In
the
event
a
dramatic
cut
in
the
drinking
water
research
program
were
to
take
place,
the
study
could
be
downsized
to
fewer
communities.
Timeline:
The
first
community
study
has
been
completed.
The
second
community
study
will
begin
in
late
1998
and
should
be
completed
in
early
2000.
The
third
community
will
be
identified
by
October
1999.

2.
SURVEY
DESIGN
2(
a)
Target
Population
and
Coverage
The
target
population
for
this
study
will
be
all
households
supplied
by
drinking
water
utilities
identified
through
the
feasibility
study.
The
surveys
will
focus
on
households
with
at
least
one
child
between
two
and
ten
years
old.
This
targeted
population
serves
to
increase
the
sensitivity
of
the
study
by
including
the
most
susceptible
population
(
children
under
ten).
13
2(
b)
Sample
Design
(
I)
Sampling
frame.
The
sampling
frame
will
be
unique
to
each
community.
The
frame
to
be
used
will
depend
on
which
one
will
give
greatest
access
to
households
with
children.
This
could
include
but
is
not
limited
to
elementary
school
rosters,
health
maintenance
organization
patient
lists
or
utility
billing
lists.

(
ii)
Sample
size.
A
sample
size
of
approximately
1000
households
was
selected;
we
anticipate
an
average
of
2.2
persons
per
household.
The
sample
size
is
based
on
the
approximate
number
of
individuals
that
would
be
needed
to
be
covered
for
12
months.
Reports
have
suggested
that
drinking
water
could
be
responsible
for
as
much
as
30%
of
acute
gastroenteritis.
A
sensitivity
of
being
able
to
detect
a
10%
difference
in
disease
rates
was
considered
feasible
and
meaningful.
Larger
numbers
of
households
could
be
used,
however,
cost
considerations
and
community
size
are
limiting
factors.

(
iii)
Stratification
variables.
Not
applicable.

(
iv)
Sampling
method.
After
the
sampling
frame
has
been
determined,
a
simple
random
sample
of
households
will
be
selected
to
participate
in
the
study.

(
v)
Multi­
stage
sampling.
Not
applicable.

2(
c)
PRECISION
REQUIREMENTS
(
I)
Precision
targets.
The
survey
is
designed
to
show,
with
95%
confidence,
the
attributable
risk
associated
with
microbes
in
drinking
water
provided
that
risk
is
10%
or
greater.

(
ii)
Nonsampling
error.
Most
health
and
epidemiology
studies
are
concerned
with
errors
associated
with
misclassification
of
both
disease
and
exposure.
Exposure
misclassification
will
be
minimized
by
evaluating
subjects
exposure
to
all
sources
of
drinking
water.
There
is
some
concern
over
misclassification
of
disease
since
we
are
relying
on
self­
reporting.
However,
the
standard
practice
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.
The
other
concern
is
under
reporting
of
illnesses.
We
will
maximize
contact
with
the
respondent
through
the
occasional
phone
call
or
post
card
to
remind
subjects
to
report
illnesses.
It
is
assumed,
however,
there
will
be
a
certain
amount
of
under
reporting.
There
is
no
evidence
to
suggest
any
one
category
of
people
under
report
more
than
another.
Under
reporting
can
bias
the
results
towards
the
null
(
no
difference),
so
will
be
unlikely
to
overestimate
the
effect
of
drinking
water
on
human
health.

Other
types
of
error
are
those
associated
with
confounding.
There
are
two
major
confounders
associated
with
the
acute
symptomatology
that
we
will
be
examining.
The
most
significant
confounder
is
age.
Since
we
will
be
collecting
that
information,
we
can
control
for
it
by
producing
age
specific
or
age
adjusted
rates
in
the
analyses.
A
major
source
of
exposure
to
enteric
organisms
is
through
food.
This
is
assumed
to
not
be
a
major
problem
given
the
random
nature
of
its
impact,
and
the
lack
of
an
association
between
contamination
of
food
and
municipal
drinking
water
quality.

2(
d)
QUESTIONNAIRE
DESIGN
The
questionnaire
consists
of
a
health
diary.
It
has
been
used
previously
in
three
studies
by
EPA,
one
14
study
by
the
Centers
for
Disease
Control
and
Prevention,
and
by
an
EPA
funded
study
in
Quebec,
Canada.
It
has
been
pretested
extensively
and
has
proven
to
be
consistent
is
providing
accurate
and
reliable
information.
The
health
diary
can
be
found
in
Appendix
C.

3.
PRETESTS
AND
PILOT
TESTS
This
health
diary
has
been
used
extensively
in
three
previous
studies
and
by
a
study
team
in
Canada.
There
are
no
plans
to
pretest
or
modify
the
questionnaire.

4.
COLLECTION
METHODS
AND
FOLLOW­
UP
4(
a)
COLLECTION
METHODS
A
random
selection
of
households
(
see
2(
a)
and
(
b))
will
be
sent
a
letter
of
invitation
to
participate.
Previous
experience
has
been
that
approximately
80%
respond
as
willing
to
participate.
An
initial
household
visit
is
conducted
at
the
start
of
the
study.
Baseline
information
on
demographic
(
age
and
sex)
are
obtained
and
the
instructions
on
completing
the
health
diary
are
explained.
Subsequently,
the
households
are
contacted
monthly
by
mail
and
asked
to
return
the
old
diary
and
fill
in
the
new.
Non­
responders
are
contacted
by
phone
and
the
information
is
collected
at
that
time.
The
household
visitors
and
the
phone
interviewers
will
receive
20
hours
of
training
on
instructing
the
subjects
to
fill
out
the
health
diary.
Emphasis
in
training
will
be
on
making
sure
that
the
subjects
understand
how
to
complete
the
check
list,
the
need
to
be
thorough,
and
to
check
all
requested
symptoms
experienced
regardless
of
whether
they
perceive
the
symptoms
to
be
relevant
or
not.
Subjects
are
assured
that
they
can
receive
a
summary
of
results
when
the
study
has
been
completed.
Telephone
interviewers
will
be
trained
on
prompting
subjects
for
response.
Again
the
emphasis
will
be
on
completeness
of
reporting
for
all
members
of
the
household.

4(
b)
SURVEY
RESPONSE
AND
FOLLOW­
UP
The
initial
response
rate
to
participate
is
expected
to
be
between
70
and
80
percent.
This
is
based
on
two
previous
studies
of
this
type.
Households
that
fail
to
return
three
health
diaries
in
a
row
will
be
asked
if
they
wish
to
drop
out
of
the
study.
Previous
experience
has
indicated
that
approximately
five
percent
of
the
households
will
drop
out
of
the
study.
The
sample
size
estimates
account
for
this
drop
out
rate.

5.
ANALYZING
AND
REPORTING
SURVEY
RESULTS
5(
a)
DATA
PREPARATION
An
in­
house
computer
program
will
verify
that
data
submitted
is
internally
consistent,
as
keyed.
The
program
will
also
flag
missing
data
items
and
other
inconsistencies,
as
well
as
items
with
potential
keystroke
errors.

5(
b)
ANALYSIS
Analyses
will
be
conducted
by
comparing
disease
rates
to
water
quality
parameters.
These
are
typically
accomplished
by
age
stratified
Mantel­
Hansel
chi
squares.
If
significant
associations
are
found,
log­
linear
15
regression
analysis
is
conducted
to
see
if
the
disease
rate
(
dependent
variable)
can
be
predicted
by
some
measure
of
water
quality
(
independent
variable).
Results
will
be
displayed
in
table
format
including
variables,
Chi­
square,
p­
value
and
95
percent
confidence
intervals.

5(
c)
REPORTING
RESULTS
A
report
on
each
of
the
utilities
will
be
developed
and
available
to
agency
personnel
and
the
public.
At
the
conclusion
of
all
studies
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
study
site
will
be
submitted
for
publication
in
a
peer
reviewed
scientific
journal.
16
APPENDIX
A:
SDWA
Sec
1458
SEC.
1458.
(
a)
SUBPOPULATIONS
AT
GREATER
RISK­­

(
1)
IN
GENERAL.
­­
The
Administrator
shall
conduct
a
continuing
program
of
studies
to
identify,
groups
within
the
general
population
that
may
be
at
greater
risk
than
the
general
population
of
adverse
health
effects
from
exposure
to
contaminants
in
drinking
water.
The
study
shall
examine
whether
and
to
what
degree
infants,
children,
pregnant
women,
the
elderly
individuals
with
a
history
of
serious
illness,
or
other
subpopulations
that
can
be
identified
and
characterized
are
likely
to
experience
elevated
health
risks,
including
risks
from
cancer,
from
contaminants
in
drinking
water.

(
2)
REPORT.­­
Not
later
than
4
years
after
the
date
of
enactment
of
this
subsection
and
periodically
thereafter
as
new
and
significant
information
becomes
available,
the
Administrator
shall
report
to
the
Congress
on
the
results
of
the
studies.

SEC.
1458.(
b)
BIOLOGICAL
MECHANISMS.­­
The
Administrator
shall
conduct
biomedical
studies
to
­­
(
1)
understand
the
mechanisms
by
chemical
contaminants
are
absorbed,
distributed,
metabolized,
and
eliminated
from
the
human
body,
so
as
to
develop
more
accurate,
physiologically
based
mechanisms
of
the
phenomena;

(
2)
understand
the
effects
of
contaminants
and
the
mechanisms
by
which
the
contaminants
cause
adverse
effects
(
especially
noncancer
and
infectious
effects)
and
the
variations
in
the
effects
among
humans,
especially
subpopulations
at
greater
risk
of
adverse
effects,
and
between
test
animals
and
humans;
and
(
3)
develop
new
approaches
to
the
concept
of
complex
mixtures,
such
as
mixtures
found
in
drinking
water,
especially
to
determine
the
prospects
for
synergistic
or
antagonistic
interactions
that
may
affect
the
shape
of
the
dose­
response
relationship
of
the
individual
chemicals
and
microbes,
and
to
examine
noncancer
endpoints
and
infectious
diseases,
and
susceptible
individuals
and
populations.

SEC.
1458.(
c)
STUDIES
ON
HARMFUL
SUBSTANCES
IN
DRINKING
WATER
­­

(
1)
DEVELOPMENT
OF
STUDIES.­­
The
Administrator
shall,
not
later
than
180
days
after
the
date
of
enactment
of
this
section
and
after
consultation
with
the
Secretary
of
Health
and
Human
Services
,
the
Secretary
of
Agriculture,
and
as
appropriate,
the
heads
of
other
Federal
agencies,
conduct
the
studies
described
in
paragraph
(
2)
to
support
the
development
and
implementation
of
the
most
current
version
of
each
of
the
following:

(
A)
Enhanced
Surface
Water
Treatment
Rule
(
59
Fed.
Reg.
38832
(
July
29,
1994)).
(
B)
Disinfect
and
Disinfection
Byproducts
Rule
(
59
Fed.
Reg.
38668
(
July
29,
1994)).
(
C)
Ground
Water
Disinfection
Rule
(
availability
of
draft
summary
announced
at
(
57
Fed.
Reg.
33960;
July
32,
1992)).

(
2)
CONTENTS
OF
STUDIES.­­
The
studies
required
by
paragraph
(
1)
shall
include,
at
a
minimum,
17
each
of
the
following:

(
A)
Toxicological
studies
and,
if
warranted,
epidemiological
studies
to
determine
what
levels
of
exposure
from
disinfectants
and
disinfection
byproducts,
if
any,
may
be
associated
with
developmental
and
birth
defects
and
other
potential
toxic
endpoints.

(
B)
Toxicological
studies
and
,
if
warranted,
epidemiological
studies
to
quantify
the
carcinogenic
potential
from
exposure
to
disinfection
byproducts
resulting
from
different
disinfectants.

(
C)
The
development
of
dose­
response
curves
for
pathogens,
including
Cryptosporidium
and
Norwalk
virus.

SEC.
1458.(
d)
WATERBORNE
DISEASE
OCCURRENCE
STUDY.­­

(
1)
SYSTEM.­­
The
Director
of
the
Centers
for
Disease
Control
and
Prevention,
and
the
Administrator
shall
jointly­­

(
A)
within
2
years
after
the
date
of
the
enactment
of
this
section,
conduct
pilot
waterborne
disease
occurrence
studies
for
at
least
5
major
United
States
communities
or
public
water
systems;
and
(
B)
within
5
years
after
the
date
of
the
enactment
of
this
section,
prepare
a
report
on
the
findings
of
the
pilot
studies,
and
a
national
estimate
of
waterborne
disease
occurrence.
18
APPENDIX
B:
Feasibility
Study
Questionnaire
Study
of
Efficacy
of
Drinking
Water
Treatment
Disinfection/
Distribution
System
1.
Have
you
determined
the
contact
time
(
CT)
value
for
your
disinfection
process?

____
No

a.
What
is
the
normal
time
allowed
for
the
disinfectant
to
react
with
the
water
before
delivery
to
the
first
customer?

____
minutes
b.
What
is
the
normal
concentration
of
disinfectant
residual
after
this
contact
time?

____
ppm
____
Yes

What
is
the
CT
value?
___

2.
How
many
miles
of
pipe
do
you
have
in
your
distribution
system?

____
miles
3.
What
is
the
storage
capacity
of
your
distribution
system?
(
MG
=
Gallons
in
millions)

Elevated
storage
tanks:
____
MG
Above
ground
reservoirs:
____
MG
Underground
reservoirs:
____
MG
Other:
Specify:
____________________
____
MG
What
is
your
Total
Distribution
Storage
Capacity?
____
MG
4.
Are
your
distribution
storage
tanks/
reservoirs
covered
or
uncovered?

____
Covered
____
Uncovered
____
Both
5.
Has
hydraulic
modeling
or
analysis
of
your
distribution
system
been
conducted?

____
No
____
Yes

If
yes,
a.
When
was
the
last
one
performed?
___
___
19___
mo
day
year
b.
Would
it
be
possible
to
obtain
a
copy
of
the
report?

____
No
____
Yes
19
Source
Water
6.
Is
the
quantity
of
water
from
the
source(
s)
sufficient
to
meet
the
current
needs
of
the
community(
ies)
served?

____
No
____
Yes
7.
Is
the
quantity
of
water
from
the
source(
s)
sufficient
to
meet
the
projected
needs
of
the
community(
ies)
served
for
the
next
10
years?

____
No
____
Yes
8.
Does
your
facility
have
a
well­
head
protection
program
currently
in
place?

____
No
____
Yes

If
yes,

9.
Have
you
ever
had
a
sanitary
survey
performed
on
your
watershed(
s)?

____
No
____
Yes

a.
When
was
the
last
survey
performed?
___
___
19___
mo
day
year
b.
Would
it
be
possible
to
obtain
a
copy
of
the
report?

____
No
____
Yes
20
10.
What
was
the
average
monthly
temperature
of
the
water
in
your
DISTRIBUTION
SYSTEM
for
the
past
12
months?
(
Enter
information
in
degrees
centigrade
OR
degrees
Fahrenheit).

Month
Year

C

F
January
1997
February
1997
March
1997
April
1997
May
1997
June
1997
July
1997
August
1997
September
1997
October
1997
November
1997
December
1997
21
11.
Please
enter
all
relevant
information
for
your
water,
if
known.

Type
of
Water
Source
for
___________________
Storage
Capacity
(
MG)
Average
Flow
Rate
(
MGD)
Depth
(
feet)
Rated
Capacity
(
GMG)

Rivers
Reservoirs
Creeks
Lakes
Well
water,
under
the
influence
of
surface
water
Well
water,
not
under
the
influence
of
surface
water
Spring
water,
under
the
influence
of
surface
water
Spring
water,
not
under
the
influence
of
surface
water
Rainy
well,
under
the
influence
of
surface
water
Other
(
specify):
Monitoring
Activities
of
the
RAW
SYSTEM,
AFTER
DISINFECTION,
and
for
the
DISTRIBUTION
SYSTEM
12.
Please
indicate
which
tests
are
done
at
your
facility
and
provide
the
frequency
of
testing,
the
type
of
laboratory
and
protocol
used
at
your
facility
for
the
most
recent
year
of
monitoring,
and
the
number
of
sampling
points
in
your
distribution
system.
If
a
test
is
not
done,
please
check
not
done
in
the
test
section
below
the
test
name.

Raw
System
After
Disinfection
Distribution
System
Test
Frequency
of
Testing
(
Times
Per)
Lab
(
Check
One)
EPA
Protocol
(
Check
One)
Frequency
of
Testing
(
Times
Per)
Lab
(
Check
One)
EPA
Protocol
(
Check
One)
Frequency
of
Testing
(
Times
Per)
Lab
(
Check
One)
EPA
Protocol
(
Check
One)
No.
of
Sampling
Points
Turbidity
___
done
___
not
done
___
day
___
month
___
year
___
Inhouse
___
State
___
Private
___
Yes
___
No
___
day
___
month
___
year
___
Inhouse
___
State
___
Private
___
Yes
___
No
___
day
___
month
___
year
___
Inhouse
___
State
___
Private
___
Yes
___
No
Particle
Counting
___
done
___
not
done
___
day
___
month
___
year
___
Inhouse
___
State
___
Private
___
Yes
___
No
___
day
___
month
___
year
___
Inhouse
___
State
___
Private
___
Yes
___
No
___
day
___
month
___
year
___
Inhouse
___
State
___
Private
___
Yes
___
No
pH
___
done
___
not
done
___
day
___
month
___
year
___
Inhouse
___
State
___
Private
___
Yes
___
No
___
day
___
month
___
year
___
Inhouse
___
State
___
Private
___
Yes
___
No
___
day
___
month
___
year
___
Inhouse
___
State
___
Private
___
Yes
___
No
Color
___
done
___
not
done
___
day
___
month
___
year
___
Inhouse
___
State
___
Private
___
Yes
___
No
___
day
___
month
___
year
___
Inhouse
___
State
___
Private
___
Yes
___
No
___
day
___
month
___
year
___
Inhouse
___
State
___
Private
___
Yes
___
No
Total
Coliforms
___
done
___
not
done
___
day
___
month
___
year
___
Inhouse
___
State
___
Private
___
Yes
___
No
___
day
___
month
___
year
___
Inhouse
___
State
___
Private
___
Yes
___
No
___
day
___
month
___
year
___
Inhouse
___
State
___
Private
___
Yes
___
No
Fecal
Coliforms
___
done
___
not
done
___
day
___
month
___
year
___
Inhouse
___
State
___
Private
___
Yes
___
No
___
day
___
month
___
year
___
Inhouse
___
State
___
Private
___
Yes
___
No
___
day
___
month
___
year
___
Inhouse
___
State
___
Private
___
Yes
___
No
Heterotrophic
Plate
Count
___
done
___
not
done
___
day
___
month
___
year
___
Inhouse
___
State
___
Private
___
Yes
___
No
___
day
___
month
___
year
___
Inhouse
___
State
___
Private
___
Yes
___
No
___
day
___
month
___
year
___
Inhouse
___
State
___
Private
___
Yes
___
No
Total
Organic
Carbon
___
done
___
not
done
___
day
___
month
___
year
___
Inhouse
___
State
___
Private
___
Yes
___
No
___
day
___
month
___
year
___
Inhouse
___
State
___
Private
___
Yes
___
No
___
day
___
month
___
year
___
Inhouse
___
State
___
Private
___
Yes
___
No
Total
Chlorine
Residual
___
done
___
day
___
month
___
Inhouse
___
State
___
Yes
___
No
___
day
___
month
___
Inhouse
___
State
___
Yes
___
No
___
day
___
month
___
Inhouse
___
State
___
Yes
___
No
Raw
System
After
Disinfection
Distribution
System
Test
Frequency
of
Testing
(
Times
Per)
Lab
(
Check
One)
EPA
Protocol
(
Check
One)
Frequency
of
Testing
(
Times
Per)
Lab
(
Check
One)
EPA
Protocol
(
Check
One)
Frequency
of
Testing
(
Times
Per)
Lab
(
Check
One)
EPA
Protocol
(
Check
One)
No.
of
Sampling
Points
___
not
done
___
year
___
Private
___
year
___
Private
___
year
___
Private
Free
Chlorine
Residual
___
done
___
not
done
___
day
___
month
___
year
___
Inhouse
___
State
___
Private
___
Yes
___
No
___
day
___
month
___
year
___
Inhouse
___
State
___
Private
___
Yes
___
No
___
day
___
month
___
year
___
Inhouse
___
State
___
Private
___
Yes
___
No
Total
Organic
Halides
___
done
___
not
done
___
day
___
month
___
year
___
Inhouse
___
State
___
Private
___
Yes
___
No
___
day
___
month
___
year
___
Inhouse
___
State
___
Private
___
Yes
___
No
___
day
___
month
___
year
___
Inhouse
___
State
___
Private
___
Yes
___
No
Total
Trihalomethanes
___
done
___
not
done
___
day
___
month
___
year
___
Inhouse
___
State
___
Private
___
Yes
___
No
___
day
___
month
___
year
___
Inhouse
___
State
___
Private
___
Yes
___
No
___
day
___
month
___
year
___
Inhouse
___
State
___
Private
___
Yes
___
No
Other
Disinfection
Byproducts
___
done
___
not
done
___
day
___
month
___
year
___
Inhouse
___
State
___
Private
___
Yes
___
No
___
day
___
month
___
year
___
Inhouse
___
State
___
Private
___
Yes
___
No
___
day
___
month
___
year
___
Inhouse
___
State
___
Private
___
Yes
___
No
Viruses
___
done
___
not
done
___
day
___
month
___
year
___
Inhouse
___
State
___
Private
___
Yes
___
No
___
day
___
month
___
year
___
Inhouse
___
State
___
Private
___
Yes
___
No
___
day
___
month
___
year
___
Inhouse
___
State
___
Private
___
Yes
___
No
Giardia
Cysts
___
done
___
not
done
___
day
___
month
___
year
___
Inhouse
___
State
___
Private
___
Yes
___
No
___
day
___
month
___
year
___
Inhouse
___
State
___
Private
___
Yes
___
No
___
day
___
month
___
year
___
Inhouse
___
State
___
Private
___
Yes
___
No
Cryptosporidium
Oocysts
___
done
___
not
done
___
day
___
month
___
year
___
Inhouse
___
State
___
Private
___
Yes
___
No
___
day
___
month
___
year
___
Inhouse
___
State
___
Private
___
Yes
___
No
___
day
___
month
___
year
___
Inhouse
___
State
___
Private
___
Yes
___
No
IF
YOU
HAVE
AN
ANNUAL
REPORT
THAT
PROVIDES
THE
MONITORING
INFORMATION,
YOU
DO
NOT
NEED
TO
COMPLETE
QUESTION
13,
14,
15A,
AND
15B.
JUST
ATTACH
A
COPY
OF
THE
ANNUAL
REPORT.
Monitoring
Activities:
RAW
SYSTEM
13.
Please
provide
the
most
recent
monthly
results
of
your
RAW
SYSTEM
monitoring
activities.
Enter
ND
for
months
where
No
Data
are
available.

Tests
Variable
(
monthly
average)
Jan
97
Feb
97
Mar
97
Apr
97
May
97
Jun
97
July
97
Aug
97
Sept
97
Oct
97
Nov
97
Dec
97
Turbidity
(
NTU=
s)
Mean
Range
Particle
Counting
(#
2
15
microns)
Mean
Range
pH
Mean
Range
Color
Mean
Range
Total
Coliforms
(
per
100
ml)
Mean
Range
Fecal
Coliforms
(
per
100
ml)
Mean
Range
Heterotrophic
Plate
Count
(
per
100
ml)
Mean
Range
Total
Organic
Carbon
(
mg/
ml)
Mean
Range
Viruses
(
MPN/
L)
Mean
Range
Giardia
Cysts
(
per
100
L)
Mean
Range
Cryptosporidium
Mean
Oocysts
(
per
100
L)
Range
Monitoring
Activities:
AFTER
DISINFECTION
14.
Please
provide
the
most
recent
monthly
results
of
the
monitoring
activities
at
the
treatment
plant
AFTER
DISINFECTION.
Enter
ND
for
months
where
No
Data
are
available.
Tests
Variable
(
monthly
average)
Jan
97
Feb
97
Mar
97
Apr
97
May
97
Jun
97
Jul
97
Aug
97
Sept
97
Oct
97
Nov
97
Dec
97
Turbidity
(
NTU=
s)
Mean
Range
Particle
Counting
(#
2
15
microns)
Mean
Range
pH
Mean
Range
Color
Mean
Range
Total
Coliforms
(
per
100
ml)
Mean
Range
Fecal
Coliforms
(
per
100
ml)
Mean
Range
Heterotrophic
Plate
Count
(
per
100
ml)
Mean
Range
Total
Chlorine
Residual
(
mg/
L)
Mean
Range
Total
Organic
Halides
(
mg/
L)
Mean
Range
Total
Trihalomethanes
(
mg/
L)
Mean
Range
Total
Haloacetic
Acid
(
mg/
L)
Mean
Range
Viruses
Mean
(
MPN/
L)
Range
Giardia
Cysts
(
per
100
L)
Mean
Range
Cryptosporidium
Oocysts
(
per
100
L)
Mean
Range
Monitoring
Activities:
DISTRIBUTION
SYSTEM
C
NEAREST
POINT
15a.
Please
provide
the
most
recent
monthly
results
taken
at
a
site
NEAREST
THE
DISINFECTION
POINT
of
your
DISTRIBUTION
SYSTEM.
Enter
ND
for
months
where
No
Data
are
available.

Tests
Variable
(
monthly
average)
Jan
97
Feb
97
Mar
97
Apr
97
May
97
Jun
97
Jul
97
Aug
97
Sept
97
Oct
97
Nov
97
Dec
97
Turbidity
(
NTU=
s)
Mean
Range
Particle
Counting
(#
2
15
microns)
Mean
Range
pH
Mean
Range
Color
Mean
Range
Total
Coliforms
(
per
100
ml)
Mean
Range
Fecal
Coliforms
(
per
100
ml)
Mean
Range
Heterotrophic
Plate
Count
(
per
100
ml)
Mean
Range
Total
Chlorine
Residual
(
mg/
L)
Mean
Range
Total
Organic
Halides
(
mg/
L)
Mean
Range
Total
Trihalomethanes
(
mg/
L)
Mean
Range
Total
Haloacetic
Acid
(
mg/
L)
Mean
Range
Viruses
(
MPN/
L)
Mean
Range
Giardia
Cysts
(
per
100
L)
Mean
Range
Cryptosporidium
Oocysts
(
per
100
L)
Mean
Range
Monitoring
Activities:
DISTRIBUTION
SYSTEM
C
FARTHEST
POINT
15b.
Please
provide
the
most
recent
monthly
results
taken
at
a
site
FARTHEST
FROM
THE
DISINFECTION
POINT
of
your
DISTRIBUTION
SYSTEM.
Enter
ND
for
months
where
No
Data
are
available.

Tests
Variable
(
monthly
average)
Jan
97
Feb
97
Mar
97
Apr
97
May
97
Jun
97
Jul
97
Aug
97
Sept
97
Oct
97
Nov
97
Dec
97
Turbidity
(
NTU=
s)
Mean
Range
Particle
Counting
(#
2
15
microns)
Mean
Range
pH
Mean
Range
Color
Mean
Range
Total
Coliforms
(
per
100
ml)
Mean
Range
Fecal
Coliforms
(
per
100
ml)
Mean
Range
Heterotrophic
Plate
Count
(
per
100
ml)
Mean
Range
Total
Chlorine
Residual
(
mg/
L)
Mean
Range
Total
Organic
Halides
Mean
(
mg/
L)
Range
Total
Trihalomethanes
(
mg/
L)
Mean
Range
Total
Haloacetic
Acid
(
mg/
L)
Mean
Range
Viruses
(
MPN/
L)
Mean
Range
Giardia
Cysts
(
per
100
L)
Mean
Range
Cryptosporidium
Oocysts
(
per
100
L)
Mean
Range
29
16.
Do
you
have
records
of
monitoring
results
for
the
previous
years?

____
No
____
Yes

If
yes,
Would
it
be
possible
to
obtain
a
copy
of
the
results?

____
No
____
Yes
17.
If
your
comunity
is
selected
for
a
study
of
enteric
illness,
would
you
continue
to
be
interested
in
participating?

____
No
____
Yes
THANK
YOU
FOR
YOUR
COOPERATION.
Enrollment
Questionnaire
and
Instructions
APPENDIX
C:
Environmental
Health
Study
Questionnaires
City
ID#___________
31
U.
S.
EPA
ENTERIC
ILLNESS
STUDY
[
Mark
here
if
more

]

Enrollment
Questionnaire
Date:
_______
/
_______
/
________

Month
Day
Year
Name:
Name:
Name:

Individual
ID
#:
Individual
ID
#:
Individual
ID
#:

Family
ID
#:
DOB:
__________
/
__________
/
__________

Month
Day
Year
DOB:
__________
/
__________
/
__________

Month
Day
Year
DOB:
__________
/
__________
/
__________

Month
Day
Year
Sex
(
Circle
male
or
female)

Male

Female

Male

Female

Male

Female
Is
bottled
water
the
only
drinking
water
source
at
home?

Yes

No

Yes

No

Yes

No
Is
anyone
in
this
household
taking
any
medicines
prescribed
by
a
doctor?
If
Yes,
list
below

Yes

No
For
Office
Use
Only

Yes

No
For
Office
Use
Only

Yes

No
For
Office
Use
Only
Prescription
Medicine
#
1
Prescription
Medicine
#
2
Prescription
Medicine
#
3
Prescription
Medicine
#
4
Prescription
Medicine
#
5
Is
anyone
in
this
household
taking
any
medicine
that
can
be
obtained
without
a
doctor=
s
prescription?

(
Mark
one)
If
Yes,
list
below.

Yes

No
For
Office
Use
Only

Yes

No
For
Office
Use
Only

Yes

No
For
Office
Use
Only
Non­
Prescription
Medicine
#
1
Non­
Prescription
Medicine
#
2
Non­
Prescription
Medicine
#
3
Non­
Prescription
Medicine
#
4
Non­
Prescription
Medicine
#
5
Is
anyone
in
the
household
being
treated
regularly
by
a
doctor?
(
Mark
one)
If
Yes,
list
below.

Yes

No
For
Office
Use
Only

Yes

No
For
Office
Use
Only

Yes

No
For
Office
Use
Only
Illness
#
1
Illness
#
2
Illness
#
3
Check
any
of
the
following
that
apply
to
filtering
City
ID#___________
32
systems
in
your
home:

Activated
carbon
filter

Reverse
osmosis

Ion
exchange
(
deionization)

Other
(
Specify)
_________________________


Whole­
house
system

Kitchen

Both

No
filtering
system
For
Office
Use:

Field
Staff:
______________
____________

Initials
Date
Reviewer:
__________________
_________________

Initials
Date
Data
Entry:
_________________
________________

Initials
Date
OMB
#:
2080­
0050
Medications
of
Special
Interest
Corticosteroids
Antacids
H­
2
Blockers
Aerobid
Anti­
inflammatory
agent
Aristocort
Aristocort
Forte
Aristospan
Celestone
Soluspan
Cortisone
Dalalone
Decadrol
Decadron
Elixir
Decadron
Phospate
with
Xylocaine
Decadron­
La
Deltasone
Depo
Pred
Depo­
medrol
Dexamethasone
Dexamethasone
sodium
Florinef
Hydeltra­
T.
B.
A.
Hydrocortisone
Medrol
Methylprednisolone
Orasone
Pediapred
Prednisolone
Prednisone
Prelone
Solu­
Medtrol
Tac­
3
Triam
Triamcinolone
Triamolone
40
Alka­
Seltzer
Alternagel
Aludrox
Amphojel
Arm
and
Hammer
Baking
Soda
Basaljel
Bismuth
Chooz
Antacid
gum
Citrocarbonate
Di­
Gel
Dycyclomine
Gaviscon
Gelusil
Levsin
Losec
Maalox
Magnesia
(
Milk
of)
Mag­
Ox
Magnesium
Oxide
Marblen
Mylanta
Nephrox
Pepto­
Bismol
Riopan
Riopan
Plus
Rolaids
Sodium
Bicarbonate
Spasmolin
Titralac
Trioval
Tums
Uro­
Mag
WinGel
Axid
Pepcid
Tagamet
Zantac
Health
Conditions
of
Special
Interest
34
U.
S.
EPA
Enteric
Illness
Study
Illness
Health/
Conditions
of
Special
Interest
(
Updated:
June
3,
1996)

Immune
Deficiency
Disorders
Autoimmune
Disorders
Agammaglobulinemia
AIDS
Aplasia
or
dysplasia
with
immunodeficiency
Ataxia
Telangiectasia
Chediak­
Higashi
Syndrome
Chronic
Mucocutaneous
candidiasis
DiGeorge
Syndrome
G6PD
Deficiency
Job­
Buckley
Syndrome
Nezelof=
s
Syndrome
Nucleoside
Phosphorylase
Deficiency
Reticular
Dysgenesis
Short
Limb
dwarfism
Thymic
alymphoplasia
Wiskott­
Aldrich
Syndrome
Bullous
pemphigoid
Diabetes
mellitus
Glomerulonephritis
Goodpasture=
s
Syndrome
Grave=
s
Disease
Hashimoto=
s
Thyroiditis
Hemolytic
Anemia
Idiopathic
Addison=
s
Disease
Mixed
Connective
Tissue
Disease
Myasthenia
Gravis
Pemphigus
Pernicious
Anemia
Polyglandular
Syndromes
Polymyositis
Progressive
Systemic­
Sclerosis
Rheumatoid
arthritis
Schmidt=
s
Syndrome
Sjögren=
s
Syndrome
Systemic
Lupus
Erythematosus
Thrombocytopenic
Purpura
35
U.
S.
EPA
Enteric
Illness
Study
Risk
Factor
Questionnaire
Subject
ID#:

Date
of
Interview:
________
/
_______
/
_______
MM
DD
YY
Time
of
Interview:

__________
am
/
pm
Interviewer
Initials:

*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*

1.
Do
you
work
or
go
to
school
in
a
city
other
than
city
>

A=?


No

Yes
1a.
IF
YES,
where?
_______________________________________

1b.
IF
YES,
do
you
drink
tap
water
there?

No

Yes
(
Average
number
of
8
oz.
glasses
per
day________)

2.
Do
you
have
any
pets?


No

Yes
IF
YES,
Type(
s)_______________________________
______________________________________________________________________________________
______________________________________________________________________________________

3.
Do
you
have
direct
contact
with
animals?

No

Yes
Type(
s)________________________
______________________________

4.
Do
you
have
contact
with
children
in
diapers?

No

Yes
5.
Do
you
have
contact
with
children
who
attend
day­
care?

No

Yes
6.
Do
you
eat
meals
away
from
home?
(
For
example
at
a
restaurant,
cafeteria
or
friend=
s
house)

No

Yes
(
Average
number
of
meals
away
per
week________)

7.
Do
you
eat
raw
fruits
or
vegetables?

No

Yes
(
Average
number
of
servings
per
week________)

8.
Do
you
eat
hamburger
or
poultry

No

Yes
36
cooked
less
than
>

well­
done=?

9.
Do
you
eat
raw
shellfish?

No

Yes
10.
Do
you
eat
raw
eggs
(
such
as
in
home
made
mayonnaise,
Caesar
salad
dressing
or
drinks?)

No

Yes
11.
Do
you
drink
tap
water?
(
Include
drink
mixes)

No

Yes
(
Average
number
of
8
oz.
glasses
per
day________)

11.
a
Do
you
use
tap
water
to
brush
teeth?

11.
b
Do
you
use
tap
water
to
wash
fruits
and
vegetables
that
will
be
eaten
raw?

No

No

Yes

Yes
12.
Do
you
drink
any
untreated,
unboiled
water
from
a
lake,
pond
or
stream
(
this
would
include
water
you
swallow
by
accident
such
as
while
swimming)?

No

Yes
13.
Do
you
swim
in...

1.
an
outdoor
pool?

No

Yes
2.
an
indoor
pool?

No

Yes
3.
a
Jacuzzi,
hot
tub,
whirlpool?

No

Yes
4.
seawater?

No

Yes
5.
a
lithotripter
or
other
medical
procedure
involving
water?

No

Yes
f.
other
(
specify)
___________________

No

Yes
14.
Do
you
perform
any
gardening
activities?

No

Yes
IF
YES,
do
you
do
any
of
the
following:

plant
or
dig
in
the
soil

apply
manure

weed

compost

other
(
specify)
___________________________________
37
15.
Do
you
tend
to
have
diarrhea
on
a
regular
basis
such
as
weekly
or
monthly?


No

Yes
Attachment
:
Risk
Factor
Questionnaire
U.
S.
EPA
Enteric
Illness
Study
Risk
Factor
Questionnaire
38
U.
S.
EPA
Enteric
Illness
Study
Daily
Diary
and
Instructions
Family
ID
#:
Name:
Name:
Name:
Name:
Nam
e:

Individual
ID
#:
Individual
ID
#:
Individual
ID
#:
Individual
ID
#:
Indi
vidu
al
ID
#:

Week
of:
___
/
_____
/
____
Week
of:
___
/
_____
/
____
Week
of:
___
/
_____
/
____
Week
of:
___
/
_____
/
____
Wee
k
of:

___

/
___

__
/

___

_

SYMPTOM
S
M
T
W
T
F
S
S
M
T
W
T
F
S
S
M
T
W
T
F
S
S
M
T
W
T
F
S
SM
TW
TFS
1
Mark
if
you
were
out
of
town
2
Nausea
(
Mark
each
day
nausea
occurred)

3
Vomiting
­
Mark
number
of
times/
day
4
5
Diarrhea
(
Respond
to
as
many
categories
as
appropriate
with
number
of
times
per
day.)
Soft
stools
6
Liquid
stools
(
without
blood)

7
Liquid
stools
with
blood
present
8
Fever
(
Oral
temperature
greater
than
100

)

9
Fever
present
but
not
measured
10
Abdominal
cramps
11
Headache
12
Cold
or
Flu
13
Absent
from
school
or
work,
or
unable
to
carry
out
normal
activities
Attachment
:
Risk
Factor
Questionnaire
U.
S.
EPA
Enteric
Illness
Study
Risk
Factor
Questionnaire
39
14
Stayed
in
bed
for
part
of
day
or
more
15
Physician
or
other
health
professional
seen
due
to
illness
(
Mark
day
of
visit
and
list
diagnosis.)

16
Diagnosis:

17
Medications
taken
(
Indicate
if
medications
were
taken.
Include
prescription
and
overthe
counter
drugs
and
specify
below.)

18
Medicine
#
1
19
Medicine
#
2
20
Medicine
#
3
For
Office
Use:

OMB
#:
2080­
0050
Field
Staff:
__________________
________________

Initials
Date
Reviewer:
__________________
_________________

Initials
Date
Data
Entry:
__________________
________________

Initials
Date
Daily
Diary
and
Instructions
40
Instructions
for
completion
of
Daily
Diary:

Please
fill
out
the
diary
each
day.

Line
#
1:
Mark
each
day
you
are
out­
of­
town
for
the
entire
24­
hour
period.

If
any
symptoms
are
present,
mark
the
appropriate
boxes
(
rows)
for
that
day
(
column)

Line
#
2:
Nausea
includes
any
feelings
of
queasiness
Line
#
3:
If
vomiting
is
present,
mark
the
total
number
of
times
you
or
your
family
member
vomited.

Line
#
4­
7:
If
diarrhea
occurred,
mark
all
of
the
appropriate
categories
with
the
number
of
times
per
day.

Line
#
8­
9:
If
known
fever
was
present
(
oral
temperature
measured
at
100

or
higher
(
equivalent
to
99
axillary
(
under
the
arm)
or
101

rectally),
mark
row
#
8.
If
fever
is
suspected,
but
temperature
was
not
taken,
mark
row
#
9.

Line
#
10:
Mark
if
cramping
pain
(
not
related
to
menstrual
cycle).

Line
#
11:
Record
any
occurrence
of
a
headache
severe
enough
to
require
aspirin,
Tylenol,
or
another
medication
whether
related
to
a
diagnosed
illness
or
not.

Line
#
12:
Record
any
instances
of
symptoms
like
those
experienced
when
you
have
a
cold
or
flu.

Line
#
13:
Mark
each
day
an
absence
from
work
or
school
occurred
due
to
illness,
or
a
day
in
which
regular
activities
could
not
be
carried
out
due
to
illness.

Line
#
14:
Mark
each
day
the
individual
stayed
in
bed
(
part
or
all
of
day)
due
to
illness.

Line
#
15:
Mark
the
day
a
doctor,
nurse,
or
clinic
professional
was
seen
due
to
an
illness.

Line
#
16:
Provide
diagnosis
made
by
doctor
or
nurse.

Line
#
17:
Mark
each
day
a
medication
was
taken.

Line
#
18­
20:
List
medications
that
were
taken.
