Document ID: EPA-HQ-ORD-2003-0008-0001
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2003-07-29T04:00Z

Health
Effects
of
Particulate
Matter
and
Co­
Pollutants
in
Children
Living
in
El
Paso,
Texas
Page
1
SECTION
1.

A.
SUPPORTING
STATEMENT
1.
IDENTIFICATION
OF
THE
INFORMATION
COLLECTION
1(
a)
TITLE
Health
Effects
of
Particulate
Matter
and
Co­
Pollutants
in
Children
Living
in
El
Paso,
Texas.

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
parents
and
children
in
this
collection
of
information
is
strictly
voluntary.

This
information
is
being
collected
as
part
of
a
research
program
consistent
with
the
strategic
plan
for
EPA's
Office
of
Research
and
Development
(
ORD).
ORD's
strategic
plan
has
identified
research
on
airborne
particulate
matter
as
a
high­
priority
research
area
with
particular
emphasis
on
"
studying
the
heightened
sensitivity
/
susceptibility
of
certain
subpopulations
(
e.
g.,
children)".
EPA
has
broad
legislative
authority
to
establish
air
quality
criteria
and
to
conduct
research
to
support
these
criteria.

This
data
collection
is
for
an
epidemiological
study
to
identify
and
evaluate
exposure
to
and
effects
of
air
pollutants
on
human
health
as
part
of
EPA's
research
program
on
the
short­
term
and
long­
term
effects
of
air
pollutants
on
human
health
pursuant
to
42
U.
S.
C.
§
7403
(
d)
(
1)
(
A).
(
cf.
Appendix
A)

The
parents
of
all
the
fourth
and
fifth
grade
children
enrolled
in
the
El
Paso
Independent
School
District
will
receive
an
eight­
page
questionnaire
along
with
a
request
for
written
permission
for
their
children
to
participate
in
lung
function
measurements.
At
a
selected
group
of
schools,
those
children
with
parental
consent
will
be
asked
to
perform
a
routine
lung
function
examination
that
consists
of
blowing
three
to
eight
times
into
a
spirometer
that
measures
air
flow
rates
and
lung
volumes.
Supplemental
measures
of
ambient
air
pollutants
will
be
collected
at
the
time
of
the
lung
function
examinations.
The
schools
for
the
lung
function
measurements
will
be
selected
based
on
enrollment
numbers
in
the
fourth
and
fifth
grades,
school
location
with
respect
to
major
roadways,
and
prior
participation
in
previous
air
pollution
monitoring
studies.
The
information
will
be
converted
into
electronic
form
and
stored
in
a
computerized
database.

The
information
collected
by
this
study
will
be
used
to
estimate
the
respiratory
health
effects
of
ambient
air
pollutants
in
the
study
community.
The
questionnaire
health
data
will
be
compared
with
routinely
collected
air
quality
measurements,
with
supplemental
measurements
collected
at
schools,
and
with
exposure
estimates
from
air
quality
models.
The
lung
function
measurements
will
be
compared
to
the
same
air
quality
measurements
and
Health
Effects
of
Particulate
Matter
and
Co­
Pollutants
in
Children
Living
in
El
Paso,
Texas
Page
2
to
the
health
data
from
the
questionnaires.
The
analysis
will
focus
on
determining
whether
any
air
quality
parameters
are
associated
with
increased
prevalence
of
respiratory
symptoms
or
illness
or
with
decreased
lung
function.

The
estimated
respondent
burden
for
this
study
is
5,145
hours
and
$
61,332.
The
estimated
agency
cost
for
conducting
this
study
is
5,881
hours
and
$
494,805.
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
an
epidemiological
study
to
identify
and
evaluate
exposure
to
and
effects
of
air
pollutants
on
human
health
as
part
of
the
U.
S.
Environmental
Protection
Agency's
research
program
on
the
short­
term
and
long­
term
effects
of
air
pollutants
on
human
health
pursuant
to
42
U.
S.
C.
§
7403
(
d)
(
1)
(
A).
The
law
specifically
authorizes
such
studies.

These
studies
will
provide
information
on
currently
regulated
air
pollutants
(
nitrogen
dioxide,
fine
particulate
matter
or
PM2.5),
on
several
air
toxics
(
volatile
organic
compounds),
and
on
ultrafine
particulate
matter
for
possible
regulation.
These
studies
will
also
provide
information
on
the
level
of
respiratory
symptoms
and
illness
in
children
associated
with
air
quality.

2(
b)
PRACTICAL
UTILITY
/
USERS
OF
THE
DATA
The
information
will
be
used
by
the
EPA's
Epidemiology
and
Biomarkers
Branch.
EPA
investigators
will
present
the
results
of
this
study
to
the
local
community,
local
school
and
public
health
officials,
and
EPA
regional
scientists.
EPA
investigators
also
will
present
the
study
results
at
scientific
conferences
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
Air
Quality
Planning
and
Standards
to
set
air
quality
standards,
and
/
or
to
evaluate
the
benefit
of
the
current
National
Ambient
Air
Quality
Standards.
Information
from
the
survey
may
be
useful
to
local
school
and
public
health
officials
in
the
design
and
implementation
of
public
heath
education
and
intervention
programs.

3.
NONDUPLICATION,
CONSULTATIONS,
AND
OTHER
COLLECTION
CRITERIA.

3(
a)
NONDUPLICATION
The
children's
health
questionnaires
and
pulmonary
function
measurements
do
not
duplicate
any
existing
information.
While
this
study
closely
follows
the
design
and
conduct
of
several
previous
studies
(
see
Appendix
D),
no
previous
study
has
been
conducted
of
the
health
effects
of
children's
exposures
to
motor
vehicle
emissions
in
the
El
Paso
metropolitan
area.

Supplemental
air
quality
measurements
will
complement,
but
do
not
duplicate,
the
local
air
pollution
Health
Effects
of
Particulate
Matter
and
Co­
Pollutants
in
Children
Living
in
El
Paso,
Texas
Page
3
measurements
and
meteorologic
data
routinely
collected
and
reported
by
the
City
and
County
of
El
Paso
and
the
Texas
Natural
Resource
Conservation
Commission.
The
existing
monitors
are
mainly
located
in
the
downtown
area,
and
near
the
international
border
crossings.
Supplemental
measurements
at
elementary
schools
have
been
shown
that
nitrogen
dioxide
levels
tend
to
decrease
with
increased
distance
from
the
city
center
and
from
the
international
border
crossings.
To
account
for
the
spatial
variability
in
air
pollution
levels
at
the
location
of
the
schools,
supplemental
air
quality
measurements
will
be
collected
at
a
selected
group
of
schools
distributed
throughout
the
school
district
at
the
time
lung
function
tests
are
administered
to
the
students.

3(
b)
FEDERAL
REGISTER
NOTICE
The
announcement
of
a
public
comment
period
for
this
ICR
was
published
in
the
Federal
Register
(
FR)
on
December
13,
1999.
The
FR
notice
is
in
Appendix
B.
No
comments
were
received.

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

Archie
Claus,
Texas
Natural
Resource
Conservation
Commission­
El
Paso,
915­
783­
6631
Steve
Niemeyer,
Texas
Natural
Resources
Conservation
Commission­
Austin,
512­
239­
3606
Jesus
Reynoso,
El
Paso
City­
County,
915­
771­
5800
Ed
Siwik,
El
Paso
Independent
School
District,
915­
834­
5398
Bob
Currey,
University
of
Texas
at
El
Paso,
915­
747­
6274
Oscar
Ramirez,
EPA
Region
6
Dallas,
US­
MexicoBorder
Program,
214­
655­
7101
Allyson,
Siwik,
EPA
Region
6
El
Paso
Border
Office,
915­
533­
7273
Luis
Escobedo,
University
of
Texas
Houston
School
of
Public
Health
at
El
Paso,
915­
747­
8505
Public
Meetings:
The
proposed
studies
have
been
publicly
discussed
at
the
following
meetings:

Border
XXI
Environmental
Health
Workgroup
Annual
Bi­
National
Meeting,
October
1999
Southwest
Center
for
Environmental
Research
and
Policy,
November
1999.

The
response
from
these
organizations
has
been
favorable.

3(
d)
EFFECTS
OF
LESS
FREQUENT
COLLECTION
The
questionnaire
information
and
the
lung
function
measurements
will
be
collected
only
once
during
the
study.
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
and
storage
of
hard
copies
in
locked
files.
Contractor
involvement
will
be
monitored
by
requiring
hard
copies
to
be
stored
at
EPA
after
the
contractor
has
completed
data
processing.
The
Health
Effects
of
Particulate
Matter
and
Co­
Pollutants
in
Children
Living
in
El
Paso,
Texas
Page
4
contractor
has
agreed
to
observe
the
rules
of
confidentiality
regarding
the
health
information
provided
by
individuals
and
their
families.

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
school
children
who
are
enrolled
at
an
elementary
school
in
the
El
Paso
Independent
School
District.
All
of
the
fourth
and
fifth
grade
students
enrolled
in
the
district
will
be
eligible
for
the
questionnaire
study.
Based
on
school
district
records,
it
is
anticipated
about
9,100
students
will
be
enrolled
in
these
grades
during
the
2000­
2001
school
year.
Children
will
be
eligible
to
participate
in
the
lung
function
measurements
if
he/
she
is
enrolled
in
the
fourth
or
fifth
grade
of
a
participating
school
and
have
written
parental
permission
for
the
examination.

Schoolchildren
may
constitute
a
susceptible
subpopulation
due
to
the
rapid
growth
and
development
of
the
respiratory
system
in
early
childhood
and
the
common
respiratory
infections
among
children.
Most
elementary
schoolchildren
(
a)
do
not
smoke
cigarettes,
(
b)
are
not
exposed
to
hazardous
occupational
environments,
(
c)

have
more
limited
spatial
mobility
than
most
adults,
and
(
d)
have
a
more
limited
lifetime
residential
history
than
their
parents.

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

Each
questionnaire
will
ask
the
child's
parents
for
the
information
listed
below.
The
questionnaire
can
be
found
in
Appendix
C
and
a
detailed
discussion
of
the
questionnaire
design
is
presented
in
section
2(
d).
The
requested
information
includes
questions
specific
to
the
child
including
general
demographic
information,

childhood
respiratory
illness
and
history
of
asthma,
current
respiratory
health
conditions,
and
general
household
characteristics.

This
study
will
use
air
pollution
monitoring
data
and
meteorologic
data
routinely
collected
by
local
environmental
agencies
in
electronic
format.
Supplemental
air
quality
measurements
will
also
be
collected
at
a
subset
of
elementary
schools.

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

(
ii)
Respondent
Activities
The
parents
of
each
child
will
receive
one
Spanish
and
one
English
version
of
the
questionnaire.
In
their
language
of
preference,
they
will
be
requested
to
read
the
questionnaire
instructions
and
to
respond
to
questions
regarding
their
child's
respiratory
health
in
early
childhood
and
within
the
past
year.
The
parents
will
also
be
Health
Effects
of
Particulate
Matter
and
Co­
Pollutants
in
Children
Living
in
El
Paso,
Texas
Page
5
asked
to
read
and
respond
to
the
informed
consent
form
regarding
a
subsequent
pulmonary
function
examination.

Finally,
the
parents
will
also
be
requested
to
return
the
questionnaire
and
consent
form,
as
directed,
to
the
child's
school.

Each
child
enrolled
at
a
school
selected
for
air
monitoring,
and
for
whom
the
parent
has
given
consent
to
participate,
will
have
their
lung
function
measured
according
to
standardized
methods
designed
to
measure
peak
expiratory
flow
rates
during
forced
breathing
maneuver.
Usually
four
to
five
forced
breathing
maneuvers
are
sufficient
to
capture
the
flow
rates
in
children
from
this
age
group.

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

answering
respondent
questions,
reviewing
respondent
submissions,
converting
the
data
to
electronic
form,

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

5(
b)
COLLECTION
METHODOLOGY
AND
MANAGEMENT
The
respiratory
symptom
and
child
characteristics
information
will
be
collected
using
a
machine
scanable
questionnaire
(
Appendix
C).
A
detailed
discussion
of
the
questionnaire
design
is
presented
in
section
2(
d).
The
lung
function
measurements
will
be
collected
by
automated
spirometers
directly
into
an
electronic
format.

The
air
quality
measurements
will
be
collected
by
the
existing
air
quality
monitoring
system.
No
additional
burden
will
be
placed
on
the
local
air
pollution
agencies
in
El
Paso,
Texas.
Supplemental
measurements
during
the
lung
function
tests
will
be
independently
conducted
by
an
EPA
contractor
using
Federal
reference
methods.

All
data
will
be
reviewed
for
unusual
or
unacceptable
values.
The
scanned
questionnaire
data
will
be
verified
through
the
comparisons
of
multiple
scans
and
with
the
original
records.
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
questionnaire
distribution
and
collection,
and
for
lung
function
measurements,
have
been
designed
to
minimize
the
burden
to
the
teachers
and
administrators
of
the
El
Paso
Independent
School
District.

We
have
taken
special
steps
to
brief
the
school
superintendent
regarding
the
design
of
this
study
and
we
will
conduct
informational
meetings
with
the
involved
teachers.

5(
d)
COLLECTION
SCHEDULE
The
administration
of
the
questionnaires
and
lung
function
examinations
will
be
coordinated
with
the
school
calendar,
and
local
air
pollution
characteristics.
Health
Effects
of
Particulate
Matter
and
Co­
Pollutants
in
Children
Living
in
El
Paso,
Texas
Page
6
The
time
line
for
this
study
is
to
(
a)
hold
an
informational
School
Board
meeting
during
August
2000,
(
b)

hold
short
meetings
at
each
school
to
inform
principals,
teachers,
school
nurses
and
other
persons
about
the
study
between
September
1
and
October
15,
(
c)
distribute
the
questionnaire
packets
to
fourth
and
fifth
grade
students
in
the
days
after
each
school
meeting,
(
d)
collect
all
completed
questionnaires
within
one
month
of
distribution,

(
e)
prepare
an
annotated
list
of
children
with
parental
permission
for
the
lung
function
test,
(
f)
conduct
the
lung
function
tests
of
students
with
parental
permission
during
the
winter
months
of
2000­
2001,
and
(
g)
collect
air
pollution
measurements
at
the
schools
concurrently
with
lung
function
tests.
Preliminary
data
sets
will
be
delivered
by
the
end
of
December
2000
for
the
questionnaires,
and
the
end
of
May
2001
for
the
lung
function
examinations.
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
Questionnaire:
Based
on
consultation
with
the
individuals
listed
in
3(
c),
a
pilot
administration
to
EPA
staff,

and
our
experience
with
similar
types
of
information
collection,
we
estimate
that
each
child's
parents
will
spend
an
average
of
25
minutes
completing
this
questionnaire
and
will
require
no
record
keeping.
This
includes
the
time
for
reviewing
the
informed
consent
form,
reviewing
the
instructions,
filling
out
the
questionnaire
and
returning
the
questionnaire.

Lung
Function
Test:
Based
on
our
experience
with
lung
function
measurements
in
similar
field
studies
of
elementary
schoolchildren,
we
estimate
that
each
child
will
spend
an
average
20
minutes
performing
the
lung
function
measurements.
This
includes
time
spent
measuring
height
and
weight,
receiving
instruction,
giving
assent
to
participate,
and
performing
repeated
breathing
maneuvers.

TABLE
1.
ESTIMATED
RESPONDENT
BURDEN
Type
of
Respondent
Respondent
Activities
Estimated
Number
of
Respondents
Burden
Hours
Frequency
Annual
Reporting
Burden
Annual
Cost
Parent
Complete
Questionnaire
9100
0.40
hr.
1
3640
hr
$
53,581
a
Child
Lung
Function
Examination
4300
0.35
hr.
1
1505
hr
$
7,751
b
Totals
5145
hr
$
61,332
a
$
14.72/
hour
(
average
hourly
wage)

b
$
5.15/
hour
(
minimum
wage)

ANNUAL
REPORTING
BURDEN:
5,145
hours
Health
Effects
of
Particulate
Matter
and
Co­
Pollutants
in
Children
Living
in
El
Paso,
Texas
Page
7
ANNUAL
RESPONDENT
COST:
$
61,332
NO
ANNUAL
RECORD
KEEPING
BURDEN
6(
b)
ESTIMATING
RESPONDENT
COSTS
Questionnaire:
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
0.40
hour
burden,
the
respondent
cost
for
each
child's
parent
is
$
5.89.

Lung
Function
Test:
The
wage
estimate
for
the
child
was
calculated
using
the
minimum
hourly
wage
($
5.15
per
hour).
Given
the
0.35
hour
burden,
the
respondent
cost
for
each
child
is
$
1.80.

6(
c)
ESTIMATING
AGENCY
BURDEN
AND
COST
TABLE
2.
AGENCY
COST
BURDEN
Burden
Hours
Cost
($)

AGENCY
ACTIVITIES
Contractor
EPA
Freq
Total
Hours
Contractor
$
90/
hour
EPA
$
49/
hr
Prepare
and
format
questionnaires
60.00
80.00
1
140
$
5,400
$
3,920
Prepare
questionnaire
packages
0.04
0.00
9100
364
$
32,760
$
0
Plan
and
conduct
meetings
12.00
2.00
54
756
$
58,320
$
5,292
Distribute/
collect
questionnaires
20.00
2.00
54
1188
$
97,200
$
5,292
Process
collected
questionnaires
0.035
0.01
9100
409.5
$
28,665
$
4,459
Prepare
statistical
data
sets
and
reports
60.00
0.00
2
120
$
10,800
$
0
Collect/
analyze
air
pollution
data
15.00
2.00
100
1700
$
135,000
$
9,800
Perform
lung
function
testing
0.20
0.01
4300
903
$
77,400
$
2,107
Convert
data
to
electronic
form
0.25
0.25
200
100
$
4,500
$
2,450
Perform
statistical
analysis
40.00
160.00
1
200
$
3,600
$
7,840
TOTAL
5881
$
453,645
$
41,160
AGENCY
TOTAL
ANNUAL
BURDEN:
5,881
hours
AGENCY
TOTAL
ANNUAL
COST:
$
494,805
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
the
El
Paso
Independent
School
District's
enrollment
for
1999­
2000,
we
estimate
that
the
respondent
universe
is
9,100
children
for
the
questionnaire
and
4,300
children
for
the
lung
function
examination.
Health
Effects
of
Particulate
Matter
and
Co­
Pollutants
in
Children
Living
in
El
Paso,
Texas
Page
8
Thus
the
total
estimated
respondent
burden
for
this
study
is
5,145
hours
and
$
61,332.

6(
e)
BOTTOM
LINE
BURDEN
HOURS
AND
COSTS
/
BURDEN
TABLES
The
estimated
respondent
burden
for
this
study
is
5,145
hours
and
$
61,332.
The
estimated
agency
cost
for
conducting
this
study
is
5,881
hours
and
$
494,805.

6(
f)
BURDEN
STATEMENTS
Questionnaire:
Parental
reporting
burden
for
this
collection
of
information
is
estimated
to
average
25
minutes
and
will
require
no
record
keeping.
This
includes
the
time
for
reviewing
the
informed
consent
form,
reading
the
instructions,
filling
out
the
questionnaire
and
returning
the
questionnaire.

Lung
Function
Test:
The
children's
reporting
burden
for
this
collection
of
information
is
estimated
to
average
20
minutes
per
child.
This
includes
times
for
receiving
instruction,
giving
verbal
assent
to
participate,

performing
repeated
breathing
maneuver.

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
(
2822),
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
and
OMB
control
number
in
any
correspondence.

B.
STATISTICAL
APPROACH
1.
SURVEY
OBJECTIVES,
KEY
VARIABLES,
AND
OTHER
PRELIMINARIES
1(
a)
SURVEY
OBJECTIVES
The
objective
of
the
study
is
to
determine
the
burden
of
respiratory
illness
among
children
living
in
U.
S.

communities
exposed
to
similar
levels
of
ambient
air
pollution.
Health
Effects
of
Particulate
Matter
and
Co­
Pollutants
in
Children
Living
in
El
Paso,
Texas
Page
9
1(
b)
KEY
VARIABLES
The
questionnaire
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".
Height,
weight,

and
lung
function
will
be
measured
for
children
who
have
parental
consent.

1(
c)
STATISTICAL
APPROACH
The
health
status
of
the
study
population
will
be
evaluated
along
with
the
air
quality
in
the
local
area
in
which
they
live.
Statistical
associations
between
health
effects
and
air
quality
parameters
will
be
calculated.
The
targeted
population
will
be
children
approximately
age
9
to
11.
The
sampling
base
may
change
for
each
school
depending
on
size.
The
children
will
be
identified
from
school
rosters.
The
parents
of
all
children
in
the
chosen
school
district
will
receive
a
questionnaire
to
fill
out.
Children
from
a
subset
of
schools
will
have
their
lung
function
measured.

1(
d)
FEASIBILITY
Obstacles:
Based
on
previous
experience
with
health
diaries,
the
major
problem
has
been
non­
response.
This
is
usually
improved
by
providing
an
envelope
to
return
the
questionnaire.

Sufficient
funds:
This
study
has
been
budgeted
with
sufficient
funds
from
a
long
standing
program.
In
the
event
a
dramatic
cut
in
the
air
quality
research
program
were
to
take
place,
the
study
could
be
downsized
to
fewer
schools.

Time
line:
The
study
field
operations
will
be
completed
by
the
end
of
March
2001.
Processing
of
pulmonary
function
data
sets
will
be
completed
by
June
2001.

2.
SURVEY
DESIGN
2(
a)
Target
Population
and
Coverage
The
target
population
for
this
study
will
be
elementary
school
children
exposed
to
various
levels
of
air
pollutants
from
mobile
sources
in
the
El
Paso
metropolitan
area.
This
target
population
is
responsive
to
a
Congressional
mandate
to
evaluate
the
effects
of
environmental
pollutants
on
sensitive
sub­
populations
including
schoolchildren.
The
target
population
will
be
constrained
to
those
children
who
are
old
enough
to
perform
the
lung
function
examination,
but
not
yet
in
middle
school
where
the
prevalence
of
active
cigarette
smoking
is
much
higher
than
in
the
elementary
grades.

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

The
sampling
frame
will
be
elementary
school
enrollment
rosters
for
fourth
and
fifth
grades
in
the
El
Paso
Independent
School
District
for
the
2000­
2001
school
year.
Children
below
the
fourth
grade
are
generally
not
capable
of
performing
consistently
in
lung
function
examinations,
while
children
enrolled
in
middle
schools
may
have
begun
smoking
cigarettes.
Health
Effects
of
Particulate
Matter
and
Co­
Pollutants
in
Children
Living
in
El
Paso,
Texas
Page
10
(
ii)
Sample
size.

The
sample
size
for
this
study
is
constrained
by
the
numbers
of
children
enrolled
in
the
local
elementary
schools.
During
the
1999­
2000
school­
year,
the
El
Paso
Independent
School
District
operated
53
elementary
schools
with
a
total
enrollment
of
approximately
9,100
students
in
the
fourth
and
fifth
grades.
The
twenty
largest
schools
contained
approximately
half
of
the
target
population.
From
earlier
studies,
we
estimate
that
this
sample
size
will
provide
90%
power
to
detect,
with
95%
confidence,
the
expected
association
between
petroleum­
related
volatile
organic
compounds
(
primarily
from
mobile
sources
such
as
automobiles),
and
lower
respiratory
symptoms.
This
sample
size
will
provide
80%
power
to
detect
the
expected
association
between
asthma
and
nitrogen
dioxide.
Our
power
to
detect
the
health
effects
of
ultrafine
particles
depends
on
the
precision
of
our
exposure
assessment
model,
which
is
currently
under
development.
A
complete
discussion
of
the
statistical
power
and
the
precision
targets
for
the
study
is
in
Appendix
D.

(
iii)
Stratification
variables.

Not
applicable.

(
iv)
Sampling
method.

All
fourth
and
fifth
grade
students
enrolled
in
the
El
Paso
Independent
School
District
during
the
2000­
2001
school
year
will
be
eligible
for
the
study.
Those
students
enrolled
at
selected
schools,
and
who
also
have
parental
permission,
will
also
attempt
to
perform
a
simple
test
of
lung
function.
The
schools
where
lung
function
will
be
done
have
been
selected
based
on
location,
the
availability
of
previous
air
pollution
measurements
and
the
number
of
students
enrolled
in
the
fourth
and
fifth
grades.

(
v)
Multi­
stage
sampling.

Not
applicable.

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

The
survey
is
designed
to
show,
with
95%
confidence,
the
odds
ratio
associated
specifically
with
a
15
ppb
increment
of
nitrogen
dioxide
provided
that
risk
is
21%
or
greater.

(
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
air
pollution
measurements
at
schools,
and
by
considering
indoor
exposures,
and
indoor­
to­
outdoor
differences
in
air
pollution
levels.
There
is
some
concern
over
misclassification
of
respiratory
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.
Health
Effects
of
Particulate
Matter
and
Co­
Pollutants
in
Children
Living
in
El
Paso,
Texas
Page
11
Although
some
parents
may
fail
to
fully
report
respiratory
symptoms
and
illness
among
their
children,
the
propensity
to
report
should
not
be
associated
with
the
exposures
of
interest
after
adjusting
for
the
parent's
socioeconomic
status.
Parental
under­
reporting
of
respiratory
conditions
that
are
not
associated
with
the
exposures
of
interest
(
non­
differential
misclassification)
will
reduce
the
statistical
power
of
the
study,
and
bias
the
observed
association
of
interest
towards
the
null
(
no
difference).

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
air
pollution
exposures,
differences
in
the
distribution
of
various
independent
determinants
of
respiratory
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
questionnaire
is
divided
into
several
sections
of
related
questions:
personal
identifying
information,

child's
personal
data,
child's
medical
history,
child's
current
health
(
common
respiratory
symptoms,
chest
illnesses,
gastrointestinal
illness,
and
asthma),
home
characteristics,
family
history,
and
current
household
members.
The
structure
of
the
specific
questions
in
each
group
are
detailed
below.
The
numbers
in
parentheses
refer
to
the
question
number
on
the
questionnaire.
Copies
of
the
questionnaire
in
both
English
and
Spanish
are
included
in
Appendix
C.

The
personal
identifying
information
on
the
cover
page
of
the
questionnaire
(
name,
address,
phone
number,

parents
names,
school,
grade
and
teacher
are
required
to
ensure
and
to
document
informed
consent
by
a
parent
or
guardian
for
an
subsequent
lung
function
testing.
This
cover
page
will
be
detached
and
stored
physically
separate
from
the
statistical
information
on
the
remainder
of
the
questionnaire.
The
personal
identifying
information
will
not
become
part
of
the
statistical
data
base.

The
child's
personal
data
are
required
to
determine
the
child's
age
(
1,
3,
4),
sex
(
2),
Hispanic
status
(
5)
and
race
(
6).
These
variables
are
all
potential
confounders
of
the
association
of
interest.
The
information
on
today's
date
and
the
child's
birth
date
will
allow
us
to
check
the
direct
parental
report
of
the
child's
age.
The
selfidentification
of
ethnicity
is
especially
relevant
for
the
evaluation
of
the
subsequent
lung
function
measures
which
show
considerable
ethnic
variation
in
anthropomorphic
relationships.

The
questions
in
the
child's
medical
history
section
fall
into
three
categories:
restriction
variables
(
16­
19),

outcome
measures
(
20,
21),
and
effect
modifiers
(
7­
13,
14,
15,
20,
21).
Children
with
low
birth
weight
or
born
prematurely,
especially
those
kept
in
intensive
care
or
given
supplemental
oxygen,
may
be
at
much
greater
risk
of
developing
respiratory
illness
in
later
life
(
7­
13).
An
early
history
of
severe
chest
illness
(
14,
15)
may
also
predispose
a
child
to
respiratory
illness
and
increase
their
susceptibility
to
environmental
insults.
Some
Health
Effects
of
Particulate
Matter
and
Co­
Pollutants
in
Children
Living
in
El
Paso,
Texas
Page
12
preexisting
health
conditions
may
be
so
severe
and
rare
as
to
preclude
inclusion
of
such
children
in
the
statistical
analysis
such
as
chest
operations
and
injuries,
cystic
fibrosis,
and
pediatric
heart
disease
(
16­
19).
Hay
fever
and
other
allergies
characteristic
of
atopy
may
identify
children
with
increased
susceptibility
to
environmental
insults
or
the
exposure
of
interest
may
have
increased
the
prevalence
of
atopy
(
20,
21).

The
questions
in
the
child's
current
health
section
(
22­
32)
are
related
to
the
outcomes
of
interest
during
the
12
months
prior
to
the
questionnaire.
While
this
section
seems
lengthy,
the
information
solicited
by
these
questions
are
important
and
directly
related
to
the
purpose
of
this
study.
The
parents
of
healthy
children
will
rapidly
pass
through
these
questions,
while
parents
of
children
with
respiratory
conditions
should
be
given
the
opportunity
to
fully
and
accurately
describe
these
conditions.

The
questionnaire
requests
information
about
several
common
respiratory
conditions
(
cough,
phlegm,
hay
fever,
runny
nose,
and
ear
infections)
before
proceeding
to
more
severe
respiratory
illnesses
(
asthma,
pneumonia,

bronchitis,
and
other
chest
illnesses).
We
want
to
provide
parents
of
children
with
relatively
mild
respiratory
symptoms
an
opportunity
to
report
these
symptoms
in
order
to
limit
the
over­
reporting
of
the
more
severe
respiratory
illnesses.
Chronic
cough,
especially
chronic
morning
cough
(
22,
23),
and
productive
cough,

especially
apart
from
colds
(
24,
25),
are
indicators
of
chronic
respiratory
conditions
such
as
asthma
and
bronchitis,
but
these
symptoms
may
be
present
in
children
with
subclinical
disease.
The
hay
fever
question
is
repeated
with
reference
to
the
last
12
months
and
treatment
by
a
physician
for
this
condition
provides
an
indicator
of
the
condition's
severity
(
26).
Similarly,
persistent
runny
nose
and
ear
infections
are
an
indicator
of
upper
respiratory
infections
(
27,
28).

The
more
serious
chest
illness
questions
constitute
the
principal
outcomes
of
interest
for
this
study
(
29).
The
introductory
question
on
chest
illness
permits
the
parents
of
children
without
chest
illnesses
in
the
last
12
months
to
skip
to
question
30
on
gastrointestinal
illness.
The
initial
chest
illness
questions
focus
on
the
severity
of
the
chest
illness
(
29A,
29B)
and
on
the
physician's
diagnosis
(
29C).
The
subsequent
questions
focus
on
differentiating
between
asthma,
bronchitis,
pneumonia,
and
other
chest
illnesses;
on
the
severity
of
each
condition;

and
on
seasonal
patterns
of
disease.
The
first
question
in
each
subsection
refocuses
the
parent
on
illnesses
during
the
last
12
months
and
asks
about
the
frequency
and
duration
of
such
illnesses
(
D1­
2,
E1­
2,
F1­
2,
G1­
2).
The
questions
on
medications
provide
a
check
on
the
differential
diagnosis
of
these
four
conditions,
for
examples,

steroids
would
be
inappropriate
for
pneumonia
and
antibiotics
are
not
generally
prescribed
for
asthma
(
D3,
E3,

F3,
G3).
The
questions
on
hospitalization
provide
an
indication
of
the
severity
of
the
illness
(
D4,
E4,
F4,
G4).

Since
both
air
pollution
and
respiratory
disease
follow
a
seasonal
pattern,
we
ask
about
the
timing
of
the
illness
(
D5,
E5,
F5,
G5).

Gastrointestinal
illness
is
not
thought
to
be
related
to
the
air
pollution
exposure
of
interest
and
provides
a
negative
control
for
the
analysis
of
subsequent
associations
(
30).
Health
Effects
of
Particulate
Matter
and
Co­
Pollutants
in
Children
Living
in
El
Paso,
Texas
Page
12
The
questionnaire
proceeds
to
questions
on
subclinical
asthma
evidenced
by
wheezing
(
31)
and
a
further
characterization
of
clinical
asthma
(
32).
By
providing
parents
of
wheezing
children
an
opportunity
to
report
on
their
children
in
question
31,
we
hope
to
focus
the
next
question
(
32)
solely
on
clinical
asthma.
Persistent
wheeze,
especially
apart
from
episodes
of
respiratory
infections
(
colds)
(
31B­
D),
shortness
of
breath
with
wheezing
(
31F),
night­
time
wheezing
(
31G),
and
exercise
induced
wheezing
(
31K)
are
indicators
of
subclinical
asthma.
We
also
ask
about
the
life­
time
history
of
wheeze
(
31A),
the
seasonal
pattern
of
wheezing
(
31E),
and
the
severity
of
the
wheezing
(
31H­
J).
We
ask
about
the
child's
history
of
asthma
medication
(
32A)
and
symptoms
(
32B)
and
the
seasonal
pattern
of
asthma
severity
(
32C).

The
questions
in
the
home
characteristics
section
fall
into
two
categories:
potential
confounders
(
37­
48,51­
53),
and
effect
modifiers
(
33­
36,
49,
50).
Children
who
spend
more
time
in
the
city
during
the
past
year
(
33),
and
who
have
lived
a
greater
portion
of
their
lives
in
the
city
(
34),
near
their
current
residence
(
35),

and
in
their
current
residence
(
36)
may
show
a
stronger
association
between
health
status
and
residential
location
as
a
surrogate
for
air
pollution
exposures.
As
mentioned
earlier,
potential
confounders
include
socioeconomic
status
as
indicated
by
the
type
of
residence
(
37),
age
of
residence
(
38),
size
of
residence
(
39,
40)
and
ownership
status
(
41).
Other
potential
confounders
include
indoor
exposures
to
furry
pets
and
birds
(
42),
pests
(
43),

pesticides
(
44),
gas
stoves
(
45),
especially
those
with
pilot
lights
(
45A)
or
those
used
as
supplemental
heaters
(
45B),
and
unvented
heaters
(
46­
48).
Indoor
mold
exposures
are
of
special
epidemiological
interest
as
potential
confounders
and
are
characterized
by
water
damage
(
51),
visible
molds
(
52),
or
humidifiers
(
53).
Air
conditioners
(
49)
and
air
cleaners
(
50)
may
act
as
effect
modifiers
by
altering
the
air
exchange
rate
and
by
removing
gasses
and
particles
of
outdoor
origin
from
the
indoor
air.

The
questions
in
the
family
history
section
are
all
related
to
potential
confounders.
A
history
of
respiratory
illness
in
the
biological
father
(
54­
56)
or
the
biological
mother
(
57­
59)
may
be
an
indicator
of
a
genetic
predisposition
of
the
child
to
respiratory
illness.
A
more
important
potential
confounder
is
the
child's
early
exposures
to
environmental
tobacco
smoke
either
during
pregnancy
(
60),
prior
to
two
years
of
age
(
61­
62),
or
after
two
years
of
age
and
prior
to
first
grade
(
63­
64).
Some
studies
have
found
that
maternal
smoking
(
61,
63)

is
more
important
than
smoking
by
others
in
the
home
(
62,
64).

The
questions
in
the
current
household
members
section
are
all
related
to
potential
confounders.
Family
size
(
65,
66)
is
an
indicator
of
socioeconomic
status.
The
number
of
persons
aged
14
years
and
over
(
65)
may
be
related
to
environmental
tobacco
smoke,
while
the
number
of
children
under
14
(
66)
may
be
related
to
the
frequency
of
respiratory
infections.
The
respondent's
sex
(
67),
relationship
to
the
child
(
68),
and
language
proficiency
(
69)
may
be
related
to
the
accuracy
of
the
questionnaire.
The
educational
level
of
both
the
respondent
(
70)
and
the
other
primary
adult
(
73A)
are
the
best
indicators
of
socioeconomic
status
on
this
questionnaire.
We
have
omitted
sensitive
questions
regarding
family
income
which
have
been
used
by
other
investigators.
The
Health
Effects
of
Particulate
Matter
and
Co­
Pollutants
in
Children
Living
in
El
Paso,
Texas
Page
13
child's
current
exposures
to
environmental
tobacco
smoke
in
the
home
are
determined
by
questions
on
the
smoking
status
(
71,
73B,
74),
number
of
cigarettes
(
71A,
73­
B1,
74A),
and
smoking
of
pipe
or
cigars
(
72,
73C)

for
the
respondent
(
71,
72),
for
the
other
primary
adult
(
73),
and
for
any
other
smokers
in
the
home
(
74).

Style
of
questions
While
most
questions
have
forced
choice
between
multiple
responses,
we
also
provide
opportunities
for
the
respondent
to
provide
a
free­
form
response
to
some
questions.
Free­
form
responses
are
the
easiest
way
of
asking
about
continuous
variables
(
1,
3,
4,
8).
A
combination
of
multiple
choice
and
free­
form
responses
is
used
to
avoid
forcing
a
response
into
an
inappropriate
multiple
choice
(
14A,
15A,
29C),
when
the
respondent
may
know
a
medication's
name
but
not
its
general
classification
(
29­
D3,
29­
E3,
29­
F3,
29­
G3),
to
obtain
more
information
on
a
positive
response
in
order
to
classify
an
illness
(
16,
17,
30C),
or
when
a
set
of
multiple
choices
may
not
be
exhaustive
(
21A,
37,
42,
43,
46).

Purpose
of
Questions
The
outcomes
of
interest
are
determined
by
questions
on
common
respiratory
conditions
(
22­
28)
and
chest
illnesses
including
asthma,
pneumonia,
bronchitis,
and
other
chest
illnesses
(
29).
The
questionnaire
solicits
information
on
subclinical
asthma
evidenced
by
wheezing
(
31)
and
a
further
characterization
of
clinical
asthma
(
32).
Gastrointestinal
illness
is
not
thought
to
be
related
to
the
air
pollution
exposure
of
interest
and
provides
a
negative
control
for
the
analysis
of
subsequent
associations
(
30).
The
quality
of
parental
reporting
may
depend
on
the
respondent's
sex
(
67),
relationship
to
the
child
(
68),
and
language
proficiency
(
69).

Potential
confounders
include
the
child's
age
(
1,
3,
4),
sex
(
2),
Hispanic
status
(
5)
and
race
(
6);
severe
preexisting
health
conditions
of
the
child
(
16­
19);
a
history
of
respiratory
illness
in
the
biological
parents
as
an
indicator
of
genetic
predisposition
(
54­
59);
and
socioeconomic
status
as
indicated
by
the
child's
residence
(
37­

41),
family
size
(
65­
66)
or
the
parent's
education
level
(
70,
73A).
We
also
examine,
as
potential
confounders,

various
indoor
exposures
(
42­
48),
especially
mold
exposures
(
51­
53),
and
environmental
tobacco
smoke
exposures
(
60­
64,
71­
74).

Potential
modifiers
of
the
association
of
interest
include
the
child's
age
(
1,
3,
4),
sex
(
2),
and
residential
history
(
33­
36).
Low
birth
weight
(
7,
8),
prematurity
(
9),
neonatal
care
(
10­
13),
an
early
history
of
severe
chest
illness
(
14,
15),
or
atopy
(
20,
21)
may
also
increase
the
child's
susceptibility
to
environmental
insults.
Air
conditioners
(
49)
and
air
cleaners
(
50)
may
act
as
effect
modifiers
by
altering
air
exchange,
and
by
removing
gasses
and
particles
of
outdoor
origin
from
the
indoor
air.
Health
Effects
of
Particulate
Matter
and
Co­
Pollutants
in
Children
Living
in
El
Paso,
Texas
Page
14
3.
PRETESTS
AND
PILOT
TESTS
This
questionnaire
follows
the
standard
questions
for
respiratory
symptoms
in
children
established
by
the
Epidemiology
Standardization
Project
of
the
American
Thoracic
Society
and
the
Division
of
Lung
Diseases.
A
similarly
worded
questionnaire
was
used
in
the
Harvard
Six
Cities
Studies
and
in
the
Harvard
24­
Cities
Study
of
over
13,000
children
in
24
communities
in
the
United
States
and
Canada.
These
earlier
successful
studies
constitute
the
pretest
of
this
questionnaire.
Since
we
want
to
maximize
the
comparability
of
this
study's
results
to
the
results
of
those
earlier
studies,
we
do
not
plan
to
modify
the
questionnaire.

4.
COLLECTION
METHODS
AND
FOLLOW­
UP
4(
a)
COLLECTION
METHODS
An
informational
meeting
with
EPA
regional
scientist(
s),
the
district
superintendent
of
schools,
the
principals
of
the
selected
schools,
the
local
public
health
officer,
and
other
interested
persons
will
be
held
to
explain
the
study.
After
the
meeting,
a
letter
of
endorsement
will
be
requested
from
the
school
district
superintendent
to
the
principals
providing
a
general
endorsement
of
the
study.

To
ensure
a
more
organized
and
efficient
questionnaire
distribution,
each
school
will
be
requested
to
provide
a
current
list
of
students
enrolled
in
the
fourth
and
fifth
grades
by
class
including
the
complete
name
of
each
student,
the
teacher
responsible
for
the
class.
If
such
lists
are
not
available,
the
principal
will
be
requested
for
the
number
of
fourth
and
fifth
grade
classes,
a
list
of
the
names
of
the
fourth
and
fifth
grade
teachers
responsible
for
each
class,
and
the
anticipated
number
of
students
in
each
class.
Class
lists
will
be
maintained
in
a
locked
filing
cabinet
at
EPA's
Human
Studies
Facility
in
Chapel
Hill,
NC.

Short
meetings
will
be
held
at
each
school
for
the
involved
teachers,
the
school
nurse,
principal
and
any
others
interested
in
attending.
An
explanation
of
the
logistics
for
questionnaire
distribution
and
collection
will
be
given.
The
study
schedule
for
each
class,
and
sample
English
and
Spanish
versions
of
the
questionnaires
will
be
provided.

Individual
packets
will
be
prepared
for
each
of
the
fourth
and
fifth
grade
student
in
the
district.
The
packet
will
consist
of
a
copy
of
the
superintendents
letter,
one
blank
English
and
one
blank
Spanish
questionnaire,
and
a
sharpened
#
2
lead
pencil
enclosed
within
a
plain
envelope
with
a
gummed
flap.
In
each
packet,
the
English
and
Spanish
questionnaires
and
the
packet
envelope
will
be
stamped
with
a
unique
lithography
number
in
permanent
ink.
Each
teacher
will
receive
a
bundle
of
questionnaire
packets
for
his/
her
students.
The
students
will
carry
the
packets
home
for
their
parents
to
complete
a
questionnaire
in
their
preferred
language.

Within
one
week,
the
questionnaires
will
be
collected
directly
from
the
schools.
After
one
month
and
a
possible
second
distribution
to
nonresponders,
we
will
assume
that
the
parents
have
chosen
not
to
participate
in
this
voluntary
dat
solicitation.
At
the
field
study
office,
the
packets
will
be
opened
and
the
consent
form
removed
Health
Effects
of
Particulate
Matter
and
Co­
Pollutants
in
Children
Living
in
El
Paso,
Texas
Page
15
from
the
questionnaire.
The
only
identifier
which
links
questionnaire
to
the
child's
name
and
other
personal
information
is
the
pre­
printed
subject
identification
number
on
the
questionnaire
and
the
consent
form.
The
consent
forms
will
be
stored
in
a
locked
filing
cabinet,
separate
from
the
questionnaires.

The
children
with
written
permission
from
their
parent
or
guardian
will
be
scheduled
for
lung
function
examinations
at
their
elementary
school.
At
the
exam,
a
trained
field
technician
will
explain
the
testing
protocol
in
the
child's
preferred
language
(
either
English
or
Spanish)
and
ask
the
child
whether
he/
she
wishes
to
participate
in
the
examination.
Any
child
who
is
unwilling
to
participate
will
be
returned
to
their
classroom.
The
field
technician
will
then
ask
the
child
whether
they
have
ever
smoked
more
than
five
cigarettes
in
their
lifetime
and
whether
they
have
had
a
recent
respiratory
infection.
Any
child
who
answers
positive
to
either
question
will
be
given
the
testing
incentive
and
returned
to
their
classroom.
In
any
of
these
cases,
the
reason
for
the
child's
disqualification
from
the
study
will
be
held
confidential.

The
field
technician
will
record
each
child's
height
and
weight,
explain
in
more
detail
the
forced
expiratory
maneuver,
and
coach
the
child
to
perform
a
series
of
forced
expiratory
maneuvers.
The
lung
function
examination
will
be
conducted
according
to
guidelines
developed
by
the
American
Thoracic
Society.
A
sterile,

disposable
mouthpiece
will
be
used
for
each
child.
The
lung
function
examinations
will
be
conducted
in
the
child's
elementary
school
during
normal
school
hours
and
no
child
will
be
left
alone
at
any
time
in
the
custody
of
a
single
field
technician.
A
school­
nurse
will
be
present
at
the
elementary
school
during
the
examinations.

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
The
completed
questionnaires
will
be
optically
scanned
into
an
electronic
database.
An
in­
house
computer
program
will
verify
that
data
submitted
is
internally
consistent,
as
scanned.
The
program
will
also
flag
missing
data
items
and
other
inconsistencies,
as
well
as
items
with
potential
data
entry
errors.

5(
b)
ANALYSIS
Analyses
will
be
conducted
by
comparing
respiratory
symptoms
and
illness
to
air
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
any
excess
between­
school
variability
in
student
characteristics.
In
the
first
step,
school­
specific
adjusted
logits
of
symptom
prevalence
will
be
calculated
from
a
logistic
regression
model
for
the
respiratory
Health
Effects
of
Particulate
Matter
and
Co­
Pollutants
in
Children
Living
in
El
Paso,
Texas
Page
16
symptoms
of
interest
controlling
for
age,
sex,
rage,
child's
history
of
atopy,
parental
history
of
asthma,

environmental
tobacco
smoking
in
the
home
and
parental
education.
In
the
second
step,
these
school­
specific
adjusted
logits
will
be
regressed
against
the
school­
specific
air
pollutant
concentrations
using
weights
inversely
proportional
to
the
sum
of
the
between­
school
and
within­
school
variances
of
the
adjusted
logits.
Several
previous
studies
have
indicated
that
the
between­
school
variation
in
subject
characteristics
is
not
large
and,

consequently,
that
the
adjusted
logits
are
nearly
equal
to
the
crude
or
unadjusted
logits.
Schools
with
approximately
equal
numbers
of
students
will
have
equal
weight
in
the
second­
stage
regression.

5(
c)
REPORTING
RESULTS
A
report
on
each
of
the
schools
air
quality
monitoring
data
will
be
developed
and
available
to
the
school
district,
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.
Health
Effects
of
Particulate
Matter
and
Co­
Pollutants
in
Children
Living
in
El
Paso,
Texas
Page
17
APPENDIX
A:
Clean
Air
Act
TITLE
42
­
PUBLIC
HEALTH
CHAPTER
85
­
AIR
POLLUTION
PREVENTION
AND
CONTROL
PART
A
­
AIR
QUALITY
AND
EMISSIONS
LIMITATIONS
Section
7403.
Research,
investigation,
training,
and
other
activities
(
d)
Environmental
health
effects
research
(
1)
The
Administrator,
in
consultation
with
the
Secretary
of
Health
and
Human
Services,
shall
conduct
a
research
program
on
the
short­
term
and
long­
term
effects
of
air
pollutants,
including
wood
smoke,
on
human
health.
In
conducting
such
research
program
the
Administrator
­

(
A)
shall
conduct
studies,
including
epidemiological,
clinical,
and
laboratory
and
field
studies,
as
necessary
to
identify
and
evaluate
exposure
to
and
effects
of
air
pollutants
on
human
health;

(
B)
may
utilize,
on
a
reimbursable
basis,
the
facilities
of
existing
Federal
scientific
laboratories
and
research
centers;
and
(
C)
shall
consult
with
other
Federal
agencies
to
ensure
that
similar
research
being
conducted
in
other
agencies
is
coordinated
to
avoid
duplication.
Health
Effects
of
Particulate
Matter
and
Co­
Pollutants
in
Children
Living
in
El
Paso,
Texas
Page
18
APPENDIX
B:
Federal
Registrar
Notice
Health
Effects
of
Particulate
Matter
and
Co­
Pollutants
in
Children
Living
in
El
Paso,
Texas
Page
19
Health
Effects
of
Particulate
Matter
and
Co­
Pollutants
in
Children
Living
in
El
Paso,
Texas
Page
20
Health
Effects
of
Particulate
Matter
and
Co­
Pollutants
in
Children
Living
in
El
Paso,
Texas
Page
21
APPENDIX
C:
Respiratory
Health
Questionnaire
Health
Effects
of
Particulate
Matter
and
Co­
Pollutants
in
Children
Living
in
El
Paso,
Texas
Page
38
APPENDIX
D:
Statistical
Power
and
Precision
Analytic
Methods
The
study
design
is
a
semi­
ecological
study
of
a
Bernoulli
variable
(
a
questionnaire
report
of
an
individual
child's
respiratory
symptom
status)
with
group
level
data
on
environmental
exposures
(
school­
based
exposure
measurements)
and
individual
level
data
on
potential
confounders
from
the
questionnaire.
The
research
hypothesis
is
that
a
proportion
(
school­
specific
prevalence
of
a
respiratory
symptom)
covaries
with
a
continuous
measure
of
exposure
after
adjustment
for
group­
level
variations
in
confounder
prevalence.
This
common
study
design
has
been
used
in
several
previous
community­
based
studies
of
the
association
of
central­
site
measurements
of
air
pollutant
exposures
with
questionnaire
reports
of
respiratory
symptoms
and
potential
confounders
(
1,
2).

The
analysis
will
be
conducted
using
methods
developed
in
the
previous
studies
and
will
use
a
two­
step
analysis
to
correct
for
any
excess
between­
school
variability
in
student
characteristics.
In
the
first
step,

schoolspecific
adjusted
logits
of
symptom
prevalence
will
be
calculated
from
a
logistic
regression
model
for
the
respiratory
symptom
of
interest
controlling
for
age,
sex,
race,
child's
history
of
atopy,
parental
history
of
asthma,

environmental
tobacco
smoking
in
the
home
and
parental
education.
In
the
second
step,
these
school­
specific
adjusted
logits
will
be
regressed
against
the
school­
specific
air
pollutant
concentrations
using
weights
inversely
proportional
to
the
sum
of
the
between­
school
and
within­
school
variances
of
the
adjusted
logits.
Several
previous
studies
have
indicated
that
the
between­
school
variation
in
subject
characteristics
is
not
large
and,
consequently,

that
the
adjusted
logits
are
nearly
equal
to
the
crude
or
unadjusted
logits.
Schools
with
approximately
equal
numbers
of
students
will
have
equal
weight
in
the
second
stage
regression.

Power
compared
with
previous
studies
The
proposed
study
is
similar
in
design,
exposures,
and
health
outcomes
to
a
previous
study
of
the
respiratory
health
effects
of
volatile
organic
compounds
among
7,796
children
attending
74
elementary
schools
in
Kanawha
County,
WV
(
2).
The
most
relevant
finding
from
the
earlier
study
was
an
association
between
questionnaire
reports
of
a
physician's
diagnosis
of
asthma
(
10%
prevalence)
and
a
10
µ
g/
m3
increment
in
petroleum­
related
compounds
measured
by
passive
sampling
devices
(
odds
ratio
(
OR)
=
1.05,
95%
confidence
interval
(
CI)
1.02­
1.08,
t
=
3.34).
If
we
were
replicating
this
earlier
study,
we
would
have
92%
probability
(
statistical
power)
of
observing
a
health
effect
of
this
magnitude.
In
the
present
study,
our
power
will
be
increased
by
more
precise
estimates
of
symptom
prevalence
at
each
school
(
due
to
their
larger
average
enrollment)
but
reduced
by
the
smaller
number
of
schools.

The
proposed
study
is
also
similar
to
several
national
studies
of
the
health
effects
of
air
pollutants.
The
Harvard
24­
Cities
Study
of
13,369
schoolchildren
in
24
cities
in
the
United
States
and
Canada
found
an
association
between
questionnaire
reports
of
a
physician's
diagnosis
of
bronchitis
and
sulfate
particles
(
OR
=
1.65,
95%
CI
Health
Effects
of
Particulate
Matter
and
Co­
Pollutants
in
Children
Living
in
El
Paso,
Texas
Page
39
(
)
(
)
[
]
SE
N
Y
X
 
 
 
=
2
2
(
)
[
]
Z
H
N
Z
A
Y
X
 
 
 
 
=






 
 
2
2
1
2
(
)
(
)
(
)
[
]
min
H
Z
Z
N
A
Y
X
=
+
 
 
1
2
2
2
 
 
 
 
1.12­
2.42,
t
=
5.09).
Across
the
24
cities,
the
adjusted
prevalence
of
bronchitis
ranged
from
3%
to
10%
with
an
average
of
6.5%,
while
annual
mean
sulfate
particles
concentrations
(
in
µ
g/
m3)
ranged
from
0.7
to
7.4
with
a
mean
of
4.7
and
a
variance
of
4.85.
Each
of
the
communities
contained
about
550
children
in
the
fourth
and
fifth
grades.

Although
our
proposed
study
will
have
fewer
children
in
each
ecological
group,
we
will
have
approximately
the
same
number
of
groups.

Power
of
current
study
For
our
estimate
of
the
precision
of
the
proposed
study,
we
assume
that
the
first­
stage
regression
does
not
greatly
alter
the
crude
prevalences
and
that
the
weights
in
the
second­
stage
regression
are
approximately
equal.
The
precision
of
the
second­
stage
regression
may
be
calculated
from
the
number
of
elementary
schools,
the
estimated
variance
of
exposure
across
these
elementary
schools,
and
the
estimated
variance
of
the
adjusted
prevalence
of
the
outcome
measure.
The
formulas
for
calculating
the
standard
error
of
the
regression
coefficient
(
SE(
 )),
the
standard
normal
deviate
(
Z
 )
for
the
probability
of
observing
an
association
greater
than
an
arbitrary
value
(
HA)

with
95%
confidence
as
a
measure
of
statistical
power,
and
the
minimal
observable
health
association
(
min(
HA))
as
a
measure
of
statistical
precision
are:

where
is
the
standard
Z
1
2
 
 
normal
deviate
for
the
95%
confidence
level,
or
1.96;
is
the
standard
normal
deviate
for
power
(
for
80%
power,
Z 
Z 
is
0.842;
N
is
the
number
of
ecological
groups
(
cities
or
schools);
is
the
variance
of
exposure
across
the
ecological
 
X
2
groups;
and
is
the
variance
of
the
logit
of
the
prevalence
for
each
group.
 
Y
2
For
our
proposed
study,
the
sample
size
is
fixed
at
22
by
the
number
of
elementary
schools
in
the
El
Paso
Independent
School
District
where
we
have
conducted
direct
exposure
measurements.
We
also
will
collect
questionnaire
information
for
children
attending
all
53
schools
and
attempt
to
estimate
exposures
from
geographic
information
system,

but
we
want
to
have
adequate
power
for
the
smaller
sample
of
22
schools
with
direct
measurements.
At
the
22
elementary
schools,
the
average
enrollment
in
the
fourth
and
fifth
grades
was
196
students
and
18
schools
contained
more
than
150
children.
In
our
pilot
study
in
El
Paso,
we
observed
nitrogen
dioxide
concentrations
that
ranged
from
12
to
38
ppb
across
24
passive
monitors
with
a
variance
of
63.8.
Based
on
the
Kanawha
Valley
Health
Study,
we
Health
Effects
of
Particulate
Matter
and
Co­
Pollutants
in
Children
Living
in
El
Paso,
Texas
Page
40
estimate
that
the
mean
prevalence
of
a
lifetime
history
of
a
physician's
diagnosis
of
asthma
among
school­
children
in
the
fourth
and
fifth
grades
will
be
at
least
8%.

The
calculations
of
the
power
and
precision
for
the
proposed
study
were
made
using
a
spreadsheet
(
table
1).
The
table
also
provides
a
sensitivity
analysis
and
a
comparison
of
estimated
to
actual
power
and
precision
for
the
Harvard
24­
Cities
Study.
Columns
1
and
2
provide
the
base­
line
symptom
prevalence
and
number
of
participating
children
in
each
school.
For
the
binomial
proportion,
columns
3
through
6
provide
the
variance
(
pq/
n),
the
standard
error,
and
approximate
95%
confidence
interval
limits
for
the
proportion
(
p
±
1.96

SE(
p)).
Columns
7
through
9
are
the
logits
(
ln(
 /(
1­
 ))
of
the
values
in
columns
1,
5
and
6.
Column
10
provides
the
estimate
of
the
standard
error
of
the
logit
(
SE(
logit)
=
(
UL
­
LL)
/
(
2

1.96)).
Columns
11
through
12
provide
the
standard
error
of
the
regression
coefficient,

the
standard
normal
deviate
(
Z
 )
for
the
probability
of
observing
an
odds
ratio
greater
than
1.40
with
95%
confidence
as
a
measure
of
statistical
power,
and
the
minimal
observable
odds
ratio
(
min(
OR))
with
80%
power
and
95%

confidence
as
a
measure
of
statistical
precision.

In
practice
for
the
Harvard
24­
Cities
Study,
this
spreadsheet
gave
an
estimate
for
the
standard
error
of
the
regression
coefficient
(
0.149)
that
was
nearly
equal
to
the
observed
standard
error
(
0.145).
Thus,
based
on
these
assumptions,
we
estimate
that
the
proposed
study
of
22
schools
will
have
more
than
a
70%
probability
of
detecting
with
95%
confidence
an
association
between
a
lifetime
history
of
a
physician's
diagnosis
of
asthma
and
a
15
ppb
increment
of
nitrogen
dioxide
assuming
a
true
odds
ratio
of
1.40
or
greater.
Across
all
53
schools,
we
estimate
that
the
proposed
study
will
have
more
than
an
80%
probability
of
detecting
with
95%
confidence
an
association
between
a
lifetime
history
of
a
physician's
diagnosis
of
asthma
and
a
15
ppb
increment
of
nitrogen
dioxide
assuming
a
true
odds
ratio
of
1.21
or
greater.

The
proposed
effect
estimate
is
similar
in
magnitude
to
effects
observed
in
other
studies.
In
an
earlier
study
of
nitrogen
dioxide's
health
effects
among
1,567
schoolchildren,
a
composite
indicator
of
lower
respiratory
symptoms
derived
from
a
parental
questionnaire
was
associated
with
a
15
ppb
increment
in
nitrogen
dioxide
measured
inside
each
child's
home
with
a
passive
monitor
(
odds
ratio
=
1.40,
95%
CI
1.14­
1.72,
t
=
3.21).
We
have
observed
more
than
a
25
ppb
range
in
nitrogen
dioxide
exposures
across
the
schools
in
our
pilot
study.

Sensitivity
analysis
Our
sensitivity
analysis
showed
that,
as
expected,
the
power
and
precision
of
the
proposed
study
would
be
reduced
by
any
loss
of
sample
size
within
each
school
and
for
symptoms
with
a
lower
prevalence.
Even
if
questionnaires
are
returned
for
only
120
children
at
each
school,
we
still
will
have
60%
power.
We
believe
that
our
participation
levels
will
be
much
higher
than
this
since
the
average
enrollment
at
the
22
elementary
schools
was
196
students
in
the
fourth
and
fifth
grades
and
participation
rates
in
previous
studies
have
routinely
exceeded
85%.
Given
our
initial
assumptions,
we
also
will
have
more
than
60%
power
for
symptoms
with
a
mean
prevalence
greater
than
6%
Health
Effects
of
Particulate
Matter
and
Co­
Pollutants
in
Children
Living
in
El
Paso,
Texas
Page
41
1.
Dockery
DW,
Cunningham
J,
Damokosh
AI,
Neas
LM,
Spengler
JD,
Koutrakis
P,
Ware
JH,
Raizenne
M,
Speizer
FE.
Health
effects
of
acid
areosols
on
north
american
children:
Respiratory
symptoms.
Environ
Health
Perspect
1996;
104:
500­
505.

2.
Ware
JH,
Spengler
JD,
Neas
LM,
Samet
JM,
Wagner
GR,
Coultas
D,
Ozkaynak
H,
Schwab
M.
Respiratory
and
irritant
health
effects
of
ambient
volatile
organic
compounds:
The
Kanawha
Valley
Health
Study.
Am
J
Epidemiol
1993;
137:
1287­
1301
across
22
schools.
Across
the
larger
study
of
53
schools,
we
will
have
more
than
an
80%
power
to
detect
a
true
odds
ratio
of
1.40
or
greater
for
respiratory
symptoms
with
a
prevalence
of
5%
or
greater.
When
the
logit
variance
is
inflated
by
25%
to
accommodate
the
possibility
of
overdispersion,
we
still
have
more
than
an
80%
power
to
detect
a
true
odds
ratio
of
1.40
or
greater
for
respiratory
symptoms
with
a
prevalence
of
8%
or
greater.

References