1
TABLE
OF
CONTENTS
FOR
ICR
SUPPORTING
STATEMENT
PART
A
OF
SUPPORTING
STATEMENT
PAGE
2
PART
B
OF
SUPPORTING
STATEMENT
PAGE
9
APPENDIX
A:
MATERNAL
QUESTIONNAIRE
PAGE
12
APPENDIX
B:
FIRST
FEDERAL
REGISTER
NOTICE
PDF
FILE
2
PART
A
OF
ICR
SUPPORTING
STATEMENT
1.
IDENTIFICATION
OF
THE
INFORMATION
COLLECTION
1(
a)
Title
of
the
Information
Collection:
Seven
County
Study
of
Air
Quality
and
Birth
Defects:
Computer­
Assisted
Telephone
Questionnaire
for
Subset
of
Study
Population
1(
b)
Short
Characterization/
Abstract:
The
computer­
assisted
telephone
interview
(
CATI)
is
one
component
of
a
larger
study
based
on
a
linked­
records
case­
control
analysis
that
will
examine
the
association
between
exposure
to
five
criteria
air
pollutants
(
carbon
monoxide,
nitrogen
oxides,
ozone,
sulfur
dioxide,
and
PM
10)
and
the
risk
of
selected
congenital
cardiac
defects
and
oral
clefts
in
seven
counties
(
Bexar,
Dallas,
El
Paso,
Harris,
Hidalgo,
Tarrant,
Travis)
in
Texas
between
1997
and
1999.
The
computer­
assisted
telephone
interview
is
a
sub­
study
designed
to
help
improve
exposure
assignment
and
understand
better
the
relationship
between
certain
individual
behaviors
and
ambient
air
pollution
exposure,
and
ultimately
how
those
behaviors
may
modify
the
risks
of
birth
defects
associated
with
exposure
to
air
pollutants.
The
questionnaire
contains
a
maximum
of
28
questions
categorized
into
6
sections:
Residential
History,
Work
History,
Time
Spent
Outside
the
Home
(
Weekdays),
Time
Spent
Outside
the
Home
(
Weekends),
Multivitamin
Use,
and
Tobacco
Use.
Participants
in
the
telephone
interview
will
be
the
mothers
of
babies
born
with
and
without
birth
defects
in
1999
in
seven
Texas
counties
and
will
be
randomly
selected
from
the
larger
case­
control
study
of
air
pollution
and
birth
defects
in
the
state.
Potential
participants
will
be
first
contacted
by
mail
to
provide
basic
information
about
the
questionnaire.
Within
two
weeks
of
receipt
of
the
letter,
they
will
be
telephoned
and
invited
to
complete
the
questionnaire
over
the
telephone.

2.
NEED
FOR
AND
USE
OF
THE
INFORMATION
COLLECTION
2(
a)
Need/
Authority
for
the
Collection:
Previous
U.
S.
studies
examining
the
relationship
between
air
pollution
and
birth
defects
or
other
adverse
reproductive
outcomes
have
not
used
data
beyond
the
Environmental
Protection
Agency's
stationary
ambient
monitors
to
estimate
exposure.
This
questionnaire
will
provide
necessary
data
to
refine
the
exposure
assessment.
Maternal
residence
at
conception
(
rather
than
relying
on
the
assumption
that
the
mother
was
lived
at
the
residence
reported
at
delivery,
when
she
conceived)
will
allow
us
to
more
precisely
estimate
her
exposure
during
the
critical
window
for
the
birth
defects
under
study,
weeks
three
through
eight.
Maternal
work
history
will
allow
us
to
divide
women
by
whether
they
were
employed
or
not,
the
assumption
being
that
their
exposure
to
air
pollution
may
be
greater
if
they
worked
outside
the
home
(
and
were
therefore
commuters)
than
if
they
did
not
work
outside
the
home.
The
sections
on
time
spent
outside
the
home
on
weekdays
and
weekends
try
to
estimate
the
amount
of
time
(
and
intensity
of
activity)
spent
out
of
doors,
as
well
as
the
time
spent
traveling
in
vehicles.
Both
types
of
activities
will
likely
increase
one's
exposure
to
air
pollution
and
can
help
refine
the
assessment.
The
sections
on
maternal
vitamin
use
and
smoking
during
pregnancy
will
provide
relevant
data
on
potential
confounders
of
the
association
between
air
pollution
and
birth
defects.
3
2(
b)
Practical
Utility/
Users
of
the
Data:
This
data
will
be
used
by
the
study
investigators,
to
help
estimate
the
association
between
air
pollution
exposure
and
risk
of
selected
birth
defects.
This
will
be
the
first
study
in
this
research
area
to
collect
this
type
of
data,
and
if
it
proves
useful,
will
indicate
a
need
for
such
supplemental
data
collection
in
future
studies.
In
addition,
it
may
lead
to
the
recommendation
of
certain
traffic­
or
outdoor­
activity­
related
preventive
measures
to
reduce
exposure
to
air
pollution
during
pregnancy,
and
thereby
reduce
the
risk
of
selected
birth
defects.

3.
NON
DUPLICATION,
CONSULTATIONS
AND
OTHER
COLLECTION
CRITERIA
3(
a)
Non
duplication:
We
know
of
no
other
effort
at
this
time
to
study
the
effects
of
air
pollution
exposure
on
the
risk
of
birth
defects
that
employs
a
supplemental
questionnaire
to
gather
this
level
of
data.
There
is
no
existing
database
or
repository
of
this
type
of
information
that
we
could
access.

3(
b)
Public
Notice
Required
Prior
to
ICR
submission
to
OMB:
The
first
Federal
Register
notice
was
published
on
December
23,
2002
(
see
Appendix
B).
We
received
no
public
comment.
3(
c)
Consultations:
Not
applicable
3(
d)
Effects
of
Less
Frequent
Collection:
The
information
will
be
collected
once.
This
factor,
therefore,
does
not
apply
to
this
study.

3(
e)
General
Guidelines:
We
have
adhered
to
all
of
OMB's
general
guidelines.
Potential
participants
will
be
contacted
by
mail
and
provided
with
basic
information
about
the
study.
They
will
be
given
a
phone
number
to
call
if
they
are
not
interested
in
being
contacted
to
participate
in
the
interview.
Potential
participants
who
do
not
call
to
express
their
lack
of
interest
will
be
contacted
by
telephone
approximately
2
weeks
after
receiving
the
mailed
information.
They
will
be
read
a
standard
script
requesting
informed
consent,
and
if
elicited,
will
be
invited
to
complete
the
telephone
interview.

3(
f)
Confidentiality:
We
will
adhere
to
all
standard
steps
to
maintain
confidentiality.
These
include
the
exclusion
of
unique
identifiers
from
the
database
following
completion
of
the
telephone
interviews
and
storage
of
hard
copies
in
locked
files.
Contractor
involvement
will
be
monitored
by
requiring
hard
and/
or
electronic
copies
to
be
stored
at
EPA
after
the
contractor
has
completed
data
processing.
The
contractor
will
agree
to
observe
the
rules
of
confidentiality
regarding
the
health
information
provided
by
individuals.
Any
electronic
copies
of
data
containing
personal
information
will
be
kept
in
password
protected
computers
or
CDs
in
a
locked
filing
cabinet.
No
reports
will
contain
any
uniquely
identifying
information
about
the
participants.

3(
g)
Sensitive
Questions:
Mothers
of
cases
or
controls
who
were
stillborn,
electively
terminated
or
died
in
utero
may
be
particularly
sensitive
to
any
questions
about
their
pregnancies.
4
In
order
to
ensure
that
these
mothers
are
treated
with
the
utmost
sensitivity,
the
interviewers
will
not
be
blinded
to
their
status.
If
the
interviewer
detects
that
the
mother
is
becoming
emotionally
distressed
during
the
interview,
he
or
she
will
be
trained
to
offer
to
stop
the
interview.
Before
beginning
the
questionnaire,
all
participants
will
be
reminded
of
their
right
to
not
answer
any
question
or
stop
the
interview
at
any
time.
Arguably,
the
questions
about
vitamin
use
and
cigarette
smoking
may
be
more
sensitive,
in
that
there
are
socially
acceptable
responses
based
on
what
may
be
more
commonly
known
about
their
role
in
relation
to
the
risk
of
birth
defects.
No
questions
about
very
sensitive
issues
such
as
sexual
behaviors,
income
and
illness,
are
asked.

4.
THE
RESPONDENTS
AND
THE
INFORMATION
REQUESTED
4(
a)
Respondents:
Respondents
of
the
computer­
assisted
telephone
questionnaire
will
be
mothers
of
birth
defect
cases
and
healthy
controls
participating
in
a
larger
case­
control
study
of
how
air
pollution
may
affect
the
risk
of
birth
defects.
They
will
have
all
given
birth
in
1999
in
one
of
the
seven
counties
under
investigation.
We
expect
between
700
and
1000
respondents.

4(
b)
Information
Requested
(
i)
Data
items,
including
record
keeping
requirements
a.
Section
1:
Residential
History
(
4
questions):
Our
database
will
contain
an
address
from
the
Texas
Birth
Defects
Registry
(
for
the
mothers
of
birth
defect
cases)
or
the
birth
certificate
(
for
the
mothers
of
non­
malformed
controls).
However,
in
order
to
more
accurately
determine
the
air
pollution
exposure
during
the
early
part
of
pregnancy,
we
need
to
be
able
to
place
the
participants
in
geographical
space
and
time,
to
link
them
with
an
ambient
air
pollution
monitor.
We
will
be
recording
all
residences
in
which
the
mothers
lived
for
at
least
one
month
between
the
estimated
date
of
conception
and
the
date
of
birth
of
the
case
or
control
child.
It
is
helpful
to
know
where
the
mother
resided
when
she
found
out
she
was
pregnant
(
as
opposed
to
simply
knowing
residence
at
delivery
as
available
in
the
birth
defects
registry
or
vital
records
database)
and
whether
she
moved
during
the
course
of
her
pregnancy.
If
a
mother
states
that
the
address
in
our
database
is
the
same
as
her
address
when
she
found
out
she
was
pregnant,
the
remaining
questions
in
that
section
are
skipped.
If
a
mother
cannot
recall
or
does
not
wish
to
reveal
the
exact
address,
we
will
probe
to
ask
for
the
street
intersection.
The
structure
of
this
section
is
derived
from
that
of
the
National
Birth
Defects
Prevention
Study
(
a
Centers
for
Disease
Control­
funded
initiative).
b.
Section
2:
Work
History
(
1
question):
In
order
to
categorize
participants
by
whether
they
worked
outside
the
home
during
the
early
part
of
their
pregnancy,
we
ask
one
question.
Women
who
did
not
work
outside
the
home
may
have
been
more
likely
to
be
near
their
homes
during
the
day;
the
air
pollution
exposure
estimates
for
these
women
may
be
more
accurate
than
for
women
who
worked
outside
the
home.
5
c.
Section
3:
Time
Spent
Outside
the
Home
on
Weekdays
(
5
questions):
This
section,
perhaps
the
most
important
section
for
improving
the
assessment
of
air
pollution
exposure,
asks
women
to
recall
the
amount
of
time
they
typically
spent
outdoors
on
a
given
weekday
during
the
first
three
months
of
pregnancy.
They
are
then
asked
to
estimate
how
much
of
this
time
was
spent
as
a
driver
or
passenger
in
a
vehicle,
and
the
type
of
road
where
most
of
the
driving
took
place.
They
are
then
asked
to
estimate
how
much
of
the
time
was
spent
in
outside
activities
and
how
much
of
the
activity
was
vigorous
enough
to
work
up
a
sweat.
Mobile
sources
of
air
pollution
are
a
large
component
of
total
air
pollution,
and
an
attempt
to
estimate
the
intensity
of
exposure
to
air
pollution
via
a
crude
quantification
of
traffic­
related
exposures
will
be
helpful.
Women
engaging
in
outdoor
activities
in
which
they
break
a
sweat
will
indicate
an
increased
respiration
rate
and
a
greater
likelihood
of
absorbing
potentially
harmful
air
pollutants.
d.
Section
4:
Time
Spent
Outside
the
Home
on
Weekends
(
5
questions):
These
are
the
same
set
of
five
questions,
except
that
they
ask
women
to
focus
more
on
their
weekend
activities.
e.
Section
5:
Multivitamin
Use:
(
2
questions
minimum;
7
questions
maximum):
Respondents
are
asked
to
recall
whether
they
took
any
kind
of
vitamin,
supplement
or
vitamin
complex
from
the
three
months
before
conception
through
the
first
trimester
of
pregnancy.
They
are
asked
to
recall
when
they
started
and
stopped
taking
the
vitamin,
or
if
they
cannot
remember
the
dates,
approximately
how
long
they
took
the
vitamin
in
total.
They
are
also
asked
how
frequently
they
took
it.
They
are
allowed
up
to
four
responses.
This
set
of
questions
is
validated
and
in
use
in
a
national
study
of
birth
defects.
The
protective
role
of
folic
acid
in
the
prevention
of
neural
tube
defects
is
wellestablished
and
there
is
some
suggestive
data
that
some
vitamins
may
protect
against
other
birth
defects
as
well.
It
is
an
important
confounder
in
this
analysis,
and
may
also
serve
as
an
important
source
of
effect
modification,
if
the
vitamin
consumption
increases
the
mother's
ability
to
fight
the
adverse
effects
of
air
pollution.
The
structure
of
this
section
is
derived
from
the
National
Birth
Defects
Prevention
Study
(
a
Centers
for
Disease
Control­
funded
initiative).
f.
Section
6:
Cigarette
Smoking:
(
3
questions
minimum;
6
questions
maximum):
Respondents
are
asked
to
report
on
their
cigarette
consumption
ever,
and
specifically
during
the
first
trimester
of
pregnancy.
Cigarette
smoking
may
be
a
confounder
of
the
association
between
air
pollution
and
birth
defects,
and
may
also
be
an
important
effect
measure
modifier.
The
questions
are
validated
and
used
in
a
number
of
population­
based
surveys
including
NHANES
and
the
Pregnancy
Risk
Assessment
Monitoring
System
(
a
Centers
for
Disease
Control­
funded
study).
The
last
two
questions
ask
about
environmental
tobacco
smoke
exposure,
which
may
also
be
an
important
confounder
of
the
effects
of
ambient
air
pollution.
6
(
ii)
Respondent
activities:
Potential
respondents
will
be
mailed
an
introductory
letter
and
informational
brochure
about
the
study
about
two
weeks
prior
to
receiving
a
call.
The
interviewer
will
elicit
verbal
informed
consent
when
calling
to
conduct
the
interview.
The
respondents
need
only
reply
to
the
questions
asked
in
the
telephone
interview.
The
risks
associated
with
this
activity
do
not
extend
beyond
those
of
daily
living.

5.
THE
INFORMATION
COLLECTED
 
AGENCY
ACTIVITIES,
COLLECTION
METHODOLOGY,
AND
INFORMATION
MANAGEMENT
5(
a)
Agency
Activities:
The
Agency
has
a
support
contract
in­
place
with
a
private
research
organization
whose
scope
of
work
includes
the
ability
to
conduct
all
aspects
of
this
project.
The
contractor's
workplan
will
include
the
production
of
the
final
brochure,
the
mailing
of
the
introductory
letter
and
brochure,
the
tracking
of
phone
numbers,
the
conversion
of
the
interview
script
into
a
computer­
assisted
telephone
questionnaire,
the
finalization
of
an
interviewer's
guide,
the
conduct
of
the
interviews,
and
the
assembly
of
the
results
into
a
SAS
dataset.
The
Agency
will
administer
the
contract
and
perform
quality
assurance
procedures
for
the
data
collection.

5(
b)
Collection
Methodology
and
Management:
All
mothers
of
cases
and
controls
from
1999
will
be
sent
an
introductory
letter
and
study
fact
sheet
in
the
mail.
Approximately
two
weeks
later,
a
trained
interviewer
will
telephone
the
mother
to
follow­
up
on
the
mailing.
After
introducing
him
or
herself,
the
interviewer
will
inquire
as
to
whether
the
woman
received
the
mailed
materials.
If
she
did,
the
interviewer
will
ask
if
she
is
interested
in
participating,
and
if
so,
will
gather
her
verbal
informed
consent
and
proceed
with
the
interview.
If
at
any
point
in
time,
the
participant
has
any
questions,
the
interviewer
will
respond
to
them.
If
the
woman
does
not
wish
to
continue
with
the
interview
at
any
point
in
time,
the
interviewer
will
end
the
interview,
only
probing
as
to
why
the
woman
would
not
like
to
continue.
The
contractor
will
assemble
the
data
into
a
SAS
dataset,
using
only
an
identifying
code
to
link
with
the
already
established
dataset
assembled
from
the
records
linkage.
The
electronic
questionnaires
with
unique
identifiers
will
be
turned
over
to
the
EPA
and
kept
on
CD
in
the
principal
investigator's
office.
Quality
assurance
measures
will
be
taken;
the
principal
investigators
may
call
a
sample
of
participants
to
ask
them
about
the
quality
of
the
interview
experience.
Also,
a
subset
of
the
interviews
will
be
conducted
by
one
of
the
principal
investigators,
a
US
EPA
pre­
doctoral
trainee.

5(
c)
Small
Entity
Flexibility:
The
procedures
for
the
CATI
have
been
designed
to
minimize
the
burden
to
the
mothers
who
agree
to
participate
in
the
study.

5(
d)
Collection
Schedule:
The
entire
questionnaire,
including
the
gathering
of
informed
consent,
should
last
approximately
10
minutes.
The
completion
of
all
interviews
should
take
approximately
3
months.
Preliminary
data
sets
will
be
extensively
reviewed
for
quality
assurance
prior
to
any
analysis.
7
6.
ESTIMATING
THE
BURDEN
AND
COST
OF
THE
COLLECTION
6(
a)
Estimating
Respondent
Burden:

The
burden
will
be
approximately
10
minutes
per
respondent
including
the
gathering
of
informed
consent
and
the
conduct
of
the
CATI.

TABLE
1.
ESTIMATED
ANNUAL
RESPONDENT
BURDEN
Type
of
Respondent
Respondent
Activities
Estimated
Number
of
Respondents
Burden
Hours
Frequency
Annual
Reporting
Burden
Annual
Cost
X
14.72
Mother
CATI
1000
.167
1
167
$
2,458.24*

*$
14.72/
hour
(
average
hourly
wage)

Annual
Reporting
Burden:
167
hours
Annual
Respondent
Cost:
$
2,458.24
No
Annual
Record
Keeping
Burden
6(
b)
Estimating
Respondent
Costs
(
i)
Estimating
Labor
Costs
(
CATI):
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/
hour.
Given
the
.17
hour
burden,
the
respondent
cost
for
each
family
is
$
2.50.
(
ii)
Estimating
Capital
and
Operations
and
Maintenance
Costs:
No
capital
costs
are
involved.
(
iii)
Capital/
Start­
Up
Operating
and
Maintenance
(
O&
M)
Costs:
No
capital/
startup
costs
are
involved.
(
iv)
Annualizing
Capital
Costs:
Not
applicable
6(
c)
Estimating
Agency
Burden
and
Cost:

The
Agency
already
has
a
support
contract
in
place
with
a
private
research
organization
whose
scope
of
work
includes
the
ability
to
conduct
all
aspects
of
this
project.

TABLE
2.
AGENCY
COST
ANNUAL
BURDEN
Burden
Hours
Costs
($)

AGENCY
ACTIVITIES
Contractor
EPA
Freq
Total
Hours
Contractor
$
66/
hour
EPA
$
49/
hour
Prepare
and
format
questionnaires
60
80
1
140
3,960
3,920
8
Prepare
computers
120
8
1
128
7,920
392
Plan
logistics
and
coordination
40
40
1
80
2,640
2,640
Participant
Tracing
(
including
mailing)
160
0
1
160
10,560
0
Interviewer
Training
40
0
1
40
2,640
0
Telephone
Interview
(
allowing
multiple
attempts
at
contacting
individual
and
documentation)
1000
0
1
1000
66,000
0
Prepare
statistical
datasets
and
reports
80
0
1
80
5,280
0
Quality
Assurance
and
Quality
Control
40
10
1
50
2,640
490
Convert
Data
to
Electronic
Form
10
0
1
10
660
0
Perform
Statistical
Analysis*
0
20
1
20
0
980
TOTAL
1708
102,300
8,422
*
The
statistical
analyses
will
be
largely
conducted
by
a
stipended
predoctoral
fellow
at
the
EPA.

Agency
Total
Annual
Burden:
1,708
hours
Agency
Total
Annual
Cost:
$
102,300
+
$
8,422
=
$
110,722
These
agency
burden
estimates
were
based
on
our
prior
experience
in
developing
and
gathering
information
for
research
purposes.
The
agency
costs
are
based
on
a
GS­
13(
6)
for
the
primary
investigator
and
include
benefits.
The
majority
of
the
data
analysis
will
be
conducted
by
a
doctoral
student
who
is
not
a
paid
EPA
employee.
The
contractor
costs
are
based
on
a
composite
cost
given
the
people
needed
to
conduct
this
study.

6(
d)
Estimating
the
Respondent
Universe
and
Total
Burden
and
Costs:

Assuming
a
100%
response
rate,
we
could
have
up
to
1,000
respondents
to
the
telephone
questionnaire.
This
would
be
a
10,000
minute
(
167hours)
time
burden.
Operating
under
this
assumption
the
total
estimated
respondent
costs
would
be
$
2,458.24.
A
more
realistic
assumption
is
a
70%
response
rate
resulting
in
the
conduct
of
700
interviews
and
a
total
burden
of
7000
minutes,
or
approximately
117
hours.
This
would
result
in
a
total
cost
of
$
1722.24.

6(
e)
Bottom
Line
Burden
Hours
and
Cost
Tables
(
i)
Respondent
Tally:
167
hours
at
a
cost
of
$
2458.24.
(
ii)
The
Agency
Tally:
1708
hours
at
a
cost
of
$
110,722.
(
iii)
Variations
in
the
Annual
Bottom
Line:
This
project
will
last
less
than
one
year,
therefore
this
factor
is
not
applicable.
9
6(
f)
Reasons
for
a
Change
in
Burden:
There
is
no
change
in
the
burden,
therefore
this
factor
is
not
applicable.

6(
g)
Burden
Statement:

The
annual
public
reporting
and
record
keeping
burden
for
this
collection
of
information
is
estimated
to
average
10
minutes
per
respondent.
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.

To
comment
on
the
Agency's
need
for
this
information,
the
accuracy
of
the
provided
burden
estimates,
and
any
suggested
methods
for
minimizing
respondent
burden,
including
the
use
of
automated
collection
techniques,
EPA
has
established
a
public
docket
for
this
ICR
under
Docket
ID
No.
ORD­
2003­
0001,
which
is
available
for
public
viewing
at
the
Office
of
Environmental
Information
Docket
in
the
EPA
Docket
Center
(
EPA/
DC),
EPA
West,
Room
B102,
1301
Constitution
Ave.,
NW,
Washington,
DC.
The
EPA
Docket
Center
Public
Reading
Room
is
open
from
8:
30
a.
m.
to
4:
30
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
telephone
number
for
the
Reading
Room
is
(
202)
566­
1744,
and
the
telephone
number
for
the
Environmental
Information
Docket
is
(
202)
566­
1753.
An
electronic
version
of
the
public
docket
is
available
through
EPA
Dockets
(
EDOCKET)
at
http://
www.
epa.
gov/
edocket.
Use
EDOCKET
to
submit
or
view
public
comments,
access
the
index
listing
of
the
contents
of
the
public
docket,
and
to
access
those
documents
in
the
public
docket
that
are
available
electronically.
Once
in
the
system,
select
"
search,"
then
key
in
the
docket
ID
number
identified
above.
Also,
you
can
send
comments
to
the
Office
of
Information
and
Regulatory
Affairs,
Office
of
Management
and
Budget,
725
17th
Street,
NW,
Washington,
DC
20503,
Attention:
Desk
Office
for
EPA.
Please
include
the
EPA
Docket
ID
No.
(
ORD­
2003­
0001)
and
ICR
number
(
2109.01)
in
any
correspondence.

PART
B
OF
ICR
SUPPORTING
STATEMENT
1)
Introduction
The
results
of
this
computer­
assisted
telephone
interview
will
help
refine
the
exposure
assessment
to
air
pollution,
and
provide
data
on
probable
confounders
of
the
association
between
air
pollution
and
the
risk
of
birth
defects.
In
Part
B
of
this
supporting
statement,
the
survey
10
objectives,
design
and
key
variables
will
be
explained.
In
addition,
the
methods
of
data
collection
and
analysis
will
be
outlined.

2)
Survey
Objectives,
Key
Variables
The
objective
of
this
telephone
questionnaire
is
to
gather
some
supplemental
data
to
help
refine
the
assessment
of
exposure
to
air
pollution
during
early
pregnancy
(
See
Appendix
A).
The
survey
also
hopes
to
collect
data
on
probable
confounders
of
the
association
between
air
pollution
and
the
risk
of
selected
birth
defects.
The
survey
is
divided
into
six
sections:
Residential
History,
Work
History,
Time
Spent
Outside
the
Home
on
Weekdays,
Time
Spent
Outside
the
Home
on
Weekends,
Vitamin
Use,
and
Cigarette
Smoking.
Key
variables
from
each
section
are
as
follows:

Section
1:
all
addresses
lived
at
for
at
least
one
month
from
conception
through
the
first
three
months
of
pregnancy
Section
2:
participant
work
outside
the
home
(
yes/
no)
during
early
pregnancy
Section
3:
on
average
weekday,
time
spent
outside
the
home;
time
spent
as
driver
or
passenger
of
vehicle;
time
spent
outside
in
activities
such
as
walking,
running,
gardening;
time
spent
vigorously
engaged
in
these
activities
Section
4:
the
same
set
of
questions
as
Section
3,
except
pertaining
to
outdoor
activities
on
weekends
Section
5:
any
vitamin
use
from
three
months
before
conception
through
first
trimester;
type,
duration
and
frequency
of
vitamin
use
Section
6:
any
lifetime
cigarette
smoking
(
more
than
100
cigarettes);
any
cigarette
smoking
during
early
pregnancy;
amount
of
cigarettes
smoked;
environmental
tobacco
exposure
at
work
or
school
3)
Survey
Design
3(
a)
Target
Population
and
Coverage
The
target
population
for
this
computer
assisted
telephone
interview
study
will
be
mothers
delivering
an
infant
with
or
without
a
birth
defect
in
seven
Texas
counties
in
1999.
3(
b)
Sample
Design
(
i)
Sampling
Frame
The
sampling
frame
will
be
mothers
already
under
analysis
in
the
linked­
records
component
of
the
Seven
County
Study
of
Air
Quality
and
Birth
Defects.
(
ii)
Sample
Size
The
sample
size
will
be
constrained
by
the
ability
to
ascertain
the
correct
contact
information
for
mothers
whose
last
recorded
address
was
in
1999.
The
record
linkage
component
of
the
study
will
have
approximately
1500
cases
and
1500
controls.
We
do
not
expect
to
have
the
statistical
power
that
we
have
for
the
record
linkage
analyses,
and
expect
a
maximum
of
1000
cases
and
controls
combined.
A
more
realistic
estimate
is
700
respondents.

4)
Pretests,
Pilot
Tests,
Collection
Methods
and
Analyzing
Survey
Results
11
The
survey
has
been
informally
pretested,
yet
there
have
not
been
any
formal
pilots.
As
indicated
above,
three
sections
of
the
questionnaire
have
been
validated
by
use
in
well­
established
telephone
and
in­
person
interviews.
The
data
collection
will
be
via
a
computer­
assisted
telephone
interview
and
will
be
conducted
in
a
large
part,
by
an
EPA
contractor
with
expertise
in
this
area.

The
data
will
be
compiled
into
a
SAS
dataset
for
analysis
by
the
principal
investigators.
Data
analysis
will
explore
the
statistical
associations
between
measurements
of
air
quality
(
based
on
EPA
ambient
monitoring
data)
and
the
risk
of
selected
birth
defects,
accounting
for
factors
such
as
vitamin
use
(
which
decreases
the
risk
of
some
birth
defects)
and
cigarette
smoking
(
which
increases
the
risk
of
some
birth
defects).
The
questionnaire
asks
about
residential
history
in
order
to
estimate
exposure
more
accurately
early
in
gestation
by
using
residence
at
conception
instead
of
residence
at
delivery.
The
analysis
will
compare
the
exposure
estimates
at
the
different
address
locations
and
ultimately
quantify
the
misclassification
of
exposure
based
on
using
address
at
delivery.
In
addition,
the
study
will
compare
estimates
of
the
association
between
air
quality
and
risk
of
birth
defects
using
the
two
different
addresses
to
estimate
exposure.
The
questions
about
commuting
patterns
and
outdoor
activities
during
pregnancy
will
help
us
understand
how
exposure
to
ambient
air
pollution
may
change
with
changes
in
individual
behaviors.
First,
the
analysis
will
measure
the
association
between
these
individual
activities
and
exposure
to
ambient
air
pollution,
and
will
ultimately
examine
the
statistical
interaction
between
these
activities
and
ambient
exposure.
12
APPENDIX
A:
MATERNAL
QUESTIONNAIRE
IF
LIVE
BORN
INFANT:
The
first
set
of
questions
is
about
where
you
were
living
when
you
were
pregnant
with
[
NAME
OF
INDEX
CHILD
(
NOIC)]
that
you
delivered
on
[
DATE
OF
INDEX
BIRTH
(
DOIB)].

IF
TERMINATION
OR
FETAL
DEATH:
The
first
set
of
questions
is
about
where
you
were
living
during
the
pregnancy
that
ended
on
[
DATE
OF
PREGNANCY
TERMINATION
(
DOPT)].

Residential
History
A1.
From
[
ESTIMATED
DATE
OF
CONCEPTION
(
EDC)]
to
DOIB/
DOPT,
how
many
different
residences
did
you
live
in
for
more
than
one
month?
NUMBER
OF
DIFFERENT
RESIDENCES
______
RF
DK
A2.
What
was
your
complete
address
on
[
EDC]?
LIST
ALL
IN
CHART.
What
was
your
address
after
that?
PROBE
IF
NEEDED:
It
is
important
for
the
study
that
we
get
at
least
a
general
location
of
your
household.
Would
you
please
identify
the
intersection
of
roads
that
was
closest
to
your
home?
A3.
What
month
and
year
did
you
start
living
there?
A4.
What
month
and
year
did
you
stop
living
there?
Do
you
still
live
there?

A.
STREET
CITY
COUNTY
STATE
ZIP
Or
STREET
1
STREET
2
MONTH
____
YEAR
______
MONTH
_____
YEAR
______

CURRENTLY
LIVING
THERE
=
DATE
OF
INTERVIEW
B.
STREET
CITY
COUNTY
STATE
MONTH
____
YEAR
______
MONTH
_____
YEAR
______

CURRENTLY
LIVING
13
ZIP
Or
STREET
1
STREET
2
THERE
=
DATE
OF
INTERVIEW
C.
STREET
CITY
COUNTY
STATE
ZIP
Or
STREET
1
STREET
2
MONTH
____
YEAR
______
MONTH
_____
YEAR
______

CURRENTLY
LIVING
THERE
=
DATE
OF
INTERVIEW
D.
STREET
CITY
COUNTY
STATE
ZIP
Or
STREET
1
STREET
2
MONTH
____
YEAR
______
MONTH
_____
YEAR
______

CURRENTLY
LIVING
THERE
=
DATE
OF
INTERVIEW
Work
History
B1.
Were
you
working
at
a
job
outside
your
home
between
[
EDC]
and
[+
3]?
YES
NO
RF
DK
Time
Spent
Outside
the
Home
(
Weekdays)

The
next
few
questions
are
about
the
time
spent
outside
your
home
on
a
typical
weekday
between
[
EDC]
and
[+
3]
14
C1.
About
how
much
time
per
day
did
you
spend
outside
of
your
home
or
another
building,
including
time
spent
outdoors
or
traveling
in
a
vehicle?
MINUTES
__
HOURS
__
RF
DK
C2.
About
how
much
of
this
[
RESPONSE
TO
C1]
was
spent
in
a
car,
truck
or
bus
as
a
driver
or
passenger?
MINUTES
__
HOURS
__
RF
DK
C3.
On
what
type
of
road
did
you
mostly
travel
during
this
[
RESPONSE
TO
C2]?
[
READ
LIST]
Major
highways
or
freeways
City
streets
with
stoplights
City
streets
without
stoplights
Paved
country
roads
Unpaved
roads
RF
DK
C4.
About
how
much
of
this
[
RESPONSE
TO
C1]
was
spent
outside,
in
activities
such
as
walking,
gardening,
exercising
or
job­
related
outdoor
activities?
MINUTES
__
HOURS
__
RF
DK
C5.
About
how
much
of
this
[
RESPONSE
TO
C4]
were
you
active
enough
to
work
up
a
sweat?
MINUTES
___
HOURS
___
RF
DK
Time
Spent
Outside
the
Home
(
Weekends)

The
next
few
questions
are
about
your
time
spent
outside
your
home
on
a
typical
weekend
between
[
EDC]
and
[+
3].

D1.
About
how
much
time
per
day
did
you
spend
outside
of
your
home
or
another
building,
including
time
spent
outdoors
or
traveling
in
a
vehicle?
15
MINUTES
__
HOURS
___
RF
DK
D2.
About
how
much
of
this
[
RESPONSE
TO
D1]
was
spent
in
a
car,
truck
or
bus
as
a
driver
or
passenger?
MINUTES
__
HOURS
__
RF
DK
D3
On
what
type
of
road
did
you
mostly
travel
during
this
[
RESPONSE
TO
D2]?
Major
highways
or
freeways
City
streets
with
stoplights
City
streets
without
stoplights
Paved
country
roads
Unpaved
roads
RF
DK
D4.
About
how
much
of
this
[
RESPONSE
TO
D1]
was
spent
outside,
in
activities
such
as
walking,
gardening,
exercising
or
job­
related
outdoor
activities?
MINUTES
__
HOURS__
RF
DK
D5.
About
how
much
of
this
[
RESPONSE
TO
D4]
were
you
active
enough
to
work
up
a
sweat?
MINUTES
___
HOURS
___
RF
DK
Multivitamin
use
E1.
Did
you
take
any
kind
of
vitamin,
multivitamin
or
vitamin
complex
between
[
 
3]
and
[
EDC]?
YES
NO
RF
DK
16
E2.
Did
you
take
any
kind
of
prenatal
vitamin,
multivitamin,
or
vitamin
complex
between
[
EDC]
and
[
DOIB/
DOPT]?
YES
NO
RF
DK
FOR
EACH
VITAMIN
ASK
E3
THROUGH
E5.
IF
YOU
GET
EXACT
DATES
IN
E4
and
E5,
SKIP
E6.
E3.
What
vitamin
did
you
take?
PROBE:
Anything
else?
Do
you
remember
what
it
was
called?
E4.
When
did
you
start
using
(
VITAMIN)?
E5.
When
did
you
stop
using
(
VITAMIN)?

OR
E6.
How
long
did
you
take
it?
E7.
How
often
did
you
use
the
vitamin?

A.
_________
DK
_
_
/
_
_/
_
_
_
_
_
_
/
_
_/
_
_
_
_
Day(
s)
___
Week(
s)
___
Months(
s)
___
Year(
s)
____
RF
DK
Per
day
___
Per
week
___
Per
month
___
Per
year
____
RF
DK
B.
_________
DK
_
_
/
_
_/
_
_
_
_
_
_
/
_
_/
_
_
_
_
Day(
s)
___
Week(
s)
___
Months(
s)
___
Year(
s)
____
RF
DK
Per
day
___
Per
week
___
Per
month
___
Per
year
____
RF
DK
C.
_________
DK
_
_
/
_
_/
_
_
_
_
_
_
/
_
_/
_
_
_
_
Day(
s)
___
Week(
s)
___
Months(
s)
___
Year(
s)
____
RF
DK
Per
day
___
Per
week
___
Per
month
___
Per
year
____
RF
DK
D.
_________
DK
_
_
/
_
_/
_
_
_
_
_
_
/
_
_/
_
_
_
_
Day(
s)
___
Week(
s)
___
Months(
s)
___
Year(
s)
____
RF
DK
Per
day
___
Per
week
___
Per
month
___
Per
year
____
RF
DK
17
Cigarette
Smoking
The
next
questions
are
about
tobacco
use.

F1.
Have
you
smoked
at
least
100
cigarettes
in
your
entire
life?
YES
NO,
GO
TO
F5
RF
DK
The
following
questions
ask
about
tobacco
use
only
between
[
EDC]
and
[+
3].

F2.
Were
you
smoking
at
all?
YES
NO,
GO
TO
F5
RF
DK
F3.
Were
you
smoking
cigarettes
every
day?
YES
NO,
GO
TO
F5.
RF
DK
F4.
How
many
cigarettes
did
you
smoke
per
day?
SPECIFY:
RF
DK
IF
SKIPPED
F2­
F4
SAY:
The
next
two
questions
are
about
your
exposure
to
cigarette
smoke
between
[
EDC]
and
[+
3].

F5.
Did
anyone
in
your
household
smoke
cigarettes?
YES
NO
RF
DK
F6.
Did
anyone
smoke
cigarettes
near
you
at
a
workplace
or
school?
YES
NO
RF
DK
18
Conclusion
of
Questionnaire
Thank
you
very
much
for
participating
in
this
study.
We
believe
that
your
responses
will
help
us
to
better
understand
how
the
quality
of
the
air
we
breathe
may
be
related
to
birth
defects.
Thanks
again
and
have
a
great
day.
19
APPENDIX
B:
FIRST
FEDERAL
REGISTER
NOTICE
