Document ID: EPA-HQ-ORD-2003-0007-0001
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2003-07-29T04:00Z

1
Supporting
Statement
for
Information
Collection
Request
1887.02
1
(
a).
Title
ICR:
Personal
Exposure
of
High­
Risk
Subpopulations
to
Fine
Particles
EPA
ICR
Number:
1887.02
OMB
Control
Number:
2080­
0058
1
(
b)
Short
Characterization/
Abstract
Approval
was
granted
in
1999
for
a
series
of
four
studies
of
personal
exposure
of
high­
risk
subpopulations
to
particles
and
associated
gases.
Three
of
these
studies
have
been
completed,
but
the
fourth
is
still
continuing.
The
OMB­
approved
questionnaire
expires
July
31,
2002.
This
ICR
requests
a
renewal
for
an
additional
three
years.
There
is
no
new
burden
and
no
additional
participants
in
the
studies
beyond
what
was
calculated
in
the
original
ICR
1887.01.

The
studies,
which
have
been
recommended
by
the
National
Academy
of
Sciences
(
NAS)
under
a
directive
from
Congress,
are
considered
necessary
to
support
the
proposed
new
National
Ambient
Air
Quality
Standard
(
NAAQS)
for
fine
particles
(
PM
2.5).
The
information
will
be
used
by
scientists
within
ORD
and
external
to
the
Agency
to
determine
the
relationship
between
personal
exposure,
indoor
concentrations,
and
concentrations
measured
at
central
monitoring
site
for
one
or
more
high­
risk
subpopulations,
including
particularly
persons
with
chronic
obstructive
pulmonary
disease
(
COPD)
and
persons
with
cardiovascular
disease.
The
data
will
also
be
used
by
the
Office
of
Air
Quality
Planning
and
Standards
(
OAQPS)
in
their
review
of
the
basis
for
the
proposed
PM
2.5
regulation.
The
information
will
appear
in
the
form
of
final
EPA
reports,
journal
articles,
and
will
also
be
made
publicly
available
in
an
electronic
data
base.

2.
Need
for
and
Use
of
the
Collection
2
(
a)
Need/
Authority
for
the
Collection
A
number
of
epidemiological
studies
have
linked
daily
mortality
and
morbidity
statistics
with
increased
particle
concentrations
measured
outdoors.
The
mortality
studies
have
taken
place
in
many
different
cities
around
the
world
and
appear
to
agree
surprisingly
well,
showing
an
increase
of
a
few
percent
in
deaths
per
50
ìg/
m3
increase
in
outdoor
air
particles,
with
no
apparent
threshold
concentration.
From
a
study
of
death
certificates
on
days
with
higher
pollution,
the
affected
persons
appear
to
be
those
with
existing
respiratory
disease
(
particularly
those
with
2
chronic
obstructive
pulmonary
disease,
or
COPD)
and
cardiovascular
disease.
Although
the
studies
have
often
included
other
outdoor
pollutants,
such
as
sulfur
dioxide,
sulfates,
and
nitrogen
oxides,
the
strongest
relationships
have
generally
been
found
to
be
with
particles.
Modeling
studies
have
often
suggested
that
it
is
the
fine
particles
(
less
than
2.5
or
3.5
micrometers
in
diameter)
that
are
the
more
likely
agent.
These
findings
have
led
the
US
EPA
to
propose
a
new
National
Ambient
Air
Quality
Standard
(
NAAQS)
for
particles
less
than
2.5
micrometers
in
diameter
(
PM
2.5)
of
65
ìg/
m3
for
24
hours
(
to
be
exceeded
no
more
than
once
per
year)
and
an
annual
standard
of
15
ìg/
m3.

However,
a
number
of
studies
of
personal
exposure
to
particles
have
shown
little
or
no
correlation
of
the
personal
exposure
with
concurrent
outdoor
air
concentrations.
This
has
led
to
concern
for
the
adequacy
of
the
scientific
underpinning
of
the
EPA
standard.
This
concern
was
recognized
by
Congress
in
FY
1998
and
resulted
in
their
providing
an
increased
budget
to
EPA
to
study
the
health
effects
of
particles.
Congress
specified
that
the
EPA
should
be
guided
in
its
research
by
the
recommendations
of
a
special
National
Academy
of
Sciences
study
of
research
needs.
The
resulting
NAS
report
laid
out
a
"
portfolio"
of
recommended
research
over
the
next
13
years.
In
particular,
the
NAS
report
found
that
the
relationship
of
the
exposure
of
the
high­
risk
subpopulations
to
outdoor
concentrations
was
unknown,
and
recommended
about
three
studies
in
different
areas
around
the
country
to
improve
our
knowledge
of
this
relationship.
The
NAS
estimated
the
cost
of
each
of
these
studies
as
about
$
1M/
year
for
three
years,
or
a
total
of
$
9M
over
the
three
years.

Concurrently,
EPA's
Office
of
Research
and
Development
(
ORD),
through
its
National
Exposure
Research
Laboratory
(
NERL)
had
been
planning
a
study
along
exactly
the
lines
recommended
by
the
NAS.
A
Request
for
Applications
(
RFA)
was
published
in
the
Commerce
Business
Daily
(
CBD)
on
April
15,
1998,
inviting
proposals
to
study
the
exposure
to
fine
particles
of
high­
risk
subpopulations.
An
external
peer
review
panel
reviewed
the
proposals
and
found
that
three
were
of
high
scientific
value
worthy
of
funding.
EPA
has
funded
all
three
proposals
as
competitive
cooperative
agreements.
The
three
principal
institutions
include
the
Harvard
School
of
Public
Health,
the
New
York
University
School
of
Medicine,
and
the
University
of
Washington.
In
addition,
EPA
funded
a
fourth
study
using
in­
house
personnel
with
contractual
support.
All
four
studies
used
the
same
basic
questionnaire,
approved
by
OMB
in
July
of
1999
and
due
to
expire
July
31,
2002.

The
goal
of
these
studies
is
to
determine
the
parameters
of
the
relationship
between
personal
exposure
to
particles,
as
measured
by
a
personal
monitor,
and
outdoor
concentrations
as
measured
at
a
central
site,
for
a
group
of
persons
considered
to
be
at
high
risk
due
to
their
respiratory
or
cardiovascular
conditions.
Of
particular
interest
is
the
portion
of
the
subjects'
exposure
that
is
due
to
outdoor
sources.
Since
most
persons
are
indoors
most
of
the
time,
this
requires
measuring
the
rate
at
which
outdoor
particles
are
entering
the
home
and
also
studying
the
parameters,
such
as
the
penetration
factor
through
the
building
envelope
and
the
deposition
rate
3
of
particles
on
interior
surfaces,
that
affect
the
ultimate
fate
of
the
outdoor
particles.
Also,
since
it
has
been
found
that
personal
exposures
differ
from
indoor
concentrations,
it
is
necessary
to
measure
indoor
concentrations
at
some
location
in
the
home
as
well
as
the
personal
and
outdoor
concentrations.
Additionally,
since
it
is
still
not
certain
that
particles
alone
are
responsible
for
the
increased
mortality
on
high­
pollution
days,
gases
that
are
associated
with
particles,
such
as
carbon
monoxide
(
CO),
nitrogen
dioxide
(
NO
2),
and
sulfur
dioxide
(
SO
2)
are
being
measured
concurrently
with
the
particles.
Since
the
particle
sizes
associated
with
higher
morbidity
and
mortality
are
also
unclear,
both
fine
and
coarse
particles
will
be
measured.
Fine
particles
are
those
less
than
2.5
micrometers
in
aerodynamic
diameter
(
A.
D.);
coarse
particles
are
those
between
2.5
and
10
micrometers
in
A.
D.

One
previous
study
of
personal,
indoor,
and
outdoor
concentrations
of
particles
has
been
carried
out
by
EPA:
the
Particle
TEAM
(
PTEAM)
Study,
carried
out
in
1990
in
Riverside,
CA.
The
questionnaire
for
that
study
was
approved
by
OMB
and
has
been
used
as
the
basis
for
developing
the
questionnaire
for
this
study.
Based
on
extensive
analysis
of
the
PTEAM
questionnaire,
some
questions
have
been
found
not
to
be
as
useful
as
could
be
wished
and
have
been
omitted
from
the
present
questionnaire,
thus
reducing
the
burden
on
the
respondent.

2
(
b)
Practical
Utility/
Users
of
the
Data
The
data
will
show
how
well
a
central
site
can
represent
the
actual
exposure
of
selected
members
of
the
population
most
at
risk.
Since
the
proposed
EPA
regulation
of
PM
2.5
includes
requirements
for
a
large
number
of
monitoring
sites
throughout
the
country,
a
knowledge
of
how
well
those
sites
can
do
their
job
is
clearly
of
great
practical
utility.
The
main
users
of
the
data
include
scientists
studying
personal
exposure
to
airborne
pollutants,
Federal
and
State
regulators
responsible
for
administering
their
respective
laws
regarding
air
pollution,
and
the
regulated
community.

Within
EPA,
users
of
the
data
include
measurement
scientists
and
modelers
within
ORD,
and
program
analysts
and
regulators
within
OAQPS.
Also
within
ORD,
the
office
responsible
for
preparing
the
Particle
Criteria
Document,
the
National
Center
for
Exposure
Assessment
(
NCEA),
will
abstract
the
data
for
use
in
the
Criteria
Document.

State
agencies
responsible
for
running
the
State
programs
on
monitoring
air
pollution
will
also
scrutinize
the
data
for
information
relevant
to
siting
their
stations.

In
the
private
sector,
members
of
the
regulated
community
such
as
the
American
Petroleum
Institute
(
API)
and
the
Electric
Power
Research
Institute
(
EPRI)
will
use
the
data
to
study
the
impact
of
their
member
companies
on
outdoor
air
pollution
and
the
associated
impact
on
personal
exposure.
4
3(
a)
Non­
duplication
Two
earlier
pilot
studies
of
the
exposure
of
COPD
patients
have
been
carried
out,
by
the
Harvard
School
of
Public
Health
under
the
sponsorship
of
the
API
and
the
EPRI.
The
first
study,
in
Nashville,
included
just
10
patients
who
were
followed
for
only
6
days,
3
days
with
PM
2.5
measurements
and
3
days
with
PM
10
measurements.
The
number
of
subjects
was
too
small
and
the
number
of
days
too
short
for
reaching
any
conclusions,
but
the
study
served
the
purpose
of
demonstrating
the
feasibility
of
the
approach.
The
second
study,
in
Boston,
included
a
larger
number
of
subjects
(
18)
and
a
greater
number
of
days
(
6­
18).
However,
the
NAS
has
emphasized
that
studies
should
be
done
in
many
different
areas
of
the
country,
due
to
the
different
sources,
aerosol
types,
and
meteorology
encountered
in
different
areas.
Therefore
the
present
set
of
studies
has
been
designed
to
have
fairly
wide
geographic
coverage,
with
studies
having
been
completed
in
Boston,
New
York,
Atlanta,
Fresno,
Raleigh
and
Seattle.
Two
studies
that
remain
in
progress
are
taking
place
in
Anaheim
and
Seattle.

Since
other
organizations
are
planning
similar
studies,
EPA
has
set
up
a
coordinating
committee
including
the
other
sponsoring
agencies
and
also
the
principal
investigators
of
the
associated
universities
to
be
sure
that
no
duplication
occurs.
Private
organizations
such
as
API
and
EPRI
are
also
represented
on
the
committee.
This
committee
held
its
first
meeting
in
Boston
in
August,
1998,
and
the
members
are
continuing
to
correspond
and
coordinate
their
studies
closely.
For
example,
the
Health
Effects
Institute
and
the
EPA
collaborated
on
pilot
studies
in
Boston
and
upper
New
York
State
to
test
the
sampling
methodology
thoroughly
before
employing
the
instruments
in
the
field.
Also,
the
California
Air
Resources
Board
has
contributed
to
carry
out
additional
studies
in
Los
Angeles,
and
EPRI
added
resources
for
additional
pollutants
to
be
measured
in
the
Atlanta
study.

3(
b)
Public
Notice
EPA
solicited
public
comment
on
this
request
for
a
renewal
of
its
information
collection
plans
by
publishing
a
notice
in
the
Federal
Register
on
April
2,
2002
(
67
FR
15565).
No
comments
were
received.

3(
c)
Consultations
We
have
consulted
on
an
informal
basis
with
our
respondents
regarding
the
burden
of
the
study,
both
from
wearing
the
personal
monitors
and
providing
space
in
the
home
for
the
indoor
monitors,
and
from
answering
the
questionnaire.
Comments
were
received
indicating
that
the
burden
of
wearing
the
monitors
was
sometimes
noticeable;
that
it
was
sometimes
difficult
to
keep
children
from
exploring
the
area
of
the
home
reserved
for
indoor
monitoring;
and
that
answering
the
questionnaire
was
sometimes
slightly
boring.
However,
no
respondents
(
out
of
more
than
200
so
far)
have
broken
off
their
data
collection
before
the
planned
end
of
their
participation,
so
we
5
infer
that
the
burden
of
the
study
is
being
well
accepted
by
all
respondents,
who
are
of
course
all
volunteers
with
no
compulsion
to
participate.

3(
d)
Effects
of
Less
Frequent
Collection
Since
this
is
a
one­
time
study,
this
section
is
not
applicable.

3(
e)
General
Guidelines
We
are
adhering
to
OMB's
general
guidelines
as
described
on
page
A­
12
of
EPA's
ICR
Handbook.

3(
f)
Confidentiality
The
identity
of
the
participants
will
remain
confidential.
All
questionnaires
and
other
data
for
each
person
have
been
identified
with
a
unique
number.
All
hard
copy
documents
have
this
number
as
their
identification,
as
do
all
entries
in
the
electronic
database.
A
single
hard
copy
document
relating
the
name
of
the
person
to
the
number
is
kept
under
lock
and
key
by
a
single
qualified
individual
at
each
of
the
institutions
carrying
out
the
study.

3(
g)
Sensitive
Questions
There
are
no
questions
of
a
sensitive
nature
included
on
the
questionnaire.

4
Respondents
and
Information
Requested
4(
a)
Respondents/
SIC
Codes
Respondents
have
been
and
will
be
patients
selected
from
certain
diagnostic
categories
by
cooperating
physicians.

4(
b)
Information
Requested
(
i)
Data
Items
The
data
items
requested
are
contained
in
the
attached
copy
of
the
questionnaire
and
the
associated
instructions.

(
ii)
Respondent
Activities
Of
the
six
activities
listed
in
the
1995
PRA
Definition
of
"
Burden,"
(
3502.
(
2))
and
the
6
nine
activities
listed
in
OMB's
Definition
of
Burden
in
OMB's
Final
Rules
(
5
CFR
1320.3(
b)(
1)
only
the
following
three
are
relevant:

1.
Reviewing
instructions.

2.
Completing
and
reviewing
the
collection
of
information.

3.
Transmitting,
or
otherwise
disclosing
the
information.

Our
estimates
of
the
amount
of
time
it
will
take
each
respondent
for
each
of
these
three
activities
are
contained
in
our
tables
estimating
burden.

5
The
Information
Collected­­
Agency
Activities,
Collection
Methodology,
and
Information
Management
5(
a)
Agency
Activities
The
major
agency
activities
associated
with
these
studies
are:

1.
Monitoring
progress
of
universities
and
contractors
on
main
studies.
8a.
Reviewing
progress
reports.
8b.
Reviewing
costs
and
schedule
compliance.
8c.
Providing
funds
to
the
researchers
on
an
annual
basis.

2.
Assisting
in
field
sampling
and
analysis
(
including
training
of
Agency
personnel).

3.
Analyzing
data.

4.
Writing,
editing,
and
publishing
final
reports.

5.
Creating
and
maintaining
a
publicly
available
electronic
data
base.

5(
b)
Collection
Methodology
and
Management
Pretesting
of
the
collection
instrument
was
performed
on
several
members
of
the
university
research
teams.
The
time
required
to
answer
the
questions
was
recorded
and
forms
the
basis
of
the
estimates
in
the
following
tables.

Data
are
keyed
into
IBM­
compatible
PCs.
Data
quality
have
been
and
will
be
checked
by
100%
re­
keying
of
the
questionnaire
items.
7
5(
c)
Small
Entity
Flexibility
This
item
is
not
applicable
to
this
ICR.

5(
d)
Collection
Schedule
The
collection
schedule
varies
somewhat
between
the
three
university
consortia
and
the
EPA/
contractor
study,
but
in
all
cases
the
household
questionnaire
is
administered
on
the
first
day
that
the
technicians
arrive
at
the
house.
The
daily
24­
hour
recall
questionnaire
is
then
administered
on
each
day
that
the
technicians
collect
the
used
personal
monitor
and
provide
a
new
monitor
to
the
participant.
In
most
cases,
the
respondent
has
been
or
will
be
monitored
for
between
6
and
14
successive
days.
In
some
cases,
the
respondent
will
be
monitored
again
in
a
second
season.
The
exact
number
of
days
that
each
respondent
will
be
monitored
depends
on
the
schedule
of
the
monitoring
team
and
the
respondent,
and
cannot
be
provided
in
this
document.

6
Estimating
the
Burden
and
Cost
of
the
Collection
6
(
a)
Estimating
Respondent
Burden
Table
1
provides
our
estimate
of
the
respondent
burden
according
to
the
three
relevant
categories
appearing
in
OMB's
final
rules:
reviewing
instructions,
completing
the
information
collection,
and
transmitting/
disclosing
the
information.

For
reviewing
the
instructions,
we
assumed
approximately
6
minutes
per
person.
Based
on
our
pretest,
we
found
that
the
time
to
complete
the
questionnaire
was
approximately
12
minutes;
we
have
assumed
24
minutes
to
allow
for
somewhat
slower
responses
from
our
elderly
population.
We
allowed
an
additional
6
minutes
for
transmitting/
disclosing
the
information
to
the
technician,
although
if
there
were
no
problems
with
filling
out
the
questionnaire
this
activity
(
handing
over
the
questionnaire)
would
take
essentially
no
time.
Thus
we
estimate
the
total
time
burden
per
day
to
be
36
minutes
(
0.6
h)
per
respondent.
It
should
be
noted
that
this
table
summarizes
the
total
burden
for
all
respondents,
not
just
those
remaining
to
be
monitored.

6(
b)
Estimating
Respondent
Costs
Since
participation
is
voluntary
and
an
incentive
payment
is
offered,
there
are
no
respondent
costs
or
capital
costs
associated
with
the
study.

6(
c)
Estimating
Agency
Burden
and
Cost
For
the
five
Agency
activities
identified
in
Section
5,
we
have
estimated
an
Agency
burden
and
cost
as
shown
in
Table
2.
Most
items
are
self­
explanatory.
However,
we
note
that
we
have
8
placed
the
extramural
funding
of
$
6M
into
Item
1c,
Provision
of
Funds
to
Research
Entities.
Since
each
of
the
four
consortia/
contractors
has
a
different
breakout
of
labor
categories
and
salaries,
and
since
each
of
the
consortia
but
one
includes
several
subcontractors,
it
has
not
been
feasible
to
provide
a
full
breakout
by
category,
labor
hours,
and
costs.
However,
each
lead
University
investigator
has
broken
out
his
own
labor
costs
by
category
and
this
information
is
included
in
Table
3.
Again,
it
should
be
noted
that
these
tables
provide
the
total
cost
for
all
four
studies;
most
of
this
cost
has
already
been
borne.

6(
d)
Estimating
the
Respondent
Universe
and
Total
Burden
and
Costs
The
estimated
burden
per
respondent
was
multiplied
by
the
number
of
respondents
to
arrive
at
an
estimate
of
the
3­
year
total
and
average
annual
respondent
burden
(
Table
1).

6(
e)
Bottom
Line
Burden
and
Cost
Tables
Tables
1
and
2
contain
the
total
estimated
respondent
burden
and
Agency
burden
and
costs.

6(
f)
Reasons
for
Change
in
Burden
There
is
no
change
in
the
total
burden
originally
estimated
in
ICR
1887.01.

6(
g)
Burden
Statement
The
average
total
respondent
burden
is
estimated
to
be
20.1
hours
per
person
per
year.
This
estimate
includes
the
time
for
reviewing
instructions,
collecting
and
recording
information,
and
transmitting
the
information
to
those
administering
the
questionnaire.

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.
9
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,
OP
Regulatory
Information
Division,
U.
S.
Environmental
Protection
Agency
(
2822T),
401
M
St.,
S.
W.,
Washington,
D.
C.
20460;
and
to
the
Office
of
Information
and
Regulatory
Affairs,
Office
of
Management
and
Budget,
725
17th
Street,
NW,
Washington,
DC
20503,
Attention:
Desk
Officer
for
EPA.
Include
the
EPA
ICR
No.
1887.02
and
OMB
Control
Number
2080­
0058
in
any
correspondence.