1
Part
A:
Supporting
Statement
for
Information
Collection
Request
2126.01
1(
a).
Title
ICR:
Longitudinal
Study
of
Young
Children's
Exposures
in
their
Homes
to
Selected
Pesticides,
Phthalates,
Brominated
Flame
Retardants,
and
Perfluorinated
Chemicals
(
A
Children's
Environmental
Exposure
Research
Study
­
CHEERS)

EPA
ICR
Number:
2126.01
1(
b).
Short
Characterization/
Abstract
The
US
EPA's
Office
of
Research
and
Development's
National
Exposure
Research
Laboratory
(
ORD/
NERL)
proposes
to
conduct
a
two­
year
longitudinal
field
measurement
study
of
young
children's
(
aged
0
to
3
years)
potential
exposures
to
current­
use
pesticides
and
selected
phthalates,
polybrominated
diphenyl
ethers,
and
perfluorinated
compounds
that
may
be
found
in
residential
environments.
The
study
will
be
conducted
in
Duval
County,
Jacksonville,
Florida
over
a
two­
year
period
from
2004
to
2006.
Sixty
young
children
will
be
recruited
into
this
study
in
two
cohorts:
(
1)
infants
recruited
into
the
study
soon
after
birth,
and,
(
2)
children
recruited
into
the
study
at
approximately
12
months
of
age.
The
study
involves
up
to
six
data
collection
events
at
each
home
during
the
two­
year
study
period.
During
each
event,
environmental
and
biological
samples
will
be
collected
to
measure
chemical
concentrations
and
questionnaires
will
be
administered
to
collect
data
that
will
be
used
to
estimate
aggregate
exposures
and
to
analyze
the
measurement
data.
Aggregate
exposures
will
be
estimated
for
the
current­
use
pesticides
and
selected
phthalates
in
the
study.
The
data
collected
on
the
polybrominated
diphenyl
ethers
and
the
perfluorinated
compounds
will
be
used
to
evaluate
the
potential
magnitude
for
exposure
and
to
determine
the
temporal
and
spatial
variability
of
these
chemicals
in
residences.
The
study
will
collect
data
to
fill
critical
gaps
in
our
understanding
of
very
young
children's
exposure
to
chemicals
in
their
residences.
The
study
will
help
the
Agency
reduce
uncertainty
in
exposure
and
risk
assessments
for
children
by
providing
data
on
exposure
factors
and
validated
tools
for
estimating
children's
exposure
to
contaminants,
as
well
as
providing
much
needed
measurement
data
for
model
refinement.
The
exposure
factors
generated
in
this
study
will
be
included
in
the
National
Center
for
Environmental
Assessment's
(
NCEA)
Child
Specific
Exposure
Factors
Handbook.
Additionally,
the
information
will
appear
in
the
form
of
final
EPA
reports,
journal
articles,
and
will
also
be
made
publicly
available
in
an
electronic
database
for
use
by
the
scientific
community,
risk
assessors,
and
risk
managers.
2
2.
NEED
FOR
AND
USE
OF
THE
COLLECTION
2(
a).
Need/
Authority
for
the
Collection
The
U.
S.
Environmental
Protection
Agency
(
EPA)
has
pledged
to
increase
its
efforts
to
provide
a
safe
and
healthy
environment
for
children
by
ensuring
that
all
EPA
regulations,
standards,
policies,
and
risk
assessments
take
into
account
special
childhood
vulnerabilities
to
environmental
chemicals.
In
evaluating
environmental
health
risks
to
children,
it
is
important
to
understand
that
children
are
not
little
adults.
Children's
exposures
to
environmental
contaminants
are
expected
to
be
different
and,
in
many
cases,
much
higher
than
older
persons
due
to
differences
in
their
physiological
function,
surface
to
volume
ratio,
ratio
of
food
consumption
to
body
weight,
and
the
way
children
intimately
interact
(
e.
g.,
eating
from
the
floor,
sitting,
crawling,
rolling
or
sleeping
on
the
floor,
putting
toys
and
other
objects
into
their
mouths)
with
their
environment.
Furthermore,
the
hypothesis
that
young
children's
exposures
to
environmental
chemicals
vary
as
a
function
of
their
age
and
developmental
stage
needs
to
be
tested.

Exposure
and
risk
assessments
for
very
young
children's
exposures
to
chemicals
in
the
residential
environment
rely
heavily
on
default
assumptions
based
on
sparse
data.
In
1999,
the
10X
Exposure
Working
Group
produced
the
report,
Exposure
Data
Requirements
for
Assessing
Risks
from
Pesticide
Exposure
of
Children
(
US
EPA
1999).
This
report
defined
the
components
of
a
complete
and
reliable
data
set
and
described
why
these
components
are
currently
not
available.
Critical
elements
that
are
missing
include
an
understanding
of
the
most
important
pathways
of
exposure
for
young
children,
approaches
for
evaluating
exposure
for
critical
pathways
such
as
dermal
and
indirect
ingestion
exposure,
protocols
for
generating
the
exposure
data,
and
exposure
factor
data.
Concurrently,
the
EPA's
Office
of
Research
and
Development
(
ORD)
developed
the
Strategy
for
Research
on
Environmental
Risks
to
Children
to
articulate
the
problems
and
research
needs
associated
with
children's
exposure
to
environmental
contaminants
(
US
EPA
2000).
Three
specific
objectives
are
articulated
in
this
Strategy
to
(
1)
make
use
of
existing
information
to
develop
improved
risk
assessment
methods
and
models
for
children;
(
2)
design
and
conduct
research
on
exposure,
effects,
and
dose­
response
that
will
answer
questions
about
age­
related
differences
in
exposure
and
risks
that
will
lead
to
better
risk
assessments
for
children;
and,
(
3)
explore
opportunities
for
prevention
and
reduction
of
risks
to
children.

The
Children's
Exposure
Research
Program
at
the
EPA
ORD's
National
Exposure
Research
Laboratory
(
NERL)
has
been
designed
to
meet
these
objectives.
The
first
phase
of
the
program
was
to
use
existing
data
to
develop
improved
methods.
A
comprehensive,
systematic
approach
is
required
to
understand
and
adequately
address
all
of
the
components
of
children's
aggregate
exposure
assessments.
To
develop
NERL's
research
strategy
and
approach,
factors
influencing
children's
exposure
to
environmental
contaminants
were
reviewed
and
the
quality
and
quantity
of
available
data
associated
with
default
assumptions
for
exposure
factors
were
evaluated
(
Cohen
Hubal
et
al.,
2000a).
A
framework
to
systematically
identify
the
important
sources,
routes,
and
pathways
for
exposure
was
developed
(
Cohen
Hubal
et
al.,
2000b).
This
framework
is
based
upon
the
development
of
a
conceptual
model
for
aggregate
exposure
and
provides
the
basis
3
for
developing
a
protocol
to
measure
and
assess
aggregate
exposures,
as
well
as
for
developing
sophisticated
stochastic
models.
This
framework
also
allows
researchers
to
systematically
identify
the
most
critical
research
needs
and
data
gaps
associated
with
children's
exposures.
NERL
researchers
identified
four
priority
research
areas,
including
pesticide
use
patterns,
spatial
and
temporal
distribution
of
pesticides,
dermal
and
indirect
ingestion,
and
dietary
ingestion
exposures.
Laboratory
studies,
small
pilot
field
studies,
and
larger,
collaborative
studies
were
designed
and
implemented
to
address
these
research
needs.

A
Draft
Protocol
for
Measuring
Children's
Non­
Occupational
Exposure
to
Pesticides
by
all
Relevant
Pathways
(
i.
e.,
Draft
Protocol)
was
developed
by
NERL
researchers
to
provide
guidance
for
generating
data
that
can
be
used
to
improve
exposure
assessments
for
young
children
(
US
EPA
2003).
Currently,
standard
protocols
for
conducting
exposure
field
studies
that
provide
data
for
measurement­
based
exposure
assessments
do
not
exist.
Likewise,
protocols
for
developing
exposure
factor
data
to
be
used
for
modeling
assessments
are
not
available.
Although
research
on
children's
exposure
to
pesticides
and
other
toxic
chemicals
has
been
performed
within
EPA,
academia,
industry,
and
other
research
organizations,
protocols
for
specific
studies
have
not
always
collected
all
of
the
data
required
for
reliable
exposure
assessments.
The
Draft
Protocol
fills
a
critical
need
for
standardization
of
the
approaches
and
methods
for
collecting
exposure
concentration
and
exposure
factor
data.
One
of
the
objectives
of
the
proposed
study
is
evaluate
and
validate
the
Draft
Protocol.
Although
it
has
been
evaluated
in
a
set
of
small
pilot
studies
performed
by
NERL
researchers,
it
has
not
been
evaluated
in
a
large
field
study.
It
is
essential
that
the
Draft
Protocol
is
fully
evaluated
for
estimating
exposure
of
young
children
to
pesticides
and
other
environmental
contaminants
so
that
future
exposure
assessments
are
conducted
with
a
systematic
and
standardized
approach.
Use
of
this
standardized
protocol
will
facilitate
comparison
of
data
collected
in
children's
exposure
studies
conducted
by
different
groups
in
government,
academia,
and
other
research
organizations.
This
standardized
approach
will
lead
to
better
exposure
and
risk
assessments.

The
CHEERS
study
will
also
directly
address
questions
about
age­
related
differences
in
exposure
and
risks
by
designing
and
conducting
research
on
exposure,
effects,
and
dose­
response
as
detailed
in
the
ORD
children's
Research
Strategy.
The
study
has
been
designed
with
repeated
data
collection
for
the
same
participating
children
in
order
to
estimate
aggregate
exposures
and
exposure
factors
at
the
different
developmental
ages
defined
by
EPA's
Risk
Assessment
Forum.
These
data
are
critical
for
improved
exposure
and
risk
assessments
and
required
by
the
Agency's
risk
assessors.

Four
classes
of
chemicals
for
which
environmental
and
biological
data
are
needed
for
assessing
human
exposures
include
current­
use
pesticides,
phthalates,
polybrominated
diphenyl
ethers,
and
perfluorinated
organic
compounds.
These
chemicals
are
found
in
a
wide
variety
of
consumer
products
that
are
used
extensively
indoors,
have
been
identified
in
many
environmental
media,
and
are
a
concern
for
the
potential
for
adverse
human
health
effects.
However,
data
on
the
levels
of
these
compounds
in
the
human
environment
are
limited.
More
data
are
needed
on
the
potential
exposures
of
very
young
children
to
these
chemicals
in
their
environment.
Longitudinal
4
exposure
data
are
not
available
for
many
of
these
compounds.
The
proposed
study
has
been
specifically
designed
to
collect
data
that
will
be
used
to
evaluate
temporal
variability
of
concentrations
of
these
chemicals
in
environmental
and
biological
media.

Pesticides
are
chemicals
for
control
of
a
wide
range
of
pests
in
the
environment.
They
are
essential
for
use
on
crops;
small
amounts
of
residues
are
tolerated
in
our
food
supplies.
Pesticides
are
also
needed
to
control
insects
and
other
pests
both
outdoors
and
in
indoor
environments.
The
EPA's
regulatory
programs
address
the
needs
for
these
chemicals
along
with
their
potential
risks.
The
pesticides
used
most
frequently
indoors
are
currently
the
synthetic
pyrethroids.
However,
there
are
limited
data
on
indoor
concentrations
of
these
chemicals.
This
study
addresses
potential
exposures
to
these
chemicals
and
the
factors
that
may
affect
children's
exposures
to
pesticides
in
their
homes.

Phthalates
are
used
in
the
manufacture
of
a
wide
range
of
plastic
and
non­
plastic
products,
including
medical
packaging,
cosmetics,
children's
toys,
wood
finishes,
paints,
upholstery,
and
insect
repellents
(
Hoppin
et
al.
2002;
Koo
et
al.
2002).
However,
the
characterization
of
human
exposure
to
phthalates
is
limited
and
the
National
Toxicology
Program's
Center
for
the
Evaluation
of
the
Risks
to
Human
Reproduction
concluded
that
more
data
regarding
the
potential
for
human
exposure
to
phthalates
are
needed
(
Hoppin
et
al.
2002).

Polybrominated
diphenyl
ethers
(
PBDEs)
are
used
primarily
in
electronic
and
upholstery
foams
because
of
their
fire
retarding
properties.
However,
PBDEs
are
thought
to
volatilize
from
these
products
during
use.
European
and
Canadian
researchers
have
been
investigating
the
prevalence
of
PBDEs
in
soil,
water,
wildlife,
fish,
and
human
breast
milk
samples
for
the
last
couple
years.
Evidence
in
the
literature
suggests
that
PBDEs
are
ubiquitous
in
the
environment
(
Rice
et
al.
2002).

Organic
fluorochemical
compounds
are
found
in
polymers,
lubricants,
fire
retardants,
pesticides,
and
surfactants
(
Hansen
et
al.
2002).
One
study
has
shown
trace
levels
of
certain
fluorochemical
compounds
in
the
serum
of
non­
occupationally
exposed
humans
and
tissues
from
wildlife
samples
(
see
ref.
in
Hansen
et
al.
2002).
Although
the
manufacture
of
perfluorooctane
sulfonate
(
PFOS),
one
of
the
major
fluorochemicals
used
to
treat
upholstery
and
textiles,
has
been
discontinued
in
the
US,
the
chemical
is
of
concern
due
to
the
number
of
potential
sources
present
indoors.
There
are
very
limited
data
(
most
collected
by
the
manufacturer)
that
are
available
to
adequately
evaluate
the
potential
for
human
exposure
to
the
organic
fluorochemical
compounds.
There
is
also
concern
that
perfluorooctanoic
acid
(
PFOA)
is
a
persistent
bioaccumulative
toxicant
in
animals
and
humans.
The
Agency
and
industry
are
currently
addressing
that
concern.
Measurements
of
the
perfluorinated
chemicals
in
this
proposed
study
are
important
because
they
will
provide
data
that
is
complimentary,
but
independent
of
industry­
generated
data
for
these
chemicals.

Evidence
in
the
literature
has
shown
that
longitudinal
human
exposure
data
for
pesticides,
PBDEs,
perfluorinated
compounds,
and
phthalates
are
extremely
limited.
This
study
will
greatly
5
increase
our
understanding
of
young
children's
potential
exposures
to
chemicals
found
in
their
everyday
environment.
Data
will
be
available
for
the
pesticides
and
phthalates
to
perform
aggregate
exposure
estimates,
to
apportion
exposure
pathways,
and
to
identify
exposure
factors
as
they
relate
to
changes
in
age
and
developmental
stage.
For
the
BFRs
and
perfluorinated
chemicals,
the
data
on
concentrations
in
the
indoor
environment
will
fill
a
critical
data
gap.
This
research
will
also
provide
much
needed
preliminary
data
for
identifying
research
needs
and
designing
future
field
studies
targeting
chemicals
of
interest.

2(
b).
Practical
Utility/
Users
of
the
Data
The
data
generated
from
this
study
will:

1)
validate
the
systematic
approach
for
evaluating
aggregate
exposure
described
in
the
Draft
Protocol,
thus
providing
for
a
standardized
approach
for
future
exposure
assessments
2)
evaluate
the
variability
in
exposure
based
on
the
age
and
developmental
stage
of
the
child,
thus
answering
questions
about
age­
related
differences
in
exposure
and
risks
3)
estimate
the
aggregate
exposures
of
a
cohort
of
very
young
children
to
current­
use
pesticides
in
their
residential
environments,
for
which
data
are
currently
limited
4)
evaluate
the
relationship
between
biomarker
concentrations
and
exposure
estimates
based
on
measurements
of
current­
use
pesticides
in
environmental
media
and
diet
and
information
on
activities
that
may
lead
to
exposure,
data
which
will
be
useful
in
interpreting
results
from
programs
such
as
the
National
Health
and
Nutrition
Examination
Survey
(
NHANES)
5)
evaluate
and
apportion
the
exposure
pathways
for
the
current­
use
pesticides
6)
estimate
the
aggregate
exposures
of
a
cohort
of
very
young
children
to
the
selected
phthalates
in
their
residential
environments
7)
evaluate
the
relationship
between
biomarker
concentrations
and
exposure
estimates
based
on
measurements
of
the
selected
phthalates
in
environmental
media
and
diet
8)
evaluate
and
apportion
the
exposure
pathways
for
the
selected
phthalates
9)
determine
spatial
and
temporal
variability
of
the
PBDEs
in
residences
and
the
potential
for
children's
exposure
based
on
concentrations
in
environmental
samples
and
diet
10)
determine
spatial
and
temporal
variability
of
the
perfluorinated
compounds
in
residences
and
the
potential
for
children's
exposure
based
on
concentrations
in
environmental
samples
and
diet
The
primary
users
of
the
data
generated
in
this
study
will
be
risk
assessors
and
risk
managers
within
and
outside
of
the
Agency.
Within
EPA,
users
of
the
data
include
exposure
assessors,
risk
assessors,
human
exposure
modelers,
and
scientists
in
ORD,
OPP,
and
OPPT.
In
addition,
NCEA
will
include
the
exposure
factors
generated
from
this
study
in
the
Child
Specific
Exposure
Factors
Handbook.
EPA
regions
and
state
agencies
who
conduct
risk
assessments
will
also
utilize
the
data.
In
the
private
sector,
industry
groups
will
be
able
to
use
this
exposure
factor
data
for
their
risk
assessments
and
risk
management
programs.
Furthermore,
data
generated
in
this
study
will
be
used
to
determine
the
need
for
additional
research
on
exposures
to
these,
or
other,
persistent
chemicals.
If
additional
research
is
required,
results
of
the
proposed
study
will
be
instrumental
in
efficient
and
effective
study
designs.
The
protocol
and
methods
used
and
6
evaluated
in
the
proposed
study
will
be
available
as
validated
and
standardized
procedures
for
future
studies
by
the
Agency
and
other
researchers.

3.
NONDUPLICATION,
CONSULTATIONS,
AND
OTHER
COLLECTION
CRITERIA
3(
a).
Non­
duplication
Data
on
children's
exposures
and
exposure
factors
have
been
collected
in
a
number
of
studies
(
Simcox
et
al.
1995;
Zartarian
et
al.
1995,
1997,
1998;
Loewenherz
et
al.
1997;
Melnyk
et
al.
1997;
Reed
et
al.
1999;
Freeman
et
al.
1999,
2001;
Quackenboss
et
al.
2000;
Hore
2003;
Shalat
et
al.
2003).
However,
these
studies
(
1)
did
not
use
the
systematic
approach
for
exposure
assessment
proposed
for
this
study,
(
2)
focused
on
a
limited
number
of
environmental
chemicals
in
a
limited
number
of
media,
(
3)
generally
did
not
include
measurements
for
all
routes
and
pathways
of
exposure
including
dietary,
(
4)
could
not
be
used
to
develop
estimates
of
aggregate
exposures,
(
5)
included
a
small
number
of
children
in
the
study
(
usually
less
than
nine),
and,
(
6)
focused
on
exposures
of
children
older
than
3
years
of
age.
However,
none
of
these
studies
have
adequately
addressed
the
impact
of
children's
age
and
activities
on
differences
in
exposure.
Furthermore,
environmental,
biological,
and
activity
pattern
data
were
not
systematically
collected
in
a
way
that
allowed
the
relationships
between
environmental
and
biological
measurements
to
be
evaluated.
None
of
these
studies
are
longitudinal.
EPA's
Children's
Total
Exposure
to
Pesticides
and
Other
Persistent
Organic
Pollutants
(
CTEPP)
study
attempted
to
address
a
number
of
the
deficiencies
identified
in
previous
children's
exposure
studies
by
measuring
young
children's
exposures
to
various
environmental
chemicals
in
child
care
and
residential
settings.
Although
CTEPP
is
providing
a
valuable
database
on
children's
exposures,
it,
like
other
prior
studies,
does
not
provide
adequate
data
on
children
younger
than
three
years
of
age
and
did
not
collect
information
that
can
be
used
to
assess
the
impact
of
age­
related
changes
in
children's
activities
and
their
aggregate
exposures
to
chemicals
in
their
home.
The
proposed
CHEERS
study
will
allow
EPA
to
collect
longitudinal
data
on
exposure
concentrations
and
exposure
factors
using
a
systematic
approach
that
will
address
the
data
gaps
and
provide
the
data
needed
to
reduce
the
use
of
default
assumptions
in
the
risk
assessment
process.

3(
b).
Public
Notice
EPA
solicited
public
comment
on
its
information
collection
plans
by
publishing
a
notice
in
the
Federal
Register
(
68
FR
57442)
on
October
3,
2003.

The
EPA
received
one
public
comment
concerning
the
proposed
study.
Listed
below
are
the
comments
and
EPA's
response
to
the
comments.

EPA's
response
to
comments
placed
on
the
edocket
by
the
American
Chemistry
Council's
Phthalate
Esters
Panel
on
December
2,
2003
7
Docket
ID
Number
ORD­
2003­
0011
Proposed
Collection:
Longitudinal
Field
Measurement
Study
of
Infant
and
Toddler's
Aggregate
Exposure
to
Pesticides
and
Persistent
Pollutants,
EPA
ICR
Number
2126.01,
68
FR
57442
(
October
3,
2003)

Comment:
Phthalates
are
not
persistent
compounds
and
therefore
cannot
serve
to
meet
EPA's
objective
of
studying
"
persistent
pollutants".
Therefore,
they
should
not
be
included
in
the
proposed
collection.
If
EPA
nevertheless
continues
to
propose
to
include
phthalates,
it
should
change
the
name
of
the
study
to
avoid
mischaracterizing
phthalates
as
persistent,
a
characterization
not
supported
by
the
science.

Response:
EPA
will
change
the
title
of
the
study
to
the
following:
Longitudinal
Study
of
Young
Children's
Exposures
in
their
Homes
to
Selected
Pesticides,
Phthalates,
Brominated
Flame
Retardants,
and
Perfluorinated
Chemicals
(
A
Children's
Environmental
Exposure
Research
Study
­
CHEERS)

Comment:
Inclusion
of
phthalates
in
the
proposed
collection
would
not
meet
the
necessity
and
practical
utility
requirements
of
the
Paper
Reduction
Act.
Excellent
data
already
exist
on
phthalate
exposure
factors,
routes
and
pathways
of
exposure.
Those
data
demonstrate
that
exposures
to
phthalates
are
well
below
levels
that
could
be
anticipated
to
pose
health
concerns,
and
therefore
that
no
further
regulation
of
phthalates,
which
are
already
well
regulated
by
EPA,
is
needed.
Furthermore,
many
meaningful
risk
assessments
already
exist
for
the
phthalates
and
support
the
low
health
concerns
and
lack
of
need
for
further
regulation.
It
is
hard
to
find
another
class
of
compounds
as
well
studied,
evaluated
and
assessed
as
the
phthalates.
The
existing
data
and
risk
assessments
indicate
that
phthalates
should
be
a
low
priority
for
further
study
and
risk
assessment
by
EPA.
Therefore,
the
proposed
collection
is
not
necessary
to
proper
performance
of
the
functions
of
EPA
and
would
have
only
marginal
utility.

Response:
EPA
appreciates
the
compilation
of
citations
listed
by
the
Phthalate
Esters
Panel
in
their
comments.
However,
the
citations
clearly
show
the
need
for
a
longitudinal
study
as
proposed
by
the
EPA.
°
There
is
no
data
to
show
how
young
children's
exposure
to
phthalates
changes
as
a
result
of
the
age
and
developmental
stages
proposed
by
the
EPA's
Risk
Assessment
Forum.
The
CHEERS
study
has
been
designed
with
repeated
data
collection
for
the
same
participating
children
in
order
to
estimate
aggregate
exposures
at
different
developmental
stages.
°
The
CDC
citation
does
not
provide
metabolite
levels
for
children
younger
than
6
years
of
age.
Therefore,
collection
of
metabolite
data
from
children
younger
than
3
years
will
significantly
expand
EPA's
and
the
scientific
community's
understanding
of
phthalate
metabolite
levels
in
very
young
children.
°
The
Phthalate
Esters
Panel
relies
heavily
on
a
publication
by
Brock
et
al.
2002
to
argue
that
EPA
is
conducting
duplicative
research.
However,
the
publication
by
Brock
et
al.
does
not
use
a
systematic
approach
to
evaluate
young
children's
exposure
to
phthalates.
8
The
only
samples
collected
in
this
study
are
one
or
two
urine
samples
from
the
participating
children
which
prevents
an
evaluation
of
the
exposure
factors
as
a
function
of
age
and
developmental
stage
to
phthalates
in
the
residential
environment.
Furthermore,
the
Brock
et
al.
study
discusses
the
need
for
further
research
to
(
1)
determine
the
sources
of
phthalate
exposures
in
young
children,
and
(
2)
to
fully
assess
the
exposures
to
phthalates
multiple
urine
samples
should
be
collected
from
each
participating
child.
The
CHEERS
study
will
address
both
of
these
listed
needs
for
further
research.

°
Table
1
shows
the
lack
of
data
for
phthalate
exposures
for
very
young
children.
As
can
be
seen
in
the
table,
there
is
no
data
relating
environmental
and
biological
measurements;
there
are
only
19
data
points
for
young
children
in
the
age
range
of
12­
18
months;
and,
there
is
no
data
for
children
younger
than
12
months.

Table
1.
Data
outlining
why
CHEERS
is
a
critically
needed
study.

Citation
Major
Data
Contributed
by
Citation
Need
for
CHEERS
study
Blount
et
al.;
CDC
references
Adult
urine
samples
EPA
study
will
collect
data
from
children
younger
than
3
years
of
age
Brock
et
al.
One
or
two
urine
samples
from
19
children
ranging
in
age
from
12
to
18
months
EPA
study
will
collect
six
urine
samples
during
each
monitoring
event
from
children
younger
than
3
years
of
age;
EPA
study
will
also
relate
the
environmental
samples
to
the
biological
samples
Health
Canada;
Zaleski
et
al.;
Kavlock
et
al.;
Clark
et
al.
Model
work;
no
measurement
data
generated
EPA
study
will
generate
environmental,
biological,
and
activity
pattern
data
and
exposure
factors
critical
to
model
validation
and
refinement
EPA
CTEPP
study
One
time
aggregate
exposure
assessment
of
children
ranging
in
age
from
3
to
5
years;
urine
metabolites
were
not
measured
EPA
CHEERS
study
is
a
longitudinal
aggregate
exposure
study
to
numerous
chemicals
found
in
the
residence
°
EPA
will
collect
environmental
and
biological
samples
during
the
monitoring
period
to
9
conduct
an
aggregate
exposure
assessment
for
the
young
children's
exposure
to
phthalates.
There
is
no
published
data
that
allows
researchers
to
evaluate
exposure
to
phthalates.

Comment:
EPA's
Study
Design
for
the
proposed
collection
was
developed
and
peer­
reviewed
for
scientific
merit
only
with
respect
to
the
pesticide
component.
The
Panel
raises
questions
that
indicate
the
study
design
may
be
inappropriate
for
collection
of
data
on
phthalates,
resulting
in
biased
data
that
will
then
lack
utility
because
of
its
unreliability.
Therefore,
EPA
should
not
include
any
other
classes
of
chemicals
in
the
information
collection,
including
phthalates,
unless
and
until
the
study
design
is
modified
and
peer­
reviewed
with
respect
to
those
chemicals.

Response:
The
design
for
the
proposed
study
was
developed
in
consultation
with
both
government
and
non­
government
experts
in
the
field
of
exposure
assessment.
While
the
study
was
originally
designed
as
a
current­
use
pesticide
exposure
study,
the
exposure
factors
generated
in
this
study
will
be
applicable
to
any
chemicals
found
in
the
residential
environment.
In
addition,
the
EPA
has
formed
an
advisory
committee
that
will
provide
technical
guidance
and
review
study
procedures
during
the
course
of
the
study.

Comment:
Are
any
phthalates
(
or
other
add­
on
chemicals)
present
in
the
pesticide
formulations?

Response:
EPA
is
evaluating
the
aggregate
exposures
of
young
children
to
pesticides
and
phthalates
in
their
residential
environment.
EPA
is
collecting
the
environmental,
biological,
and
activity
pattern
data
needed
to
evaluate
the
exposure
factors
necessary
for
assessing
aggregate
exposure.
EPA
is
not
attempting
to
identify
the
source
of
the
phthalates,
but
the
young
children's
exposure
to
them.
Therefore,
the
design
of
the
study
is
adequate
to
collect
the
data
needed
to
conduct
an
aggregate
exposure
assessment
to
any
chemical
found
in
the
residential
environment.

Comment:
Are
the
questionnaires
appropriately
designed
to
collect
exposure
information
relevant
to
sources
of
phthalates?
For
example,
detailed
information
on
use
patterns
and
use
timing
in
relation
to
exposure
measurements
would
be
needed
to
place
results
in
a
meaningful
context.

Response:
After
consultation
with
many
government
and
non­
government
researchers,
the
conclusion
was
reached
that
there
are
no
validated
questionnaires
currently
being
used
for
exposure
assessments
to
phthalates.
However,
EPA
believes
it
critically
important
to
use
questionnaires
that
have
been
evaluated
or
used
by
other
researchers.
This
helps
in
consistency
of
the
analysis
and
interpretation
of
the
data.
Therefore,
the
questions
relating
to
potential
phthalate
exposures
have
been
taken
from
other
researchers.

Comment:
Do
methods
exist
for
urine
collection
from
infants
that
would
not
result
in
possible
sample
contamination
with
phthalates?

Response:
The
Brock
et
al.
study
used
urine
collection
bags.
The
same
manufacturer
of
the
urine
collection
bags
also
distributes
other
urine
collection
devices
that
could
be
applicable
to
the
10
collection
of
urine
from
young
children.

Comment:
Does
EPA
have
appropriate
analytical
techniques
for
environmental
media
other
than
air
and
dust,
and
for
aggregating
the
data?

Response:
The
Contractor
for
the
EPA
has
extensive
analytical
expertise
with
a
wide
variety
of
compounds,
including
phthalates.
As
pointed
out
in
the
comments,
the
EPA
has
analyzed
for
phthalates
in
the
CTEPP
study.
As
discussed
in
the
Draft
Protocol,
the
EPA
has
methods
for
aggregating
the
data.

3(
c).
Consultations
The
design
for
the
proposed
study
was
developed
in
consultation
with
many
experts
in
the
field
of
exposure
assessment.
Government
and
non­
government
individuals
have
been
involved
in
the
development
of
the
peer­
reviewed
study
design.
Their
expertise
was
critical
in
the
planning
of
the
collection
and
development
of
the
approach
necessary
to
minimize
burden
in
a
study
of
this
type.
The
persons
most
closely
associated
with
the
design
and
review
of
the
longitudinal
children's
study
are
given
in
Table
1.

Table
1.
Peer­
reviewers
for
the
study
design
document.

Responsibility
Individual
Affiliation
2002
Peer­
Review
Panel
Mary
Kay
O'Rourke
Univ.
of
Arizona
(
520)
626­
6835
Maria
Morandi
Univ.
of
Texas
SPH
(
713)
500­
9288
Luke
P.
Naeher
Univ.
of
Georgia
(
706)
542­
2454
Karen
Hammerstrom
US
EPA/
NCEA
Michael
Firestone
US
EPA/
OCHP
David
J.
Miller
US
EPA/
OPP
Cathy
Fehrenbacher
US
EPA/
OPPT
ACC
Review
Coordinator
Tina
Bahadori
American
Chemistry
Council
(
703)
741­
5214
3(
d).
Effects
of
Less
Frequent
Collection
11
Repeated
data
collection
is
required
to
meet
the
objective
to
determine
age­
related
differences
in
exposures
to
the
chemicals
and
to
collect
data
on
exposure
factors
that
can
be
used
to
reduce
uncertainties
in
the
Agency's
risk
assessment
process
for
children
of
different
ages.
Any
less
frequent
data
collection
will
not
allow
for
adequate
evaluation
of
the
developmental
age
bins
as
proposed
by
the
EPA
Risk
Assessment
Forum.

3(
e).
General
Guidelines
All
study
activities
will
adhere
to
OMB's
general
guidelines
for
information
collections.
Data
collection
activities
will
not
start
before
OMB
approval.
In
addition,
participation
is
voluntary.
Informed
consent
will
be
obtained
before
the
field
technicians
begin
any
data
collection
activities.
Participants
are
free
to
withdraw
their
consent
any
time
during
the
study.

Specifically,
study
participants
are
not
required
to
do
any
of
the
following:
°
Report
information
to
the
Agency
more
often
than
quarterly.
°
Prepare
a
written
response
to
a
collection
of
information
in
fewer
than
30
days
after
receipt
of
a
request.
°
Submit
more
than
an
original
and
two
copies
of
any
document.
°
Retain
records,
other
than
health,
medical,
government
contract,
grant­
in­
aid,
or
tax
records,
for
more
than
three
years.
°
Participate
in
a
statistical
survey
that
is
not
designed
to
produce
data
that
can
be
generalized
to
the
universe
of
the
study.
°
Utilize
a
statistical
data
classification
that
has
not
been
reviewed
and
approved
by
OMB.
°
Receive
a
pledge
of
confidentiality
that
is
not
supported
by
authority
established
in
statute
or
regulation,
that
is
not
supported
by
disclosure
and
data
security
policies
that
are
consistent
with
the
pledge,
or
which
unnecessarily
impedes
sharing
of
data
with
other
agencies
for
compatible
confidential
use.
°
Submit
proprietary,
trade
secret,
or
other
confidential
information
unless
the
Agency
can
demonstrate
that
it
has
instituted
procedures
to
protect
the
information's
confidentiality
to
the
extent
permitted
by
law.

3(
f).
Confidentiality
Assuring
respondents
of
the
confidentiality
of
their
data
is
a
key
to
obtaining
participation
and
continued
success
in
survey
data
collection.
In
addition
to
standard
confidentiality
procedures
outlined
below,
the
proposed
study
will
obtain
a
Certificate
of
Confidentiality.
Our
standard
procedures
cover
the
following
key
concerns:
°
Preventing
disclosure
of
information
containing
personal
or
organizational
identifiers
We
require
that
all
data
be
identified
with
unique
participant
identification
numbers.
Participant
identification
numbers
are
the
only
identifying
information
12
that
will
be
associated
with
the
respondent's
data,
responses
to
questionnaires,
or
the
results
of
the
analysis
of
samples
collected.

°
Storing
hardcopy
files
The
links
between
the
identification
numbers
and
personally
identifying
information,
addresses,
or
names
are
maintained
in
locked
file
cabinets,
with
access
limited
to
senior
project
staff.
Questionnaires,
consent
forms,
and
compensation
receipts
will
be
stored
by
the
Contractor
in
a
locked
file.

°
Assuring
computer
data
security
The
computer
data
generated
from
the
proposed
study
will
be
password­
protected.
Only
authorized
staff
members
will
have
access
to
the
data.
The
paper
document
and
hardcopies
of
the
computer
files
will
be
secured
in
locked
file
cabinets
in
locked,
limited­
access
rooms.

°
Disposing
of
completed
forms
that
are
outdated
At
the
conclusion
of
the
proposed
study,
the
EPA
Project
Officer
will
authorize
disposal
of
outdated,
completed
forms
by
a
qualified
commercial
Contractor
specialized
in
disposing
of
documents.
A
certificate
will
be
provided
by
the
Contractor
to
state
that
these
documents
were
properly
disposed
of.

3(
g).
Sensitive
Questions
The
questionnaires
prepared
for
the
study
do
not
contain
any
questions
concerning
sexual
behavior
or
attitudes,
religious
beliefs,
or
other
matters
usually
considered
private.

4.
RESPONDENTS
AND
INFORMATION
REQUESTED
4(
a).
Respondents/
SIC
Codes
Participants
in
this
study
will
be
residents
of
Duval
County
in
the
greater
Jacksonville,
Florida
area.
Participants
must
meet
certain
eligibility
requirements
as
outlined
in
the
list
below.
°
Age
of
the
child
at
the
time
of
recruitment
is
a
newborn
or
12­
months
of
age
°
High
pesticide
use
in
the
home
°
Participant
child
will
not
attend
day
care
outside
the
home
°
Participant
lives
in
a
permanent
residence
(
not
transient
housing)
°
Participant
is
willing
to
advise
field
measurement
team
of
planned
pesticide
applications
°
Participant
is
willing
to
collect
urine
and
diet
samples,
and,
°
Participant
is
willing
to
participate
in
the
study
for
two
years.
The
population
ultimately
selected
will
be
a
convenience
sample
based
on
the
Duval
County
13
Health
Department's
community­
based
approach.

4(
b).
Information
Requested
(
i)
Data
Items
The
reporting
items
requested
are
contained
in
the
attached
copies
of
questionnaires.
These
include
the
questionnaires
necessary
to
determine
eligibility
of
the
potential
participants,
to
screen
the
potential
participants
prior
to
enrollment
into
the
study,
and
to
collect
information
during
the
data
collection
monitoring
events.
Questionnaires
administered
in
the
proposed
study
will
collect
information
on
sources
of
chemicals
and
participant
activities.
This
information
is
needed
to
systematically
evaluate
aggregate
exposures.
The
questionnaire
data
are
needed
in
combination
with
measurements
of
chemical
concentrations
in
environmental
and
biological
media
to
perform
calculations
to
estimate
aggregate
exposures,
to
determine
the
exposure
factors,
and
to
measure
spatial
and
temporal
variability
of
the
chemicals.
Additionally,
the
Vineland
Adaptive
Behavioral
Scales
will
be
administered
twice
during
the
study
to
evaluate
the
feasibility
of
collecting
developmental
data
in
exposure
studies
for
future
large
studies.
A
copy
of
each
questionnaire
is
included
as
an
appendix
to
this
document.
In
addition,
a
separate
document
explains
the
rationale
and
use
for
each
question
administered
to
the
participants
(
titled
Appendix
to
Part
A).

In
addition
to
the
reporting
items
collected
with
the
questionnaires,
environmental
and
biological
samples
will
be
collected.
The
samples
to
be
collected
from
the
study
participant
or
caregiver
include
urine
samples,
duplicate
diet
samples,
a
cotton
pajama
worn
to
collect
chemical
residues
from
surfaces
contacted
by
the
child,
accelerometer
measurements,
and
a
short
videotape
of
the
child's
activities.
Six
urine
samples,
collected
with
diapers
or
as
voids,
will
be
collected
from
each
participating
child
during
each
data
collection
event.
For
children
recruited
under
three
months
of
age,
there
will
be
six
data
collection
events
for
each
of
the
30
children
in
the
cohort.
Therefore,
a
total
of
36
urine
samples
will
be
collected
from
each
child
during
the
two­
year
study.
For
each
of
the
30
children
recruited
into
the
study
at
one
year
of
age,
six
urine
samples
will
be
collected
during
each
of
five
data
collection
events
for
a
total
of
30
urine
samples
from
each
child
during
the
two­
year
study.
In
addition
to
collection
of
urine
samples
from
the
participating
children,
the
caregiver
of
the
child
will
be
asked
to
provide
two
urine
samples
during
two
data
collection
events
during
the
study,
for
a
total
of
240
adult
urine
samples
that
can
be
compared
to
the
children's
urine
sample
results.
The
total
number
of
urine
samples
for
the
study
will
be
2220.
The
samples
will
be
analyzed
for
the
metabolites
of
pyrethroid
pesticides,
diazinon,
chlorpyrifos,
and
phthalates.
During
the
last
data
collection
event
for
40
children,
a
request
will
be
made
for
a
blood
sample
from
the
child
and
from
the
caregiver
that
can
be
analyzed
for
perfluorinated
chemicals
and
brominated
flame
retardants.
This
will
be
voluntary
and
the
child
and
caregiver
are
not
required
to
provide
blood
samples
to
participate
in
the
study.

Duplicate
diet
samples
will
be
collected
by
the
caregiver
during
each
data
collection
event
for
a
24­
hour
period.
The
duplicate
diet
sample
consists
of
equal
portions
of
foods
that
the
child
14
ate
during
the
period.
The
food
samples
will
be
analyzed
for
all
of
the
chemicals
in
order
to
determine
their
intake
of
the
chemicals
during
the
period.
Data
on
concentrations
of
the
chemicals
in
the
food
are
essential
for
estimating
aggregate
exposures
because
food
may
be
the
primary
source
of
exposure
to
select
chemicals.
Duplicate
diet
samples
have
been
collected
in
many
previous
exposure
studies
and
the
procedures
for
collecting
duplicate
diet
samples
have
been
developed
to
minimize
the
burden
on
the
participant.

To
determine
if
children
are
exposed
to
chemicals
during
the
study
due
to
contact
with
residues
on
the
floor
or
other
surfaces
where
the
child
plays,
the
participating
child
will
be
asked
to
wear
a
one­
piece
cotton
garment
("
pajama")
for
approximately
one
hour
during
each
data
collection
event.
The
cotton
will
then
be
analyzed
to
determine
chemical
concentrations
on
the
material.
This
method
for
estimating
dermal
exposure
to
chemicals
is
similar
to
dosimeter
methods
used
to
measure
occupational
exposures.
It
has
been
evaluated
in
a
number
of
pilot
studies
(
Hore
2003).
An
approach
has
been
developed
that
minimizes
the
participant
burden.
Participation
in
this
activity
is
strictly
voluntary.
Participating
children
will
wear
an
accelerometer
during
the
data
collection
event
so
that
their
level
of
activity
can
be
related
to
surface
residue
concentrations
to
estimate
dermal
exposure.
Caregivers
will
also
collect
at
least
12
minutes
of
videotape
with
a
camera
provided
to
them
in
order
to
classify
the
level
of
activity
during
indoor
play,
quiet
time,
eating,
and
play
outdoors.

The
field
technicians
for
the
technical
support
Contractor
will
collect
the
environmental
samples
at
the
study
participant's
residence
during
each
data
collection
event.
The
participant
will
not
be
involved
in
collection
of
these
samples.
The
samples
to
be
collected
by
the
Contractor
technicians
include
air
samples,
surface
transferable
residues,
floor
dust,
dust
on
furniture,
soil,
and
water.
A
summary
of
the
samples
to
be
collected
in
the
proposed
study
is
provided
in
the
attached
study
design
document.
Environmental
samples
will
only
be
analyzed
for
the
compounds
listed
in
Table
2.
A
multi­
residue
analysis
method
will
be
used
to
quantitate
the
pesticides
and
brominated
flame
retardants.
Separate
aliquots
will
be
analyzed
for
the
selected
phthalates
and
perfluorinated
compounds.
Table
3
lists
the
target
analytes
for
the
biological
samples.

The
environmental
and
biological
samples
chosen
for
collection
and
analysis
will
be
used
to
evaluate
the
systematic
approach
needed
for
an
aggregate
exposure
assessment.

(
ii)
Respondent
Activities
Of
the
six
activities
listed
in
the
1995
PRA
Definition
of
Burden
and
nine
activities
listed
in
OMB's
Definition
of
Burden
in
OMB's
Final
Rules
(
5
CFR1320.3(
b)(
1)),
the
following
are
relevant
to
the
respondents:
°
Reviewing
instructions,
°
Training
personnel
to
be
able
to
respond
to
a
collection
of
information,
and
°
Completing
and
reviewing
the
collection
of
information.

The
respondent
activities
specific
to
this
study
include
the
following:
15
°
Screening
and
enrollment
into
the
study
°
Training
of
the
respondents
for
data
collection,
°
Collection
of
samples
to
include
urine
samples,
duplicate
diet,
cotton
garment
("
pajama"),
videotaping
segments,
and
the
accelerometer,
and
°
Completion
of
the
survey
forms
(
questionnaires
and
reporting
items).

1.
Screening
and
Enrollment
­
The
respondents
will
provide
information
to
the
Agency's
Contractor
staff
with
the
Eligibility
Screening
Questionnaire
that
will
be
administered
at
clinics,
hospitals,
and
other
community
sites
to
determine
potential
participants
for
the
study.
Respondents
that
meet
the
basic
eligibility
criteria
will
be
further
screened.
The
Home
Pesticide
Inventory
and
Use
Screening
Questionnaire
will
be
used
by
the
Contractor
technician
to
collect
information
that
can
be
used
to
verify
potential
participant
use
of
pesticides
in
their
homes
prior
to
final
enrollment
into
the
study.

2.
Training
­
Individuals
who
agree
to
participate
in
the
study
will
be
trained
for
the
following
activities:
°
Completion
of
survey
forms
during
the
study,
and
°
Collection
of
the
duplicate
diet,
urine
samples,
cotton
garment,
videotaping
segments,
and
the
accelerometer.

3.
Collection
of
Samples
­
Participants
will
collect
some
samples,
such
as
duplicate
diet,
urine
samples,
cotton
garment,
videotaping
segments,
and
the
accelerometer
during
the
study.
They
will
also
allow
the
Contractor
project
staff
to
collect
environmental
samples
from
multiple
media.
The
samples
and
data
to
be
collected
in
the
study
are
summarized
above
and
in
the
study
design
document.

4.
Completion
of
Survey
Forms
(
Questionnaires)
­
Study
participants
will
provide
information
via
interviews
with
the
Contractor's
technicians.
The
survey
instruments
to
be
completed
by
each
respondent
are
included
as
attachments.
The
Eligibility
Screening
Questionnaire
will
be
administered
at
clinics,
hospitals,
and
other
community
sites
to
determine
potential
participants
for
the
study.
The
Home
Pesticide
Inventory
and
Use
Screening
Questionnaire
will
be
administered
to
verify
potential
participant
use
of
pesticides
in
their
homes
prior
to
final
enrollment
into
the
study.
The
other
questionnaires
will
be
completed
during
each
data
collection
monitoring
event.
They
include
the
following:
°
Participant
and
Housing
Characteristics
Questionnaire
°
Monitoring
Period
Questionnaire
°
Activity
Time
Line
°
Food
Diary
°
Monthly
Pesticide
Purchase
and
Inventory
Log
°
Monthly
Cleaning
Products
Purchase
and
Inventory
Log
The
Vineland
Adaptive
Behavior
Scales
will
be
completed
during
only
two
of
the
data
collection
events.
The
proposed
activity
schedule
for
each
participant
during
each
data
collection
16
event
is
summarized
in
Table
4.
17
Table
2.
List
of
chemicals
to
be
analyzed
in
environmental
media
and
duplicate
diet.

Organophosphate
Pesticides
(
OPs)
Pyrethroid
Pesticides
Chlorpyrifos
cis,
trans,
total
Allethrin
Diazinon
Resmethrin
Phenyl­
Pyrazole
Bifenthrin
Fipronil
Sumithrin
Synergist
Tetramethrin
I,
II,
total
Piperonyl
butoxide
lamda­
Cyhalothrin
Phthalates
cis,
trans,
total
Permethrin
Butyl
benzyl
phthalate
Pyrethrin
I,
II
Dibutyl
phthalate
Cyfluthrin
I,
II,
III,
IV,
total
Diethyl
phthalate
Cypermethrin
I,
II,
III,
IV,
total
Di(
2­
ethylhexyl)
phthalate
Esfenvalerate
Diisononyl
phthalate
Delta/
Tralomethrin
Diisodecyl
phthalate
Brominated
Flame
Retardants
Perfluorinated
Compounds
PBDE
congeners
47,
99,
100,
153,
154,
181,
183,
190,
197,
209
Perfluorooctanoic
acid
(
PFOA)

Hexabromocyclododecane
(
HBCD)
Perfluorooctane
sulfonate
(
PFOS)

Tetrabromobisphenol
A
(
TBBPA)
18
Table
3.
List
of
chemicals
to
be
analyzed
in
biological
media.

Analyte
Analyte
3­
phenoxybenzoic
acid
Mono
ethyl
phthalate
4­
fluoro­
3­
phenoxybenzoic
acid
Mono
butyl
phthalates
cis­
3­(
2,2­
dichlorovinyl)­
2,2­
dimethylcyclopropane­
1­
carboxylic
acid
Mono
benzyl
phthalate
trans­
3­(
2,2­
dichlorovinyl)­
2,2­
dimethylcyclopropane­
1­
carboxylic
acid
Mono­
2­
ethylhexyl
phthalate
cis­
3­(
2,2­
dibromovinyl)­
2,2­
dimethylcyclopropane­
1­
carboxylic
acid
Mono
isononyl
phthalate
cis­
3­(
2,2­
dimethylvinyl)­
2,2­
dimethylcyclopropane­
1­
carboxylic
acid
Mono
isodecyl
phthalate
trans­
3­(
2,2­
dimethylvinyl)­
2,2­
dimethylcyclopropane­
1­
carboxylic
acid
PBDE
Congeners
47,
99,
100,
153,
154,
181,
183,
190,
197,
209
3,5,6­
trichloro­
2­
pyridinol
Hexabromocyclododecane
(
HBCD)

2­
isopropyl­
4­
methyl­
6­
hydroxypyrimidine
Tetrabromobisphenol
A
(
TBBPA)

Perfluorooctanoic
acid/
Perfluorooctane
sulfonate
19
Table
4.
Schedule
of
Activities
for
Each
Data
Collection
Monitoring
Event.

Day
Activity
­
2
(
background
sample
collection)
1.
Contractor
field
technician
collects
background
samples
(
surface
wipes,
air
samples,
etc.)
prior
to
a
pesticide
application
2.
Technician
completes
or
updates
Participant
and
Housing
Characteristics
survey
3.
Technician
provides
training
and
instructions
to
participant
for
data
collection
4.
Participant
collects
urine
samples,
Activity
Time
Line,
accelerometer,
and
videotape
information
­
1
(
return
after
24
hours)
1.
Contractor
field
technician
retrieves
air
samples
and
wipe
samples
2.
Contractor
field
technician
retrieves
urine
samples,
Activity
Time
Line,
and
accelerometer
information
3.
Technician
provides
new
urine
collection
devices,
duplicate
diet
containers,
and
Activity
Time
Line
form
to
participant
4.
Technician
provides
instructions
and
training
as
required
1
(
following
a
pesticide
application)
1.
Technician
sets
up
air
samplers
and
collects
other
environmental
samples
(
surface
wipes,
hand
wipes,
etc.)
2.
Participant
collects
urine,
duplicate
diet
samples,
accelerometer,
Food
Diary,
and
Activity
Time
Line
information
3.
Technician
collects
Monthly
Pesticide
Purchase,
Inventory,
and
Use
Log
and
Monthly
Cleaning
Products
Purchase,
Inventory,
and
Use
Log
2
1.
Technician
retrieves
air
samples
2.
Technician
collects
other
environmental
samples
3.
Technician
retrieves
urine
and
diet
samples
from
participant
4.
Technician
administers
Monitoring
Period
Questionnaire
3
1.
Retrieve
final
urine
sample
20
5.
THE
INFORMATION
COLLECTED
­­
Agency
Activities,
Collection
Methodology,
and
Information
Management
5(
a).
Agency
Activities
The
study
is
expected
to
span
three
years,
beginning
in
FY
2004.
Agency
activities
associated
with
the
proposed
study
include
the
following:
°
Develop
and
program
questionnaires
and
prepare
ICR
package,
°
Set
up
master
database,
°
Obtain
Institution
Review
Board
(
IRB)
approval,
°
Screen
and
enroll
participants,
°
Train
participants,
°
Collect
samples
from
respondents,
°
Complete
survey
forms,
°
Database
entry
and
management,
and
°
Data
review
and
validation.

5(
b).
Collection
Methodology
and
Management
The
design
for
the
proposed
study
was
developed
by
scientists
at
ORD.
It
was
revised
based
on
the
comments
and
recommendations
of
the
external
peer­
review
panel.
The
questionnaires
used
for
information
collection
are
based
on
similar
questionnaires
used
in
other
exposure
measurement
studies.
Questionnaires
were
compiled
from
both
large
and
small
studies
and
evaluated.
Questions
were
included
in
the
CHEERS
survey
instruments
only
if
the
information
was
required
to
estimate
aggregate
exposures,
assess
temporal
or
spatial
variability,
or
interpret
the
data.
The
survey
instruments
for
the
proposed
study
have
in
part,
or
full,
been
evaluated
in
pilot
studies.
The
time
required
to
complete
each
instrument
has
been
determined
by
testing
with
fewer
than
nine
individuals
in
pilot
studies
or
with
co­
workers.

Survey
Instruments
The
following
questionnaires
will
be
administered
electronically
to
ease
burden
and
increase
participation.
They
include:

°
Eligibility
Screening
Questionnaire
°
Home
Pesticide
Inventory
and
Use
Screening
Questionnaire
°
Participant
and
Housing
Characteristics
Questionnaire
°
Monitoring
Period
Questionnaire
The
following
questionnaires
will
be
administered
in
paper
copy
to
facilitate
completion
by
the
participant.
Contractor
field
technicians
will
check
data
quality
by
reviewing
the
responses
to
questions
at
the
time
that
the
questionnaires
are
retrieved
and
will
verify
questionable
responses
with
the
study
participants
during
the
data
collection
event
at
the
participant's
residence.

°
Activity
Time
Line
°
Food
Diary
21
°
Monthly
Pesticide
Purchase
and
Inventory
Log
°
Monthly
Cleaning
Product
Purchase
and
Inventory
Log
°
Monthly
Cleaning
Product
Use
Log
°
Vineland
Adaptive
Behavioral
Scales
Sampling
Methodology/
Targeted
Chemicals/
Data
Management
and
Analysis/
Accuracy
and
Reliability/
Data
Processing
Sampling
methodology,
selected
targeted
chemicals,
data
management
and
analysis,
accuracy
and
reliability,
and
data
processing
are
discussed
in
the
attached
study
design.
For
data
collected
on
hard
copy,
a
specially
designed
data
entry
program
will
perform
quality
control
checks
as
paper
data
are
entered,
such
as
range
checks,
consistency
checks,
and
checks
for
properly
followed
skip
patterns.
All
paper
data
will
be
keyed
in
twice
and
verified
with
a
computer
verification
program.

Public
Access
to
Collected
Data
The
data
and
study
results
will
be
made
available
to
the
general
public
via
several
different
sources,
including
the
internet
(
EPA's
Home
page:
www.
epa.
gov)
and
libraries.
Summaries
of
study
results
will
be
provided
in
newsletters
sent
periodically
to
all
members
of
the
proposed
cohorts
and
other
interested
individuals
and
organizations.

5(
c).
Small
Entity
Flexibility
Since
the
proposed
study
involves
voluntary
participation
on
the
part
of
the
children
and
their
primary
caregivers
and
no
regulatory
efforts
are
involved,
small
entity
flexibility
is
not
applicable.

5(
d).
Collection
Schedule
The
schedule
for
data
collection
covers
three
years
beginning
in
2004
and
ending
in
2006.
The
study
involves
repeated
visits
to
collect
information
for
the
study
participants.
Multiple
data
collections
will
be
made
each
year,
but
will
not
be
more
frequently
than
quarterly.
The
schedule
for
information
collection
during
the
study
differs
for
the
two
cohorts
of
study
participants.
For
the
30
participants
recruited
at
the
age
of
less
than
3
months,
information
collection
will
be
performed
at
the
participant
ages
of
3,
6,
9,
12,
18,
and
24
months
(+/­
approximately
2
months).
For
children
recruited
into
the
study
at
12
months
of
age,
information
collection
will
be
performed
at
the
participant
ages
of
12,
18,
24,
30,
and
36
months
(+/­
approximately
2
months).
The
ages
of
the
children
were
selected
based
on
the
EPA's
Risk
Assessment
Forum
proposed
age
bins
for
developmental
stages.
The
Eligibility
Screening
Questionnaire
will
be
administered
at
a
health
clinic,
hospital,
doctor's
office
or
other
community
contact
location.
If
the
participant
is
eligible,
a
screening
visit
will
be
schedule
to
visit
the
potential
participant's
home.
During
the
visit,
the
Contractor
technician
will
collect
information
with
the
Home
Pesticide
Inventory
and
Use
Screening
Questionnaire.
If
the
potential
participant
meets
all
eligibility
criteria,
s/
he
will
be
enrolled
into
the
study.
The
schedule
for
information
collection
at
each
subsequent
time
period
was
described
previously
in
Table
4.
22
6.
ESTIMATING
THE
BURDEN
AND
COST
OF
THE
COLLECTION
6(
a).
Estimating
Respondent
Burden
Estimates
for
study
activities
were
based
on
information
on
burden
from
similar
EPA
pilot
and
field
measurement
studies.
The
times
necessary
to
complete
the
questionnaires
were
also
based
on
pre­
testing
of
the
instruments
by
EPA
personnel.

Estimates
of
the
time
each
participant
(
respondent)
must
spend
to
complete
each
study
activity
during
each
of
the
data
collection
monitoring
events
are
listed
in
Table
5.
As
described
previously,
this
study
involves
repeated
visits
to
collect
data
from
each
study
participant.
For
children
enrolled
at
0
to
3
months
of
age,
there
will
be
six
repeated
visits;
for
children
enrolled
at
one
year
of
age,
there
will
be
five
repeated
data
collection
events.
Therefore,
the
total
number
of
data
collection
events
are
11.
Table
6
lists
the
total
respondent
burden
for
the
study
using
the
burden
estimates
for
each
activity
listed
in
Table
5.
As
indicated
in
Table
6,
the
total
respondent
labor
hours
for
the
complete
study
are
1174
hours
for
all
60
respondents
over
three
years,
or
an
average
of
6.52
hours
per
respondent
annually.

6(
b).
Estimating
Respondent
Costs
Respondents
are
study
participants
who
are
individuals
living
in
private
residences.
The
wages
of
the
respondents
are
unknown.
The
estimates
for
respondent's
costs
are
based
on
the
median
per
capita
income
of
$
9.98
(
rounded
to
$
10.00)
per
hour
in
Duval
County,
Florida,
based
on
Census
2000
data.
These
estimates
are
used
for
each
respondent
activity
and
the
basis
for
all
subsequent
calculations.
The
average
annual
respondent
labor
costs
are
$
65.22,
as
shown
in
Table
7.
Participants
are
individuals
living
in
private
residences;
there
are
no
capital
and
operations
and
maintenance
costs
associated
with
information
collection
from
the
participants
except
for
the
direct
costs
associated
with
the
collection
of
data
for
this
survey
that
include
approximately
$
1
for
electricity
and
approximately
$
3
for
each
duplicate
diet
sample,
for
which
participants
will
be
reimbursed.
23
Table
5.
Respondent
burden
estimates
for
completing
each
activity
one
time.
Data
Item
Time
(
minutes)

SCREENING
AND
ENROLLMENT
Complete
Eligibility
Screening
Questionnaire
10
Complete
Home
Pesticide
Inventory
and
use
Screening
Questionnaire
20
Describe
study
and
obtain
informed
consent
20
Discuss
scheduling
5
TRAINING
Instructions
to
collect
the
duplicate
diet
5
Instructions
to
collect
the
urine
samples
5
Instructions
to
collect
the
cotton
garment
5
Instructions
to
collect
the
videotaping
segments
5
Instructions
on
the
use
of
the
accelerometer
5
COLLECT
SAMPLES
Pre­
application
urine
samples
2
Post­
application
urine
samples
4
Duplicate
diet
7
Cotton
garment
5
Videotaping
segments
12
Accelerometer
5
COMPLETE
SURVEY
FORMS
Participant
and
Housing
Characteristics
Questionnaire
30
Monitoring
Period
Questionnaire
30
Activity
Time
Line
15
Food
Diary
10
Monthly
Pesticide
Purchase,
Inventory,
and
Use
Log
5
Monthly
Cleaning
Products
Purchase,
Inventory,
and
Use
Log
5
Vineland
Adaptive
Behavioral
Scales
20
TOTALS
230
24
Table
6.
Total
study
burden
estimates
and
costs
for
all
respondents
participating
in
all
data
collection
monitoring
events
(
total
study
burden
for
three
years).

Data
Item
Time
per
data
item
(
hours)
No.
of
Participants
in
Each
Monitoring
Eventa
Total
Respondent
Labor
Hours
per
Monitoring
Event
Total
Respondent
Labor
Hours
for
the
Complete
Studyb
Capital
/
Start
Up
Cost
($)
O&
M
Cost
($)
Total
Cost
for
the
Study
($)
c
SCREENING
AND
ENROLLMENT
Complete
Eligibility
Screening
Questionnaired
0.17
60
10
10
0
0
100
Complete
Home
Pesticide
Inventory
and
use
Screening
Questionnaire
d
0.33
30
10
20e
0
0
200
Describe
study
and
obtain
informed
consent
0.33
30
10
20e
0
0
200
Discuss
scheduling
0.08
30
2.5
27.5
0
0
275
TRAINING
Instructions
to
collect
the
duplicate
diet
0.08
30
2.5
27.5
0
0
275
Instructions
to
collect
the
urine
samples
0.08
30
2.5
27.5
0
0
275
Instructions
to
collect
the
cotton
garment
0.08
30
2.5
27.5
0
0
275
Instructions
to
collect
the
videotaping
segments
0.08
30
2.5
27.5
0
0
275
Instructions
on
the
use
of
the
accelerometer
0.08
30
2.5
27.5
0
0
275
COLLECT
INFORMATION
Pre­
application
urine
samples
0.03
30
1
11
0
0
110
Post­
application
urine
samples
0.07
30
2
22
0
0
220
Data
Item
Time
per
data
item
(
hours)
No.
of
Participants
in
Each
Monitoring
Eventa
Total
Respondent
Labor
Hours
per
Monitoring
Event
Total
Respondent
Labor
Hours
for
the
Complete
Studyb
Capital
/
Start
Up
Cost
($)
O&
M
Cost
($)
Total
Cost
for
the
Study
($)
c
25
Duplicate
diet
0.12
30
3.5
38.5
0
0
385
Cotton
garment
0.08
30
2.5
27.5
0
0
275
Videotaping
segments
0.20
30
5
55
0
0
550
Accelerometer
0.08
30
2.5
27.5
0
0
275
COMPLETE
SURVEY
FORMS
Participant
and
Housing
Characteristics
Questionnaire
0.5
30
15
30f
0
0
300
Monitoring
Period
Questionnaire
0.5
30
15
165
0
0
1650
Activity
Time
Line
0.25
30
7.5
247.5g
0
0
248
Food
Diary
0.17
30
5
55
0
0
550
Monthly
Pesticide
Purchase,
Inventory,

and
Use
Log
0.08
30
 
h
120h
0
0
1200
Monthly
Cleaning
Products
Purchase,

Inventory,
and
Use
Log
0.08
30
 
h
120h
0
0
1200
Vineland
Adaptive
Behavioral
Scales
0.33
30
10
40i
0
0
400
TOTALS
3.8
­­
­­
1174
0
0
$
11,740
aOne
cohort
of
30
respondents
participates
in
each
monitoring
event
(
for
eligibility
screening,
the
number
is
assumed
to
be
60,
but
screening
only
occurs
once
during
the
study).

bThere
will
be
11
data
collection
monitoring
events
during
the
three
years
of
the
study;
burden
estimates
in
this
column
are
hours
per
monitoring
event
times
11.
The
total
of
1174
is
for
all
60
participants.
Total
respondent
hours
per
participant
are
19.57
for
the
complete
study.

c
Labor
cost
was
estimated
based
on
per
capita
income
data
for
Duval
County,
Florida
from
Census
2000;
median
annual
per
capita
income
was
$
20,753.

Divided
by
2080
=
$
9.98/
hour,
which
was
rounded
to
$
10.00
per
hour
for
the
calculation.

d
Eligibility
screening
questionnaire
administered
one
time
to
estimate
of
120
respondents.
26
e
Home
pesticide
inventory
and
use
screening
questionnaire
and
consent
form
are
only
completed
once
by
30
respondents
in
each
cohort
for
a
total
of
60
respondents
in
the
study.

fParticipant
and
housing
characteristics
questionnaire
is
only
completed
once
by
each
participant.

gActivity
time
line
is
completed
for
three
separate
24­
hour
periods
during
each
monitoring
event
(
30
respondents
per
cohort
X
3
forms
X
11
events)

fParticipant
completes
each
month.

gDevelopmental
assessment
will
be
completed
twice
during
the
study.

h
Logs
will
be
completed
once
each
month
by
each
of
the
60
respondents
for
24
months.

i
The
Vineland
will
be
completed
only
two
times
during
the
study
by
each
of
the
60
respondents.
27
Table
7.
Annual
respondent
burden
and
cost
estimates.

Data
Item
Annual
burden
per
respondent
(
hours)
a
Annual
labor
cost
per
respondent
($)
b
Capital
/
Start
Up
Cost
($)
O&
M
Cost
($)
Annual
cost
per
respondent
($)
c
SCREENING
AND
ENROLLMENT
Complete
Eligibility
Screening
Questionnaired
0.06
0.56
0
0
0.56
Complete
Home
Pesticide
Inventory
and
use
Screening
Questionnaire
d
0.11
1.10
0
0
1.10
Describe
study
and
obtain
informed
consent
0.11
1.10
0
0
1.10
Discuss
scheduling
0.15
1.53
0
0
4.53
TRAINING
Instructions
to
collect
the
duplicate
diet
0.15
1.53
0
0
4.53
Instructions
to
collect
the
urine
samples
0.15
1.53
0
0
4.53
Instructions
to
collect
the
cotton
garment
0.15
1.53
0
0
4.53
Instructions
to
collect
the
videotaping
segments
0.15
1.53
0
0
4.53
Instructions
on
the
use
of
the
accelerometer
0.15
1.53
0
0
4.53
COLLECT
INFORMATION
Pre­
application
urine
samples
0.06
0.61
0
0
0.61
Post­
application
urine
samples
0.12
1.22
0
0
1.22
Data
Item
Annual
burden
per
respondent
(
hours)
a
Annual
labor
cost
per
respondent
($)
b
Capital
/
Start
Up
Cost
($)
O&
M
Cost
($)
Annual
cost
per
respondent
($)
c
28
Duplicate
diet
0.21
2.14
0
0
2.14
Cotton
garment
0.15
1.53
0
0
1.53
Videotaping
segments
0.31
3.06
0
0
3.06
Accelerometer
0.15
1.53
0
0
1.53
COMPLETE
SURVEY
FORMS
Participant
and
Housing
Characteristics
Questionnaire
0.17
1.67
0
0
1.67
Monitoring
Period
Questionnaire
0.92
9.17
0
0
9.17
Activity
Time
Line
1.38
13.75
0
0
13.75
Food
Diary
0.31
3.06
0
0
3.06
Monthly
Pesticide
Purchase,
Inventory,
and
Use
Log
0.67
6.67
0
0
6.67
Monthly
Cleaning
Products
Purchase,
Inventory,

and
Use
Log
0.67
6.67
0
0
6.67
Vineland
Adaptive
Behavioral
Scales
0.22
2.22
0
0
2.22
TOTALS
6.52
$
65.22
0
0
$
65.22
a
Numbers
rounded.
Actual
values
used
to
calculate
labor
cost.

b
Labor
cost
was
estimated
based
on
per
capita
income
data
for
Duval
County,
Florida
from
Census
2000;
median
annual
per
capita
income
was
$
20,753.

Divided
by
2080
=
$
9.98/
hour,
which
was
rounded
to
$
10.00
per
hour
for
the
calculation.
29
6(
c).
Estimating
Agency
Burden
and
Cost
The
estimates
for
the
Agency
burden
and
cost
are
presented
in
Table
8.
The
table
includes
labor
hours
and
costs
for
Agency
staff
and
for
the
Contractor
that
are
applicable
to
the
activities
described
in
Section
5.
Costs
are
included
for
developing
and
programming
the
questionnaires
and
developing
the
ICR
package,
setting
up
the
database,
obtaining
IRB
approval,
recruitment
costs
that
include
screening
and
enrollment
and
the
collection
of
the
data
items
described
in
Section
4.
Labor
hours
and
costs
are
not
included
for
collection
and
analysis
of
environmental
samples
and
tasks
associated
with
the
exposure
measurements.
Labor,
capital
startup,
and
operation
&
maintenance
(
O&
M)
values
for
the
Contractor
portion
of
this
table
have
been
estimated
based
upon
confidential
business
information
related
to
the
Agency's
Contractor
quoted
cost
estimates
for
performing
the
field
data
collection.
Labor
costs/
hr
recorded
in
the
table
represent
those
from
off­
site
contract
employees
currently
expected
to
provide
Agency
support
in
the
data
collection
and
represent
loaded
costs
(
incorporating
labor,
overhead,
G&
A,
fringe,
fee)
using
an
average
rate
for
the
primary
categories
of
staff
that
will
perform
the
work.
There
will
be
minimal
capital
start­
up
costs
associated
with
the
survey
and
the
questionnaire­
type
information
collection.
O&
M
costs
are
included
which
cover
items
such
as
copying
of
forms
and
purchase
of
containers
and
supplies
needed
for
samples
to
be
collected
by
the
participants.

The
estimated
labor
cost
of
Agency
staff
is
based
on
GS
pay
scales
(
Research
Triangle
Park,
NC­
locality).
GS
rates
were
used
to
provide
the
estimates
using
the
1.6
time
rule
for
inclusion
of
fringe
benefit
costs.
Agency
labor
associated
with
the
direct
collection
of
respondent
data
and
the
direct
interaction
of
Agency
staff
with
respondents
in
the
collection
of
data
is
limited.
Contract
staff
(
whose
labor
has
been
estimated
in
the
table)
have
the
responsibility
of
performing
nearly
all
of
the
data
collection.

The
annual
Agency
labor
per
respondent
is
estimated
to
be
89.5
hours.
The
Agency
labor
cost
is
estimated
to
be
$
6,801
per
respondent
per
year.
The
total
annual
Agency
labor
and
capital
costs
are
estimated
to
be
$
6,954
per
respondent
per
year.

6(
d)
Estimating
the
Respondent
Universe
and
Total
Burden
and
Costs
The
respondent
universe
will
be
60
study
participants
that
voluntarily
enroll
in
the
study.
The
total
respondent
burden
and
costs
were
presented
in
Table
6.
The
estimated
annual
burden
per
respondent
of
6.5
hours
was
multiplied
by
the
number
of
respondents
(
60)
multiplied
by
3
years
to
determine
the
total
respondent
burden
for
the
study
of
1,174
hours.
The
total
respondent
cost
for
the
60
respondents
for
3
years
is
$
11,740
($
65.22
multiplied
times
60
respondents
times
3
years).

There
are
a
total
of
22
individual
respondent
activities
under
the
four
primary
categories
of
activities,
as
shown
in
Table
5.
The
Eligibility
Screening
Questionnaire,
Home
Pesticide
Inventory
and
Use
Screening
Questionnaire,
Informed
Consent,
and
Participant
and
Housing
Characteristics
Questionnaire
are
completed
once
during
the
study.
The
Vineland
Adaptive
Behavioral
Scales
is
completed
twice.
Most
other
activities
are
performed
eleven
times.
The
pesticide
and
cleaning
product
use
logs
are
completed
monthly.
The
total
number
of
activities
is
14,
520
for
the
full
study.
30
Table
8.
Annual
EPA
(
Agency
and
Contractor)
burden
hours
and
costs
per
respondent
(
Part
I
of
table).

Information
Collection
Activity
Contractor
Legal
($
165)
­

hours
Contractor
Mgr.
(
P4)

($
159)
­

hours
Contractor
Team
Lead
(
P3)

($
106)
­

hours
Contractor
Support
Staff
(
P2)

($
90)
­

hours
Contractor
Tech.

(
T1)
($
56)

­
hours
Contractor
Clerical
($
64)
­

hours
EPA
Legal
($
79)
­

hours
EPA
Mgr.

(
GS­
15)

($
79)
­

hours
EPA
Scientist
(
GS­
14)

($
67)
­

hours
Develop
questionnaires
and
ICR
0
1.2
2.0
7.8
3.4
0.2
0
1.1
0.3
Set
up
master
database
0
0.9
2.7
0.7
0.3
0.1
0
0
0
Obtain
IRB
approval
0
1.3
0
0.4
0
0
0
0.2
0.2
Screen
and
enroll
participants
0
2.1
0.2
6.2
15.1
0.4
0
0.4
0
Train
participants
0
0.1
0.2
0
1.5
0
0
0
0
Collect
samples
from
participants
0
0.1
0.4
0
2.8
0
0
0
0
Complete
survey
forms
0
0.7
1.4
0
6.9
0
0
0
0
Database
entry
and
management
0
0.2
0.7
0
6.4
0
0
0
0
Data
review
and
validation
0
0.2
0.3
3.7
0.7
0
0
0
0
31
Table
8.
Annual
EPA
(
Agency
and
Contractor)
burden
hours
and
costs
per
respondent
(
Part
II
of
table).

Information
Collection
Activity
EPA
Scientist
(
GS­
13)

($
57)
­

hours
EPA
Clerical
($
48)
­

hours
Labor
Hours
per
Respondent
per
Year
Agency
Labor
Cost
($)
per
Respondent
per
Year
Capital
Start
Up
Costs
per
Respondent
per
Year
O&
M
Costs
per
Respondent
per
Year
Total
Cost
per
Respondent
per
Year
Number
of
Respondents
Total
Costs
for
Study
(
all
3
years)
a
Develop
questionnaires
and
ICR
9.3
0
25.3
1945
0
0.83
1946
60
350,212
Set
up
master
database
0.7
0
5.3
552
0
0.56
553
60
99,481
Obtain
IRB
approval
0
0
2.1
274
0
0.28
274
60
49,304
Screen
and
enroll
participants
1.8
0.2
26.4
1930
0
51.07
1981
60
356,641
Train
participants
0.4
0
2.2
138
0
6.11
144
60
25,963
Collect
samples
0
0
3.3
220
55
19.38
294
60
52,906
Complete
survey
forms
0
0
9.0
649
0
20.23
669
60
120,388
Database
entry
and
management
1.8
0
9.1
560
0
0
560
60
100,812
Data
review
and
validation
1.8
0
6.7
534
0
0
534
60
96,060
Total
­­
­­
89.5
$
6,801
$
55
$
98
$
6,954
60
$
1,251,766
a
Note:
Due
to
rounding
of
numbers
values
may
differ
slightly
when
calculated
from
values
provided
in
the
table.
32
6(
e).
Bottom
Line
Burden
Hours
and
Cost
Tables
(
i)
Respondent
Tally
The
bottom
line
burden
hours
and
costs
for
respondents
were
shown
in
Table
6,
labeled
as
the
"
Total
study
burden
estimates."
As
discussed
in
the
previous
sub­
section,
the
total
respondent
burden
and
cost
was
presented
in
Table
6.
The
estimated
annual
burden
per
respondent
of
6.5
hours
was
multiplied
by
the
number
of
respondents
(
60)
multiplied
by
3
years
to
determine
the
total
respondent
burden
for
the
study
of
1,174
hours.
The
total
respondent
cost
for
the
60
respondents
for
3
years
is
$
11,740
($
65.22
multiplied
times
60
respondents
times
3
years).
The
burden
and
cost
are
summarized
in
Table
9.

Table
9.
Total
Estimated
Respondent
and
Agency
Burden
and
Cost
Summary
(
Primary
data
in
Table
6).

Number
of
Respondents
Total
Number
of
Activities
for
Study
Total
Hours
for
the
Study
Total
Capital
Start
up
($
K)
Total
O&
M
($
K)
Total
Cost
for
the
Study
($
K)

Respondent
60
14,520
1,174
$
0
$
0
$
11.7
Agency
­­
­­
16,110
$
9.9
$
17.7
$
1.251
TOTAL
­­
­­
17,284
$
9.9
$
17.7
$
1.264
(
ii)
Agency
Tally
The
bottom
line
burden
hours
and
costs
for
the
Agency
for
the
three
years
of
the
study
were
shown
in
Table
8.
The
total
Agency
labor
burden
(
Table
8)
is
16,110
hours
(
89.5
hours
per
respondent
times
60
respondents
times
3
years).
The
Total
Agency
Cost
is
$
1,251,766
($
6,954
times
60
respondents
times
3
years),
as
shown
in
Table
9.

iii.
Variations
in
the
Annual
Bottom
Line
Significant
variations
(>
25%)
are
not
anticipated
in
the
annual
respondent
burden.
The
data
collection
events
are
expected
to
begin
in
the
middle
of
2004
and
end
in
2006,
resulting
in
a
similar
number
of
data
collections
in
each
of
the
three
years.

6(
f).
Reasons
for
Change
in
Burden
This
section
is
inapplicable
to
this
ICR.

6(
g).
Burden
Statement
The
annual
public
reporting
and
recordkeeping
burden
for
this
collection
of
information
is
estimated
to
average
6.52
hours
per
person
per
year.
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;
33
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
0011,
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
Office
of
Environmental
Information
Docket
is
(
202)
566­
1752.
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
Officer
for
EPA.
Please
include
the
EPA
ICR
No.
2126.01
in
any
correspondence.

References
Cohen
Hubal,
E.
A.,
L.
S.
Sheldon,
M.
J.
Zufall,
J.
M.
Burke,
K.
W.
Thomas.
2000a.
The
challenge
of
assessing
children's
exposure
to
pesticides.
JEAEE
10:
638­
649.

Cohen
Hubal,
E.
A.,
L.
S.
Sheldon,
J.
M.
Burke,
T.
R.
McCurdy,
M.
R.
Berry,
M.
L.
Rigas,
V.
G.
Zartarian,
N.
C.
G.
Freeman.
2000b.
Children's
exposure
assessment:
a
review
of
factors
influencing
children's
exposure,
and
the
data
available
to
characterize
and
assess
that
exposure.
Environ
Hlth
Perspect
108:
475­
486.

Freeman,
N.
C.
G.,
M.
Jimenez,
K.
J.
Black,
S.
Gurunathan,
R.
D.
Edwards,
A.
Roy,
J.
L.
Adgate,
E.
D.
Pellizzari,
J.
Quackenboss,
K.
Sexton,
P.
J.
Lioy.
2001.
Quantitative
analysis
of
children's
microactivity
patterns:
the
Minnesota
children's
pesticide
exposure
study.
JEAEE
11(
6):
501­
509.

Freeman,
N.
C.
G.,
P.
J.
Lioy,
E.
Pellizzari,
H.
Zelon,
K.
Thomas,
A.
Clayton,
J.
Quackenboss.
1999.
Responses
to
the
region
5
NHEXAS
time/
activity
diary.
JEAEE
9(
5):
414­
426.

Hansen,
KJ,
HO
Johnson,
JS
Eldridge,
JL
Butenhoff,
LA
Dick.
2002.
Quantitative
characterization
of
trace
levels
of
PFOS
and
PFOA
in
the
Tennessee
River.
Environ
Sci
Technol
34
36(
8):
1681­
1685.

Hoppin,
JA,
JW
Brock,
BJ
Davis,
DD
Baird.
2002.
Reproducibility
of
urinary
phthalate
metabolites
in
first
morning
urine
samples.
Environ
Hlth
Perspect
110(
5):
515­
518.

Hore,
P.
2003.
Pesticide
accumulation
patterns
for
child
accessible
surfaces
and
objects
and
urinary
metabolite
excretion
by
children
for
two
weeks
after
a
professional
crack
and
crevice
application.
Dissertation.
Rutgers
Univeristy.

Koo,
J­
W,
F
Parham,
MC
Kohn,
SA
Masten,
JW
Brock,
LL
Needham,
CJ
Portier.
2002.
The
association
between
biomarker­
based
exposure
estimates
for
phthalates
and
demographic
factors
in
a
human
reference
population.
Environ
Hlth
Perspect
110(
4):
405­
410.

Loewenherz,
C.,
R.
A.
Fenske,
N.
J.
Simcox,
G.
Bellamy,
D.
Kalman.
1997.
Biological
monitoring
of
organophosphorus
pesticide
exposure
among
children
of
agricultural
workers
in
central
Washington
State.
Environ
Hlth
Perspect
105(
12):
1344­
1353.

Melnyk,
J.
J.,
M.
R.
Berry,
L.
S.
Sheldon.
1997.
Dietary
exposure
from
pesticide
application
on
farms
in
the
agricultural
health
pilot
study.
JEAEE
7(
1):
61­
80.

Quackenboss,
JJ,
ED
Pellizzari,
P
Shubat,
RW
Whitmore,
JL
Adgate,
KW
Thomas,
NCG
Freeman,
C
Stroebel,
PJ
Lioy,
AC
Clayton,
K
Sexton.
2000.
Design
strategy
for
assessing
multipathway
exposure
for
children:
the
Minnesota
Children's
Pesticide
Exposure
Study
(
MNCPES).
JEAEE
10(
2):
145­
158.

Reed,
K.
J.,
M.
Jimenez,
N.
C.
G.
Freeman,
P.
J.
Lioy.
1999.
Quantification
of
children's
hand
and
mouthing
activities
through
a
videotaping
methodology.
JEAEE
9(
5):
513­
520.

Rice,
CP,
SM
Chernyak,
L
Begnoche,
R
Quintal,
J
Hickey.
2002.
Comparisons
of
PBDE
composition
and
concentration
in
fish
collected
from
the
Detroit
River,
MI
and
Des
Plaines
River,
IL.
Chemosphere
49:
731­
737.

Shalat,
S.
L.,
K.
C.
Donnelly,
N.
C.
G.
Freeman,
J.
A.
Calvin,
S.
Ramesh,
M.
Jimenez,
K.
Black,
C.
Coutinho,
L.
L.
Needham,
D.
B.
Barr,
J.
Ramirez.
2003.
Nondietary
ingestion
of
pesticides
by
children
in
an
agricultural
community
on
the
US/
Mexico
border:
preliminary
results.
JEAEE
13:
42­
50.

Simcox,
N.
J.,
R.
A.
Fenske,
S.
A.
Wolz,
I.
C.
Lee,
D.
A.
Kalman.
1995.
Pesticides
in
household
dust
and
soil:
exposure
pathways
for
children
of
agricultural
families.
Environ
Hlth
Perspect
103(
12):
1126­
1134.

US
EPA
1999.
Exposure
Data
Requirements
for
Assessing
Risks
from
Pesticide
Exposure
of
Children.
Office
of
Pesticide
Programs,
U.
S.
Environmental
Protection
Agency,
Washington,
D.
C.,
Federal
Register:
September
7,
1999
(
Volume
64,
Number
172),
Notices,
Page
48617­
48618,
March
1999.
http://
www.
epa.
gov/
oppfead1/
trac/
science/#
10­
fold
35
US
EPA
2003.
Draft
Protocol
for
Measuring
Children's
Non­
Occupational
Exposure
to
Pesticides
by
all
Relevant
Pathways.
Office
of
Research
and
Development,
Washington,
D.
C.
EPA/
600/
R­
03/
026.

US
EPA
2000.
Strategy
for
Research
on
Environmental
Risks
to
Children.
Office
of
Research
and
Development,
Washington,
D.
C.
EPA/
600/
R­
00/
068,
August,
2000.
http://
www.
epa.
gov/
ncea/
risk2kids.
htm
Zartarian,
V.
G.,
A.
C.
Ferguson,
J.
O.
Leckie.
1997.
Quantified
dermal
activity
data
from
a
fourchild
pilot
field
study.
JEAEE
7(
4):
543­
552.

Zartarian,
V.
G.,
A.
C.
Ferguson,
J.
O.
Leckie.
1998.
Quantified
mouthing
activity
data
from
a
four­
child
pilot
field
study.
JEAEE
8(
4):
543­
553.

Zartaria,
V.
G.,
J.
Streicher,
A.
Rivera,
C.
S.
Cornejo,
S.
Molina,
O.
F.
Valadez,
J.
O.
Leckie.
1995.
A
pilot
study
to
collect
micro­
activity
data
of
two­
to
four­
year­
old
farm
labor
children
in
Salinas
Valley,
California.
JEAEE
5(
1):
21­
34.
36
APPENDIX
TO
PART
A:
SUPPORTING
STATEMENT
FOR
INFORMATION
COLLECTION
REQUEST
2126.01
LONGITUDINAL
STUDY
OF
YOUNG
CHILDREN'S
EXPOSURES
IN
THEIR
HOMES
TO
SELECTED
PESTICIDES,
PHTHALATES,
BROMINATED
FLAME
RETARDANTS,
AND
PERFLUORINATED
CHEMICALS
Short
Title
­
A
Children's
Environmental
Exposure
Research
Study
(
CHEERS)

INFORMATION
COLLECTION
REQUEST
Rationale
for
Data
Collection
Forms
37
Eligibility
Screening
Questionnaire
(
Version
Final
Draft
11/
24/
2003)

Qx
#
Question
Rationale
Analytic
Use
1
Do
you
live
in
Duval
County?
Information
to
verify
where
potential
participant
may
live.
Used
to
determine
eligibility;

analysis
will
be
on
the
spot
as
the
responses
"
no",
"
don't
know",
or
"
refused
to
answer"
are
exclusion
criteria.

2,
2A,

2B,
2C
Are
you
the
parent
or
legal
guardian
of
a
child
under
the
age
of
14
months?
If
you
are
pregnant,
what
is
your
due
date?
How
many
children
under
the
age
of
14
months
do
you
have?
What
is
the
child's
date
of
birth?
Information
to
verify
whether
the
potential
participant
has
a
child
in
the
appropriate
age
range.
Used
to
determine
eligibility;

analysis
will
be
on
the
spot
as
the
responses
"
no",
"
don't
know"
or
"
refused
to
answer"
are
exclusion
criteria.

3,
3A
(
Does
your
child/
Do
your
children)
under
the
age
of
14
months
stay
home
during
the
week
(
that
is,
not
attend
a
day
care
or
stay
with
a
baby
sitter
at
a
place
away
from
your
home)?
How
many
days
per
week
and
hours
per
day
(
does/
do)
your
(
child/
children)
go
to
a
day
care
center
or
baby
sitter
away
from
home?
Information
to
verify
whether
the
potential
participant
has
a
child
who
attends
day
care.
Participants
who
answer
positively
to
this
question
will
be
retained
in
the
pool
of
eligible
participants
in
the
event
that
recruitment
is
low.
Used
to
determine
eligibility.

4,
4A,
4B
Do
you
plan
on
sending
your
child
under
the
age
of
14
months
to
a
day
care
or
a
baby
sitter's
home
in
the
near
future?
At
what
age
(
how
many
months
old)
do
you
plan
on
sending
your
child
to
a
day
care
or
a
baby
sitter's
home?
About
how
many
days
per
week
and
hours
per
day
do
you
plan
on
sending
your
(
child/
children)
to
a
day
care
center
or
a
baby
sitter's
home?
Information
to
determine
whether
the
child
will
be
away
from
home
for
extensive
periods
of
time.
Used
to
determine
eligibility.
Qx
#
Question
Rationale
Analytic
Use
38
5
Are
pesticides
or
chemicals
to
kill
bugs
used
inside
your
home?
Potential
participants
need
to
be
regular
pesticide
users
to
participate
in
this
study.
Used
to
determine
eligibility;

analysis
will
be
on
the
spot
as
the
responses
"
no",
"
don't
know"
or
"
refused
to
answer"
are
exclusion
criteria.

6,
6A,
6B
How
long
have
you
lived
in
your
current
home?
Do
you
plan
on
living
in
your
current
home
for
at
least
the
next
two
years?

Will
you
be
moving
to
a
different
home
within
Duval
County?
Potential
participants
need
to
be
residents
of
Duval
County
for
the
entire
study
period.
Used
to
determine
eligibility.

7
Children's
exposures
may
change
as
they
grow
older
and
engage
in
different
activities.
We
would
like
to
study
children's
exposures
to
pesticides
and
chemicals
in
their
homes
for
two
years.
If
you
were
selected
to
participate
in
this
study,
would
you
be
willing
to
participate
in
this
study
for
up
to
two
years?
This
study
is
a
longitudinal
study
and
participants
will
have
to
interact
with
the
field
technicians
for
two
full
years.
Used
to
determine
eligibility.

8
In
this
study,
we
want
to
evaluate
your
child's
potential
exposure
to
pesticides
that
you
use
to
kill
bugs
in
your
home.
The
timing
of
our
data
collection
activities
will
depend
on
the
time
of
your
pesticide
application.
This
is
very
important
to
the
success
of
the
study.
If
you
were
selected
to
participate
in
this
study,
would
you
be
willing
to
contact
us
and
let
us
know
when
you
plan
to
apply
pesticides
inside
your
home?
This
study
is
a
longitudinal
study
and
participants
will
have
to
interact
with
the
field
technicians
for
two
full
years.
The
potential
participants
have
to
be
willing
to
inform
the
field
staff
of
planned
pesticide
activities
prior
to
them
occurring.
Used
to
determine
eligibility.
Qx
#
Question
Rationale
Analytic
Use
39
9
For
us
to
understand
how
your
child
is
potentially
exposed
to
pesticides,
we
will
ask
you
to
collect
some
samples
of
the
food
your
child
eats,
to
collect
some
urine
samples,
and
to
videotape
some
of
your
child's
activities
during
each
data
collection
event.
Our
research
staff
will
show
you
how
to
do
this
and
provide
you
with
the
needed
supplies
and
the
camcorder.
If
you
were
selected
to
participate
in
this
study,

would
you
be
willing
to
help
us
conduct
these
activities?
This
study
is
a
longitudinal
study
and
participants
will
have
to
interact
with
the
field
technicians
for
two
full
years.
The
participants
would
have
to
be
willing
to
help
the
field
staff
by
collecting
samples.
Used
to
determine
eligibility.

10
Who
usually
applies
pesticides
or
chemicals
to
kill
bugs
inside
your
home?
Pesticide
usage
is
critical
to
evaluating
exposure
factors.
The
pesticide­
related
questions
allow
us
to
rank
the
potential
participants
as
low,
medium,
or
high
pesticide
users.
Used
to
determine
eligibility.

11
What
kind
of
bugs
do
you
usually
try
to
kill
inside
your
home?
Pesticide
usage
is
critical
to
evaluating
exposure
factors.
The
pesticide­
related
questions
allow
us
to
rank
the
potential
participants
as
low,
medium,
or
high
pesticide
users.
Used
to
determine
eligibility.

12
Are
pesticides
or
chemicals
that
kill
bugs
normally
applied
in
your
home
by
you
or
someone
else
using
an
aerosol
can,
sprayer
or
fogger?
Pesticide
usage
is
critical
to
evaluating
exposure
factors.
The
pesticide­
related
questions
allow
us
to
rank
the
potential
participants
as
low,
medium,
or
high
pesticide
users.
Used
to
determine
eligibility.

13
Do
you
use
any
other
types
of
chemicals
inside
your
home
to
kill
bugs,
such
as...?
Pesticide
usage
is
critical
to
evaluating
exposure
factors.
The
pesticide­
related
questions
allow
us
to
rank
the
potential
participants
as
low,
medium,
or
high
pesticide
users.
Used
to
determine
eligibility.
Qx
#
Question
Rationale
Analytic
Use
40
14,
14A
During
the
hot
months,
from
May
through
October,
did
you
use
any
pesticides
or
chemicals
to
kill
bugs
inside
your
home?

How
often
did
you
use
pesticides
or
chemicals
to
kill
bugs
during
the
hot
months?
Pesticide
usage
is
critical
to
evaluating
exposure
factors.
The
pesticide­
related
questions
allow
us
to
rank
the
potential
participants
as
low,
medium,
or
high
pesticide
users.
Used
to
determine
eligibility.

15,
15A
During
the
cold
months,
from
November
through
April,
did
you
use
any
pesticides
or
chemicals
to
kill
bugs
inside
your
home?

How
often
did
you
use
pesticides
or
chemicals
to
kill
bugs
during
the
cold
months?
Pesticide
usage
is
critical
to
evaluating
exposure
factors.
The
pesticide­
related
questions
allow
us
to
rank
the
potential
participants
as
low,
medium,
or
high
pesticide
users.
Used
to
determine
eligibility.

16
Did
anyone
use
pesticides
or
chemicals
to
kill
bugs
inside
you
home
in
the
past...?
Pesticide
usage
is
critical
to
evaluating
exposure
factors.
The
pesticide­
related
questions
allow
us
to
rank
the
potential
participants
as
low,
medium,
or
high
pesticide
users.
Used
to
determine
eligibility.

17,
17A
In
the
past
30
days,
how
many
times
did
someone
use
pesticides
or
chemicals
to
kill
bugs
inside
your
home?
Where
was
it
applied
inside
your
home?
Pesticide
usage
is
critical
to
evaluating
exposure
factors.
The
pesticide­
related
questions
allow
us
to
rank
the
potential
participants
as
low,
medium,
or
high
pesticide
users.
Used
to
determine
eligibility.

18,
18A
What
is
the
name
of
the
child
who
is
eligible
to
participate
in
the
study?
Confirm
child's
gender.
Used
to
identify
the
age
eligible
child
for
participation
in
the
study.
Identification
information.

19,
19A
What
is
your
name?
What
is
your
relationship
to
the
child?
Contact
information
for
potential
participants.
Contact
information
for
study
participants.

20
What
is
your
spouse's
(
or
partner's)
name?
Contact
information
for
potential
participants.
Contact
information
for
study
participants.

21
What
is
your
home
address?
Contact
information
for
potential
participants.
Contact
information
for
study
participants.
Qx
#
Question
Rationale
Analytic
Use
41
22,
22A,

22B,
22C,

22D,
22E
Can
you
suggest
the
best
way
to
contact
you?
Do
you
have
a
phone
number
that
we
can
reach
you?
What
is
the
phone
number?

Do
you
have
other
phone
numbers
or
pagers
that
we
can
reach
you?
What
are
the
phone
numbers?
What
will
be
the
best
times
to
call
you?
Do
you
have
an
email
address
that
we
can
reach
you?
What
is
your
email
address?
Contact
information
for
potential
participants.
Contact
information
for
study
participants.
42
Home
Pesticide
Inventory
and
Use
Screening
Questionnaire
(
Version
Final
Draft
11/
24/
2003)

Qx
#
Question
Rationale
Analytic
Use
1
Respondent's
name
Confirm
that
the
most
appropriate
person
is
answering
the
questions
on
pesticide
use.
Allows
for
interpretation
of
the
quality
of
the
data
collected.

2
Relationship
to
the
child
Confirm
that
the
most
appropriate
person
is
answering
the
questions
on
pesticide
use.
Allows
for
interpretation
of
the
quality
of
the
data
collected.

3
I
will
be
asking
you
some
questions
about
the
specific
products
of
pesticides
or
chemicals
that
have
been
used
to
kill
bugs,

rodents
(
rats),
weeds
or
grass,
inside
or
outside
your
home
during
the
past
year.

These
could
have
been
used
by
you,
a
family
member,
a
professional
pest
control
worker,
and/
or
the
building
(
or
apartment)

maintenance
staff.
You
may
no
longer
use
some
of
these
products
now,
but
we
would
still
like
to
know
what
you
have
used
during
the
past
year.
If
the
application
was
done
by
a
professional
pest
control
worker
or
the
building
(
or
apartment)
maintenance
staff,
and
you
don't
know
what
was
used
to
treat
your
home,
we
will
ask
you
to
contact
them
to
find
out
the
product
used
to
treat
your
home.
Let's
start
with
the
pesticides
and
chemicals
that
you
currently
use
in
your
home.
Field
technician
needs
the
pesticide
products
to
complete
the
inventory.
Aids
in
the
ranking
of
the
type
of
pesticide
user.

3A
Assign
the
product
code
for
each
product.
Label.
Differentiate
between
products.

3B
What
is
the
name
of
the
product?
Record
information
on
product
used.
Provides
information
on
active
ingredients,
application
information,

and
frequency
of
use.
This
information
is
used
to
rank
the
participant
as
a
low,
medium,
or
high
pesticide
user.
Qx
#
Question
Rationale
Analytic
Use
43
3C
What
is
the
EPA
registration
number?
Record
information
on
product
used.
Provides
information
on
active
ingredients,
application
information,

and
frequency
of
use.
This
information
is
used
to
rank
the
participant
as
a
low,
medium,
or
high
pesticide
user.

3D
Who
usually
applied
this
product?
Record
information
on
product
used.
Provides
information
on
active
ingredients,
application
information,

and
frequency
of
use.
This
information
is
used
to
rank
the
participant
as
a
low,
medium,
or
high
pesticide
user.

3E
How
was
this
product
applied
(
What
was
the
method
of
application?)
Record
information
on
product
used.
Provides
information
on
active
ingredients,
application
information,

and
frequency
of
use.
This
information
is
used
to
rank
the
participant
as
a
low,
medium,
or
high
pesticide
user.

3F
What
kind
of
bugs
did
you
usually
try
to
kill
with
this
product?
Did
the
participant
use
it
to
kill
weeds?
Record
information
on
product
used.
Provides
information
on
active
ingredients,
application
information,

and
frequency
of
use.
This
information
is
used
to
rank
the
participant
as
a
low,
medium,
or
high
pesticide
user.

3G1,
3G1A,

3G2,
3G2A
Was
this
product
used
during
the
hot
months
from
May
through
October?
How
often
was
it
used
between
May
and
October?
Was
this
product
used
during
the
cold
months
from
November
through
April?
How
often
was
it
used
between
November
and
April?
Record
information
on
product
used.
Provides
information
on
active
ingredients,
application
information,

and
frequency
of
use.
This
information
is
used
to
rank
the
participant
as
a
low,
medium,
or
high
pesticide
user.
Qx
#
Question
Rationale
Analytic
Use
44
3H
When
was
this
product
last
applied?
Record
information
on
product
used.
Provides
information
on
active
ingredients,
application
information,

and
frequency
of
use.
This
information
is
used
to
rank
the
participant
as
a
low,
medium,
or
high
pesticide
user.

3I
Where
was
it
applied
inside
and
outside
your
home?
Record
information
on
product
used.
Provides
information
on
active
ingredients,
application
information,

and
frequency
of
use.
This
information
is
used
to
rank
the
participant
as
a
low,
medium,
or
high
pesticide
user.

3J
Interviewer:
If
the
product
was
applied
by
a
commercial
company
or
a
building
maintenance
staff,
ask
the
participant
to
contact
the
company
to
find
out
the
product
information.
Also
obtain
the
company
information
here.
Prompting
for
information
on
products
used
but
not
in
stock,
and
commercial
applications.
Provides
a
complete
picture
of
the
pesticide
usage.
45
Participant
and
Housing
Characteristics
Questionnaire
(
Version
Final
Draft
11/
24/
2003)

Qx
#
Question
Rationale
Analytic
Use
1
Is
this
the
same
house
as
the
previous
sampled
house?
Indicates
whether
the
participant
was
living
in
the
same
home
as
the
last
sampling
period.
Determines
whether
this
questionnaire
needs
to
be
completed.

2
Since
the
last
monitoring
visit,
have
there
been
any
changes
to
the
following
house
or
household
information?
Prompts
for
specific
changes
in
the
house
characteristics
or
participant
demographics.
Prompts
for
updates
to
the
questionnaire.

A1
Which
of
the
following
best
describes
your
home?
It's...
Classification
of
housing
type.
Demographic
characterization.

A2
About
what
year
was
this
house/
building
first
built?
Classification
of
housing
type.
Demographic
characterization.

A3
Is
there
an
enclosed
garage
attached
to
this
house/
apartment?
Information
needed
to
determine
the
potential
movement
of
contaminants
from
outside
to
inside
the
house.
Used
to
track
contaminant
movement.

A4
Is
air
conditioning
used
to
cool
your
home
during
hot
weather?
Information
needed
to
estimate
air
exchange
rates
and
amount
of
mixing
in
the
house.
Estimation
of
air
exchange
rates.

A5
Which
kinds
of
air
conditioning
units
do
you
use?
Information
used
to
estimate
mixing.
Helps
to
interpret
the
concentrations
of
chemicals
measured
in
air.

A6
Do
you
use
any
heating
device
to
provide
heat
in
your
home
during
cold
weather?
Data
used
to
estimate
air
exchange
rates
and
amount
of
mixing.
Interpret
concentrations
in
air
in
the
residence.

A7
Which
kinds
of
heating
devices
or
systems
do
you
use?
Data
used
to
estimate
amount
of
mixing
in
the
residence.
Interpret
concentrations
in
air
in
the
residence.

A8
What
is
the
source
of
tap
water
in
your
home?
Response
helps
to
identify
each
unique
water
source
that
needs
to
be
collected.
Responses
will
be
used
to
limit
the
number
of
water
samples
collected
in
the
study.
Field
technician
uses
this
response
to
determine
if
a
water
sample
needs
to
be
collected.
Qx
#
Question
Rationale
Analytic
Use
46
A9­
1
Let's
start
with
the
room
where
(
participating
child's
name)
spend
most
time
doing
activities
during
the
day
(
child's
primary
play
room).
Identification
of
primary
play
room
by
caregiver.
Information
identification.

Identification
of
child's
primary
play
room
for
sample
collection.

A9A
Is
this
also
the
room
where
(
participating
child's
name)
sleeps?
Information
on
sleeping
locations
of
the
young
participant.
Identification
of
the
child's
sleeping
location
for
sample
collection.

A10,
A10A
What
type
of
floor
does
this
room
have?

Interviewer:
Check
the
room
and
estimate
the
%
of
each
floor
type.
Collection
of
flooring
type.
Used
in
the
dermal
and
indirect
ingestion
exposure
algorithms.

A10B
How
old
is
the
carpet
(
area
rug)
in
the
room?
Age
of
carpet.
Estimates
the
amount
of
dust
that
could
be
collected
for
chemical
loadings
in
the
residence.

A11
Is
there
any
ceiling
fan
in
the
room?
Response
provides
information
on
air
exchange
rates
and
mixing.
Used
to
estimate
mixing
for
air
concentrations.

A12
Is
there
a
window
air
conditioning
unit
or
portable
AC
in
this
room?
Room
inventory.
Estimate
of
air
exchange
rate
and
mixing
to
explain
the
air
concentrations.

A13,
A13A
Are
there
any
major
electronic
devices
such
as
television,
stereo,
or
computer
in
this
room?
How
many
major
electronic
devices
in
this
room?
Inventory
of
the
number
of
electronic
devices.
Responses
used
to
generate
a
brominated
flame
retardant
loading.

A14,
A14A
Are
there
any
windows
with
draperies
or
curtains
in
the
room?
How
many
windows
with
draperies
or
curtains
in
the
room?
Inventory
of
the
number
of
draperies/
textiles
in
the
residence.
Responses
used
to
generate
a
brominated
flame
retardant
loading.

A15,
A15A
Is
there
any
upholstered
furniture
(
that
is,

furniture
made
with
fabric,
padding)
in
the
room?
Please
tell
me
the
type
and
number
of
upholstered
pieces
of
furniture
in
the
room.
Inventory
for
the
amount
of
textiles
in
the
residence.
Responses
used
to
generate
a
brominated
flame
retardant
loading.
Qx
#
Question
Rationale
Analytic
Use
47
A9­
2
Now
what
about
this
room?
Complete
room
inventory.
Aids
field
technician
in
completing
room
inventory.

A9­
3
Now
what
about
this
room?
Complete
room
inventory.
Aids
field
technician
in
completing
room
inventory.

A16
What
kind(
s)
of
pets
do
you
have?
How
many
do
you
have?
Response
aids
in
cataloging
the
number
and
type
of
pets.
Used
to
determine
the
potential
for
collecting
pet
wipe
samples.

A17
Do
you
keep
your
pet(
s)
inside
or
outside
the
house?
Response
aids
in
estimating
track­
in.
Used
in
assessing
the
potential
movement
of
contaminants
from
outdoors
to
indoors
by
the
pet.
Aids
in
interpretation
of
the
sample
wipe.

A18
How
often
does
(
participating
child's
name)
play
with
or
touch
the
pets?
Response
aids
in
evaluating
the
amount
of
interaction
between
the
child
participant
and
the
pets.
Used
in
the
indirect
ingestion
algorithm.

B1
How
many
people
live
in
this
household?
Response
used
for
household
demographics.
Household
demographics.

B2,
B2A
Would
you
please
tell
me
the
first
name
of
the
head
of
the
household?
This
will
help
me
finish
the
interview
quickly
and
correctly.
Interviewer:
Is
the
head
of
the
household
the
respondent?
Data
will
be
collected
on
the
two
primary
caregivers
to
the
child.
Household
demographics.

B3
What
is
((
name
in
B2)'
s/
your)

relationship
to
(
participating
child's
name)?
Contact
information.
Household
demographics.

B4
Is
(
name
in
B2)
a
male
or
female?
Response
used
to
classify
the
participant.
Household
demographics.

B5
What
is
(
the
date
of
birth
of
(
name
in
B2)/
your
date
of
birth)?
Response
used
to
classify
the
participant.
Household
demographics.

B6
What
is
the
highest
grade
or
level
of
schooling
that
(
name
in
B2/
you)

(
has/
have)
completed?
Response
used
to
classify
the
participant.
Household
demographics.
Qx
#
Question
Rationale
Analytic
Use
48
B7,
B7A
(
Is(
name
in
B2)/
Are
you)
currently
working
outside
the
home?
(
Is(
name
in
B2)/
Are
you)
currently
self­
employed
or
working
at
home?
Response
used
to
evaluate
the
potential
for
chemical
exposures
inside
the
home.
Used
to
evaluate
the
potential
for
contaminants
to
be
found
in
the
home.

B8
What
kind
of
business
or
industry
(
does
(
name
in
B2)/
do
you)
work
at?
Response
used
to
determine
potential
exposures
to
chemicals
in
the
workplace.
Used
to
predict
confounding
levels
of
chemicals.

B9
What
kind
of
work
(
does
(
name
in
B2)/
do
you)
do?
Response
used
to
determine
potential
exposures
to
chemicals
in
the
workplace.
Used
to
predict
confounding
levels
of
chemicals.

B10
(
Does
(
name
in
B2)/
Do
you)
work
with
pesticides
on
this
job?
Response
used
to
determine
potential
exposures
to
pesticides
in
the
workplace.
Used
to
predict
confounding
levels
of
pesticides.

B11A
(
Does
(
name
in
B2)/
Do
you)
work
in
a
manufacturing
job
or
industry
where
the
following
types
of
chemicals
are
used?

Phthalates?
Response
used
to
determine
potential
exposures
to
phthalates,
brominated
flame
retardants,
and
perfluorinated
compounds
in
the
workplace.
Used
to
predict
confounding
levels
of
chemicals.

B11B
Brominated
flame
retardants?
Response
used
to
determine
potential
exposures
to
phthalates,
brominated
flame
retardants,
and
perfluorinated
compounds
in
the
workplace.
Used
to
predict
confounding
levels
of
chemicals.

B11C
Perfluorinated
compounds?
Response
used
to
determine
potential
exposures
to
phthalates,
brominated
flame
retardants,
and
perfluorinated
compounds
in
the
workplace.
Used
to
predict
confounding
levels
of
chemicals.

B12
Is
your
child
a...?
Data
used
to
classify
the
child
participant.
Participant
demographics.

B13
What
is
your
child's
race?
Is
he/
she...?
Data
used
to
classify
the
child
participant.
Participant
demographics.

B14,
B14A,

B14B
What
was
your
total
household
income
last
year?
Was
it...
How
many
people,

including
you,
were
supported
by
that
income?
Does
anyone
in
your
household
currently
receive
public
assistance,
such
as
food
stamps,
AFDC,
WIC,
or
any
other
government
support?
Responses
used
to
classify
the
participants.
Household
demographics.
Qx
#
Question
Rationale
Analytic
Use
49
C1
Condition
of
exterior
structure
Classification
of
exterior
of
the
house
to
estimate
chemical
usage.
Household
characteristics.

C7
Is
there
standing
water
around
the
house/
building?
Response
used
to
predict
the
likelihood
of
exterior
pesticide
applications.
Used
to
predict
pesticide
usage.

C8
Surrounding
area
Area
characterization.
Area
characterization.

C9
Sketch
locations
and
surroundings
of
the
house/
building.
Sketch
used
to
record
items
of
interest,
sampling
locations,
etc.
Sketch
for
field
notes.

Sketch
interior
of
the
house/
building.
Sketch
used
to
record
items
of
interest,
sampling
locations,
etc.
Sketch
for
field
notes.
50
Monitoring
Period
Questionnaire
(
Version
Final
Draft
11/
24/
2003)

Qx
#
Question
Rationale
Analytic
Use
A1
Interviewer:
Enter
the
dates
and
times
of
the
48­

hour
monitoring
period.
Information
entered
by
field
technician
for
interview
preparation.
Prepares
field
technician
for
interview
with
participant.

A2,
A3
Interviewer:
Measure
the
height
and
weight
of
child.
CAPI
calculates
child's
age.
Record
height
and
weight
of
child.
Data
needed
in
the
aggregate
exposure
calculations.

A4
Interviewer:
Record
(
with
verification
from
caregiver,
as
required)
child's
movements
are
primarily...
Record
mobility
of
chid.
Data
used
to
determine
sampling
locations.

A5
Interviewer:
Is
this
the
same
house?
Response
from
participant
triggers
the
field
technician
to
update
the
other
questionnaires.
Field
technician
will
analyze
the
response
and
address
the
relevant
questions.

A6
Interviewer:
Record
the
date/
time
of
pesticide
application.
Review
monthly
pesticide
use
log.

Record
application
and
EPA
registration
number.
Field
technician
records
the
information
to
document
the
specific
pesticide
application
and
confirm
that
an
application
did
occur.
Confirm
pesticide
application.

A7
Since
our
last
visit,
have
any
of
the
following
renovations
or
repairs
been
performed
in
your
home?
Response
provides
information
on
household
activities
that
may
lead
to
introduction
of
chemicals
inside
the
residence
that
could
affect
sampling.
Provides
evidence
of
household
alterations
that
may
impact
chemical
loadings
in
the
residence.

A8,
A8A
Have
there
been
any
other
changes
to
your
home,
household
members
or
activities
since
our
last
visit?
What
sort
of
changes?
Responses
may
include
anything
that
the
field
technician
has
not
specifically
asked
about.
Open­
ended
question
to
collect
information
that
may
have
not
been
recorded
elsewhere.

B1
During
the
last
48­
hours,
were
any
doors
or
windows
opened
to
allow
for
natural
air
ventilation?
Response
used
to
estimate
mixing
in
the
home.
Estimate
air
exchange
rate.

B2
During
the
last
48­
hours,
were
any
fans
or
heating/
air
conditioning
units
used?
Response
used
to
estimate
mixing
in
the
home.
Estimate
air
exchange
rate.
Qx
#
Question
Rationale
Analytic
Use
51
B3,
B3A
During
the
last
48­
hours,
did
anyone
dust,

sweep,
wet
mop,
vacuum,
or
steam­
clean
your
home
(
any
rooms)?
Please
tell
me
which
rooms
were
cleaned
and
how
it
was
cleaned.
Responses
used
to
record
cleaning
habits
during
the
monitoring
period.
Responses
used
to
interpret
any
anomalies
in
the
data.

B4
Have
you
used
the
following
toiletries
or
medical
products
on
(
child's
name)
during
the
last
48
hours?
Response
used
to
assess
potential
exposures
to
products
that
may
contain
phthalates.
Analyze
data
and
validate
relationship
between
questionnaire
response
and
biomarker
data.

B5
Does
(
participating
child's
name)
frequently
play
in
the
yard
that
would
involve
contact
with
soil?
Response
used
to
assess
potential
exposures
to
outdoor
chemicals.
Response
used
in
the
dermal
and
indirect
ingestion
exposure
algorithms.

B6
Have
the
following
chemical
products
been
used
in
your
home
during
the
last
48
hours
(
whether
by
you
or
others)?
Response
used
to
assess
potential
exposures
to
products
that
may
contain
phthalates.
Analyze
data
and
validate
relationship
between
questionnaire
response
and
biomarker
data.

B7
Were
any
of
the
following
cleaning
products
used
in
your
home
during
the
last
48
hours
(
whether
by
you
or
others)?
Response
used
to
assess
potential
exposures
to
products
that
may
contain
phthalates.
Analyze
data
and
validate
relationship
between
questionnaire
response
and
biomarker
data.

B8
Have
you
used
the
following
toiletries
and
cosmetics
during
the
last
48
hours?
Response
used
to
assess
potential
exposures
to
products
that
may
contain
phthalates.
Analyze
data
and
validate
relationship
between
questionnaire
response
and
biomarker
data.

B9
Are
you
(
still)
breastfeeding
(
child's
name)?
Response
used
to
assess
potential
exposures
to
products
that
may
contain
phthalates.
Analyze
data
and
validate
relationship
between
questionnaire
response
and
biomarker
data.

B9A
Did
you
visit
a
beauty
salon
during
the
last
48
hours?
Response
used
to
assess
potential
exposures
to
products
that
may
contain
phthalates.
Analyze
data
and
validate
relationship
between
questionnaire
response
and
biomarker
data.

B9B
Was
your
hair
permed,
straightened,
or
relaxed
during
the
last
48
hours?
Response
used
to
assess
potential
exposures
to
products
that
may
contain
phthalates.
Analyze
data
and
validate
relationship
between
questionnaire
response
and
biomarker
data.
Qx
#
Question
Rationale
Analytic
Use
52
B9C
Did
you
apply
hair
perm,
straightener,
or
relaxer
to
your
own
hair
or
someone
else's
hair
during
the
last
48
hours?
Response
used
to
assess
potential
exposures
to
products
that
may
contain
phthalates.
Analyze
data
and
validate
relationship
between
questionnaire
response
and
biomarker
data.

B9D,
B9D1
Was
your
hair
colored
or
highlighted
during
the
last
48
hours?
Please
tell
me
what
type
of
coloring
was
used.
Was
it...?
Response
used
to
assess
potential
exposures
to
products
that
may
contain
phthalates.
Analyze
data
and
validate
relationship
between
questionnaire
response
and
biomarker
data.

B9E,
B9E1
Did
you
apply
a
hair­
coloring
product
to
your
own
hair
or
someone
else's
hair
during
the
last
48
hours?
Please
tell
me
what
type
of
coloring
was
used.
Was
it...?
Response
used
to
assess
potential
exposures
to
products
that
may
contain
phthalates.
Analyze
data
and
validate
relationship
between
questionnaire
response
and
biomarker
data.

B9F
Was
nail
polish
removed
or
applied
to
your
finger
or
toe
nails
during
the
last
48
hours?
Response
used
to
assess
potential
exposures
to
products
that
may
contain
phthalates.
Analyze
data
and
validate
relationship
between
questionnaire
response
and
biomarker
data.

B9G
Did
you
apply
or
remove
nail
polish
from
your
own
or
someone
else's
nails
during
the
last
48
hours?
Response
used
to
assess
potential
exposures
to
products
that
may
contain
phthalates.
Analyze
data
and
validate
relationship
between
questionnaire
response
and
biomarker
data.

B9H
Did
you
have
someone
apply,
fill,
or
remove
artificial
nails
for
you
during
the
last
48
hours?
Response
used
to
assess
potential
exposures
to
products
that
may
contain
phthalates.
Analyze
data
and
validate
relationship
between
questionnaire
response
and
biomarker
data.

B9I
Did
you
apply,
fill,
or
remove
artificial
nails
for
someone
during
the
last
48
hours?
Response
used
to
assess
potential
exposures
to
products
that
may
contain
phthalates.
Analyze
data
and
validate
relationship
between
questionnaire
response
and
biomarker
data.

B10,
B10A,

B10B,

B10C
The
next
few
questions
are
about
your
pets.
If
you
have
a
dog
or
a
cat,
did
(
child's
name)
play
with,
and
have
contact
with
it
during
the
last
48
hours?
We
would
like
to
see
if
there
are
any
pesticides
on
your
pet's
fur
by
wiping
a
dry
cloth
across
your
pet.
May
we
collect
the
sample?
What
is
your
pet's
name?
Interviewer:

Record
whether
the
pet
is
a
cat
or
a
dog.
Response
used
to
record
information
on
interactions
with
pets.
Also
aids
in
proper
sample
collection.
Response
aids
in
collecting
the
sample
from
the
pet
that
the
child
interacts
with
in
the
event
there
is
more
than
one
pet
in
the
household.
Qx
#
Question
Rationale
Analytic
Use
53
C1
On
the
day
of
the
pesticide
application,
did
you
use
a
central
forced
air
system
for
air
conditioning
or
heating?
Response
used
to
evaluate
the
amount
of
air
mixing
in
the
house.
Estimates
mixing
and
air
exchange
rates.

D1
Interviewer:
Verify
with
the
participant
about
the
item
provided
to
the
child.
Response
used
to
verify
standard
object
provided
to
the
child
during
the
study.
Data
collected
for
inputs
to
the
indirect
ingestion
exposure
algorithm.

D2,
D2A,

D2B
Did
your
child
use
the
item
during
the
last
24
hours?
Approximately,
how
many
hours
during
the
last
24­
hour
period?
How
long
has
it
been
since
your
child
sucked
on
the
(
item
in
D1)?
Responses
used
to
generate
exposure
factors
for
the
indirect
ingestion
algorithm.
Data
collected
for
inputs
to
the
indirect
ingestion
exposure
algorithm.

D3
Is
(
child's
name)
currently
teething?
Response
used
to
assess
the
likelihood
of
mouthing
because
of
the
developmental
stage.
Data
collected
for
inputs
to
the
indirect
ingestion
exposure
algorithm.

D4,
D4A
Does
(
child's
name)
use
a
pacifier?
How
often
does
(
child's
name)
use
a
pacifier?
Response
used
to
assess
the
likelihood
of
mouthing
because
of
the
developmental
stage.
Data
collected
for
inputs
to
the
indirect
ingestion
exposure
algorithm.

D5,
D5A
How
often
does
(
child's
name)
put
his/
her
hands
into
his/
her
mouth
when
indoors?
How
much
of
his/
her
hand
does
he/
she
generally
put
into
his/
her
mouth
when
indoors?
Responses
used
to
assess
mouthing
of
hands
and
objects
of
the
child
participant.
Data
collected
for
inputs
to
the
indirect
ingestion
exposure
algorithm.

D6,
D6A
How
often
does
(
child's
name)
put
his/
her
hands
into
his/
her
mouth
when
outdoors?
How
much
of
his/
her
hand
does
he/
she
generally
put
into
his/
her
mouth
when
outdoors?
Responses
used
to
assess
mouthing
of
hands
and
objects
of
the
child
participant.
Data
collected
for
inputs
to
the
indirect
ingestion
exposure
algorithm.

D7
How
often
does
(
child's
name)
put
objects
into
his/
her
mouth
when
indoors?
Responses
used
to
assess
mouthing
of
hands
and
objects
of
the
child
participant.
Data
collected
for
inputs
to
the
indirect
ingestion
exposure
algorithm.

D8
How
often
does
(
child's
name)
put
objects
into
his/
her
mouth
when
outdoors?
Responses
used
to
assess
mouthing
of
hands
and
objects
of
the
child
participant.
Data
collected
for
inputs
to
the
indirect
ingestion
exposure
algorithm.

D9
Please
tell
me
the
3
most
favorite
toys,
objects,

or
surfaces
that
(
child's
name)
likes
to
put
his/
her
mouth
on
while
indoors.
Field
technician
uses
this
data
to
collect
the
appropriate
field
samples
while
in
the
residence.
Data
used
to
aid
the
field
technician
in
applicable
sample
collection
for
the
indirect
ingestion
exposure
algorithm.
Qx
#
Question
Rationale
Analytic
Use
54
D10,
D10A
Does
(
child's
name)
watch
TV?
Where
does
your
child
normally
spend
time
when
watching
TV?
Responses
used
to
assess
the
likelihood
of
dermal
exposure.
Data
collected
for
inputs
to
the
dermal
exposure
algorithm.

D11
Where
does
your
child
normally
spend
time
when
playing
with
favorite
toys?
Responses
used
to
assess
the
likelihood
of
dermal
exposure.
Data
collected
for
inputs
to
the
dermal
exposure
algorithm.

D12
Where
does
your
child
normally
spend
time
when
being
read
to?
Responses
used
to
assess
the
likelihood
of
dermal
exposure.
Data
collected
for
inputs
to
the
dermal
exposure
algorithm.

D13
If
your
child
likes
to
be
on
the
floor,
how
would
you
describe
his/
her
typical
contact
with
the
floor?
Responses
used
to
assess
the
likelihood
of
dermal
exposure.
Data
collected
for
inputs
to
the
dermal
exposure
algorithm.

D14
If
your
child
likes
to
be
on
the
furniture,
how
would
you
describe
his/
her
typical
contact
with
the
furniture?
Responses
used
to
assess
the
likelihood
of
dermal
exposure.
Data
collected
for
inputs
to
the
dermal
exposure
algorithm.

D15
Except
when
(
child's
name)
is
sleeping,

typically
when
he/
she
is
laying
on
his/
her
back,

stomach,
or
side,
would
you
describe
(
child's
name)
as...
Responses
used
to
assess
the
likelihood
of
dermal
exposure.
Data
collected
for
inputs
to
the
dermal
exposure
algorithm.

E1
Is
this
duplicate
diet
representative
of
what
(
child's
name)
normally
eats
in
a
24­
hour
period?
Response
confirms
data
collected
in
food
diary.
Data
to
confirm
food
diary
and
foods
typically
eaten.

E1A,
E1A1,

E1A2
Was
breakfast
different?
Why
was
breakfast
not
usual?
Did
(
child's
name)
eat
more
than
the
sample
collected,
did
he/
she
eat
less,
or
did
he/
she
simply
eat
different
food?
Why
did
this
happen?
If
the
response
to
E1
was
"
no"
or
"
don't
know",

then
the
field
technician
asks
about
each
individual
meal
to
determine
which
meal
is
different
and
why.
Data
collected
for
inputs
to
the
dietary
exposure
algorithm.

E1B,
E1B1,

E1B2
Was
lunch
different?
Why
was
lunch
not
usual?

Did
(
child's
name)
eat
more
than
the
sample
collected,
did
he/
she
eat
less,
or
did
he/
she
simply
eat
different
food?
Why
did
this
happen?
If
the
response
to
E1
was
"
no"
or
"
don't
know",

then
the
field
technician
asks
about
each
individual
meal
to
determine
which
meal
is
different
and
why.
Data
collected
for
inputs
to
the
dietary
exposure
algorithm.
Qx
#
Question
Rationale
Analytic
Use
55
E1C,
E1C1,

E1C2
Was
dinner
different?
Why
was
dinner
not
usual?
Did
(
child's
name)
eat
more
than
the
sample
collected,
did
he/
she
eat
less,
or
did
he/
she
simply
eat
different
food?
Why
did
this
happen?
If
the
response
to
E1
was
"
no"
or
"
don't
know",

then
the
field
technician
asks
about
each
individual
meal
to
determine
which
meal
is
different
and
why.
Data
collected
for
inputs
to
the
dietary
exposure
algorithm.

E1D,
E1D1,

E1D2
Were
snacks
different?
Why
were
snacks
not
usual?
Did
(
child's
name)
eat
more
than
the
sample
collected,
did
he/
she
eat
less,
or
did
he/
she
simply
eat
different
food?
Why
did
this
happen?
If
the
response
to
E1
was
"
no"
or
"
don't
know",

then
the
field
technician
asks
about
each
individual
meal
to
determine
which
meal
is
different
and
why.
Data
collected
for
inputs
to
the
dietary
exposure
algorithm.

F1
In
the
next
question,
I
will
read
a
list
of
activities
related
to
eating
habits.
Please
tell
me
whether
(
child's
name)
did
it
during
the
last
24­

hours...
Responses
used
to
evaluate
the
potential
added
chemical
contaminations
in
the
diet
from
the
habits
of
the
child
while
eating.
Data
collected
for
inputs
to
the
dietary
and
indirect
ingestion
exposure
algorithms.

F2
For
(
child's
name)'
s
age,
do
you
think
his/
her
eating
habits
are...?
Response
used
to
determine
eating
behavior
based
on
observations.
Describes
eating
behavior.

F3
Interviewer:
Was
the
child
provided
a
standard
food
object?
Response
used
to
record
whether
the
standard
food
item
was
provided
and
then
used
by
the
child.
Assess
and
generate
exposure
factors
on
indirect
ingestion
based
on
a
standard
food
item.
Data
collected
for
inputs
to
the
dietary
and
indirect
ingestion
exposure
algorithms
based
on
a
standard
food
item
provided
to
the
children.

F3A
The
following
questions
are
about
the
cheese
cube
we
provided
to
(
child's
name).
I
will
read
a
list
of
eating
activities.
Please
tell
me
whether
(
child's
name)
did
it
all
the
time,
frequently,

occasionally,
rarely,
or
never
when
he/
she
was
eating
the
cheese
cube.
Response
used
to
record
whether
the
standard
food
item
was
provided
and
then
used
by
the
child.
Assess
and
generate
exposure
factors
on
indirect
ingestion
based
on
a
standard
food
item.
Data
collected
for
inputs
to
the
dietary
and
indirect
ingestion
exposure
algorithms
based
on
a
standard
food
item
provided
to
the
children.

F3B
For
(
child's
name)'
s
age,
do
you
think
the
way
he/
she
ate
the
cheese
cube
was...?
Response
used
to
record
observations
on
eating
a
standard
food.
Describes
eating
behavior.
Qx
#
Question
Rationale
Analytic
Use
56
G1,
G1A
In
the
past
three
months,
how
many
times
has
(
child's
name)
visited
a
health
care
provider
such
as
a
doctor
or
nurse
practitioner
for
health
conditions?
What
was
the
reason
or
reasons
that
(
child's
name)
went
to
the
health
care
provider
for
the
(
first)
visit?
Response
used
to
record
types
of
illnesses
experienced
by
the
child.
Analyzed
to
evaluate
the
general
health
and
well­
being
of
the
study
participants.
57
Activity
Time
Line
(
Version
Final
Draft
11/
24/
2003)

Diary
used
by
caregiver
to
record
microenvironment
and
macroactivity
information
needed
in
the
models
to
estimate
aggregate
exposure.
Also
needed
in
the
evaluation
of
the
interrelationship
between
environmental
measurements,
activity,
and
biological
markers
in
estimating
aggregate
exposure.
58
Food
Diary
(
Version
Final
Draft
11/
24/
2003)

Data
needed
in
the
models
to
estimate
dietary
ingestion
exposure
algorithms.
59
Monthly
Pesticide
Purchase,
Inventory,
and
Use
Log
(
Version
Final
Draft
11/
24/
2003)

The
data
collected
in
this
log
is
used
in
the
models
to
estimate
aggregate
exposure.
This
data
is
also
needed
to
define
the
interrelationship
between
a
pesticide
application
and
the
environmental
measurements.
60
Monthly
Cleaning
Products
Purchase,
Inventory,
and
Use
Log
(
Version
Final
Draft
11/
24/
2003)

Diaries
used
to
collect
information
on
cleaning
products
that
may
contain
pesticides
that
may
be
used
in
the
home.
This
information
is
important
to
the
Office
of
Pollution,
Prevention,
and
Toxics
(
OPPT).
OPPT
will
use
this
data
to
monitor
the
various
types
of
antimicrobial
cleaning
products
on
which
they
should
focus
their
risk
assessments.
61
Vineland
Adaptive
Behavioral
Scale
The
Vineland
Adaptive
Behavioral
Scale
is
a
semi­
structured
interview
administered
to
a
parent
or
other
primary
caregiver.
It
is
published
in
four
versions:
interview
edition,
survey
form,
expanded
form,
and
classroom
edition.
This
study
will
employ
the
survey
form
which
contains
297
items
spanning
adaptive
behavior
components
from
birth
to
age
18.
Only
a
small
fraction
of
the
available
items
will
be
used
in
the
present
study;
the
exact
number
will
be
determined
by
the
individual
child's
age
and
developmental
status.
Each
interview
will
take
approximately
20
minutes
to
complete.
Raw
scores
and
chronological
age
information
will
be
converted
to
derived
scores.
The
derived
scores
provide
norm­
referenced
information
based
on
the
performance
of
representative
national
standardization
samples
of
4,800
handicapped
and
non­
handicapped
subjects.
Interview
and
scoring
materials
are
available
in
both
Spanish
and
English.
