1
of
10
6/
22/
06
UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
HUMAN
STUDIES
REVIEW
BOARD
(
HSRB)
JUNE
27­
30,
2006
*
PUBLIC
MEETING
Tuesday,
June
27,
2006
One
Potomac
Yard
(
South
Building)
2777
Crystal
Drive
Arlington,
VA
22202
703­
305­
7090
HSRB
WEB
SITE
http://
www.
epa.
gov/
osa/
hsrb/
Docket
Telephone:
(
202)
566
1752
Docket
Number:
EPA­
HQ­
ORD­
2006­
0384
C
1:
00
PM
Introduction
and
Identification
of
Board
Members
 
Celia
Fisher,
Ph.
D.
(
HSRB
Chair)

C
1:
15
PM
Welcome
 
George
Gray,
Ph.
D.
(
EPA
Science
Advisor)

C
1:
25
PM
Opening
Remarks
 
Mr.
Jim
Jones
(
Director,
Office
of
Pesticide
Programs
[
OPP],
EPA)

C
1:
35
PM
Meeting
Administrative
Procedures
­
Paul
Lewis,
Ph.
D.
(
Designated
Federal
Officer
[
DFO],
HSRB,
OSA,
EPA)

C
1:
40
PM
Meeting
Process
 
Celia
Fisher,
Ph.
D.
(
HSRB
Chair)

C
1:
55
PM
Update
on
EPA
Follow­
up
of
HSRB
Recommendations
 
Mr.
John
Carley
(
EPA,
OPP)

C
2:
10
PM
Informational
Presentation
of
Proposed
Workshop
on
Best
Practices
for
EPA,
National
Exposure
Research
Laboratory
Observational
Human
Exposure
Measurement
Studies
­
Roy
Fortmann,
Ph.
D.
(
NERL,
Office
of
Research
and
Development,
EPA)

Chloropicrin
C
2:
30
PM
Science
and
Ethics
of
Chloropicrin
Human
Studies
 
Elissa
Reaves,
Ph.
D.
(
OPP,
EPA)
and
Mr.
John
Carley
(
OPP,
EPA)

C
3:
15
PM
Break
C
3:
30
PM
Public
Comments
C
4:
00
PM
Board
Discussion
Chloropicrin
is
a
non­
selective
soil
fumigant
whose
primary
toxic
effect
is
sensory
irritation
in
which
stimulated
free
nerve
endings
mediate
sensations
and
clinical
signs
in
the
nose,
eyes,
throat,
and
upper
respiratory
tract.
Chloropicrin
is
a
unique
soil
fumigant
in
that
it
is
also
used
as
an
indicator
chemical
or
warning
agent
(
2%
or
less
by
weight
in
formulations).
The
Agency
is
developing
an
assessment
to
estimate
inhalation
risk
to
bystanders
and
workers
from
acute
exposures
to
chloropicrin.
2
of
10
1.
Scientific
considerations:

The
Agency's
"
Weight
of
Evidence"
(
WOE)
document
and
Data
Evaluation
Records
(
DER)
for
chloropicrin
describe
the
study
design
of
the
acute
inhalation,
human
toxicity
study.
The
Agency
has
concluded
that
the
human
toxicity
study
is
appropriate
for
developing
a
point
of
departure
for
extrapolation
of
inhalation
risk
to
bystanders
and
workers
exposed
to
chloropicrin.

Please
comment
on
whether
the
study
is
sufficiently
sound,
from
a
scientific
perspective,
to
be
used
to
estimate
a
safe
level
of
inhalation
exposure
to
chloropicrin.

2.
Ethical
considerations:

The
Agency
requests
that
the
Board
provide
comment
on
the
following:

a.
Is
there
clear
and
convincing
evidence
that
the
conduct
of
the
Cain
study
was
fundamentally
unethical?

b.
Is
there
clear
and
convincing
evidence
that
the
conduct
of
the
study
was
significantly
deficient
relative
to
the
ethical
standards
prevailing
at
the
time
the
research
was
conducted?

Insect
Repellent
Product
Performance
Testing
Guideline
C
5:
00
PM
Science
and
Ethics
of
Insect
Repellent
Efficacy
Guidelines
 
Mr.
Kevin
Sweeney
(
OPP,
EPA),
Clara
Fuentes,
Ph.
D.
(
OPP,
EPA),
Roger
Gardner,
Ph.
D.
(
OPP,
EPA)
and
Mr.
John
Carley
(
OPP,
EPA)

C
6:
00
PM
Adjournment
3
of
10
UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
HUMAN
STUDIES
REVIEW
BOARD
(
HSRB)
JUNE
27­
30,
2006
*
PUBLIC
MEETING
Wednesday,
June
28,
2006
One
Potomac
Yard
(
South
Building)
2777
Crystal
Drive
Arlington,
VA
22202
703­
305­
7090
HSRB
WEB
SITE
http://
www.
epa.
gov/
osa/
hsrb/
Docket
Telephone:
(
202)
566
1752
Docket
Number:
EPA­
HQ­
ORD­
2006­
0384
C
8:
30
AM
Convene
Meeting
 
Celia
Fisher,
Ph.
D.
(
HSRB
Chair)

C
8:
40
AM
Follow­
up
From
Previous
Day's
Discussion
 
Mr.
John
Carley
(
OPP,
EPA)

Insect
Repellent
Product
Performance
Testing
Guideline
C
8:
50
AM
Public
Comments
C
9:
15
AM
Board
Discussion
The
U.
S.
EPA
Office
of
Pesticide
Programs
requests
that
the
HSRB
review
and
comment
on
the
draft
"
Product
Performance
of
Skin­
Applied
Repellents
of
Insects
and
Other
Arthropods"
Testing
Guideline
in
order
to
determine
what
changes,
if
any,
are
necessary
for
the
guideline
to
be
made
consistent
with
the
requirements
for
protection
of
human
research
subjects
set
forth
in
40
CFR
part
26.
Below
is
a
list
of
questions
that
focus
on
these
topics.

a.
What
actions
should
an
investigator
routinely
take
to
minimize
the
risks
to
human
subjects
exposed
during
laboratory
and
field
research
on
the
efficacy
of
repellents?

b.
What
types
of
toxicity
data
should
be
routinely
generated
before
an
investigator
conducts
repellent
efficacy
testing
on
human
subjects
with
a
new
product?

C
10:
15
AM
Break
C
10:
30
AM
Board
Discussion
c.
In
private
and
university
research
laboratories,
investigators
themselves
have
sometimes
served
as
research
subjects
when
assessing
chemicals
for
insect
repellent
activity.
What
scientific
and
ethical
issues
would
such
a
practice
raise?
Under
what
conditions,
if
any,
would
such
a
practice
be
acceptable?
4
of
10
d.
Please
comment
on
the
scientific
and
ethical
issues
arising
from
the
use
of
(
or
decision
not
to
use)
negative
controls
groups
in
repellent
efficacy
studies,
in
both
laboratory
and
field
studies.

e.
Please
comment
on
the
scientific
and
ethical
issues
raised
by
the
design
of
studies
to
collect
data
sufficient
to
support
assessment
of
repellent
efficacy
using
the
two
different
efficacy
metrics:
time
to
first
confirmed
bite
(
TFCB),
and
time
providing
x%
protection
of
treated
subjects
from
bites
relative
to
untreated
controls
(
RP).

f.
Please
comment
on
appropriate
approaches
for
estimating
the
minimum
number
of
subjects
needed
to
evaluate
the
level
of
efficacy
of
a
repellent
in
laboratory
and
field
studies.

g.
Please
comment
on
whether
or
not
investigators
should
have
an
ethical
obligation
to
provide
subjects
of
repellent
efficacy
research
with
insurance
to
cover
possible
future
medical
costs
or
other
losses
that
result
from
injury
or
illness
experienced
by
the
subjects
as
a
consequence
of
their
participation
in
the
research.

C
12:
30
PM
Lunch
C
1:
30
PM
Board
Discussion
h.
Please
comment
on
any
special
considerations
that
should
be
addressed
in
the
informed
consent
materials
provided
people
who
are
candidates
to
become
subjects
in
insect
repellent
efficacy
research.

i.
Does
the
HSRB
recommend
that
the
draft
guideline
be
revised?
If
so,
please
explain
what
aspects
or
sections
might
improve
with
revision.

Human
Studies
Research
Protocols
C
2:
15
PM
Introduction
 
Peter
Preuss,
Ph.
D.
(
Director,
National
Center
for
Environmental
Assessment,
Office
of
Research
and
Development,
EPA)

HSRB
Review
of
Protocol
Criteria
C
2:
45
PM
HSRB
Science
and
Ethics
Criteria
of
Human
Studies
Protocols
 
Celia
Fisher,
Ph.
D.
(
HSRB
Chair)

C
3:
30
PM
Break
C
3:
45
PM
HSRB
Science
and
Ethics
Criteria
of
Human
Studies
Protocols
 
Celia
Fisher,
Ph.
D.
(
HSRB
Chair)
5
of
10
Research
on
the
Efficacy
of
Insect
Repellents
C
4:
15
PM
Science
and
Ethics
of
Research
on
the
Efficacy
of
Insect
Repellents
 
Mr.
Kevin
Sweeney
(
OPP,
EPA),
Clara
Fuentes,
Ph.
D.
(
OPP,
EPA),
Roger
Gardner,
Ph.
D.
(
OPP,
EPA)
and
Mr.
John
Carley
(
OPP,
EPA)

C
5:
15
PM
Adjournment
6
of
10
UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
HUMAN
STUDIES
REVIEW
BOARD
(
HSRB)
PUBLIC
MEETING
Thursday,
June
29,
2006
One
Potomac
Yard
(
South
Building)
2777
Crystal
Drive
Arlington,
VA
22202
703­
305­
7090
HSRB
WEB
SITE
http://
www.
epa.
gov/
osa/
hsrb/
Docket
Telephone:
(
202)
566
1752
Docket
Number:
EPA­
HQ­
ORD­
2006­
0310
C
8:
30
AM
Convene
Meeting
 
Celia
Fisher,
Ph.
D.
(
HSRB
Chair)

C
8:
40
AM
Follow­
up
From
Previous
Day's
Discussion
 
Mr.
John
Carley
(
OPP,
EPA)

Research
on
the
Efficacy
of
Insect
Repellents
C
8:
50
AM
Public
Comments
C
9:
20
AM
Board
Discussion
Study
EMD­
003
from
Carroll­
Loye
Biological
Research
a.
Does
the
proposed
research
described
in
[
name
/
designation
of
the
protocol]
appear
likely
to
generate
scientifically
reliable
data,
[
useful
for
assessing
the
efficacy
of
the
repellent]
/
[
useful
(
together
with
other
data)
assessing
the
potential
levels
of
pesticide
exposure
received
by
people
when
mixing,
loading
or
applying
a
pesticides]?

b.
Does
the
proposed
research
described
in
Study
EMD­
003
from
Carroll­
Loye
Biological
Research
appear
to
comport
with
the
applicable
requirements
of
40
CFR
part
26,
subparts
K
and
L?

C
10:
15
AM
Break
C
10:
30
AM
Board
Discussion
Study
EMD­
004
from
Carroll­
Loye
Biological
Research
a.
Does
the
proposed
research
described
in
Study
EMD­
004
from
Carroll­
Loye
Biological
Research
appear
likely
to
generate
scientifically
reliable
data,
useful
for
assessing
the
efficacy
of
a
test
substance
for
repellent
ticks?
7
of
10
b.
Does
the
proposed
research
described
in
Study
EMD­
004
from
Carroll­
Loye
Biological
Research
appear
to
comport
with
the
applicable
requirements
of
40
CFR
part
26,
subparts
K
and
L?

C
11:
45
AM
Lunch
Research
on
Agricultural
Handlers'
Exposure
to
Pesticides
C
12:
45
PM
Science
and
Ethics
of
Research
on
Agricultural
Handler's
Exposure
to
Pesticides
­
Mr.
Jeffrey
Dawson,
(
OPP,
EPA),
Mr.
Jeffrey
Evans
(
OPP,
EPA)
and
Mr.
John
Carley
(
OPP,
EPA)

C
1:
45
PM
Public
Comments
C
2:
15
PM
Board
Discussion
The
Agricultural
Handlers
Exposure
Task
Force
(
AHETF)
has
submitted
protocols
for
five
pesticide
exposure
studies
that
are
part
of
a
larger
research
program
the
AHETF
is
conducting.
The
premise
of
the
AHETF
research
program
is
that
data
can
be
used
generically
by
various
stakeholders
(
e.
g.,
applicants,
registrants,
EPA,
and
others)
for
calculating
exposures
for
the
occupational
handlers
of
pesticides.
The
scope
of
the
AHETF
research
program
is
very
broad
in
that
it
intends
to
address
exposures
related
to
many
job
functions
in
agriculture
and
also
to
assess
generally
the
impacts
of
various
parameters
on
exposure
(
e.
g.,
How
do
changes
in
the
pounds
of
pesticide
handled
or
acres
treated
affect
exposure
levels?).
The
protocols
submitted
for
HSRB
review
describe
studies
to
measure
exposures
for
five
specific
scenarios
(
i.
e.,
closed
or
open
system
mixing/
loading
,
airblast
applications
to
trellis
and
orchard
crops,
or
pilot
exposures
from
fixed
wing
agricultural
aircraft).

The
Agency
believes
these
studies
improve
EPA's
ability
to
assess
the
risks
of
using
pesticides
because
the
data
will
reflect
current
agricultural
practices,
equipment
and
techniques
and
will
allow
for
more
refined
exposure
estimates.
Further,
the
monitoring
techniques
to
be
used
for
these
studies
also
have
been
standardized
for
use
across
the
AHETF
research
program..
These
more
refined
and
reliable
data
will
allow
the
Agency
to
estimate
better
how
worker
exposure
levels
are
affected
by
changes
in
various
factors
such
as
the
amount
of
active
ingredient
handled,
type
of
application
equipment
used,
application
rate
used,
volumes
handled,
and
personal
protective
equipment
used.

It
should
be
noted,
however,
that
the
use
of
the
data
generated
in
this
study
by
the
U.
S.
EPA
and
other
stakeholders
will
depend
upon
the
nature
of
the
results.
For
example,
the
adequacy
of
the
field
or
laboratory
quality
control
data
may
dictate
that
correction
factors
are
applied
to
adjust
monitored
exposure
levels
to
account
for
losses
from
field
samplers
or
low
performing
analytical
methods.

1.
AHETF
Closed
System
Mixing/
Loading
of
Liquids
Protocol
a.
Does
the
proposed
research
described
in
Study
No.
AHE34
from
the
Agricultural
Handlers
Exposure
Task
Force
appear
likely
to
generate
8
of
10
scientifically
reliable
data,
which
will
be
useful,
together
with
other
data,
for
assessing
the
potential
levels
of
pesticide
exposure
received
by
people
when
mixing,
loading
or
applying
a
liquid
pesticide
with
closed
systems?
[
Note:
In
a
few
cases,
corresponding
application
events
are
also
to
be
monitored;
the
same
question
applies
to
those
elements
of
the
study.]

b.
Does
the
proposed
research
described
in
Study
No.
AHE34
from
the
Agricultural
Handlers
Exposure
Task
Force
appear
to
comport
with
the
applicable
requirements
of
40
CFR
part
26,
subparts
K
and
L?

C
3:
15
PM
Break
C
3:
15
PM
Board
Discussion
2.
AHETF
Airblast
Application
to
Trellis
Crops
in
the
West
Protocol
a.
Does
the
proposed
research
described
in
Study
No.
AHE36
from
the
Agricultural
Handlers
Exposure
Task
Force
appear
likely
to
generate
scientifically
reliable
data,
which
will
be
useful,
together
with
other
data,
for
assessing
the
potential
levels
of
pesticide
exposure
received
by
people
when
making
an
airblast
application
of
a
pesticide
to
a
trellis
crop
under
conditions
found
in
the
western
United
States?
[
Note:
In
a
few
cases,
corresponding
mixing/
loading
events
are
also
to
be
monitored;
the
same
question
applies
to
those
elements
of
the
study.]

b.
Does
the
proposed
research
described
in
Study
No.
AHE36
from
the
Agricultural
Handlers
Exposure
Task
Force
appear
to
comport
with
the
applicable
requirements
of
40
CFR
part
26,
subparts
K
and
L?

3.
AHETF
Airblast
Application
to
Trellis
Crops
in
the
East
Protocol
a.
Does
the
proposed
research
described
in
Study
No.
AHE37
from
the
Agricultural
Handlers
Exposure
Task
Force
appear
likely
to
generate
scientifically
reliable
data,
which
will
be
useful,
together
with
other
data,
for
assessing
the
potential
levels
of
pesticide
exposure
received
by
people
when
making
an
airblast
application
of
a
pesticide
to
a
trellis
crop
under
conditions
found
in
the
eastern
United
States?
[
Note:
In
a
few
cases,
corresponding
mixing/
loading
events
are
also
to
be
monitored;
the
same
question
applies
to
those
elements
of
the
study.]

b.
Does
the
proposed
research
described
in
Study
No.
AHE37
from
the
Agricultural
Handlers
Exposure
Task
Force
appear
to
comport
with
the
applicable
requirements
of
40
CFR
part
26,
subparts
K
and
L?

C
5:
00
PM
Adjournment
9
of
10
UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
HUMAN
STUDIES
REVIEW
BOARD
(
HSRB)
PUBLIC
MEETING
Friday,
June
30,
2006
One
Potomac
Yard
2777
Crystal
Drive
Arlington,
VA
22202
703­
305­
7090
C
8:
30
AM
Convene
Meeting
 
Celia
Fisher,
Ph.
D.
(
HSRB
Chair)

C
8:
40
AM
Follow­
up
From
Previous
Day's
Discussion
 
Mr.
John
Carley
(
OPP,
EPA)

Research
on
Agricultural
Handlers'
Exposure
to
Pesticides
C
9:
00
AM
Board
Discussion
4.
AHETF
Closed
Cab
Airblast
Application
to
Orchards
Protocol
a.
Does
the
proposed
research
described
in
Study
No.
AHE38
from
the
Agricultural
Handlers
Exposure
Task
Force
appear
likely
to
generate
scientifically
reliable
data,
which
will
be
useful,
together
with
other
data,
for
assessing
the
potential
levels
of
pesticide
exposure
received
by
people
when
making
an
airblast
application
of
a
pesticide
to
orchard
crops?
[
Note:
In
a
few
cases,
corresponding
mixing/
loading
events
are
also
to
be
monitored;
the
same
question
applies
to
those
elements
of
the
study.]

b.
Does
the
proposed
research
described
in
Study
No.
AHE38
from
the
Agricultural
Handlers
Exposure
Task
Force
appear
to
comport
with
the
applicable
requirements
of
40
CFR
part
26,
subparts
K
and
L?

5.
AHETF
Fixed­
Wing
Aerial
Application
Protocol
a.
Does
the
proposed
research
described
in
Study
No.
AHE42
from
the
Agricultural
Handlers
Exposure
Task
Force
appear
likely
to
generate
scientifically
reliable
data,
which
will
be
useful,
together
with
other
data,
for
assessing
the
potential
levels
of
pesticide
exposure
received
by
people
making
an
aerial
application
of
a
pesticide
from
fixed­
wing
aircraft?
[
Note:
In
a
few
cases,
corresponding
mixing/
loading
events
are
also
to
be
monitored;
the
same
question
applies
to
those
elements
of
the
study.]

b.
Does
the
proposed
research
described
in
Study
No.
AHE42
from
the
Agricultural
Handlers
Exposure
Task
Force
appear
to
comport
with
the
applicable
requirements
of
40
CFR
part
26,
subparts
K
and
L?
10
of
10
C
10:
30
AM
Break
May
2­
3,
2006
HSRB
Meeting
Report
C
10:
45
AM
HSRB
Review
of
May
2­
3,
2006
HRSB
Meeting
Report
 
Celia
Fisher,
Ph.
D.
(
HSRB
Chair)

C
11:
00
AM
Public
Comments
C
11:
30
AM
Lunch
C
12:
30
PM
Board
Discussion
and
Decision
on
Report
Chromium
Methyl
Isothiocyanate
Carbofuran
C
2:
00
PM
Summary
and
Next
Steps
 
Celia
Fisher,
Ph.
D.
(
HSRB
Chair)
and
Paul
Lewis,
Ph.
D.
(
HSRB
DFO)

C
2:
30
PM
Adjournment
*
Agenda
times
are
approximate
For
further
information,
please
contact
the
Designated
Federal
Officer
for
this
meeting,
Paul
Lewis,
via
telephone:
(
202)
564­
8381
or
email:
lewis.
paul@
epa.
gov
