ISC
AMVAC
5
April
2006
1
AMVAC
Overview
EPA
Human
Studies
Review
Board.

Ian
Chart
Vice
President
Director
of
Regulatory
Affairs
Amvac
Chemical
Corporation
ISC
AMVAC
5
April
2006
2
HUMAN
DATA
"
EPA
believes
that
in
general
it
can
best
protect
public
health
by
considering
all,
available,
relevant,

scientifically
sound
information,

including
information
developed
through
research
with
human
subjects"
ISC
AMVAC
5
April
2006
3
Human
Testing
and
DDVP
Database

All
DDVP
human
studies
were
commissioned
or
completed
before
1996.


They
were
not
performed
in
response
to
FQPA.


The
DDVP
human
database
addresses
the
10X
default
interspecies
factor.


The
DDVP
database
is
so
robust
that
it
can
also
address
the
intraspecies
factor.
ISC
AMVAC
5
April
2006
4
DDVP
HUMAN
DATA
AND
HSRB
PROCESS

The
amount
of
time
made
available
for

Registrant s
response
to
the
EPA
charge

HSRB
review
of
all
data
was
totally
inadequate.


Some
of
the
critical
data
(
more
than
one
dozen
technical
documents)
were
made
available
to
the
HSRB
only
days
ago.


AMVAC
disagrees
with
EPA's
position
that
a
WOE
argument
is
only
as
robust
as
the
individual
studies.
ISC
AMVAC
5
April
2006
5
Human
Testing
and
DDVP
Database

AMVAC
has
neither
commissioned
nor
advocated
clinical
trials
on
pregnant
women
and
children.


DDVP
is
unique
as
it
has/
had
pharmaceutical,

veterinary,
and
public
health
pesticidal
uses.


The
DDVP
human
database
has
been
developed
by
many
organizations
(
WHO,
CDC
and
FAA),

over
many
years,
all
over
the
world.


There
are
hundreds
of
human
studies
on
DDVP
and
it
unlikely
that
such
a
vast
database
will
ever
be
developed
for
a
pesticide
again.
ISC
AMVAC
5
April
2006
6
Human
Testing
and
DDVP
Database

The
DDVP
human
database
is
unique
and
should
be
treated
in
totality.


The
human
studies
considered
together
are
scientifically
relevant
and
ethically
valid.


The
assessment
of
the
"
true"
interspecies
uncertainty
factor
for
DDVP
is
dependent
on
the
totality
of
the
data,
not
on
any
one
study.


It
is
inappropriate
to
dismiss
individual
studies
without
considering
the
database
as
a
whole
ISC
AMVAC
5
April
2006
7
Meta­
Analysis
Research

Meta­
analysis
of
adult­
only
biomarker
data
should
not
be
disqualified
merely
because
some
of
the
data
in
the
full
database
are
available
on
children
and/
or
pregnant
women.


The
"
research"
is
the
meta­
analysis.


It
contains
data
only
on
non­
pregnant
adults.


This
research
is
in
compliance
with
the
rule.
ISC
AMVAC
5
April
2006
8
PRODUCT­
IN­
USE
STUDIES

Registered
consumer
products
have
been
approved
by
the
EPA
for
general
use,
which
includes
approval
of
exposure
to
children
and
pregnant
women.


It
is
inappropriate,
scientifically,
ethically
and
legally,
to
selectively
exclude
data
from
studies
of
exposures
to
these
products.
ISC
AMVAC
5
April
2006
9
Conclusion

It
is
inappropriate
to
dismiss
individual
studies
without
considering
the
database
as
a
whole

The
human
studies
considered
together
are
scientifically
relevant
and
ethically
valid.


The
DDVP
human
database
provides
more
than
sufficient
scientifically
sound
information
to
warrant
reduction
of
the
interspecies
uncertainty
factor.
