Document ID: EPA-HQ-OPP-2004-0296-0012
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2004-10-12T04:00Z

ATTACHMENT
A
UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
WASHINGTON,
D.
C.
20460
OFFICE
OF
PREVENTION,
PESTICIDES
AND
TOXIC
SUBSTANCES
Elliot
Gordon,
PhD,
DABT
Makhteshim­
Agan
of
North
America
Inc.
551
Fifth
Avenue,
Suite
1100
New
York,
NY
10176
Subject:
Third
Party
Review
for
Reclassification
of
Captan's
Carcinogenicity
Dear
Dr.
Gordon:

Thank
your
for
meeting
with
us
on
July
22,
2003.
This
letter
is
a
follow­
up
to
that
meeting,
to
provide
you
with
more
formal
comments
on
your
proposed
process
for
conducting
a
third
party
review
of
the
cancer
classification
for
captan.
As
stated
at
the
meeting,
we
will
not
formally
approve
your
protocol,
but
rather
will
provide
you
with
comments
intended
to
make
the
process
more
balanced
and
objective.
We
believe
that
addressing
our
comments
will
allow
your
process
to
deliver
a
third
party
product
at
the
level
of
quality
necessary
for
presentation
to
the
Agency's
Scientific
Advisory
Panel
(
SAP).
All
of
the
comments
below
were
discussed
at
the
July
22nd
meeting,
however,
I
am
including
them
here
for
your
records.

1.
Schedule.
The
process
should
allow
enough
time
for
both
EPA
and
the
SAP
reviews.
EPA
will
require
at
least
4
to
6
weeks
and
the
SAP
will
require
an
additional
6
to
8
weeks
for
review.
Based
on
the
peer
review
schedule
and
the
needs
of
the
EPA
and
SAP,
it
does
not
appear
possible
to
address
the
captan
reclassification
issue
at
the
December
meeting.
If
the
third
party
report
on
captan
is
ready
with
sufficient
lead
time,
the
Agency
will
try
to
include
it
in
an
SAP
meeting
in
Spring
2004.

2.
Public
Notification.
EPA
believes
that
public
involvement
will
contribute
to
creating
a
credible
end
product.
As
you
are
aware,
EPA
has
revamped
many
of
its
processes
to
increase
the
opportunity
for
public
participation
and
involvement.
Suggestions
for
improved
public
involvement
in
the
captan
process
include:
 
Individually
notifying
organizations
such
as
the
Natural
Resources
Defense
Council,
Farmworker
Justice
Fund,
and
other
interested
parties
involved
in
the
captan
reregistration
eligibility
decision
(
RED)
of
the
proposed
process
and
meetings
 
Distribute
press
releases
and
other
announcements
of
the
process
to
more
diverse
groups
and
organizations
(
the
current
list
is
restricted
to
scientists)
 
Ensure
that
any
web
postings
are
placed
in
a
prominent
internet
location
that
can
be
easily
accessed
by
the
public,
without
needing
a
direct
link
 
Providing
adequate
opportunity
for
public
comments
before
and
during
meetings
 
Including
and
announcing
a
phone
link
at
the
meetings
for
anyone
who
might
want
to
listen
in
from
a
remote
location
3.
Transparency
of
Process.
EPA
believes
that
a
transparent
process
will
contribute
to
creating
a
credible
end
product.
EPA
has
revamped
many
of
its
processes
to
be
more
transparent,
which
we
believe
leads
to
a
higher
quality
final
product
that
is
more
defensible.
Following
some
or
all
of
the
Office
of
Pesticide
Programs'
existing
processes
will
enhance
the
credibility
of
the
end
product.
Suggestions
for
improved
transparency
of
the
process
include:
 
Publicize
criteria
that
were
used
to
evaluate
potential
organizations
to
serve
as
third
parties,
including
other
organizations
that
may
have
been
considered,
and
the
rationale
for
selecting
the
proposed
third
party
 
Publicize
criteria
that
were
used
to
select
panel
members,
and
the
rationale
for
making
final
selections
4.
Conflict
of
Interest
Issues.
The
process
should
be
portrayed
as
a
"
third
party"
review,
rather
than
an
"
independent"
review.
Do
not
hesitate
to
acknowledge
that
the
registrant
is
paying
for
the
third
party
review
being
conducted
by
TERA.
All
potential,
actual
or
perceived
conflicts
of
interest
for
both
the
third
party
and
panel
members
should
be
open
and
made
freely
available
to
the
public.

5.
Panel.
Expertise
of
the
panel
should
be
broad
enough
to
adequately
cover
all
scientific
areas
of
interest.
EPA
is
concerned
that
the
proposed
panel
is
composed
largely
from
members
of
industry
or
related
groups.
The
lack
of
representatives
from
environmental
organizations
and
academia
could
lead
to
the
end
product
being
less
credible
than
you
desire.
At
the
July
22nd
meeting,
you
mentioned
that
holding
the
meeting
in
September
makes
it
more
difficult
to
recruit
academics.
If
necessary,
perhaps
you
should
consider
rescheduling
the
meeting
a
bit
later
in
the
fall
to
accommodate
these
potential
members.
A
diverse
panel
enhances
the
credibility
of
the
end
product.
Moreover,
all
views
of
the
review
panel
members
should
be
reflected
in
the
final
report,
including
any
dissenting
views.

6.
Data
provided
to
panel.
All
of
the
data
should
be
provided
to
panel
members
and
be
the
main
source
of
information
for
the
peer
review.
Dissemination
of
an
overview
document
is
not
sufficient
for
the
review
panel
to
make
an
informed
decision.
Ultimately,
all
of
the
data
will
also
need
to
be
provided
to
the
SAP.
EPA
also
believes
that
a
presentation
to
the
panel
by
the
registrant
could
undermine
the
credibility
of
your
process.
The
data
should
speak
for
themselves.
We
also
advise
you
to
carefully
word
all
documents,
including
the
protocol,
to
ensure
no
value­
laden
language
is
included
(
for
example,
the
protocol
states
that
public
comments
during
meetings
will
be
"
restricted
in
time
such
that
panel
deliberations
are
not
adversely
affected").

Although
these
comments
are
advisory,
I
strongly
encourage
you
to
incorporate
them
into
your
process,
as
they
will
significantly
enhance
the
credibility
of
the
end
product.
I
also
want
to
thank
you
for
your
efforts
in
furthering
this
project
and
if
you
have
any
questions,
please
contact
Michael
Goodis
at
703­
308­
8157
or
Susan
Jennings
at
706­
355­
8574.

Sincerely,

Betty
Shackleford,
Acting
Director
Special
Review
and
Reregistration
Division
Office
of
Pesticide
Programs