28
June,
2004
Dr.
Paul
Gilman
Dr.
Larry
Reiter
Assistant
Administrator
Director,
NHEERL
Laboratory
U.
S.
Environmental
Protection
Agency
U.
S.
Environ.
Protection
Agency
Ronald
Reagan
Office
Building
Research
Triangle
Park
Washington,
DC
20460
Durham,
North
Carolina
Re:
ORD
Biotechnology
Program
Framework
Dear
Drs.
Gilman
and
Reiter:

This
is
a
letter
report
from
the
Board
of
Scientific
Counselors
(
BOSC)
reviewing
the
EPA
ORD
Biotechnology
Research
Program.
An
overview
of
the
Program
was
presented
by
Dr.
Reiter
to
the
BOSC
executive
committee
on
May
13­
14,
2004,
at
their
meeting
in
Research
Triangle
Park.
This
was
the
third
time
that
BOSC
had
been
briefed
on
ORD
Biotechnology
research,
beginning
with
the
____,
2002
meeting
of
the
BOSC,
and
following
with
the
____,
2003
meeting.

The
Framework
document
on
the
ORD
Biotechnology
Research
Program
was
provided
to
members
of
the
BOSC
Ad­
hoc
Subcommittee
on
Biotechnology
in
the
spring
of
2004,
and
other
executive
committee
members
who
requested
it.
The
Subcommittee
consisted
of
Jerry
Schnoor,
Chair,
and
members
James
Johnson,
James
Clark,
George
Daston,
Rogene
Henderson,
and
Gary
Sayler.
Schnoor
made
notes
of
executive
committee
members'
comments
during
the
meeting
on
May
13,
and
wrote
a
draft
letter
report
which
was
circulated
to
members
of
the
Subcommittee
at
the
end
of
June.
Subcommittee
members
made
revisions
to
the
initial
draft,
and
these
suggestions
were
incorporated
into
the
final
letter
report
by
James
Johnson,
Chair
of
BOSC.
The
letter
report
was
then
approved
by
the
entire
BOSC
executive
committee.

The
BOSC
Subcommittee
understands
that
EPA's
role
in
the
area
of
genetically
modified
crops
is
largely
defined
by
statutory
jurisdictional
authority
under
the
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(
FIFRA).
The
Act
requires
that
EPA
ensures
pesticides
will
not
pose
unreasonable
risk
to
human
health
or
the
environment,
so
plant
incorporated
protectorants
(
PIPs),
which
serve
in
lieu
of
pesticide
applications,
are
properly
within
EPA's
regulatory
control,
and
ORD
seeks
to
provide
research
relevant
to
this
mission
of
the
Agency.
The
four
areas
of
research
that
ORD
has
identified
(
risk
to
human
health,
risk
to
non­
target
organisms,
the
potential
for
gene
flow,
and
insect
resistance
and
management
plans)
are
important
and
proper.
BOSC
believes
that
the
greatest
emphasis
in
the
ORD
research
portfolio
at
the
present
time
should
address
genetically
modified
crops
which
contain
genes
for
production
of
Bacillus
thuringensis
toxin
(
Bt)
because
these
could
conceivably
cause
all
four
effects:
allergenicity,
resistance
in
target
populations,
risks
to
non­
target
organisms,
and
conveyance
of
a
selective
advantage
to
cross­
hybridized
wild­
type
plants.

Human
allerginicity
has
been
addressed
by
ORD
as
a
risk
to
human
health,
and
BOSC
recommends
that
not
all
research
in
this
area
be
related
to
digestibility.
Respiratory
allergenicity
should
also
be
included,
and
SAR­
based
approaches
should
be
considered
such
as
epitope
mapping.
ORD
should
not
assume
that
they
know
how
to
detect
all
allergenicities
to
humans.
However,
developing
an
animal
model
(
mouse
model)
for
identifying
mechanisms
of
allergenicity
is
believed
to
be
important
by
BOSC,
as
stated
in
the
Framework
document.
In
addition,
ORD
should
consider
how
their
approach
on
BTproducts
can
be
extrapolated
to
other
GM
crops
that
may
be
developed
in
the
future,
such
as
herbicide­
resistant
spring
wheat
and
others.
Collaboration
that
has
already
been
established
with
NIAID
and
NIEHS,
in
matters
of
human
allerginicity
is
encouraged,
and
use
of
the
pharmaceutical
models
of
FDA
for
safety
testing
(
levels
1,
2,
and
3)
may
prove
helpful.

Risks
to
non­
target
organisms
and
the
environment
remain
as
one
of
the
largest
potential
problems
of
GM
crops
in
the
minds
of
the
public.
The
findings
so
far
by
EPA
ORD,
that
Bt­
proteins
have
narrow
spectrum
insecticidal
activity
and
that
no
serious
effects
are
anticipated
on
non­
target
organisms,
seems
justified,
but
ORD
should
be
ever­
vigilant
to
the
possibility
of
subtle,
long­
term
effects
that
are
difficult
to
measure
without
an
expensive
monitoring
program.
BOSC
agrees
that
the
approach
to
monitor
a
few
key
indicator
organisms
and
habitats
over
a
long
period
of
time
is
the
proper
approach
to
this
problem.
BOSC
further
recommends
that
the
ORD
Biotechnology
program
include
the
recent
ecological
field
studies
of
GM
crops
in
the
U.
K.
in
their
research
data
base.
These
studies
indicated
that
ecological
diversity
could
either
increase
or
decrease
due
to
the
use
of
GM
crops,
depending
on
the
crops,
non­
target
organisms,
and
cropping
practices
considered.
It
would
be
prudent
to
learn
whatever
can
be
gleaned
from
these
studies
and
not
to
reproduce
them.
Also,
the
Agency
should
track
closely
the
overall
use
of
pesticides
(
both
herbicides
and
insecticides)
on
GM­
cropland
in
the
U.
S.
A
recent
report
by
the
Northwest
Science
&
Environmental
Policy
Center
states
that
in
the
three­
year
period
from
2001
to
2003,
the
cultivation
of
such
crops
increased
herbicide
applications
on
herbicide­
tolerant
crops
to
keep­
up
with
community
composition
changes
and
tougher­
to­
control
weed
species
(
http://
www.
biotechinfo.
net/
technicalpaper6.
html).

BOSC
asks
ORD
to
consider
whether
their
research
on
biotechnology
and
its
effects
on
the
environment
is
properly
focused
to
address
concerns
in
countries
of
the
European
Union,
Asia,
Africa,
and
South
America?

The
potential
for
gene
flow
between
GM
crops
and
wild­
type
plants
is
recognized
by
BOSC
as
a
consequence
of
all
hybrid
crops
from
conventional
plant­
breeding
programs,
as
well
as
from
genetically
modified
crops.
As
stated
by
ORD,
the
issue
is
whether
cross
hybridization
with
wild­
type
plants
(
such
as
Bt­
corn
with
wild
maize
in
Mexico)
is
a
serious
consequence
and
whether
it
conveys
a
selective
advantage
to
crops
in
the
wild.
The
Framework
document
outlines
a
good
program
to
study
gene
flow
from
transgenic
plants
to
non­
crop
hybrids
using
genomic
techniques
to
confirm
expression
of
transgenes
and
to
evaluate
the
fitness
and
ecological
effects
on
crops
and
non­
crop
hybrids.
Canola
and
creeping
bentgrass
are
model
plants
being
utilized.
Gene
introgression
(
retention
of
the
genetic
characteristics
in
subsequent
generations
of
the
non­
crop
hybrids)
and
gene
expression
after
3­
5
years
in
mesocosms
is
a
good
approach
for
studying
these
important
ecological
questions.

The
insect
resistance
and
management
plan
of
ORD
is
an
important
component
in
the
research
portfolio
of
its
biotechnology
program.
The
idea
to
work
with
NASA
on
remote
sensing
of
crops
for
risk
management
is
excellent.
The
provision
for
creation
of
refuges
is
logical,
but
there
should
be
some
social/
behavioral
research
considered
that
measures
how
and
under
what
circumstances
farmers
actually
perform
the
recommended
practices.
The
rapid
PCR
screens
and
modeling
strategy
to
assess
resistance
management
is
a
good
approach
by
ORD.
But
what
are
the
markers
being
used
to
detect
insect
resistance?
In
the
high
dose,
structured
refuge
resistance
management
research,
BOSC
recommends
that
a
population
genetics
study
of
resistance
genes
in
root
worm
populations
under
Bt­
crops
be
considered.
Overall,
however,
since
there
are
only
two
organisms
that
have
ever
been
reported
to
become
resistant
to
Bt­
toxin
in
30
years
of
use
as
a
pure
insecticide,
BOSC
wonders
whether
proportionally
there
are
too
many
resources
being
allocated
to
the
resistance
question.
The
risk
of
loss
of
a
technology
is
important
to
consider
but,
ultimately,
it
is
a
risk
that
the
agrochemical
industry
must
bear.

Finally,
BOSC
discussed
other
social
justice
issues
of
biotechnology
including
the
potential
for
countries,
especially
in
the
developing
world,
to
become
dependent
on
a
few
companies
for
their
food
production
system,
rendering
such
countries
vulnerable
to
price
increases
or
even
embargoes.
These
are
important
issues
of
food
security
which
are
recognized
by
the
United
Nations
Declaration
of
Human
Rights
and
other
international
legal
instruments.
In
addition,
countries
in
sub­
Saharan
Africa
have
refused
food­
aid
from
the
United
States
during
times
of
famine
because
they
perceived
a
problem
with
the
safety
of
the
crops
and
because
they
worried
that
farmers
might
be
unable
to
trade
with
the
European
Union
if
grain
bins
became
contaminated
with
GM­
products.
Another
issue
is
the
perception
that
organic
farmers
cannot
assure
that
their
produce
is
free
from
GM­
pollen
and
GM­
proteins
because
of
the
possibility
of
cross­
hybridization
with
genetically
modified
crops.
It
was
stated
that
this
is
not
EPA's
role
to
regulate
intellectual
property,
global
trade,
or
food
security
impacts.
It
is
the
role
of
the
USDA
to
regulate
organic
food
and
of
the
World
Trade
Organization
to
oversee
trade.
But
BOSC
asks
that
EPA
and
ORD
be
aware
and
sensitive
to
such
concerns
as
they
develop
research
products,
interact
with
federal
agencies,
and
communicate
risks
to
the
public.

In
conclusion,
members
of
BOSC
believe
that
EPA
ORD
is
on
the
right
track
and
making
good
progress
with
its
Biotechnology
Program.
Please
let
us
know
if
you
need
any
further
information
regarding
this
report.

Sincerely
yours,
James
Johnson,
Chair
Board
of
Scientific
Counselors
