Summary
of
OMB
Briefing
Notes/
Questions
November
14,
2004
40
CFR
Part
158
Data
Requirements:
Biochemical
and
Microbial
Pesticides
The
following
people/
Agency
and
issues
were
identified
as
requiring
follow­
up:

1.
Burleson
Smith/
USDA
­
How
many
Bt
pesticides
have
been
registered
prior
to
1984?
In
other
words,
what
portion
of
the
early
microbials
were
Bt's?
The
Agency
estimated
that
about
half
of
those
registered
were
Bt
pesticides
but
promised
to
get
back
to
him
with
details.
Burleson
also
asked
how
toxins
isolated
from
microbial
pesticides
would
be
evaluated,
i.
e.
as
microbial
pesticides
or
conventional
chemical
pesticides.
The
Agency
responded
that
isolated
toxins
often
had
to
be
evaluated
as
conventional
pesticides
because
the
testing
protocols
for
microbial
pesticides
would
not
be
relevant
for
purified
toxins.

In
checking
the
actual
microbials
registered
up
to
1984,
we
find
the
following
list.
Of
ten
registrations,
three
are
Bt's.
However,
under
the
policies
existing
at
that
time,
additional
isolates/
registrations
of
Bt
have
been
registered
under
these
groups.
In
fact,
at
the
time
of
the
1961
registration,
microbial
taxonomy
did
not
recognize
subspecies
of
Bt
 
the
designation
"
kurstaki"
was
added
later.
In
addition,
"
subsp
Berliner"
is
no
longer
an
acceptable
name
for
Bt
subspecies.
In
actuality,
pre
1984
registrations
included
several
different
isolates
under
the
three
named
in
the
list.
It
is
a
bit
difficult
at
this
point
in
time
to
positively
identify
exactly
how
many
different
isolates
of
Bt
were
registered
by
1984
under
these
three
names,
but
the
best
guess
would
be
around
8
which
would
have
a
ratio
of
about
8
to
a
total
of
14
different
registered
microbial
isolates
 
a
little
more
than
half.
Fortunately,
the
Bt
reregistration
process
will
give
separate
registration
identification
to
each
different
Bt
registered
active
ingredient
and
our
computer
database
will
be
revised
to
reflect
each
registration
on
a
one
to
one
basis.

Bts
1948
B.
popilliae
&
B.
lentimorbus
(
mixed)
1961
B.
thuringiensis
subsp
kurstaki*
1981
B.
thuringiensis
subsp
israelensis*
1984
B.
thuringiensis
subsp
Berliner*

Others
1975
Heliothis
NPV
baculovirus
1976
Douglas
fir
tussock
moth
NPV
1978
Gypsy
moth
NPV
1979
Agrobacterium
radiobacter
K84
1980
Nosema
locustae
1982
Colletotrichum
gloeosporioides
f.
sp.
aeschynomene
1983
Phytophthora
palmivora
MWV
With
respect
to
isolated
toxins
from
microbials,
our
concern
is
a
broader
issue
than
just
for
Bt
pesticides.
Actually,
for
Bt,
the
products
are
almost
an
isolated
toxin,
since
the
insecticidal
delta­
endotoxin
is
produced
in
a
crystal
at
the
time
the
bacterium
turns
into
a
spore
so
you
get
a
relative
large
amount
of
toxin
along
with
each
spore
in
the
final
product.
However,
purified
microbial
toxins
are
usually
treated
as
a
conventional
pesticide
because
the
protocols
for
testing
living
microorganisms
address
endpoints
like
pathogenicity
and
infectivity
and
assess
the
persistence
of
the
living
microbial
in
the
test
system.
Thus
these
tests
are
not
appropriate
to
assess
the
chemical
toxin
itself.
A
representative
toxin
from
a
microorganism
would
be
an
antibiotic
such
as
Streptomycin,
used
to
control
the
bacteria
and
fungi
causing
plant
diseases.

2.
Burleson
Smith/
USDA
­
Is
phytotoxicity/
pathogenicity
data
being
required
as
part
of
Tier
IV?

In
general,
phytotoxicity
effects
testing
is
available,
if
needed,
at
the
Tier
I
(
885.4300),
II
(
885.5200,
to
determine
exposure)
and
Tier
IV
(
850.2500
 
field
test)
levels
for
microbials.

3.
Burleson
Smith/
USDA
­
How
many
PR
notices
have
been
issued
since
1984
concerning
biochemical
and
microbial
pesticides?

The
following
PR
notices
have
been
issued
which
address
biochemical
and
microbial
pesticides:

Pesticide
Registration
(
PR)
Notice
97­
1,
Agency
Actions
under
the
Requirements
of
the
Food
Quality
Protection
Act.,
January
31,
1997.
This
is
available
at
the
following
website:
http://
www.
epa.
gov/
opppmsd1/
PR_
Notices/
pr97­
1.
html
Pesticide
Registration
(
PR)
Notice
97­
3,
Guidelines
for
Expedited
Review
of
Conventional
Pesticides
under
the
Reduced­
Risk
Initiative
and
for
Biological
Pesticides.
September
4,
1997:
http://
www.
epa.
gov/
opppmsd1/
PR_
Notices/
pr97­
3.
html
In
addition,
a
large
number
of
PR
Notices
addressing
pesticides
generically
(
i.
e.
without
regard
to
pesticide
type)
has
been
issued
since
1984.
Few
PR
Notices
are
specific
to
type
of
pesticide.

4.
Burleson
Smith/
USDA
­
Non
target
insect
testing
 
885.4340
 
how
many
species
does
this
cover­
we
have
a
test
cost
of
$
10,500,
does
that
address
one
species
or
multiples
species?
Are
we
testing
for
insects
close
to
the
target
or
further
away?

The
885.4340
guideline
identifies
three
possible
species
to
be
tested.
If
the
Agency
does
require
this
study
then
all
three
species
are
required
to
be
tested,
thus
performing
this
test
on
three
species
would
increase
the
average
cost
of
the
study
by
a
multiple
of
three,
approximately.
The
Agency
has
confirmed
that
the
average
cost
of
$
10,500
is
applicable
to
only
one
species,
therefore,
assuming
a
multiple
of
three,
the
range
of
test
costs
would
be
$
21,000
(
low)
to
$
42,000
(
high),
with
an
average
of
$
31,500.
The
economic
analysis
will
be
revised
to
reflect
this
change.

While
required
at
a
higher
frequency
for
microbials
than
biochemicals,
the
non­
target
insect
study
is
estimated
as
a
negative
incremental
cost
in
the
economic
analysis.
Taking
into
consideration
the
anticipated
burden
reduction
and
negative
incremental
cost,
this
increase
in
estimated
average
cost
would
not
alter
the
overall
economic
impact.
Nontarget
testing
is
often
waived
based
on
available
scientific
literature.

Specific
Issues:
1.
Al
Jennings/
USDA
­
We
appreciate
consultations
with
APHIS.
Do
we
need
something
more
formal
to
avoid
problems?

The
Agency
continues
to
collaborate
with
USDA
for
Biochemical
and
Microbial
Pesticide
Registration
activities.
The
Plant
Protection
Quarantine
Division
(
PPQ)/
USDA
follows
the
Agency's
FR
announcements
of
microbial
pesticide
applications
and
when
it
is
a
potential
plant
pathogen,
the
Agency
notifies
USDA.
Conversely,
Bob
Flanders/
USDA,
responsible
for
their
science
review
group,
contacts
EPA
if
there
are
any
pesticide
issues
they
believe
would
be
of
interest
to
EPA.
The
Agency
notifies
USDA
on
issues
of
mutual
interests.
We
have
also
coordinated
with
the
Biotechnology
Group
on
genetically
engineered
microbial
pesticides.
We
will
continue
to
formalize
the
process
as
opportunities
arise.
We
plan
to
ask
for
specific
comment
on
this
issue
in
the
proposed
rule
as
a
result
of
this
question.

2.
Al
Jennings/
USDA
­
Stakeholder
consultation.
We
should
ask
USDA
as
one
of
the
stakeholders
because
they
are
involved
in
biopesticide
development.
USDA
wants
to
be
involved
before
the
final
rule.
Dr.
Jennings
was
disappointed
that
they
were
not
consulted
when
industry
and
academia
were
consulted.
We
agreed
that
next
time
we
could
make
sure
they
were
at
the
table
earlier
in
the
process.
