Angela
Hofmann
Director
of
Regulatory
Coordination
for
Prevention,
Pesticides,
and
Toxic
Substances
(
OPPTS),
EPA
Mailcode:
7101M
1200
Pennsylvania
Ave.,
N.
W.,
Washington,
DC
20460
(
Location:
EPA
East
Building
Room
3426
A)
Phone
number:
202­
564­
0258;
Fax
number:
202­
564­
0263
________
Dear
Mr.
Smith,

Thank
you
for
your
letter
dated
December
5,
2005,
concerning
the
Biochemical
and
Microbial
Pesticide
of
Notice
of
Proposed
Rulemaking,
which
addresses
the
data
requirements
for
registration
of
these
pesticides.
The
following
is
a
response
to
the
issues
identified
in
your
letter.

EPA
Should
Seek
Methods
to
Reduce
Barriers
and
Accelerate
Registration
Process.

In
an
effort
to
improve
transparency,
increase
efficiency
and
reduce
burden,
EPA
is
describing
in
the
preamble
its
policy
titled
"
Consultations
with
Applicants."
Under
this
policy,
EPA
assists
applicants
in
determining
what
data
or
information
are
appropriate
to
support
registration
of
a
biochemical
or
microbial
pesticide.
EPA
is
encouraging
applicants
to
request
pre­
submission
meetings
to
discuss
these
data
issues.
EPA
will
also
provide
assistance
to
applicants
in
preparation
of
an
applicant's
data
waiver
after
submission
of
an
application.
This
assistance
will
be
provided
on
an
as­
needed,
case­
bycase
basis.
This
process
can
accelerate
the
time
for
review
at
EPA
and
the
amount
of
time
and
effort
it
takes
to
prepare
the
application
for
submission
to
EPA.
EPA
has
experienced
that
some
registrants
are
unclear
about
which
data
are
required
for
their
pesticide.
Pre­
submission
meetings
help
the
applicant
determine
what
data
are
necessary
and
what
data
are
already
available
in
the
literature,
which
reduces
the
burden
on
the
registrant
to
provide
unnecessary
information
or
conduct
unnecessary
tests.

EPA
notes
that
applications
for
biochemical
and
microbial
pesticides
frequently
involve
substances
that
present
low
risk
to
human
health
and
the
environment
(
i.
e.,
naturally­
occurring,
non­
toxic
mode
of
action,
minimal
exposure).
EPA
acknowledges
that
certain
data
requirements,
even
as
proposed,
may
be
satisfied
by
existing
data
in
the
open
literature
or
other
available
data
or
information.
In
some
cases,
the
applicant
may
not
be
aware
of
a
potential
rationale
for
a
data
waiver,
or
be
able
to
identify
available
data
or
information
that
may
satisfy
a
data
requirement
in
lieu
of
generating
new
data.
Thus,
EPA
encourages
applicants
to
seek
pre­
submission,
and
where
appropriate,
postsubmission
meetings,
to
discuss
the
appropriate
data
or
information
required
supporting
their
product
and
the
opportunity
for
requesting
data
waivers.
The
usefulness
of
a
postsubmission
meetings
typically
occurs
when
some
additional
data
are
needed
after
the
original
reviews
are
completed
and
a
data
gap
has
been
identified.
Coordination
with
Minor
Crop
Pest
Management
Program
(
IR­
4),
USDA
Program
to
Reduce
Burden
The
Agency
recognizes
the
need
to
coordinate
with
USDA's
IR­
4
Program
and
participates
regularly
in
IR­
4
quarterly
meetings.
Members
from
EPA's
Biopesticides
Pollution
Prevention
Division
(
BPPD)
and
Michael
Braverman,
Manager
of
Biopesticide
Program,
USDA
IR­
4
Project,
Rutgers
University,
discuss
the
status
of
the
registration
of
various
products
at
the
quarterly
meetings
and
pre­
submission
meetings
are
typically
held
for
actions
when
IR­
4
will
be
representing
a
biopesticide
registrant.
The
Agency
expects
these
discussions
to
continue.
BPPD
would
welcome
similar
meetings
with
Agricultural
Research
Service
and
other
USDA
Agencies
working
with
biopesticides.
If
USDA
believes
additional
strategies
for
coordination
would
achieve
mutually
beneficial
results,
EPA
is
willing
to
consider
those
approaches.

Data
Requirements
for
Pheromones
The
Agency
agrees
with
USDA
that
the
data
requirements
for
the
straight
chain
lepidopteran
pheromones
(
SCLP)
have
been
significantly
reduced.
This
reduction
in
data
requirements
is
reflected
in
the
proposed
rule.
In
addition
to
SCLP
reductions
noted
by
USDA,
the
proposed
rule
exempts
all
arthropod
pheromones
from
nontarget
organism
and
environmental
fate
data
requirements.
The
Agency
based
this
decision
in
large
part
on
data
and
information
provided
by
the
semiochemicals
industry.
If
USDA
or
any
other
organization
wishes
to
provide
data
to
address
human
health
and
ecological
effects
concerns
for
other
pheromone
classes
and
structures,
the
Agency
is
willing
to
review
such
data
in
order
to
determine
whether
it
satisfies
the
data
requirements.

USDA
Encourages
EPA
to
Exempt
FDA
Approved
Food
Additives
EPA
recognizes
that
FDA
also
exercises
regulatory
jurisdiction
over
substances
used
as
food
additives
under
FFDCA
section
409,
and
that
some
of
those
substances
are
also
intended
for
use
as
pesticides
under
FIFRA.
FDA
uses
different
regulatory
processes,
depending
on
whether
the
potential
food
additive
is
claimed
to
be
"
Generally
Recognized
as
Safe"
(
GRAS)
or
not.
When
reviewing
new,
non­
GRAS
food
additives,
FDA
requires
companies
seeking
approval
to
develop
and
submit
safety
data
on
their
products.
For
a
new
food
additive
that
is
claimed
to
be
GRAS
substances,
a
person
may
certify
that
the
substance
meets
FDA's
criteria
for
GRAS.
Although
FDA
does
not
require
submission
of
the
data,
a
person
is
required
to
base
the
certification
on
adequate
data
and
to
make
the
data
are
available
to
FDA
on
request.

EPA
is
willing
to
consider
data
on
a
product
submitted
to
FDA
and
any
FDA
review
of
that
data
as
part
of
EPA's
determination
on
a
pesticidal
substance
regulated
under
FFDCA
section
408
and
FIFRA
section
3.
Many
aspects
of
FDA's
review
processes
are
similar
to
those
of
EPA,
and
the
Agency
is
interested
in
finding
ways
to
make
its
decision­
making
process
more
efficient.
Taking
advantage
of
previous
FDA
assessments
offers
an
opportunity
to
save
both
time
and
resources
 
both
for
applicants
and
the
Agency.
Nonetheless,
the
Agency
notes
that
the
findings
it
makes
under
FIFRA
and
FFDCA
section
408
differ
from
FDA's
required
findings
under
FFDCA
section
409.
For
example,
EPA
is
required
to
consider
the
potential
ecological
effects
of
a
pesticide,
while
FDA
normally
does
not.
Therefore,
EPA
may
need
to
perform
additional
assessments
before
reaching
a
decision
whether
to
register
a
pesticide
under
FIFRA
that
FDA
has
approved
as
a
food
additive
under
FFDCA.

Potential
Incentives
for
Biopesticide
Registrations
The
Agency
welcomes
any
opportunity
to
work
with
USDA
on
the
development
of
incentives
for
registration
of
biochemical
and
microbial
pesticides.
EPA
suggests
quarterly
meetings
with
the
Agricultural
Research
Service
and
other
USDA
Agencies
working
with
biopesticides
to
discuss
various
policies
and
registration
activities.
Assuming
such
meetings
would
be
useful
to
USDA,
EPA
will
work
in
the
near
future
to
plan
such
meetings.

Requiring
APHIS
Permits
as
Condition
of
Registration
In
response
to
your
recommendation,
EPA
proposes
that
the
following
be
added
to
the
preamble
section
XVI,
FIFRA
Review
Requirements:

"
The
Agency
and
USDA
have
had
discussions
on
the
registration
process
of
microbial
pesticides
and
the
coordination
process
needed
when
an
APHIS
movement
permit
under
7
CFR
Part
340
is
required
by
USDA.
USDA
requested
the
Agency
to
require
the
registrants
to
submit
the
applicable
APHIS
permits
as
part
of
the
registration
application,
to
ensure
compliance
with
the
applicable
requirements.
Therefore,
the
Agency
is
seeking
public
comment
on
the
most
appropriate
method
to
ensure
APHIS
permitting
and
EPA
registrations
are
coordinated."

Conclusion
In
summary,
the
Agency
proposes
additional
meetings
with
Agricultural
Research
Service
and
other
USDA
Agencies,
and
EPA
plans
to
take
the
actions
recommended
by
USDA
and
as
discussed
above.
In
addition
to
the
issues
addressed
within
the
letter
submitted
by
USDA,
EPA
has
developed
a
response,
see
attachment,
to
the
questions
raised
during
the
pre­
briefing
with
USDA
and
the
Office
and
Management
and
Budget
on
November
14,
2005.
The
Agency
views
the
meetings
and
review
process
with
USDA
as
a
method
to
improve
the
proposed
rule,
and
we
are
grateful
for
your
time
and
consideration
in
our
endeavor
to
update
the
data
requirements
for
biochemical
and
microbial
pesticides.
We
look
forward
to
future
meetings
and
discussion
with
this
proposed
rule.
Again,
thank
you
for
your
time.
If
you
have
any
questions,
please
feel
free
to
contact
Janet
Andersen
at
703­
308­
8712
or
at
andersen.
janet@
epa.
gov.
