Document ID: EPA-HQ-OPP-2003-0411-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2004-05-10T04:00Z

Summary
of
Public
Comments
on
the
Public
Participation
Process
List
of
Commentors:

$
Aventis
(
AV)

$
California
Citrus
Quality
Council
(
CCQC)

$
Consumers
Union
(
CU)

$
Implementation
Working
Group
(
IWG)

$
National
Agricultural
Aviation
Association
(
NAAA)

$
Natural
Resources
Defense
Council
(
NRDC)

$
North
Carolina
Farm
Bureau
Federation
(
NC­
FBF)

$
Oklahoma
State
University
Cooperative
Extension
Service
(
OSU)

$
Pest
Management
Regulatory
Agency,
Health
Canada
(
PMRA)

$
Weed
Science
Society
of
America
(
WSSA)

The
following
responded
but
provided
comments
about
TRAC,
not
the
proposed
public
participation
process:

$
National
Alliance
of
Independent
Crop
Consultants
(
NAICC)

$
New
England
Fruit
Consultants
(
NEFC)
2
I.
General
Comments
About
the
Public
Participation
Process
A.
Questions,
Concerns
and
Suggestions
1.
One
commentor
requested
that
the
public
participation
process
be
subject
to
open
discussion
and
sign­
off
by
the
stakeholder
committee
that
will
replace
the
Tolerance
Reassessment
and
Advisory
Committee
(
TRAC).

EPA's
Response:
EPA
and
USDA
have
worked
with
the
Committee
to
Advise
on
Reassessment
and
Transition
(
CARAT)
to
discuss
how
to
effectively
use
the
public
participation
process
to
its
fullest
potential.
(
CARAT
is
the
new
stakeholder
committee
created
in
June
2000,
which
was
established
by
EPA
and
USDA
after
the
final
TRAC
meeting
in
October
1999.)

2.
One
commentor
believes
that
EPA
has
a
responsibility
to
hold
a
public
meeting
on
the
interim
public
participation
process
prior
to
the
issuance
of
the
final
Federal
Register
notice
on
the
full
public
participation
process
to
discuss
EPA's
findings,
decisions,
and
plan
of
action
regarding
the
interim
process.

EPA's
Response:
EPA
and
USDA
do
not
believe
a
public
meeting
is
necessary
because
the
interim
process
has
been
well
explained,
and
applied
to
many
pesticide
decisions.
EPA
has
provided
descriptions
of
the
interim
process
on
its
website
and
in
the
Federal
Register
notices
announcing
the
public
availability
of
risk
assessments
and
related
documents
for
pesticides
that
used
the
interim
process.
The
information
provided
on
the
website
and
in
the
Federal
Register
notices
should
have
sufficiently
described
the
interim
process,
but
if
an
individual
needed
additional
information,
the
notices
identified
EPA
contact
persons
who
could
provide
clarification.

3.
One
commentor
states
that
a
safeguard
appeals
provision
is
needed
for
"
stakeholders
who
feel
that
they
have
been
excluded
from
the
process
or
that
the
process
has
not
been
followed
in
good
faith."

EPA's
Response:
EPA
and
USDA
are
making
a
significant
effort
to
involve
all
interested
stakeholders
in
the
public
participation
process,
and
have
an
"
open
door"
policy
for
communication
with
all
stakeholders.
Stakeholders
have
opportunities
during
and
after
the
process
to
raise
concerns,
therefore,
a
formal
appeals
process
is
not
warranted.

4.
Two
commentors
asked
about
the
specific
obligations
and
responsibilities
under
FQPA
of
the
other
Federal
government
agencies
mentioned
in
the
proposed
public
participation
process
(
USDA,
FDA,
HHS)
and
whether
memoranda
of
understandings
are
in
place
among
these
agencies
and
EPA
regarding
the
work
to
3
be
accomplished.

EPA's
Response:
EPA,
USDA,
FDA,
and
CDC/
HHS
are
actively
discussing
roles
and
responsibilities
under
FQPA
and
the
public
participation
process.
Memoranda
of
Understanding
may
be
used
in
the
future
to
formally
establish
partnerships
but
have
not
been
determined
to
be
needed
at
this
time.

5.
One
commentor
suggested
the
establishment
of
an
ombudsman's
office
that
would
be
responsible
for
assisting
stakeholders
as
they
work
to
participate
in
the
public
participation
process.
An
ombudsman's
office
could
"
lead
to
a
more
dynamic,
interactive
exchange
between
the
agencies
and
stakeholders,
and
ultimately
lead
to
more
inclusive
and
rational
decisions."

EPA's
Response:
EPA
appreciates
this
suggestion
and
is
considering
ways
to
ensure
that
this
important
communication
function
is
accommodated.

6.
Three
commentors
stated
that
comments
received
from
other
Federal
government
agencies
must
be
recorded
and
made
available
in
the
public
docket,
as
well
as
EPA's
response
to
those
comments.

EPA's
Response:
EPA
agrees
that
any
formal
comments
received
from
other
Federal
government
agencies
should
be
part
of
the
docket
for
that
pesticide.

7.
Canada's
Pesticide
Management
Regulatory
Agency
wants
to
be
considered
as
if
it
were
a
U.
S.
Federal
government
agency.
They
are
requesting
the
same
review
privileges
that
are
now
afforded
to
USDA.

EPA's
Response:
EPA
welcomes
opportunities
to
work
with
Canada
on
pesticide
issues
including
risk
assessment
and
risk
management
harmonization.
The
Agency
also
has
undertaken
a
number
of
joint
reviews
with
Canada.
These
efforts
are
expected
to
continue
where
there
is
mutual
interest
and
benefit.

8.
On
commentor
felt
that
the
proposed
public
participation
process
should
be
promulgated
by
rulemaking
because
of
its
"
implied
air
of
legal,
binding
obligation,"
and
suggested
that
future
programs,
such
as
those
that
might
be
needed
for
registration
review,
should
use
this
public
participation
process.

EPA's
Response:
EPA
believes
it
is
not
necessary
or
appropriate
to
codify
the
public
participation
process
through
rulemaking.

9.
One
commentor
wants
a
process
adopted
for
peer
review
of
the
"
science
policies,
models,
and
assumptions"
that
are
generally
applied
to
risk
assessments
(
i.
e.,
general
tools).
4
EPA's
Response:
EPA
does
rely
on
established
peer
review
processes
for
the
development
of
science
polices,
methodologies,
and
models,
including
the
FIFRA
Scientific
Advisory
Panel
(
SAP).

10.
Two
commentors
suggested
that
the
proposed
public
participation
process
needs
to
be
flexible
to
accommodate
the
level
of
complexity
associated
with
each
pesticide.
One
commentor
stated
that
the
phases'
timeframes
should
be
lengthened
based
on
experience
under
the
pilot
public
participation
process.
The
commentor
stated,
"
If
timeframes
are
routinely
exceeded
or
extended
because
of
circumstances
that
are
in
fact
foreseeable,
it
makes
more
sense
to
establish
realistic
timeframes
up
front,
rather
then
risk
erosion
of
public
confidence
in
the
process."
The
process
could
be
abbreviated
for
less
complicated
pesticides.
One
commentor
requested
that
specific
process
modification
criteria
be
established,
such
as
"
the
number
of
acres
treated
and
the
number
of
crops
and
geographical
areas
involved",
and
the
public
should
be
notified
of
chemical­
specific
process
changes.

Two
commentors
strongly
recommended
against
adopting
the
full
public
participation
process.
One
commentor
stated
that
the
full
process
"
would
lock
EPA
into
a
lengthy,
regimented
procedure
that
will
be
unnecessary
in
many
cases,
while
delaying
the
decisionmaking
process
in
the
few
cases
that
will
generate
significant
risk
mitigation
challenges."
The
other
commentor
strongly
urged
the
Agency
to
adopt
a
modified
version
of
the
streamlined
interim
process
(
which
was
designed
for
those
non­
organophosphates
undergoing
tolerance
reassessment
and
reregistration
in
2000),
asserting
that
the
shorter
timeframes
would
allow
EPA
to
meet
the
tolerance
reassessment
deadlines
established
in
FQPA.

EPA's
Response:
EPA
agrees
that
the
proposed
public
participation
process
needs
to
be
flexible.
In
the
proposal,
the
Agency
anticipated
that
modifications
to
the
public
participation
process
would
be
appropriate
for
pesticides
with
limited
use
and
usage,
low
risk
concerns,
a
small
number
of
users,
or
other
factors.
The
final
process
includes
both
full
and
modified
versions,
recognizing
that
less
process
is
appropriate
for
pesticides
requiring
less,
or
no,
risk
mitigation.
The
Agency
believes
a
case­
by­
case
approach
is
best
for
determining
which
pesticides
will
undergo
a
modified
process
rather
than
establish
specific
criteria.
EPA
will
inform
the
public
of
modifications
to
the
public
participation
process
that
are
warranted
for
a
pesticide.
In
addition,
EPA
plans
to
continue
to
meet
the
tolerance
reassessment
deadlines
established
by
FQPA.
In
August
1999,
EPA
met
the
first
statutory
deadline
by
reassessing
greater
than
33
percent
of
existing
pesticide
tolerances.
In
August
2002,
the
Agency
met
the
second
deadline,
completing
more
than
66
percent
of
all
required
tolerance
reassessment
decisions.
EPA
is
committed
to
meeting
the
final
statutory
deadline
and
completing
100
percent
of
all
required
tolerance
reassessment
decisions
by
August
3,
2006.
5
11.
One
commentor
expressed
concern
that
risk
management
decisions
for
a
pesticide
could
be
made
prior
to
the
completion
of
the
public
participation
process.
Existing
statutory
mechanisms
should
be
utilized
for
addressing
unacceptable
risks
associated
with
pesticide
product
uses,
such
as
the
emergency
suspension
process,
rather
than
create
a
mechanism
as
part
of
the
public
participation
process.
On
the
other
hand,
two
commentors
stressed
that
EPA
must
continue
to
reserve
its
authority
to
improve
the
effectiveness
of
risk
mitigation
and
comply
with
FQPA,
and
ensure
that
stakeholders
are
given
adequate
notice
that
action
is
being
taken.

EPA's
Response:
EPA
reaffirms
its
intention
to
issue
risk
management
decisions
on
certain
uses
of
a
pesticide
at
any
time
before
or
during
the
public
participation
process
if
such
action
is
warranted
by
high
risk
levels
identified
in
the
risk
assessments.
EPA
is
bound
by
statute
to
make
such
decisions
and
take
action
when
it
is
warranted.
EPA
is
not
adding
a
mechanism
to
the
public
participation
process
when
it
utilizes
the
tools
and
processes
established
by
statute
to
achieve
this
type
of
action.
While
EPA
may
exercise
this
authority
at
any
time
during
this
process,
the
Agency
will
continue
to
ensure
that
stakeholders
and
other
Federal
government
agencies
are
informed
and
involved
in
the
decisionmaking
process
through
meetings
and
conference
calls.

12.
One
commentor
strongly
recommended
that
EPA
always
"
couple
together"
for
a
pesticide
both
tolerance
reassessment
under
FQPA
and
FIFRA's
reregistration
components,
including
the
assessment
of
environmental
fate
and
ecological
effects,
worker
protection,
endangered
species,
etc.

EPA's
Response:
EPA
generally
is
reviewing
pesticides
for
both
tolerance
reassessment
and
reregistration
eligibility
at
the
same
time.
However,
on
a
caseby
case
basis,
the
Agency
may
move
to
complete
the
tolerance
reassessment
decision
earlier,
given
individual
circumstances.
The
Agency
is
required
to
reconsider
certain
tolerances
because
of
FQPA
and
if
based
on
anticipated
residues.

13.
One
commentor
recommended
that
the
public
participation
process
will
prove
too
lengthy
to
use
in
the
cumulative
risk
assessment
phase.
(
FQPA
requires
the
assessment
of
the
cumulative
effects
of
pesticides
that
share
a
common
mechanism
of
toxicity
before
tolerance
reassessment
for
those
pesticides
can
be
achieved.)

EPA's
Response:
With
advice
and
input
from
CARAT,
EPA
and
USDA
developed
a
process
to
ensure
ample
opportunities
for
public
participation
in
EPA's
development
of
the
preliminary
and
revised
organophosphate
cumulative
risk
assessments.
For
additional
information,
see
EPA's
pesticide
cumulative
risk
website,
http://
www.
epa.
gov/
pesticides/
cumulative/
.
6
14.
Several
commentors
expressed
differing
opinions
about
the
stakeholder
conference
calls
that
USDA
would
hold
during
several
phases
of
the
public
participation
process
and
the
interim
process.
One
commentor
suggested
that
unless
conference
calls
are
used
sparingly
and
judiciously,
they
are
a
poor
investment
of
EPA's
and
USDA's
resources
because
they
are
time­
consuming
to
organize
and
frustrating
to
participate
in.
One
commentor
wanted
EPA
and
USDA
to
clearly
define
in
the
public
participation
process
the
number
of
conference
calls
that
would
always
be
held,
and
the
number
that
would
be
held
in
each
region
of
the
country.
Other
commentors
were
supportive
of
conference
calls
as
described
in
the
public
participation
process
proposal.

EPA's
Response:
EPA
and
USDA
believe
that
conference
calls
can
be
an
effective
tool
to
communicate
with
stakeholders
throughout
the
public
participation
process.
Stakeholder
communication
needs
will
be
different
for
each
pesticide
(
because
of
the
number
of
uses,
complexity
of
risk
issues,
etc.);
therefore,
EPA
and
USDA
believe
that
the
number
and
frequency
of
conference
calls
must
be
determined
on
a
pesticide­
specific
basis.
Conference
call
attendees
are
not
restricted
to
only
a
small
select
group
(
as
one
commentor
charged),
but
may
include
a
broad
range
of
interested
stakeholders,
including
those
who
express
interest
during
Pre­
Phase
1.

B.
Comments
About
the
Interim
Process
1.
Several
commentors
objected
to
the
use
of
an
interim
process
for
nonorganophosphate
pesticides
undergoing
tolerance
reassessment
and
reregistration,
stating
that
the
interim
process
limits
public
participation
and
is
too
short
in
time.

EPA's
Response:
EPA
has
employed
the
interim
process
for
many
nonorganophosphate
pesticides
undergoing
tolerance
reassessment
and
reregistration
eligibility
decision
development
work
during
the
past
several
years.
In
most
instances,
the
Agency
has
limited
use
of
the
shortened
process
to
those
decisions
where
no
risks
of
concern
have
been
identified,
or
where
risks
could
be
mitigated
easily
through
label
amendments.
In
developing
decisions
for
these
pesticides,
the
Agency
has
made
a
concerted
effort
to
engage
stakeholders
in
discussions
and
consultations
through
meetings
and
conference
calls.
Some
non­
OP
pesticides
with
more
complex
uses,
issues,
and/
or
risks
have
been
reviewed
using
a
full,
six
phase
process.
Examples
include
atrazine,
carbaryl,
and
lindane.
For
the
organophosphate
pesticides,
EPA
has
continued
to
apply
the
pilot
public
participation
process
because
these
pesticides
have
made
significant
progress
through
that
process.
In
reviewing
the
remaining
pesticides
scheduled
for
tolerance
reassessment
and
reregistration
development
work
in
2004
and
beyond,
EPA
will
continue
to
use
a
shortened,
modified
process
where
appropriate.
7
C.
Supportive
Comments
EPA
received
numerous
comments
supporting
various
aspects
of
the
public
participation
process.
The
following
provides
a
short
synopsis
of
these
supportive
comments.

1.
EPA's
efforts
have
made
the
risk
assessment
and
related
documents
more
available,
user­
friendly,
and
visible
to
the
public.

2.
EPA
is
to
be
commended
for
working
with
USDA
and
with
grower
and
applicator
groups
in
addressing
pesticide
issues.
The
process
EPA
has
used
with
USDA,
especially
the
Office
of
Pest
Management
and
Policy
(
OPMP),
has
provided
sound
judgement
and
input
into
some
difficult
tolerance
reassessment/
reregistration
decisions.

3.
The
proposed
process
for
public
participation
substantially
maintains
the
openness
of
the
pilot
public
participation
process
for
reviewing
risk
assessments
and
risk
management
strategies
for
individual
pesticides.

4.
Support
was
expressed
for
three
separate
public
participation/
comment
periods
(
use
and
usage
characterization
in
Pre­
Phase
1/
Phase
1,
risk
assessment
in
Phase
3,
and
risk
management
in
Phase
5),
and
in
this
sequence
so
that
corrections
and
adjustments
can
be
made
at
the
earliest
appropriate
stage
rather
than
waiting
until
possible
problems
are
aggregated
and
compounded.

5.
Support
was
expressed
for
enhanced
Pre­
Phase
1
activities
because
this
phase
provides
an
important
opportunity
to
enhance
public
support
and
confidence
in
the
process
and
is
very
likely
to
increase
actual
participation.
Pre­
Phase
1
will
provide
more
of
an
opportunity
to
collect
and
supply
to
EPA
and
the
pesticide
registrants
information
and
actual
data
on
how
a
pesticide
product
is
actually
used.
This
data
and
information
will
aid
EPA
in
achieving
its
goal
of
using
sound
science
in
the
assessment
of
pesticides.

6.
Many
commentors
were
supportive
of:

$
applying
the
public
participation
process
to
all
pesticides
in
tolerance
reassessment
and
reregistration;

$
the
public
release
of
the
pesticide's
use
and
usage
data
early
in
the
process,
and
$
the
release
of
risk
management
options
and
alternatives
in
Phase
5
because
the
public
will
be
able
to
understand
the
options
available
to
the
Agency
and
provide
meaningful
comment.

7.
In
addition,
many
commentors
were
appreciative
of
EPA's
efforts
to
make
risk
assessments
and
related
documents
accessible
to
the
public
through
its
website.
8
II.
Comments
Specific
to
the
Phases
of
the
Public
Participation
Process
A.
Pre­
Phase
1
1.
Three
commentors
objected
to
the
Agency's
proposal
to
not
use
the
word
"
preliminary"
to
describe
the
risk
assessments
that
are
released
to
the
public
in
the
early
phases
of
the
public
participation
process
because
the
public
may
mistakenly
believe
that
the
documents
are
final
when
they
are
still
subject
to
revision
as
the
public
participation
process
progresses.

EPA's
Response:
EPA
maintains
that
the
risk
assessments
now
under
development
contain
many
more
refinements
than
previous
preliminary
risk
assessments,
such
as
probabilistic
dietary
risk
assessments,
and
therefore
may
be
called
risk
assessments.
EPA
will
include
information
describing
the
stage
of
development
of
a
pesticide's
risk
assessments
when
they
are
released
during
the
early
stages
of
the
public
participation
process,
just
as
the
Agency
has
done
for
each
of
the
organophosphate
pesticides.

2.
Two
commentors
suggested
that
EPA
make
a
public
announcement
when
Pre­
Phase
1
activities
for
a
pesticide
are
going
to
start.
The
method
of
this
public
announcement
could
be
an
annual
notice
listing
pesticides
planned
for
tolerance
reassessment
and
reregistration
work
the
next
year.

EPA's
Response:
EPA
agrees
that
registrants
and
other
interested
stakeholders
will
benefit
from
knowing
which
pesticides
are
scheduled
to
start
the
public
participation
process.
The
proposal
stated
that,
"
EPA
will
inform
the
public
well
in
advance
about
pesticides
that
are
scheduled
for
the
public
participation
process."
For
the
past
several
years,
EPA
has
been
posting
on
its
pesticide
reregistration
website
and
including
in
its
annual
Federal
Register
notice
on
Pesticide
Reregistration
Performance
Measures
and
Goals
lists
of
RED,
IRED,
and
TRED
candidate
pesticides
for
the
then­
current
and
following
fiscal
year.
EPA
now
has
posted
on
its
reregistration
website
the
schedule
for
completing
all
remaining
REDs,
IREDs,
and
TREDs.
A
related
Public
Comment
Period
Schedule,
updated
quarterly,
indicates
when
public
participation
opportunities
are
expected
to
begin
for
these
pesticides
during
the
next
six
months.

3.
The
proposal
stated
that,
"
Registrants
will
be
asked
to
identify
any
ongoing
studies
and
analyses
that
are
relevant
to
the
risk
assessments,
and
EPA
will
announce
for
each
pesticide
the
due
dates
for
the
submission
of
data,
information,
and
analyses."
One
commentor
asked
that
the
Agency
give
more
thought
to
how
the
registrants
learn
about
outstanding
and
new
data
requirements,
the
timeframes
for
data
submission,
and
how
the
notification
of
data
submission
requirements
are
transmitted
to
them.
9
EPA's
Response:
EPA
commits
to
improving
these
communication
issues.

4.
One
commentor
wants
use
and
usage
information
released
during
or
at
the
beginning
of
Pre­
Phase
1
instead
of
at
the
end.

EPA's
Response:
A
significant
focus
of
Pre­
Phase
1
is
to
engage
stakeholders
as
early
as
possible,
to
ensure
the
accuracy
of
key
information
on
pesticide
use
and
use
practices
that
affect
risk
assessment.
Using
the
Agency's
website,
EPA
plans
to
share
information
describing
the
Agency's
understanding
of
currently
labeled
uses,
usage,
and
use
practices
for
a
pesticide
during
Pre­
Phase
1,
based
on
input
from
USDA,
registrants,
users,
and
other
stakeholders.
This
use/
usage
information
may
be
updated
throughout
the
process
as
new
information
becomes
available
to
the
Agency.

5.
One
commentor
suggested
that,
throughout
Pre­
Phase
1,
EPA
should
post
information
on
its
website
as
a
way
to
ensure
that
individuals
and
stakeholder
groups
who
are
more
difficult
to
access
because
of
size
or
distance
will
be
able
to
participate
in
this
important
phase.
This
commentor
was
also
concerned
that
EPA
not
judge
a
stakeholder
by
their
opinions
expressed
early
in
this
stage
of
the
process,
because
the
stakeholder
may
revise
his/
her
position
after
reviewing
the
risk
assessments
during
Phase
3'
s
public
comment
period.

EPA's
Response:
EPA
is
considering
the
types
of
information
that
may
be
helpful
to
the
public
at
this
very
early
stage.
EPA
understands
that
opinions
expressed
by
stakeholders
may
change
over
the
course
of
the
public
participation
process.

6.
One
commentor
stated
that
Pre­
Phase
1
would
possibly
add
much
more
time
to
an
already
lengthy
process,
mostly
contribute
large
quantities
of
anecdotal
information
that
should
not
be
used
to
affect
or
lower
risk
numbers,
and
be
too
resource
intensive
for
EPA
and
USDA.
Another
commentor
cautioned
EPA
not
to
allow
Pre­
Phase
1
to
delay
the
actual
public
participation
process.

EPA's
Response:
EPA
and
USDA
firmly
believe
that
consultations
with
stakeholders
about
use
and
usage
during
this
early
stage
are
a
worthwhile
investment
of
time.
These
discussions
will
allow
EPA
to
develop
risk
assessments
that
are
based
on
the
best
information
available,
and
overall
will
help
to
expedite
the
assessment
of
the
pesticide.
The
resulting
risk
assessments
will
generate
fewer
error
comments
from
registrants
during
Phase
1
and
from
the
public
during
Phase
3,
thereby
allowing
EPA
to
expedite
its
consideration
of
comments
and
revision
of
risk
assessments.
Another
important
benefit
of
Pre­
Phase
1
activities
is
that
the
public
will
be
alerted
in
advance
when
a
pesticide
they
may
be
interested
in
is
about
to
start
the
public
participation
process.
10
EPA
does
not
supplant
scientifically
generated
data
with
anecdotal
information.
Anecdotal
information
about
a
pesticide's
use
and
usage
may
be
used
in
the
risk
assessments
to
add
another
scenario
under
which
potential
human
and/
or
environmental
exposure
to
the
pesticide
can
be
estimated.
Exposure
scenarios
that
are
developed
using
the
labeled
rates
of
the
pesticide
will
continue
to
be
very
necessary
and
an
important
part
of
pesticide
risk
assessments.

B.
Phase
1
1.
One
commentor
asserted
that
Phase
1'
s
30­
day
timeframe
does
not
provide
sufficient
time
for
registrants
to
complete
a
thorough
error
identification
review
of
the
risk
assessments.
Contrarily,
a
different
commentor
stated
that
given
the
low
frequency
of
significant
errors
identified
by
registrants
(
as
reported
by
EPA
in
the
process
proposal),
a
fourteen
day
registrant
error
identification
review
should
be
sufficient.
If
significant
errors
are
identified,
then
an
additional
14
review
days
could
be
granted
by
EPA.

EPA's
Response:
EPA
maintains
that
30
days
is
both
a
sufficient
and
an
appropriate
amount
of
time
for
registrants
to
review
the
risk
assessments
for
errors.
As
reported
in
the
proposal,
the
large
majority
of
comments
received
from
registrants
during
Phase
1
of
the
organophosphate
pesticides
pilot
public
participation
process
were
considered
to
be
non­
error
comments.
The
majority
of
these
non­
error
comments
were
general
comments
about
the
preliminary
risk
assessments.
Registrants
need
not
develop
or
submit
non­
error
comments
during
Phase
1
because
EPA
will
not
respond
to
them
prior
to
the
release
of
the
risk
assessments
in
the
first
public
comment
period
(
Phase
3).
Registrants
should
submit
their
non­
error
comments
during
Phase
3,
as
well
as
any
additional
errors
that
they
have
identified.
While
EPA
would
like
to
have
all
errors
corrected
prior
to
the
release
of
the
risk
assessments
for
public
comment,
the
Agency
recognizes
that
the
process
provides
additional
opportunities
for
revisions
to
the
assessment
documents.

2.
One
commentor
stated
that
the
risk
assessments
should
not
be
released
to
the
public
while
data
still
needs
to
be
reviewed
or
is
still
outstanding.
The
timeframes
for
submission
of
the
data
should
be
carefully
thought
out,
and
the
Agency
should
explain
how
the
data
call­
in
authority
of
FIFRA
3(
c)(
2)(
B)
and
FFDCA
408(
f)
would
be
used
in
this
phase.
Similarly,
another
commentor
asked
if
regulatory
decisions
will
be
made
if
the
Agency
has
knowledge
that
the
submission
of
data
is
imminent.
On
the
other
hand,
one
commentor
stated
that
EPA
should
stick
to
its
intention
of
not
delaying
work
when
a
study
submission
date
is
beyond
the
timeframe
of
the
public
participation
process.

EPA's
Response:
EPA
will
use
the
data
requirement
notification
process
in
11
FFDCA
section
408(
f)
when
additional
data
or
information
of
any
type
are
deemed
necessary
to
support
continuation
of
a
tolerance.
Nevertheless,
the
Agency
does
not
believe
that
section
408(
f)
requires
the
deferral
of
tolerance
decision­
making
until
pesticide
registrants
or
others
have
been
given
every
possible
opportunity
to
generate
additional
data
that
may
further
refine
an
existing
risk
assessment.
Likewise,
the
Agency
does
not
interpret
section
408(
f)
as
requiring
the
Agency
to
"
call­
in"
all
data
that
could
conceivably
affect
a
tolerance
risk
assessment.
Where
EPA
finds
that
additional
data
or
information
are
not
appropriate
or
necessary,
the
Agency
will
leave
it
to
the
discretion
of
registrants
and
other
interested
parties
to
determine
which
additional
information
they
believe
would
most
likely
affect
risk
assessments,
and
then
to
submit
that
information.
Many
registrants
have
already
chosen
to
submit
additional
data,
not
required
by
the
Agency,
to
be
considered
as
part
of
an
FQPA
tolerance
reassessment.

FIFRA
and
FFDCA
give
the
Agency
considerable
flexibility
in
choosing
a
course
of
regulatory
action
that
appropriately
carries
out
the
broad
statutory
intent
of
protecting
public
health
and
the
environment.
When
a
risk
assessment
indicates
a
potential
concern,
EPA
revisits
critical
assumptions
and
pivotal
data.
It
is
often
at
or
before
this
preliminary
assessment
phase
that
registrants,
growers,
or
other
stakeholders
choose
to
submit
additional
data
relating
to
their
products
that
assist
us
in
refining
the
assessment.

If,
after
careful
evaluation
of
all
available
information,
the
Agency
still
sees
a
significant
risk,
we
believe
that
it
is
appropriate
to
take
action
to
address
that
risk
even
though
we
may
still
require
additional
data
(
or
registrants
or
other
sponsors
may
opt
to
develop
and
submit
additional
data).
The
Agency
recognizes,
too,
that
there
may
be
instances
where,
after
all
of
the
data
have
been
examined,
the
extent
of
the
risk
does
not
become
reasonably
clear
and
the
Agency
is
unable
to
make
a
definitive
safety
finding.
Under
these
circumstances
EPA
may
need
to
require
new
studies
from
the
registrant
and
either
defer
a
decision
until
the
new
data
are
received
and
reviewed,
or
make
an
interim
decision.
As
noted
earlier,
the
Agency
does
not
believe
that
section
408(
f)
requires
the
deferral
of
decision­
making
until
pesticide
registrants
or
others
have
been
given
every
possible
opportunity
to
generate
additional
data
that
may
further
refine
an
existing
risk
assessment.

3.
One
commentor
finds
Phase
1
"
unacceptable
in
the
extreme",
claiming
that
a
prior
consent
agreement
precludes
EPA
from
limiting
the
release
of
information
to
only
a
limited
number
of
stakeholders,
and
from
holding
private
negotiations
with
pesticide
registrants.

EPA's
Response:
Phase
1
is
limited
to
the
identification
by
registrants
of
errors
and
Confidential
Business
Information
in
the
risk
assessments.
In
the
cover
letter
that
EPA
uses
to
transmit
the
risk
assessments
to
registrants,
they
are
asked
to
12
identify
any
parts
in
the
Agency's
risk
assessments
that
they
want
to
claim
as
confidential.
(
Screening
for
CBI
must
be
accomplished
by
law
before
the
Agency
can
release
documents
to
the
public.)
In
addition,
the
Agency
does
not
enter
into
or
initiate
negotiations
with
registrants
in
Phase
1.
Registrants
are
clearly
informed
in
the
transmittal
cover
letter
that
EPA
is
only
receptive
to
the
identification
of
errors
in
the
risk
assessments
because
EPA
would
like
to
have
all
errors
corrected
prior
to
the
release
of
the
risk
assessments
to
the
public.

C.
Phase
2
1.
One
commentor
asserted
that
EPA
did
not
need
30
days
to
consider
the
errors
identified
by
the
registrant.

EPA's
Response:
EPA
strives
to
release
the
revised
risk
assessments
to
the
public
as
soon
as
possible.
Agency
staff
actually
have
only
two
weeks
to
address
errors
because
it
takes
two
weeks
to
prepare
for
the
opening
of
the
public
docket.
All
documents
must
be
screened
for
Confidential
Business
Information
and
then
formatted
for
Internet
posting,
and
the
Federal
Register
notice
must
be
prepared
and
published.

D.
Phase
3
1.
One
commentor
suggested
that
the
risk
assessment
summary
documents
provided
to
the
public
by
the
agency
should
clearly
point
out
when
the
Agency
has
employed
assumptions
and
models
in
developing
the
estimates
of
risk.

EPA's
Response:
EPA
is
continuously
striving
to
improve
the
clarity
and
content
of
the
risk
assessment
summary
documents
in
order
to
provide
the
public
with
useful
information
about
the
pesticide
under
review.

2.
One
commentor
believes
that
it
is
premature
to
identify
pesticide
alternatives
during
Phase
3;
rather,
alternatives
should
be
a
part
of
the
later
phases
devoted
to
risk
management.
On
the
other
hand,
one
commentor
strongly
supported
the
release
to
the
public
of
pesticide
alternatives
at
this
stage,
including
non­
pesticidal
alternatives.

EPA's
Response:
EPA
has
received
many
comments
in
the
past
requesting
that
the
Agency
begin
a
discussion
of
risk
management
earlier
in
the
public
participation
process.
The
Agency
agrees
that
the
public
will
benefit
in
receiving
a
basic
understanding
of
not
only
the
risks
that
are
identified
in
the
initial
risk
assessments
but
also
how
the
Agency
characterizes
those
risks.
This
will
allow
the
public
to
discern
the
Agency's
level
of
concern
(
if
any)
for
each
use
at
this
stage
in
the
development
of
the
risk
assessments.
During
this
phase,
EPA
and
USDA
also
may
13
begin
to
solicit
input
from
stakeholders
on
the
role
and
importance
of
the
pesticide
in
pest
management
for
particular
crops
or
uses.
This
information
can
help
set
the
stage
for
further
consideration
of
benefits
later
in
the
process,
if
necessary.

3.
One
commentor
suggested
that
EPA
establish
rules
for
when
a
60­
day
comment
period
is
appropriate
for
the
risk
assessments,
versus
when
a
90­
day
comment
period
is
warranted.
Similarly,
another
commentor
agreed
that
the
timeframe
for
Phase
3
should
be
60­
90
days,
although
60
days
should
be
sufficient
for
the
majority
of
pesticides,
and
that
the
complexity
of
risk
issues
should
be
the
major
criteria
used
in
setting
a
pesticide's
comment
period.

EPA's
Response:
The
Agency
believes
a
case­
by­
case
approach
is
best
for
determining
which
pesticides
will
receive
a
60­
or
a
90­
day
public
comment
period.
This
determination
will
be
made
considering
the
complexity
of
the
risk
issues
associated
with
the
pesticide,
the
number
of
stakeholders
who
may
be
interested
in
participating
(
based
partially
on
stakeholder­
Agency
interactions
during
Pre­
Phase
1),
the
number
of
use
patterns,
and
other
factors.

E.
Phase
4
1.
One
commentor
requested
that
EPA
release
to
the
public
along
with
the
revised
risk
assessments
a
description
of
how
the
Agency
considered
public
comment
in
developing
the
revised
risk
assessments.

EPA's
Response:
The
Agency
fully
intends
to
continue
the
current
practice
of
releasing
to
the
public
its
consideration
of
public
comments
received
during
Phase
3
(
public
comment
on
the
risk
assessments)
and
Phase
5
(
public
comment
on
risk
management).
The
Agency
has
released
"
Response
to
Public
Comments"
documents
since
the
initiation
of
the
organophosphate
pesticides
pilot
public
participation
process.

2.
One
commentor
stated
that
if
the
Agency
continues
to
solicit
comments
and
ideas
from
the
public
during
conference
calls,
then
the
public
docket
needs
to
remain
open
to
allow
for
the
submission
of
additional
comments
and
data.

EPA's
Response:
Meeting
minutes
from
all
meetings
and
conference
calls
with
stakeholders
are
always
added
to
the
public
docket,
regardless
of
the
phase
during
which
they
occurred.
In
this
way,
the
public
can
keep
abreast
of
the
Agency's
ongoing
discussions
with
all
types
of
stakeholders.
Comments
and
information
are
occasionally
submitted
by
stakeholders
to
the
docket
after
the
close
of
the
formal
public
comment
period.
While
EPA
does
not
disregard
these
late
submissions,
the
Agency
may
not
have
adequate
time
to
fully
consider
comments
that
are
submitted
too
near
the
end
of
that
public
participation
phase.
These
late
comments
will
be
14
addressed
in
a
subsequent
risk
assessment
or
risk
management
revision
stage.

3.
A
commentor
suggested
that
EPA
needs
to
prepare
the
fullest
range
of
risk
management
options
for
public
comment
during
Phase
5.
Too
few
options
may
lead
the
public
to
believe
that
the
Agency
has
already
decided
on
the
final
risk
management
approach.

EPA's
Response:
The
Agency
fully
intends
to
develop
and
present
for
public
comment
a
risk
management
proposal
that
clearly
lays
out
a
good
range
of
options.

4.
One
commentor
requested
at
least
30
days
notice
of
Technical
Briefings
in
order
to
allow
the
public
to
prepare
for
and
attend
these
important
public
meetings.

EPA's
Response:
The
Agency
maintains
that
in
general,
based
on
its
experience
under
the
pilot
public
participation
process,
2
weeks
is
sufficient
notice
for
most
Technical
Briefings.
Nevertheless,
the
Agency
will
strive
to
give
more
advance
notice
for
pesticides
with
complex
risk
assessments.

5.
One
commentor
suggested
that
while
"
up­
to­
90
days"
was
an
appropriate
time
period
for
this
phase,
EPA
should
make
every
effort
to
finish
the
risk
assessment
revisions
as
soon
as
possible.

EPA's
Response:
EPA
agrees.

F.
Phase
5
1.
One
commentor
asserted
that
the
revised
risk
assessment
released
to
the
public
during
Phase
5
should
be
available
for
public
comment.

EPA's
Response:
EPA
maintains
that
the
proposed
public
participation
process
provides
the
public
with
a
sufficient
number
of
opportunities
to
review
and
comment
on
a
pesticide's
risk
assessments.
The
process
includes
significant
stakeholder
consultation
about
the
pesticide's
use
and
usage
during
Pre­
Phase
1,
and
formal
public
comment
during
Phase
3.
While
Phase
5
serves
to
release
to
the
public
the
risk
assessments
that
have
been
revised
based
on
public
comments,
its
main
purposes
are
to
formally
propose
risk
management
options
for
public
consideration
and
comment,
and
engage
stakeholders
in
a
dialogue
about
the
risk
management
options.
Further,
today's
risk
assessments
generally
are
quite
refined
by
Phase
3,
and
there
would
be
little
value
added
by
eliciting
further
comment
on
them
during
Phase
5.

2.
One
commentor
asserts
that
USDA
must
organize
conference
calls
in
Phase
4
in
all
15
cases.

EPA's
Response:
USDA
believes
that
it
is
important
to
have
flexibility
in
the
public
participation
process
in
order
to
maintain
the
ability
to
tailor
communications
to
meet
stakeholder
needs.
Stakeholder
meetings
and
other
types
of
public
meetings
may
be
more
suited
for
some
pesticides,
whereas
conference
calls
may
suffice
for
others.
USDA
remains
committed
to
ensuring
active
stakeholder
participation
in
the
public
participation
process.

3.
One
commentor
suggested
that
the
timeframe
for
Phase
5
be
30
to
60
days
because
not
all
pesticides
will
need
a
full
60
days.
EPA
could,
on
a
rare
occasion,
extend
the
comment
period
an
additional
30
days
if
public
interest
is
high.

EPA's
Response:
EPA
believes
that,
in
general,
a
full
60
days
is
necessary
for
public
comment
on
the
risk
management
proposal/
options.
EPA
and
USDA
understand,
based
on
frequent
comments
from
stakeholders
during
the
pilot
public
participation
process,
that
stakeholders
are
very
interested
in
the
activities
associated
with
developing
risk
management.
EPA
and
USDA
want
to
give
the
public
adequate
time
to
participate.
It
is
possible
that
EPA
would
occasionally
consider
shortening
or
lengthening
the
comment
period
on
a
case­
by­
case
basis.
EPA
and
USDA
will
strive
to
let
stakeholders
know
in
advance
if
the
Agency
were
to
use
the
flexibility
that
is
part
of
the
public
participation
process
to
modify
the
length
of
the
public
comment
period.

G.
Phase
6
1.
One
commentor
questioned
whether
the
final
risk
management
would
be
available
for
public
comment.

EPA's
Response:
EPA
will
make
the
risk
management
decisions
available
to
the
public
and,
at
a
minimum,
provide
for
public
comment
on
those
actions
that
require
it
by
statute
(
such
as
the
modification
or
revocation
of
a
pesticide
tolerance,
and
cancellations).
EPA
plans
to
conduct
close­
out
conference
calls
with
interested
stakeholders
to
describe
the
regulatory
decisions
presented
in
the
risk
management
decisions.

2.
One
commentor
suggested
that
while
"
up­
to­
60
days"
was
an
appropriate
time
period
for
this
phase,
EPA
should
reach
a
final
risk
management
decision
as
soon
as
practicable.

EPA's
Response:
EPA
agrees.

3.
One
commentor
suggested
that
EPA
needs
to
be
explicit
about
how
it
intends
to
16
pursue
risk
management
for
those
pesticides
that
do
and
do
not
share
a
common
mechanism
of
toxicity.

EPA's
Response:
The
public
participation
process
establishes
a
means
for
moving
pesticides
through
assessment
while
ensuring
public
involvement.
The
process
is
not
intended
nor
designed
to
be
a
vehicle
for
establishing
policy
about
FQPA
implementation.
EPA
has
published
science
policy
papers
that
discuss
how
risk
management
for
common
mechanism
pesticides
will
be
pursued.
These
science
policy
papers
are
available
on
EPA's
internet
website
at
www.
epa.
gov/
oppfead1/
trac/
science
.

4.
One
commentor
suggested
that
an
additional
step
in
the
process
be
added
to
ensure
that
risk
mitigation
measures
and
resulting
label
changes
do
not
create
problems
to
the
user
community,
such
as
unclear
use
instructions,
or
use
changes
that
are
impractical
and
inconsistent
with
current
crop
production
practices.

EPA's
Response:
EPA
recognizes
the
importance
of
crafting
risk
management
and
any
resulting
labeling
changes
that
make
sense
to
the
pesticide
user
as
well
as
achieve
the
necessary
risk
mitigation.
A
major
benefit
of
the
public
participation
process
is
the
open
communication
among
EPA,
USDA,
and
interested
stakeholders,
including
discussions
about
the
risk
reduction
options
that
EPA
will
propose
for
public
comment
during
Phase
5.
These
risk
reduction
options
should
be
drafted
clearly
enough
to
enable
the
public
to
give
the
Agency
and
USDA
advice
and
insight
into
the
feasibility
of
the
proposed
risk
mitigation,
or
at
least
to
initiate
discussion
about
the
proposed
measures,
and
provide
a
basis
for
the
pubic
to
suggest
risk
management
proposals.
Phase
5
was
designed
and
intended
to
seek
public
comment,
initiate
discussion,
and
elicit
public
ideas
and
input
about
risk
reduction
and
risk
management,
and
the
use
changes
potentially
entailed.
EPA
therefore
does
not
believe
that
any
additional
steps
or
phases
are
needed
for
this
purpose.