Document ID: EPA-HQ-OPP-2004-0038-0039
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2006-01-27T05:00Z

1
Summary
of
EPA
Responses
to
Public
Comments
Concerning
Proposed
Rule,
"
Pesticides;
Emergency
Exemption
Process
Revisions,"
September
3,
2004,
Federal
Register
and
Pilot
Program,
April
24,
2003,
Federal
Register
I.
Introduction
&
Background
EPA
published
a
proposed
rule
in
the
Federal
Register
on
September
3,
2004,
that
included
two
primary
proposals
to
revise
the
pesticide
emergency
exemption
process
under
section
18
of
the
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(
FIFRA).
The
proposed
rule
also
included
a
number
of
minor
proposed
revisions
to
the
regulations.
EPA
solicited
comment
on
the
proposed
rule,
and
the
public
comment
period
ended
on
November
2,
2004.
This
document
summarizes
comments
submitted
to
the
public
docket
for
the
proposed
rule,
and
provides
the
Agency's
responses
to
those
comments.

Prior
to
the
proposed
rule,
on
04/
24/
03,
EPA
published
a
Federal
Register
Notice
(
FRN)
that
initiated
a
pilot
program
to
test
the
two
primary
revisions
later
included
in
the
proposed
rule,
and
to
solicit
public
comment
on
those
potential
revisions
and
others.
Unit
III
of
this
document
provides
an
overview
of
the
comments
received
on
the
04/
24/
03
FRN,
and
responses
to
comments
on
the
FRN
not
addressed
by
responses
to
comments
on
the
proposed
rule.

A
public
docket
was
established
for
the
09/
03/
04
proposed
rule
and
for
the
04/
24/
03
FRN.
Each
docket
contains
the
Federal
Register
document,
support
documents
entered
by
EPA,
and
all
public
comments
received.
Anyone
interested
may
view
the
comments
on­
line
through
EPA's
EDocket
as
explained
below,
or
other
methods
explained
in
the
Federal
Register
documents.

II.
Public
Comments
on
Proposed
Rule,
and
EPA
Responses
In
this
unit,
EPA
summarizes
applicable
public
comments
received
on
the
proposed
rule
by
briefly
paraphrasing
each
substantive
comment,
followed
by
EPA's
response
to
that
comment.
Where
multiple
commenters
made
a
substantially
similar
comment,
it
is
stated
once,
with
an
indication
of
how
many
made
the
comment,
by
commenter
type.
Comments
which
support
the
proposed
revisions
without
modification,
and
comments
that
are
strictly
testimonial
in
nature,
may
not
be
included
in
this
summary.
Unit
II
is
organized
to
address
comments
on
each
of
the
two
primary
proposals
in
separate
sections,
followed
by
a
section
for
general
comments
and
comments
on
all
other
proposed
revisions
and
related
issues.
Each
section
is
further
divided
to
address
comments
of
those
opposed
to
the
proposal
separately
from
comments
of
those
who
generally
support
the
proposed
revision,
but
suggest
modifications.
The
order
that
comments
are
presented
is
not
related
to
the
level
of
significance
with
which
the
Agency
views
them.

A
total
of
28
submissions
containing
public
comments
on
the
proposed
rule
were
received
1AAPCO
is
the
American
Association
of
Pesticide
Control
Officials,
which
represents
the
States
in
pesticide
regulatory
matters.

2The
total
number
of
submissions
does
not
equal
the
sum
of
submissions
by
commenter
type
because
some
submissions
were
submitted
jointly
by
groups
in
more
than
one
commenter
type.
A
single
submission
may
be
counted
in
multiple
commenter
types,
but
only
once
in
the
total.

2
and
entered
into
the
public
docket.
All
of
these
comments
are
available
in
the
public
docket
and
in
the
Agency's
E­
Docket
system
on
the
web
at
http://
www.
epa.
gov/
edocket.
At
the
E­
docket
website,
use
"
Quick
Search"
to
find
the
individual
docket,
using
OPP­
2004­
0038
for
this
rule.
A
total
of
41
commenters
were
represented
by
these
comments
as
some
of
the
submissions
were
submitted
jointly
by
multiple
parties.
For
ease
of
discussion
and
a
better
understanding
of
the
sources
of
the
various
comments,
commenters
are
grouped
according
to
the
type
of
organization
or
interest.
The
following
is
a
listing
of
the
number
of
comment
submissions
on
the
09/
03/
04
proposed
rule,
by
type
of
commenter:

Number
of
Comments,
by
Commenter
Type
Commenter
Type
#
of
Comment
Submissions
Education/
research
2
Agriculture/
food
industry
3
Environmental/
public
interest
1
(
joint
submission
by
13
groups)
Grower
group
12
Pesticide
industry/
registrant
2
Private
citizen
1
State
lead
agency
10
(
9
states
+
AAPCO1)
TOTAL
282
(
41
commenters
represented,
due
to
joint
submissions)

Generally,
all
except
for
the
environmental
/
public
interest
groups
and
the
private
citizen
favored
both
of
the
two
primary
proposals,
although
a
few
only
commented
on
one
of
the
two,
and
some
suggested
modifications.
The
13
environmental
/
public
interest
groups
and
the
private
citizen
were
opposed
to
both
of
these
primary
revisions.

A.
Comments
Concerning
Re­
certification
Applications
for
Repeat
Requests
The
first
primary
revision
in
the
proposed
rule
would
have
authorized
applicants
for
certain
repeat
exemptions
to
re­
certify
that
an
emergency
condition
continues
in
the
second
and
third
years,
and
to
incorporate
by
reference
all
information
submitted
in
a
previous
application
rather
than
annually
submit
complete
applications.
Six
commenters
(
three
grower
groups,
two
State
lead
agencies,
and
one
agriculture/
food
industry
group)
support
the
re­
certification
proposal
without
modification;
those
comments
are
not
included
below.

1.
Comments
of
those
opposed
to
re­
certification
proposal
3
Comment
#
1:
Applicants
should
not
be
allowed
to
re­
certify
emergency
conditions.
Repeat
conditions
are
routine,
and
therefore
not
an
emergency,
as
defined
in
the
regulations.
Repeat
requests
reflect
poor
management
by
growers.
Repeat
exemptions
should
be
more
difficult,
not
easier,
to
obtain.
EPA
already
grants
too
many
repeat
exemptions
and
ignores
progress­
towardregistration
requirements,
and
this
proposal
would
only
make
matters
worse.
Repeat
applicants
should
be
required
to
document
at
least:
(
a)
what
effect
the
exemption
had
on
the
emergency
condition
the
first
year,
(
b)
why
the
exemption
continues
to
be
necessary,
(
c)
that
there
are
no
feasible
non­
chemical
alternatives,
and,
(
d)
that
the
original
predictions
of
economic
harm
are
legitimate.
[
This
comment
was
made
by
13
environmental
/
public
interest
groups
in
a
joint
submission.
All
but
the
last
sentence
was
also
reflected
by
one
private
citizen.]

EPA
Response:
An
emergency
may
continue
for
multiple
years
when
the
emergency
condition
continues
to
be
non­
routine
relative
to
the
routine
situation
prior
to
the
first
occurrence
of
the
emergency.
This
most
commonly
occurs
when
a
pesticide,
formerly
relied
upon
by
growers,
becomes
unavailable
for
use
or
loses
effectiveness
and
no
other
effective
means
of
control
is
available.
Such
a
situation
would
continue
indefinitely,
until
an
alternative
control
becomes
available,
e.
g.,
an
effective
alternative
pesticide
becomes
registered
for
the
use,
or,
an
effective
alternative
non­
chemical
control
becomes
available.

Re­
certification
that
an
emergency
condition
that
was
previously
granted
an
exemption
continues
to
exist
would
be
part
of
a
streamlined
application
for
an
emergency
exemption.
A
recertification
application
is
no
more
likely
to
be
approved
than
a
full
application
for
the
same
repeat
request.
Like
a
full
application,
a
re­
certification
application
would
be
reviewed
for,
and
could
be
denied
owing
to
any
of
the
following:
new
risk
information;
availability
of
new,
effective
alternative
controls;
or,
insufficient
progress
toward
registration
of
the
requested
pesticide
use.

Concerning
the
commenters'
suggested
documentation
requirements
for
repeat
requests:
(
a)
Applicants
would
still
be
required
to
include
a
description
of
the
effect
the
exemption
had
on
the
emergency
condition,
annually,
in
a
post­
exemption
report.
EPA
plans
to
issue
improved
guidance
on
this
part
of
the
report.
(
b)
A
re­
certification
application
must
contain
a
certification
that
the
same
emergency
condition
previously
documented
continues
and
is
the
reason
the
exemption
continues
to
be
necessary.
(
c)
EPA
believes
that
the
applicant
is
in
a
better
position
than
the
Agency
to
identify
availability
of
a
non­
chemical
alternative
for
the
specific
use
in
their
State.
EPA
agrees
that
it
would
be
appropriate
to
have
applicants
for
repeat
exemptions
document
availability
and
effectiveness
of
new
non­
chemical
controls
since
the
previous
year's
application,
or
to
certify
that
none
are
known.
Therefore,
in
the
final
rule
EPA
has
added
a
requirement
that
applicants
certify
that
they
are
not
aware
of
any
alternative
non­
chemical
practice
that
may
offer
a
meaningful
level
of
pest
control,
or
else
provide
documentation
that
each
such
known
practice
does
not
provide
adequate
control
or
is
not
economically
or
environmentally
feasible.
In
situations
where
such
effective
and
feasible
cultural
practices
are
available,
EPA
would
not
grant
the
exemption
because
there
would
not
be
an
emergency
condition,
by
definition.
4
(
d)
One
way
to
validate
the
reasonableness
of
the
estimated
losses
would
be
to
allow
them
to
happen,
i.
e.,
to
grow
the
crop
under
the
emergency
condition
without
use
of
the
requested
pesticide.
EPA
already
has
the
discretion
to
grant
a
repeat
exemption
subject
to
the
condition
that
some
research
areas
be
grown
under
the
emergency
condition
without
use
of
the
requested
pesticide,
although
such
validation
has
generally
not
been
required.
Occasionally,
confirmatory
data,
such
as
comparative
product
performance
studies,
are
required
on
repeat
requests.
The
recertification
program
would
not
alter
this
practice.
Furthermore,
re­
certification
requires
that
other
economic
factors
that
result
in
a
projection
of
an
SEL
(
e.
g.
cost
of
alternative,
crop
prices)
have
not
changed
substantially,
and
that
there
is
no
new
information
about
pest
damage.

Comment
#
2:
Voluntarily
canceled
pesticides
should
be
added
to
the
list
of
pesticide
categories
which
are
not
eligible
to
use
a
re­
certification
application.
The
proposal
already
lists
several
categories
of
pesticides
(
e.
g.,
new
active
ingredient,
1st
food
use,
canceled
pesticides)
that
warrant
heightened
review
and
public
notice,
and
are
therefore
not
eligible
for
re­
certification.
There
should
not
be
a
loophole
to
allow
re­
certification
for
voluntarily
canceled
pesticides.
[
This
comment
was
made
by
13
environmental
/
public
interest
groups
in
a
joint
submission.]

EPA
Response:
The
proposed
rule
listed
several
categories
of
pesticides
as
ineligible
for
recertification
Specifically,
the
existing
regulations
at
40
CFR
166.24(
a)
identify
a
number
of
situations
where,
upon
receipt
of
an
application
for
an
emergency
exemption,
the
regulatory
status
of
a
pesticide
product
calls
for
public
notice
and
comment.
EPA
believes
there
is
a
legitimate
need
for
heightened
review
and
awareness
of
exemption
requests
with
the
listed
regulatory
statuses.
Both
the
notice­
and­
comment
requirements
as
well
as
the
need
for
heightened
review
would
preclude
the
benefit
of
an
expedited
review
that
would
otherwise
be
expected
from
a
recertification
application.
The
categories
proposed
as
ineligible
for
re­
certification
include
new
pesticide
active
ingredients,
first
food
uses,
cancelled
or
suspended
pesticides,
and
pesticides
that
have
been
the
subject
of
a
Special
Review.
Because
a
pesticide
that
has
been
voluntarily
cancelled
by
its
registrant
may
be
similar
to
these
other
categories
of
pesticides,
the
Agency
agrees
with
this
comment
and
believes
this
category
of
pesticide
uses
should
also
be
ineligible
for
re­
certification.
Therefore,
the
proposed
40
CFR
166.20(
b)(
5)
is
modified
accordingly
in
the
final
rule.
Also,
EPA
is
expanding
the
provision
for
40
CFR
166.24
to
add
this
category
of
pesticides
uses
to
those
for
which
EPA
will
issue
a
Notice
of
Receipt.
Therefore,
a
Notice
of
Receipt
will
be
published
in
connection
with
the
submission
of
emergency
exemption
uses
that
involve
pesticide
uses
which
have
been
voluntarily
cancelled.
Therefore,
while
applicants
may
still
request
exemptions
for
a
voluntarily­
cancelled
pesticide,
the
streamlined
re­
certification
application
process
will
not
be
allowed
for
such
uses.

2.
Comments
of
those
who
generally
support
re­
certification
proposal,
but
suggest
modifications
Comment
#
3:
Re­
certification
applications
should
be
allowed
beyond
the
third
year
of
an
applicant's
exemption.
EPA's
main
rationale
for
not
allowing
re­
certification
after
the
third
year
5
is
the
regulatory
presumption
against
reasonable
progress
toward
registration
of
the
use
after
the
third
year.
Re­
certification
is
specifically
and
solely
for
determining
the
existence
of
an
emergency
condition,
which
is
entirely
separate
and
unrelated
to
the
status
of
progress
toward
registration.
Commenters
argued
that
even
if
an
applicant
re­
certifies
the
existence
of
the
emergency,
EPA
could
still
decline
the
exemption
request
based
on
insufficient
progress
toward
registration
(
or
due
to
new
risk
information,
or
new
alternative
controls).
A
full
application
would
not
aid
EPA
in
making
the
progress­
toward­
registration
determination.
In
addition,
full
registration
of
a
pesticide
product
often
takes
longer
than
three
years,
even
when
States
move
expeditiously
to
identify
the
need.
States
and
affected
growers
should
not
be
penalized
when
registration
actions
take
longer
than
three
years,
due
to
registrants
moving
slowly
to
submit
full
applications,
or
priorities
and
resource
limitations
within
EPA's
registration
program
and
USDA's
IR­
4
program.
A
re­
certification
application
does
not
make
a
request
more
likely
to
be
granted,
it
simply
reduces
the
burden
and
sometimes
speeds
the
decision.

Among
commenters
requesting
that
re­
certification
be
allowed
beyond
year
three,
suggestions
for
alternative
limitations
varied,
including:
°
no
limitation
°
allow
one
or
more
additional
three­
year
cycles
for
re­
certification,
wherein
applicants
would
submit
full
applications
in
the
first
year
of
each
cycle,
and
re­
certifications
in
the
second
and
third
years
of
each
cycle.
°
allow
re­
certification
through
year
5
or
6
°
allow
re­
certification
through
year
5
for
IR­
4
uses
°
allow
re­
certification
after
year
3
if
a
complete
application
has
been
submitted
to
EPA
[
This
general
comment
was
made
by
22
commenters
(
9
grower
groups,
7
State
lead
agencies,
2
Education/
research
groups,
2
Ag/
Food
industry
groups,
and
2
pesticide
industry/
registrants).]

EPA
Response:
The
Agency
agrees
that
re­
certification
applications
should
not
be
limited
to
the
second
and
third
years.
Regardless
of
whether
a
re­
certification
application
or
a
full
application
is
used,
in
order
to
grant
an
exemption
EPA
must
determine
that:
1.
There
is
an
emergency
condition
2.
No
effective
alternative
controls
are
available
3.
The
risk
does
not
exceed
statutory
or
regulatory
standards
4.
There
has
been
reasonable
progress
toward
registration
A
re­
certification
application
would
simply
help
the
Agency
make
the
first
determination
more
quickly,
without
changing
the
finding.
However,
like
a
full
application,
a
re­
certification
application
would
be
reviewed
for
the
other
three
criteria
as
they
have
been
in
the
past.
EPA
may
find
that
an
emergency
condition
exists
based
on
an
applicant's
re­
certification
of
the
emergency,
but
still
deny
the
request
for
a
repeat
exemption
due
to
any
one
of
the
other
three
factors.
If
new,
effective
chemical
or
non­
chemical
alternatives
have
become
available
since
the
previous
year's
request,
then
the
emergency
is
eliminated,
by
definition.
New
risk
information
or
lack
of
sufficient
progress
toward
registration
could
also
result
in
a
re­
certification
application
being
denied,
in
spite
of
the
emergency
condition.
EPA
believes
that
a
re­
certification
application
would
not
6
improve
the
chance
of
having
the
exemption
granted,
relative
to
a
full
application
for
the
same
request.

The
benefits
of
re­
certification
(
reduced
burden
to
applicants
and
EPA,
and
quicker
emergency
response)
would
continue
indefinitely
for
repeat
requests.
In
addition,
the
Agency
sees
no
negative
effect
of
allowing
it
beyond
year
three.
Also,
any
specific
limit
to
the
number
of
years
of
eligibility
for
re­
certification
would
be
arbitrary.
Therefore,
the
best
approach
is
to
allow
re­
certification
applications
indefinitely.
Therefore,
in
the
final
rule
EPA
has
chosen
to
remove
the
applicability
restriction
for
re­
certification
that
would
have
limited
it
to
the
second
and
third
years.
However,
this
modification
includes
the
authority
for
EPA
to
declare
an
exemption
ineligible
for
re­
certification
at
any
time,
on
a
case­
by­
case
basis.

B.
Comments
Concerning
a
Revised
Approach
for
Determining
"
Significant
Economic
Loss"
(
SEL)

The
second
primary
revision
in
the
proposed
rule
would
re­
define
SEL,
which
is
the
most
common
basis
for
an
emergency
finding
by
EPA.
An
emergency
finding
is
necessary
(
but
not
sufficient)
for
EPA
to
grant
an
emergency
exemption.
The
new
definition
would
change
the
requirements
for
documenting
and
determining
a
SEL.
A
total
of
11
commenters
(
5
State
lead
agencies,
3
grower
groups,
2
education/
research
groups,
and
1
agriculture/
food
industry
group)
support
the
revised
SEL
proposal
without
modification;
those
comments
are
not
included
below.

1.
Comments
of
those
opposed
to
Significant
Economic
Loss
(
SEL)
proposal
Comment
#
4:
The
proposed
tiered
approach
to
document
an
SEL
would
unreasonably
expand
the
definition
of
emergency
and
make
it
easier
to
find
that
an
emergency
exists.
The
proposed
method
allows
prohibited
pesticide
uses
for
profit.
The
proposed
new
approach
together
with
the
quantitative
thresholds
for
the
three
tiers
are
unlawful,
arbitrary
and
capricious,
and
contrary
to
congressional
intent.
[
This
comment
was
made
by
13
environmental
/
public
interest
groups
in
a
joint
submission.]

EPA
Response:
EPA's
analysis
of
past
exemption
requests
shows
that
the
proposed
approach
would
not
make
SEL
findings
more
common
and
would
not
expand
the
definition
of
emergency.
The
analysis
shows
that
virtually
the
same
number
of
requests
would
result
in
an
SEL
finding
using
the
proposed
approach
as
actually
occurred
under
the
current
approach,
although
different
findings
may
occur
(
in
both
directions)
in
some
individual
cases.
7
Self­
Employed
Farmer
Salaried
Worker
equivalent
Gross
Revenue
=
PxQ
None
"
Net
Revenue"
=
PxQ
­
VC
None
"
Profit"
=
PxQ
­
VC
­
FC
Gross
Pay
"
Profit"
­
personal
taxes,
health
insurance,
retirement
account,
etc.
Net
Pay
Table
1
Comparison
of
measures
of
income
for
a
farmer
and
salaried
worker.
EPA
acknowledges
that
economic
terms
such
as
"
net
revenue"
and
"
net
farm
income"
may
be
confusing
and
are
not
always
used
the
same
way
by
all
parties.
Although
the
proposed
threshold
for
the
third
tier
for
SEL
is
50
percent
of
"
net
revenues,"
as
defined
in
the
preamble
to
the
proposed
rule,
this
is
not
equivalent
to
"
profits"
as
it
does
not
include
fixed
costs.
Table
1
may
clarify
the
meaning
of
the
these
terms.
Gross
revenue
is
the
total
value
of
the
crop,
i.
e.,
price
(
P)
times
quantity
(
Q).
For
the
purpose
of
this
rule,
EPA
defines
net
revenue
as
gross
revenue
less
variable
operating
costs
(
VC).
These
costs
include
such
things
as
seed,
fertilizer,
pesticides,
water
for
irrigation
and
hired
labor.
A
calculation
of
"
profit"
would
typically
subtract
fixed
costs
(
FC)
from
this
amount.
Fixed
costs
include
such
things
as
land
rent,
equipment
costs
(
capital
depreciation)
and
business
taxes
such
as
property
taxes
on
land
and
equipment.
In
this
case,
"
profit"
is
roughly
equivalent
to
the
gross
pay
of
a
typical
salaried
employee
and
is
essentially
the
return
to
the
farmer's
labor
and
managerial
skills.
This
is
also
referred
to
as
"
net
farm
income."
If
typical
fixed
costs
were
included
in
the
consideration
of
impacts
on
income,
a
loss
of
50
percent
of
net
revenues
would,
according
to
USDA
statistics,
result
in
approximate
elimination
of
net
farm
income.
Note
that
the
typical
self­
employed
farmer
must
pay,
from
his
or
her
"
profit,"
personal
income
and
Social
Security
taxes
(
both
employee
and
employer
contributions),
health
insurance
and
retirement
benefits
before
arriving
at
an
amount
comparable
to
net
or
take­
home
pay
for
a
salaried
worker.
Section
18
of
FIFRA
is
very
broad
in
its
application,
directing
EPA
to
define
and
determine,
by
regulation,
when
an
emergency
exists.
The
Agency
believes
that
the
proposed
approach
and
thresholds
are
not
arbitrary
or
capricious,
as
it
essentially
makes
the
standard
that
has
been
used
for
years
more
uniform
and
equitable,
without
raising
or
lowering
it.

Comment
#
5:
Economic
loss
does
not
justify
an
emergency,
and
is
only
an
excuse
by
profiteering
manufacturers
to
avoid
regulation
and
use
dangerous
chemicals.
[
This
comment
was
made
by
one
private
citizen.]

EPA
Response:
Many
situations
causing
economic
loss
are
not
considered
emergencies.
However,
a
SEL
as
defined
in
the
proposal
would
be
a
loss
that
would,
based
on
average
farm
income
statistics,
eliminate
net
farm
income
in
order
to
qualify
as
an
emergency.
For
many
years
the
vast
majority
of
emergency
exemptions
the
Agency
has
granted
have
been
due
to
economic
loss.
Even
if
EPA
determines
that
an
emergency
condition
exists,
the
exemption
will
not
be
granted
if
the
risks
are
unacceptable
or
insufficiently
known.
Virtually
all
emergency
exemptions
8
granted
are
for
pesticides
that
are
already
registered
for
use
on
other
crops,
so
the
risk
profiles
of
the
chemicals
are
well
known.
EPA
would
also
like
to
note
that
emergency
exemptions
are
requested
by
states,
on
behalf
of
their
agricultural
producers,
not
by
or
for
pesticide
manufacturers.

2.
Comments
of
those
who
generally
support
Significant
Economic
Loss
(
SEL)
proposal,
but
suggest
modifications
Comment
#
6:
The
thresholds
for
the
three
tiers
for
determining
SEL
should
be
lower,
as
the
proposed
thresholds
require
total
elimination
of
net
income
to
qualify.
Also,
EPA
should
be
allowed
flexibility
to
use
judgement
to
make
a
SEL
finding
for
situations
not
meeting
any
of
the
thresholds.
Commenters
argued
that
total
elimination
of
annual
net
income
is
too
severe
a
threshold,
and
that
something
less
certainly
constitutes
a
significant
economic
loss.
The
current
proposal
does
not
allow
for
any
flexibility
or
judgement
to
determine
an
SEL,
even
for
situations
just
short
of
a
threshold.
These
commenters
feel
the
three
tiers
should
be
screens
to
identify
obvious
emergencies,
and
that
such
flexibility
should
be
added
to
identify
the
less
obvious
emergencies.
A
few
of
these
commenters
suggested
that
we
leave
the
thresholds
out
of
the
regulatory
text
and
use
them
as
guidelines,
at
least
until
we
gain
more
experience
with
the
new
method.
However,
most
suggested
lowering
the
thresholds
and
adding
flexibility.
No
commenter
suggested
an
alternative
level
for
any
threshold.
[
This
general
comment
was
made
by
17
commenters
(
9
grower
groups,
4
State
lead
agencies,
2
Ag/
Food
industry
groups,
and
2
pesticide
industry/
registrants).]

EPA
Response:
It
is
true
that,
according
to
USDA
statistics,
the
proposed
thresholds
for
SEL
would
be
roughly
equivalent
to
elimination
of
net
farm
income
from
the
affected
crop,
when
fixed
costs
are
included
and
when
averaged
across
all
farms
and
crops.
While
this
may
seem
severe,
it
is
approximately
the
same
standard
used
in
the
current
approach,
only
it
would
be
more
uniformly
applied.
An
analysis
of
past
emergency
exemption
requests
shows
that
about
the
same
number
would
have
received
a
SEL
finding
using
the
proposed
approach
and
thresholds,
although
some
that
were
denied
under
the
current
approach
would
be
granted
with
the
proposed
approach,
and
vice
versa.
This
is
because
the
loss
required
for
an
SEL
finding
under
the
current
approach
varies
widely,
as
it
is
dependent
on
recent
fluctuations
in
net
revenue
or
net
farm
income
for
the
subject
crop
and
State.
When
the
States
recommended
a
regulatory
revision
to
base
SEL
on
yield
losses
rather
than
past
profit
fluctuations,
their
stated
reason
was
to
gain
a
consistent,
equitable
standard.
EPA
received
no
stakeholder
input
saying
that
the
existing
standard
for
SEL
was
too
high.
The
proposed
quantitative
thresholds
allow
an
easy
comparison
to
farm
income
statistics,
although
they
do
not
raise
the
standard
relative
to
the
current
average
standard.

Furthermore,
the
standard
for
SEL
was
always
intended
to
identify
and
avert
true
economic
emergencies,
and
was
never
intended
to
maintain
farm
income
at
or
near
a
certain
level.
EPA
believes
that
there
should
be
a
high
standard
for
allowing
an
exemption
from
the
requirements
of
registration.
Even
if
EPA
were
to
consider
a
lower
standard,
the
Agency
is
not
aware
of
a
basis
for
selecting
a
lower
standard
that
would
not
be
arbitrary.
9
Even
though
EPA
believes
that
the
proposed
thresholds
are
appropriate
and
should
not
be
relaxed,
the
Agency
agrees
that
flexibility
should
be
available
to
allow
EPA
to
use
judgement
to
make
an
SEL
finding
where
projected
losses
are
difficult
to
quantify
or
other
factors
warrant
an
emergency
exemption.
The
Agency
interprets
the
rule
to
allow
for
sufficient
flexibility
to
consider
qualitative
information
along
with
quantitative
information
in
determining
whether
the
thresholds
for
SEL
have
been
exceeded.
EPA
is
revising
the
final
rule
to
ensure
it
also
has
the
flexibility
to
apply
an
appropriate
methodology
for
assessing
the
consequences
of
any
emergency.
Because
agriculture
is
extremely
variable
any
quantitative
approach
to
identify
SEL
may
be
incomplete.
When
no
threshold
is
met
using
quantitative
data
alone,
the
Agency
would
expect
to
exercise
judgement
to
make
an
SEL
finding,
only
in
rare
cases
and
on
the
basis
of
convincing
evidence.

C.
Comments
on
Other
Aspects
of
Proposed
Rule,
and
General
Comments
In
addition
to
the
two
primary
proposals,
a
number
of
revisions
are
proposed
to
correct
or
update
several
minor
administrative
aspects
of
the
emergency
exemption
regulations.
Also,
the
proposed
rule
includes
a
revision
to
clarify
that
treatment
of
"
invasive
species"
is
a
valid
basis
for
issuing
a
quarantine
exemption.
Comments
and
responses
on
all
issues
other
than
the
two
primary
proposals,
as
well
as
general
comments
on
the
proposed
rule
and
emergency
exemption
program
are
presented
below.
Comments
supporting
these
proposed
revisions
without
modification
are
not
included
below.

Comment
#
7:
Exemptions
for
the
purpose
of
Resistance
Management
(
RM)
should
be
allowed.
Commenters
were
disappointed
that
EPA
abandoned
their
plans
to
include
this
idea
in
the
proposed
rule.
Although
PRIA
may
help,
it
is
unrealistic
to
believe
that
it
will
be
sufficient
to
address
the
lack
of
RM
tools,
particularly
for
minor
crops.
Commenters
said
that
in
cases
where
pesticides
exist
that
could
help
to
delay
or
prevent
the
development
of
resistance,
it
is
irresponsible
to
wait
until
resistance
develops
and
then
declare
an
emergency
and
grant
an
exemption
to
use
the
pesticide,
usually
repeatedly
for
several
years,
when
it
could
have
prevented
the
emergency
in
the
first
place
if
RM
exemptions
were
available.
While
these
commenters
recognize
the
need
to
prevent
abuse
of
RM
exemptions,
and
the
difficulty
in
developing
clear
criteria
for
approval
of
an
exemption
for
RM,
they
believe
that
there
is
ample
middle
ground
between
allowing
any
excuse
for
RM
and
allowing
no
such
exemptions.
One
commenter
offered
to
work
with
EPA
to
develop
criteria
for
RM
exemptions.
Some
stated
that
the
implementation
of
FQPA
is
causing
an
increased
need
for
RM
tools,
particularly
for
minor
crops.
One
commenter
noted
that
many
comments
on
the
pilot
FRN
supported
RM
exemptions,
and
none
opposed
the
idea.
AAPCO
agreed
that
PRIA
will
not
sufficiently
address
RM
needs,
but
said
the
Agency
should
continue
working
with
States
to
address
pest
resistance
and
the
lack
of
resistance
management
tools,
particularly
for
specialty
crops.
[
This
general
comment
was
made
by
19
commenters
(
9
grower
groups,
4
State
lead
agencies,
2
Education/
research
groups,
2
Ag/
Food
industry
groups,
and
2
pesticide
industry/
registrants).]

EPA
Response:
EPA
believes
that
section
18
is
an
inappropriate
avenue
for
addressing
the
worthy
goal
of
managing
pest
resistance,
for
several
reasons.
Virtually
all
commenters
that
10
addressed
RM
agree
with
EPA
that
any
potentially
successful
approach
for
RM
exemptions
would
be
proactive,
allowing
exemptions
before
resistance
has
occurred
for
a
particular
use
in
the
field.
Most
also
agree
that
predicting
and
documenting
a
case
of
resistance
would
be
highly
variable
and
complex.
The
Agency
believes
that
the
burden
to
applicants
of
preparing
a
request
for
an
RM
exemption
that
included
such
documentation
would
be
substantially
higher
than
the
burden
of
preparing
other
exemption
requests.
EPA
believes
such
costly
and
complex
burden
is
contrary
to
the
purpose
of
this
rulemaking.
Likewise,
the
burden
to
EPA
of
reviewing
and
deciding
on
such
a
request
would
be
high,
diverting
resources
from
other
priorities.
EPA
feels
that
such
a
burden
is
not
the
best
use
of
Agency
resources,
and
that
other
means
of
dealing
with
RM
would
be
both
more
efficient
and
more
appropriate.
Furthermore,
a
need
for
an
RM
tool
to
address
a
future
problem
arguably
does
not
fit
within
a
conventional
interpretation
of
"
emergency."

EPA
understands
the
importance
of
pest
resistance
management
and
continues
to
explore
how
to
best
use
its
regulatory
and
non­
regulatory
authorities
to
support
and
facilitate
effective
resistance
management.
The
Agency
believes
that
RM
capabilities
will
be
improved
through
a
multi­
faceted
approach
involving
incorporating
resistance
management
considerations
into
pesticide
labeling
(
i.
e.,
Pesticide
Registration
Notice
2001­
5),
registering
more
pesticides
for
minor
crops,
resistance
management
education
programs,
crop
management
and
stewardship
programs,
further
crop
grouping
for
tolerance
setting,
and
outreach
efforts
with
stakeholders.
Under
PRIA,
EPA
is
making
more
timely
decisions
and
accelerating
the
registration
of
many
products
expected
to
be
useful
for
RM.
EPA's
process
for
classifying
a
pesticide
product
as
"
reduced­
risk"
considers
RM
as
an
important
factor.
New
products
that
would
address
significant
RM
needs
would
reach
the
market
sooner,
thereby
providing
a
strong
incentive
to
registrants
to
incorporate
RM
in
their
registration
submissions.
Also,
the
IR­
4
process
has
continued
to
improve
in
recent
years,
identifying
priority
pesticides
needs
for
minor
crops
and
facilitating
quicker
registrations,
including
many
useful
RM
tools.

Comment
#
8:
EPA's
focus
on
streamlining
comes
at
the
expense
of
obligations
to
protect
human
health
and
the
environment.
The
number
of
exemptions
granted
has
increased
sharply
since
FQPA
(
doubled
in
first
2
years),
and
the
proposals
would
make
matters
worse.
Notably,
EPA
does
not
assert
that
faster
approvals
will
benefit
public
health,
only
that
the
proposals
will
not
compromise
current
protections.
[
This
comment
was
made
by
13
environmental
/
public
interest
groups
in
a
joint
submission.]

EPA
Response:
It
is
true
that
this
is
primarily
a
streamlining
rule
and
that
it
would
not
increase
protections.
However,
the
Agency
strongly
believes
that
the
benefits
of
reduced
burden
and
quicker
decisions
will
not
come
at
the
expense
of
protections
for
humans
and
the
environment.
While
the
proposals
affect
how
applicants
document
an
emergency
condition,
the
risk
side
of
the
review
and
decision
will
not
be
affected.
Also,
the
proposed
revisions
are
not
expected
to
increase
the
frequency
of
an
emergency
finding.
Therefore,
EPA
fully
expects
that
this
rule
will
not
reduce
protections,
will
not
increase
the
number
of
exemptions,
will
lower
costs,
and
will
improve
emergency
response.
Although
the
number
of
exemptions
granted
did
increase
11
after
FQPA,
the
Agency
sees
no
accounting
scenario
in
which
they
doubled.
The
276
exemptions
granted
in
1995,
the
year
before
FQPA
was
enacted,
increased
by
49%,
to
410
exemptions
in
1998,
two
years
after
FQPA.
Furthermore,
the
number
of
exemptions
granted
has
decreased
significantly
since
the
post­
FQPA
peak
around
1999
­
2001.
Below
are
statistics
on
the
number
of
emergency
exemptions
granted
for
the
10
years
ending
in
2004.

TEN
YEARS
OF
SECTION
18s
`
95
`
961
`
97
`
98
`
992
`
00
`
01
`
02
`
03
`
04
Receipts
411
407
422
601
630
549
542
503
431
536
Crises
66
62
121
125
124
71
59
63
67
58
Granted
276
361
384
410
455
458
470
412
344
352
Denied
25
10
17
27
22
34
19
13
6
4
1.
FQPA
passed
in
4th
quarter
of
FY96
2.
FY99
was
the
first
year
for
a
large
number
of
requests
for
use
of
coumaphos
in
beehives
(
41
total),
which
explains
much
of
the
increase
in
receipts.

Comment
#
9:
EPA's
section
18
activities
routinely
violate
the
Endangered
Species
Act
(
ESA).
The
streamlining
proposals
would
make
matters
worse.
EPA
does
not
list
a
single
example
of
consultation
with
the
U.
S.
Fish
and
Wildlife
Service
(
FWS)
or
the
National
Marine
Fisheries
Service
(
NMFS)
in
the
course
of
a
section
18
review.
The
commenters
cite
a
recent
letter
from
FWS
to
EPA
Region
2
stating
that
the
section
18
process
insufficiently
addresses
EPA's
consultation
obligations
under
ESA.
[
This
comment
was
made
by
13
environmental
/
public
interest
groups
in
a
joint
submission.]

EPA
Response:
EPA
disagrees
that
the
proposed
rule
in
any
way
lessens
protections
for
threatened
and
endangered
species.
Indeed,
EPA
plans,
as
discussed
in
the
proposal,
explain
that
the
Agency
and
FWS
and
NMFS
(
the
Services)
have
developed
mechanisms
to
provide
increased
and
more
expeditious
scrutiny
to
these
issues
than
the
Agency
has
in
the
past.

The
Services,
in
collaboration
with
EPA
and
USDA,
have
developed
a
counterpart
regulation
(
50
CFR
part
402),
that
would
make
the
process
of
consultation
about
EPA
actions
involving
pesticides
­
including
any
necessary
consultations
for
emergency
exemptions
under
section
18
­
more
efficient,
effective,
and
timely,
thereby
strengthening
the
protections
for
endangered
and
threatened
species.
As
part
of
the
work
supporting
the
counterpart
rule,
the
Services
and
EPA
reviewed
the
Agency's
approach
to
the
assessment
of
potential
risks
to
listed
species
resulting
from
pesticide
use.
The
Services
agreed
that
EPA's
approach
to
ecological
risk
assessment
"
will
produce
effects
determinations
that
reliably
assess
the
effects
of
pesticides
on
listed
species
and
critical
habitat
pursuant
to
section
7
of
the
ESA
and
implementing
regulations.
"
(
69
FR
at
47735).
12
EPA
looks
closely
at
potential
ecological
risks
of
pesticide
use
in
connection
with
decisions
on
requests
for
emergency
exemptions.
As
a
result
of
the
Services'
acceptance
of
the
Agency's
ecological
risk
assessment
process,
the
Agency
intends
to
provide
new
guidance
and
to
work
closely
with
applicants
for
emergency
exemptions,
to
improve
the
information
submitted
concerning
threatened
and
endangered
species
and
possible
effects
on
them
of
the
requested
use.
EPA
anticipates
that
these
measures
will
fall
within
existing
requirements
but
should
increase
the
availability
of
essential
information
needed
to
make
a
timely
and
substantive
determination
of
the
potential
impact
to
endangered
and
threatened
species.
As
EPA
develops
this
new
guidance,
EPA
will
look
for
opportunities
to
enhance
consideration
of
these
impacts
in
its
emergency
exemption
decision
process,
including
any
need
to
consult
with
FWS
and
NMFS.

Comment
#
10:
The
section
18
pilot
violates
the
Administrative
Procedure
Act
(
APA)
as
a
binding
regulation
without
notice
and
comment.
EPA
solicited
public
comment
on
the
pilot
provisions
in
the
FRN
that
initiated
the
pilot,
but
has
not
responded
to
those
comments.
[
This
comment
was
made
by
13
environmental
/
public
interest
groups
in
a
joint
submission.]

EPA
Response:
This
comment
is
not
relevant
to
the
proposed
or
final
rule.
While
EPA
disagrees
with
the
comment,
the
issue
is
moot
because
EPA
has
ended
the
pilot
program.
The
section
18
pilot
program
is
not
a
binding
regulation
and
does
not
require
notice
and
comment
rulemaking
under
section
553
of
the
APA.
EPA
believes
that
participants
in
the
section
18
pilot
program
conformed
to
the
requirements
of
the
Agency's
existing
regulations
pertaining
to
emergency
exemption
requests
at
40
CFR
part
166.
The
purpose
of
the
pilot
was
to
investigate
whether
the
section
18
process
might
be
improved.
The
pilot
was
intentionally
limited
in
scope.
During
the
course
of
the
pilot,
less
than
five
percent
of
all
applications
received
were
eligible
for
the
pilot
and
utilized
its
provisions.
No
applicant
was
required
to
use
the
pilot.
EPA
is
confident
that
the
pilot's
standard
for
an
emergency
finding
was
no
higher
or
lower
than
the
current
average
standard.
The
risk
side
of
the
assessment
and
decision
process
was
not
changed
for
the
pilot.
Furthermore,
an
additional
safety
margin
was
essentially
added
to
the
pilot
with
the
limitation
to
"
reduced­
risk"
pesticides.

During
development
of
the
proposed
rule,
EPA
carefully
considered
public
comments
received
on
the
Federal
Register
Notice
that
initiated
the
pilot.
Those
comments
are
summarized
in
Unit
3
of
this
document.

Comment
#
11:
EPA
should
use
section
18
to
promote
IPM,
by
confirming
the
efficacy
and
economics
of
non­
chemical
alternatives.
[
This
comment
was
made
by
13
environmental
/
public
interest
groups
in
a
joint
submission.]

EPA
Response:
The
existing
section
166.20(
a)(
4)(
ii)
already
requires
applicants
to
explain
why
alternative
practices
would
not
provide
adequate
control
or
would
not
be
economically
or
environmentally
feasible.
Some
time
after
this
final
rule
is
issued,
EPA
plans
to
provide
new
guidance
for
applicants
to
improve
the
quality
and
consistency
of
information
submitted
on
nonchemical
alternatives.
Although
EPA
supports
and
encourages
IPM
and
use
of
risk­
reducing,
13
alternative,
non­
chemical
controls,
as
evidenced
by
the
Agency's
voluntary
Pesticide
Environmental
Stewardship
Program,
the
Agency
does
not
directly
regulate
cultural
practices.
For
this
reason
and
because
applicants
are
typically
State
agricultural
agencies,
EPA
believes
that
the
applicant
is
in
a
better
position
than
the
Agency
to
identify
availability
of
a
non­
chemical
alternative
practice
for
the
specific
use
in
their
State,
and
to
assess
its
effectiveness
and
feasibility.
In
the
final
rule,
a
new
provision
has
been
added
at
§
166.20(
b)(
5)(
vi)(
E)
to
require
that
applicants
using
the
re­
certification
process
separately
certify
that
they
are
not
aware
of
any
available
chemical
alternatives
or
reasonable
non­
chemical
alternative
practices,
or
if
they
know
of
any
such
practice
that
they
include
with
the
application
documentation
demonstrating
that
the
chemical
or
practice
does
not
provide
adequate
control
or
is
not
economically
or
environmentally
feasible.

Comment
#
12:
For
crisis
exemptions,
the
proposal
to
have
applicants
notify
EPA
and
receive
verbal
confirmation
from
the
Agency
of
no
risk­
based
objections
before
using
the
crisis
provisions
needs
clarification
and
possible
revision.
The
proposal
says
that
EPA
will
attempt
to
provide
such
confirmation
as
quickly
as
possible,
and
within
36
hours.
Commenters
stated
that
they
may
not
be
able
to
reach
the
appropriate
EPA
contact
on
a
Friday,
a
weekend,
or
a
holiday,
which
could
delay
confirmation
and
use
of
the
crisis
exemption
until
36
hours
after
the
beginning
of
the
next
work
day.
They
suggest
that
EPA
make
someone
available
at
all
times,
or,
add
a
provision
that
notification
can
be
made
by
voicemail,
and
a
default
would
be
assumed
after
36
hours
if
the
applicant
has
not
heard
back
from
EPA
by
that
time.
One
commenter
also
suggested
that
we
make
exceptions
to
the
36­
hour
waiting
period
for
EPA
confirmation
for
some
uses,
including
public
health
crises,
bioterrorism
attacks,
and
non­
food
uses.
[
This
comment
was
made
by
two
State
lead
agencies.]

EPA
Response:
The
reason
for
this
revision
is
to
replace
the
current
ambiguous
language
at
40
CFR
166.43(
a),
which
allows
for
the
possibility
of
a
State
or
federal
agency
notifying
EPA
after
beginning
use
of
the
crisis
provisions.
The
revision
will
codify
a
process
that
has
been
widely
practiced
and
accepted
by
applicants,
and
that
has
become
more
necessary
after
enactment
of
FQPA.
FQPA
expressly
required
that
time­
limited
tolerances
be
established
for
emergency
exemption
uses
that
may
result
in
residues
in
food.
EPA
maintains
that
it
is
in
the
best
interest
of
all
parties
(
including
States,
EPA,
users
of
pesticides
under
section
18,
the
food
processing
and
marketing
industries,
etc.)
that
there
is
some
assurance
before
the
use
begins
that
EPA
will
be
able
to
establish
a
"
safe"
tolerance
for
a
pesticide
to
be
used
under
a
crisis
exemption.
Without
that
assurance,
users
run
the
risk
of
producing
an
adulterated
crop
that
results
in
unsafe
pesticide
residues
and
would
be
illegal
to
sell.
It
is
also
important
that
EPA
be
given
the
opportunity
to
voice
other
objections
to
a
use
being
considered
for
a
crisis
exemption.
The
Agency
may
be
aware
of
risk
issues
unknown
to
the
applicant,
and
has
the
authority
to
deny
crisis
provisions
for
a
particular
pesticide
use,
under
§
166.41(
a).

EPA
is
keenly
aware
of
the
time­
sensitivity
of
emergency
situations
for
which
crisis
exemptions
are
needed.
The
Agency
will
continue
to
make
every
effort
to
receive
and
quickly
respond
to
notifications
of
intent
to
declare
a
crisis.
EPA
believes
that
the
concerns
raised
by
these
commenters
can
be
adequately
addressed
in
the
same
manner
that
EPA
has
managed
these
14
issues
since
enactment
of
FQPA.
It
is
true
that
EPA
staff
are
not
available
at
all
times,
such
as
at
night
or
during
weekends,
to
receive
notification
of
a
State's
intent
to
declare
a
crisis.
However,
EPA
believes
that
applicants
generally
first
become
aware
of
the
need
for
a
crisis
exemption
at
least
a
few
days
before
notifying
EPA
of
its
intent
to
issue
a
crisis
exemption.
If
an
applicant
notifies
the
Agency
of
their
intent
to
declare
a
crisis
as
soon
as
possible,
even
before
they
have
gathered
all
of
the
necessary
information,
EPA
should
be
able
to
provide
confirmation
before
use
of
the
pesticide
is
needed.
The
Agency
believes
that
the
existing
confirmation
process
now
being
codified
has
not
caused
significant
delays
to
use
of
crisis
exemptions
in
the
past.
In
fact,
there
have
been
cases
where
EPA
staff
have
worked
with
applicants
during
weekends
in
order
to
provide
timely
confirmation,
and
in
extraordinary
circumstances
EPA
will
continue
to
do
this
in
the
future.
A
default
presumption
of
no
EPA
objection
to
a
crisis
exemption,
in
cases
when
the
Agency
cannot
be
immediately
reached,
would
provide
neither
the
necessary
assurances
for
users
of
the
pesticide,
nor
proper
protections
for
human
health
and
the
environment.

EPA
is
not
taking
the
commenter's
suggestion
that
an
exception
to
the
need
for
EPA
confirmation
be
made
in
cases
of
non­
food
uses,
or
public
health
or
bioterrorism
threats.
For
non­
food
uses,
EPA
can
generally
provide
confirmation
more
quickly
than
for
food
uses,
but
must
still
be
allowed
the
opportunity
to
identify
other
unacceptable
risks.
In
the
case
of
major
public
health
threats
or
bioterrorism,
a
national
emergency
network
and
system
is
in
place
that
will
enable
applicants
to
contact
EPA
at
any
time,
and
EPA
will
quickly
respond.
Through
the
National
Infrastructure
Protection
Plan,
as
part
of
a
network
of
federal,
State,
and
local
governments,
agencies
can
quickly
contact
EPA
whenever
a
public
health
threat
arises,
including
terrorism.
In
such
cases
the
Agency
expects
to
be
able
to
act
very
quickly
and
at
any
time.
For
certain
listed
biological
threats,
there
is
an
expedited
process
in
place
whereby,
once
notified
of
the
emergency
need
for
an
unregistered
pesticide
or
use,
EPA
would
evaluate
the
applicant's
remedial
action
plan
and,
after
considering
the
safety
and
efficacy
of
such
use,
would
decide
whether
to
issue
a
crisis
decision.

The
Agency
has
modified
the
proposed
language
at
§
166.43(
a)
for
the
final
rule,
to
remove
references
to
EPA's
confirmation
and
the
36
hour
time
period,
as
it
is
not
appropriate
in
this
paragraph
for
notification
by
applicants
to
EPA.
EPA
will
strive
to
provide
the
confirmation
as
quickly
as
possible
and
within
the
customary
36
hours,
and
will
attempt
to
match
the
urgency
of
decision­
making
with
the
urgency
of
the
situation.
This
final
rule
does
not
attempt
to
change
the
timeframe
in
which
EPA
provides
confirmation.
The
Agency's
practice
will
continue
that
the
36­
hour
clock
does
not
start
until
EPA
actually
receives
and
acknowledges
the
notice,
and
only
applies
to
business
days.
The
lack
of
a
response
in
36
hours
should
not
be
interpreted
as
approval
of
the
crisis
exemption;
this
final
rule
does
not
include
decision
by
default.
The
language
in
the
proposed
§
166.40(
c)
is
modified
for
this
final
rule
to
allow
EPA
to
withhold
confirmation
due
to
any
objection,
not
just
risk­
based
objections.

Comment
#
13:
Endangered
species
(
ES)
documentation
requirements
for
exemption
requests
need
clarification,
further
guidance.
Also,
EPA,
the
U.
S.
Fish
and
Wildlife
Service
(
FWS)
and
the
National
Marine
Fisheries
Service
have
ES
data
that
States
don't
have;
either
the
15
federal
agencies
should
provide
it,
or
make
it
readily
available
to
States.
One
commenter
suggested
that
when
mitigation
measures
for
ES
are
necessary,
EPA
should
involve
the
State
early
(
before
decision).
[
This
comment
was
made
by
three
State
lead
agencies
and
by
AAPCO.]

EPA
Response:
EPA
believes
that
an
important
aspect
of
assuring
protections
of
endangered
and
threatened
species
in
the
implementation
of
the
emergency
exemption
program
is
to
have
available
good
information
on
the
potential
exposure
and
risk
of
a
requested
use
to
a
listed
species
and
its
habitat.
Some
time
after
the
final
rule
is
published,
EPA
plans
to
issue
improved
guidance
on
what
information
regarding
threatened
and
endangered
species
should
be
included
with
an
application.
EPA
will
continue
to
involve
applicants
in
the
discussion
of
possible
mitigation
measures
as
soon
as
it
appears
that
they
may
be
necessary.

Comment
#
14:
Eligibility
for
the
current
pilot
testing
the
two
primary
revisions
is
limited
to
Reduced­
Risk
pesticides.
EPA
should
eliminate
that
restriction
in
the
final
rule.
[
This
comment
was
made
by
one
State
lead
agency
and
one
grower
group.]

EPA
Response:
The
pilot
restriction
to
Reduced­
Risk
pesticides
was
for
the
purpose
of
significantly
limiting
the
scope
of
the
pilot
while
effectively
adding
an
additional
margin
of
safety
during
the
testing
of
the
proposed
approaches.
The
restriction
is
not
a
part
of
the
proposed
rule,
in
order
to
allow
the
benefits
of
the
revised
approaches
to
apply
as
broadly
as
possible.
EPA
agrees
that
this
restriction
should
not
apply
in
the
final
rule.

III.
Public
Comments
on
4/
24/
03
Federal
Register
Notice
(
FRN)

A.
Background
EPA
solicited
public
comment
in
the
4/
24/
03
Federal
Register
Notice
(
FRN,
or,
"
pilot
FRN")
on
three
potential
improvements
to
the
emergency
exemption
process:
(
1)
allowing
applicants
for
certain
repeat
exemptions
to
re­
certify
the
existence
of
an
emergency
condition
in
the
second
and
third
years;
(
2)
a
tiered
approach
to
determining
and
documenting
a
significant
economic
loss;
and,
(
3)
allowing
exemptions
for
the
purpose
of
pest
resistance
management.
The
Notice
initiated
a
pilot
program
to
test
the
first
two
potential
revisions,
while
resistance
management
exemptions
were
not
included
in
the
pilot.
The
two
primary
proposals
in
the
proposed
rule
were
essentially
the
same
as
the
two
revised
practices
in
the
pilot
(
and
the
first
two
listed
above).
As
noted
above,
in
Unit
I,
EPA
is
providing
an
overview
of
comments
received
on
the
pilot
FRN,
in
spite
of
the
fact
that
it
was
not
a
rulemaking
document,
and
was
therefore
not
subject
to
the
notice­
and­
comment
requirements
of
the
Administrative
Procedure
Act.
This
overview
does
not
provide
a
detailed
summary
of
each
substantive
comment.
Comments
are
briefly
paraphrased,
and
similarities
and
differences
between
the
comments
received
on
the
pilot
FRN
and
those
received
on
the
proposed
rule
are
discussed.
Where
responses
to
comments
on
the
proposed
rule
(
Unit
II)
adequately
address
comments
from
the
pilot
FRN
on
the
same
issue,
3Does
not
add
because
some
submissions
were
submitted
jointly
by
groups
in
more
than
one
commenter
type,
so
a
single
submission
may
be
counted
in
multiple
commenter
types,
but
only
once
in
the
total.

16
they
are
not
repeated
here.
Where
comments
on
the
pilot
FRN
were
not
also
made
on
the
proposed
rule,
and
therefore
not
responded
to
above,
the
responses
are
included
below.

B.
Overview
of
Comments
A
total
of
35
submissions
containing
public
comments
on
the
4/
24/
03
pilot
FRN
were
entered
into
the
public
docket
for
that
Notice.
All
of
these
comments
are
available
in
the
public
docket
and
in
the
Agency's
E­
Docket
system
on
the
web
at
http://
www.
epa.
gov/
edocket,
under
docket
ID
number
OPP­
2002­
0231.
A
total
of
57
commenters
were
represented
by
these
comments
as
some
of
the
submissions
were
submitted
jointly
by
multiple
parties.
For
ease
of
discussion
and
a
better
understanding
of
the
sources
of
various
comments,
commenters
are
grouped
according
to
the
type
of
organization
or
interest.
The
following
is
a
listing
of
the
number
of
comment
submissions
on
the
4/
24/
03
Notice,
by
type
of
commenter:

Number
of
Comments,
by
Commenter
Type
Commenter
Type
#
of
Comment
Submissions
Education/
research
6
Environmental/
public
interest
2
Grower
group
11
Pesticide
industry/
registrant
5
Private
citizen
1
State
lead
agency
12
TOTAL
353
(
57
commenters
represented,
due
to
joint
submissions)

Overall,
comments
on
the
pilot
FRN
were
similar
to
the
comments
on
the
proposed
rule,
which
are
summarized
in
Unit
II,
above.
The
biggest
difference
is
that
many
comments
on
the
pilot
FRN
addressed
the
potential
revision
to
allow
resistance
management
exemptions,
which
was
not
included
in
the
proposed
rule.
Therefore,
fewer
comments
concerning
resistance
management
exemptions
were
received
in
response
to
the
proposed
rule.
With
respect
to
comments
on
the
pilot
FRN,
generally,
all
except
for
the
environmental
/
public
interest
groups
favored
the
proposals
for
both
the
streamlined
re­
certification
application
and
the
revised
SEL
approach,
although
a
few
only
commented
on
one
of
the
two,
and
some
suggested
modifications.
All
six
of
the
environmental
/
public
interest
groups
were
opposed
to
both
of
these
potential
revisions.

Comments
of
those
opposed
to
re­
certification
and
the
revised
SEL
included:

The
following
comments
are
similar
to
ones
received
on
the
proposed
rule.
The
responses
given
17
in
Unit
II
also
apply
to
these
comments,
and
are
not
repeated
here:

°
These
revisions
are
focused
on
expediting
the
exemption
process
rather
than
protecting
man
and
the
environment.
These
changes
would
allow
the
Agency
to
increase
the
frequency
of
emergency
exemption
approvals,
which
is
already
too
high.
°
EPA
should
make
repeat
exemptions
more
difficult
to
obtain,
not
easier
as
the
recertification
proposal
would
do,
as
repeat
exemptions
are
not
non­
routine
as
required.
°
The
revised
definition
of
significant
economic
loss
expands
the
emergency
definition
unreasonably.

The
following
comments
on
the
pilot
FRN
were
not
repeated
in
comments
on
the
proposed
rule.
Nevertheless,
EPA's
responses
are
provided
below:

Comment
#
15:
The
original
impetus
for
the
AAPCO
recommendations
on
which
these
revisions
are
based
(
fear
that
FQPA
would
slow
decisions,
decrease
approval
rate,
and
increase
burden)
has
proven
unfounded,
therefore
EPA
should
not
be
guided
by
those
recommendations.

EPA
Response:
It
is
true
that
the
original
AAPCO
recommendations
were
submitted
in
early
1997,
shortly
after
promulgation
of
FQPA,
and
that
the
States
then
had
those
concerns.
However,
AAPCO
revised
their
recommendations
in
2002,
eliminating
five
of
the
original
eight.
This
indicated
AAPCO's
recognition
that
some
of
the
recommendations
are
no
longer
necessary.
These
recommendations
are
being
considered,
by
both
AAPCO
and
EPA,
as
to
whether
they
offer
improvements
relative
to
the
current
situation
for
the
emergency
exemption
program.
The
proposed
rule
includes
proposed
revisions
based
on
only
two
of
the
three
final
AAPCO
recommendations,
and
these
two
proposed
revisions
have
been
significantly
modified
and
refined
relative
to
the
recommendations
from
AAPCO.

Comment
#
16:
The
revisions
being
proposed
are
based
on
recommendations
from
AAPCO,
representing
the
States,
which
are
the
primary
applicants
for
emergency
exemptions.
EPA's
negotiations
and
policy­
setting
with
applicants
for
emergency
exemptions
violates
the
Federal
Advisory
Committee
Act
(
FACA).

EPA
Response:
AAPCO
is
not
an
advisory
committee
subject
to
FACA.
In
order
to
be
subject
to
FACA
as
an
advisory
committee,
section
3
of
FACA
would
require
that
it
be:
(
A)
established
by
statute
or
reorganization
plan,
or
(
B)
established
or
utilized
by
the
President,
or
(
C)
established
or
utilized
by
one
or
more
agencies,
in
the
interest
of
obtaining
advice
or
recommendations
for
the
President
or
one
or
more
agencies
or
officers
of
the
Federal
Government....

AAPCO
was
not
"
established"
by
statute
or
reorganization
plan,
by
the
President,
or
by
any
Federal
agency.
Neither
EPA
nor
the
President
has
"
utilized"
AAPCO
(
an
advisory
committee
is
"`
utilized'
by
an
agency
only
if
it
is
amenable
to
...
strict
management
by
agency
18
officials."
Byrd
v.
EPA,
174
F.
3d
239,
245
(
D.
C.
Cir.
1999)).
Inasmuch
as
FACA
does
not
apply
here,
there
has
been
no
violation
of
FACA.
Moreover,
the
Agency
has
gone
to
great
lengths
to
make
the
rulemaking
a
transparent
process
and
to
solicit
and
receive
input
from
all
interested
stakeholders,
even
before
the
rulemaking
notice­
and­
comment
process
began.
The
two
primary
revisions
that
were
tested
in
the
pilot
and
included
in
the
proposed
rule
were
significantly
revised
and
refined
relative
to
either
the
AAPCO
recommendations
or
the
early
suggestions
of
the
individual
States.
The
current
form
of
each
revision
was
affected
by
the
concerns
expressed
by
a
variety
of
stakeholders,
and
adopted
by
EPA
as
the
best
approach,
all
concerns
considered.

Comments
of
those
suggesting
modifications
to
proposals
for
re­
certification
and
the
revised
SEL
included:

The
following
comments
are
similar
to
ones
received
on
the
proposed
rule.
The
responses
given
in
Unit
II
also
apply
to
these
comments,
and
are
not
repeated
here:

°
EPA
should
eliminate
the
restriction
to
Reduced­
Risk
pesticides
which
applies
to
the
limited
pilot.
°
The
re­
certification
process
should
be
revised
to
allow
it
to
be
used
beyond
an
applicant's
third
year
of
an
exemption.
°
EPA
should
clarify
the
basis
for
the
chosen
thresholds
for
the
three
tiers
for
SEL
and
whether
they
would
be
"
hard"
or
preliminary
to
provide
further
justification.

The
following
comments
on
the
pilot
FRN
were
not
repeated
in
comments
on
the
proposed
rule.
Nevertheless,
EPA's
responses
are
provided
below:

Comment
#
17:
EPA
should
consider
approving
applicable
exemptions
for
three
years,
rather
than
allowing
re­
certifications
in
second
and
third
years.

EPA
Response:
This
idea
was
suggested
by
some
stakeholders
early
in
the
process
of
exploring
improvements
to
the
emergency
exemption
program,
and
was
considered
by
EPA.
However,
three­
year
exemptions
could
result
in
an
exemption
continuing
for
longer
than
the
emergency
condition
might
last.
Moreover,
when
an
applicant
re­
certifies
the
existence
of
an
emergency
condition,
EPA
would
have
the
opportunity
to
consider
the
availability
of
new
alternative
controls,
new
risk
information,
and
progress
toward
registration.

Comment
#
18:
The
eligibility
criteria
for
re­
certification
of
an
emergency
condition
should
not
exclude
new
active
ingredients,
first
food
uses,
and
chemicals
under
Special
Review.
If
such
an
exemption
was
granted
the
first
year
then
re­
certification
of
the
emergency
condition
should
be
allowed,
since
the
emergency
condition
has
nothing
to
do
with
the
registration
status
of
the
requested
chemical,
and
the
Agency
could
still
deny
the
request
due
to
new
risk
concerns.

EPA
Response:
EPA
believes
that
emergency
exemption
applications
involving
such
19
pesticides
would
generally
benefit
from
more
detailed
review
than
applications
pertaining
to
other
pesticides.
Also,
historically
there
have
been
very
few
exemptions
granted
for
these
categories
of
pesticides,
so
the
lack
of
eligibility
for
the
streamlined
application
for
them
should
have
very
little
impact.

Comments
on
issues
other
than
the
proposals
for
re­
certification
and
the
revised
SEL
included:

The
following
comments
are
similar
to
ones
received
on
the
proposed
rule.
The
responses
given
in
Unit
II
also
apply
to
these
comments,
and
are
not
repeated
here:

°
Exemptions
for
the
purpose
of
resistance
management
(
RM)
should
be
allowed,
using
a
proactive
approach
to
address
pest
resistance
before
it
occurs,
when
possible.
Proper
documentation
of
a
high
likelihood
that
resistance
will
develop,
or
of
observed
resistance,
will
vary
considerably
depending
on
the
pest/
crop
combination
and
other
factors.
Most
commenters
agreed
that
due
to
this
variability,
a
case­
by­
case
approach
would
be
necessary
to
determine
when
an
RM
exemption
would
be
appropriate
and
what
documentation
by
applicants
would
be
acceptable.
Comments
on
RM
on
the
pilot
FRN
differed
from
those
on
the
proposed
rule
in
that
they
focused
more
on
the
specifics
of
implementation.
°
EPA's
emergency
exemption
program
activities
violate
the
Endangered
Species
Act
(
ESA).

The
following
comments
on
the
pilot
FRN
were
not
repeated
in
comments
on
the
proposed
rule.
Nevertheless,
EPA's
responses
are
provided
below:

Comment
#
19:
Time­
limited
tolerances
for
emergency
exemptions
should
be
established
with
a
less
rigorous
process
than
for
section
3
registrations,
due
to
generally
far
less
exposure.
EPA
should
pilot
a
process
to
set
tolerances
virtually
immediately
for
crisis
exemptions,
or
they
are
rendered
useless.

EPA
Response:
EPA
does
take
into
consideration
the
expected
exposure
from
use
under
the
requested
exemption.
Although
tolerances
for
exemptions
are
not
established
until
later,
implicit
in
the
granting
of
an
exemption
is
EPA's
judgement
that
it
will
be
able
to
establish
a
tolerance.
For
crisis
exemptions,
the
Agency
understands
the
time­
sensitivity
involved
and
attempts
to
make
this
judgement
in
a
very
short
time,
before
the
exemption
is
used,
however,
EPA
cannot
merely
assume
the
pesticide
meets
the
tolerance
criteria.
For
any
exemption,
the
Agency
attempts
to
identify
the
earliest
possible
harvest
date,
and
makes
every
effort
to
have
the
tolerance
established
before
that
date.
EPA
believes
that
this
approach
has
caused
very
few
significant
problems
for
users
of
pesticides
under
exemptions.