Document ID: EPA-HQ-OPP-2004-0404-0053
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2006-08-09T04:00Z

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Response
to
Comments
This
document
responds
to
issues
raised
in
comments
on
the
July
13,
2005
Notice
of
Proposed
Rulemaking
that
were
not
addressed
in
the
Notice
of
Final
Rule­
making
establishing
procedures
for
the
Registration
Review
Program.
That
notice
is
available
elsewhere
in
this
docket.

EPA
received
23
comments
on
the
proposed
rule,
as
follows:

 
one
individual
 
two
consultants
 
one
public
interest
group
 
four
registrants
 
one
state
pesticide
safety
coordinator
 
three
state
lead
agencies
for
pesticides
 
five
California
water
sanitation
agencies
 
six
trade
associations
I.
Generic
Issues
Relating
to
Licensing
of
Pesticides
A.
Review
of
Product
Registrations
1.
Product
specific
data
Comments
from
industry
expressed
concern
about
the
Agency's
requirements
for
product
specific
data,
as
follows:

o
Comment:
Industry
comments
asserted
that
the
Agency
should
be
more
selective
in
determining
when
new
productspecific
data
are
needed.
EPA
should
create
broader
groups
or
clusters
for
end
use
products,
bridge
more
data
­­
especially
storage
stability
 
in
order
to
avoid
unnecessary
data
requirements,
and
expedite
product
chemistry
and
acute
toxicity
data
reviews.
Industry
asserted
that
storage
stability
studies
for
end­
use
products
are
very
timeconsuming
and
a
review
of
state
enforcement
analytical
results
may
show
that
additional
GLP
storage
stability
studies
are
unnecessary
and
would
not
add
new
information.

Response:
EPA
agrees
that
bridging
data
may
be
appropriate
in
some
circumstances
and
is
addressing
this
issue
through
pilot
projects
in
the
product
reregistration
program.
In
one
project
involving
an
active
ingredient
with
hundreds
of
registered
products,
EPA
found
that
the
existing
storage
stabilities
studies
are
adequate.
EPA
finds
that
storage
stability
data
are
needed
to
establish
proper
storage
conditions
and
to
assure
that
products
are
properly
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labeled
with
respect
to
storage
conditions.
This
is
especially
important
because
some
pesticides
have
increased
in
toxicity
from
degradates
when
improperly
stored.

o
Comment:
Industry
comments
asserted
that
there
is
insufficient
laboratory
capacity
to
conduct
replacement
efficacy
studies
for
public
health
pesticides.

Response:
EPA
believes
that
the
issue
of
insufficient
laboratory
capacity
for
efficacy
studies
is
unlikely
to
arise
until
the
Agency
adopts
new
efficacy
testing
methods
and
requires
existing
studies
to
be
replaced
with
new
tests.
If
laboratory
capacity
appears
to
be
a
problem,
the
Agency
and
its
stakeholders
will
develop
a
strategy
for
managing
it.

2.
Label
changes
for
products
with
multiple
active
ingredients
Comment:
An
industry
trade
association
stated
that
label
changes
for
end­
use
products
are
costly
and
recommended
that
the
Agency
postpone
label
changes
for
products
with
multiple
active
ingredients
until
the
last
active
ingredient
has
undergone
registration
review.

Response:
As
with
the
Agency's
reregistration
program,
products
containing
multiple
active
ingredients
can
belong
to
more
than
one
registration
review
case.
Accordingly,
such
pesticide
products
may
undergo
registration
review
two
or
more
times
during
the
15­
year
registration
review
cycle.
The
procedural
rules
for
registration
review
give
the
Agency
flexibility
to
develop
appropriate
approaches
for
such
situations
when
they
arise.

3.
Accept
data
that
were
not
conducted
under
EPA's
Good
Laboratory
Practice
(
GLP)
regulations
to
support
product
chemistry
requirements
Comment:
An
industry
trade
association
asked
EPA
to
accept
both
GLP
and
non­
GLP
studies
currently
on
file
to
fulfill
product
chemistry
requirements
regardless
if
studies
now
are
required
to
be
run
by
GLP.

Response:
The
issue
of
the
acceptability
of
product
chemistry
studies
that
do
not
meet
GLP
requirements
is
of
concern
in
the
registration
of
new
products
and
in
reregistration
as
well
as
in
registration
review.
Accordingly,
it
is
being
handled
outside
of
the
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rule­
making
for
registration
review.
For
example,
this
GLP
issue
was
recently
discussed
in
the
July
2006
meeting
of
the
Pesticide
Program
Dialogue
Committee
(
PPDC)
workgroup
on
product
chemistry.

4.
End­
use
products
in
the
U.
S.
should
be
exempt
from
the
Global
Harmonization
System
(
GHS)

Comment:
A
trade
association
commented
that
because
initiatives
such
as
GHS­
mandated
changes
would
complicate
the
process
of
updating
labels
in
the
registration
review
program,
enduse
products
in
the
US
should
be
exempt
from
GHS
requirements.

Response:
GHS
is
explained
on
EPA's
website:
http://
www.
epa.
gov/
oppfead1/
international/
globalharmon.
htm.
EPA
is
planning
a
public
meeting
in
the
fall
of
2006
to
discuss
issues,
such
as
this
one,
that
were
raised
in
comments
on
its
2004
White
Paper
on
GHS.
The
Agency
may
consider
options
for
implementing
GHS
label
changes.

5.
Label
Review
Manual
Comment:
A
trade
association
commented
that
EPA
should
revise
its
Label
Review
Manual
before
implementing
the
registration
review
program.
A
state
pesticide
safety
coordinator
commented
that
EPA
must
directly
incorporate
label
language
improvements
via
updates
to
Label
Review
Manual.

Response:
EPA
publishes
a
Label
Review
Manual
as
guidance
for
EPA
reviewers
and
updates
it
from
time
to
time
to
reflect
changes
in
labeling
policy.
The
Label
Review
Manual
does
not
establish
labeling
requirements
or
announce
new
policies.
As
label
policies
change,
EPA
will
update
the
Manual
for
its
use
in
the
registration
and
registration
review
programs.

B.
Announcing
pending
registration
actions
Comment:
A
trade
association
commented
that
EPA
should
not
include
information
about
pending
registration
decisions
in
the
registration
review
case
docket
unless
the
Agency
is
required
to
announce
such
pending
actions
in
the
Federal
Register.

Response:
EPA
agrees.
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II.
Risk
assessment
procedures
A.
Timeliness
of
EPA's
data
reviews
Comment:
A
trade
association
commented
that
EPA
should
be
required
to
promptly
review
and
reflect
in
its
regulatory
decisions
results
of
studies
submitted
in
response
to
data
call­
ins.
The
comment
alleges
that
EPA
has
not
completed
data
reviews
of
studies
called
in
and
submitted
many
years
earlier.
In
the
meantime,
study
guidelines
have
changed
and
some
studies
may
not
meet
Agency
requirements.
This
has
wasted
resources
and
caused
needless
animal
sacrifice.
Data
submitters
have
been
deprived
of
their
rights
for
data
compensation
because
the
period
of
compensability
elapsed
before
the
Agency
completed
its
review
of
data
submitted
pursuant
to
data
call­
ins.

Response:
EPA
believes
that
this
situation
should
not
arise
in
the
registration
review
program.
In
registration
review,
EPA
will
call­
in
only
those
data
that
it
believes
are
likely
to
affect
its
regulatory
position
on
the
pesticide.
Because
these
data
are
critical,
EPA
will
review
them
as
quickly
as
possible
to
complete
the
registration
review
decision.
.

B.
Inert
ingredients
Comment:
A
trade
association
asked
what
process
EPA
will
use
to
characterize
List
3
inert
ingredients.
Another
trade
association
suggested
that
EPA
could
use
the
low
toxicity
methodology
adopted
for
tolerance
reassessment
when
it
reviews
inert
ingredients
for
which
no
tolerances
or
exemptions
from
tolerance
have
been
established.
A
registrant
advised
that
clearance
of
new
inerts
can
be
accomplished
most
efficiently
through
a
dedicated
team
specializing
in
lower
toxicity
evaluations.

Response:
EPA's
activities
on
inert
ingredients
are
described
in
http:/
www.
epa.
gov/
opprd001/
inerts/.
The
commenters
are
referring
to
EPA's
"
Guidance
Document
on
Methodology
for
Determining
the
Data
Needed
and
the
Types
of
Assessments
Necessary
to
Make
FFDCA
Section
408
Safety
Determinations
for
Lower
Toxicity
Pesticide
Chemicals"
that
is
posted
on
EPA's
website.
It
generally
describes
the
screening
level
assessments
that
EPA
is
using
to
reassess
inert
ingredient
tolerance
exemptions.
EPA
agrees
that
the
processes
described
in
this
guidance
document
may
prove
useful
in
evaluating
inert
ingredient
that
are
used
only
in
non­
food
pesticide
products
and
therefore
do
not
have
tolerance
exemptions.
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C.
Risk
Assessment
1.
Risk
assessment
methods
Comment:
A
public
interest
group
suggested
that
EPA
publish
guidance
explaining
how
the
risk
assessment
process
will
function
in
the
registration
review
program.
A
registrant
commented
that
EPA
should
propose
a
process
to
establish
guidelines
for
completion
and
interpretation
of
studies
on
immunotoxicity,
cumulative
risk,
and
endocrine
disruption.
The
registrant
and
a
trade
association
also
commented
that
EPA
should
establish
a
transparent
process
for
deciding
when
to
require
endangered
species
data.
A
water
sanitation
agency
recommended
that
EPA
should
change
the
defaults
it
uses
in
estimating
exposures
from
water
when
monitoring
data
are
not
available.

Response:
EPA's
risk
assessment
process
remains
the
same
whether
EPA
is
reviewing
a
new
registration
action
or
conducting
a
review
of
a
registered
pesticide.
EPA
involves
the
public
in
the
development
of
risk
assessment
procedures,
including
procedures
for
estimating
exposures
from
water,
cumulative
risk
assessments
or
endangered
species
assessments.
EPA
may
hold
public
workshops
to
develop
approaches,
consult
with
experts,
convene
advisory
committees
under
the
Federal
Advisory
Committee
Act,
or
ask
the
FIFRA
Scientific
Advisory
Panel
(
SAP)
authorized
by
FIFRA
to
peer
review
proposed
risk
assessment
procedures.
EPA
has
established
a
guideline
for
immunotoxicity
studies;
it
is
available
on
the
Agency
website
website
at:
http://
www.
epa.
gov/
opptsfrs/
publications/
OPPTS_
Harmonized/
87
0_
Health_
Effects_
Test_
Guidelines/
Series/.
EPA
has
a
public
procedure
for
developing
endocrine
disruptor
testing
methods
(
see
http://
www.
epa.
gov/
scipoly/
oscpendo/
pubs/
assayvalidation/
index.
htm).

2.
Use
of
methodology
for
assessing
lower
toxicity
chemicals
Comment:
When
deciding
on
the
scope
and
depth
of
reviews,
EPA
could
rely
on
the
experience
gained
in
the
reassessment
of
inert
ingredients
and
the
development
of
the
methodology
for
assessing
lower
toxicity
chemicals.

Response:
EPA
agrees
with
this
comment.

3.
Will
EPA
relax
its
standards?

Comment:
A
statel
lead
agency
commented
that
EPA
should
recognize
the
extent
to
which
state
agencies
rely
on
EPA's
risk
assessments
and
should
avoid
weakening
the
data
requirements
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and
summaries
associated
with
risk
assessments.
This
commenter
implied
that
under
the
proposed
registration
review
process,
EPA
will
relax
its
standards
regarding
the
data
needed
to
support
a
registration
decision.
The
commenter
advised
EPA
to
limit
the
use
of
data
requirement
waivers
which
he
believes
have
contributed
significantly
to
the
gaps
in
reregistration
risk
assessments.

Response:
EPA's
risk
assessments
account
for
each
applicable
data
requirement.
These
documents
explain
the
basis
for
any
decision
to
waive
a
requirement.
In
registration
review,
the
public
will
generally
have
opportunity
to
review
draft
risk
assessments
and
may
comment
on
the
completeness
or
thoroughness
of
the
draft
risk
assessment.

4.
Will
EPA's
risk
assessments
account
for
regional
or
local
environmental
conditions?

Comment:
A
state
lead
agency
commented
that
when
conducting
risk
assessments
or
evaluating
risk
management
approaches,
EPA
should
remain
aware
of
variations
among
states
with
regard
to
climates,
topographies,
soils,
and
water
resources.
States
do
not
have
resources
to
evaluate
or
customize
state
registrations
to
protect
local
environments
from
impacts
not
anticipated
or
evaluated
during
federal
registration
review.

Response:
EPA
agrees
that
its
risk
assessments
should
consider,
to
the
extent
practicable,
a
range
of
regional
and
local
variations
in
climate,
topography,
soils,
and
water
resources.
However
it
is
generally
not
possible
to
routinely
conduct
risk
assessments
that
capture
each
variation
in
environmental
conditions.
To
assure
that
its
risk
management
decisions
will
be
protective
of
sensitive
environments,
EPA
assesses
the
effects
of
the
pesticide
in
environments
that
it
believes
to
be
the
most
vulnerable
to
the
potential
effects
of
the
pesticide.

5.
EPA's
definition
of
"
sound
science"

Comment:
A
public
interest
group
commented
that
EPA
should
avoid
adopting
a
definition
of
"
sound
science"
that
would
cause
the
Agency
to
delay
restricting
or
banning
the
use
of
a
dangerous
pesticide
until
harm
is
"
proven."
This
comment
stated
that
replicable,
reliable
studies
conducted
by
government
or
independent
researchers
that
show
a
strong
association
between
a
pesticide's
use
and
harm
to
public
health
or
the
environment
should
qualify
as
sound
science.
An
individual
commented
that
EPA's
risk
assessments
must
include
the
latest
scientific
information
on
health
and
safety.
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Response:
In
accordance
with
the
Data
Quality
Act,
EPA
has
issued
guidance
regarding
the
quality
of
information
it
relies
upon
for
regulatory
decisions.
This
guidance
is
available
at
EPA's
website
at:
htpp://
www.
epa.
gov/
quality/
informationguidlines/.
Under
these
guidelines,
EPA
may
base
a
regulatory
decision
on
data
developed
by
the
government
or
independent
researchers.

6.
Are
exposure
assessment
models
compensable
data?

Comment:
A
trade
association
asserted
that
if
exposure
assessment
models
are
improved
by
compensable
data,
such
as
those
generated
by
task
forces
and
joint
ventures,
then
these
models
themselves
should
be
subject
to
compensation.
They
believe
that
EPA
should
develop
a
plan
to
assure
that
data
generators'
contributions
are
recognized
and
compensated
under
FIFRA.

Response:
The
issue
of
how
to
compensate
data
generators
for
data
used
in
models
is
a
generic
issue
arising
in
registration
as
well
as
in
registration
review.
Under
FIFRA
section
3(
g),
data
compensation
applies
to
data
submitted
to
support
or
maintain
registrations
in
connection
with
registration
review.
EPA
regulations
at
40
CFR
Part
152.80
through
152.99
and
the
preamble
to
those
1984
regulations
explain
the
circumstances
under
which
data
submitted
in
support
of
registration
and
continuing
registration
activities
are
protected
by
EPA.
We
believe
Congress
intended
that
the
same
protections
be
extended
to
data
that
EPA
relies
upon
to
support
decisions
made
in
registration
review.

D.
Data
requirements
and
risk
assessment
methods
for
antimicrobial
pesticides
1.
EPA
lacks
data
requirements
for
antimicrobial
pesticides
Comment:
A
trade
association
asserted
that
FIFRA
section
3(
h)(
3)
required
EPA
to
issue
final
regulations
establishing
data
requirements
for
registration
of
antimicrobial
pesticides.
EPA
missed
this
deadline
and
still
hasn't
published
these
regulations.
The
publication
in
2005
of
proposed
draft
guidance
on
data
requirements
for
antimicrobial
pesticides
doesn't
relieve
EPA
of
its
obligation
to
establish
data
requirements
by
regulation.

Response:
As
explained
in
the
preamble
to
the
final
rule,
as
a
standard
program
practice
in
the
absence
of
updated
part
158
rules,
the
Agency
makes
case­
by
case
determinations
in
the
registration,
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reregistration
and
tolerance
assessment
programs.
The
Agency
believes
that
the
registration
review
program
can
operate
effectively
in
the
absence
of
updated
part
158
rules.
The
Agency
is
developing
revised
part
158
rules
for
antimicrobial
pesticides
and
will
release
its
rule­
making
schedule
in
the
Regulatory
Agenda
to
be
published
in
the
Federal
Register
in
October.

2.
EPA's
application
of
policy
on
antimicrobial
data
requirements
Comment:
A
trade
association
commented
that
although
EPA
has
published
policies
regarding
data
requirements
and
risk
assessment
methodologies
for
antimicrobial
pesticides,
the
Agency
frequently
and
arbitrarily
departs
from
these
policies.
Data
requirements
for
antimicrobial
pesticides
are
less
clear
than
they
were
when
FQPA
was
enacted.

Response:
EPA
uses
its
published
data
requirement
and
risk
assessment
policies
to
guide
decisions
on
individual
pesticide
cases.
Based
on
the
available
information
in
a
particular
case,
EPA
may
determine
that
aspects
of
a
policy
do
not
apply
to
that
case.
Departures
from
published
policy
are
infrequent
and
are
taken
on
a
case­
by
case
basis,
but
when
they
do
occur,
they
are
explained
and
documented.

3.
Applicability
of
"
new
decision
paradigm"
to
registration
or
reregistration
decisions
Comment:
A
trade
association
commented
that
EPA
currently
does
not
apply
the
"
new
decision
paradigm"
in
its
current
activities
with
respect
to
antimicrobial
pesticides.
EPA
still
requires
data
to
"
complete
the
data
base."
EPA
requires
data
even
when
risk
estimates
that
are
based
on
worst
case
default
assumptions
(
used
when
there
are
no
data)
show
acceptable
margins
of
exposure.

Response:
EPA
has
used
the
term
"
new
decision
paradigm"
to
describe
the
process
that
it
will
use
in
registration
review
to
decide
whether
it
can
continue
to
rely
on
existing
risk
assessments.
In
registration
review
it
is
appropriate
to
focus
on
what
has
changed
since
the
last
risk
assessment
and
registration
or
reregistration
decision.
Pesticides
undergoing
registration
review
already
meet
or
exceed
requirements
for
registration
that
were
established
in
1984.
In
registration
of
new
pesticides
or
reregistration
of
pesticides
that
were
registered
before
1984,
EPA
focuses
on
having
registrants
meet
data
requirements
before
it
conducts
a
risk
assessment.
Accordingly,
the
"
new
decision
paradigm"
would
not
apply
to
such
actions.
Docket
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E.
Scope
of
risk
assessments
1.
Consider
risks
posed
by
formulated
products,
inert
ingredients
and
degradates
Comment:
Water
sanitation
agencies
commented
that
EPA
should
not
evaluate
individual
pesticide
ingredients
and
degradates
separately
­­
EPA
should
consider
effects
of
pesticide
formulations,
inert
ingredients,
degradates
and
cumulative
effects.
The
comment
further
stated
that,
when
considering
the
risks
of
formulated
products,
EPA
should
not
confine
review
to
acute
toxicity
but
consider
all
risks.
A
state
lead
agency
commented
that
EPA
should
characterize
environmental
fate
and
toxicity
of
inert
ingredients.

Response:
EPA
agrees
that
it
should
evaluate
the
risk
posed
by
pesticide
products,
including
the
active
ingredient,
other
ingredients
in
the
pesticide
product,
and
degradates
and
metabolites
of
these
ingredients.
To
the
extent
practicable,
the
Agency's
test
guidelines
take
these
aspects
into
account.
In
addition
to
data
on
the
active
ingredient,
EPA
requires,
where
applicable,
information
regarding
environmental
fate,
residue
chemistry
and
toxicological
effects
of
typical
end­
use
products.

2.
Consider
endocrine­
disruption
effects
Comment:
A
state
lead
agency
commented
the
EPA
should
consider
states'
concerns
related
to
pesticides
and
endocrine
disruption.

Response:
As
required
under
section
408(
p)
of
the
Federal
Food,
Drug
and
Cosmetic
Act,
EPA
is
developing
a
program
to
assess
endocrine
disruption
potential
of
pesticides.
As
explained
in
the
preambles
to
the
proposed
and
final
rules,
EPA
intends
to
use
registration
review
as
the
framework
for
managing
the
endocrine
screening
and
testing
program
for
pesticides.

3.
Scope
of
review
under
EPA's
"
new
decision
paradigm"

Comment:
A
trade
association
commented
that
EPA
proposed
a
"
new
decision
paradigm"
for
registration
review
and
is
premising
the
program
in
part
on
the
assumption
that
for
a
significant
proportion
of
cases
reviewed
each
year,
there
will
be
no
need
for
new
data.
However,
they
believe
that
this
assumption
is
inconsistent
with
the
results
of
the
pilot
study.
Another
trade
association
asserted
that
EPA
will
not
be
able
to
complete
50
registration
review
cases
per
year
if
it
asks
for
a
lot
of
data.
Docket
EPA
HQ
OPP
2004­
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2006
Response:
The
Agency
does
not
agree
with
this
interpretation.
The
Agency
is
premising
the
program
on
its
finding,
based
on
the
results
of
the
feasibility
study,
that
it
is
possible
to
determine
reasonably
quickly
whether
it
can
continue
to
rely
on
existing
risk
assessments,
and
if
not,
whether
it
can
update
them
with
available
data.
After
the
Agency
determines
the
scope
and
depth
of
a
pesticide's
registration
review
(
including
any
needs
for
new
data),
it
will
develop
schedules
for
completing
the
work
that
take
into
account
time
needed
to
develop
any
new
data.
EPA
plans
to
complete
registration
review
decisions
on
about
45
cases
per
year.
However,
many
of
these
cases
will
be
cases
that
were
carried
over
from
previous
years
as
data
are
developed
and
submitted
and
risk
assessments
are
completed.
Many
of
the
cases
opened
in
a
given
year
will
be
completed
in
subsequent
years.

III.
Risk/
benefit
decisions
A.
Assessing
risks
and
benefits
in
endangered
species
assessments
Comment:
A
registrant
commented
that
the
challenge
for
EPA
is
to
provide
adequate
protection
for
non­
target
organisms
while
minimizing
economic
losses
or
negative
impacts
on
agricultural
production
or
pest
control.
For
endangered
species,
it
was
Congress'
intent
that
mitigation
measures
should
minimize
impact
on
agriculture
(
Section
1010
of
Public
Law
100­
478,
October
7,
1988).

Response:
EPA
agrees
that
finding
this
balance
in
registration
review
will
be
a
challenge.
Accordingly,
the
final
rule
provides
EPA
the
flexibility
to
expand
opportunities
for
public
participation
in
the
development
of
risk
mitigation
measures.

B.
Assessing
risks
of
potential
substitutes
Comment:
Water
sanitation
agencies
commented
that
when
EPA
looks
at
alternatives
to
a
pesticide
that
must
be
phased
out,
it
should
consider
risks
from
the
urban
uses
of
the
alternative
pesticide,
including
the
costs
incurred
by
publicly­
owned
water
treatment
facilities
when
expanded
use
of
the
alternative
pesticide
would
result
in
impairment
of
water
bodies
or
cause
these
facilities
to
violate
NPDES
permits.

Response:
EPA
agrees
that
it
should
evaluate
the
risks
posed
by
urban
uses
and
on
a
case­
by­
case
basis
it
would
consider
water­
treatment
facilities'
costs
in
assessing
various
options
for
risk
management
of
a
pesticide
that
poses
risks
of
concern.
Docket
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HQ
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IV.
Risk
Mitigation
A.
Timeliness
Comment:
A
trade
association
asked
EPA
to
consider
the
time
that
registrants
need
to
obtain
state
approvals
of
new
labels
when
EPA
sets
timeframes
for
implementing
risk
mitigation.
Water
sanitation
agencies
commented
that
phase­
outs
should
be
accelerated
as
much
as
possible,
especially
if
safer
pesticides
are
available.

Response:
EPA
agrees
that
mitigation
should
be
implemented
as
promptly
as
possible.

B.
Effectiveness
1.
Implementation
of
new
measures
Comment:
A
registrant
asserted
that
EPA
should
assure
that
risk
mitigation
measures
are
implemented
and
maintained
by
all
the
registrant
community,
not
just
the
technical
registrants.
A
pesticide
safety
coordinator
commented
that
EPA
should
reduce
the
number
of
multiple
labels
for
the
same
product
because
having
multiple
labels
complicates
education
and
enforcement.

Response:
EPA
agrees
that
risk
mitigation
measures
should
be
adopted
for
all
products
for
which
the
measures
apply.
The
Agency
acknowledges
that
having
multiple
labels
for
the
same
product
might
pose
problems
for
some
stakeholders.

2.
Disposal
of
phased­
out
products
Comment:
Water
sanitation
agencies
commented
that
retailers
and
the
public
need
guidance
on
appropriate
disposal
of
phased­
out
pesticides.
They
reported
that
after
diazanon
was
cancelled,
people
apparently
immediately
discontinued
use
of
the
product
and
disposed
of
it
dumping
it
into
wastewater
which
adversely
affected
water
quality.
Municipalities
found
that
retailers
were
unaware
of
disposal
options
for
unsold
diazanon
products.
The
water
sanitation
agencies
asserted
that
EPA
should
provide
funds
to
help
municipalities
collect
and
dispose
of
phased­
out
pesticides.

Response:
EPA
agrees
that
phased­
out
products
should
be
disposed
of
appropriately.
Municipalities
should
not
have
the
burden
of
collecting
and
disposing
of
unsold
phased­
out
pesticides.
Docket
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V.
Financing
the
Registration
Review
Program
A.
Agency
funding
Comment:
Several
trade
associations
and
a
public
interest
group
expressed
concern
about
the
Agency's
capacity
and
resources
to
conduct
the
program
described
in
the
preamble
to
the
proposed
rule.
One
trade
association
commented
that
the
registration
review
program
should
be
funded
through
appropriations,
not
user
fees
for
industry.

Response:
Unless
Congress
authorizes
user
fees,
the
registration
review
program
will
be
funded
through
appropriations.

B.
States'
costs
Comment:
Water
treatment
agencies
commented
that
EPA
or
registrants
should
fund
collection
of
water
quality
data.
A
state
lead
agency
stated
that
states
need
federal
support
to
quantify
local
impacts
and
for
enforcement.

Response:
When
a
chemical
poses
a
significant
water
quality
concern
EPA
may
require
registrants
to
conduct
monitoring,
or
to
conduct
analyses
of
samples
collected
by
states.
For
example,
EPA
required
registrants
to
monitor
vulnerable
watersheds
for
atrazine,
and
required
the
registrant
of
a
new
chemical
­­
isoxaflutole
­­
to
conduct
sample
analyses
for
states.
Although
the
Agency
does
not
have
the
resources
to
support
each
state's
efforts
to
assess
water
quality
impacts,
OPP
has
recently
entered
into
an
agreement
with
the
U.
S.
Geological
Survey
to
jointly
plan
for
additional
projects
to
assess
pesticide
impacts
on
water
quality.

C.
Registrants'
costs
Comments:
A
registrant
and
an
industry
consultant
commented
that
application
of
FIFRA
requirements
for
small
business
and
large
international
conglomerates
is
inherently
unequal
because
small
businesses
have
to
comply
with
the
same
regulatory
requirements
and
registration
fees
as
large
businesses.
They
suggested
that
small
businesses
should
have
a
special
rate
and
that
there
should
be
a
separate
fee
category
for
non­
dangerous
products.
A
trade
association
expressed
its
concern
that
small
businesses
could
be
adversely
affected
if
the
public
perceives
that
EPA
review
means
the
product
is
dangerous.

Response:
EPA
does
not
have
authority
to
adjust
registration
fees
for
small
businesses
or
to
establish
a
fee
category
for
less
toxic
products.
EPA
acknowledges
that
economies
of
scale
may
favor
large
business.
Where
possible,
EPA
accommodates
the
needs
of
small
business
with
respect
to
implementing
data
requirements.
Docket
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EPA
acknowledges
that
public
perception
can
affect
a
product's
marketability.
Accordingly,
along
with
continuing
efforts
to
explain
the
registration
review
program
to
the
public,
the
Agency
has
adopted
a
transparent
process
for
conducting
registration
review.
The
Agency
hopes
that
these
efforts
are
sufficient
to
assuage
small
business
concerns
in
this
regard.

VI.
Issues
Relating
to
Specific
Cases
Comment:
A
registrant
commented
on
the
composition
of
the
copper
oxides
reregistration
case.
They
asked
EPA
to
differentiate
between
metallic
copper
and
cuprous
or
cupric
oxides
because
metallic
copper
is
safe
for
human
consumption
whereas
the
cuprous
or
cupric
oxides
are
toxic.
Because
EPA
failed
to
make
this
distinction
in
reregistration,
EPA
evaluation
of
copper­
containing
antifoulant
paint
mischaracterized
the
leaching
potential
of
their
product.

Response:
The
reregistration
case
and
the
anticipated
registration
review
case
for
copper
compounds
includes
copper
oxide,
cuprous
oxide,
cupric
oxide
and
metallic
copper.
While
individual
products
may
have
one
specific
compound
as
the
active
ingredient,
once
the
product
is
in
service,
the
substance
of
interest
is
the
copper
ion
which
is
released
into
the
surrounding
soil
or
water
and
is
primarily
responsible
for
the
toxicity
of
copper
compounds
to
wildlife
and
aquatic
organisms.

VII.
Registrant
Support
of
Registration
Review
Cases
Comment:
A
trade
association
noted
that
EPA
prefers
to
determine
as
early
as
possible
whether
a
given
product
will
be
supported
in
registration
review
and
suggested
that
EPA
could
send
a
questionnaire
to
registrants
informing
them
of
anticipated
issues
or
data
requirements
and
asking
them
whether
they
intend
to
support
their
product.

Response:
The
questionnaire
contemplated
in
this
comment
is
similar
to
an
application
for
registration
review.
The
NPRM
explained
that
the
Agency
had
considered
adopting
an
application
procedure
for
the
registration
review
program
but
dropped
this
idea
because,
among
other
things,
stakeholders
objected
to
it.

VIII.
GPRA
Goals
Comment:
Regarding
the
preamble
discussion
of
measuring
environmental
outcomes
as
required
under
the
Government
Performance
and
Results
Act
(
GPRA),
an
industry
trade
association
commented
that
EPA
must
consider
and
articulate
the
need
to
protect
the
nation's
food
supply,
property
and
public
health
from
pests
and
develop
measures
of
the
program's
effectiveness.
They
suggested
that
EPA
should
seek
input
on
the
criteria
used
to
measure
environmental
outcomes
of
registration
review
to
ensure
a
clear
cause
and
effect
relationship.
Docket
EPA
HQ
OPP
2004­
0404
Page
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2006
Response:
The
Agency's
Strategic
Plan
(
available
at:
http://
www.
epa.
gov/
ocfo/
plan/
2003.
pdf)
describes
the
Agency's
goals
and
the
criteria
for
measuring
success
in
achieving
these
goals.
The
social
benefits
of
pesticide
use
are
discussed
in
Appendix
1
of
the
Agency's
Strategic
Plan
for
2003­
2008.
The
Agency
invites
public
comment
on
its
draft
strategic
plans.