Document ID: EPA-HQ-OPP-2002-0218-0005
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2003-04-25T04:00Z

March
31,
2003
1
SUPPORTING
STATEMENT
FOR
AN
INFORMATION
COLLECTION
REQUEST
(
ICR)

1.
Identification
of
the
Information
Collection
1(
a).
Title
of
the
Information
Collection
Title:
Tolerance
Petitions
for
Pesticides
on
Food/
Feed
Crops
and
New
Inert
Ingredients
EPA
ICR
No.
0597.08
OMB
Control
No.
2070­
0024
1(
b).
Short
Characterization/
Abstract
The
use
of
pesticides
to
increase
crop
production
often
results
in
pesticide
residues
in
or
on
the
crop.
To
protect
the
public
health
from
unsafe
pesticide
residues,
the
Environmental
Protection
Agency
(
EPA)
sets
limits
on
the
nature
and
level
of
residues
permitted
pursuant
to
section
408
of
the
Federal
Food,
Drug
and
Cosmetic
Act
(
FFDCA)(
Attachment
A).
A
pesticide
may
not
be
used
on
food
or
feed
crops
unless
the
Agency
has
established
a
tolerance
(
maximum
residue
limit)
for
the
pesticide
residues
on
that
crop,
or
established
an
exemption
from
the
requirement
to
have
a
tolerance.

It
is
EPA's
responsibility
to
ensure
that
the
maximum
residue
levels
likely
to
be
found
in
or
on
food/
feed
are
safe
for
human
consumption
through
a
careful
review
and
evaluation
of
residue
chemistry
and
toxicology
data.
In
addition
it
must
ensure
that
adequate
enforcement
of
the
tolerance
can
be
achieved
through
the
testing
of
submitted
analytical
methods.
Once
the
data
are
deemed
adequate
to
support
the
findings,
EPA
will
establish
the
tolerance
or
grant
an
exemption
from
the
requirement
of
a
tolerance.

There
are
basically
three
types
of
tolerance
actions:

(
1).
Permanent
tolerance
(
or
an
exemption
from
the
requirement
for
a
permanent
tolerance)
for
residues
which
would
result
from
a
pesticide
use
registered
under
FIFRA.
These
tolerances
can
be
established
for
raw
and
processed
foods
and
they
can
address
both
active
and
inert
ingredients
in
pesticides.
The
vast
majority
of
these
actions
are
taken
in
response
to
petitions,
but
the
Agency
may
also
initiate
such
actions.
As
indicated
previously,
this
ICR
only
applies
to
the
information
collection
activities
associated
with
tolerance
petitions,
not
Agency
initiated
actions.

(
2).
Temporary
tolerance
(
or
an
exemption
from
the
requirement
for
a
temporary
tolerance)
to
permit
the
sale
of
commodities
containing
residues
resulting
from
authorized
experimental
use
of
an
unregistered
pesticide.
In
the
absence
of
such
a
tolerance
or
exemption,
all
such
commodities
must
be
destroyed.
In
submitting
an
application
for
Experimental
Use
Permit
(
EUP),
the
applicant
may
also
request
that
the
Agency
establish
a
tolerance
or
an
exemption
from
the
tolerance
requirement.
This
ICR
does
not
cover
EUP
related
March
31,
2003
2
tolerance
information
collection
activities,
which
are
covered
by
the
ICR
entitled,
"
Application
for
Experimental
Use
Permit
(
EUP)
to
Ship
and
Use
a
Pesticide
for
Experimental
Purposes
Only"
(
OMB
Control
#
2070­
0040,
EPA
ICR
#
276).

(
3).
Time­
limited
tolerance
(
or
an
exemption
from
the
requirement
for
a
time­
limited
tolerance)
to
permit
the
sale
of
commodities
containing
residues
resulting
from
a
pesticide
whose
use
was
authorized
under
Section
18
of
FIFRA.
Under
FIFRA
§
18,
EPA
may
allow
States
to
use
a
pesticide
for
an
unregistered
use
for
a
limited
time
if
EPA
determines
that
emergency
conditions
exist.
FQPA
requires
EPA
to
establish
tolerances
to
cover
all
pesticide
residues
in
food,
even
residues
resulting
from
emergency
uses.
Although
the
Agency
initiates
these
tolerance
actions,
these
actions
are
taken
in
response
to
petitions
for
the
Agency
to
issue
an
action
under
FIFRA
§
18.
This
ICR
does
not
cover
information
collection
related
to
FIFRA
§
18
tolerance
activities,
which
is
collected
under
the
ICR
entitled,
"
Application
and
Summary
for
an
Emergency
Exemption
for
Pesticides"
(
OMB
Control
#
2070­
0032,
EPA
ICR
#
596).

This
ICR
only
applies
to
the
information
collection
activities
associated
with
the
submission
of
a
petition
for
a
tolerance
action.
While
EPA
is
authorized
to
set
pesticide
tolerances,
the
Food
and
Drug
Administration
(
FDA)
is
responsible
for
their
enforcement.
Food
or
feed
commodities
found
to
contain
pesticide
residues
in
excess
of
established
tolerances
are
considered
adulterated,
and
are
subject
to
seizure
by
FDA,
and
may
result
in
civil
penalties.

2.
Need
For
and
Use
of
the
Collection
2(
a).
Need/
Authority
for
the
Collection
The
tolerances
for
pesticide
residues
in
food
or
feed
are
set
primarily
under
the
authority
of
section
408
of
the
Federal
Food,
Drug
and
Cosmetic
Act
(
FFDCA),
as
amended.
The
Agency
takes
these
tolerance
actions
either
on
its
own
initiative
pursuant
to
FFDCA
§
408(
e)
or
in
response
to
a
petition
filed
pursuant
to
FFDCA
§
408(
d).
The
regulations
covering
tolerances
are
contained
in
Title
40
of
the
Code
of
Federal
Regulations
(
CFR)
Part
180.
Actual
listings
of
individual
tolerances
by
chemical
are
also
found
in
Part
180
(
Attachment
B).

Under
FFDCA
§
408(
d),
any
person
may
file
a
petition
with
EPA,
proposing
the
issuance
of
a
regulation
establishing,
modifying,
or
revoking
(
a)
a
tolerance
for
a
pesticide
chemical
residue
in
or
on
food,
or
(
b)
an
exemption
from
the
requirement
to
have
a
tolerance
for
such
residue.
The
Agency
publishes
a
notice
of
receipt
for
such
petitions
in
order
to
provide
an
opportunity
for
public
comment
on
the
request,
and
then
either
issues
a
final
regulation,
or
a
notice
denying
the
petitioner's
request.
FFDCA
§
408(
d)(
4)
directs
the
Agency
to
issue
a
final
regulation
after
considering
the
petitioner's
request.

Under
FFDCA
§
408(
e),
at
any
time
the
Agency
may
issue
a
regulation
establishing,
modifying,
suspending,
or
revoking
(
a)
a
tolerance
for
a
pesticide
chemical
residue
in
or
on
food,
March
31,
2003
3
or
(
b)
an
exemption
from
the
requirement
to
have
a
tolerance
for
such
residue.
When
initiating
such
actions,
FFDCA
§
408(
e)(
2)
requires
the
Agency
to
issue
a
notice
of
proposed
rulemaking
to
provide
an
opportunity
for
public
comment.

The
Food
Quality
Protection
Act
of
1996
(
FQPA),
which
amended
the
two
primary
statutes
regulating
pesticides,
i.
e.,
FFDCA
and
the
Federal
Insecticide,
Fungicide
and
Rodenticide
Act
(
FIFRA),
requires
that
tolerances
be
set
at
a
level
to
ensure
that
there
be
"
a
reasonable
certainty
that
no
harm
will
result
from
aggregate
exposure."
Among
other
things,
FQPA
requires
EPA
to
consider
a
number
of
factors
when
setting
such
tolerances
or
registering
pesticide
products,
including:
1)
special
protection
for
infants
and
children;
2)
aggregate
exposure
and
risk
from
foods
and
other
known
sources,
such
as
drinking
water
and
household
pesticide
use;
3)
consideration
of
common
mechanisms
of
toxicity
(
some
chemicals
have
different
molecular
structures
but
cause
deleterious
effects
in
the
same
manner);
and
4)
consideration
of
endocrine
disruptor
effects.

The
collection
of
information
covered
by
this
ICR
is
needed
to
ensure
that
the
statutory
requirements
related
to
tolerances
can
be
met
by
the
public
and
EPA.
Food
or
feed
commodities
found
to
contain
residues
of
a
pesticide
without
or
in
excess
of
established
tolerances
are
considered
adulterated,
and
are
subject
to
seizure
by
FDA,
and
may
result
in
civil
penalties.

2(
b).
Practical
Utility/
Users
of
the
Data
The
FQPA
directs
the
Agency
to
consider
aggregate
exposures
from
dietary
and
nonoccupational
sources
when
assessing
the
risks
of
a
chemical
and
setting
tolerances.
In
addition
to
dietary
exposure,
such
sources
as
drinking
water
and
residential
lawn
care
use
need
to
be
considered.
EPA
must
make
the
statutory
determination
that
the
resulting
pesticide
residues
in
food
or
feed
will
result
in
a
reasonable
certainty
of
no
harm
effects
of
human
health
from
aggregate
exposure
through
dietary,
non­
occupational,
and
drinking
water
routes
of
exposure
before
establishing
the
tolerance.

EPA
is
applying
the
FQPA
standard
to
all
tolerances
for
newly­
registered
chemicals
and
food
uses.
In
addition,
FQPA
has
set
a
schedule
for
reassessing
all
10,000
existing
tolerances
under
this
new
standard
by
2006.
FQPA
did
not
provide
for
a
phase­
in
period
for
many
of
the
new
requirements
which
had
not
previously
been
a
part
of
EPA's
risk
assessment
process.
Although
EPA
does
not
require
registrants
to
submit
any
additional
information
under
this
ICR,
the
FQPA
provisions
requires
EPA
to
consider
additional
information
in
order
to
make
the
necessary
regulatory
decisions.
Petitioners
who
submitted
data
to
the
Agency
prior
to
passage
of
FQPA
were
therefore
encouraged
to
supplement
their
original
submissions
with
additional
information.
Respondents
submitting
new
petitions
may
want
to
submit
supplemental
information.
Section
408
of
FFDCA
requires
petitioners
submit
"
an
information
summary
of
the
petition
and
of
the
data,
information
and
arguments
submitted
or
cited
in
support
of
the
petition."
To
allow
for
the
most
efficient
processing
and
review
of
tolerance
petitions,
the
Agency
has
provided
a
description
of
the
types
of
information
that
EPA
considers
helpful
in
the
appendices
to
Pesticide
Registration
(
PR)
Notice
No.
97­
1,
Attachment
D.
March
31,
2003
4
PR
Notice
97­
1
applies
to
most
applicants
with
registration
applications,
non­
cropdestruct
experimental
use
permit
applications,
and
tolerance
or
tolerance
exemption
petitions
pending
within
the
Agency.
It
also
applies
to
most
future
applicants
seeking
new
or
amended
pesticide
registrations
and
all
actions
involving
synthetic
chemicals,
antimicrobial,
biochemical
and
microbial
pesticides.
However,
the
notice
does
not
apply
to
applicants
seeking
fast
track
"
metoo
registrations
or
amendments
not
involving
new
uses.

EPA
uses
the
data
collected
to
set
the
tolerance.
The
Agency's
Risk
Managers
review
all
regulatory
aspects
of
each
petition,
coordinate
scientific
review
of
supporting
data,
and
prepare
the
public
notices
and
rules
necessary
to
establish
a
tolerance
or
an
exemption.
The
Agency's
Residue
Chemists
review
the
residue
data
submitted
to
determine
if
the
nature
and
magnitude
of
likely
residues
are
adequately
characterized,
and
ensure
that
acceptable
analytical
methods
are
available
to
enforce
the
tolerance
once
established.
The
Agency's
Toxicologists
review
the
toxicology
data
to
evaluate
the
potential
effects
of
the
residues
on
health,
and
assess
the
cumulative
dietary
significance
of
residues
of
the
pesticide
on
other
crops
and
commodities,
and
the
likelihood
of
exposure
to
particularly
sensitive
sub­
populations.
As
a
result
of
these
reviews,
EPA
is
able
to
make
the
statutory
determination
that
the
resulting
pesticide
residues
in
food
or
feed
will
not
cause
unreasonable
adverse
dietary
effects
on
human
health.

3.
Non
Duplication,
Consultations,
and
Other
Collection
Criteria
3(
a).
Non
duplication
To
avoid
potential
overlap
between
the
requirement
of
developing
data
in
support
of
a
tolerance
petition
and
the
development
of
data
for
a
FIFRA
registration,
EPA
allows
the
use
of
data
required
to
support
a
tolerance
petition
that
are
already
archived
in
EPA
records
for
use
as
part
of
a
FIFRA
registration
of
a
pesticide
to
be
used
in
a
like
manner
and
in
the
same
use
pattern.

3(
b).
Public
Notice
Required
Prior
to
ICR
Submission
to
OMB
In
proposing
to
renew
this
ICR,
EPA
published
a
Federal
Register
(
FR)
Notice
(
Attachment
E)
that
provided
a
60­
day
public
notice
and
comment
period
that
ended
on
December
31,
2002
.
No
comments
were
received
in
response
to
this
notice.

3(
c).
Consultations
In
order
to
reduce
the
petition
processing
time,
the
Agency
often
conducts
pre­
filing
conferences
to
identify
and
resolve
possible
problem
issues
on
petitions.
However
once
a
petition
is
filed,
consultation
and/
or
dialogue
between
the
petitioner
and
the
EPA
occurs
on
an
informal,
ongoing
"
as
needed"
basis.
Most
dialog
occurs
at
the
time
of
a
re­
submission
to
correct
a
deficiency
and
the
subsequent
review
of
the
petition
data.
Our
experience
has
been
that
when
any
sort
of
a
problem
arises,
whether
it
is
technical,
administrative,
or
of
any
other
nature,
the
participants
have
ample
opportunity
and
do
not
hesitate
to
contact
the
Agency.
March
31,
2003
5
During
the
preparation
of
this
ICR
renewal,
EPA
staff
contacted
the
following
representatives
of
pesticide
registrants
by
e­
mail
and
asked
them
for
their
assessment
of
the
burden
estimates
in
the
ICR:

Russell
Schneider
Monsanto
Co.
St.
Louis,
MO
russell.
p.
schneider@
monsanto.
com
Greg
Watson
Syngenta
Crop
Protection
Greensboro,
NC
336­
632­
2993
Don
Carlson
FMC
Corp.
donald.
carlson@
fmc.
com
Jack
Cain
DuPont
cain.
jack@
dupont.
com
Paul
Cain
Bayer
cain.
paul@
bayerus.
com
Hoyt
Jamerson
IR­
4
jamerson.
hoyt@
epa.
gov
The
representatives
from
DuPont,
Bayer,
FMC,
and
IR­
4
did
not
respond.
The
responses
from
Monsanto
and
Syngenta
are
included
in
this
supporting
statement
as
Attachment
F.
The
representatives
of
both
Monsanto
and
Syngenta
both
noted
that
it
was
difficult
to
estimate
the
burdens
for
preparing
petitions
because
their
complexity
can
vary
immensely.
Both
respondents
also
noted
that
obtaining
burden
estimates
for
preparing
the
studies
needed
for
a
tolerance
petition
would
be
very
resource­
intensive,
especially
since
CropLife
America
is
currently
conducting
a
survey
of
its
members
to
obtain
the
same
information.
Since
the
results
of
that
survey
are
not
expected
to
be
completed
until
later
in
2003,
too
late
for
the
renewal
cycle
for
this
ICR,
the
Agency
asked
respondents
to
provide
estimates
only
for
the
administrative
preparation
of
tolerance
petitions
and
not
to
include
the
cost
of
data
production.

Mr.
Watson
of
Syngenta
commented
that
the
burden
hours
for
reading
regulations
and
otherwise
preparing
to
submit
a
tolerance
petition
should
include
reviewing
previous
petitions
submitted
to
EPA,
and
that
hours
for
maintaining
information
should
include
time
to
maintain
electronic
archives
in
addition
to
the
required
records
maintenance
based
on
paper.
The
Agency
believes
that
these
specific
activities
are
not
associated
with
paperwork
burdens
imposed
by
law
or
regulation.
EPA
believes
those
activities
are
based
on
Syngenta's
corporate
decisions
and
are
part
of
their
"
customary
and
usual"
business
practices.

Syngenta
estimated
that
it
submits
an
average
of
ten
tolerance
petitions
per
year,
with
each
petition
taking
an
average
of
6
hours
to
prepare.
For
the
same
activity,
they
estimate
that
the
technical
work
on
each
petition
is
approximately
9
hours,
and
that
clerical
activities
involve
about
2
hours
per
petition.
Syngenta's
estimates
indicate
that
the
Agency
may
have
significantly
overestimated
the
paperwork
burden.

It
is
interesting
to
note
that
while
Syngenta
commented
on
the
estimates
for
all
activities
March
31,
2003
6
except
conducting
the
field
trial,
Monsanto
commented
only
on
that
activity.
Monsanto
noted
that
the
approximately
1,300
hours
estimated
in
the
ICR
for
the
paperwork
involved
in
generating
the
data
to
support
a
petition
was
a
reasonable
estimate
of
the
cost
of
one
crop
residue
study,
but
that
estimates
could
vary
widely
depending
on
the
type
of
data
needed.
For
instance,
preparation
of
a
reduced
risk
rationale
or
compilation
of
complete
toxicological
or
environmental
fate
data
might
result
in
far
higher
estimates.

The
Agency
considered
the
comments
of
both
petitioners
carefully
and
decided
to
leave
its
estimates
unchanged
given
the
difficulty
cited
by
both
Syngenta
and
Monsanto
to
assess
average
burdens.
Indeed,
the
Agency
has
encountered
similar
difficulties.
Syngenta's
estimates
may
well
accurately
reflect
the
actual
burdens
involved
in
preparing
and
submitting
a
typical
petition.
However,
the
Agency
also
notes
that
the
company
has
many
years
of
experience
submitting
petitions
and
therefore
may
have
developed
efficiencies
not
shared
by
other
respondents.

While
EPA
reviewed
the
burden
estimates
that
Monsanto
submitted,
the
Agency
felt
that
these
estimates
reflected
more
difficult
and
complex
tolerance
petitions
associated
with
more
unusual
situations
rather
than
those
associated
with
a
"
typical"
tolerance
petition."
We
must
also
note
that,
as
stated
in
Section
6
of
this
Supporting
Statement,
the
estimates
identified
by
the
Agency
apply
only
to
the
paperwork
burdens
of
the
required
activities.
The
technical
burdens
(
such
as
the
actual
conduct
of
scientific
trials)
may
be
substantially
higher
than
the
paperwork
burdens
identified
here.
Therefore,
EPA
decided
not
to
use
the
higher
Monsanto
burden
estimates
when
calculating
the
ICR.
The
Agency
looks
forward
to
reviewing
the
results
of
CropLife
America's
member
survey
and
hopes
that
the
survey
data
will
better
inform
our
burden
estimates
when
we
next
seek
to
renew
this
ICR.

3(
d).
Effects
of
Less
Frequent
Collection
Not
applicable.
This
activity
is
conducted
only
once
per
"
event,"
so
a
less
frequent
collection
is
not
possible.

3(
e).
General
Guidelines
Due
to
the
statutory
mandate
for
the
permanent
retention
of
supporting
chemistry
and
toxicological
data
related
to
pesticides,
the
data
included
in
petitions
must
be
maintained
for
the
life
of
the
pesticide.
This
mandate
exceeds
the
PRA
guideline
that
records
be
retained
for
no
more
than
three
years.

When
this
information
collection
activity
was
re­
approved
in
2000,
OMB
directed
the
Agency
to
submit
additional
analysis
of
non­
labor
costs
associated
with
this
collection.
Regrettably,
the
Agency
cannot
provide
the
information
to
OMB
at
this
time
because
the
information
necessary
to
be
appropriately
analyzed
for
OMB's
purposes
is
not
available.
As
Syngenta,
Monsanto,
and
the
Agency
have
noted,
these
costs
may
vary
greatly
from
chemical
to
chemical,
petition
to
petition,
and
costs
associated
with
testing
requirements
vary
from
test
guideline
to
test
guideline.
The
presentation
of
averages
or
proxy
estimates
for
these
costs
would
March
31,
2003
7
not
be
appropriate
at
this
time
as
the
Agency
would
be
forced
to
present
skewed
and
inaccurate
information.
However,
EPA
is
evaluating
potential
methodologies
that
will
enable
the
Agency
to
estimate
the
non­
labor
costs
in
the
future.
As
discussed
with
OMB,
since
this
task
is
complicated
and
will
result
in
changes
to
other
ICRs,
EPA
will
develop
and
seek
comment
on
a
proposed
method
that
would
then
be
incorporated
into
this
ICR
when
it
is
finalized.

OMB's
regulations
require
agencies
to
provide
a
statement
indicating
whether
the
proposed
collection
of
information
involves
the
use
of
automated,
electronic,
mechanical,
or
other
technological
collection
techniques
or
other
forms
of
information
technology,
e.
g.,
permitting
electronic
submission
of
responses,
and
an
explanation
of
the
decision
(
5
CFR
1320.5(
a)(
iii)(
E)).
In
December
2001,
EPA
announced
that
registrants
now
have
the
option
to
electronically
submit
underlying
study
data
required
by
the
Agency
in
support
of
the
tolerance
petition
process.
At
this
time,
OPP
is
not
offering
a
fully
electronic
submission
option.
Neither
OPP
nor
the
Agency's
Office
of
Environmental
Information
have
developed
the
information
technology
approaches
that
would
adequately
protect
FIFRA
Confidential
Business
Information
submitted
over
the
Internet
via
EPA's
Central
Data
Exchange
portal.

Ordinarily,
petitioners
would
be
required
to
submit
3
paper
copies
of
study
data
to
EPA.
Under
this
hybrid
option,
petitioners
need
only
submit
2
two
paper
copies
if
they
submit
the
required
study
data
in
Adobe
Acrobat
Portable
Document
Format
(
PDF)
on
a
compact
disc.
Once
EPA
staff
have
become
familiar
with
the
electronic
submission
process
and
the
technology,
OPP
believes
that
this
option
will
allow
the
Agency
to
achieve
operating
efficiencies
in
the
regulation
of
pesticides
through
the
promotion
and
facilitation
of
the
electronic
submission
process,
including
the
delivery,
review,
data
interchange
capability
and
archiving
of
data
supporting
the
petitions.
The
time
normally
required
for
OPP
to
complete
its
review
of
the
data
should
be
shortened,
thereby
allowing
faster
regulatory
decision­
making.

The
Agency
also
believes
that,
once
petitioners
have
become
familiar
with
the
electronic
submission
process
and
the
technology,
they
would
be
able
to
prepare
their
data
submissions
in
less
time.
OPP
expects
that
petitioners
will
spend
less
time
and
money
preparing
copies
and
sending
their
submissions
using
the
hybrid
paper­
electronic
submission
option,
and
stand
to
benefit
from
the
efficiencies
that
EPA
expects
to
experience
during
data
reviews.

OPP
began
piloting
electronic
data
submission
with
the
pesticide
registrant
community
in
1999,
engaging
a
number
of
firms
including
Bayer,
BASF,
Dow
AgroSciences,
Syngenta
and
Aventis.
During
this
process,
OPP
developed
extensive
guidance
and
has
made
it
available
to
the
participants
on
the
OPP
Internet
site
(
see
Attachment
G).
As
part
of
its
outreach
efforts,
OPP
held
a
joint
workshops
on
electronic
data
submission
with
the
American
Crop
Protection
Association
(
now
CropLife
America)
in
2000
and
2002.
OPP
has
also
worked
closely
with
Canada's
Pest
Management
Regulatory
Agency
(
PMRA)
through
a
joint
North
American
Free
Trade
Agreement
project
to
ensure
compatible
procedures.
OPP
and
PMRA
will
jointly
hosted
an
Organization
for
Economic
Cooperation
and
Development
workshop
on
electronic
data
submission
last
year
to
share
information
on
the
electronic
technologies
in
use
by
regulatory
agencies.
EPA
has
not
yet
estimated
any
cost
savings
or
burden
reduction
associated
with
the
March
31,
2003
8
electronic
submission
option
as
the
level
and
extent
of
industry
participation
has
not
yet
been
determined.

3(
f).
Confidentiality
Trade
secret
or
confidential
business
information
(
CBI)
is
frequently
submitted
to
the
EPA
in
this
program
because
submissions
usually
include
the
manufacturing
process,
product
formulation,
and
supporting
data.
When
such
information
is
provided
to
the
Agency,
the
information
is
protected
from
disclosure
under
FIFRA
Section
10.
CBI
data
submitted
to
the
EPA
is
handled
strictly
in
accordance
with
the
provisions
of
the
FIFRA
Confidential
Business
Information
Security
Manual.

3(
g).
Sensitive
Questions
Not
applicable.
No
information
of
a
sensitive
or
private
nature
is
requested
in
this
information
collection
activity.

4.
The
Respondents
and
the
Information
Requested
4(
a).
Respondents/
NAICS
Codes
Respondents
to
this
information
collection
activity
include
anyone
who
files
a
petition
asking
the
Agency
to
take
a
specific
tolerance
action.
Although
such
petitions
typically
come
from
those
businesses
engaged
in
the
manufacturing
of
pesticides,
the
Agency
may
also
receive
petitions
from
other
entities,
including
the
Interregional
Research
Project
No.
4
(
IR­
4),
third
party
registrants,
grower
groups,
importers
or
other
governments,
and
concerned
citizens.

Although
it
is
impossible
to
identify
all
the
North
American
Industrial
Classification
System
(
NAICS)
codes
for
all
of
the
potential
respondents,
the
NAICS
code
assigned
to
this
program
is
325320
(
Pesticide
and
other
Agricultural
Chemical
Manufacturing).

4(
b).
Information
Requested
(
i)
Data
Items,
Including
Record
Keeping
Requirements
In
addition
to
a
cover
letter
and
fee,
a
tolerance
petition
must
include
the
following
nine
parts:
March
31,
2003
9
Chemical
identity
The
name,
chemical
identity,
and
composition
of
the
pesticide
chemical.
If
the
pesticide
chemical
is
an
ingredient
of
a
pesticide,
the
complete
quantitative
formula
of
the
resulting
pesticide
product
should
be
submitted.
The
submission
of
this
information
does
not
restrict
the
application
of
any
tolerance
or
exemption
granted
to
the
specific
formula(
s)
submitted.

Chemical
use
The
amount,
frequency,
and
time
of
application
of
the
pesticide
chemical.

Safety
reports
Include
reports
of
investigations
made
with
respect
to
the
safety
of
the
pesticide
chemical.
These
reports
should
include,
when
necessary,
detailed
data
derived
from
appropriate
animal
or
other
biological
experiments
in
which
the
methods
used
and
the
results
obtained
are
clearly
set
forth.

Residue
test
results
The
results
of
tests
on
the
amount
of
residue
remaining,
including
description
of
the
analytical
method
used.
(
See
40
CFR
180.34
for
further
information
about
residue
tests.)

Residue
removal
Practicable
methods
for
removing
residue
that
exceeds
any
proposed
tolerance.

Proposed
tolerance
Proposed
tolerances
for
the
pesticidal
chemical
if
specific
tolerances
are
being
proposed.

Grounds
for
petition
Reasonable
grounds
in
support
of
the
petition.

Supplemental
information
Analysis
of
factors
relevant
to
the
provisions
of
FQPA,
specifically,
aggregate
exposure,
children's
exposure,
special
sensitivities,
cumulative
effects
and
endocrine
disruptor
effects.

Summary
An
informative
summary
of
the
petition
or
application,
including
a
summary
of
the
supporting
data,
information,
accompanying
rationales,
and
a
statement
providing
permission
to
publish
such
summary.
This
summary
should
indicate
how
approval
of
the
petition
will
meet
the
statutory
determination
required
of
"
reasonable
certainty
of
no
harm."

There
are
no
forms
associated
with
this
information
collection.
The
data
compiled
should
be
submitted
as
separate
sections,
suitably
identified.
If
data
has
already
been
submitted
with
an
earlier
application,
the
present
petition
may
incorporate
it
by
reference.
The
petition
must
be
submitted
in
triplicate.
The
petitioner
must
also
show
that
the
pesticide
is
already
registered
for
the
related
food
or
feed
use,
or
that
an
application
for
the
registration
of
a
pesticide
for
the
related
food
or
feed
use
has
been
submitted
pursuant
to
section
3
of
FIFRA.
March
31,
2003
10
(
ii)
Respondent
Activities
In
order
for
a
tolerance
to
be
established
for
a
pesticide
product,
a
respondent
(
petitioner)
must
do
the
following:

Review
regulations
Read
applicable
FFDCA
provisions
and
related
tolerance
regulations;

Conduct
tests
Conduct
any
toxicological
or
residue
chemistry
studies
and
develop
analytical
methods
required
in
order
to
provide
the
EPA
with
the
data
necessary
to
make
a
decision
to
accept
or
reject
a
tolerance
petition
and
review
the
requested
data
for
accuracy/
appropriateness;

Prepare
correspondence
Generate
petition
correspondence,
including
preparing
a
informative
summary
to
be
published
in
the
Federal
Register;

Review
Agency
comment
If
applicable,
read
any
Agency
notice
of
petition
deficiency;

Respond
to
Agency
comment
Submit
supplemental
information
or
petition,
or
request
that
petition
be
filed
as
submitted;
and
Maintain
records
Store,
file
and
maintain
the
information
submitted.

5.
The
Information
Collected
­
Agency
Activities,
Collection
Methodology,
and
Information
Management
5(
a)
Agency
Activities
Upon
receipt
of
a
tolerance
petition,
EPA
performs
the
following
activities:

Log
Receipt
Log
petition
and
associated
fee.

Review
petition
Screen
petition,
fee,
and
supporting
data
for
completeness
and
acceptability;
resolve
any
deficiencies
with
petitioner.

Prepare
Federal
Register
notice
Upon
acceptance,
publish
notice
of
filing
in
Federal
Register.

Review
data
Review
supporting
residue
chemistry,
toxicology
data
and
other
assessments
received.

Test
analytical
methods
Test
proposed
analytical
methods
in
EPA
laboratories,
if
they
are
new
or
modified.
March
31,
2003
11
Integrate
review
Integrate
data
reviews
and
determine
adequacy;
resolve
any
deficiencies
with
petitioner,
make
registration
decision.

Prepare
decision
document
Prepare
decision
document,
Federal
Register
Notice
with
rule
establishing
the
tolerance(
s)
or
exemption(
s).

Maintain
records
Record
all
actions
and
decisions
in
official
records.

5(
b).
Collection
Methodology
and
Management
Specific
studies
submitted
as
part
of
petition
are
catalogued
and
archived
as
they
are
received.
When
the
Agency
review
is
complete,
the
remaining
portions
of
the
petition
record,
including
correspondence
subsequent
to
filing
and
all
reviews,
notices,
and
other
materials
created
by
EPA
in
the
course
of
its
review,
are
catalogued
and
archived.
All
petition
materials
are
retained
permanently.

5(
c).
Small
Entity
Flexibility
At
times,
small
entities
seek
a
tolerance
or
an
exemption
from
the
requirement
of
a
tolerance
for
pesticide
residues
resulting
from
registered
uses.
These
actions
are
usually
initiated
for
minor
crop
uses
for
which
the
pesticide
registrant
is
unwilling
to
seek
a
tolerance
or
for
residues
on
commodities
which
are
not
grown
in
the
United
States
and
therefore
for
which
there
is
no
U.
S.
registrant,
such
as
import
tolerances.
In
such
cases,
the
EPA
can
reduce
the
burden
and
cost
to
small
entities
by
adjusting
the
range
of
data
requirements
to
be
commensurate
with
the
extent
of
pesticide
use.
The
Agency
also
uses
this
type
of
regulatory
flexibility
to
set
tolerances
for
residues
on
commodities
which
are
not
grown
in
the
United
States.

5(
d).
Collection
Schedule
Not
applicable.
This
is
not
a
scheduled
collection.
A
petition
is
required
only
once
for
each
raw
or
processed
commodity
on
which
the
pesticide
is
used.

6.
Estimating
the
Burden
and
Cost
of
the
Collection
6(
a).
Estimating
Respondent
Burden
The
respondent
burden
reflected
in
this
ICR
is
for
petition
requests
for
new
tolerance
actions.
This
ICR
does
not
reflect
burden
associated
with
the
Agency's
pesticide
tolerance
reassessment
program.
The
bulk
of
tolerance
reassessment
activities
are
conducted
through
the
reregistration
program.
As
a
result,
the
respondent
burden
associated
with
the
FQPA
standards
for
tolerance
reassessment
activities
have
been
estimated
as
part
of
the
Data
Generation
for
Pesticide
Reregistration
ICR
(
OMB
No.
2070­
0107;
EPA
ICR
No.
1504)
for
active
ingredients
and
Data
Acquisition
for
Registration
ICR
(
OMB
No.
2070­
0122;
EPA
ICR
No.
1503)
for
inert
ingredients,
and
are
not
included
in
this
ICR.
March
31,
2003
1It
is
important
to
note
that
these
numbers
represent
the
number
of
petitions
that
were
received,
not
the
number
of
tolerance
actions
that
were
requested
per
petition.

12
Since
1995,
the
Agency
has
allowed
for
the
use
of
a
single
petition
to
request
a
tolerance
action(
s)
for
a
group
of
similar
crops,
or
"
Crop
Groupings,"
rather
than
submitting
individual
petitions
on
a
crop
by
crop
basis.
In
reviewing
some
of
the
petitions,
it
is
apparent
that
many
petitioners
take
advantage
of
this
flexibility,
including
in
the
petition
requests
for
several
tolerance
actions.
Some
have
sought
as
many
as
15
crops
per
petition,
including
crop
groupings.
The
Agency
calculated
that
during
the
years
2000­
2002,
there
were
on
average
nine
crops/
uses
per
petition.
In
addition,
the
FQPA
amendments
allow
anyone
to
submit
a
petition,
where
previously
only
registrants
could
submit
the
petition.

Two
types
of
burden
on
respondents
are
considered
in
this
analysis:
administrative
burden
and
technical
burden.
The
respondents'
administrative
burden
is
defined
as
the
time
spent
to
prepare
and
submit
a
petition
to
the
Agency.
It
includes
the
time
spent
working
with
the
Agency
throughout
the
petition
process,
gathering
the
required
data
(
such
as
the
safety
reports,
residue
test
data,
residue
removal
data),
gathering
supplemental
information,
drafting
the
grounds
for
the
petition,
reviewing
and
submitting
the
petition.
The
technical
burden
includes
the
labor
needed
to
actually
derive
the
test
data
which
involves
designing
the
test,
performing
it,
compiling
test
data
and
summarizing
the
results.
For
the
purposes
of
calculating
paperwork
burden,
only
the
technical
burden
related
to
the
documentation
of
the
test
results,
complying
with
good
laboratory
standards
in
conducting
the
tests,
and
storing
testing
information
in
files
are
included
in
the
burden
estimates
for
this
ICR.

To
quantify
the
administrative
burden,
the
Agency
estimated
the
amount
of
labor
as
a
percentage
of
the
total
test
costs.
The
Agency
assumed
that
respondents
would
expend
approximately
two
percent
of
the
total
test
cost
for
administrative
paperwork
burden.
This
percentage
represents
an
estimate
obtained
from
expert
opinion,
industry
sources,
and
proprietary
data.
The
Agency
assumed
that
the
value
of
this
time
is
equally
divided
among
management
and
technical
staff
members.

The
methodology
for
calculating
the
technical
burden
differs
from
the
administrative
burden.
One­
third
of
the
total
test
cost
represents
labor.
Management,
technical
and
clerical
comprise
the
labor
staff.
A
proportional
labor
rate
is
used
to
calculate
the
number
of
hours.
Approximately
70
percent
is
technical,
20
percent
management,
and
10
percent
clerical.

This
ICR
estimates
that
an
average
of
150
tolerance
petitions
will
be
submitted
to
the
Agency
each
year
for
the
next
three
years.
The
estimate
has
not
changed
from
the
previous
ICR
and
is
based
on
an
average
of
the
number
of
petitions
received
for
fiscal
years
2000
(
156),
2001
(
131),
and
2002
(
159)
1.
The
Agency
estimates
that
the
average
paperwork
burden
associated
with
the
submission
of
a
single
tolerance
petition
is
1,726
hours.
Assuming
that
the
Agency
will
receive
an
average
150
tolerance
petitions
each
year
for
the
next
3
years,
the
Agency
estimates
that
the
overall
annual
paperwork
burden
will
be
258,900
hours.
March
31,
2003
13
Table
1
B
ANNUAL
RESPONDENT
BURDEN/
COST
ESTIMATES
ACTIVITIES
BURDEN
HOURS
(
per
petition)
COSTS
(
per
petition)

Mgmt.
$
130/
hr
Tech.
$
88/
hr
Cler.
$
40/
hr
Total
Hours
Total
Costs
a)
Review
FFDCA
regulations
CFR
citation;
PRN
97­
1
25
48
24
97
$
8,434
b)
Conduct
Field
Trial
252
1,080
25
1,357
$
128,800
c)
Prepare
Petition
42
30
116
188
$
12,740
d)
Read
Notice
of
any
petition
deficiency
1
1
1
3
$
258
e)
Prepare
response
2
44
12
58
$
4,612
f)
Maintain
information
1
8
14
23
$
1,394
TOTAL
BURDEN
323
1,211
192
1,726
$
156,238
ANNUAL
BURDEN:
1,726
total
hours
x
150
petitions
=
258,900
hours
6(
b).
Estimating
Respondent
Costs
The
overall
annual
cost
associated
with
this
information
collection,
based
on
an
estimate
of
150
petitions
per
year,
is
estimated
to
be
$
23,435,700.
For
respondents,
the
value
of
labor
per
hour
for
management,
technical,
and
clerical
is
$
130,
$
88,
and
$
40,
respectively.
As
part
of
this
ICR
renewal,
EPA
increased
its
previously
estimated
labor
rates
for
respondents
by
factoring
in
an
inflation
cost
index
of
1.056
based
on
the
Gross
Domestic
Product.
These
labor
rates
are
fully
loaded
and
include
benefits
and
overhead
costs.
Using
the
Agency's
burden
estimate
and
the
fully­
loaded
labor
rates,
the
Agency
estimates
the
applicant
costs
to
be
approximately
$
156,238
per
response.

ANNUAL
COSTS:
(
a)
Management
­
323
hours
x
$
130
x
150
applicants
$
6,298,500
(
b)
Technical
­
1211
hours
x
$
88
x
150
applicants
$
15,985,200
(
c)
Clerical
­
192
hours
x
$
40
x
150
applicants
$
1,152,000
TOTAL
$
23,435,700
These
labor
burden
estimates
represent
the
average
time
and
costs.
Some
tolerance
petitions
will
require
less
effort
and
more
complicated
petitions
will
require
more
of
each.
The
analysis
assumes
that
one
respondent
will
generate
the
data
for
a
given
petition.
If
a
consortium
takes
responsibility
for
the
petition,
the
burden
and
cost
will
be
distributed
across
members
of
the
consortium.
March
31,
2003
14
6(
c).
Estimating
Agency
Burden
and
Cost
The
Agency
needs
to
process,
review
and
document
their
evaluation
of
the
tolerance
petitions.
Each
year,
the
Agency
may
spend
345,000
hours
for
150
petitions
in
labor
burden.
Agency
labor
rates
are
based
on
Office
of
Personnel
Management
salary
tables
for
federal
employees
for
the
years
1999
through
2001
and
include
benefits
and
overhead
costs,
as
well
as
locality
pay
for
the
Washington,
DC­
Baltimore
area.
Estimates
for
the
Agency's
burden
are
provided
below.

Table
2
B
ANNUAL
AGENCY
BURDEN/
COST
ESTIMATES
COLLECTION
ACTIVITIES
BURDEN
HOURS
(
per
year)
COSTS
(
per
year)

Mgmt.
$
96/
hr.
Tech.
$
70/
hr
Cler.
$
33/
hr
Total
Hours
Total
Costs
a)
Log
petition
and
associated
fee
0
8
0
8
$
560
b)
Screen
petition
request
for
completeness
1
2
0
3
$
236
c)
Draft
and
publish
Federal
Register
notice
1
4
0
5
$
376
d)
Review
Residue
Chemistry
and
Toxicology
data
200
1,642
3
1845
$
134,239
e)
Verify
new
analytical
methods
in
EPA
Lab.
and
resolve
any
deficiencies
34
223
1
258
$
18,907
f)
Integrate
Data
Reviews
67
100
2
169
$
13,498
g)
Prepare
decision
document
and
Federal
Register
Notice
4
4
2
10
$
730
h)
Record
actions
in
official
records.
0
0
2
2
$
66
TOTAL
BURDEN
307
1983
10
2300
$
168,612
(
a)
Management
­
307
hours
x
$
96
x
150
petitioners
$
4,420,800
(
b)
Technical
­
1,983
hours
x
$
70
x
150
petitioners
$
20,821,500
(
c)
Clerical
­
10
hours
x
$
33
x
150
petitioners
$
49,500
TOTAL
$
25,291,800
March
31,
2003
15
6(
d).
Bottom
Line
Burden
Hours
And
Cost
Tables
Table
3
B
MASTER
TABLE:
Total
Annual
Burden
Hours
and
Costs
Total
Annual
petitions
Annual
Burden
Hours
Annual
Costs
per
petition
Total
per
petition
Total
Respondents
(
Petitioners)
150
1726
258,900
$
147,538
$
23,435,700
Agency
150
2300
345,000
$
147,001
$
25,291,800
6(
e).
Reasons
for
Change
in
Burden
Respondent
costs
for
this
ICR
have
increased
due
to
increases
in
labor
rates
for
both
respondents
and
Agency
personnel.
As
a
result,
there
is
an
increase
of
$
1,305,000
in
the
estimated
total
annual
respondent
cost
(
from
$
22,130,700
to
$
23,435,700).
This
change
is
an
adjustment.

6(
f).
Burden
Statement
The
total
estimated
annual
respondent
paperwork
burden
to
comply
with
this
information
collection
activity
is
258,900
hours.
According
to
the
Paperwork
Reduction
Act,
"
burden"
means
the
total
time,
effort,
or
financial
resources
expended
by
persons
to
generate,
maintain,
retain,
or
disclose
or
provide
information
to
or
for
a
Federal
agency.
For
this
collection,
it
is
the
time
reading
the
regulations,
planning
the
necessary
data
collection
activities,
conducting
tests,
analyzing
data,
generating
reports
and
completing
other
required
paperwork,
and
storing,
filing,
and
maintaining
the
data.
The
agency
may
not
conduct
or
sponsor,
and
a
person
is
not
required
to
respond
to,
a
collection
of
information
unless
it
displays
a
currently
valid
OMB
control
number.
The
OMB
control
number
for
this
information
collection
appear
at
the
beginning
and
the
end
of
this
document.
In
addition
OMB
control
numbers
for
EPA's
regulations,
after
initial
display
in
the
final
rule,
are
listed
in
40
CFR
part
9.

Send
comments
regarding
burden
estimate
or
any
other
aspect
of
this
collection
of
information,
including
suggestions
for
reducing
the
burden
to:
Director,
Collection
Strategies
Division,
U.
S.
Environmental
Protection
Agency
(
2822T),
1200
Pennsylvania
Avenue,
NW,
Washington,
D.
C.
20460.
Include
the
OMB
control
number
in
any
correspondence,
but
do
not
submit
the
requested
information
or
forms
to
this
address.
The
requested
information
should
be
submitted
in
accordance
with
the
instructions
in
the
Federal
Register
Notice
seeking
comment
on
this
ICR.
Please
reference
this
document
by
the
OMB
Control
No.
2070­
0024
in
all
correspondence.
March
31,
2003
16
Attachments
to
the
Supporting
Statement
ATTACHMENT
A:
FFDCA
Sections
402,
406,
408,
and
409
(
21
U.
S.
C.
Sections
342,
346,
346a,
and
348,
respectively)
­
available
electronically
at
http://
uscode.
house.
gov/
usc.
htm.

ATTACHMENT
B:
40
CFR
Parts
180.7
through
180.41
­
Tolerances
and
Exemptions
from
Tolerances
for
Pesticide
Chemicals
in
or
on
Raw
Agricultural
Commodities
­
available
electronically
at
http://
www.
access.
gpo.
gov/
nara/
cfr/
cfrhtml_
00/
Title_
40/
40cfr180_
00.
html.

ATTACHMENT
C:
FIFRA
Section
3
(
7
U.
S.
C.
136a)
­
available
electronically
at
http://
www.
epa.
gov/
epahome/
laws.
htm.

ATTACHMENT
D:
PR
Notice
97­
1
­
Agency
Actions
under
the
Requirements
of
the
Food
Quality
Protection
Act
­
available
electronically
at
http://
www.
epa.
gov/
opppmsd1/
PR_
Notices/
pr97­
1.
html
ATTACHMENT
E:
67
FR
66392
­
Tolerance
Petitions
for
Pesticides
on
Food/
Feed
Crops
and
New
Inert
Ingredients;
Renewal
of
Pesticide
Information
Collection
Activities
and
Request
for
Comments
(
published
October
31,
2002)
­
available
electronically
at
http://
www.
epa.
gov/
fedrgstr/
EPA­
PEST/
2002/
October/
Day­
31/
p27704.
htm
ATTACHMENT
F
Response
to
EPA
on
ICR
Burden
­
Consultation
with
Monsanto
and
Syngenta
­
An
electronic
copy
of
this
attachment
follows
in
the
electronic
file
for
this
ICR.

ATTACHMENT
G:
Electronic
Submission
Interim
Guidance
Documents
­
available
electronically
at
http://
www.
epa.
gov/
oppfead1/
eds/
esr_
guidance.
htm
ATTACHMENT
H:
Display
Related
to
OMB
Control
#
2070­
0024
­
Listings
of
Related
Regulations
in
40
CFR
9.1
­
An
electronic
copy
of
this
attachment
follows
in
the
electronic
file
for
this
ICR.
F­
1­
1
ATTACHMENT
F
­­­­­
Forwarded
by
Jim
Tompkins/
DC/
USEPA/
US
on
01/
30/
03
06:
53
AM
­­­­­

greg.
watson@
syngenta.
com
01/
29/
03
03:
50
PM
To:
Jim
Tompkins/
DC/
USEPA/
US@
EPA
cc:
Subject:
Re:
Tolerance
Petition
Burden
Estimate
Jim,

I
have
put
together
an
estimate
at
what
you
requested
in
the
following
table.
However,
one
MAJOR
caveat:
it
is
really
impossible
to
look
at
this
on
an
annual
basis,
as
each
year
brings
a
different
number
of
petitions
and
the
complexity
of
the
petition
varies
immensely
(
i.
e.,
aggregate
&/
or
cumulative
assessment).
One
other
point:
I
have
NOT
included
the
time
need
to
prepare
a
reduced
risk
rationale;
this
is
a
major
component
of
many
tolerance
petition
summaries
so
please
pass
this
along
to
the
folks
working
on
this.

Just
to
let
you
know
how
I
have
got
to
an
annual
number:
we
have
averaged
in
the
legacy
companies
of
Syngenta
about
10
tolerance
petitions
each
year.
Each
tolerance
petition
takes
a
Regulatory
Manager
an
average
of
6
hours
to
prepare
(
depending
on
whether
this
is
a
new
AI
or
an
existing
AI
where
a
previous
petition
can
be
used
as
a
basis
to
begin).
Therefore,
on
an
annual
basis
we
average
about
60
hours
of
management
time.

The
technical
work
on
the
petition
itself
is
about
1.5X
that
of
the
Regulatory
Manager,
as
calculations
of
the
risk
cup
need
to
be
done,
as
do
summaries
of
residue
/
tox
data,
etc.
so
we
average
about
90
hours
of
technical
time
on
an
annual
basis.

Clerical
time
is
limited
to
binding
/
printing
&
copying
/
preparing
the
submission,
etc.
and
is
about
20
hours
per
petition
so
the
math
comes
out
to
200
hours
on
an
annual
basis.

As
for
the
response
to
petition
deficiencies,
this
again
varies
with
what
you
have
on
the
EPA
workplan
for
that
year.
Since
Syngenta
has
been
fairly
successful
in
RR
/
OP
alternative
products
and
we
have
worked
with
IR
4,
I
have
increased
the
estimates
to
reflect
what
we
normally
have
had
on
the
workplan.
One
thing
to
remember
is
that
responses
to
EPA
reviews
of
petitions
have
gotten
far
more
complicated,
given
the
FQPA
paradigm
changes
(
i.
e.,
aggregate
assessments
including
water
input,
acute
&
chronic
endpoints).

Review
of
the
regulations
is
about
correct;
I
have
increased
this
to
include
a
review
of
previous
petitions
that
we
have
received
from
EPA.
This
is
one
of
the
best
ways
to
keep
current
&
improve
your
petitions
(
i.
e.,
make
changes
based
on
our
experience).

Maintain
information
has
gotten
more
complicated
as
well,
as
most
companies
now
have
a
paper
archive
BUT
an
electronic
archive
as
well.
I
have
increased
the
burden
estimates
again
to
reflect
this.
F­
1­
2
Table
1
ANNUAL
RESPONDENT
BURDEN/
COST
ESTIMATES
ACTIVITIES
BURDEN
HOURS
(
per
year)
COSTS
(
per
year)
H
Mgmt.
Tech.
Cler.
Total
Hours
a)
Review
FFDCA
regulations
CFR
citation;
PRN
97­
1
30
60
20
110
b)
Conduct
Field
Trial*

c)
Prepare
Petition
60
90
200
350
d)
Read
Notice
of
any
petition
deficiency
3
4
1
8
e)
Prepare
response
40
65
20
125
f)
Maintain
information
5
10
25
40
TOTAL
BURDEN
138
229
246
633
H
respondent
did
not
include/
discuss
related
paperwork
costs
*
respondent
did
not
include/
discuss
paperwork
burdens
related
to
field
trials
Hopefully
this
will
help
give
you
something
to
work
with;
please
let
me
know
if
we
need
anything
further
on
this.

Best
Regards,

Greg
Watson
NAFTA
Herbicide
Team
Lead,
Regulatory
Affairs
ph
336
632
2993
fax
336
292
6374
F­
2­
1
­­­­­
Forwarded
by
Jim
Tompkins/
DC/
USEPA/
US
on
01/
29/
03
10:
48
AM
­­­­­

"
SCHNEIDER,
RUSSELL
P
[
AG/
1920]"
<
russell.
p.
schneider@
monsanto.
com>
01/
29/
03
10:
04
AM
To:
Jim
Tompkins/
DC/
USEPA/
US@
EPA
cc:
Subject:
FW:
Tolerance
Petition
Burden
Estimate
Jim,

Per
your
request,
and
knowing
it
is
hard
to
estimate
costs
since
tolerance
petitions
can
have
very
wide
(
ie.,
a
number
of
crops
with
complicated
issues)
or
very
limited
(
ie.,
one
crop,
recent
data,
no
complications)
scope,
there
is
really
no
such
thing
as
an
average
petition.
In
addition,
it
is
very
much
a
question
of
"
what
do
you
want
to
count".

When
we
look
at
the
estimate
provided
at
the
bottom
of
this
document,
it
includes
about
1300
man
hours
for
the
technical
aspect
of
generating
the
data
(
ie.,
about
0.65
person­
year).
This
is
a
reasonable
estimate
of
the
cost
of
one
crop
residue
study.
Therefore
we
can
conclude
that
the
tabular
estimates
there
are
connected
to
the
data­
driven
incremental
addition
of
one
new
crop,
and
the
respective
food
tolerances,
to
an
otherwise
complete
database
for
the
chemical.
In
that
context,
we
believe
that
188
hours
(
ie,
4
weeks)
is
an
overestimate
by
perhaps
a
factor
of
2­
fold.
2
weeks
of
full­
time
effort
is
sufficient
time
to
write
the
petition,
write
the
crop­
specific
directions
for
use,
write
the
Reasonable
Grounds,
and
formulate
the
volume.
However,
this
does
not
include
a
"
Reduced
Risk
Rationale"
or
doing
the
actual
technical
residue
work.
However,
being
wrong
by
a
factor
of
2
is
reasonably
close,
and
we
could
live
with
that
error,
and
if
one
had
a
complex
situation
where
there
was
a
lot
of
historical
baggage
to
explain
and
document,
4
weeks
of
effort
is
not
out
of
the
question.

The
broader
question
about
generating
the
toxicology
and
environmental
fate
data
to
support
the
other
aspects
of
"
aggregate
Risk
Assessment"
is
much
more
complicated.
Obviously,
a
complete
toxicology
and
environmental
fate
data
set
takes
five
years
to
complete
at
a
cost
of
about
$
20M.
If
you
assume
scientists
are
budgeted
at
about
$
200K
per
person
year,
this
translates
to
about
200,000
hours
of
technical
work.
This
figure
totally
swamps
the
estimates
above
about
a
residue
study
and
petition.
If
we
assume
that
an
average
pesticide
chemical
has
uses
on
5
crops,
we
could
pro­
rate
the
core
toxicology
and
e­
fate
across
all
five,
and
reduce
it
to
40,000
hours
each,
which
is
still
20­
fold
greater
than
the
estimated
residue
data
and
tolerance
petition
cost.

There
are
also
rotational
crop
issues,
animal
feeding
studies,
and
crop
and
animal
metabolism
studies
that
are
not
being
counted
into
this.
These
are
big
and
expensive
studies,
and
would
increase
the
toxicology
/
e­
fate
estimate
immediately
by
perhaps
another
50%.

I
hope
somewhere
in
here
are
the
figures
you
need.

Russ
H­
1
ATTACHMENT
H
Display
Related
to
OMB
Control
#
2070­
0024
­
Listings
of
Related
Regulations
in
40
CFR
9.1
As
of
May
10,
1993,
the
OMB
approval
numbers
for
EPA
regulations
in
Chapter
I
of
Title
40
of
the
Code
of
Federal
Regulations
(
CFR)
appear
in
a
listing
in
40
CFR
9.1
(
58
FR
27472).
This
listing
fulfills
the
display
requirements
in
section
3507(
f)
of
the
Paperwork
Reduction
Act
(
PRA)
for
EPA
regulations.
The
listing
at
40
CFR
9.1
displays
this
OMB
Control
number
for
the
following
regulations:

Program
Title
40
CFR
citation
Pesticide
Registration
and
Classification
Procedures
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
Part
152.50
Good
Laboratory
Practice
Standards
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
Part
160
Certification
of
Usefulness
of
Pesticide
Chemicals
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
Part
163.4
.
.
.
.
.
.
.
.
.
.
.
.
163.5
Issuance
of
Food
Additive
Regulations
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
Part
177.81
.
.
.
.
.
.
.
.
.
.
.
177.92
.
.
.
.
.
.
.
.
.
.
.
177.98
.
.
.
.
.
.
.
.
.
.
.
177.99
.
.
.
.
.
.
.
.
.
.
177.102
.
.
.
.
.
.
.
.
.
.
177.105
.
.
.
.
.
.
.
.
.
.
177.110
.
.
.
.
.
.
.
.
.
.
177.116
Tolerances
and
Exemptions
from
Tolerances
for
Pesticide
Chemicals
in
or
on
Raw
Agricultural
Commodities
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
Part
180.7
.
.
.
.
.
.
.
.
.
.
.
.
180.8
.
.
.
.
.
.
.
.
.
.
.
.
180.9
.
.
.
.
.
.
.
.
.
.
.
180.31
.
.
.
.
.
.
.
.
.
.
.
180.32
.
.
.
.
.
.
.
.
.
.
.
180.33