Document ID: EPA-HQ-OPP-2004-0109-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2004-04-29T04:00Z

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SUPPORTING
STATEMENT
FOR
AN
INFORMATION
COLLECTION
REQUEST
(
ICR)

1.
IDENTIFICATION
OF
THE
INFORMATION
COLLECTION
1(
a)
Title
of
the
Information
Collection:
Data
Acquisition
for
Anticipated
Residue
and
Percent
of
Crop
Treated
OMB
NO.:
2070­
0164;
EPA
NO.:
1911.02
1(
b)
Short
Characterization/
Abstract
This
information
collection
request
(
ICR)
involves
an
information
collection
activity
related
to
the
statutorily
mandated
re­
evaluation
of
previous
Agency
decisions
regarding
the
establishment
of
a
tolerance
(
maximum
residue
limit)
for
pesticide
residues
on
food
or
feed
crops.

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).
A
pesticide
may
not
be
used
on
food
or
feed
crops
unless
the
Agency
has
established
a
tolerance
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.

This
ICR
will
enable
EPA's
Office
of
Pesticide
Programs
(
OPP)
to
obtain
information
needed
to
re­
evaluate
the
Agency's
original
tolerance
decisions
as
mandated
by
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).
Among
other
things,
FQPA
amended
FFDCA
to
authorize
the
Agency
to
use
anticipated
or
actual
residue
(
ARs)
data
and
percent
crop
treated
(
PCT)
data
to
establish,
modify,
maintain,
or
revoke
a
tolerance
for
a
pesticide
residue.
However,
the
law
also
requires
that
tolerance
decisions
based
on
ARs
or
PCT
data
be
verified
to
ensure
that
residues
in
or
on
food
are
not
above
the
residue
levels
relied
on
for
establishing
the
tolerance.

In
order
to
conduct
the
required
re­
evaluation,
a
Pesticide
Registrant
may
be
required
to
submit
specific
data
necessary
to
demonstrate
that
residues
do
not
exceed
the
residue
levels
used
to
establish
the
tolerance.

The
burden
and
costs
associated
with
establishing
a
tolerance
or
an
exemption
from
a
tolerance
are
covered
under
ICR
number
2070­
0024,
Tolerance
Petitions
for
Pesticides
on
Food/
Feed
Crops
and
New
Inert
Ingredients.
This
ICR
only
addresses
the
burden
and
costs
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associated
with
the
information
collection
activities
related
to
the
re­
evaluation
of
tolerances
pursuant
to
FFDCA
section
408(
b)(
2).

2.
NEED
FOR
AND
USE
OF
THE
COLLECTION
2(
a)
Need/
Authority
for
the
Collection
FIFRA
sections
3(
a)
and
12(
a)(
1)
require
a
person
to
register
a
pesticide
product
with
the
EPA
before
that
product
may
be
lawfully
sold
or
distributed
in
the
United
States.
A
pesticide
registration
is
a
license
that
allows
a
pesticide
product
to
be
sold
and
distributed
for
specific
uses
under
specified
terms
and
conditions
such
as
use
instructions
and
precautions.
A
pesticide
product
may
be
registered
or
remain
registered
only
if
it
meets
the
statutory
standard
for
registration
given
in
FIFRA
section3(
c)(
5).
Under
FFDCA
section408,
before
a
pesticide
may
be
used
on
food
or
feed
crops,
the
Agency
must
establish
a
tolerance
for
the
pesticide
residues
on
that
crop
or
established
an
exemption
from
the
requirement
to
have
a
tolerance.

The
authority
for
the
information
collection
activities
contained
in
this
ICR
can
be
found
in
FFDCA
section408(
b)(
2)(
E)
and
(
F),
which
authorizes
the
Agency
to
use
anticipated
or
actual
residue
(
ARs)
data
and
percent
crop
treated
(
PCT)
data
to
establish,
modify,
maintain,
or
revoke
a
tolerance
for
a
pesticide.
The
FFDCA
requires
that
if
AR
data
are
used,
data
must
be
reviewed
five
years
after
a
tolerance
is
initially
established.
If
PCT
data
are
used,
the
FFDCA
affords
EPA
the
discretion
to
obtain
additional
data
if
any
or
all
of
several
conditions,
including
but
not
limited
to
the
following,
are
met:

°
the
existing
data
have
been
found
unreliable;
°
exposure
estimates
underestimate
exposures
for
any
significant
population
group;
°
dietary
exposure
must
be
re­
evaluated
periodically
As
noted
above,
when
re­
evaluating
tolerance
actions,
Section
408(
f)
of
FFDCA
generally
requires
EPA
to
issue
DCIs
whenever
ARs
data
have
been
relied
on,
and
affords
the
EPA
the
discretion
to
issue
DCIs
when
PCT
data
have
been
relied
on.
OPP
issues
a
DCI
to
affected
registrants
under
the
authority
of
the
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(
FIFRA)
section
3(
c)(
2)(
B).
The
data
obtained
from
the
DCIs
are
needed
to
reassess
the
risk
and
to
confirm
that
use
of
a
pesticide
is
not
likely
to
cause
unreasonable
adverse
effects
to
human
health
or
the
environment.

2(
b)
Practical
Utility/
Users
of
the
Data
OPP
will
evaluate
the
data
obtained
from
registrants
to
ensure
that
residues
in
or
on
food
are
not
above
the
residue
levels
relied
on
for
establishing
the
tolerance.
If
the
submitted
residue
data
demonstrates
that
the
residue
levels
are
above
the
levels
relied
on
for
establishing
the
tolerance,
EPA
will
take
appropriate
action
to
modify
or
revoke
the
tolerance.
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3.
NON­
DUPLICATION,
CONSULTATIONS
AND
OTHER
COLLECTION
CRITERIA
3(
a)
Non­
duplication
OPP
supports
several
activities
to
eliminate
duplication
and
promote
efficiency
in
information
collection
efforts
for
registration.
Before
any
DCI
is
conducted,
internal
files
are
referenced
to
determine
whether
the
required
data
is
already
on
hand.
No
other
federal
agency
regulates
these
chemicals
as
comprehensively
as
EPA
does.
Since
much
of
the
percent­
croptreated
information
can
be
obtained
internally,
DCIs
will
only
be
issued
when
more
data
is
necessary.
The
data
for
anticipated
residues,
on
the
other
hand,
is
unique
to
the
requirements
of
FIFRA,
and,
therefore,
must
be
submitted
to
the
Agency.

OPP
also
publishes
a
list
of
data
submitters
and
encourages
the
industry
to
act
cooperatively
in
the
development
of
data
or
in
its
use.
OPP
allows
cost­
sharing
agreements
among
manufacturers
of
specific
pesticide
chemicals
in
order
to
minimize
the
duplication
of
laboratory
tests
conducted
for
this
program.
All
DCI
notices
explain
the
statutory
provisions
for
cost­
sharing
agreements
under
FIFRA.

3(
b)
Public
Notice
Required
Prior
to
ICR
Submission
to
OMB
In
preparing
to
renew
this
ICR,
EPA
will
publish
a
notice
in
the
Federal
Register
which
will
provide
a
60­
day
public
notice
and
comment
period.
The
Agency
will
consider
any
comments
on
this
ICR
in
response
to
that
notice.

3(
c)
Consultations
Before
a
particular
DCI
is
issued
under
either
program,
the
procedures
for
both
programs
provide
several
opportunities
for
consultations
with
the
affected
registrants,
as
well
as
with
the
public
and
other
interested
parties.

In
the
initial
stage
of
AR/
PCT
reviews,
the
Agency
announces
its
intent
to
conduct
such
a
review
and
require
additional
studies.
Registrants
and
other
interested
parties
have
the
opportunity
to
comment
on
the
Agency's
intent.
Generally
the
Agency
consults
with
registrants
before
a
data
call­
in
notice
is
issued
to
discuss
the
Agency's
need
for
particular
information
and
the
protocol
to
be
used
to
conduct
the
study.
OPP
is
always
open
to
communications
with
registrants
concerning
any
issue
they
may
have
with
the
requirements
for
data.
As
mentioned,
registrants
may
request
waivers
of
data
requirements
if
they
believe
that
OPP
can
properly
evaluate
their
pesticide
without
additional
data.
The
Agency
may
modify
its
DCI
requirements
if
warranted
by
information
provided
by
registrants
or
the
public.
In
addition,
registrants
may
respond
to
the
DCI
by
requesting
waivers
of
data
requirements
if
they
believe
that
OPP
can
properly
evaluate
their
pesticide
without
additional
data.
The
Agency
has
already
on
several
occasions
discussed
the
statutory
requirements
and
data
requirements
for
the
AR/
PCT
reviews
with
the
stakeholders.
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In
addition,
during
preparation
of
this
ICR
renewal,
EPA
staff
will
contact
representatives
from
a
cross­
section
of
respondents
by
e­
mail
and
telephone
to
seek
feedback
on
the
burden
estimates
in
the
ICR,
the
clarity
of
instructions
provided,
the
feasibility
of
reporting
the
data
by
electronic
means,
and
other
questions
pertaining
to
the
requirements
of
the
program.

3(
d)
Effects
of
Less
Frequent
Collection
Information
is
collected
one
time
within
the
five
years
preceding
the
reliance
on
ARs
or
PCT
data.
This
one
time
collection
is
required
by
(
FFDCA
408(
b)(
2)(
E)(
I)
and
408(
b)(
2)(
F)
and
cannot
be
collected
less
frequently.

3(
e)
General
Guidelines
The
only
guideline
established
under
the
Paperwork
Reduction
Act
(
PRA)
that
is
exceeded
in
this
collection
is
the
time
period
for
retaining
records.
EPA
requirements
in
40
CFR
169.2(
k)
state
that
records
containing
research
data
relating
to
registered
pesticides
be
retained
as
long
as
the
registration
is
valid
and
the
producer
remains
in
business.
Registrations
are
valid
until
they
are
canceled
by
the
Agency,
either
by
request
of
the
registrant
or
on
the
initiative
of
EPA.
Since
most
pesticides
remain
on
the
market
for
15
to
30
years,
the
PRA
guidelines
specifying
that
data
other
than
health,
medical
or
tax
records
not
be
required
to
be
retained
for
more
than
three
years
is
exceeded
in
this
program.

3(
f)
Confidentiality
Except
as
provided
in
FIFRA
section
10(
d)(
1)(
A),
(
B)
or
(
C),
health
and
safety
data
submitted
by
registrants
under
FIFRA
must
be
made
available
by
the
Agency
upon
request
from
anyone
not
affiliated
with
a
multi­
national
pesticide
firm.
These
exceptions,
however,
specifically
prohibit
disclosure
of
the
inert
ingredients
in
a
pesticide,
or
of
its
manufacturing
or
quality
control
processes.

Registrants
may
claim
at
the
time
of
submission
that
specific
data
are
subject
to
treatment
as
confidential
for
reasons
other
than
falling
within
the
exclusions
for
mandatory
release.
All
data
subject
to
such
claims,
or
falling
within
FIFRA
section
10(
d)(
1)(
A),
(
B),
or
(
C)
are
handled
strictly
in
accordance
with
the
provisions
of
the
FIFRA
Confidential
Business
Information
Security
Manual.
The
manual
requires
that
all
CBI
must
be
marked
or
flagged
as
such,
all
CBI
must
be
kept
in
secure
(
double­
locked)
areas,
and
all
CBI
intended
to
be
destroyed
must
be
cleared
by
a
Document
Control
Officer
and
shredded.

3(
g)
Sensitive
Questions
No
information
of
a
sensitive
or
private
nature
is
requested
in
conjunction
with
this
information
collection
activity,
and
this
information
collection
activity
complies
with
the
provisions
of
the
Privacy
Act
of
1974
and
OMB
Circular
A­
108.
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4.
THE
RESPONDENTS
AND
THE
INFORMATION
REQUESTED
4(
a)
Respondents/
NAICS
Codes
The
North
American
Industrial
Classification
System
(
NAICS)
code
for
respondents
to
this
ICR
is
325320
(
Pesticide
and
other
Agricultural
Chemical
Manufacturing).

4(
b)
Information
Requested
(
i).
Data
items,
including
record
keeping
requirements
The
kinds
of
data
that
may
be
the
subject
of
a
DCI
under
this
ICR
may
include
one
or
more
of
the
following
data
items,
which
are
included
in
40
CFR
Part
158,
Data
Requirements
for
Pesticide
Registration:

1)
Monitoring
data
(
PDP,
FDA,
FSIS,
States,
special
monitoring
[
market
basket,
single
serving,
etc.])
2)
Field
trials,
3)
Processing
studies,
4)
Reduction
in
residue
data
(
washing,
peeling,
cooking,
etc.),
5)
Livestock
feeding
studies
6)
Metabolism
studies
7)
Percent
crop
treated
data
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SOURCE
OF
DATA
USED
IN
ANTICIPATED
RESIDUES
DATA
NEEDED
TO
CONFIRM
ANTICIPATED
RESIDUES
5
YEARS
LATER
Monitoring
data
(
Pesticide
Data
Program
(
PDP),
FDA,
FSIS,
States,
special
monitoring
[
market
basket,
single
serving,
etc.])
Updated
monitoring
data
are
required.
The
registrant
may
use
any
of
the
publicly
available
sources
used
by
the
Agency.
Data
should
reflect
the
time
period
since
establishment
of
the
tolerance.
If
data
are
not
available
from
the
above
sources,
then
the
registrant
must
conduct
an
appropriately
designed
monitoring
study.
The
design
of
this
study
must
be
approved
by
the
Agency.

Field
trials
The
registrant
must
EITHER
verify
that
the
pesticide
formulations,
application
rates,
timing,
intervals,
geographic
distribution
of
use,
etc.,
have
not
changed
OR
provide
field
trial
data
that
reflect
any
changes
in
the
use
pattern
that
may
lead
to
increased
residues.

Processing
studies
Reduction
in
residue
data
(
washing,
peeling,
cooking,
etc.)
The
registrant
must
EITHER
certify
that
commercial
processing
practices
have
not
changed
significantly
OR
provide
new
processing
studies
reflecting
current
commercial
practices.
A
similar
requirement
applies
to
any
study
used
to
demonstrate
reduction
in
residues
between
farm
gate
and
consumption.

Livestock
feeding
studies
and
metabolism
studies
Registrant
must
EITHER
verify
that
the
dietary
burden
calculations
that
were
incorporated
in
the
original
AR
derivation
for
meat,
milk,
poultry
or
eggs
are
still
valid
OR
provide
a
new
animal
feeding
study
that
reflects
current
feeding
practices.
Dietary
burden
calculations
could
change
due
to
increased
residue
levels
on
feed
items
or
from
changes
in
the
relative
abundance
or
use
of
a
particular
feed
item
over
time.

EPA
has
published
guidelines
for
studies
listed
in
40
CFR
Part
158,
Data
Requirements.
Internal
guidelines
have
also
been
established
for
monitoring
studies
which
require
a
registrant
to
submit
and
obtain
approval
of
the
study
protocol
prior
to
initiating
a
study.
The
protocol
must
describe
crops
and
pesticides
to
be
covered
by
the
study.
After
approval,
the
applicant
must
adhere
to
the
protocol
or
seek
approval
for
major
deviations.
SOP
No.
HED
AR­
1
contains
the
specific
requirements
when
ARs
are
used
(
see
Attachment
A).

If
EPA
relies
on
ARs
data
when
establishing
or
reassessing
a
tolerance,
it
generally
must
issue
a
DCI,
and
if
the
EPA
used
the
percent
of
crop
treated
data
estimates
for
a
tolerance
action,
it
may
generally
issue
a
DCI.
A
DCI
is
a
letter
sent
to
the
registrant
that
explains
the
data
submission
requirement,
requests
specific
data,
sets
out
a
time
frame
for
a
response
to
EPA,
and
provides
applicable
forms
and
guidelines
to
assist
the
registrant
with
the
completion
of
the
DCI
request.
A
registrant
must
respond
within
90
days
of
receipt
of
the
DCI.
The
response
must
describe
plans
to
submit
the
required
data
in
accordance
with
the
time
frame
specified,
and,
if
applicable,
contain
suggested
protocols
for
monitoring
studies.
Failure
to
generate
the
requested
data,
or
respond
to
the
DCI
in
a
timely
manner,
could
result
in
Agency
action
to
modify
or
revoke
the
tolerance.
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March
31,
2004
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7
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There
are
two
main
categories
of
applications
for
this
collection:
those
requiring
submission
of
a
full
complement
of
supporting
data,
(
e.
g.,
new
chemicals,
and
biorationals);
and
those
requiring
submission
of
little
or
no
data,
(
e.
g.,
"
me­
too"
products)
for
previously
registered
chemicals
and
use
patterns.
Applicants
for
a
"
me­
too"
product
(
i.
e.,
a
pesticide
claimed
to
be
substantially
similar
in
composition
and
use
to
a
product
previously
registered
by
the
EPA)
may
be
required
only
to
use
EPA
Form
8570­
34,
Certification
with
Respect
to
Citation
of
Data
(
in
Pesticide
Registration
(
PR)
Notice
98­
5),
and
EPA
Form
8570­
35,
Data
Matrix
(
also
in
PR
Notice
98­
5),
to
certify
that
the
applicant
intends
to
rely
on
data
previously
submitted
to
the
EPA
by
another
producer,
the
applicant
has
contacted
the
appropriate
company
(
owning
the
data
that
the
applicant
is
referencing),
and
the
applicant
has
offered
to
pay
reasonable
compensation
for
the
use
of
the
data.
These
forms
are
already
approved
under
ICR
number
2070­
0060,
Application
for
New
or
Amended
Registration.

(
ii).
Respondent
Activities
A
registrant
must
take
the
following
actions
to
comply
with
a
DCI:

Read
instructions
Read
the
DCI
letter
to
understand
what
data
are
to
be
submitted;

Plan
activities
Plan
the
activities
necessary
to
comply
with
the
DCI.
These
may
include:
a)
request
a
waiver;
b)
agree
to
do
data;
c)
certify
offer
of
compensation
with
original
data
submitter;
d)
volunteer
to
cancel
the
registration
of
concern;
e)
claim
a
generic
data
exemption;

Create
information
Conduct
research,
administer
tests,
analyze
data
to
develop
studies,
perform
and
report
laboratory
analyses;

Gather
information
Search
for
existing
data
that
will
satisfy
the
DCI;

Compile
and
review
Assemble
and
evaluate
data
for
accuracy
and
appropriateness
for
compliance
with
the
DCI;

Complete
paperwork
Prepare
necessary
correspondence
documents
and
packages
for
submitting
data
to
EPA;
and
Submit
and
file
Transmit
the
data
and
other
information
to
EPA
and
catalog
in
company
files.
DRAFT
FOR
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COMMENT
March
31,
2004
Page
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5.
THE
INFORMATION
COLLECTED:
AGENCY
ACTIVITIES,
COLLECTION
METHODOLOGY,
AND
INFORMATION
MANAGEMENT
5(
a)
Agency
Activities
The
Agency
must
perform
the
following
actions
to
conduct
a
DCI:

Develop
DCI
notice
Determine
data
requirements
and
prepare
the
DCI
letter
identifying
all
data
needed
and
respondent's
options;
issue
DCI;

Answer
questions
Respond
to
any
questions
the
registrant
may
have
regarding
the
DCI;

Examine
responses
and
data
submissions;
archive
documents
Examine
responses
and
data
submissions
for
acceptability
and
responsiveness
to
DCI;
if
necessary,
clarify
or
seek
additional
information
from
registrant;
process,
catalog
and
archive
DCI
data
into
the
Pesticide
Document
Management
System
(
PDMS);
refer
non­
responders
to
the
Office
of
Enforcement
and
Compliance
and
Assurance
for
action;

Analyze
data
Conduct
scientific
reviews
of
the
data;
and
Record
and
store
DCI
data
Record
facts
of
the
submission
for
compliance
monitoring
and
archive
in
EPA
files.

5(
b)
Collection
Methodology
and
Management
OPP
tracks
DCIs
and
all
registrant
responses
through
the
Office
of
Pesticide
Programs
Information
Network
(
OPPIN),
OPP's
general
purpose
action
tracking
system.
Additionally,
the
Reference
Files
System
(
REFS)
is
used
if
the
registrant
voluntarily
cancels
a
product
in
response
to
a
DCI.
The
Pesticide
Data
Management
System
lists
the
bibliography
of
data
submitters
for
the
DCI
and
OPPIN
tracks
the
submissions.
All
correspondence
associated
with
the
issuance
and
response
to
the
DCI
is
filed
in
the
master
registration
file
or
`
registration
jacket'
of
affected
products.
Data
submitted
in
response
to
a
DCI
is
processed,
catalogued
and
archived
in
the
PDMS.
Failures
to
comply
with
DCI
requirements
are
referred
to
EPA's
Office
of
Enforcement
and
Compliance
Assurance
for
appropriate
follow­
up
actions.
Records
submitted
pursuant
to
a
DCI
are
subject
to
Freedom
of
Information
Act
(
FOIA)
requests.

5(
c)
Small
Entity
Flexibility
Currently,
pesticide
registrants
may
be
divided
into
two
groups.
Approximately
10
percent
of
the
total:
manufacture
or
import
chemical
active
ingredients
intended
for
use
as
pesticides,
sell
these
active
ingredients
to
other
firms
for
formulation
into
pesticide
products,
and/
or
make
the
end­
products
themselves.
The
second,
and
by
far
the
larger,
group
of
registrants
purchase
the
active
ingredients
in
their
pesticide
products
from
members
of
the
first
group,
and
combine
them
with
pesticide
inert
ingredients
or
sometimes
simply
repackage
them
to
make
their
end­
use
products.

This
second
group
is
primarily
comprised
of
small
businesses.
When
small
businesses
use
a
registered
source
of
the
active
ingredient
to
formulate
their
products,
they
generally
are
exempt
from
DRAFT
FOR
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COMMENT
March
31,
2004
Page
9
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30
generating
health
and
safety
data
for
pesticide
active
ingredients
("
generic
data").
Consequently,
they
usually
need
only
respond
to
a
DCI
for
active
ingredient
data
by
claiming
the
"
generic
data
exemption."
They
do
not
incur
any
other
information
burden
associated
with
the
generic
data
call­
in.

5(
d)
Collection
Schedule
DCIs
will
generally
be
issued
whenever
ARs
data
is
relied
upon,
either
to
establish
new
tolerances
or
reassess
existing
tolerances.
Registrants
have
five
years
before
data
must
generally
be
submitted
in
support
of
the
ARs
used.
Data
must
also
be
periodically
reviewed
when
PCT
estimates
are
relied
upon,
but
in
most
cases
the
Agency
will
be
able
to
internally
collect
or
generate
this
data.
In
cases
where
the
Agency
is
unable
to
get
the
information
itself,
the
registrant
must
submit
data
within
five
years
of
the
use
of
PCT
estimates.
A
registrant
must
respond
within
90
days
of
receipt
of
the
DCI.
The
response
must
describe
plans
to
submit
the
required
data
in
accordance
with
the
time
frame
specified,
and,
if
applicable,
contain
suggested
protocols
for
monitoring
studies.
Additional
time
is
provided
for
development
of
new
studies
appropriate
to
the
nature
of
the
studies
required.

6.
ESTIMATING
THE
BURDEN
AND
COST
OF
THE
COLLECTION
6(
a)
Estimating
Respondent
Burden
The
annual
respondent
burden
for
the
collection
of
information
associated
with
this
activity
is
estimated
to
average
between
59
and
13,636
burden
hours
per
DCI,
depending
upon
the
type
of
response
requested.
The
total
estimated
burden
for
this
ICR
of
28,569
burden
hours
is
based
on
the
Agency's
estimate
of
the
potential
burden
and
number
of
responses
for
each
of
the
following
four
types
of
potential
DCIs:

1)
DCI
for
anticipated
residues
requiring
a
base
set
of
data
(
13,636
hrs.);
2)
DCI
for
anticipated
residues
requiring
minimum
data
(
69
hrs.);
3)
DCI
for
anticipated
residues
collected
from
publically
available
sources
(
137
hrs.);
and
4)
DCI
for
percent
crop
treated
using
existing
information
(
59
hrs.).

The
following
information
presents
the
Agency's
burden
estimates
for
each
type
of
DCI.

DCI
Type
1
­
DCI
for
anticipated
residues
requiring
a
base
set
of
data:

Respondent
burden
hours
for
generating
and
submitting
data
in
response
to
a
DCI
for
anticipated
residues
requiring
a
base
set
of
data
to
be
submitted
are
estimated
at
13,636
burden
hours
per
response.
EPA
also
considered
the
typical
burden
for
reading
instructions,
planning
activities,
compiling
and
reviewing
the
submission,
submitting
the
data
to
EPA,
and
related
record
keeping
in
estimating
the
total
per
response
burden
and
costs.
Using
the
EPA
PDP
contracts
as
the
basis,
EPA
estimated
the
burden
for
conducting
a
monitoring
study
to
gather
the
necessary
data,
and
the
annual
respondent
cost
for
meeting
40
CFR
part
158
data
requirements
for
anticipated
residues.
See
Table
1.
DRAFT
FOR
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COMMENT
March
31,
2004
Page
10
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30
Since,
in
most
cases,
registrants
will
be
able
to
get
the
information
from
federal
and
state
monitoring
programs,
EPA
estimates
that
no
more
than
2
registrants
might
generate
their
own
monitoring
data
in
response
to
the
DCI.
The
total
burden
for
this
type
of
DCI
is
therefore
estimated
to
be
27,272
hours
per
year
for
two
respondents.

TABLE
1
­
Annual
Respondent
Burden/
Cost
Estimates
for
Anticipated
Residues
Generating
Anticipated
Residue
Data
BURDEN
HOURS
(
per
year)
TOTAL
ACTIVITIES
Mgmt.
$
130
Tech.
$
88
Cler.
$
40
Hours
Costs
1)
Read
instructions
2
0
0
2
260
2)
Plan
activities
4
0
0
4
520
3)
Create
information
0
13,600
0
13,600
1,196,800
4)
Gather
information
0
16
0
16
1,408
5)
Compile
and
review
1
8
0
9
854
6)
Complete
paperwork
2
0
2
4
340
7)
Maintain
and
file
0
0
1
1
40
TOTAL
9
13,624
3
13,636
$
1,200,202
BURDEN:
13,636
hours
x
Average
of
2
responses
=
27,272
Total
Burden
Hours.

DCI
Type
2
­
DCI
for
anticipated
residues
requiring
minimum
data:

Minimum
data
captures
the
burden
for
cases
in
which
the
respondent
verifies
that
nothing
has
changed;
i.
e.,
the
formulation,
use
rate,
geographic
distribution
of
use,
etc.
have
not
changed
since
the
ARs
where
used
to
establish
or
reassess
the
tolerance.
Average
burden
hours
per
respondent
for
submitting
a
base
set
of
data
for
updating
use
information
is
estimated
at
69
burden
hours
per
year
per
response.
EPA
estimates
that
no
more
than
20
respondents
each
year
will
comply
with
a
DCI
by
submitting
a
base
set
of
data
for
updating
use
information.
As
such,
the
total
respondent
burden
hours
per
year
are
estimated
at
1,380
hours.
See
Table
2.
DRAFT
FOR
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March
31,
2004
Page
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30
TABLE
2
­
Annual
Respondent
Burden/
Cost
Estimates
for
Anticipated
Residues
Requiring
Minimum
Data
Burden
Hours
(
per
year)
Total
Collection
Activities
Mgmt.
$
130
Tech.
$
88
Cler.
$
40
Hours
Costs
1)
Read
Instructions
8
0
0
8
1,040
2)
Plan
Activities
16
0
0
16
2,080
3)
Create
Information
0
0
0
0
0
4)
Gather
Information
0
16
0
16
1,408
5)
Compile
and
Review
2
16
0
18
1,668
6)
Complete
Paperwork
2
0
8
10
580
7)
Submit
and
File
0
0
1
1
40
Total
28
32
9
69
$
6,816
BURDEN:
69
hours
x
Average
of
10
responses
=
690
Total
Hours.

DCI
Type
3
­
DCI
for
anticipated
residues
collected
from
publically
available
sources:

The
average
respondent
burden
for
submitting
a
base
set
of
data
for
updating
monitoring
information
is
estimated
at
137
burden
hours
per
year.
EPA
estimates
that
an
average
of
4
respondents
each
year
are
likely
to
be
able
to
comply
with
a
DCI
by
submitting
data
from
publically
available
sources.
As
such,
the
total
annual
respondent
burden
for
this
type
of
DCI
is
estimated
to
be
548
burden
hours.
See
Table
3.

TABLE
3
­
Annual
Respondent
Burden/
Cost
Estimates
for
Anticipated
Residues
Collected
from
Publicly
Available
Sources
Burden
Hours
(
per
year)
Total
Collection
Activities
Mgmt.
$
130
Tech.
$
88
Cler.
$
40
Hours
Costs
1)
Read
Instructions
8
0
0
8
1,040
2)
Plan
Activities
16
0
0
16
2,080
3)
Create
Information
0
0
0
0
0
4)
Gather
Information
0
60
0
60
5,280
5)
Compile
and
Review
2
40
0
42
3,780
6)
Complete
Paperwork
2
0
8
10
580
7)
Submit
and
File
0
0
1
1
40
Total
28
100
9
137
12,800
DRAFT
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March
31,
2004
Page
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30
BURDEN:
137
hours
x
Average
of
4
responses
=
548
Total
Hours.

DCI
Type
4
­
DCI
for
percent
crop
treated
using
existing
information:

The
annual
per
respondent
burden
for
generating
percent
crop
treated
estimates
using
existing
information
is
estimated
to
be
59
burden
hours.
Percent
crop
treated
estimates
are
generally
conducted
within
the
Agency,
and
only
in
rare
instances
would
a
registrant
need
to
gather
the
information;
one
per
year
may
be
an
overestimation.
The
estimated
costs
assume
that
cost
of
purchasing,
or
obtaining
percent
crop
treated
information
derived
from
existing,
contracted
data
sources.
See
Table
4.

TABLE
4
­
Annual
Respondent
Burden/
Cost
Estimates
for
Percent
Crop
Treated
Using
Existing
Information
Burden
Hours
(
per
year)
Total
Activities
Mgmt.
$
130
Tech.
$
88
Cler.
$
40
Hours
Costs
1)
Read
Instructions
1
1
0
2
218
2)
Plan
Activities
0
2
0
2
176
3)
Create
Information
0
8
0
8
704
4)
Gather
Information
0
22
0
22
1,936
5)
Compile
and
Review
1
20
0
21
1,890
6)
Complete
Paperwork
1
0
2
3
210
7)
Submit
and
File
0
0
1
1
40
Total
3
53
3
59
$
5,174
BURDEN:
59
hours
x
average
of
generating
1
response
=
59
Total
Hours
6(
b)
Estimating
Respondent
Costs
The
corresponding
estimated
respondent
cost
for
this
collection
is
$
2,524,938.
Respondent
costs
are
based
on
managerial,
technical
and
clerical
burden
hours
estimated
at
$
130,
$
88,
and
$
40
per
hour,
respectively.
EPA
has
calculated
the
estimated
labor
rates
for
respondents
to
the
requirements
of
this
ICR
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.

The
total
estimated
cost
for
this
collection
is
based
on
the
Agency's
estimate
of
the
potential
cost
and
number
of
responses
for
each
of
the
following
four
types
of
potential
DCIs:

1)
DCI
for
anticipated
residues
requiring
a
base
set
of
data
­
$
2,400,404
2)
DCI
for
anticipated
residues
requiring
minimum
data
­
$
68,160
3)
DCI
for
anticipated
residues
collected
from
publically
available
sources
­
$
51,200;
and
4)
DCI
for
percent
crop
treated
using
existing
information
­
$
5,174.
DRAFT
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31,
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13
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6(
c)
Estimating
Agency
Burden
and
Costs
Annual
Agency
burden
for
managing
individual
information
from
Type
1,
2
or
3
DCIs
is
estimated
at
99
burden
hours
per
response.
The
hourly
rates
are
$
96,
$
70,
and
$
33
per
hour
for
management,
technical,
and
clerical
staff,
respectively.
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.
The
annual
Agency
cost
for
managing
an
individual
response
is
estimated
at
$
6,501
per
response.

Since
the
average
number
of
responses
each
year
for
these
DCIs
is
estimated
to
be
16,
the
total
annual
burden
for
the
Agency
activities
is
estimated
to
be
1,584
burden
hours,
with
an
associated
cost
of
$
104,016
per
year.
See
Table
5.

TABLE
5
­
Annual
Agency
Burden/
Cost
Estimates
for
Processing
DCI
Types
1­
3
Burden
Hours
(
per
year)
Total
Collection
Activities
Mgmt.
$
96
Tech.
$
70
Cler.
$
33
Hours
Costs
Develop
DCI
notice
1
0
2
3
162
Answer
Registrants'
questions
0
4
5
9
445
IN­
process
data
submissions
0
0
4
4
132
Analyze
data
1
80
0
81
5,696
Record
and
store
DCI
data
0
0
2
2
66
Total
2
84
13
99
$
6,501
BURDEN:
99
hours
x
16
responses
=
1,584
Total
Hours
COSTS:
$
6,432
x
16
responses
=
$
104,016
Total
Costs
The
annual
Agency
burden
for
managing
individual
DCI
information
for
percent
crop
treated
is
estimated
at
59
hours
per
response,
with
an
estimated
cost
of
$
3,701
per
response.
Since
the
Agency
estimates
no
more
than
1
response
each
year,
if
any,
the
total
annual
Agency
burden
and
cost
is
59
burden
hours,
and
$
3,701
See
Table
6.
DRAFT
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TABLE
6
­
Annual
Agency
Burden/
Cost
Estimates
for
Processing
DCI
Type
4
Burden
Hours
(
per
year)
Total
Collection
Activities
Mgmt.
$
96
Tech.
$
70
Cler.
$
33
Hours
Costs
Develop
DCI
notice
1
0
2
3
162
Answer
Registrants'
questions
0
4
5
9
445
IN­
process
data
submissions
0
0
4
4
132
Analyze
data
1
40
0
41
2,896
Record
and
store
DCI
data
0
0
2
2
66
Total
2
44
13
59
$
3,701
BURDEN:
59
hours
x
1
response
=
59
Total
Hours
COSTS:
$
3,701
x
1
responses
=
$
3,701
Total
Costs
6(
d)
Bottom
Line
Burden
Hours
and
Cost
Table
The
total
estimated
annual
respondent
burden
is
28,569
burden
hours
(
28,509
burden
hours
for
all
AR
DCI
submissions
+
59
burden
hours
for
Percent
Crop
Treated
DCI
submissions),
with
an
associated
cost
of
$
2,524,938
($
2,519,764
for
all
AR
DCI
submissions
+
$
5,174
for
Percent
Crop
Treated
DCI
submissions).
See
Table
7.

The
total
estimated
annual
Agency
burden
is
1,643
burden
hours
(
1,584
burden
hours
for
all
AR
DCI
submissions
+
59
burden
hours
for
Percent
Crop
Treated
DCI
submissions).,
with
an
associated
cost
of
$
107,717
($
104,016
for
all
AR
DCI
submissions
+
$
3,701
for
Percent
Crop
Treated
DCI
submissions).

Key
Activities
Hours
Costs
Respondents
Total
respondent
burden/
costs
for
generating
anticipated
residue
data.
27,272
$
2,400,404
Total
respondent
burden/
costs
for
submitting
minimal
anticipated
residue
data.
690
$
68,160
Total
respondent
burden/
costs
for
submitting
anticipated
residue
data
from
publicly
available
sources.
548
$
51,200
Total
respondent
burden/
costs
for
submitting
percent
crop
treated
data
using
existing
information.
59
$
5,174
Total
estimated
respondent
burden/
costs.
28,569
$
2,524,938
DRAFT
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Agency
Total
Agency
burden/
costs
for
managing
anticipated
residue
DCI's
1,584
$
104,016
Total
Agency
burden/
costs
for
managing
percent
crop
treated
DCI's.
59
$
3,701
Total
Agency
burden/
costs.
1,643
$
107,717
6(
e)
Reasons
for
Change
in
Burden
In
the
previous
ICR,
OMB
approved
29,807
burden
hours,
with
a
cost
of
$
2,773,866.
This
ICR
renewal
request
reflects
a
decrease
of
approximately
1,238
burden
hours
for
an
annual
respondent
burden
of
28,569
hours
and
a
decrease
in
cost
of
$
248,928,
for
an
annual
respondent
cost
of
$
2,524,938.
These
reductions
are
adjustments
due
to
the
fact
that
the
Agency
expects
to
issue
fewer
data
call­
ins
under
this
program
than
originally
estimated.
Oftentimes,
data
can
be
acquired
more
efficiently
without
issuing
a
DCI.
For
example,
OPP
works
closely
with
USDA's
Pesticide
Data
Program
(
PDP)
which
generates
publically
available
monitoring
data.
OPP
can
get
the
PDP
monitoring
data
more
quickly
and
in
a
format
most
usable
to
the
Agency
by
requesting
the
data
directly
from
USDA.
This
would
eliminate
the
cost
to
the
pesticide
registrants
and
would
save
the
Agency
time
and
the
administrative
expense
associated
with
a
data­
call­
in.
Similarly,
data
on
changes
in
processing
practices
that
may
lead
to
increases
in
residues
can
more
efficiently
collected
in
cooperation
with
food
industry
associations.
Also,
in
many
cases
the
Agency
can
continue
to
stand
by
its
safety
finding
without
requiring
additional
data
because
the
risk
is
so
low
that
even
large
increases
in
exposure
would
not
create
a
risk
of
concern.

6(
f)
Burden
Statement
The
total
annual
respondent
burden
for
this
ICR
is
estimated
to
be
28,569
hours,
ranging
from
59
hours
to
13,636
hours
per
response,
depending
on
the
type
of
DCI.

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.

An
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
numbers
for
EPA's
regulations
in
title
40
of
the
CFR,
after
appearing
in
the
Federal
Register,
are
listed
in
40
CFR
part
9,
and
included
on
the
related
collection
instrument
or
form,
if
applicable.

To
comment
on
EPA's
need
for
this
information,
the
accuracy
of
the
provided
burden
estimates,
and
any
suggested
methods
for
minimizing
respondent
burden,
including
the
use
of
automated
collection
techniques,
EPA
has
established
a
public
docket
for
this
ICR
under
Docket
ID
No.
OPP­
2004­
0109,
which
is
available
for
public
viewing
at
the
OPP
Docket
in
the
Public
Information
and
Records
Integrity
Branch,
Rm.
119,
Crystal
Mall
#
2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA.
This
docket
facility
is
DRAFT
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31,
2004
Page
16
of
30
open
from
8:
30
a.
m.
to
4:
00
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
docket
telephone
number
is
(
703)
305­
5805.

An
electronic
version
of
the
public
docket
for
this
ICR
renewal
is
available
through
EPA
Dockets
(
EDOCKET)
at
http://
www.
epa.
gov/
edocket.
Use
EDOCKET
to
submit
or
view
public
comments,
access
the
index
listing
of
the
contents
of
the
public
docket,
and
to
access
those
documents
in
the
public
docket
that
are
available
electronically.
Once
in
the
system,
select
"
search,"
then
key
in
the
docket
ID
number
identified
above.
Also,
you
can
send
comments
to
the
Office
of
Information
and
Regulatory
Affairs,
Office
of
Management
and
Budget,
725
17th
Street,
NW,
Washington,
DC
20503,
Attention:
Desk
Officer
for
EPA.
Please
include
the
EPA
Docket
ID
No.
OPP­
2004­
0109
and
OMB
Control
No.
2070­
0164
in
any
correspondence.
DRAFT
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ATTACHMENTS
TO
THE
SUPPORTING
STATEMENT
ATTACHMENT
A:
SOP
No.
HED
AR­
1.
This
attachment
follows
the
Supporting
Statement
in
the
electronic
file.
ATTACHMENT
A
SOP
No.
HED
AR­
1
Title:
Use
of
Anticipated
Residues
in
Risk
Assessment
Revision
No.
Original
Effective
Date:
FEB­
15­
99
Page
18
of
30
1.0
Purpose
To
standardize
the
procedures
used
by
scientists
in
the
Health
Effects
Division
for
calculation
of
anticipated
residues.

2.0
Scope
This
procedure
shall
be
followed
by
all
HED
personnel
involved
in
the
manipulation
of
data
to
calculate
anticipated
residues
to
be
used
in
risk
assessment
estimates.

3.0
Outline
of
Procedures

Regulatory
Background

Interpretations
of
FFDCA

Definition
of
Terms
Used
in
this
Document

Dietary
Exposure

Data
Needed
to
Verify
Anticipated
Residues

Non­
Detects

Documentation
Requirements
4.0
References

Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA)

Federal
Insecticide,
Fungicide
and
Rodenticide
Act
(
FIFRA)

Food
Quality
Protection
Act
(
FQPA)

Residue
Chemistry
Guidelines
OPPTS
860.1500,
860.1520

Acute
Dietary
Exposure
Assessment
OPP
Policy,
June
1996

Chronic
Dietary
Exposure
Assessment
OPP
Policy,
???
1997

Chemistry
Science
Advisory
Council
(
CHEM
SAC)
Decisions
5.0
Specific
Procedures
5.1
Regulatory
Background
Section
408(
b)(
2)(
E)
of
FFDCA
as
amended
by
FQPA
requires
that
if
EPA
relies
on
anticipated
residues
(
ARs)
or
Actual
Residues
to
establish,
modify,
or
leave
in
effect
a
tolerance,
then
EPA
must
require
that
data
be
provided
five
years
after
the
tolerance
decision
is
made
to
demonstrate
that
such
residue
levels
have
not
changed.

Section
408(
b)(
2)(
F)
of
the
Act
states
that
the
Agency
may
use
data
on
the
actual
percent
of
food
treated
or
"
percent
crop
treated"
(
PCT)
in
chronic
dietary
risk
if
such
data
are
reliable
and
its
use
will
not
understate
exposure
for
any
significant
population
subgroup.
ATTACHMENT
A
SOP
No.
HED
AR­
1
Title:
Use
of
Anticipated
Residues
in
Risk
Assessment
Revision
No.
Original
Effective
Date:
FEB­
15­
99
Page
19
of
30
Section
408(
f)
of
FFDCA
"
Special
Data
Requirements"
states
that
if
EPA
requires
additional
data
or
information
to
support
a
tolerance
or
exemption,
it
shall
issue
(
a)
a
DCI,
(
b)
a
rule
requiring
testing
or
(
c)
an
order
in
the
FR.

5.2
Interpretations
of
FFDCA
5.2.1
408(
b)(
2)(
E)­­
If
EPA
relies
on
anticipated
or
actual
residue
levels
in
establishing,
modifying
or
leaving
in
effect
a
tolerance,
it
must
call
in
data
within
five
years
for
all
crops
for
which
AR's
were
used
for
a
pesticide.
Such
data
will
be
used
to
demonstrate
that
the
residue
levels
are
not
above
the
(
anticipated)
levels
relied
on.
If
the
residues
are
higher,
EPA
shall
reassess
the
risk
posed
by
the
pesticide
and
modify
or
revoke
the
tolerance
as
required
to
assure
no
adverse
health
concerns
result
from
the
pesticide.

5.2.2
408(
b)(
2)(
F)­­
Whenever
PCT
has
been
used,
EPA
will
obtain
data
through
its
usual
sources
(
i.
e.,
BEAD)
within
five
years
and
determine
whether
the
risks
have
increased
unacceptably.
EPA
will
not
issue
a
data­
call­
in
(
DCI).

5.2.3
408(
f)­­
EPA
may
use
three
methods
to
require
data,
but
will
use
DCIs.

No
rule
is
required
for
implementation
of
these
provisions
of
the
Act,
but
an
Information
Collection
Request
(
ICR)
covering
the
AR
DCI
data
must
be
cleared
through
the
Office
of
Management
and
Budget
(
OMB)
before
DCIs
can
be
issued.
A
PR
Notice
will
be
issued
to
notify
registrants
and
the
public
about
FQPA's
requirements
on
AR/
PCT
and
the
process
the
Agency
will
follow.

5.2.4
FIFRA
Section
18
Tolerances­­
Any
tolerances
established
in
conjunction
with
FIFRA
Section
18s
that
use
ARs
and/
or
PCT
are
subject
to
FQPA.
Data
or
information
required
to
verify
these
tolerances
are
required
to
be
submitted
five
years
after
their
issuance
unless
EPA
obtains
and
uses
new
information
that
either
corroborates
or
changes
the
initial
AR
data.
If
a
Section
18
tolerance
is
repeatedly
renewed
with
little
or
no
new
information,
data
must
be
called
in.

To
obtain
AR
data
for
Section
18
exemptions,
OPP
may:
(
a)
issue
a
letter
requesting
data
from
the
main
registrant
(
producer
of
the
technical)
at
the
same
time
that
the
Section
18
is
issued;
(
b)
place
a
notice
in
the
initial
Section
18
approval
telegram
(
and
in
subsequent
years)
indicating
that
data
are
required
to
be
submitted
five
years
later
or
else
a
Section
18
will
not
be
granted
and
the
tolerance
will
be
revoked
(
registrants
would
also
be
notified
by
letter
of
this
requirement);
or
(
c)
both.

5.3
Definition
of
Terms
Used
in
this
Document
5.3.1
Anticipated
Residues
are
estimates
of
the
level
of
residues
of
a
pesticide
likely
to
be
present
on
a
given
crop
and
are
generally
lower
than
tolerances.
Data
used
for
these
estimates
are
ATTACHMENT
A
SOP
No.
HED
AR­
1
Title:
Use
of
Anticipated
Residues
in
Risk
Assessment
Revision
No.
Original
Effective
Date:
FEB­
15­
99
Page
20
of
30
based
on:

1)
Field
Trial
Studies
designed
to
show
what
residue
levels
will
be
present
in
crops
at
harvest.
These
studies
are
conducted
at
maximum
label
rate
and
minimum
pre­
harvest
interval,
and
are
designed
to
show
the
maximum
residues
likely
to
be
present.
Field
trial
data
can
be
used
to
project
the
residue
amounts
on
treated
crops
and
how
various
factors
may
affect
those
levels.
Field
trial
data
can
therefore,
be
combined
with
percent
crop
treated
data
to
produce
a
more
realistic
estimate
of
human
exposure.

2)
Monitoring
Data
which
provide
measurements
of
actual
residues
in/
on
commodities
as
they
move
in
commerce.
Monitoring
data
or
actual
residue
data
are
collected
by
sampling
a
crosssection
of
a
crop
and
it
include
treated
and
untreated
commodities.
Actual
residue
data
reflects
both
the
processes
measured
by
field
trial
studies
and
the
percent
of
the
crop
actually
treated.
Therefore,
actual
residue
data
for
a
given
commodity
would
generally
not
be
combined
with
either
field
trials
data
or
percent
crop
treated
information
for
that
commodity
in
estimating
human
exposure.
Actual
residue
measurements
are
taken
on
samples
gathered
as
the
commodities
leave
the
farm
(
e.
g.,
FDA
Surveillance
samples
taken
as
close
as
possible
to
the
point
of
production),
when
the
food
is
in
the
general
channels
of
distribution
(
e.
g.,
USDA's
PDP
taken
at
food
distribution
centers),
or
at
the
retail
level
(
e.
g.,
EBDCs
market
basket
survey).
Actual
residues
are
provided
by:

a)
FDA
Programs­­
Surveillance/
Compliance
Monitoring
and
Total
Diet.
b)
USDA
Programs
 
AMS
Pesticide
Data
Program
and
FSIS
Monitoring
Program
(
meat
and
poultry).
c)
Special
Studies­­
FDA
Total
Diet
Survey
which
show
residues
after
consumer
preparation
or
cooking
of
foods.

3)
Processing
Studies
designed
to
determine
the
concentration
or
reduction
of
residues
when
the
raw
agricultural
commodity
is
processed
commercially.

4)
Degradation/
Decline
Studies
showing
the
degradation
rates
of
pesticide
residues.

5)
Livestock
Feeding
Studies
and
Nature
of
the
Residue
in
Livestock
to
identify
the
nature
of
the
residue
in
the
edible
tissue
of
livestock
and
the
transfer
of
these
residues
to
meat,
milk,
poultry,
and
eggs.
These
studies
are
required
when
a
pesticide
is
applied
directly
to
livestock,
to
crops
or
crop
parts
used
for
feed,
or
when
livestock
premises
are
to
be
treated.

5.3.2
Percent
Crop
Treated
means
the
scope
of
pesticide
treatment
for
a
crop
expressed
as
a
percentage.
Percent
crop
treated
information
is
useful
for
estimating
exposure
because
it
defines
what
segment
of
the
crop
is
pesticide
free.

5.4
Dietary
Exposure
ATTACHMENT
A
SOP
No.
HED
AR­
1
Title:
Use
of
Anticipated
Residues
in
Risk
Assessment
Revision
No.
Original
Effective
Date:
FEB­
15­
99
Page
21
of
30
Dietary
exposure
to
pesticides
in
foods
is
estimated
by
multiplying
the
daily
consumption
of
the
food
forms
of
a
given
commodity
by
the
amount
of
pesticide
residues
on
the
food
forms.
Exposures
based
on
tolerance
levels
are
Theoretical
Maximum
Residue
Contribution
(
TMRC)
estimates.
A
TMRC
is
considered
a
"
worst
case"
estimate
because
it
assumes
that
the
food
contains
residues
at
the
tolerance
level
and
that
100
percent
of
the
crop
is
treated.
If
the
TMRC
exceeds
the
reference
dose
or
poses
an
unacceptable
lifetime
cancer
risk,
EPA
attempts
to
derive
a
more
accurate
estimate
of
residues
likely
to
be
present
in
foods
(
anticipated
residues).

5.4.1
Tiered
Approach
to
Estimating
Dietary
Exposure:
In
an
attempt
to
conserve
resources,
the
Agency
developed
a
tiered
process
by
which
pesticide
tolerance
data
(
40
CFR
158.240)
are
refined
to
reflect
pesticide
residues
in
food
as
consumed
(
dinner­
plate).
This
tiered
approach
flows
from
conservative
to
more
refined
assumptions
as
the
risk
management
situation
dictates.
Dietary
exposure
estimates
based
on
tolerance
level
residues
(
farm­
gate)
reflect
a
Theoretical
Maximum
Residue
Contribution
(
TMRC)
which
overestimate
actual
dietary
exposure.
The
best
estimate
of
pesticide
residues
in
food,
as
consumed,
is
termed
the
Anticipated
Residue
(
AR)
estimate.
When
estimating
ARs
the
Agency
uses
all
available
data,
therefore,
reviewers
must
exercise
considerable
scientific
judgment
to
derive
anticipated
residue
estimates.

Attachment
1
summarizes
applicability
of
the
various
tiers
in
estimating
acute
and
chronic
exposures.

5.5
Data
Needed
to
Verify
Anticipated
Residues
Verification
of
the
anticipated
residues
used
in
establishing
a
tolerance
depends
on
the
data
source.
Table
1
below
addresses
specific
cases.
ATTACHMENT
A
SOP
No.
HED
AR­
1
Title:
Use
of
Anticipated
Residues
in
Risk
Assessment
Revision
No.
Original
Effective
Date:
FEB­
15­
99
Page
22
of
30
Table
1.
Data
Needed
to
Verify
Anticipated
Residue
Calculations
SOURCE
OF
DATA
USED
IN
ANTICIPATED
RESIDUES
DATA
NEEDED
TO
CONFIRM
ANTICIPATED
RESIDUES
5
YEARS
LATER
Monitoring
data
(
PDP,
FDA,
FSIS,
States,
special
monitoring
[
market
basket,
single
serving,
etc.])
Updated
monitoring
data
are
required.
The
registrant
may
use
any
of
the
publicly
available
sources
used
by
the
Agency.
Data
should
reflect
the
time
period
since
establishment
of
the
tolerance.
If
data
are
not
available
from
the
above
sources,
then
the
registrant
must
conduct
an
appropriately
designed
monitoring
study.
The
design
of
this
study
must
be
approved
by
the
Agency.

Field
Trials
The
registrant
must
EITHER
verify
that
the
pesticide
formulations,
application
rates,
timing,
intervals,
geographic
distribution
of
use,
etc.,
have
not
changed
OR
provide
field
trial
data
that
reflect
any
changes
in
the
use
pattern
that
may
lead
to
increased
residues.

Processing
studies
Reduction
in
residue
data
(
washing,
peeling,
cooking,
etc.)
The
registrant
must
EITHER
certify
that
commercial
processing
practices
have
not
changed
significantly
OR
provide
new
processing
studies
reflecting
current
commercial
practices.
A
similar
requirement
applies
to
any
study
used
to
demonstrate
reduction
in
residues
between
farm
gate
and
consumption.

Livestock
feeding
studies
and
metabolism
studies
Registrant
must
EITHER
verify
that
the
dietary
burden
calculations
that
were
incorporated
in
the
original
AR
derivation
for
meat,
milk,
poultry
or
eggs
are
still
valid
OR
provide
a
new
animal
feeding
study
that
reflects
current
feeding
practices.
Dietary
burden
calculations
could
change
due
to
increased
residue
levels
on
feed
items
or
from
changes
in
the
relative
abundance
or
use
of
a
particular
feed
item
over
time.

5.5.1
Hypothetical
Scenario:
A
tolerance
is
established
for
a
chemical
already
registered
for
use
on
ten
food
crops.
Anticipated
residues
are
developed
for
seven
of
ten
previously
registered
crops
to
support
registration
of
crop
11
as
shown
in
Table
2.

Table
2.
Data
Sources
Used
to
Support
the
Tolerance
for
"
New
Crop
11
TOLERANCES
DATA
SOURCE
RESIDUE
ESTIMATE
ANTICIPATED
RESIDUE?

Old
crop
1
Monitoring
Mean
Yes
Old
crop
2
Monitoring
Mean
Yes
Old
crop
3
Monitoring
Mean
Yes
Old
crop
4
Monitoring
Mean
Yes
Old
crop
5
Monitoring
Mean
Yes
ATTACHMENT
A
SOP
No.
HED
AR­
1
Title:
Use
of
Anticipated
Residues
in
Risk
Assessment
Revision
No.
Original
Effective
Date:
FEB­
15­
99
Page
23
of
30
Old
crop
6
Field
trials
Mean
Yes
Old
crop
7
Field
trials
Mean
Yes
Old
crop
8
Field
trials
Tolerance
No
Old
crop
9
Field
trials
Tolerance
No
Old
crop
10
Field
trials
Tolerance
No
estimated
residue
consumption
from
crops
1­
10
=
80%
of
RfD
New
crop
11
Field
trials
Tolerance
No
estimated
residue
consumption
from
crops
1­
11
=
90%
of
RfD
In
accordance
with
the
interpretation
in
Section
5.2
above,
the
registrant
has
to
verify
that
the
ARs
on
crops
1
through
7
still
support
the
tolerance
on
crop
11
after
5
years.
Each
individual
AR
for
crops
1
through
7
must
be
confirmed
with
data
similar
to
that
originally
used
to
derive
the
AR
for
that
crop
(
see
Table
1).
This
confirmation
will
be
on
a
crop
by
crop
basis.
If
the
anticipated
residue
for
any
commodity
exceeds
the
value
relied
on
previously
then
a
new
dietary
risk
assessment
will
be
necessary
to
determine
if
the
tolerance
on
crop
11
needs
to
be
altered
or
revoked.

5.6
Non­
Detects
There
are
two
possible
explanations
for
residues
reported
as
"
not
detected":
either
the
residues
are
for
all
practical
purposes
zero
(
e.
g.,
pesticide
was
not
applied)
or
the
residues
may
be
present
at
levels
lower
than
the
limit
of
detection
(
LOD)
of
the
analytical
method
used.
The
Chem
SAC
recommendations
for
handling
non­
detects
are
as
follows:

1.
A
true
zero
may
be
entered
for
non­
detects
if
the
percentage
of
samples
reported
as
non­
detects
is
equal
or
greater
than
the
percent
crop
not
treated.
The
number
of
samples
entered
as
zeros
should
be
directly
proportional
to
the
percent
crop
not
treated.
The
reviewer
should
work
closely
with
BEAD
in
selecting
the
appropriate
percent
crop
treated
figure
(
e.
g.,
maximum,
average,
or
other
PCT
figure).

2.
A
zero
may
be
used
to
represent
non­
detects
if
metabolism
studies,
data
at
shorter
PHIs,
exaggerated
rate
data,
etc.
support
this
decision.

3.
A
value
such
as
½
LOD
or
½
LOQ
or
the
Lower
Limit
of
Method
Validation
(
LLMV)
may
be
used.
[
LLMV:
lowest
concentration
at
which
the
method
was
validated.
A
LLMV
could
be
higher
than
true
LOQ.]

5.7
Documentation
Requirements
Estimation
of
anticipated
residues
must
be
thoroughly
documented.
All
HED
documents
transmitted
to
RD
or
SRRD
that
are
concerned
with
either
establishing,
modifying,
or
leaving
in
effect
a
tolerance
must
contain
the
following
information:
ATTACHMENT
A
SOP
No.
HED
AR­
1
Title:
Use
of
Anticipated
Residues
in
Risk
Assessment
Revision
No.
Original
Effective
Date:
FEB­
15­
99
Page
24
of
30
a.
Percent
Crop
Treated
(
PCT):
Indicate
whether
assumption
of
100
percent
crop
treated
is
made
or
actual
percent
crop
treated
data
were
used.
If
PCT
data
were
used,
include
the
source
of
these
data
(
e.
g.,
for
BEAD
data,
attach
transmittal
memorandum
documenting
years
the
PCT
represent
for
each
crop).
Describe
any
assumptions
made
and
actual
PCT
values
used.

b.
Dietary
Exposure
Assessment:
Must
contain
a
clear
and
complete
account
of
the
basis
for
estimating
dietary
exposure.
For
each
food
form
included
in
the
assessment,
indicate
whether
exposure
was
based
on
tolerance
level
residues
or
anticipated
residues
and
whether
PCT
data
were
used.

c.
Anticipated
Residues:
If
ARs
were
used,
list
actual
numerical
estimates
used
and
the
source
of
the
estimate
(
i.
e.,
FDA
monitoring
data,
field
trial
data,
processing
studies,
etc.)
Document
must
fully
describe
all
values,
assumptions,
and
data
manipulation
used
in
deriving
anticipated
residues
including
use
of
default
values
(
e.
g.,
½
LOD/
LOQ
for
non­
detects,
½
LOQ
for
BQLs,
etc.).
The
sources
of
all
data
must
be
documented
sufficiently
that
any
interested
party
could
repeat
the
calculations.

The
HED
recommended
format
for
documentation
of
anticipated
residues
derived
from
field
trials,
monitoring
data,
and
processing
studies
is
provided
in
examples
given
in
Attachment
2.

d.
Dietary
Exposure
Assessments:
Must
be
documented
in
the
form
of
a
memorandum
containing
all
of
the
elements
found
in
the
HED
DEEM
SOP
(
being
prepared
by
DRES
committee).
Each
memorandum
will
contain,
at
a
minimum,
a
description
of
the
following
information:

a.
Type
of
action
(
section
18,
reregistration,
new
use,
etc.).
b.
Toxicological
Information
(
RfD,
data
gaps,
uncertainty
factor,
NOEL,
carcinogenicity,
etc),
including
reference
to
HED
documents
containing
these
data.
c.
Residue
Information
(
CFR
references,
PCT,
AR
data,
concentration
factors,
etc.)
including
reference
to
HED
documents
containing
these
data.
d.
Results
and
Discussion
(
refinements
to
the
analysis,
TMRC
and
ARC
numbers,
changes
to
concentration
factors,
population
subgroups
exceeding
100%
RfD,
commodity
contribution
analysis
if
RfD
exceeds
100%.
e.
Names
of
preparer
and
reviewer,
date,
and
file
location.
f.
For
Monte
Carlo
runs
attach
input
and
output
files.

Attachment
1
Tiered
Approach
to
Estimating
Dietary
Exposure
*

Dietary
Assessment
ATTACHMENT
A
SOP
No.
HED
AR­
1
Title:
Use
of
Anticipated
Residues
in
Risk
Assessment
Revision
No.
Original
Effective
Date:
FEB­
15­
99
Page
25
of
30
Acute
Chronic
(
Carcinogenic
and
non­
carcinogenic)

Single
Serving
Blended
Single
Serving/
Blended
Tier
1

Tolerance

100%
CT

Tolerance

100%
CT

Tolerance

100%
CT
Tier
2

Tolerance

100%
CT

Average
residue
from
field
trials

100%
CT

Tolerance

Adjust
for
%
CT
Tier
3

Entire
distribution
of
data
from
field
trials

Adjust
for
%
CT

Average
residue
from
field
trials

Adjust
for
%
CT

Processing
factors
­
or­

Entire
distribution
of
monitoring
data

100
%
CT.


Processing
factors

Average
residue
from
field
trials

Adjust
for
%
CT

Processing
factors
­
or­

Average
residue
of
monitoring
data

Adjust
for
%
CT

Processing
factors
Tier
4

Single
Serving
Market
basket
survey

Cooking

Residue
decline

Residue
degradation

Use
monitoring
data
directly

Cooking

Residue
decline

Residue
degradation

Single
Serving
Market
basket
survey

Cooking

Residue
decline,


Residue
degradation
*
For
meat,
milk,
poultry,
and
eggs,
if
monitoring
data
are
not
available,
1)
calculate
the
dietary
burden
using
anticipated
residues
for
feedstuffs;
2)
extrapolate
from
livestock
feeding
studies
ATTACHMENT
A
SOP
No.
HED
AR­
1
Title:
Use
of
Anticipated
Residues
in
Risk
Assessment
Revision
No.
Original
Effective
Date:
FEB­
15­
99
Page
26
of
30
Attachment
2
XYZ
(
Chemical
#
000001)­­
Anticipated
Residues
Derived
from
Monitoring
Data
Commodity
Data
Source
No.
of
Samples
No.
of
Detects
%
Detects
LOD
ppm
LOQ
ppm
%
Crop
Treated
Max.
Residue
Average
Residue
95th
Percentile
caneberries
blackberries
boysenberries
dewberries
loganberries
raspberries
FDA
92­
96
158
19
12
0.02
55
0.204
0.0089
0.02
blueberries
FDA
92­
96
176
10
5.7
0.02
80
0.08
0.0093
T
cranberries
FDA
92­
96
69
1
1.4
0.02
7
0.02
0.0008
ND
FODC
92­
96
111
0
0.0
0.02
7
ND
ND
grapes
PDP
95­
96
1215
0
0.0
0.023
1
ND
0.0001
ND
strawberries
FDA
92­
96
644
78
12.1
0.02
28
0.28
0.0133
0.08
ATTACHMENT
A
SOP
No.
HED
AR­
1
Title:
Use
of
Anticipated
Residues
in
Risk
Assessment
Revision
No.
Original
Effective
Date:
FEB­
15­
99
Page
27
of
30
XYZ
(
Chemical
#
000001)­­
Anticipated
Residues
Derived
from
Monitoring
Data
(
continued)

Commodity
Data
Source
No.
of
Samples
No.
of
Detects
%
Detects
LOD
ppm
LOQ
ppm
%
Crop
Treated
Max.
Residue
Average
Residue
95th
Percentile
grapefruit
FDA
92­
96
133
0
0.0
0.02
1
ND
0.0001
ND
orange
PDP
95­
96
1209
6
0.5
0.037
1
0.028
0.0002
ND
orange
juice
PDP
97
604
0
0.0
0.02
1
ND
0.0001
ND
apple
PDP
95­
96
1723
0
0.0
0.037
15
ND
0.003
ND
apple
juice
PDP
96
177
1
0.6
0.023
15
<
0.017
0.002
ND
tomatoes
PDP
96
174
0
0.0
0.030
2
ND
0.0003
ND
whole
grain
wheat
PDP
95­
96
940
275
29.3
0.01
100
2.874
0.065
0.305
wheat
flour
FDA
92­
96
113
79
69.9
0.02
100
1.056
0.0631
0.247
milk
PDP
96
558
0
0.0
0.0033
­­
ND
0.0017
ND
ATTACHMENT
A
SOP
No.
HED
AR­
1
Title:
Use
of
Anticipated
Residues
in
Risk
Assessment
Revision
No.
Original
Effective
Date:
FEB­
15­
99
Page
28
of
30
XYX
(
Chemical
#
000001)­­
Anticipated
Residues
Derived
from
Field
Trial
Studies
Crop
Average
Residue
Maximum
Residue
PCT
Anticipated
Residue
Source
of
Data
Review
Reference
Macadamia
nuts
0.05
0.1
6
0.00300
MRID
44076801
DP
Barcode
Chestnuts
0.261
0.632
100
1.00000
MRID
44478401
DP
Barcode
Walnuts
0.05
0.10
9
0.00450
MRID
44383301
DP
Barcode
Figs
0.203
0.387
6
0.01220
MRID
44061201
DP
Barcode
Guava
0.159
0.48
100
0.15900
MRID
44391501
DP
Barcode
Passion
Fruit
0.0564
0.121
100
0.05640
or
8??
MRID
44472801
DP
Barcode
ATTACHMENT
A
SOP
No.
HED
AR­
1
Title:
Use
of
Anticipated
Residues
in
Risk
Assessment
Revision
No.
Original
Effective
Date:
FEB­
15­
99
Page
29
of
30
XYZ
(
Chemical
#
000001)­­
Anticipated
Residues
Reflecting
Processing
Factors
Crop
Processed
Form
Concentration
or
Dilution
Factor
Source
of
Data
Review
Reference
Grapes
Juice
0.1X
MRIDXXXXXXX
DP
Barcode
Raisins
0.4X
MRIDXXXXXXX
DP
Barcode
Citrus
Fruits
Juice
0.06X
MRIDXXXXXXX
DP
Barcode
Apples
Juice
0.13X
MRIDXXXXXXX
DP
Barcode
Tomatoes
Juice
0.03X
MRIDXXXXXXX
DP
Barcode
Puree
0.6X
MRIDXXXXXXX
DP
Barcode
Catsup
0.8X
MRIDXXXXXXX
DP
Barcode
Rice
Milled
0.02X
MRIDXXXXXXX
DP
Barcode
Corn
Oil
0.01X
MRIDXXXXXXX
DP
Barcode
Cottonseed
Oil
0.007X
MRIDXXXXXXX
DP
Barcode
Meal
0.07X
MRIDXXXXXXX
DP
Barcode
Mint
Oil
12.7X
MRIDXXXXXXX
DP
Barcode
ATTACHMENT
A
SOP
No.
HED
AR­
1
Title:
Use
of
Anticipated
Residues
in
Risk
Assessment
Revision
No.
Original
Effective
Date:
FEB­
15­
99
Page
30
of
30
Methidathion
(
PC
Code
100301)­­
Anticipated
Residues
Derived
from
Monte
Carlo
Assessments
Crop/
Food
Form
Data
source
#
of
Samples
PCT
Residues
found
(
Total
non­
zeros)
Total
zeros
Value
Entered
for
NDs
Comments
orange
juice
PDP­
1997
692
100
10
­­
­­

apples
PDP­
1998
100
3
3
97
½
LOQ
pears
PDP­
1997
100
11
11
89
½
LOQ
apple
juice
PDP­
1997
683
100
­­
½
LOQ
apple
juice
PDP
­
1996
177
100
olives
FDA?
2
2
2
98
½
LOQ
oranges
Field
trial
11
11
11
89
­­
MRID#
44491001
also
used
for
citron
&

kumquats
maximum
value
3.4
ppm
Food
Form
(
RAC/
Processed)
year/

data
source
#
of
data
points
Conc.
Range
Average
Tolerance/

food/
feed
additive
#
of
nondetects
LOD
LOQ
Data
Handling
grapefruit
1996/
field
trials
10
0.76­
3.76
1.55
4
dried
pulp
8