Document ID: EPA-HQ-OPP-2003-0084-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2003-04-14T04:00Z

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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:
Submission
of
Unreasonable
Adverse
Effects
Information
under
FIFRA
Section
6(
a)(
2)

ICR
Nos.:
OMB
No.
2070­
0039;
EPA
No.
1204.09
1(
b)
Short
Characterization/
Abstract
This
Information
Collection
Request
(
ICR)
is
a
renewal
of
an
existing
ICR
that
is
currently
approved
by
OMB
and
is
due
to
expire
January
31,
2004.
Section
6(
a)(
2)
of
the
Federal
Insecticide,
Fungicide
and
Rodenticide
Act
(
FIFRA)
requires
pesticide
registrants
to
submit
information
to
the
Agency
that
they
acquire
which
may
be
relevant
to
the
balancing
of
the
risks
and
benefits
of
a
pesticide
product
(
see
Attachment
A).
In
CSMA
and
NACA
v.
EPA
484
F.
Supp.
513
(
1980),
the
U.
S.
District
Court
for
the
District
of
Columbia
agreed
with
EPA
that
FIFRA
Section
6(
a)(
2)
covers
all
information
relevant
to
EPA's
determination
of
whether
a
pesticide
may
cause
unreasonable
adverse
effects.
The
Court
agreed
that
submissible
information
includes
the
same
type
of
information
as
that
provided
by
a
registrant
as
part
of
an
application
for
registration.
The
Court
specifically
rejected
the
argument
that
the
responsibility
for
determining
what
constitutes
an
unreasonable
adverse
effect
shifts
to
industry
once
EPA
has
granted
a
registration.

The
statute
requires
the
registrant
to
submit
any
factual
information
that
it
acquires
regarding
adverse
effects
associated
with
its
pesticidal
products,
and
it
is
up
to
the
Agency
to
determine
whether
or
not
that
factual
information
constitutes
an
unreasonable
adverse
effect.
In
order
to
limit
the
amount
of
less
meaningful
information
that
might
be
submitted
to
the
Agency,
the
EPA
has
limited
the
scope
of
factual
information
that
the
registrant
must
submit.
On
September
19,
1997,
the
Agency
published
final
regulations
(
62
FR
49370)
that
provided
a
detailed
description
of
the
reporting
obligations
of
registrants
under
FIFRA
section
6(
a)(
2).
The
regulations
became
effective
on
August
17,
1998.

As
expected,
implementation
of
the
final
regulations
initially
resulted
in
an
increase
in
the
number
of
incident
reports
submitted
annually.
That
was
assumed
to
be
the
result
of
increased
awareness
and
understanding
on
the
part
of
pesticide
registrants
of
their
reporting
responsibilities
under
FIFRA
section
6(
a)(
2).
After
the
first
year
under
the
regulations,
reporting
leveled
off
and
has
remained
generally
consistent
for
both
studies
and
incident
reports.
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2.
NEED
FOR
AND
USE
OF
THE
COLLECTION
2(
a)
Need/
Authority
for
the
Collection
This
information
collection
stems
from
a
non­
discretionary
statutory
requirement.
Submission
of
information
about
unreasonable
adverse
effects
is
specifically
required
under
section
6(
a)(
2)
of
the
Federal
Insecticide
Fungicide
and
Rodenticide
Act
(
FIFRA)
(
7
USC
136d(
a)(
2)):

"
If
at
any
time
after
the
registration
of
a
pesticide
the
registrant
has
additional
factual
information
regarding
unreasonable
adverse
effects
on
the
environment
of
the
pesticide,
he
shall
submit
such
information
to
the
Administrator."

The
Agency's
FIFRA
section
6(
a)(
2)
regulations
are
codified
in
the
Code
of
Federal
Regulations
(
CFR)
at
40
CFR
part
159.
(
Attachment
B)

2(
b)
Practical
Utility/
Users
of
the
Data
The
Office
of
Pesticide
Programs
(
OPP)
is
the
primary
user
of
the
information
that
registrants
would
submit
to
the
Agency
under
FIFRA
section
6(
a)(
2).
The
information
submitted
is
an
essential
component
of
the
Agency's
pesticide
registration
and
reregistration
programs
because
it
requires
the
submission
of
important
information
regarding
a
pesticide's
adverse
effects
­­
information
which
may
not
have
been
available
at
the
time
of
the
Agency's
initial
review
of
a
registration
application.
Because
this
information
has
possible
significant
consequences
for
human
health
or
the
environment,
had
the
information
been
available
earlier,
the
Agency's
determination
with
regard
to
the
registration
of
the
pesticide
may
well
have
been
different.
If
warranted
by
the
information
provided,
EPA
may
seek
to
amend
the
registration
in
order
to
address
the
concerns
raised
by
the
information.

In
essence,
this
information
provides
an
important
means
of
focusing
EPA
attention
on
key
problem
areas
regarding
the
use
of
the
pesticide
in
question.
The
adverse
effects
information
submitted
under
section
6(
a)(
2)
is
considered
by
EPA
in
conjunction
with
other
information
to
determine
whether
pesticides
containing
a
specific
active
ingredient
should
be
reregistered,
or
whether
the
terms
and
conditions
of
registration
should
be
changed.
This
type
of
information
may
also
be
pertinent
to
granting
emergency
exemptions
under
section
18
of
FIFRA.

Registrants
perform
studies
voluntarily
in
support
of
registration
applications
or
in
response
to
data
call­
ins
issued
by
EPA.
The
authority
to
call
in
data
is
found
in
section
3(
c)(
2)(
B)
of
FIFRA,
and
are
covered
by
other
ICRs
that
are
also
approved
by
OMB.
The
outcome
of
those
studies
­­
whether
they
demonstrate
known
effects
or
new
adverse
effects
­­
are
carefully
analyzed
by
registrants
and
presented
to
the
Agency.
This
rule
does
not
impose
the
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requirement
to
perform
studies
but
merely
to
identify
and
promptly
submit
adverse
effects
information
to
the
Agency.
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Many
registrants
have
indicated
that
adverse
effects
information
is
valuable
to
them
as
well.
Registrants
who
actively
seek
6(
a)(
2)
information
justified
their
actions
as
part
of
product
stewardship,
customer
relations,
minimizing
liability,
and
protecting
or
expanding
market
share.
According
to
feedback
that
EPA
has
received,
registrants
acquire
and
use
this
information
as
a
way
of
determining
whether
actual
product
use
circumstances
reveal
new
risk
issues
that
did
not
emerge
when
the
data
were
developed
for
the
original
registration
application.
These
registrants
believe
that
it
is
an
integral
part
of
their
product
stewardship
program
and
that
collecting,
analyzing
and
reacting
to
adverse
effects
information
is
essential
to
the
way
in
which
they
conduct
business
as
a
routine
matter.
For
example,
the
web
site
for
CropLife
America,
the
trade
association
for
registrants
of
agricultural
pesticide
products,
describes
its
stewardship
practices
for
crop
protection
and
specialty
pest
management
products.
Among
the
practices
for
customer
product
stewardship
is
implementation
of
a
system
to
obtain
feedback
of
information
related
to
product
use,
misuse,
and
adverse
effects.
The
web
site
for
Consumer
Specialty
Products
Association,
the
trade
association
for
registrants
of
antimicrobial
pesticide
products,
describes
its
Product
Care
program.
Among
the
principles
of
the
voluntary
program
is
In­
Market
Support,
Incident
Evaluation
and
Follow­
Up.

3.
NON
DUPLICATION,
CONSULTATIONS,
AND
OTHER
COLLECTION
CRITERIA
3(
a)
Non
Duplication
The
information
required
to
be
submitted
is
generally
available
only
from
registrants
who
have
opted
to
secure
registration
of
their
pesticide
product(
s).
The
only
feasible
means
of
collecting
the
required
information
is
from
pesticide
registrants
because
it
is
either
health
and
safety
data
generated,
owned
or
used
by
the
registrants,
or
is
submitted
to
registrants
by
consumers
and
other
interested
parties.
This
information
collection
avoids
duplication
by
limiting
the
submission
requirements
under
FIFRA
section
6(
a)(
2)
to
information
which
has
not
been
submitted
to
the
OPP
previously.
Further,
it
exempts
information
submitted
under
section
8(
e)
of
the
Toxic
Substances
Control
Act
(
TSCA).
Information
in
published
articles
is
generally
also
exempt
from
submission.

3(
b)
Public
Notice
Required
Prior
to
ICR
submission
to
OMB
Pursuant
to
5
CFR
1320.8(
d),
EPA
published
a
Federal
Register
notice
on
[
Insert
date
and
cite
of
FRN]
soliciting
comments
on
this
information
collection
activity
and
the
Agency's
intent
to
renew
the
OMB
approval
of
this
ICR.
The
Agency
[
did/
did
not]
receive
any
comments
on
this
ICR
renewal.
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3(
c)
Consultations
[
Insert
information
about
consultation
with
5
­
9
registrants]

[
Insert
response
to
comments
received
on
either
of
the
FRN's].

In
addition
to
the
activities
discussed
above,
dialogue
between
industry
and
the
Agency
on
adverse
effects
information
reporting
requirements,
content,
definitions,
format,
and
timing
is
frequent
and
on­
going.
In
addition
to
phone
conversations,
e­
mails,
and
letters,
Agency
staff
from
time
to
time
participate
in
meetings
with
individual
registrants
as
well
as
gatherings
of
large
groups
of
registrants.
These
communications
permit
an
exchange
of
issues,
problems,
and
solutions
on
many
issues.

3(
d)
Effect
of
Less
Frequent
Collection
Under
FIFRA
section
6(
a)(
2)
the
information
collection
activity
is
a
one
time,
nonrepetitive
submission
of
information.
As
such,
there
is
no
set
interval
for
multiple
collections.
The
information
is
submitted
one
time,
according
to
the
timeframes
described
in
the
rule
for
various
categories
of
information.

3(
e)
General
Guidelines
This
information
collection
is
well
within
the
guidelines
provided
under
the
PRA
and
the
implementing
regulations
issued
by
OMB.
It
should
be
noted,
however,
that
even
though
the
regulations
do
not
prescribe
specific
recordkeeping
requirements,
the
EPA
requirements
in
40
CFR
Section
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
either
voluntarily
canceled
or
withdrawn
by
the
registrant
or
until
EPA
has
cause
to
suspend
or
cancel
the
registration.
Since
the
average
period
of
marketability
of
a
pesticide
ranges
from
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
will
be
exceeded
for
those
studies
which
are
required
to
support
registration
or
reregistration
under
FIFRA
section
3
or
section
4,
and
which
show
adverse
effects
that
make
them
reportable
under
section
6(
a)(
2).
The
burdens
associated
with
this
recordkeeping
requirement
have
already
been
approved
by
OMB
under
another
ICR
and
are
therefore
excluded
from
this
ICR.

3(
f)
Confidentiality
Much
of
the
information
submitted
pursuant
to
section
6(
a)(
2)
constitutes
FIFRA
section
10(
d)(
1)
safety
and
efficacy
information.
On
September
28,
1999,
the
Agency
issued
a
class
determination
that
safety
and
efficacy
information
submitted
under
section
6(
a)(
2)
of
FIFRA
is
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not
entitled
to
confidential
treatment.
The
determination
enables
the
Agency
to
respond
more
quickly
and
efficiently
to
requests
for
information
submitted
under
section
6(
a)(
2).

Data
submitted
to
the
Agency
are
handled
in
accordance
with
the
provisions
of
the
FIFRA
Confidential
Business
Information
(
CBI)
Security
Manual
which
provides
procedures
for
protecting
information
claimed
as
confidential
in
accordance
with
FIFRA
section
10.
If
the
information
is
not
protected
under
FIFRA
section
10,
and
it
is
not
otherwise
protected
from
release
under
the
Freedom
of
Information
Act
(
FOIA),
EPA
is
obligated
to
make
it
available
to
members
of
the
public
upon
request
under
FOIA.

3(
g)
Sensitive
Questions
No
questions
of
a
sensitive
or
private
nature
are
included
in
this
information
collection.
If
information
of
a
sensitive
nature
is
submitted,
the
Agency
will
protect
it
appropriately,
as
provided
by
the
Privacy
Act
or
other
relevant
statutes.

4.
THE
RESPONDENTS
AND
THE
INFORMATION
REQUESTED
4(
a)
Respondents/
NAICS
Codes
Potential
respondents
affected
by
the
collection
activities
under
this
ICR
include
anyone
who
holds
or
ever
held
a
registration
for
a
pesticide
product
issued
under
FIFRA
section
3
or
24(
c).
The
North
American
Industrial
Classification
System
(
NAICS)
code
is
325320
(
Pesticide
and
Other
Agricultural
Chemical
Manufacturing).

4(
b)
Information
Requested
i)
Data
items,
including
record
keeping
requirements
As
further
defined
by
the
final
rule
implementing
the
FIFRA
section
6(
a)(
2)
requirements,
registrants
are
required
to
report
on:

(
1)
studies
showing
new
or
more
severe
toxicological
responses
than
previously
reported
of
any
type
in
any
strain
of
test
organism;
(
2)
epidemiological
or
exposure
studies
of
human
population
groups
indicating
greater
exposure
than
previously
reported;
(
3)
studies
or
incidents
tending
to
show
lack
of
efficacy
of
certain
pesticide
products
with
public­
health
related
uses;
(
4)
incidents
involving
toxic
or
adverse
effects
to
human
or
other
non­
target
organisms;
(
5)
information
on
excess
residues
on
food
or
feed,
or
residues
in
surface
water,
ground
water
or
drinking
water;
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(
6)
information
on
metabolites,
degradates,
contaminants
or
impurities
which
may
be
of
toxicological
concern;
(
7)
information
showing
that
certain
health­
related
products
fail
to
perform
as
claimed
or
that
pests
have
developed
resistance
to
a
product;
and
(
8)
other
information
which
may
be
relevant
to
risk/
benefit
determinations
of
any
type.

ii)
Respondent
Activities
Respondents
must:

(
1)
read
the
final
rule
or
instructions,
(
2)
plan
activities
to
ensure
required
information
is
identified
and
submitted,
(
3)
process,
compile
and
review
information
for
accuracy
and
appropriateness,
(
4)
complete
written
instruments
to
effectuate
a
submission,
and
(
5)
submit
the
information
to
EPA.

Under
FIFRA
section
6(
a)(
2),
as
implemented
by
the
final
rule,
pesticide
registrants
have
no
obligation
to
create
or
seek
out
adverse
effects
information.
Such
activities
may
be
conducted
by
the
registrant
in
support
of
pesticide
registration
under
FIFRA
section
3,
or
reregistration
under
section
4
(
which
are
approved
by
OMB
under
separate
ICR
approvals),
or
in
the
normal
course
of
business,
such
as
following
up
on
consumer
complaints
to
gather
more
information.
Regardless
of
how
the
information
comes
into
the
possession
of
the
registrant,
once
the
registrant
acquires
information
subject
to
submission
under
section
6(
a)(
2)
as
defined
by
the
final
rule,
the
registrant
must
submit
it
to
EPA.

5.
THE
INFORMATION
COLLECTED­­
AGENCY
ACTIVITIES,
COLLECTION
METHODOLOGY,
AND
INFORMATION
MANAGEMENT
5(
a)
Agency
Activities
The
Agency
will
continue
the
following
current
activities
with
regard
to
the
FIFRA
section
6(
a)(
2)
program:
1)
answering
questions
and
providing
guidance
to
respondents;
2)
receiving
and
recording
data
submissions;
3)
analyzing
claims
of
confidentiality
and
providing
appropriate
protection;
4)
storing
the
data
submitted;
and
5)
screening
and
analyzing
the
information
for
significance.
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5(
b)
Collection
Methodology
and
Management
The
final
rule
allows
flexibility
in
the
method
or
format
for
the
required
submission.
In
essence,
the
final
rule
specifies
the
types
of
data
that
should
be
reported
to
the
extent
the
information
is
available
and
the
reporting
time­
frames.
For
incident
information
(
but
not
studies),
these
vary
according
to
the
significance
of
the
information.

Scientific
studies
containing
6(
a)(
2)
information
are
assigned
a
Master
Record
Identifier
Number
as
are
all
other
pesticide
studies.
Adverse
effects
incident
reports
are
entered
into
a
computerized
data
base
which
can
track
incidents
by
chemical,
submitter,
type
of
incident,
date
of
submission,
and
other
parameters.
All
6(
a)(
2)
submissions
are
screened
by
subject
matter
experts
throughout
the
pesticide
program.
Data
are
forwarded
to
and
reviewed
by
pesticide
product
managers
and
science
reviewers
for
relevance
to
the
regulatory
status
of
the
pesticide
product(
s)
to
which
the
submitted
information
pertains.
The
public
may
access
the
data
by
making
a
request
under
FOIA.

OPP
has
established
standards
for
voluntary
submission
of
study
reports
in
electronic
form
(
Adobe
PDF
on
CD­
ROM).
A
6(
a)(
2)
study
could
be
submitted
electronically
just
as
easily
as
a
non­
6(
a)(
2)
study.
Regarding
incidents,
electronic
submission
is
possible,
but
would
require
a
number
of
activities
to
be
completed
as
prerequisites.
First,
OPP
would
work
with
registrants
to
develop
a
standard
form
for
submitting
incident
reports.
The
resulting
form
would
have
to
be
approved
by
OMB.
This
standard
form
would
be
an
essential
precursor
to
electronic
submission
of
incident
data.
In
addition,
the
Agency
is
developing
technical
specifications
for
its
Central
Data
Exchange,
the
portal
for
submission
of
direct
reports
to
EPA
via
a
telecommunications
network.
Finally,
OPP
is
working
on
conversion
of
all
its
existing
databases
to
a
single
integrated
system.
The
current
incident
data
base
is
expected
to
become
part
of
integrated
system,
but
conversion
has
not
yet
been
scheduled.
This
too
would
be
an
essential
precursor
to
electronic
submission
of
incident
data.

It
should
be
noted
that
at
the
time
the
final
regulations
went
into
effect
and
at
the
request
of
the
regulated
community,
OPP
staff
worked
with
industry
representatives
and
trade
associations
on
voluntary
forms
for
incident
reporting.
This
was
done
by
the
trade
associations
as
a
service
for
their
members.
The
agency
accepts
incident
reports
using
the
voluntary
forms
as
well
as
incidents
formatted
in
other
ways.
The
voluntary
forms
may
well
serve
as
the
foundation
for
standardized
forms.

5(
c)
Small
Entity
Flexibility
Regardless
of
the
size
of
the
registrant,
the
6(
a)(
2)
regulations
provide
simplified
reporting
and
extended
reporting
time­
frames
for
most
incident
reports.
The
Agency
does
not
mandate
a
specific
format
for
the
required
submission,
but,
as
noted
above,
has
worked
with
industry
to
DRAFT
FOR
PUBLIC
COMMENT
April
3,
2003
Page
9
of
17
provide
one
to
facilitate
submissions.
It
is
interesting
to
note
that
of
the
1,877
registrants
with
active
registrations,
849
hold
only
one
product
registration
and
780
hold
from
two
to
ten
registrations.

The
requirements
of
FIFRA
section
6(
a)(
2)
related
to
studies
fall
largely
on
basic
producers,
i.
e.,
a
producer
who
produces
the
active
ingredient
from
raw
materials,
because
they
are
the
registrants
most
likely
to
generate
and
possess
data
subject
to
the
information
collection.
Formulators
(
companies
that
do
not
manufacture
active
ingredients)
are
exempt
from
generating
most
health
effects
data
required
to
support
registration
except
for
product­
specific
acute
toxicity
studies.

Both
basic
producers
and
formulators,
however,
may
register
and
market
end
use
products
and
receive
incident
reports
from
distributors
and
users
of
their
products
as
well
as
other
sources
such
as
state
regulatory
agencies.
The
number
of
incident
reports
associated
with
a
pesticide
product
depends
on
such
variables
as
the
volume
of
sales
of
that
product,
and
whether
it
is
sold
to
the
general
public
or
is
restricted
to
experienced
and
trained
applicators.
Some
registrants
put
toll
free
telephone
numbers
on
their
labels
making
it
easy
for
consumers
to
contact
them
with
incident
reports.
Other
registrants,
however,
do
not.
Thus,
it
is
difficult
to
generalize
about
the
relative
burden
of
incident
reporting
in
terms
of
small
versus
large
companies.

To
further
simplify
compliance,
EPA
has
issued
detailed
Guidance,
see
attachments
D
and
E.
The
6(
a)(
2)
regulations,
however,
provide
the
maximum
possible
flexibility
to
pesticide
registrants,
including
small
entities.

5(
d)
Collection
Schedule
The
information
required
to
be
submitted
under
FIFRA
section
6(
a)(
2)
is
not
based
on
any
schedule
because
the
information
is
non­
repetitive
in
nature.
As
such,
the
information
required
to
be
submitted
by
respondents
is
generally
on
an
"
as
received
basis".
The
regulations
establish
timeframes
within
which
reportable
information
received
by
registrants
must
be
submitted
to
EPA.
The
reporting
time­
frames
vary
according
to
the
organism
exposed
and
the
relative
severity
or
rarity
of
the
alleged
effects.
Allegations
of
human
deaths
must
be
reported
individually
by
registrants
within
15
days
of
acquiring
the
information.
Other
serious
and
rare
incidents
are
reported
individually.
Generally,
they
may
be
accumulated
for
one
month
and
submitted
by
the
end
of
the
month
following
the
accumulation
period.
Minor
or
common
incidents
are
reported
as
aggregate
counts
of
incidents
and
effects
for
each
product
registration
number
or
active
ingredient.
They
may
be
accumulated
for
three
months
and
submitted
by
the
end
of
the
second
month
following
the
accumulation
period.
DRAFT
FOR
PUBLIC
COMMENT
April
3,
2003
Page
10
of
17
6.
ESTIMATING
THE
BURDEN
AND
COST
OF
THE
COLLECTION
6(
a)
Estimating
Respondent
Burden
To
estimate
the
respondent
burden,
the
Agency
used
current
statistics
on
the
number
of
registrants
of
active
products.
For
burden
estimates
related
to
study
and
incident
data
submissions,
actual
statistics
for
FY
2002
were
used.

As
of
March
2003,
for
purposes
of
this
analysis,
the
Agency
assumes
1,877
registrants
with
active
registrations.
The
number
of
registrations
held
by
each
registrant
ranges
from
1
to
697
and
the
median
is
two.
For
example,
856
registrants
hold
only
one
product
registration
and
1,629
hold
ten
or
fewer
registrations.
Thirty­
one
registrants
hold
51
­
100
product
registrations.
Only
39
companies
hold
more
than
100
registrations.

Former
registrants
have
an
obligation
to
report
adverse
effects
information
for
one
year
after
the
cancellation
or
transfer
of
their
product
so
long
as
the
former
registrant
holds
no
active
registrations.
Since
stocks
of
the
formerly
registered
products
diminish,
it
is
unlikely
these
former
registrants
would
acquire
or
submit
much
adverse
effects
information
to
the
Agency.
Former
registrants,
therefore,
are
not
included
in
the
estimated
1,877
registrants
assumed
for
this
analysis.

The
Agency
received
312
study­
related
submissions
in
FY
2002.
For
purposes
of
this
analysis,
the
Agency
assumes
325
study­
related
submissions
will
be
received
each
year.
This
gives
some
margin
for
studies
showing
adverse
effects
submitted
in
support
of
Food
Quality
Protection
Act
registration
reviews
and
tolerance
reassessments
over
the
life
of
the
ICR.

During
FY
2002,
the
Agency
received
914
submissions
from
registrants
containing
reports
of
nearly
46,000
incidents.
Of
these,
approximately
5,100
were
individually
reported
and
40,600
were
reported
as
aggregate
statistics.
A
small
number
of
incidents
­
approximately
700
­
were
reported
by
parties
other
than
registrants.
These
include
states,
EPA
regional
offices,
and
private
groups
and
individuals.
These
parties
are
not
required
to
report
adverse
effects
information
to
the
Agency,
but
their
reports
are
received
and
processed
in
the
same
way
as
registrant­
submitted
information.

The
level
of
registrant
reporting
could
have
been
substantially
higher
had
it
not
been
for
action
taken
by
the
Agency
to
eliminate
certain
types
of
incident
reports.
The
final
regulations
included
the
following
as
a
condition
for
reporting
incidents:

40
CFR
159.184(
a)(
2)
­
The
registrant
is
aware
or
has
been
informed
that
the
person
or
non­
target
organism
suffered
a
toxic
or
adverse
effect
or
may
suffer
a
delayed
or
chronic
adverse
effect
in
the
future.
(
Emphasis
added)
DRAFT
FOR
PUBLIC
COMMENT
April
3,
2003
Page
11
of
17
A
literal
interpretation
of
the
italicized
language
above
could
have
resulted
in
registrants
reporting
all
asymptomatic
exposures.
Those
are
cases
in
which
someone
alleges
exposure
to
a
pesticide,
but
is
experiencing
no
symptoms.
Or
someone
may
call
a
registrant
to
ask
if
they
may
get
sick
after
an
exposure
or
to
express
concern
that
they
may
get
sick
in
the
future
as
a
result
of
an
exposure.
(
These
were
referred
to
as
`
may
suffer'
incidents.)
OPP
consulted
with
a
major
poison
control
center
to
determine
the
volume
of
asymptomatic
exposure
calls
they
receive.
According
to
the
poison
control
center's
statistics
for
a
major
pesticide
company,
nearly
half
the
calls
they
handled
were
asymptomatic
exposures.
In
order
to
focus
resources
­
both
the
Agency's
and
registrants'
­
on
a
manageable
volume
of
useful
incident
reports,
the
Agency
eliminated
the
requirement
to
report
`
may
suffer'
incidents.
This
was
accomplished
in
PR
Notice
98­
4
(
Attachment
E),
which
referenced
the
Agency's
authority
under
Part
159.155
of
the
FIFRA
6(
a)(
2)
regulations
to
eliminate
specified
requirements
by
written
notice
to
registrants.
Elimination
of
the
requirement
is
still
in
effect.

The
number
of
registrants
represented
by
the
incident
report
submissions
is
150.
Registrants
may
report
for
themselves
alone
or
they
may
report
for
themselves
and
related
entities
such
as
their
divisions
or
subsidiaries.
Registrant
task
forces
such
as
the
Acetochlor
Registration
Partnership
may
report
for
their
member
registrants
for
specific
types
of
incidents.

For
purposes
of
this
ICR,
the
Agency
estimates
that
it
will
continue
to
receive
46,000
incident
reports
from
the
regulated
community
each
year.
It
is
the
estimated
number
of
incidents
­
not
the
total
number
of
registrants
or
number
of
registrants
represented
by
current
incident
reporting
­
that
drives
the
burden
estimates
in
this
analysis.

Another
aspect
of
the
respondents'
burden
is
ongoing
employee
training
on
compliance
with
6(
a)(
2)
reporting
requirements.
New
employees
would
require
training
and
experienced
employees
are
likely
to
receive
refresher
training.
Each
company
would
plan
training
and
track
the
status
of
training
efforts.
For
purposes
of
determining
the
number
of
employees
that
need
to
be
trained
on
adverse
effects
information
reporting,
EPA
assumed
an
average
of
10
[
need
to
consult
on
this]
employees
per
registrant
or
18,770
individuals
requiring
training
each
year.
Please
note
that
this
estimate
is
strictly
an
average.
The
actual
number
would
range
from
one
person
in
a
small
company
to
several
dozen
in
a
large
company.
The
Agency
does
not
believe
that
a
high
proportion
of
people
in
any
company
need
detailed
training
in
6(
a)(
2)
requirements.
Most
employees
who
are
likely
to
receive
information
concerning
the
effects
of
pesticide
products
are
simply
made
aware
of
the
need
to
pass
information
along
to
an
appropriate
individual
or
unit
within
the
company
that
evaluates
reports
and
prepares
submissions
to
the
Agency.

The
ICR
that
accompanied
the
final
regulations
estimated
substantial
burden
associated
with
the
first
year
of
implementation
of
the
regulatory
program.
Since
the
one­
time
effort
to
learn
about
the
regulations
and
establish
or
modify
internal
processes
and
systems
has
been
accomplished,
this
ICR
estimates
burden
hours
and
costs
associated
with
a
mature,
on­
going
DRAFT
FOR
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COMMENT
April
3,
2003
Page
12
of
17
6(
a)(
2)
program.

6(
b)
Estimating
Respondent
Costs
i)
Estimating
Labor
Costs
The
following
tables
illustrate
the
estimated
respondent
burden
and
costs.
While
the
spreadsheets
that
underlie
the
tables
calculated
in
dollars
and
cents,
the
results
are
rounded
to
the
nearest
dollar.
Please
note
that
the
burden/
costs
are
calculated
differently
for
6(
a)(
2)
studies
and
incidents
and
for
training
as
an
additional
activity.
Respondent
costs
are
based
on
managerial,
technical
and
clerical
burden
hours
estimated
at
$
130,
$
88,
and
$
40
per
hour,
respectively.
EPA
has
increased
its
estimated
labor
rates
for
respondents
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.
Respondent
labor
rates
in
the
existing
ICR
are
$
123,
$
83,
and
$
38
per
hour.

Table
1:
Annual
Respondent
Burden/
Cost
Estimates
per
Submission
­
STUDIES
BURDEN
HOURS
(
PER
YEAR)
TOTAL
COLLECTION
ACTIVITIES
Mgmt
$
130/
hr
Tech
$
88/
hr
Cler
$
40/
hr
Hours
Costs
($)

Read
Instructions
0.10
0.20
0.00
0.30
31.00
Create
Information
0.00
1.00
0.00
1.00
88.00
Compile
and
Review
0.10
0.50
0.00
0.60
57.00
Complete
Paperwork
0.00
0.10
0.50
0.60
29.00
Store
and
Maintain
Data
0.00
0.20
0.50
0.70
38.00
TOTAL
0.20
2.00
1.00
3.20
242.00
ANNUAL
BURDEN:
3.2
Total
Hours
x
325
Studies
=
1,040
Hours
ANNUAL
COSTS:
(
a)
Management:
0.20
hours
x
$
130
x
325
Studies
=
$
8,450
(
b)
Technical:
2.00
hours
x
$
88
x
325
Studies
=
$
57,200
(
c)
Clerical:
1.00
hours
x
$
40
x
325
Studies
=
$
13,000
TOTAL
=
$
78,650
DRAFT
FOR
PUBLIC
COMMENT
April
3,
2003
Page
13
of
17
Table
2:
Annual
Respondent
Burden/
Cost
Estimates
per
Submission
­
INCIDENTS
BURDEN
HOURS
(
PER
YEAR)
TOTAL
COLLECTION
ACTIVITIES
Mgmt
$
130/
hr
Tech
$
88/
hr
Cler
$
40/
hr
Hours
Costs
($)

Read
Instructions
0.00
0.10
0.00
0.10
9.00
Create
Information
0.00
0.50
0.00
0.50
44.00
Compile
and
Review
0.20
0.50
0.00
0.70
70.00
Complete
Paperwork
0.00
0.00
0.50
0.50
20.00
Store
and
Maintain
Data
0.00
0.10
0.20
0.30
17.00
TOTAL
0.20
1.20
0.70
2.10
160.00
ANNUAL
BURDEN:
2.10
Total
Hours
x
46,000
Incidents
=
96,600
Hours
ANNUAL
COSTS:
(
a)
Management:
0.20
hours
x
$
130
x
46,000
Incidents
=
$
1,196,000
(
b)
Technical:
1.20
hours
x
$
88
x
46,000
Incidents
=
$
4,857,600
(
c)
Clerical:
0.70
hours
x
$
40
x
46,000
Incidents
=
$
1,288,000
TOTAL
=
$
7,341,600
Table
3:
Total
Annual
Respondent
Burden/
Cost
for
Required
Submissions
Per
Submission
Estimates
Total
Submissions
Expected
each
Year
Totals
Burden
Hours
Costs
($)
Burden
Hours
Costs
($)

Studies
3.2
242.00
325
1,040
78,650
Incident
2.1
160.00
46,000
96,600
7,360,000
TOTAL
5.3
402.00
46,325
97,640
7,438,650
Table
4:
Registrant
Burden/
Cost
Estimates
for
Additional
Activities
­
TRAINING
Activities/
registrants
Burden
Hour
per
Respondent
Totals
Mgmt
$
130/
hr
Tech
$
88/
hr
Cler
$
40/
hr
Hours
Costs
($)

Plan
training
0.50
0.10
0.00
0.60
74.00
Conduct
employee
training
0.50
1.50
1.00
3.00
237.00
Follow­
up,
tracking
0.00
0.10
0.20
0.30
17.00
Total
1.00
1.70
1.20
3.90
328.00
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3,
2003
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Table
5:
Total
Registrant
Burden/
Cost
Estimates
for
Additional
Activities
­
TRAINING
Activity
Per
Registrant
­
Total
#
Expected
Totals
Hours
Costs
($)
Hours
Costs
($)

Plan
training
0.6
74.00
1,877
1,126
138,898
Conduct
employee
training
3.0
237.00
18,770
56,310
4,448,490
Follow­
up,
tracking
0.3
17.00
1,877
563
31,909
Total
3.9
328.00
22,524
57,999
4,619,297
Table
6:
Total
Annual
Burden/
Cost
for
Registrants
Per
Activity
Total
Estimates
Total
Activities
Totals
Burden
Hours
Costs
($)
Burden
Hours
Costs
($)

Studies
3.2
242.00
325
1,040
78,650
Incidents
2.1
160.00
46,000
96,600
7,360,000
Training
3.9
328.00
22,524
57,999
4,619,297
TOTAL
155,639
12,057,947
ii)
Estimating
Capital
and
Operations
and
Maintenance
Costs
There
are
no
capital
expenditures
associated
with
this
information
collection
activity.

6(
c)
Estimating
Agency
Burden
and
Cost
Agency
activities
include:
screening
6(
a)(
2)
submissions
by
subject
matter
experts
to
determine
the
significance
of
the
information;
information
management
activities
to
record,
file,
and
track
the
submissions;
communicating
with
registrants,
providing
guidance
on
the
requirements;
and
management
and
oversight
of
the
process.

Screening
and
managing
submitted
information
involves
fairly
high
level
of
management/
technical
personnel
due
to
the
complex
and
variable
nature
of
submitted
material.
For
purposes
of
this
estimate
we
have
used
an
average
grade
of
GS­
14,
Step
5
with
an
hourly
rate
of
$
78.
Some
tasks
can
be
performed
by
clerical
workers
with
an
average
grade
of
GS­
7,
Step
5
with
an
hourly
rate
of
$
29.
The
Agency
contracts
out
much
of
the
incident
data
and
document
management
activities.
(
This
is
reflected
in
Table
8
below.)
This
practice
will
continue
over
the
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April
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2003
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15
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17
life
of
the
ICR.

The
Agency
burden
estimate
does
not
include
the
effort
to
fully
review
a
6(
a)(
2)
study
or
to
prepare
the
resulting
documents.
Nor
does
the
burden
estimate
include
the
effort
to
take
regulatory
action
that
may
result
from
6(
a)(
2)
adverse
effects
information.
The
burden
associated
with
those
activities
is
covered
under
other
ICR's.

The
following
tables
illustrate
the
estimated
Agency
burden
and
costs:

Table
7:
Annual
Agency
Burden/
Cost
Estimates
per
Submission
­
STUDIES
BURDEN
HOURS
(
per
year)
TOTAL
COLLECTION
ACTIVITIES
Mgmt/
Tech
$
83/
hr
(
GS­
14,
Step
5)
Cler
$
33/
hr
(
GS­
7,
Step
5)
Hours
Costs
($)

Screen
submitted
information
2.00
0.00
2.00
166.50
Record,
file
and
track
submissions
3.60
0.90
4.50
329.76
TOTAL
5.60
0.90
6.50
496.26
ANNUAL
BURDEN:
6.5
Total
Hours
x
325
studies
=
2,112
Hours
ANNUAL
COSTS:
(
a)
Mgmt/
Tech:
5.6
hours
x
$
83
x
325
studies
=
$
151,060
(
b)
Clerical:
0.9
hours
x
$
33
x
325
studies
=
$
9,652
TOTAL
=
$
160,712
Table
8:
Annual
Agency
Burden/
Cost
Estimates
per
Submission
­
INCIDENTS
BURDEN
HOURS
(
per
year)
TOTAL
COLLECTION
ACTIVITIES
Mgmt/
Tech
$
83/
hr
(
GS­
14,
Step
5)
Cler
$
33/
hr
(
GS­
7,
Step
5)
Hours
Costs
($)

Screen
submitted
information
0.052
0.00
0.052
4.33
Record,
file
and
track
submissions
0.020
0.006
0.026
1.87
Communications,
Guidance
0.017
0.00
0.017
1.41
TOTAL
0.089
0.006
0.095
7.61
ANNUAL
BURDEN:
0.095
Total
Hours
x
46,000
submissions
=
4,370
Hours
ANNUAL
COSTS:
(
a)
Mgmt/
Tech:
0.089
hours
x
$
83
x
46,000
submissions
=
$
339,802
(
b)
Clerical:
0.006
hours
x
$
33
x
46,000
submissions
=
$
9,108
(
c)
Contractor
Costs
=
$
80,000
TOTAL
=
$
428,910
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April
3,
2003
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Table
9:
Total
Annual
Burden/
Cost
for
Agency
Per
Submission
Estimates
Total
Submissions
Expected
each
Year
Totals
Burden
Hours
Costs
($)
Burden
Hours
Costs
($)

Studies
6.50
496.26
325
2,112
160,712
Incidents
0.095
7.61
46,000
4,370
428,910*

TOTAL
6,482
589,622
*
Includes
$
80,000
contractor
costs
6(
d)
Bottom
Line
Hours
and
Cost
Tables
The
total
burden
hours
and
costs
for
respondents
and
the
Agency
have
been
calculated
and
are
presented
in
Table
10:

Table
10:
MASTER
TABLE
TOTAL
Hours
Cost
Annual
Respondent
Burden/
Cost
Estimates
155,639
$
12,057,947
Annual
Agency
Burden/
Cost
Estimates
6,483
$
589,622
TOTAL
162,122
$
12,647,569
The
average
per
respondent
burden
is
83
hours(
155,639
total
hours
÷
1,877
total
potential
respondents),
and
the
average
cost
is
$
6,424
per
respondent
($
12,057,947
total
cost
÷
1,877
total
potential
respondents).
Not
all
of
the
potential
respondents
are
likely
to
submit
information
each
year.
This
calculation
is
a
simple
average
of
the
burden
and
does
not
reflect
a
the
more
likely
potential
respondent
burden
which
is
characterized
by
the
type
of
submission,
the
number
registrations
held,
and
the
number
of
incidents
that
need
to
be
reported.

6(
e)
Reasons
for
Change
in
Burden
In
the
previous
ICR,
OMB
approved
166,266
burden
hours
for
submission
of
information
from
pesticide
registrants
under
FIFRA
6(
a)(
2)
with
a
cost
of
$
12,414,068.
This
ICR
renewal
request
reflects
a
decrease
of
approximately
10,600
burden
hours
to
an
annual
respondent
burden
of
155,640
hours
at
cost
of
$
12,057,947.
The
change
in
burden
reflects
a
number
of
adjustments.
First,
for
the
renewal
ICR,
there
are
slightly
fewer
registrants
of
active
products
(
1,877
versus
1,890)
and
fewer
employees
to
be
trained
(
18,770
versus
18,900)
than
reflected
in
the
prior
ICR.
Burden
estimates
associated
with
the
number
of
studies
the
respondents
might
submit
on
an
annual
basis
have
been
reduced
because
the
estimated
number
of
study
submissions
is
reduced
DRAFT
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April
3,
2003
Page
17
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17
from
350
studies
to
325.
Based
on
four
years
experience
with
the
6(
a)(
2)
regulations,
the
burden
hour
estimate
for
study
and
incident
report
submissions
are
reduced
by
nine
per
cent.
For
studies,
the
burden
hours
are
reduced
from
5.9
to
3.2
hours
per
study.
For
incident
reports,
the
burden
hours
are
reduced
from
2.3
to
2.1
hours.
These
reductions
reflect
a
mature
program
and
the
familiarity
with
the
regulations
that
comes
with
experience.
Burden
costs,
however,
are
not
comparably
reduced
because
of
the
higher
labor
rates.

6(
f)
Burden
Statement
The
total
annual
"
respondent"
(
applicant)
burden
for
ICR
entitled
Submission
of
Unreasonable
Adverse
Effects
Information
Under
FIFRA
Section
6(
a)(
2),
which
is
approved
by
OMB
under
OMB
Control
No.
2070­
0039,
is
estimated
to
be
155,640
hours,
with
an
average
potential
per
respondent
burden
of
83
hours.
According
to
the
PRA,
"
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
numbers
for
EPA's
regulations,
after
initial
display
in
the
final
rule,
are
listed
in
40
CFR
part
9,
and
appear
on
the
information
collection
instrument
as
applicable,
i.
e.,
form
or
instructions.

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
(
2822),
1200
Pennsylvania
Avenue,
NW,
Washington,
D.
C.
20460.
Include
the
OMB
control
number
in
any
correspondence
but
do
not
submit
the
requested
information
to
this
address.
The
requested
information
should
be
submitted
in
accordance
with
the
instructions
accompanying
the
form,
or
as
specified
in
the
corresponding
regulation.