Document ID: EPA-HQ-OPP-2003-0335-0003
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2003-11-17T05:00Z

Pesticide
Registration
(
PR)
Notice
2003­
3
NOTICE
TO
MANUFACTURERS,
FORMULATORS,
PRODUCERS
AND
REGISTRANTS
OF
PESTICIDE
PRODUCTS
ATTENTION:
Persons
Interested
in
Pesticide
Policy
Development
and
Persons
Responsible
for
Registration
of
Pesticide
Products
SUBJECT:
Procedural
Guidance
for
EPA's
Office
of
Pesticide
Programs
Procedures
Concerning
the
Development,
Modification,
and
Implementation
of
Policy
Guidance
Documents
EPA's
Office
of
Pesticide
Programs
(
OPP)
will
use
the
following
procedures
for
developing,
modifying,
and
implementing
its
pesticide
program
policy
guidance
documents.
These
procedures
have
two
goals.
The
first
is
to
facilitate
public
participation
in
the
development,
modification,
and
implementation
of
OPP
policy
guidance
documents;
the
second
is
to
clarify
that
while
such
documents
are
non­
binding
policy
statements
and
not
legally
binding
rules,
they
nonetheless
play
an
important
role
in
helping
to
ensure
a
consistent
starting
point
for
OPP
decision­
making.

For
several
years
OPP
has
provided
an
opportunity
for
the
public
to
comment
on
proposed
and/
or
draft
policy
guidance
documents
and
related
substantive
revisions.
This
practice
reflects
OPP's
general
preference
for
public
and
stakeholder
participation
in
the
development
of
most
significant
policy
approaches.
OPP
believes
that
routinely
providing
an
opportunity
for
public
review
and
comment
has
not
only
helped
stakeholders
interact
with
OPP
more
effectively
but
also
has
improved
the
quality
of
the
resulting
policy
guidance
documents.
Accordingly,
OPP
believes
that
it
makes
sense
to
adopt
procedural
guidelines
for
its
staff
indicating
when
providing
an
opportunity
for
public
comment
on
draft
policy
guidance
may
be
most
valuable
and
should
be
used,
and
when
doing
so
might
provide
little
added
value
and
merely
delay
the
issuance
or
implementation
of
a
policy
or
policy
refinement.

OPP
believes
that
procedural
guidance
on
policy
development
and
refinement
should
also
help
policy
writers
develop
useful
guidance
documents
that
do
not
cross
the
line
between
nonbinding
policy
statements
and
legally
binding
regulations.
EPA,
as
well
as
other
federal
agencies,
have
increasingly
faced
litigation
claiming
that
policy
documents
are,
in
effect,
thinly­
disguised
regulations
and
that
they
are
invalid
for
failure
to
comply
with
the
procedural
requirements
of
the
Administrative
Procedures
Act
(
APA)
(
5
U.
S.
C.
§
553).
See,
e.
g.,
General
Electric,
Co.
v.
EPA,
290
F.
3d
377,
384
(
D.
C.
Cir.
2002);
Appalachian
Power
Co.
v.
EPA,
208
F.
3d
1015,
1023
(
D.
C.
Cir.
2000).
The
challenge
is
to
provide
guidance
to
staff
to
help
insure
consistent
agency
decisionmaking
while
at
the
same
time
not
constraining
agency
discretion
or
appearing
to
discourage
affected
parties
from
seeking
alternatives
to
agency
policy
approaches.
Accordingly,
this
policy
guidance
document
provides
procedural
guidance
for
OPP's
drafters
of
policy
guidance
documents
that
will
help
them
balance
the
sometimes
conflicting
objectives
of
consistency
and
flexibility.

I.
EFFECT
OF
THIS
PROCEDURAL
GUIDANCE
DOCUMENT
This
document
sets
forth
procedures
on
developing
policy
guidance
documents.
In
addition,
it
explains
how
staff
should
use
policy
guidance
documents
in
agency
decision­
making.
These
procedures
are
not
binding
on
EPA
and
any
affected
party
may
urge
EPA
to
follow
a
different
approach
to
policy
development.

II.
GENERAL
STATEMENT
OF
OPP'S
POLICY
UNDERLYING
THESE
PROCEDURES
OPP
thinks
that
public
involvement
in
the
development
of
all
types
of
policy
guidance
documents
is
useful.
Therefore,
OPP's
general
practice
should
be
to
provide
notice
and
an
opportunity
for
public
comment
as
early
as
practicable
and
appropriate
in
the
development
of
all
significant
new
pesticide
policy
guidance
documents
(
defined
below)
or
significant
modifications
to
such
policy
guidance
documents.
Non­
significant
policy
guidance
documents
(
defined
below)
should
be
available
to
the
public
and
a
procedure
should
be
described
by
which
affected
parties
can
communicate
their
views
on
such
documents
to
OPP.

All
policy
guidance
documents
should
clearly
explain
that,
while
they
are
intended
to
aid
consistent
decision­
making
by
OPP,
they
are
not
binding
either
on
OPP
or
on
affected
parties.
In
other
words,
policy
guidance
documents
define
a
framework
and
starting
point
for
OPP
decisionmaking
but
each
regulatory
action
considered
by
OPP
presents
the
opportunity
to
reassess
both
the
policy
itself
and
its
application
to
the
particular
circumstances.

III.
DEFINITIONS
"
Policy
guidance
document"
 
A
policy
guidance
document
describes
OPP
policies
of
general
applicability
for
the
benefit
of
OPP
staff,
the
regulated
community,
advocacy
groups,
and
the
general
public.
Policy
guidance
documents
generally
include
the
term
"
policy"
or
"
guidance"
in
their
titles.
Policy
guidance
documents
generally
would
not
include
pesticide­
specific
peer
reviews
or
registration,
reregistration,
or
tolerance
decision
documents
(
including
orders
issued
under
FIFRA
section
3(
c)(
2)(
B),
whether
issued
to
a
registrant
of
an
individual
pesticide
or
multiple
registrants
of
a
group
of
pesticides),
internal
OPP
administrative
procedures,
reports,
speeches,
press
materials,
or
letters
or
other
correspondence
with
individuals,
organizations,
or
companies.
This
document
describes
two
subgroups
of
policy
guidance
documents:
"
significant
policy
guidance
documents"
and
"
non­
significant
policy
guidance
documents."

"
Significant
policy
guidance
document"
 
The
judgment
that
a
policy
guidance
document
is
significant
should
take
into
account,
among
other
things,
the
following
factors:
(
1)
the
potential
impact
of
the
policy
on
regulated
entities
and
on
the
public
health
and
the
environment
and
whether
some
stakeholders
are
likely
to
regard
the
impact
as
significant;
(
2)
whether
the
policy
involves
the
initial
implementation
of
statutory
or
regulatory
changes;
(
3)
the
complexity
of
the
science
or
technical
issues
involved;
(
4)
the
policy's
potential
for
creating
controversy;
and
(
5)
the
potential
breadth
of
applicability
of
the
document.
For
example,
each
of
these
factors
suggests
that
OPP's
policy
implementing
the
FQPA
provision
for
an
additional
safety
factor
to
protect
infants
and
children
would
qualify
as
significant.
OPP
believes
that
its
guidelines
for
performing
pesticide
testing
would
also
be
significant
in
most
instances.
Further,
many
Pesticide
Registration
Notices
would
meet
these
criteria
for
significance.

"
Non­
significant
policy
guidance
document"
 
Any
policy
guidance
document
that
is
not
"
significant"
is
considered
a
"
non­
significant
policy
guidance
document."
Examples
of
documents
which
generally
would
not
qualify
as
significant
include
Standard
Operating
Procedures
for
EPA
review
of
studies,
or
memoranda
by
any
of
OPP's
internal
peer
review
committees,
unless
they
contain
significant
new
policy
guidance.
Additionally,
Pesticide
Registration
Notices
that
simply
convey
information,
such
as
where
to
send
application
materials,
would
also
be
considered
nonsignificant
policy
guidance.

IV.
PROCEDURES
FOR
SIGNIFICANT
POLICY
GUIDANCE
DOCUMENTS
A.
Procedures
For
significant
policy
guidance
documents
or
significant
modifications
of
such
policy
documents,
notice
of
a
draft
policy
and
a
comment
opportunity
should
be
provided
in
a
manner
likely
to
insure
it
comes
to
the
attention
of
interested
stakeholders.
At
a
minimum,
this
should
include
a
clear
notice
on
the
Agency's
website
(
e.
g.,
OPP's
or
the
Science
Advisory
Panel's
(
SAP)
website)
and
the
publication
of
a
notice
in
the
Federal
Register.
In
some
cases,
it
may
also
be
appropriate
to
provide
individual
notice
to
affected
parties.
When
OPP
or
the
SAP
announces
the
opportunity
to
comment
on
a
significant
policy
guidance
document
in
the
Federal
Register,
it
will
also
follow
applicable
procedures
for
establishing
and
maintaining
a
public
docket
(
including
procedures
for
ensuring
that
confidential
business
information
is
not
inadvertently
released),
utilizing
EPA's
online
docket
and
comment
system,
EDOCKET
at
http://
www.
epa.
gov/
edocket.
The
period
for
public
comment
should
be
long
enough
to
allow
meaningful
comment,
taking
into
account
any
needs
of
OPP
to
act
quickly.

B.
Timing
of
Comment
Opportunity
To
the
extent
practical
and
appropriate,
a
notice
and
comment
opportunity
for
a
significant
policy
guidance
document
should
be
provided
prior
to
the
issuance
of
the
document
for
implementation.
Frequently,
however,
policy
positions
are
first
implemented
in
individual
pesticide
registration
or
tolerance
decisions,
and
only
after
accumulating
experience
through
a
case­
by­
case
approach
does
OPP
draft
a
policy
guidance
document
for
general
applicability.
Where
such
policy
guidance
documents
principally
systemize
and
extend
the
policies
developed
through
earlier
case­
by­
case
decisions,
the
concept
of
preimplementation
notice
and
comment
must
be
adapted
to
recognize
the
facts
of
the
situation.
When
a
policy
guidance
document
makes
a
significant
break
with
prior
OPP
practice,
preimplementation
notice
and
comment
is
more
appropriate;
however,
it
is
still
important
to
take
into
account
such
factors
as
any
need
for
OPP
to
act
quickly
to
protect
the
public
health
and
the
environment
or
other
goals
of
importance.
If
pre­
implementation
notice
and
comment
is
not
provided,
a
prompt
post­
implementation
notice
and
comment
period
should
be
held.

C.
Response
to
Comment
When
OPP
provides
a
comment
opportunity
on
a
significant
policy
guidance
document,
a
document
responding
to
all
significant
comments
should
generally
be
prepared.
This
document
should
generally
be
made
available
in
the
same
time
frame
as
when
the
policy
guidance
document
is
issued
and
should
be
in
a
form
that
shows
how
EPA
evaluated
public
comments.
To
ensure
easy
and
direct
public
access,
this
document
will
be
placed
in
the
public
docket
established
for
the
draft
policy
guidance
document.
In
circumstances
where
commenters
voice
a
significant
disagreement
with
a
draft
policy
guidance
document,
release
of
a
response
to
comments
document
prior
to
revision
of
the
draft
policy
guidance
document
should
be
considered
if
such
further
interaction
with
stakeholders
might
substantially
aid
implementation
of
the
guidance
document.

V.
PROCEDURES
FOR
NON­
SIGNIFICANT
POLICY
GUIDANCE
DOCUMENTS
A.
Procedures.
Policy
guidance
documents
that
OPP
does
not
regard
as
significant
should
be
made
available
to
the
public
on
OPP's
website
if
they
are
of
public
interest.
Documents
likely
to
fall
into
this
category
are
certain
OPP
Standard
Operating
Procedures
and
minor
modifications
to
significant
policy
guidance
documents.
As
part
of
placing
the
document
on
the
website,
the
document
should
identify
a
contact
person
within
OPP
and
the
public
docket
established
in
EDOCKET
to
which
comments
on
the
document
may
be
sent.

B.
Timing.
Placement
of
such
policy
guidance
documents
on
the
website
should
occur
as
soon
as
practical
after
the
document
is
issued.
Staff
should
plan
time,
before
posting
the
documents
on
the
EPA
website,
to
review
the
document
for
the
presence
of
trade
secret
and
Confidential
Business
Information
(
CBI)
and
for
the
preparation
of
the
document
to
comply
with
requirements
for
accessibility
by
people
with
disabilities
(
29
U.
S.
C
§
794d).

C.
Response
to
Comments.
Non­
frivolous,
substantive
comments
received
on
nonsignificant
policy
guidance
documents
placed
on
OPP's
website
should
be
acknowledged
and
addressed
appropriately,
either
individually
or
by
preparing
a
generic
response
document.
Comments
received
and
OPP's
responses
will
be
placed
in
the
public
docket.

VI.
PROCEDURES
TO
CLARIFY
THE
NON­
BINDING
NATURE
OF
POLICY
GUIDANCE
DOCUMENTS
Policy
guidance
documents
do
not
bind
either
outside
parties
(
regulated
entities,
advocacy
groups,
or
the
public)
or
OPP.
Under
general
principles
of
administrative
law,
a
document
of
general
applicability
including
binding
requirements
is
not
a
policy
but
a
regulation,
and
thus
must
comply
with
the
statutory
requirements
for
promulgating
regulations,
i.
e.,
the
APA
or
other
applicable
statutory
authority.

Every
OPP
policy
guidance
document
should
clearly
state
that
it
is
not
binding
on
the
public
or
OPP,
and
that
OPP
decision­
makers
and
staff
should
not
treat
any
policy
guidance
document
as
if
it
were
a
legally
binding
rule.
Each
policy
guidance
document
should
also
explain
that
OPP
staff
should
remain
open
to
consideration
of
alternative
approaches,
and
that
affected
parties
remain
free
to
assert
that
the
policy
should
not
apply
B
in
whole
or
in
part
B
to
a
given
situation,
or
to
urge
a
totally
different
policy
approach
on
OPP.
A
model
statement
is
included
in
the
Appendix.

VII.
PROCEDURES
TO
AID
IN
CONSISTENT
DECISION­
MAKING
UNDER
POLICY
GUIDANCE
DOCUMENTS
Each
policy
guidance
document
should
also
emphasize
the
importance
of
consistent
application
of
policy
guidance
documents
by
OPP
staff.
Nonetheless,
because
policy
guidance
documents
are
not
binding,
they
should
also
note
that
a
decision
cannot
be
justified
simply
by
citing
to
the
policy
guidance
document
but
must
also
contain
the
rationale
for
the
decision.

Further,
the
policy
guidance
document
should
specifically
highlight
the
importance
of
explaining
the
rationale
for
any
departure
from
existing
policy
guidance
documents.
Although
OPP
policy
guidance
documents
are
non­
binding,
they
reflect
the
current
thinking
of
OPP,
and
therefore
OPP
staff
are
expected
to
apply
them
consistently
unless
there
is
a
good
reason
for
adopting
an
alternative
approach.
If
OPP
staff
believe
an
alternative
approach
is
warranted,
that
approach
and
rationale
should
be
presented
to
OPP
decision­
makers.
Any
decision
by
OPP
to
vary
from
a
policy
guidance
document
should
explicitly
state
how
it
varies
from
existing
guidance
and
provide
a
written
explanation
for
the
variation.
A
model
statement
explaining
these
points
is
included
in
the
Appendix.

After
release
of
a
policy
guidance
document,
decisions
made
with
regard
to
the
policy
guidance
document
should
be
periodically
examined
to
determine
if
the
policy
guidance
document
has,
in
fact,
aided
in
consistent
decision­
making.
This
evaluation
process
may
be
helpful
in
deciding
whether
the
policy
guidance
document
should
be
retained,
revised,
or
eliminated.
Appendix
 
Model
Language
to
Include
in
OPP
Policy
Guidance
Documents
Non­
binding
Nature
of
This
Policy
Guidance
Document
This
document
describes
a
current
policy
position
of
OPP,
but
it
is
not
a
legally
binding
regulation.
It
binds
no
one
 
not
the
regulated
community,
not
advocacy
groups,
not
the
public,
and
not
OPP.
In
any
decision
before
OPP,
any
stakeholder
may
urge
OPP
to:
(
1)
conclude
that
this
policy
guidance
document
is
inapplicable;
(
2)
consider
factors
other
than
those
described
in
this
policy
guidance
document;
(
3)
make
an
exception
to
the
policy
guidance
document
as
written;
or
(
4)
amend
or
abandon
the
policy
in
its
entirety.
Even
if
no
such
arguments
are
made
to
OPP,
OPP
may
decide
on
its
own
initiative
that
the
circumstances
warrant
the
Agency
to
act
at
variance
from
this
policy
guidance
document.
Thus
affected
parties
should
not
assume
that
carefully
following
this
policy
guidance
document
will
guarantee
a
specific
decision
or
action
by
OPP.
If
OPP
does
decide
to
vary
from
this
policy
guidance
document,
OPP
would
explicitly
state
how
it
varies
from
the
policy
and
provide
a
written
explanation
for
this
variance
in
the
context
of
that
decision.

Consistent
Application
of
This
Policy
Guidance
Document
Although
OPP's
policy
guidance
documents,
including
this
one,
are
non­
binding,
they
reflect
the
current
thinking
of
OPP,
and
therefore
OPP
staff
are
expected
to
use
them
as
guides
for
decision­
making
unless
there
is
a
good
reason
for
adopting
an
alternative
approach.
Accordingly,
this
policy
guidance
documents
should
serve
as
a
reference
and
starting
point
for
OPP
staff
for
analyzing
the
issues
as
they
arise
in
individual
pesticide
matters.
Importantly,
it
should
be
remembered,
however,
that
this
policy
guidance
document
does
not
provide
authority
for
reaching
specific
results
B
each
individual
decision
must
be
based
on
sound
factual,
scientific,
and
legal
conclusions.
Further,
if
OPP
staff
believe,
based
upon
their
own
analysis
or
upon
comments
of
any
stakeholder,
that
an
alternative
decision­
making
approach
to
the
one
outlined
in
this
policy
guidance
document
is
warranted,
that
approach
would
be
presented
to
OPP
decision­
makers
for
their
consideration.
Any
decision
by
OPP
to
vary
from
this
policy
guidance
document
should
be
accompanied
by
a
written
explanation
provided
in
the
context
of
that
decision
specifically
addressing
the
reason
for
the
variance.