Document ID: EPA-HQ-OPP-2003-0335-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2003-11-17T05:00Z

1
Several
other
commenters
submitted
comments
that
were
similar
to
those
of
AFBF.
To
avoid
repetition,
a
separate
response
has
not
been
provided
on
those
comments.
RESPONSE
TO
PUBLIC
COMMENTS:
PROCEDURES
CONCERNING
THE
DEVELOPMENT,
MODIFICATION,
AND
IMPLEMENTATION
OF
POLICY
GUIDANCE
DOCUMENTS
Significant
comments
are
summarized
and
responded
to
below.
The
comments
and
comment
response
have
been
grouped
by
commenter.

A.
American
Farm
Bureau
Federation
and
CropLife
America
(
both
referred
to
as
AFBF)
1
1.
Supports
use
of
"
intermediate"
policy/
rule.
AFBF
stated
that
it
supports
the
policy's
adoption
of
a
form
of
policy
that
holds
a
status
"
intermediate"
between
"
informal
`
policy'
and
formal
`
rulemaking.'"

Response:
OPP
has
no
intention
of
creating
a
new
type
of
policy.
Policies
developed
through
use
of
these
procedures
are
intended
to
be
standard­
issue
policies
under
the
Administrative
Procedure
Act
(
APA)
(
5
U.
S.
C.
§
553),
as
such
policies
have
been
defined
by
the
APA
and
the
extensive
case
law
regarding
APA
policies.
These
procedures
are
merely
intended
to
aid
in
increasing
public
participation
in
policy
development
and
Agency
coordination
in
implementation
of
policies.

2.
Notice
and
comment
procedures
should
be
used
with
regard
to
policy
decisions
reflected
in
individual
registration
and
tolerance
actions.
AFBF
recognized
that
OPP
will
continue
to
make
case­
by­
case
decisions
on
many
pesticide
matters
but
contended
that
OPP
should
use
notice
and
comment
before
making
any
policy
decision
in
an
individual
matter
that
may
have
general
applicability.
AFBF
urges
OPP
to
minimize
the
practice
of
making
policy
decisions
in
acting
on
individual
pesticides.

Response:
These
procedures
are
designed
for
the
development
of
generic
policy
guidance
documents,
not
pesticide­
specific
matters
under
FIFRA
and
the
FFDCA.
Both
FIFRA
and
the
FFDCA
contain
extensive
procedural
requirements
pertaining
to
EPA's
decisionmaking
on
specific
pesticide
actions.
Nothing
in
this
procedural
guidance
should
be
construed
to
limit,
in
any
respect,
EPA's
authority
to
take
pesticide­
specific
action
under
FIFRA
or
the
FFDCA.
As
the
procedural
guidance
notes,
OPP
frequently
takes
policy
positions
in
resolving
individual
pesticide
registration
and
tolerance
actions.
OPP
believes
this
is
a
reasonable
procedure
because
it
is
often
much
more
difficult
to
develop
policy
approaches
in
a
vacuum
than
in
concrete
factual
situations.
OPP
does
not
foresee
any
change
in
its
historical
practice
in
this
regard.

3.
Significant
policy
guidance
should
be
consistently
applied
unless
and
until
the
policy
is
officially
changed
by
OPP.
AFBF
stated
that
OPP
should
deviate
from
existing
policies
only
in
"
unusual
circumstances."
Response:
OPP
recognizes
the
value
of
consistency
in
its
decision­
making.
Nonetheless,
a
policy
is
a
non­
binding
document.
Although
OPP
may
bear
some
burden
of
explanation
for
any
departure
from
existing
policy,
it
is
not
consistent
with
APA
principles
to
suggest
that
before
EPA
may
depart
from
an
existing
policy
some
threshold
showing,
such
as
the
presence
of
"
unusual
circumstances,"
must
be
satisfied.

4.
Non­
significant
policies
should
be
made
public
immediately
upon
completion
and
prior
to
implementation.
AFBF
asked
that
non­
significant
policies
should
be
made
public
immediately
upon
completion
and
prior
to
implementation
and
that
procedures
for
public
comment
on
such
policies
should
be
made
clear.

Response:
This
procedural
guidance
recommends
that
non­
significant
policies
be
made
available
as
soon
as
practical.
Given
such
policies
non­
significant
nature,
this
seems
to
be
a
reasonable
approach.
OPP
plans
to
clearly
enunciate
comment
procedures
in
making
such
policies
available.

5.
Finalization
of
policies.
AFBF
asked
that
EPA
clarify
what
mechanism
will
be
used
to
finalize
the
current
policy
as
well
as
future
policies.

Response:
This
procedural
guidance
has
been
placed
on
OPP's
website.
What
mechanism
is
used
to
release
future
policies
will
depend
on
the
nature
of
the
policy.
In
the
past
EPA
has
often
used
PR
Notices
to
announce
policy
positions
but
science
policy
papers
generally
have
just
been
published
on
OPP's
website
6.
APA
analysis.
AFBF
stated
that
OPP
must
conduct
a
"
thorough
legal
analysis"
on
any
proposed
policy's
conformity
with
the
APA
and
that
such
analysis
should
be
incorporated
in
the
public
docket.

Response:
OPP
endeavors
to
ensure
that
each
of
its
policies
are
consistent
with
all
relevant
statutory
authorities,
including
the
APA.
The
level
of
analysis
depends,
to
large
degree,
on
the
policy
in
question.
To
the
extent
OPP
believes
that
legal
issues
are
of
importance
to
public
comment
periods,
it
may
include
a
legal
discussion
in
materials
made
available
to
the
public.
Further,
to
the
extent
that
commenters
raise
significant
legal
issues,
those
legal
issues
will
be
addressed
in
the
appropriate
response
to
comment
document
and
included
in
the
docket.

7.
OPP
should
clarify
when
it
will
not
provide
pre­
implementation
notice
and
comment.
AFBF
particularly
requested
that
OPP
specify
what
is
meant
by
the
phrase
"
other
goals
of
importance."

Response:
As
the
procedures
note
there
are
likely
to
be
frequent
instances
when
the
concept
of
pre­
implementation
notice
and
comment
for
policy
guidance
documents
does
not
mesh
with
the
reality
of
OPP's
regulatory
approach.
Even
in
instances
where
OPP
acknowledges
that
pre­
implementation
notice
and
comment
may
be
more
appropriate,
OPP
left
itself
broad
leeway
by
stressing
the
need
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."
This
language
recognizes
that
notice
and
comment
procedures
are
not
required
for
policy
promulgation
and
that
the
value
of
voluntarily
providing
such
notice
and
comment
should
not
be
viewed
apart
from
other
worthy
OPP
goals,
e.
g.,
meeting
statutory
or
court­
ordered
deadlines
or
otherwise
making
timely
decisions,
in
management
of
the
pesticide
program.

8.
Protection
of
CBI.
AFBF
asked
that
OPP
take
steps
to
protect
CBI
that
is
submitted
as
a
comment
in
response
to
a
draft
policy
guidance
document.

Response:
OPP
agrees
that
protection
of
CBI
is
important
and
has
added
a
reference
to
it
in
the
guidance
document
to
ensure
that
proper
procedures
are
followed
with
regard
to
CBI.

9.
Access
to
the
Access
to
Interpretive
Documents
(
AID)
and
Courtesy
Copy
Policy
(
CCP).
AFBF
requested
that
access
to
these
polices
be
made
available
via
OPP's
website.

Response:
These
documents
are
intended
as
guidance
to
staff
instructing
them
on
procedures
for
clearing
documents
for
release
to
the
public
and
directing
them
to
make
documents
available
to
other
parts
of
the
government.
As
such
they
are
not
relevant
to
the
policy
and
mention
of
these
documents
has
been
deleted
from
the
policy.

10.
Retroactive
implementation
of
these
procedures.
AFBF
requested
that
OPP
identify
all
existing
policies
and
evaluate
their
compliance
with
these
procedures.

Response:
These
procedures
are
designed
as
a
guide
to
future
policy
development.
OPP
sees
little
purpose
in
retroactively
examining
OPP's
"
compliance"
with
these
procedures
in
its
prior
efforts
in
developing
policies.
Further,
OPP
would
note
that
it
has
taken
farreaching
steps
to
make
existing
policies
readily
available
on
its
website,
for
example
by
posting
previously
issued
PR
Notices
at
http://
www.
epa.
gov/
opppmsd1/
PR_
Notices/

11.
Access
to
contact
persons.
AFBF
stated
that
"
in
order
to
evaluate
the
policy
basis
of
a
specific
action
or
decision,
registrants
must
have
immediate
access
to
a
primary
authority
at
OPP."

Response:
OPP
would
note
that
in
soliciting
comments
on
policy
guidance
documents
in
the
past
it
has
routinely
published
the
name
of
a
contact
person.
OPP
fully
intends
to
continue
this
practice.

12.
Consequences
of
policy
guidance
documents.
AFBF
asked
that
policy
guidance
documents
clearly
state
the
consequences
of
failure
to
comply
with
any
obligations
imposed
by
such
documents.

Response:
Because
policy
guidance
documents
are
non­
binding,
they
do
not
impose
obligations
on
anyone.
To
the
extent
such
documents
make
recommendations
regarding
actions
by
regulated
parties,
OPP
will
attempt
to
explain
what
procedures
OPP
may
follow
with
regard
to
parties
who
choose
not
to
adopt
such
recommendations.
As
part
of
this
explanation,
OPP
will
inform
affected
parties
regarding
appropriate
times
for
communicating
with
OPP
concerning
the
matter.

13.
Early
release
of
response
to
comments
document.
AFBF
urged
OPP
to
consider
making
public
its
response
to
comments
prior
to
releasing
a
revised
policy
guidance
document.
Such
prior
release,
AFBF
contended,
will
help
avoid
"
misunderstandings,
mistakes,
and
unexpected
policy
revisions
of
policies."

Response:
Where
public
comment
causes
OPP
to
rethink
a
proposed
policy
guidance
document,
OPP
may
decide
to
issue
a
revised
proposal
for
public
comment.
OPP
does
not
expect
that
it
would
routinely
release
its
response
to
comment
document
prior
to
issuing
a
revised
policy
because
such
an
action
is
likely
to
stimulate
yet
another
round
of
public
comment
further
delaying
the
policy
development
process.
Nonetheless,
OPP
has
added
language
to
the
policy
recommending
that
early
release
of
the
response
to
comments
document
be
considered
if
the
comments
evidence
a
wide
variation
of
opinion
or
strong
disagreement
with
the
policy
and,
it
is
believed,
that
early
release
may
aid
in
the
ultimate
implementation
of
the
policy.
If
OPP
has
questions
regarding
a
particular
comment,
it
may
contact
the
commenter
for
clarification.

14.
Post­
issuance
comment
on
policy
guidance
documents.
AFBF
requested
that
the
policy
be
clear
that
if
OPP
does
issue
a
policy
guidance
document
without
first
holding
a
notice
and
comment
period
that
a
post­
issuance
comment
period
be
held.

Response:
OPP
has
added
language
to
the
policy
recommending
that
a
prompt
postissuance
comment
period
be
held
in
such
circumstances.

15.
Acknowledgment
of
deviation
from
established
policy.
AFBF
asked
that
OPP
explicitly
acknowledge
decisions
that
deviate
from
existing
policy
as
well
as
explaining
the
reason
for
that
deviation.

Response:
OPP
agrees
that
this
is
appropriate
and
has
added
language
to
the
policy
to
capture
this
idea.

16.
OPP
should
encourage
stakeholders
to
continue
to
provide
relevant
information
on
policies
even
after
comment
periods
have
ended.

Response:
OPP
is
always
interested
in
receiving
information
relevant
to
its
policies.
At
times,
ending
dates
need
to
be
established
for
consideration
of
comments
so
that
policy
guidance
documents
can
be
completed.
Information
received
after
any
such
date
would
be
considered
as
part
of
the
Agency's
ongoing
examination
of
its
policies.

B.
S.
C.
Johnson
S.
C.
Johnson
asked
that
the
policy
guidance
document
be
withdrawn
because
it
is
so
flexible
that
policies
drafted
under
it
"
will
not
offer
any
assurance
to
the
public
or
the
regulated
community
that
[
OPP]
will
follow
its
own
procedures,
policies,
and
guidance."

Response:
Because
a
policy
guidance
document
must
be
non­
binding
upon
OPP
to
qualify
as
a
policy
under
the
APA,
OPP
has
necessarily
made
clear
in
these
procedures
for
policy
development
that
policies
should
advise
Agency
staff,
regulated
parties,
and
the
public
that
they
are
non­
binding.
OPP
believes
that
policies
have
role
to
play
in
its
implementation
of
its
statutory
authorities
and
this
procedural
guidance
is
designed
to
ensure
that
policies
are
compliant
with
the
APA.

C.
Kentucy
Department
of
Agriculture
The
Kentucky
Department
of
Agriculture
stated
that
OPP
policies
have
not
always
in
the
past
been
applied
consistently
by
EPA's
various
regional
offices
and
by
OPP
staff.
The
Department
suggested
the
OPP
track
policies
through
a
series
of
evaluation
protocols
to
ensure
that
headquarters
and
regional
staff
understand
the
policies
and
apply
them
in
a
consistent
manner.
Further,
the
Department
requested
that
contact
persons
on
nonsignificant
policies
should
be
able
to
explain
the
such
policies'
impact
on
regulated
parties
and
the
public
and
that
the
non­
binding
character
of
policies
be
clarified.

Response:
OPP
agrees
that
it
is
important
to
ensure
that
staff
understand
policies
so
that
they
can
be
applied
consistently.
OPP
is
considering
ways
in
which
it
can
review
the
implementation
of
its
significant
policy
guidance
documents
and
has
included
language
in
the
document
to
encourage
systematic
reevaluation
of
policy
guidance
documents.
As
to
contact
persons,
OPP
intends
to
list
a
knowledgeable
person
as
the
contact
for
nonsignificant
policies.
Preferably
this
will
be
a
person
who
participated
in
development
of
the
policy.
As
to
the
non­
binding
character
of
policies,
OPP
believes
that
the
boilerplate
language
included
in
the
appendix
to
this
procedural
guidance
will
be
helpful
in
clarifying
the
non­
binding
nature
of
policies.

D.
Consumer
Specialty
Products
Association
(
CSPA)

First,
CSPA
cautioned
OPP
to
be
careful
in
classifying
policy
guidance
documents
as
significant
or
non­
significant
and
suggested
that
OPP
seek
public
input
on
this
decision.
Second,
CSPA
asserted
that
one
of
the
factors
in
the
procedural
guidance
for
evaluating
whether
a
policy
is
significant
or
not
is
inappropriate.
According
to
CSPA,
the
issue
of
"
whether
the
policy
involves
the
initial
implementation
of
statutory
or
regulatory
changes,"
is
improper
because
if
the
policy
does
involve
implementation
of
statutory
changes
it
should
be
promulgated
as
an
APA
rule.

Response:
OPP
believes
it
has
defined
significant
policies
sufficiently
broadly
that
CSPA's
concern
here
should
not
be
a
problem.
To
the
extent,
however,
that
a
stakeholder
believes
that,
as
to
a
particular
policy,
OPP
has
mistakenly
classified
it
as
a
non­
significant
policy,
that
policy
should
be
brought
to
OPP's
attention
so
it
can
be
determined
whether
further
public
participation
is
warranted.
With
regard
to
the
criterion
on
the
significant/
nonsignificant
determination
pertaining
to
initial
implementation
of
statutory
changes,
OPP
disagrees
with
CSPA's
judgment.
Although
in
some
instances,
an
agency
will
choose
to
implement
statutory
changes
through
rulemaking,
an
agency
is
not
barred
from
using
policy
guidance
documents
to
aid
in
implementation
of
new
statutory
provisions.
For
example,
many
of
OPP's
recent
science
guidance
policies
were
prepared
in
response
to
new
statutory
requirements
in
the
Food
Quality
Protection
Act
of
1996.
OPP
concluded
that
these
were
proper
topics
for
guidance
policies
because
they
provided
non­
binding
recommendations
regarding
implementation
of
important
science
issues.