Document ID: EPA-HQ-OPP-2003-0132-0672
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2006-10-17T04:00Z

Steven
Knott/
DC/
USEPA/
US
06/
16/
2006
11:
05
AM
To
William
Jordan/
DC/
USEPA/
US@
EPA
cc
Angela
Hofmann/
DC/
USEPA/
US@
EPA,
Peterj
Smith/
DC/
USEPA/
US@
EPA,
Keith
Matthews/
DC/
USEPA/
US@
EPA,
John
Carley/
DC/
USEPA/
US@
EPA,
Nathanael
Martin/
DC/
USEPA/
US@
EPA,
Jim
Jones/
DC/
USEPA/
US@
EPA,
sheering@
isr.
umich.
edu
bcc
Subject
Fw:
Extension
of
SAP
waiver
for
Nursing
Women
rule
Bill,

Below
I
am
forwarding
the
concurrence
for
the
requested
extensio
n.

Thanks.

Steve
­­­­­
Forwarded
by
Steven
Knott/
DC/
USEPA/
US
on
06/
16/
2006
10:
50
AM
­­­­­
Steve
Heeringa
<
sheering@
isr.
umich.
edu>
06/
16/
2006
10:
47
AM
To
Steven
Knott/
DC/
USEPA/
US@
EPA
cc
Subject
RE:
Extension
of
SAP
waiver
for
Nursing
Women
rule
Dear
Steve,

Based
on
my
original,
detailed
review
of
the
nursing
women
rule
change
on
May
17­
18,2006
I
approve
the
request
that
the
FIFRA
SAP
extend
its
May
18,
2006
waiver
of
scientific
review
and
comment
on
the
draft
final
rule
to
include
waiver
of
FIFRA
SAP
scientific
review
and
comment
on
the
proposed
rule.

This
is
a
minor
administrative/
legal
modification
and
does
not
affect
the
substance
of
my
May
17,18
review.
I
understand
that
the
text
of
the
proposed
and
final
rules
is
identical,
the
substantive
text
of
the
proposed
and
final
rules
will
be
the
same
as
that
previously
submitted
to
the
FIFRA
SAP
in
the
form
of
the
draft
final
rule.
I
do
request
that
in
the
event
that
public
comment
on
the
rule
leads
EPA
to
change
the
content
of
the
rule,
EPA
will
afford
the
FIFRA
SAP
an
opportunity
to
comment
on
any
revisions.

Sincerely,

Steven
G.
Heeringa
Chair,
FIFRA
Science
Advisory
Panel
­­­­­
Original
Message­­­­­
From:
Knott.
Steven@
epamail.
epa.
gov
[
mailto:
Knott.
Steven@
epamail.
epa.
gov]

Sent:
Friday,
June
16,
2006
10:
38
AM
To:
Steve
Heeringa
Subject:
Fw:
Extension
of
SAP
waiver
for
Nursing
Women
rule
Dr.
Heeringa,

Below
I
am
forwarding
a
request
from
the
EPA
Office
of
Pesticide
Programs
(
OPP)
to
extend
the
FIFRA
SAP's
May
18,
2006
waiver
of
scientific
review
and
comment
on
EPA's
draft
final
rule
entitled
"
Protections
for
Subjects
in
Human
Research:
Nursing
Women"
to
a
proposed
form
of
the
rule.
As
explained
in
more
detail
in
OPP's
request,
the
EPA
has
decided
to
issue
this
rule
following
a
slightly
different
procedure
than
envisioned
at
the
time
the
draft
final
rule
and
original
waiver
request
were
submitted
to
the
FIFRA
SAP.
Under
the
new
procedure,
both
a
proposed
and
final
form
of
the
rule
will
be
published
concurrently,
allowing
an
opportunity
for
public
comment.
Issuance
of
this
rule
in
proposed
and
final
forms,
concurrently,
is
a
procedural
matter
that
will
not
change
the
scope
of
the
rule
nor
introduce
new
scientific
issues
that
warrant
review
by
the
Panel.
The
request
further
explains
that
the
text
of
the
proposed
and
final
rules
is
identical,
the
substantive
text
of
the
proposed
and
final
rules
will
be
the
same
as
that
previously
submitted
to
the
FIFRA
SAP
in
the
form
of
the
draft
final
rule,
and,
in
the
event
that
public
comment
on
the
rule
leads
EPA
to
change
the
content
of
the
rule,
EPA
will
afford
the
FIFRA
SAP
an
opportunity
to
comment
on
any
revisions.

Therefore,
I
am
requesting
that
the
FIFRA
SAP
extend
its
May
18,
2006
waiver
of
scientific
review
and
comment
on
the
draft
final
rule
to
include
waiver
of
FIFRA
SAP
scientific
review
and
comment
on
the
proposed
rule.

Please
let
me
know
whether
you
concur
with
this
request
via
reply
e­
mail
(
please
reply
with
history)
and
I
will
forward
your
response
to
the
Agency.

Sincerely,

Steve
Knott
Executive
Secretary
FIFRA
Scientific
Advisory
Panel
202­
564­
0103
knott.
steven@
epa.
gov
­­­­­
Forwarded
by
Steven
Knott/
DC/
USEPA/
US
on
06/
16/
2006
09:
13
AM
­­­­­

William
Jordan/
DC/
USEPA/
US
To
Steven
Knott/
DC/
USEPA/
US@
EPA
06/
16/
2006
09:
06
cc
AM
Angela
Hofmann/
DC/
USEPA/
US@
EPA,
Peterj
Smith/
DC/
USEPA/
US@
EPA,
Keith
Matthews/
DC/
USEPA/
US@
EPA,
John
Carley/
DC/
USEPA/
US@
EPA,
Nathanael
Martin/
DC/
USEPA/
US@
EPA,
Jim
Jones/
DC/
USEPA/
US@
EPA
Subject
Extension
of
SAP
waiver
for
Nursing
Women
rule
Dear
Steve
­­

As
you
recall,
on
May
18,
2006,
the
FIFRA
SAP
waived
scientific
review
and
comment
on
the
EPA's
draft
final
rule
entitled
"
Protections
for
Subjects
in
Human
Research:
Nursing
Women."
In
providing
this
waiver,
the
SAP
concurred
with
the
EPA's
position
that
the
draft
final
rule
is
very
limited
in
scope
and
does
not
contain
new
scientific
issues
that
warrant
review
by
the
Panel.

When
EPA
sent
its
draft
final
rule
and
waiver
request
to
the
FIFRA
SAP,
we
intended
to
promulgate
the
final
rule
without
first
issuing
a
proposed
rule
for
public
comment
The
Agency
thought
that
issuing
a
proposed
rule
would
not
be
in
the
public
interest
because
the
time
required
for
notice
and
comment
procedures
as
typically
conducted
under
the
Administrative
Procedures
Act
would
delay
implementing
the
additional
protections
for
nursing
women.
Subsequent
to
receiving
the
FIFRA
SAP's
waiver,
the
EPA
had
decided
that,
in
addition
to
issuing
a
final
rule,
it
would
be
appropriate
to
offer
the
public
an
opportunity
to
comment.
Thus,
EPA
will
follow
a
slightly
different
procedure
in
which
we
concurrently
publish
the
rule
in
both
proposed
and
final
forms.
The
rule
text
for
both
the
proposal
and
final
is
identical.
If
there
are
no
adverse
public
comments,
the
final
rule
will
take
effect
after
the
end
of
the
comment
period.
If,
however,
there
are
adverse
comments,
EPA
will
not
make
the
final
rule
effective.
Rather,
EPA
would
consider
the
comments,
modify
the
rule
if
appropriate,
and
release
the
final
rule
together
with
a
document
responding
to
comments.
If
EPA
follows
this
latter
course,
the
SAP
would
have
an
opportunity
to
comment
on
the
final
rule.

Since
the
substantive
content
of
the
proposed
rule
and
final
rule
is
identical,
I
am
asking
that
the
May
18,
2006
waiver
of
FIFRA
SAP
review
of
the
draft
final
rule
be
extended
to
include
waiver
of
FIFRA
SAP
review
of
the
proposed
rule.
I
make
this
request
without
resubmitting
the
text
of
the
draft
final
rule
or
submitting
the
text
of
the
proposed
rule
for
the
following
reasons:

1)
the
substantive
text
of
the
concurrently
issued
proposed
and
final
rules
will
be
the
same
as
that
previously
submitted
to
the
FIFRA
SAP
in
the
form
of
the
draft
final
rule;
and
2)
the
issuance
of
this
rule
in
proposed
and
final
forms,
concurrently,
is
a
procedural
matter
that
will
not
change
the
scope
of
the
rule
nor
introduce
new
scientific
issues
that
warrant
review
by
the
Panel;
and
3)
in
the
event
that
public
comment
on
the
rule
leads
EPA
to
change
the
content
of
the
rule,
EPA
will
afford
the
panel
an
opportunity
to
comment
on
any
revisions.

Please
let
me
know
whether
you
concur
with
this
request
via
reply
e­
mail
(
please
reply
with
history).

Thanks,

Bill
William
L.
Jordan
Senior
Policy
Adviser
Office
of
Pesticide
Programs
­­
Mail
code
7501C
U.
S.
Environmental
Protection
Agency
1200
Pennsylvania
Avenue,
NW
Washington,
DC
20460
(
703)
305­
1049
(
voice)
(
703)
308­
4776
(
fax)