Document ID: EPA-HQ-OPP-2003-0132-0008
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2003-04-02T05:00Z

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Press
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By
Headquarters
Press
Release
Date
Press
Releases
By
Washington,
DC
Title
For
Release
12/
14/
2001
Press
Releases
en
Espanol
AGENCY
REQUESTS
NATIONAL
ACADEMY
OF
SCIENCES
INPUT
ON
CONS
IDERATION
OF
CERTAIN
HUMAN
TOXICITY
STUDIES;
ANNOUNCES
INTERIM
POLICY
Archived
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Releases
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Environmental
News
FOR
RELEASE:
FRIDAY,
DECEMBER
14,
2001
AGENCY
REQUESTS
NATIONAL
ACADEMY
OF
SCIEN
CES
INPUT
ON
CONSIDERATION
OF
CERTAIN
HUMAN
TOXICIT
Y
STUDIES;
ANNOUNCES
INTERIM
POLICY
Contact:
David
Deegan,
202­
564­
7839
/
deega
n.
dave@
epa.
gov
In
a
letter
released
today,
the
Environmental
Protection
A
gency
is
requesting
that
the
National
Academy
of
Sciences
conduct
an
expeditious
review
of
the
complex
scientific
and
ethical
issues
posed
by
EPA's
possible
use
of
third­
party
studies
which
intentionally
dose
human
subjects
with
toxicants
to
identify
or
quantify
their
effects.

EPA
will
ask
the
Academy
to
furnish
recommendations
regard
ing
the
particular
factors
and
criteria
EPA
should
consider
to
determine
the
potential
ac
ceptability
of
such
third­
party
studies.
Recently,
most
submissions
to
the
Age
ncy
have
concerned
toxicity
testing
of
pesticides,
such
as
studies
used
to
establish
a
No
Observed
Adverse
Effect
Level
or
No
Observed
Effect
Level
for
systemic
toxicity
of
pesticides.
The
Academy
is
also
being
asked
to
provide
recommendations
on
whether
int
ernationally
accepted
protocols
or
the
Protection
of
Human
Subjects
Rule
("
the
C
ommon
Rule,"
which
details
the
protection
of
human
subjects
of
EPA­
conducted
or
supported
research)
could
be
applied
to
develop
the
scientific
and
ethical
criteria
for
EPA
to
eva
luate
such
studies.
These
third­
party
studies
that
will
be
the
focus
of
the
Academy
review
are
those
that
have
not
been
conducted
or
funded
by
a
federal
agency
in
compliance
with
EPA's
Common
Rule,
or
its
equivalent.

"
Our
paramount
concern
in
developing
our
policy
on
these
s
tudies
must
be
protection
of
human
health
and
adherence
to
the
most
rigorous
ethical
an
d
scientific
standards,"
said
EPA
Administrator
Christie
Whitman.
"
Formulating
a
policy
that
appropriately
reflects
our
competing
concerns
in
this
matter
will
not
be
easy,
an
d
I
thank
the
National
Academy
of
Sciences
for
agreeing
to
assist
EPA
in
evaluating
these
complex
issues.
The
one
thing
that
all
parties
agree
upon
is
the
need
for
EPA
to
formula
te
a
formal
policy
on
the
use
of
human
testing
data,
and
we
will
do
so
in
a
transparent
and
responsible
manner."

The
Agency
will
ask
that
the
Academy
incorporate
early
in
its
review
an
open,
public
and
participatory
process
through
which
all
interested
parties
may
raise
their
concerns
and
ideas
for
consideration.
Following
the
Academy's
review,
E
PA
will
engage
in
an
open
and
participatory
process
involving
federal
partners,
interest
ed
parties
and
the
public
during
its
policy
development
and/
or
rule
making
regarding
future
acceptance,
consideration
or
regulatory
reliance
on
such
human
studies
.

During
the
Academy's
consideration
of
the
issues
and
until
a
policy
is
in
place,
the
Agency
will
not
consider
or
rely
on
any
such
human
studies
in
its
regulatory
decision
making,
whether
previously
or
newly
submitted.
Should
EPA
be
legally
required
to
consider
or
rely
on
any
such
human
study
during
this
inter
im
period,
the
Agency
will
assemble
a
Science
Advisory
Board
subpanel
to
review
and
c
omment
on
scientific
appropriateness
and
ethical
acceptability
of
the
study
in
question,
and
the
Agency
will
provide
an
opportunity
for
public
involvement.
This
extern
al
review
would
occur
prior
to
consideration
of
the
study
and
would
allow
the
Science
Adv
isory
Board
to
review
all
available
information
on
the
study.

Notwithstanding
the
interim
policy,
existing
provisions
of
the
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
and
the
Toxic
Substances
Co
ntrol
Act,
continue
to
require
industry
to
report
any
adverse
effects
information
from
su
ch
studies.
In
any
instance
where
third­
party
human
testing
data
suggests
a
public
hea
lth
concern,
the
Agency
would
promptly
consider
that
information.

Attachment
R­
246
#
#
#
__________________________________________________________
______________________________

[
Image]

UNITED
STATES
ENVIRONMENTAL
PROTECTIO
N
AGENCY
WASHINGTON
D.
C.,
20460
December
14,
2001
OFFICE
OF
PREVENTION,
PESTICIDES
AND
TOXIC
SUBSTANCES
Dr.
Bruce
Alberts
President
National
Academy
of
Sciences
2101
Constitution
Avenue,
NW
Washington,
D.
C.
20418
Dear
Dr.
Alberts:

I
am
writing
to
request
that
the
National
Academy
of
Scien
ces
(
NAS)
provide
recommendations
to
the
Agency
to
help
address
the
scientif
ic
and
ethical
questions
related
to
whether
to
accept,
consider,
or
rely
on
researc
h
involving
deliberate
exposure
of
human
subjects
to
toxicants
when
used
to
ident
ify
or
quantify
toxic
endpoints.
The
Agency
asks
that
the
Academy
review
these
i
ssues
and
provide
recommendations
that
will
help
EPA
develop
appropriate
fac
tors
and
criteria
to
apply
when
it
makes
these
difficult
decisions.
The
advice
of
the
Academy
will
be
weighed
heavily
as
we
develop
and
implement
a
policy
to
govern
the
se
decisions
in
future.

The
Agency's
particular
focus
of
concern
is
on
studies
whi
ch,
since
they
are
not
conducted
or
supported
by
a
federal
agency,
may
not
be
per
formed
subject
to
regulations
that
protect
human
subjects,
such
as
EPA's
Protection
of
H
uman
Subjects
Rule
("
the
Common
Rule"),
40
CFR
26.
We
are
particularly
concerned
ab
out
'
third­
party'
studies
submitted
by
regulated
entities
for
the
Agency's
considera
tion.
For
these
purposes,
EPA
is
considering
"
third­
party
studies"
as
studies
that
have
not
been
conducted
or
funded
by
a
federal
agency
pursuant
to
regulations
that
protect
h
uman
subjects.
These
types
of
studies
generally
come
to
the
Agency's
attention
only
afte
r
the
research
has
been
completed
and
reported.
At
this
point
it
is
generally
too
late
for
the
Common
Rule
requirements
to
apply
since
these
requirements
cover
prior
review
and
approval
of
proposed
research,
involving
fully
informed,
voluntary
con
sent
of
the
participants
to
protect
the
subjects
in
the
research.

One
particular
concern
of
the
Agency
is
for
determining
th
e
acceptability
of
third­
party
research
designed
to
identify
or
quantify
toxic
endpoints
in
human
subjects,
such
as
those
done
to
define
a
No
Observed
Adverse
Effect
Level
(
N
OAEL)
or
No
Observed
Effect
Level
(
NOEL)
for
systemic
toxicity
in
humans.
Studies
of
t
his
kind
are
submitted
to
the
agency
from
time
to
time,
and
have
been
evaluated
prior
to
regulatory
decision
in
several
Agency
programs.
In
the
recent
past
most
such
subm
issions
have
been
of
studies
designed
to
define
a
NOAEL
for
pesticide
toxicity
in
human
s.

EPA
asks
the
Academy
to
undertake
a
critical
review
of
app
ropriate
standards
for
the
scientific
and
ethical
assessment
of
research
entailing
de
liberate
dosing
of
human
subjects
with
toxic
agents.
This
review
should
incorporate
and
be
informed
by
an
early
open,
public,
participatory
process
through
which
interest
ed
people
can
express
their
suggestions
or
concerns
to
the
Academy
reviewers.

The
Agency
subscribes
fully
to
the
principles
of
the
Commo
n
Rule
and
the
related
rules
of
other
federal
agencies,
as
they
protect
the
human
subje
cts
of
research
conducted
or
supported
by
the
federal
government.
We
are
pleased
with
o
ur
record
of
compliance
with
the
Common
Rule
in
our
own
research,
and
of
the
favorable
review
by
our
human
subjects
protection
program
in
a
recent
survey
by
the
National
Bioe
thics
Advisory
Commission.

The
Agency
will
consider
the
Academy's
advice
resulting
fr
om
this
review
as
we
develop
a
policy
to
guide
its
future
decisions
to
accept,
consider,
or
rely
on
such
studies
in
regulatory
decision
making.
As
the
Academy
evaluates
the
s
cientific
rationale
and
the
ethical
framework
for
these
studies,
it
would
be
most
help
ful
if
the
Academy
would
include
in
its
general
advice
responses
to
the
following
q
uestions:

*
What
factors
should
the
Agency
consider
in
determinin
g
whether
to
accept,
consider,
or
rely
on
human
studies
performed
by
third
parties?
Are
there
clear
boundaries
between
acceptable
and
unacceptable
human
research?
I
f
so,
what
are
they?
If
not,
what
range
of
factors
should
the
agency
consider,
and
how
should
these
factors
be
applied
in
making
decisions
to
accept,
consider,
or
r
ely
on
specific
research?

*
What
range
of
information
should
the
Agency
consider
in
determining
whether
completed
research
with
human
subjects
conducted
by
t
hird
parties
was
conducted
in
compliance
with
the
appropriate
ethical
standards,
su
ch
as
the
Declaration
of
Helsinki,
which
may
be
cited
in
the
research
report?

*
Do
criteria
such
as
those
in
the
Common
Rule
provide
an
adequate
framework
for
assessing
the
scientific
and
ethical
acceptability
of
such
studies?
Should
such
a
standard,
designed
to
protect
human
participants
in
r
esearch,
be
applied
after
the
fact
to
completed
research
conducted
by
third
parties
to
determine
whether
it
is
acceptable
as
the
basis
for
regulatory
action?

*
Are
there
other
standards,
such
as
the
Declaration
of
Helsinki
or
various
standards
of
good
clinical
practice,
relevant
to
assessing
acce
ptability
of
research
to
define
or
quantify
toxic
endpoints
in
human
research
subjects?
Should
standards
intended
to
govern
human
safety
studies
for
diagnosti
c
or
therapeutic
agents
be
applied
to
research
involving
deliberate
exposures
to
environmental
toxins?

I
look
forward
to
meeting
with
you
soon
to
work
out
the
de
tails
and
timing
of
your
review,
and
to
a
constructive
collaboration
on
this
projec
t.

Sincerely,

Stephen
L.
Johnson
Assistant
Administrator
cc:
E.
William
Colglazier
Ann
Marie
Mazza
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