Document ID: EPA-HQ-ORD-2006-0384-0062
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2006-07-12T04:00Z

California
Code
of
California
Code
of
Regulations
Regulations
Title
3
Section
6710
Title
3
Section
6710
Pesticide
Exposure
Studies
Involving
Human
Participants
2
Title
3
Section
6710
Title
3
Section
6710
(
a)
No
person
shall
conduct
any
pesticide
exposure
study
in
California,
which
involves
human
participants,
unless
the
Director
[
of
CDPR]
has
given
written
authorization
to
the
study
director
to
conduct
the
pesticide
exposure
study
according
to
an
approved
protocol.
3
Title
3
Section
6710
Title
3
Section
6710
(
b)
The
study
director
shall
submit
the
protocol
to
the
Director
for
review
and
provisionary
determination
of
acceptability
(
c)
The
Director
shall
forward
a
copy
of
the
protocol
and
review
documentation
to
the
Office
of
Environmental
Health
Hazard
Assessment
for
concurrent
review.

(
d)
The
Director
shall
provide
comments
to
the
study
director
on
the
basis
of
Department
of
Pesticide
Regulation
review
and
any
comments
from
the
Office
of
Environmental
Health
Hazard
Assessment.
The
study
director
shall
make
any
changes
deemed
necessary
by
the
Director.
Upon
receipt
of
the
Director's
provisionary
determination
of
acceptability,
the
study
director
shall
obtain
a
review
and
approval
from
an
Institutional
Review
Board
(
IRB).
The
IRB
must
conduct
its
review
in
compliance
with
40
CFR
Part
26.
4
Title
3
Section
6710
Title
3
Section
6710
(
e)
The
study
director
shall
submit
to
the
Director
the
IRB's
approval
of
the
protocol
and
all
documentation
exchanged
between
the
IRB
and
the
study
director
related
to
the
review.

(
f)
The
Director
shall
make
the
final
decision
regarding
approval
or
denial
of
the
protocol
based
on
the
information
required
in
subsection
(
e),
other
relevant
available
information
available
to
the
Director.
The
Director
shall
notify
the
study
director
in
writing
of
the
decision
and
the
basis
for
the
decision.
5
Title
3
Section
6710
Title
3
Section
6710
(
g)
The
Director
shall
establish
an
expiration
date
for
the
approved
protocol.
In
no
instances
shall
the
expiration
date
exceed
that
established
by
the
IRB.
If
a
pesticide
exposure
study
is
not
completed
by
the
expiration
date
established
by
the
Director,

the
study
director
shall
not
continue
the
pesticide
exposure
study
until
the
Director
has
approved
the
renewal
of
the
protocol
in
writing
as
required
in
subsection
(
i).
6
Title
3
Section
6710
Title
3
Section
6710
(
h)
Protocol
Amendment.

°
The
study
director
shall
not
make
an
amendment
to
the
approved
protocol
that
may
impact
the
health
of
the
human
participants
without
approval
from
the
Director.
For
amendments
where
participant
health
is
potentially
impacted,

the
study
director
shall
make
the
request
in
writing.
The
proposed
amendment,
justification,
potential
impact
on
study
participants,
and
any
measures
proposed
to
mitigate
potential
impacts
shall
accompany
the
request.
.
.
.

°
The
Director
shall
provide
comments
to
the
study
director.
.
.
.

°
The
study
director
shall
make
any
changes
deemed
necessary
by
the
Director.
Upon
receipt
of
the
Director's
provisionary
determination
of
acceptability,
the
study
director
shall
obtain
a
review
and
approval
of
the
proposed
amendment
from
an
IRB.

.
.
.
7
Title
3
Section
6710
Title
3
Section
6710
(
i)
Renewal
of
Protocol.
.
.
.

(
j)
In
the
event
of
any
complications
or
adverse
health
effects
identified
during
the
conduct
of
the
study,
the
study
director
shall
take
immediate
action
to
ensure
the
health
and
safety
of
the
human
participants.
The
study
director
shall
immediately
notify
the
Director
of
such
complications
or
adverse
health
effects
and
the
immediate
actions
taken.
8
Title
3
Section
6710
Title
3
Section
6710
(
k)
The
study
director
shall
submit
the
following
information
to
the
Director
by
the
expiration
date:

(
1)
A
statement
regarding
the
status
of
the
study
including
information
as
to
whether
the
study
was
completed,

postponed,
or
cancelled.

(
2)
A
report
and
explanation
of
any
complications
or
adverse
health
effects
involving
the
human
participants
and
what
actions
were
taken.

(
l)
The
Director
or
agricultural
commissioner
of
the
county
where
the
study
is
taking
place
may
inspect
the
pesticide
exposure
study
activities
to
evaluate
compliance
with
the
protocol.
.
.
.