Document ID: EPA-HQ-ORD-2006-0310-0033
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2006-05-01T04:00Z

1
Carbofuran
Charge
To
The
HSRB
Carbofuran
Charge
To
The
HSRB
Carbofuran
is
an
N­
methyl
carbamate
(
NMC)
pesticide
whose
primary
toxic
effect
is
neurotoxicity
caused
by
the
inhibition
of
the
enzyme,
acetylcholinesterase,
via
carbamylation
followed
by
rapid
recovery.
Carbofuran
can,

at
sufficiently
high
doses,
lead
to
a
variety
of
clinical
signs.

The
Agency
is
conducting
acute,
aggregate
(
single
chemical,
multi­
route)
and
worker
risk
assessments
of
carbofuran.
In
addition,
carbofuran
is
a
member
of
the
Nmethyl
carbamate
common
mechanism
group
and
is
thus
included
in
the
cumulative
(
multi­
chemical,
multi­
route)
risk
assessment
for
the
NMCs.
2
Carbofuran
Charge
To
The
HSRB
Carbofuran
Charge
To
The
HSRB
1.
Scientific
considerations
a.
Comment
on
the
scientific
evidence
that
supports
the
conclusion
to
use
the
oral
human
study
to
identify
a
point
of
departure
for
the
single
chemical
assessment
and
in
informing
the
interspecies
uncertainty
factor
for
the
cumulative
assessment.

b.
Comment
on
the
scientific
evidence
that
supports
the
conclusion
to
use
the
dermal
human
studies
to
identify
a
point
of
departure
for
the
single
chemical
assessment.
3
Carbofuran
Charge
To
The
HSRB
Carbofuran
Charge
To
The
HSRB
2.
Ethical
considerations
The
Agency
requests
that
the
Board
provide
comment
on
the
following:

a.
Is
there
clear
and
convincing
evidence
that
the
conduct
of
the
human
oral
study
conducted
with
carbofuran
was
fundamentally
unethical?

b.
Is
there
clear
and
convincing
evidence
that
the
conduct
of
the
oral
study
was
significantly
deficient
relative
to
the
ethical
standards
prevailing
at
the
time
the
research
was
conducted?
4
Carbofuran
Charge
To
The
HSRB
Carbofuran
Charge
To
The
HSRB
2.
Ethical
considerations,
con't
c.
Is
there
clear
and
convincing
evidence
that
the
conduct
of
either
of
the
human
dermal
studies
conducted
with
carbofuran
was
fundamentally
unethical?

d.
Is
there
clear
and
convincing
evidence
that
the
conduct
of
the
dermal
studies
was
significantly
deficient
relative
to
the
ethical
standards
prevailing
at
the
time
the
research
was
conducted?