1
Oxamyl
Oxamyl
Charge
to
the
HSRB
Charge
to
the
HSRB
Similar
to
aldicarb
and
methomyl,
oxamyl
is
a
member
of
the
N­
methyl
carbamate
(
NMC)
common
mechanism
group
based
on
its
ability
to
inhibit
acetylcholinesterase
via
carbamylation
and
is
thus
included
in
the
NMC
cumulative
risk
assessment.

The
Agency
has
previously
completed
the
acute,

aggregate
(
single
chemical,
multi­
route)
risk
assessment
of
oxamyl.
The
Agency
is
now
considering
the
use
of
the
oxamyl
acute
oral,
human
toxicity
study
to
inform
the
inter­
species
uncertainty
factor
in
the
cumulative
risk
assessment
of
the
NMCs.
2
Oxamyl
Oxamyl
Charge
to
the
HSRB
Charge
to
the
HSRB
1.
Scientific
considerations:

The
Agency's
WOE
document
and
DER
for
oxamyl
describe
the
study
design
and
results
of
the
oxamyl
acute
oral,
human
toxicity
study.
The
WOE
document
also
discusses
the
Agency's
conclusions
regarding
the
usefulness
of
the
human
study
in
the
cumulative
risk
assessment
for
the
NMCs.
For
oxamyl,
the
Agency
has
concluded
that
the
human
toxicity
study
is
sufficiently
robust
for
reducing
the
10X
inter­
species
(
ie,
animal
to
human)
uncertainty
factor
in
the
cumulative
risk
assessment.

Please
comment
on
the
scientific
evidence
that
supports
this
conclusion.
3
Oxamyl
Oxamyl
Charge
to
the
HSRB
Charge
to
the
HSRB
2.
Ethical
considerations:

a.
The
Agency
requests
that
the
Board
provide
comment
on
the
following:


Whether
inclusion
in
the
protocol
submitted
to
the
ethics
committee
of
a
factually
inaccurate
statement
regarding
unavailability
of
data
on
accidental
or
incidental
exposure
to
oxamyl
should
be
considered
significantly
deficient
relative
to
the
ethical
standards
prevailing
when
the
study
was
conducted;
4
Oxamyl
Oxamyl
Charge
to
the
HSRB
Charge
to
the
HSRB
2.
Ethical
considerations:

a.
cont'd.
The
Agency
requests
that
the
Board
provide
comment
on
the
following:


Whether
the
absence
from
the
protocol
of
any
discussion
of
the
potential
risks
to
subjects
or
benefits
to
society
of
conducting
the
proposed
research
(
as
required
by
the
Declaration
of
Helsinki,
Principle
#
5)
should
be
considered
significantly
deficient
relative
to
the
ethical
standards
prevailing
when
the
study
was
conducted;
and
5
Oxamyl
Oxamyl
Charge
to
the
HSRB
Charge
to
the
HSRB
2.
Ethical
considerations,
cont'd:

b.
The
Agency
asks
that
the
Board
provide
comment
on
the
following,
taking
into
account
all
that
is
known
about
the
ethical
conduct
of
[
this/
each]
study:


OPP's
conclusion
that
there
is
not
clear
and
convincing
evidence
that
the
conduct
of
the
research
was
fundamentally
unethical.


Whether
there
is
clear
and
convincing
evidence
that
the
conduct
of
the
study
was
significantly
deficient
relative
to
the
ethical
standards
prevailing
when
the
study
was
conducted
