Document ID: EPA-HQ-OPPT-2002-0029-0041
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2002-10-10T04:00Z

Comments
to
EDMVS
Concerning
Proposed
Wildlife
Studies
July
23­
24,

2002
Ellen
M.

Mihaich,
Ph.
D.,

DABT
Rhodia
Inc.
Raleigh,
NC
Amphibian
DRP
°

Rationale
for
using
an
amphibian
as
a
"general
vertebrate
model"

is
vague
and
unsubstantiated.

The
rat
is
already
a
sensitive
species
for
thyroid.
°

Additional
endpoints
added
to
the
study
to
help
improve
sensitivity
yet
their
link
to
thyroid
activity
is
uncertain.
Big
data
gaps.
°

Funding
should
be
for
basic
research,
not
standardization
and
validation
at
this
point
in
time.
"…
the
objective
of
this
DRP
is
to
develop
a
method
to
determine
the
effects
of
chemicals
on
normal
thyroid
function
using
an
amphibian
as
a
general
vertebrate
model."

(Amphibian
DRP
p.

6
line
3)
Mysid
Life­

Cycle
°

Currently
the
1­

generation
mysid
test
is
an
apical
test
used
primarily
in
pesticide
registration.
What
evidence
is
there
to
suggest
that
a
2
generation
test
will
perform
any
better
than
a
1
generation
study?
Mysid
DRP
°

While
ecdysteroids
and
EAT
are
steroid
hormones,
no
justification
that
effects
on
ecdysteroids
in
mysids
could
be
extrapolated
to
effects
on
EAT
in
vertebrates
is
supported.
°

Effects
on
biochemical
endpoints
is
not
indicative
of
endocrine
disruption.

Testosterone
studies
cited
indicate
only
that
general
detoxification
enzymes
can
be
affected
by
exposure
to
test
substances.

This
is
not
evidence
of
"endocrine
disruption"

in
crustaceans
nor
does
it
suggest
the
likelihood
of
"endocrine
disruption"

in
other
animals.
°

"The
limited
available
data
on
vertebrate­
type
steroids
in
crustaceans
are
insufficient
to
conclude
that
these
steroids
function
as
hormones."
(p.

196;

Verslycke
et
al.

2002
Gen.

Comp.

Endocrinol.
126:
190­
199).
Conclusions
&

Suggestions
°

Both
of
these
studies
require
significant
basic
research
to
determine
relevancy
and
usefulness.
Such
an
effort
is
clearly
basic
scientific
research
that
should
not
be
funded
from
the
EDSP
validation
and
standardization
effort.
°

Resources
and
effort
may
be
better
spent
in
validating
and
standardizing
truly
relevant
assays.