Document ID: EPA-HQ-OPPT-2003-0027-0005
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2003-08-04T04:00Z

Questions
for
EDMVS
on
the
Draft
Detailed
Review
Paper
for
Avian
Two­
Generation
Toxicity
Test
(
23
April
2003)

The
purpose
of
this
DRP
is
to
provide
the
basis
and
purpose
of
the
proposed
two­
generation
test
for
definitively
evaluating
the
adverse
consequences
of
a
possible
endocrine
disrupting
chemical
to
birds.
The
DRP
summarizes,
explains,
and
documents
decisions
regarding
the
relevant
principles,
methods,
and
techniques
recommended
in
developing
a
protocol
and
identifies
issues
which
should
be
addressed
before
interlaboratory
validation.

1.
Does
the
EDMVS
agree
that
a
two­
generation
method
recommended
with
Japanese
quail
is
appropriate?

2.
Does
the
EDMVS
agree
that
for
purposes
of
evaluating
potential
adverse
consequences
of
putative
endocrine
disrupting
chemicals
in
Tier
2
that
fitness
endpoints
should
be
emphasized
more
than
mechanistic
endpoints?
Does
the
EDMVS
have
recommendations
for
balancing
the
inclusion
of
mechanistic
endpoints?

3.
Does
the
EDMVS
have
suggestions
to
improve
the
DRP?
Questions
for
EDMVS
on
the
Draft
Comparative
Evaluation
of
Vitellogenin
Reports
(
Fathead
minnow
­
May
2003;
Zebrafish
&
Medaka
­
July
2003)

The
purpose
of
the
comparative
evaluation
was
to
survey
existing
analytical
methods
for
measuring
vitellogenin
in
small
fish
to
determine
the
qualitative
and/
or
quantitative
comparability
of
existing
methods.

4.
Does
the
EDMVS
believe
a
single
analytical
method
be
selected
(
for
each
of
the
three
species),
optimized,
validated
and
standardized
or
would
the
establishment
of
strict
performance
criteria
be
sufficient
to
allow
choice
of
method?

5.
Does
the
EDMVS
agree
that
a
single
vitellogenin
method
(
for
each
species)
be
used
in
the
interlaboratory
validation
of
the
fish
assays?
Questions
for
EDMVS
on
the
Draft
Report
on
the
Comparative
Evaluation
of
Fathead
Minnow
Assays
for
Detecting
Endocrine
Disrupting
Chemicals
(
July
2003)

The
purpose
of
this
comparative
evaluation
was
to
demonstrate
the
transferability
and
suitability
of
a
short­
term
reproduction
assay
with
fathead
minnow
developed
by
EPA
for
Tier
1
screening
of
endocrine
disrupting
chemicals
(
EDCs)
and
compare
this
assay
to
two
other
assays,
one
with
non­
spawning
adults
and
the
other
an
abbreviated
version
of
the
short­
term
reproduction
assay.

6.
Does
the
EDMVS
agree
that
the
concordance
observed
with
the
EPA
method
for
the
four
chemicals
evaluated
(
methoxychlor,
trenbolone,
flutamide,
and
fadrozole)
adequately
demonstrates
the
transferability
and
suitability
of
the
assay
as
a
Tier
1
screen?

7.
Does
the
EDMVS
agree
that
based
on
the
results
of
the
comparative
study
it
can
be
concluded
that
fish
in
spawning
condition
are
more
sensitive
than
non­
spawning
fish
for
detecting
likely
EDCs?
If
not,
does
the
EDMVS
have
recommendations
for
additional
work
needed
to
support
such
a
conclusion?

8.
Does
the
EDMVS
agree
that
the
abbreviated
EPA
method
(
14­
day
reproduction)
shows
promise
but
should
be
further
evaluated
before
supplanting
the
full
21­
day
method?