Pete says: <You are not really addressing the issue, which is: Why Maryann
Frazier felt compelled to address the EPA and the USDA in a national press
conference over their alleged non-recognition of academic research due to
lack of compliance to Lab Procedures.
Does anyone think that the Fraziers are not performing their studies
according to sufficient rigor? To me this seems to be the tip of the iceberg of
a much bigger question: If the Fraziers are on to something, and it is
being ignored for any reason>
Actually, I'm saying that her statement runs contrary to what EPA is
legally mandated to do. EPA clearly outlines their approach to data resultant
from 'research lacking compliance' - and please, let's drop the adjective
ACADEMIC. It is not an ACADEMIC matter - its a matter of data accuracy
irrespective of who or what type of institution conducted the study.
Contrary to the assertions of the Fraziers, EPA does not necessary reject
data just because it was exploratory and/or not performed under GLP.
In the agency’s own words: "Ideally, tests to gather such information
have been conducted under optimum conditions and follow good laboratory
practice (GLP). However, for the purpose of satisfying a specific .. data
element2, it is important to consider existing information that might not have
been generated under ideal conditions."
Even other published scientists have acknowledged that: :If the study is
well conducted and reproducible and the interpretation is clear, it can be
used by EPA to support risk assessment.
The Fraziers often cite European studies. In Europe, there is always a
push to standardize or harmonize everything, regardless of whether their
standard approach works in other countries – I’ve been involved in those types
of discussions since the late 1970s – and its always the same. I remember
a series of workshops aimed at long-term monitoring and the selection of
sentinel/indicator animals and plants. Only problem, many of the proposed
species were unique to Europe and did not occur in North America.
Thus, one will see reference in European studies to the Klimisch score.
EPA has been accused of blindly following this approach and in doing so
rejecting useful data.
EPA has addressed this accusation, saying: The Klimisch method “ is
similar in principle to EPA’s tiered approach in that both methods present
specific criteria for evaluating existing data. In fact, the data reliability
criteria presented by Klimisch and by EPA (in Tier I) are remarkably
similar. The difference between the two approaches is in how the criteria are
used.
Klimisch et al. use their criteria in the following scoring system for
evaluating data reliability3: 1 = reliable without restrictions; 2 = reliable
with restrictions; 3 = not reliable; and 4 =not assignable. The Klimisch
ranking system does not conflict with the EPA approach.
Klimisch et al. define adequacy as “the usefulness of data for risk
assessment purposes”, whereas EPA uses the "term to mean usefulness for hazard
identification purposes."
EPA goes on to state: Assigning a numerical value to each study is both
useful and comprehensive; however, EPA believes using the same criteria as a
screen (Tier I as described below) results in the appropriate “weeding out”
of data/studies not useful in describing an endpoint. For example, studies
assigned Klimisch reliability codes “3" or “4" would not advance to Tier
II in the EPA approach, except for those cases in which a
weight-of-the-evidence analysis might be used (see below).
NOTE the weight-of-the-evidence criteria is important and applies to the
type of studies in question. When weight-of-the-evidence comes into play,
and EPA applies their Tiered Approach:
"Tier I assesses “experimental fitness”; thus, existing data rejected in
Tier I for a particular endpoint may
be identified as a data gap that needs to be filled by testing."
Jerry
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