>> [I harbor grave concerns about the]
>> crop-protection product [using RNAi]
>> before the EPA, which has a far shorter history.
> I am in agreement with Jim on this point
> (although I'm not sure that the history is
> "far" shorter), as detailed in my comments
> to EPA...
The view of the EPA's own scientific advisory panel on RNAi were released
only this week as a powerpoint presentation. After working "through
channels", and waiting patiently for the consensus view to be published, I
am disappointed that the SAP would slide their evaluation into the document
stack only after the public comment period was closed, as it would have
simplified all the comments to "Listen to your own &@^$%# Scientific
Advisory Board!"
"Environmental Considerations for Non-PIP RNAi End-Use Products"
EPA-HQ-OPP-2013-0485-0040
http://www.noticeandcomment.com/Environmental-Considerations-for-Non-PIP-RNA
i-End-Use-Products-fn-98984.aspx
http://tinyurl.com/q2qm6z8
For those without PowerPoint, the slides of interest are pasted below,
unedited:
================
SLIDE 2:
The Agency has many years' experience of PIP ecorisk assessments
No Agency experience with hazard/ecorisk assessment with dsRNA end-use
products applied directly to the environment
Screening level assessments currently used for traditional chemical
pesticides many not be applicable due to unique modes of action of dsRNA
active ingredients
Environmental fate/effects of dsRNA active ingredients are poorly understood
and present unique challenges
SLIDE 14:
UNIQUE HAZARDS:
Limitations of Current Testing Paradigm
Off-target gene silencing
Silencing the target gene in unintended organisms
Immune stimulation
Saturation of the RNAi machinery in cells
SLIDE 15:
Other unanticipated hazards/exposures may occur
Accurate, standardized methods for measurement/assessment of unique hazards
are not available
Availability of robust, independently validated analytical methods for
various environmental matrices (water, soil, animal, plant) are not
available
SLIDE 16:
SUMMARY - UNCERTAINTIES
Are current methods sufficient to assess all hazards and exposures?
Target Specificity
Unanticipated Physiological Effects
-Target Species
-Non-Target Species
Stability in the Environment
Environmental Fate
-Unanticipated Breakdown Products?
- Amplification in treated article?
=================
So, it is not yet even clear to the SAP what questions need to be asked, let
alone how to develop metrics with which to evaluate these issues. For any
crop-protection product approval process to proceed in the face of such a
lack of even a basic regulatory roadmap from the EPA's own hand-picked SAP
would be an abandonment of the basic premise of "Environmental Protection".
I am struggling to come up with a metaphor or aphorism of "where we are"
with this technology, and all I can summon up is Madame Curie - who won two
Nobel prizes for her groundbreaking work, but died from the unanticipated
and drastic "downside" of the precise elements she discovered and
"harnessed" for productive purposes. What we have the equivalent of an
application for a nuclear power plant license from Madame Curie. So, yes,
she had a pair of Nobel Prizes in her back pocket, but she also carried
around highly radioactive materials in her front pocket!
Or, as I had to remind marketing on a weekly basis at Bell Labs: "A Project
is Not A Product".
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