>> [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". *********************************************** The BEE-L mailing list is powered by L-Soft's renowned LISTSERV(R) list management software. For more information, go to: http://www.lsoft.com/LISTSERV-powered.html