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Date: | Wed, 2 Sep 2020 01:16:32 +0000 |
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" Would
Randy's data and research be useable or would it have to be replicated?"
I really do not know what data the EPA would want to see. At minimum they would likely want to see residue data in honey and wax for oxalic acid when the product is used according to the proposed label. So, the very first thing needed is a proposed use label. I would not think residues of glycerin would be of concern. After all, our own bodies make glycerine every day as a part of normal metabolism. Per their long standing practice on data they would want the data generated with good laboratory practices (GLP). GLP has next to nothing to do with doing good science and getting correct results. Rather, GLP is about record keeping and quality insurance inspections, lab records and written standard operating procedures for each operation not covered in detail in the written study protocol. Things like what was the lot number of all reagents used, what was the date those bottles were opened and were they properly labeled upon opening to record who opened the bottle, an opening date and expiration date. If you used an acetone wash bottle was its label updated every time it was refilled even if you refill it three times in one day. Do you have written records showing which balance was used for every weighing and do you have written records that it had its calibration checked with some documented check weight every day that balance was used. Are your notebooks properly witnessed daily? If you used a refrigerator do you have paper documentation that shows the temperature record on that fridge for every day it was part of the study? Do you have a secured fire proofed archives where you can store all study records forever? GLP truly does result in cutting Jame's forest of trees to supply the paper. The whole objective of GLP is to provide more than enough documentation that someone skilled in the art can repeat the study as originally done and get the same answer and also demonstrate that all equipment used was in good working order the day it was used and that a QA inspector checked such things and checked all calculations to make sure they were done properly. In general EPA has no interest in any study not done in compliance with GLP.
Randy's work is about determining how to use the stuff to get efficacy in killing mites. EPA has no real interest in weather the stuff actually kills mites and does not want efficacy studies. That is entirely different from the FDA and drugs where the big issue is does the stuff actually work. For pesticides failure to work or working but causing some unwanted collateral damage such as killing the queen is resolved by a user suing the supplier for damages in civil courts. Remember, EPA wants data that says the stuff is safe for the applicator to use, the products produced are safe for the consumer to use and the chemical does not cause unacceptable environmental damage. I would not think they would have much, if any, concern about the user or environment for either oxalic acid or glycerin. But there are limits on how much oxalic acid a person is allowed to eat per day so some type of residue data would be indicated to protect the consumer. We all know that you could not use enough oxalic acid to cause a consumer health issue from eating honey from treated hives and so does the EPA. But knowing it and having proof are two different things and the EPA employees are going to protect themselves from a mistake by asking for some sort of data on residues. In the case of a dribble or sublimed oxalic they could rely on data in foreign registration packages such as Canada or the EU. Maybe you could convince them to rely on EU data in this case also as I think some oxalic glycerin concoction is registered in the EU as a dribble. Worst case might be going to some contract lab that has GLP in place (there are bunches of them) and spending $30,000 or $60,000 for the analytical work and report. Someone would need to do the field work to get the samples and GLP is required for the field work. But, I imagine one of the field testing outfits that does Ag chems would be willing to do a bee study, particularly if a bee person agreed to do all the hive work and all the field testing site really needed to do was watch what the bee person did and keep records and supply the GLP compliance statement and report. So, another bunch of thou for the field work. Paper is not cheap.
Also remember that EPA was getting heat from Michelle Obama to register oxalic dribble and sublimed and as a result registered with less data than I have ever seen them register anything in the past. If not for her political clout we likely would not have those uses registered in the US today. She is no longer first lady so no longer has any club to swing at people. And, as Brushy, the registrant, is no longer in business the current registration for dribble or sublimed is only good until the agency has some question they want answered and as the registrant does not exist perhaps the registration will get cancelled? Every registration gets fully reviewed at least every 15 years so at some point that will happen with dribble and sublimed? Someone must be the registrant for that review.
Dick
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