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Informed Discussion of Beekeeping Issues and Bee Biology <[log in to unmask]>
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Sat, 1 Apr 2023 14:58:27 +0000
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EPA approval of a new formulation for a registered use is generally very fast and very easy.  To make sure everyone understands exactly what I am saying I will give a hypothetical example.  Suppose I sell some registered fungicide.  On the label I have a whole bunch of crops listed and also list preharvest interval and dose per acre.  Now suppose this registration is for a water dispersible granule which is simply a granulated product you can throw directly into your spray tank.  And suppose my new formulation is water based flowable with the active suspended in the water in the bucket you buy.  But the amount applied per acre and the crops it can be used on are identical to the water dispersible granule.  Such a new formulation is generally approved in under a couple of months.
Now, lets look at the new Api-Bioxal formulation of oxalic acid in glycerin.  It has about twice as much oxalic acid per ml as the older dribbled formulation of oxalic acid in water plus sugar.  Yet you still dribble five mls per frame of bees.  In effect you are treating at twice the amount per bee.  This is far more than simply a new formulation.  It has the advantage that both oxalic acid and glycerin are natural products and also that EPA has said they are not worried about the small amounts of oxalic acid in honey.  So, the registration may sail right thru time wise.  But, I would expect it to slow the process a little.  It also introduces a brand new factor.  It is well known that oxalic acid dissolved in glycerin forms an ester between the glycerin and acid with great ease.  That ester is not a natural product.  Is EPA going to want data showing how much ester is present?  Is EPA going to want any kind of tox data on the ester?  Is EPA going to want any kind of data showing where that ester distributes inside the hive in honey or wax?  The people at EPA are smart and are going to spot this problem in about a heart beat.  I presume the Italians are also smart and have already done studies to show what the ester concentrations are in their formulation versus time as such a study would be part of a routine shelf stability study on the formulation.   I have never heard of anyone trying to register a formulation without doing a shelf stability study and having at least one years data at the time the registration request was submitted.  You generally do such studies at 25 and 50 (or higher) degrees C so at one year the higher temp data give you some idea of what to expect at two or three years at room temp.  The Italians might well have the studies done to answer EPA questions.  If not it could easy take two or three years to get the new formulation approved as it might take that long to get any added studies EPA told you were needed and give time for the EPA to review those studies and decide what they say about the product.  I suppose it is even possible that some study would raise some concern that would stop registration entirely and it would never get approved.  At any rate, the time it takes to get approval is mainly a matter of how fast the registrant can respond to any EPA data requests and not how fast EPA moves.  If the registrant was smart and talked to EPA right at the start of this registration process there should be no issues at all.  If they were dumb and did not talk to EPA right at the start and sent in a surprise new registration it is their fault if the process takes years.

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