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Subject:
From:
Richard Cryberg <[log in to unmask]>
Reply To:
Informed Discussion of Beekeeping Issues and Bee Biology <[log in to unmask]>
Date:
Sat, 31 Oct 2015 17:14:02 -0700
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" Well, it is interesting to see that insects are left
 out?"

First of all I have not worked in the industry for 20 years.  Requirements are more extensive now than they were then and nothing has been deleted.  So, I do not know if any insect metabolism is required today.  Remember, the main thrust of the requirements is to prove the product is safe to the environment, to the user and to the consumer in equal portions to each.  The EPA does not care if the product actually works unlike FDA and drugs.  So, if you are registering an insecticide EPA assumes the product will kill insects if you say it kills insects.  No matter how the product is applied only a tiny amount actually ever gets to an insect.  The vast majority ends up on the ground and safety is covered by soil and water metabolism studies.  These are not like drugs where the human or animal is injected or fed the whole dose of drug and metabolizes and excretes those metabolites.  So, from the standpoint of EPA insect metabolism is of little interest as it
 is not going to impact their decision on the safety factors of interest to them.  There is no requirement to publish any data submitted in support of a registration in any public forum.  After all, if you published all the data, assuming you could find journals interested in publishing millions of pages, any competitor could take that data and use it himself to register an identical product the day your patents expire.  As a manufacturer you have a few hundred million $ invested in generating that data and are not inclined to simply give it all away for free.  EPA has established a process called data compensation where your data can be cited for a generic product after you are off patent, but the competitor does not get to see the data.  He simply must pay you a fee negotiated with EPA as arbitrator based on his market share and based on your costs of generating the data.  Some things are published.  But, it is a tiny, tiny fraction of all the data
 submitted.  This is no different than any other industry in terms of keeping trade secrets.  Intel does not publish details on design and manufacture of their puter chips.  Chemical companies do not publish details of what catalysts they use and how they manufacture those catalysts.  Banks do not publish a list of all their borrowers.  Newpapers do not publish a list of subscribers.

"Genes in their normal state are turned off"

No gene can express unless there are binding sites open on one side of the gene so transcription chemicals can bind.  That binding site is not part of the gene if I define the gene as everything from the start of the start sequence to the end of the stop sequence.  In some cases the binding site is exposed in some tissues permanently by the way the DNA is wrapped on the histone proteins and in other tissues that same binding site is hidden again due to how it is wrapped on the histones.  Without those binding sites the gene is off.  There are lots of other ways to turn the gene on besides how it is wound on the histones.  An outside chemical can bind directly or bind to something that binds to the DNA.  Genes can be turned permanently off or on epigeneitically.  There are lots of options and I am sure we are not even close to understanding all of them.  But, at the end of the day genes are all off until something outside the gene itself allows binding so
 it can be expressed.

This is all getting pretty far from bees I fear and I will try and refrain from further comment.

Dick


" Any discovery made by the human mind can be explained in its essentials to the curious learner."  Professor Benjamin Schumacher talking about teaching quantum mechanics to non scientists.   "For every complex problem there is a solution which is simple, neat and wrong."  H. L. Mencken

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