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Informed Discussion of Beekeeping Issues and Bee Biology

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Informed Discussion of Beekeeping Issues and Bee Biology <[log in to unmask]>
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Fri, 14 Apr 2023 19:40:38 +0000
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It is nice for a member to post various papers published in the scientific literature so we can all judge effectiveness for ourselves.  But, we also need to remember that FDA and EPA pay no attention to such papers at all.  They are totally irrelevant to the registration process so of no help at all in getting a new product label.  That has been the policy for EPA since the middle 1980s and I do not know how much farther back it goes with FDA.  As I remember the format EPA dictates if you want EPA to pay attention page one is the title page.  Page two is the index and page three is the Good Laboratory Practices compliance statement which has to say the study was done in compliance with good laboratory practices with only very minor exceptions allowed such as a minor change in the number of tests done compared to what was promised in the protocol.  That page must be signed and dated by the study director.  If that page is absent EPA simply has no interest in the results and will not officially review the report as it is deficient by definition and EPA will not consider any data presented in the report.  Part of what you promise when you sign a compliance statement is that all raw data, study records and Quality Assurance records will be preserved in fire proof limited access locked storage for as long as the product is registered.   If audited and any records are found missing the study is invalidated for EPA purposes.

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