Peter


As always, good information.


I've been doing a lot of digging regarding the Jan 2017 US FDA Directive.


FDA not only put this into place without apparently even being aware that under their definition, bees would become patients, but is also at fault for vague terms when using the word antibiotic.


1) Antibiotic =  anti    biotic, which could be anything biotic, but is generally considered to mean anti  microbial.
2) For bees, only three antibiotics are of concern - oxytetracycline, tylosil, and lincomycin.
3) Most of us didn't even know that lincomycin was approved for use in beehives in 2012.
4) So, FDA effectively added one antibiotic to the list of those that could be used in beehives - which is at odds to the concept of reducing antibiotic use.
5) Fumagillin is a fungicide.  Technically  Nosema is a fungus-like microsporidium.
6) Under the vague FDA use of the term antibiotics, fumagllium used to control a microbe (fungus) would be anti microbial.
7) But under the intent of the FDA Directive, fumagillin would not be covered, because FDA is actually defining antibiotic, specifically as anti - bacterial.
8) In many of FDA's explanations, the agency is focused  on AFB, which then becomes a non-issue in states that have mandatory burn regulations (since AFB can't legally be treated with antibiotics).  
9) However, FDA generally fails to mention EFB, which is in fact, the only foul brood disease treatable with antibiotics in must burn AFB states.
10) With respect to bees and other animals, FDA is not focused on reducing the use of all antibiotics.
11) FDA's focus is on reducing use of antibiotics that are frequently used to treat human diseases.
12) Peter is correct - Fumagillin is an important human antibiotic (using the broadest definition of the term antibiotic).
13) But, fumagillin is only used for very specific purposes in humans (Peter points out treatment of a microsporidium disease in immunocompromised patients) and Robert Cramer, who worked with us on Nosema, mentioned use to treat fungal eye infections, where the fungus was resistant to more conventional antibiotics.
14) Robert emphasized that fumagillin use in humans is the drug of last resort due to the fact that fumagillin is both cytotoxic and genotoxic!!  Fumagillin is not frequently used  in humans - it's use is relatively rare.


IF all of this seems to be confusing, it is.  For an agency charged with protecting human health, it's use of terms in a federal directive is  surprisingly sophomoric.









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