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Subject:
From:
James Fischer <[log in to unmask]>
Reply To:
Informed Discussion of Beekeeping Issues and Bee Biology <[log in to unmask]>
Date:
Fri, 16 Feb 2018 09:03:13 -0500
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> The FDA does zero testing of new drugs  EPA does zero testing of new
pesticides.

This is flatly wrong - the FDA and EPA test food and drugs just as
aggressively as Ms. Karpowski tests the 3rd grade's multiplication skills.

They make all the rules, the standards for methods and data, they even
specify what types of statistical analysis are acceptable.
If a manufacturer does meet the stringent criteria of either agency, they
get to start all over again.
Make no mistake, these are "EPA Tests" and "FDA Tests".  
Fail to satisfy their requirements, and you are not selling your new attempt
at "Better Living Through Chemistry".
A few of us on this list have participated in "IR4" efforts, the kinder,
gentler, low-pressure approach to pesticide review for "minor crops", and
even those are Norse Sagas. 

> Neither has the capability to do such testing.

This is also flatly incorrect - the EPA has depth and breadth of
capabilities, as they create the analytic methods to be used by most of the
planet:
https://www.epa.gov/pesticide-analytical-methods/overview-epa-pesticide-labo
ratories-and-methods
https://tinyurl.com/ybqc6qeo
 
Likewise, the FDA also has depth and breadth - they constantly screen a wide
range of items to assure public safety at 16+ labs across the USA
https://www.fda.gov/ScienceResearch/FieldScience/default.htm
https://tinyurl.com/y8ugofrv

> just like they depend on the applicant to do tests on new GMO's and supply
required data.

The difference is the cursory level of information provided on new GMOs and
the regulators' lack of ability to make actual demands 
Read "Safety Testing of Genetically Engineered Food." By Schubert and
Freese,  in the 11/2004 edition of the journal Biotechnology and Genetic
Engineering Reviews, where they critique the process of GMO "review" in
detail, and quote a typical clearance letter on the public record from FDA
to Monsanto about  "MON 810 Bt" corn:

"Based on the safety and nutritional assessment you have conducted, IT IS
OUR UNDERSTANDING that MONSANTO HAS CONCLUDED that corn products derived
from this new variety are not materially different in composition, safety,
and other relevant parameters from corn currently on the market, and that
the genetically modified corn does not raise issues that would require
premarket review or approval by FDA.. as you are aware, IT IS MONSANTO'S
RESPONSIBILITY to ensure that foods marketed by the firm are safe, wholesome
and in compliance with all applicable legal and regulatory requirements."

This is not regulatory oversight, this is a clear abdication of
responsibility.  Based only on manufacturer assurances alone, the product
gets a pass.

No wonder the WTO wants an "SPS" biosecurity protocol for GMOs.  When even
the WTO "trade at all costs" has more stringent safety concerns than we do,
our country is clearly out-of-step with the rest of civilization.

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