2003N-0312 - Animal Feed Safety System: Risk Based Safety Program
FDA Comment Number : EC13
Submitter : Mr. Robert Kavanaugh Date & Time: 09/08/2004 08:09:55
Organization : Arise Direct Marketing, Inc.
Dietary Supplement Industry
Category :
Issue Areas/Comments
Multi-Docket Comment and Concern
This open docket regarding a Risk Based Approach to Animal Feed Safety may be only one of a many open/closed dockets where these comments should appear: The genesis of this comment arises from my recent attempts to self-educate in preparation for implementation of cGMPs for Dietary Supplements but more specifically my concerns are regarding glyphosate (Roundup) introduction into animal feed components and their effects on companion animals but especially canine. Other appropriate docket subject areas might include regulations of GM modified organisms and SBRFBA the Small Business Regulatory and Fairness Enforcement Act issues as they relate to both cGMPs and animal feed safety program development.
Contextual Background
I am a very small business (per FDA) manager tasked with developing and implementing valid GMPs for manufacturing dietary supplements for humans and feed supplements for companion animals. As a consequence of FDA's anticipated release of cGMPs I have been working on developing a microbiological assay protocol for various raw materials we use to manufacture dietary supplements as well as other raw materials specific for companion animal feed supplements. One of our feed supplements calls for the use of soybean meal. In researching possible pathogenic micro-bacteria and other possible contaminates likely to occur in bulk soybean meal purchased on the open market, I came upon Monsanto's glyphosate tolerant GM modified version of glycine max detailed on the AGBIOS database on-line. One of the comments included therein was that canine are especially intolerant to glyphosate with an LD50 approximately half of mice! Upon reviewing the 1994 GM approval documentation of FDA's website, I was alarmed to learn that FDA only considered the "weeding" effects and the potential for the GM variety of this soy to produce endogenous toxin and allergens,etc. before approving its use. The actual use of glyphosate (Roundup) on soy was considered a separate question to be evaluated by the EPA. Upon reviewing the EPA's website, I was still unable to determine whether glyphosate pestisides is permitted for use on glycine max, and if so, when was glyphosate's use begun. Furthermore, I have no way to determine whether I should be designing a testing protocol to screen for glyphosate residue because (1) I don't know if the bulk glycine max I purchase to introduce into my manufacturing process is "Roundup Ready" [glyphosate tolerate] and if some or all of it is (2) I still do not know whether the glycine max might have been treated with glyphosate (Roundup). Since Monsanto's safety data regarding both the glyphosate catalysing enzyme and glyphosate seemed to rely heavily upon heating the soybean meal: (Monsanto letter to FDA states "virtually all soybean meal is heat treated.") Well, we're the "virtually" then, because we go to great lengths to preserve raw soybean meal as well as its non-pathogenic microflora as a probiotic flavone/isoflavone rich source which apprears to act as a signalling molecule increasing specific antioxidant enzyme activity in companion animals (especially canine). Since I don't want to exclude glyphosate residue testing from the protocol if it means accidently killing someone's canine someday, I will need more direction. However, if I have to pay to test every batch of raw material I ever make for glyphosate residue, I may consider filing a lawsuit pursuant to SBRFBA naming FDA (and Monsanto) under the theory that glyphosate intolerate soybean would have died if exposed to glyphosate, but in approving glyphosate tolerate varieties of glycine max without considering the consequences of glyphosate residue on my very small business (plan and practices), FDA violated SBRFBA (and I would likely name Monsanto under different legal principles related to general product liability theory.) Please comment.