Please read Cornucopia’s comments on Draft Guidance for Industry #213 (Docket No. FDA-2011-D-0889-0155) below. More information on this draft guidance is available here.

The FDA needs to hear from you about what you think of the draft guidance. Please click here to comment.

CI_FDAAntibioticsTakeAction

To Whom It May Concern:

The “judicious use” principles outlined by the U.S. Food and Drug Administration (FDA) in GFI #209 and their planned implementation, as described in GFI #213, are inadequate responses to this threat.Thank you for the opportunity to comment on draft Guidance for Industry (GFI) #213.  As a stakeholder in the fight to improve the safety of our food supply, The Cornucopia Institute believes it is imperative that antimicrobials be used responsibly in food animal production to help slow the development of antimicrobial resistance that has emerged as a major threat to human and animal health.

In the guidance documents, the FDA endorses the continued use of antimicrobials for disease prevention, despite its similarity to the use of these drugs for growth promotion.  We believe concentrated animal feeding operations (CAFOs), or “factory farms,” may very well continue to use the same antibiotics in the feed and water, at similar doses, in the name of preventing disease.  Such an occurrence will  lead to the failure of this guidance to slow the threat of antimicrobial resistance..

The Cornucopia Institute also believes the prescribed monitoring program falls short of comprehensively evaluating the changes in antimicrobial use, volumes, and levels of resistant pathogens in our food animals and meat supply.

Likewise, switching the over-the-counter (OTC) antimicrobials to Veterinary Feed Directive (VFD) status will make it extremely difficult for farmers lacking on-staff veterinary help who need to obtain life-saving medicines for their animals in times of emergencies.

This may prove especially true in places that have few large animal veterinarians.  Indeed, the Humane Society Veterinary Medicine Association finds the lack of licensed food animal veterinarians to be a major problem with the implementation of this guidance.

The Cornucopia Institute cares about the livelihoods of independent family farms, local, organic and sustainably managed, and there is a legitimate concern that farmers continue to have access to life-saving medicines for their animals when they need them.

We ask that you seriously consider these shortcomings as you continue to revise the guidance document #213.

Sincerely,
Rebecca Thistlethwaite
Farm & Food Policy Analyst
The Cornucopia Institute

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