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[Please note that we have updated the previously incorrect docket number on the sample letter.]

On December 11, 2013 the U.S. Food & Drug Administration (FDA) released a new draft guidance that asks animal-drug makers to voluntarily discontinue marketing antibiotics to farmers for faster livestock growth, limiting their use strictly to therapeutic uses. Will this billion-dollar industry make voluntary changes in order to protect the efficacy of important antibiotics used to treat human illnesses?

CI_FDAAntibioticsTakeActionWe need your help to push the FDA into addressing the draft guidance’s shortcomings.

According to the FDA an estimated 80% of all antibiotics manufactured in this country are administered to livestock — and most to promote weight gain and “feed efficiency.”

The draft guidance, written as nonbinding recommendations, calls for a voluntary three-year transition of medically important antibiotics to no longer allow their use for food-animal growth or feed efficiency purposes. However, some veterinarians and animal producers suggest drug manufacturers will instead start calling the continued use of antibiotics a “preventative strategy” to stave off bacterial outbreaks in their confinement facilities.

Indeed, the CEO of the world’s largest animal pharmaceutical company, Zoetis, stated that this change in approved uses for animal antibiotics will not slow their sales or harm profits.[i] Using antibiotics for disease prevention would not be that different from current practices of using antibiotics in feed formulas and in drinking water to promote faster animal growth.[ii]

The best preventative strategy, of course, is to limit the number and density of animals in a facility and to create a healthy environment, such that disease does not spread so rapidly.

More and more antibiotic resistance is being found in dangerous and deadly bacteria around the country. Methicillin-resistant Staphylococcus aureus (MRSA) infections, for example, kill close to 20,000 people a year in the U.S. Many studies show a multitude of drug resistant pathogens on meat and poultry products purchased in grocery stores.

A recent study published in the Clinical Infectious Diseases journal found 47% of meat and poultry samples from five U.S. cities were contaminated with Staphylococcus aureus. Ninety-six percent of those samples were resistant to at least one antibiotic, and 52% were multi-drug resistant. In addition, tests conducted by the FDA every year routinely show high levels of antibiotic resistant bacteria on retail meat.

The other major change that this FDA guidance calls for is requiring all medically important antibiotics that are administered via feed or water to have a veterinary prescription.

Currently many antibiotics are available over-the-counter (OTC). Even though most large factory farms are not buying their antibiotics from local outlets, such as their local feed store, family-scale farmers often purchase antibiotics for treatment purposes from agricultural retailers or online.

Sometimes emergencies arise, such as severe scours in a group of new bull calves or coccidiosis in poultry, where antibiotics are chosen to save the life of an animal. Requiring a veterinary prescription for those drugs may not be practicable, or economically feasible, in many remote parts of the country where large animal veterinarians are few and far between.

The FDA needs to hear from you about what you think of the draft guidance. Please go to regulations.gov and type in Docket # FDA-2011-D-0889-0155 to comment. You can read further background documents there if you wish.

The following is sample language that you can incorporate into your comments. However, we strongly encourage you to add your own thoughts to the comments as well.  Custom comments rather than boilerplate material will carry more weight.  If you are a farmer, please make that clear.

Sample Letter (please feel free to cut, paste and customize):

RE: Comment on Draft Guidance for Industry #213 (Docket No. FDA-2011-D-0889-0155)

To Whom It May Concern:

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, I believe 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.

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.

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 and that the threat of antimicrobial resistance will not subside.

I also believe 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.

Further Information:

According to Bill Bullard, CEO of R-CALF, an independent rancher organization, the indiscriminate use of antibiotics in livestock has allowed meat packers to crowd even more animals into their feedlots and exert more influence over the meat supply and prices. How about the FDA addresses the crowded conditions that spread drug-resistant pathogens throughout animal herds and flocks?

Multi-drug resistant bacteria are being found on an increasing number of meat samples taken around the country. In 2010, sampling conducted by the FDA found almost 52% of chicken breasts tested were contaminated with antibiotic-resistant E. coli. Chicken giant Foster Farms sickened more than 550 people in the last two years with Salmonella heidelberg bacteria, many strains of which were resistant to antibiotics. Safe food handling practices are probably the only reason more people are not getting sick.  But we need to do better in terms of eliminating the risk to families.

The other major change this draft guidance calls for is to bring the therapeutic uses of important antibiotics under the oversight of licensed veterinarians. While that move seems reasonable in many ways, similar to requiring a doctor’s prescription to obtain antibiotics for humans, it may disproportionately disadvantage small farmers who don’t have a regular relationship with a veterinarian.

For example, organic farmers may use a holistic veterinarian from time to time but not have a relationship with the local practitioner. They are not allowed to routinely use antibiotics, unless it is to save the life of an animal in the case of an emergency (if an organic farmer, as a last resort, uses an antibiotic, that animal no longer qualifies as organic). If they live far away from any food animal veterinarians or don’t have one on staff, how will they obtain a life-saving antibiotic in a timely manner if a prescription is required?

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.

For more information on this draft FDA guidance, follow this link here.

[i] P. Loftus, “Zoetis chief leads animal-health firm following split from Pfizer,” Wall Street Journal (2013); http://online.wsj.com/news/articles/SB10001424052702303755504579207710851450896

[ii] K. Nachman, T. Smith, & P. Martin, “Antibiotics: Call for Real Change,” Science, 10 January 2014, Vol. 343, pg. 136.


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