The debate of antibiotic use in animal agriculture revolves around the concept that antibiotic usage in food animals may induce antibiotic resistance in bacteria that may be transmitted from food animals to humans via the consumption of contaminated food products of animal origin. This has been a subject of scientific and public policy debate for years. Public health advocacy groups, consumer groups, and even members of Congress have actively joined the public discussion. This is a very complex issue and many gaps exist in the scientific understanding of the multi-factorial contributions to the development of antibiotic resistance by the use of antibiotics in humans, animal agriculture, and horticulture.

The Food and Drug Administration is taking steps that it believes will address these public health concerns but also guarantee that antibiotics are available to ensure animal health. Currently, the FDA is putting into place new rules and regulations that will change the way the poultry industry uses medically important antibiotics in the future. Medically important antibiotics are defined by FDA as those antibiotics which are used therapeutically in human medicine. The definition includes seven classes of antibiotics currently used by the poultry industry. Examples are gentamicin, lincomycin, tylosin, penicillin, virginiamycin, sulfonamides, and tetracyclines, as well as others.

The Veterinary Feed Directive

 

These changes are being implemented through two processes by the FDA; Guidance Documents 209 and 213 and the Veterinary Feed Directive. The changes are in two broad areas. First, medically important antibiotic use in food animals will be limited to therapeutic use, which is defined by FDA as the use to treat, control, or prevent a disease. This would disallow the use of medically important antibiotics solely for growth promotion. Second, the use of medically important antibiotics will involve veterinary involvement and oversight. The implementation of the new rules of the Veterinary Feed Directive will essentially change the status of many medically important antibiotics from the over-the-counter classification to the prescription only classification. In practice this will mean that in order to use a medically important antibiotic in the feed, a veterinarian will have to issue a prescription, which is called a Veterinary Feed Directive.

What this means for the poultry industry

 

The FDA is moving through the process of creating and implementing the new regulations relatively deliberately, and the expectation is that the new rules will not take effect before the end of 2016. Poultry companies should have ample time to implement processes necessary to comply with the new regulations. The ionophore antibiotics (monensin, salinomycin, narasin, etc.), which the poultry industry heavily relies upon to control coccidiosis, are not considered to be medically important antibiotics and will not be effected by the changes. Pharmaceutical companies which currently sell an antibiotic product that is labeled for growth promotion have the option to apply to FDA for a new therapeutic claim for their product. Over the next three years, we will see the phase-out of the use of medically important antibiotics for growth promotion, the phase-in of greater veterinary oversight, and potentially the addition of new therapeutic claims for existing antibiotics.