BCI Committed to Both Animal and Human Health in Antibiotics Discussion

As of late, there has been significant discussion on the topic of the use of antibiotics in animals entering the food system.

Dr. Michael Apley, Professor of Veterinary Clinical Sciences at Kansas State University and contributing staff to the Beef Cattle Institute, has been instrumental in evaluating and preparing comments on the new and proposed new regulations on the use of antibiotics in feed and water for livestock.

The Food and Drug Administration (FDA) put forth two key guidance measures in April, 2012 and December, 2103. A “guidance” is non-binding and does not carry weight of any law or regulation. According to Apley, in this case the guidance documents allow for voluntary action which will in turn quicken the action to be taken. A guidance document also allows for a first draft review by stakeholders, increasing the conversation between the stakeholders and FDA. Stakeholders could pursue other routes, but would likely be unsuccessful without prior clearance from the FDA.

The first guidance document, #209, states two principles for which the FDA Center of Veterinary Medicine will seek voluntary compliance from the pharmaceutical industry.

Principle 1: The use of medically important antimicrobial drugs in food-producing animals should be limited to those uses that are considered necessary for assuring animal health.

Principle 2: The use of medically important antimicrobial drugs in food producing animals should be limited to those uses that include veterinary oversight or consultation.

The second guidance document, #213, defines how the goals of Guidance 209 may be met by the sponsors. Drug companies have 90 days from the release Guidance #213 to voluntarily commit to the new regulations. After this, companies will have three years to fully withdraw growth promotion claims from their labels. Zoetis and Elanco have already publicly committed to the suggested regulations.

In addition to the guidance documents, a proposed new Veterinary Feed Directive (VFD) rule was also released in December 2013. According to Apley, the proposed rule outlines an intent to alter how the Veterinary Feed Directive (VFD) is currently handled and create a more user-friendly version of the VFD.

Per the Animal Veterinary Medical Association (AVMA) website, the VFD category of medicated feeds was created by the Animal Drug Availability Act of 1996 to provide an alternative to prescription status for certain therapeutic animal pharmaceuticals for use in feed.

“There are currently drugs which require a VFD. They are all antibiotics, and are labeled for use in the feed or either swine, cattle, or fish. The FDA recognizes that extending this level of detail to VFDs for all uses of antibiotics in the feed for prevention, control, or treatment of disease would be overwhelming for veterinary practitioners. Therefore, they are intending to streamline the requirements to reduce the burden on the practitioner but still adequately protect animal and human health.”

These guidance documents have been released by the FDA because of their growing concern about the use of antibiotics in food animals. Their concern is based on the potential for selection for antibiotic resistant pathogens in food animals which then may either be directly transferred to humans or transferred along the food chain. According to Apley, the last “new” group of antibiotics, for which we have a representative of the group used in food animals, was first released in 1978. Since then, new antibiotics have been created as alterations from these initial groups, but we have had no new groups for use in food animals, and Apley does not any to be approved in the foreseeable future.

He compared antibiotic usage to that of our use of water and petroleum, as well as tillage practices; “I think we will look back on our antibiotic use strategies in the future and realize that we weren’t using them as optimally as we thought”.

The BCI, which also hosts the Animal Care Training website, animalcaretraining.org, has vital interests in the process of the proposed regulations.

“Our position at the BCI should be what the actual facts and science tell us,” Apley says. “ Let the data actually verify for us what we do and don’t know. Then, these data should inform our actions rather than relying on conjecture and agendas.”

He added to that comment by saying that the BCI is committed to both animal and human health.

“What we don’t want to see happen is something done in the name of human health which has a huge adverse effect on animal health but has no actual benefit for human health. That would be the tragedy,” Apley says. “Human health is significantly challenged by antibiotic resistance today, as evidenced by the Centers for Disease Control and Prevention (CDC) 2013 report on antibiotic resistance. While we need to carefully examine the effect of food animal antibiotic uses on antibiotic resistance in bacteria such as Salmonella, it is clear from the report that the majority of human resistance concerns are for pathogens with no documented or even reasonably hypothesized link to food animal antibiotic use.”

No one should expect there to be a definitive answer to all of the questions, but advancement and changes in policy, regulation, and legislation likely won’t wait until science gives us a definitive direction. Therefore, it is essential that animal agriculture and affiliated industries stay actively engaged in the subject, and continue to insist that data serve as the primary driver for the “solutions” being evaluated.