IMPLEMENTATION OF NEW AND REVISED FDA REGULATIONS

Liz Wagstrom, DVM

The implementation of the Food and Drug Administration’s (FDA) Guidance 213 will signal one of the most significant changes ever in the regulation of antibiotics in food animal production. These impacts are likely to vary depending on the type of producer or veterinary practice. However, the overall impact on public perception of food animal production will be dependent on the industry’s commitment to successfully implementing the changes outlined in the FDA guidance.

These impacts are likely to very depending on the type of producer or veterinary practice.

• Integrated producers with staff veterinarians and company-owned feed mills have infrastructure in place that will likely allow them to implement these changes with minimal impact. Anecdotally, many of these producers have already made changes in the use of antibiotics in their production systems consistent with the FDA guidance.


• Independent producers and veterinarians will need to put systems in place to address the requirements of the veterinary feed directive (VFD) modifications. These producers will need to address their veterinaryclient- patient-relationship (VCPR), communications with their feed supplier, record-keeping and other potential regulatory requirements. However, the result of addressing these requirements may not be merely compliance with the FDA requirements, but also an enhanced producerveterinary communication and relationship.


• Small producers who mix feed on farm or who buy floor stock, may be disproportionately affected by the new changes. Due to the requirements for distributors, some retail outlets may no longer choose to stock medicated feed or water medications. Additionally, the costs of veterinary visits that would contribute to a valid VCPR and allow a veterinarian to legally write a VFD may be spread across a smaller number of animals. This would make the per-animal cost of implementation larger for these producers.

When the antibiotic changes go into effect next January, it is uncertain if there will be demonstrable impacts to animal health or performance. The FDA has clearly signaled that it is committed to allowing therapeutic uses of antibiotics that are important to protecting animal health. It is also uncertain if any measurable effect to antibiotic resistance in either animal or human disease will be observed. However, despite those uncertainties, successful implementation of Guidance 213 will continue to demonstrate the pork industry’s commitment to the responsible use of antibiotics.

---

- Liz Wagstrom, DVM
Dr. Liz Wagstrom is Chief Veterinarian, National Pork Producers Council

---

---