New regulations coming

Ray Mueller
Now Media Group


When Jan. 1, 2017, arrives, courtesy of the federal Food and Drug Administration, a whole new set of regulations will be in place for providing animals with the antibiotics which are also given to humans.

Popularly referred to as the veterinary feed directive, the new regulation will directly affect not only veterinarians but also all feeders of livestock, feed mills, and the over the counter sellers of medicated animal feeds. VFD will not apply to products such as Rumensin, Bovatec, DeCox and any others that are given only to animals.

Simply stated, the VFD rule will require that veterinarians provide a directive to all producers who want to use or obtain feed products with feed additives that contain medically important antimicrobials. That's comparable to receiving a prescription from a veterinarian to use antibiotics that are injected to animals.

VFD rule basics

The basics of the upcoming VFD rule were explained by Zoetis senior veterinarian Dick Wallace at the Extension Service's seminar on Raising Quality Heifers. He noted that the rule has roots to 2003, when the FDA defined medically significant antibiotics and assigned each of the active ingredients — only two of which are widely used in the dairy sector — to either an important, highly important, or critically important class.

By 2012, the FDA had defined and called for 'judicious use of antibiotics' and by the end of 2013 it outlined the process for implementing VFD, Wallace pointed out. He explained that 'judicious use' rules out using the 'medically important antibiotics' in feed to promote animal growth, transfers the therapeutic use of those antibiotics to oversight by veterinarians and moves water soluble powders containing antibiotics into a use only by prescription protocol.

Background factors

Although he doesn't oppose the new VFD as such, Wallace questions how things got to this point. While acknowledging that antibiotics are a tool which is sometimes abused, he stressed that there is no scientific proof that providing antibiotics to animals creates resistance to that particular antibiotic in humans.

But given that 'everybody is talking about food' and that ultimately 'consumers sign our paycheck,' Wallace understands that the FDA has responded to public pressures with a goal of helping to ensure safe food and the sustainable use of antimicrobials for both animals and humans.

Another factor leading to the new era of regulation was the number of drug residue violations in bob veal calves and dairy cows sent to slaughter — a category in which Wisconsin stood at the top among the states for the number of repeat violators in 2008 and 2010, Wallace observed. The state then did not have any repeat violators in 2011 and has had a few in recent years, he reported.

In addition to citing media headlines about drug residues and other food safety incidents, Wallace noted how 'everyone has a voice today — valid or not' in the social media. 'Don't blame it all on activists,' he said.

Wallace questions the stances, which he considers to be 'scare tactics,' taken by Chipotle, Subway and McDonald's on what standards they're applying to food suppliers. For example, 'antibiotics are not fed to chickens, but how do you prove a negative?' he asked.

Looking ahead

Under the VFD protocols taking effect at the start of 2017, users will need to have a prescription from a veterinarian licensed to practice in the state to obtain any feed with an antibiotic, no mixing of two or more antibiotics will be allowed in any product, and the extra label of feed additive antibiotics will continue to be prohibited.

Additional stipulations are that a VFD permit is limited to 6 months and that VFD records must be kept for 2 years. Those records must be kept by the veterinarian, the feed supplier and the user. Farmers who mix feed and supply it to another party can do so if they obtain a distributor's license, complete two forms and meet all of the VFD requirements.

For a veterinarian to approve a VFD permit, there must also be an existing valid veterinarian client patient relationship with the livestock producer. The permit must also identify the feed mill or other source of the medicated feed and the animals (by group or individually) receiving the feed.

Implementation steps

To prepare for the new regulations, any producers not having a VCPR need to establish one, Wallace emphasized. As a supplier of antibiotics for medicated feeds, he said Zoetis and the industry as a whole are working with FDA officials on how to implement the changes, particularly on the possibility of keeping the records in an electronic format rather than on paper.

There will also be a transition in the labeling of products and an effort to create a generic VFD permit form shared through the Global Vet Link, Wallace announced. He advises users of medicated feeds not to try to circumvent the regulations by stocking supplies that would not be used before Jan. 1 of 2017.

Specific guidance for parties directly affected by the new regulations is available on Zoetis website with an online search for ResponsibleAntibioticUse.