WASHINGTON, D.C., U.S. —  The National Grain and Feed Association (NGFA) on March 21 urged the U.S. Food and Drug Administration (FDA) to proceed with improvements to its so-called veterinary feed directive (VFD) procedures that apply to certain animal drugs used in feed.

FDA has announced plans to significantly expand the use of its VFD process to provide for additional veterinary oversight of certain antimicrobial drugs used in feed for food-producing animals that it believes are important in treating human illness. These regulatory changes will include transitioning the availability of such drugs from an over-the-counter (OTC) status to VFD status. It is anticipated that this transition will occur by the end of 2016.

The NGFA's statement commends FDA for incorporating many of the organization's previous recommendations to streamline and make more efficient the agency's current VFD process. NGFA's statement said its recommendations "would make substantial and meaningful improvements to the VFD process if retained in final regulations."

In its statement, the NGFA also commends the agency for its approach to crafting and soliciting additional public comment before "proceeding to proposed regulations, given the significance of the regulatory issues involved." NGFA also notes that it is important that the "transition by FDA of existing animal drugs to VFD status should be science-based, and limited solely to those antimicrobial drugs that truly have significant importance to human medicine. Limiting the potential number of VFD drugs would lessen the regulatory burden on all parties."

Among other things, the NGFA's statement recommends that FDA:

•           Require veterinarians to take and pass a training program - preferably available electronically - before being authorized to issue a lawful VFD. NGFA says it believes this will eliminate confusion and errors that have occurred within the existing VFD process.
•           Create a list of VFD-trained veterinarians to be made available on a publicly accessible website hosted by a professional society or by FDA itself.
•           Improve the information collected on the VFD form itself to be more appropriate and relevant to the manufacturing of medicated feed, including by eliminating the requirement that the VFD form contain a specific quantity of feed to be manufactured per order, which can vary based upon weather and other factors that affect feed consumption by animals. NGFA previously had noted that other information already required on the VFD form, such as the duration of treatment, level of animal drug allowed in the feed, feeding directions and expiration date, already provided sufficient information so that the appropriate quantity of feed is manufactured, distributed and fed to the target animals.
•           Further clarify that VFD orders under the agency's proposed amendments may be transmitted and stored with electronic systems that need not be compliant with the agency's costly and onerous electronic records/electronic signatures requirements.

"The NGFA for several years has advocated improvements to the VFD process - even though it currently is applied to a limited number of animal drugs products used in food-producing animals," the statement said. "Importantly in this regard, medicated feed manufacturers who use existing VFD animal drugs already bear the primary regulatory burden associated with administering these drugs. This regulatory burden is substantial, both in terms of time and cost, with feed mills being the focal point for inspection when regulatory officials seek to determine compliance with the VFD regulations."