2. FDA’s regulatory guidance regarding toxins
In addition to the regulations discussed above, the FDA has also issued regulatory guidance applicable to two types of toxins and contaminants naturally present within commercial feedstocks — deoxynivalenol (vomitoxin) and aflatoxin. Overall, the FDA’s regulatory guidance can fall into three categories: (1) advisory levels (to provide the industry levels which the FDA views as providing an adequate margin of safety); (2) action levels (to identify a precise level of contamination at which the agency will take affirmative enforcement action); and (3) regulatory limits (to set limits at which a court could find a per se legal violation without enforcement activity).
Within the commercial feed sector, to date, the FDA has issued an advisory level regarding vomitoxin, and has issued an action level applicable to aflatoxin. It is important to note that even if the FDA does not take action according to its guidance or action levels, these guidance documents have a broader impact as they often interplay with contractual obligations. As the FDA is well aware, FDA regulatory guidelines are often referenced in contracts to define the term “merchantable quality.” Thus, a counterparty to a feed contract could potentially reject a shipment of commercial feed if the shipment failed to comply with the FDA guidance on either of these toxins, or otherwise allow a purchaser to reject a shipment as adulterated under the Food, Drug, and Cosmetic Act.
3. The FDA and distillers grains
A last example of the increasing attention the FDA is giving to the area of commercial feed, the FDA, in 2010, has begun a program of sampling distillers grains for antibiotic residues. According to the FDA, antibiotics such as virginiamycin, penicillin and erythromycin are used within the production of commercial ethanol during the fermentation process to control bacterial contamination, and pre-sent a potential issue to the feed supply. The FDA is concerned that these antibiotics may not be broken down to inactive status within the ethanol production cycle, and is also concerned that some antibiotics may actually be concentrated within distillers grains as a result of these production processes. Although this increased attention to distillers grains has only resulted in a FDA survey to this point, this survey illustrates the increasing willingness of FDA to step in and monitor commercial feedstocks.
Don’t forget federal regulations
Although state regulations still present the more rigorous regulatory regime, a company cannot afford to overlook federal regulations applicable to commercial feed. Failure to comply with federal regulations can now result in civil, and even criminal liability for violations of regulations issued in relation to the Bioterrorism Act of 2002. Beyond these current regulations, however, a commercial feed producer should be aware of the increasing role of the FDA and pay close attention to developments within the field to remain compliant with all current and future federal regulations within this sector.
Failure to comply with the registration requirements is, however, a serious matter and can result in civil and criminal liability.
The FDA utilized a broad definition of “food facilities” which was tailored to specifically include producers of animal and pet feeds as well as other manufacturers more traditionally viewed to fall in the category of food facilities.