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The Increasing Role of Federal Regulation Within the Commercial Feed Sector

Failure to keep current with federal regulations and compliance could bear serious consequences

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By this time, most feed companies are thoroughly familiar with many of the issues presented with and by commercial feed regulations at the state level, including the widespread facility registration and inspection fee regimes that typify this field. State regulators, however, are not the only regulatory bodies interested in monitoring or controlling the commercial feed supply. Recently, federal agencies, particularly the Food and Drug Administration (FDA), are devoting an increasing degree of attention toward the commercial feed sector. In light of this increased attention, this article briefly touches upon the “hidden” and oft-times forgotten body of regulation applicable to the production of commercial feed — those regulations applicable at the federal level.

1. The Public Health and Bioterrorism Preparedness and Response Act of 2002 (“The Bioterrorism Act”)

In the immediate aftermath of 9/11, the FDA developed regulations relating to food facilities as food facilities were viewed as a potentially serious risk source for incidents of bioterrorism. To this end, the FDA wanted to develop the ability to be able to determine the location and source of a potential or actual bioterrorist attack or outbreak of food-borne illness, and to be able to quickly notify the affected food facilities if the need would ever arise. In developing these regulations, however, 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.

Overall, the FDA regulations relating to the Bioterrorism Act consisted of four components: (1) registering food facilities with the FDA; (2) requiring importers to give prior notice of food shipments being imported into the United States; (3) allowing detention of products the FDA viewed as presenting a threat of injury (to either humans or animals); and (4) imposing record-keeping requirements.

Of the four components, the registration and record-keeping requirements have had the most widespread impact upon the commercial feed sector. The registration requirement imposes an affirmative obligation upon food facilities (including producers of commercial feed) to register with the FDA in order to provide the FDA knowledge of the facility’s location and production activities (again, with the idea that this will give the FDA the ability to trace back a bioterrorist incident or the outbreak of a food-borne incident). The FDA has made facility registration a relatively painless process, and a facility can register either online, or through the mail after the proper form has been obtained via a phone request with the administration. There is no cost associated with the FDA facility registration, and there have been no renewal (annual or otherwise) requirements placed upon facilities. If, however, a facility undergoes a change in its production, ownership/control, or if it otherwise closes down, the producer must notify and update the FDA as to the change so that the administration’s records will be current regarding that facility. Failure to comply with the registration requirements is, however, a serious matter and can result in civil and criminal liability.

The record-keeping requirements are the second major category of requirements impacting commercial feed producers pursuant to these regulations. The FDA now requires food facilities to create records whenever they receive food or feed, and also when they transport these items. These records are important. If the FDA has a reasonable belief that feed is adulterated and presents the threat of serious adverse health consequences, the FDA can and will require the feed facility to make the records available to FDA inspectors within 24 hours of the request. Additionally, the FDA requires producers to maintain all records relating to animal feed for a one-year period.

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.

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