by Debora Plehn-Dujowich, Ph.D.
On October 29, 2013, the Food and Drug Administration (FDA) issued proposed rules for the regulation of animal feed. The rules were created to implement the Food Safety and Modernization Act (FSMA), which was signed into law by the President on January 4, 2011, in response to public concern over contaminated and unsafe food for both animals and humans. According to the FDA, the purpose of the FSMA is to ensure that the U.S. food supply is safe by shifting the focus from responding to contamination, to preventing it. This new law and the accompanying rules were the first major legislation since the 1930s to regulate food safety, and as a result they were widely covered by the press.
The rules cover the manufacture of food for both farm animals and pets. The proposed rules would establish regulations regarding the manufacturing, processing, packing, or holding of animal food in two ways. First, they would create new current good manufacturing practice (CGMP) regulations that specifically address the manufacturing, processing, packing, and holding of animal food.
Second, the rules require manufacturers to put a written food safety plan in place to prevent the contamination of animal feed by food-borne illnesses, such as bacteria. The rules also require that manufacturers conduct hazard analyses. The written food safety plan should include putting procedures in place at key points in the food production process, and monitoring that the procedures are being followed correctly.
The application of preventive controls would be required only in cases where facilities determine that hazards are reasonably likely to occur. The FDA does not expect that all possible preventive measures and verification procedures would be applied to all animal foods at all facilities.
Facilities that manufacture, process, pack or hold animal food and that are required to register with the FDA under section 415 of the Food, Drug & Cosmetics (FD&C) Act would be required to comply with the proposed regulation unless they are covered by an exemption. The proposed rules would exempt farms, restaurants, other retail food establishments, nonprofit food establishments where food is prepared for, or served directly to, the consumer, or fishing vessels. Also exempted would be establishments that conduct nonclinical laboratory studies in animals to support applications for research or marketing permits for products regulated by the FDA, including food or color additives, animal food additives, human and animal drugs, medical devices for human use, biological products, and electronic products.
Small companies will have more time than larger companies to put the plan into effect, and the rules require that manufacturers re-evaluate their plans at least every three years.
One item that is not regulated by the proposed rules is the use of antibiotics in animal feed. On December 11, 2013, the FDA issued a final guidance asking for drug manufacturers to voluntarily change the labels of antibiotics that are designated as important in human medicine to no longer promote such drugs for animal growth purposes over the next three years. The FDA also issued a proposed rule that would give a Veterinary Feed Directive designation to drugs that could previously be obtained over the counter. This means that these drugs will now only be available through a prescription given by a Veterinarian. Antibiotics that are not essential for human medicine will still be permitted in animal feed for growth promotion.
In conclusion, the subject of the regulation of animal feed is a hot topic at the FDA and is being closely watched by the industry as well as by the general public. In general, the industry has welcomed the collaborative approach that the FDA has taken with regards to these issues. It will be interesting to follow the developments over the next few years.
 Debora Plehn-Dujowich is a patent attorney at Drinker Biddle. Dr. Plehn-Dujowich’s practice specializes in patent preparation and prosecution as well as in due diligence and opinion drafting for University, Research Institute and Corporate clients in the biochemistry, biotechnology and chemical fields.
 Current good manufacturing practice and hazard analysis and risk-based preventive controls for food for animals, available at https://www.federalregister.gov/articles/2013/10/29/2013-25126/current-good-manufacturing-practice-and-hazard-analysis-and-risk-based-preventive-controls-for-food.