Date: May 16, 2014
On April 25, 2014, the Food and Drug Administration (FDA) issued two documents to address the impact of the FDA Food Safety Modernization Act (FSMA) animal feed Hazard Analysis and Risk-based Preventive Controls (HARPC) proposal on spent grains, and ultimately, the impact of the animal feed HARPC proposal to all waste (“co-products”) of human food production that is diverted to animal feed. The first document was a blog post from FDA's Deputy Commissioner for Foods and Veterinary Medicine, Michael Taylor, regarding spent grains. See Blog: Getting it Right on Spent Grains. The second document was a Questions and Answers document that addresses the diversion of spent grains from beer production to animal feed. See Questions and Answers for Brewers/Distillers on the FSMA Proposed Rule for Preventive Controls for Animal Food.
The animal feed HARPC proposal comment period closed on March 31, 2014; FDA has received over 2,000 comments on the proposed rule, many of which concern the obligation of facilities that produce spent grains and other co-products that are diverted to animal feed. FDA already promulgated a proposed HARPC rule for human food in January of 2013. According to many comments, facilities that would need to comply with the human food HARPC rule will be made to also comply with the animal feed HARPC requirements making the diversion of these co-products a burdensome process that will force companies to divert the co-products to landfills. More specifically, comments from both farmers and alcoholic beverage manufacturers have noted that use of spent grain by farmers is a low-risk activity that has been mutually beneficial to brewers and farmers for decades.
Therefore, in the two documents recently released by FDA, the agency has confirmed that they will clarify in the final rule that the animal feed HARPC requirements are not required above and beyond human food HARPC requirements. FDA plans to provide this clarification when the animal feed HARPC rule is reissued this summer. In justifying its decision, FDA noted that the potential hazards associated with spent grains and other co-products are minimal and really only involve the inadvertent introduction of chemical and physical hazards, which can be dealt with by applying good manufacturing practices (GMPs) at the facility. However, still of some concern may be how FDA will deal with co-products from industrial production—such as ethanol—and pet food production, both of which frequently have co-products that are diverted to animal feed applications.
It is unusual for FDA to publicly announce how a final rule will differ from a proposed rule before the final rule is issued. Therefore, FDA’s recent actions to announce such a decision could signal an increased willingness by FDA to respond more proactively to regulatory policies which garner significant attention. Keller and Heckman LLP attorneys will continue to monitor the animal feed and human food HARPC regulations, as well as all other regulatory promulgations related to FSMA.