During the month of April, a very public debate between the U.S. Food and Drug Administration (FDA) and supporters of breweries, distilleries and animal feed purchasers reached a fevered pitch. Breweries and distilleries have long sold spent grains, a by-product of the brewing process, as an ingredient for animal feed. As originally written by FDA, these spent grains constituted an ingredient in animal food, and the breweries and distilleries who sold the by-products would be deemed to be manufacturers of animal food. This classification would require breweries and distilleries to comply with all of the new safety regulations imposed on animal food manufacturers. Following numerous public comments from both stakeholders and politicians, FDA issued a statement April 25, 2014, which appeared to alleviate those concerns. On closer inspection, neither spent grains nor any other by-product being added to animal feed or pet food will be wholly exempted from the analysis and various requirements of the Food Safety Modernization Act (FSMA).
Under FSMA, two somewhat parallel regulations have been proposed. The Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventative Controls for Human Food was published on January 16, 2013. The second, Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventative Controls for Food for Animals was published on October 29, 2013. Both include two distinctly separate sections. First, both modify and/or create current Good Manufacturing Practices (cGMPs) for their respective industries. Second, both provide for a completely new process of analyzing food adulteration hazards and, based upon those hazards, creating a written safety plan that includes risk-based preventative controls designed to eliminate or minimize those adulteration risks. This process must culminate in a written safety plan. The analysis and plan is by far the more onerous of the two new requirements. FDA has repeatedly remarked upon the similarities between the requirements being placed on both the human food manufacturing industry and the animal food manufacturing industry.
As soon as the animal food regulation was proposed, questions began to arise about what requirements would be imposed on suppliers of various by-products that ultimately end up as ingredients in animal foods. While FDA has tried to provide assurances that by-products would not create significant additional obligations, there will be requirements imposed relating to those by-products.
By-Products from the Manufacture of Human Food
The manufacturing of human food routinely generates waste, which is either unusable or undesirable for the human food. Although not usable in that setting, the by-products often contain valuable vitamins or nutrients that are usable in animal food. These by-products in essence become ingredients in animal food.
Facilities that are covered by the FSMA human food regulation must follow human food cGMPs and create a safety plan for the manufacturing of their human food. Once the proposed animal food regulation was issued, FDA was deluged with questions about whether these facilities would now also have to follow the animal food cGMPs and create an animal food safety plan for the by-products. At its public meetings relating to the animal food regulations, FDA’s answer was a clear “yes.” FDA tried to minimize the impact of their response by pointing out that the requirements for cGMPs and food safety plans were quite similar between the industries and they didn’t believe it would impose any additional significant burden.
In speaking to the uproar over spent grains, on April 24, 2014, Michael Taylor, the deputy commissioner for foods and veterinary medicine with FDA, commented in a blog post on FDA Voice that language in the regulations had led to misperceptions. He acknowledged that FDA had caused concerns among manufacturers that they would have to comply with human food regulations and also comply with redundant animal feed standards. He stated, “That would not make common sense and we’re not going to do it.” It is most likely that when the revised proposed regulations are issued this summer, human food manufacturers will simply need to make their safety plan broad enough to consider any risks associated with the by-products used as ingredients in animal food or feed.
By-Products from Alcohol
So what specifically caused such uproar with breweries and distilleries? Under the human food regulation, alcohol manufacturers had received a partial exemption. Although alcohol manufacturers would be required to comply with cGMPs, they would be exempted and not required to go through the arduous process of conducting a hazard analysis, identifying risk-based preventative controls and creating a written safety plan. In the language contained in the animal food regulation, FDA specifically acknowledged the practice of breweries and distilleries selling spent grains as an ingredient for animal feed. FDA stated that because the spent grains by-product were not alcoholic beverages themselves, the sale of such by-products would bring breweries and distilleries within the definition of an animal food manufacturer. Thus, although they were exempted from the risk-based hazard analysis process in the human food regulation, by selling spent grains for animal feed they would be required to conduct that analysis as an animal food manufacturer.
After much push back, FDA issued a formal statement on April 25, 2014. It acknowledged that the potential hazards associated with the use of spent grains in animal food were minimal. FDA stated that they merely wanted brewers and distillers to take common sense and reasonable measures to ensure that the spent grains were safe from chemical and physical hazards. It also stated that when it issued a revised proposed rule this summer, it would more clearly explain how the various requirements would apply to brewers and distillers. What isn’t clear is what approach FDA will take. In some instances, FDA has found certain foods to be so low risk as to be exempt from the regulatory requirements. Alternatively, FDA may require brewers and distillers to prepare a minimal safety plan which meets its stated goals of ensuring that the by-product is safe from chemical and physical hazards.
By-Products from Produce
There has not been nearly the discussion regarding the obligations which run with produce by-products that end up in animal food or feed. In January 2013, FDA published its proposed Standards for the Growing, Harvesting, Packing and Holding of Produce for Human Consumption rule, which does not include any hazard risk analysis safety plan. Whether produce growers could fall within the requirements of animal food manufacturers by reason of their by-products going into animal food or feed has yet to be addressed.
FDA has promised that questions relating to the manufacture, sale or donation of by-products for use in animal food and feed will be clarified with revisions to the language of the currently proposed rules. In its April 25 statement, FDA said, “We are in the process of reviewing our three rules—the produce safety rule, the preventive controls rule for human food, and the preventive controls rule for animal food—to avoid inconsistencies, duplication and confusion.” In the end, the results will be based upon one or both of two criteria. The obligations in the processing of by-products which become animal food ingredients may be decided by the source of the by-product and what safety requirements are already imposed upon that source. Or the requirements may be determined based upon the inherent safety or hazards of the by-product itself.
Kathy Hardee, Esq., is co-chair of the Food & Agriculture Industry Group at Polsinelli, PC, which is comprised of a team of attorneys from every legal practice area and who each have a focused background in the food industry.