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Questions and Answers for Brewers/Distillers on the Original FSMA Proposed Rule for Preventive Controls for Animal Food
Since the March 31 close of the comment period on FDA's proposed animal feed rule, "Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals," FDA has heard many concerns from brewers and distillers about whether the rule will allow them to continue providing spent grains (by-products from alcoholic-beverage brewing and distilling) for animal feed. These spent grains are very commonly used as animal feed, and are a subset of the much broader practice of human food manufacturers sending their peels, trimmings, and other edible by-products to local farmers or feed manufacturers for animal feed uses rather than to landfills. FDA recognizes these concerns and addresses some of the questions that have been raised in the Q&A.
Why has the FDA proposed this rule?
On October 29, 2013, the FDA proposed a rule on current good manufacturing practice, hazard analysis, and risk-based preventive controls for food for animals as part of its Food Safety Modernization Act (FSMA) rule-making initiatives. The proposed rule, "Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals," is aimed at improving the safety of animal food, including pet food and animal feed, by requiring animal food facilities to take preventive steps to ensure that food for animals is safe. This proposed regulation would help prevent foodborne illness in both animals and people.
The proposal is part of the FDA Food Safety Modernization Act's larger effort to modernize the food safety system for the 21st century and focus public and private efforts on preventing food safety problems, rather than relying primarily on responding to problems after the fact.
Does FDA believe that there are significant hazards associated with spent grains?
FDA’s current understanding is that the potential hazards associated with spent grains are minimal. We want to be sure that brewers and distillers take common sense and reasonable measures to ensure that food for animals is safe from chemical and physical hazards. 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.
Under the current proposed rule, what would brewers or distillers who sell their spent grains to farmers to use as animal food need to do?
As the rule is currently proposed, brewers or distillers who sell their spent grains to farmers to use as animal food would need to follow current good manufacturing practice regulations (cGMPs), which would help prevent contamination. Breweries and distillery operations making a beverage or product for human consumption are already subject to human food cGMPs, and as a result should already be familiar with these practices.
Brewing and distilling companies that do not qualify for the very small business exemption (explained below in further detail) would also need to develop a written food safety plan, which involves identifying the hazards that are reasonably likely to occur and putting in place preventive controls to minimize or prevent those hazards. This plan would likely be as minimal as ensuring spent grains are stored in conditions that prevent contamination, such as using barrels that cannot be confused for trash bins or have not previously stored hazardous chemicals. Brewers and distillers with a food safety plan for their human product would not need to establish a separate animal feed safety plan and controls to cover their by-products, but would simply need to document those steps in their current plan.
FDA will propose revised language for this rule later this summer, and we will include more on the issue of how the requirements would apply to brewers, and welcome additional comments.
Would the proposed rule require specific action, such as drying and packaging spent grains, before providing them to producers?
No, the rule as it is currently proposed would not require specific actions, such as drying and packaging spent grains. The proposed rule is flexible, and we anticipate that companies required to implement preventive controls may either develop new preventive controls or utilize controls already in place that fit their products and operations, as long as they are adequate to significantly minimize or prevent all animal food safety hazards that are reasonably foreseeable.
Would brewers be forced to take their spent grains to a landfill?
No. FDA recognizes the efficiency and sustainability benefits of sending human food by-products to animal feed and does not intend to put in place requirements that would interfere with this practice.
Would there be any exemptions?
Yes, as proposed, very small businesses, which could include local and craft brewers, would be exempt from the written food safety plan requirement. FDA sought comment on three possible definitions of very small businesses, ranging from having less than $500,000 of total annual sales of animal food to less than $2.5 million of total annual sales of animal food. Because the exemption is based on sales, companies that donate a byproduct rather than sell it likely would qualify for the very small business exemption.
Is the FDA aware of any contamination events related to byproducts used for animal feed?
FDA is unaware of contamination events resulting specifically from spent grains relating to the brewing industry, and for that reason believes that additional steps to prevent contamination would be relatively minimal, and in many cases, may already be in place. The goal of the current good manufacturing practice and preventive controls proposed regulations under the FDA Food Safety Modernization Act is to help food and feed producers protect against contamination of and significantly reduce or prevent hazards related to their products. We have had incidents in which human food by-product for animal feed has become contaminated with chemical or physical hazards. For example, an incident where industrial waste oil was inadvertently added to a poorly labeled container holding fryer oil resulted in over 100,000 chickens being exposed to the industrial chemicals polychlorinated biphenyls (PCB).
If there has been no evidence of foodborne illness outbreaks resulting from spent grains used in animal feed, why are they now covered under this proposed rule?
The new food safety law calls for FDA to create rules that help prevent food safety problems rather than relying primarily on reacting to problems. In general, the animal food proposed rule would apply to facilities that manufacture, process, pack, and hold animal food. FDA is striving to create regulations that help keep our nation’s food supply safe while respecting longstanding partnerships such as that between farmers and brewers. The goal of the proposed regulations under FSMA is to help food and feed producers protect against contamination of and prevent food safety problems rather than reacting to problems. Because we cannot anticipate with certainty which foods could be contaminated during manufacturing, processing, packing, or holding, the proposed rule would cover a variety of animal food products.
How many comments has the FDA received on the proposed rule?
As of the close of the comment period on March 31, 2014, the FDA received more than 2,000 comments. About 1,500 of these were from either pet owners or small brewers and farmers who receive spent grains from them. The comments on the proposed rule on preventive controls for animal food are available on www.regulations.gov at the following link: http://www.regulations.gov/#!docketDetail;D=FDA-2011-N-0922.
Does the FDA have plans to publish a revised version of the proposed rule? If so, when?
Yes, the agency will propose revised language for this rule later this summer, and we will include more on the issue of how the requirements would apply to brewers, and welcome additional comments. We very much appreciate feedback and two-way dialogue on this rule and how we can achieve our food safety goals in the most practical way. Thanks in part to this dialogue, we recognize this is an area that should be addressed, and we are confident we will find a common sense solution. We are working to develop regulations that are responsive to the concerns expressed, practical for businesses, and that also help ensure that food for animals is safe and will not cause injury to animals or humans.
When will FDA issue a final rule?
We cannot speculate on a timeframe for issuing the final rule; however, the FDA is working as quickly as possible to finalize all of the rules required by the FDA Food Safety Modernization Act, while also ensuring that we get these rules right. The agency has an agreed deadline of August 30, 2015 for the final rule for current good manufacturing practice and preventive controls for food for animals.