FDA addresses concerns over proposed spent-grains rule

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Brewers’ grains and distillers’ grains have become important, high-quality feed commodities in cattle operations, and cattle provide an excellent option for utilizing these byproducts, turning what otherwise could be waste into wholesome and nutritious food. So when the FDA issued a proposed rule that would introduce new food-safety requirements on breweries and distilleries that supply the byproduct feeds, manufacturers and cattle producers expressed serious concerns.

The comment period on the proposed rule, titled "Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals," ended on March 31, and since then, FDA has worked to clarify the implications for feeding brewers’ and distillers’ grains.

According to FDA, the proposed rule intends to improve the safety of animal food, including pet food and animal feed, by requiring animal-food facilities to take preventive steps to ensure their products are safe, as a means to help prevent foodborne illness in both animals and people. The proposal is part of the FDA Food Safety Modernization Act's effort to focus on preventing food safety problems, rather than relying primarily on responding to problems after the fact.

In a recently released Q&A document, FDA indicates an understanding that 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.”

The agency also notes that the current proposal would require brewers or distillers who sell their spent grains to farmers for use as animal food would need to follow current good manufacturing practice regulations (cGMPs). They also note that 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.

Some brewing and distilling companies would qualify for a very-small business exemption under the proposal. Others would 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. 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 byproducts, but would simply need to document those steps in their current plan.

Other points from the FDA clarifications include:

  • 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.
  • The proposed rule would not require specific actions, such as drying and packaging spent grains, and will provide flexibility for companies to develop new preventive controls or utilize controls already in place that fit their products and operations.
  • 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.
  • Very-small businesses, which could include local and craft brewers, would be exempt from the written food safety plan requirement. 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.
  • 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 agency plans to propose revised language for this rule later this summer, and will include more on the issue of how the requirements would apply to brewers, and welcome additional comments. FDA has not announced a timeframe for issuing a final rule, but has agreed deadline of August 30, 2015 for the final rule for current good manufacturing practice and preventive controls for food for animals.

Read more from FDA’ Center for Veterinary Medicine


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