FDA Spent Grain Rule
In our previous post, we discussed how the proposed “FDA spent grain rule” in the FDA Food Safety Modernization Act (FSMA) would affect brewers and distillers, particularly the safety measures that would be necessary for the use or sale of spent grains. As background, for years, breweries and distilleries have either donated or sold their spent grains to farms for animal feed instead of disposing of them. For instance, New Belgium, a Colorado brewery, produced 64 million pounds of spent grains in 2013 alone–all of which were sold to one farm. According to New Belgium, if they did not sell it to the farm, the spent grain would all end up in landfill–entirely undermining any sustainability efforts.
However, on the FDA’s blog, Michael Taylor, FDA’s Commissioner for Foods and Veterinary Medicine, writes that FDA has heard from “trade groups and members of Congress, as well as individual brewers” regarding their concerns on the new proposed regulations as applied to spent grain and the additional costs associated with those regulations. Thus, in response to the opposition, Taylor states:
We understand how the language we used in our proposed rule could lead to the misperception that we are proposing to require human food manufacturers to establish separate animal feed safety plans and controls to cover their by-products, but it was never our intent to do so. In fact, we invited comment on practical ways to address by-products in keeping with their minimal potential risk.
We will take the necessary steps to clarify our intent in the rules themselves so there can be no confusion. As we previously announced, this summer we plan to issue revised proposals for comment on several key FSMA issues and we will include changes consistent with the points I’ve outlined in this blog.
So the FDA will look to revise its proposed spent grain rule when it revisits the FSMA this summer. Interestingly, Taylor suggests that FDA’s proposed new safety and handling rules in the FSMA were never intended to apply to such scenarios as breweries or distilleries use of spent grain–that it was a “misperception.” However, the previous proposed regulation seemed to clearly apply to this exact scenario–thus, it is unclear how this could be characterized as a “misperception”:
Section 116 of FSMA applies to animal food. However, the Agency is not aware of any animal food at alcoholic beverage facilities that would be exempt from section 418 of the FD&C Act under the proposed interpretation, and therefore is not aware of any animal food at alcoholic beverage facilities that would be exempt from proposed subpart C, “Hazard Analysis and Risk-Based Preventive Controls,” for animal food. For example, FDA understands that many breweries and distilleries sell spent grains, such as brewers dried grains and distillers dried grains, as animal food. Because those spent grains are not alcoholic beverages themselves, and they are not in a prepackaged form that prevents any direct human contact with the food, the Agency tentatively concludes that subpart C of this proposed rule would apply to them.
The proposed rule even specifically addresses a breweries’ or distilleries’ use of spent grain. For this reason, it would seem that the proposed rule was clearly intended to apply to spent grains, as originally written. However, likely in response to a strong and vocal opposition and considering the costs and the burdens of the regulations would outweigh the benefit of minimizing any risk of contamination, FDA appears to be rethinking this proposed rule. As Taylor even stated: “[w]e…believe the potential for any animal safety hazard to result from this practice is minimal.” For this reason, a burdensome and expensive regulation does not seem like a wise idea if there is only minimal benefit.
Ohio and Colorado Beverage Lawyers
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