FDA’s Proposed Rules May Affect Breweries and Distilleries

The Colorado Beverage Lawyers of LaszloLaw discuss the effect of the FDA’s proposed rules on the beer and liquor industry.

Colorado Beverage Lawyer | Boulder Beverage LawyerOn October 29, 2013, FDA posted proposed rules regulating the “good manufacturing practice in manufacturing, processing, packing or holding of animal food.” According to the summary, the proposed regulations “require that certain facilities establish and implement hazard analysis and risk-based preventive controls for food for animals.”  The purpose of the proposed regulations is “to provide greater assurance that animal food is safe and will not cause illness or injury to animals or humans and is intended to build an animal food safety system for the future that makes modern, science and risk-based preventive controls the norm across all sectors of the animal food system.”

At first glance, it would appear that FDA’s proposed rules under the FDA Food Safety Modernization Act (FSMA) regarding animal food would have little bearing on breweries or distilleries. However, the proposed rules contain a particular provision applicable to “alcoholic beverage facilities” that sell their spent grains to farmers for animal food:

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.

In short, the above provision states that Subpart C, “Hazard Analysis and Risk-Based Preventative Controls” will in fact apply to breweries and distilleries who sell spent grains for animal food. Thus, this means FDA does not exclude breweries and distilleries from the Hazard Analysis and Risk-Based Preventive Control measures proposed. These measures would include:

  • Written food safety plan. This includes a hazard analysis, preventative controls, monitoring procedures, corrective action procedures, and a recall plan.
  • Written hazard analysis to “identify and evaluate known or reasonably foreseeable hazards,” “determine whether there are hazards that are reasonably likely to occur,” and assess “the severity of the illness or injury if the hazard were to occur.”
  • Written preventative controls. These would include the parameters associated with the control of the hazard and the minimum and maximum levels of those parameters. Additionally, the preventative controls would have to include a process and sanitation controls and a recall plan.
  • Written recall plan.
  • Corrective actions–meaning facilities must establish and implement written corrective action procedures that would be used if preventive controls are not properly implemented and take corrective actions if necessary.
  • Verification activities must be conducted to confirm that the preventative controls are in place and that monitoring is being conducted.
  • The facility must have a “qualified individual” who would oversee the hazard analysis and implement the preventative control measures.
  • Finally, a record of all the written plans and documents above must be maintained.

As you can see, these regulations could be quite burdensome for the applicable breweries and distilleries. However, they may also lay the groundwork for a solid risk management plan for your brewery or distillery to reduce liability in the event that spent grains sold for animal food are contaminated. That being said, in its proposed rulemaking, FDA offered a few options for potential exemptions from these rules for facilities, including breweries and distilleries, with annual sales under $500,000, under $1 million, or under $2.5 million. As with the proposed rule in general, FDA requested comment, particularly from the industry, as to what would be the final exemption adopted.

Colorado Beverage Lawyers of LaszloLaw

The Colorado beverage lawyers of LaszloLaw provide legal counsel to businesses in the alcohol and liquor industry. Contact our Colorado beverage lawyers today online or at 303-926-0410 to discuss your brewery’s or distillery’s legal needs.

****UPDATED**** FDA has decided to take another look at its rules regarding spent grain for breweries and distilleries.  See our updated post on the FDA’s spent grain rule.

Written by Jeffrey Klein

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