FSMA: Preventive Controls for Human Food

The US Food and Drug Administration is finally implementing the Food Safety Modernization Act ("FSMA"). The FSMA puts a new focus on prevention of foodborne illnesses and authorizes new Preventive Controls for facilities that process human food. 

What is it? Operators who manufacture, process, pack, or store human food are usually subject to the Preventive Controls Rule ("PC Rule"). Manufacturing or processing is broadly defined and includes baking, boiling, bottling, canning, cooking, cooling, cutting, distilling, drying/dehydrating, evaporating, eviscerating, juicing, extruding, formulating, freezing, grinding, homogenizing, irradiating, labeling, milling, mixing, packaging, pasteurizing, peeling, pelleting, rendering, treating to manipulate ripening, trimming, washing, or waxing. Packing includes putting food into containers, including those activities incidental to safe packing, like sorting, grading, and weighing. Storing means holding food products and those activities performed incidental to storing the food (like fumigating or drying the food in order to safely store it).

What are the key requirements? Covered facilities must establish and implement a food safety system that includes an analysis of hazards and risk-based preventive controls. The rule requires a written food safety plan that includes the following:

  • Hazard analysis – identify potential biological, chemical, and physical hazards at the facility.
  • Preventive controls – minimize or prevent identified hazards through measures related to food allergens, sanitation, and general processes.
  • Oversight of preventive controls – monitoring, product testing, corrective actions, and verification to ensure preventive steps are effective and to correct problems as they arise.
  • Record-keeping – maintain routine records of the preventive controls monitoring

Are “farms” covered by the rule? Generally, no. The FSMA definition of “farm” includes two types of farm operations that are excepted from the rule. Operations satisfying the farm definition are not subject to the Preventive Controls rule.

  • Primary production farm – a farm operation under one management in one general area. It does not need to be a contiguous location of growing or harvesting crops or raising of animals. A primary production farm can pack or hold raw agricultural commodities (“RAC”) like fresh produce and can conduct certain manufacturing/processing activities, like dehydrating grapes to produce raisins.
  • Secondary production farm – an operation not located on the primary production farm devoted to harvesting, packing, or holding RACs. A secondary production farm must be majority owned by the primary production farm that provides the majority of the RACs. This means packing operations away from the primary farm can still be considered a “farm” under the rules.

Farms, including dairy farms, that conduct manufacturing/processing activities beyond those included in the farm definition would be subject to the PC Rule unless a specific exemption applies. Farms that only pack or store food for personal consumption on the farm are not subject to the PC Rule. But farms that process food are likely subject to at least some of the requirements under the PC Rule. Restaurants, grocery stores, and produce stands that sell directly to consumers generally are not covered under the PC Rule.

Is there a supply-chain program? Yes, but the supply-chain program has separate, later compliance dates. A manufacturing/processing facility must have a risk-based supply chain program for those materials and ingredients for which it has identified a hazard requiring a supply-chain applied control. Facilities that use preventive controls to manage a hazard do not need a supply-chain program for that particular hazard. Covered food facilities may only accept food from approved suppliers. A facility does not need to use a preventive control if that hazard will be addressed by subsequent entity. The facility will have to disclose the unaddressed hazard and obtain assurance from the subsequent entity regarding actions it will take. The receiving entity must verify the supplier’s control of the identified hazard, even if brokers or distributors also take action to verify the actions taken by facilities up the supply chain.

Where do the current good manufacturing practices fit in? Under the final CGMP, management is required to ensure that all employees who manufacture, process, pack or hold food are qualified to perform their assigned duties. The employees must have the necessary combination of education, training, and/or experience necessary to manufacture, process, pack, or hold food. Individuals must receive training in the principles of food hygiene and food safety, including the importance of employee health and hygiene.

Where do I start? Compliance dates vary, based on the type and size of the operations. Small businesses must comply by September 18, 2017. Very small businesses must be in compliance by September 17, 2018. Businesses subject to the Pasteurized Milk Ordinance also must comply by September 17, 2018. Other business (not “small” or “very small” or subject to the PMO) were required to become compliance by September 19, 2016. The supply chain program’s compliance dates range from March 17, 2017 to September 18, 2017, or six months after a supplier of raw material is required to comply with the applicable rules.

For more information, review the FDA’s recent draft guidance to the final Preventive Controls for Human Food Rule. Contact an attorney if you have questions regarding whether your operation is covered by this rule.