October 17, 2021

Questions and Answers on New Food Safety Rules

FDA-logoThe Food and Drug Administration (FDA) has released a Q&A on new food safety rules for the Food Safety Modernization Act (FSMA). The questions about the produce rule cover product tracing, record keeping requirements for high risk foods,  the scope of the rules, and information about laws, regulations, and guidance documents. And the rules for current good manufacturing practices and Hazard Analysis and Risk-Based Preventive Controls for Human Food cover compliance, fees, inspections, and recalls.

Traceability is crucial when there’s a foodborne illness outbreak. And since many outbreaks were linked to produce in the last few years, tracing this type of food is important to outbreak control and prevention. Product tracing documents the “production and distribution chain of products so that in the case of an outbreak or evidence of contaminated food, a product can be traced back to a common source or forward through distribution channels.”

The FDA established product tracing pilot programs through the Institute of Food Technologies. They will help determine the data needed to trace a product back to its common source. Tracing product forward was also tested. The foods that were part of the pilots included tomatoes, frozen Kung-Pao style dishes that contain different ingredients, and jarred peanut butter and dry packaged peanut/spice products. You can see the results of these pilots at “Pilot Projects for Improving Product Tracing along the Food Supply System.”

IFT recommended ten steps for produce tracing, including establishing a uniform set of record keeping requirements, that facilities maintain records of Critical Tracing Events and Key DAta Elements. In addition, the FDA should coordinate traceback investigations and develop response protocols between state and local health and regulatory agencies.

The CGMP rules still have not defined what a “high risk food” is, which is crucial to determining the HACCP for different facilities. Most of the questions relate to term definitions, exemptions, and details about food safety plans.

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