FDA Finalizes New Rule to Make Food Poisoning Outbreaks More Traceable

The new rule increases record-keeping requirements for food producers in order to help increase the FDA's ability to traceback food poisoning outbreaks to the source more rapidly, preventing unnecessary illnesses.

Federal regulators have finalized a new rule which will allow investigators to more easily trace certain products often found at the center of food poisoning outbreaks, helping contain new cases once problems are identified.

In a press release issued this week, the U.S. Food and Drug Administration (FDA) announced that the final rule to advance traceability of foods will require companies which manufacture, process pack, or hold foods to maintain record keeping requirements for certain foods often associated with food poisoning outbreaks that sicken hundreds of thousands annually.

According to the U.S. Centers for Disease Control and Prevention (CDC), there has been an influx in foodborne illnesses spanning across multiple states throughout the U.S. in recent years. While it is believed that many go undetected, the agency estimates hundreds of food poisoning outbreaks occur annually, resulting in 128,000 hospital treatments and 3,000 deaths.

Of these illnesses, the FDA states many are caused by gaps in record retention policies at companies, which often makes an outbreak difficult to trace due to the multiple facilities and companies involved with manufacturing, packaging and transporting food across the country.

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The FDA originally proposed the new rule in 2020, as part of the “New Era of Smarter Food Safety initiative,” which is in accordance with the FDA’s Food Safety Modernization Act (FSMA). Final promulgation comes after nearly two years of open access to the rule, which allowed for public comment and recommendations from stakeholders.

The rule includes three key features which focus on critical tracking events, traceability plans, and additional requirements for those involved in the manufacturing, processing, packaging or holding of leafy greens, melons, peppers, sprouts, herbs, tomatoes, cucumbers, and tropical tree fruits, as well as shell eggs, nut butters, fresh-cut fruits and vegetables, ready-to-eat deli salads, cheeses (other than hard cheese), finfish and crustaceans.

As part of the requirements, key data elements will be tracked during critical events throughout the supply chain, including harvesting, cooling initial packing, receiving, transforming, and shipping.

Information critical to tracing the origins of these food items will also be required, which will mandate companies to maintain records of descriptions on how lot codes for each food item are assigned as well as maintaining readily available internal traceability plans.

Among other requirements, companies involved in the supply chain will now need to keep maintenance records or “true copies” of these records, and must be able to provide them to the FDA within 24 hours of a request by the agency.

“This standardized, data-driven approach to traceability recordkeeping helps create a harmonized, universal language of food traceability that will help pave the way for industry to adopt and leverage more digital, interoperable and tech-enabled traceability systems both in the near term and the future”, said Frank Yiannas, the FDA’s deputy commissioner for food policy and response.

Interim Food-Borne Illnesses Prevention Plan

In January, the Interagency Food Safety Analytics Collaboration (IFSAC), which is a partnership between the CDC, FDA and the Food Safety and Inspection Services (FSIS) published an interim strategic plan for 2022 and 2023 indicating the group would place more emphasis on collecting data and estimating the sources of sporadic foodborne illnesses.

The IFSAC says it always focuses on estimating sources of both outbreak-associated and non-outbreak related illnesses, but prior strategic plans have largely used data from foodborne illness outbreaks. The new plan will include information from illnesses that do not stem from outbreaks.

In addition, the group will also look more closely at campylobacter outbreaks, which have traditionally been harder to track, but have been seen in several outbreaks involving unpasteurized milk and chicken liver products.

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