Choose Site

BLOG POST

Well Done

YOUR SOURCE ON FOOD LITIGATION AND REGULATION

To enhance its food traceability objective through the use of technology that strengthens the food safety system, the US Food and Drug Administration (FDA) unveiled, on May 19, its latest initiative through which it hopes to obtain valuable information and tangible solutions from various stakeholders.

By way of background, in July 2020, FDA unveiled its Blueprint for the Future, a plan that is part of the Agency’s new approach to food safety, aimed at reducing the number of foodborne illnesses—the New Era of Smarter Food Safety. The plan involves the following four core elements:

  • Tech-Enabled Traceability to offer greater traceability and visibility in the supply chain.
  • Smarter Tools and Approaches for Prevention and Outbreak Response to help strengthen FDA’s procedures and protocols for conducting root-cause analyses and to inform the Agency’s outbreak prevention methods.
  • New Business Models and Retail Modernization to address food production and distribution, as well as food safety in retailers and restaurants.
  • Food Safety Culture to support and strengthen food safety culture on farms, in food facilities, and in people’s homes, by addressing worker safety and consumer education.

To meet the commitments made under this plan, in September 2020, FDA announced a Requirements for Additional Traceability Records for Certain Foods rule, aimed at creating more record-keeping requirements for specific foods like cheese, shell eggs, melons, crustaceans, and ready-to-eat deli salads. Specifically, the proposed rule puts additional requirements on companies that manufacture, process, pack, or hold foods on the Food Traceability List to establish and maintain records related to critical tracking events (i.e., growing, receiving, shipping, transforming, and creating).

More recently, on April 29, the Agency launched a new quarterly podcast called TechTalk, the first installment of which was about tech-enabled traceability. FDA hopes the podcast will serve as a discussion platform through which the Agency together with industry experts can offer new solutions, discuss lessons learned, and share experiences in developing food traceability programs.

FDA’s latest initiative will be launched on June 1 and involves a challenge for industry, as well as technology providers, entrepreneurs, innovators, and public health advocates, “to develop traceability tools that can be implemented in a scalable, cost-effective way for food operations of all sizes.” FDA’s objective is for these stakeholders to provide the Agency with affordable solutions and tools that address various traceability needs and challenges faced by primary producers, importers, manufacturers, distributors, retailers, and food service, and which create shared value and can be adopted widely by industry, regardless of the size of the food establishment.

Both these initiatives are praiseworthy, with FDA expecting that they will help the “food industry […] gain new insights into how to solve traceability challenges.” Nevertheless, FDA is relying on industry, rather than its own scientists and budget, to offer valuable information and solutions and to validate and assess these technologies, which could lead to non-uniform adoption across the business segment. Moreover, although FDA expects to announce up to 12 winners for the June 1 challenge, it is unclear how FDA will choose the winning entries, while no monetary compensation is being offered by the Agency. Rather, challenge winners are expected to “gain significant visibility, including an opportunity to present their entry in a public forum hosted by the FDA.” Yet, it remains unclear how and how soon FDA intends to integrate the winning solutions into its overall food safety plan, and, most importantly, who will own the data collected through these solutions or whether FDA expects developers to turn all these data over to the Agency.