Yesterday, the Food and Drug Administration (FDA) held a webinar to discuss key actions it has taken since releasing its New Era of Smarter Food Safety Blueprint on July 13, 2020. FDA’s New Era of Smarter Food Safety is an initiative that aims to modernize, enhance, and streamline the agency’s approach to food safety through the use of technology and other tools. The New Era Blueprint outlines FDA’s plan for advancing the New Era’s four “core elements,” which include: (1) Tech-Enhanced Traceability, (2) Smarter Tools and Approaches for Prevention and Outbreak Response, (3) New Business Models and Retail Modernization, and (4) Food Safety Culture.
Following opening remarks by Frank Yiannas, FDA’s Deputy Commissioner for Food Policy and Response, FDA representatives summarized the progress the agency has made in implementing the New Era Blueprint over the past 100 days. Key developments that may be particularly relevant to industry include:
- In July, FDA launched a traceability pilot program for leafy greens, which will assist the agency in exploring various food traceability concepts. This program is part of FDA’s 2020 Leafy Greens STEC Action Plan.
- In August, FDA released results from the first phase of its Seafood Artificial Intelligence/Machine Learning Import Screening Pilot Program. This pilot aims to assess ways in which FDA can leverage cutting-edge technology to screen food imports for potential safety issues.
- In September, FDA published its Food Traceability Proposed Rule, which would impose additional traceability recordkeeping requirements for certain high-risk foods pursuant to section 204 of the Food Safety Modernization Act (FSMA). FDA will hold public meetings to discuss the proposed rule on November 6, November 18, and December 2, 2020. Interested stakeholders can submit comments on the proposed rule until January 21, 2021.
- In October, FDA announced a new voluntary pilot program that will evaluate the alignment of third-party food safety audit standards with FSMA’s Preventative Controls for Human Food Rule and Produce Safety Rule. The pilot program will be conducted for one year, and stakeholders have until November 25, 2020 to request to participate in the program.
FDA also highlighted key actions it plans to take to advance the New Era Blueprint over the next two years. These include:
- Finalizing FDA’s Food Traceability Rule.
- Developing an FDA platform for receiving electronic traceability data.
- Exploring ways to harmonize domestic and international traceability efforts.
- Expanding traceability pilot activities beyond leafy greens.
- Hosting workshops to engage stakeholders on Root Cause Analysis and information-sharing tools.
- Modernizing recalls by exploring ways to harmonize recall communications with the U.S. Department of Agriculture and evaluating the feasibility of developing a mobile application for government recalls.
- Planning a New Business Model Summit in 2021, at which stakeholders can identify and discuss food safety issues relevant to new food retail business models.
- Continuing to engage with stakeholders—including industry, government, academia, and consumer groups—on various other aspects of the New Era Blueprint.
What can you do?
- FDA emphasized that it will continue to collaborate with and seek input from various stakeholders, including industry, as it implements the New Era Blueprint. As such, companies should continue to evaluate how their short- and long-term interests align with the Blueprint’s objectives, and should identify ongoing opportunities to meaningfully engage with the agency on these issues.
If you have any questions concerning the material discussed in this client alert, please contact the following members of our Food, Beverage, and Dietary Supplements practice.
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