On Monday, FDA rolled out its Blueprint for Smarter Food Safety; Modern Approaches for Modern Times. The Blueprint had been nearly ready for release several months ago, but was delayed when Covid-19 required FDA to divert its resources to responding to the pandemic. The Blueprint is intended to enhance and streamline the prevention of and response to food safety events through technology.
The Blueprint centers around four core elements:
- Tech-Enabled Traceability;
- Smarter Tools and Approaches for Prevention and Outbreak Response;
- New Business Models and Retail Modernization; and
- Food Safety Culture.
Through these elements, FDA hopes to use established and emerging technologies to speed identification, quarantine, and recovery of food determined to be unsafe, such as food being recalled because it is contaminated. To facilitate rapid outbreak response, FDA proposes to use technology to streamline root cause analyses, enhance information sharing with regulatory, public health, academic, and industry stakeholders, improve the dissemination of recall information to the public, and promote collaboration with federal, state, and international partners on improved outbreak response. FDA will use new business models and approaches to improve food handling practices at retail and during delivery to homes, and will work to create a culture of safety throughout the food system, within FDA and for consumers.
FDA’s first step will be to complete rulemaking under Section 204 of the Food Safety Modernization Act (FSMA) to harmonize the key data elements and tracking for enhanced traceability for high risk foods – a category that FDA must first define. FDA explained that this will allow stakeholders in the supply chain to use digital technologies to reduce the time it takes to identify the origin of a contaminated food tied to a recall and/or outbreak and to anticipate and help prevent supply chain disruptions in a public health emergency, such as a pandemic. Of note, while FDA has indicated a desire to support and foster new technologies to facilitate traceability, FSMA expressly provides that the agency cannot prescribe specific technologies for maintaining records.
What can you do?
FDA developed the Blueprint using information gathered in a public meeting and hundreds of stakeholder comments. As the agency works to develop and implement the technologies and systems needed to implement its food safety goals, FDA will rely increasingly on industry and other stakeholder input. Now is therefore a key time for companies to consider what technologies they believe would work best within their segment of the industry to accomplish these goals in the most efficient and cost effective manner. Companies also need to consider how the new information sharing FDA is considering as it develops mechanisms to enhance its outbreak prevention and response and to modernize food handling procedures could compromise their confidential and trade secret information. Companies should evaluate ways to accomplish FDA’s goals without endangering their own intellectual property.
If you have any questions concerning the material discussed in this client alert, please contact the following members of our firm.
Back
