Tech Companies to Help FDA With Track-and-Trace Solutions
A traceability system to match FDA’s New Era of Smarter Food Safety Blueprint is a must for food manufacturers. But traceability goals will require more than regulations; a partnership between technology providers and food manufacturers will be essential.
Jeffrey Barach, Contributing EditorThe Food and Drug Administration's (FDA) traceability initiatives are fairly clear. The agency wants to encourage technology stakeholders to develop traceability hardware, software, or data analytics platforms that are low cost, or preferably no cost, to enable food operations of all sizes to implement traceability systems that are affordable, create shared value, and are adaptable for timely, widespread adoption.
The traceability initiative is derived from a need for more efficient, effective recalls as the U.S. food industry continues to struggle with foodborne illness outbreaks and allergen recalls. In fact, the Centers for Disease Control and Prevention (CDC) estimates that one in six Americans still gets food poisoning each year—leading to about 128,000 hospital stays and 3,000 deaths. The CDC says it has seen an increase in foodborne illness outbreaks that span multiple states in recent years. As well as foodborne pathogens, around half of all recalls involve allergen problems.
A traceability system meeting the aspirations of FDA’s New Era of Smarter Food Safety Blueprint must be more digital and enabled by current technology to accomplish interoperability of electronic records and cover the food chain from source to table.The current traceability requirements, as outlined in the existing Food Safety Modernization Act (FSMA), require many of the human and animal food operations to establish and maintain records to identify the immediate previous sources and the immediate subsequent recipients of foods (commonly referred to as “one-up, one-back” recordkeeping). However, a traceability system that meets the aspirations of the FDA’s New Era of Smarter Food Safety Blueprint will need to be more digital and should be enabled by current technology to accomplish interoperability of electronic records and comprehensively cover the majority of the food chain (i.e., end-to-end traceability) from source to table. The FDA says today’s consumer packaged goods companies (CPGs) need to develop better traceability systems, and the agency believes it has a suitable strategy to accomplish its traceability objectives.
The days of paper records may be numbered, and companies using software like Microsoft Excel is a step in the right direction, but it is not what the FDA envisions as high-tech enough. It is now clear to the FDA that the new traceability goals will require more than just the power of regulations, and that a partnership with technology and CPG companies will be essential to the success of this initiative.
To initiate a partnership approach, the FDA launched the FDA New Era of Smarter Food Safety Low- or No-Cost Tech-Enabled Traceability Challenge in June. This was part of the U.S. Department of Health and Human Services’ (HHS) America COMPETES Reauthorization Act of 2010.
The primary goal of this FDA challenge is to encourage stakeholders—including tech providers, public health advocates, entrepreneurs, and innovators from all disciplines—to develop hardware, software, or data analytics platforms for enhanced food traceability. The results will identify traceability solutions that utilize affordable economic models that could encourage widespread adoption by CPGs and help accomplish the New Era of Smarter Food Safety food traceability goals.
It is now clear to the FDA that the new traceability goals will require more than just the power of regulations, and that a partnership with technology and CPG companies will be essential to the success of this initiative.The FDA’s traceability challenge was open for entrants until the end of July. On Sept. 13, the FDA announced 12 winners of the FDA New Era of Smarter Food Safety Low- or No-Cost Tech-Enabled Traceability Challenge. There were 90 submissions, with the winning teams representing the U.S., Canada, and New Zealand.” Rules and guidance for the challenge participants were fairly straightforward. Submission guidelines to the challenge included:
Participants could enter as individuals or as part of a team, with both domestic and international entrants being eligible to submit their solutions to the organization called precisionFDA.
Tech-enabled solutions could be new or based on existing systems or datasets. Existing platforms or technologies could be updated, modified, or repurposed, with an explanation of how the solution redesigns or builds upon the existing systems or datasets to create a new scalable, cost-effective, tech-enabled traceability solution.
Submissions were required to be written and digital, and had to contain A/V recorded materials, in English, that included: a video uploaded to YouTube, not to exceed five minutes in duration, describing the solution and providing a demonstration of the fully functional prototype using a hypothetical situation and/or dataset, as appropriate; a completed submission form containing the URL for the uploaded YouTube video; and a summary of the solution in a PowerPoint presentation containing no more than 10 slides.
Challenge evaluation criteria
A panel of judges from the federal government with experience in the fields of technology, public health, and/or the food industry was chosen by the FDA to select the highest-performing entrants as winners of this challenge.
Judging was based upon the following weighted evaluation criteria:
Needs-based: Importance of addressing the specific traceability challenge for the target segment of the food supply chain—the ability of the solution to fulfill that need.
Innovation: Uniqueness and innovation in the use of hardware, software, and/or data analytics platforms, including any additional enhancements.
Usability: Use of design elements to increase utilization among CPG companies of the targeted segments of the food supply chain, with a focus on ease of navigation and interfaces to support the solution.
Affordability: A low-cost or no-cost option to enable traceability approaches that are viable for food operations of all sizes.
Scalability and Interoperability: Meeting the needs of the target segment of the food supply chain and enabling them to share information across data platforms used by other segments of the food supply chain.
Digital data covers an applicable segment of the food chain and results in better management of human and animal food and ingredient recalls. These new solutions will help the FDA and CPGs do a better job in protecting public health in a smarter way. Improved track and trace, as envisioned by the outcome of the challenge, should allow CPGs and the FDA to move more quickly to identify the source of a defective or contaminated product, reduce the scope of product recalls, and conduct more timely investigations to learn the root cause of the problem.
Learning how and where the contamination occurred can lead to developing food safety approaches to prevent future outbreaks. It is certain the FDA will share the challenge results with the public and further develop partnerships with industry to improve traceability systems that become more timely, more comprehensive, and suitable for CPG companies’ budgets.
Discover the latest breakthrough packaging technologies shaping the pharmaceutical sector. This report dives into cutting-edge innovations, from smart containers that enhance patient safety to eco-friendly materials poised to transform the industry’s sustainability practices. All from PACK EXPO. Learn how forward-thinking strategies are driving efficiency and redefining what’s possible in pharma packaging.
Researched List: Blister Machines for Life Sciences
Need a blister machine for life sciences packaging? Our curated list features companies serving pharmaceutical, medical device, nutraceutical, and cosmetic industries. Download to access company names, locations, machine specifications, descriptions, and more.
Jeffrey Barach, Contributing Editor
A traceability system meeting the aspirations of FDA’s New Era of Smarter Food Safety Blueprint must be more digital and enabled by current technology to accomplish interoperability of electronic records and cover the food chain from source to table.
