The FDA New Era of the Smarter Food Safety – Four Core Elements
Modern Approaches for Modern Times
Core Element 1: Tech-enabled Traceability
Link to Food Traceability HACCP Course
According to Section 204 of the Food Safety Modernization Act (FSMA) , in December 2022 FDA finalized 21 CFR Part 1 Subpart S – Requirements for Additional Traceability Records. The requirements established in the Final Rule will help the Agency rapidly and effectively identify recipients of foods to prevent or mitigate foodborne illness outbreaks and address credible threats of serious adverse health consequences or death resulting from foods being adulterated or misbranded. This rule is effective January 20, 2023. Tech-enabled Traceability is also the first of four foundational pillars of the FDA New Era of Smarter Food Safety, the other three being Smarter Tools and Approaches for Prevention and Outbreak Response, New Business Models and Retail Modernization, and Food Safety Culture. The Rule established additional recordkeeping requirements for persons who manufacture, process, pack, or hold foods the Agency has designated for inclusion on the Food Traceability List (FTL). The final rule adopts provisions requiring these entities to maintain records called Key Data Elements (KDEs) containing information on Critical Tracking Events (CTEs) in the supply chain for these designated foods. A Critical Tracking Event means an event in the supply chain of a food involving the harvesting, cooling (before initial packing), initial packing of a raw agricultural commodity other than a food obtained from a fishing vessel, first land-based receiving of a food obtained from a fishing vessel, shipping, receiving, or transformation of the food. Key data elements means information associated with a critical tracking event for which a record must be maintained and/or provided in accordance with this subpart. In addition, the Rule requires that covered entities maintain and provide a Food Traceability Plan. This Food Traceability Plan HACCP course is a comprehensive course in covering all applicable laws and regulations and assists industry to leverage their globally recognized HACCP principles to conduct traceability analysis, establish critical tracking events, and identify associated key data events followed by management components of monitoring, corrective action, verification and record-keeping.
Core Element 2: Smarter Tools and Approaches for
Prevention and Outbreak Response
Link to the Food Safety Omics HACC
“As modern food safety approaches generate new data streams – and tools for rapidly analyzing big data become available – we [FDA] are exploring their preventive value. We are looking to enhance and strengthen root cause analyses and predictive analytics. Findings of root cause analyses can be an important step in helping industry modify practices to avoid identified risks and can provide more robust data for predictive analytics. It’s also important for us [FDA] to work with others in new and creative ways. These include the domestic mutual reliance initiative, in which FDA seeks to build on existing efforts to partner with states that have comparable regulatory and public health systems, leveraging each other’s data and analytics to ensure optimal use of resources and maximize our food safety reach. They also include leveraging reliable third-party audits to advance food safety and having alternate approaches when traditional methods are not feasible. FDA “
Today HACCP is recognized, accepted and used by governments, academia and food industry nationally and globally. On January 4, 2011, the FDA Food Safety Modernization Act (FSMA) introduced seven foundational rules that essentially used the HACCP principles to ensure safety of food for humans, foods for animals, produce safety, safety of imported food, food defense, and transportation.
Just imagine combining all we have learned from HACCP and FSMA and combining them with Omics, the greatest revolution in biological, microbiological, and other biotechnological sciences and technologies ; it is known as the OMICS REVOLUTION. This course is the first of its kind in the world and is about the application of genomics, metagenomics, transcriptomics, proteomics, metabolomics, microbiomics, allergenomics, toxicogenomics and other omics (multi-omics) in food safety.
The FDA New Era of Smarter Food Safety is People-Focused and Led, FSMA-Based and Technology-Enabled.
The FoodSafetyOmics HACCP Course provides scientific, technical and regulatory understanding of the Second Core Element.
After discussing multiomics and its importance in food safety, the course covers other important food safety related topics such as bioinformatics, artificial intelligence, machine learning, big data, Internet of of Things, sensor technologies, remote sensing, GIS, GPS, Next-Generation Sequencing (NGS), sequencing science and technologies, smartphone as microscope, biosensors and chemosensors , FDA’s GenomeTrakr, FDA’s food and environmental sample sequence data to PulseNet, whole genome sequencing of pathogens, mobile inspection technology and digital reporting tools, recall modernization, food testing methodologies, predictive toxicology tools that identify and characterize food chemical hazards, root cause analysis protocols for food safety, risk ranking and predictive analytical systems, predictive toxicology tools, and much more.
Core Element 3: New Business Models and Retail Modernization
Food Retail and Food Service Modernization HACCP Course is coming soon.
We [FDA] are looking to address how to protect foods from contamination as new business models emerge and change to meet the needs of the modern consumer. The evolution of how food gets from farm to table continues with the emergence of e-commerce and new delivery models. The evolution of how food gets produced continues with the emergence of new business models that advance innovations in novel ingredients, new foods, and new food production systems. These new models include online shopping for meals and groceries, a practice that has surged during the COVID-19 pandemic.
Core Element 4: Food Safety Culture
Food Safety Culture HACCP Course is coming soon.
We should foster, support and strengthen food safety cultures on farms, in food facilities, and in homes. We will not make dramatic improvements in reducing the burden of foodborne disease without doing more to influence the beliefs, attitudes, and, most importantly, the behaviors of people and the actions of organizations.
A strong food safety culture is a prerequisite to effective food safety management.
