The food system and supply chains continue to change and evolve at an accelerated pace. That introduces new risks and challenges—and heightens some familiar ones. As we move into 2025, the Food and Drug Administration (FDA) has established priorities that will impact how food companies operate in the coming year. In addition to the FDA’s priorities, here are some of the top food safety trends KTL’s food safety experts are tracking in 2025…

FDA 2025 Priorities

On October 1, 2024, the Food and Drug Administration (FDA) began implementing its reorganization, including launching a unified Human Foods Program (HFP) to oversee all activities related to food safety and nutrition. The HFP has prioritized key deliverables for FY 2025 to strengthen regulatory oversight, advance science, and better leverage partnerships in the areas of microbiological food safety, food chemical safety, and nutrition. The FDA also restructured the Office of Regulatory Affairs (ORA) into the Office of Inspections and Investigations (OII) to allow the Agency’s field operations unit to focus on inspections, investigations, and imports.

As with any regulatory change, FDA-regulated companies need to understand the restructuring and its potential impacts. The HFP has outlined priorities and compliance expectations that companies need to align with their internal programs, protocols, etc. It will also be important to prepare for potential changes when it comes to inspections, including more frequent and more specialized inspections.

Foodborne Illness

The U.S. has experienced several high-profile food recalls in 2024 that have caused illnesses and deaths—and heightened public awareness and concern. The emergence of new bacterial and viral strains and the evolution of pathogens (e.g., Listeria, E. coli, Salmonella) that are becoming resistant to traditional food safety measures are growing concerns when it comes to preventing foodborne illnesses.

The FDA’s focus on microbiological food safety (see above) is intended to advance strategies to prevent and mitigate foodborne illnesses. On July 29, 2024, U.S. Department of Agriculture (USDA) issued its proposed rule and determination to more effectively reduce Salmonella contamination and illnesses associated with raw poultry products; final rulemaking is anticipated in 2025. The USDA Food Safety and Inspection Service (FSIS) further announced several immediate initiatives to enhance its approach to mitigating foodborne pathogens, including modernizing L. monocytogenes regulation and ready-to-eat (RTE) sampling, in response to the Boar’s Head inspection results.

Companies need to re-evaluate their food safety programs and their effectiveness. This review may necessitate changing the current level of scrutiny for current and prospective suppliers. If sourcing any products implicated in recalls, re-evaluating current suppliers’ compliance with food safety regulations is also recommended. Sanitary equipment design, robust cleaning procedures, effective traceability programs, adherence to Good Manufacturing Practices (GMPs), and adequate training will remain key to avoiding recalls.

Supply Chain Traceability

There continues to be a real need for standardization, stronger linkages throughout the supply chain, improved communication and recordkeeping, and faster response when it comes to product traceability. As such, the FDA has prioritized the advancement of traceability tools and resources to help remove contaminated products from the marketplace more quickly.

From a regulatory standpoint, companies must start meeting the requirements of the Food Traceability Rule by January 2026, though there is speculation this may be delayed due to a provision in the current draft House appropriations bill that would prohibit funding for implementation, administration or enforcement of these regulations. Regardless, organizations should be performing traceability exercises to help identify gaps, testing protocols and verifying effectiveness, implementing corrective actions, and ensuring adequate traceability processes are in place. Investing in a good technology solution that integrates with the food safety management system (FSMS) will help to further streamline the process.

Sustainability

The U.S. Environmental Protection Agency (EPA) cites that food and food packaging materials make up almost half of all municipal solid waste in the U.S. Federal and state regulatory agencies, as well as various food safety certification schemes, have begun incenting—or requiring—organizations to incorporate sustainable food management and recycling practices into their operations. For example, the New Jersey Recycled Content Law, which came into effect on January 18, 2024, is considered one of the most ambitious recycled content laws to date.

A thorough food and packaging assessment serves as the foundation for reduction efforts. Having a general understanding of operations and waste streams can help identify appropriate strategies to avoid waste, cut down on disposal costs, reduce over-purchasing and labor costs, optimize inventory management, use more recycled content, and reduce water and energy use associated with food production.

Employee Safety

Between October 2018 and September 2019, the Occupational Safety and Health Administration (OSHA) issued 1,168 citations resulting in over $7 million in fines to the food manufacturing industry, with lockout/tagout and machine guarding topping OSHA’s annual list of the most frequently cited standards in food manufacturing. Occupational safety and health risks in food manufacturing are often heightened because of the nature of the product (i.e., food or drink) being manufactured.

OSHA is watching, and facilities need to prioritize employee safety. Conduct a thorough hazard analysis of the facility, operations, and processes to identify potential safety hazards. Based on the analysis, develop, implement, and maintain the appropriate safety programs, procedures, and instructions. Provide the proper personal protective equipment (PPE) to keep employees safe. And, importantly, train employees so they understand what they need to do to protect themselves and others.

PFAS

The EPA continues to make significant contributions to confront the human health and environmental risks of per- and polyfluoroalkyl substances (PFAS). In April 2024, EPA introduced the first national drinking water standards for PFAS, and many states are introducing policies related to PFAS, including monitoring and testing for PFAS in water and banning PFAS in food packaging, clothing, and other consumer products. The FDA is further working to limit PFAS in food and food packaging. In 2024-2025, the FDA has committed to testing foods from the general food supply to more accurately estimate exposure to PFAS from foods. This includes testing total dissolved solids (TDS) samples, conducting a survey of bottled water, and conducting additional seafood testing.

Organizations need to address PFAS in their operations, products, supply chains, and waste streams; stay informed about ongoing PFAS regulatory developments; and adjust compliance programs and operational practices, as needed.

Digital Transformation

According to McKinsey & Company, automation could increase productivity by up to 20% in the food manufacturing sector. More companies are employing technology solutions to improve business efficiency, and the FDA has prioritized developing AI approaches to help monitor new data and trends in FY 2025.

AI is quickly becoming a more viable solution for many food companies in automating, monitoring, and managing food safety, helping to identify contamination risks, analyze data, predict potential hazards, conduct training simulations, and even optimize cleaning schedules. While the efficiencies and other benefits of technology solutions are many, the increased reliance on AI will require an investment, not just financially but also in oversight and management, training, and cybersecurity measures. As the digital transformation continues, companies will need to determine where automation is appropriate and where the human factor is still required.

Others to Watch

• Red No. 3: On January 15, 2025, the FDA amended its color additive regulations to no longer allow for the use of Red No. 3 in food and ingested drugs. Manufacturers who use Red No. 3 will have until January 15, 2027 (food) or January 18, 2028 (ingested drugs) to reformulate products. Foods imported into the U.S. must also comply with this requirement.
• Produce Safety Rule: Pre-Harvest Agricultural Water: In May, 2024, the FDA released the updated requirements for the Produce Safety Rule, Subpart E for pre-harvest agricultural water. Facilities are now able to justify not testing agricultural water if there are no conditions (e.g., animals, human waste, or biological soil amendments of animal origin (BSAAO)) on nearby or adjacent land that pose a risk to the water source. The first compliance date for large farms is April 7, 2025.
• SQFI New Edition 10: The Safe Quality Food Institute (SQFI) is slated to release SQF Edition 10 in July 2025. Anticipated updates focus on the identification of new food safety risks, changes in the global supply chain that may impact food safety, unforeseen events (e.g., foodborne illness outbreaks), new technology, and harmonization with other internal food safety programs.
• Bird Flu (H5N1): With the rise in cases and mutations, the USDA has announced different approaches to prevent the spread of H5N1, including testing bulk raw milk. The State of California also declared a state of emergency to allocate more resources to address the continued spread of Bird Flu.
• Food Date Labeling Reform: In December 2024, the FDA and USDA announced a joint Request for Information (RFI) regarding food date labeling (e.g., ‘Sell By,’ ‘Use By’ and ‘Best By’). Open date labeling is currently not mandated or standardized by federal law. The RFI seeks information on industry practices and preferences for date labeling.

Set Your Goals for 2025

In 2025, organizations will continue to encounter workplace challenges, regulatory adjustments, food safety concerns, and rapid technology advancements—and, in most cases, fewer resources to manage it all. KTL suggests completing the following early in 2025 to prepare for whatever is on the horizon:

• Get senior leadership commitment and invest in creating a food safety culture that prioritizes food safety, quality, and employee health and safety. Focus on changing from a reactionary to a preventive mindset. And remember that your people are as important as your products.
• Conduct a comprehensive food safety and quality gap assessment. Know your operations, inventory your ingredients, understand your supply chain, quantify your food waste. This assessment should be the starting point for understanding your regulatory and certification obligations and current compliance status—and for ensuring you are prepared to meet pending regulatory developments.
• Explore technological advancements that allow for further digitization and promote more timely and accurate collection and management of important data. This could mean stepping into the world of AI and machine learning; it could also mean implementing a digital FSMS to help manage compliance/certification and recordkeeping requirements. Technology advancements can help create significant business efficiencies when used appropriately.
• Train your staff. Every trend discussed above requires employee understanding. Train your team routinely on requirements, responsibilities, processes, expectations, etc. Of particular note for Preventive Controls Qualified Individuals (PCQIs), the International Food Protection Training Institute (IFPTI) has released Version 2.0 of the Preventive Controls for Human Foods course. The old version will no longer be taught as of May 2025, but the training will still be recognized.

Seek third-party oversight. Having external experts periodically look inside your company provides an objective view of what is really going on, helps you to prepare for audits, and allows you to implement corrective/preventive actions that ensure compliance. An outside expert can often provide the “big picture” view of what you have vs. what you need; how your plans, programs, and requirements intersect; and how you can best comply with changing requirements.