A November 29, 2022, reader poll conducted by Quality Assurance & Food Safety Magazine identified the following top food safety concerns for 2023: 25% recalls, 25% traceability, 25% supplier/supply chain issues, 12% labor shortages, 12% something else.

Over the past few years, KTL has seen many of these concerns—and others—present challenges across the food industry.  We also recognize the opportunity some of these present when appropriately and proactively addressed. Here are some of the top food safety trends KTL is tracking in 2023—and some guidance to help you as you establish your food safety priorities.

Resource Constraints and Technology Solutions

Not surprisingly, one of the biggest challenges we have witnessed our clients grappling with is related to staffing, from turnover in the quality department to being understaffed in production. Employees are stretched thin and are carrying more responsibilities that they aren’t necessarily qualified to do, including food safety. Achieving and maintaining food safety compliance and Global Food Safety Initiative (GFSI) certification requires great management and expertise to ensure all aspects of a company’s technical compliance have been identified and are being actively handled. KTL has been working with more and more food safety and quality departments to fill these gaps—either with outsourced personnel or compliance efficiency tools—as companies look to recruit food safety staff.

Guidance:

• Invest in food safety training and education for all staff and start with the basics. Even experienced workers can benefit from refresher training to correct bad habits and build efficiencies.
• Develop a relationship with someone you trust to do things in your best interest. Use them to assess your operations, help you understand what regulations apply, identify gaps in your programs, and implement solutions to eliminate risks. Rely on them as a part of your team.
• Employ information technology (IT) solutions to create compliance efficiencies. A well-designed and executed compliance information management system brings IT and management systems together to coordinate, organize, control, analyze, and visualize information in such a way that helps organizations remain in compliance and operate efficiently. 
• Build a better food safety culture starting at the top and focusing on the details (see below).

Food Traceability

Without a doubt, food traceability is a hot topic with the Food and Drug Administration (FDA) publishing the Final Food Traceability Rule in November 2022. While the agency has had previous food traceability requirements, the new rule under FSMA Section 204(d) is intended to enhance traceability recordkeeping for certain identified foods beyond a limited “one-up, one-back” traceback approach—creating standardization, stronger linkages throughout the supply chain, improved communication and recordkeeping, and faster response. The compliance date for all entities subject to the updated recordkeeping requirements is January 21, 2025.

Guidance:

• The rule is complicated with unanswered questions about recordkeeping and FDA enforcement. Do what you can to understand your requirements. Review the Food Traceability List (FTL) and start building systems and processes now that address requirements for traceability lot codes, critical tracking events (CTEs), key data elements (KDEs), and recordkeeping.
• Having a good document/records management system will be essential for maintaining the vast number of documents required by the Food Traceability Rule. Such a system can help ensure process and document standardization; central and secure storage, organization, and access to documents and records; enhanced workflows for approving and completing tasks involving documents; and easy access to documents for audits and clear audit trail.

Food Safety Culture

Food safety culture continues to garner attention and visibility across the food industry, as it is being integrated more completely and significantly into many of the GFSI-benchmarked food safety certification standards. For example, BRCGS Issue 9, which was launched on August 1, 2022, emphasizes two core themes: building core competencies and developing food safety culture.  These actions are creating defined requirements, timelines, and measurements to create a culture that embraces food safety.

Guidance:

• Get senior leadership commitment in prioritizing food safety and quality.
• Assess current food safety program elements, identify improvements that are internally desirable and required, and implement those updates that will create a strong food safety culture.
• Put robust systems in place to ensure consistent commitment, communication, procedures, training, performance measurement, and trust.  

Environmental Focus

Food companies continue to see regulatory bodies—beyond FDA and USDA—taking much more interest in them. U.S. Environmental Protection Agency (EPA) multi-media inspections, enforcement actions, and large penalties for violations persist. EPA’s proposed Safer Communities by Chemical Accident Prevention (SCCAP) rule, which is intended to strengthen current Risk Management Plan (RMP) regulations, has the potential to create significant industry requirements in the future. Facilities that use anhydrous ammonia as refrigerant may be particularly vulnerable. In addition, EPA is investing resources in addressing per- and polyfluoroalkyl substances (PFAS) contamination. Many manufacturers, especially those in the food and beverage industry, are facing new concerns about whether and how to test for and remediate PFAS contamination.

Guidance:

• Evaluate your current environmental risk level and develop strategies to minimize risks to the extent possible. Proper usage strategies, a comprehensive environmental management system (EMS), and a forward-thinking Emergency Response Plan will remain vital tools for companies to effectively manage the associated risks
• Outline steps to improve performance and safe operations, including defining organizational roles and responsibilities.
• Streamline compliance methods and improve operational efficiencies by implementing IT solutions and compliance management systems that coordinate, organize, control, analyze, and visualize information.

Food Recalls

FDA took another step toward reducing the public’s exposure to the risks of foodborne illness on March 3, 2022, issuing its final guidance for voluntary recalls: Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C. FDA’s guidance outlines the steps companies should take before a recall is mandated, including developing policies and procedures, establishing training, maintaining records, and initiating communications.

Guidance:

• Establish recall initiation procedures. Prepare, maintain, and document written procedures for initiating a recall to minimize delays and uncertainty when/if a voluntary recall becomes necessary.
• Identify and train appropriate personnel (and alternates) on recall-related responsibilities. The recall team should have a thorough understanding of recall procedures and their respective roles in carrying out a recall plan. Regular training, including mock recalls, helps ensure competency.
• Establish a recall communications plan to address communications with employees, FDA, supply chain, direct accounts, and the public, as necessary. Identify key contacts and develop draft templates that can be easily customized and distributed when needed.

Food Investments

We continue to see private equity firms investing heavily in food companies and, subsequently, in their food safety infrastructure. Any merger and acquisition (M&A) transaction, no matter the size or structure, can have a significant impact on the acquiring company—and food safety is a critical factor. Undertaking adequate due diligence is vital. It can lead to the discovery of regulatory inconsistencies that may lessen the value of an entire product line or business—and opportunities to make improvements. It can provide better insights into the risks and potential benefits of a transaction that will ensure a smoother, more effective, and sustainable business integration.

Guidance:

An assessment of the operations, production processes, equipment conditions, food safety management, quality, regulatory compliance, and all related documentation needs to be completed as part of any food-related acquisition. Prior to any acquisition, it is important to determine:

• Condition of operations (i.e., personnel, equipment, processes, facility) necessary to effectively meet existing performance standards.
• Level of food safety compliance to regulatory requirements and applicable voluntary industry certifications.
• Any potential high-level risks that would impact the transaction.

Cannabis

FDA is watching! The agency issued a number of warning letters in 2022 to companies that sell CBD-infused food and beverages and seems particularly concerned about food products that may appeal to children (e.g., cookies, gummies, etc.). While the regulatory framework for managing cannabis production is still unclear, this is a rapidly growing market, and we anticipate progress—whether at the state level or federal level—in the development and implementation of regulations and controls (e.g., Good Manufacturing Practices (GMPs), labeling requirements, etc.).

Guidance:

Several organizations have launched cannabis standards and certifications—often based on GFSI and GMPs—to improve the overall safety and quality of cannabis and cannabis-infused products in the market. Those getting involved in this rapidly growing industry need to assess operations, determine what standards might be appropriate, identify gaps in existing programs, prepare for potential regulatory action and/or certification opportunities, and implement solutions to eliminate risks.

Sustainable Food Management

According to a January 2023 article in Food Logistics Magazine, “By 2050, the Food and Agriculture Organization (FAO) estimates we will need to produce 60% more food to feed a world population reaching nearly 10 billion. Even if we hit that mark, 300 million people will still be grappling with food scarcity.” The regulatory community has identified a real need for addressing food waste and the lack of circularity in the food industry. Sustainable management of food involves “a systematic approach that seeks to reduce wasted food and its associated impacts over the entire lifecycle, starting with the use of natural resources, manufacturing, sales, and consumption, and ending with decisions on recovery of final disposal” (EPA). Watch for efforts to promote sustainable food management to expand to meet demand.

Guidance:

A thorough food and packaging assessment can help identify appropriate strategies to avoid waste, cut down on disposal costs, reduce over-purchasing and labor costs, reduce water and energy use and greenhouse gas (GHG) emissions associated with food production.

Food Safety Verification Program (FSVP)

While not a new rule, FSVP remains a key focus as the surge in food demand and lack of supply has created an environment ripe for food fraud. FDA recently sent a number of warning letters to companies across the U.S. putting them on notice for not having FSVPs for a number of imported food products, a significant violation of compliance with FSVP regulations. On January 10, 2023, FDA issued its final FSVP guidance document to help importers comply with the FSVP regulation. It offers clarification on what foods/entities the FSVP regulation applies to, what information must be included in the FSVP, and who must develop and perform FSVP activities.

Guidance:

• Assess your supplier approval/management program, focusing on the fundamental aspects of FSVP—those requirements that must be verified, recorded, and evident in documents supporting foreign shipments of food product(s) under the rule.
• Evaluate potential foreign suppliers’ performance and the risks posed by the food. Use FDA’s guidance document to determine and conduct appropriate foreign supplier verification activities.
• Implement a supplier approval and management system to improve coordination with and communication of approved suppliers; manage supplier requirements and supplier evaluations/approvals; and maintain all required documentation.
• Train your staff to have the knowledge needed to implement a successful FSVP that meets compliance requirements.

Set Your Goals for 2023

With these challenges simultaneously competing for attention—and with fewer resources to manage it all—companies need to assess priorities, needs, and requirements and create a plan for how to meet them. KTL suggests completing the following early in 2023:

• Get senior leadership commitment and invest in creating a food safety culture that prioritizes food safety and quality.
• Conduct a comprehensive food safety and quality gap assessment. This 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.
• Get your documentation in place. Update and/or develop the procedures, programs, and records you need to demonstrate compliance, and implement a reliable system to keep them organized and readily accessible.
• Leverage IT solutions to streamline compliance, manage certification requirements, and create business efficiencies.
• 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.