By: Samantha Whitsel
In the last week of October, Big Macs, taco kits, frozen waffles, and pre-made chicken are all products subject to food recalls across the United States. 2024 is predicted to be a record-breaking year for food recalls in the United States. Europe is facing a similar dilemma, the European Union has said that food recalls are on track to meet a 10-year high this year. However, reading past the fear-mongering headlines the increase in food recalls indicates innovation within the food regulatory space. This blog will explore innovations in both U.S. and EU regulatory bodies to explain why the uptick in global food recalls is not all negative.
While news coverage often focuses specifically on recalls for dangerous pathogens, food recalls encompass a wide umbrella of other safety issues including hidden allergens, mislabeling, and foreign objects. Key to ensuring the detection of these dangerous pathogens are proper regulatory and compliance structures that allow for swift tracing capabilities.
First, it is important to understand the regulatory framework of agencies responsible for food safety in the United States and the European Union.
In the United States, three agencies are responsible for food safety regulations throughout different segments of the food supply. The U.S. Food and Drug Administration (FDA) is the primary agency responsible for the safety of most foods and ensures consumers are protected against impure, unsafe, and fraudulently labeled products. The regulatory power of the administration stems from the Federal Food, Drug, and Cosmetic Act (FD&C Act) and was expanded in 2011 by the Food Safety Modernization Act (FSMA) which shifted the focus from reaction to prevention. The U.S. Department of Agriculture (USDA) Food Safety and Inspection Service (FSIS) regulates meat, poultry, and egg products. The Center for Disease Control (CDC) is responsible for gathering data on foodborne illnesses, investigating outbreaks, and monitoring the effectiveness of prevention efforts.
The European Food and Safety Authority (EFSA) is the European Union agency that provides scientific advice and information on current and potential food risks. The European Commission created its approach to food law and EFSA through Regulation (EC) No 178/2002, commonly called The General Food Law Regulation. The General Food Law also set up the Rapid Alert System for Food and Feed (RASFF), a key food safety tool that disseminates information and ensures quick response when public health risks are detected in the food chain. To protect the public from dangerous pathogens, the EU adopted an integrated approach to food safety from farm to fork that includes risk assessment, risk management, and risk communication.
Next, to understand the state of food safety, it is important to look beyond the headlines. Some experts cite the complexity and globalization of the food supply chain as a reason for the incidence rise. Another key factor, highlighted below, is the scientific innovations and regulatory modernization in the EU and the U.S. that are responsible for the more efficient detection and surveillance systems and may have aided in the rise of recalls. A food safety specialist at the Penn State Department of Food Science said, “We have much better technology in terms of identifying these issues, tracing them back to their sources, and pulling the product off shelves.” Some of these include improvements in tracing, crisis management, and technology-enhanced monitoring.
Tracing and crisis management improvements are key to early detection of food safety issues and legislators in both the U.S. and EU have taken steps to improve their existing regulatory frameworks.
The FDA released the Food Traceability Final Rule, effective January 20, 2023, which is a major component of the New Era of Smarter Food Safety Blueprint and implements Section 204(d) of FSMA. According to the FDA, “The new requirements identified in the final rule will allow for faster identification and rapid removal of potentially contaminated food from the market, resulting in fewer foodborne illnesses and/or deaths.” The Final Rule requires additional recordkeeping requirements for food designated as high-risk. High-risk foods are listed on the Food Traceability List which was developed as mandated by FSMA to include known and reasonably foreseeable contaminants in FDA-regulated human foods. § 1.1325 through 1.1350 of the Final Rule list Critical Tracking Events (CTEs) for which records containing Key Data Elements (KDEs) will be required. Unless exempted, § 1.1455 requires the data to be provided within 24 hours of an FDA request to aid during an outbreak or recall.
In 2019, the EC published an updated General Plan for Crisis Management in Food and Feed Safety. The Commission Implementing Decision explained that past experience and studies demonstrated “a need for a stronger focus on crisis preparedness, alongside crisis management, in order to avoid or minimise the public health impact of a food or feed crisis.” This plan, similar to the FDA’s Final Rule, identified extra strategies that needed to be put in place with enhanced Union coordination in the event of direct or indirect public health risks. Additionally, to increase transparency, EFSA has compiled the data from EU member states into a dashboard that gives general info on foodborne outbreaks, their causative agents and implicated food.
Finally, a major factor contributing to the uptake in food recall detection is the implementation of new technology into monitoring processes.
The FDA is implementing a variety of technology-enhanced monitoring protocols as part of the New Era of Smarter Food Safety Blueprint. The AI Imported Seafood Pilot program is in its third phase of implementation and uses AI and machine learning to improve import screening and ensure foods coming into the country are safe. AI can more efficiently comb through the huge amount of data the FDA receives on seafood imports and identify food safety issues much quicker than the current practice. The FDA’s GenomeTrakr Network is the first distributed network of laboratories that use whole genome sequencing (WGS) for pathogen identification. Public health and university labs in the network collect and share WGS data to leverage the public health benefits that can come out of open-source data sharing. Important for the global food chain, labs outside of the U.S. also contribute sequences from food. WGS is a powerful tool that can be utilized during the required food safety assessments for strain characterization, importantly including characterization of potential traits of concern.
EFSA continuously embraces monitoring innovations to protect consumers from food safety issues. In 2020, the Commission Implementing Decision 2020/1729 (EU) included clarification to the EU regulatory framework on the allowance and technical standardization requirements for WGS monitoring. In July of 2022, EFSA launched a platform for the collection of WGS data on Salmonella, Listeria monocytogenes, and Escherichia coli in food and animals which strengthens the detection and rapid outbreak assessment process. In January of 2024, EFSA assessed the persistence of microbiological hazards in food and feed production and processing environments by using molecular typing techniques and identified three pathogens with the potential to threaten public health due to their persistence in food processing environments.
In conclusion, while the increasing number of food recalls in the United States and Europe may seem alarming, it reflects significant advancements in food safety regulations and monitoring technologies. Regulatory frameworks in both regions have evolved to enhance traceability, crisis management, and early detection of safety issues, ultimately protecting public health. Innovations such as the FDA’s New Era of Smarter Food Safety Blueprint and EFSA’s WGS efforts demonstrate that heightened recall numbers can be a positive indicator of proactive safety measures and global collaboration. As the food supply chain grows more complex, continuous improvement in regulatory practices and technological integration will be essential to safeguarding consumers worldwide.
