Imagine sitting down to a delicious, homecooked meal with your family. A few days later, you suddenly start to feel sick. You are sweaty, your stomach is aching, and you start to wonder where the closest bathrooms are in case things get worse. As you assess your options, you get a call from your partner saying everyone at home is sick too and you need to get home as soon as possible.
Last month I reviewed the book Biting the Hands that Feed Us. The author, Baylen Linnekin, was critical of the Food Safety Modernization Act, FSMA. Although I understand the basic principles of food regulation, I am unfamiliar with the particulars of FSMA. When faced with such a dilemma, I turn to a former student who works closely in the field to defend the Act. Stephanie Brown, one of the best in her field, was kind enough to help me out.
Flash forward to a week later, everyone feels fine and have moved on with their lives. I am sure this story (or some version of this story) sounds familiar to you. That is because each year, an estimated one in six people will get sick (48 million people), 128,000 will be hospitalized, and 3,000 will die from foodborne illnesses. To reduce these numbers, the Food Safety Modernization Act (FSMA) was signed into law in 2011. This was the largest regulatory change to the U.S. food system regarding safety since the Food, Drug, and Cosmetic Act was released in 1938.
Unlike previous food safety regulations, FSMA focuses on preventing foodborne illnesses rather than responding to food safety problems. Since a prevention focus requires thinking about hazards and their associated risk(s) throughout the food continuum, FSMA is composed of multiple rules to meet this need. These include the (i) Preventive Controls for Human Food Rule; (ii) Preventive Controls for Animal Food Rule; (iii) Produce Safety Rule; (iv) Foreign Supplier Verification Rule; (v) Sanitary Transport Rule; (vi) Intentional Adulteration Rule; (vii) Third Party Accreditation and Certification Rule; and (viii) Food Traceability Rule.
Before detailing some of these rules and how they protect us as consumers, it’s important to clarify who and what foods must comply with FSMA. In the U.S., foods are regulated by one of two governmental agencies. The United States Department of Agriculture (USDA) oversees meat, poultry, and egg products. All other foods, including shell eggs, fall under the Food and Drug Administration’s (FDA) jurisdiction. The Food Safety Modernization Act solely focuses on FDA’s authority and the foods they regulate.
One of the biggest changes resulting from FSMA was the requirement of food safety plans for FDA regulated food facilities (as detailed in the Preventive Controls for Human Foods rule). As part of a food safety plan, facilities must review their entire operation and detail hazards that may be present for a food/grouping of foods with similar characteristics and methods of production. These include hazards that may be biological (e.g., pathogens like Salmonella spp.), chemical (e.g., allergens), or physical (e.g., plastic, glass) in nature. After potential hazards are detailed, those hazards that require a control to prevent significant health concerns are designated as needing a preventive control.
Up to this point, the approach to food safety prevention is almost identical to USDA’s hazard analysis and critical control points (HACCP) plans. With HACCP plans, the goal is to identify hazards of concern and control points that can be applied for hazard reduction or elimination during food production. Food safety plans include identification of these types of hazards and controls, and expands on this idea to include other hazards and their respective controls that would fall outside of processing. These include controls for allergen, sanitation, and supply chain related hazards. As part of the food safety plan, facilities must also have a recall plan in place. By having a recall plan written out before a recall were to potentially happen, this can expedite efforts to remove adulterated products from the supply chain, thereby reducing the public health burden.
Another way that FSMA furthers the goal of prevention is through expansion of food safety requirements to previously unregulated areas of the food industry. One notable example is for farms or other operations that grow, harvest, pack, and hold produce, which fall under the purview of the Produce Safety Rule. Similar to the Preventive Controls for Human Foods Rule, the goal is to have growers identify hazards and reduce the risks of these hazards throughout their operation. Although farm food safety plans are not required under this rule, there are training, recordkeeping, and other requirements that must be performed. Focus areas for this rule include factors that can cause widespread contamination if a hazard is present (e.g., agricultural water) and important prevention/risk reduction steps (e.g., cleaning and sanitation).
The newest rule under the FSMA umbrella is the Food Traceability Rule. Released in November 2022, this rule mandates additional recordkeeping requirements for those who make, process, pack or hold foods on the Food Traceability List. By standardizing information (key data elements) that needs to be collected at designated points (critical tracking events) during a food’s life cycle in the farm/fin to fork continuum, product tracking and ultimately product removal from the market during a recall, should be faster and easier than before. Like food safety plans, this new rule aims to move the industry towards prevention, and thereby leading to fewer injuries and illnesses from food.
Along with these rules, FSMA provided several other significant changes to the food system, including mandatory recall authority for the FDA. The power to recall foods is not as simple or insidious as it sounds. If a recall was needed because a food contains a hazard that is a significant public health concern, FDA would first notify the company of the issue. This way, the company can voluntarily issue a recall of the implicated product(s). If a company does not recall these foods when asked, and the health risk is high enough, FDA can then step in and issue a mandatory recall. Mandatory recall has rarely been used by FDA since FSMA was enacted.
The U.S. has one of the safest food systems in the world. The best way to illustrate this concept is by having you think back to all the times you have become sick over the past few years from food, then compare that number to all the meals, snacks, and beverages you have consumed during that time. This low level of illness (on a personal level) was achieved in part by food safety regulations serving as a foundational element for safe food production. While no rule is perfect and FSMA rules continue to evolve, FSMA has and is continuing to provide the framework for shifting the food industry to problem prediction rather than response. As the industry continues to innovate and bring nutritious, creative food offerings to our growing world, doing so in a landscape of preventive food safety will continue to lower illnesses, hospitalizations, and deaths related to food.
Stephanie Brown is a Food Safety Specialist at Oregon State University’s Food Innovation Center. As a member of the Kovacevic Food Safety Outreach and Research Program, Stephanie works on various research, extension, and outreach projects related to the diverse interests of the team. Some of her research projects and interests include using next generation sequencing techniques to characterize pathogens from foods and food processing environments, antimicrobial resistance, and stress response. As a Lead Instructor for the Food Safety Preventive Controls Alliance’s (FSPCA) Preventive Controls for Human Food course and trainer for the Produce Safety Alliance (PSA) Grower Training, Stephanie is part of several trainer teams in Oregon that deliver FSMA based trainings and provide technical support to stakeholders in the Pacific Northwest. Stephanie also serves as the coordinator for the Western Regional Center to Enhance Food Safety.
Coming soon: Is weight loss a signal for eating healthy?