WSL Future of Health Event

Food Safety Modernization Act: Overreach or overdue?

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The United States enjoys one of the safest food supply systems in the world; yet, according to recent data from the Centers for Disease Control and Prevention, about 48 million people (one in six Americans) get sick from food-borne illnesses.

The United States enjoys one of the safest food supply systems in the world; yet, according to recent data from the Centers for Disease Control and Prevention, about 48 million people (one in six Americans) get sick from food-borne illnesses.

Trends that have made the food supply chain more susceptible include the centralization of food production, new disease agents, changes in the U.S. population, dietary patterns, and the rapid increase of imported food and ingredients from countries where safety standards or enforcement may be weak.

Today, 15% of the U.S. food supply is imported, including 80% of seafood consumption and 50% to 60% of fresh produce consumption. The economic cost of food-borne illnesses has been estimated at over $15.6 billion. This is a significant public health problem that both industry and government realized could be prevented through a stronger regulatory system.

The Food Safety Modernization Act (FSMA), passed in 2011, mandates a complete modernization of the food safety system and fundamentally refocuses the Food and Drug Administration’s mission from reaction to prevention of food safety problems. When fully implemented, FSMA will address at least 50 deliverables in the form of regulations, industry guidance, new programs and reports. A.T. Kearney examines key elements of this act and how these deliverables will affect the food retailing industry.

Under FSMA, the FDA will implement new prevention-focused tools and a regulatory framework in the following areas:

• Preventive controls. For the first time, the FDA has a legislative mandate to require comprehensive, science-based preventive controls across the food supply; these include mandatory produce safety standards and the authority to prevent intentional contamination. Food facilities will be required to implement a written, preventive control plan.

• Inspection and compliance. Recognizing that oversight is crucial for ensuring compliance with new requirements, FSMA specifies how often the FDA should inspect both domestic and foreign facilities. In addition, the FDA will have access to industry food safety plans and require that certain food testing be handled by accredited laboratories.

• Imported food safety. The FDA has new tools to ensure that imported food meets U.S. standards and is safe for consumers. Importers will be required to verify that their foreign suppliers have adequate preventive controls in place, and the FDA will be able to accredit qualified third-party auditors to certify that foreign food facilities are complying with U.S. food safety standards, particularly for high-risk food.

• Response. For the first time, the FDA will have mandatory recall authority for all food products. The FDA will be boosting its product-tracing abilities, requiring additional record keeping for high-risk food, and establishing pilot projects to evaluate methods for rapidly identifying recipients of food, to prevent or control food-borne illnesses.

• Enhanced partnerships. The legislation recognizes the importance of collaboration among all food safety agencies — U.S. federal, state, local, territorial and tribal, as well as foreign — to achieve public health goals. The FDA will undertake state and local capacity-building, foreign capacity-building, and interagency agreements to leverage third-party inspection resources.

This regulatory shift from reaction to prevention is likely to have a significant impact across the food supply chain with regard to high-risk food, which can be defined as “any ready-to-eat food that will support the growth of pathogenic bacteria easily and does not require any further heat treatment or cooking.”

These types of food are more likely to be implicated as vehicles of food poisoning organisms consumed in food poisoning incidents. Such food products are usually high in protein, and require strict temperature control and protection from contamination. The official list of high-risk food is likely to include cooked meat and poultry and cooked meat products; dairy products such as milk, cream and cheese; egg products and products containing uncooked or lightly cooked eggs; shellfish products; and cooked rice, pasta, and couscous.

As retailers respond to consumer demand for healthful, natural food and increase store offerings of ready-to-eat food, there are likely to be significant changes to current regulations involving high-risk food procedures for recalls, traceability of products and imported food. They include:

• Mandatory recalls. Enacting mandatory recall protocols likely will not change current industry practice. It is in the best interests of both retailers and manufacturers to pull potentially hazardous products off the shelves immediately. A recent Food Marketing Institute survey indicated that 91% of consumers trust their grocery to ensure safe products. Retailers will continue to act aggressively in this area.

• Traceability of products. One possibility on the table is a requirement for retailers to comply with new regulations for high-risk food. The new law requires the FDA to publish Reportable Food Registry notifications in a format that can easily be printed by a grocery store for consumer notification. Grocery store chains (15 or more physical locations) will be required to print and post in a prominent location for two weeks notifications for products they carry, within 24 hours of notices posted on the FDA’s website.

• Imported food. High-risk food will likely require specific certification. Retailers may be required to monitor their foreign suppliers to ensure that any imported high-risk food meets safety standards. This could increase operating costs.

In 2000, the food industry recognized the need for global guidance on food safety management and chartered the Global Food Safety Initiative (GFSI).

Over the past 15 years, leading food safety experts from retail, manufacturing and food service companies have been working toward harmonizing internationally accepted protocols and promoting GFSI certification. Using a total supply chain approach, GFSI seeks continuous improvement in food safety management, cost efficiencies, a reduction in food safety risks and overall improved consumer confidence in the food supply.

It is possible that companies adhering to GFSI guidelines and current practices will meet or even exceed future FSMA regulations. For example, while the GFSI does not make policy for retailers or manufacturers, its stated mission — once certified and accepted everywhere — promotes proactive food safety collaboration and development.

Food retailers recognize the need for updated food safety practices that take into account the global nature of food distribution and the changing requirements of their customers. While full FSMA regulations have not been finalized, retailers should implement preventive approaches today. Among the steps that food retailers can take are:

• Audit internal practices. Identify the current protocols that are in place for tracing and traceability of food, as well as any redundancies or gaps in the current food safety system. Determine if current suppliers have preventive controls in place to ensure safety.

• Adopt industry-recognized certification. The GFSI provides a formal process for benchmarking food safety management schemes and ensures continuous improvement based on current food safety principles. Adopting a GFSI scheme such as BRC, IFS, Dutch HACCP or SQF should reduce redundant audit costs while maintaining high quality control.

• Exceed expectations. By proactively evaluating and upgrading food safety protocols, retailers will ensure they are prepared for future FSMA regulations and exceed consumer expectations for healthful, safe food.

Full implementation of the FSMA will ensure that every participant in the food safety supply chain embraces prevention and transparency in delivering safe food to consumers.

Food retailers, with their visible connection to consumers, have the most to gain from proactively developing and supporting a modernized food safety system.

Dave Donnan is a partner and leads the Global Food and Beverage Practice of A.T. Kearney, a strategy and management consulting firm with offices in more than 40 countries worldwide. He is based in Chicago and can be reached at [email protected].


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