Each January TAG makes our predictions for the coming year. For 2020, our team expects: 1. Romaine Outbreaks. We expect romaine outbreaks to continue, with FDA continuing to seek improvements in traceability despite the lack of regulatory authority to get what they really need. Overall, outbreaks will continue until the industry and federal regulatory agencies address the underlying hazards of co-locating large animal agricultural operations and RTE produce in the same areas. While the colocation is almost impossible to solve and much is being done at the grower end of the supply chain, it is not addressing the problems adequately. We anticipate some industry moves in 2020 to take a fresh look at this problem that will take a different approach to addressing the issues – because what is being done now is not working. 2. Traceability. FDA may release draft rules linked to Section 204 of FSMA, but these will likely be too general to require meaningful changes – even in the produce industry. We also expect FDA to continue its overall focus on its New Era of Smarter Food Safety, which it defines as people-led, FSMA- based and technology-enabled. One part of this is a focus on supply-chain digitization for transparency and traceability, which will inevitably encourage companies to adopt new technologies. The complexity of the food sourcing with its global network of suppliers has become a roadblock for fast reaction on management of outbreaks, and paper trails provide a slow response with limited information. FDA’s Technology Modernization Action Plan is a strategy that is being developed and targeted to the pharmaceutical industry, but the model has the capability to be adapted and extended to the food industry. The use of blockchain for traceability could be the first step toward the application of technology in food production but even that is only as good as the data entered. 3. Food Safety Culture. In addition to the focus on technology and data management for traceability and prevention, the New Era will have a food safety culture component throughout the supply chain, adapted to new business models such as e-commerce and home delivery of foods, together with current, traditional ones. Although everyone is talking about food safety culture, it is often poorly understood. Companies can’t define it easily, and many don’t know how to get on the road to a better food safety culture. We will hear a great deal more on this in the coming year and expect the understanding to increase across the food sector. 4. CBD, THC, and Other Cannabinoids. Although CBD products are pervasive, FDA has made it clear that these substances are not GRAS and that it is illegal under federal law to add CBD to food or market it as a dietary supplement. While FDA is working to create a regulatory framework at the federal level, there is limited scientific information available, and it will likely take some time. Thus, we’d expect that the agency will continue to prohibit the use of CBD, THC, and other cannabinoids unless Congress mandates that these compounds be considered as allowable in foods and dietary supplements. (This would only apply to non-THC cannabinoids unless we get federal cannabis legalization which is not likely). The agency’s position will be strengthened if there are any outbreaks or adverse health events associated with (non-vaping) THC- or CBD-related products in 2020. Additionally, FDA and FTC are likely to continue their enforcement as they figure out the best approach to regulating products containing CBD. While we would like to say that the regulatory framework will be clearer within the next year, we doubt that will happen without additional interventions from Congress, as FDA must follow the science and its lengthy administrative process to develop and implement final regulations. Private lawsuits will also likely continue to be a major consideration for companies looking to participate in the CBD marketplace. 5. Global Standards. GFSI and its certified audit programs, such as BRC and SQF, will likely have a challenging year as programs are questioned in terms of their delivery and implementation. Good auditors are in short supply globally, and this is the biggest challenge facing GFSI. There also is a lack of consistency and a perception among some detractors that poorly run plants are able to get high ratings, which is affecting confidence in these systems. GFSI will have to counter this perception with more proactive messaging about its value. FDA is adding to this noise about GFSI with some inspectors saying a GFSI audit is not adequate to meet the FSMA standards for supply-chain control. 6. Labeling. FDA will finally be rolling out and enforcing the new nutritional label standards, so consumers can expect to see up-to-date information on most products very soon, and we will likely see many auxiliary labeling issues come out with the revamping of labels. Companies will be looking for best industry practices for shelf-life labeling as it pertains to both quality and safety with clear “best if used by” and “best by” date labeling. The new nutritional facts also will give rise to new arguments on what is considered “healthy” or “natural” on labels; and with the advent of new and proposed laws that restrict the usage of meat terms on meat analog products, it will be an interesting area to watch. 7. FSMA. Foreign Supplier Verification Program (FSVP). We expect more tightly focused, FSMA-targeted international facility inspections and product detentions at the border. Entities that must have a written FSVP will be elevated to a higher expectation by FDA as “educate prior to regulate” has nearly stopped. More companies will be found at fault (i.e., issued a 483) for not having a properly written FSVP and/or lack of proof that the foreign supplier is producing safe food, making assistance from experienced professionals key to compliance. Food Safety Plan. FDA will continue to evaluate its two-tiered supply-chain inspection process and preventive controls, as well as the recall plan compliance of Food Safety Plans being held and managed by a corporate headquarters rather than at individual facilities. We expect that FDA will realize this is a normal business practice and allow facilities to opt out of the two requirements if held by corporate control. However, the realization will cement the need for a PCQI at headquarters to oversee and review the supply-chain and recall programs as well as having a PCQI at each facility to oversee and review the remaining aspects of the Food Safety Plans. Training of new and replacement human and animal food PCQI’s will continue at a steady pace. Intentional Adulteration (IA) Rule. As FDA begins enforcing the FSMA IA Rule by March 2020, companies will need to devote extra efforts beyond updating existing plans to ensure their food defense plan aligns with the modernized approach to preventing deliberate acts with potential for wide-scale harm to public health. FDA guidance documents, FSPCA training, the Food Defense Plan Builder, and assistance from experienced professionals also will be key in this area. The IA “Quick-Check” questions of FDA will result in a larger than expected “non-compliance” because companies may rely on GFSI Food Defense plans which do not meet the intent of the IA rule, or a company with a lackluster food safety culture in place may not accept the potential of an internal employee willing to intentionally cause mass harm. Through the “Quick Check,” FDA also is likely to find a lack of training and education for the writing of the food defense vulnerability assessment. 8. Innovation. Ghost Kitchens, Cloud Kitchens, Commissaries, and Home Delivery. Companies will continue to evolve to meet consumer expectations, and we will see more and more foodservice without traditional dining areas or counter service. This will allow companies to expand without the same investment needed as a brick and mortar storefront. It is not without risk, as companies will need to learn to manage shared space and equipment and pay special attention to how others producing in the same area may affect their operations. In-Store and Delivery Meals. Huge parts of the traditional processed foods sector will be affected by this trend where take-out or delivery meals take over from home preparation. There are many challenges in this new food production paradigm including food-handling and delivery systems that keep foods at safe temperatures, worker hygiene and food-preparation knowledge, and the need for more consistent automated preparation and heat treatment equipment. Government inspection programs are focused on big food processing and import and not in-store and commissary type operations where foods are often RTE and higher risk. What is Meat? What is a burger? Lines are becoming very fuzzy on nomenclature in this sector. Not only are plant-based “meats” more and more common, but there is now a trend to mix meats and plant-based materials for burgers and other similar products. Whole Foods is moving in this direction in 2020 as a way to reduce resource issues and environmental impacts of meat production. This will be a regulatory challenge for USDA and FDA. There will be new hazards in these mixed products, and labelling policies and regulations will need to adapt. 9. BE Food Labeling. The National Bioengineered (BE) Food Disclosure Standard will gain attention in the coming year with its January 1, 2020, implementation date. Regulated entities (food manufacturers, importers, retailers) will work to ensure their products are appropriately assessed with adequate recordkeeping to demonstrate compliance, particularly when BE disclosure is not required. The standard’s definition of BE foods as those that contain “detectable genetic material that has been modified through certain lab techniques and cannot be created through conventional breeding or found in nature” will result in increased demand for laboratory testing for the presence of modified genetic material, along with information on validated refining processes which remove the genetic material and thus the need for disclosure. BE disclosure information will begin to appear on product labels prior to the 2022 mandatory compliance date, leading to increased public interest. Industry groups will promote fact-based education regarding BE food and seek out additional scientific studies supporting the safety of these practices. 10. Food Fraud. This has been a hot topic for the last several years, and it will continue to be an issue. Governments are moving to more labelling controls and more inspections, especially in the fish and seafood sector where species substitution remains a rampant problem. The problem is further driven by predicted food-price increases exceeding income rises in the U.S. This also will mean a greater emphasis on supplier-assurance programs. Food fraud issues will continue to be covered by all types of media in 2020. The world of food safety continues to get more complex and challenging. As the risks rise through innovation and new product development, so do the consequences of not getting food safety right. 2020 is looking to be a continuation of the old supported by the implementation of the new. We will be keeping a close eye as it all pans out – and will be here to provide guidance and assistance whichever way it goes. Give us a call to help make your 2020 the best it can be! About The Acheson Group (TAG): Led by Former FDA Associate Commissioner for Foods Dr. David Acheson, TAG is a food safety consulting group that provides guidance and expertise worldwide for companies throughout the food supply chain. With in-depth industry knowledge combined with real-world experience, TAG’s team of food safety experts help companies more effectively mitigate risk, improve operational efficiencies, and ensure regulatory and standards compliance. www.AchesonGroup.com
