On March 28, FDA Commissioner Scott Gottlieb appeared before the Senate Subcommittee on Appropriations for the last time in his role as commissioner. With the purpose of addressing the 2019 FDA budget – which he stated as one of the most substantial increases for the FDA in recent years, he focused primarily on the FDA’s work to combat the opioid crisis. His statement, however, also noted the agency’s use of the funds to advance its work to ensure the safety of food (as well as drug) products and seeking of new funds to further modernize our food safety system, strengthen our response capabilities when there’s an outbreak of foodborne illness. Through this statement and the March 19 Statement on New Steps to Strengthen FDA’s Food Safety Program for 2020 and Beyond, made with Deputy Commissioner Frank Yiannas, we can get a good idea of the direction that Gottlieb is leaving as his legacy with the Agency. Assuming Acting Chief Ned Sharpless continues along these lines, at least for the short-term, we can expect FDA to ramp up its focus on fast detection and response to “bad food” and its recall, its use of whole genome sequencing (WGS), technological innovations in traceability, and support of its state partnerships and import programs. Recalls. In FY2017, FDA’s Center for Food Safety and Applied Nutrition responded to 794 recall events due to issues such as microbial contamination and undeclared allergens and oversaw the recall of 3,609 products. This, Gottlieb said, was more than any other FDA Center. Thus, there is a distinct need to invest in and further modernize the ability to detect and respond to problems in the food supply. For the food industry, this means that if FDA is looking to modernize its ability to detect and respond to issues, you should be doing so as well – ensuring not only effective detection (as discussed below) but also fast, thorough, and effective recall response should anything be detected along with all the other aspects of managing a crisis. WGS. One of the ways to ensure that contaminated food is detected and removed from the marketplace as quickly as possible is the use of WGS. Gottlieb sees WGS as having been a game changer for the way microbial contamination in foods is found and addressed. It has made it easier to determine the source of contaminated food associated with human illness, and to better identify foodborne outbreaks that previously would have gone undetected. As it has become more accessible, useable, and affordable, its widespread use has increased the number of detected outbreaks and subsequent investigations. While that could be seen as a negative, it actually is good news, in that more sources of potential food contamination are being identified they impact consumers. This also meant an increase in FDA’s workload, and its evaluation of nearly 120 potential human food safety outbreak incidents in each of the last two fiscal years (2017 and 2018) was nearly double what was reviewed in FY 2015 and 2016. Thus, FDA has requested a 2020 budget increase to support the use of WGS and add staff and resources to enhance signal detection, response to outbreaks and post-response evaluations. For the food industry, this means that all your preventive controls including your environmental monitoring and controls are becoming even more important. And, while there tends to be hesitation with the use of WGS by food facilities themselves, you may want to consider its implementation, or at least ensure that your testing is up to its level. It’s better to discover, and fix, an issue yourself than to have it discovered through and FDA inspection. FDA is still paying a lot of attention to the presence of a resident strain of either Salmonella or Listeria monocytogenes, so knowing if you have that problem before FDA does can be critical to saving yourself from a large recall. Traceability Technologies. Gottlieb illustrated the critical need for technology by referencing the two outbreaks of E. coli O157:H7 in romaine lettuce – for which records were being kept mostly on paper. In addition to working with the industry on “common sense changes, like providing greater clarity on package labeling by including harvest date and location,” FDA called for industry to better improve traceability, e.g., through the emerging track and trace technologies of recent years – for which he specifically called out blockchain. Such technologies can assist in warning consumers about risks with specific foods, implementing more targeted and efficient recalls, significantly reduce the time it takes to find a food source, minimize the number of products implicated in outbreaks reducing such costs for the industry, and enable better and more real-time root cause analysis to prevent similar reoccurrences. For the food industry, this means if you’re not already using or looking into available technologies for tracking and traceability, I’d recommend you start now. And if your traceability is still paper-based, do whatever you can to bring it into the digital age. Food innovation. New foods and ingredients such as food and color additives requiring premarket safety reviews and to improve review timeliness and eliminate unnecessary related burdens to industry, FDA has requested additional budgetary resources. In this area, Gottlieb specially calls out biotechnologies as enabling the development of promising, innovative food products, such as genome-edited animals and plants and new protein sources, such as cell-culture technology. But there also is a need to ensure such innovations are safe and don’t have any unintended consequences. To advance this, FDA developed a Plant and Animal Biotechnology Innovation Action Plan focused on clarifying its science- and risk-based approach for product developers while avoiding unnecessary barriers to future innovation in plant and animal biotechnology. For the food industry, this is good news. Innovation is one of the key ways that food companies can stay ahead in the market, and faster premarket safety reviews along with a reduction in barriers means new, innovative food products can get to market faster, without compromising food safety. State and Imports. Partnering with the state food safety resources not only helps with produce safety inspections of FSMA, FDA funding supports the states in conducting more than half of the domestic food and more than 80% of animal feed facility inspections. The assistance in those areas (along with a requested budget increase) enables FDA to focus more resources on import oversight and ensure that domestic and imported foods receive parity of oversight through the Foreign Supplier Verification Programs (FSVP) and the Import Alert program. For the food industry, this means ensuring your supply-chain program meets, better yet – exceeds, the requirements of FSMA; your imported foods/ingredients and/or foreign facilities are on par with domestic regulations and standards. While the specifics of FDA’s future direction are dependent on both the amount of funding received in its 2020 budget and the priorities that Sharpless brings to the table, my guess is that we can expect there to be at least some focus on all the above areas. None are particularly new, and all are certainly needed. Overall the regulatory and risk environment continues to become more and more complex. The growing use of technology by regulators is driving up recalls and risks to the food industry. The food industry needs to understand where their risks are and how to manage those risks which is precisely what TAG does. So, if you are not sure what all this means to you, please give us a call and we’d be happy to chat with you about your own situation and how to both assess and manage food safety risks in a cost-effective way. 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
