While TAG envisions some change in 2021, one key area of focus we expect to continue for a while yet is that of COVID-19 precautions. Initially, we had expected case counts would stay level through January 2021, then begin to fall due to increased vaccinations. However, we weren’t expecting significant impacts from vaccinations until summer. However, with the emergence of new virulent virus variants that have made their way to the U.S., we now expect cases to continue unabated and precautions to be critically important.
COVID-19. With the continuation of the pandemic, we expect business impacts to continue as well, with supply chain disruptions, increasing ingredient/food prices, and restrictions on plant workforces continuing to make production challenging. The gravest food safety concern may be that of some businesses “cutting corners” which could cause a greater risk of food adulteration, misrepresentation of ingredients, and recalls – for which we may see an overall rise in food recalls in 2021. We did not see many food recalls in 2020, partially because of fewer inspections and less enforcement, and partially because of production running with only — and often fewer of — their essential workforces. This could cause an increase in the recalls if restarted FDA inspections find issues in areas that had been put on the back burner during the pandemic. On the other hand, companies may come away from 2020 with lessons learned from their increased focus on day-to-day production, resulting in recalls remaining low.
Either way, we would expect to see a major change in business from the realization that nonessential workers need not be onsite 100% of the time, and having developed new ways to manage the business; produce safe, quality food; and, celebrate the essential workforce for their successes under reduced management. Although the Food Safety Culture strategy has been growing for the last decade, the pandemic highlighted the value of people for a business’ success. Thus, assessing a company’s Food Safety Culture maturity status will become critical, as will the implementation of metrics to determine its continuity and growth.
Food Supply Chain. With the pandemic having refocused the supply chain, we expect the 2020 focus on improved and enhanced Crisis Management Programs will continue to be an area of attention in 2021. Supplier Approval Programs will be critical, and food fraud a key focus. The use of virtual and digital tools for global, regional, and local supply chain models will grow in 2021 because of their fast response and cost-effectiveness. The speed and the level of commitment will be driven by consumer trust, B2B requirements, and financial constraints.
Food Defense. We expect that the FDA will continue to focus on facilities having a written food defense vulnerability assessment as a foundation of their written food defense plan. We don’t know when the FDA will begin enforcement of the I.A. rule. Still, we expect a continued “educate before regulate” approach utilizing the FDA IA “quick checks” that could ramp-up in earnest, especially when the pandemic comes under control and traditional on-site inspections resume. Food Defense training will continue industry-wide for those workers at actionable process steps (APS) and their immediate supervisors, as well as for those writing the food defense plan, including those implementing the I.A. VA three element approach, to potentially reduce the number of APSs at a facility.
Food Trends & Innovation. While we see a number of trends continuing, such as the growth of e-comments, meatless proteins, and consumer focus on value and health, we expect that 2021 will provide some new opportunities for innovation and increased growth in technology and data management. We also foresee that the restaurant business will begin to build back up – albeit slowly, and more mergers and acquisitions are likely to occur.
In relation to the plant-based and cultured meat products, TAG has seen companies with limited expertise or experience in foods move into this space, which can increase food safety risk due to inappropriate sanitary design, inadequate hazard analysis, limited allergen control, etc. We also expect that the FDA work on standards of identity for foods to be a focus of 2021. This will be in coordination with state efforts to restrict or allow specific terms for the labeling of plant-based products, particularly those with “meaty” terms and plant-based qualification requirements.
The continued and increasing sale of food companies is being driven in part by investment firms and the availability of low interest rates for investors. In many ways, this is a good trend, in the sense that greater capital can become available to invest in food safety infrastructure. However, it means that buyers need to scrutinize food safety systems to avoid risk in these newly acquired operations, and new management teams need to consider food safety as a critical factor.
Food Safety & Regulation. In 2021, we see FDA strengthening its focus on its New Era of Smarter Food Safety strategy; continuing its expanded use of whole genome sequencing; moving faster on outbreaks – particularly as more new food-risk pairs are implicated; increasing its attention on food safety of imported products – as well as restaurant and retail establishments; and focusing on the animal-produce risk connection. We would also expect a continued focus on risk around produce and, within that, a greater focus on the interaction between animal operations and produce operations to better understand that risk.
Concerning labeling, you can expect to see some differences coming out this year. With the new requirements for nutritional labeling passed their mandatory compliance dates for larger companies, there will likely be movement in enforcement. The Bioengineered Disclosure Standards also will start showing up on consumer packages.
We also expect the proposed traceability rule to come to fruition in 2021 since it is such a key tenet of the New Era strategy. We’d see the FDA managing to review all comments and release a final rule before the end of 2021 for 2022 implementation. Thus, it is important that all food businesses become familiar with the proposed rule, and voice any concerns or support, before the comment period ends in February 2021. In this way, you can help influence how the final rule will look and apply to industry.
Internationally, the delay of Phase 3 of the Safe Food for Canadians Regulations (SFCR) precipitated by COVID in 2020, will almost certainly end sometime later in 2021. With that, many sectors outside the regulations (baked goods, confections, snack foods, cereals, processed products) will be required to have a license and a Preventive Control Program. CFIA will step up audits in 2021, and the industry can expect a continuation of the move to a strictly auditing approach and more rigor in enforcement. Driven by illnesses in Canada in repeated years, we can expect the Public Health Agency of Canada and CFIA to continue to place restrictions on leafy greens/romaine from the U.S.
Cannabis. We expect states to continue their steady progress in the creation and implementation of regulation focused on creating programs around GMPs and hazard identification and controls, as well as specific labeling requirements to help consumers better understand exactly what they are purchasing (e.g., CBD and THC content). We also expect to see increased production of edibles, as recreational cannabis continues its legal expansion state-by-state – and along with that is likely to come a new federal regulatory focus.
Although we can’t be sure if the FDA will take cannabis regulation in the direction of FSMA or dietary supplements, we do have high hopes that the the FDA will release guidance on CBD in food and dietary supplements to create a clear regulatory framework. The guidance is currently under review at the White House Office of Management and Budget, and with a Democrat in the White House, we expect a push for regulatory clarity and the quick release of the FDA guidance.
With Democrats now in control, we expect cannabis reform to become a larger priority. While we don’t expect a complete legalization law at the federal level, there will likely be progress to decriminalize cannabis and implement social justice programs at the federal level, while allowing states to maintain oversight of their own regulatory frameworks (See the MORE Act for where things are likely to go in 2021 with Democrat control).
New Administration. Beyond that, we would expect the new administration to leave food regulation as it is in 2021, but take some deep looks – with a greater focus on retail and foodservice; then making potentially major changes in 2022 and beyond. While we wouldn’t expect any new major food safety statutes, the more outbreaks we see, the faster the change we can expect – along with increased DOJ activity and criminal prosecutions.
Overall, TAG’s recommendations for 2021 are to continue to focus on both food and worker safety, while also keeping an eye on the developments within the industry. Then be ready to lead at the right time.