A funny thing happened during last year's health disaster: no food safety disasters.
Consider coronavirus' impact on the manufacturing side of the food and beverage industry: meat and poultry plant workers catching the virus, some dying, plants closing; USDA and FDA inspectors catching it, too, plus fewer inspections; processors caught with too much commitment to foodservice or the wrong products, having to pivot to make pantry items for retail.
All those conditions and more would be perfect breeding grounds for a major food safety incident. Corners could have been cut, improperly trained employees could be in place, familiar lines might switch to making unfamiliar products, no oversight from the authorities.
"COVID-19 has caused companies to quickly adapt and even alter their business models. In doing so, it is critical that food safety and recall planning are not compromised," says Marty Detmer, a product recall & contamination broker with insurer Aon, who was quoted in a report from Stericycle Expert Solutions, which this year became Sedgwick, Brand Protection Solutions.
Nevertheless, since the beginning of the pandemic, the food industry has seen lower than normal rates of recalls. According to Sedgwick, Brand Protection Solutions, which collects data on recalls, there were 28 USDA recalls in the fourth quarter of 2019, a typical number. There were fewer recalls in the next three quarters combined – six, nine and 10, respectively.
FDA figures were similar: The agency reported 156 recalls in Q4 of 2019 and 141, 79, 106 and 92 in the four quarters of 2020.
The reasons for this vary – from less regulatory agency oversight to simpler products and less variety to increased sanitation in the facilities.
"2020 was a strange year, making it difficult to draw firm conclusions about what caused such a decline in recall activity," says Ryan Gooley, product recall advisor for Sedgwick, Brand Protection Solutions. "It's very likely that it's a combination of factors, including a decrease in typical regulatory enforcement activities, a shift in regulatory posture and even how companies were able to proactively monitor for quality and safety issues.
"That said, we know that FDA inspections were down significantly. To the extent inspections did occur, they were often announced, due to COVID-19 safety protocols," Gooley continues. "It's very likely we'll never know if safety issues slipped through the cracks. But if the regulatory agencies find out by reviewing company records that they missed a potential safety issue, there's a chance we'll see far-reaching recalls once FDA gets back to full on-site inspections."
But that was then, this is now. As the pandemic (hopefully) subsides, some emergency measures can be reversed, some seem likely to remain in place – "a new normal" – and every new year brings new regulations, ideas and challenges in the realm of food safety.
Certification for the Next Pandemic
AIB International (formerly American Institute of Baking) created a "Pandemic Prepared Certification" that "provides assurance for the food & beverage supply chain and consumers that your company is committed to establishing and maintaining best practices for COVID-19 and beyond."
At this point, it seems more aimed at future pandemics, and it addresses challenges such as crisis management, supply chain disruption, worker health, food safety and intermittent operations.
AIB claims Pandemic Prepared Certification is "the first certification created specifically for the food & beverage supply chain that elevates critical planning for people, facilities and production inputs and delivers significant social impacts, builds bottom line resiliency, and can unlock insurance benefits … This industry-supported standard builds upon recommendations and best practices from thought leaders in industry, government, academia and international agencies."
The theme for 2021 can be summarized in seven words: a more digital and traceable food system.
The new look of inspections
Inspections, which were scant and sometimes paused during 2020, undoubtedly will increase as the pandemic subsides, but they may never reach past numbers. Some of the 2020 inspections were replaced with automatic extensions of food safety certifications, video visits or more-detailed paperwork.
"Companies should expect to face some of the same COVID-19 pressures … into 2021," says a separate Stericycle Expert Solutions report. "We’ll also see the same limited in-person engagement from regulators, likely maintaining the low recall numbers we’ve seen [last] year. But that doesn’t mean that other legal and regulatory risks will follow the same trend."
Not only did USDA and FDA conduct fewer inspections because of the pandemic, so did programs of the Global Food Safety Initiative (GFSI), including the Safe Quality Food Institute (SQFI), a division of FMI (formerly the Food Marketing Institute) and administrator of the SQF program recognized by GFSI.
SQFI proudly announced in 2014 it was the first internationally accredited third-party assessment program to require unannounced audits. During the pandemic, with most plants refusing entry to outsiders, the few visits that took place were announced and planned.
"At the heart of SQF certification is the audit process. The site audit is conducted at the facility and determines the effective implementation of the site’s documented SQF food safety system," says Gigi Vita, SQFI's senior vice president and chief food safety assessment officer.
"Due to the pandemic, many facilities have adopted no-visitor policies and there is limited auditor availability," she continues. "To this end, SQFI has implemented processes for risk assessments and, if needed, can extend audits. To date, we have approved more than 2,600 requests for audit extensions and will continue to evaluate extensions presented by the SQF Certified Bodies."
Roy Kirby, director of global food safety for Mondelez International and also co-chairman of GFSI, wrote in our September 2020 issue on how GFSI-related audits were changing during the pandemic. "GFSI is gearing up for a new world of auditing and introducing the use of ICT (Information and Communications Technologies) to food safety audits. The pandemic has accelerated discussions on the potential to replace some aspects of physical audits with the use and support of ICT in the longer term."
But, the global food safety agency wrote a month later, "GFSI does not currently recognise fully remote food safety audit solutions."
SQFI's policies reflect the GFSI view. "To offset some of stresses caused by operational challenges, SQFI has released an audit policy that allows for remote activities to be conducted using ICT for all SQF Codes, including the SQF Fundamentals Program, and all audit types except for unannounced audits," Vita continues. "The SQF remote activities policy was written in alignment with GFSI requirements."
Regulatory and Other Food Safety Changes Coming In 2021
February 24, 2021 | 2 p.m.
Food Processing Editor Dave Fusaro and Director of Food Safety for The Acheson Group Eric Edmunds will discuss the regulatory (FDA and USDA) and food safety changes coming into effect in 2021. Be sure to reserve your spot for the February 24 webinar. Sign Up For the Webinar
There are two types of remote audits: partially remote audits or fully remote audits. A fully remote audit is an option during an extraordinary event, such as this pandemic, and will allow the site to fulfill the annual SQF audit requirement. However, the audit will not be recognized by GFSI, as noted above by that global body. Partially remote audits will be recognized by GFSI but can only account for up to 50% of the audit duration; a minimum of 50% of the audit still needs to be held on-site.
New rules from renewed agencies
Both USDA and FDA (and its parent agency Health and Human Services) will get new leadership from the Biden administration in the coming months, which could change the agencies' policies and actions somewhat. But for the most part, their to-do lists are already set.
The FDA has made it clear for a number of years it wants to get more preventive, than reactive, with food safety issues and increase its use of technology solutions. The Food Safety Modernization Act (FSMA), dating back to 2011, started that process, and it will be kicked into high gear as the "New Era of Smarter Food Safety" blueprint, revealed in July of last year, starts to take shape.
"The New Era" is a 10-year plan from FDA that builds on FSMA. The blueprint has four core elements: tech-enabled traceability, smarter tools and approaches for prevention and outbreak response, new business models and retail modernization, and food safety culture.
But at this point, it's only a blueprint, which needs to be fleshed out as pandemic issues subside and a new administration -- and a new Congress and new heads of FDA -- take over in Washington. Look for elaboration on "The New Era" from the agency throughout the year.
One small deadline but coming up fast – Feb. 22 – is the end of the comment period for a proposed FDA rule titled “Requirements for Additional Traceability Records for Certain Foods” – "certain foods" referring primarily to leafy greens, the source of a nasty and difficult-to-trace outbreak around Thanksgiving of 2019.
Key to the " Additional Traceability Records" rule is a Food Traceability List, which include such items as cucumbers, herbs, melons, peppers, sprouts, tomatoes, tropical tree fruits, fresh-cut fruits and vegetables and leafy greens (including lettuces, kale, chicory, watercress, chard, arugula, spinach, pak choi, sorrel, collards and endive). It also includes soft cheeses, shell eggs, nut butters, finfish, crustaceans, mollusks & bivalves and ready-to-eat deli salads.
The proposed rule would require companies to establish records, almost certainly electronic, containing information on critical tracking events in the supply chain for the designated foods, such as growing, shipping, receiving, creating and transforming the foods. Once the comments are digested, there will be a final rule and an enactment date, which probably will fall into 2022.
E-Book: Food Safety Equipment is Center Stage in 2021
As food and beverage manufacturer optimism grows, one thing is still for certain: food safety is still a top concern in 2021. For our Food Safety Equipment E-Book, we take a look at the results of Food Processing's 2021 Manufacturing Outlook survey to find out how processors are factoring coronavirus into their operations and processes. Download the E-Book Today
"The proposed requirements are intended to help the agency rapidly and effectively identify recipients of foods to prevent or mitigate foodborne illness outbreaks and address credible threats of serious adverse health consequences or death resulting from foods being adulterated or misbranded," FDA wrote.
"We see FDA managing to review all comments and release a final rule before the end of 2021 for 2022 implementation," says David Acheson, founder and CEO of food safety consultancy The Acheson Group and former associate commissioner for foods at the FDA. "Thus, it is important that all food businesses become familiar with the proposed rule and voice any concerns or support before the end of the comment period in February."
While they’re not food safety concerns, there are two regulatory issues the FDA has ducked for years that the agency may be forced to deal with in 2021. One is whether, or how, to allow the use of marijuana derivatives cannabidiol (CBD) and tetrahydrocannabinol (THC) in foods and beverages. Several states already are allowing those ingredients in foods, but the products cannot cross state lines. The other issue is related to standards of identity: whether to allow plant-based analogues to call themselves “meat” or “milk.”
2021 will see processors working on their bioengineered (BE) food and ingredients statement. This Jan. 1 was the enactment date of the USDA rule, but enforcement won't come till next Jan. 1. Many processors already have one of the required statements on their labels, but if you haven't, this is on your to-do list this year.
Consumer concern over genetically modified ingredients (we used to call them GMOs, for genetically modified organisms) reached a boiling point 2012-2015. When the federal government took no action, several states started writing their own statutes for GMO labeling. That could have spiraled into a patchwork of differing rules, driving processors crazy. Congress finally stepped up in July of 2016, passing The National Bioengineered Food Disclosure Law and assigning the regulatory job to USDA with some assistance from FDA.
USDA created four options: two symbols the agency created; on-package text that declares “Bioengineered Food” or “Contains a Bioengineered Food Ingredient”; electronic or digital disclosure (after consumers scan an on-package QR code); or a text message disclosure.
Food safety culture
While it's not a rule or anything that comes from a regulatory agency, "food safety culture" is a term that is sweeping though food and beverage companies.
"Regulatory agency investigations of foodborne illness outbreaks and recalls often conclude that the root causes involved human error in implementing food safety programs," says Leslie Krasny, a longtime regulatory law specialist who recently started her own firm, Krasny Law Office.
"In recent years, there has been heightened emphasis within the industry on strengthening food safety culture as an important way to advance public health goals, through improved risk awareness, behavior, and personal accountability," she adds.
Frank Yiannas popularized the term with his 2010 book "Food Safety Culture: Creating a Behavior-Based Food Safety Management System." “Food safety culture starts in the boardroom, not on the plant floor,” says Yiannas, who has degrees in microbiology and public health.
At the time, Yiannas was Walmart's vice president for food safety, a job he held for a decade till becoming FDA's Deputy Commissioner for Food Policy and Response in December of 2018. As of this writing, no word on whether he'll keep his job in the new administration.
"We won’t make dramatic improvements in reducing the global burden of foodborne disease, especially in certain parts of the food system and world, until we get much better at influencing and changing human behavior," Yiannas writes on his own website.
All the regulations and management prescriptions in the world will do little good if there isn't sincere buy-in from the people on the plant floor and elsewhere in every food and beverage manufacturer.
The term is catching on. Food safety culture was defined by a GFSI technical working group in a 2018 position paper as “shared values, beliefs and norms that affect mindset and behavior toward food safety in, across and throughout an organization.” In October 2020, the Codex Alimentarius Commission of the United Nations added food safety culture to its General Principles of Food Hygiene.
Food safety culture: one colony worth growing in every company's petri dish.
