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As we enter the third year of the Covid pandemic, food safety is finding its own version of the “new normal.” While a number of pandemic accommodations remain as temporary fixes, the experience has led to some permanent changes – for example, more automation, more space for plant-floor workers and more use of remote technologies.
“The New Era of Smarter Food Safety” – while that evolving FDA program was not a result of the pandemic, the title nicely sums up food safety in the 2020s.
Over the past two years, Covid caused some interruptions in both USDA and FDA inspections; Global Food Safety Initiative-related ones too. Plant shutdowns, company bans on outside visitors and illness among inspectors all contributed to fewer in-person visits. New or temporary employees brought in by processors on a fill-in basis also could have compromised food safety. Fortunately, there was not a single serious incident in 2020 or 2021, much less one that could be pinned on Covid issues.
“While FDA has continued many of our oversight activities, there is no doubt the pandemic has had an impact on our inspectional work,” the agency wrote in the introduction to a May 2021 report titled, “Resiliency Roadmap for FDA Inspectional Oversight,” outlining the agency’s inspectional activities during the pandemic.
Basically, the document prioritized inspections, promising not to slack on “mission critical” ones, which were to be identified “on a case-by-case basis.” Mission critical inspections included 29 in foreign countries.
But it’s a new year, and both of the U.S. government agencies have new initiatives and some new rules to enforce. For starters, both agencies recently got new food safety leaders. Tom Vilsack, who was confirmed a full year ago as secretary of agriculture, in November named Jose Emilio Esteban as USDA’s undersecretary for food safety.
The reverse was true at FDA. The agency’s longtime food safety specialist, Frank Yiannas, remains FDA’s deputy commissioner for food policy and response, a job he’s held since 2018. But his boss will be new. Robert Califf was nominated by President Biden, but as of mid-January had not been confirmed. Califf, like Vilsack, held that title during the Obama administration.
“I see food safety as going in two potential directions in 2022, based primarily on the direction taken by the regulatory agencies,” says David Acheson, who was the top food safety officer in FDA 2002-2009, and now heads food safety consultancy The Acheson Group (achesongroup.com).
“To explain: The industry has been dealing with supply chain pressures and workforce issues since the beginnings of the pandemic, which have diverted some focus from food safety, and I don’t see those pressures as letting up anytime soon,” Acheson says. “However, regulatory scrutiny has become more aggressive in recent months, particularly in relation to [FDA’s Food Safety Modernization Act] compliance and Food Safety Plan evaluation, and I don’t see any relaxing of that either.
“So, in general, I would see most companies continuing to do business as usual … unless they catch a regulatory eye for a food safety infraction. Such a wake-up call would force a focus to food safety enhancements,” he continues. “Absent such a prod, I would expect the continuing challenges, now exacerbated by inflation and supply costs, to retain corporate focus, with 2022 following similar lines as 2021.”
Nevertheless, 2022 brings a few changes from all the key food safety authorities. Here’s a rundown of top initiatives for the agencies.
The FDA has already penciled in the addition of sesame to the list of allergens that must be declared on food labels, although enforcement doesn’t begin till Jan. 1, 2023. That brings the total number of allergens to nine, the other eight being eggs, tree nuts, peanuts, cow’s milk, fish, shellfish, soy and wheat.
In December, FDA added acacia—also known as gum arabic or gum acacia—as part of the agency’s definition of dietary fiber. Following FDA’s stricter re-definition of fiber in 2016, only seven ingredients initially could call themselves dietary fiber. Other ingredients – such as inulin and high-amylose starch– had to prove “physiological effects that are beneficial to human health.” And acacia is the 11th ingredient to have done so (bringing the total to 18).
Last October, FDA issued voluntary guidelines for sodium in food that seek to reduce the average level in the American diet by 12%. The recommendation seeks to limit sodium consumption to 3,000mg per day, down from the current average of about 3,400. Current dietary guidelines say adults should consume at most 2,300mg.
Despite positive comments from many, including some food processors, they are “guidelines” and “voluntary”; the FDA issued similar voluntary guidelines in 2016, without much effect. But at the time of the 2021 announcement, acting FDA commissioner Janet Woodcock said companies that meet the guidelines will be rewarded—although she didn’t say how, nor if there would be consequences for those who don’t.
An unpleasant side effect of the pandemic and more recent supply chain problems has been food fraud. That’s moved higher up on the list of worries for both FDA and the Canadian Food Inspection Agency.
“Any changes to the supply chain potentially increase the risk of fraud on raw materials, ingredients, finished products, and even packaging,” says Earl Arnold, AIB International’s manager for Food Defense/FSMA, Operations, Quality Assurance. “As shortages occur, fraudsters take advantage of this and attempt to create fraudulent [products] for economic gain.”
As some ingredients and other supplies became scarce, some processors desperately looked for new suppliers – and in the process may have compromised food safety. “To help mitigate fraud, facilities should first consider developing specific and detailed procedures on what will be done if they need to obtain resources from new/emergency suppliers,” Arnold continues. “Most auditing standards and FDA requirements require food fraud programs and risk assessments.”
For a few years, FDA has been prodded to develop means to regulate marijuana derivatives—both THC and CBD—as food ingredients. A bipartisan bill was introduced in the House of Representatives in December that would require the FDA to regulate cannabidiol (CBD) in foods and beverages.
A similar bill was introduced in the Senate earlier last year. But neither bills nor lobbying efforts have forced FDA’s hand, although some day, and that day could come this year, the agency will need to deal with this issue.
Ultimately, the main effort of the FDA this year will be a continuing development of “The New Era of Smarter Food Safety.” The plan builds on the 2011 Food Safety Modernization Act and outlines the overall approach FDA will take over the next decade. Influenced at least in part by the coronavirus pandemic, the plan is centered around four core elements:
“It outlines a partnership between government, industry and public health advocates based on a commitment to create a more modern approach to food safety,” then-FDA Commissioner Stephen Hahn said at its unveiling.
“Since FDA introduced the New Era of Smarter Food Safety in July of 2020, they’ve discussed or presented information at nearly every opportunity and forum available to them,” says Arnold. “FDA developed this program because the food industry is quickly changing. New technologies, e-commerce, and expansions of the global supply chain need to be utilized and considered for traceability and food safety management activities to be successful.”
Progress on the New Era came just this past December, when FDA published its Foodborne Outbreak Response Improvement Program, “an important step … to enhance the speed, effectiveness, coordination, and communication of outbreak investigations.” Partly from introspection, partly from an outside review by the University of Minnesota’s School of Public Health, which included a look at USDA’s FSIS, the FDA will work on:
The Agriculture Department already has seen a food safety milestone: Jan. 1 was the enforcement deadline for the labeling of genetically engineered/GMO/bioengineered (BE) ingredients in food and beverage products. Although USDA created and enforces the 2018 “National Bioengineered Food Disclosure Standard,” the food end-products are just as likely – maybe more so – to be under FDA’s jurisdiction.
But the origins of BE ingredients or foods almost always lie in agricultural products – and that introduces “one of the most confusing parts of the regulations for the BE disclosure standard … the recordkeeping requirements,” says Elaine Meloan, AIB’s manager for food labeling.
“For any foods on or derived from the substances on the bioengineered food list, companies will need to maintain records showing the BE status of the food,” she explains. “A simple statement of ‘non-GMO’ from the supplier for the records would not necessarily be sufficient to show that the product is not BE. Instead, the supplier documentation would need to show one of the following:
USDA’s Food Safety and Inspection Service (FSIS) also is in the midst of a “comprehensive” effort to reduce salmonella in poultry products. The agency is gathering data and other information with a goal of a 25% reduction in salmonella illnesses.
“Reducing salmonella infections attributable to poultry is one of the department’s top priorities,” says USDA Deputy Under Secretary Sandra Eskin, who is leading the initiative. “Time has shown that our current policies are not moving us closer to our public health goal. It’s time to rethink our approach.”
So USDA this year will seek stakeholder feedback on specific salmonella control and measurement strategies, including pilot projects, in poultry slaughter and processing establishments. A key component is encouraging preharvest controls to reduce Salmonella coming into the slaughterhouse. The data generated from these pilots will be used to determine if a different approach could result in a reduction of salmonella illness in consumers.
FSIS already has held two roundtables with consumer groups and industry to hear their ideas on potential pilot projects and will be holding its next set of roundtables early this year, beginning with one on scientific support for various approaches to salmonella control in poultry.
USDA and FDA are sharing responsibility for cultured animal-cell products. “Lab-grown meats” have advanced so fast in the past year or two they’re no longer in the lab; several companies are building production facilities to make cultured meat, poultry, seafood and even dairy products. FSIS solicited comments on how to label them last fall, and work continues to develop a framework to bring them safely to consumer tables in the near future.
The two agencies also are collaborating on the Closer to Zero (C2Z) initiative. The revelation that there are heavy metals, particularly arsenic, in some foods, particularly baby foods, blew up last summer in Congress and among states’ attorneys-general. FDA is expected to provide a preliminary report this April, with phased-in limits coming in following years.
The non-governmental GFSI certifies a global network of independent food safety auditors and certification bodies, such as the Safe Quality Food (SQF) Initiative and the British Retail Consortium’s (BRC) Global Food Standard. So “benchmarking and harmonization” are perennial priorities for the global initiative, especially with a new version of the GFSI Benchmarking Requirements.
While GFSI was created by and for the private sector, “In 2022, GFSI will be rolling out an ambitious framework of government-to-business events striving to create an environment where food safety regulators trust that GFSI-recognised certification can be used for risk-based resource allocation in their national food control systems.”
Having just launched the first set of benchmarking requirements for food safety auditor Professional Recognition Bodies, “We will be moving full speed ahead to raise the profile of the profession of auditing, with the aim to attract and retain talents into this vital profession,” the agency wrote us.
Finally, the group is developing a proprietary platform to verify GFSI-recognized certificates and to otherwise differentiate its food safety certifications from others, especially fraudulent ones. The project is a response to the feedback of many GFSI stakeholders who report it is becoming increasingly difficult to distinguish GFSI-recognized certificates from non-recognized certificates or differentiate valid certificates from fraudulent ones.
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