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.
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.
Food and Drug Administration
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:- Tech-enabled traceability
- Smarter tools and approaches for prevention and outbreak response
- New business models and retail modernization
- Food safety culture
- Tech-enabled product traceback
- Root cause investigations
- Analysis and dissemination of outbreak data
- Operational improvements
United States Department of Agriculture
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:- The food is sourced from a non-bioengineered crop or source.
- The food has been subjected to a validated refinement process that shows that the modified genetic material in the food is undetectable.
- Records of testing appropriate to the specific food that confirm the absence of modified genetic material."