When the Food Safety Modernization Act first became law in early 2011, it was hailed by consumer advocates and the food industry alike as a landmark achievement in ensuring American consumers’ health.
"This is a big victory for consumers that finally brings food-safety laws into the 21st century," Jean Halloran of Consumers Union told The Washington Post in December 2010 after FSMA cleared the House of Representatives and went to President Obama’s desk. "This win is a powerful testament to the people across the country who came to Washington to tell their lawmakers how contaminated food had killed their loved ones or left them horribly sick. This win is for them and all Americans."
The law’s intent is to change the paradigm of food safety measures. Ensuring that consumers’ food was safe used to be a largely reactive process — pulling products off shelves and working through issues once problems were discovered. FSMA aims to make the process more proactive. Food and beverage manufacturers — and eventually produce farmers and importers, too — now concentrate on making sure contaminated food doesn’t ever get to consumers in the first place.
It took several years for regulations that detail exactly how FSMA works to be put together and finalized. Last year, some of those regulations finally took effect. The preventive controls part of the law — which requires large manufacturers to have plans to reduce the risk of contamination in their plants and puts them on a regular inspection schedule by the Food and Drug Administration — started being enforced in September 2016.
Before the law actually took effect, many experts predicted an immediate change on the horizon. Because of the detailed new processes to prevent contamination, many said that manufacturers slow to come into compliance might see more recalls.
It's now almost eight months into the law's enforcement and there have been many recalls involving products as diverse as powdered milk, soybean paste and chili spices. Relatively few illnesses have been reported, showing that many of these recalls were completely preventive. But the big question remains: Was it because of FSMA?
“It is too early to tell how FSMA preventive controls has had an effect on the level of recalls/illnesses,” FDA spokesman Jason Strachman-Miller told Food Dive in an email. “We have not yet had a full year of implementation with large facilities, and small and very small facilities are not yet required to comply.”
It’s difficult to compare the numbers of recalls to make this sort of determination. There is no single agency that comprehensively oversees food recalls as food safety responsibilities are spread between FDA and the U.S. Department of Agriculture. It’s also hard to tell if recalls are happening because of problems covered under FSMA — or other issues and potential contamination are at play.
Food Dive spoke with several experts who said that any “FSMA effect” on recalls is not yet visible — if it’s even happening at all.
“FSMA has not kicked in in any way yet with enough depth to do anything on recalls.”
Dr. David Acheson
Consultant and former FDA food safety official
“FSMA has not kicked in in any way yet with enough depth to do anything on recalls,” Dr. David Acheson, the founder of consulting firm The Acheson Group and a former food safety official at the USDA and FDA, told Food Dive.
“FDA’s barely inspecting against it. They’re just starting. They’re going very slowly. They recognize people have got a lot of work to do to meet regulatory requirements, so they’re going very gently," he said. "And really, the initial inspections, from a FSMA-compliance perspective, are really just starting. And I think it’s more a matter of them pointing out to food companies where they’ve missed the mark, and they’ve got to tighten up. They’ve got to do some things… they’re not doing things right, their paperwork is not in compliance, but it’s certainly not leading to recalls. Not even close.”
Why wouldn’t there be a spike in recalls?
When looking at the recalls that have occurred since FSMA went into effect, it’s important to note that many of them were not caused by the types of problems that FSMA is intended to stop. Food products can be recalled for contamination from bacteria or pathogens, but there are other reasons as well.
“Recalls are not just for contamination by bacteria,” Sandra Eskin, director of food safety policy at the Pew Charitable Trusts, told Food Dive. “They’re for allergens, and that’s a huge part. …There are pieces of plastic or metal, or some other contaminant.”
Undeclared allergens — food products containing things like dairy, soy, nuts, peanuts, gluten and eggs that aren’t on the label — lead the list of reasons why food products are recalled. Food Safety News reported that roughly since the beginning of February, 43% of all FDA food recalls have been due to this sort of labeling issue. In terms of USDA recalls, there were more related to undeclared allergens than salmonella, E. coli and listeria combined last year. These problems occur through mislabeling or equipment-sharing issues, which FSMA was not designed to correct.
Plastic and metal contamination-related recalls would not see increased prevention through FSMA, either. These recalls often come from errors in the plant, sometimes with machinery and packaging equipment.
But there may yet be time for that spike to come, Joseph Levitt, a former director of FDA’s Center for Food Safety and Applied Nutrition and now a partner at law firm Hogan Lovells, told Food Dive. He said it will be difficult to notice trends for the next several years as everyone gets used to the new law and regulations.
"In terms of product recalls, it follows the principle that the more you look, the more you find. And FSMA has companies looking more, particularly manufacturers overseeing their suppliers."
Partner at Hogan Lovells and former director of FDA’s Center for Food Safety and Applied Nutrition
“In terms of product recalls, it follows the principle that the more you look, the more you find,” Levitt said. “And FSMA has companies looking more, particularly manufacturers overseeing their suppliers. As an example, the situations where you see what to the public looks like the largest recalls — because they affect a lot of products and a lot of brands — are based on a sole ingredient supplier.”
Problems deriving from single ingredients have caused recalls to snowball. These range from the largest and deadly Peanut Corporation of America contamination in 2009, which impacted hundreds of products and caused hundreds of illnesses and nine deaths, to last year’s General Mills flour recall, which impacted several baking products in the U.S. and other countries.
But some of these seemingly large recalls — such as a cheese recall that impacted hundreds of individual products, including several with the Sargento brand — have yet to cause a single illness. These products are pulled off the shelves as preventive measures.
While manufacturers are discovering these contamination issues themselves and taking quick action, Acheson said that it isn’t because of FSMA.
“That’s ongoing regulatory strategy,” Acheson said. “That’s something that’s been in place for a while. Certainly it’s ramping up, no question, there’s more of it going on, but it’s not being driven by FSMA, even though FSMA has requirements for environmental monitoring. That’s just good practice; it’s become a regulatory focus.”
Though recalls are costly, inconvenient and come at a heavy reputational cost for the manufacturer, today’s information-obsessed culture makes manufacturers pay more attention to the quality and safety of their food. Both science and consumer culture have been moving toward an age of better internal testing and tighter quality controls, Acheson said.
“Ten years ago, I think the primary driver was regulatory. … I think the fear was, ‘We don’t want to get on the wrong side of the regulators,’” Acheson said. “Now, today, when something goes wrong with your food, social media has got a great capacity to decapitate the brand.”
How will FSMA impact recalls in the long run?
FSMA was not really designed to change the number, size and frequency of recalls, according to Levitt.
“FSMA is about prevention. The whole idea is that companies will have stronger controls in their facilities,” he said. “So that number one, you shouldn’t have as much contamination, but when you do, companies will find it even before it gets to the food, or before that food gets out to the market.”
It takes all new laws a while to make the impact they were meant to, he said. FSMA itself took years to develop, perfect and ultimately get through Congress. It took several more years for the regulations that specify exactly how FSMA works to be written. Now, the law is slowly getting to the implementation phase — though, even then, it will take years before all manufacturers, farmers and importers are working under it.
Levitt said he believes there’s a learning — or implementation — curve for all involved. It will take time for manufacturers, farmers and importers to learn exactly how to work within FSMA. In five to 10 years, a look back at recall statistics might show a sharp increase in these first months under the law, he said, but there should be fewer FSMA-related problems in the future.
“Now, today, when something goes wrong with your food, social media has got a great capacity to decapitate the brand.”
Dr. David Acheson
Consultant and former FDA food safety official
Many of the recalls that have happened since enforcement began for FSMA’s preventive control regulations were caused by the same types of things that would have caused recalls a decade ago, Acheson said. Dirty equipment, leaky roofs and improper storage and transport have always been enough to trigger a recall.
FSMA’s success should not be based on recall numbers, he added. The law is driving a lot of changes throughout the food industry: Recalls show problems that are in the position to reach the public, but they don’t show the problems that were stopped before they became a recall.
Regardless of FSMA, the rise of genome sequencing might actually cause more recalls down the line, Acheson said. Scientists can now get a genetic profile of the bacteria that causes a foodborne illness. With that genetic data, they can easily connect it to other illnesses or other bacteria that might have been found in a facility — thereby creating a new layer of traceability.
“That’s nothing to do with FSMA. That’s just regulatory strategy leveraging modern molecular technologies,” Acheson said. “And we are seeing definitely seeing more of that — no question. And if I were to predict over the next five years, we will continue to see more and more and more of it.”
Pew Charitable Trusts' Eskin said she hopes that FSMA will cut down on the number of preventable recalls as time goes on.
“Theoretically, we should have a reduction in contamination, and that would mean a reduction in recalls and a reduction in illnesses,” she said.
Notwithstanding how much FSMA changes the industry, Levitt said that recalls should not be thought of as a negative thing that need to be eliminated entirely.
“While everybody wishes there were fewer recalls, recalls themselves are not bad,” Levitt said. “Recalls are a responsible reaction to a problem identified. There will always need to be recalls, and I think the most important thing to look for in a recall is, 'Does the company respond responsibly and quickly?'”