Donna Schaffner was a food safety veteran when she got the call from Washington. A food microbiologist by trade, she had spent about two decades as a consultant for food manufacturers, helping dozens of them navigate best practices to make their food safe for public consumption.
Not every company had a Donna. A 2008 salmonella outbreak caused by Atlanta-based Peanut Corporation of America killed nine people and sickened 714 others, some critically, across almost every state in the union, and the recall that ensued affected 3,913 products from over 300 companies.
The outbreak was no accident — Stewart Parnell, PCA’s chief executive, was sentenced to 28 years in prison for knowingly allowing tainted products to go to market. In response to what was then the most extensive recall in U.S. history, President Barack Obama signed the Food Safety Modernization Act in 2011, which required all food manufacturers to be proactive instead of reactive about food safety.
“You can’t inspect safety into something,” Schaffner said. “[With FSMA], the onus is on the food processor to make the food safely. If they’re not, [the FDA] can shut them down. They can take away their registration to stop them from producing food, they can make them recall food if they feel like it was made unsafely, they can fine them and, in some cases, people can go to jail.”
Schaffner’s extensive consulting experience led the FDA to contact her directly, putting her in the alliance that created one of the FSMA’s eight cardinal rules: Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food. The rule requires that every company that makes FDA-inspected food products — other than seafood and juice, which are subject to a different certification — has a qualified individual on site in charge of writing and adhering to a food safety plan.
Today, Schaffner trains hundreds of people a year on preventive controls and other rules through the Rutgers Food Innovation Center, where she is the associate director of food safety, quality assurance, and training. She’s one of 21 people in the world with a top-tier certification to train on preventive controls, meaning she can train those who train others—and she’s trained more people on the rule than anyone else.
Most of the FSMA’s eight rules are fully rolled out. In addition to the preventive controls for human food rule, there’s one for animal food. Other regulations set requirements for the sanitary transportation of food, standards for growing and harvesting produce, standards for importers and foreign suppliers, and mitigation strategies to protect against intentional adulteration.
At the FIC, Schaffner and her team certify individuals in foreign supplier verification in addition to preventive controls.
“The food or the ingredients that you import are supposed to be just as safe as if they were made in the U.S., so you have to have a qualified individual that’s checking all that paperwork and making sure that those things are being done for your foreign supplier,” she explained.
Before the foreign supplier verification rule went into effect two years ago, the importers shouldered minimal responsibility for the safety of the food coming into the country. Now, if they can’t prove that they followed safety protocols, the shipment could be rejected, and the importer could lose its ability to ship to the U.S.
Eva Rodriguez Szewczyk, who started teaching FSMA courses at the FIC last year, spent part of her 30-year food safety career working for an importer when that rule didn’t exist.
“It was always something that was missing in my opinion,” she said. “Importers brought food from outside the United States and directly passed it to the clients, but there was no real, ‘stop here, let me check it out.’”
Rodriguez Szewczyk’s employer allowed her to create a system to check the importer’s paperwork to ensure it was emphasizing food safety and quality control.
“We did it because I felt bad passing product and not being responsible for food safety,” she said. “Now it’s required. This is a good law.”
Soon, the FIC will also certify individuals on mitigating the intentional adulteration of food, though that rule hasn’t been finalized.
And now, thanks to Rodriguez Szewczyk, the certifications offered by the FIC are more accessible than ever: the former director of food quality and safety for Johanna Foods teaches FSMA courses in Spanish.
As of May 1, the USDA website listed 58 current recalls. The FDA, which lists non-meat recalls, had even more, including multiple recalls from the past month: Chips Ahoy Chewy Cookies, recalled for an unapproved ingredient; and various brands of cut fruit due to salmonella.
What caused all the recalls? In a word, scrutiny. Schaffner said food manufacturers are paying greater attention to what they’re putting out.
“You only find what you look for — or you only find what you test for,” she said. “With FSMA regulations, companies are looking much closer at what they’re doing, and so of course they find more things that before got out to the public.”
The Centers for Disease Control and Prevention estimates that each year 48 million Americans, or one in every six, falls ill with a foodborne illness. Of those, 128,000 are hospitalized and 3,000 die.
Multiple outbreaks have hospitalized people in 2019, including a listeria outbreak linked to deli meats and cheeses that spanned four states and has killed one person in Michigan; and an E.coli outbreak linked to ground beef with no deaths but 117 reported cases across 10 states.
So with FSMA established, why are there still outbreaks?
“That’s the million-dollar question, right? That remains to be seen. We haven’t seen the data from the FDA comparing the number of outbreaks after FSMA and before FSMA,” said Rodriguez Szewczyk.
“We’re still training a lot of people that are beginning to understand FSMA and put it in effect at their companies. So I think we are in the early stages, but I do hope that in five years, we have less recalls and less outbreaks.”