The Food Safety Modernization Act (FSMA), signed into law 10 years ago, gave the US Food & Drug Administration new authority to prevent and respond to food safety issues. For the first time, the FDA could require comprehensive, science-based preventive controls that included requiring food manufacturers to document and implement these plans. Inspections, testing and records access were new tools FSMA put in the hands of the FDA to ensure oversight, and FDA was given the ability to issue mandatory recalls in the event a company fails to do so voluntarily.
Manufacturers faced other consequences as well, such as administrative detention for products potentially in violation of the law, suspension of facility registration, enhanced product tracing and additional record-keeping requirements for high-risk foods.
Lee Sanders, senior vice president, government relations and public affairs, American Bakers Association (ABA), explained the new approach: “What systems do you have in place to ensure that your product is always safe, that you have the right staff trained for those critical jobs and that protocols are always being followed so that you’re confident in the product that leaves the production facility?”
FSMA also gave the FDA authority to hold imported food to the same standard as domestic products and encouraged the agency to bolster its partnerships with other federal agencies and those at the state and local level. While the food industry experienced a culture shift as it implemented FSMA, FDA’s new focus on partnership required a similar shift in the agency as well.
“I think there’s been a concerted effort for FDA to be more open,” Sanders said of FSMA guidance. “While the nutrition staff at FDA was more accustomed to working with the industry, the food safety staff took more of a compliance approach. The FDA realized it needed to change that culture. … The agency has been open to listening and partnering with us, and having framework in place where we could do that as the whole food industry was critical.”
She’s referring to the Food and Beverage Issue Alliance (FBIA), which is a broad coalition of more than 50 US-based food and beverage trade associations that communicate regularly with federal agencies like FDA and the US Department of Agriculture regarding regulations and guidance.
“Early on as the FSMA rules came together, we saw the need to bring the food industry together as a whole to dialogue with the FDA to share the challenges we’re seeing and provide an opportunity to weigh in and share information,” said Rasma Zvaners, vice president, regulatory and technical services, ABA. “We may not always agree, but we’re more proactive getting in front of issues and asking questions. I look back, and if we hadn’t had that proactive conversation and structure in place, we wouldn’t have been able to be as nimble in responding to COVID-19 because we knew how to engage with the agency and have an open dialogue.”
When it comes to the details of FSMA — and there are many — a few themes emerged that have completely revamped the way the food industry, including the baking sector, thinks about food safety programs. One of the most significant is the emphasis on having preventative controls and documentation that the company is implementing those controls effectively. This forces companies to be proactive and significantly raises accountability, as well as the number of audits and inspections.
“FSMA made all companies of all sizes think about their food safety plans, their company’s internal workings and their team’s approach to food safety day-by-day,” Sanders said. “There are a lot of audits and inspections now, and bakers have to know how to manage those and make sure they’re covering those critical points. Being able to demonstrate to customers that they are doing the right thing every day has been a big driver in all of this.”
Audits and inspections aren’t new to the baking industry. Before FSMA, the industry largely followed standards set forth by the Global Food Safety Initiative (GFSI) and were audited by a third party to confirm those standards were being met.
“I don’t think the baking industry was shocked by what was coming from FSMA,” said Judi Lazaro, senior category director, food safety, AIB International. “They were surprised by the regulatory action that FDA would now show up and hold them accountable. The industry was previously used to only being held accountable by customers and consumers.”
In addition to GFSI audits, bakeries today undergo audits by individual customers as well as FDA inspections and, in many instances, AIB International inspections. The focus has changed too, Lazaro — who once was an inspector — pointed out.
“Now you can’t do business without an independent inspection,” she said. “And they have greatly evolved. When I was a food safety inspector, that meant 75%-80% of my time was on the production floor inspection, and 20% was spent looking at records and programs. Now we focus more on the programs and records and some time on the floor.”
Lazaro warns, however, that this emphasis on inspections and audits could backfire.
“I do think there comes a time where we have an audit overload that we are so worried about the audit that we lose sight of what we’re preparing for, which should be prioritizing food safety,” she said.
The other piece of FSMA that will come into play next is the focus on modernization and using the technology of today to take food safety to the next level.
“The FDA is looking at smarter food safety through its Smarter Food Safety initiative,” said Joe Stout, founder and general manager of Commercial Food Sanitation LLC. “In the age of iPhones, iPads and other computerization, it seems to me that we should be able to have a much brighter and connected food safety program in manufacturing plants. That includes pre-op inspections, recording them, tracking them. The technology has really helped us out on monitoring critical control points. You can see the information live on your desktop and know exactly what’s going on; lab results come in automatically, and all of this saves us time and money and helps us be more efficient.”