Food safety is a concern as old as food itself. In the United States, laws regarding food safety reach back more than 100 years. In 1906, the original Food and Drugs Act as well as the Meat Inspection Act were passed by Congress. 

Food safety regulations have evolved to reflect changing times, but major themes have remained the same: understanding the safety and nutrition of ingredients, preventing the adulteration of food, ensuring truthful communication to consumers, controlling allergens and foreign materials, and keeping food manufacturing facilities clean. All to keep the US food supply as safe as possible.

“We have the safest food supply in the world in the US at the most affordable cost,” said Joe Stout, founder and general manager of Commercial Food Sanitation LLC. “I think it’s a precious gift and industry that we have.”

While many of the themes of food safety have remained the same, new challenges have emerged. And to maintain the gift of a safe food supply, food safety practices must evolve to keep up. In the past 10 years, with the passage of the Food Safety Modernization Act (FSMA), the industry has seen a complete overhaul of the country’s approach to food safety. While the goal may be the same, the tools and approach are brand new. 

Getting proactive

While there have been many landmark shifts in food safety over the past century, the most significant one recently was the passage of FSMA in 2011. From the Food and Drug Administration (FDA)’s relationship with the industry to the companies’ approach to food safety, the importance of this law cannot be overstated.

“Nothing has positively impacted food safety in the baking industry like FSMA” said Judi Lazaro, senior category director, food safety, AIB International. “The impact has been tremendous. Even though FSMA didn’t go into effect as soon as it was signed into law, in a way it did because consumers and customers expected more from food manufacturers. … It’s the most sweeping change in 70 years.”

FSMA was passed in response to several significant food safety events shook the public’s confidence in the US food supply, most notably a 2008 Salmonella outbreak traced to a Georgia factory operated by the Peanut Corp. of America. The outbreak resulted in 700 cases of Salmonella poisoning and nine deaths. The former chief executive officer of the company was sentenced to 28 years in prison, the harshest sentence handed down for someone responsible for a foodborne illness outbreak.

This incident signaled to both government agencies and the food industry that a systemic shift in how the industry approached food safety was needed. Rather than reacting to incidents, the food industry needed to be more proactive in preventing them. FSMA was designed to provide guidance and tools to ensure that happened.

“FSMA was the catalyst for the change, the enhancements, the additions,” explained Lee Sanders, senior vice president, government relations and public affairs, American Bakers Association (ABA). “FDA changed their inspection focus from a snapshot-in-time to a system that is always in place. That’s a completely different approach.” 

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.

Sanders 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.” 

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,” Stout said. “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.”