The U.S. Food and Drug Administration (FDA) is the federal agency tasked with, among other things, protecting food safety.
The agency does this through inspecting and regulating the facilities where food is produced.
But a new report from the Office of Inspector General for the Department of Health and Human Services identifies some red flags in the FDA’s inspection protocol.
The review points out that the FDA “consistently failed to conduct timely follow-up inspections” after a violation was first identified.
It also notes that the overall number of food facilities inspected by the FDA has decreased.
The criticism comes even as a new program intended to take a more proactive approach to food safety is rolled out.
The FDA’s Food Safety Modernization Act (FSMA), which is intended to prevent problems before they arise, is in the early stages of its implementation.
A widespread problem
Every year, 48 million people in the United States get sick with a foodborne illness.
Of this number, 128,000 people are hospitalized and 3,000 die.
For facilities that produce food, containing the risk of foodborne illness can be a serious challenge.
“Listeria is a very serious foodborne pathogen and is responsible for more deaths, percentage-wise, than just about any other pathogen,” Robert E. Brackett, PhD, professor of food science and nutrition at the Illinois Institute of Technology, told Healthline. “In terms of numbers, though, salmonella is a much greater hazard. There are millions of cases of that every year.”
Brackett points out that the risks vary depending on the type of food a facility is producing.
“If a facility is making, say, canned beans, the presence of listeria is not really going to constitute a hazard because the product is canned,” he said. “That said, the fact that there’s listeria there shows that they are not doing a great job in sanitation because it shouldn’t be there.”
One of the challenges involved in preventing listeria outbreaks is that the pathogen is an environmental contaminant.
That means it can come back into a facility from outside sources, even after the facility is thoroughly sanitized.
“It takes a lot of aggressive cleaning and sanitizing to keep listeria at bay, and the area where it’s going to be the most concern is with ready-to-eat foods like produce or cheeses. Those have been the main sources of illness for listeria,” said Brackett.
Early days for the program
The FSMA, signed into law in 2011, is designed to take a proactive, rather than a reactive, approach to the FDA’s food safety recommendations.
“It was a big change in the way that the FDA regulates food,” said Brackett. “In the past, and this is sort of by tradition as well as by statutory limits, it was very reactive. It would wait until something happened before they would actually go in and do something. What the FSMA did is it made things more preventive, and that’s the whole theme of that law and all of the regulations that came out of it.”
Brackett said one of the most notable changes the FSMA brings is the information that FDA inspectors will have access to.
“The number one tool is record access, which they never had before,” he said. “So they don’t have to pop into a facility. They can actually go through the company’s files and see if they have been doing things properly, and that’s going to be a very powerful tool for them.”
In addition to record access, the FSMA also expects companies to conduct a hazard analysis and produce a written food safety plan that identifies potential hazards in the foods they produce as well as a plan to prevent these hazards and thorough documentation.
“Now, inspectors can actually go in and look through these records, see if they have a food safety plan, see if they identified any hazards, and how they’re going to deal with it in the future,” said Brackett. “They’re on notice that it’s their job that their operations are using good manufacturing practices and standards of care that are expected of them.”
Different times for implementation
The fact that the FSMA has been on the books for six years doesn’t tell the whole story.
Compliance for food companies was staggered depending on their size, and the first compliance period, for larger companies, only went into effect in 2016.
This means that the full effects of the FSMA won’t likely become apparent for some time.
“They did the survey between 2010 and 2015 and the important point is that the law was not implemented for food companies until 2016,” said Brackett. “The FDA during that time was not sitting idle but doing what they call ‘educating while regulating.’ They were in the plants telling these companies what is going to be expected of them so they could give them information that would help them comply.”
The Office of Inspector General report notes that the FDA is on track to meet the time frames for the initial cycle of FSMA.
It also makes several recommendations, including calling on the FDA to improve how it allocates its resources, improve its timeliness, and conduct prompt follow-up inspections.
FDA officials agree with these recommendations.
Lauren Sucher, press officer for the agency, provided this statement to Healthline:
“The FDA Food Safety Modernization Act (FSMA), signed into law in 2011, changed our approach to food safety from one of reaction to one of prevention. To implement it, we are working as effectively and rapidly as possible, and our commitment to public health remains strong and unwavering. We agree with the Office of the Inspector General’s recommendations with respect to the conducting and follow-up of domestic inspections and we are working to implement these recommendations. The FDA recognizes the importance of its oversight of domestic food facilities, the need to ensure that resources are utilized in the most efficient way, and the importance of following up on public health concerns identified during inspections in a timely manner.”