By Brian Ronholm, Director of Food Policy for Consumer Reports, and
Michael Hansen, Senior Scientist for Consumer Reports
For decades, the FDA has upheld a strict “zero tolerance” policy for Listeria monocytogenes — a dangerous bacteria that poses a severe health threat primarily to pregnant individuals, newborns, older adults, and immunocompromised people. It can lead to severe invasive infections, hospitalizations, miscarriages, or death.
However, at a recent public meeting, the FDA signaled it might consider a shift away from this zero tolerance standard. The agency has been subject to growing pressure from some industry voices and scientists to adopt a “risk-based” approach, similar to what is currently practiced in Canada and the European Union. This approach argues that, because some food products naturally contain low, “low-risk” levels of Listeria, it should eliminate the need for the zero-tolerance policy and allow for a focus on management rather than total prevention.
While the concept of “risk-based” management may sound scholarly and refined, applying it to Listeria policy represents a dangerous gamble with public health. The risk is underscored by the evidence, which demonstrates that the zero-tolerance policy protects consumers and abandoning this policy could increase the risk of foodborne illness.
Higher rates abroad
If we look at the actual rates of listeriosis — the infection caused by this bacteria — the numbers show that the U.S. approach is vastly more effective than the international alternatives. In the European Union, the rate of listeriosis is nearly three times higher than it is in the U.S. In Canada, the rate is nearly double.
According to FoodNet data covering 2020 to 2023, the U.S. listeriosis incidence rate stood at 0.25 cases per 100,000 person-years (PY). Earlier figures from the CDC’s Listeria Initiative estimated the 2019 U.S. rate at 0.24 cases per 100,000—representing approximately 792 cases across a population of 328.3 million.
In comparison, international surveillance metrics from 2023 reflect markedly higher rates:
- European Union: Data from the European Centre for Disease Prevention and Control indicates a rate of 0.67 cases per 100,000 PY, which is 2.8 times higher than the U.S. rate.
- Canada: National reported surveillance estimated 0.45 cases per 100,000 PY, making Canada’s rate 1.9 times higher than that of the U.S.
The zero tolerance advantage
Despite arguments that a zero-tolerance policy discourages testing for fear of finding the bacteria, such that Listeria levels would gradually increase over time due to reduced testing, recent trends show the exact opposite. Research suggests that exposure to Listeria in the U.S. actually dropped by 16 percent between 2008 and 2023.
We know that certain groups — including pregnant individuals, newborns, older adults, and those with weakened immune systems — are most at risk from Listeria. What’s striking, however, is that despite an aging population and demographic shifts that should have logically led to higher infection rates, the U.S. has maintained a stable, lower rate of listeriosis.
A study from the August 2026 issue of Open Forum Infectious Diseases offers a key insight into why: While demographic changes suggested we should be seeing more cases, we haven’t. The researchers concluded that this stability is likely because our exposure to Listeria appears to have actually decreased by roughly 16 percent since 2008. This suggests that the current safety framework is working effectively to protect even our most vulnerable populations.
Why risk it?
The argument for a “risk-based” approach rests on the idea that companies are afraid to test for Listeria because finding it carries legal and financial burdens. Critics suggest that if we were more lenient, companies would be more transparent.
But we shouldn’t be forced to choose between transparent testing and food safety. The fact that Listeria exposure appears to be on the decline in the U.S. suggests that food companies are already effectively managing their safety protocols under the current zero-tolerance framework.
If the current FDA zero-tolerance policy is producing lower rates of illness compared to the policies in Canada and the EU, why would we want to move toward their model? The FDA has a responsibility to protect consumers, and that starts with maintaining the zero-tolerance policy. When it comes to the safety of our food supply, we shouldn’t settle for “low risk.” We should continue to strive for no risk at all.
During a summer when the public already feels the food safety regulatory system is broken, the FDA must avoid dismantling an approach that actually doesn’t need fixing.
About the author: Before joining Consumer Reports, Brian Ronholm was the deputy under secretary for food safety at USDA, where he ran the agency that inspects meat, poultry and processed eggs.
