Cronobacter, bacteria at heart of formula shortage, may become reportable pathogen

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The federal government may soon ask states to notify them when doctors or epidemiologists identify infections caused by a common bacteria that can cause severe illness in the very young and was at the center of last year’s baby formula crisis.

A working group convened by the Council of State and Territorial Epidemiologists, which advises the federal government on disease surveillance, is expected to recommend that the Centers for Disease Control and Prevention require states to track and report cases of Cronobacter sakazakii. As they do with salmonella and more than 100 other pathogens, state and local health departments would be required to notify documented cases to the CDC so the bacteria can be tracked nationally.

Food safety advocates have long called for the move, which would require a vote by state epidemiologists and approval by the CDC to become federal policy. But those calls intensified last year after four babies fell ill, two of whom died, from a bacterial infection after drinking powdered formula manufactured at an Abbott Nutrition plant in Michigan.

Abbott has denied that the bacteria came from its plant and investigators were not able to definitively identify the source of the bacteria. Still, the company recalled 5 million units of powdered formula and shuttered the plant for five months to address problems identified by the Food and Drug Administration, sparking a nationwide shortage that lingers still. Formula prices jumped in April to an all-time high, up nearly 9 percent from a year ago, according to Bureau of Labor Statistics data.

The fight to keep little-known bacteria out of powdered baby formula

Cronobacter infections are rare, and the vast majority of exposed children will never become ill. Since 2002, the CDC has received fewer than 80 reports of cases in infants, the agency said. This is probably an undercount, food safety experts say, because health-care providers aren’t required to report cases to the government, as they are with salmonella.

Last week in a blog post, FDA Commissioner Robert Califf said that while cronobacter infections seem very rare, it may be because only two states — Minnesota and Michigan — are currently required to report infections to public health departments.

The CSTE said last year it was not considering any formal proposals to make the bacteria reportable. After Congress and food safety advocates lambasted Abbott, the FDA and the CDC over their handling of last year’s outbreak, the CSTE is rethinking its position.

“Any time we have a large-scale national outbreak or a multi-jurisdictional outbreak, that is something that warrants additional review,” said CSTE executive director Janet Hamilton. “Every time we run into these kinds of scenarios it’s worthwhile to do a review. Public health surveillance evolves over time.”

In June, Hamilton said, the council will meet to review the proposal from a working group of epidemiologists, and will develop a position statement that will require a majority vote from the country’s 50 state epidemiologists, at which time it will go to the CDC for approval.

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Hamilton said if national notification is part of the recommendation and it received that majority vote from state epidemiologists, it would probably be instituted in January 2024.

“By the time we get to that point in the process,” she said, “it would be highly unusual for the recommendation not to be taken by the CDC.”

She had several caveats: The recommendation would not come with funding, so “we have to look at the realities around resources,” she said. And it might not immediately be added to states’ rules, with many states operating for a while under their current regulations.

But her biggest caution is about how this is only a partial solution to keeping babies safe from this bacteria.

“We need to educate individuals and parents about those children who are most high risk,” she said. “We want infections to be prevented. Our work happens after something tragic has already occurred. It doesn’t drive that education that is so needed for parents.”

Newborns, premature infants and immunocompromised babies are more at risk of becoming very sick from the bacteria, and it is more prevalent in powdered formula than in sterile liquid formula, facts that are sometimes insufficiently conveyed by doctors, nurses or formula manufacturers.

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“I am glad to see this is getting the attention it deserves,” said Kimberly Sisk, whose son Slade contracted spinal meningitis from cronobacter when he was 3 weeks old, a disease she said came from powdered infant formula. “Parents have a right to know what they are feeding their babies, so they can make choices and do everything possible to minimize the risk. I think if I had known about the risk of powdered infant formula, I would have fed him only liquid.”

Abbott Nutrition has previously expressed its support for the bacteria becoming nationally notifiable.

In a statement to The Washington Post last year, it said, “We support increased awareness around cronobacter as a notifiable disease.”

Scott Faber, a food safety expert with the Environmental Working Group, which has advocated for making cronobacter a reportable disease, likens the CSTE announcement to “waiting for the accident before we build the stop light.”

“Will this mean we are taking steps to reduce the risk of contamination? That is to be determined, but this is a step in the right direction,” he said.

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