This column was first published by Q/A and is reprinted here with permission of the author and Q/A.

By Mitzi Baum

At Stop Foodborne Illness (STOP), we are dedicated to creating effective food safety policy and educating consumers to further protect themselves from risk of foodborne illness. With nearly three decades of professional food safety industry experience, I’ve learned that the path to success isn’t measured in miles, it’s measured in inches. In June, we moved our mission a few inches forward as the Centers for Disease Control and Prevention (CDC) announced that Cronobacter spp will be added to its list of 2024 reportable diseases.

Cronobacter, including C. sakazakii, is not a new concern in the infant formula industry, as it is ubiquitous in the formula production environment. Always labeled as a “rare” occurrence, Cronobacter is a pathogen that when ingested by infants can lead to death. More concerning is that due to the preparation methods of infant formula, there is no “kill” step for the pathogen at home (i.e. boiling water). This means that if a container of formula is contaminated with Cronobacter, there is little a consumer can do to safeguard against it.

Until the CDC’s reportable decision, manufacturers and suppliers of infant formula were not required to disclose positive Cronobacter cases to the Food and Drug Administration (FDA), CDC or even the Departments of Health in their states. This has resulted in ambiguous data on the pathogen, including how it develops and just how widespread it is in facilities. In the search for sakazakii, it has been an unclear journey.

While we are encouraged to see Cronobacter added to the reportable disease list, the work is just getting started. It’s important to note that there is no way to have zero risk of Cronobacter while continuing to manufacture and supply infant baby formula at necessary volumes to nourish our newborns. The focus shouldn’t be on elimination, but rather on risk-based prevention and education.

As we look towards a future of safeguarding our children, the below steps are necessary to continue moving forward:

  1. Augmented diagnostics to predict and prevent contamination. The best way to reduce the risk of Cronobacter is through ongoing testing and source tracking of contamination, including raw material, environmental and production monitoring. In the FDA’s recent call-to-action for Cronobacter, it specifically mentioned frequent environmental monitoring as a way to identify contamination in the facility before Cronobacter can proliferate in raw materials. We’re optimistic about the cutting-edge detection tools that are now available to provide enhanced insight into quality control programs to minimize the risk of Cronobacter. Besides the detection tools, when identifying a testing partner, look for an organization that has an end-to-end portfolio of solutions that utilizes the latest science and aligns with the FDA’s recent call-to-action for Cronobacter. The right partner will also be knowledgeable in the wider food safety landscape and can guide you to implement — or enhance — your diagnostic testing plan, as well as analyze data to determine gaps in your processes. While the routine testing using high-quality detection tests is needed to ensure the production of safe infant baby formula, there is also a need to incorporate Cronobacter in the list of routinely surveilled food-borne pathogens such as Salmonella, E. coli (STEC), Listeria and Campylobacter through the PULSENET program. The resulting data from such a surveillance program cannot only monitor and flag any emerging outbreaks, but the genomes generated through the program can be a valuable resource in designing next-generation detection and source-tracking tools.
  2. Consumer education and awareness. An educated consumer is the best consumer, as increased knowledge allows them the opportunity to advocate for themselves and their families. That includes educating medical professions (from NICU to nurses), parents and the general public. Consumers play a role in their own safety, and they can only take part through greater education and awareness of the risks out there.  It takes the industry as a whole to fund and disseminate education campaigns to medical professionals and consumers.
  3. Establishing a unique International Classification of Diseases (ICD) code for C. sakazakii. Making Cronobacter a reportable disease means that, for the first time, there will be Cronobacter data available to unlock a deeper understanding of the pathogen, its causes and ways to enhance prevention of the colony-forming units. While this is a step in the right direction, we encourage the CDC to establish a unique ICD code to further distinguish C. sakazakii  from the group of pathogens it is currently grouped with to provide detailed surveillance data.                            

As someone who has spoken directly with families impacted by foodborne illnesses, some with devastating consequences, I believe we must continue to advocate for our most vulnerable population who are unable to advocate for themselves. In the formula industry, those who make safe products will continue to exist, while those that don’t will become extinct. To strengthen our formula supply chain, the industry must look at cutting-edge science and innovative methods to modernize its tools and processes to solve the problem of Cronobacter and maximize successful distribution of safe products. 

Mitzi Baum

About the author: Mitzi Baum joined the team at Stop Foodborne Illness (STOP) as Chief Executive Officer in May 2019. Prior to her tenure at STOP, Baum cultivated a 23-year career at Feeding America, rising to the senior level position of managing director of food safety. Baum earned a Master of Science in Food Safety and a certificate in Food Law from Michigan State University. She received her Bachelor of Science degree from Bowling Green State University and has obtained certificates in Non-Profit Management from the University of Chicago, Quality Management from DePaul University, and Food Safety Management from Cornell University. She is the 2021 Joseph Leiter Lecturer of the Medical Library Association and National Library of Medicine, an adjunct instructor for Michigan State University’s Online Food Safety Program, a certified seafood HACCP instructor, a certified PCQI, a member of the National Restaurant Association’s Food Safety Advisory Council and a board member of the American National Standards Institute. 

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