Series Description

The FDA Grand Rounds highlights cutting-edge research underway across the agency and its impact on protecting and advancing public health. Each session features an FDA scientist presenting on a key public health challenge and how FDA is applying science to its regulatory activities.

Lecture Description
Foodborne illness outbreaks receive considerable attention in the national news, involve multiple states, and cause many human illnesses that are often serious enough to involve hospitalizations and death. However, large outbreaks only represent a small fraction of the human illness cases each year.

Importantly, infants (<1 yr) account for about 1 in 7 reported cases of salmonellosis (~6,500 cases per year). We sought to learn more about these non-outbreak cases by analyzing the publicly available pathogen sequence database. The comparative analysis of hundreds of thousands of pathogen sequences used in this study yielded important clues related to the sources of contamination. While more than half of all infant illnesses were not members of clusters, over 80% of the clusters with infants also included older individuals. This implies most cases in infants (i.e. <=3 mos), who consume only breast milk and infant formula, occur because of cross-contamination from non-infant food or early feeding of complementary foods.

Most cases, regardless of age, were in small clusters (e.g. <= size 4). Despite this, they appear to be associated with contamination from central sites since most clusters had members from multiple states. Furthermore, over half the Salmonella cases were in clusters whose first and last reported case were separated by almost 3 years.

Finally, our results clearly demonstrate the value of interrogating very large genomic datasets for the purpose of understanding sporadic foodborne illnesses.

References

• Lipman DJ, Cherry JL, Strain E, Agarwala R, Musser SM. (in press). Genomic perspectives on foodborne illness, PNAS a. Preprint: Lipman DJ, Cherry JL, Strain E, Agarwala R, Musser SM. Genomic perspectives on foodborne illness. medRxiv [Preprint]. 2024 May 16:2024.05.16.24307425. doi: 10.1101/2024.05.16.24307425. PMID: 38903069; PMCID: PMC11188124.
• Jackson BR, Tarr C, Strain E, Jackson KA, Conrad A, Carleton H, Katz LS, Stroika S, Gould LH, Mody RK, Silk BJ, Beal J, Chen Y, Timme R, Doyle M, Fields A, Wise M, Tillman G, Defibaugh-Chavez S, Kucerova Z, Sabol A, Roache K, Trees E, Simmons M, Wasilenko J, Kubota K, Pouseele H, Klimke W, Besser J, Brown E, Allard M, Gerner-Smidt P. Implementation of Nationwide Real-time Whole-genome Sequencing to Enhance Listeriosis Outbreak Detection and Investigation. Clin Infect Dis. 2016 Aug 1;63(3):380-6. doi: 10.1093/cid/ciw242. Epub 2016 Apr 18. PMID: 27090985; PMCID: PMC4946012.
• Ebel ED, Williams MS, Cole D, Travis CC, Klontz KC, Golden NJ, Hoekstra RM. Comparing Characteristics of Sporadic and Outbreak-Associated Foodborne Illnesses, United States, 2004-2011. Emerg Infect Dis. 2016 Jul;22(7):1193-200. doi: 10.3201/eid2207.150833. PMID: 27314510; PMCID: PMC4918141

Series Objectives

• Discuss the research conducted at the FDA
• Explain how FDA science impacts public health

Learning Objectives After completion of this activity, the participant will be able to:

• Describe the age distribution of foodborne illnesses caused by the four pathogens: Campylobacter, Salmonella, Escherichia coli, and Listeria.
• Explain the evidence supporting the inference that the many small, independent contamination episodes are due to distribution from central sites as opposed to local sources.
• Evaluate which Salmonella serovars are best suited for reduction upstream of the consumer and why.

Target Audience
This activity is intended for physicians, pharmacists, nurses, and other scientists within the agency and external scientific communities.

Registration Information
Registration is complimentary; therefore refunds are not applicable. For information on how to register to attend this activity, please contact the Activity Coordinator(s) listed above.

Requirements for Receiving CE Credit

All learners claiming credit must attest to their attendance and complete all required activity evaluation(s) in the FDA CE Portal (ceportal.fda.gov) within 14 days after an activity ends. Upon completion, learners may view/print statement of credit.

Attention NABP Pharmacists and Pharmacy Technicians: The FDA CE Team will report your credit to the National Association of Boards of Pharmacy (NABP) provided you add your NABP ID and date of birth to your profile in the FDA CE Portal. The only official Statement of Credit is the one you pull from CPE Monitor®. If you do not see your credit reflected on CPE Monitor®* after 45 days of attestation, please contact FDACETeam@fda.hhs.gov.
*CPE Monitor® sets a strict 60-day limit on uploading credits.

Disclosure

Faculty

• Lipman, David, MD, Senior Science Advisor for Bioinformatics and Genomics, CFSAN/FDA - nothing to disclose

Planning Committee

• Dinatale, Miriam, DO, Team Leader, Food and Drug Administration - nothing to disclose
• Pfundt, Tiffany, PharmD, Program Coordinator, FDA/CDER/OTBB - nothing to disclose
• Shahidzadeh, Rokhsareh, RN, MSN, Senior Regulatory Health Education Specialist, FDA - nothing to disclose

CE Consultation and Accreditation Team

• Faberlle, Alexandra M., Training Specialist / FDA/CDER/OEP/DLOD - nothing to disclose
• Bryant, Traci, M.A.T., Lead Training Specialist, FDA/CDER/OEP/DLOD - nothing to disclose
• Wood, Sara, Accreditation Program Administrator, CECAT, FDA/CDER/OEP/DLOD - nothing to disclose