In the news

The FDA and CDC, state and local partners, are investigating illnesses in a multistate outbreak of E. coli O157:H7 infections linked to organic walnuts from Gibson Farms, Inc. of Hollister, California that were distributed to multiple natural food and co-op stores in AK, AR, AZ, CA, CO, HI, ID, KS, LA, MT, NE, NM, NV, OR, SD, TX, UT, WA, and WY. Ten people were interviewed about the foods they ate the week before becoming ill. Of the ten interviewed, all 10 (100%) reported eating walnuts, and almost all reported buying organic walnuts from bulk bins in food co-ops or natural food stores. On April 27, 2024, Gibson Farms, Inc. initiated a voluntary recall and contacted their distributing customers. Distributors and retailers that may have received recalled bulk organic walnuts should follow the recommendations above and contact their customers. @ https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-e-coli-o157h7-bulk-organic-walnuts-april-2024?utm_medium=email&utm_source=govdelivery

The FDA reported that on 04/26/2024, Gibson Farms recalled Organic Light Halves and Pieces shelled walnuts because they received information that they could be contaminated with E. Coli 0157:H7. The Organic Light Halves and Pieces shelled walnuts were sold to distributors located in CA and WA. Gibsons Farms Organic Light Halves and Pieces shelled walnuts were sold in bulk boxes in Net Wt. 25 lbs quantities. Gibson Farms, Inc. has voluntarily recalled the product(s) after being notified by the CDC of 12 recorded illnesses allegedly linked to consuming organic halves and pieces of shelled walnuts. A full investigation is underway to determine the potential source of the contamination. The products may have been repacked from their original packaging or sold in bulk. @ https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/gibson-farms-voluntarily-recalls-organic-light-halves-and-pieces-shelled-walnuts-because-possible?utm_medium=email&utm_source=govdelivery

In Applied and Environmental Microbiology, scientists from Cornell University published an article on how weather affects key aspects of bacterial behavior on plants as a tool to assess the risk of crop contamination with human foodborne pathogens. A novel mechanistic model informed by weather factors and bacterial state was developed to predict population dynamics on leafy vegetables and tested against published data tracking Escherichia coli O157:H7 (EcO157) and Salmonella enterica populations on lettuce and cilantro plants. The model utilizes temperature, radiation, and dew point depression to characterize pathogen growth and decay rates. The model accurately predicted EcO157 and S. enterica population sizes on lettuce and cilantro leaves in the laboratory under various conditions of temperature, relative humidity, light intensity, and cycles of leaf wetness and dryness. In nearly all field trials, the model successfully predicted EcO157 population dynamics on 4-week-old romaine lettuce plants under variable weather conditions. Prediction of initial EcO157 population decay rates after inoculation of 6-week-old romaine plants in the same field study was better than that of long-term survival. @ https://journals.asm.org/doi/10.1128/aem.00700-23

On April 29, 2024, the FDA took action aimed at helping to ensure the safety and effectiveness of laboratory developed tests, or LDTs, which are used in a growing number of healthcare decisions and about which concerns have been raised for many years. The FDA announced a final rule today amending the FDA’s regulations to make explicit that IVDs are devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Historically, the FDA has generally exercised enforcement discretion for most LDTs, meaning that the agency has not enforced applicable requirements concerning most LDTs. Now, many LDTs are widely used for a larger and more diverse population, with large laboratories accepting specimens from across the country. The FDA is aware of numerous examples of potentially inaccurate, unsafe, ineffective, or poor quality IVDs offered as LDTs that caused or may have caused patient harm. “Today’s action is a critical step toward helping to ensure the safety and effectiveness of LDTs while also taking into account other public health considerations, including continued access to critical tests patients rely upon,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. @ https://www.fda.gov/news-events/press-announcements/fda-takes-action-aimed-helping-ensure-safety-and-effectiveness-laboratory-developed-tests?utm_medium=email&utm_source=govdelivery