PA21-259, PHS 2021-2 Omnibus Solicitation of the NIH, CDC and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical

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Project Summary Our proposed effort addresses foodborne illness caused by pathogenic bacteria surviving inadequate sanitization processes. Fresh sprouts are a known vehicle of foodborne illness due to industry reliance on an insufficient process for disinfecting sprout seeds. The FDA acknowledges their recommended chlorine-based (Cl) treatment inadequately eliminates bacterial pathogens4 and welcomes the development of new treatments.5 The objective of this SBIR is to develop and commercialize a novel organic sprout seed sanitizer based on an AEMS Corp. proprietary technology called an Agent Delivery Matrix (ADM). Our sanitizing ADM are intentionally composed entirely of Generally Recognized As Safe (GRAS) ingredients in order to be amenable with fast-track FDA approval and to ensure food, worker, and environmental safety. Adoption of our sanitizing ADM could foster a new era of environmentally friendly organic sprout production that lowers the incidence of sprout-related foodborne illness, saves the grower time and money, enhances worker safety, and promotes the health-food benefits of sprouts desired by consumers and producers. We will demonstrate our treatment can be an effective replacement of Cl treatment through two primary Aims. During Aim 1, we will validate ADM as an effective new approach to deliver GRAS sanitizers capable of killing Escherichia coli. We will use a clinical isolate of the pathogenic E. coli O157:H7 throughout Phase I instead of a surrogate bacterium to realistically validate the efficacy of our treatment. Combinatorial screens will yield a library of sanitizing ADM materials for sprout seed sanitization. The most effective ADM will be studied in Aim 2 to sanitize sprout seeds in simulated industrial growing conditions at UC Davis. Since nearly all cases of sprout- related foodborne illness originate from infected seed that is improperly sanitized, we will exercise a real-life scenario for sprouting after intentionally infecting alfalfa seeds with E. coli O157:H7 to test for sanitation efficacy. We will also evaluate germination rate and sprout yield to evaluate our treatment’s effects on sprout quality. Aim 2 imposes realistic conditions to accurately reflect industrial production of sprouts to facilitate adoption of our technology and garner commercial interest. Inadequate sanitization of sprout seeds will continue to jeopardize the safety and security of the food supply until a new treatment is adopted. Successful completion of this SBIR Phase I project will lead to a new way to produce sprouts safer for human consumption. Extension of ADM technology to other seed coatings and food processing facility surfaces will improve the safety of other food products. Future research and development will extend the ADM platform to other applications in human health and food safety. Funding will ensure the safety of food and promote the integrity of the food supply by reducing the incidence of foodborne illness.