SBIR-STTR Award

In 2011, the CDC estimated that in the U.S. alone 3,000 deaths are caused each year due to foodborne illness. The cost to treat food poisoning comes to $14 billion a year, according to a July 2012 study published in the Journal of Food Protection, including the medical expenses of the 128,000 who are hospitalized annually. The total cost to the U.S. economy is estimated to exceed $70 billion annually. One key to reducing foodborne illnesses is proper sanitation and subsequent verification in food processing operations. Without effective methods in place, microbiological contamination can result in food spoilage, reduction in shelf life and food quality, and foodborne illnesses. Existing sanitation verification methods have significant challenges that impede their effectiveness and create an opportunity for a novel approach. Advances in bioengineering have produced a material that enables the development of a highly efficient, effective, and low-cost sanitation verification method. This material is DNATrax, a biological tracer developed at Lawrence Livermore National Laboratory and exclusively licensed for all fields of use to SafeTraces. DNATrax offers an opportunity to verify sanitation in food processing plants by using the product as a pathogen surrogate during the sanitation process. These surrogates are short DNA sequences, encapsulated in food safe materials of different properties that under sanitation conditions behave in ways that correlate well to the behaviors of their corresponding target pathogens. They will be applied before the sanitation process and if found after sanitation, serve as indicator that sanitation was not performed properly. Detected within minutes, DNATrax based surrogates will allow for accurate sanitation verification more quickly than previously possible, enabling timely sanitation intervention. DNATrax is a safe and versatile material already recognized by the Food and Drug Administration as a Generally Recognized As Safe (GRAS) food additive. This project aims to establish the feasibility of developing a DNATrax-based method to rapidly and effectively verify whether sanitation in food processing operations has been executed according to governmental standards. Specifically this will entail: (a) the development of DNATrax as a single surrogate for a target pathogen; (b) the laboratory evaluation of the surrogate and benchmarking against the target pathogen; and (c) the development of a LAMP assay for fast, low-cost detection of pathogen surrogates in collaboration with Diagenetix. In addition, the project aims to establish that from a cost perspective, DNATrax will be a viable technology for different sectors of the food industry, including small businesses.

Public Health Relevance Statement:


Public Health Relevance:
Food Safe Pathogen Surrogates for Rapid Verification of Sanitation in Food Processing. Food-related emergencies cause approximately 3,000 deaths in the USA each year, and their impact can be significantly mitigated with the improved ability to verify sanitation in food-processing operations. Existing sanitation verification methods are not always accurate and may require days to produce results. We propose the development food safe pathogen surrogates and a detection method, which will allow effective, low-cost sanitation verification for food processing facilities in a few minutes with very high level of confidence.

Project Terms:
No Project Terms available.

Food safety is a major issue with global impact. The CDC estimates that in the U.S. alone, 3,000 deaths are caused each year due to foodborne illnesses. It is estimated that a total of 76 million food-related illness cases occurred in 2013, with the U.S. spending $40 billion on treatment rather than prevention (Food Quality and Safety Magazine, 2015). Even though foodborne illnesses are often attributed to meat, dairy, and seafood, outbreaks due to contaminated produce have been on the rise (Harris et al., 2003; Lynch et al., 2009; Callejòn et al., 2015). Fresh fruits and vegetables are mostly grown outdoors, leaving them susceptible to potential environmental contamination. Washing is the primary method employed by processors to ensure the safety of the produce they supply. However, washing is not always effective in removing microbial contaminants (decontamination). If the wash system is improperly managed, cross contamination can covert a small contamination event into an outbreak event. SafeTraces is proposing the development of SafeTracers™, a reliable, repeatable, continuous, fast, on-site test performed on finished product, to ensure appropriate washing by assessing decontamination and risk of cross-contamination of fresh produce. SafeTracers™ are edible (Generally Recognized As Safe) microparticles, tagged with non-living, non-viable DNA, that behave like pathogens under wash conditions. They will enable validation, verification, and continuous monitoring of decontamination and cross-contamination in wash systems. SafeTracers™ will be easily retrofitted on any wash system, and will be robust and simple to operate. During Phase II, we will compare SafeTracers™ to prominent pathogens for their attachment, detachment, transfer, and inactivation on abiotic (glass and stainless steel) and on produce (spinach) surfaces. We will develop a simple workflow to sample finished product, measure SafeTracers™ levels, and assess the effectiveness of the wash process, all in less than 30 minutes. Furthermore, we will develop a SafeTracers™-based method to assess the risk of E. coli cross contamination for leafy produce commodities in both one-pass and flume wash systems using chlorinated water wash. Finally, we will complete validation studies for the two SafeTracers™-based methods aimed at assessing the risks for insufficient decontamination and cross contamination in wash systems operating under validated conditions and processing leafy greens.

Public Health Relevance Statement:
Food Safe Pathogen Surrogates for Rapid Verification of Sanitation in Food Processing Phase II Project Narrative Foodborne illnesses result in nearly 3,000 deaths every year in the US, and their impact can be significantly mitigated with the improved ability to validate, verify and monitor sanitation in food- processing operations. We propose to develop SafeTracers™, a reliable, repeatable, continuous, fast, on-site test performed on finished product, to ensure appropriate washing by assessing decontamination and risk of cross contamination of fresh produce. SafeTracers™ can be easily retrofitted on any wash system, and are robust and easy to operate.

Project Terms:
No Project Terms available.