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Salmonellae continue to be one of the leading causes of foodborne disease worldwide. According to the FSIS USDA, ca. 75% of the annual cases of human salmonellosis are due to the consumption of contaminated poultry, beef, and egg products. In an effort to increase the safety of poultry products, the USDA recently (May 14, 2010) issued "New performance standards for Salmonella and Campylobacter in young chicken and turkey slaughter establishments: new compliance guides," which further limited the allowable Salmonella levels in young chickens and in post-chilled, young turkey carcasses. <P> These initiatives, when fully implemented, will have a positive impact on the safety of poultry products; however, their successful implementation depends, in part, on the availability of tools to manage and limit Salmonella levels in poultry. Thus, there is a clear and urgent need for new products and approaches that can be used as part of an overall program for Salmonella control. <P>Any such products should be effective, cheap, safe, environmentally friendly, and easy to use - and there would also be potential advantages for products that target specific Salmonella serotypes; e.g., serotypes predominantly associated with human illness. We believe that a bacteriophage-based preparation may be one such modality. Intralytix previously developed and is currently marketing a phage-based product (ListShield) for eliminating or significantly reducing contamination of foods with Listeria monocytogenes, another deadly foodborne bacterial pathogen. <P>Therefore, we now propose to develop a similar bacteriophage-based preparation/cocktail (designated "SalmoShield"), which can be used to help eliminate or significantly reduce contamination of poultry foods and, eventually, other foods with Salmonella.<P> Our proposed Phase I project has two specific aims. First, perform studies required to identify the appropriate lytic phages for inclusion in SalmoShield, and formulate a preliminary version of the candidate cocktail. Second, perform pilot efficacy studies to determine the optimal treatment regimen for using SalmoShield to reduce Salmonella loads on raw poultry meats and poultry RTFs.<P> After the studies proposed in this Phase I application are successfully completed, we will be in a strong position to move forward with additional Phase II studies and regulatory approvals of SalmoShield, and subsequent product commercialization. The SalmoShield preparation, and the technology described in this proposal, have a potential to help significantly reduce Salmonella contamination of poultry, and, therefore, to have a significant impact on improving food safety/public health, and on reducing the cost of manufacturing and buying poultry products.<P> In addition, the results obtained during the studies proposed in this Phase I SBIR application can play a critical role in further developing a bacteriophage-based platform technology for the development of a new class of safe and environmentally-friendly, "green" products for preventing and treating diseases caused by other foodborne bacterial pathogens.
NON-TECHNICAL SUMMARY: <BR> Our project envisions developing a bacteriophage-based product, designated SalmoShield, for eliminating or significantly reducing contamination of poultry products (and eventually other foods) with Salmonella. Salmonellae continue to be one of the leading causes of foodborne disease worldwide, causing 1.3-1.4 million cases of salmonellosis annually in the USA, with associated costs estimated to be as high as $12.8 billion/year (in 1998 dollars). According to the Food Safety and Inspection Service (FSIS) of the US Department of Agriculture (USDA), ca. 75% of the annual cases of human salmonellosis are due to the consumption of contaminated poultry, beef, and egg product. In the absence of a definitive means of eradicating the bacteria, the USDA articulated the concept of Salmonella control through a "multiple hurdle" approach, which encourages implementation of procedures to reduce the risk of contamination during slaughter, while at the same time seeking to limit contamination of broiler flocks and the final food products. Under these circumstances, there is a clear need and market for products and approaches that can be used as part of an overall program of Salmonella control. Any such product should be effective, cheap, safe, environmentally-friendly, and easy to use - and there would also be potential advantages for products that target specific Salmonella serotypes; e.g., serotypes predominantly associated with human illness. Bacteriophage-based preparations may be one such modality. Indeed, lytic bacteriophages possess strong bactericidal activity against their specific bacterial hosts; thus, they have the potential to eliminate or significantly reduce the levels of their targeted bacteria in various food safety-relevant settings. The SalmoShield preparation, and the technology described in this proposal, have a potential to help significantly reduce Salmonella contamination of poultry, and, therefore, to have a significant impact on improving food safety/public health, and on reducing the cost of manufacturing and buying poultry products.
<P> APPROACH: <BR> Our ultimate goal is to develop a commercial product (tentatively designated SalmoShield) that can be applied directly onto the surfaces of raw chicken (or other poultry) carcasses or RTF poultry products to eliminate or reduce their contamination with Salmonella. Subsequently, we will link this product with a service component which will monitor product efficacy (including factors such as the development of resistance to specific phages), optimize and customize phage administration, and assist producers in their overall efforts to control Salmonella contamination. Intralytix has extensive, and in many ways unique, experience in developing phage-based products for food safety applications, and we believe that this experience can be instrumental in our commercializing SalmoShield - the product we propose to develop with support from the USDA's SBIR program. Salmonella contamination of poultry is a complex phenomenon that involves various stages of poultry processing from eggs, through slaughter, to post-chill processing and packaging of chicken carcasses. While bacteriophage application can be effective/contemplated in various stages of that cycle, we believe that the most effective and commercially viable approach is to use bacteriophages in the post-harvest environment, specifically by direct application of phages on (i) raw chicken carcasses after post-chill processing and before the carcasses are packaged, and (ii) on final food products, including RTFs. Correspondingly, our regulatory approval strategy would be to have SalmoShield approved as generally-recognized-as-safe (GRAS), for direct applications on post-processed poultry products, including RTFs. Our goal would be to pursue additional studies required for assembling a GRAS application/notification package for the FDA during our Phase II SBIR project, after the studies proposed in this Phase I SBIR project are successfully completed. The FDA typically issues a GRAS "no-objection" letter within 180 days after they receive a GRAS application. Thus, the overall timeframe for this project, from Phase I through Phase II and to commercialization is potentially very short - an excellent outcome for a SBIR application whose ultimate goal is to help rapidly to commercialize promising technologies. The studies proposed in this Phase I SBIR application are well focused and realistic, the necessary experience is in place, and we, therefore, fully anticipate successfully completing them in the timeframe allocated to the project. The Work Plan contains more detailed descriptions of the studies we will undertake during the current Phase I project. We will proceed by addressing the following two specific aims: Specific Aim #1. Perform studies required to identify phages for inclusion in SalmoShield, and formulate a preliminary version of the candidate phage cocktail. Specific Aim #2. Perform pilot efficacy studies to determine the optimal treatment regimen for using SalmoShield to reduce Salmonella loads on chicken carcasses and poultry RTFs.