Industrial and Regulatory Issues in Bacteriophage Applications in Food Production and Processing

This chapter’s main focus is on ‘‘direct food safety’’ applications for phages, i.e., using them to treat food processing facilities and directly adding them to foods prepared and packaged in them. Numerous factors may improve the speed with which phage-based preparations for improving food safety can be introduced into the marketplace and the degree to which they ultimately will be integrated into hazard analysis and critical control point programs by various food producers. Although phage-based preparations can, under certain conditions, be regulated as foodcontact substances, it is likely that most regulatory approvals for phage-based food safety products will be pursued as (i) direct food additives, (ii) "Generally Recognized as Safe" (GRAS), (iii) dietary supplements, and/or (iv) processing aids. The specific regulations for those four categories are briefly reviewed in the chapter. Food additives are further subdivided into two broad categories: (i) direct food additives and (ii) indirect food additives. Among various applications of bacteriophages, those developed for animal and human therapeutic uses were fairly common, and several large pharmaceutical companies produced commercial phage products for various phage therapy applications. The chapter briefly reviews various types of phage-related patents. Although the focus of this chapter is on food applications of bacteriophages, patents for all applications of bacteriophages are discussed in the chapter because often the same patented bacteriophage may be used to improve both food safety and human health.