Will probiotics and prebiotics for animals sell at Wal-Mart? Science vs reality. Probiotics and Prebiotics in Animal Feeds

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1 Will probiotics and prebiotics for animals sell at Wal-Mart? Science vs reality Probiotics and Prebiotics in Animal Feeds Applications and Market Potentials Alternatives to Antibiotic Growth Promoters Genetically Modified Microorganisms Regulatory issues

2 Why are probiotics and prebiotics added to animal diets? Protection of animals and humans Reduce pathogens Immunomodulation and disease resistance Improve digestibility ensilage Stabilize GI microbiota Reduce undesirable substances bioremediation

3 What is the potential demand? Production animals Food: e.g., chickens, pigs, cattle, aquaculture Other: e.g., mink >4,000 mill. metric tons of feed in 2002 >650 mill. metric tons as milled products Companion animals Small: e.g., dogs, cats, guinea pigs Large: e.g., horses >20 mill. metric tons for Probiotics and Prebiotics: Alternatives for Antibiotic Growth Promoters Critical Questions: Why are AGPs effective? Are Probiotics and Prebiotics suitable alternatives for AGPs? How to enhance the efficacy of Probiotics and Prebiotics as alternatives to AGPs? What are the costs relative to the benefits?

4 Mechanisms of AGP action Protection of nutrients from bacteria Improvement of mucosal characteristics Decreased production of bacterial toxins Reduced incidence of sub-clinical infection Costly immune functions are diminished Probiotics vs AGPs Growth of Broiler Chickens Lasolocid: anticoccidial Bacitracin: AGP YCR: Yeast Culture Residue Chickens were infected with 3 species of Eimeria Stanley et al., 2004; Poultry Sci. 83

5 ProbioticsvsAGPs Growth Performance of Broilers PrebioticsvsAGP Swine data

6 Selling Probiotics and Prebiotics as alternatives to antibiotics Enhance the efficacy of probiotics and prebiotics Incorporate integrated approach Natural antimicrobials Immunomodulators Convince producers/pet owners/regulatory agencies of efficacy and safety Genetically Modified Probiotics The good Potential for improvements in efficacy Additional applications Industrial production of metabolites The concerns Transfer of antibiotic resistance Release of bacteria delivering therapeutics

7 Benefits of GM Probiotics 1. Engineering probiotics to provide disease resistance Molecular mimickry 2. Delivery of therapeutics IL-10 and Trefoil factors for treatment of IBD 3. Delivery of enzymes degradation of NDO Regulatory Issues-Safety From EC; Directive 1831 (2003) Questions of Concern Is proposed use safe for animals? Can use lead to antibiotic resistance? Acquisition or transfer Do products include GMM? Does use present risks to consumers? Does use present risks to the environment? Are proposed conditions of use acceptable? Conclusion: Some Bacillus and Enterococcus strains may be problematic

8 Regulatory terms (U.S. perspective): Intended use determines regulatory status Dietary supplement: product taken by mouth that contains a dietary ingredient intended to supplement the diet no pre-market review for human applications, animals yes Biological product: an organism applicable to the prevention, treatment, or cure of a disease of condition require pre-market review Drug: article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease Probiotics used to prevent or treat diseases are considered as drugs and biological products Regulatory Concerns & Issues Inconsistent use or misuse of terms (e.g. probiotic, biological product, GRAS) Inadequate production controls Inadequate evaluation of efficacy and safety A lack of internationally recognized regulations and standards

9 Addressing Adversity How to react to negative reports? Prebiotics cause laminitis in horses and cows Milinovich et al., 2006; Env Microbiol 8 Thoefner et al., 2004; J Dairy Sci 87 Induced using g/kg oligofructose Probiotics and sepsis Poor or low efficacy Meeting regulatory issues Calsporin (Silley J.Appl. Microbiol. 2006;101) Costs for licensing ~1.4 million euros for animal applications Expanding the roles of Probiotics and Prebiotics Expected growth of human population 6 billion in 2000 to > 9 billion in 2050 Increasing demands for animal feeds Increased costs for feed components corn and oils for fuels Use of lower cost/quality components Developing and using probiotics, prebiotics, and postbiotics to improve health and nutrition of animals