Analytical approach to determination of safety of milk ingredients from hyperimmunized cows

Bovine milk-derived ingredients from cows hyperimmunized with a variety of antigens have been available experimentally or commercially for several decades. Although the safety of milk is rarely questioned, an assessment of ingredients derived from the milk of cows hyperimmunized with a proprietary bacterin (S100) was made to determine that these ingredients share the human food safety profile traditionally ascribed to regular milk. The critical elements in this determination are: (1) quantitative determination of the difference between S100 and regular dairy ingredients, (2) comparison of exposures resulting from proposed uses to background exposures already in the American diet, and (3) corroborative results of controlled clinical trials comparing safety outcomes from consumption of S100 with those of conventional dairy ingredients. Comparative analytical data reveal that the only difference between S100 and conventional dairy ingredients is significantly higher active (undenatured) immunoglobulin G (IgG) (61-79% vs. control Grade A fluid and powdered skim, respectively, p < 0.005) with slightly altered specific antibody activity. Estimated daily intake projections show that use of S100 ingredients at maximum proposed levels results in exposures to active (undenatured) IgG below background in the present American diet in infants but above background in children and adults, whose intake of conventional dairy products is markedly lower. Safety of this consumption level is corroborated by clinical results showing no difference in safety outcomes between S100 ingredients, consumed at exaggerated levels, and conventional dairy products, in a variety of adult populations. There is no evidence that demonstrates a hazard to the public when S100 ingredients are used at levels that might reasonably be expected from the proposed applications.