ABSTRACT
This chapter analyzes various process establishment procedures for aseptic processing of heterogeneous foods in relation to the regulatory framework. Aseptic processing technology has gained wide acceptance among food processors, particularly for fluid foods, since the 1981 approval of hydrogen peroxide as a container sterilant by the US Food and Drug Administration (FDA). If the product is a low-acid food but contains little or no meat, then the FDA has regulatory responsibility, and a process filed with and accepted by the agency before product can be shipped in interstate commerce. If the product contains more than 2% poultry or 3% raw red meat, it will fall within the regulatory jurisdiction of the US Department of Agriculture and the process to be used for that product must be approved by the agency before that product can be manufactured. Heterogeneous foods could potentially be aseptically processed in a variety of systems, all with the ultimate aim of consistent delivery of commercially sterile product.
