Resolution of EPA policy issue related to the registration of a commercial sterilant for food packaging materials and equipment used in aseptic processing and packaging of low-acid foods.

摘要

The goal of this project was to establish a policy within the Environmental Protection Agency (EPA) to register existing and new commercial sterilants for use in low-acid aseptic food packaging systems.; Low-acid aseptic packaging provides a system where food with a pH greater than 4.6 can be packaged in shelf-stable packaging, which prevents the need for refrigeration.; The low-acid aseptic process involves sterilizing the packaging and the food product separately and then filling and sealing the containers in a sterile environment. The goal is to create a shelf-stable packaged food that is free of spoilage and pathogenic microorganisms. Low-acid foods currently require cold transport and storage to extend shelf life and reduce spoilage and foodborne pathogen contamination risks. Below is a basic schematic of an aseptic system.*; Hydrogen peroxide has been the only commercial sterilant used in the United States since 1981. There is a need for new chemical commercial sterilant technologies to aseptically package foods in light-weight plastic containers, such as polyethylene terephthalate (PET).; Commercial sterilants are required to be registered with the EPA Office of Pesticide Programs (OPP) before chemical suppliers can place products on the market.; However, OPP has not had a registration policy. Thus, new technologies could not make it to market. OPP approval of a registration pathway that included a test method and claim structure was necessary before an applicant could proceed with a new commercial sterilant registration.; Key regulations, challenges, and benefits were researched and discussed with OPP. An analysis of technical, social, environmental and economic impacts was completed in preparation for policy discussions.; After approximately three years of meetings, discussions, and negotiations the final goal was achieved. The EPA OPP established a registration policy and approved the first commercial sterilant for low-acid food aseptic packaging on October 25, 2006.; A second registration commercial sterilant registration was granted by the EPA OPP on November 14, 2006. Thus, a policy framework has been established that facilitates registration of new commercial sterilants for use in aseptic packaging systems.; *Please refer to dissertation for diagrams.