Vincent J Sewalt
DuPont Industrial Biosciences, USA
Title: Use of standardized enzyme safety evaluation methodology in the GRAS process - a model for other food ingredients and jurisdictions
Biography
Biography: Vincent J Sewalt
Abstract
Enzymes are used as processing aids in various food applications including baking, brewing, protein processing and manufacture of dairy products. In the US, any ingredients added to food, even if only as processing aids, require premarket approval unless they are generally recognized as safe (GRAS). The enzyme industry has effectively pursued GRAS exemption claims for its products as described recently. A thorough enzyme safety evaluation considers aspects of the enzyme itself, its production organism (including genetic engineering aspects), the manufacture process, and the exposure in the intended use, in addition to safety studies. The success in pursuing and notifying FDA of GRAS status for enzymes in an expedited manner was based on extensive collaboration within industry and with academia to summarize available toxicological studies for enzymes produced with genetically engineered microbes, made available for publication in review papers by Pariza and Johnson and; Pariza and Cook, all pointing at no adverse effects for microbial food enzymes. The Pariza papers also elaborated the concept of safe strain lineage (SSL) as part of a safety evaluation decision tree methodology, which allows extrapolation of existing toxicological data to evaluate new products. The SSL concept builds on the repeated use of common production organisms such as Bacillus subtilis, B. licheniformis, and Trichoderma reesei and the repeated assessment of these production organisms using the decision tree. These efforts resulted in a standardized, generally recognized safety evaluation methodology, and a high success rate in US FDA’s GRAS notification program. Other food safety professionals have commented that the concerted effort by the enzyme industry make clear the value in developing such processes. Indeed, this approach may serve as a model to other food ingredient categories for a scientiï¬cally sound, rigorous, and transparent application of the GRAS process and as inspiration to other jurisdictions involved in safety oversight of microbial products.