Safety screening for candidate proteins during the product development phase

To prevent potentially hazardous proteins from advancing into the final product development phase, candidate proteins are evaluated for their potential allergenic-ity and toxicity at an early stage in the time line of developing genetically modified plants. This early evaluation includes a comparison of the amino acid sequence of a candidate protein to known toxins, allergens, and all known proteins in publicly available databases, as well as an evaluation of the sensitivity of the protein to digestion with pepsin in a simulated gastric fluid (SGF) assay. The underlying assumption is that proteins that are not related to any potentially harmful proteins, e.g., toxins and allergens, and that are related to proteins with a history of safe consumption and/or are readily digestible with pepsin in SGF are highly unlikely to pose a health risk. On the other hand, a high level of similarity of the candidate protein to known allergens or toxins, together with resistance to digestion with pepsin, implies that protein-specific studies will be required to rule out a hazard to human health, and consequently, such candidate proteins may not be selected for advancement into a final product. A candidate protein that has passed the initial safety screening and advanced into the product development would then be subjected to a thorough and comprehensive safety evaluation prior to submission to regulatory agencies to obtain the authorizations required to enter the market, as described below.

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