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Module 5: Allergenicity

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Food Allergies - Influence of Biotechnology - Conclusion

In summary, when a gene is taken from a source with no history of allergenicity, it should first undergo amino acid sequence similarity tests. If the sequence similarity tests are negative, then the protein should undergo stability digestive/processing tests. If the protein is not stable under digestive and processing conditions, it can be decided with reasonable assurance that the protein is not allergenic. However, if the protein is stable under digestive and processing conditions (which is characteristic of food allergens) then there should be consultation with regulatory agencies, such as the FDA and the EPA. The FDA (Food and Drug Administration) assesses safety, including the nutritional profile, food quality, and food processing. The EPA (Environmental Protection Agency) oversees the regulation and testing of non-digestible proteins expressed as plant pesticides.

When a gene is taken from a source that is commonly allergenic or less commonly allergenic, it should first undergo solid phase immunoassay tests. If the ideal number of subjects were used, and the tests were ambiguous, then the protein should undergo skin prick tests, however if the tests were negative it can be assumed the protein is not allergenic. If the ideal number of subjects were used, and the immunoassay tests were positive, then it is appropriate to assume the protein is allergenic, and thus should be appropriately labeled. However, if the number of subject used in the immunoassay tests is less than 5, then the testing should proceed to digestive stability and processing tests, followed by consultation with regulatory agencies.

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