The primary goal of the protein allergenicity assessment process is characterization of transgenic proteins prior to their inclusion in foods so that risk of allergenic protein exposure remains low. An excellent example of the success of this process was the proposed transfer of a Brazil nut 2S albumin encoding gene into soybean in an attempt to improve nutritional quality.68 Because the Brazil nut was a known allergenic food, the 2S albumin was assessed for its potential allergenicity. Using the assessment process, this protein was found to be allergenic and the GM product never reached the consumer market place. With regard to potential alterations to the allergenicity of proteins, there is to date no evidence from marketing surveys or other studies that a nonallergenic, transgenic protein expressed in food has become altered to affect human allergy.69-71

Consensus on the methods used in the allergy assessment of novel proteins has progressed in recent years with the impetus toward standardized methods that can reliably describe the safety of those proteins to consumers. Early-stage screening with bioinformatic approaches helps to identify known allergens or crossreac-tive proteins so they are not included in biotechnology food product development. Databases that contain the newest protein sequences help ensure that biotechnology food proteins can be accurately characterized for their allergy potential. Continuing research and inclusion of newly described allergens into public databases help to increase the value of bioinformatic assessments. Concern over novel or transgenic proteins initiating new allergies continues to be addressed with a combination of laboratory assessments addressed in this review.

Biotechnology proteins in foods retain a low risk of induced allergy due to safety assessments that can distinguish likely protein allergens. Recent attempts to agree on standard safety tests of allergenicity for biotechnology foods (FAO/WHO17 and the Codex Alimentarius Commission72) outlined strategies and recommendations which include bioinformatic comparisons to known allergens, evaluating transgenic protein abundance, and biochemical characterizations prior to any commercialization of GM foods. These analyses are intended to characterize a biotechnology-derived food protein for allergenic potential and determine the likelihood of safe consumption. Current allergy safety assessments do not include animal models and in vitro measures of immunogenicity due to the lack of clear, mechanistic information regarding clinical allergy disease progression in animals or humans. It is therefore critical that food protein allergenicity be assessed with a multilevel approach using standardized methods in order to avoid a case-by-case testing regimen for each biotechnology food product. As biotechnology is increasingly used to modify the protein content of foods, risk assessment strategies can be initiated to assess safety. In fact, risk assessments are beginning to be employed to determine the level of allergy risk of new biotechnology food proteins and will make use of hazard assessments, dose-response measures, exposure assessments, and risk characterization.28 As the mechanisms of allergy are more fully understood, safety assessments of biotechnology-derived food proteins will continue to benefit from new research and help maintain a low level of allergy risk to consumers.

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