BACKGROUND: There is an emerging consensus that, as with other risks in society, zero risk for food-allergic people is not a realistic or attainable option. Food allergy challenge data and new risk assessment methods offer the opportunity to develop quantitative limits for unintended allergenic ingredients which can be used in risk-based approaches. However, a prerequisite to their application is defining a tolerable level of risk. This requires a value judgement and is ultimately a 'societal' decision that has to involve all relevant stakeholders. OBJECTIVE: The aim of the workshop was to bring together key representatives from the stakeholders (regulators, food industry, clinical researchers and patients), and for the first time ever discuss the definition of a tolerable level of risk with regard to allergic reactions to food. RESULTS: The discussions revealed a consensus that zero risk was not a realistic option and that it is essential to address the current lack of agreed action levels for cross-contamination with allergens if food allergen management practice is to be improved. The discussions also indicated that it was difficult to define and quantify a tolerable level of risk, although both the clinical and the industry groups tried to do so. A consensus emerged that doing nothing was not a viable option, and there was a strong desire to take action to improve the current situation. CONCLUSIONS AND CLINICAL RELEVANCE: Two concrete actions were suggested: (1) Action levels should be derived from the data currently available. Different scenarios should be examined and further developed in an iterative process. On the basis of this work, a tolerable level of risk should be proposed. (2) 'One-dose' clinical trial with a low challenge dose should be performed in multiple centres to provide additional information about the general applicability of dose-distribution models and help validate the threshold levels derived.
BACKGROUND: There is an emerging consensus that, as with other risks in society, zero risk for food-allergicpeople is not a realistic or attainable option. Food allergy challenge data and new risk assessment methods offer the opportunity to develop quantitative limits for unintended allergenic ingredients which can be used in risk-based approaches. However, a prerequisite to their application is defining a tolerable level of risk. This requires a value judgement and is ultimately a 'societal' decision that has to involve all relevant stakeholders. OBJECTIVE: The aim of the workshop was to bring together key representatives from the stakeholders (regulators, food industry, clinical researchers and patients), and for the first time ever discuss the definition of a tolerable level of risk with regard to allergic reactions to food. RESULTS: The discussions revealed a consensus that zero risk was not a realistic option and that it is essential to address the current lack of agreed action levels for cross-contamination with allergens if food allergen management practice is to be improved. The discussions also indicated that it was difficult to define and quantify a tolerable level of risk, although both the clinical and the industry groups tried to do so. A consensus emerged that doing nothing was not a viable option, and there was a strong desire to take action to improve the current situation. CONCLUSIONS AND CLINICAL RELEVANCE: Two concrete actions were suggested: (1) Action levels should be derived from the data currently available. Different scenarios should be examined and further developed in an iterative process. On the basis of this work, a tolerable level of risk should be proposed. (2) 'One-dose' clinical trial with a low challenge dose should be performed in multiple centres to provide additional information about the general applicability of dose-distribution models and help validate the threshold levels derived.
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Authors: Paul J Turner; Nandinee Patel; Barbara K Ballmer-Weber; Joe L Baumert; W Marty Blom; Simon Brooke-Taylor; Helen Brough; Dianne E Campbell; Hongbing Chen; R Sharon Chinthrajah; René W R Crevel; Anthony E J Dubois; Motohiro Ebisawa; Arnon Elizur; Jennifer D Gerdts; M Hazel Gowland; Geert F Houben; Jonathan O B Hourihane; André C Knulst; Sébastien La Vieille; María Cristina López; E N Clare Mills; Gustavo A Polenta; Natasha Purington; Maria Said; Hugh A Sampson; Sabine Schnadt; Eva Södergren; Stephen L Taylor; Benjamin C Remington Journal: J Allergy Clin Immunol Pract Date: 2021-08-23
Authors: Benjamin Zepeda-Ortega; Anne Goh; Paraskevi Xepapadaki; Aline Sprikkelman; Nicolaos Nicolaou; Rosa Elena Huerta Hernandez; Amir Hamzah Abdul Latiff; Miu Ting Yat; Mohamed Diab; Bakr Al Hussaini; Budi Setiabudiawan; Urszula Kudla; R J Joost van Neerven; Leilani Muhardi; John O Warner Journal: Front Immunol Date: 2021-06-10 Impact factor: 7.561
Authors: Jungang Xie; Larisa C Lotoski; Rishma Chooniedass; Ruey-Chyi Su; F Estelle R Simons; Joel Liem; Allan B Becker; Jude Uzonna; Kent T HayGlass Journal: PLoS One Date: 2012-10-11 Impact factor: 3.240