Key issues for the assessment of the allergenic potential of genetically modified foods: breakout group reports.

On the final afternoon of the workshop "Assessment of the Allergenic Potential of Genetically Modified Foods," held 10-12 December 2001 in Chapel Hill, North Carolina, USA, speakers and participants met in breakout groups to discuss specific questions in the areas of use of human clinical data, animal models to assess food allergy, biomarkers of exposure and effect, sensitive populations, dose-response assessment, and postmarket surveillance. Each group addressed general questions regarding allergenicity of genetically modified foods and specific questions for each subject area. This article is a brief summary of the discussions of each of the six breakout groups regarding our current state of knowledge and what information is needed to advance the field

Assessment of immunotoxicity in the 21st century: where we are and what we need to replace animals

The field of immunotoxicity assessment has traditionally relied on animal models, which have raised ethical concerns and presented limitations in terms of predictive accuracy and relevance to human health. This paper reviews the current state of immunotoxicity evaluation, emphasizing the importance of transitioning away from animal testing. Modern approaches, including in vitro methods, human-based studies, adverse outcome pathways (AOPs), and computational modeling, are discussed as viable alternatives. These non-animal methods offer enhanced predictive power and the potential for regulatory acceptance, though technical and practical challenges remain. Case studies demonstrate the success of non-animal methods, such as AOPbased assessments for skin sensitization and the pyrogen assay using whole blood cytokine assays. Despite these advances, further research is needed in areas like respiratory sensitization, developmental immunotoxicology (DIT), and microphysiological systems (MPS). Recommendations are provided to accelerate the adoption of new approach methodologies (NAMs), focusing on AOP frameworks. In conclusion, the paper highlights the key findings from current non-animal immunotoxicity research and issues a call to action for advancing these methods to improve safety assessment practices in the 21st century

Assessment of allergenic potential of genetically modified foods: an agenda for future research.

Speakers and participants in the workshop "Assessment of the Allergenic Potential of Genetically Modified Foods" met in breakout groups to discuss a number of issues including needs for future research. These groups agreed that research should progress quickly in the area of hazard identification and that a need exists for more basic research to understand the mechanisms underlying food allergy. A list of research needs was developed

A statement on the developmental immunotoxicity of bisphenol A (BPA) : answer to the question from the Dutch Ministry of Health, Welfare and Sport

The Panel wishes to thank EFSA staff member Cristina Croera for the support provided to this scientific opinion.Publisher PD