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US FDA "Redbook II" Immunotoxicity Testing Guidelines and Research in Immunotoxicity Evaluations of Food Chemicals and New Food Proteins

Biochemical and Analytical Toxicology Branch, Division of Toxicological Studies, Office of Special Research Skills, Center for Food Safety and Applied Nutrition, Food and Drug Administration, Washington, DC

The rapid advances in the field of immunology and an understanding of the potential adverse effects of xenobiotics on the immune system have resulted in the development of a discipline in toxicology now referred to as immunotoxicology. This discipline has evolved steadily over the last 2 decades as a result of research in the national and international communities. Various US, European, and Japanese regulatory agencies have recognized a need to promulgate testing guidelines for immunotoxicity in support of the approval process involving toxicological testing. The US Food and Drug Administration "Redbook II" guidelines and some of the research conducted in support of the concepts and testing strategies are presented here. Concerns raised with regard to these guidelines are included, as are on-going initiatives in development of experimental approaches for assessing allergic potential and/or hypersensitivity responses to new foods and food constituents.

Key Words: Immunotoxicity guidelines • food additives • Redbook II • food proteins

Toxicologic Pathology, Vol. 28, No. 3, 467-478 (2000)
DOI: 10.1177/019262330002800318


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