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Advancing the 3Rs in Regulatory Toxicology - Carcinogenicity Testing: Scope for Harmonisation and Advancing the 3Rs in Regulated Sectors of the European Union
Annys, E., R. Billington, R. Clayton, K. Bremm, M. Graziano, J. McKelvie, I. Ragan, M. Schwarz, J. Willem van der Laan, C. Wood, M. Oberg, P. Wester, AND K. Woodward. Advancing the 3Rs in Regulatory Toxicology - Carcinogenicity Testing: Scope for Harmonisation and Advancing the 3Rs in Regulated Sectors of the European Union. REGULATORY TOXICOLOGY AND PHARMACOLOGY. Elsevier Science Ltd, New York, NY, 69(2):234-42, (2014).
Traditional carcinogenicity bioassays have been used for many years as the global standard for identifying chemicals with carcinogenic potential in humans.However, these test require enormous time and resources, making them unfeasible as a tool to screen and evaluate the large numbers of chemicals currently in production. This limitation has led to repeated efforts to identify more efficient alternative models. This article provides global perspectives on carcinogenicity testing that may inform future EPA research, testing strategies, and regulatory requirements. The work broadly supports goals of Theme2 (Systems Models) within the ORD Chemical Safety for Sustainability (CSS) research program (Task 2.2.1).
Abstract Different government agencies operating in the European Union regulate different types of chemical products, but all require testing for carcinogenicity to support applications for product marketing and commercialisation. A conference was held in Brussels in 2013 where representatives of the pharmaceutical, animal health, chemical and plant protection industries, together with representatives of regulatory agencies, universities and other stakeholders, met under the auspices of The European Partnership for Alternative Approaches to Animal Testing (EPAA) to discuss the varying requirements for carcinogenicity testing, and how these studies might be refined to improve hazard evaluation and risk assessment while implementing principles of the 3Rs (replacement, refinement and reduction in animal studies). While there are some similarities, the regulatory approaches in pharmaceutical, animal health, chemical and plant protection sectors have varying degrees of flexibility in requirements for carcinogenicity testing, to an extent reflecting concerns over the magnitude and duration of human exposure, either directly as in therapeutic exposure to pharmaceuticals, or indirectly through the ingestion of residues of veterinary drugs or plant protection chemicals. The article discusses these differences and other considerations for modified carcinogenicity testing paradigms on the basis of scientific and 3Rs approaches.