Search

The article focuses on how the toxicity testing reform for U.S. chemicals laws fits into the legal and policy landscape. It informs that the U.S. federal system that controls the use of chemicals consist of the Toxic Substances Control Act (TSCA), the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and their regulations. It mentions that many evolutionary changes in toxicology provide for regulatory revolution for evaluating chemical hazards for chemicals.

Systemic toxicity testing forms the cornerstone for the safety evaluation of substances. Pressures to move from traditional animal models to novel technologies arise from various concerns, including: the need to evaluate large numbers of previously untested chemicals and new products (such as nanoparticles or cell therapies), the limited predictivity of traditional tests for human health effects, duration and costs of current approaches, and animal welfare considerations. The latter holds especially true in the context of the scheduled 2013 marketing ban on cosmetic ingredients tested for systemic toxicity. Based on a major analysis of the status of alternative methods (Adler et al., 2011) and its independent review (Hartung et al., 2011), the present report proposes a roadmap for how to overcome the acknowledged scientific gaps for the full replacement of systemic toxicity testing using animals. Five whitepapers were commissioned addressing toxicokinetics, skin sensitization, repeated-dose toxicity, carcinogenicity, and reproductive toxicity testing. An expert workshop of 35 participants from Europe and the US discussed and refined these whitepapers, which were subsequently compiled to form the present report. By prioritizing the many options to move the field forward, the expert group hopes to advance regulatory science. [ABSTRACT FROM AUTHOR]

One of the most important challenges facing risk mangers in the coming decades is the joint management of chemical and radiological wastes. Born out of different traditions, radiation and chemical risk approaches can differ sharply. Radiation protection generally focuses on establishing effective dose levels across media and utilizes an approach that incorporates the philosophy of ALARA. In contrast, chemical risk management strategies are medium specific and risk based. In practice these differences can complicate decision making and potentially lead to duplicative efforts. We have undertaken a series of case studies to determine the extent and nature of the barriers that exist with regard to the potential harmonization of risk management approaches. Built upon the results of an interactive workshop held in June 1998, these case studies examine how cleanup decisions were made at a series of contaminated sites around the United States. It is anticipated that these case studies will demonstrate (1) the areas of greatestdiscord among chemical and radiological risk management approaches, and (2) how gaps in approaches could be bridged. This presentation will review the important conclusions of these case studies and (if possible) offer suggestions about how chemical and radiation risk management can be harmonized. [ABSTRACT FROM AUTHOR]