Implementing the National Academy's Vision and Strategy for Toxicity Testing: Opportunities and Challenges Under the U.S. Toxic Substances Control Act

2010 ◽  
Vol 13 (2-4) ◽  
pp. 376-384 ◽  
Author(s):  
Paul A. Locke ◽  
D. Bruce Myers
1999 ◽  
Vol 01 (03) ◽  
pp. 329-347 ◽  
Author(s):  
REBECCA A. EFROYMSON

The Toxic Substances Control Act (TSCA) is the legislation used by the U.S. Environmental Protection Agency to regulate releases of genetically engineered microorganisms. The rule defining the scope of the notification requirements for releases of microbial products of biotechnology was published in April 1997. The Environmental Protection Agency (EPA) had some latitude regarding the extent to which various categories of microorganisms would be regulated, but the agency was constrained by requirements of TSCA and an interagency agreement about how to regulate products of biotechnology. This paper investigates the extent to which the scope of oversight is based on risk. A risk-based rule is defined as one where the reporting requirements are based on potential for exposure or expected adverse effects. The evolution of the rule is described, and risk-based components are discussed. In conclusion, the scope of oversight of microbial releases is determined to be based on risk to the extent that legislation and institutional constraints permit.


2001 ◽  
Vol 20 (2) ◽  
pp. 175-187 ◽  
Author(s):  
Odelia Funke

This article explores long-term issues and problems that have seriously undermined the U.S. Chemical Testing Program established by the Environmental Protection Agency (EPA) under the Toxic Substances Control Act. This program is meant to gather information needed to protect human health and the environment from damaging exposure to toxic chemicals. Despite seemingly broad and impressive authority under the statute, there are a number of inherent difficulties, as well as substantial political constraints, that impede comprehensive oversight of chemicals in U.S. commerce. The article discusses several approaches that EPA has adopted to overcome statutory and political limitations and increase chemical testing information. The most recent and promising of these efforts has involved international negotiations to harmonize testing approaches with OECD nations and to cooperate on an agenda that will better share the testing burden on an international level.


Author(s):  
David Vogel

This chapter looks at American and European policies toward the risks of chemicals and hazardous substances. The 1976 Toxic Substances Control Act (TSCA) significantly strengthened American chemical regulations and contributed to the 1979 decision of the EU to both harmonize and strengthen its chemical regulations, though they remained weaker than those of the United States. While there has been no major statutory change in American chemical regulation since then, in 2006 the EU approved REACH—the Registration, Evaluation, Authorization and Restriction of Chemicals, which made European chemical regulations significantly more stringent and comprehensive than those of the United States. Meanwhile, risk assessments by the U.S. federal government do not consider the hazardous substances in electronics deposited in landfills as a threat to public health.


Author(s):  
Robert Laumbach ◽  
Michael Gochfeld

This chapter describes the basic principles of toxicology and their application to occupational and environmental health. Topics covered include pathways that toxic substances may take from sources in the environment to molecular targets in the cells of the body where toxic effects occur. These pathways include routes of exposure, absorption into the body, distribution to organs and tissues, metabolism, storage, and excretion. The various types of toxicological endpoints are discussed, along with the concepts of dose-response relationships, threshold doses, and the basis of interindividual differences and interspecies differences in response to exposure to toxic substances. The diversity of cellular and molecular mechanisms of toxicity, including enzyme induction and inhibition, oxidative stress, mutagenesis, carcinogenesis, and teratogenesis, are discussed and the chapter concludes with examples of practical applications in clinical evaluation and in toxicity testing.


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