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TSCA Reform Should Embrace the Best Application of Toxicological Science — a Perspective From its Practitioners | Commentary

The federal law governing chemicals used in commerce in the United States affects every person and business, but few are aware of its importance to their lives or that it is outdated and in serious need of modernization.

That law, the Toxic Substances Control Act, was enacted by Congress when Gerald Ford was president in 1976 and has not been revised since. During that time, our knowledge and abilities to develop, evaluate and manage chemicals has dramatically improved. The new Congress offers an opportunity to take advantage of these advanced capabilities and ensure a revised law will enable application of future scientific and technological progress and that the best science is used to protect public health and the environment.

The Society of Toxicology, which is composed of scientists from across academia, government and industry, will be on the front lines of implementing a revised law and intends to play an active role in determining how that new law develops to best ensure the health and safety of all Americans. The very basis of chemical safety regulation — evaluating hazard, exposure and risk — are core activities that toxicologists engage in daily.

Toxicology provides science and information essential to supporting innovation and addressing human and environmental health, and it is essential that any TSCA reform legislation reflect the human health and economic value of science-informed decision making.

The SOT’s approximately 8,000 members worldwide represent the broad spectrum of sciences that toxicology encompasses, ranging from the more mature disciplines of pharmacology, biology, chemistry, microbiology, molecular biology, pathology, pharmacy and veterinary sciences to emerging disciplines such as genomics and computational biology.

As scientists, we advocate for the science. We do not engage on the commercial or political elements that will, no doubt, also influence TSCA modernization. Our goal is simple — to ensure the best science is applied to protect public health and the environment.

SOT formed its TSCA Task Force in 2010. Our TSCA reform efforts adhere to three main principles:

1. Ensure the revised legislation affords flexibility in selection of the best available science for generating and evaluating information used in the safety and risk assessment process.

2. Ensure protection of the authority of the Environmental Protection Agency, working with the scientific community, to judge when and how to apply new techniques and methods.

3. Ensure the terms and concepts used in the legislative language that apply to the science of toxicology are consistent, accurate and unambiguous.

“Best available science” means that experiments and their findings are transparent and reproducible and the methods used are underpinned by our current understanding of the underlying biology. This understanding is not static but is constantly evolving. Congress should resist the temptation to try to spell out specific scientific methods in law and allow scientific evolutionary progress to continue.

Molecular biology advances are now being used to better describe and understand the basic biology of cells and provide tools to evaluate the effects of chemicals on early cellular processes. Advancements in analytical techniques and data analysis have opened a new level of capability for determining the types and amounts of chemicals we actually encounter in everyday life. Alternative approaches to traditional animal testing are increasingly being developed and used, along with an explosion of high through-put tools that offer key insights, in near “real time,” into a chemical’s intrinsic hazard potential.

The law should ensure that as we scientists learn more, we should be free to apply this new understanding to develop and use new methods and approaches for evaluating chemicals for the protection of public health.

TSCA reform should also ensure that only those government agencies with the appropriate scientific expertise, such as the EPA, shall have the authority to judge when to adopt and how to apply new techniques and methods for generating information for safety and risk assessment within TSCA. Recognizing the potential of the many advances in available tools requires a deep understanding of both the capabilities, as well as the limitations, of the science and the skill to be able to synthesize this information to make chemical safety decisions.

At its core, TSCA is about protection of human health and the environment through the evaluation and regulation of chemicals in commerce. Evaluation of chemical hazard and risk fundamentally involves toxicological sciences. SOT is deeply committed to providing knowledge and working with all stakeholders so that sound, progressive and protective TSCA legislation will emerge in 2015.

Norbert E. Kaminski is president of the Society of Toxicology. Want More Stories Like This? Subscribe to our Thought Leaders Newsletter.

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