National Toxicology Program (U.S.)

Given the intense and perhaps unwarranted fear that nanotechnology has evoked in the public mind, symbolized by novels such as Michael Crichton's Prey, nanotechnology is one of the key concerns of the U.S. National Toxicology Program (NTP). The NTP is an interagency program whose mission is to evaluate agents of public health concern by developing and applying tools of modern toxicology and molecular biology. The NTP has a challenging task, as an estimated 80,000 chemicals are registered for use in the United States, and an estimated 2,000 new ones enter the market each year. The NTP concentrates on identifying the effects of these chemicals and the safe level of human exposure, or in other words, their toxicology.

The NTP was established in 1978 by Joseph A. Califano, Jr., Secretary of Health, Education and Welfare (today known as the Department of Health and Human Services), and in the background of increasing concern about the unanticipated toxic effects of the miracle inventions of the earlier decades. Such concerns sharpened after the publication of Silent Spring (1962) by the American biologist Rachel Carson, who described the adverse impact of DDT in the United States. Carson's book led to the birth of the modern environmental movement, and also raised awareness regarding the toxicity of chemicals in the environment, leading to a 1972 ban on DDT in the United States.

The NTP was born in this context, and was created as a cooperative effort to (1) coordinate toxicology testing programs within the federal government; (2) strengthen the science base in toxicology; (3) develop and validate improved testing methods; (4) provide information about potentially toxic chemicals to health, regulatory and research agencies, scientific and medical communities, and the public. In an era of converging technologies “nano-bio-info-cogno” NTP is also at the forefront of policy making for the regulatory governance of new initiatives, such as nanotechnology. In October 1981, the Secretary of Health and Human Services in the cabinet of President Ronald Reagan, Richard Schultz Schweiker, granted permanent status to the NTP.

NTP is an interagency program headquartered at the National Institute of Environmental Health Sciences of the National Institutes of Health (NIEHS/NIH). Three agencies, NIEHS/NIH, the National Institute for Occupational Safety and Health of the Centers for Disease Control and Prevention (NIOSH/CDC), and the National Center for Toxicological Research of the Food and Drug Administration (NCTR/FDA), form the core of the NTP. The director of the NIEHS/NIH also serves as the NTP Director.

In 2003, the Rice University Center for Biological and Environmental Nanotechnology (CBEN) nominated nanoscale materials to the NTP toxicology testing program. Nanotechnology raises concerns of toxicity at two levels: (1) very little research exists regarding the potential toxicity of manufactured nanoscale materials; and (2) the unique and diverse physicochemical properties of nanoscale materials indicate that toxicological properties may differ from materials of similar composition but larger size. Moreover, the interaction of nanomaterials with the environment, and particularly its role in eliciting biological responses, make evaluation of potential adverse events to exposure to these materials a complex task.

The NTP has launched a broad-based research program to identify potential human health hazards associated with the manufacture and use of nanoscale materials. The NTP hopes that this research program will evaluate the toxicological properties of major nanoscale materials classes, which represent a cross section of composition, size, surface coatings, and physicochemical properties. The findings will then be used as model systems to investigate fundamental questions concerning if and how nanoscale materials can interact with biological systems.

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