Regulation (U.S.)

It is the duty of the federal government to set appropriate standards, guidelines, and regulations to protect the public and the environment. The National Nanotechnology Initiative (NNI) program was established in fiscal year 2001 to coordinate federal nanotechnology research and development. Under the purview of the National Science and Technology Council (NSTC), a cabinet-level council through which the president coordinates technological, scientific, and space policies, NNI is charged with providing a national long-term vision of nanotechnology. This includes regulating nanomaterials and nanoscience. The United States has no central regulatory body responsible for the regulation of nanomaterials and nanotechnology. Rather, given the multidisciplinary nature of nanoscience (i.e., engineering, chemistry, medicine), the regulation of nanomaterials and nanotechnology is under the purview of the responsible existing regulatory agency pertaining to the type of work being performed or the type of materials being produced. The result is a highly decentralized regulatory framework.

Currently, the NNI consists of 25 federal agencies working individually or jointly in a wide range of research and regulatory roles. Government regulation of nanomaterials falls under no less than six separate governmental agencies, including the Environmental Protection Agency (EPA), Food and Drug Administration (FDA), National Institute for Occupational Safety and Health (NIOSH), National Institutes of Health (NIH), National Institute of Standards and Technology (NIST), and the National Science Foundation (NSF). While EPA, the FDA, and NIOSH are dealing with the promulgation of regulations, agencies such as NIH and NSF are sponsoring important research to determine the public health risks posed by nanomaterials.

NIST is working to develop a database of characteristics and potential health and environmental hazards of nanomaterials. This is necessary to ensure the quality of data and usefulness of results generated in research involving the effects of nanomaterials in the environment. Accurate measurements can also eliminate uncertainties that may complicate regulatory and policy decisions.

The current state of regulation focuses almost primarily on the public heath risks posed by nanomaterials and how to properly determine and assess those risks. This focus is similar to that in the chemical industry and uses a process known as risk assessment. Risk assessment requires the weighing of potential risks posed to health and the environment against the value of the product in commerce. In the United States, chemicals are regulated by the 1976 Toxic Substances Control Act (TSCA). In Europe, they are regulated by a process known as the Registration, Evaluation, and Authorization of Chemicals (REACH). Concentration on risk assessment is being performed by the various federal agencies.