This article addresses regulatory issues of nanotechnology and takes an in-depth look at how the United States Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), and the U.S. Occupational Safety and Health Administration (OSHA) have dealt with nanotechnology regulation since a November 2007 memorandum from the Office of Science and Technology Policy, and the Council on Environmental Quality, stated that federal agencies “must implement sound policies to protect public health and the environment” from risks related to nanotechnology.
Regulatory agencies, both in the U.S. and abroad, have struggled to keep pace with this rapidly emerging technology, questioning whether existing regulations are sufficient to protect consumers and workers, or if a new regulatory framework is needed. The process is often complicated by having to define exactly what a nanomaterial is, such as whether the definition should be based on size, biopersistence, shape, or all three. The definition is critical to industry as it determines if a manufacturer will be subject to proposed legislation. Overall, the article says, the FDA and OSHA have taken little action to regulate nanotechnology, with FDA’s position being that existing regulations are sufficient to protect consumers. The EPA has been the most active in developing regulations, with current rules and regulations for nanomaterials being developed under both the Toxic Substances Control Act (TSCA) and the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The article outlines all of the history and action on the part of the EPA regarding nanomaterial regulation. The article concludes by saying “…it is unclear whether the United States will enact comprehensive nanotechnology legislation and regulation in the future. Many questions must be answered before sweeping legislation can be enacted, such as how “nanomaterial” should be defined, which types of products and operations should be regulated, and how effective existing programs are at regulating nanotechnology. Decision making on future legislation and regulation will develop pending the results of ongoing studies on the effects of nanomaterials and the effectiveness of current regulatory programs. The one thing that is clear is that nanotechnology and its regulation are dynamic, will continue to evolve, and will demand close attention.” The article can be viewed online at the link below.