The Food and Drug Administration (FDA) will consider whether a regulated product involves the application of nanotechnology, the agency announced last week. The FDA issued a guidance document in draft form for comment from stakeholders. When in its final form, the document will “not establish any regulatory definitions. Rather, it is intended to help industry and others identify when they should consider potential implications for regulatory status, safety, effectiveness, or public health impact that may arise with the application of nanotechnology in FDA-regulated products.”
The document notes that “FDA does not categorically judge all products containing nanomaterials or otherwise involving application of nanotechnology as intrinsically benign or harmful.” However, it goes on to say that “[b]ased on FDA's current scientific and technical understanding of nanomaterials and their characteristics, FDA believes that evaluations of safety, effectiveness or public health impact of such products should consider the unique properties and behaviors that nanomaterials may exhibit.”
The FDA lists two key points it will consider when determining whether to review products’ use of nanotechnology. The first is whether an engineered material or end product has at least one dimension in the nanoscale range of approximately 1 to 100 nanometers. FDA distinguishes between materials that naturally occur at that scale and those specifically engineered at that scale to take advantage of unique properties and behaviors.
The second point FDA will consider is “[w]hether an engineered material or end product exhibits properties or phenomena, including physical or chemical properties or biological effects, that are attributable to its dimension(s), even if these dimensions fall outside the nanoscale range, up to one micrometer.” This allows the FDA some flexibility in its review process, because there is not a definitive answer for what constitutes the upper size limit of nanomaterials.
The FDA is not the only federal agency reviewing the use of nanotechnology in new products. The Environmental Protection Agency (EPA) announced last week that it would be collecting information on nanoscale materials in pesticides. In its press release announcing the move, the EPA says that it “will gather information on what nanoscale materials are present in pesticide products to determine whether the registration of a pesticide may cause unreasonable adverse effects on the environment and human health.”
EPA notes that it already requires information on how pesticides are made and the potential exposure of people and the environment to them of all new pesticides. However, because of the different properties of nanoscale materials, it may now tailor its questions accordingly.
EPA also acknowledges the potential benefits of the use of nanotechnology in pesticides, saying that the “use of nanoscale materials in pesticide products and treated articles may allow for more effective targeting of pests, use of smaller quantities of a pesticide, and minimizing the frequency of spray-applied surface disinfection. These could contribute to improved human and environmental safety and could lower pest control costs.”
EPA’s full announcement may be viewed here.