FDA and EPA to Examine Nanotechnology

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Publication date: 
14 June 2011

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.

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