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Nanotechnology: Too Small to be Ignored

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The Food and Drug Administration on April 20 issued a draft guidance advising food manufacturers on what they should consider when determining whether changes in manufacturing processes, including those involving nanotechnology, create a significant change in food substances.

The draft guidance titled "Assessing the effects of significant manufacturing process changes, including emerging technologies, on the safety and regulatory status of food ingredients and food contact substances, including food ingredients that are color additives" was distributed for comment purposes only.

Nanotechnology generally is defined as the control and restructuring of matter at the nanoscale, in the size range of approximately 1 to 100 nanometers, in order to create materials, devices and systems with fundamentally new properties and functions due to their small structure. A nanometer is one-billionth of a meter (the thickness of a human hair is about 75,000 nanometers).

The F.D.A. said nanotechnology has the potential to be used in a broad array of F.D.A.-regulated products, including foods. The F.D.A. noted nanomaterials, materials developed from using nanotechnology, may have different chemical, physical, or biological properties than their conventionally-scaled counter-part materials used in many products regulated by the agency. This may "introduce issues that warrant additional or different evaluation during a safety assessment of a food substance," the F.D.A. said.