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Small particles may present big regulatory issues

Today we take up small matters.

Not small matters in the sense that they will have small consequences, but small in the old-fashioned sense.
The subject today is “engineered nanoscale materials.” An emerging science, “nanotechnology” has already proven to have promising applications for a whole range of technologies, including drugs, food ingredients, and food packaging. But there are questions about whether the existing legal framework is sufficient to address the special challenges presented by ENMs.

An ENM is one with a particle size of 100 nanometers or smaller. A nanometer is one billionth of a meter. That’s about 1⁄100,000 of the width of human hair.

Such particles are already in use in a range of consumer products, including paints, coatings, clothing, drugs, cosmetics, foods, and, most relevantly here, food packaging.

When you intentionally make particles so very small, they often can have different characteristics and perform differently than the traditional-sized particle of the chemical. The nanoparticle has a lot more surface area than the larger particle, and it can be stronger or more effective at various chemical and physical properties. Carbon nanostructures and metal oxides have already been manipulated for beneficial properties at nanoscale.

Various regulatory agencies and other institutions have begun to examine a range of important regulatory issues raised by ENMs. One that has examined the regulatory challenges presented by these materials has been the Project on Emerging Nanotechnologies within the Washington, D.C.-based Woodrow Wilson International Center for Scholars, in collaboration with the Grocery Manufacturers Assn., an industry trade group. The participants included government representatives from the Food and Drug Administration, the U.S. Department of Agriculture, and the Environmental Protection Agency; representatives of industry (I was one of them); various trade organization representatives; and consumer advocacy organizations.

Called the Case Study Project, the effort was spearheaded by Michael R. Taylor, a former FDA and USDA official who is now a research professor at George Washington University School of Public Health and Health Services.

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