The United States Food & Drug Administration has denied a 2006 petition from a consumer advocacy group to require premarket safety testing and labelling of nanoscale materials in consumer products, such as food packaging and sunscreen. The agency has instead opted to propose voluntary guidelines that industry should follow to ensure the safety of nanomaterials in food and cosmetics. The agency released the draft guidelines on 20 April, the same day it denied the petition. The guidelines encourage industry to consult with FDA before putting products that contain nanomaterials on the market. But manufacturers are not required to do so. FDA suggests that standard safety tests may need to be modified to determine how factors such as particle size, surface area, aggregation, and shape affect absorption, distribution, metabolism, and excretion. For cosmetics, FDA also recommends consideration of inhalation and oral routes of exposure, not just dermal exposure. Now there are clearer guidelines from the agency to industry to indicate how they should be thinking to ensure products that contain nanoscale materials are safe, says Andrew D. Maynard, director of the University of Michigans Risk Science Centre. Before this point, there was a lot of uncertainty about what a manufacturer should do if they want to use a nanoscale material, he notes. Consumer groups are disappointed with FDAs decision not to require industry to follow the guidelines. We have yet to see any real progress on nanotech safety with any of the voluntary approaches taken thus far and thus see no reason to expect a shift with this new guidance, says Carolyn Cairns, program leader for product safety at Consumers Union, an advocacy group. Nonetheless, FDAs recognition that nanomaterials can have unique effects represents some progress, she says. Jaydee Hanson, policy director at the International Centre for Technology Assessment, the group that led the 2006 petition, says the guidelines are better than nothing. But he predicts that by not requiring companies to disclose nanomaterials in their products, the U.S. will run into conflict with its trading partners. The European Union, for example, requires labelling nanomaterials in cosmetics and is likely to make the same requirement for foods, he says.
Chemical & Engineering News, 30 April 2012 ;http://pubs.acs.org/cen/news ;