Issue Date: June 27, 2011
Toward Nanotech Regulation
Federal guidelines proposed on June 9 for the regulation and oversight of products containing engineered nanoscale materials have gotten a mixed reception. The government policies aim to protect public health and the environment without stifling innovation, but some stakeholders see room for improvement.
The long-awaited guidelines from the Environmental Protection Agency, the Food & Drug Administration, and the White House are meant to serve as a first step toward regulation of nanotechnology products. The White House document provides a set of principles for agencies to follow to achieve consistency across the federal government with respect to nanotech regulation. The EPA and FDA proposals attempt to provide clarity for industry regarding what constitutes a nanotech product and what data industry needs to provide when marketing such products.
EPA’s policy specifically addresses nanotechnology in pesticides. The agency is proposing to require that industry provide data regarding “unreasonable adverse effects on the environment and human health” when a pesticide that contains nanotechnology is registered. Importantly, EPA considers only particle size in determining what is a nanotech product.
The agency is also considering an alternative way to obtain toxicity information for nanotech products. It could simply ask industry for specific information, such as inhalation toxicity data, rather than the whole universe of possible adverse effects.
Industry prefers the targeted approach. Groups including the American Chemistry Council and CropLife America have been urging EPA not to require all data on adverse health and environmental effects, saying such a requirement stigmatizes the field and implies that products containing nanotechnology are inherently dangerous.
“This new draft policy from EPA has the potential to create an unjustifiable bias against nanotechnology,” says Jay West, senior director of the ACC Nanotechnology Panel. “EPA is creating the false impression that there are always adverse effects from using nanotechnology in pesticides.”
Observers who follow the nanotech industry say the specific information requests favored by industry typically do not give EPA the information it needs to protect public health. “Most of the data calls associated with engineered nanomaterials to date have not been that successful,” says Andrew D. Maynard, director of the Risk Science Center at the University of Michigan School of Public Health. EPA has been “bogged down in a lack of responsiveness from industry and wrangling over what exactly a nanomaterial is and what should be reported,” he notes. “It becomes a fishing expedition” for EPA.
EPA’s proposal follows some of the White House guidelines, but it fails to incorporate “new thinking about evidence-based nanoscale material regulation,” Maynard says. In contrast, the FDA proposal closely follows the White House guidelines, which call for a science-based regulatory approach that considers a material’s properties and potential risks, not just the size of the material. FDA’s proposal is intended to clarify for industry when an FDA-regulated product—such as food packaging, drugs, or cosmetics—is considered to be a nanotech product, without providing a regulatory definition of nanotechnology.
In general, the EPA and FDA proposals “are heading in the right direction to create greater certainty for industry, but there is a long way to go yet,” Maynard tells C&EN.
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