Federal guidelines proposed June 9 for the regulation and oversight of products containing engineered nanoscale materials have gotten a mixed reception from affected industries. 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 EPA, FDA, and the White House are meant to serve as a first step toward regulation of nanotech 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 need to provide when marketing such products.
EPA’s policy specifically addresses nanotechnology in pesticides. EPA is proposing to require industry to provide data regarding “unreasonable adverse effects on the environment and human health” when a pesticide that contains nanotechnology is registered. Importantly, EPA only considers particle size in determining what is a nanoproduct.
But, the agency is considering an alternative way to obtain toxicity information. 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 latter 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, manager 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 that 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. “They’ve 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, he adds.
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, and 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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