US Government Regulators Take on Nanomaterials

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Besides a big funding gap that has prevented many nascent nanotechnologies from reaching the marketplace, two major obstacles to nanotech's advance are a seeming lack of a regulatory framework, especially in food and drugs, and environmental, health and safety (EHS) concerns.

This week, in what appears to be a coincidence, the US Food & Drug Administration (FDA) and the National Nanotechnology Initiative (NNI) have both issued formal announcements that should have an impact on both regulations and EHS concerns. The FDA has outlined a policy for overseeing nanomaterials in food, drugs and even cosmetics. Yesterday, the NNI provided an overview of progress on the implementation of the 2011 NNI Environmental, Health and Safety (EHS) Research Strategy.

Both the FDA and NNI have been pressured to address both regulations and EHS concerns. Some industry analysts have blamed the FDA’s dependence on nanoparticle size dimensions as a hindrance to the development of nanomedicines.

Dr. Raj Bawa, patent agent at Bawa Biotech LLC, a biotechnology consultancy and patent law firm, told me that he was distressed that the FDA and other government bodies have “labored under the strict size guideline laid out by the original definition proposed by the National Nanotechnology Initiative. That guideline does not consider anything to be nanotech unless one or more of its dimensions are under 100nm.”

However, Bawa, and others, were encouraged that the FDA had been hinting that they were pursuing a science-based regulatory framework rather than on based purely on policy. Reading the FDA’s most recent announcement, the optimism seems to have been well placed as evidenced by the official statements accompanying its latest recommendations.

"We are taking a prudent scientific approach to assess each product on its own merits and are not making broad, general assumptions about the safety of nanotechnology products," said FDA Commissioner Margaret Hamburg.

Since 2012, the US Food & Drug Administration (FDA) has been following a careful, and industry inclusive, approach to finding a regulatory framework for the use of nanomaterials in both foods and drugs.

This stood in stark contrast to the approach taken in the UK back in 2010 in which a lengthy public inquiry into the “nanotechnology” used in food was researched. The end result of all their well-intentioned proceedings  was a public statement that amounted to “We don’t know if there are nanomaterials in our food, or not.”

And they weren’t going to find out much more because they had put the food industry in the position of a witch in a proverbial witch trial. Short of burning them at the stake, the food industry was not saying what nanomaterials were in their products.

The FDA has tried to take a “good cop” approach with the food and drug industry in the hope that they would work together with the regulators. Whether this will actually happen remains to be seen, but this latest announcement from the FDA seems to makes this approach the agency's official policy going forward.

The NNI has also been feeling the pressure perhaps not so much from industry but from consumer groupsother government bodies and finally itself to spend more of its budget on EHS research.

The results of an increased budget and greater focus on EHS issues surrounding nanotech have resulted in what would appear to be significant movements in the right direction, including a measurement tool to consider the full life cycle of nanomaterials in various media (a full list can be found on the NNI website).

Whether these results are going to be enough to satisfy those who wrap nanotechnology up in the same bundle with the evils of big international corporations and totalitarianism will be a lingering question. But I will speculate that they won’t be happy with these two most recent developments.

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Nanoclast

IEEE Spectrum’s nanotechnology blog, featuring news and analysis about the development, applications, and future of science and technology at the nanoscale.

 
Editor
Dexter Johnson
Madrid, Spain
 
Contributor
Rachel Courtland
Associate Editor, IEEE Spectrum
New York, NY
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