US Agency Releases Assessment Report on Nanotechnology, Calls for Refined Regulatory Approach

Posted 30 April 2012 | By

The President's Council of Advisors on Science and Technology (PCAST) has released a report assessing the US's progress in implementing a broad-based program to promote the research and development of nanotechnologies, including regulatory strategies aimed at generating new medicines and technologies.

One of the PCAST report's highest concerns was for workplace safety and implementing and enforcing adequate regulations to ensure manufacturing facilities are safe for workers.

"As new modes of manufacturing are developed and explored, the need to address occupational health and safety issues will take on even greater urgency," wrote PCAST in its report, Report to the President and Congress on the Fourth Assessment of the National Nanotechnology Initiative.

"A recent survey found that 59 percent of U.S. nanomaterials companies do not monitor the workplace for nanoparticles despite government recommendations to do so," noted PCAST. "It is therefore critical that the appropriate Federal agencies engage with companies in a non­regulatory capacity to increase their awareness of and ability to use the latest knowledge and guidance being generated on this topic."

PCAST also called upon numerous federal agencies, including the US Food and Drug Administration, to "clarify the development pathway and increase their emphasis on transitioning nanotechnology to commercialization, including making sustained meaningful investments in focused areas to help accelerate technology transfer to the marketplace."

FDA has recently made additional strides in that area, releasing new regulations guiding the development of cosmetic products containing nanomaterials.

In a statement released in the journal Science on April, FDA Commissioner Margaret Hamburg said FDA's approach to the regulation of nanotechnology is likely to become "more nuanced" over time. Hamburg also called upon manufacturers to work more closely with the agency when developing nanomaterials-an approach endorsed by PCAST.

PCAST also called upon FDA and other agencies to integrate their respective research, saying the lack of integration risked blinding agencies to related safety concerns.

Read more:

Report to the President and Congress on the Fourth Assessment of the National Nanotechnology Initiative

PCAST Releases Assessment of National Nanotechnology Initiative

Regulatory Focus - Hamburg: Nanotechnology Regulation Likely to Become 'More Nuanced,' Outlines Regulatory Approach


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