I would like to share with the Nanotechnology Community regulatory developments that occurred last week in Washington, DC on Thursday, June 9th. Paul Stimers, Partner, K&L Gates and NanoBusiness Public Policy Advisor stated the following.

Thursday, June 9, 2011 was a busy day for federal nanotechnology policy, with action from two regulatory agencies and the White House on the environmental, health, and safety aspects of nanotechnology. The NanoBusiness Commercialization Association continues to call for more research on this front, so that any regulatory activity addresses real needs, avoids unnecessary burdens on small businesses, and enables safe and useful products to reach the market.

EPA announced plans to gather information on nanomaterials in pesticide products to determine “whether the registration of a pesticide may cause unreasonable adverse effects on the environment and human health.” The agency plans to gather information both by requiring pesticide registrants to inform EPA of new information “regarding unreasonable adverse effects on the environment” and through data call-in notices. EPA also will propose a new case-by-case approach for determining “whether a nanoscale ingredient is a ‘new’ active or inert ingredient for purposes of scientific evaluation under the pesticide laws, when an identical, non-nanoscale form of the nanoscale ingredient is already registered under the pesticide law.” The full prepublication notice, including instructions for commenting, is available at http://www.epa.gov/pesticides/regulating/prepub-nanopest.pdf.

FDA issued draft guidance for industry that describes the agency’s “current thinking on whether FDA-regulated projects contain nanomaterials or otherwise involve the application of nanotechnology.” It represents a more expansive approach than has been taken in the past by the NNI and industry. FDA stated that its two key criteria in answering that question will be:

1) Whether an engineered material or end product has at least one dimension in the nanoscale range (approximately 1 nm to 100 nm);


2) Whether an engineered material or end product exhibits properties or phenomena, including physical or chemical properties or biological effects, that are attributable to its dimension(s), even if these dimensions fall outside the nanoscale range, up to one micrometer.

Importantly, FDA noted that “these considerations apply not only to new products, but also may apply when manufacturing changes alter the dimensions, properties, or effects of an FDA-regulated product or any of its components.” FDA also indicated that the criteria are subject to change in the future as more data becomes available. The full document, including instructions for submitting comments within 60 days, is available at http://www.fda.gov/RegulatoryInformation/Guidances/ucm257698.htm.

The White House also issued a joint memorandum on the regulation of nanotechnology from the Office of Science and Technology Policy, the Office of Management and Budget’s Office of Information and Regulatory Affairs, and the office of the U.S. Trade Representative. The memo provides guidance to agency heads, stating that “regulators should use flexible, adaptive, and evidence-based approaches that avoid, wherever possible, hindering innovation and trade while fulfilling the federal government’s responsibility to protect public health and the environment.” The memo lists principles that agencies should follow. It is available at http://www.whitehouse.gov/sites/default/files/omb/inforeg/for-agencies/nanotechnology-regulation-and-oversight-principles.pdf.

This message is for informational purposes and does not contain or convey legal advice. The information herein should not be used or relied upon in regard to any particular facts or circumstances without first consulting a lawyer.

These recent regulatory developments, discussed by Paul will, have an impact on our Nanotechnology Community. I would be happy to answer any questions in regard to these recent regulatory developments.


Vincent Caprio “Serving the Nanotechnology Community for Over a Decade”
Executive Director
NanoBusiness Commercialization Association