Nanotechnology Lawyer & Attorney : Porter Wright Morris & Arthur : Nanotechnology Law Report - Germanium nanobead image provided by UT-Battelle, which manages Oak Ridge National Laboratory for the Department of Energy

The primary disagreement appears to be whether to issue a policy at all, or rely on existing statutory and regulatory controls.  As one might expect, the panel was split on this issue, resulting in no action in the short term.  The split was right down the middle with 5 panel members voting in favor of a policy, 5 voting against, and 1 abstaining.

The panel did agree that FDA should collaborate with OSHA and EPA should either agency begin drafting a policy concerning nanoparticles.  FDA will hold a public meeting in September to discuss particle size in drugs and how to obtain such information from its current database.

FDA's inaction is not wholly surprising given the state of nanotechnology regulation.  However, the even split was somewhat unexpected.  The debate seems to center around the data submissions by companies seek FDA approval on products and what is already required.  I, personally, would not have thought the division would be so even (unless purposefully manufactured).  Perhaps this is a mircochasm of the public generally, that being a 50/50 split on what the next step should be?  Or perhaps this is administrative gridlock in an election year?  Or perhaps this is simply an administrative agency continuing to act deliberately in considering the nanotechnology question?

The report, available on the Institute's website, lists twelve policy considerations that it believes should be considered as a policy framework is developed.  Those policy considerations are: 1) societal goals, 2) public education and engagement, 3) activity and information inventories, 4) identification of lead agencies, 5) technical issue identification such as terminology and metrology, 6) regulatory framework priority identification including risk assessment, science, and stakeholder involvement, 7) labeling and consumer protection, 8) liability and intellectual property issues, 9) support for science and research, 10) commercialization and economic benefits, 11) training, and 12) security.

The report delves into each consideration in more detail, but the Institute believes that each should be developed in order to establish a solid nanotechnology framework in Canada.

Interestingly, the report also touches on barriers to a national nanotechnology policy in Canada, many of which are the same as those facing the United States.  The report cites such policy development challenges as the lack of information and lack of tools to "deal responsibly" with nanomaterials already in commerce.  The needed tools the Institute points to include: standard definitions, labels, and data sheets, as well as "structures and resources for public education and engagement."  These are some of the very challenges facing policy development in the United States.

Through consideration of the twelve points above, the Institute believes that Canada can begin to create a policy framework.  The Institute states that at this early stage, "our proposed policy framework focuses on goals; on what needs to be attended to; and to a lesser extent how it should be done: the elements of a policy framework."

Clearly nanotechnology policy development is an international issue, with many, if not all, of the same challenges and questions arising for each country to delve into the regulatory questions surrounding nanotechnology.