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Let’s face it:  Industry would just as soon be left alone.  But in this modern society, that’s simply not possible.  Government regulation is necessary to advance policy goals, which include the safety and health of the general public.  Industry recognizes this, of course, and wants to be able to undertake its activities knowing what the government requires (mandatory) and expects (voluntary) of it.  This is even more critical in the world of global commerce, where an industry may be subject to varying – and sometimes even contradictory – standards in different countries.  In the United States alone, separate state regulation of nanotechnology could lead to confusing and incompatible standards.

 Isn’t the nanotechnology industry entitled to a uniform set of definitions to be able to interpret and apply regulatory standards?

 This is the gist of an article that appeared recently in the BNA Daily Environment Report at

Pat Rizzuto & Bill Pritchard, Industry Developing Nanoengineered Goods Frustrated by Regulators’ Lack of Definitions, 93 Daily Envt. Rpt. (BNA) B-1 (May 17, 2010) (available by subscription)

In recent months, various bodies have been attempting to address this issue, but it is likely that nothing representing a consensus may emerge soon.  Yet, there may be some urgency to the task.  As reported in the article, one industry executive in a company developing electronics using nanomaterials said that regulatory certainty is necessary in determining whether to move its operations from the United States to China.  The article went on to discuss the efforts that many countries are making to develop standard definitions for nanomaterials.  This, of course, is only a precursor to regulation.  There is currently no agreement as to what the size of a particle means in the regulatory world and whether a workable definition should be based solely on size.

The International Organization for Standardization (ISO) hopes to have a set of definitions by the end of the year.  The article goes on to indicate that a coalition of businesses may become involved in developing standardized definitions.

 The European Commission’s Joint Research Commission (JRC) released a report July 2, 2010, emphasizing the need for a uniform definition of the term “nanomaterial” and providing “practical guidance for a definition for regulatory purposes.”  The report recommends the following criteria, suggesting that a definition:

  •  only concern particulate nanomaterials,
  •  be broadly applicable in EU legislation, and in line with other approaches worldwide,
  • use size as the only defining property.

European Commission, Joint Research Centre, Considerations on a Definition of Nanomaterial for Regulatory Purposes 5 (2010).

 The JRC report may be accessed at

 http://ec.europa.eu/dgs/jrc/downloads/jrc_reference_report_201007_nanomaterials.pdf

 Clearly, we have not yet arrived at the point of being able to speak the same nanolanguage around the world.  Every nanostep helps, however.  But time is of the essence.  And consensus is crucial.