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|Lynn L. Bergeson
Bergeson & Campbell, P.C.
The August 25, 2011, issue of Nature includes a letter from Dr. Hermann Stamm, European Commission (EC) Joint Research Centre (JRC), Institute for Health and Consumer Protection (IHCP). In response to Dr. Andrew Maynard's article entitled "Don't define nanomaterials," in the July 7, 2011, issue of Nature, Stamm argues that a definition of engineered nanomaterials for regulatory purposes is "urgently needed."
September 2nd, 2011
To Define or Not to Define: The War of Words
The August 25, 2011, issue of Nature includes a letter from Dr. Hermann Stamm, European Commission (EC) Joint Research Centre (JRC), Institute for Health and Consumer Protection (IHCP) ( http://www.nature.com/nature/journal/v476/n7361/full/476399c.html ) In response to Dr. Andrew Maynard's article entitled "Don't define nanomaterials," in the July 7, 2011, issue of Nature, Stamm argues that a definition of engineered nanomaterials for regulatory purposes is "urgently needed."
Maynard's comment in Nature proposes that a "‘one size fits all' definition of nanomaterials will fail to capture what is important for addressing risk," and suggests that regulators use "a list of nine or ten attributes (including size and surface area) for which certain values trigger action" ( http://www.nature.com/nature/journal/v475/n7354/full/475031a.html )
Stamm, however, maintains that size is "the most appropriate parameter on which to base a broad definition." Maynard concludes that adaptive regulations are necessary to respond to scientific evidence, while Stamm acknowledges that a definition "would need revision in line with fresh scientific evidence."
The debate illustrated by the Nature commentaries is an excellent example of a debate that is raging in the nanotechnology community globally. Several organizations (ISO, OECD, etc.) have been defining various nanotechnology-related terms for years now, and making significant progress. But a far fewer government agencies have attempted to define nanotechnology terms for regulatory purposes. Many government agencies have been reluctant to define terms pertinent to this emerging technology in the absence of additional data and information recognizing that the consequence of non-compliance with a regulatory mandate invites monetary and other unintended consequences.
A very recent example of the mischief that can arise in this regard is the U.S. Environment Protection Agency's (EPA) June 2011 proposed policy statement regarding nanopesticides. 76 Fed. Reg. 35383 (June 17, 2011). EPA's Office of Pesticide Programs offered a "working definition" of nanoscale material. EPA likewise proposed to apply reporting requirements under Section 6(a)(2) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) to obtain information about the presence of a nanoscale material component in a FIFRA registered pesticide product. If implemented, the policy would impose enforceable legal obligations on FIFRA registrants the non-compliance with which could result in monetary, civil, or even criminal penalties.
Many industry stakeholders filed comments opposing the application of Section 6(a)(2) reporting obligations for these purposes, and many questioned the dubious legality of extending the Section 6(a)(2) reporting obligation through a policy statement as opposed to notice and comment rulemaking.
The point here is that much mischief could arise from one program office within a single federal agency (let alone the federal government) unilaterally proposing a "working" definition of nanomaterial and imposing legally binding reporting obligations under a federal law that is based on the application of that definition. The reason why many regulatory agencies have been reluctant to embrace definitions for regulatory purposes is that many believe a one-size-fits-all approach is scientifically indefensible and likely to do more harm than good.
The debate will continue for some time. In the interim, stakeholders need to remain vigilant in monitoring global initiatives and try as best as possible to encourage regulatory agencies to define no term prematurely or inappropriately. The consequences of a rush to judgment will not help advance regulatory goals, may well confuse an already muddled area, and compromise the commercialization of a promising technology.