The Task Force is clear and candid in acknowledging the pervasive potential of nanotechnology to affect virtually every product category FDA regulates—from pharmaceuticals and devices to cosmetics and food supplements— and in calling for a wide range of FDA actions to prepare for and execute its oversight role. While available evidence does not suggest that all materials with nanoscale dimensions will be hazardous, the Task Force correctly concludes that the agency needs new safety assessment tools, greater nano-specific staff expertise and more risk research to assess the likelihood of long-term health effects from exposure to specific nanoscale materials.
The report also recognizes the need to gather more information from industry, especially to answer safety-related questions, and to provide companies with clear guidance so there can be reasonable and safe pathways to market for the many potential applications of nanotechnology under FDA’s jurisdiction.
Equally important, the report signals FDA’s commitment to a transparent public process for developing its regulatory policies. Public participation will be key both to developing good policies and winning public confidence in the agency’s oversight of nanotechnology, and I applaud the Task Force and FDA for taking this approach.
Finally, the extensive nanotechnology “to do” list outlined in the report should remind Congress, as it considers FDA’s 2008 budget, that it needs to fix the problem of FDA’s chronic underfunding. The agency urgently needs more resources to do what needs to be done on nanotechnology—and do it urgently—along with the many other challenges the agency faces.-Project on Emerging Nanotechnologies
