FDA Forced to Act on Nanotechnology Petition?
In May 2006, the International Center for Technology Assessment and other NGOs, including Friends of the Earth and Greenpeace, filed a Citizen Petition with FDA requesting the agency take a series of actions related to nanotechnology including declaring “all currently available sunscreen drug products containing engineered nanoparticles...an imminent hazard to public health...” and enacting “new regulations...establishing and requiring..., nanomaterials be subjected to nano-specific paradigms of health and safety testing....”
Although comments were filed on the petition by several stakeholders including the Center for Regulatory Effectiveness, the FDA has not yet acted on the petition. That may change.
The recently signed FDA Amendments Act contains a section related to Citizen Petitions that includes a provision stating that “The Secretary shall take final agency action on a petition not later than 180 days after the date on which the petition is submitted. The Secretary shall not extend such period for any reason....”
Should the newly passed law apply to the NGO nanotech petition and compel agency action, it is essential that the agency’s response comply with the Data Quality Act and that such compliance be publicly documented.
See FDA Nanotechnology Petition docket
See ICTA website
