On December 21, IATP joined five other NGOs, headed by the International Center for Technology Assessment (ICTA), to sue the Food and Drug Administration for failure to regulate nanoparticles. The lawsuit is the first concerning the health and environmental effects of nanoparticles and nanotechnology enabled products. The FDA currently does not require pre-market health and environmental safety testing of nanomaterials prior to their introduction on the marketplace.
A June 9, 2011 White House memo acknowledged that a broad array of products containing sub-molecular sized particles, including those engineered for “disease detection” under FDA authority, are marketed in the United States. IATP’s Steve Suppan said that part of the FDA response to the lawsuit must be the testing of engineered nanoparticles “as part of a pre-market safety assessment in a broader regulatory initiative to protect public health.”
The decision to sue resulted from FDA’s failure to respond substantively and specifically to a May 2006 ICTA et al petition to regulate nano-titanium dioxide in sunscreen and engineered nano-particles in FDA regulated products. Nano-titanium dioxide is mixed in sunscreen to provide enhanced protection against ultraviolet rays and can penetrate the skin, but the public health effects, particularly as a result of chronic exposure, are not clearly understood. Nano-titanium dioxide is also reportedly an ingredient in a coating applied to fruits and vegetables to retard spoilage caused by ultra-violet rays.
The lawsuit was filed in a northern Californian court two weeks after the U.S. House of Representatives had passed “Regulations from the Executive in Need of Scrutiny” (REINS). The legislation, which President Barack Obama’s advisors recommended that he veto if it were passed by the Senate, would require Congress to approve any major regulation it judged to have more than $100 million economic impact. REINS also would kill any major regulation if Congress did not approve it within 70 days. In early December, the U.S. Chamber of Commerce wrote in support of the legislation, as Congressional allies praised the legislation as necessary for job creation.
It perhaps goes without saying that the Chamber opposes “excessive government regulation” of nanotechnology. Under REINS, any nanotechnology regulation would be regarded as “major” and hence subject to Congressional disapproval for broad reasons of placing U.S. companies at a competitive disadvantage, except in cases of public health emergencies. However, as IATP emphasized in its June 2011 report, “Racing Ahead: U.S. Agri-Nanotechnology in the Absence of Regulation,” minimizing research into the environmental, health and safety effects of nanotechnologies, while allowing industry to effectively “self-regulate” nanotechnology will not enable the “New Industrial Revolution of the 21st Century” that nanotechnology promoters promise.
