It’s amazing how items accumulate in an in-box when you’ve been out of town. Such is the case here. Several articles and other items of interest have come to my attention, but posting them here has been difficult lately. With that, here are some regulatory items that may be of interest to readers:
First, a forthcoming paper from the American Chemistry Society, "The Impact of Toxicity Testing Costs on Nanomaterial Regulation," analyzes the costs of testing the toxicity of nanoparticles in relation to the regulating agencies that bear the burden of this risk analysis. The author suggests a tiered regulatory system, such as the EU’s REACH program.
Second, Michael Berger of Nanowerk published an article discussing the adequacy of current regulations in relation to nanomaterials. The article draws heavily from a PhD thesis, "Regulation and Risk Assessment of Nanomaterials– Too Little, Too Late?" Mr. Berger uses this thesis to reopen the discussion concerning the adequacy of current regulation as it relates to nanotechnology development.
Third, the International Medical Device Regulatory Monitor reports that FDA "has no plans to toughen its regulations on nanotechnology." The article quotes Norris Alderson, FDA’s Associate Commissioner for science, as saying, "the science does not dictate that there is a need to do more than what we’re already doing now." The article also reports that FDA has no plans to update its 2007 Task Force report. The article points out this may be a departure from the considerations of international counterparts.
Finally, the Risk Policy Report indicates that California may be getting ready to move forward on nanotechnology regulation. AB 935 has been proposed, and it is expected that the bill will be amended "to propose a detailed nanotechnology regulatory program for California." As it currently sits, AB 935 is a general, place-holder, bill “to state the Legislature’s intent to enact legislation to address emerging toxicity issues surrounding the increasingly widespread utilization of engineered nanomaterials."
I hope this is enough reading material for your Monday morning. Enjoy!