Richard Denison, Ph.D., is a Senior Scientist.
It’s been a few months now since the White House took the unusual step of articulating some “Principles for Nanotechnology EH&S Oversight.” Given recent events, it’s worth again reflecting on this official memorandum, which was signed by the heads of the White House’s Council on Environmental Quality (CEQ) and Office of Science and Technology Policy (OSTP) and sent to the heads of all federal agencies and departments.
Despite the title, it’s very hard not to read this document as one intended primarily to throw up barriers to effective oversight.
Consider the following features of the Principles memorandum:
• As Andrew Maynard has already pointed out, it clearly prioritizes nanotechnology’s potential benefits over its potential risks: How else to explain that the foremost purpose of the principles is to ensure that any oversight is “cognizant of the potential benefits”? This would be one thing in a document describing the overall federal approach to nanotechnology; it’s quite another in a document that is ostensibly about oversight.
• It claims that statutory authorities are adequate and no changes are needed. Over the past couple of years, this has become a constant refrain of government officials across the board. While most independent analyses conclude that nanomaterials fall generally within the scope of existing environmental statutes, major challenges in actually implementing or applying each relevant authority to nanomaterials have also been identified, for example, here and here. In future posts, I’ll explore this question in relation to the Environmental Protection Agency’s (EPA) exercising of its authorities under the Toxic Substances Control Act (TSCA).
• It argues that “standard” risk assessment and risk management approaches can and should be used for NMs without modification – very different from the conclusions of a scientific expert committee in the European Union, which identified numerous areas where modification and enhancements are needed.
• It then advances a series of statements to govern the “regulatory path forward” that are either patently obvious (e.g., “Regulation should focus where need exists”), or invoke criteria being used elsewhere to undermine or slow regulatory action: Regulatory actions should not impede innovation; they should be performance-based; they should be case-by-case; their benefits should outweigh their costs.
Finally, the document methodically lists all of the regulatory hoops agencies already have to jump through, even going so far as to provide a handy weblink to each of them – as if regulatory agencies were not already acutely aware of the hurdles that any proposed regulation faces these days.
So what exactly was the purpose of issuing this document? It’s not as if there was a need to rein in upstart federal agencies chomping at the bit to regulate nanotechnology. Such agencies have been decidedly unable or unwilling even to require nanotech companies to identify themselves or submit whatever information they happen to have. Instead, EPA dallied for more than two years before finally launching its open-ended voluntary reporting program, and at the same time effectively exempted new nano forms of all chemicals on the TSCA Inventory from meeting requirements applicable to any other new chemical.
The Food and Drug Administration’s Nanotechnology Task Force, meanwhile, appears to have reversed FDA’s earlier position that suggested nanomaterials are really nothing new – but then recommends only that the agency issue guidance for manufacturers to use on a voluntary basis. While acknowledging there are major gaps in available information – especially for those classes of products, such as cosmetics, for which FDA has no pre-market approval authority – the task force does not recommend taking any steps, beyond conducting more research, to address these serious problems.
Frankly, given this reality on the ground in Washington, it’s hard not to see the Principles memorandum as yet another manifestation of the conflict of interest emerging between the dual roles the National Nanotechnology Initiative (NNI) has been charged with, one that creates a false choice between promoting the development of nanotechnology and exercising effective and timely oversight.