In a June 9, 2011, memorandum to the heads of U.S. executive departments and agencies, entitled Policy Principles for the U.S. Decision-Making Concerning Regulation and Oversight of Applications of Nanotechnology and Nanomaterials, the White House confirmed its commitment to a “science-based” approach to health and safety matters related to nanotechnology. The memorandum issued from the Office of Science and Technology Policy, the Office of Management and Budget, and the Office of the U.S. Trade Representative. The memorandum described its approach as
“generally applicable principles relevant to promoting a balanced, science-based approach to regulating nanomaterials and other applications of nanotechnology in a manner that protects human health, safety, and the environment without prejudging new technologies or creating unnecessary barriers to trade or hampering innovation.”
The memorandum went on to explain that the approach it establishes is inherent in the risk-based approach commonly used by federal agencies such as the FDA, but is grounded in best available, and evolving, science.
This is a tall order. It is important that the White House explicitly addressed nanotechnology and nanomaterials, rather than using the vague term “emerging technologies,” as it has done in the past. But perhaps the most significant part of the memorandum is in its elevation of the science-based approach over other possible approaches (technology-based, economics-based, etc.) to the study and regulation of nanomaterials.
Intending to provide guidance to existing federal agencies, the memorandum stated: “Federal agencies should avoid making scientifically unfounded generalizations that categorically judge all applications of nanotechnology as intrinsically benign or harmful.” Consumer trust, the memorandum went on to say, is important in encouraging technological innovation.
On the one hand, the memorandum eased industry concerns that nanotechnology will be viewed as “bad” and all nanomaterials as “hazardous” because of the flurry of attention focused on the technologies and the concerns voiced by various groups. But on the other hand, the message is clear that science will govern the study of nanomaterials and any decisions about whether or how to regulate. And that is also a message to industry to come forward with the science that the agencies need.
The memorandum also announced the creation of an interagency working group to coordinate this basic framework across agency lines, promote coordination of regulatory activities, and share information.
How is this policy likely to play out in the relevant departments and agencies? Here are a couple of recent steps that illustrate the initial approach:
● On June 10, 2011, the FDA issued a Draft Guidance, Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology, to provide manufacturers, suppliers, importers, and other stakeholders with the FDA’s “current thinking” on the subject. The Draft Guidance was issued in conjunction with the White House memorandum. The document provided no definitions, nor did it provide any information on the regulatory status of any products. Rather, the document stated that its purpose is “to help industry and others identify when they should consider potential implications for regulatory status, safety, effectiveness, or public health impact that may arise with the application of nano-technology in FDA-regulated products.”
The FDA Draft Guidance is available at
http://www.fda.gov/RegulatoryInformation/Guidances/ucm257698.htm
● A similar document was issued by EPA setting forth its proposed policy for obtaining data on nanoscale materials in pesticides, pursuant to its authority under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Another important aspect of what EPA is considering is a case-by-case analysis of whether a nanoscale ingredient in a pesticide is considered “new” for the purpose of study and regulation. This is a sharp departure from EPA’s earlier stance that it would consider all nanoscale ingredients as “new,” whether or not a non-nanoscale form of the ingredient was already registered under FIFRA. The new approach is consistent with the urging of the White House memorandum that agencies avoid generalizations about nanomaterials and based all decision on the scientific evidence.
The prepublication version of this notice is available at
http://www.epa.gov/pesticides/regulating/prepub-nanopest.pdf
The White House memo is available at
