In a recent speech to the IFT International Nanoscience Conference, Dr. Annette McCarthy of the FDA, is quoted as saying "We believe that the regulatory authority is sufficient to address nanotechnology. But there are further questions we need to address".
J. Clarence Davies, currently with the Woodrow Wilson International Center project on Emerging Nanotechnologies, might agree with the latter part of that statement, but certainly not with the former.
In the recently published "Oversight of Next Generation Nanotechnology", Davies looks at existing regulatory agencies that would have oversight of nanoproducts and finds them lacking:
The current oversight system was designed to deal with the problems of steam engine technology in the context of a pre-computer economy. . , ,
It was based on assumptions that most programs are local, that programs can be segmented and isolated from each other, that technology changes slowly and that all the important problems have been identified. All of these concepts are no longer valid. . . . The antiquated conceptual basis of the system has been made more evident by the massive erosion of money and manpower from a system that always suffered from inadequate resources.
The inadequacy of the current system to deal with new technologies is obvious. Especially in the United States, regulatory oversight has always been somewhat deficient, and over the past 30 years it has been allowed to deteriorate to the point where only major changes can rescue it. On both sides of the Atlantic, extreme free market ideologies have contributed to the erosion of oversight. Furthermore, there has been a failure to anticipate and analyze the new technologies that are being created and commercialized at an ever-increasing rate.
Mr. Davies offers what some might see as a radical solution, dissolving such agencies as EPA, CPSC, etc, and creating a new cabinet level Department of Environmental and Consumer Protection, which would have the authority to and be tasked with product and technology regulation, pollution control, etc.
No one will, I think, disagree with Davies observations on the current state of US regulatory agencies. Decades of decreasing budgets, decreasing staff, and the dominance of a political ideology that viewed government regulation of anything as evil effectively rendered agencies such as CPSC impotent and unable to perform their duties. This impotence extended to other agencies as well- we have only to look at the near collapse of the economy to see that agencies charged with regulating economic matters failed as well. With a change in administrations and public outrage the various failures of regulatory agencies, those agencies are finally beginning to see an increase in their budgets, manpower and authority.
Certainly also, one cannot disagree with Davies assertion that the agencies that he focuses on were designed to regulate products created by 19th and early 20th century technologies and industries and are in need of a review and updating. However, one has to wonder if Davies proposal of tearing the regulatory structure down and starting over is a practical solution.
Davies assumes that a new Department of Environmental and Consumer Protection’s budget would equal the combined total of the budgets of the agencies and departments it would be replacing. Given the way that the federal budget process operates, that’s an assumption that is unlikely to happen. Further, it’s also unlikely that moving agencies from one department to another and merging agencies to create an new department would be a smooth and easy process. Each one would have it’s own particular office culture which might create friction among personnel. Also, aside from the lobbying of various interest groups to contend with, Congressional Committees and Subcommittees that have budgetary control might not be willing to give that control and power up.
Having said this, Davies report does serve as a starting point for a long overdue discussion of needed changes in regulatory agencies that have and will have responsibility for regulation of nanotechnology and nanoindustry. As Davies points out early on in the report, the purposes of regulation are to safeguard the public and create conditions that allow for the safe growth of, in this case, nanoindustry, something that I think most of us reading and writing on this blog want to see.
