Grey Goo

The regulation of nanotechnologies—products and processes which incorporate extremely small particles ( a nanometer is one billionth of a meter, and nanoparticles are usually described as those between 1 and 100 nanometers) – has popped into public visibility in the last year or so. Both federal and state governments have been promoting these technologies in a big way over the last several years—the multiple federal agencies that are part of the National Nanotechnology Initiative (NNI) have been spending close to a billion dollars a year to research and promote these technologies, and states have been avidly chasing the firms which do the research and produce the products. Products have been moving out of the lab and into the marketplace at an increasingly rapid rate—inventories maintained by the Project on Emerging Nanotechnologies at the Woodrow Wilson International Center for Scholars currently list over 300 products incorporating these particles and that’s almost certainly on the low side.

All of this development has happened without much attention to the consequences of large scale use of these products, particularly in the short run. Beginning with a book by futurist Eric Drexler in 1986 and continuing through a widely cited article by Bill Joy and Michael Crichton’s book Prey, there have been vivid dystopian scenarios of self-replicating nanobots covering the earth with “grey goo” which could annihilate the biosphere. More prosaically, there appears to have been little systematic effort to assess the environmental and health risks associated with nanoparticles. Recent reports by the British Royal Society and a distinguished largely American group which published an article in Nature a couple of months ago have noted this lack of attention. There is at least some evidence that these risks are not trivial— substances which are not reactive at larger scales may be so at nanoscale, but other factors besides size also come into play. The Nature article calls for a fifteen year research program to reduce the current uncertainty about the consequences of widespread use of these products.

The immediate question is what we do in the meantime. There have been calls for a moratorium on nanotechnological products until risks are better understood, but this seems unlikely to materialize. Federal regulatory agencies such as the FDA and EPA are beginning to regulate nanoproducts under their existing statutes—the EPA just announced a couple of months ago that that manufacturers of products which use nanosilver products to kill bacteria in such products as washing machines and shoe liners must now submit data showing these products have no adverse environmental or public health impact. How readily nanoproducts can be regulated under existing law isn’t really clear---some commentators have noted regulatory holes in the statutes authorizing federal action, which were written before nanomaterials came on the scene. Given the holes in the science and in the law, it may be a while before we have a coherent federal regulatory framework in place. It’s not difficult to imagine a scenario in which legal challenges limit federal agencies’ ability to regulate nanoproducts and Congress is reluctant to support expanded funding for risk research, increases in the budgets of regulatory agencies, or changes in regulatory legislation.

Given this potentially slow pace in Washington, it wouldn’t be surprising if the first serious attempts to regulate nanotechnologies come from state or even local governments. In fact, it’s already started---Berkeley, California has recently adopted an ordinance which requires users of nanomaterials to file an inventory and safety plan similar to those required for users of hazardous materials. This isn’t the first time local governments have acted to regulate cutting edge technology—since the late 1970’s, for example, anybody wishing to use recombinant DNA within the borders of Cambridge, Massachusetts has been required to secure a permit from the city health department that covers a wide range of biosafety issues. States typically have broad constitutional powers to protect the public health, and there may be fewer legal obstacles to state or local action than to federal. Even if federal action proceeds relatively rapidly, individual states or localities may wish to adopt additional health and environmental protection requirements for nanoproducts, and it’s far from clear that these would be pre-empted or invalidated in any way by federal regulatory action.

The major determinant of the future of nanoregulation in this country is likely to be political. The Cambridge ordinance had its origins in a rancorous spat between the city and Harvard in which the university basically blew off residents’ concerns. Similar conflicts over nanotechnology products are a real possibility. While “grey goo” scenarios are implausible, the real scientific uncertainty about how safe nanoproducts are, as well as the increased activism around these issues by environmental groups, may make some communities cautious about the conditions under which they allow research or manufacturing using these materials within their borders. Public opinion polls show considerable distrust of the ability of industry to regulate itself and support for governmental regulation of nanoproducts. Nanotech industry groups claim to get this, and have promoted “responsible development” of nanotechnology with appropriate acknowledgement of risks and uncertainties. What this means in particular circumstances, however, is still very much an open question.
- Jim Fossett, AMBI/Rockefeller Institute Federalism and Bioethics Initiative
(With thanks to Summer Johnson)

HPV Fights - Once Again, the States Decide!

It ain’t over, said Yogi Berra, until it’s over, and the debate over what to do about Gardasil, the vaccine developed by Merck against the strands of the human papilloma virus (HPV) that cause cervical cancer. is still raging hot and heavy in many states. While the vaccine has been recommended for routine use by the CDC’s vaccine advisory committee and a number of professional groups such as the American Cancer Society and the American Academy of Pediatrics, the question of whether states should mandate the vaccine for school girls has been more controversial. Only one state—Texas—has formally mandated the vaccine to date, but over 30 states are reportedly considering some form of mandate.

As frequently happens in politics, the debate over mandating has in many places been about things other than the merits of the vaccine. HPV’s are sexually transmitted, and many conservative groups have complained that mandating the vaccine will encourage sexual activity and promiscuity. Other groups have complained about the intensity of Merck’s campaign to sell the mandate. The company has mounted strong lobbying campaigns in favor of a mandate in a number of states and has financed a major cervical cancer awareness and pro-mandate initiative by Women in Government, a advocacy group of women state legislators. Merck is charging $360 for the three shot vaccine regimen, and there have been charges that the company is trying to secure market share before a competitive vaccine being brought out by GlaxoSmithKline hits the market later this year, which will almost certainly cause the price to come down. The backlash against these activities has been so severe that Merck has announced it is terminating its lobbying efforts.

All this political flap seems unfortunately likely to divert attention from the vaccine’s merits, which seem considerable. Cervical cancer is not the problem in this country than it is elsewhere, because most women get regular PAP smears, but there are some 10,000 new cases a year and over 3,500 fatalities. The CDC’s most recent prevelance estimates (published in this week’s JAMA) for HPV infection detected the two strands of the virus that cause cervical cancer in over two percent of the women in the United States, with an additional 10 percent or so being infected with other “high risk” forms of the virus. Gardasil also vaccinates against two “low risk” HPV’s which are associated with genital warts and other low level cervical changes. Overall, HPV infection and cervical cancer are most common among low income women who may have trouble accessing or affording regular PAP smears. In clinical trials, Gardasil demonstrated close to 100 percent efficacy in preventing the precursors of cervical cancer, and side effects appear infrequent and mild.

The case for mandating is weaker, but still reasonable. Typically vaccine mandates take a longer time to roll out after there has been more experience with the vaccine in the general population and side effects or other problems have had time to emerge. The professional groups that have endorsed the vaccine have typically not taken a position on mandating. The vaccine is currently very expensive, but the price may come down once the competing vaccine hits the market. Federal vaccination support programs typically cover younger children, but not the teenagers and young women who are also major targets for a vaccination effort, so insuring adequate access remains an issue. Absent a mandate, access to the vaccine will remain limited to those who know about it and can afford it, which are not those groups at greatest risk who need the vaccine the most. Past mandates do appear to have been relatively successful in expanding vaccination rates and equalizing access to vaccines, but additional funding would be required. Medicaid and CHIP are obvious possible funding sources for girls under 18.

What seems likely to happen is that different states will do different things—some states will mandate with a variety of different conditions and some will not, and there will be significant disparities across the states in who does and doesn’t have access to the vaccine. I know we’re getting boring about this, but what happens in state capitals is more important than what’s happened in Washington.

Jim Fossett
AMBI/Rockefeller Institute
Federalism and Bioethics Initiative

More State Bioethics: HPV Vaccine Proposals Snowball

Kaiser Network really lays it out: states matter at least as much as what feds do—even in red states…and the HPV situation proves it.
- Jim Fossett

Scaring Off Science: Missouri Anti-Stem Cell Research Crowd Takes a Page from the New Jersey Playbook and Tries to Kill Construction

Although they don't mention it, Jonathan Moreno and Sam Berger are ripping on New Jersey pro-life tactics as well as those in the Show Me State. This in their new web piece about Missouri on the CAP site, a nice review of the problems in that state, and a clear indication that people are taking seriously the importance of moving from federal to state examination of bioethics problems.
hat tip: Art Caplan