As nanotechnology matures, providing more and more products with particles measured in nanometers, the risk of exposure to these particles needs to be assessed and regulated.  Being able to determine what size of particles can be expelled by the body and what sizes accumulate in the body helps shape the questions for the regulatory landscape.  But it doesn’t close off exploration into potential risks.

While other regulatory models can provide useful examples, it’s important to remember that the scale of these particles may provide unique concerns.  I would hope that the hard lessons of chemical regulation – where accumulated exposure flew under the regulatory radar for years (see Krimsky’s Hormonal Chaos for a good overview), could be used to good effect here.  It may not be enough that the small particles can be expelled.  Enough transitory exposures over time could have unfortunate effects, much like enough small doses of certain chemicals have had dramatic effects on endocrine systems.

There is a history.  Nearly every person engaged with science and technology policy in the United States seems to think their field started and ended with Vannevar Bush in the late 1940s.  This ignores over 150 years of prior activity in the United States.  The Lewis and Clark Expedition and the U.S. Census are two ventures in the field that date back nearly to the founding of the republic.   The Forest Service and Geological Survey are also good pre-World War II examples of federal science and technology at work.

There were ‘losers’. Arguably Vannevar Bush is both a loser and a winner.  While his name and Science: The Endless Frontier still carry cachet in science policy circles, the plan in that document was not approved by President Truman.  He sought the advice of a different panel, chaired by John Steelman.  That report, and Steelman, are treated as footnotes by many, while the report is a good faith effort to chart the health of the national research enterprise – a valuable contribution to debates about how to support it, both then and now.

Change is usually incremental – Part of the consequence of ignoring history is to think of new developments as being more new than they actually are.  While World War II is usually acknowledged as an influence on post-war transformations of science and technology policy, the assessment stops there.  World War I (which saw the advent of the National Research Council) and the interwar period were also influential in establishing or refining some of the institutions that contributed to the post-war landscape of U.S. science policy.

So, what’s the bottom line?  Treating an initiative – or some acheivement – as an obvious outcome is to ignore history.  Science has a tendency to focus on the winners, on the successful experiments and theories.  For science policy to follow the same trend is to ignore knowledge that can be as vaulable and useful as what you can learn from the winners and success stories.

By that, he meant that social scientists were around to entertain, look good, but nothing more. My experiences suggest that there is some element of truth in his description of the relationship of science studies with the broader scientific community, especially in those situations where the funding of the science studies scholars depends upon the largesse of the broader scientific community that they are working with. It is a difficult issue because one of the lessons from science studies research is the need for a close relationship with stakeholders, which for many science studies scholars are the scientists themselves.

I was motivated to blog on this after reading a column in the Philadelphia Inquirer by Arthur Caplan, a University of Pennsylvania bioethicist, discussing the challenges of putting limits on science. He observes,

The moral standoff that will quickly come to characterize the 21st century is becoming clear. It is not the teaching of intelligent design vs. evolution in American schools. Almost no one but biblical literalists takes the ID position with any seriousness as science. Nor will it be the heated squabble over embryonic stem-cell research. That scrum is actually over as well: Many nations around the world are doing this type of research, so the question is only where not whether.

The real battle – the battle that will come to occupy the moral center stage of American politics, morality, law, public policy, editorial pages, and water-cooler discussions – will be waged over where genetic engineering ought to take us and whether we are satisfied to leave it to scientists to guide us there.

Caplan acknowledges that “there here are plenty of reasons to worry about the misapplication and misuse of genetics.” But even with such concern, Caplan quickly turns to a defense of the inexorable advance of research, and allaying of concerns about the role of scientists in shaping such advances,

Still it is a grave, grave mistake to argue that we must put all forms of genetic engineering off limits. Too much good will be lost. Our only hope of combating some of the worst pests and plagues that beset us and will torment our grandchildren is through genetic manipulation and engineering. The genetic revolution you and I are witnessing is humankind’s last, best hope since it offers the prospect of more and safer food; the repair and elimination of genetic maladies like Tay-Sachs, juvenile diabetes, sickle cell disease, and hemophilia; the conquest of TB, malaria, avian flu, SARS, HIV, and many other plagues. And it will allow us to rebuild broken, worn out, or injured body parts.

Any of these alone would be enough reason to pursue genetic research. Together, they all but obligate us to do it. They are an all but unanswerable reply to those who say “No” to genetic research and engineering. Our society would be foolish and cruel to forbid or ban genetic research given the needs of the sick, starving, impaired and those of future generations for solutions and treatments. Will we really turn away from those who literally are dying before our eyes, or who will die before our children’s eyes, simply out of fear of scientists guiding public policy?

Caplan offers a defense of scientific advancement much like the old saw, “guns don’t kill people, people kill people,”

I do not believe we have much to fear from the actions of any individual scientist. Few, contrary to the pope’s concern, aspire to play God. Science has no tolerance for such fantasies.

Geneticists know how little they know individually and how hard it is to manipulate nature. Moreover, none of them, not even the best and brightest, is capable of transforming a discovery from the lab into the real world by himself or herself. That sort of power is reserved for the deity, governments or the market.

What the deity does is beyond our control. But what government or the market does or is allowed to do is very much a matter of politics, regulation and oversight. When theologians or members of the public point the finger of moral worry at scientists, they need to redirect it. It is governments and the marketplace that we need to shape and hold accountable for how genetic knowledge is or is not applied.

I generally agree with Caplan that genetic technologies may hold great promises and that almost every scientist is a good and decent person. But these general feelings about the science and scientists are no substitute for the fact that (a) genetic technologies may pose unknown risks (e.g., concerns raised about GMOs and the environment) and simply be morally wrong (e.g., chimeras), and (b) scientists, like any group in society, are not above democratic accountability.

Caplan suggests that the an unfulfilled role for scientists – and their science studies lapdogs – is to communicate the importance of research so that the public will allow it to go forward and support it.

What scientists need to do – and quickly – is come out of their laboratory lairs and be seen in public. You need to know about their aspirations, dreams, hopes, and values. You need to know they stand shoulder to shoulder with all of us in wanting a better world. They see a better future and a way to get there.

Genetic research in the hands of those who practice is not aimed at power, fame, ambition, or transforming oneself into a god. If it is about anything, it is about love: the love of life, the love of people, the drive to make a better life for the sick and those at risk of becoming so.

These last few statements are pretty incredible. The Hwang Woo-Suk and Gerald Schatten stem cell affair (see the University of Pittsburgh report in PDF) may have been an aberration but it did provide a window into a world where power, fame, and ambition are not so uncommon. In light of this recent experience, for an ethicist to suggest otherwise is a bit pollyannaish, and quite a bit too much cheerleadering from where I sit.

Caplan is of course right on when he asks us to

Hold your politicians accountable. Ask them to explain how funding for genetics is allocated and accounted for. Insist that they ensure that commercial interests do not succeed in keeping private genetic applications and products that might offend the moral sense of the community or, worse, our health and well-being.

But part of such accountability in my view is public engagement in the process of deciding on what research is and is not appropriate, not simply engaging abroader set of stakeholders in decisions about commercialization after the research is well underway or completed in the form of products. Along these lines, a perspective of “upstream engagement” has been discussed here in the context of the excellent work of a UK think tank called DEMOS. (Have a look at their most recent report on governing nanotechnology here.) Caplan goes too far when he asserts, “The genetic genie is out of the bottle. There is not much anyone can do to put it back nor, once we understand its potential for good, ought we to do so.” There are many genies and many bottles. Deciding which genies to free and which to keep in their bottle is an important part of the democratic governance of science and technology.

Caplan’s piece reminded me of Langdon Winner’s comments about the societal aspects of nanotechnology in Congressional testimony in 2003. Winner had some strong things to say about science studies scholars,

The professional field of bioethics, for example, (which might become, alas, a model for nanoethics) has a great deal to say about many fascinating things, but people in this profession rarely say “no.”

Indeed, there is a tendency for career-conscious social scientists and humanists to become a little too cozy with researchers in science and engineering, telling them exactly what they want to hear (or what scholars think the scientists want to hear). Evidence of this trait appears in what are often trivial excercises in which potentially momentous social upheavals are greeted with arcane, highly scholastic rationalizations. How many theorists of “intellectual property” can dance on the head of a pin?

One way to avoid the drift toward moral and political triviality is to encourage social scientists and philosophers to present their findings in forums in which people from business, the laboratories, environmental organizations, churches, and other groups can join the discussion. It is time to reject the idea there are only a few designated stakeholders that are qualified to evaluate possibilities, manage the risks, and guide technology toward beneficial outcomes.

As issues of science and technology continue to occupy an even more central role in important societal questions, there will be difficult questions raised about the role of science studies with respect to their relationship with science, politics, and policy. Science studies scholars will have to confront questions about what sorts of roles they ought to play and under what institutional, financial, and social dynamics. To oversimplify, what will it be, cheerleader, marketer, or critic?

Here is a link to the inventory.

The inventory has implications both for the economic value of nanotech investments (currently over $1 Billion in US federal funding alone), and also for the EHS (Environmental, Health, and Safety) dimenions of nanotech in society. We might think of these as conflicting understandings of “health” – one focused on economic health, the other on human and environmental health.

Not too long ago, a report “slammed” nanotech research and its funding for not delivering economically. The Wilson Center’s inventory may this reassure some as a contrary indicator.

On the other hand, Congress held hearings late last year and last month to explore EHS issues related to nanotech. The Wilson inventory may thus also raise alarms about health and safety.

An article in Friday’s Washington Post includes discussion of both of these dimensions of health. Here is an excerpt:

“The growing variety of nano-based consumer products “is what you’d hope for after a billion-dollar investment in this country,” said Vicki Colvin, director of the Center for Biological and Environmental Nanotechnology at Rice University in Houston. But with regulators still not sure what to make of the new science, Colvin said, “these companies have a great responsibility right now to do the safety testing and, to the extent possible, make those findings public.”"

In the November 18 issue of Science, Robert Service reports on the truly amazing possibilities in treating cancer with nanotechnology. How’s this for cool: gold-covered nanoparticles that attach to cancer cells and then heat up to more than 40C, cooking the cancer cells to death! Stay tuned for the remake of the Incredible Journey… The article concludes with a brief discussion on the toxicity of nanoparticles, stating, “environmental health and safety agencies around the world continue to grapple with how best to regulate these novel materials.” Despite the promise of nanotech (indeed, it’s already being used in some products), research and development should proceed with one eye on potential benefits, and the other eye on possible harms. We should avoid moving so quickly that we find ourselves with the nanotech equivalent of asbestos, MTBE (methyl tertiary-butyl ether… a gasoline additive now being phased out due to contamination in of groundwater and uncertainty regarding its health effects in large doses), or even worse, the dreaded ‘grey goo’.

However, before any health or environmental agency can regulate nanotechnology, agencies need information about the risks of nanotech. Unfortunately, only a small percentage of total R&D focuses on identifying such risks. Today, however, the NY Times reports, “the much smaller field that investigates the technology’s possible risks is also growing”. The Times continues: “The most comprehensive effort yet to provide such a research database is to go online today at nanotechproject.org… The database, which includes just over 200 research programs, also has a small number of projects financed by the European Union, Germany, Britain, Canada and Taiwan, as well as some work that has been paid for by the private sector.” I encourage you to visit the site, sponsored by the Project on Emerging Nanotechnologies of the Woodrow Wilson International Center for Scholars.

In addition to the database, the Project’s Director, David Rejeski, recently testified before the House Science Committee. He identified four challenges regarding nanotech safety research needs: more transparency and disclosure of government research; the need for the Fed to address public perception of nanotech risks; perform a thorough analysis of regulatory and oversight institutions in order to assess their ability to address future safety issues; and the need to prepare for the unexpected.

I applaud the Project’s work and I view this as an important step in gathering and collating the necessary information to ensure public safety. While Rejeski rightly drives home the importance of transparency and legitimacy in research needs (a point which cannot be overstated), he missed one important factor concerning the production of useful research. For the scientific research to be useful, it also needs to be relevant. Does the nanotech safety research community know what kind of information policy makers may need? Are the researchers assessing the safety of nanotech at different scales and quantities? Do researchers take into account the political constraints and realities of policy making, that is, the more rapid pace of political decision-making, the need to make decisions under uncertainty, and the shorter strategic planning horizon characteristic of U.S. politics? More importantly, are researchers, regulators, industry, and other concerned stakeholders communicating about what research is available, needed, and useful?

While this point may seem obvious, research on the production of ‘useful’ information for a variety of environmental and health policy issues indicate that science and policy are often disconnected from each other. Scientists produce information that may not be relevant to policy makers, and in turn, policy makers’ information needs go unmet or they may be unaware of existing information. Nanotechnology safety research needs to be relevant, transparent, and intentional. While the promise of nanotechnology is exciting, uncertainties regarding its health and safety effects are too great to for ‘business as usual’ in the production of policy-relevant information. Time to bring scientists, stakeholders, policy makers, and industry together to develop a plan for the production of useful scientific information.

**Post submitted by Bobbie Klein

The hearing comes on the heals of an assessment of the National Nanotechnology Initiative (NNI), a report that was required by the 2003 act authorizing federal funding for nanotech R&D. This law called for a National Nanotechnology Advisory Panel to conduct the assessment. In 2004, President Bush designated PCAST as the NNAP.

The law requires NNI activities to integrate research on ethical concerns surrounding nanotechnology into R&D activities, and requires the NNAC (now PCAST) to assess “whether societal, ethical, legal, environmental, and workforce concerns are adequately addressed by the [NNI]” and to make recommendations for improvement. The PCAST report, however, can be interpreted as fairly insubstantial in its treatment of how ethical concerns are being addressed (see Howard Lovy’s entertaining summary). For instance, in stressing the role of “sound science” over “perceived fears,” the language of the report appears to downplay the role of ongoing ethical assessment with respect to R&D activities.

During the hearing, PCAST co-chairman Floyd Kvamme, one of the witnesses, suggested that health, safety, and environment issues are mostly workplace related. For example, employees who install nanotubes into, say, tennis balls may face heath and safety risks. Yet, once the nanotubes are in the tennis ball, Kvamme stated, “we are far less concerned because of the technology involved there.” (By contrast, another hearing witness, Matthew Nordan, stated “the truth is we don’t know right now” whether the nanotubes in a given product may separate from their composite matrix after 20-50 years in a landfill).

Towards the end of the hearing, House Science committee member Brad Sherman had a telling exchange with the PCAST co-chairman. Asked what the administration was doing to carry out the mandate to study the potential impacts of nanotech activity, Kvamme referred to a popular work of science fiction that has come to epitomize the “perceived fear” of nanotechnology.

Later, Kvamme defended the decision not to assess the NNI with respect to ethical issues concerning artificial intelligence – issues mentioned explicitly in the 2003 act – on the grounds that research projects do not appear at present to be “going on.” Sherman responded that the provision to study the impacts of such projects “weren’t designed to become operative a year before [they] were technologically possible.”

At one point, Sherman stated “you’re supposed to be looking at the societal problems and you’re looking at the technological capacity.” In other words, “[you] don’t want to study the societal problems of doing it, [you] want to study how to do it.”

The dichotomy between “science” and “perception” can sometimes suggest an unduly high level of certainty. Consequently, ethical concerns that extend beyond the scientific capacity to address them may fall into the category of unscientific or even irrational, and may be largely dismissed. One problem with this is that real risks and significant impacts that are slow to emerge can be ignored until it is too late to effectively address them. On the other hand, popular perceptions and concerns about an emerging science can certainly be wildly inaccurate. To simply ignore these concerns, however, is to dismiss consumer and taxpayer perceptions, which can undermine commercialization efforts.

The ethics policy that the NNI ultimately adopts will in many ways involve what perspectives on uncertainty happen to be prevalent – for instance, how much legitimacy policymakers grant to the uncertainty surrounding various specific ethical concerns, or the degree to which they consider it important to focus on reducing regulative uncertainty, which can also undermine commercialization.

Another key factor will entail who actually makes the decisions. The congressional authorizing committee upon which Sherman sits contributed to the law’s language about ethical concerns. There is a running debate on what authority congressional authorizing committees actually have in comparison to congressional appropriations committees (a nice follow up post here on Prometheus?). Implementation of the law rests with administrative agencies and committees. When Sherman somewhat sarcastically wondered out loud whether “authorizing committees, even when successful in getting their language into law, are not in a position to influence administrative policy,” the PCAST co-chairman responded, “possibly not.” Needless to say, the congressman didn’t take well to the implication that authorizing committees may simply be “wasting [their] time.”

A webcast of the hearing, entitled “Nanotechnology: Where Does the U.S. Stand?,” is available here.

The report has occasioned editorials such as one posted on SciDev.Net by David Dickson.

Dickson suggests the report points to two key challenges facing nanotechnology and nanoscience: adequately ensuring that nanotechnologies address the needs of the world’s poor and building social markets favorable to nanotechnologies.

To address the risk of a “nano-divide” between the world’s rich and poor nations, Dickson calls for the development of nanotech skills among poorer nations, dissemination channels for nano products, and informed public debate.

Characterizing the content of this debate, Dickson writes: “informed public debate…must include authoritative information about potential health and environmental consequences; there is no room for those who dismiss all such concerns as merely the unreasonable demands of whose who seek a risk-free society.”

It is not always clear on what basis information should be considered “authoritative” nor who should decide this. The approach outlined by Dickson would seem to include information and demands that might otherwise be disqualified on the grounds of being “unreasonable.” This type of approach may be encouraging to those who would make such demands, but it stops short of outlining what counts as “reasonable.”

While defining “reasonable demands” is risky business, without clear parameters, what gets debated could too easily be determined by the agendas of those who get to decide, rather than by a reasonable process.

The U.S. government must nurture and oversee the burgeoning field on nanotechnology.

Occasionally, scientific and technical discoveries open up vast new disciplines, and herald new inventions that fundamentally change our way of life. For instance, engines, planes, and computers have drastically changed our society in just the last few centuries and even decades. Now, scientists and engineers around the world work feverishly in a field that promises even greater transformations; nanotechnology.

Nanotechnology describes a range of products and procedures that utilize properties at miniscule sizes, less than 1/10th the diameter of a human hair or 100 nanometers. Working at this tiny scale, researchers can take advantage of unique and sometimes entirely unexpected properties to produce tremendous new products. Nanotechnology will produce materials built atom by atom that are vastly stronger and lighter than any in existence today. Doctors may create new drugs that seek out diseased cells. Nanotechnology has already arrived, in fact, in stain resistant Docker’s pants and new systems to purify water.

Much work remains however, and most nanotech products lie many years away, yet a nanotech future is imminent and we had better prepare. For along with the potential for economic gain and furthering U.S. prominence in science and engineering, nanotechnology brings risk as well. Just as cars have brought tremendous personal freedom to travel, yet kill over 40,000 people a year in the U.S.; nanotechnology will have costs as well. The novel properties that make nanotechnology so exciting are not benign, nature’s laws do not play favorites. As pointed out in a recent New York Times article by Barneby Feder, toxicology studies of nanomaterials lag far behind the creation of new ones. Yet even materials like carbon, that seem innocuous, have proven exceptionally toxic in the form of tiny ‘nanotubes’ through the risk of inhalation and suffocation. The health, environmental, and social effects of nanotechnology products are not known, and current practice will not discover harms before it is too late.

The federal government actively funds nanotechnology research. The National Nanotechnology Initiative was begun by President Clinton in 2000, and has funding billions of dollars in research and development efforts. Last week, Congress approved the 21st Century Nanotechnology Development Act, creating a permanent place for nanotechnology within federal science funding, and beginning to address the broader needs of nanotechnology through the National Nanotechnology Program. The bill provides for public input and monies for research into the ethical, legal, and environmental concerns, but does not go far enough.

Research alone will not help nanotechnology mature into a responsible industry. Through this act, the government will continue to fund research based on identifying and containing harms well below research and development activities. Even if this investment were greatly enhanced, there remains no mechanism for action if and when problems are found. Current efforts amount to watching what the kids are doing, but having no authority to act when you catch them misbehaving.

The industry needs a clear statement from the public and government on what precautions are needed while developing nanotechnology products. Lack of clarity has left companies and researchers guessing what measures they should take, creating a system ripe for abuse. The FDA, EPA, and other regulatory agencies should cooperate to take substantial steps to blaze a path to market for nanotechnology products. Straightforward guidelines will ensure that all nanotechnology research contains safeguards that appropriately contain risk, provide efficiency to new product production, and give the public confidence in this emerging market.

Nanotechnology includes real risks and great awards, but a single-minded obsession with either will only result in failure. Simple steps now can have profoundly positive effects on the long-term viability and success of nanotechnology. It’s time to give the little guy a hand.