Japan’s recent 9.0 magnitude earthquake and the tsunami it caused together killed 9,737 people and left an additional 16,501 missing. The destruction left millions homeless and caused almost $200 billion in damage.

These natural disasters caused severe damaged to 4 of the 6 reactors at the Fukushima Daiichi nuclear plant, leaving them without functioning primary, secondary, or tertiary cooling systems. The resulting partial meltdown of the core at one reactor and of a waste fuel rod storage tank in another has resulted in the release of radioactive material into the atmosphere, soil, and water, forcing the evacuation of what was at first a 12-mile radius and now a 19-mile radius surrounding the facility.

Though reactors in the United States are built to strict safety standards, they are nevertheless vulnerable to any number of natural and manmade disasters, from earthquakes and tsunamis to flash floods, droughts, and hurricanes. U.S. reactor safety standards have been effective in preventing catastrophe, though a recent report highlights 14 “near misses” where improperly implemented safety protocols nearly caused major problems. More troublingly, many of these standards were based on an understanding of our climate system that is now 40 years out of date. Today we know that climate change is making floods, droughts, and hurricanes stronger and more frequent, which means we must ask whether our safety standards, even when followed perfectly, are enough to prevent disaster.

As the Nuclear Regulatory Commission conducts its review of U.S. nuclear safety in the wake of the Fukushima meltdown, they need to be sure they are doing a thorough review of all possible risks, and should not ignore recent science about how climate change could increase those risks.

Current state of US nuclear plant safety

The United States currently has 104 functioning power reactors at 65 sites around the country, roughly a quarter of which use the same “Mark 1” containment vessel design used in the failing Japanese reactors. They supply roughly 20 percent of the country’s total electricity needs. Nuclear plants demand large sources of water in order to cool and control the core temperatures of the reactors that power them. To meet this inevitable requirement, nuclear plants are situated in low-lying areas near rivers and lakes, and many others are built on the coasts. This proximity leaves these plants vulnerable to floods and other water-related disasters.  (See our map below.)

(click for a high res version.)

Many regulations are already in place to ensure that nuclear energy remains safe from floods, surges, tsunamis, and droughts. The Nuclear Regulatory Commission, or NRC, oversees licensing applications, reactor specifications, and radioactive waste disposal. The Advisory Committee on Reactor Safeguards, or ACRS, also reviews the adequacy of proposed safety standards and creates individualized specifications to withstand the projected worst-case disasters for each plant location. Nuclear facilities are initially granted a 40-year license that must be renewed after 20 years. They then have the opportunity to extend their license for additional 20-year increments.

The problem is that our nuclear reactors are all old. Thirty years old on average in fact, since political will for new nuclear reactors has weakened since the 1979 Three Mile Island incident. Seven operating reactors have eclipsed their original 40 year lifespans and been permitted to operate for another 20 years. This makes them vulnerable to problems, like stronger floods caused by climate change, about which we had considerably less knowledge three to four decades ago when the plants were built.

Climate change will increase certain risks

Climate change will compound existing weather-related risks. In the years since most of our nuclear reactors were built, we’ve learned that climate change is increasing the risk profile of many kinds of extreme weather. Two scientific studies published this year in Nature have supported this. Large and destructive floods once thought likely to happen only once in 100 years on average are now expected to happen every 20 years: a five-fold increase. Similar trends hold for droughts, hurricanes, and wildfires. Droughts and heat waves can impact nuclear reactors because they use large amounts of water in the power generation process. If water levels drop too low, or the temperature of adjacent water bodies rises too high, the ability of the reactors to operate can be impaired. Sea-level rise is also of particular concern, since many of our nuclear facilities are located on the coast.

In response to this growing awareness of disasters that can result from climate change, the International Atomic Energy Agency, or IAEA, released a safety guide in 2003 detailing flood-related hazards to nuclear power plants on coastal and river sites. The safety guide suggests that newly constructed plants should account for several consequences of climate change over the lifespan of the plant:

• Rise in mean sea level: 35-85 cm
• Rise in air temperature: 1.5-5 ⁰C
• Rise in sea or river temperature: 3 ⁰C
• Increase in wind strength: 5-10 percent
• Increase in precipitation: 5-10 percent

Higher sea levels, in combination with the warmer air, water, and sea temperatures will produce larger, stronger waves, increase the flow rate of rivers, and alter the dominant wind patterns, according to the report. The IAEA recommendations offer a good framework for assessing siting of new nuclear facilities, but current safety standards at the 104 operating nuclear reactors in the United States remain in question. Are they sufficient to deal with the increased risks caused by climate change?

This is a question we must answer, and soon. As we have written at Science Progress before, climate change creates considerable uncertainty for businesses and governments who must make difficult decisions that will affect the way we do business over the next 10, 20, or 40 years. In making long-term decisions about policy and business, decision makers need to have all the data they can get. The problem is that extremely rare events by definition provide us with little opportunity for study, even though their impacts can be catastrophic.

The seawalls at the Fukushima Daiichi reactor complex, for example, were designed to withstand an 18-foot wave, though the tsunami that caused the eventual nuclear meltdown was estimated to have been more than 40 feet high. Japanese engineers simply didn’t have enough data to accurately predict just how big a tsunami could be. Could this happen in the United States? For reference, the San Onofre reactor in California is built right on Pacific coast, with a sea wall of only 23 feet.

The bottom line is that sometimes, what we think to be a “worst case” scenario is not really the worst case. Just because there is uncertainty about how climate and weather will affect our nuclear reactors does not mean we should ignore the issue. Quite the opposite; it would be negligent to ignore this uncertainty as we continue to assess our nation’s nuclear safety standards.

The Nuclear Regulatory Commission has taken some steps to incorporate current climate science into its standards, but it has not gone far enough. In 2009, the NRC released an information notice that suggested plants re-evaluate flood protection measures, but they did not require action. To make matters worse, the guidelines in use were established in 1977, with the latest updates occurring in 1984. As the Nuclear Regulatory Commission conducts its review of U.S. nuclear safety in the wake of the Fukushima meltdown, they need to be sure they are doing a thorough assessment of all possible risks, and should not ignore recent science about how climate change could increase those risks.

Countries around the world have already begun to take increased risks from climate change into account in their nuclear safety protocols.  It’s high time the United States follows suit. The United Kingdom has insisted that new nuclear plants demonstrate countermeasures taken to prevent damage from more extreme floods, France has begun reviewing all 58 of its reactors to check how much flooding they can handle, and Austria has even called for nuclear “stress tests” similar to those banks undergo. Germany has even ordered all reactors built prior to 1980 (all American reactors would qualify) to be shut down for three months.

The disaster in Japan has afforded the United States the opportunity to re-examine the safety of its own fleet of nuclear reactors. Given how often we underestimate the “worst-case” scenario, this is an opportunity we cannot afford to miss.

Sean Pool is Assistant Editor for Science Progress, Elaine Sedenberg is an Intern with Science Progress, and Matt Woelfel is an Intern with CAP’s Energy Opportunity team. The authors would like to thank Kate Gordon, Richard Caperton, and Valeri Vasquez, and Evan Hansleigh for their invaluable contributions to the article.

Eric Schwaab, the administrator of the National Marine Fisheries Service, or NMFS, stood before a crowd of fisheries experts on Monday at the Boston Seafood Show. Schwaab had made many forays to New England—home of some of the squeakiest wheels in our nation’s fishing industry—since taking over the job about a year ago. But this time was different. He came bearing a remarkable message: We are witnessing the end of overfishing in U.S. waters.

One of the biggest changes to fisheries law in the 2007 reauthorization of the Magnuson-Stevens Fishery Conservation and Management Act was the imposition of strict annual catch limits, or ACLs, in fisheries experiencing overfishing beginning in 2010, and for all other fisheries in 2011, “at a level such that overfishing does not occur.” Schwaab said the 2010 target of putting ACLs in place for all overfished fisheries was achieved, and “We are on track to meet this year’s deadline of having [ACLs] in place, as required, for all 528 managed stocks and complexes comprising U.S. harvest.”

Schwaab went on to call this accomplishment an “enormous milestone.” Quite frankly, that is an even more enormous understatement.

The end of overfishing should be shouted from rooftops from New England to the Carolinas to the Gulf Coast to Alaska to the Pacific Island territories and back to NMFS’s Silver Spring, Maryland headquarters. This is the biggest national news story our fisheries have seen in years.

So where are the headlines? A few stories trickled onto the pages of local New England newspapers. But even the Boston Globe didn’t spare so much as a column inch. Prophetically, Schwaab alluded to the likelihood of radio silence during the second half of his remarks, in which he suggested the National Oceanic and Atmospheric Administration should “do a better job of getting out the word on the progress made.”

Fisheries doomsayers have certainly been more successful at garnering attention. Dr. Boris Worm, a scientist at Dallhousie University in Canada, published a study in November 2006 that splashed across major media outlets worldwide. His study, “Impacts of Biodiversity Loss on Ocean Ecosystem Services,” contained a message far more digestible than its title: Continuing the world’s current rate of fishing would lead to the “global collapse” of fish populations by 2048.

Now that’s a headline.

As panic ensued about the possibility of empty seafood menus, Dr. Ray Hilborn of the University of Washington penned “Faith-Based Fisheries.” It was a sharp rebuke of not just Worm, but the entire scientific publishing community, which he accused of accepting “articles on fisheries not for their scientific merit, but for their publicity value.”

This all sounds esoteric on the surface. In the elevated discourse of academia, however, Hilborn’s words should have sparked nothing short of a Biggie-versus-Tupac-level throwdown.

Yet instead of Worm or Hilborn upping the ante with the academic journal iteration of “Hit ‘Em Up”—Tupac’s vitriolic rap widely credited with escalating the east coast/west coast hip-hop conflagration—a funny thing happened. The two scientists decided they had more in common than in opposition, so they sat down to work on a collaborative assessment of world fisheries.

Science published the result of their efforts, “Rebuilding Global Fisheries,” in July 2009. It is a comprehensive assessment of 10 large ocean ecosystems with the most comprehensive catch data. The findings showed that fishing in half of the areas they studied was either already sustainable or showing significant progress toward sustainability and that “combined fisheries and conservation objectives can be achieved by merging diverse management actions, including catch restrictions, gear modification, and closed areas.”

Not coincidentally, all of these practices are in place in the United States today to varying degrees.

Of course, an important distinction to draw here is the difference between the act of “overfishing” and the fact that some fish populations remain “overfished.” Overfishing means taking more fish out of the ocean than natural reproduction rates can replace—think of it as withdrawing principal from an endowment instead of just the interest. A fish stock that is overfished is defined as being below an optimal population level. While the two conditions can be and often are interrelated, one can also exist without the other.

In effect, this is the difference between a household’s budget and debt. Exceeding an annual budget is overspending. Overspending for multiple years will accumulate debt, which can be referred to as being in an “overspent” state. Even when overspending stops, the red ink doesn’t magically turn black. The deficit remains. Many of our fisheries are still overfished (or overspent), but the first step in resolving that dilemma is halting overfishing.

We balance our fisheries budget by ending overfishing. Then we can deal with the deficit. NMFS’s rebuilding plans establish catch limits that pay down the principal on the fishy debt we have accrued because in addition to ending overfishing, the law also requires that such limits rebuild fish populations to more productive levels within 10 years. Simultaneously, fishermen are already seeing some returns as a result of their sacrifices as fish stocks recover toward their rebuilding targets.

Schwaab touted Exhibit A in his statement: NMFS will increase catch limits for 12 of the 20 fish populations managed in the historic New England groundfishery for the new fishing year that begins on May 1. This includes haddock, flounders, and the iconic cod. This announcement follows decades of mismanagement that saw fishermen’s opportunity to fish cut deeper and deeper until by 2009 the average groundfisherman was allowed to operate for fewer than three weeks a year.

As an independent indicator of New England’s nascent success, the Monterey Bay Aquarium’s Seafood Watch program shifted several groundfish species, including haddock and pollock, from the red “avoid” list to the yellow “good alternatives” list. And it even added line-caught haddock to the green “best choices” list.

Meanwhile, controversy continues to roil in New England ports about the implementation of a new regulatory system known as sector management that took effect in 2010. The next column in this series will delve deeper into the details of that saga. We must acknowledge, too, that reductions under the previous system, referred to as Days-at-Sea, took steps to begin reducing the overfishing that plagued the industry in the early 1990s.

After decades of decline—and thousands of pages of apocalyptic rhetoric—it’s time to give our fishermen and our fisheries managers a little credit. They are making the difficult choices. They have endured tremendous hardships. And they are turning a critical corner to ensure a healthy, sustainable future for America’s most historic profession.

This feature is part of a new series from CAP dealing with fisheries management issues. The series will publish biweekly on Fridays. It is a joint column with Science Progress.

Read more articles from the “Fish on Fridays” series.

Michael Conathan is Director of Ocean Programs at American Progress.

Lots of folks seem to think we have too much regulation of drugs and devices already—among them Paul Howard at the Manhattan Institute and Scott Gottlieb at the American Enterprise Institute—so much so that it is choking innovation to death. But, if that is so, then why are there so many scandals?

One possible answer is that the companies know they have problems but sit on that knowledge. If that’s sometimes (or oftentimes) the case, then we need a regulatory system that can get around that kind of immoral behavior. We don’t have that system.

What we have is a regulatory system that is too skewed toward looking at the earliest stages of research. Moreover, the way it is designed makes recalls almost inevitable. The diabetes drug Avandia is the latest in a long parade of failures of our current post-clinical trial drug approval process.

Avandia went through the usual approval process with the U.S. Food and Drug Administration. The drug was a blockbuster. But sales began to fall after a 2007 study of people taking the drug suggested that Avandia could cause heart attacks and strokes. I first learned about this while serving on a bioethics advisory board for GlaxoSmithKline, the developer of the drug—a panel that was looking at research ethics issues in poor nations. The panel, on which Science Progress Editor-in-chief Jonathan Moreno also served, came to an abrupt halt.

In response, the FDA put a black-box warning on the drug telling doctors of the heart attack risk. GlaxoSmithKline was not happy. There was a lot of back and forth about the safety of the drug. Over the past few months more evidence become public that shed doubt on Avandia’s safety. Worse, it appears the company withheld data about serious side-effects. The FDA appointed an advisory panel this July to consider these allegations, but the panel itself quickly got caught up in charges of conflict of interest among its members. It is likely that more black-box warnings to doctors will follow, should GlaxoSmithKline choose to keep Avandia on the market.

Avandia is not alone. The drug’s problems in the marketplace follow hard on the heels of Prempro, a hormone replacement therapy made by Wyeth Pharmaceuticals, now part of Pfizer Inc., which became caught up in lawsuits alleging it caused breast cancer. More recently, the FDA released a warning about the Afluria flu vaccine, made by CSL Ltd. of Australia, concerning high fever and seizures. Prior to that was Merck & Co.’s widely publicized recall of Vioxx, which came after problems with Astra Zeneca’s Seroquel, Abbott Laboratory’s Meridia, Pfizer’s Rezulin, C.R. Bard Inc.’s G2 filter, Bayer’s Baycoll, Boston Scientific Inc.’s Express Stent, and on and on.

So is there a real phenomenon here or just more PR associated with recalls? And if there are more recalls going on then what is wrong with the oversight of new drugs and devices?  It is not clear from the literature whether there are more recalls taking place in recent years—there is no real database that would show such a trend. There are certainly more stories about recalls and more people studying the objectivity of the marketplace surveillance being done by pharmaceutical, biotech, and device companies.

No one seems to have reliable numbers on recall trends, yet the Institute of Medicine and other groups still warn that the existing system of drug protections after the FDA approval process is complete does not seem adequate to handle the products that are reaching the market. Fortunately, there is a way to fix the system.

The major problem today is that too many lousy or dangerous drugs and devices get to you without adequate safety review because drug and device regulation is heavily weighted in the United States toward early stages of research. Every drug has to be tried in animals to roughly determine safety. Then drugs are introduced into a small number of humans to further check safety—so-called phase one trials. Then dose and mode of administration are checked for safety, biological activity, and signs of effectiveness—phase two. Only after all this safety testing is a drug or device ready to go to phase three clinical trials. In these studies hundreds or sometimes thousands of subjects are recruited to receive the drug or product for periods of time that range in nearly every case from a few months to a year.  Phase three trials are almost always placebo controlled randomized, blinded studies.

So there is a lot of effort to try and make sure that subjects are not hurt in phase three trials. The deaths of subjects in phase one clinical trials, among them Ellen Roche and Jesse Gelsinger in early stage studies over a decade ago seem to have reinforced regulatory anxiety about the risk of deaths in first in-human studies.

Meanwhile, the weakest link is the fourth and final step in the research process—phase four—in which drugs are to be monitored when out in actual use in the world for adverse events and problems. Drug companies sometimes promise to do these trials to get final product approval but don’t. These studies are heavily weighted to support the funders of these studies, Big Pharma, which results in much more rosy reporting then studies done by independent groups.

Reporting of problems in phase four is left to doctors and patients who rarely do so.  And there is no systematic tracking of a subpopulation taking new drugs or other medical products to see what is going on with real patients in real world conditions. Deaths have to mount rapidly and obviously to get regulatory or physician attention before phase four studies are ever seriously undertaken.

But a lack of independent, well designed phase four trials is not the only problem.  Approving drugs based on current standards for phase three testing has its own built-in limits. Testing drugs and devices in randomized, blinded, placebo control trials is great, but it means that approval is given on the basis of highly controlled studies on highly selective populations—often subjects who are not that old, not that sick and are highly compliant. That’s not the real world, where patients take lots of drugs, some legal some not, are poorly compliant, have multiple diseases, and can be very old or very young.

So what looks safe in a phase two or phase three study can prove lethal when given to real people in uncontrolled, unsupervised environments. What’s more, phase three studies are also relatively short. What looks safe after three months exposure or six may not be after three or six years.

The seemingly endless parade of horrors of FDA approved drugs gone bad merits a reexamination of a regulatory system that is not keeping us safe.  The issue is not too much bureaucracy and too much red tape, but a strategy of safety that puts the emphasis in the wrong place—early not late—and then uses techniques that by themselves cannot ensure safety for real people in the long run.

Update August 17 2010: CNN Money reported that the number of drug recalls in the U.S. surged to 1,742 in 2009, up 309 percent from the 2008 level. Recalls so far in 2010 are also on pace greatly exceed previous levels. However, not all of these recent recalls were due to the drugs themselves being unsafe—some were due to problems with the manufacturing process of generic, over-the-counter drugs.

Arthur Caplan, PhD, is the Director of the Center for Bioethics and the Sidney D Caplan Professor of Bioethics at the University of Pennsylvania

The children were given IQ tests at age 5, and those “exposed to the most pollution before birth scored on average four to five points lower than children with less exposure,” Tanner wrote. This is the first research to link prenatal pollution exposure to lower IQ scores.

“Reproductive Roulette,” a new Center for American Progress report by Reece Rushing, provides an overview of many research studies examining chemical exposure and its consequences for reproductive health. The report catalogs increases in fertility problems, premature births, and birth defects and disabilities connected to environmental toxins. It also includes recommendations for increased funding for chemical safety research, stronger chemical safety laws, and greater public access to chemical safety data. “Poor and minority children are exposed to lead and other dangerous chemicals at the highest levels,” Rushing writes.

The percentage of “U.S. students treated for a learning disability increased from 8.3 percent in 1976 to 13.8 percent in 2005,” the research demonstrates. The increase is attributable to chemical exposure and improved diagnostic criteria. Adolescents are unknowingly exposed to damaging chemicals from everyday consumer products including toys, food containers, nail polish, air fresheners, medical devices such as IV tubes, and compact discs, the CAP report indicates.

“Reproductive Roulette” also cites a study that found 287 industrial chemicals present in ten newborn umbilical cords. After birth, babies may be exposed to chemicals such as phthalates that may leech from baby bottles, powder, lotion, and shampoo.

Exposure to phthalates, a group of chemicals used to soften plastics, is linked to a higher incidence of childhood autism, Rushing reports. Cases of autism increased 10-fold since the 1990s, according to a study he cites. Yet CAP calls from more research in this area, as the “connection between chemical exposures and autism remains unclear.”

The report also supports an expansion of the Integrated Risk Information System, an Environmental Protection Agency database of information on the human health effects of exposure to environmental contaminants. IRIS should provide public access to more chemical safety information in “a timely manner and free of political influence,” Rushing argues. Administrator of the EPA Lisa Jackson indicated that the agency will streamline the IRIS process and curb political influence in a joint Senate Environment and Public Works Committee and Subcommittee on Oversight hearing last month.

These recent reports highlight the fact that “you don’t have to live right next door to a belching factory to face pollution health risks,” Tanner wrote.

This morning, the Senate Environment and Public Works Committee and Subcommittee on Oversight held a joint hearing on “Scientific Integrity and Transparency Reforms at the Environmental Protection Agency,” which included discussion of the new procedures. Lisa Jackson, administrator of the EPA, testified on how the new IRIS process will help fulfill President Obama’s memorandum on scientific integrity by increasing transparency in science-based regulation.

EPA will now manage the entire IRIS review process, rather than the Office of Management and Budget, Jackson said. Dr. Francesca Grifo, Senior Scientist and Director of the Scientific Integrity Program at the Union of Concerned Scientists, discussed the importance of this change in control in a Science Progress podcast last month. The OMB previously had the power to change scientific advice, Grifo said, and described the problematic regulatory process under the Bush administration. “What we saw in the past was, rather than be courageous and come out and talk about which parts were policy and which parts were science, we saw changes in the science to cover up an often unpopular policy decision,” she said. Grifo explained in that interview that administration policy could break with the scientific advice, but the reasoning had to be clear, rather than resorting to an obfuscation of the data. “The key here is for all of us to see the scientific basis,” she said.

The new IRIS process requires that all written scientific comments on IRIS drafts provided by federal agencies be made public. Furthermore, most contaminant evaluations will be available on IRIS within two years of the review start date, Jackson said. The condensed process not only presents health-related information to the public more quickly, but also eliminates steps agencies could potentially use to inhibit the process, explained John B. Stephenson, director of natural resources & environment at the U.S. Government Accountability Office. Under the old rules, agencies could declare a need for additional research to suspend the IRIS process and prevent or delay a substance from being added to the database. This gave agencies time to present studies that conflicted with the original “best available science,” Stephenson said.

Image: AP

Rep. John Dingell (D-MI), who co-sponsors the “Food Safety Enhancement Act of 2009″ with Rep. Henry Waxman (D-CA), noted on the committee site that “Consumer confidence in the nation’s food supply is low.”

The legislation would further give the FDA greater power to prevent problems through heightened inspection regiments, as well as the authority to initiate mandatory recalls in the event of a contamination or outbreak.

Waxman notes as well on the committee site that the poor state of the food safety system is a threat not just to public health, but to food companies themselves. Hence, Layton reports that “the proposal would put greater responsibility on growers, manufacturers and food handlers by requiring them to identify contamination risks, document the steps they take to prevent them and provide those records to federal regulators.”

Such a system would also present an opportunity for the FDA to provide relevant portions of those records to the public in an accessible format—and the bill summary indicates that the registry would require unique identification numbers for food facilities and importers. This information could make a welcome future addition to Data.gov, so that third parties and citizen groups can keep up with the safety of what’s in the their shopping cart.

Image: AP/John Bazemore

To right past wrongs and prevent assaults on the future work of government scientists, President Obama issued a memorandum on scientific integrity in March. The document tasked the Director of the Office of Science and Technology Policy with coordinating a set of recommendations “to guarantee scientific integrity throughout the executive branch.” OSTP opened up the process to the public by requesting comment on the six principles outlined in the memorandum on its new blog, which the President highlighted in his recent speech at the National Academy of Sciences. The public comment period closes this Wednesday, May 13.

Over the past few years, the Scientific Integrity Program at the Union of Concerned Scientists has focused closely on the impacts of the Bush administration’s manipulations on environmental regulation, public health, and the morale of federal scientists.

Science Progress spoke with Francesca Grifo, the senior scientist and program director, about the forward-looking comments her group submitted to the administration—which focus on protecting government scientists, making science-based policymaking more transparent, and monitoring potential abuses—as well as the need to look backwards and repair past abuses. This interview has been editing and condensed. For the full conversation, see the audio available in the sidebar.

Andrew Plemmons Pratt, Science Progress: Was it the Bush administration’s abuses that led to these priorities that you focus on, or were there existing problems in the system that went unaddressed from previous administrations?

Francesca Grifo: I think there are both. Obviously, we are responding very much to the last eight years, but I think we are also equally certain that there are some agencies that have always been troublesome, that have been places where, for example, corporate influence has been a way of life. Obviously, those are much deeper, harder, more difficult problems to address.

When we look at the specific items that we put into these comments, we’re mostly referring to the last eight years. In our publication, “Federal Science and the Public Good,” we tried to characterize the abuses of science and then make the connections between those specific abuses and what we need to do about it.

It’s not a simple thing to say, “Oh, let’s just outlaw abuses of science.” It’s actually a fairly nuanced, complex thing to look at. So we really focused on protecting scientists and making the government more transparent.

That being said, we also have another set of processes going on, and in fact very soon, we’ll hear back on them—the administration’s decisions on regulatory reform. That’s another big piece of it, but it’s not in these comments because the president has a separate process for that.

SP: What are some of the problems over the years that necessitate a focus on whistleblower protections for government scientists?

Grifo: What we realized is that, obviously, we can’t have our eyes and ears everywhere. In fact we rely heavily on those who are I the midst of these situations to be able to speak about them.

We have many examples of where there has been retaliation or job changes. We know of one whistleblower at the FDA, for example, who was moved to an empty office with just a desk and nothing else after he blew the whistle on an issue. We’ve had other problems at different agencies, but the FDA has had quite a few.

It’s really important that the public be able to hear from these folks—that they feel empowered to speak out. Now, we do have whistleblower protections, but unfortunately, most of those protections have been significantly eroded by the courts. So we need to come out and be clear about more specific protections and protections that really do address federal scientists and the particular needs of those federal scientists.

SP: And the second issue you’re talking about is transparency: making information and research available to the public and to third parties so they can review what goes into policy decisions. It seems like this would work in concert with whistleblower protections, so that ultimately, whistleblowers didn’t have to be the people sounding the alarm.

Grifo: We would love to put whistleblowers out of business. We would like to make it so that we no longer needed them. That’s really the key.

Many of these things that we talk about as examples in the Bush administration were things that happened because the doors were closed; because the meetings were closed; because drafts of documents, when they moved from an agency to the White House, to the Office of Management and Budget were not made public in between. So we left it open for scientific documents coming out of the agencies to be changed. And the public didn’t know, except that we at UCS got documents dropped on our doorstep, and phone calls, and it was all very cloak-and-dagger. But fortunately, there were a lot of courageous people who revealed what was going on.

SP: What sort of role is strengthening scientific integrity going to play in the development of climate and energy legislation?

Grifo: When this climate legislation becomes law, it’s going to be a law that’s around for many decades. And because of that, it’s going to be making periodic science-based decisions. Let’s think ahead to 2040, or another time in the future, and recall that conditions will change. The scientific knowledge will change. What we know about climate change and what we know about the success or failure to mitigate climate change and to stop climate change will all be a changing scenario.

And so we’re going to want to revisit these things. We’re going to want to ask questions about how we’re doing on emissions reductions. We may want to look at the size of the cap, and so on, as we get this new information.

The special interests that have been responsible for the problems in the past—they’re not going to go away. They’re going to continue to be engaged in this. So what we want to do is have this climate legislation be a smart law—a law that is bulletproof, that has specifics in place that will prevent the abuses of science in the future.

Another example are the National Ambient Air Quality laws. Again, this is something that is examined periodically, as the science comes in periodically. And unfortunately, as we’ve watched ozone and particulate matter and these other standards get set, we’ve seen that that the process was open to manipulation. So we’re trying to learn from this past experience to say, “How can we scientific integrity-ize” or make the new laws something that will really be robust to this sort of interference?

Again, we come back to the same sorts of things: transparency, protecting whistleblowers, trying to set the law up so that we’re paying attention to conflicts of interest.

SP: This need for “smart laws” seems important, because we know enough to act, but we don’t know everything about these issues at this particular moment. We’re going to learn things and we’re going to have to make continual adjustments. This seems like another important reason for protecting scientific integrity now, as well as going forward.

Grifo: The devil is in the details. I think it’s very tempting to think only about these big-picture climate issues. That’s exciting and important—don’t get me wrong. But I think we need to ask: Are the scientific studies and other research transparent and publicly accessible? Are the scientists’ dissenting views part of the public record? Can these scientists discuss their work with the media? Do we have legislation that incorporates scientific advisers and advisory committees? And if we have those committees, let’s think about the selection process—how will we resolve potential conflicts of interest?

There are many, many details like that, and we’ve learned from past experience how to do the right thing in the future.

SP: I want to back up to a survey that UCS released last year on scientific interference at the Environmental Protection Agency. One of the most astounding numbers that came out of that was the fact that 60 percent of the respondents to the survey said they had personally experienced at least one incident of political interference with scientific work during the last five years. What’s the mood at agencies like the EPA now?

Grifo: Obviously, we haven’t re-surveyed, so we don’t have numbers, but when we have talked to people, the mood has definitely been better. When we look at the memo to employees that Administrator Lisa Jackson sent out on January 23rd, there is some amazing language in there. For example: “Science must be the backbone for EPA programs.” She talks about respecting the workforce, and making sure that Americans don’t lose faith in their government. And the way to do that, of course, is transparency.

What was also important was she followed that up on April 23rd on transparency in EPA’s operations. In that memo she specifically lays out guiding principles, she talks about revealing appointment calendars, the Freedom of Information Act, rulemaking proceedings. Because much of EPA’s business is conducted through rulemaking, she says, “each EPA employee should ensure that all written comments regarding a proposed rule received from members of the public, including regulated entities and interested parties, are entered into the rulemaking docket.”

What that means is, there’s no behind-closed-doors meetings. If there’s a meeting with industry, that information gets put into the public rulemaking docket—and that’s huge.

Unfortunately, they’re not quite where we’d like to see them on communications policies and media policies. They’re still struggling with that and we look forward to working with them because, obviously media policy is very important. And they’re close; they’ve made progress, certainly, but that is one place where we’ll continue to work with them.

SP: What would you like to see in terms of media policies that would really set things aright in comparison to the last administration?

Grifo: One key piece is the role of the public affairs officials. In the past some have been very harsh gatekeepers, picking and choosing among scientists with different perspectives to decide who gets to have an interview and who doesn’t.

What we think the role of the public affairs office really is, is if a scientist gets a request for an interview, you don’t have a “minder” on the interview—a “minder” being someone from the office listening in. That’s just difficult and intimidating. What you have to have is a system where the scientist does the interview; they let public affairs know they’re doing it; they then report back to public affairs on how the interview went and what they discussed, so that public affairs is in the loop, but they’re not controlling the scientists’ information.

Now the other thing that’s important to be clear on is this: you don’t have every scientist in the agency making policy and confusing the public. We get that. That’s not a good thing for anybody: not for the agency, not for the public, not for the scientist. But rather, this applies when a scientist is discussing research results. This is not decisions based on those research results; this is not interpretations based on those research results for policy decisions; this is discussing research results. When we’re talking about more complex things like policy decisions, that’s different. But even in a policy decision, even taking those research results and applying them—a scientist can do that. They simply need to take off their federal agency hat and say, “I am now speaking as a private citizen. This is what I think.”

It’s also very important for scientists to be clear about, “Here’s what I know and here’s what I have the data to support; here’s what I think that means; and here’s where I’m being speculative. And I’m going to make sure everybody’s clear on which things go in those three baskets.” And that’s key to good communication.

SP: In the comments you submitted to the administration, you talk about ways of presenting non-official materials by scientific authors working in the government that don’t represent policy positions, but are still available for the public and interested parties to look at. Are there any precedents for that? It seems like a tricky way of communicating with the public.

Grifo: There are precedents. And that was part of our media scorecard work where we looked at a number of different agencies and compared not just their actual media policies, but the implementation of that media policy. And we found agencies that do it very well. We found agencies that do allow this sort of thing, and, you know, the sky doesn’t fall. The agency doesn’t fall apart. And that was part of why we did it. We really wanted people to be able to see that in fact this is doable. It doesn’t create this nebulous, difficult-to-deal-with situation.

SP: One of the first things that the Obama administration has done in the first 100 days is rescind the Bush Executive Order 13422, which gave the Office of Management and Budget a large amount of control over the scientific and regulatory work that was being done by these other agencies. How can the government go about reinstating the distance between the White House and these other agencies that are working independently?

Grifo: Again, it’s about clarity and it’s about transparency. With the regulatory reform, one of the big issues has been that the agencies do their bit, the science happens; scientific advice is incorporated; you end up with a draft for a rule; and it goes to the White House and gets changed.

So I think one of the most simple, straightforward things is that in that rulemaking process, the agencies need to have a draft that is made public. Very clearly, just out there for everybody to see before it goes to the White House for finalization.

Does the preliminary rule need to be made public? No necessarily. It would be great, but not necessarily. What needs to be made public, most importantly, is the scientific information that is going into that rulemaking process.

Furthermore, this does not have to be terribly burdensome. This is something agencies are pulling together anyway. And we’re not asking of early, pre-decision drafts. People say, “Oh you want us to document and reveal everything.” No. Not everything. But at a point where the scientific piece is done in the agency and is going to go on to inform the White House’s policy decision, there’s no reason we can see why that scientific piece can’t be made public, so that we call understand the scientific basis for that policy action.

So the White House has to be courageous and come out and say, “The science is telling me to do this, but I’m doing this. Because this is not a scientific decision; this is a policy decision.” And that’d okay. We may not like it. But that’s how the system works.

Sometimes decisions are made entirely on the science; sometimes they’re made on a variety of factors. And of course in many instances the law determines what that balance is. In other instances, the White House determines that. But the key here is for all of us to see the scientific basis. And what we saw in the past was, rather than be courageous and come out and talk about which parts were policy and which parts were science, we saw changes in the science to cover up an often unpopular policy decision. And that’s what really does nobody any good service.

SP: You mention in your comments the need to redesign online portals like science.gov and regulations.gov. How important is it that these sites get an overhaul?

Grifo: I think at some point when someone made these, they had the right idea, and they meant well. But I think they don’t function; they don’t work. And the bottom line there is to improve search and browsing functionality so that people can use them.

Rulemaking is not meant to be a process for just 20 people in the beltway. Really and truly, the best rules are the ones that benefit from the knowledge and input of many, many forms of expertise. And the only way to do that is to have a website where people can easily track and follow and know what’s going on in terms of seeing the text of these rules, the scientific basis of the rules, and with that full understanding, interact with the rulemaking process.

The sites don’t work the way they are; they’re difficult. Anybody who wasn’t determined would just say, “Forget this.” And that’s not what we want.

SP: The administration just released rules on lifecycle emissions for biofuels. What role does scientific integrity play in this set of regulations?

Grifo: It’s going to be the same as all these other issues. When we’re talking about biofuels and the way that they’re regulated, again: Are the scientific studies and other research transparent and publicly accessible? Do the federal scientists have the freedom to discuss their work with their colleagues and around the world? It comes down to dealing with conflicts of interest; creating accountability in the system; looking at transparency; being clear about the role of the Office of Management and Budget in formulating that policy.

The questions are the same. That’s what made this scientific integrity issue so interesting and so broad, and in some sense, so timeless. We’re talking about process. We’re talking about how the government uses scientific information to make the best rules.

So whether it’s biofuels or biodiversity, the process really needs to be one that is robust and that stands up to scrutiny. And that scrutiny is about the scientific information not being tampered with, but coming into the process clean and then staying clean through the process.

SP: Any concluding thoughts while the administration is still absorbing information from the public on this issue?

Grifo: As much as we want to go forward, and as much as this administration wants to look forward, I think there’s a certain amount of going backwards that we have to do to make sure that we undo the problematic decisions in the past.

What comes to mind immediately in that respect are many endangered species decisions that were made with lousy science. The Endangered Species Act specifically says “best available science,” and in multiple species’ instances, that was not the case.

So that’s just one example of where those decisions still stand, and each of those decisions have consequences and you get this rippling effect outward of the consequences of one lousy decision that was based on manipulated science.

Much as we all want to look forward, unfortunately, some of us have to continue to look backwards to clean up a number of messes that are still out there.

Another big issue that the administration is still grappling with is that of conflict of interest.

When we look at all of these committees and the way that scientific advice comes into the administration, we have to make sure that scientists whose science we trust aren’t getting money from the regulated entity.

Now it’s hard to think how this would apply when you’re talking about somewhat esoteric or basic research. But if we’re talking about places like the Food and Drug Administration—where scientists are making recommendations on these advisory committees on which drugs to approve and which drugs not to approve—we ought to have zero tolerance. I don’t think those scientists can make the best decisions if they’re taking money from a drug company whose products we’re talking about, or from a related product maker. It’s just not going to happen.

So we have to be creative and devise other ways of still getting their expertise, but not allowing them to be in the decision-making position.

SP: Are there significant differences between implementing scientific integrity rules in biomedical science versus environmental science?

Grifo: Not really. Where we see the difference is when we’re talking about an agency that is a research agency versus an agency that is a regulatory agency. That’s where I would say there are two classes of agencies.

Because obviously the pressure is much greater from special interests and others on the agencies that are making the rules—and that’s FDA, that’s EPA. Whereas the pure research agencies, such as National Institutes of Health and the National Science Foundation—while they’re certainly not perfect and totally clean, the level of this problem is so much less—significantly lower than it is at the regulatory agencies.

This fascinating conference, sponsored by the Food and Drug Law Institute and aimed largely at company officials, offered panel after panel of lawyers telling nanotech execs how to avoid getting sued by…other lawyers.

Whether it’s about suing or being sued, it seems that nanotechnology—and every other new technology with a still-uncertain benefit-to-risk ratio—is a 21^st century Full Employment Act for attorneys.

“‘Sophisticated user’ is a great defense….That’s how we’ve escaped liability for lots of clients.”

“If you think nanotech liability claims are never going to be a problem, you’re dreaming,” said Lynn L. Bergeson, a partner at Bergeson & Campbell P.C. in Washington, noting that even a “fear of disease” is sufficient basis these days for filing a lawsuit. That’s a standard that may not be difficult to meet today given the array of worrisome, if inconclusive, studies about the possible health risks posed by nanotech’s microscopic fibers and engineered particles, which, depending on who you ask, are either the key to future techno-prosperity or the harbingers of environmental and medical Armageddon. It’s even possible, Bergeson said, that a court might consider it a violation of current worker safety laws if a company is not maintaining detailed records of each employee’s exposure to nanomaterials, for reference years later should certain cancers or other ailments come to be associated with the high-tech materials.

In short, if you are a nanotech company you need to start developing a legal strategy for “how to protect yourself,” summarized Henry Chajet, an attorney with Patton Boggs. Listening, I felt sheepish for thinking it was about how to protect your employees and customers.

Truth be told, such defensiveness is understandable. Some critics have exaggerated the negative health implications of preliminary animal studies involving nanomaterials and have unfairly ignored the technology’s real promise. And plaintiffs’ attorneys already are boldly trolling the Internet for potential clients who believe they may have been harmed by nanotechnology.

“They are actively hunting for that next [equivalent to an] asbestos case, which, by the way, made them billions,” said James Chen of Crowell & Moring LLP, a DC-based food and drug law firm.

One of the best ways to stay clear of such lawsuits is to post adequate safety warnings for workers and consumers, Chajet advised, so that any user who eventually claims to have been harmed by the stuff can be argued in court to have been a “sophisticated user”—someone who was aware of the risks and took them anyway.

“‘Sophisticated user’ is a great defense,” Chajet said. “That’s how we’ve escaped liability for lots of clients.”

“Don’t test yourself out of a product.”

Nowhere is the nanotech industry’s nervousness about its own potential liability more apparent than in its relationship with regulators, several of whom also made presentations at the FDLI conference. Agencies such as the Environmental Protection Agency and the Food and Drug Administration are still trying to work out how nanotech fits into existing regulations, and whether new guidances or rules may be required to protect the public. That means that for now, at least, regulators are largely relying on their sparkling personalities and cajoling invitations to “come talk to us” just to find out what nano-companies are up to.

Not that any lawyer would encourage a company to participate.

“You can be the government’s guinea pig if you turn in a lot of data,” warned George Burdock, president of the Burdock Group, an Orlando-based consulting firm. While companies should do enough safety tests of their products to show they were reasonably diligent, Burdock added, they should not overdo it. “Don’t test yourself out of a product,” he advised.

Given warnings like that one, it should not be surprising that companies have hardly been lining up at regulator’s doors. Fewer than 30 companies have offered information under a one-year-old EPA program that asks nanocompanies to volunteer information. In the words of Jesse Barkas, a program attorney in EPA’s chemical control division, that’s “really pretty low participation.” What’s more, participating companies have ultimately provided “little actual data,” Barkas lamented. And for those of you who might want to know more, don’t come to the EPA. Much of what the companies provided is classified as “confidential business information” so is unavailable for public review.

Participation has been even lower for the agency’s voluntary “in-depth” program, in which companies are asked to divulge even more details about their products. Only four companies have volunteered, Barkas said. And although they have been generally forthcoming about the physical characteristics of their products, they have provided “very little data on eco-toxicity.”

All told, Barkas said, there is a “pretty big gap” between what the agency knows about nanoproducts and what is out there on the marketplace. The agency needs a lot more information, she said, “so we can get our arms around what it is we are regulating.”

In a few cases, nonetheless, the EPA has begun to use sticks as well as carrots. In March it will begin enforcing a decree that requires all manufacturers and importers of carbon nanotubes—some types of which have been shown to cause tissue damage similar to that caused by asbestos fibers—to notify the agency before releasing their products onto the market. Federal regulators also recently declared that they will demand tighter controls on nanoscale particles of titanium dioxide (used in paints and pigments) and alumina/silica, in recognition of the added health risks these ultrafine powders appear to pose compared to their larger particulate cousins.

Some states are also getting tougher. In January, California’s Department of Toxic Substances Control sent letters to the 27 companies and universities that it believes are manufacturing or importing carbon nanotubes, and asked a series of tricky legal questions such as: “When released, does your material constitute a hazardous waste under California Health & Safety Code provisions?”

“I’m not here to give legal advice,” said John Monica, of Porter Wright Morris & Arthur LLP, a Washington law firm, “but…God help you if you say ‘yes’ to that.”

Jim O’Reilly, of Baker & Daniels in Cincinnati, encouraged nanotech execs to hire a few experts to do enough basic studies so they can at least argue that they made a good effort to determine employee risks. The expense will pale in comparison to the cost of defending yourself in a tort case, he said, noting that “for one lawyer’s time you can hire four industrial hygienists.”

Given all the money being spent and made in the field of nano-liability, some are wondering aloud what they will do for a living if this self-sustaining element of the U.S. economy ever peters out. In the words of Donald Ewert, an environmental health and safety manager at Oso BioPharmaceuticals Manufacturing LLC in Albuquerque: “I’m wondering…what we’re all going to do when we find out that nanotechnology is not dangerous?”

But lawyers are nothing if not good at spotting the next income stream. “Synthetic biology!” one quickly shouted, referring to the controversial new science of making artificial bacteria and viruses from scratch.

Well, I’m not here to give legal advice. But if you think you’ve been harmed by a synthetic life form, there is definitely an attorney out there who wants to talk to you.

Rick Weiss is a Senior Fellow at the Center for American Progress and Science Progress.

Yesterday, officials from the FDA and the Centers for Disease Control and Prevention announced an expanded nationwide recall of products made from peanuts processed at the Georgia plant to include ingredients released as far back as January 2007. That expansion-which makes this recall one of the biggest in U.S. history-made sense, they said, as it has become clear that the company repeatedly failed to keep products off the market despite their having tested positive on several occasions for Salmonella, a bacteria that can cause food poisoning.

The toll to date: 501 people known to have been sickened in 43 states and in Canada. Of those, 108 hospitalized. And eight people so far believed to have died from having eaten the tainted products. All of the deaths have been people 59 years old or older. But fully half of the known cases of illness have been in children 16 years old or younger-a reflection of the prevalence of peanut butter and concentrated peanut paste in snack foods.

FDA and CDC are asking the right questions of the folks at Peanut Corp. And before long, so will lawyers for the victims. But there are equally important questions that independent investigators need to ask FDA and CDC, among them:

• How is it that a company’s internal testing can repeatedly come up positive for a disease-causing microbe and yet that company can have no obligation to report those findings to anyone, ever-not even the FDA or state health officials when they come around periodically to see how things are going?
• When the FDA subcontracts to state health departments its responsibility to inspect food processing plants, as it often does because of federal manpower shortages, how does the agency validate the professionalism and accuracy of those contracting departments?
• Might there be a need to clarify, either in the regs or through legislation, a company’s responsibility to act on initial test results that indicate contamination-that is, to keep those products off the market-as opposed to retesting (as Peanut Corp. repeatedly did) until a negative result is obtained?
• At what point are current FDA requirements that the agency keep sensitive information about companies confidential counterproductive to good manufacturing practices and to the public’s legitimate right to know?

As PeanutGate and the financial meltdown both exemplify, the regulatory philosophy in this country has historically been one that relies on the foxes to out themselves when they’ve indulged in malfeasance. Sure, everyone knows that too much oversight can stifle the flexibility that is key to ingenuity and innovation. But the pendulum has swung awfully far. Do we really have to wait until the fox gets caught with blood on its claws-and tainted peanut butter in its teeth-before we consumers get to find out what’s going on behind closed doors?

Image: flickr.com/dberlind

Okay, so according to the Lyndsey Layton in today’s Washington Post, the FDA has issued clear information that major brands of jarred peanut butter on grocery shelves are not subject to the recall. But there are hundreds of products affected–so many that the FDA has set up a database to track them all. If you want to stay on top of future recalls, the agency actually has a dedicated Twitter feed. (Science Progress is following.)

This is all the result of Salmonella in one Georgia plant. As Rick Weiss pointed out in his Monday column, it’s “a vivid example of our intensively centralized food production and distribution system.”

Cartoon: Mike Luckovich, Atlanta Journal-Constitution. From the Cartoonist Group.

A prolific scholar, Harvard law professor Cass Sunstein has written on anything from the implications of the Internet for democracy (in 2001’s Republic.com) to animal rights and human cloning. But a central focus of his research has been on ways of making the government regulatory process more efficient and effective—and this has included the embrace of so-called “cost benefit analysis,” which many environmental advocates accuse of being a rigged methodology that always seems to favor doing less for public health and the environment. (Perhaps the most thorough presentation of the anti-cost benefit case came in Frank Ackerman and Lisa Heinzerling’s 2004 book Priceless: On Knowing the Price of Everything and the Value of Nothing, which argued for the utter jettisoning of the technique.)

For a long time, OIRA has been seen as the place where regulations go to die, and cost-benefit analysis—in combination with improper second-guessing of scientific research produced by expert agencies—as the chief executioner. Bush’s controversial first OIRA director, John Graham, was a strong cost-benefit proponent, and at least for some, Sunstein sounds uncomfortably close to him in outlook. Frank O’Donnell, the president of Clean Air Watch, recently wrote that compared with Graham—whose confirmation was opposed by no less than 37 senators—Sunstein has a “similar anti-regulatory view.” And Rena Steinzor, the president of the Center for Progressive Reform, has added that the appointment “means that those of us expecting a revival of the protector agencies—EPA, FDA, OSHA, CPSC, and NHTSA—have reason to worry that ‘yes, we can’ will become ‘no, we won’t.’”

Balanced against such concerns, however, are the fact that Sunstein serves at the pleasure of the president—who is very much in favor of stronger environmental regulation—and furthermore, that he’s certainly not a proponent of cost-benefit analysis above all else. Rather, as you can see in this extensive and thoughtful Sunstein article in The New Republic­—reviewing Ackerman’s and Heinzerling’s book—he simply believes it’s a flawed but nevertheless useful methodology, leading to a better chance, over all, of making the wisest decisions in a context that always requires some balancing of competing values.

Still, peering into Sunstein’s writings on risk, rationality, and regulation—and other scholars’ reactions to them—there’s a troubling sense of what might be called, for lack of a better word, elitism. Or as Sunstein put it in his book Risk and Reason), “when ordinary people disagree with experts, it is often because ordinary people are confused.” Sunstein even admits in the book that his approach is “highly technocratic.”

The problem is this angle could oversimplify matters, for we also have very strong reasons to be very skeptical of so-called “experts” on science and risk. Anyone who has peered into these sorts of debates closely—over, say, the herbicide atrazine or arsenic in drinking water—knows not only that the issues are exceedingly complex but also that there is a lot of ideological distortion of science by ”experts” who are really ideological allies of special interests. If the choice is between such experts and the public, I’ll take the public every time.

Perhaps, then, the issue is not cost-benefit analysis itself, but what form of it you practice. One cost-benefit proponent, OSH whistleblower Adam Finkel, has himself written that Sunstein has “managed to sketch out a brand of QRA [quantitative risk analysis] that may actually be less scientific, and more divisive, than no analysis at all.” Finkel’s take on Sunstein is worth quoting at length, because it captures not only the complexity of the issues involved but also the great divergence of “experts” on risk assessment itself, and where Sunstein stands on the spectrum:

I actually do understand Sunstein’s frustration with the center of gravity of public opinion in some of these areas. Having worked on health hazards in the general environment and in the nation’s workplaces, I devoutly wish that more laypeople (and more experts) could muster more concern about parts per thousand in the latter arena than parts per billion of the same substances in the former. But I worry that condescension is at best a poor strategy to begin a dialogue about risk management, and hope that expertise would aspire to more than proclaiming the “right” perspective and badgering people into accepting it. Instead, emphasizing the variations in expertise and orientation among experts could actually advance Sunstein’s stated goal of promoting a “cost-benefit state,” as it would force those who denounce all risk and cost-benefit analysis to focus their sweeping indictments where they belong.

For now, the environmental community seems to be settling on the following position with respect to Sunstein. He’s going to go through, though senators should question him seriously at his confirmation hearing. In particular, let’s hope we hear that he rejects the idea that his office should be in the business of questioning the scientific determinations made by expert agencies like the EPA; that he plans to use cost-benefit analysis to improve regulation, not stifle it; and that he’ll show some serious skepticism towards many of the “experts” who tout “science” in these areas, and not just towards the allegedly irrational public.

Chris Mooney is contributing editor to Science Progress and author of several books, including The Republican War on Science and the forthcoming Unscientific America: How Scientific Illiteracy Threatens Our Future, co-authored by Sheril Kirshenbaum. He and Kirshenbaum blog at “The Intersection.”

Such is the case with the Food and Drug Administration’s handling last week of the nation’s first formal application by a company to market a human medicine produced by genetically engineered farm animals—specifically, a medicine made in the udders of goats.

The medicine is antithrombin III (brand name ATryn), a protein that aims to prevent blood clots in people with a rare but dangerous hereditary propensity to clot when they should not, manufactured by GTC Biotherapeutics of Massachusetts. More to the point, it is manufactured by the company’s transgenic goats, which contain a human gene that directs production of the anti-clotting protein in their milk.

It’s a cool approach. The only antithrombin III approved in the United States today is purified from donated human plasma, an unpredictable source that periodically dries up, leaving American patients scrambling. And compared to conventional means of producing biological drugs, such as gene-altered bacteria grown in vats, goats are stalwart and generous, churning out massive quantities in every glass of the white stuff. “Got Antithrombin III? You betcha!”

GTC’s application is the first of its kind, but others are on deck. The company, along with more than 20 other research teams around the country, anticipates a not-too-distant future in which transgenic farm animals will make many human medicines. Endowed with the right genes, a small herd of lactating goats could squirt out enough malaria medicine for all of Africa faster than you could sing a few verses of “Old MerckDonald had a Pharm.”

Problem is, federal regulators were not fully prepared when the folks at GTC anted up for a fast-track review. As I’ve written, it was not until September that the FDA released a draft version of its Guidance for Industry #187, which would codify how the agency will review applications to approve food or drugs from gene-altered farm animals. The agency accepted public comments through December and has yet to release any final guidance.

That made for an awkward situation on Friday, when an FDA advisory committee was asked to rule on whether the medicine made by GTC’s goats was safe and effective and therefore suitable for sale—without the agency’s veterinary center having even finished writing the rules on what constitutes an acceptable production process in animals.

Also embarrassing, if not plainly disingenuous: Agency officials had promised that its reviews of the first foods and drugs made in gene-altered animals would include public meetings at which they would discuss animal welfare, environmental, and public health issues openly. Yet Friday’s meeting had jurisdiction only over the safety and efficacy of the drug itself. After some hemming and hawing, FDA veterinary officials conceded that no public meeting dedicated to those other important issues was likely to happen for this first approval, in part because of statutory requirements that demand the agency move quickly on applications, such as this one, that have won fast-track designation. (The company’s hurry was not explained. In similar cases the problem has often been a shortage of funds and the need to achieve a key regulatory success in order to attract fresh venture capital.)

Friday’s presenters did divulge a few details about ATryn pharming. Company officials and FDA scientists (who have repeatedly inspected GTC’s operations), described all seven generations of the clot-busting goats as hale and healthy (indeed, the founder goat—the grand patriarch of this valuable line—was repeatedly described using the scientific term “handsome fella”). To prevent escape and ensure that their meat and medicinal milk never find their way onto grocery shelves, the goats are double-fenced and under constant video surveillance. They even have electronic transponders implanted under their skin so scientists can track them, if necessary, through the Massachusetts woods. A shockingly thin (read: single sheet of paper) agency-led “Environmental Assessment” concludes that the herd “is unlikely to result in significant effects on the environment.”

Several observers, including Greg Jaffe, director of biotechnology at the Center for Science in the Public Interest, were rightly unimpressed.

“More information about the risk analysis surrounding the genetically engineered goats needs to be made public and scrutinized by independent experts before any product approvals,” Jaffe told me, calling the FDA’s work to date “a good first step.”

Nina Mak, a research analyst with the American Anti-Vivisection Society, raised animal welfare issues. Typically, she said, hundreds to thousands of animals are engineered before an acceptable founder is created. “Unintended and unexpected problems are frequent, greatly increasing animal suffering.”

Mak said it was “astounding” that the FDA would consider approving a drug from a genetically engineered animal when it has not even decided what the rules for such approvals should be. She is right. The only tempering factor is that a number of FDA officials all but conceded that they, too, were chagrined. “Ordinarily,” said the FDA’s Eric Flamm, “we may want to coordinate the two reviews” of the drug itself and of the engineered animals and their various impacts.

After the advisory committee was told, to some members’ open dismay, that it could consider only whether goat-derived ATryn is safe and effective in patients, it voted yes. A final FDA decision is expected by next month. By then the FDA will presumably have released a more finished document describing the rules for approving drugs from gene-altered animals (I predict a release on Jan. 16, the last government workday of the Bush administration), and agency officials will have declared that GTC’s goats passed muster, though it will be too late for the public to weigh in.

A lot of eyes ought to be watching to see if the agency keeps its promise to do better next time.

Rick Weiss is a Senior Fellow at the Center for American Progress and Science Progress.

When and how did the U.S. government become so dependent on contractors to do its basic work? Some said these developments reflect Bush administration policies; others traced them to Reagan- and Thatcher-era distrust for big government. In fact, the reliance on contractors to do the government’s basic work is neither new nor an accident. It is the predictable and predicted outcome of a mid-20th-century, bipartisan decision to grow government through the use of contractors. What’s more, this decision was made in the name of science and was seen by the science policy elite at the time as a reform of truly Constitutional dimensions.

This far-from-accidental reform yielded civilization-shaking developments—the Manhattan and Apollo projects, innumerable breakthroughs in biomedical research, and, of course, the Internet. But as is now apparent from the day’s front-page headlines, the 21st-century legacy of this reform is a government dependent on contractors to do its most basic work, such as feeding our soldiers, protecting our diplomats, and collecting intelligence on the battlefield, often with too little official control or even awareness.

Today, dual sets of laws and policies govern the use of government officials and contractors—even as they may increasingly work side by side performing the same work. Consequently, laws enacted to define and limit government and protect Americans against abuse increasingly do not apply to those doing the real work of government.

Proclamations that more competition and better management will render government by contract accountable are no longer acceptable. Official oversight is inadequate, competition is too often limited, and the laws enacted to assure official control are too often placebos. The country needs to know the real condition of its public workforce. The path to reform requires not only transparency but also analysis to prevent new imbalances. If contractors are to continue to do basic government work, then not only must laws and reality be reconciled, but also the public-service ethic must be extended to encompass the entire taxpayer-funded workforce.

To begin to understand how we reached the point where dedicated contracts for specific scientific projects with profound national security implications morphed into a default determination to meet new challenges by deploying contractors instead of civil servants, we must start with the perspective of mid-20th-century science policy. For it is there that the reliance on contractors to do the government’s work was conceived as a profound reform, with those present at the creation understanding the strengths and limits of reform with acute foresight that is relevant today.

From the Manhattan Project to the military-industrial complex

America entered World War II with a small government and a tradition of distaste for Big Government. The war, however, required rapid deployment of the nation’s scientific and industrial resources. The Manhattan Project to develop the first atomic bomb, and the further wartime research sponsored by the famed Office of Scientific Research and Development, showed that the genius of America lay not only in its natural scientists and inventors but also in its management techniques—the ability to use the contract to organize private enterprise for public tasks of enormous complexity.

That’s how the atomic bomb was built speedily in secrecy by a combination of universities and industrial giants working on contract at secret, government-owned, contractor-operated sites throughout America. As Office of Scientific Research and Development historian Walter A. Macdougall observed, OSRD established the practice “of state funded but privately executed R&D. In a matter of minutes, patterns that had characterized American research throughout its history were undone.”

That wartime success of the public-private partnerships led OSRD director and presidential science adviser Vannevar Bush to recommend to President Franklin D. Roosevelt, in the classic report Science: The Endless Frontier, that the government continue contract relationships with nonfederal organizations after the war. Incomprehensible today, but plausible in the shadow of mid-century totalitarianism, Bush needed to explain to corporate colleagues why taking money from Washington was okay. As Bush’s memoir explains, his good friend the president of Bell Labs “was sure that we were inviting federal control of colleges and universities, and of industry for that matter, that this was an entering wedge for some kind of socialistic state.”

Two decades later, in his 1965 The Scientific Estate, science policy eminence Don Price, first dean of the Kennedy School of Government at Harvard University, provided a classic explanation for developments calculated to satisfy corporate and science beneficiaries of the government contracting process. The United States, Price argued, needed more government to prepare to fight the Soviet Union, develop infrastructure, provide social welfare, and cure disease. The use of private contractors would permit the federal government to draw on private expertise, provide corporations with funding that would allay corporate fears that America was turning socialist, and would provide a force to countervail the dead hand of a central official bureaucracy.

Price hailed the transformational import of the “fusion of economic and political power” and the “diffusion of sovereignty,” both chapter headings in his book. Specifically, he argued that:

the general effect of this new system is clear; the fusion of economic and political power has been accompanied by the diffusion of sovereignty. This has destroyed the notion that the future growth of the functions and expenditures of governments would necessarily take the form of a vast bureaucracy.

American government was undergoing a reform of Constitutional dimensions. Scientists, with their world-shattering, public-private research-and-development projects, were providing the elixir that would make the world safe for a new kind of government. But even before Price championed public-private contracting as benign reform of Constitutional dimensions, other, less flattering perspectives were also emerging. Most famously, in his 1961 farewell address, President Eisenhower declared the new public-private contract-based R&D partnerships to be the “military-industrial complex.”

President Kennedy early in his presidency waded into this debate by commissioning a cabinet-level report to examine the implications of contract-dependent R&D. The 1962 “Bell Report” (named after Budget Bureau Director David Bell) served as a springboard for the first public congressional hearings on the Rand Corporation and other government-created contract “think tanks” and “systems managers” spawned at the nexus of government and the aerospace industry. It is the last, best, and indeed only (save for Ike’s speech) White House review of the wisdom of government by contract, and it foretold much of what has since come to pass.

The report declared that the “blurring of the boundaries between public and private” raised profound questions about the axiom that officials must be able to account for the work of government. The report said the use of contractors to respond to Cold War emergencies made sense in the short term. But over the longer term, the axiom of official government control over contractors to the federal government would be challenged unless corrective action were taken.

The “Bell Report” put its finger on the problem: the disparity between the rules of law governing officials and contractors. Americans, ever concerned with big government, have enacted over two centuries laws to protect against official abuse. These began with the Constitution and its Bill of Rights, which define the limits of government and provide for individual rights against government abuse, and now include laws on ethics, pay, freedom of information, and political activity.

By and large, these laws do not apply to those outside government—even contractors doing government work on taxpayer dollars. They do not apply on the dual premise that officials will have the capacity to oversee contractors and that the qualities for which contractors are valued may be constrained if they are subject to rules governing officials. Yet as the “Bell Report” prophesied, when the decision to rely increasingly on contractors for key government work was coupled with the freedom of contractors from rules limiting government officials, the predictable effect would be the erosion of some, if not all, official capability to oversee contractors.

Why, the “Bell Report’s” logic foretold, should experienced government officials choose to remain in government service when they can work as contract employees who are not governed by official pay caps and the stringent constraints of official ethics—and do work no less interesting than that in government?

But the “Bell Report” backed away from answering the basic questions it raised. The new public-private mix, it found, was essential to Cold War programs. “Philosophical issues,” the report said, needed to be deferred. Thereafter, as government grew, third-party government grew without pause, on automatic pilot driven by bipartisan limitations on civil servants.

From the “Bell Report” to Abu Ghraib

Cold War agencies such as the Atomic Energy Commission, the Department of Defense, the National Aeronautics and Space Administration, and the U.S. Agency for International Development, provided the initial template for the deployment of contractors as a permanent workforce to perform central public tasks. From the get go, and in its present incarnation in the Department of Energy, the nation’s nuclear weapons complex has been essentially government-owned and contractor-operated.

“NASA,” the Washington Post observed following the Columbia tragedy, “may hire the astronauts,” but “at the Johnson Space Center, the contractors are in charge of training the crew and drawing up flight plans. The contractors also dominate mission control, though the flight directors and the ‘capcom’ who talk to the crew in space are NASA employees.”

With each new agency or program, contractors were trained and deployed to do the basic work. In this fashion, federal funding gave birth to information technology and the Internet and also to an increasingly sizeable contract (and university and further nonprofit grant) workforce. In the 1960s and 1970s, these contracting models were transferred from Cold War agencies to civilian agencies as the Great Society programs initiated by President Johnson rushed to embrace contractor-generated management products, such as PERT (Program Evaluation and Design Technique) and PPBS (Planning, Programming, Budgeting, and Execution), incentive contracting, and systems analysis. All these products promised to solve the problems of the inner cities as well as those in Vietnam.

In 1971, looking back on developments, John Corson, who opened McKinsey Corporation’s Washington office, marveled at what had been wrought. “There is,” he wrote in Business in the Humane Society, “little awareness of the extent to which traditional institutions, business, government, universities, and others, have been adapted and knit together in a politico-economic system which differs conspicuously from the venerated patterns of the past.” Post-war contracting, he said, was a “new form of federalism.”

From the perspective of the Nixon White House, what had been invented was not a new way of government but a new way of patronage. The “Political Personnel Manual” uncovered by the Senate Watergate investigations showed that Nixon White House staffers, seeking to catalog ways to control the presumably Democratic-leaning civil service, were bemused to discover that, under the guise of efficiency, JFK and LBJ had used cutbacks in the civil service to hire friends as contractors—with, the Nixon staffers noted, of course, higher taxpayer costs. Turning the tables, at the Office of Equal Opportunity, the central War-on-Poverty agency, two young administration officials named Donald Rumsfeld and Richard Cheney hired their own contractor, Booz Allen, to help take control of the agency, shuffling civil servants under the guise of agency reorganization.

In the 1980s and 1990s, a new generation of reformers—the privatizers, downsizers, and reinventors—came to argue for the reform of Big Government, often with little evident knowledge of the history or legacy of the reform that had been occurring for decades in America. When, in 1993, the Clinton administration announced its intention to “reinvent government,” it declared it would reduce Big Government by further reducing the numbers of civil servants, with little demonstrable recognition that this had long been the means for growing, not reducing, government.

Ironically, the eponymous book that heralded the Clinton administration’s “Reinventing Government” reform was itself focused on local government reform and noted that many of the “public-private” partnership methods advocated had long been used at the federal level. Reinventing government followed the footsteps of the Price logic—the diffusion of sovereignty was a good thing that can be kept under control by modern management techniques such as “performance contracting.” The task was to cut red tape and make the use of contractors simpler and more efficient.

Thus, a key reform was to centralize purchasing in the General Services Administration, so that other agencies could essentially buy from a catalog without need for further competition. As Iraq showed, however, an effect of the reform was to maximize potential for unaccountability. When the public learned that a contractor called CACI had been at work interrogating prisoners at Abu Ghraib, there was a scramble to find out exactly how the Army hired the contractor. It turned out that the contract was originally awarded by the GSA, assigned to the Department of Interior for administration, and then used by the Army in Iraq.

With responsible GSA officials evidently unaware of what was happening with their contract, the Army used the contractor for purposes that were (unlawfully) beyond what the GSA contract provided, contrary to the Army’s own prohibition against the use of contractors to perform such intelligence gathering, and contrary to the rule against using contractors to serve, in essence, as integrated members of the government workforce. Thus, in context, the contracting scandals of the Bush administration are not an aberration but rather the predictable and predicted consequence of a half century of government contracting reform.

President Bush entered the White House committed to paring the federal government, but, as with predecessors, the means was not to reduce the size of government but rather to increase the number of contractors. Thus, one of the pillars of the Bush “Management Agenda” was to put out for competition up to 850,000 civil-service jobs. After 9/11, the new Department of Homeland Security was borne aloft on a contractor workforce and limited official capacity for its oversight.

Or consider Iraq. In March 2002, before the war began, the Secretary of the Army sent a troubled memorandum to top Pentagon officials explaining that Pentagon Army planners had little clue as to the size of the contractor workforce, the costs associated with it, “and of the organizations and missions supported by them.” In April 2002, the Army told Congress that its own estimates of the size of the civilian support workforce varied from 100,000 to 600,000. In short, assuming the Iraq war were to be waged, contracting would be the predictable means to be used—and an inability to oversee contractors the predictable consequence.

Re-envisioning 20th-century government contract reform

The domestic “diffusion of sovereignty” that Price foresaw, and indeed urged, has now meshed with a global diffusion of sovereignty. Research and development is now a matter of networks of multinational corporations, “global universities,” and numerous governments. But at home, Price’s vision has (as the “Bell Report” prophesied) left a legacy that must now be addressed. We can no longer assume that the official workforce has the capacity to understand and control the basic work of government. We have the diffusion of sovereignty, but we do not have the rule of law to match it.

In short, 20th-century reform has taken a remarkable journey but is now adrift from its moorings—and we need a map for the future of reform. Today, we have two alternative frameworks for viewing the government system that science policy helped create. In practice, neither of these is adequate to hold contractors to account.

First, governing law and policy enshrine what might be called the “presumption of regularity” or the “rule of law” vision, in keeping with longstanding legal tradition that officials may be presumed to act with the good faith, diligence, and competence expected of them. Under the Western rule-of-law tradition, the presumption of regularity envisions that officials must be subject to rules that define and limit government authority and protect against government abuse. This is known as public law. If the presumption of regularity is valid, then these rules need not apply to contractors because contractors will be accountable to officials.

The problem, as the front pages increasingly tell us, is that this presumption of regularity does not reflect reality, where contractors have long since been engaged to do the government’s basic work. When it became apparent, at the dawn of contract reform, that the presumption was imperiled, the Eisenhower White House issued a policy that only officials can perform “inherently governmental” functions. That policy (now found in Office of Management and Budget Circular A-76) has become a fiction or fig leaf. It been dutifully reiterated by every White House since—most recently by the Bush administration virtually coincident with the start of the Iraq war and the wholesale deployment of contractors on the battlefield.

Second, while formally reiterating legal principles, bipartisan governing policy embraces what might be called the “governance-accountability” vision. This vision, a modern version of Price’s “diffusion of sovereignty,” holds that the work of the public is best done by a mix of government, civil society, and market organizations—with attention to results and not to who does the work or the “boundary between public and private.” This vision premises that it does not matter so much who is doing the public’s work, but rather whether there is “accountability” for that work.

In the world of governance today, accountability is to be provided in three interlocking ways:

• Modern management and social science techniques, which will align public and third-party interests by structuring contract performance standards and incentives properly
• The force of competition between or among contractors and interest groups, which will help keep the system honest
• Transparency as an aid to the first two tools.

While not forsaking the premise that officials must be able to account for all government work, proponents of this governance and accountability model suggest that the civil service must be transformed into a workforce that functions substantially, or even primarily, to manage third parties. The problem, as the front pages once again tell us, is that the tools of governance are insufficient and can even be counterproductive—especially in the age of diminished official oversight.

The upshot: competition in procurement is a key tenet of procurement law today, but the reality is that it is often limited because competitors may be few (particularly in security areas where workforces must have clearances), competition costly, and competition further restricted by socioeconomic preferences. Similarly, performance measures are hard to come by for novel public tasks that often require unavailable resources to police, which in turn makes poor performance hard to penalize. Because the work has to get done, and because too harsh a penalty may eliminate a competitor needed if there is to be competition, performance measures are often mostly useless. As for transparency—again it is nice in theory—the contract workforce too often remains largely invisible within agencies, never mind the public at large.

By consequence of the limits of these two visions, the evolution of the rules of the game often owes more to what might be called a “muddling through, common law” model. When crises arrive, they are handled with limited regard for the big picture. In the absence of coherent congressional and executive oversight, this model has, by default, become the primary means by which new rules of law are set to govern contractors and other third parties who perform the basic work of government.

This model accepts that rules of public law should apply to those who perform public tasks and applies those rules on a piecemeal basis to nongovernmental actors who perform the public’s work. In doing so, it draws from the Anglo-American legal tradition, which (as in the case of public utilities regulation) has long applied public obligations to private entities that serve public purposes and to public procurement law itself.

“The Science of Muddling Through,” as Yale professor Charles Lindblom’s classic article explained, is the American way—but it has its weaknesses, as the evolution of reform by contract well illustrates. First, successful muddling through requires a healthy crew of diverse and well-funded nongovernmental watchdogs to keep policy and practice honest. Government contracting is an insider’s game. Public watchdogs have been few and far between.

Case in point: the history of the ethical standards applicable to contractors illustrates the difficulty of developing a rule that works in the public interest. At the onset, no conflict-of-interest rules at all applied to contractors. As Price observed, during the 1950s, “no Congressmen chose to make political capital out of an investigation of the interlocking structure of corporate and government interests in the field of research and development.”

The concept of “organizational conflict of interest,” or OCI, was conceived only when some contractors felt that other contractors were using their inside track to unfair competitive advantage. It said nothing about circumstances where collective contractor interest is served but public interest disserved. In the late 1970s, the notion of “public interest,” as well as competitor interest, was added to the OCI concept. Even so, contractors may be hired where conflicts exist.

Moreover, while civil servants can go to jail if they work for the Department of Transportation and General Motors, no criminal conflict of interest rules govern contractors. But the real problem is that disclosures of potential conflict are exempt from disclosure under the Freedom of Information Act, and there is no routine of independent audits of the integrity of the disclosure and review process.

Most importantly today, as Lindblom explained, the science of muddling through produces change by increment that serves the interests of those pushing the change, with often little regard for a big picture that may be increasingly out of kilter. As is the case with government contracting, whenever incremental changes neglect the big picture, which is the fundamental and continuing erosion of official oversight capacity and the disconnection between law and reality, muddling through may be the problem and not the answer.

A path to re-envisioning reform

The presumption of regularity, governance, and muddling through all represent frameworks for understanding how the ship of state got to where it is. But none of them provides an adequate chart for today’s waters. There is no current vision to replace the one that kicked off reform of the scientific estate over a half century ago, but there are steps that can be taken to address its legacy and to re-envision the reform.

Proclamations that more competition and better management will render government by contract accountable are no longer acceptable. Official oversight is inadequate, competition is too often limited, and the laws enacted to assure official control are too often placebos. The country needs to know the real condition of its public workforce. The path to reform requires not only transparency but also analysis to prevent new imbalances. If contractors are to continue to do basic government work, then not only must laws and reality be reconciled, but also the public-service ethic must be extended to encompass the entire taxpayer-funded workforce.

Truth in government: public workforce must be seen and planned for as whole

The third-party workforce must be rendered visible—to Congress, officials, and the public. Federal budgets, organizational charts, and agency directories provide details on the federal workforce, but there is no such detail on the third-party workforce—even where it works side by side with officials in federal buildings. Data must be supplemented by analysis. Because reliance on contractors to perform the basic work of government remains invisible in substantial respects, independent analyses of how and how well the system works are exceedingly rare.

The White House (through the Office of Federal Procurement Policy, but also the Deputy for Management) needs to be able to perform, or coordinate, research and analysis that addresses topics including the extent to which

• Functions vital to national security and well being are in danger of being contracted beyond official oversight capability
• Competition can be relied on to award contracts to perform governmental activities
• Reviews of past performance, are, in fact, used and useful in contracts for performance of the work of government.

In addition, the White House must examine the role of contractors in providing “networked government,” especially how and how well contractors who work for multiple agencies (or public agencies and private regulatees) perform network functions, and how potential conflicts are addressed. And the new president and his administration must ensure the adequacy of the procurement oversight workforce, including the availability of third-party resources (both contractors and citizens using the False Claims Act or otherwise).

All this analysis must then be put to use. In creating new programs or agencies, Congress and the White House should ask, “Who will do the work and can officials account for it?”

Before funding new programs, relevant congressional committees and the White House Office of Management and Budget should assess the ability of the official workforce to perform core government functions, including oversight of contractors. The Department of Homeland Security, for example, was created without evident regard for the reality—as evidenced by the problems of Deepwater Port and much else—that the official workforce was from the get go inadequate to oversee contractors. As the country creates new programs to address, for example, climate change and energy security, funding must be preceded by review of the adequacy of official oversight in light of the Department of Energy’s long dependence on contractors.

The White House must have capacity to lead

Today dual sets of laws and policies govern the use of officials and contractors—even as they may increasingly work side by side performing the same work. There must be public review and comparison of the differing rules that apply to federal employees and to nongovernmental actors in the performance of the government’s work. The sharp concern about contractors on the battlefield in Iraq should be the beginning, but not the end, of the review, which must encompass work at home as well as abroad.

Generations of procurement law reform have had mixed results, and the attempt to relate procurement and personnel law will be all that more difficult. Moreover, mechanical application of uniform rules to officials and contractors may be counterproductive and negate qualities for which contractors and civil servants are valued.

Thus, at the same time, the White House needs to develop an ethic of public service that can be applied to contractors who do basic government work. The focus should not be so much on conduct that is plainly illegal and covered by current law—bribery or kickbacks, for example—but on conduct that is problematic because it takes advantage of the difference between the presumption of regularity that is enshrined in law and the practical reality of limited official oversight.

It is a tenet of modernity that information asymmetries dog relationships between experts and laypeople, or, in a related vein, between principals and agents. Unless controlled, the actor with more information may be able to take advantage of the client or principal who has called on him or her for help. Sadly, the primary legacy of 20th-century contract reform is the potential to abuse information asymmetry.

First, in many cases the only experts on a subject are those in the contracting sector. Second, the dual sets of rules governing officials and contractors provide incentives for those experts the government does possess to join the contractor workforce. Third, information asymmetry is further amplified by the compartmentalization of the procurement process that attended contract reforms in the 1990s: officials with responsibility see part of the big picture, but contractors, with contacts, and experience throughout government may see the whole playing field.

Professional codes have evolved to limit the abuse of information asymmetry by experts in their dealings with clients. Doctors, for example, must fully disclose and obtain informed consent of patients. Ethical codes also, of course, govern those who perform the public’s work as civil servants. There are no generally applicable ethical principles that govern special ethical problems when private citizens do public service on taxpayer dollars. In part, the very need for such principles has been obscured by repeated official proclamations that officials must be in control.

In contrast to a patient or a legal client, the U.S. government might be thought to have the resources (authority, people, knowledge, money) to make decisions and protect itself. Indeed, this thought is given legal form in the presumption of regularity and the inherently governmental principle. But it is simply not the case today. Three remedies, then, present themselves for immediate attention.

First, there must be independent audits of the contractor conflict-of-interest disclosure and review process. Criminal conflict-of-interest laws that severely limit civil servants do not apply to contractors on the premises, which means that contractors must be effectively overseen by civil servants. In fact, it may be in the public interest for contractors to work for others than the government. Current law also requires contractors to disclose relevant interests to government, but disclosures are not publicly available, and there has been scant independent review of their workings. Investigations conducted by Sen. David Pryor (D-AK) found that even on key national security issues, contractors too often failed to disclose relevant interests, and when disclosure was made, the government too often failed to take note.

Second, there must be attention to the increasing circumstances where contractors are put to work in violation of the law—notably where the work is beyond the scope of the contract (as in contracting interrogation at Abu Ghraib), or where contractor employees staff offices alongside officials (in violation of the prohibition against personal service contracts), or where contractors are used to perform inherently governmental functions, in violation of inherently governmental policy. Abu Ghraib crystallized the problem. Among other things, it brought to public light the reality that much GSA “supply schedule” contract work, such as one for prison interrogation, is outside the scope of that permitted in the basic GSA agreement. Addressing this, contractor lawyers explained to the Washington Post that it was not for the contractor to tell the government that assigned work was beyond that provided for by law.

If the presumption of regularity were valid, then it might be argued that contractors may rely on government for the “regularity” of contracts. But where it is known that official oversight may be limited, and, to boot, where contractors talk of themselves as “partners” to government, the duty of disclosure seems clear.

Third, there are too many instances where work that is poorly specified or not needed at all is performed by contractors—again on the grounds that the government asked for it and, therefore, the work can be presumed to be reasonable. The objection will be raised that to impose ethics principles would be to stop government in its tracks because of the profound dependence on contractors. But the focus, at least at the onset, may be on disclosure.

As with current contractor conflict-of-interest laws, once disclosure is done, then the government can affirm that the contract should proceed—even where a problem that cannot be mitigated may exist. A point of the effort should be to alert officials to problems they may not have seen, to require official reflection on problems that are seen but not addressed, and to create a public record of the need for variation from principle on which reform can proceed.

If, for example, contractors routinely note that their work appears to be impermissible personal service or inherently government contracting, and if procurement officials routinely determine there is no alternative to proceeding, then Congress and the White House will have a basis to consider whether such law and policy have outlived their functions, or, if not, what alternatives must be crafted.

In sum, it is time to explore, at the highest level, the possibility and efficacy of an ethos or ethic of public service to govern all those who do the work of government, not just the civil service. If ethics may seem a weak reed to account for the powerful forces unleashed by 20th-century reform, then the logic by which contracting information asymmetry has grown may provide a comparative advantage in the development of ethical principles. The “revolving door” assures that there will be a steady flow of contractor officials who understand the government perspective (in ways, for example, that doctors or lawyers may not understand their patient or client perspective).

Finally, there is America’s role as the pioneer of modern government by contract for uses of historic importance. The American system is unique among modern governance systems in its scope of reliance on contractors to do the basic work of government. At the same time, contracting for government services appears to be a growing global phenomenon, for which the American system may be a model for study and, with appropriate local modifications, adoption.

Strengthening the ability of the American system to creatively address and solve the difficult questions that are the legacy of 20th-century contract reform may be crucial in the globalized world and best in keeping with the genius that was the spirit of mid-20th-century reform.

Dan Guttman teaches at  at Johns Hopkins University, is co-author of The Shadow Government and a fellow of the National Academy of Public Administration. He is a Visiting Professor at the Peking University School of Law Public Interest Law Program and Senior Fellow at the Tsinghua University US-China Center.  Guttman was counsel to Senator David Pryor in contractor oversight investigations, and shared in an Investigative Reporters and Editors 2004 award for “Outsouricng the Pentagon.”

At the time, Michael Crichton had recently come out with his terror novel, Prey, which is about self-organizing nanoparticles running amok and unleashing coordinated attacks against humanity. There was talk about the book being made into a major motion picture. “All I can say is we better get our messaging out about nano before the movie comes out,” an NSF official said to me during a break. “Otherwise the battle is lost.”

As it turns out, the movie did not get made. But two new studies published last week suggest that it may not matter much whether the NSF gets around to educating the public about this new technology, at least not in the conventional sense of education. Despite the common conception that a better-educated public is more likely to appreciate and support scientific and technological advances, the new study found that deeply ingrained psychological and cultural factors drive individuals’ acceptance or rejection of new and potentially frightening technologies—much more so than factual information.

For people whose cultural views leave them disinclined to trust new technologies, the act of getting more information—even very balanced information—can harden rather than soften attitudes of opposition.

“Our study reinforces the conclusions of other researchers who have cautioned against assuming that enlightened public opinion will spontaneously emerge from accumulating scientific information on the risks and benefits of nanotechnology,” write Dan M. Kahan, of the Yale Law School, and his colleagues in the December 7 online edition of Nature Nanotechnology.

Indeed, the team found, for people whose cultural views leave them disinclined to trust new technologies, the act of getting more information—even very balanced information—can harden rather than soften attitudes of opposition. That finding, along with the conclusions from an accompanying study that finds a strong link between religiosity and rejection of nanotechnology, suggest that proponents of the technology—along with federal regulators—have some serious work to do beyond public education if the field is to break through safely to commercial success.

A 20-second refresher: Nano has to do with engineered particles, fibers, and devices between 1 and 100 billionths of a meter in diameter—a scale so small that it involves in some cases the manipulation of individual atoms. Ordinary materials behave in extraordinary ways at that size scale, offering materials scientists a new palette of chemical, electrical, and optical properties to work with, but also posing potential threats because of these substances’ ability to get into the body or contaminate the environment.

Many studies have shown that, in general, Americans have vaguely positive feelings about nanotechnology but also that they know very little about it. To see what underpins those feelings and what impact more information might have, Kahan and his colleagues surveyed 1,862 adults. The goal was to see which of two models best described how people come to perceive nano’s risks and benefits: the “familiarity hypothesis,” which posits that the more people know about nano the more they will appreciate and trust it, or the “cultural cognition” hypothesis, which predicts that preexisting worldviews (in particular, whether one is in essence “individualistic” or “communitarian”) will largely determine people’s attitudes toward the science, irrespective of how much they actually know about it. (The individualists tend to be supportive, while communitarians worry about negative impacts on others and on the world.)

Among those in the study who knew relatively little about nano and were not told anything new in the survey, people of both worldviews were equally likely to be supportive of the technology—about 61 percent of them. But that changed when people of each worldview were given identical, balanced fact sheets that offered equal amounts of detail on both benefits and risks. Their knowledge-bases thusly enriched, people with individualistic worldviews became 25 percent more likely to support the science than they were before. By contrast, communitarians responded to the same information by becoming 38 percent less likely to be supportive than they had been.

After reading the same information, that is, two groups of people who once felt the same about the technology suddenly were split, 86 percent to 23 percent—scientific proof, of a sort, that some people really do see the glass as half empty while others see it as half full.

In the second study, led by Dietram A. Scheufele of the University of Wisconsin, Madison, researchers compared Americans’ attitudes about whether nanotechnology “is morally acceptable” against measures of their religiosity, and found the two to be inversely correlated. (Surveys have found similar trends for other areas of science, perhaps because of a sense among some religious people that scientists are meddling with aspects of nature that are properly God’s domain.) Then, going further, they surveyed people in several European countries. They found a clear continuum in which people in countries with the lowest levels of religiosity had the highest odds of finding nanotech to be morally acceptable, while those living in countries with high measures of religiosity (the United States being higher than even the highest in Europe, namely Ireland and Italy) had the lowest odds of finding nanotech to be morally acceptable.

Those relationships held true even when the researchers applied correction factors to account for differences in the countries’ general alignment with science, as measured by national research productivity and high-school science scores.

One way to gain public confidence and acceptance, of course, is to reassure consumers that the government has assessed the science and implemented responsible oversight policies. As I’ve written here and here, and as confirmed last week in a new report from the National Research Council, the feds still have a lot of work to do in this regard.

But if the new studies are right about the importance of pre-existing worldviews and religiosity, then it will take more than government pronouncements to gain widespread public support for nano, which the Commerce Department has hailed as nothing less than “the next industrial revolution.”

Worldviews and religiosity are not easily changed or overcome. So is the prospect for a positive consensus on nano altogether out of reach?

“Nothing in our study suggests that cultural polarization over nanotechnology is inevitable,” Kahan and his colleagues write. “Social psychology is making important advances in identifying techniques for framing information on controversial policy issues in a manner that makes it possible for people of diverse values to derive the same factual information from it.”

To which I can only say: Really? That sounds awfully close to the line between education and brainwashing, doesn’t it?

Come to think of it, compared to being subjected to educational materials engineered by social psychologists that are guaranteed to convince me that everything is okay, I wonder if I might just rather live in an intellectually stunted, religiously suffused, and hopelessly divided country where there is at least a free and full, if largely fruitless, debate still going on.

That’s my (very small) worldview. And I’m sticking to it.

Rick Weiss is a Senior Fellow at the Center for American Progress and Science Progress.

In January 2008, scientists at the J. Craig Venter Institute announced that they had created the first complete synthetic genome, setting the stage for the complete “reprogramming” of an organism with synthetic DNA. While the ramifications of this accomplishment are stunning, the news itself was not a surprise to those who have followed the progress of biotechnology research.

Technologies that can “read,” map, and manipulate the genetic code of living organisms have escalated in power and capabilities over the past 30 years, yielding an unprecedented amount of data and a more sophisticated understanding of how genetic materials give form and function to living cells. This new knowledge has, in turn, given rise to a new engineering discipline for living organisms—a discipline that has become known as “synthetic biology.”

As evidenced by the Venter Institute announcement, synthetic biology seems to be on the brink of two noteworthy accomplishments: to be able to “streamline” and redesign the genetic material of living organisms to make them operate more efficiently; and to design and assemble entirely new, artificial life forms from scratch.

How Synthetic Biology Works

According to the tenets of synthetic biology, living organisms are made up of discrete components that perform in distinctive ways, much in the same way as the functions of transistors and other electronic components can be assembled first into circuits, and then into systems designed to accomplish specific tasks. In synthetic biology, “bioengineers” are developing an inventory of biological parts, which they sometimes refer to as “biobricks,” using chemical ingredients and equipment that are common to any modern biology lab. Like electronic components, the researchers claim, these biobricks—which include genes and chromosomes, as well as proteins that can sense and report activities within a cell—can be assembled and programmed to compel organisms to operate in specific ways, or to produce custom chemicals that can later be “harvested” from cells and sold.

Both the discipline and the budding industry of synthetic biology are made possible by two concurrent technological trends. One trend is the increased power, sophistication and availability of technologies for sequencing genomes and for synthesizing and assembling DNA molecules into long strings of functional genes and genomes. The second trend is the rapidly decreasing cost of these powerful technologies. The productivity of sequencing technologies has increased 500-fold over the past 10 years, and is doubling every 24 months. At the same time, costs have declined from $1 to less than $.001 for each base pair sequenced.[1] Similarly, the productivity of DNA synthesis technologies has increased by a factor of 700 over 20 years, doubling every 12 months. The accuracy of the synthesis process has increased as well, while costs have dropped from $30 per base pair to less than $1 over the same period.[2]

These advances in automated processes and improved chemistry have made it possible to make large quantities of a wide range of moderate-length DNA sequences. The process is now so easy to do that many suppliers accept orders for custom DNA sequences over the Internet and deliver them by mail. These advances have catalyzed an industry of low-cost DNA suppliers around the globe.

Unknowns and Uncertainties

Synthetic biology represents an amalgam of scientific disciplines and sub-disciplines, public and private funding, public and private institutions, complex cross-sector collaborations and, in some cases, new approaches to intellectual property protection. Not surprisingly, most of the significant synthetic biology research and development is taking place in the United States, where most of the world’s biotechnology R&D activities are also centered. But other countries, most notably those in Europe, are also investing heavily in synthetic biology development.

Proponents of this new engineering discipline claim that the ability to create, manipulate and cheaply manufacture customized or unique life forms will produce many benefits across a wide range of applications, from medicine to energy generation and environmental remediation. In the near term, their vision of the future includes designer microorganisms and other engineered life forms that can be deployed as “devices” to stimulate tissue repair and cell regeneration and sense changes in body chemistry that might be precursors to disease. They also say synthetic organisms will be able to produce new kinds of pharmaceutical compounds and plastics, as well as detect toxins, break down air and water pollutants, destroy cancer cells, and generate hydrogen and other substances for new energy technologies.

But that vision does not adequately acknowledge an equally lengthy list of potential risks, as well as broad scientific and social concerns, that as yet are largely unaddressed.

The most obvious risk, which has caused the most concern to date, is the ability bestowed by synthetic biology to design and manufacture biological weapons in the form of virulent pathogens, most notably microbes such as bacteria and viruses. Other risks come under the heading of “bioerror,” rather than bioterror: namely, the consequences of accidental release of engineered organisms that were not intended to come into contact with the open environment; the mutation of “harmless” man-made organisms into ones that are harmful to people and/or the environment; or the effects of alien organisms that invade and destroy native populations and become impossible to eliminate, in much the same way as non-native, “invasive” species of plants, animals and microbes do today.

Many other critical questions have to do with broader, unacknowledged issues about scientific uncertainty. In 2007, a global consortium organized by the U.S. National Human Genome Research Institute, or NHGRI, published the results of a four-year study to identify and analyze the functional elements of the human genome—the “biobricks” upon which the discipline and industry of synthetic biology (and the entire biotechnology industry, for that matter) are built.[3] To the researchers’ surprise, according to the NHGRI announcement, they found that the genome is not a “tidy collection of independent genes.” Instead, it appears to operate as a “complex, interwoven network,” where components interact and overlap with one another and with other components in ways that are not yet fully understood.

The study, called the Encyclopedia of DNA Elements, or ENCODE, raises serious questions for synthetic biologists about the limitations of the “engineering” paradigm that they are applying to living systems. While there may be encyclopedic knowledge of the mechanics of electronic components and their interactions, clearly there remain far more questions than answers about the biological mechanisms that govern living organisms.

In fact, in many respects scientists know less today about these mechanisms than they did even just five years ago. As the NHGRI said at the release of the ENCODE report, scientists are now challenged “to rethink some long-held views” about genetic components and what they do. Given this scarcity of knowledge, can synthetic biologists truly claim to know enough about living, reproducing biological systems to design artificial organisms—and, more important, to reliably predict their behavior and effects once they have been released? Are the parallels they draw between electronic components and biological parts accurate, or even relevant?

More specifically, synthetic biologists have left unaddressed several critical mechanisms that limit their ability to predict the long-term consequences of synthetic organisms. One is the effects of horizontal gene transfer—the natural mechanism that moves genetic material between species and even kingdoms and facilitates, for example, the transmission of avian influenza to other animals, including mammals—when artificial genes make their inexorable move across species to indigenous organisms, or vice versa. Also unaddressed are issues about mutation and evolution; that is, how synthetic organisms will adapt to their environment once they are released. Likewise, synthetic biologists do not know how effective are the methods (such as sterilization of engineered organisms) that they say they will use to prevent synthetic life forms from reproducing. In fact, a 2004 National Academies study addressing the “bioconfinement” of genetically engineered organisms stated flatly that no single method could be considered effective.[4]

Under normal circumstances, these kinds of issues might best be considered as part of a scientific research agenda, and not as topics that should fall within the purview of governance and regulatory oversight. But the circumstances surrounding synthetic biology’s development are anything but normal. Rarely, if ever, has scientific discovery been so tightly coupled with proprietary commercial development, with so little time set aside for reflection and testing, so little consideration of results in the context of broader understanding, and so little independent review of research findings in anticipation of commercial release.

In fact, the technologies and products for creating synthetic components are already affordable and widely available to virtually anyone with access to the Internet, a credit card and a shipping address—or to any clever biology student, for that matter. When Eckard Wimmer, professor at the State University of New York, Stony Brook, who first synthesized the poliovirus from single nucleotides, was interviewed for a 2006 journal article on synthetic biology, he said, “With this technology you can make poliovirus for 50 cents. [I]n five years you [could] have this synthesis facility in every university lab. … You cannot stop this technology because there is a great hunger for it from many biologists.”[5]

Wimmer’s “five years” could conceivably come much sooner. For two years before the Venter Institute’s January 2008 announcement, for example, hundreds of undergraduates from around the world had spent their summer holidays making biological parts and building systems with them. In 2006 alone, 32 teams that participated in the International Genetically Engineered Machines, or iGEM, competition, hosted by the Massachusetts Institute of Technology, added 724 new biobricks to MIT’s Registry of Standard Biological Parts. In 2008, 84 teams and more than 1,000 undergraduate participants from 21 countries across Asia, Europe, Latin America, and the U.S. participated. Biotech companies and venture funds from around the world sponsor teams in the competition.

The iGEM competition is only one example of the investment money and taxpayer-funded research dollars that are flooding the nascent field of synthetic biology. The potential payoff for the ability to build and sell novel living organisms is considered to be so great that venture capitalists, government agencies and multinational corporations, including BP (formerly British Petroleum), Shell, Cargill, and Dupont, are already investing in research and partnerships with startup companies to drive synthetic biology products to market as quickly as possible.

Synthetic biology products may eventually comprise a significant portion of what analysts at Morgan Stanley estimate will be a trillion-dollar market for alternative fuels by 2030. Several companies, including Dupont, already produce commercial “bioplastics” that are manufactured by semi-synthetic bacteria. The synthetic biology company Solazyme recently announced that it would partner with Chevron, the world’s seventh-largest corporation, to develop biodiesel from synthetically redesigned algae. BP is an equity investor in Craig Venter’s company, Synthetic Genomics, Inc. (Financial terms for the latter two deals were not disclosed by the companies.)

In addition, several U.S. government agencies, including the Departments of Defense and Energy, the National Institutes of Health, and the National Science Foundation, have already made investments of millions of dollars in synthetic biology centers and projects, and published NSF research priorities for the 2009 fiscal year indicate synthetic biology funding may increase.[6] A handful of science-minded foundations, most notably the Bill and Melinda Gates Foundation, are investing in synthetic biology projects. Not wanting to be left behind, the European Union is funding the development of a European strategy for synthetic biology, including “stimulation activities” for the mobilization of public and private resources to fuel the nascent industry. Researchers in Africa, Canada, India, Israel, Japan, Korea, Latin America, Slovenia, Turkey, and many other countries are said to be actively pursuing synthetic biology projects as well.

A Profound Challenge for Governance

Synthetic biology poses what may be the most profound challenge to government oversight of technology in human history, carrying with it significant economic, legal, security and ethical implications that extend far beyond the safety and capabilities of the technologies themselves. Yet by dint of economic imperative, as well as the sheer volume of scientific and commercial activity underway around the world, it is already functionally unstoppable. With hundreds of millions of dollars worldwide already spent or committed to synthetic biology R&D across several sectors, and what is almost certainly millions more in undisclosed venture financing and corporate partnerships, companies are driving hard to deliver products for commercial release. This drive to market, coupled with no substantive expert, stakeholder or public policy discussion regarding the balance of risk and benefit for its products, has led many observers to declare that synthetic biology is a juggernaut already beyond the reach of governance.

Proponents are quick to point out that synthetic biology research and its products are not entirely unregulated. In the United States, the NIH still requires laboratories receiving NIH funds to comply with laboratory procedures as outlined in their Recombinant DNA Guidelines. A drug produced by a synthetic organism would be evaluated like any other by the Food and Drug Administration. Also, depending on the application, the Environmental Protection Agency or the U.S. Department of Agriculture would oversee the potential release of synthetic organisms into the environment.

This argument, however, presumes that present regulations are appropriate for evaluating the products of synthetic biology. The critical question that has not been explored is whether synthetic biology poses unique risks that are unconsidered by present health and safety regulations (and regulatory approaches), as well as by financial regulations that govern intellectual property rights and trade.[7]

Some of synthetic biology’s researchers, investors and funders acknowledge the possibility of unintended consequences, but for the most part they minimize the risk, openly acknowledging that they want to avoid synthetic biology becoming the new target for the negative perceptions that many people around the world continue to hold for biotech crops and other biotech products. As a group, they overwhelmingly insist that if synthetic biology is to fulfill its promise, scientists must be trusted to do the right thing, and that existing regulations are sufficient to shield the public from any hazards that might result from the products of synthetic biology. This perspective is best expressed by a recent statement made by Victor de Lorenzo, vice director of the National Centre of Biotechnology in Madrid, Spain. In a 2006 article in the journal of the European Molecular Biology Organization, he said, “I think the question of regulation should not be the first question. … Let’s first see what [the technology] is good for. If you first ask the question about risk, then you kill the whole field.”[8]

The main argument used in favor of self-regulation of synthetic biology’s processes is that they are simply the result of a more sophisticated application of the aforementioned laboratory techniques developed for working with recombinant DNA. As for the products of synthetic biology, practitioners argue that they already fall within the purview of existing regulations that govern genetically engineered organisms and the substances that these organisms may produce. But these characterizations sell short several fundamental, related differences between the two practices, and ignore the history of how genetically engineered organisms came to be as lightly regulated as they are today.

The Difference Between Synthetic Biology and Genetic Engineering

These differences and regulatory history are worth reviewing before turning our attention to recommendations for improving the governance of synthetic biology’s products and processes.

1. Synthetic biology is based on the intentional design of artificial biological systems, rather than on an understanding of natural biology.

Like traditional genetic engineering, synthetic biology uses recombinant DNA techniques to manipulate and construct various kinds of DNA molecules. The goal of a synthetic biology engineering project, like that of traditional genetic engineering, is to create an organism that does what its engineer has designed it to do. But as one report notes, “genetic engineering [is] a cut and paste affair,” shuttling traits from one naturally existing organism to another. “By contrast,” the report continues, “today’s synthetic biologists are armed with the biological equivalent of word processors.”[9] That is, rather than simply being able to splice DNA “words” into or out of existing organisms, synthetic biologists are now in the early stages of learning to write and assemble from scratch the entire paragraphs of code needed to make an entire organism.

Creating unprecedented life forms that can grow, reproduce, mutate, evolve and transfer their genes to other, naturally occurring organisms will yield consequences that are impossible to anticipate with today’s knowledge. The process is dramatically different from modifying the function of an existing organism using the techniques of traditional genetic engineering.

For example, part of the early sales pitch for genetic engineering was that it is more precise and predictable than traditional cross-breeding. But in reality, genetic engineering often triggers unpredictable mutations in an organism’s genome. While most of these mutations are screened out of commercial transgenic products before they reach the market, they do occur. And when they do, they can cause unexpected and sometimes harmful changes in a living organism. (Witness the foreshortened life span and health problems that have plagued genetically engineered and cloned animals.)

While synthetic biologists use the tools of traditional genetic engineering, they aim to eliminate such random events by designing, writing, or rewriting an organism’s genetic code, then synthesizing the sequence of molecules themselves, using the aforementioned “standardized” parts and DNA synthesis equipment. They say such stripped-down, intentional design, coupled with directly synthesizing the genome themselves, will eliminate much of the expensive trial and error that typifies traditional genetic engineering. They believe that they will be able to far more quickly and cheaply fabricate new or more “efficient” life forms of their own design that predictably and precisely display the desired traits.

But as mentioned earlier, there remain many unanswered questions about synthetic biology that bear only a partial resemblance to those asked about traditional genetic engineering. Among them is what effects artificial life forms may have on natural organisms, and vice versa. The larger, more important point is the presupposition by synthetic biologists that their existing understanding about DNA and the processes of heredity is sufficient to enable them to safely and predictably eliminate what they believe to be “inefficiencies” in natural organisms.

As evidenced by the ENCODE study, this is not specious questioning by fearful people who do not understand the science. To wit: researchers are only now beginning to discover that the so-called junk DNA that is present in all organisms (it comprises between 80 and 90 percent of the human genome, for example) serves a critical function in organisms, even though it does not contain instructions for making proteins or other cell products. What is the meaning of “efficiency” when researchers understand only a fraction of how basic biological systems function and how organisms interact with each other and their environments? What is the long-term effect of willful action in the context of so much scientific ignorance and uncertainty?

Finally, the fact that synthetic biology technology can be used to design and synthesize dangerous pathogens not found in nature also challenges existing laws regarding what are known as “select agents”—the toxins and pathogens that can pose a severe threat to human, plant or animal health that are regulated by the Centers for Disease Control and Prevention. Traditional recombinant DNA technology has raised similar or related concerns, but the de novo products that synthetic biology promises will eliminate the need for those with ill intent to gain access to known, naturally occurring agents or naturally occurring genetic material from these agents. This not only greatly expands the potential availability of select agents but also circumvents the CDC regulatory framework that presently governs their possession and use.[10]

2. Synthetic biology’s practitioners are not, as a rule, biologists or even molecular biologists. Many are computer scientists or come from disciplines that do not study or work with whole organisms, but instead apply an even more mechanistic, reductionist perspective to living systems than do traditional genetic engineers.

Synthetic biology’s design and construction of simplified biological systems are, at the very least, supposed to provide scientists with a useful way to test their understanding of the complex functional networks that mediate life processes. However, this understanding is still extremely limited, and extends only to the cell and to a few very small, very simple organisms. As a rule, synthetic biologists do not concern themselves with the relationship between the genetics of organisms and their environment; that is, with how whole organisms mutate and evolve, or how disparate species exchange genetic material in nature, outside of the laboratory.

Traditional genetic engineers generally hold this reductionist perspective as well, but even if they tend to ignore the long-term evolutionary or network effects of their creations, at least they have had to learn how to make alien DNA behave properly within the genomes of natural plants and animals. Synthetic biologists, having no such restrictions, can ignore even this relatively low level of complexity.

But at whose peril? If the goal is a regulatory environment that intelligently anticipates the unintended consequences of a new technology, these distinctions and relationships—between molecules, cells, organisms, and ecosystems—are critical. Biologists who study organisms and ecosystems are steeped in the complexity of biological systems, and understand the limitations of their knowledge about how organisms behave and interact in the real world. The plants, animals, and microbes they study demonstrate to them on a daily basis that the cell and its molecular components are not, in fact, wholly analogous to electronic circuitry. DNA and other components of heredity do not always behave in nature in the same way as they do under the controlled laboratory conditions of synthetic, or even traditional molecular biology. Without this understanding, synthetic biologists cannot reliably predict how their inventions will behave in the natural world.

3. If the goal for synthetic biologists is both public acceptance and credible risk assessment of their products and processes, genetic engineering should not be considered a model for best practices in the context of proper governance and regulation of biological innovations.

A thorough examination of the historical record shows that politics and industrial interests, at least as much as scientific evidence, drove the regulatory process for genetically engineered products from its genesis in the White House Office of Science and Technology Policy in 1986. The same is true today of synthetic biology.

OSTP’s starting assumption for biotech regulation, made at the behest of industry, was that only the products of genetic engineering, and not the radical new process (recombinant DNA) that was used to create them, should be considered in a safety evaluation. This assumption was noted as scientifically questionable by several administrators and scientists inside the FDA itself at the time the first regulation for a genetically engineered organism was being developed. Among other things, they noted, the product category was brand-new, thus literally no evidence or historical data, other than that provided by industry applicants, existed upon which to base such a statement. What’s more, they said, while various experts in molecular biology, chemistry, toxicology, and related fields were asked to provide input to the FDA regarding risk, not one risk analyst was invited to do so—despite the fact that the entire purpose of risk analysis is to scientifically assess the potential effects of taking action in the presence of uncertainty. By selectively narrowing the scope of their concerns and a priori not considering the process of genetic engineering itself as part of their risk evaluations, regulators were able to speed the products of genetic engineering to market.[11]

When confronted with the historical record on biotech regulation, proponents often say that there have been no known health or environmental effects as a result of genetically engineered organisms, so the approach was the right one. However, in the United States at least, there is no objective way of knowing whether that statement is true. Existing regulations contain no requirements for monitoring the movement of genetically engineered organisms in the field once they have been approved, or for labeling products with genetically engineered ingredients in the marketplace. There is no tracking or monitoring of the potential effects that engineered organisms may be producing in other living things. As a result, both the organisms and their effects are literally untraceable, should a health or safety issue arise.

Nonetheless, synthetic biologists today are arguing that existing laws and policies are sufficient for their products in the presence of even more scientific uncertainty and less historical data than are available for transgenic organisms. It is an easy argument to make, and one that is not likely to be refuted by the regulators themselves, since both U.S. law and regulatory philosophy tends to place the burden of proof regarding risk or hazard on those who oppose a new technology. If new regulations cannot be avoided, agencies often work closely with regulated industries to develop the rules and select the methods that will inform the assessment process. As a result, safety determinations about a technological innovation are almost always based on evidence that regulators know the scientists can provide—a situation that inevitably leaves unasked many of the larger, more complex questions about potential hazards that scientists cannot easily answer.

Self-regulation is already running into snags in the context of intellectual property; that is, who owns and controls the discoveries upon which the nascent industry of synthetic biology is based.

Many academic scientists who are at the forefront of developing the technology publicly support the development of a synthetic biology “commons”—a legal framework for public access to common resources and goods (such as water) for a given community. In the context of synthetic biology, an intellectual property commons would ensure that standard biological parts remain freely available and unfettered by patent thickets that have been known to slow or halt academic research, stifle innovation and keep the fruits of discovery out of economic reach for those who might need them most. At the same time they are encouraging the development of this bioparts “commons,” and in seemingly contradictory fashion, many of these same academics serve on the scientific advisory boards of synthetic biology companies that are working to develop the proprietary patent portfolios that are required to attract investors.

This paradox spotlights another critical issue regarding the credibility and objectivity of the evidence that scientists provide regulators regarding the risks of synthetic biology’s products and processes. Most synthetic biology researchers, even more than traditional biotechnologists, operate simultaneously in several spheres: as academic researchers receiving government funding for research and product development, as inventors seeking patentable discoveries, as company founders receiving investment capital from the private sector to finance product development based on those patents, and as members of scientific advisory boards for groups that are engaged in similar activities.

How these conflicts affect synthetic biologists’ attitudes and perspectives on risk, and their impact on both the quality of research and the long-term viability of the nascent synthetic biology industry, has not been addressed in proponents’ reports or studies on the topic.

Recommendations for Improved Governance (listed in terms of priority)

The wide variety of products, activities and players involved in synthetic biology research and development can be separated into some general categories (see Appendix). Hundreds of scientists, companies and organizations worldwide are associated with these categories.[12] Not all of them are key to emerging governance issues, but it is important to keep all of them in mind, because many of these categories include product offerings, methods, and practices that are shared with traditional biotechnology research and product development (such as DNA synthesis).

As a result, a very large “industry-in-waiting,” so to speak, is poised to take advantage of advancements in synthetic biology. Without regulatory acknowledgment of the differences between traditional genetic engineering and synthetic biology products, these players will not have to change their existing practices or offerings very much to “upgrade” into the synthetic biology category. This will quietly increase the sector’s activity, the potential volume of products and, subsequently, the risks it poses. It is also important to note that some categories of research and development in synthetic biology are closely related to nanotechnology, another area of scientific innovation that has proven to be challenging for proper regulatory oversight and governance.

Because of the untested nature of both the risks and the benefits of synthetic biology, and the tremendous financial impetus to bring commercial products based on the technology to market, it is important to take action as quickly as possible to improve the oversight and governance of synthetic biology. Four recommendations are given below. The goal is to get to Priority 3, the comprehensive risk assessment, as quickly as possible. Priorities 1 and 2 must be done first in order to best inform that assessment, and they, too, should be done without delay.

Priority 1. Research and report the current regulatory situation for synthetic biology across agencies and sectors. Because of the “déjà vu” argument being presented by proponents, this research should include a reassessment of the viability and utility of regulations for the products of traditional genetic engineering.

A detailed and comprehensive assessment of the regulatory environment for synthetic biology, both in the United States and abroad, is critical in order to provide a realistic foundation for future conversations about this technology. Because synthetic biologists are likely to use the official safety record of genetically engineered organisms as an argument for no additional regulations, it is important to reassess the shortcomings of these existing policies as well.

In addition to including the process as well as the products of synthetic biology, this assessment must include the current thinking about scientific uncertainties in genomics-related disciplines, starting with the ramifications of findings such as those produced by the ENCODE study.

In the context of the synthetic biology “commons” and other intellectual property issues, the assessment must also consider how synthetic biology is being considered within the World Trade Organization and in the context of its Trade-Related Aspects of Intellectual Property Rights agreement (commonly referred to as TRIPS), as well as within individual countries’ thinking and activities in the area.

A tremendous amount of synthetic biology activity, much of which is intended to eventually yield commercial products, is taking place around the world. It is critical to learn which way governments around the world are leaning in terms of synthetic biology regulation. If one of their scientists or companies were to announce that it was ready to ship a commercial synthetic organism in the next 12 months, what would be the policy response, if any?

Also critical to this assessment will be mapping where various agencies’ responsibilities and practices create gaps, conflicts or overlaps in regulatory coverage. For example, given our assessment that there are fundamental differences between synthetic biology and genetic engineering, under what circumstances will (and/or should) existing biosecurity regulations be applied?

As a starting point, it might be helpful to use the concept of “select agents” and the recent report from the National Science Advisory Board for Biosecurity on synthetic biology.[13] Select agents are pathogens or biological toxins that have been declared by the Department of Health and Human Services or by the USDA to have the “potential to pose a severe threat to public health and safety.” Possibly the most influential agency in the context of synthetic biology regulation, NSABB represents more than a dozen U.S. government offices and agencies, including EPA and USDA, which may be charged with regulating the products of synthetic biology.

In the summary of its findings, the report noted the need for additional clarity about existing regulations, because “responsible agencies, affected scientists, and commercial providers differ in their interpretation of the laws, regulation and policies” as they affect synthetic biology. Given the global ubiquity of synthetic biology research and the possibly imminent release of synthetic biology products, policymakers need to be able to gauge the effectiveness of the existing oversight system—including the consistency of coordination (or lack thereof) across agencies sharing the oversight responsibility and the realities of field practice.

Furthermore, the report stated that the speed of technological advances “will require governance options that are capable of keeping pace with rapidly evolving science.” One of the questions to be addressed, the answer to which would be of broad utility, is “How can possible risks associated with the generation of novel organisms be addressed?”

It might also be useful to investigate whether non-obvious policy alternatives exist that could be deployed if agencies cannot be compelled to take proper action.

Priority 2. Conduct a comprehensive critique of the synthetic biology reports that have been published so far, and assess their impact on decision makers.

Virtually all the reports on synthetic biology have come from the synthetic biology community or from a proponent’s or an opponent’s point of view. These reports have serious logical flaws and omissions of fact and critical perspective, and they should be countered by a more objective source as soon as possible.

Of the most concern in the context of risk and governance are the reports that uncritically support synthetic biology, as they encourage development and commercial release with little or no acknowledgment of the degree of scientific uncertainty that surrounds the endeavor. A 174-page report on synthetic biology published by Bio-Economic Research Associates in 2007 and funded by the Department of Energy (which itself has invested heavily in synthetic biology research), contained but a single, three-quarter-page discussion of the limitations of the engineering paradigm as applied to living systems. Giving such short shrift to a topic that is still under deep consideration in the broader scientific community lends an air of certainty to a highly uncertain endeavor. Such under-representation has real significance from the perspective of investment and economic risk, as well as from that of health and the environment.

Similarly, and perhaps most disappointingly, a $500,000 report funded by the Alfred P. Sloan Foundation on synthetic biology’s “Options for Governance” was co-authored by two of the pioneering institutions of synthetic biology, the J. Craig Venter Institute and MIT, along with the Center for Strategic and International Studies.[14] Promoted as a “stakeholder” study on the broader societal risks and implications of synthetic biology, the Sloan study instead focused mainly on the largely benign laboratory procedures for handling synthetic organisms in the context of biosafety. It did not substantively address the more significant issues of scientific uncertainties, intellectual property conflicts, or the social implications and the intended and unintended effects of synthetic biology’s products on human health or the natural environment. Not surprisingly, given its co-authors, the “options for governance” that were presented in the study’s conclusions weighed heavily in favor of self-regulation.

Discovering the degree to which such biased perspectives and recommendations have affected decision makers will be an important step in a more relevant and comprehensive approach to assessing synthetic biology’s risks. This knowledge will also be an important factor in deciding how quickly action must be taken to counter their biases, as legal judgments or official decisions on synthetic biology become imminent.

Priority 3. Using (and challenging the assumptions of) the data and scenarios in the above-mentioned reports, conduct a comprehensive risk characterization of synthetic biology.

Given the financial and intellectual momentum of the nascent industry, it is not surprising that there is a tremendous aversion in the synthetic biology community to speaking directly about the risks of unintended or unanticipated consequences, or to involving risk practitioners who are schooled in methods that are designed for highly uncertain issues or experts from other sectors in assessments of its future. It is very difficult to find a synthetic biology report that uses the word risk more than in passing, let alone directly addresses the subject at any depth.

One reason for this omission is that many scientists believe the word risk refers to a technical calculation of probability that is demonstrable only by way of “evidence” that a risk exists. Such calculations are near impossible, however, when analyzing technological innovations, where there are no historical precedents other than by analogy and sparse data to use in a probability calculation. Yet without data, these scientists say, there is no risk, only speculation. While technically “scientific” in its approach, this circular argument forces decision makers to consider only a very narrow, pre-determined and ultimately subjective view of the important issues they are being asked to address.

However, there is another approach to risk assessment that has proven very useful for decisions regarding scientific and technological innovations. This approach combines data analysis and extensive deliberation with a broader representation of relevant scientific expertise, as well as parties who are interested in the issue or who will be affected by the outcome of the analysis. This process of analysis and deliberation is described in the 1996 National Academy of Sciences study, Understanding Risk: Informing Decisions in a Democratic Society.[15]

Should this type of assessment be undertaken, the analytic deliberative approach could be augmented with a methodology that is under development by myself and Baruch Fischhoff at Carnegie Mellon University, designed to address unprecedented risks such as those presented by synthetic biology. It uses scenario narratives to develop comprehensive risk models that are computable over time, as research continues and data become available.[16] There are several credible scenarios available regarding synthetic biology that, taken together, could provide the foundation for characterizing and assessing synthetic biology’s risks and benefits.

Such an assessment would be designed to yield five important outcomes:

(a) A mutually agreed-upon risk/benefit model for lawmakers to use in regulatory decisions. This model would map critical scientific uncertainties associated with commercialization and/or release of synthetic organisms (e.g., the effects of evolution, environmental and health effects, assessment of product versus process, the significance of horizontal gene transfer, synergies between synthetic biology and nanotech), as well as economic, legal, biosecurity, social and ethical implications for the United States and its relationship to other countries;

(b) An understanding of the degree to which existing biotech regulations can usefully be applied to synthetic biology processes and products and, conversely, where they should not be used;

(c) A scientific research agenda for addressing knowledge gaps and known risks as revealed by the assessment process;

(d) A contingency/preparedness plan for unintended consequences, including potential legal strategies should rational approaches not prevail; and

(e) A public database/repository to collect information on synthetic biology so that risks (and regulations) can be reassessed as new data are added and uncertainties are reduced.

Priority 4. Convene cross-sector stakeholder working groups on elements in the assessment that were deemed most important to address.

After the risk characterization has been completed, stakeholder groups should develop policy recommendations for addressing the issues and elements of concern. At this point, these groups would likely be organized around at least the following three elements:

(a) Scientific uncertainties. How should the nature and extent of the scientific uncertainties in synthetic biology, discovered during the risk-characterization process, affect regulatory policies? Are there examples of more iterative (Bayesian) approaches to policy that can be deployed for issues such as these, where well-informed decision makers have determined there is a need to move forward with research and development despite scientific uncertainty? What is required in terms of research funding to better address these uncertainties in advance of commercial deployment?

(b) Patents and intellectual property. How do existing patent and intellectual property laws add to or lessen the broad risk profile for synthetic biology products? What would happen if a significant portion of the field’s intellectual property remained in the public domain or commons, as some synthetic biologists want? What would be the social and economic implications of various patent approaches to synthetic parts and organisms? Having this conversation soon, before too many synthetic biology patents are issued, could be tremendously useful.

(c) Human factors. What human factors affect the regulatory/policy profile for synthetic biology’s products and processes, and what kinds of interventions can best address them? Who are the equivalents of the nuclear plant operators in synthetic biology scenarios, i.e., what constitutes risky behavior for humans using synthetic biology in the field? This group would look at implications for deliberate misuse of the technology as well as for bioerror.

Conclusion: Opportunity Costs

If even a fraction of its proposed applications pan out over the long term, synthetic biology has the capacity to radically change our approach to some of the most pernicious problems of our time. That human beings may someday know enough to safely and predictably engineer life forms that can eliminate ocean pollution, generate sustainable energy sources, or help to eliminate infectious diseases will be nothing short of transformative. So it is no wonder, standing at what seems to be the very brink of such tremendous promise, that proponents of synthetic biology want to dismiss most conversations about risk as speculation.

But it is important to note that in its early stages, the promised benefits of any technological innovation are purely speculative as well. While there may not be historical precedent for synthetic biology, the history of science is replete with examples of the high price of biological interventions that were brought to market or released without sufficient consideration of consequences.

For example, the toads that were imported from Hawaii to rid Australia’s sugarcane plantations of beetles have instead eaten all the native amphibian and invertebrate species in their path—except the cane beetle. The morning-sickness drug DES, sold to millions of women between 1940 and 1971, was almost entirely ineffectual for its ostensible purpose, yet has passed along its carcinogenic mutations to children in every subsequent generation. The overuse of man-made antibiotics has created new strains of “superbugs” that are virtually unkillable and can make being admitted to a hospital more life-threatening than staying at home. And we have not yet begun to tally the costs of regulatory myopia about nanotechnology, where agencies remain loathe to step in despite the demonstrated health and environmental risks of some nanomaterials.

Synthetic biology stands to have a far greater impact than all of these—especially if its products are allowed to be released without pausing for thoughtful consideration of risk and benefit in the context of scientific uncertainty. Many of synthetic biology’s proponents see such consideration as an opportunity cost, maintaining that both money and benefit are lost each day their activities are questioned or delayed. But the role of government is to understand these developments in a broader context, properly oversee them, and ensure that society is not forced to bear the cost of that opportunity, should plans go awry. Today, with the benefit of hindsight, we have developed the methods to practice foresight in these matters. We have in hand the means to practically address scientific uncertainty and risk for the benefit of all stakeholders: the industry, the independent research community, and the public. The sooner and more willingly that we as a society embrace those means, the greater the opportunity will be for synthetic biology to fulfill its promise.

I am grateful to David Rejeski at the Woodrow Wilson International Center for Scholars for supporting the research and the writing of this report; and to the Center for American Progress and Rick Weiss for its final production and publication. All views expressed herein are my own, and do not necessarily reflect the positions of either organization.

Denise Caruso is executive director and co-founder of the Hybrid Vigor Institute, an independent, not-for-profit research organization and consultancy that is dedicated to interdisciplinary and collaborative problem solving. She is the author of Intervention: Confronting the Real Risks of Genetic Engineering and Life on a Biotech Planet, which won a Silver Medal in the Science Category of the 2007 Independent Publisher Book Awards, and was listed as a “Best Business Book of 2007” by strategy+business magazine. She also edits and contributes to the Institute’s blog, at hybridvigor.org and, in 2008, was named a contributing editor for strategy+business, where she writes about risk, public policy, and innovation.

Caruso has developed and served as co-principal investigator on research projects that aim to improve upon traditional methods of risk and decision analysis for innovations in science and technology. Topics of case studies in which she has been involved, funded by the National Science Foundation, have included the risks of xenotransplantation using genetically modified pigs, and the risks of pandemic avian influenza. She is an affiliated researcher at the Center for Risk Perception and Communication at Carnegie Mellon University. Since 2003, she has been a member of Global Business Network, a worldwide organization that works to enhance competitive and adaptive capacities in organizations through collaboration, scenario development, and strategic planning.

Caruso is also a veteran journalist and analyst. In 2007, she wrote “Re:framing,” a column on innovation and creativity, for the Bright Ideas page in the Sunday Business section of The New York Times. She also chronicled the converging industries of digital technology and interactive media from the mid-1980s to 2000. For the five years prior to founding Hybrid Vigor in 2000, she wrote the Technology column for the Monday Information Industries section of The New York Times.

One of the first journalists to focus on the intersection of technology, commerce, and culture, Caruso is a director emerita of the Electronic Frontier Foundation. She was elected to the board of directors of the Independent Media Institute in January 1995, and continues to serve in that capacity. She is a trustee of the Molecular Sciences Institute, a non-profit laboratory conducting research into basic biological processes. She also serves on the advisory boards of several organizations, including Public Knowledge and London-based SustainAbility.com; she recently became an advisor to Echo & Shadow, an intelligent robot company.

Appendix: An Overview of the Synthetic Biology Landscape

Hundreds of scientists, companies, and organizations are already engaged in synthetic biology research and development. A comprehensive, albeit somewhat dated list, with an emphasis on research and researchers in North America and Europe, may be found in the European Union report “Synbiology: An Analysis of Synthetic Biology Research in Europe and North America,” published in October 2005.[17]

The general categories of key products, applications and players in the field of synthetic biology (listed alphabetically) are populated as follows.

• Funders and investors, including venture capital firms, U.S. government agencies and foundations, and corporations directly funding scientific research and/or development;
• Government agencies and regulators, including those governing trade and commerce as well as those responsible for risk regulation;
• Issues analysis and strategy, which includes media coverage; private and public studies and reports on the economic, ethical, and political impact of synthetic biology, including intellectual property protection; and risk analysis and decision-making/regulatory strategies by industry organizations, consulting firms, non-government organizations, and academic researchers;
• Laboratory-based molecular and nanotechnology development, which includes the development of molecular machines and strategies for machine evolution and the development of self-assembling biomaterials and bioelectronics, reporters, and sensors and artificial life;
• Products and applications of synthetic biology, including artificial genes and genomes; drugs, chemical agents, plastics, fuel, electricity, and other products manufactured by synthetic or semi-synthetic bacteria; tissues, organs and organisms generated by design; and biofuels and bioelectricity;
• (Practical) engineering in living organisms, which includes engineering of structural functions; artificial evolution and strategies for optimizing artificial evolution; design of semi-synthetic organisms; engineering of cell regulatory functions; the biobricks strategy of biological parts characterization, fabrication and assembly; and engineering of programmable systems of organisms;
• Related and enabling technologies, which include DNA sequencing, synthesis and design equipment; analytic devices such as diagnostics, microarrays, chromatography, and microfluidic chips; and cell technology, including cell cultures and stem cell technologies; and
• (Theoretical) computerized modeling, which includes computer analysis and modeling of natural systems, molecular networks, and synthetic biology systems.

Within these categories, the activities of a handful of key players are being closely watched. These are some of the best known:

1. George Church: professor of genetics, Harvard Medical School; director, Center for Computational Genetics, Harvard University; co-founder, Codon Devices; co-founder, LS9 Inc.

Considered one of the pre-eminent synthetic biology researchers, Church is also a well-known figure in the larger biology community. His 1984 Ph.D. dissertation included a description of the first direct genomic sequencing. He also co-initiated the Human Genome Project while serving as a postdoctoral fellow at Biogen and as a Monsanto fellow at the University of California, San Francisco. As director of the Center for Computational Genetics, he is developing broadly distributed, integrated models for biomedical, biofuel, and ecological systems. The Center’s research currently focuses on genome engineering and synthetic biology development to build “genetic circuits,” vaccines and optimal drug biosyntheses. Among many other active and advisory affiliations, Church also co-founded Codon Devices in Cambridge, the first venture-backed synthetic biology company that is focused on synthesizing very long pieces of custom DNA, and LS9, which is designing biofuels produced by microbes created via industrial synthetic biology.

2. Drew Endy: assistant professor in the Department of Bioengineering at Stanford University

The former assistant professor at the Massachusetts Institute of Technology moved to Stanford University in fall 2008 to become its first synthetic biology professor and is probably the best-known and most public face of synthetic biology. Widely acknowledged as a founder of the field, he is one of its most active participants in all aspects, from academic research to social implications and commercial development. At MIT, he co-founded the Registry of Standard Biological Parts as well as the annual iGEM international synthetic biology design competition, where teams of undergraduate students create novel biological parts and build them into working systems. He is a co-founder of Codon Devices.

He also started the non-profit BioBricks Foundation, whose mission is to ensure that standard biological parts remain freely available to the public and to encourage the development of codes of standard practice for the use of standard biological parts.

3. Foundations

a. The Bill & Melinda Gates Foundation

The Gates Foundation is helping drive synthetic biology research out of the lab and into applications by investing in health-related synthetic biology products. In addition to the $42.6 million it granted to three organizations for the development of a synthetic microbe to produce an anti-malarial compound, the Foundation has granted $19.4 million to a consortium, led by the Seattle Biomedical Research Institute’s Viral Vaccines Program, to create synthetic molecules to trigger antibodies against HIV.[18]

b. The Alfred P. Sloan Foundation

The Sloan Foundation is one of the few remaining private philanthropies that funds direct research in selected areas of scientific significance. In 2005, Sloan’s Bioterrorism Program awarded $500,000 to the J. Craig Venter Institute, in collaboration with the Center for Security and International Studies and the Synthetic Biology Group at MIT, to examine the risks and benefits of synthetic genomics in the context of regulations and governance.

Through its Bioterrorism Program, Sloan has also made several other grants aimed at addressing issues of potentially dangerous applications of synthetic biology. These include a feasibility study to develop a global network of bioscientists, support for a workshop on Genomics for Development, Bioterrorism, and Human Security, and an assessment of the World Health Organization’s oversight of smallpox virus research.

4. Jay Keasling: director, SynBERC, University of California, Berkeley; co-founder, Amyris Biotechnologies

Keasling is responsible for two of the field’s largest and most visible synthetic biology projects, spanning both academic research and commercial development. He is director of the Synthetic Biology Engineering and Research Center (SynBERC) at U.C. Berkeley, funded with $16 million from the National Science Foundation and $4 million from the biotech industry and participating universities.

Amyris, which he co-founded, is developing synthetic microbes capable of producing novel pharmaceuticals, renewable fuels and specialty chemicals. SynBERC and Amyris, along with OneWorld Health, were Gates Foundation grantees for the development of synthetic microbes to produce artemisinin, an anti-malarial compound.

5. U.S. Government

The U.S. government is a primary driver of the nascent industry of synthetic biology. Several agencies have each committed several millions in taxpayer dollars to synthetic biology researchers and organizations, most of which is directed toward specific applications. These include the NIH, including the National Cancer Institute, the National Institute for Allergy and Infectious Diseases, the National Institute of General and Medical Sciences, the National Institute of Biomedical Imaging and Bioengineering, the NIH Roadmap Program, the Nanomedicine Program, and the NIH Cancer Biology Training Grants Program.

The Department of Energy is funding research and development into synthetic organisms to produce biofuels and clean up pollution, as well as explorations into societal consequences such as the relationship of synthetic biology to intellectual property law. The Department of Commerce’s Advanced Technology Program has awarded a grant for the development of synthetic microbes to convert sugars into plastic. The NSF also has committed several millions of dollars to synthetic biology research, primarily to academic institutions.

6. J. Craig Venter: founder, Synthetic Genomics, Inc., and the J. Craig Venter Institute

Venter is still best known for his role in mapping the human genome, but his personal ambition, combined with his ability to draw worldwide media attention, has placed his organizations’ activities at the center of the synthetic biology field. He and Drew Endy are generally the scientists of record when questions about the risks of synthetic biology are raised by outsiders.

Venter’s activities are also the most visible example of the fluid financial arrangements that typify synthetic biology. His privately held company, Synthetic Genomics, is developing synthetic genomes and organisms for commercial applications in renewable energy and bioremediation—based on research done under the auspices of his own non-profit research institute, the J. Craig Venter Institute. The institute, which is funded by government grants as well as by Synthetic Genomics, is focused on trying to develop a minimal cell in order to build a new cell and organism with optimized functions. Synthetic Genomics’ president is Aristides Patrinos, former director of the Office of Biological and Environmental Research for the DOE, which made significant investments in synthetic biology and, more specifically, in Venter’s projects during the period when Patrinos was at the helm.

7. Venture Capital Firms

Venture capital may be more responsible for driving the creation of a synthetic biology industry than are the scientific discoveries coming from the research community. At the time Codon Devices received its first round of venture capital, for example, its co-founders and principals (named above) were basically the entire roster of synthetic biology researchers in the world. A handful of well-known venture capital firms, primarily those that have been involved in early-stage science and technology investments in Silicon Valley and in Cambridge-based startup companies, have already established a beachhead in the synthetic biology area. These firms include Alloy Ventures, Khosla Ventures, Kleiner Perkins Caufield & Byers, Mohr Davidow, and X/Seed Capital.

Notes

[1] A base pair refers to the two nucleotides that form a “rung” of the DNA ladder. The number of base pairs is used to describe the length of a DNA strand. DNA sequencing is the process of determining the exact order of the base pairs that comprise individual genes as well as whole genomes. DNA synthesis is a natural cellular process that replicates DNA, but as used here refers to artificial, chemical replication.

[2] James Newcomb, Robert Carlson, Steven Aldrich, Genome Synthesis and Design Futures: Implications for the U.S. Economy (Cambridge, MA: Bio Economic Research Associates, 2007).

[3] The ENCODE (ENCyclOpedia of DNA Elements) Project, available at http://www.genome.gov/10005107 (accessed August 18, 2008).

[4] Committee on Biological Confinement of Genetically Engineered Organisms, “Biological Confinement of Genetically Engineered Organisms” (National Research Council, 2004).

[5] Holger Breithaupt, “The engineer’s approach to biology,” EMBO Reports, 7(1)(2007): 21-24, available at http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=1369239 (accessed August 8, 2008).

[6] Elizabeth Pain, “Getting Ready for Synthetic Biology,” Science Careers, October 17, 2008, 10.1126/science.caredit.a0800152, accessed at http://sciencecareers.sciencemag.org/career_magazine/previous_issues/articles/2008_10_17/caredit.a0800152.

[7] Arti Rai and James Boyle, “Synthetic Biology: Caught Between Property Rights, the Public Domain, and the Commons,” PLoS Biology, March 13, 2007, available at: http://biology.plosjournals.org/perlserv/?request=get-document&doi=10.1371%2Fjournal.pbio.0050058&ct=1 (accessed August 8, 2008).

[8] Breithaupt, “The engineer’s approach to biology.”

[9] The ETC Group, “Extreme Genetic Engineering: An Introduction to Synthetic Biology” (Ontario, Canada, 2007), available at: http://www.etcgroup.org/en/materials/publications.html?pub_id=602 (accessed August 18, 2008).

[10] National Science Advisory Board for Biosecurity, “Addressing Biosecurity Concerns Related to the Synthesis of Select Agents” (Rockville, MD: National Institutes of Health, 2006).

[11] A lengthy discussion of this issue can be found in Intervention: Confronting the Real Risks of Genetic Engineering and Life on a Biotech Planet, Chapter 6, “Politics, Science and Substantial Equivalence” (Hybrid Vigor Press, San Francisco, 2006).

[12] European Commission, “Synbiology: An Analysis of Synthetic Biology Research in Europe and North America: Output D3: Literature and Statistical Review,” European Commission FP6 Reference: 15357 (2005), pp 28-40, available at: http://www2.spi.pt/synbiology/documents/SYNBIOLOGY_Literature_And_Statistical_Review.pdf (accessed August 18, 2008).

[13] National Science Advisory Board for Biosecurity, “Addressing Biosecurity Concerns Related To The Synthesis Of Select Agents.”

[14] Michelle S. Garfinkel, Drew Endy, Gerald L. Epstein, Robert M. Friedman, “Synthetic Genomics: Options for Governance,” (Rockville, MD, Washington, DC, Cambridge, MA: J. Craig Venter Institute, Center for Strategic and International Studies, Massachusetts Institute of Technology, 2007), available at: Available at http://www.jcvi.org/cms/fileadmin/site/research/projects/synthetic-genomics-report/synthetic-genomics-report.pdf (accessed August 18, 2008).

[15] Paul C. Stern, Harvey V. Fineberg eds., Understanding Risk: Informing Decisions in a Democratic Society (Washington, DC: Committee on Risk Characterization, National Academy of Sciences: National Academy Press, 1996).

[16] Denise Caruso and Baruch Fischhoff, principal investigators, “Understanding Genomic Risks: An Integrated Scenario and Analytic Approach” (Washington, DC: National Science Foundation Award No. SES-0350493, 2006).

[17] European Commission, “Synbiology: An Analysis of Synthetic Biology Research in Europe and North America.”

[18] Seattle Biomedical Research Institute, press release: “Sbri Receives $19.4 Million HIV/AIDS Research Grant From Gates Foundation” (Seattle, WA: 2006), available at: http://www.sbri.org/news/2006/releases_06/SBRI-Receives-$19.4M-Gates-Grant-for-HIV-Vaccine-Research.pdf (accessed August 18, 2008).

The new rules would be among the most controversial deregulatory steps of the Bush era and could be difficult for his successor to undo. Some would ease or lift constraints on private industry, including power plants, mines and farms.

Those and other regulations would help clear obstacles to some commercial ocean-fishing activities, ease controls on emissions of pollutants that contribute to global warming, relax drinking-water standards and lift a key restriction on mountaintop coal mining.

Once such rules take effect, they typically can be undone only through a laborious new regulatory proceeding, including lengthy periods of public comment, drafting and mandated reanalysis.

For a refresher on the seven-and-a-half years of conservative approaches to just one regulatory sphere, the environment (to say nothing of pharmaceuticals and other consumer products), check out this timeline of the administration’s record. Boo.

Weiss’s Notebook

CAP Senior Fellow Rick Weiss covered science and medicine for The Washington Post for 15 years, and now he brings his investigative eye to science policy. From cloning and stem cells to agricultural biotechnology and nanotechnology, Weiss examines the issues at the intersection of cutting edge research and public policy.

Cleanliness is next to Godliness, it’s been said. And Godliness, like a Visa card, is arguably priceless. But that doesn’t mean you can’t put a price on cleanliness. And now someone has: $1.98.

That’s how much it costs a hospital every time a health care professional fails to wash his or her hands, according to a study released last week.

A doctor fails to wash her hands after examining a patient, spreading a few germs that could seed a new infection and perhaps necessitate a round of tests and antibiotics. Kaching! Ring up, on average, $1.98.

A nurse forgets to wash up after taking a patient’s blood pressure, then moves on to the next room. Kaching! Another $1.98.

An aide removes Patient A’s food tray and delivers a fresh one to Patient B without the benefit of a handwashing intermezzo. Kaching!

Two bucks may not seem like a lot of money, but it adds up fast when you consider the thousands of interactions that can occur in a hospital every day. To be precise, it adds up to a whopping $1.77 million a year at a typical 200-bed hospital, Duke University Medical School researchers reported at the Interscience Conference on Antimicrobial Agents and Chemotherapy, held in Washington.

Indeed, as we prepare to welcome a new administration, handwashing, I would argue, is the metaphor of the day.

The key to stemming this health care expense is simple and uncontroversial. Handwashing is highly effective. It takes less than half a minute. And one can hardly turn around in a hospital without bumping into a sink or a hand sanitizer dispenser. Yet even highly trained professionals either forget or semiconsciously cut corners with some regularity. And so do we non-medical personnel as we go about our days holding handrails and subway straps in this season of sniffles.

All of which raises the question: Why aren’t all of us—doctors and nurses especially, but all of us really—more diligent about washing our hands? Or more to the point: What would it take to make handwashing a higher priority?

As it turns out, a large number of studies have addressed that simple question, and the answers have relevance far beyond the sink. Indeed, without a stretch, they get to the very heart of human nature and, in doing so, they say something important about smart governance and policymaking on a larger scale—something worth considering as the country closes the door on an era of regulatory slumber and unencumbered greed and considers anew how to get people and institutions to behave in more socially responsible ways.

Indeed, as we prepare to welcome a new administration, handwashing, I would argue, is the metaphor of the day.

To start, let’s consider last year’s survey sponsored by the American Society for Microbiology and the Soap and Detergent Association—one in which the famed polling company Harris Interactive won the questionably attractive contract to go undercover in restrooms and observe, firsthand, what 6,076 adults actually did. It found that while 92 percent of adults claim they always wash their hands after using a public restroom, only three-quarters truly do. Other studies have found considerably lower rates, in the 40 to 50 percent range.

So the first challenge is getting people to face the problem squarely.

Here’s one way: In a 2002 study, researchers clandestinely observed whether doctors washed their hands after having direct contact with patients and confronted those who didn’t. Each offending doctor was then enrolled in an “importance-of-handwashing” educational program. When asked in followup interviews which part of the educational program was, in the doctor’s opinion, most effective in getting him or her to recommit to regular handwashing, it turned out that no part of the program had made as big an impression as the mere act of getting busted in the first place.

In short, every doctor already knew that handwashing is important. But, well, laxness happens (or “hand washing apathy,” as a 2002 research report called it). And there is nothing like enforcement—and the shame that comes with being made an enforcee— to revitalize one’s commitment to doing the right thing.

Fortunately, there are similarly effective ways of getting people to change their handwashing habits that do not involve being pulled over, cited and sentenced to a remedial hygiene class. All of us, it turns out, have the power to bring handwash scofflaws to the sink. In one study of women using a public restroom, only 11 of 28 washed their hands when they thought no one was there to see them, but 24 of 31 did so when a another woman was plainly in the room. In other words, the simple knowledge that one is perhaps being watched can cause significant changes in behavior—a truth familiar to anyone who has considered quietly reaching for the cookie jar, whether in the kitchen or on Wall Street.

A second study compared handwashing rates among women using the restroom in a bar, under two kinds of situations: when another woman was present and made eye contact and initiated a conversation, and when another woman was present but talked on a cell phone the whole time and did not make eye contact. The results were robust: Women in the first situation were twice as likely to wash their hands compared to their counterparts who thought they were being ignored, 56 percent to 27 percent.

This is not to say that handwashing or any other single behavior can singlehandedly (as it were) eliminate hospital-acquired infections, which affect up to 2 million Americans each year and kill an estimated 100,000. And some parts of the solution may come from other, unexpected places.

A 2004 study at a teaching hospital in New York, for example, found that about half of all neckties worn by doctors harbored disease-causing bacteria—a prevalence five times greater than for ties worn by other hospital staffers who had no contact with patients. No one knows if neckties really contribute to the spread of disease inside hospitals, but statistics like those led the British Medical Association in 2006 to recommend that doctors “refrain from wearing functionless pieces of clothing, such as ties” (and has helped launch renewed interest in bowties, which give doctors the professional look they want without flopping from one germy patient to the next).

Financial incentives can obviously help, too. In October, the federal Medicaid and Medicare programs announced they would no longer reimburse hospitals for the treatment of infections caused by those hospitals. No more sugar daddy picking up that $1.77 million tab.

All told, however, the lesson for anyone trying to encourage best practices, whether they are hospital administrators or government regulators, is that at least as important as making smart policy changes—fixing the “neckties” in the system—is creating a system that is truly transparent and that includes a real threat of enforcement, something there has been precious little of during the Bush administration.

A few plain-clothed observers could go a long way toward cleaning up the worlds of government and finance. No doctor, no mortgage derivatives trader, no recipient of a big defense department contract wants to be seen doing the perp walk to handwashing class.

Rick Weiss is a Senior Fellow at the Center for American Progress and Science Progress.

flickr.com/morganmorgan

In a surprising move last week, the Environmental Protection Agency sided with science, environmentalists, and America’s children. It has been 30 years since the United States saw a reduction in lead emissions standards, but on October 15, EPA reduced the limits from 1.5 micrograms per cubic meter to 0.15. The move will force smelters, metal mines, and waste incinerators to reduce their emissions of the toxic metal. Since 1990, over 6,000 studies have confirmed the dangerous effects of lead, especially on children, as it lowers their IQ and damages learning and memory abilities. In adults, lead can cause brain, kidney, and cardiovascular damage.

The move garnered praise from bloggers at The Pump Handle and Switchboard, usual critics of the Bush administration’s environmental policy. But even with the new limits, the number of emissions monitoring stations has dropped from 800 in 1980 to around 130 stations currently, according to both blogs. The EPA plans to add or relocate 236 monitoring sites to meet requirements, still less than half of the previous number. Additionally, polluters will not need to comply with the new .15 μg/cubic meter standards until 2017. Gina Solomon at Switchboard writes: “That’s too late! We’ve already waited 30 years for this new lead standard, and it’s crazy to wait almost 10 more years for it to come into effect.”

But the history of lead in human civilization goes back even further. There have been several phases in the regulation of lead-based paint and leaded gasoline, taking nearly a century for public policy to catch up with scientific warnings. David Michaels, in his book, Doubt is Their Product: How Industry’s Assault on Science Threatens Your Health, describes the history of the battle between the paint and gas industry’s PR machines and public health advocates and environmentalists. Here’s a timeline of what’s happened in the United States over the past 100 years:

1900s: Lead was regarded as a highly toxic chemical, with lead-based paint regarded as the most identifiable hazard. If a child ate paint chips, people recognized it could cause seizure, coma, and death. If it didn’t traumatically harm the child, he or she may have learning and behavioral disabilities.

1922: Lead was first introduce into gasoline, immediately drawing headlines concerning public health. The form of lead in gasoline was known as tetraethyl lead and it raised the octane level of gasoline, resulting in “premium” gas for high-performance engines.

1924: Five workers at a New Jersey plant died, with four of them going “insane” before their death. The New York Times (subscription) covered the story, and New York City, Philadelphia, and other jurisdictions banned the sale of leaded gasoline.

1930s: The industries rejected scientific evidence, claiming there was no proof of causation and tried to blame the children and families as being irresponsible for allowing children to eat the paint chips, claiming that they were “sub-normal to start with.”

1965: A geochemist named Clair Patterson in Greenland brought the airborne lead issue into American consciousness. Until then, industry experts claimed only workers were at risk for lead poisoning, and that because lead has always been naturally in the air, it must be safe. Using ice core samples, Patterson found that higher levels of lead existed in recent samples than older ice. He further concluded that the amount of lead Americans had in their blood was 100 times greater than natural levels.

1970: Nixon signed the Clean Air Act of 1970 into law on December 31st, and the Environmental Protection Agency, formed on December 2, had a task worth attacking. “Year of the Environment came to an end on an extremely upbeat note with the signing of a major piece of environmental legislation. The Clean Air Act (CAA) of 1970 was the perfect bookend to balance the National Environmental Policy Act the President had signed with such a flourish on New Year’s Day,” states the EPA. Along with lead, the EPA was required to lower emissions of hydrocarbons, carbon monoxide, and nitrogen oxides by 90 percent in only a few years.

1971: President Richard Nixon signed the Lead-Based Paint Poisoning Prevention Act, which restricted the lead content in paint used in housing built with federal dollars and provided funds for states to reduce the amount of lead in paint. Subsequent legislation created the Consumer Product Safety Commission, which effectively banned leaded paint in 1976.

1984: The U.S. Senate considered banning the use of lead in gasoline, with Vernon Houk, director of the Centers for Disease Control and Prevention’s Center for Environmental Heath, reporting that “if no lead had been allowed in gasoline since 1977, there would have been approximately 80 percent fewer children identified with lead toxicity.”

1985: The EPA discussed a total ban on leaded gasoline by 1988.

1990: In amendments to the Clean Air Act, lead was banned from gasoline. The measures would take effect in 1995, giving gasoline companies five more years to completely phase out lead.

2002: According to a study, levels of lead found in human blood were reduced more than 80 percent from 1976 to 1999 in American children one to five years old, and these children had IQs that were, on average, 2.2-4.7 points higher than comparable groups in the 1970s. In terms of economic impact, the authors estimate that each IQ point raises worker productivity 1.76-2.38 percent. The estimated economic benefit for each year’s newborns ranges from $110 billion to $319 billion.

2008: EPA tightens air emission rules for lead, requiring industries to reduce levels to .15 μg/cubic meter. The new standard is 10 times greater than previous requirements set 30 years ago.

2013: States are required to submit state implementation plans outlining how they will reduce pollution to meet the standards no later than June.

2017: States are required to meet the new standards no later than January.

Bioethics meets voting technology: Summer Johnson grabs a story on blog.bioethics.net on how mobile voting machines could empower those who cannot commute to a polling station.

Nat Torkington has thoughts on better tools for teaching evolution in high school science classes at O’Reilly Radar.

Sheril Kirshenbaum at Next Generation Energy dreams of New York…with wind turbines.

Center for American Progress Fellow Bob Sussman has a three part series on the Clean Air Interstate Rule and how to rebuild clean air policy.

Over at social-networking megasite Mashable, Paul Glazowski discovers scivee.tv, a new site that integrates scientific posters and papers with video commentary from researchers.

Liz Borkowski picks up news that California is taking product safety rules into its own hands with a Green Chemistry Initiative, over at The Pump Handle.

At a recent congressional hearing, several Members of Congress articulated the view that more regulation is necessary. Rep. Diana DeGette (D-CO) announced that in addition to working to change funding rules, she was developing legislation to increase federal ethical oversight of stem cell research, possibly by creating a new oversight body within the National Institutes of Health that would be responsible for monitoring all stem cell research in the United States, regardless of the source of funding.^[1] In response, prominent researchers noted that stem cell research is already subject to significant oversight at institutions across the country.^[2]

Stem cell research—embryonic and adult—and the processes used to turn this research into therapies are already extensively regulated.

While academic research advances, companies are also making progress translating that research into therapies. Osiris Therapeutics of Columbia, MD and Aldagen of Durham, NC have demonstrated scientific successes using adult stem cell products, and Geron Corp. of Menlo Park, CA recently filed the first Investigational New Drug, or IND, application for an embryonic stem cell based product.^[3] In anticipation of future filings, the Food and Drug Administration’s Cellular, Tissue and Gene Therapies Advisory Committee recently held a public meeting to discuss the creation of standards for the approval of embryonic stem cell based products.

These developments have led to increased emphasis by research advocates on the issues surrounding regulatory oversight of such products. At the CTGTAC meeting, Amy Rick, President of the Coalition for the Advancement of Medical Research, an organization historically focused on changing NIH funding rules, spoke about the agency’s drug approval standards. She urged the FDA not to apply “an extra layer of risk averseness or safety requirements” on embryonic stem cell products simply because this technology has been controversial.^[4]

Thus, it is appropriate to review all the oversight mechanisms currently in place at each stage of the research and development process for stem cell based products. Similar to previous literature,^[5] we use the term “stem cell based products” to include the use of embryonic pluripotent or adult multipotent stem cells to create human tissues for transplantation into patients with medical conditions caused by the degeneration or injury of cells, tissues, and organs. Such replacement tissues derived from stem cell lines may or may not include undifferentiated stem cells in the final product. In some cases, multipotent cells might be transplanted, while in others all the cells will have already differentiated in culture prior to transplantation.^[6]

Stem cell research—embryonic and adult—and the processes used to turn this research into therapies are already extensively regulated. The FDA enforces long-standing regulations for preclinical development and clinical testing of cell-based products. The NIH applies oversight rules that govern research by grantees. Moreover, the National Academies provide research guidelines that have been widely adopted, and house a national stem cell research advisory committee. Legislation by individual state governments and review committees at research institutions also serve to prevent improper conduct.

In combination, these structures govern scientific, legal, and ethical considerations and appropriately balance patient protections with the need to promote product development. There is no evidence to suggest that this system is not working. Efforts to change or “strengthen” these rules, however well intentioned, should be carefully considered prior to adoption. Moreover, the regulations currently in place have governed many generations of previous biotech products, ensuring that patients with unmet medical needs have access to safe, effective treatments as fast as possible. Proponents of change have the burden of demonstrating why their proposed modifications are needed.

Food & Drug Administration

The Food and Drug Administration regulates all stem cell based products under the Tissue Action Plan, a set of rules designed to regulate human cells, tissues, and cellular and tissue-based products, or HCT/Ps. The FDA defines HCT/Ps as “articles containing or consisting of human cells or tissues that are intended for implantation, transplantation, infusion, or transfer into a human recipient.” This includes, but is not limited to, “hematopoietic stem/progenitor cells derived from peripheral and cord blood, manipulated autologous chondrocytes, and semen or other reproductive tissues.”^[7] The TAP regulations are intended to prevent the use of contaminated tissues and the improper handling and processing of materials and products, as well as to ensure clinical safety and effectiveness for highly processed tissue.^[8]

The TAP requires: registration of all HCT/P products by all establishments conducting HCT/P development, donor eligibility screening and testing, and the use of Current Good Tissue Practices, or cGTP. cGTP includes requirements relating to: facilities; environmental controls; equipment; supplies and reagents; processing and process controls; labeling controls; storage, receipt, pre-distribution shipment, and distribution of an HCT/P; donor eligibility determinations; and donor screening and testing.^[9] The FDA conducts inspections to determine compliance with these regulations through site visits. In response to violations, the FDA has the authority to issue orders for retention, recall, or destruction of HCT/Ps.^[10]

The FDA anticipates using a certain degree of flexibility, within regulations, for these new and innovative technologies, working early with sponsor companies to help with study and test design.

If a stem cell based product entails more than “minimal manipulation” or cells for other than “homologous use,” the FDA will also impose its regulations for biologics (or devices).^[11] It is expected that most stem cell products as currently envisioned will be regulated in this manner.^[12] Regulation of stem cell based products as biologics will be performed by the FDA’s Center for Biologics Evaluation and Research and its Office of Cellular, Tissue and Gene Therapies. Prior to obtaining permission for a Phase I safety study in humans, the sponsor of a clinical trial must provide “adequate information about the pharmacological and toxicological studies…on the basis of which the sponsor has concluded that it is reasonably safe to conduct the proposed clinical investigations. The kind, duration, and scope of animal and other tests required vary with the duration and nature of the proposed clinical investigations.”^[13] These studies need to demonstrate, using the best science available, the product’s safety and efficacy via proof of sterility, purity, potency, identity, and stability. Since it may be difficult to characterize the composition of a stem cell based product, having detailed knowledge of the source and manufacturing processes of the product is essential.^[14] Thus, as with other biologics, the FDA is likely to evaluate manufacturing processes used during production in addition to analyzing the product itself. Only once the FDA is satisfied that safety requirements are met will an Investigational New Drug be approved for human clinical trials.

Additionally, some human embryonic stem cell products will fit the definition of xenotransplantation as written in CBER guidance documents, and therefore will be regulated by the Xenotransplantation Action Plan.^[15] Some cell lines are established using nonhuman feeder cell layers (typically murine-based, meaning they are derived from mice or lab rats) or grown using nonhuman serum media that have the potential to contain nonhuman viruses and endogenous retroviruses and bacteria. As part of the safety and efficacy evaluations of these INDs, it must be demonstrated that the product is free from these potential infectious agents and will not pose a risk of transmission to recipients.

The FDA anticipates using a certain degree of flexibility, within regulations, for these new and innovative technologies, working early with sponsor companies to help with study and test design. Sponsor companies are not only invited to schedule the typical “pre-IND” meetings with the FDA, but are also encouraged to interact early during development, “pre-pre-IND,” to informally discuss progress with the agency.^[16] These additional interactions can increase the FDA’s knowledge and ability to regulate stem cell based product development.

As part of efforts to better understand scientific issues, the Cellular, Tissue and Gene Therapies Advisory Committee, housed within the Center for Biologics Evaluation and Research, held a meeting in April 2008 regarding cellular therapies derived from human embryonic stem cells. Attendees discussed the scientific considerations of preclinical safety testing that would be part of an IND application before testing is allowed in humans. The meeting focused on the issues of uncontrolled differentiation and tumorigenicity, and on whether sufficient science exists both to characterize cells being implanted and to monitor cell fate after infusion. In the past, other advisory committee proceedings have led to the development of guidance documents and product-class-specific standards for safety and efficacy.

National Institutes of Health

The NIH oversees stem cell research at institutions receiving NIH funding through the grant review process and through the activities of the Recombinant DNA Advisory Committee, known as the RAC. Currently, NIH grants for human embryonic stem cell research can only be obtained for research involving an approved cell line or lines that must be identified at the time of the grant application. Grants for adult stem cell research must also meet other NIH guidelines.^[17] By reviewing the scientific merit and ethical implications of research at the time of grant proposals, the NIH oversees research to prevent misconduct. The RAC reviews research if it involves “protocols that raise novel or particularly important scientific, safety, or ethical considerations.”^[18]

To ensure that federal funds support only embryonic stem cell research that is scientifically sound, legal, and ethical, NIH examines stem cell lines and maintains a registry of lines that satisfy the criteria established in NIH guidelines.^[19] NIH guidelines state that the agency will only fund research using embryonic stem cells if it meets the following conditions:^[20]

• Removal of cells from the embryo must have been initiated before August 9, 2001.
• The embryo from which the stem cell line was derived must no longer have had the possibility of developing further as a human being.
• The embryo must have been created for reproductive purposes but no longer be needed for them.
• Informed consent must have been obtained from the parent(s) for the donation of the embryo, with no financial inducements.

Institutions and companies that do not receive NIH funding are not required to follow any NIH guidelines, but NIH standards have become almost universally accepted as safe scientific practice. Additionally, peer-reviewed scientific journals may require compliance with these guidelines in order for a researcher to publish results.

National Academy of Sciences

The National Academies provide additional guidance for oversight of stem cell research. The Guidelines for Human Embryonic Stem Cell Research, first published in 2005 and updated in 2007, “offer[s] a common set of ethical standards for a field that, due to the absence of comprehensive federal funding, was lacking national standards for research.”^[21] The Guidelines are intended for use by the scientific community, including researchers in universities, industry, or other private-sector organizations. They cover all derivations of human embryonic stem, or hES, cell lines and all research using hES cells derived from (1) blastocysts made for reproductive purposes and later obtained for research from in vitro fertilization clinics, (2) blastocysts made specifically for research using IVF, and (3) somatic cell nuclear transfer. Many guidelines also apply to research with adult stem cells, fetal stem cells, or embryonic germ cells derived from fetal tissues. The Guidelines address: procurement of gametes, blastocysts or cells; derivation of cell lines; banking and distribution of cell lines; research use of cell lines; international collaboration; and recommended actions by the community to ensure the Guidelines are implemented.^[22]

The Guidelines made recommendations that led to the creation of a new system of oversight specifically for embryonic stem cell research. Under these recommendations, oversight of the research at an institution should be performed by an Embryonic Stem Cell Research Oversight, or ESCRO, committee.^[23] These committees should include members of the lay public as well as experts in scientific, legal, and ethical aspects of stem cell research. Committees are charged with:

1. Providing institutional oversight over all issues related to derivation and use of human embryonic stem cell lines
2. Reviewing and approving the scientific merit of research protocols
3. Reviewing compliance of all in-house hES cell research with all relevant regulations and these guidelines
4. Maintaining registries of hES cell research conducted at the institution and hES cell lines derived or imported by institutional investigators
5. Facilitating education of investigators involved in hES cell research.^[24]

While there are no comprehensive statistics yet published, it is generally believed that most institutions in the United States that are engaged in stem cell research have established ESCROs per the Guidelines.^[25] Additionally, some state and private funding for research requires review by an ESCRO.^[26]

To facilitate national discussions about stem cell research and to create periodic updates to the Guidelines, the National Academies created the Human Embryonic Stem Cell Research Advisory Committee in May 2006. The committee held its first meeting in July 2006 and has held four subsequent meetings, the last in February 2008.^[27] In addition to these meetings, the committee hosted a public symposium in November 2006 on “Emerging Issues in Human Embryonic Stem Cell Research” and several regional workshops in 2007 focused on implementation of the Guidelines.^[28] Discussions at these events led to the 2007 Amendments to the National Academies’ Guidelines for Human Embryonic Stem Cell Research, which provided clarifications to the policies. As new issues arise and the science progresses, the committee may publish further amendments as necessary. The National Academies and the committee have also created a listserv to facilitate discussions among those involved in the oversight at institutions around the United States.^[29]

Local Institutional Committees

Committees at each institution where research takes place provide additional oversight. An institution’s ESCRO committee performs the majority of the evaluation of proposed stem cell research. Stem cell research is also overseen by all the same processes as other institutional research, which may include examination by committees focusing on the conduct of research, science and technology policy, radiation safety, conflicts of interest, animal care and use, biosafety, protection of human subjects, and others issues as appropriate.

The committees most commonly reviewing stem cell research are focused on human subjects protection, animal care and use, biosafety, and radiation safety. If any research involves human subjects or donors for stem cell line derivation, the Institutional Review Board will provide regulatory and ethical review, including overseeing the creation and application of appropriate consent documentation and addressing issues such as subject reimbursement. If the research involves animals, the Institutional Animal Care and Use Committee, or IACUC, will evaluate and approve the protocols. If recombinant DNA technology is involved in the derivation, maintenance, or differentiation of cell lines, the Institutional BioSafety Committee, or IBC, will also need to approve the research protocols. If radiation is used in the preparation of stem cell research materials, researchers must follow the institution’s radiation safety regulations. Many of these institutional committees are affiliated with national oversight bodies. Each IBC is registered with the Recombinant DNA Advisory Committee at the National Institutes of Health, and the FDA Office for Human Research Trials or the Department of Health and Human Services Office for Human Research Protections may oversee each IRB.

State Laws & Policies

While it is not our intention to provide a comprehensive overview of the state stem cell regulation landscape in this report, it is important to note state policies that have contributed to the oversight of stem cell research. Of course, some states either prohibit embryonic stem cell research outright or restrict the use of state funds. States that do authorize stem cell research address oversight in different ways. For example, California, Connecticut, New Jersey, and New York require research to be reviewed by ESCRO committees created under the National Academies Guidelines. Grant applications in Maryland must include a section covering the ethics of proposed research and applicants are encouraged to reference guidelines from the National Academies or other professional societies. Massachusetts requires grantees to identify any institutional research policies or protocols that apply to the project and to state how they are addressed.^[30]

All states require that funded research comply with all applicable institutional, state, and federal policies and regulations about human subjects, animal welfare, and safe research practices. Databases of state policies and pending legislation are available online from the National Conference of State Legislatures and other organizations.^[31]

Conclusion

The existing oversight structure for stem cell research and product development is extensive and appropriately accounts for scientific, legal, and ethical concerns. Figure 1 (below) provides a summary of the oversight system for basic research. Figure 2 (below) provides a summary of the oversight of products for clinical applications in humans. With certain necessary exceptions, primarily regarding use of embryos, stem cell based products are treated in the same manner as other cell based therapies and biologics or devices. In general, this type of oversight has allowed scientists to develop generations of biological products safely and get them to the market to treat unmet medical needs as quickly as possible. Policymakers seeking to modify these rules have the burden of demonstrating why the existing system is inadequate and how any proposed changes will improve, rather than hamper, patient access to new therapies.

Michael J. Werner is President of The Werner Group, a Washington DC-based firm that provides lobbying, regulatory, and bioethics consulting services for life sciences companies, health care organizations, investors, and broad-based coalitions.

Hans Smith is a Research Associate with The Werner Group and is pursuing a Master of Bioscience degree at the Keck Graduate Institute in Claremont, CA. He can be contacted via email at Hans_Smith@kgi.edu.

Notes

[1] Reps. DeGette and Mike Castle (D-DE) working on new bill to regulate embryonic stem cell research, BNA Medical Research Law and Policy (May 21, 2008).

^[2] “We did not have the opportunity to respond to her, that all institutions are complying with ESCRO guidelines. We’re not just doing what we want.” – John Gearhart, MD. “Legislator proposes NIH provide ‘ethical oversight’ for all US stem-cell research,” available at http://blogs.nature.com/reports/theniche/2008/05/legislator_proposes_nih_provid.html (last accessed July 29, 2008).

^[3] As of this writing, this IND is being reviewed by the FDA and is on hold.

[4] “[O]n behalf of CAMR and the patient communities [we request] that in spite of the high visibility and great amount of controversy …around human embryonic stem cell research that you not put an extra layer of risk averseness or safety requirements on this research simply because the nature of the visibility or the controversy on the issue…I would plead that you do not, as scientists, allow external controversy in any way to interfere with your analysis.” – Amy Comstock Rick at April 10, 2008 CTGTAC hearing. Meeting minutes available at http://www.fda.gov/ohrms/dockets/ac/cber08.html#CellularTissueGeneTherapies, (last accessed July 21, 2008).

[5] Kessler, D., Halme, D., The New England Journal of Medicine, 355 (2006), pp. 1730-1735

[6] Ibid.

[7] 21 CFR Part 1271 “HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS”

[8] FDA – CBER – “Tissue Action Plan,” available at http://www.fda.gov/CbER/tissue/tissue.htm (last accessed July 18, 2008).

[9] FDA – CBER – “Concerning the Current Good Tissue Practice (cGTP) Final Rule,” available at http://www.fda.gov/CBER/rules/gtpq&a.htm (last accessed July 18, 2008).

[10] 21 CFR Part 1271 “HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS”

[11] Processes that entail more than “minimal manipulation” are defined as those “that alter the relevant biological characteristics of cells or tissues.” Common ways of creating, maintaining, and using cell lines, such as inducing multipotency of an adult cell or causing targeted differentiation of an embryonic stem cell line, would be considered processes that alter biological characteristics. According to 21 CFR 1271.3: “Homologous use means the repair, reconstruction, replacement, or supplementation of a recipient’s cells or tissues with an HCT/P that performs the same basic function or functions in the recipient as in the donor.”

[12] Kessler, D., Halme, D. (2006).

[13] 21 CFR 312.23(a)(8) DRUGS FOR HUMAN USE – Investigational New Drug Application.

[14] Donald W. Fink, Jr., Ph.D., Office of Cellular, Tissue and Gene Therapies, presentation, “Embryonic Stem Cell-based Therapies: US-FDA Regulatory Expectations” February 12, 2007, available at http://www.fda.gov/CbER/genetherapy/stemcell012907df.htm (last accessed July 23, 2008).

^[15] Xenotransplantation is any procedure that involves the transplantation, implantation, or infusion into a human recipient of either (a) live cells, tissues, or organs from a nonhuman animal source, or (b) human body fluids, cells, tissues or organs that have had ex vivo contact with live nonhuman animal cells, tissues or organs, available at http://www.fda.gov/Cber/xap/xap.htm (last accessed July 23, 2008).

[16] Donald W. Fink, Jr., Ph.D., “Embryonic Stem Cell-based Therapies: US-FDA Regulatory Expectations.”

^[17] National Institutes of Health, “GUIDANCE FOR INVESTIGATORS AND INSTITUTIONAL REVIEW BOARDS REGARDING RESEARCH INVOLVING HUMAN EMBRYONIC STEM CELLS, GERM CELLS AND STEM CELL-DERIVED TEST ARTICLES,” NOT-OD-02-044 (April 10, 2002).

[18] Recombinant DNA Advisory Committee, “Recombinatant DNA and Gene Transfer,” available at http://www4.od.nih.gov/oba/rac/aboutrdagt.htm.

[19] National Institutes of Health, “NIH Human Embryonic Stem Cell Registry, available at http://stemcells.nih.gov/research/registry/.

[20] National Institutes of Health, “Frequently Asked Questions (FAQs): Funding Questions,” available at http://stemcells.nih.gov/info/faqs.asp#funding.

[21] Committee on Guidelines for Human Embryonic Stem Cell Research, Institute of Medicine, Guidelines for Human Embryonic Stem Cell Research (The National Academies Press, 2005), available at http://books.nap.edu/catalog.php?record_id=11278 (last accessed July 15, 2008).

[22] “To help ensure that these guidelines are taken seriously, stakeholders in hES cell research—sponsors, funding sources, research institutions, relevant oversight committees, professional societies, and scientific journals, as well as investigators— should develop policies and practices that are consistent with the principles inherent in these guidelines. Funding agencies, professional societies, journals, and institutional review panels can provide valuable community pressure and impose appropriate sanctions to ensure compliance. For example, ESCRO committees and IRBs should require evidence of compliance when protocols are reviewed for renewal funding agencies should assess compliance when reviewing applications for support, and journals should require that evidence of compliance accompanies publication of results,” from the Guidelines for Human Embryonic Stem Cell Research, 2005.

^[23] “An ESCRO committee should include independent representatives of the lay public as well as persons with expertise in developmental biology, stem cell research, molecular biology, assisted reproduction, and ethical and legal issues in hES cell research,” from the 2007 Amendments to the National Academies’ Guidelines for Human Embryonic Stem Cell Research.

In response to the recent progress in adult stem cell science, many institutions have created committees that review research involving both embryonic and adult stem cells; sometimes titled Stem Cell Research Oversight (SCRO) committees.

[24] Guidelines for Human Embryonic Stem Cell Research (2005).

^[25] Personal communication with Anne Hiskes, PhD, Director of Research Ethics and Education for Stem Cell Research and Chair of the ESCRO; Associate Professor, Philosophy; The University of Connecticut. Dr. Hiskes performed a national survey in early 2007 of ESCRO committees that provided some initial data. Survey results are available at http://www.escro.uconn.edu/survey.html (last accessed July 23, 2008).

^[26] California requires research funded by California Institute for Regenerative Medicine (CIRM) to be reviewed by a ESCRO committee(s) established in accordance with the requirements of Code of California Regulations, title 17, section 100060, available at http://www.cirm.ca.gov/reg/default.asp. In Connecticut, an ESCRO must review “all research funded by the State of Connecticut Stem Cell Research Fund, including those that do not use human embryonic stem cells”; available at http://www.das.state.ct.us/rfpdoc/DPH06/bids/2007stemcellresearchgrant.pdf. New Jersey institutions must establish an ESCRO to receive funding. Additionally an ethics panel guided by the National Academy of Science’s 2005 Guidelines for Stem Cell Research and the New Jersey Human Stem Cell Research Act performs a review during the grant application process; available at http://www.state.nj.us/scitech/stemcell/grants/.

[27] Human Embryonic Stem Cell Research Advisory Committee, “Project Information,” available at http://www8.nationalacademies.org/cp/projectview.aspx?key=46992 (last accessed July 17, 2008).

[28] National Academies, “Stem Cells at the National Academies: Events” available at http://dels.nas.edu/bls/stemcells/events.shtml (last accessed July 17, 2008).

^[29] National Academies, “ESCRO Committee Listserv,” http://dels.nas.edu/bls/stemcells/escro-listserv.shtml (last accessed July 23, 2008).

^[30] More information available at: http://www.mscrf.org/index.cfm, http://www.masslifesciences.com/index.html, http://www.idph.state.il.us/irmi/index.html, http://www.state.nj.us/scitech/stemcell/grants/index.html, http://stemcell.ny.gov/grantee_requirements.htm, http://www.cirm.ca.gov/reg/default.asp, and http://www.das.state.ct.us/rfpdoc/DPH06/bids/2007stemcellresearchgrant.pdf.

^[31] See: National Conference of State Legislatures: http://www.ncsl.org/programs/health/Genetics/embfet.htm; International Society for Stem Cell Research: http://isscr.org/public/regions/states.cfm; Henry J. Kaiser Foundation, http://www.statehealthfacts.org.

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The U.S. Court of Appeals for the District of Columbia Circuit decided on Tuesday in Sierra Club v. EPA to throw out a rule that prevented states from implementing their own pollution-limiting permits. This marks marks yet another instance of a U.S. court overturning a Bush administration Environmental Protection Agency air quality rule on the grounds that it did not actually protect air quality.

This time the court ruled against the EPA because their actions directly violated the stipulations of the Clean Air Act. As John Walke at NRDC’s Switchboard points out, it’s interesting that the Bush administration would have dared to take away the power of the states to regulate their own pollution levels, given the precision of the language in the Clean Air Act:

No grants shall be made under this section until the Administrator has consulted with the appropriate official as designated by the Governor or Governors of the State or States affected… Not later than 3 years after the date of the enactment of the Clean Air Act Amendments of 1990, the Governor of each State shall develop and submit to the Administrator a permit program under State or local law or under an interstate compact meeting the requirements of this title.

The rule that was just overturned prevented states from doing exactly this, which crippled the states’ ability to regulate themselves, and increased the power of the industries that profit from a lack of regulations. Walke quotes some juridical advice from the ruling: “(1) Read the statute; (2) read the statute; (3) read the statute.” Among the industry groups that supported the EPA’s case against state-level regulatory action was the American Petroleum Institute.

The Washington Post reports that phthalates are so ubiquitous today that in one study, the Food and Drug Administration found traces of the chemicals in every one of its 1,000 subjects. Despite strong lobbying from the chemical industry, especially Exxon Mobil, Congress moved to outlaw the chemicals from commercial products, pending further research. The Post indicates that a White House spokesman stated that President Bush opposes the legislation. Sarah Vogel explained the scientific maneuvering that led to this much-needed oversight earlier this year at The Pump Handle. Describing a Senate hearing on bisphenol A and phthalates oversight, she wrote: “At stake is the means by which society determines chemical risks and benefit.”

Bob Dinneen, CEO and President of of the Renewable Fuels Association testified that ethanol production has a very small effect on food prices, and may actual be keeping them down. He told committee members that corn growers heeded the market signal sent by the RFS mandate last year, producing an additional 2.5 billion bushels of corn over the previous year’s yield, of which only 600 million bushels went towards producing ethanol. Thus, he argued, there was actually an increase in available corn.

Dinneen followed up by citing research which shows that only two percent of the world supply of corn is used goes into ethanol production and that only three percent of food price increases was attributable to that production. He said the main driver of increased food prices was the price of oil. Removing the RFS, he said, would only increase the price of energy, driving up food prices even further.

Rick Tolman, CEO of the National Corn Growers Association backed up Dinneen’s claim, explaining that the main culprit of increased food prices is the price of oil, which plays a significant role in each part of the food production chain. Tolman cited a recent study suggesting that a $1-per-gallon increase in the price of gas has three times the impact on food prices than a $1-per-bushel increase in the price of corn. He also testified that only 19 cents of each consumer dollar in the United States can be attributed to farm products such as grain, oil seeds, and meat. Labor costs 38 cents, and transportation, packaging, energy, and other costs make up the remaining 43 cents. He cited USDA economist Ephraim Liebtag, who calculates that a 50 percent increase in corn prices would translate to an increase in retail food prices of less than one percent.

Don’t remove the mandates, but don’t increase them either was the recommendation from Scott Faber, Vice President of Federal Affairs for the Grocery Manufacturers Association. He acknowledged that many factors are involved in the recent spike, “including increasing global food demand, export and other restrictions, adverse weather in some countries, commodity speculation, and higher energy prices.” He said that the one factor that is under the control of Congress is the package of “mandates and subsidies diverting food into fuel production.” Congress should be mindful, he said, that rising food prices are a significant challenge to the poorest twenty percent of Americans who spend about one-third of their after-tax income on food.

The food price spike has also pushed millions of people around the world in to poverty, he said, forcing food aid programs to ration their supplies. He asked Congress to revisit the mandate schedule; to push harder for second- and third- generation biofuels; and to increase support of international food programs and agricultural development.

Fortunately, there is a sufficient supply of biofuel feedstocks that do not compete with food crops: see “Alternative Cellulosic Biomass By the Numbers.”

Bob Dinneen, CEO and President of the Renewable Fuels Association, defended the RFS, saying that it “makes more sense today then when it was passed.” He argued that the RFS plays a major role in reducing the price of gasoline and U.S. dependence on foreign oil; curtailing greenhouse gas emissions; creating new jobs; and revitalizing rural America.

He claimed that this year’s mandate, if met, will bring GHG emission reductions equivalent to taking 2.5 million cars off the road. He also addressed the recent Searchinger report arguing that biofuel production may actually cause increased GHG emissions. Dinneen cited a response to the study questioning its underlying model and said that more research is needed to address the issue. Searchinger himself has countered such critiques of the study, saying that its conclusions hold regardless of adjustments to the model.

Dinneen also testified that biofuels are also lowering oil prices, citing a recent Merrill Lynch report suggesting world oil prices would be 15 percent higher without the current expansion of biofuel production. He called for greater investment in delivery methods and transportation infrastructure to bring ethanol to where its needed quickly and cheaply.

Charles Drevna, President of the National Petrochemical & Refiners Association offered an opposing view, asking Congress to do away with the RFS and instead let the market dictate the integration of alternative (note: not “renewable”) fuels into the transportation fuel mix. He told the hearing audience that the mandates not only distort the market, but stifle competition and innovation.

He took issue with Dinneen’s claim of lower gas prices from the introduction of biofuels, saying that adding ethanol to fuel does not actually translate into cost savings at the pump. Because current biofuels have less energy content then gasoline, cars end up requiring more fuel, which offsets lower prices he said. To solidify his claim, Drevna cited a report which found that E85 ethanol cost eighty cents more per gallon then gasoline when its price was adjusted for its lower combustion efficiency.

Drevna also disagreed with Dinneen that biofuels are reducing the cost of gasoline because ethanol production is subsidized, offering the appearance of lower prices. But he failed to note that the government has been very generous in supporting oil production in recent years. As Sam Davis and Dan Weiss of the Center for American Progress point out, in 2004 and 2005, big oil companies received tax breaks worth over $17 billion over the next decade. This assistance, they also say, “continues even as BP, ConocoPhillips, and Shell just posted record first quarter 2008 profits—a combined total of $20.8 billion.”

If the ethanol subsidy is removed, Drevna argued, ethanol would be uneconomical in comparison to gasoline on a thermal energy scale. He also claimed that the U.S. lacks the necessary infrastructure to meet the mandates, leaving refiners to unfairly pay the price of penalties imposed by Congress. He asked committee members to do away with the current tariff on imported ethanol to afford flexibility to refiners trying to meet these increased RFS mandates.

During his testimony, John Stephenson, director of the Government Accountability Office’s Natural Resources & Environment department, criticized the thirty-two-year-old Toxic Substances Control Act for being “outdated” and “cumbersome.” TSCA requires the EPA to secure information on all new and old chemical substances and to regulate those chemicals found to cause unreasonable risk to the public or environment. This means the EPA, and not the chemical manufacturers, must prove the safety of chemicals. As history would suggest, this is a Sisyphean task for an already resource-strapped agency. According to senator Frank Lautenberg (D-NJ), of the 80,000 or so chemicals currently used by industry, the Agency has only tested 200.

Is there a solution to this appalling situation? Stephenson believes the answer may lie in the Europe Union’s Registration, Evaluation, Authorization and Restriction of Chemicals program, also known as REACH. In 2006, the EU passed REACH, a 849-page piece of legislation requiring that all chemicals produced or imported in the EU of one ton or more in volume be tested for health and safety risks and registered with a central chemical authority. What makes the policy unique is that chemical manufacturers and importers must prove to federal authorities their chemicals are safe, not vice versa. (For a more in-depth analysis of REACH, see the BBC’s Q&A report on the program).

Stephenson went on to praise REACH, believing its model fosters a fruitful partnership between industry and government because authorities can better protect the public and chemical companies can avoid litigation if hazardous chemicals are identified upfront rather than down the road. Critics argue such approaches could hamstring the chemical industry’s ability to innovate; force companies to move off-shore, costing U.S. jobs; and forcing many small businesses under. Minority witness V.M. Delisi of Fanwood Chemical Inc. echoed these concerns, suggesting it was a “myth” to believe chemical companies have unlimited sources to deal with the onus of proving the safety of their products. Chairman Barbara Boxer (D-CA) countered such fears, saying companies that have created safer alternatives to toxic chemicals have seen their products kept out of the market because weak regulation favors cheaper, more hazardous chemicals. Stronger regulation would foster innovation and safer options, she argued. Annette Gellert, co-founder of the WELL Network, a nonprofit focused on the environment and its connection to the health of children and families, noted that if the U.S. maintains weak chemical regulation it could become a dumping ground for toxic products that cannot be sold in Europe and other stricter countries.

As Chris Mooney explained in his recent column, the EPA is in the midst of a complete meltdown. After censoring its own scientists, demonstrating disdain for scientific integrity, and failing to prevent mercury pollution, repairing the damage done to the EPA by the Bush Administration will require the upmost attention of the next President. But some are left to wonder why it even came to this stage. As Tuesday’s hearing wrapped up, Chairman Boxer’s (D-CA) said simply: “No one can explain to me where there is room for politics when you are looking at the health and safety of the American people.”

Juran, who died on February 28 at the age of 103, was a giant in the quality movement that revolutionized manufacturing, first in Japan and then in the United States and the rest of the industrialized world. Juran and those who followed him extended quality principles across the entire business sector and into other aspects of society. It is now clear that Juran’s views on teamwork and his ideas about continuous improvement and quality assurance management techniques are even more important today to the United States’ position as an intellectual and practical world leader in innovation.

Juran’s key insight is that process matters.

But first, a bit more on Juran’s critical legacy. Born in a primitive East European village, Juran immigrated to the United States as a child, and at age 21 was one of the first engineers to apply statistical methods to quality inspection in manufacturing. Ultimately, he became Western Electric’s corporate Head of Industrial Engineering and then went on to re-engineer military logistics during World War II. On loan from Western Electric to the federal government, Juran led a multi-agency team that redesigned the U.S. armed forces’ shipping processes, reducing the amount of paperwork, significantly cutting costs, and aiding the war effort.

After the war, Juran became a full-time quality consultant, and is credited with transforming the Japanese post-war economy. He popularized the Pareto Principle—the idea that 80 percent of potential improvements are due to 20 percent of operations—teaching that the most successful organizations optimize that vital 20 percent first.

Juran’s key insight is that process matters. He stressed the importance of empowering individual workers, the reinforcing nature of teamwork and quality circles, and the importance of extending quality management techniques to suppliers and customers. And he taught the importance of benchmarking to understand and meet the challenge of competitors. Japan’s embrace of quality management placed it on the road to world manufacturing leadership, as documented in The Machine that Changed the World. Japan’s recognition of his contribution led to the award by the Emperor of Japan of the Order of the Sacred Treasure Award, that nation’s highest honor. This is why the Japanese were so amused when, in the 1970s, American companies wanted to learn Japanese management techniques. The Japanese believed that they were practicing American management as taught by Juran and his colleague Dr. Edwards Deming.

Juran’s book, Total Quality Management, is the bible on this topic. At age 82, Juran was the star witness in the Congressional hearings that led to the creation of the Malcolm Baldrige National Quality Award, which honors superior performance in organizations that function at the highest quality level.

Juran’s Lessons For America Today

Management guru Peter Drucker stated in a 1996 PBS documentary that “whatever advances American manufacturing has made in the last thirty to forty years, we owe to Joe Juran.” Indeed most of the large companies worldwide have embraced his ideas, including U.S. quality award-winning manufacturers Boeing Co., General Motors Corp.’s Cadillac unit, high-end textile and chemicals company Milliken & Co., and Texas Instruments Inc., and quality award-winning service companies The Ritz Carlton Co. and Federal Express Corp.

Yet, U.S. manufacturing today accounts for only 15 percent of our Gross Domestic Product. This is less than Japan, Germany, and other high-wage economies. Why? The reason is that services now dominate our economy. Americans, however, often wonder where the service is in our service economy.

Quality principles apply in services as strongly as they do in manufacturing, but the problem is that much of our service and manufacturing sectors still cling to the rigid industrial efficiency production models of Frederick Taylor, the turn-of-the-last-century’s most famous efficiency management expert. The high throughput, Taylorist model that treats workers as automatons, quality as an after-the-fact consideration, and customers as uninformed and undemanding still appears to dominate.

Taiwan’s industrial parks now often bundle leading research universities and government agencies to provide research and policy expertise for integrated solutions.

Nor are we as a nation aware of how fast our competition is moving. Other countries are taking quality a step further by considering how their governments and educational institutions need to restructure to better accomplish their national goals. Taiwan’s industrial parks now often bundle leading research universities and government agencies to provide research and policy expertise for integrated solutions. The result is a nation that has moved from a underdeveloped country famous for cheap goods to the world’s largest manufacturer of all manner of computer peripherals—and increasingly the inventor, designer, and manufacturer of cutting-edge electronic technologies.

Or consider Finland, which has coupled its emphasis on quality in business with application of quality principles to its schools with the goal of empowering its students and teachers. Despite deemphasizing standardized tests, they have raised performance levels to the point where students are among the best in the world, both in standardized tests and adaptability in the workforce upon graduation.

Countries across the globe are aggressively modernizing, and once again, as in the 1970s, the United States is not keeping up. That’s why Science Progress is preparing policy positions for the next presidential Administration, among them a commitment to reengineer government through quality management. This begins with recognition that public welfare and the health of our private sector are intertwined.

Public Policy Quality Management

Ten years ago in the book The Death of Common Sense, legal scholar Philip K. Howard documented the rise of rules in American government. We were then and still are a society in which rules and procedures often inhibit creativity and problem solving. Much of government is driven by the same bureaucratic approach that Joe Juran spent a lifetime working to replace.

When people say that they dislike government, they highlight the maze of rules and regulations, the lengthy and seemingly illogical processes, and the difficulty in getting governments to make decisions. Too often, government acts after the fact when something goes wrong—the analog of old-fashioned quality control—rather than working with its constituencies to avoid problems, an approach that lies at the heart of today’s quality assurance programs in the private sector.

Once something goes wrong, too often our government embraces an overbroad rule to prevent it from happening again. One shoe bomber and thousands of Americans take off their shoes to comply with a rule that does not make us more secure and does not anticipate the next event.

Why not solve the problems in situ and work for much smaller recalls well before failure occurs?

Joe Juran and his colleagues have shown us the way out. It is now time for the government at all levels, and wherever feasible, to replace end-of-the-line regulation with active participation. A re-engineered regulatory agency should be able to deliver a higher level of public safety by working with companies and all other interested parties on setting commonly acceptable standards that guarantee a high level of public good in a cost-effective manner.

For instance, state auto inspections could be redesigned to increase public safety. Data that they routinely collect could be targeted to that 20 percent of components that cause 80 percent of the safety problems—the 80/20 rule again. Faulty components could be traced back to a manufacturing lot and allow auto companies and their suppliers to correct unusual patterns of wear. Currently wide-ranging recalls happen only after significant and catastrophic failure. Why not solve the problems in situ and work for much smaller recalls well before failure occurs?

Critics will claim that the active participation of government agencies and industries in solving problems will result in what’s known as “regulatory capture,” in which the industry being regulated commandeers the agency policing it. But that’s what happens when regulations are rules-based; companies work hard to change the rules. It also assumes we are still in an international environment where the competition is much slower than it is today. In contrast, quality assurance management, if properly implemented, replaces regulatory capture with cooperation, and brings public officials, private industry, and consumer and workers groups together to achieve maximum efficiency, innovation, and speed in getting the product or service right the first time.

A government operating on its own priorities at a bureaucratic pace does not deliver timely solutions—just when U.S. international economic competitiveness demands timely action. To be effective in the 21^st century, governments need to switch to a quality approach in conducting government business. This means going digital wherever possible, which in turn will necessitate setting privacy-protection for the mining of that data, working with manufacturing and services industries on developing common language, and setting standards to make government/industry interactions as seamless as possible.

We need to realize that government services are part of the international competitiveness of private companies.

In short, it will require a government commitment to excellence in forcing out waste and maximizing efficiency in its functions, and in committing to what is best for private sector entities and the common good. Just imagine a government that continuously reviews how it is serving public health and safety, works cooperatively with business to do so in a business-friendly manner, and measures failure to achieve their combined goals at the industry standard of six sigma—a commitment to achieve highly capable processes with an almost perfect level of quality.

We need to realize that government services are part of the international competitiveness of private companies. Joe Juran championed international benchmarking for companies. We need to benchmark government delivery of services against the most efficient governments in the world. We need to get over assuming that everything in the United States is above average.

Finally, we must recognize our nation’s inherent advantages and work to strengthen them as well. We have one of the world’s longest traditions of democracy and of productively working together. The Internet has greatly increased the efficiency of democracy by rewarding open systems and by making distributive work and decision-making easier. Premium services from government are one of the offsets we can offer to low wages from other countries.

Quality and ingenuity can reclaim our nation’s competitive edge. We have every reason to believe that the United States can once again emerge as a world leader in productivity and quality of life if we focus on the vital issues where we can make the greatest improvements; if we err on the side of an open and free society; if we reorganize to empower our entire workforce; and if we update Joe Juran’s gift of quality through a commitment on focused, continuous improvement.

Jim Turner is Chief Counsel, Committee on Science and Technology, U.S. House of Representatives. Maryann Feldman is the Miller Distinguished Professor of Higher Education at the University of Georgia. Both are writing as individuals and not in their official capacities.

Announcement of the winners may be delayed until the FCC and Congress decide what to do with the D-Block license which failed to sell, receiving only a $472 million offer, well short of the $1.3 billion reserve price. The D-block license is for a wireless network that covers the entire nation, and includes a requirement for the creation of a public/private partnership to build a national emergency response network. House Subcommittee on Telecommunications and the Internet Chairman Edward Markey (D-MA) promised to hold a hearing to discuss how the D-block rules must be revised for a second auction. FCC Chairman Kevin Martin hinted at the possibility of separating the D-block from the rest of the auction so that winners can be announced.

Bidding on the sought-after C-block reached $4.75 billion, exceeding the $4.6 billion reserve bid and thus triggering a provision requiring the auction winners to provide open access to the network. Google lobbied the FCC to include open access rules to this group of licenses, offering to meet the minimum reserve to guarantee the network sold with the attached condition.

Things will only get more interesting in the coming weeks and months: auction winners will be allowed to negotiate with losing bidders and partners over the licenses. How the winners of C-block licenses choose to define “openness” may also prove to be a prickly situation.

Consumers advocacy groups, like Save the Internet, hailed the bill as “a blow to the gatekeepers,” lauding it for protecting consumers from discrimination by Internet providers and bringing the net neutrality debate outside the influence of corporate lobbyists and into an arena where the public–and not the cable and phone companies–decide the future of the Internet. The proponents say the bill would maintain the open marketplace of the Internet where all information is treated equal. Some bloggers complained that the bill, which has the support of Google and Amazon, is a “watered-down” version of Markey’s previously stronger “net neutrality” bill which failed to pass through Congress in 2006. They bemoaned the lack of an enforcement provision or penalty for violating net neutrality as another example of legislators too afraid to confront telecom companies.

On the other side, telecom companies expressed concerns that this bill would introduce regulation that would not only stifle competition and innovation, but would threaten much-needed investment in expanding the network infrastructure. With less financial incentives to expand the infrastructure, they argue, consumers and tax-payers would essentially have to fund the expansion as public works. While Representative Markey assured telecom companies that the bill “contains no requirements for regulations on the Internet whatsoever,” it did little to allay the fears of Scott Cleland, President of NetCompetition.org, who called the bill “a ‘wolf in sheep’s clothing’ because it seeks regulation of the Internet under the guise of ‘Internet freedom.’” The organization, whose members include telecom giants such as Verizon, Comcast, AT&T, Qwest, and Time Warner Cable, goes on to say that the “net neutrality” debate is not even a political concern, but a “fringe issue and a factional business dispute.” Another telecom-funded interest group, Hands off the Internet, shared the same sentiments, claiming that current federal law already provides for an open Internet and the new bill would be “an expensive and unnecessary burden” on the FCC.

The Council for Citizens Against Government Waste took issue with the bill over the proposed summits. They questioned what would be gained from the expensive studies, which would cover issues already addressed by the FCC during earlier deliberations.

Image credit: flickr.com/aaronw79

Image credit: AP/John Weeks III

There is good reason to worry. Before it collapsed, the Minneapolis bridge was one of more than 70,000 bridges nationwide declared by the Department of Transportation to be structurally deficient. One in three urban bridges fall into this category.

“We do not know which bridges should be taken out of the system, and which should be maintained.”

Such bridges may be safe for travel so long as they are carefully monitored. Recent advancements in sensor technology provide the opportunity to collect detailed, real-time data on bridge performance. But this technology is being used on less than a handful of bridges nationwide. Current inspection methods, unfortunately, cannot be relied on to catch a bridge on the brink of collapse.

“We do not know which bridges should be taken out of the system, and which should be maintained,” said A. Emin Aktan, a professor of civil engineering at Drexel University and director of the Intelligent Infrastructure and Transportation Safety Institute.

Every two years, each government-owned bridge is required to receive a “routine” inspection, in which technicians or engineers observe the bridge and take measurements of its physical condition. Underwater structures, meanwhile, must be inspected by divers every five years. There are guidelines but no requirements for “in-depth” inspections, which can include things like probing of the bridge, laboratory analysis of bridge material, and testing of surrounding environmental and water conditions.

This heavy reliance on visual inspection is inadequate for three major reasons. First, inspections are susceptible to human error. Indeed, a 2001 study by the Federal Highway Administration found that inspectors regularly missed problems and inconsistently rated bridge conditions. Second, there are long intervals between required inspections, during which time serious problems may emerge. And third, inspections may be superficial and might not produce the detail necessary to spot deficiencies.

This is not to say that visual inspection is unimportant—visual inspection is crucial to assess bridge conditions, in particular cracks and corrosion. But more is needed to assure the safety of the nation’s bridges.

The Minneapolis collapse has created a political opportunity to modernize bridge monitoring.

That’s where sensor technology comes in. Instead of relying on sporadic and error-prone observations, matchbox-sized wireless sensors can be attached or embedded on bridges to take precise, continuous measurements of virtually anything relevant to a bridge’s condition, including strain, tilt, vibrations, temperature, and seismic activity. This sort of data is particularly important as the nation’s bridge population ages—the mean bridge age is now 40 years old—and traffic and truck loads continue to increase, causing more rapid deterioration.

The Minneapolis collapse has created a political opportunity to modernize bridge monitoring. In its aftermath, Secretary of Transportation Mary E. Peters initiated an ongoing review of the agency’s bridge inspection program to, in her words, “make sure that everything is being done to keep this kind of tragedy from occurring again.”

Congress, meanwhile, is also engaged in finding solutions. Rep. James Oberstar (D-MN), chairman of the House Transportation Committee, is developing legislation to significantly improve bridge inspection requirements as part of “a data-driven performance-based approach to systematically address structurally deficient bridges on our nation’s core highway network.”

Sensor technology can help meet the goals expressed by Peters and Oberstar. What’s needed now is a plan to move forward.

First Steps for Sensor Technology

Recently, the Federal Highway Administration awarded funding to the Connecticut Department of Transportation and the University of Connecticut to deploy and study different types of sensor systems for long-term bridge monitoring.

Over the long run, sensors may even pay for themselves by more precisely identifying when and where repairs are needed.

“The goal is to generate information between inspections, so that if there’s a major change, we can take action to prevent something catastrophic from happening,” said project leader John DeWolf, a professor of civil engineering, who became involved in bridge monitoring following the 1983 collapse of the Mianus River Bridge on Interstate 95 in Greenwich, Connecticut.

Over the last several years, six bridges in Connecticut have been outfitted with unique sensor systems. Five of these are wired systems, in which cables connect the sensors to a computer. The sixth relies on solar-powered wireless sensors. This wireless system is particularly exciting because it holds great promise to be more widely replicated.

It can take a great deal of labor and expense to run cables over a bridge—especially one that is large and difficult to access. For a wireless system, however, cables are not an issue. Sensors merely need to be placed in desired locations on the bridge. Installation typically takes no more than a few hours, at a cost less than half that of a wired system.

Because of these advantages, DeWolf decided to go wireless for Connecticut’s longest bridge, the Goldstar Bridge, which crosses the Thames River on Interstate 95 in New London. Like all new technologies, wireless sensors are expected to get much cheaper over time. But even now they are affordable. Installation of 12 sensors at the Goldstar cost about $30,000.

Wireless sensors on the Goldstar Bridge in Connecticut. Photo courtesy of the University of Connecticut School of Engineering.

Over the long run, sensors may even pay for themselves by more precisely identifying when and where repairs are needed. Ten wireless sensors were recently used to test stress levels from passenger trains on the Ben Franklin Bridge, which crosses the Delaware River from Philadelphia to Camden, New Jersey. The state believed the bridge was in need of major repairs based on advice it received from an engineering consultant. But data gathered by the sensors showed the bridge was in fact secure, saving tens of thousands of dollars in unnecessary repairs.

Sensors can also reveal problems as they emerge—before there is visual evidence such as cracking. This allows remedial action to be taken in time to head off serious structural damage, which can be very expensive to repair. “If you get to it quickly and fix it, it’s not going to be a major problem,” said Mike Robinson, vice president for sales and marketing at MicroStrain Inc., which developed the sensors for the Ben Franklin Bridge. “You can reduce the overall life-cycle cost of the bridge.”

DeWolf approached MicroStrain to develop the solar-powered sensors specifically for the Goldstar. The sensors used on the Ben Franklin were powered by batteries—fine for short-term testing, but not long-term monitoring. Batteries eventually run out of power and then need to be changed or recharged, which is a difficult task on a bridge like the Goldstar, where sensors are in hard-to-reach locations.

The solar-powered system relies on photovoltaic panels to harvest energy from the sun. These panels are connected to the sensors to supply power for daytime monitoring and recharge batteries for overnight observation. This system is expected to generate power for years with little or no maintenance. MicroStrain is also developing other solutions for long-term power, including mini wind turbines and super efficient battery-powered sensors, according to Robinson.

MicroStrain first installed its solar-powered system on the Corinth Canal Bridge in Greece to monitor seismic activity. There, the sun is strong enough for continuous monitoring, which is crucial given the unpredictability of seismic activity. At the Goldstar, where the sun is not as bright, data are gathered for 5 to 10 minutes every hour to conserve energy. For what’s being measured, strain and vibrations, this is considered plenty sufficient.

“Let’s not debate that visual inspection has proven insufficient.”

The data collected are temporarily stored on the sensors and then downloaded daily to an onsite laptop computer. From there, the data can be remotely accessed through a DSL connection. Of course, it is not possible to manually analyze the voluminous amounts of data generated. Instead, automated systems are programmed to comb through and pick out relevant information for DeWolf and his team to review.

Ultimately, this information can help confirm whether the bridge is safe. Vibrations, for example, can be monitored to ensure that they do not exceed potentially dangerous thresholds. For the vast majority of the nation’s bridges, this sort of information is not available. Indeed, Connecticut is now the only state using sensors for long-term monitoring of multiple bridges. Other states rely on the same visual inspection methods that failed in Minneapolis.

“Let’s not debate that visual inspection has proven insufficient,” Aktan said. “Instead, we should focus on strengthening bridge monitoring, so that one day there will be little worry about another bridge collapsing.” Wider use of wireless sensor technology is an important part of the solution.

Building a Nationwide Sensor System

In the aftermath of Minneapolis, public attention is now appropriately focused on detecting an imminent collapse. Thousands of the nation’s bridges are badly in need of repair. The possibility that one might collapse is very real.

Installing sensors on all of the nation’s 70,000 structurally deficient bridges, however, is not practical or even desirable. Within the “structurally deficient” category, there can be vast differences among bridges. Some bridges may be quite safe, in need of relatively minor repairs, while others may have major problems that should be addressed immediately.

The Federal Highway Administration, unfortunately, does not systematically identify priorities among these bridges. Nor are bridges of greatest concern necessarily given more attention. Rather, each bridge is subject to the same biannual requirement for visual inspection regardless of physical condition.

It is thus paramount that more detailed categories be developed that group bridges by degree of concern. High priority bridges, of course, should be repaired as quickly as possible. But repairs may take time to complete, or funding may not be immediately forthcoming. In the meantime, sensors could be deployed to provide more careful monitoring and help further refine priorities for repairs.

Sensors, however, should not only be installed on the very worst bridges. Ideally, they should be used to assist routine maintenance, so that bridges never get to the point of imminent collapse. This requires a system to smartly and economically deploy sensors to monitor the nation’s entire bridge population.

The first step in this process is to classify bridges according to type. A suspension bridge like the Brooklyn Bridge obviously has different characteristics than a truss bridge like the Goldstar and the I-35 bridge that collapsed in Minneapolis. But even bridges of the same general type can have critical differences. Truss bridges, for example, employ a variety of bracing designs, may or may not use pins to connect joints, and may carry traffic on the top, middle, or bottom of the structure.

Bridges will deteriorate in different ways and at different rates depending on such variables. Currently, however, the nation’s bridges are not carefully categorized by similar design features. This information is needed to determine which bridges to outfit with sensors.

Because similar bridges can be expected to perform alike, it is necessary to install sensors only on a sample from each category. Again, this sort of sampling is not part of the current monitoring system—each bridge is subject to the same biannual inspection. “Looking at each bridge as an individual is ridiculous,” Aktan said. “There are tremendous similarities between certain types of bridges, but we don’t leverage knowledge about those similarities.”

The Federal Highway Administration recently launched an initiative—the Long-Term Bridge Performance Program—that begins to move in this direction. The goal of the program is to generate “high-quality, quantitative performance data” based on a representative sample of the nation’s bridges, likely numbering 500 to 1,000 bridges representing the majority of structure types. This includes data on deterioration and its causes—traffic load, corrosion, fatigue, and weather, among others—as well as the effectiveness of maintenance strategies.

FHWA’s research deserves the full support of Congress and the administration. The amount currently appropriated is barely enough to get off the ground.

As part of its data-gathering efforts, FHWA intends to subject the bridges in its sample to detailed periodic evaluations, over at least a 20-year period, using sensor technology and other state-of-the-art monitoring tools. In addition, a subset of bridges in the sample will be instrumented to permit continuous monitoring, while decommissioned bridges will undergo forensic autopsies.

Congress created this program under legislation enacted in August 2005, with funding authorized through FY 2009. FHWA requested $20 million a year, but will have to operate with only about $5.5 million a year over the first four years. Thus, decisions must be made over which parts of the program to launch immediately and which to postpone pending higher levels of funding.

The initiative will be especially valuable in determining what data to collect and what the data means. In particular, it is not always clear what and where to measure. If sensors measure the wrong things or are placed in the wrong spot, they may miss critical deficiencies. FHWA’s research will begin to identify key factors and pressure points in the deterioration of different types of bridges. “A doctor knows where to take a patient’s pulse,” Aktan said. “We need to know where to take the bridge’s pulse.”

A critical part of this process is knowing how to interpret the pulse, so that sick bridges are diagnosed and treated. The vast majority of bridges lack baseline performance data—that is, data collected at the time they were built—from which to judge deterioration over time. Without this information, there is uncertainty about a bridge’s optimal performance and exactly what constitutes poor performance.

FHWA intends to address this problem by comparing newer and older bridges of similar type to identify and predict life-cycle changes. This should bring into sharper focus the large amounts of data generated by sensors. “The problem we have now is making sense of this data,” said an FHWA engineer involved in the Long-Term Bridge Performance program. “That’s what we are trying to address. Determining the sample of bridges is the most critical step.” FHWA has already developed methodology to identify bridges for the sample. But the final selection will not be made until after a prime contractor is chosen, expected within the next couple of months, to oversee the program’s day-to-day operations.

FHWA’s research deserves the full support of Congress and the administration. The amount currently appropriated is barely enough to get off the ground. One enduring problem, unfortunately, is the tendency of Congress to fund transportation research through earmarks to specific universities or private contractors. These earmarks sometimes go to worthy projects, but frequently they are awarded according to political considerations rather than merit.

Moreover, because funding is disjointed and somewhat arbitrary, transportation research is not well integrated and coordinated. The Long-Term Bridge Performance Program can help add cohesion by drawing together information generated by disparate research efforts, including other FHWA-funded initiatives such as the sensor project in Connecticut. “We will try to piggyback on other research projects and make them fit into this national approach,” the FHWA engineer said.

Confronting the ‘Infrastructure Crisis’

For years, the president and Congress have repeatedly deferred needed maintenance of bridges in favor of other budgetary priorities. This shortsightedness will cost the nation far more in the end, as the scale and severity of needed repairs balloon and become impossible to ignore. For Minneapolis, the Department of Transportation released $55 million in emergency funds and Congress authorized $250 million for rebuilding.

Other critical infrastructure—including roads, dams, and levees—are similarly deteriorating and could also benefit from enhanced monitoring through sensors. Substandard road conditions contribute to 30 percent of all fatal highway accidents, according to the FHWA. More than 3,500 dams are unsafe or deficient, many of which may not hold during significant flooding or an earthquake, according to state inspectors. And nearly 150 of the nation’s levees pose a high risk of failing during major flooding, according to the U.S. Army Corps of Engineers. The American Society of Civil Engineers, which gathered these statistics, terms the current situation an “infrastructure crisis.”

The Minneapolis bridge collapse provided dramatic evidence of this crisis. But it was by no means an isolated event. Just last year, for example, an earthen dam in Kauai, Hawaii gave way and let loose nearly 300 million gallons of water, killing seven people. In late 2005, a 120-ton concrete beam fell from a bridge in Pennsylvania onto Interstate 70. And of course, the levees in New Orleans were not only breached during Hurricane Katrina, but structurally failed.

It is crucial that investments are made to upgrade the nation’s crumbling infrastructure. In the meantime, however, more failures should be expected. The question now is whether we will be able to anticipate these failures in time to head off disaster. Sensor technology, if effectively implemented, would give reason for hope.

Reece Rushing is the Director of Regulatory and Information Policy at the Center for American Progress.

Three hundred drug and medical instrument manufacturers have been shut down; pharmaceutical companies withdrew 7,300 applications for drug approval; and 1,100 previously approved drugs and medical appliances were found to have been approved illegally. Wu Zhen, deputy commissioner of the SFDA told a press conference that, “the pharmaceutical companies are examining themselves in this special campaign and their awareness for drug safety has been greatly enhanced.”

Internal corruption has also plagued the SFDA. Former director Zheng Xiaoyu was executed in July for taking some $850,000 in bribes during his tenure.