In the past 5 years, the science of genetic engineering has made giant strides. Starting from scratch using lifeless chemicals, scientists are now able to create viruses, such as the polio virus. Technically, viruses are not "alive" because they require cells to survive. But soon -- perhaps some time this year -- scientists expect to create bacteria, which are definitely alive. From there, it will be a short step to manufacturing new forms of life that have never existed on Earth before. This startling new enterprise is called "synthetic biology."

Background

Life begins as lifeless chemicals, called nucleotides. You can buy them off the shelf. Under some circumstances, these can combine into complicated chains to create DNA molecules. Long strands of DNA form genes, and genes give rise to proteins and eventually to cells and viruses. Cells metabolize, adapt to their environment, and reproduce themselves using the information packed away in their DNA -- thus fulfilling the definition of living things. The nucleotides are just ordinary lifeless chemicals, but by the time they combine into cells they have become the stuff of life itself.

Scientists have spent 300 years working backward from cells, trying to discover how all this works. Along the way they learned that genes can give creatures particular characteristics. Starting 30 years ago they began snipping genes from one creature and inserting them into a different creature, hoping to give the recipient some new characteristic that humans would find valuable. For example, trout can tolerate cold water, so perhaps a gene from a trout inserted into a tomato will help the tomato tolerate cold weather. This has become known as "gene splicing" or "genetic engineering."

All this activity can be described as "reading" the genetic code. But now scientists know enough to begin "writing" their own genetic code -- putting together chains of nucleotides into chunks of DNA, and pasting these together to create living things.

In 2002 a team of scientists at the State University of New York at Stony Brook took mail-ordered pieces of synthetic, lifeless DNA and pasted them together to create a polio virus -- a feat that took two years of hard work. It was the first time humans had ever created a functioning organism from scratch. Since then, things have speeded up.

In 2003 a team led by Craig Venter produced a second synthetic virus from scratch -- and they did it in 14 days. "Scientists predict that within 2-5 years it will be possible to synthesise any virus; the first de novo [meaning, "starting from scratch"] bacterium will make its debut in 2007," says a new report (1 Mbyte PDF) from the ETC Group in Canada. (pg. 1) Bacteria are definitely alive, so the creation of life from scratch, starting with simple chemicals, is upon us.

In 2005, researchers at Mount Sinai School of Medicine in New York and the U.S. Centers of Disease Control (CDC) in Atlanta announced that "They had resurrected the lethal [1918 flu] virus. They published details of the completed genome sequencing in Nature and details of the virus recreation in Science." (p. 24) The flu virus that swept the world in 1918 was especially adept at transmitting itself from one person to the next, and it was especially deadly, killing somewhere between 20 million and 50 million humans. Reconstructing the virus using gene-splicing techniques may help us avoid another pandemic like that of 1918 -- or it may give some "genetic hacker" an idea for creating mischief on a monumental scale.

Obviously the ability to create the polio virus, or the 1918 flu virus, is an extraordinary scientific accomplishment, but freighted with dark possibilities.

In response to recreation of the 1918 virus, technology gurus Bill Joy and Ray Kurzweil told the New York Times, "This is extremely foolish, the genome [of the 1918 flu virus] is essentially the design of a weapon of mass destruction. No responsible scientist would advocate publishing precise designs for an atomic bomb... revealing the sequence for the flu virus is even more dangerous."(p. 24)

Despite such grim warnings, many new start-up firms are competing to find ways to profit from these new techniques.

Craig Venter -- the golden boy of synthetic biology -- and hundreds of other scientists are now trolling the depths of the oceans, the canopies of jungles and the far corners of earth to catalog and patent life's genetic heritage. A new report from the ETC Group titled "Extreme Genetic Engineering" (1 Mbyte PDF) says, "Venter claims that his expedition has discovered 3,995 new gene families not previously known, and 6-10 million new genes -- which he describes as 'design components' of the future."(p. 14)

The gold rush is on. Synthetic biology -- heralded as the next "big thing" to fuel economic growth -- is genetic engineering on steroids. Cataloging our genetic heritage is just the beginning. Armed with desktop synthetic biology machines, scientists can now create DNA on demand, freely combining the best or worst characteristics of any known organism and inventing completely new life forms.

This is all very exciting for scientists and their financial backers who dream of making huge profits. "They hold growing patent portfolios and foresee industrial products for uses as diverse as energy production, climate change remediation, toxic cleanup, textiles and pharmaceutical production."(p.3) Huge sums of money are now pouring from private foundations, government programs and venture capital to invent new medical and chemical products.

As the synthetic biology industry hurtles into the future, civil society organizations are now asking if we shouldn't at least have widespread debate and legally-binding regulation before we rush into this great unknown?

Evidence is accumulating that we really don't know how to control this new technology. For example, Greenpeace just released a report documenting the growing number of cases of unapproved GMO [genetically modified organisms] food crops showing up in regular food crops. GMO rice, corn, soy, cotton and other crops have now 'contaminated' the gene pools of their non-GMO cousins in 142 different incidents since the introduction of GMO crops 12 years ago in 1996.

If we can't control the spread of GMO crops -- relatively large, visible organisms -- how will we control microscopic viruses and bacteria?

Scientists at Berkeley University backed by a $42.5 million grant from the Bill and Melinda Gates Foundation, are developing synthetic drugs to combat malaria. This work gives synthetic biology the blessing of major philanthropy -- but the eventual outcomes for society are unpredictable. The Berkeley team says it will create unlimited and cheap production of the previously scarce drug Artemisinin to treat malaria in the developing world.(p. 20)

Artemisinin is naturally produced by the wormwood (artemisia) plant which is widely cultivated in Africa and Asia. Tea made from the plant is used as a natural medicine to prevent and cure malaria. Although synthetic biology may eventually yield an affordable synthetic alternative, it will likely disrupt indigenous agriculture that provides a livelihood for thousands of small-scale farmers.

And the ETC Group even questions whether the Berkeley work will produce a low-cost drug: "Pharmaceutical companies will accumulate control and power over the production process; artemisia producers will lose a source of income; and local production, extraction and (possibly) manufacturing of ACT [Artemisinin Combination Therapies] in regions where malaria is prevalent will shift to the main production sites of Western pharmaceutical companies."

The ETC Group report outlines six major areas where synthetic biology needs to be carefully watched and where it could undermine the public interest and local/regional economies.

** Biological weapons -- more dangerous, more stealthy

** Biofuels -- to replace petroleum with ethanol and other chemicals derived from genetically modified organisms -- instead of focusing on conservation and efficiency

** Creating intellectual monopolies -- why not own the world? Companies are aiming to create new monopolies by patenting all manner of natural forms and substances

** Conservation biology -- prevent and reverse extinction, thus introducing alien species into contemporary ecosystems

** New commodities -- rubber, silk, you name it; will they interfere with existing crops? Can we anticipate the problems they will create?

** Public health and safety -- trust us, we're experts. What will happen when new organisms enter ecosystems, evolve, and mutate?

The details of each are well worth reading (pgs. 23-48). The common theme is that corporate profits are the primary motivation for all of these innovations. When profit comes first, there is often little room for ethical and democratic exploration of better alternatives.

So what is an ostensibly-democratic society supposed to do? The ETC Group suggests, "...in keeping with the Precautionary Principle, synthetic microbes should be treated as dangerous until proven harmless. At a minimum, environmental release of de novo synthetic organisms should be prohibited until wide societal debate and strong governance are in place, and until health, environmental and socioeconomic implications are thoroughly considered."(p. 50)

The synthetic biology industry has made some soft proposals of self- governance, as a preemptive measure. Most of these have focused on biological weapons. "One proposal was... to boycott gene synthesis companies that did not screen orders for dangerous pathogens, and the development of software that could check genetic code for sequences that could be used maliciously." And a second, "He [Stephen Maurer, a Berkeley attorney] also proposed a confidential hotline for synthetic biologists to check if their work, or the work of others, was ethically acceptable."

But even some synthetic biologists doubt that self-policing can work. Drew Endy of MIT -- a synthetic biology leader and advocate of 'open-source' biology -- said, "I expect that this technology will be misapplied, actively misapplied.... I don't think [these proposals] will have a significant impact on the misuse of this technology."(p. 47)

In May of 2006, the synthetic biology 2.0 conference was held in Berkeley California. When the ETC Group tried to register to attend the event, they were turned away because of "limited space." So they submitted an open letter signed by 38 civil society organizations calling on the synthetic biology industry to "participate in a process of open and democratic oversight of the technology."(p. 50)

"Scientists creating new life-forms cannot be allowed to act as judge and jury," explained Sue Mayer, director of GeneWatch. "The implications are too serious to be left to well-meaning but self interested scientists. Public debate and policing is needed."(p. 47)

The ETC Group report makes the following recommendations:(p. 50)

** There must be a broad societal debate on synthetic biology's wider socioeconomic and ethical implications, including potential impacts on health, environment, human rights and security."

** Civil society should meet at national, regional and international levels to evaluate and plan a coordinated response to the emergence of synthetic biology in the context of wider, converging technologies.

** Governments should maintain zero tolerance for biowarfare agents, synthesised or otherwise, and adopt strong legal measures and enforcement to prevent the synthesis of biowarfare agents.

** The building blocks of life must not be privatised: Despite earnest calls for "open source biology," exclusive monopoly patents are now being won on the smallest parts of life -- on gene fragments, codons and even the molecules that make living organisms (i.e., novel amino acids and novel base pairs).

** To facilitate coordinated global action, an international body should be established to monitor and assess societal impacts of emerging technologies, including synthetic biology.

Can regulation work?

If society does create rules for the development of synthetic biology it should remember that, "scientists are ill-equipped by their training to grapple with the ethical and moral dimensions of their work. Scientists have no equivalent of the Hippocratic Oath -- "First do no harm" -- that guides the behavior of physicians. The Hippocratic oath counsels restraint, humility, and caution. In science, on the other hand, wherever your curiosity takes you is the right place to go, even if it takes you into "a darker bioweapons future."

Even when industry accepts regulation we must be wary. First, history tells us that government regulation translates mostly into government approval. Furthermore, new products are invented so fast that government can't keep up with the onslaught. And when someone is harmed and sues, manufacturers will use regulation as an excuse to evade responsibility: "The government approved this so I'm not liable."

In addition, regulation gives big firms unfair advantage over their smaller competitors. Complicated regulations require armies of lawyers and engineers -- "compliance specialists" -- who "do nothing but read the regulations and fill out the burdensome paperwork, bellyaching all the way to the bank."

Let us remember these words, from the ETC group's open letter to the 2006 synthetic biology 2.0 meetings:
"We believe that this potentially powerful technology is being developed without proper societal debate concerning socioeconomic, security, health, environmental and human rights implications. We are alarmed that synthetic biologists meeting this weekend intend to vote on a scheme of voluntary self-regulation without consulting or involving broader social groups. We urge you to withdraw these self-governance proposals and participate in a process of open and inclusive oversight of this technology."