"The Department of Health and Human Services is concerned about whether or not there may be additional need for oversight for this new technology," said Mark Hemphill of the Centers for Disease Control, part of Health and Human Services.
The department in November created a working group on the hazards of synthetic biology within the National Science Advisory Board for Biosecurity. The working group's recommendations are due in July.
The stakes are high. An article in the current edition of the journal The New Atlantis reported that synthetic biology could "bring about epochal changes in medicine, agriculture, industry, ethics, and politics, and ... may have a profound influence on the definition of life."
The field is already transforming the hunt for new medicines. The Bill and Melinda Gates Foundation in 2004 donated $42.6 million to the University of California, Berkeley, as part of a program to make a cheaper, synthetic form of the highly effective malaria drug artemisinin, now extracted from wormwood. To produce the compound, researchers plan to create a novel chain of interacting genes, called a gene circuit, to produce a precursor to the drug.
Scientists hope to use the new technology to make cells that fight cancer or regenerate tissue. They may one day manufacture genes or whole organisms to make new chemicals or fabrics, detect and neutralize pollutants or, perhaps, mass-produce hydrogen or ethanol fuel.
The technology for synthesizing large pieces of DNA has swiftly advanced. As a result, the cost of purchasing mail-order DNA has fallen 50 percent per year in each of the past three years.
Today, some companies are offering DNA at a cost of $1.25 for every nucleotide base pair - the chemical units that make up strands of DNA.
Drew Endy, a biological engineer at MIT, said the new technology coupled with the Internet will make it possible for scientists and students around the world to do advanced genetic research. "We're perhaps on the cusp of broader access to biological technology," he said.
Endy is president of the BioBricks Foundation, which has created a Web site where anyone with the proper training can design new circuits of genes from a selection of functional segments of DNA.
Scientists have used the BioBricks site to make genes that, when inserted into bacteria, make them flash on and off like marquee lights. Other bacteria have been engineered to record images like a photographic negative.
These are playful efforts, but some experts are nervous about making such potentially powerful tools so freely available.
Jonathan B. Tucker, a biological weapons expert at the Monterey Institute's Center for Nonproliferation Studies, called MIT's Endy "a bit naive" for his belief in sharing the technology as widely as possible. "He's very idealistic," Tucker said. "He thinks that if you make this technique open that people will use it for good purposes. I hope he's right."
In the March/April edition of MIT's Technology Review, author Mark Williams outlined a darker view of the new genetic technology. There was, he reported, a "consensus" among researchers that the field had "advanced to the point that terrorists and rogue states could engineer dangerous novel pathogens."
Williams cited the work of Mark Buller of Saint Louis University. In 2003, Buller announced he had created a highly lethal form of the mousepox virus by splicing in a gene that makes Interleukin-4, or IL-4. Mousepox, a relative of smallpox, can't harm humans but affects rodents. The modified virus, the scientist said, was unusually lethal - it killed 100 percent of the mice infected, even those treated with antiviral drugs and vaccines.
"What would happen if bioterrorists spliced IL-4 into chickenpox and released the hybrid into the population?" Williams wrote. Maybe nothing, he acknowledged. But it could turn chickenpox into a highly lethal disease. Modification of the virus, he wrote, could be done by a competent molecular biologist at a cost of about $10,000 in equipment and materials.
Despite the concern of many scientists, some bioweapons experts say the fears are overblown. In a book last year, Assessing the Biological Weapons and Bioterrorism Threat, Milton Leitenberg, a biowarfare expert at the University of Maryland, College Park, wrote that the threat of bioterror "has been systematically and deliberately exaggerated" by an "edifice" of government-funded institutes and experts who run programs and conferences.
Germ weapons need to be carefully cultured, transported, stored and effectively disseminated, said Raymond Zilinskas, a policy expert and biologist at the Center for Nonproliferation Studies. Groups like al-Qaida and Japan's Aum Shinrikyo attempted, and abandoned, efforts to make germ weapons because the task was too difficult.
National governments are far more likely to exploit synthetic biology for weapons production, many nonproliferation experts say.
According to the Web site of the Nuclear Threat Initiative, China, Iran, Syria, North Korea and Israel have all been accused by the U.S. government of secretly developing bioweapons. Moscow once had a massive biological weapons program, and may still have the capability to develop new agents.
A 2001 Pentagon report said "some elements" of the former Soviet bioweapons program "may remain intact and could support future agent production."
Synthetic biology could make such research much simpler, and "may have a significant impact on the future of bioweapons," said Alan Pearson, director of biological and chemical weapons control at the Center for Arms Control and Nonproliferation in Washington. "Whether it does or not is going to depend on how we handle it."