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Synthetic biology: The next biotech revolution is brewing
March 25, 2009Landmark report addresses regulatory oversight for emerging technology
Washington, DC - The safety of early applications of synthetic biology may be adequately addressed by the existing regulatory framework for biotechnology, especially in contained laboratories and manufacturing facilities. But further advances in this emerging field are likely to create significant challenges for U.S. government oversight, according to a new report authored by Michael Rodemeyer of the University of Virginia. Synthetic biology promises major advances in areas such as biofuels, specialty chemicals, and agriculture and drug products.
In New Life, Old Bottles: Regulating First-Generation Products of Synthetic Biology, Rodemeyer examines the benefits and drawbacks of using the existing U.S. regulatory framework for biotechnology to cover the new products and processes enabled by synthetic biology. According to Rodemeyer, initial synthetic biology products will be relatively simple modifications of current technology and can be addressed by existing biotechnology regulations with only modest revisions.
However, as the technology develops, regulatory agencies such as the Environmental Protection Agency and Food and Drug Administration will face challenges in assessing potential risks and the adequacy of controls, especially if complex synthetic microorganisms are released into the environment. Today's risk assessment practices and laws like the Toxic Substances Control Act and Federal Food, Drug, and Cosmetic Act, simply are not designed to handle 21st century technological advances.
"Before synthetic biology matures, Congress and policymakers should consider how to rationalize and modernize the regulation of new converging technologies, instead of attempting to shoehorn each new area of technological development into laws previously written for a different set of issues and potential risks," Rodemeyer argues.
A five-minute video interview with Rodemeyer is available at: http://www.synbioproject.org/news/project/rodemeyer/.
"It would be easy to relegate discussions about oversight to the backburner. But procrastination bears a risk. A productive dialogue may become more difficult as synthetic biology evolves and stakeholders become divided in their opinions about benefits and risks. The existing regulatory framework for biotechnology is the natural starting point for synthetic biology oversight. But the framework is at best a patchwork quilt of decades old guidelines and laws that could impede innovation, undercut public confidence, and compromise the promised benefits of synbio," says David Rejeski, the director of the Foresight & Governance Project at the Woodrow Wilson International Center for Scholars. "Policymakers, industry, and other key stakeholders should start a discussion now on the basic question of whether existing regulations will work with advanced synthetic biology, and if not, what changes may be needed to ensure safe development and application of the science."
Project on Emerging Nanotechnologies
However, as the technology develops, regulatory agencies such as the Environmental Protection Agency and Food and Drug Administration will face challenges in assessing potential risks and the adequacy of controls, especially if complex synthetic microorganisms are released into the environment. Today's risk assessment practices and laws like the Toxic Substances Control Act and Federal Food, Drug, and Cosmetic Act, simply are not designed to handle 21st century technological advances.
"Before synthetic biology matures, Congress and policymakers should consider how to rationalize and modernize the regulation of new converging technologies, instead of attempting to shoehorn each new area of technological development into laws previously written for a different set of issues and potential risks," Rodemeyer argues.
A five-minute video interview with Rodemeyer is available at: http://www.synbioproject.org/news/project/rodemeyer/.
"It would be easy to relegate discussions about oversight to the backburner. But procrastination bears a risk. A productive dialogue may become more difficult as synthetic biology evolves and stakeholders become divided in their opinions about benefits and risks. The existing regulatory framework for biotechnology is the natural starting point for synthetic biology oversight. But the framework is at best a patchwork quilt of decades old guidelines and laws that could impede innovation, undercut public confidence, and compromise the promised benefits of synbio," says David Rejeski, the director of the Foresight & Governance Project at the Woodrow Wilson International Center for Scholars. "Policymakers, industry, and other key stakeholders should start a discussion now on the basic question of whether existing regulations will work with advanced synthetic biology, and if not, what changes may be needed to ensure safe development and application of the science."
Project on Emerging Nanotechnologies
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As scientists work toward making genetically altered bacteria create living "circuits" to produce a myriad of useful proteins and chemicals, they have logically assumed that the single-celled organisms would always respond to an external command in the same way.
With a flash of light, a neuron's function is revealed
There's a new way to explore biology's secrets. With a flash of light, scientists from the U.S. Department of Energy's Lawrence Berkeley National Laboratory and the University of California, Berkeley zeroed in on the type of neural cell that controls swimming in larval zebrafish.
UCSF researchers program cells to be remote-controlled by light
UCSF researchers have genetically encoded mouse cells to respond to light, creating cells that can be trained to follow a light beam or stop on command like microscopic robots.
Researchers rapidly turn bacteria into biotech factories
High-throughput sequencing has turned biologists into voracious genome readers, enabling them to scan millions of DNA letters, or bases, per hour.
Genetically engineered bacteria compute the route
US researchers have created 'bacterial computers' with the potential to solve complicated mathematics problems.
Finding the constant in bacterial communication
The Rosetta Stone of bacterial communication may have been found. Although they have no sensory organs, bacteria can get a good idea about what's going on in their neighborhood and communicate with each other, mainly by secreting and taking in chemicals from their surrounding environment.
Boston University biomedical engineers teach bacteria to count
Biomedical engineers at Boston University have taught bacteria how to count. Professor James J. Collins and colleagues have wired a new sequence of genes that allow the microbes to count discrete events, opening the door for a host of potential applications, which could include drug delivery and sensing environmental hazards.
Research team finds important role for junk DNA
Scientists have called it "junk DNA." They have long been perplexed by these extensive strands of genetic material that dominate the genome but seem to lack specific functions.
Using combinatorial libraries to engineer genetic circuits advances synthetic biology
Streamlining the construction of synthetic gene networks has led a team of Boston University researchers to develop a technique that couples libraries of diversified components with computer modeling to guide predictable gene network construction without the back and forth tweaking.
Synthetic Gene Circuit Allows Precise Dosing of Gene Expression
Researchers have crafted a gene circuit that permits precise tuning of a gene's expression in a cell, an advance that should allow for more accurate analysis of the gene's role in normal and abnormal cellular function.
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