Synthetic biology sparks bioterrorism fear
Scientists are divided over how best to guard against the use of synthetic genes or DNA sequences for bioterrorism. In response, the US government has issued draft guidelines for how synthetic-biology companies should screen customers and their gene orders to protect against such an occurrence.
Designer DNA
Yes, we can now custom design DNA sequences and therefore the functionality of that DNA. It is production line stuff nowadays. As our expertise in ‘designing’ DNA has grown along with the ability to mass produce it on demand, there is equally growing concern about who is getting hold of this DNA and what they might do with it.
Some of these synthetic DNA sequences are potentially dangerous as they might code for dangerous toxins or be used in designing dangerous pathogens. There are an estimated 50 companies worldwide involved in the production of synthetic DNA. Together they pump out about 50,000 gene orders per year. The difficulty is how to screen this number of orders for sequences matching or closely matching known dangerous DNA sequences. Screening can be done with a computer, but the costly human element is following up all orders that match the dangerous sequences. We need to know who is making the order and why? There is also the problem that the rapid progress of the field makes it difficult to have any sort of comprehensive database of known dodgy sequences.
Although this is not confirmed, my sources say Australia doesn’t have companies that manufacture and sell synthetic DNA sequences or genes, even oligonucleotides, the bread and butter of biotech research labs. But Australia has loads of research happening that would come under the banner of synthetic biology. The research stuff, however, is regulated through agencies such as the Office of the Gene Technology Regulator (OGTR).
To clarify, synthetic DNA is different from taking existing genes (for instance, the human insulin gene) and inserting it into bacteria. This is your bog standard transgenics and is regulated by the OGTR.
The background
Questions over the synthetic DNA industry arose in August 2009, when two gene-synthesis companies said they would not abide by an internationally agreed industry protocol for screening synthetic genes. These two companies and three others have since signed up to another similar protocol. See Nature News story (subscription required for full story)
The new US government guidance asks companies to screen both customers and their orders using a standard set of procedures including automated steps that would detect sequences unique to the US select agents and toxins registry. Any ‘hit’ “should be further investigated by the provider to find out what they intend to do with their order. See Nature News
What is Australia doing?
This all hit the media about a week ago, but my slow response is because it took me until today to get an answer from the appropriate Australian government people about how Australia is responding to this situation. It is the silly season and Santa is big distraction, so I will forgive them their tardy response. Actually the key people were overseas or at conferences.
Australia doesn’t have legislation or regulatory guidelines specific to synthetic DNA, but we have the following:
Australian government is informal chair of the Australia group, a group of 40 countries and the European Commission that is a cooperative and voluntary body dedicated to the adoption, implementation and enforcement of cutting-edge measures to counter the spread of technologies and materials that could assist states of concern and terrorist groups in obtaining or developing chemical and biological weapons. In a recent meeting they agreed to form a synthetic biology advisory body as a means of ensuring the Group is kept abreast of, and can respond quickly and appropriately to, technological developments in this area.
Australian Government Department of Health and Ageing (DHA)
Security Sensitive Biological Agents (SSBA) regulatory scheme is controlled by DHA and implemented to improve the security of biological agents of security concern in Australia. They don’t have any regulatory powers that include synthetic biology, but they do keep tabs on biowarfare agents, foot and mouth, viruses and other nasty agents. It all falls under the National Health Security Act 2007
OGTR, of course regulates the research of anything involving a genetically modified organism, which would include modifying something with synthetic genes or DNA sequence.
What I have yet to confirm in any detail and would like to is how Australia’s regulatory authorities are monitoring the situation (other than the Australia Group)? Do we have just a watching brief or are there plans to regulate this in some way should Australia start delving into this area commercially? Do we even need to regulate it?
It should not be a question of banning this application of the technology as there is a lot of socially important and legitimate research being done with these genetic sequences, similarly with the technology that enables it to be done. Nobody denies the risks; it is how Australia is prepared to manage the risks that need to be thought about?
Selection of Australian research involving synthetic biology
Australian Institute of Bioengineering and Nanotechnology
Jason Major