Who is regulating the release of the GM mosquito?
By Jason Major
TechNyou
A burst of research involving modified mosquitos to control diseases such as malaria and dengue has prompted scrutiny of the research itself and the regulatory oversight attached to it.
For previous news on this research see
Even though the research has been happening in the lab for some time, there are concerns we don’t have sufficient scientific knowledge about potential effects on the environment and human health and the regulatory authorities in the respective countries haven’t the legislation to deal with this novel technology. Others of course dispute this, namely one of the companies involved in the development of a genetically-modified mosquito.
PLOS has dedicated their January 2012 edition to tropical and neglected diseases and sought the opinion of the various players in this area for their views on the science surrounding genetically modified insets and their regulation. The focus is on the US and Europe, but Australia gets a mention and generally we fair pretty well
Issues raised
The main issues were raised by Reeves et al in their article, Scientific Standards and the Regulation of Genetically Modified Insects.
Their key gripes were a lack of transparency in the regulatory system, a lack of data to support their decisions and an over reliance on unpublished data, as suggested by the following:
“The selective use of unpublished or non-peer reviewed evidence to support contentious conclusions has been repeatedly questioned”
“Additionally, the failure of US regulators to publish data (in this case their own data) prior to their inclusion in regulatory documents represents a worrying precedent for the scientific quality and transparency of future environmental impact assessments.”
“However, despite these advantages, the flow of information to the public and scientific domain over the last 9 years has been limited. In fact, it can be argued that dissemination of relevant information is so restricted that it undermines the value of public consultation exercises, as comments will almost by definition be ill-informed and readily dismissed as such.”
For the defence
The defence being the people from Oxitec who is developing genetics-based control solutions for pest insects. One of these is the GM mosquito modified to control dengue fever, which they have had limited trial releases of in the Caymans and Malaysia.
These guys actually agree that greater transparency in permit applications, reports and the science is in most, if not all, cases better. If for no other reason, one would hope it would help build confidence in the regulatory system. But the Oxitec guys defend this position only so far claiming a right to protect their intellectual property.
The question is can we achieve public accountability and still allow companies to protect their IP? This ain’t my area of expertise, but I would have thought that it was possible.
They also defend the regulators use of unpublished data calling their assumptions naive. Their following barbs pretty sum up their feelings here:
“Reeves et al. are also on weak ground when they assert that regulators should consider only information published in peer-reviewed journals. This assertion depends on three assumptions: that journal peer-review is a superior guarantee of quality than any other method, that no data from any other source can be of adequate quality to warrant consideration, and that regulators themselves are incapable of adequately assessing the quality and significance of data provided to them. Each of these assumptions is naïve at best.
…Furthermore, journals select papers for publication using criteria that are not fully congruent with the needs of regulators. In particular, it is difficult to publish negative data. Studies showing lack of difference between a transgenic strain and its unmodified wild-type counterpart may be of great interest to regulators but not to journal editors.”
Suffice to say that there is healthy debate. The difference with these opposing groups is that there is no outright rejection of the science or its potential uses simply because it involves GMOs. The debate lies with the regulatory response and how the scientific and regulatory process is communicated to society to ensure adequate oversight.
Oz regulations
One of the problems, of course, is that regulations are not consistent across countries. So how does it work in Australia if a company or research group wants to release genetically modified mosquitos, or any other insect? Who regulates and monitors this and do we have oversight that is robust enough to minimise risk to the environment and human health? Of course, what is an appropriate risk will differ for each person, but the following is how it works in Australia. Whether it is adequate is for you to judge.
For anything to do with a genetically modified organism (GMO) the bucks starts and stops with the Australian Gene Technology Regulator who comes with the Arnie-inspired nickname, The Regulator. He (Joe Smith) gets support and advice from the Australian Office of the Gene Technology Regulator (OGTR). The legislation for regulating gene technology is comprised of the Commonwealth Gene Technology Act 2000, the Gene Technology Regulations 2001 and corresponding State and Territory legislation.
Although Australia has yet to release into the environment any genetically modified animal there has been considerable research on using the technology to control pest animals such as the European Carp, mouse, rabbit and fox. None of this left the laboratory.
Process to release GM animals in Australia
The following relates to groups wanting to intentionally release a GMO into the environment. This falls under the criteria called Dealings involving and Intentional Release (DIR).
They can be a limited controlled release (ie small numbers in a limited area usually a field trial), or a commercial release such as what Oxitec want to eventually do with their GM dengue mozzie. Each are treated differently under OGTR regulations
A limited release DIR has a 150 day assessment process where they assess the application, confer with the states and territories and put together a risk management plan. This is then made public (online, etc) for comment. The OGRT make any decisions regarding the granting of a licence or if there are any risk management criteria that accompany such a licence based on these consultations and any other associated scientific literature and reports available.
If the request is for a commercial release then the assessment process is 255 days and there are two rounds of public consultation allowed for assessment of the risk management strategy.
Some context
As pointed out in the last PLOS article by Mumford, billions of mass-reared insects, which are not GM, are released into the wild each week around the world. Many are non-native pest species reared, irradiated, and distributed in sterile insect release programs.
In Australia we have released loads of fertile insects and other organisms such as fungi as biological control agents. Thousands of other similar biological control agents have been released worldwide. The cane toad is the obvious example that went wrong, but today there is years of science done and intense regulatory oversight for any proposed biological control organism.
The Wolbachia example
Wolbachia-infected mosquitos have had a limited trial release in Australia in the hope they will help control dengue fever. For the story on the Wolbacia research see here
Because the Wolbachia-infected mosquito is not a genetically modified organism, the scientists involved in the research and the mosquito’s release report at a conference they struggled to find the appropriate regulatory procedures that applied to their technology to ensure responsible oversight and approval. The risk assessors in that case have called for the regulatory process to be reviewed to ensure that it is appropriate for both proponents and regulators.
From Mumford, PLOS: “Although it is not a GM release as neither of the organisms involved have foreign genes inserted, the recent Australian release of Ae. aegypti transformed with Wolbachia (which reduces the capacity of the mosquito to act as a vector of dengue) is an interesting example of the state of regulation in this general area. The authors state “Approval for the release of Aedes aegypti containing Wolbachia was provided by the Australian Pesticides and Veterinary Medicines Authority.”
GMO pig feeding trials – the data
By Jason Major
TechNyou
In reference to the news story I posted this morning about the feeding trials of pigs with Bt corn, the kind people from Teagasc has supplied me with some proceedings and slide presentations from this research – see below.
I will appreciate anyone’s thoughts on the study, their analysis, it implications and any shortcomings in the research methodology and initial results, etc,
I mentioned that I thought the data was unpublished. It turns out that part of the research – the short-term feeding stuff – has been published in the British Journal of Nutrition and is now available for review (Walsh et al., 2011).
Links to
Proceeding paper
Pig_Conference_Proceedings2011
Slide presentation
Hanging questions and caveats
The proceedings paper doesn’t explicitly say if the GM and non GM Bt corn used in the trials were exactly the same cultivars – see following extract:
The Bt maize was grown in a neighbouring plot to the non-GM maize counterpart under identical environmental conditions in Valtierra, Navarra, Spain and the only difference between the two maize types was the Bt toxin.
This is important as two cultivars of corn can have radically different nutrient profiles, and levels of other compounds such as naturally occurring allergens, toxins and anti-nutrients. They were at least grown under identical conditions – something else that can significantly change these components.
These results only apply to the short and medium-term studies because the laboratory analysis for the long-term data is still happening. There a few lines of, “further research will need to be done to find out what is happening…” in the proceedings so we will have to wait and see. It is possible the long-term feeding analysis will provide some answers and clarification.
Couple of findings
I have yet to analyse the paper in detail and will probably wait until the long-term trial analysis is completed, but here a couple of the findings that jumped out.
Results from the medium-term study found that feeding Bt maize to pigs for 110 days had no effect on body weight, their average daily weight gain or their average daily feed intake. But average daily feed intake (ADFI) was higher in pigs fed Bt maize during days 14-31 and overall from day 0-31. However, there was no difference in body weight between the two groups of pigs on day 31. Overall, feed efficiency was not affected by feeding Bt maize even though pigs fed Bt maize were less efficient on days 14-31 which was a consequence of higher feed intake by these pigs at that time. In other words weanling pigs were eating more during days 14-31 but their weight gain was the same as the conrol pigs.
If this difference in ADFI at days 14-31 is real (ie, it would need to be repeated and probably with a larger sample) then it would be interesting to know why this is happening.
In the slide presentation they present the finding that Bt maize may offer protection against an inflammatory response observed following non-GM maize consumption. I wonder if this is because maize is notoriously affected by a fungal toxin that is prevalent in corn damaged by insects? Has anyone got any knowledge on this and if this may be a cause?
Update (30 Jan 2012)
Peadar Lawlor the head of the Irish component of the project got back to me re: the research and plans for publication. His response, “… we will have ~12 peer review papers from this work by the middle of this year. We have published in the British Journal of Nutrition, Animal, PLoS ONE etc. We will publish all our work from the project.” All links to papers and research updates will be posted on their website see Teagasc link above
And here is the link to their PLoS One paper
Home page image: impactlab.net
Science from the mouths and minds of babes
By Jason Major
TechNyou
Science from the mouths and minds of babes
Only the following comments and insight could come from children. Innocence, curiosity, and doubtless other traits that a psychologist will be able to explain seems to allow this freedom of expression and they can get away it because we say “they don’t understand”. Sometimes I wonder?
In my time as a science communicator, from personal experience with students and my collaboration with colleagues, I am continually amazed at how kids process information and then either ask a serious question or come out with an honest quip that has you rolling on the floor laughing, or should that be ROTFL?
So here is a short list of those experiences, most are actually from my friends at CSIRO Education:
A CSIRO education girl is explaining movement by sitting on a skateboard and pushing herself along with her feet – apparently an occasion not to wear hipster jeans. The demonstration led one observant Grade 4 girl to announce, “That’s a G-string (poking up from the now extra low slung hipster jeans). My dad’s got one of those.” Ah, so it has nothing to do with the science, but it was at a holiday event and loads of parents were there and heard this, so I was ROTFL
CSIRO Ed’s chemistry session. During a discussion about the nature of chemical reactions, a Grade 5 boy asked, “Is it a chemical reaction when you have liposuction and they suck the fat out and then heat it?”
We sometimes underestimate children’s knowledge, in this case on states of matter (liquid, solid, gas – and plasma if you want to be technical). Note, this kid was in preps – ie about 4 years old. When asked to give an example of a gas this preppy declared confidently, “a fart”.
CSIRO Education often get their classes to guess what the acronym CSIRO stands for. Apparently the O stumps them most. A presenter gave them a clue suggesting, “Think of a word that means a bunch of scientists working together.” Several children simultaneously answered, “Obstacle”. (Personally, I think this is GOLD.)
In an explanation about how some chemical reactions go backwards (are reversible) and some don’t (non-reversible), a grade 1 student pointed out that if you watch the reaction on TV you can rewind it. Another Grade 1 student after being warned not to eat anything in a chemistry lab added, “Even if your reaction makes wine, you can’t drink it.”
I would cherish people’s similar experiences with children. Who knows, we could turn it into an Airport bestseller, or maybe not. If nothing else we can get a laugh.
Many thanks to my CSIRO and other colleagues. I stumbled across the above collection during a cleanout so some of these colleagues have moved on, but thank you anyway.
Backyard Biotech and the rise of the Biohacker
By Jason Major
Technyou
There is a large, active and vibrant community of backyard biotechnologists out there and, until recently, I had no idea they existed. Known as ‘Biohackers’, this group of citizen scientists could be a creative resource, but do they also represent a risk, even if a negligible one at this stage?
Some of these guys tinker with biological parts such as genes to create novel biological systems, potentially novel life with the tools used for synthetic biology, though most are doing nothing more harmful than DNA extraction. But the ability to get into the risky stuff could become easier as equipment costs continue to plummet, our understanding of genetics increases and the plug and play genetic parts available already get a bit more sophisticated.
Escape
The risk is the potential for these novel organisms to escape from the lab (or garage, kitchen…), either accidentally or by those with more nefarious intentions. This raises the question of how and if we should monitor and regulate such activity? You want to avoid suppressing the potential creativity and freedom of this activity yet prevent the nutters out there from expressing their own version of freedom?
Come into my lab, and see what’s on the slab
My ignorance of the extent of biohacking is embarrassing, though it is hard to ascertain how many in these groups are actually doing science and how many are just joining in the conversation. Even so, I was astounded at the complexity of some of the research being done and equipment readily available and accessible to anyone with the inclination. I’m not talking simple chemical sets and kitchen chemistry such as DNA extractions; I mean proper gene sequencing, gene transformation and synthetic biology. They make everything from bioluminescent yogurt to arsenic biodetectors.
One self proclaimed biohacker, Meredith Patterson is conducting experiments in her kitchen on a budget of less than $200. She is attempting to transform yogurt bacteria to signal the presence of melamine, the toxic stuff found in dairy products in China a couple of years ago.
Pocket money
To give you an indication of the rapid changes, when I did my undergrad between 1987 and 1989 the cost of a standard gel electrophoresis kit was such that we were only allowed to watch the lecturer operate it in case we broke it, which we probably would have. Nowadays you can buy them from toy shops and many high schools have them. Even the cost of sequencing DNA is plummeting. The DNA synthesizing machine is what you will need to make your DNA strands, which could be genes or bits of RNA that control how your genes work. You can get a small or older model DNA synthesizer on e-Bay for less than $1000. PCR machines (your DNA photocopier) can be even cheaper. Or you can simply bypass this step. For a few cents per nucleotide, there are companies that will synthesize your genes or DNA sequences for you and ship them to you anywhere in the world. You can pick up a centrifuge for about $50 that hooks up to your drill. A lot of chemical supplies are easily bought online or local supplier and in Australia, at least, there are companies that sell small quantities for schools and people like me. Live in a shoebox? No problem, there are organisations that rent out lab space with all the machines that go bing that specifically target themselves to biohackers.
There is even an iPhone app to check the compatibility of chemicals so you don’t burn down or blow up your garage or worse, your Mum’s kitchen.
Given a kid with an after school job and some pocket money could quickly save enough to set up a basic operation, this sort of science is no longer just the domain of those with well-funded university or industry laboratories. Nor do you require a PhD or similar educational background. The how to bit is easily sourced from an extensive network of support groups all just a mouse click away.
Some chemicals and equipment, of course are hard to get and far from cheap, but like any hobby, it depends on how far you want to take it. Cycling, scuba diving, all these hobbies of mine could easily cost me 10s of thousands if I became like some of the gear freaks I have knocked around with. I am unsure, but I am also guessing that there would be certain chemicals and equipment that should you manage to purchase them or even attempt to, would raise flags with certain authorities.
Getting inspiration
One large support network that appears to be actively encouraging the biohacker network is the International Genetically Engineered Machine Foundation (iGEM) which is an open, community-based organisation dedicated to education in this scientific field. Each year they run a synthetic biology competition originally available only to undergraduate students through their universities, but last year they introduced a category for high school and this year there is an entrepreneurial category.
Teams are given a kit of biological parts from the Registry of Standard Biological Parts to use, plus whatever genetic parts they have designed themselves to build their own biological system and operate them in living cells. this is where you get those plug and play parts, I mentioned. This registry is where you get those plug-and-play genetic parts I mentioned above. These parts include genes, gene promoters, etc that have universal bits of DNA on the end to allow you to plug any part together like LEGO.
Regulation
Now that we can (sort of) create synthetic life in our lab – backyard version or otherwise – how do we make sure it stays there, or that it is used responsibly? Is this even possible? No technology, in fact nothing full stop is risk free. Synthetic biology, however, does result in living things that have the potential to breed, though bacteria divide rather than breed.
For now, our limited knowledge means that anything produced in a nice controlled lab environment will be unlikely to survive in the harsh and dog-eat-dog natural world. And access to dangerous viral agents or their genetic sequences is restricted. Technically, you could get the necessary genetic bits for a virus and stitch them together, but that really does requires a sophistication beyond the backyarders, even most well-funded research labs, largely because of the level of containment required to prevent infecting yourself. But how long can this low risk environment last? Knowledge in this field is proceeding at a rapid pace.
I doubt such a group could self regulate so I dare say big brother will have a hand in this somewhere. Likely there will also need to be some form of voluntary code of conduct and self-policing, which many groups are already advocating and developing alongside regulatory agencies, research labs and other organisations such as the Woodrow Wilson Center’s Synthetic Biology Project.
The crash of the ivory tower
If nothing else, this sort of DIY science strips out the elitism surrounding this area of science and makes it accessible to the public. It may help ignite interest, excitement and understanding about science that no text book or lecture can. Suppression of this via over-regulation should be avoided. One thing for the biohackers to consider is the term biohacker. Personally, it conjures up images of nefarious dudes in dim garages plotting to destroy the world. Does anyone have a better term?
Who are these biohackers?
There is no shortage of groups and expertise to tap into, all readily available via the myriad social media networks and Internet. This short list will get you links to most of the groups and individuals operating in this space
Biocurious: “… a nonprofit community lab, education facility, and “hackerspace” for biotechnology hobbyists and professionals.”
DIY Bio: “…dedicated to making biology an accessible pursuit for citizen scientists, amateur biologists and biological engineers who value openness and safety.”
Garage Bio: “…a podcast devoted to cheap and DIY approaches to biology. The goal is to make academic and industry advances understandable to an amateur audience and promote a spirit of scientific discovery and fun exploration.”
Update
I just found that Australia’s Office of the Gene Technology Regulator (OGTR) has at least recognised that biohacking exists
More info
Nature Biotechnology Biotech in the basement December 2009 Vol 27 (12) pp 1077-1078
Re-programmable cells key to creation of new life forms
A project to develop a biological cell-equivalent of a computer operating system could pave the way for scientists to create completely new and useful forms of life.
University of Nottingham: 7 November 2011
Would you eat synthetic meat?
So would you. Our new video explores this question
Would it change the way you feel about animals? Would it change our relationship with animals. If you are a vegetarian would you consider this acceptable to eat?
It can also be found on our YouTube channel
RiAus PDplus teacher notes: Food security
What impact may climate change, water security, poor soils and crop disease have on Australia’s food security in the future?
Themes:
- Farmers breeding crops that are resistant to disease
- Seed banks and why they’re so important to food security
- How climate change and population growth is interfering with crop growth
- Sustainable farms of the future
- Making your diet more sustainable
Download teacher notes
A gene: invention or discovery
The gene patent war is hotting up again with the US courts recently deeming the patent owned by Myriad Genetics for two breast cancer genes are valid – again
What does all this mean? What are the implications for Australia? I for one, am not even going to try to explain, but The Conversation has found three people with different perspectives to give their thoughts.
Luigi Palombi
David John Brennan
Phillip Soos
Previous TechNyou gene patent stories
TnY – Without patents people will die
Helping teachers teach new technologies
TechNyou’s new online science resource will help science teachers bring the latest and most exciting developments in emerging technologies to the classroom.
TechNyou Science Education resource website
Termites as biofuel refineries
Scientists have has discovered a cocktail of enzymes from the guts of termites that might help get around the barriers that inhibit fuel production from woody biomass.
PhysOrg: 5 July 2011
Image: Purdue Agricultural Communication photo/Tom Campbell