GeneWatch Vol. 25 No. 3

GeneWatch THE MAGAZINE OF THE COUNCIL FOR RESPONSIBLE GENETICS | ADVANCING THE PUBLIC INTEREST IN BIOTECHNOLOGY SINCE 1983

Volume 25 Number 3 | April-May 2012

Inside >> Trivializing Extinction by Rob DeSalle

The Frozen Zoo ISSN 0740-9737

by Oliver Ryder

Interview: Mark Stoeckle on DNA barcoding

GeneWatch

Vol. 25 No. 3

5 Trivializing Extinction Genetic technologies may make it possible for us to resurrect some species—but what happens when we let ourselves stop thinking of extinction as permanent? By Rob DeSalle 8 Smugglers, Poachers, and DNA Barcoding An emerging technology and an expanding reference library make it possible to identify species from samples of sushi, bushmeat, maybe even leather—and it’s accessible enough to turn high school students into bona fide conservation sleuths. Interview with Mark Stoeckle 12 The Genetic Jungle If releasing genetically modified organisms for conservation purposes proves effective, there’s still another question to ask: Isn’t there an easier way? By Guy Reeves 14 Hatch and Release In 2009, genetically modified mosquitoes were released in the Cayman Islands. It was another year before the world knew about it. By Camilo Rodríguez-Beltrán 17 GM Mosquitoes: Flying Through the Regulatory Gaps? As a company sells its genetically modified mosquitoes to developing countries, regulators try to figure out how to handle a novel technology released into the wild. By Lim Li Ching

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19 The Frozen Zoo Wildlife gene banks provide a tool for studying species and monitoring conservation efforts. By Oliver Ryder 21 A Primer on GMOs and International Law Two different international frameworks attempt to govern genetically modified organisms ... and they don’t always agree with one another. By Phil Bereano *** Topic Updates 25 Forensic DNA: Database Expansion in New York 25 Forensic DNA: Protections for the Innocent in Massachusetts 26 Gene Patents: Supreme Court Orders New Review of Myriad Gene Patents 26 Animal Biodiversity: Rhino DNA Database Leads to Poacher Arrests

Volume 25 Number 3

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GeneWatch April-May 2012 Volume 25 Number 3

Editor and Designer: Samuel W. Anderson Editorial Committee: Jeremy Gruber, Sheldon Krimsky, Ruth Hubbard GeneWatch is published by the Council for Responsible Genetics (CRG), a national, nonprofit, taxexempt organization. Founded in 1983, CRG’s mission is to foster public debate on the social, ethical, and environmental implications of new genetic technologies.

The views expressed herein do not necessarily represent the views of the staff or the CRG Board of Directors.

Address 5 Upland Road, Suite 3 Cambridge, MA 02140 Phone 617.868.0870 Fax 617.491.5344 www.councilforresponsiblegenetics.org

board of directors

Sheldon Krimsky, PhD, Board Chair Tufts University Peter Shorett, MPP Treasurer The Chartis Group Evan Balaban, PhD McGill University Paul Billings, MD, PhD Life Technologies Corporation Sujatha Byravan, Phd Centre for Development Finance, India Robert DeSalle, Phd American Museum of Natural History Robert Green, MD, MPH Harvard University Jeremy Gruber, JD Council for Responsible Genetics Rayna Rapp, PhD New York University Patricia Williams, JD Columbia University staff

Jeremy Gruber, President and Executive Director Sheila Sinclair, Manager of Operations Samuel Anderson, Editor of GeneWatch Andrew Thibedeau, Senior Fellow Magdalina Gugucheva, Fellow Editorial & Creative Consultant Grace Twesigye

Editor’s Note

Samuel W. Anderson

This issue of GeneWatch explores technologies varying widely in their method, but connected by their impacts on the biodiversity of our planet’s fauna. Certainly there are technologies which have the very real potential to harm biodiversity—or, in the case of genetically modified Atlantic salmon, possibly entire ecosystems. But some DNA technologies can be helpful conservation tools, particularly when they help us better understand and monitor the species we are trying to preserve. Wildlife gene banks provide researchers with samples to conduct genetic studies on endangered and even extinct species, and genome sequencing provides new insights into what makes a species tick. Building reference libraries of DNA sequences—and importantly, making them publicly available—allow scientists and conservationists to identify a species based on a tiny biological sample. Mark Stoeckle talks in this issue of GeneWatch about DNA barcoding, an approach that simplifies species identification from DNA samples to the point that high school students can uncover mislabeled seafood.

These advances can provide real benefits to global biodiversity, but many of those who have worked to create and improve these technologies will also be the first to tell you that no technology is a silver bullet when it comes to conservation. DNA barcoding can be an essential tool in prosecuting wildlife smugglers or monitoring animal populations, but it won’t preserve habitat. Even if mosquitoes can be genetically modified to reduce disease pressure on endangered animals, they won’t stop the advance of invasive species. And even if we can resurrect an extinct species from a cryogenically frozen DNA sample, once that preserved species steps off the Ark, what kind of home will be left for it?

Complex problems caused by human actions—and with current extinction rates estimated at anywhere from 1,000 to over 10,000 times faster than just a few centuries ago, loss of biodiversity is very much a man-made problem—cannot be solved without corrections in the human behaviors that got us there. Wind and solar energy play an important role in reducing our use of fossil fuels, but they are no substitute for changing our behaviors to use less energy. Genetic technologies are increasingly useful for understanding and protecting biodiversity, but they are no substitute for protecting habitats.

As in so many other cases, it’s not just about whether we have the technologies—it’s about how we use them. nnn

Write to (or for) GeneWatch GeneWatch welcomes article submissions, comments and letters to the editor. Please email anderson@gene-watch.org if you would like to submit a letter or with any other comments or queries, including proposals for article submissions.

Cover photograph: Barney Moss www.flickr.com/photos/barneymoss www.wheresbarney.com

Unless otherwise noted, all material in this publication is protected by copyright by the Council for Responsible Genetics. All rights reserved. GeneWatch 25,3 0740-973

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Trivializing Extinction Genetic technologies may make it possible for us to resurrect some species—but what happens when we let ourselves stop thinking of extinction as permanent? By Rob DeSalle It has been suggested that 99.9% of all the species that have ever existed on this planet have gone extinct.

Given that there are about 1.8 million named species and an estimated order of magnitude more unnamed, this means that there have been 2 billion or so species that have existed on our planet since life began here 3.5 billion years ago. The numbers could be even higher when the full extent of microbial life on our planet is realized. Extinction prior to humans has been an ongoing process, considered part of the natural way of existence on this planet. Scientists have been able to characterize past extinctions and have concluded that there have been five major extinction periods Volume 25 Number 3

since organisms began to diverge on the planet. Each of these five previous extinctions is presumed to have occurred as a result of natural consequences, like extreme geological change such as volcanism or asteroid impact.

In 1993, the Harvard biologist E.O. Wilson estimated that each year about 30,000 species go extinct. If you do the math, Wilson’s estimate in the 1990s meant that three species went extinct every hour. Since this estimate, things have not gotten better but rather worse, and the impact of extinction on biodiversity on our planet can be described as extremely grim. The current rate of extinction is so high that some biologists call it

the Sixth Extinction. My colleague Niles Eldredge has written extensively on the subject and points out that the current massive number of extinctions is different than the previous five. The current Sixth Extinction is different in that the source of the extinctions are almost entirely biotic—that is, caused by humans as a result of our changing the landscape, overexploiting wildlife, polluting the environment and challenging pristine environments with introduced species.

The problem begs our attention, and over the past several decades the discipline of conservation biology was birthed and matured. The immediacy of the problem has prompted GeneWatch 5

B

U A

Uses and Abuses of Biology

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U Essay Competition A The Uses and Abuses of Biology Programme is inviting students and recent graduates aged 30 or younger to enter its 2012 essay competition.

B

U A

B “Explore the ways in which contemporary

U A

genetics both challenges and underpins notions of human freedom, value and identity”

1st prize = £1000 2nd prize = £500

3rd prize = £250

The UAB Programme investigates contemporary nonscientific uses and abuses of biological thought in the domains of philosophy, the social sciences, the media, religion and politics.

www.uabgrants.org faraday.essay@st-edmunds.cam.ac.uk

scientists to call conservation biology a “crisis discipline” like cancer biology or infectious disease research.

Crisis disciplines often work under the “desperate times call for desperate measures” principle. The problem is that most people don’t understand just how desperate the times have become, nor what a “desperate measure” really is.

Take for example the recent suggestion that cloning (writ large) can be used as a conservation tool. This suggestion fits exactly with our current Western “throwaway” society.

The idea garnered a lot of media attention after being suggested a few years ago, and it seemed like every month some critically endangered species was being cloned or a project was being announced that was targeted at an endangered species.

Many saw cloning as a drastic measure whose time had come. While I do not want to disparage the intent of scientists who made this suggestion, I think it trivializes what extinction really is and gets us back to the importance of understanding just how intense our desperate times really are.

In addition to cloning, a large proportion of conservation biologists would rather be called conservation geneticists. This moniker points to the use of modern genetic technology to assay and screen populations that are threatened and endangered.

The use of genetics to understand populations and to characterize variability has also been viewed as a drastic measure by many conservation biologists. It has been challenged by some conservation biologists as unnecessary, even to the point where it is called “conversation genetics” by those who are critical of genetics as a tool in conservation. Nevertheless, these genetic approaches are viewed by the public as drastic measures that, I guess, are soothing with respect to Volume 25 Number 3

the crisis. It is easy for the public to say, as a result of these technologies being applied to conservation: “Hey, look, we are throwing everything we have at the problem!” But here is where the widespread lack of understanding of the current mass extinction comes back into the story.

My colleague Mike Novacek has suggested that much of the problem is on the shoulders of educators who have failed to make clear the role of biodiversity in a healthy planet. The general public’s lack of knowledge about what extinction is can be demonstrated by an interesting survey that City College of New York researcher and educator Yael Wyner has conducted. In the survey she asked over 1,500 New York area undergraduate students if the current demise of the panda in China is natural selection. The obvious answer to anyone who has studied evolutionary biology and the process of natural selection is a resounding “No stupid, it’s us.” However, nearly 50% of the students have answered that it IS natural selection, and a large proportion of those who answer “no” cannot properly explain why. This is yet another way we are trivializing extinction: through the inadequate education of our students and the public in evolutionary biology. The fact that a majority of Republican candidates for President of the United States this year take on a biblical interpretation of diversity on our planet trivializes extinction even more.

Another colleague of mine, George Amato, has strongly argued that it all ultimately comes down to funding. When it comes to funding, the study of biodiversity is a weak sister discipline to the more reductionist approaches such as molecular biology and genomics. The piggybacking of biodiversity funding with business (the European Union has initiated a

Business@Biodiversity program) or with basic science such as genomics or infectious disease research are examples of funding trends currently in place by government agencies. Two examples of the latter trend are the piggybacking of biodiversity funding with research on emerging zoonotic diseases and the so called “one health” initiatives; and The Barcode of Life program, which piggybacks biodiversity studies with genetic technology. By providing only marginal funding for research that could help to slow the rate of extinction, it

The problem is that most people don’t understand just how desperate the times have become, nor what a ‘desperate measure’ really is. is as if governments are trying to put a band-aid on a bullet wound.

What can we do? First, we have to resist thinking that technology will solve the problem of large-scale extinction. Technology will help us understand the problem better, but it is not the silver bullet. Second, we need to educate the general public better so that we all understand the immediacy and breadth of extinction.

Finally, we need to get governments to focus on the problem. The longer biodiversity is underfunded and piggybacked with other disciplines, the more species appear in the rearview mirror. nnn Rob DeSalle, PhD, is a curator in the American Museum of Natural History’s Division of Invertebrate Zoology and codirector of its molecular laboratories and a member of CRG’s Board of Directors.

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Smugglers, Poachers, and DNA Barcoding An emerging technology and an expanding reference library make it possible to identify species from samples of sushi, bushmeat, maybe even leather—and it’s accessible enough to turn high school students into bona fide conservation sleuths.

Interview with Mark Stoeckle

Mark Stoeckle, MD, is an Adjunct Faculty Member in the Program for the Human Environment at The Rockefeller University. He has been involved in the DNA Barcoding Initiative since its beginnings in 2003. DNA barcoding is a technique for identifying species from DNA samples using a short genetic marker at a standard and agreed-upon position in the genome.

GeneWatch: What do you need in order to scan an organism’s DNA barcode? How easy is it to do?

Mark Stoeckle: DNA barcoding is 8 GeneWatch

just a simple, standardized way of identifying species by DNA. With animals, for instance, you analyze one specific gene region and you try to match that sequence to your reference library. That makes it important to have a really good reference library—and that’s where most of the effort is, in building that library, so that when you get a DNA sequence from a sample there is something in the library to match it to. It’s like a database of fingerprints: you need fingerprints in the database in order to identify your sample.

The sequencing technology is

pretty simple, and it’s getting simpler.

It still requires a laboratory, but I can imagine it will only get easier. That part is a straightforward technology. You can get a result in about a day, and it could be faster in the future. Then you match that result to the library just like you would use a Google search to look something up. Since these are public databases, you’re just entering the sequence and seeing what in the database it’s matched to.

With people and labs all over the world doing this, how do you make April-May 2012

sure everyone is looking at the right location on the genome?

It’s a standardized approach, so the idea is that everybody is going to use the same gene region. There’s no rule exactly; it’s kind of a social agreement among scientists that it makes sense, if you’re analyzing a new species or going through your museum specimens, to analyze this specific gene or portion of the gene and to put that into the public databases.

There’s a social agreement that for DNA barcoding, we all use the same gene region.

What is the margin of error? Is it very easy to confuse two very similar species, or would an unexpected mutation make it harder to identify species?

For animals, I would say something like 95% of the time it’s very straightforward and there is no ambiguity about the boundaries between species. The groups that you would get from just doing the DNA sequence alone fall under sets of similar sequences, and those turn out to match very closely one-to-one with the same groups that biologists have identified as being the species. So it’s amazingly close.

There are maybe 5% of cases where two species are genetically very similar, and there it might be harder but not impossible to tell them apart; and there are some cases of organisms that biologists call different species, but in this particular gene region they are identical. Biologists call them two different species, maybe they don’t interbreed, but by analyzing this gene region there’s just not enough information to tell them apart. You know it’s one of the two species, but you don’t know which one it is.

Mutations haven’t turned out to be Volume 25 Number 3

much of an issue. For instance, if you were to analyze this same region of the genome among people, any two individuals might differ in one or two positions in the barcode; but people differ from chimpanzees by about 50 positions. So you wouldn’t be confusing one with the other.

So, in practical terms, it’s very good. The limitation right now is the library. There are lots of species— there are two million named species of plants and animals, and the most recent estimate is there are another eight million that we haven’t named yet.

that the U.S. Fish and Wildlife Service has then used in prosecution of people importing products made from endangered species.

So DNA barcoding can be used to identify species, but it doesn’t go beyond that.

There’s nothing magical about DNA barcoding. It aims to be a toaster: a technology that you don’t have to read the instructions to use.

Right, it’s not good for identifying individuals. Obviously crime labs use DNA to identify individuals, but you have to analyze more gene regions in order to do that. The goal here is to make it as small and simple as possible, accepting the fact that in the few percent of cases you’re not going to be able to distinguish closely related species from this gene region alone.

DNA barcoding has been used to identify bushmeat species and seafood and even tea. How far can it be taken? How about, say, alligator boots?

You know, DNA is an amazingly hardy molecule. Scientists have recovered DNA from very ancient specimens that are tens of thousands of years old. More recently, people have tried things that are very processed— leather is certainly one of those. I think we’re just beginning to look at that. I know that George Amato’s group at the American Museum of Natural History has retrieved DNA, and specifically DNA barcodes, out of leather products—information

So is DNA barcoding generally being accepted as evidence in court?

The FDA, as recently as last fall, published DNA barcoding as their official method for seafood identification, and the FDA does investigate seafood fraud. That’s the first government agency that I know of that has said, “This is our legal standard,” but I think that’s going to increase. FDA is a model for agencies in other coun-

tries, and I know that other government agencies like USDA are looking at this. INTERPOL is also looking at it for detecting commercial fraud. In individual cases, the U.S. Fish and Wildlife Service has certainly used it in court. So yes, it has been used in court cases, and I think it will get adopted by more agencies.

What’s the alternative? What’s it replacing? What is, say, USDA using instead of DNA barcoding?

They were using something called isoelectric focusing and protein electrophoresis for identifying seafood.

It’s really not a very robust method.

And I think for a lot of seafood, there just isn’t any other method [besides GeneWatch 9

DNA barcoding]. Once you cut up a fish, you don’t know what it is. Once you cut a fin off of a shark, no one can identify it. In that area, barcoding is a completely new technology.

How is DNA barcoding proving most useful for conservation purposes?

I think we’re at the beginning of the practical uses of it. Major uses are trade in products of regulated or endangered species, such as fish and bushmeat, where you need to be able to identify which species the product comes from. Most of those samples are from a product in the form that people use—they’re hard to identify because they’re cut up into pieces or processed in some way.

I think another area where barcoding could be useful in conservation is for conducting biosurveys—trying to figure out what lives in a certain area.

Say you get a thousand samples of invertebrates and you send the crickets to a cricket specialist and the moths to a moth specialist to try to figure out what they are. Instead, you could run the DNA on all of them and you wouldn’t need an expert. It would potentially be an easier, cheaper and faster way to do biosurveys. Barcoding is already being used that way for freshwater quality surveys. The best indicator of the health of a watershed, what’s most sensitive, is the life forms in the pond or the stream.

And those are hard even for experts to identify, so that’s where people are using DNA barcoding.

It has also been mentioned as a potential tool for invasive species.

How would that work?

One of the ways we get invasive species is in ballast water in ships. You’re supposed to be checking the ballast water to make sure it doesn’t have 10 GeneWatch

certain species in it. That’s hard to do, but it might be easier to test it by just taking a water sample—don’t even look at what’s in there—just sort of spin it down and get some DNA out of it.

Another way that’s just starting to be used with water, along the same lines, is to not try to collect organisms, just collect water. For instance, in Europe, the American bullfrog is an invasive species. If you want to know if there are bullfrogs in the pond, you can just collect a water sample and see if there is American bullfrog DNA in the water sample.

Again, that’s capitalizing on this ability to use very small amounts of DNA. You have worked with high school students to use this tool for some conservation sleuthing—first “Sushigate,” when you helped your daughter and a friend uncover mislabeled sushi, and now with the Urban Barcode Project. That raised a question for me: How easy is it for someone to do their own DNA detective work?

The Urban Barcode Project is a really fun project, run by Cold Spring Harbor Laboratories. It’s a competition among high schools in New York City, mainly public schools, to use DNA barcoding to do an investigation that they think is interesting.

It’s pretty simple. In this project, the students are thinking of what they want to know and they’re collecting the samples. They then bring them to a laboratory in a classroom that’s set up with the right equipment, where they go through the steps to isolate the DNA and amplify the barcode gene. The equipment costs a few thousand dollars— it’s not ten thousand or a hundred thousand—and students can sort of walk in and, if they have someone

supervising them, they can do it on the spot. It doesn’t require extensive training. Then the samples are sent to a lab that does sequencing, sort of like how we used to send film for processing. So the students send the DNA to lab to do the actual sequencing. It’s really pretty simple. It’s not a toaster yet, but it’s getting there.

So you send out the sample with the DNA isolated and the barcode section amplified, the lab sends you back the sequence, and you go and match it against the reference library.

Right, and that’s done on the Internet. They send you sequence, and the mapping is something you do just like you’d do a Google search, using GenBank or the Barcode of Life database.

There’s nothing magical about DNA barcoding. It aims to be a toaster: a technology that you don’t have to read the instructions to use.

We’re not quite there yet, but the basic principles of it are there. The work for the scientific community is to build up the reference library, because the method is only as good as the library. High school students like my daughter were able to see that sushi labeled as white tuna was actually tilapia, and they could only do that because researchers had deposited sequences of tuna and tilapia in the public database.

The education potential is very big. High school students—anybody, but say high school students—can discover things that no one else knows. Most science projects, the teacher knows the answer; but with this technology, students can think of an investigation, collect the samples, and until you do the DNA investigation, you really don’t know what you have. And that’s just such a fun thing … it’s discovery. nnn April-May 2012

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The Genetic Jungle If releasing genetically modified organisms for conservation purposes proves effective, there’s still another question to ask: Isn’t there an easier way?

By Guy Reeves

I have an image of walking through a tropical jungle sometime in the future. It looks and sounds just like an idealized jungle should: birds singing, luxuriously green, with the perceptible sound of insects doing the myriad of things that insects do. Yet despite the idyllic vista, I experience a sense of disquiet knowing how some of the organisms got into the picture. There are butterflies genetically modified to be resistant to a viral disease; an iconic orchid which was genetically modified to protect it from hybridizing its way out of existence with an accidentally introduced relative; and there are frogs with a genetically modified bacteria growing on their skins to help protect them from a fungal plague that had previously devastated their populations. The jungle certainly looks and feels more like a jungle in having its native butterflies, orchids and frogs. However, the presence of these GM organisms can also be seen as evidence of past failures to protect the environment, rather than as technological triumphs.

A case for genetically modified mosquitoes in saving endangered species With the full knowledge that the above view of the future will in most 12 GeneWatch

people engender a fair degree of disquiet, including myself, I will nevertheless argue in favor of developing (though not necessarily using) an approach that could reasonably be seen as a first step down this road.

The Hawaiian Islands are the bird extinction capital of the world and approximately 70% of native Hawaiian bird species are already extinct or endangered. Bird malaria (avian malaria) is a significant factor in the continued loss of bird species. The mosquito that spreads avian malaria was accidently transported to the Hawaiian Islands in the 1820s, with the avian malaria parasite arriving about a hundred years later. Since then, many bird species have been in a race to evolve resistance to the

disease. Some species have already won this evolutionary race with the malaria parasite and continue to thrive, while some have lost and gone extinct, while others teeter on the edge of extinction.

The last known Po’ouli individual died in 2004, its extinction was attributed to a combination of malaria, non-native predators and habitat loss.

Part of the reason why avian malaria in Hawaii cannot be controlled is because both of our most effective tools against insect-spread diseases cannot be used. The application of chemical insecticides in the forest is not only extremely difficult, but any killing of non-target insects has the potential to disrupt the ecosystem.

April-May 2012

Despite decades of sustained effort to develop a vaccine for human malaria, there has been little success and, as such, there is no reason to expect that a vaccine for bird malaria will become available. Given these realities, is it inevitable that bird extinctions will continue to the point that almost an entire level of the Hawaiian ecosystem is permanently lost?

What are genetically modified mosquitoes and how could they be useful?

A number of diverse genetic approaches to control insect-spread diseases are at various stages of development. For example, more than 13 million Aedes aegypti mosquitoes, which are genetically modified to be partially sterile, have already been released into the wild in Malaysia, Brazil and the Cayman Islands (releases have also recently been proposed in Key West, Florida). Another interesting approach is the development of a fungus which infects mosquitoes, that has been genetically modified to block malaria transmission.

However, the use of GM mosquitoes in Hawaiian bird conservation is based on a different approach, in which synthetic disease-resistant genes are introduced into populations of the mosquito species that spreads avian malaria. These genes would sustainably stay in the chromosomes of the wild mosquito population and stop them spreading malaria. The driving of genes into wild populations is not easy, but already two systems have been developed in the laboratory, and more are in development. Some systems allow these introduced genes to be completely removed from the wild if desired.

This work is largely motivated by the goal of controlling human diseases spread by insects, like human malaria and lymphatic filariasis, and not by the conservation role discussed here.

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A synthetic gene that is substantially effective in preventing mosquitoes from transmitting avian malaria has already been developed.

While it is difficult to predict if techniques to drive genes into populations of mosquitoes will ultimately prove effective, it is clear that considerable effort and progress is being made towards this goal. However, if this approach is ever to be used in conservation, it should at some point be possible to argue to local residents that the introduction of about 5,000 bases of foreign DNA into the 600,000,000 base genome of the Culex quinquefasciatus mosquito (every base of which is foreign to Hawaii) is a safe and attractive alternative to other available solutions.

Are there alternative solutions?

Avian malaria is only one factor in the continued loss of bird species and there are intensive (but rather under resourced) efforts to address the impact of habitat loss and non-native predators. However, efforts to develop ways to directly reduce the impact of malaria have made little progress.

This is despite a range of realistic proposals, which include: (1) Eradicating the mosquito through the coordinated large-scale release of sterile males, which effectively prevent wild females from having any offspring (males never blood feed). This technique, first developed by American scientists in the 1950s, was used to eradicate screwworms (which were non-native flies) from most of continental USA, in an area more than 100 times the total size of the Hawaiian Islands.

(2) Eliminating feral pigs from some reserve areas may create malaria free refuges for birds because the action of feral pigs feeding creates pools of water where mosquitoes

breed.

(3) Providing animals with small amounts of food that includes a drug that is harmless to birds and mammals but is lethal to mosquitoes when ingested during blood feeding could result in areas with fewer mosquitoes. A number of drugs routinely used for treating worm infections in people and animals have this property.

Surprisingly, none of these have been vigorously evaluated in the context of Hawaiian conservation, despite the fact that this could be achieved for much less than the cost of building one mile of freeway. In contrast, the development of GM mosquitoes has over the last decade attracted more than $30 million to address pressing human health problems like human malaria and dengue fever. The possibility that the resulting technological advances could also be harnessed to save species is an appealing one. However, if GM mosquitoes are ever used for conservation purposes, failure to vigorously pursue alternative approaches is likely to prove critical in retrospectively resolving the question posed at the start of this article. If simple and available solutions appear to have been ignored in favor of complex genetic techniques, the imagined ‘genetic jungle’ may in fact represent a realistic outcome.

Guy Reeves, PhD, is a researcher at the Max Planck Institute for Evolutionary Biology in Germany and is currently developing genetic systems that could drive disease resistance genes into insect populations in a reversible manner.

However, he would be content if the application of alternative, more attractive approaches meant that these techniques were not used outside of the laboratory.

Email: reeves@evolbio.mpg.de

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Hatch and Release In 2009, genetically modified mosquitoes were released in the Cayman Islands. It was another year before the world knew about it. By Camilo RodrĂ­guez-BeltrĂĄn In 2010 I read for the first time about the initial field experiments of genetically engineered mosquitoes that had taken place a year earlier in the Cayman Islands. This news came as a surprise to me, as I considered myself part of the independent scientific community continuously monitoring modern biotechnology advances and applications. Although 14 GeneWatch

British biotech company Oxitec’s venture in developing GE mosquitoes was known, the astonishment came from the sudden jump to field release. I soon realized that I was not the only one missing a year of surveillance on this exercise: the release remained a de facto confidential test for a year.

It was difficult to understand the

silence, intentional or not, on the experimental release of these mosquitoes, in particular because there were not hidden military or obscure purposes underlying the technology. In fact, the intended use was described as a tool to tackle dengue fever, one of the major public health issues in many developing countries.

With over 50 million infections every April-May 2012

year, the fight against this disease is one of the most important priorities for societies not only in the developing world but also in some regions of the developed world. Strategies range from vector management to early and accurate diagnosis, and while the research on vaccines and viral drugs is under development, no commercial vaccine is available for the moment.

Aedes aegypti is the principal, but not only, species of mosquito capable of transmitting the virus through bites from the female to humans.

For this specific case, the technological strategy revolves around the release of mainly male engineered A. aegypti mosquitoes. This technology is called RIDL—Release with a Dominant Lethal—where the insects carry a specific genetic switch that under certain conditions causes death at the larval stage of their offspring. This application aims to reduce the incidence of dengue fever by suppressing the mosquito population.

At the molecular level, these GE mosquitoes have been designed with two transgenes. The first one (DsRed2) produces a red fluorescency in the organism under white light. This is a useful marker for selection and also for monitoring.

But the most interesting, and also complex, piece of the system comes from the second transgene, the RIDL regulation system.

Imagine your office door slightly open on a windy day: little by little the door opens more and more as the wind pushes through. You can stand up to try to close it but the wind is so strong that it will reopen it again, and at one stage the door will be so wide open that the wind will be strong enough to create a chaos Volume 25 Number 3

(flying pages, knocking over the coffee cup etc.). But suddenly you find the key to that door, and by closing the door you have reduced the flow necessary to create the chaos. Well, that is the RIDL system, a positive genetic feedback loop that produces a protein (tTAV) that is able to guide more production of itself (by acting positively on its own genetic promoter). This results in an over expression of tTAV, at a concentration that becomes lethal to mosquitoes’ larvae. However there is one antidote, a chemical called tetracycline, which if present will bind the tTAV protein, reducing its presence in a free form to activate its promoter. tTAV will still be produced, but at a lower concentration with no toxic effect for the larvae. Just like the absence of a key allowed wind to knock over the coffee cup inside the office, absence of tetracycline will produce a lethal effect at the larval stage of the mosquitoes.

From a biosafety standpoint, risks related to these organisms follow some general issues: (1) On modified mosquitoes: What will be the consequences in the ecological network of mosquitoes?

What will be the effect on preys and predators? What will be the influence in other species of disease carrying mosquitoes? Could they benefit from a reduction in competition? Can the virus adapt better to other vectors because of this selection pressure?

(2) On GE organisms: What is the effect of the exposure to the DSRed2 and the tTAV proteins?

What is the likelihood of instability of the genetically added trait?

Could it evolve resistance to the lethal mechanism?

There are other specific issues related to the ability of flying and the difficulty of monitoring the distribution of the mosquitoes (in particular during transboundary movements), as well as issues related to the associated technology (for example, the need to act under absence of tetracycline).

Some of these uncertainties regarding the implications on ecosystems and health have apparently been accepted by some risk assessors, who have given approvals for the field release of the GM mosquitoes not only in the Cayman Islands

The fact is that the potential of having survivors is a reality, and some of these will be females—and female mosquitoes, genetically engineered or not, bite humans. but also in Malaysia and Brazil, with further approvals pending in the United States. Some have highly criticized the scientific approach used on these regulatory processes, and another article in this issue of GeneWatch addresses the regulatory gaps in these experiences.

I believe that the issues related to the associated technology are of particular interest. It has been GeneWatch 15

Race? Debunking a Scientific Myth “New techniques and new approaches can and will tell us an enormous amount about the biological history of our species; but they also teach us that this history was a very complex one that is very inaccurately – indeed, distortingly – summed up by any attempt to classify human variety on the basis of discrete races. While we can acknowledge that our ideas of race do in some sense reflect a historical reality, and that human variety does indeed have biological underpinnings, it is important to realize that those biological foundations are both transitory and epiphenomenal. Despite cultural barriers that uniquely help slow the process down in our species, the reintegration of Homo sapiens is proceeding apace.

And this places the notion of “races” as anything other than sociocultural constructs ever more at odds with reality. Increasingly, it seems, we are simply who we think we are.”

- from Race?

Debunking a Scientific Myth

By Ian Tattersall and CRG Board member Rob DeSalle

Available from Texas A&M University Press. Order by calling 800-826-8911, or visit www.tamupress.com.

16 GeneWatch

acknowledged by Oxitec that in the absence of tetracycline, the survival rate of the GM mosquito larvae is about 3% under laboratory conditions (the specific reasons for this percentage of survival are unknown). It is interesting that some of the strongest discussions with the promoter of these technologies are about the numbers of surviving mosquitoes: Does it matter? Is it significant? Is it negligible? Debates are currently ongoing and will continue, but the fact is that the potential of having survivors is a reality, and some of these will be females—and female mosquitoes, genetically engineered or not, bite humans.

Another interesting factor is that the survival rate of GE mosquitoes can be underestimated in real conditions—not only because of the possibility of building a genetic resistance, but in particular because the antidote, tetracycline, is one of the major antibiotics used both for human health and agricultural practices. The major concentration of tetracycline in urban areas is likely to be in sewage systems, and recent literature has shown that A. aegypti does breed in dirty water; therefore the scenario of breeding and development in potentially tetracycline-contaminated aquatic environments, with the risk of suppressing the lethal system, should now be considered. One could argue that the concentrations in these environments will not be enough to trigger survival, but in order to know this a meticulous surveillance system of tetracycline concentration over time will be needed in the regions intended for release. For the moment I am not aware of any such initiatives, and I believe these will be very expensive and hard to put in

place.

Aside from these questions, what has not been covered is a thorough analysis of the appropriateness of this strategy. It seems that the context is not ready for the technology.

The RIDL system was not developed to tackle dengue; before mosquitoes, the technology was designed for cotton bollworms, and it seems that other agricultural pests will be targeted in the future. In other words, rather than developing a technology for the purpose of reducing the incidence of dengue fever, Oxitec developed the technology first and then looked for situations where it could be put into use. In this particular case, the use of tetracycline as an antidote makes things out in the environment a little bit more complicated. If the technological solution had started from the real challenge or opportunity then it seems very unlikely that it would rely on an antidote that is currently available exactly where you don’t want it: in the waters where mosquito larvae grow.

I advocate for challenging solutions that rely solely on technology and forget to start from a contextcentered approach. I put the weight on the challenge not really to the private companies, but on the governments and public research initiatives that should be deciding the best for all. Before asking “Does it work?” we need to ask: “Is it appropriate?”

Camilo Rodríguez-Beltrán, MSc, is cofounder of the Taleo Initiative and was awarded the TEDGlobal2010 Fellowship.

April-May 2012

GM Mosquitoes: Flying Through the Regulatory Gaps?

As a company sells its genetically modified mosquitoes to developing countries, regulators try to figure out how to handle a novel technology released into the wild.

By Lim Li Ching In December 2010, 6,000 genetically modified mosquitoes were released in my country, Malaysia. This followed releases of large numbers of mosquitoes engineered with the same modification—a dominant lethal gene—in the Cayman Islands, where over 3.3 million GM mosquitoes were released in 2009 and 2010.

Since February 2011, more than 3 million of these mosquitoes were released in the city of Juaziero in northeastern Brazil. The release of these same mosquitoes is currently being considered in the Florida Keys in the United States. Many other countries are reportedly evaluating the GM mosquitoes for laboratory research and possible future field releases.

The genetic modification in question targets Aedes aegypti, commonly known as the yellow fever mosquito, which is a vector of dengue fever and other diseases. The so-called RIDL technology involves a genetic regulation that, in the absence of the antibiotic tetracycline, causes death at the larval stage of the offspring. The release of mainly male GM mosquitoes carrying this lethal gene is intended to result in mosquito population suppression, with the consequent aim of reducing the incidence of dengue fever.

The GM mosquitoes were developed and the associated technology patented by the UK-based company Oxitec, which appears to be approaching many countries and offering the mosquitoes as a potential solution to the dengue problem.

Volume 25 Number 3

Dengue fever is a serious problem in many countries, and authorities are increasingly looking for alternatives, as tools such as pesticides are rendered ineffective due to resistance development.

However, the release of these GM mosquitoes into the environment raises many scientific, social, ethical and regulatory concerns. Even while these issues are still being debated, it seems that there is a headlong rush to release the GM mosquitoes.

The situation is compounded by the fact that the international regulatory and risk assessment frameworks governing GM insects in general, and GM mosquitoes in particular, are still immature. So much so that in the US, discussion is on-going as to which

agency should regulate the proposed release of GM mosquitoes in Florida, since this is a completely new area which the regulatory world is unfamiliar with.

Moreover, under the Cartagena Protocol on Biosafety—the only international law dealing exclusively with genetic engineering and genetically modified organisms—a technical expert group revised its guidance last year for GM mosquito risk assessment. This guidance, part of a larger package of guidance on risk assessment, will be forwarded to the Parties of the Cartagena Protocol for consideration in October 2012.

To my knowledge, a corresponding group which convened under the World Health Organization to

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develop guidance principles for GM mosquito evaluation has yet to finish this task.

At the national level, the first release of GM mosquitoes in the world, which occurred in the Cayman Islands, was conducted in the absence of a biosafety law. While the release was approved by the authorities concerned, the Cayman Islands only had a draft biosafety bill at the time. Moreover, the provisions of the Cartagena Protocol did not apply to the Cayman Islands, even though the UK, under which the Caymans are a British Overseas Territory, is a Party to the Protocol. This meant that specific biosafety questions may not have been fully considered nor evaluated, because of the absence of a detailed and comprehensive biosafety regulatory framework.

Indeed, the risk assessment that was used to support the approval of the releases in the Cayman Islands has been roundly criticized. Scientists at the Max Planck Institute for Evolutionary Biology in Germany conducted a thorough examination of the regulatory procedures and documents. They concluded that the risk assessment was incomplete, with no provision of experimental data on the releases; that there was poor referencing (unlikely to meet peer review standards); and worst of all, that there was a marked absence of discussion of the potential health or environmental hazards specific to the GM mosquito in question.

This trend of substandard regulatory oversight is regrettably not a one-off. The Max Planck scientists assessed the regulatory process in the first three countries (US, Cayman Islands, Malaysia) permitting releases of GM insects (including GM mosquitoes in the latter two countries) in terms of pre-release transparency and scientific quality, and found the process wanting. They 18 GeneWatch

suggest deficits in the scientific quality of the regulatory documents and a general absence of accurate experimental descriptions available to the public prior to the releases.

Worryingly, they judged the world’s first environmental impact statement on GM insects, produced

by US authorities in 2008, to be scientifically deficient. This assertion is made on the basis that (1) by and large, the consideration of environmental risk was too generic to be scientifically meaningful; (2) it relied on unpublished data to establish central scientific points; and (3) despite the approximately 170 scientific publications cited, the endorsement of the majority of novel transgenic approaches was based on just two laboratory studies of only one of the four species covered by the document.

However, the environmental impact statement appears to be used as the basis for regulatory approvals around the world, including that of the GM mosquitoes.

One of the most obvious questions to ask is whether humans can be bitten by the GM mosquitoes. In public information available on the Cayman Islands and Malaysian trials, however, this question is either conspicuously ignored or it is implied that there is no biting risk, ‘as only male mosquitoes are released and they cannot bite.’

However, as detailed by the Max Planck scientists, it is probable that transgenic daughters of the released males will bite humans. This is because the males are only partially sterile as the technology is not 100 percent effective. Furthermore, if the mosquitoes encounter tetracycline contamination in the wild, the numbers of survivors could increase. The likely presence of transgenic females in the environment requires the consideration of a more complex series of potential hazards, but this does

not appear to have been done.

Public information, consultation and participation have been also lacking. In the case of the Cayman Islands, while Oxitec and the local Mosquito Research and Control Unit claim that adequate information was provided to the public prior to the release of the GM mosquitoes, the video information provided by MRCU for outreach does not once mention that the mosquitoes in question are genetically modified. Moreover, given the significance of the first release of GM mosquitoes in the world, it is puzzling as to why Oxitec only announced the fact of the release more than a year after they occurred, catching even scientists in the field of transgenic insects off guard.

It is clear that the regulatory processes that have governed the release of GM mosquitoes into the environment so far have been lacking.

While international guidance may have recently been completed, the implementation at national level still suffers from a lack of adequate experience in dealing with this novel application of genetic engineering, a lack of rigorous risk assessment and robust investigation of unanswered questions and a lack of effective and meaningful public consultation and participation. In light of this, the push to release the GM mosquitoes in various countries is grossly premature.

Lim Li Ching, M.Phil., works in the biosafety program at Third World Network and is Deputy Editor of Science in Society.

April-May 2012

The Frozen Zoo Wildlife gene banks provide a tool for studying species and monitoring conservation efforts.

By Oliver Ryder

In the course of their work, field biologists, veterinarians, and zoo scientists often collect biological specimens in order to assist ongoing studies on the biology and health of species. If, in doing so, they make additional efforts to bank specimens for future studies, they provide future scientists—who may have access to technologies undreamed of by their forbears—with opportunities to gain insights that may contribute to conservation efforts for declining species. With the declines in biological diversity that have been well known for the better part of a century, these biobanking efforts have rather quietly been underway for over thirtyfive years at the institution where I work. The Frozen Zoo at the San Diego Zoo’s Institute for Conservation Research now encompasses gametes, embryos and cell cultures from over 9,000 animals, comprising more than 1,000 species.

The frozen cultures of viable cells may be thawed, grown and divided into more cells, which can be frozen again. Although not an infinitely expendable resource, it provides the opportunity to conduct studies now, while still keeping supplies for the future.

Hundreds of scientific studies have used samples from the Frozen Zoo. New species have been identified after their distinctiveness was revealed by genetic studies of biobank Volume 25 Number 3

GeneWatch 19

samples. Studies of species and individual identity, for wildlife management and forensic applications, have been undertaken and have expanded the database of DNA profiles and barcodes. Infertile animals have been identified from genetic testing, parentage relationships identified and incorporated into species management programs; and now, whole genome sequencing and studies of the repertoire of expressed genes—the “transcriptome”—are being studied using samples banked over the last four decades. From most of the small population management programs of zoos, questions have arisen that are answerable by genetic testing, if appropriate samples are available.

The Frozen Zoo has played a crucial role in all these activities.

Opportunities for the future Before Dolly, the sheep cloned

by Dr. Ian Wilmut’s team in 1996, most scientists—myself included— considered that the differentiated adult cells of the body could not be reprogrammed and proceed again through or guide the mammalian development. It was a surprise again when Dr. Shinya Yamanaka’s team demonstrated that cultured fibroblast (skin) cells could be reprogrammed by transiently activating as few as four genes introduced into these cells. If the techniques for producing induced pluripotent stem cells (iPS, cells capable of becoming any cell type in the body) could be adapted to provide similar results with fibroblasts from many other species, the Frozen Zoo potentially represents the source of the largest and most diverse collection of stem cells anywhere.

After more than a year of dedicated work, Dr. Inbar Ben-Nun, in Professor Jeanne Loring’s group at The Scripps Research Institute, 20 GeneWatch

and a team from U.C. San Diego and the San Diego Zoo Institute for Conservation Research announced the production of iPS from two endangered species, the drill and the northern white rhinoceros. The drill is a large African monkey with a declining population in U.S. zoos and endangered in its habitats in Cameroon because of habitat loss and illegal poaching. The northern white rhinoceros is the most endangered form of rhinoceros. Studies of skull characteristics and genetics analyses resulted recently in this African rhinoceros being named a separate species, distinct from its southern relatives.

These studies demonstrate the potential for stem cells to be used in veterinary medicine and for treating illnesses. The question also arises of the potential for applying new approaches in assisted reproductive technologies. These might include producing sperm and eggs in tissue culture flasks, the production of embryos, and down the road, northern white rhino babies. But it is a long road to travel. Time is running out for the northern white rhino, and although it may be one of the last tools remaining, technology may not be sufficient to prevent its extinction.

Impacts of induced pluripotency It is altogether reasonable that we pause and consider what we might do, for what reason, and for whose benefit.

The use of DNA banks to produce living animals, restore to life extinct species, and provide novel life forms is entrenched in popular musings.

The broadly reported effort to clone a mammoth seems to be known by people of all ages.

Given the limitations of our times and our global society in addressing the declines in biological diversity

and loss of species, should we strive to produce a living animal that went extinct ten thousand years ago?

Could it play a role today as it did in its native ecosystem?

If the motivation for developing advances in assisted reproductive technologies were to be based on preventing ongoing losses of biological diversity and reducing the risk of extinction of species that have undergone dramatic recent declines because of human activities, the investments and benefits would reflect a different set of values.

The way to sustain and conserve species is in natural habitats. However, without invoking additional and alternative strategies, losses of biological diversity will surely be large, for many species continue to disappear from their habitats.

The controversies that arise around the discussions of conservation strategies and methods stand in a different realm from the efforts of museums, zoos, and research institutes to prospectively bank biological samples that can assist conservation assessments, monitoring and management. Efforts devoted to banking cells desperately need to be expanded by and for the global community. nnn Oliver A. Ryder, PhD, is Director of Genetics at the San Diego Zoo Institute for Conservation Research and an Adjunct Professor of Biology at The University of California, San Diego.

April-May 2012

A Primer on GMOs and International Law Two different international frameworks attempt to govern genetically modified organisms ... and they don’t always agree with one another. By Phil Bereano Introduction Two international instruments changed the playing field in the past decade regarding the international regulation of genetically engineered organisms. One is the Cartagena Protocol on Biosafety, which is intended to regulate the international transfer of “living modified organisms” (LMOs). The second is a set of guidelines, the Risk Analysis Principles for Foods Derived from Biotechnology, established by a little-known United Nations body called the Codex Alimentarius Commission.

These two instruments signal attempts by the world community to establish rules governing the production, trade and use of genetically modified foodstuffs. Both agreements emphasize the rights of consumers and farmers, and the protection of ecosystems. However, it is still not completely clear how their provisions will work alongside the free-trade rules of the World Trade Organization (WTO).

The Cartagena Protocol: a greener way By joining the WTO, countries agree to limit their freedom to impose restrictions on foreign trade.

The Cartagena Protocol, however, stresses that trade considerations need not always be given precedence over other national objectives.

It recognizes that the need to protect biodiversity, the environment and human health are valid priorities in decision-making. As of today, some 163 countries (minus several of the most important agricultural Volume 25 Number 3

exporters, including the United States, Canada, Argentina and Australia) have ratified the Protocol, which came into force on 11 September 2003.

The Protocol establishes a procedure called Advanced Informed Agreement. Under an AIA, those planning to export LMOs for introduction into the environment must notify the country to which they are being sent. That country is then entitled to authorize or refuse permission for the shipment, based on a risk assessment. Furthermore, the Protocol allows the recipient nation to invoke precautionary regulation if, in its judgment, there is not enough scientific information to make a proper assessment: “Lack of scientific certainty due to insufficient relevant scientific information and knowledge regarding the extent of the potential adverse effects of a living modified organism on the conservation and sustainable use of biological diversity in the Party of import, taking also into account risks to human health, shall not prevent that Party from taking a decision, as appropriate, with regard to the import of that living modified organism...”

The Protocol does not specify how to resolve any conflict between its own rules allowing an importing country to control trade in LMOs and that country’s obligations not to impede trade if it is also a member of the WTO. The state of international law regarding LMOs is intentionally fuzzy in some respects; diplomatic concerns for the WTO resulted in

having a Protocol Preamble containing three intentionally conflicting provisions: that trade and the environment should be “mutually supportive”; that the agreement does not change any Party’s international rights and obligations; and that the Protocol should not be interpreted as being “subordinate” to any other treaty. In particular, the Protocol’s adoption of the precautionary principle—the idea that an action should not be carried out if the consequences of it are unknown but highly likely to be negative—is claimed by trade interests to run counter to the WTO mandate.

Those involved in drafting the Protocol, along with other observers, also acknowledge that there are a number of outstanding issues relating to the oversight of genetic manipulation technologies even after adoption of the Protocol text. These include: •

“Living modified organisms” (LMOs) is a more restricted category than “genetically modified organisms” (GMOs), since it excludes those no longer alive, and their products.

• “Intentional introduction into the environment” may not address situations where the exporter knows that some shipped modified grain, for instance, will be planted within the importing country, but does not necessarily “intend” this to happen.

• Many important countries are not members of the Protocol, including the largest growers and exporters of LMOs: the United GeneWatch 21

States, Canada, Argentina and Australia.

• The Protocol’s provisions on trade in LMOs between a party and a non-party state does not require that its procedures be followed.

• The Protocol says nothing about any regulatory oversight within a country.

In the fall of 2010, a Supplemental Protocol on issues of liability and redress for damages caused by LMOs was adopted after 7 years of intense negotiations, and is in the process of being ratified by the requisite 40 countries.

The Codex Alimentarius: focus on food safety Two months before the Protocol entered into force, a separate breakthrough took place. In July 2003, with the backing of all its 168 member nations, the Codex Alimentarius Commission produced the first set of international guidelines for assessing and managing any health risks posed

by GM foods.

A relatively obscure United Nations agency, the Commission is charged with the key global task of setting international guidelines for food quality and safety. It was established in 1963 by the Food and Agriculture Organization (FAO) and the World Health Organization (WHO), and given the mandate of “protecting the health of the consumers and ensuring fair practices in the food trade”. The Commission draws up voluntary international food guidelines through negotiations in approximately 30 committees and task forces.

The most significant element of the 2003 guidelines is that they call for safety assessments of all GM foods prior to their approval for commercial sale. This has important 22 GeneWatch

implications for WTO members. In 1995, the WTO had agreed that Codex norms should be the reference point for evaluating the legitimacy of food regulatory measures that are challenged as restrictions on trade.

Thus, although the Codex guidelines are strictly voluntary, they have legal significance for WTO members as a defense to charges of “unfair trade.”

Also significant is that all of the major countries growing GMOs—the US, Canada, Argentina, and Australia—are Codex members and agreed to these risk assessment guidelines.

The Codex risk assessment guidelines contain much language about the need for a “scientific” evaluation of the actual hazards presented by the new foods. But they also recommend that “risk managers should take into account the uncertainties identified in the risk assessment and implement appropriate measures to manage these uncertainties”. This wording appears to acknowledge the validity of a precautionary regulatory regime, similar to that allowed for international shipments under the Cartagena Protocol.

The Codex also recognizes that “Other Legitimate Factors”—nonscientific in nature—can form a valid basis for regulations, such as using halal or kosher standards. Other

provisions within the guidelines call for a “transparent” safety assessment, that should be communicated to “all interested parties” that have opportunities to participate in “interactive” and “responsive consultative processes” where their views are “sought” by the regulators.

These non-scientific aspects are consistent with the second prong of the Codex mandate, namely its role in deterring deceptive practices.

Such practices might, for example, include selling or distributing GM foods to consumers without labeling them as such. As a top world food exporter, the United States has vigorously advocated that only “objective” and “scientific” health claims be used as the basis for regulating GM foods, but consumer groups have vigorously contested this position. In the summer of 2011, after 18 years of struggle, Codex finally adopted a guidance document recognizing that countries can adopt laws and regulations covering the labeling of GE foods, including mandatory labeling.

Too rich a mix?

It is not obvious how the Protocol, the Codex guidelines and WTO rules mesh together. Seeking a simple answer to this question assumes that the negotiation of these agreements April-May 2012

was guided by a logical process. In fact, they were produced at different times, by delegations from different national ministries with various missions (trade, environment, food, agriculture, health, etc), and without any reference to the bigger picture.

These agreements also reflect the different configurations of industry and public interest groups that helped shape them.

Environmentalists argue that the new Codex guidelines on GM foods simply underscore how easy it has been for industry to bring GM foods to market without regulatory supervision, for example in the US. This practice has been criticized by many activist organizations and a growing number of scientists, as well as several international authorities on food safety matters.

Many of these critics point out that there is virtually no peer-reviewed, published scientific research on the risks or benefits of GM food that would allow for safety claims to be tested. They argue that the lack of evidence of risk is not the same as evidence of no risk. Many civil society organizations have insisted that precautionary steps should be taken to avert potential risks. Even the WTO Appellate Body, which settles its disputes, has recognized that divergent scientific views may be considered in making assessments, such as those evaluating food risks.

Using the precautionary principle to manage risks also puts the burden of proof on those seeking to introduce the new technology. The United States and other exporters of GM foods have blocked efforts to incorporate the principle explicitly into the Codex guidelines. But some commentators and activists believe that, despite no actual mention of it in those guidelines, the precautionary principle is implicit in the document’s suggestions for risk analysis Volume 25 Number 3

because these call for the safety of a GM food to be analyzed before it is produced and sold.

The governments blocking the inclusion of the precautionary principle into the Codex guidelines have argued that if it were to be applied to regulating GM foods, it could be used to justify regulations intended primarily to protect domestic industries from foreign competitors — in violation of the WTO agreements.

Others point out, however, that it is not the purpose of the Codex guidelines to stimulate trade, but rather, to protect consumers. The WTO is supposed to follow Codex norms, not vice versa.

Whither GMO politics?

The political storm raging round GM foods continues to grow in intensity, largely because the economic stakes rise steadily while scientific debate remains unresolved. Given the frameworks described above, what conclusion can one draw about the prospects for adequate regulatory supervision of the technology, and for proper protection of human health and the environment?

The four countries keen to export GM crops—the United States, Canada, Argentina and Australia—are all Codex members, but none of them are a party to the Cartagena Protocol. Therefore, one could argue that it would be inappropriate for such countries to object about others that choose to use the Codex risk assessments, since they all voted in Codex to adopt them.

On the other hand, as the countries that signed the Protocol meet to work out the details for carrying out risk assessments under its aegis, and to set rules on traceability and liability, none of these four nations will be legally able to block action taken under the Protocol. In reality,

however, several nations which are Parties to the Protocol seem to be acting to protect the interests of these exporters.

As a result, the Protocol is likely to lead to rules that focus on protecting biodiversity and health more than any rules devised by the WTO. On that basis, there are grounds for believing that the future will see better environmental and health protection than exists at present.

A different situation, however, is likely to unfold behind the scenes as GM food exporters—particularly the United States—put pressure on countries, one by one, to waive their rights under international law. This already happened before the Protocol was enacted, where weak nations such as Croatia and Thailand had been subjected to pressure by the United States. And last year, Kenya— under enormous pressures from the US, Monsanto, the Gates Foundation and GE interests in South Africa—adopted a very weak “biosafety” law that will likely lead to the largescale introduction of GE crops being grown in that country. Thus the responses of civil society will be crucial to ensure democratic and transparent oversight of this technology.

Phil Bereano, JD, is Professor of Technology and Public Policy at the University of Washington, Seattle. He is on the roster of experts for the Cartagena Protocol, co-founder of the Council for Responsible Genetics, and currently represents the Washington Biotechnology Action Council and the 49th Parallel Biotechnology Consortium at international meetings.

An earlier version of this article appeared in the April 2004 issue of Seedling magazine, published by Genetic Resources Action International (GRAIN).

GeneWatch 23

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  

 FGPI is a collaboration of the following organizations:

Topic update: Forensic DNA

Database Expansion in New York

Protections for the Innocent in Massachusetts

This past March, New York State enacted S. 6733, “DNA testing of certain offenders convicted of a crime,” becoming the first state in the country to adopt an “all crimes” forensic DNA database. Expected to double the size of the current database, this dramatic expansion now allows police in the state of New York to collect DNA samples from individuals convicted of even petty crimes, including loitering, reckless speeding or writing a bad check. The state already collects DNA samples from people convicted of felonies and class A misdemeanors, but Governor Andrew Cuomo successfully claimed that including people convicted of such minor crimes—for which DNA evidence isn’t even relevant—is vital because the bigger the database the better chance of catching a criminal in the future. Despite offering only a handful of anecdotal examples, the Governor received the support of all 62 district attorneys in the state as well as a litany of law enforcement notables and legislative leaders.

Despite active and vocal attempts by several civil society organizations (including the Council for Responsible Genetics) raising the obvious civil liberties issues as well as concerns about an overburdened system and risk of error and fraud, public discussion and criticism were largely ignored. Seemingly emboldened, many other states are moving forward with similar proposals.

The first exoneration through DNA testing occurred in 1989.

Since then, over 280 people in the United States alone have been exonerated by DNA testing after they were convicted of a crime, including a number of individuals who originally pled guilty and almost twenty people on death row. The innocent individuals had served an average of 13 ½ years in prison before exoneration and release.

This past February, Governor Patrick of Massachusetts signed into law S.1987, “an Act providing access to forensic and scientific analysis.” Championed by Representative John Fernandes and Senator Cynthia Creem, this vital legislation allows Massachusetts to join the 48 other states that grant their citizens the statutory right to their own DNA to prove their innocence after they have been convicted of a crime, with Oklahoma the lone state remaining.

This new law was the result of diligent efforts over three years by the Massachusetts ACLU, the New England Innocence Project, the Massachusetts Bar Association and the Council for Responsible Genetics, which twice testified before the Massachusetts legislature in support.

Volume 25 Number 3

Genetic Justice: DNA Data Banks, Criminal Investigations, and Civil Liberties National DNA databanks were initially established to catalogue the identities of violent criminals and sex offenders. However, since the mid-1990s, forensic DNA databanks have in some cases expanded to include people merely arrested, regardless of whether they’ve been charged or convicted of a crime. The public is largely unaware of these changes and the advances that biotechnology and forensic DNA science have made possible.

Yet many citizens are beginning to realize that the unfettered collection of DNA profiles might compromise our basic freedoms and rights.

Two leading authors on medical ethics, science policy, and civil liberties take a hard look at how the United States has balanced the use of DNA technology, particularly the use of DNA databanks in criminal justice, with the privacy rights of its citizenry.

Sheldon Krimsky is a founding member of the CRG Board of Directors, Professor of urban and environmental policy and planning at Tufts University, and author of eight books and over 175 published essays and reviews.

Tania Simoncelli is a former member of the CRG Board of Directors and Science Advisor at the American Civil Liberties Union. She currently works for the U.S. Food and Drug Administration.

GeneWatch 25

Topic update: Gene Patents

Supreme Court Orders New Review of Myriad Gene Patents The legal case against patents on human genes was given new life this spring after the Supreme Court vacated a federal appeals court’s ruling that upheld Myriad Genetics’ patents on human genes linked to inherited forms of breast and ovarian cancer.

With the backing of medical, research and patient advocacy groups, the American Civil Liberties Union and the Public Patent Foundation originally filed suit against Myriad’s BRCA1 and BRCA2 gene patents in 2009. A US District Court invalidated the patents in 2010, but last fall the US Court of Appeals for the Federal Circuit upheld Myriad’s patents in a 2-1 decision. Now the Supreme Court has ordered those same three judges to reconsider their ruling.

It was significant that the Supreme Court even agreed to take up the matter, says ACLU attorney Sandra Park.

“Most petitions that are filed at the court are denied—the vast, vast

majority of them,” Park says. “It was for us a very good development that the court granted the petition and vacated the lower court’s decision.”

Gene patent opponents have another case to thank for the development. Shortly before vacating the Myriad decision, the Supreme Court ruled on Mayo v. Prometheus, unanimously finding invalid Prometheus Labs’ patents on methods of evaluating patients’ drug responses. Prometheus, having patented a method of adjusting dosages based on patients’ biological response, originally brought the case against Mayo Collaborative Services, which had developed a similar test. The Supreme Court’s ruling in favor of Mayo hinged on its finding that Prometheus’ claimed patent matter was a law of nature—reaffirming, Park points out, its well established precedent of finding laws of nature and natural phenomena not patentable.

A key element of the Mayo decision is the Supreme Court’s assertion

that patents of natural phenomena hamper future innovation. The Myriad plaintiffs—who also filed an amicus brief siding with Mayo—have made the same argument against gene patents, and Park sees it as a good sign that the Supreme Court cited it before vacating the Myriad decision.

“We have argued all along that patents on DNA impede innovation because they prevent others from working or examining the DNA itself.”

However, the future of the case against gene patents is far from certain.

“No court has yet applied Prometheus to the issue of DNA patents, so we don’t know yet how that will play out,” Park says. And either way, it’s doubtful the case will stop there: “Regardless of the outcome at the Federal Circuit, it’s likely that whatever side does not win will appeal the case further.”

Topic update: Animal Biodiversity

Rhino DNA Database Leads to Poacher Arrests A rhinoceros DNA database in South Africa has led to 380 arrests and 25 sentences for poachers. The project, called RhODIS (for “rhino DNA index system”) helps to link samples from recovered horns to samples taken from the carcasses of poached rhinos.

The operation, based on the FBI’s Combined DNA Index System for humans (CODIS), was developed through a collaboration between 26 GeneWatch

wildlife officers and the South African Police Service’s forensics lab.

Between samples collected from horns, the carcasses left behind by poachers, and rhinos living on game preserves, the database contains DNA profiles for over 4,000 individual rhinoceroses.

The system was recently adopted in Kenya, with other countries such as India and Botswana showing an interest as well.

In South Africa, those working on RhODIS say funding is a primary problem, with expensive laboratory costs and over 17,000 rhinos still to be profiled—and 171 rhinos poached in the first 100 days of this year.

To learn more about WWF’s African Rhino Programme, visit www.wwf.org.za/what_we_do/ species/arp/

April-May 2012

Race and the Genetic Revolution

Science, Myth, and Culture

Edited by Sheldon Krimsky and Kathleen Sloan

“I can hardly wait for this book to begin circulation. It should be read and taught as widely as possible.” —Adolph Reed, Jr., University of Pennsylvania Divided into six major categories, the collection begins with the historical origins and current uses of the concept of “race” in science. It follows with an analysis of the role of race in DNA databanks and its reflection of racial disparities in the criminal justice system. Essays then consider the rise of recreational genetics in the form of for-profit testing of genetic ancestry and the introduction of racialized medicine, specifically through an FDA-approved heart drug called BiDil, marketed to African American men.

Concluding sections discuss the contradictions between our scientific and cultural understandings of race and the continuing significance of race in educational and criminal justice policy, not to mention the ongoing project of a society that has no use for racial stereotypes.

SHELDON KRIMSKY is professor of urban and environmental policy and planning and adjunct professor of public health and community medicine at Tufts University. He is the author of Science in the Private Interest: Has the Lure of Profit Corrupted Biomedical Research?

KATHLEEN SLOAN is a human rights advocate specializing in global feminism. She has run nonprofit organizations for more than twenty years and has directed communications and public relations functions for multinational corporations and nonprofits.

CO LU M B I A U NIVE R S ITY PRE S S Tel: 800-343-4499 Fax: 800-351-5073 cup.columbia.edu

$35.00 / £24.00 paper 978-0-231-15697-4 $105.00 / £72.50 cloth 978-0-231-15696-7 304 pages, 1 line drawings, 4 tables A PROJECT OF THE COUNCIL FOR RESPONSIBLE GENETICS

“Novel and forward thinking, this book will be a valuable addition to a literature that needs to be brought up to speed.” —David Rosner, Columbia University and Mailman School of Public Health

ORDER ONLINE AND SAVE 30% To order online: www.cup.columbia.edu Enter Code: RACKR for 30% discount Race and the Genetic Revolution Edited by Krimsky Sloan (304 pages) paper ISBN 978-0-231-15697-4 regular price $35.00, now $24.50 Regular shipping and handling costs apply.

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