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Jul 272016
GMO corn field in Kauai

Photo by Ian UmedaA GMO corn field in Kauai. While a recent National Academy of Sciences study found no evidence that eating genetically engineered food can cause adverse health effects, it also found no evidence that GE traits have provided measureable increases in overall crop productivity.

Unresolved safety questions about gene-editing technologies underscore need for caution

While expressing support for the watered-down GMO labeling bill, which was passed by Congress last week and is now awaiting President Obama’s signature, White House spokeswoman Katie Hill told Bloomberg News: “While there is broad consensus that foods from genetically engineered crops are safe, (emphasis added) we appreciate the bipartisan effort to address consumers’ interest in knowing more about their food….”

Making these kinds of broad statements about all genetically modified foods being “safe” seem to be a common quirk among even among science journalists who write about  GMOs. There is a tendency to describe genetically engineered crops as though they are just one thing. True, GMOs have many traits in common, but so do planes, trains, and automobiles. Writers who lump them together often ignore important subtleties and distinctions between each GMO crop, how they are created and used, as well as the damaging agricultural practices most of the transgenic crops under commercial cultivation promote.

Consider, for example, this story at by William Saletan which proclaims that “there’s no good evidence” that GMOs are unsafe. “The deeper you dig,” he writes, “the more fraud you find in the case against GMOs. It’s full of errors, fallacies, misconceptions, misrepresentations, and lies.”

Saletan could find no room for a single mention of the nagging, unresolved safety questions involving new gene-editing biotechnologies like RNA interference or CRISP/Cas9, or to investigate industry claims about increased crop yields, or to note that while less than a handful of GM crops like the ringspot-resistant papaya (engineered to resist a virus that once threatened to wipe out the fruit from the Hawaiian islands) have definitely helped save a fruit crop, biotech corporations have largely focused on commodity crops like corn, soy, and cotton, where the profit margin is higher.

It’s not that he was crimped for space. He rambled on for 10,000 words, or about three times the length of a long-form magazine article. Although such details can annoyingly disrupt a story’s overall arc, they are newsworthy nonetheless. At the time his article was published (June 2015) the safety of these newer technologies was already generating robust debates among scientists.

You can find the same kind of superficial analysis of GMOs in this September 2014 Forbes piece (“The Debate About GMO Safety Is Over”), as well as in this August 2015 Scientific American article (“Why People Oppose GMOs Even Though Science Says They Are Safe. ”)

However, if you are looking for a somewhat more nuanced perspective about this technology, which has been around for only a couple decades, you might want to put aside media reports and official statements, and turn to “Genetically Engineered Crops: Experiences and Prospects,” a study published in May 2016 by the National Academy of Sciences. While many reports about the study claimed that the NAS had concluded that GE foods were “safe,” a fair reading of the NAS study reveals that the safety of GE products is much more complicated than you might think.

The truth is, the NAS study delves into both the benefits and problems associated with the biotechnology. While, as many of the new reports about the study noted, it found no evidence that eating genetically engineered food can cause adverse health effects, it also found no evidence that GE traits have provided measureable increases in overall crop productivity.  “Although emerging genetic-engineering technologies have the potential to assist in achieving a sustainable food system, broad and rigorous analyses will be necessary to determine the long-term health, environmental, social, and economic outcomes of adding specific crops and traits to an agroecosystem,” the report said.

This finding explodes the agrochemical industry’s oft-repeated claim that genetically engineered foods are a key to ending the problem of world hunger.

The NAS found that crop yields for corn, soybeans, and cotton have shown little or no improvements since GE varieties of these crops were first introduced in the early 1990s. Or as the study puts it, nationwide data “do not show a significant signature of genetic engineering technology on the rate of yield increase.”

Doug Gurian-Sherman, a scientist with the Center for Food Safety, said this finding “strongly implies that other factors, such as advances in conventional breeding methods, have played a critical role in raising crop productivity.”

While GMOs may not be a solution to world hunger, they may be a solution to sagging corporate profits.

The academy points out that roughly half of US land in crop production in 2014 was planted with genetically engineered seeds — mainly corn, soybeans and cotton — which command a premium price over conventional seeds. Almost all most of these crops were engineered with the ability to resist herbicides, insecticides, or a combination of the two. The sale of these pesticides is also a source of revenue for Big Ag corporations.

The 407-page study makes clear that there are other potential problems with the biotechnology. For example, it surveys the explosive evolution of herbicide-resistant superweeds and the rise of insecticide-resistant superbugs as a result common GMO cultivation practices that rely heavily on pesticides and herbicides.

It found that in many cases, GE crops that are engineered to include the bacterial toxin Bt are contributing to the evolution of insect pests that are resisting the Bt toxin, eroding the benefits of these crops. It also found that the use of herbicide-resistant crops, such as those that are engineered to withstand applications of the weed-killer glyphosate, “were initially correlated with decreases in total amount of herbicide applied per hectare of crop per year, but the decreases have not generally been sustained.”

Some weed species have even increased in abundance as herbicide-resistant crops have become widely planted, the NAS said.

Unfortunately, there are some significant gaps in NAS’ safety analysis too, such as its failure to mention that GE products have been found to cause harm to farmworkers when they are grown with the aid of synthetic pesticides such as glyphosate and 2,4-D, as they most often are. Both pesticides have been linked to cancer by the World Health Organization.

The academy also considered the potential hazards of emerging “gene-editing” biotechnologies like RNA interference (RNAi, also known as “gene silencing”) and “clustered regularly interspaced short palindromic repeats “ or CRISPR, which the food biotech industry is increasingly turning to. These technologies work by editing or altering certain genes in the crop itself to create traits such as disease resistance and drought tolerance (unlike first-generation GMOs that are created by inserting genes from other organisms into a crop.)

Interestingly, the version of the GMO labeling bill that Obama is scheduled to sign into law makes no mention of gene-editing technologies — an omission that critics say has been pushed by the biotech industry. Which means, as the bill stands now, crops or packaged foods that include gene-edited ingredients wouldn’t require labeling.

Unfortunately, at a time when we need more reliable information about the ramifications of these emerging technologies, the NAS’s discussion of them is rather superficial. For example, its section on RNAi focused almost solely on the findings of a white paper by Environmental Protection Agency scientists that is nearly three years old, but it failed to mention the safety warnings advanced in several newer studies.

These new studies suggest that genetically modified molecules produced by RNAi biotechnology may be reaching the human bloodstream. One controversial study even found they could damage a person’s health by compromising the human body’s ability to neutralize harmful types of cholesterol. This study’s findings have been wholly or partially confirmed by several other studies but have been dismissed here, here and here. The debate rages on.

The NAS believes that other gene-editing techniques, such as CRISPR may be capable to hitting the targeted genes more accurately than RNAi. However, the science is far from settled. Safety reviews of CRISPR technologies have yet to be completed.

Moreover, the NAS neglected to mention that the EPA is far from finished with its own safety review of RNAi technology.

In March 2016, after the agrochemical corporations Monsanto and Dow applied for an EPA permit to release SmartStax Pro, an RNAi-derived pesticidal corn product, the EPA announced it would take a closer look at the product’s safety this fall when it will convene its Scientific Advisory Panel (SAP).

SmartStaxPro corn seeds are engineered to release a toxin that kills the western corn rootworm, one of its main nemeses. It is one of the few RNAi-derived pesticidal products developed so far, but the EPA expects there will be more.

The EPA says it expects to make a decision on the SmartStaxPro application sometime next spring. Of course, if research studies had already proven that all GMOs are safe, there would be no point in conducting these safety reviews.

“This will be the first serious evaluation of agricultural RNAi technology done by the US government,” says Mardi Mellon, a science consultant for the Center for Food Safety, a food advocacy group. “Putting together another SAP to look at a specific RNAi crop suggests the agency is going to thoroughly consider the technologies’ risks.

Mellon notes that a review by of SmartStaxPro by the Food and Drug Administration “barely mentioned risks,” and that a review by the US Department of Agriculture “was superficial and deferred in part to the EPA review, which at the time had yet to be completed.”

Corporations like Monsanto that produce of genetically engineered seeds have responded to herbicide resistant weeds by “stacking” resistance to various combinations of herbicides like glyphosate, glufosinate, 2,4-D, and dicamba in their seeds.

But the NAS said that this strategy appears to be misguided. It recommended that farmers should attempt to delay the evolution of weeds that are resistant to herbicides by avoiding the practice of “simply spraying mixtures of herbicides.”

All of this goes to show that, in the absence of enough, thoroughly researched scientific information on the varied impacts of genetically engineered crops, including crops created using the next generation of genetic manipulation technologies, it’s not too much to want to know whether they are turning up in the food we put on the table.

Sadly, the version of the federal GMO-labeling bill we have now will allow companies to hide this information behind hard to read codes and links to websites that would require shoppers to have smartphones and Internet access. Seems like the “Deny Americans the Right to Know” or DARK Act is living up to its name.

Jul 192016

head-in-sandBy Sharon Begley (STAT)

WASHINGTON — At scientific meetings on genome-editing, you’d expect researchers to show pretty slides of the ribbony 3-D structure of the CRISPR-Cas9 molecules neatly snipping out disease-causing genes in order to, everyone hopes, cure illnesses from cancer to muscular dystrophy. Less expected: slides of someone kneeling on a beach with his head in the sand.

Yet that is what Dr. J. Keith Joung of Massachusetts General Hospital showed at the American Society of Hematology’s workshop on genome-editing last week in Washington. While the 150 experts from industry, academia, the National Institutes of Health, and the Food and Drug Administration were upbeat about the possibility of using genome-editing to treat and even cure sickle cell disease, leukemia, HIV/AIDS, and other blood disorders, there was a skunk at the picnic: an emerging concern that some enthusiastic CRISPR-ers are ignoring growing evidence that CRISPR might inadvertently alter regions of the genome other than the intended ones.

“In the early days of this field, algorithms were generated to predict off-target effects and [made] available on the web,” Joung said. Further research has shown, however, that such algorithms, including one from MIT and one called E-CRISP, “miss a fair number” of off-target effects. “These tools are used in a lot of papers, but they really aren’t very good at predicting where there will be off-target effects,” he said. “We think we can get off-target effects to less than 1 percent, but we need to do better,” especially if genome-editing is to be safely used to treat patients.

That, of course, is the hope of companies including Editas Medicine, which Joung cofounded, CRISPR Therapeutics, Caribou Biosciences, and Sangamo BioSciences, which all presented at the ASH workshop.

Off-target effects occur because of how CRISPR works. It has two parts. RNA makes a beeline for the site in a genome specified by the RNA’s string of nucleotides, and an enzyme cuts the genome there. Trouble is, more than one site in a genome can have the same string of nucleotides. Scientists might address CRISPR to the genome version of 123 Main Street, aiming for 123 Main on chromosome 9, only to find CRISPR has instead gone to 123 Main on chromosome 14.

In one example Joung showed, CRISPR is supposed to edit a gene called VEGFA (which stimulates production of blood vessels, including those used by cancerous tumors) on chromosome 6. But, studies show, this CRISPR can also hit genes on virtually every one of the other 22 human chromosomes. The same is true for CRISPRs aimed at other genes. Although each CRISPR has zero to a dozen or so “known” off-target sites (where “known” means predicted by those web-based algorithms), Joung said, there can be as many as 150 “novel” off-target sites, meaning scientists had no idea those errors were possible.

One reason for concern about off-target effects is that genome-editing might disable a tumor-suppressor gene or activate a cancer-causing one. It might also allow pieces of two different chromosomes to get together, a phenomenon called translocation, which is the cause of chronic myeloid leukemia, among other problems.

Many researchers, including those planning clinical trials, are using web-based algorithms to predict which regions of the genome might get accidentally CRISPR’d. They include the scientists whose proposal to use CRISPR in patients was the first to be approved by an NIH committee. When scientists assure regulators that they looked for off-target effects in CRISPR’d cells growing in lab dishes, what they usually mean is that they looked for CRISPR’ing of genes that the algorithms flagged.

As a result, off-target effects might be occurring but, because scientists are doing the equivalent of the drunk searching for their lost keys only under the lamppost, they’re not being found.

One little-appreciated feature of CRISPR’s DNA-cutting enzyme is that it doesn’t stop at one. Even if the enzyme cuts its intended target, the risk of off-target cutting remains. The enzyme “still has energy to bind with off-target sites,” Joung said, so “it can still cleave those sites.”

Scientists from some of the leading genome-editing companies said they are confident they will be able to minimize off-target CRISPR’ing, by picking “high-quality” guide RNAs, among other methods. While “bad” RNAs hit as many as 152 wrong targets, studies show, good ones hit only one, and the algorithms “capture most of” the potential off-target effects, said Dr. Bill Lundberg, chief scientific officer of CRISPR Therapeutics. Still, he conceded, “At the end of the day we’re taking a cell where we can’t predict a priori where the edit has happened.”

Scientists have recently recognized another reason to worry about off-target effects: No two people’s genomes are identical. Off-target-identifying methods, which are based on a composite or “reference” human genome, might indicate that there are no stretches of DNA that CRISPR can mistakenly snip. But because of random mutations and genetic variations, some patients might have additional “123 Main Street”s, attracting CRISPR and its DNA-cutting enzyme where they’re not supposed to go.

“There are a significant percent of sites, more than I would have thought,” where that might happen, said Joung, “and it varies by ethnic group.”

Said Andrew May, chief scientific officer of Caribou: “There is going to have to be some consideration of that” as genome-editors try to bring CRISPR to patients.

Jul 122016
Golden Rice grain compared to white rice grain in screenhouse of Golden Rice plants. IRRI Photos

Golden Rice grain compared to white rice grain in screenhouse of Golden Rice plants. IRRI Photos

by  Ted Greiner, PhD (Independent Science News)
What better way to discredit your critics than to rope in 107 naive Nobel Prize winners (all without relevant expertise) to criticize your opposition?

But such tactics are not new. Long ago, the GMO industry spent well over $50 million to promote “Golden Rice” as the solution to vitamin A deficiency in low income countries. They did so well before the technology was completely worked out, let alone tested. Let alone consumer acceptability tested. Let alone subjecting it to standard phase 2 and 3 trials to see if it could ever solve problems in the real world.

So why has this apparently straightforward scientific project not reached completion after so many decades?

Because the purpose of Golden Rice was never to solve vitamin A problems. It never could and never will. It’s purpose from the beginning was to be a tool for use in shaming GMO critics and now to convince Nobel Laureates to sign on to something they didn’t understand.

I worked with a conventional fortified rice technology (Ultra Rice) for years for the NGO PATH in several countries. It became clear to us that rice-consuming populations were extremely picky about their rice and unwilling to accept even the tiniest changes in its appearance, smell or taste.

They are now to be convinced to eat rice that’s bright yellow in color? That will never happen on any large scale. If it does, it will be because a huge investment was made to overcome consumer resistance. Money that COULD have been spent to convince people simply to eat the low-cost plant foods easily available in all countries that can prevent vitamin A deficiency.

Consumer resistance has special importance among the really poor people for whom Golden Rice actually might otherwise prove useful. That’s because when rice is poorly stored it can be infected with a yellow mould causing the deadly “yellow rice disease” (beriberi) if consumed. Only a decade ago this was thought to have killed dozens of male sugar workers in the Maranhao region of Brazil (Rosa et al., 2010). Is that really a type of consumer resistance we want to debunk?

The Rosa paper does not prove that the epidemic and accompanying deaths in Brazil were due to the mould, just that the mould was present in rice in the area of the outbreak. However, Brazilian authorities we talked with in 2007 believed that the mould was almost certainly involved and probably the main cause. But one does see beriberi in the East (this is the first large-scale outbreak in the West) among hard working men who drink a lot of alcohol and eat mainly white rice.

Penicillium citreonigrum Dierckx is the name of the mould that turns rice yellowish. Another can turn it brownish. Infected rice does not really look like Golden Rice. My point is rather that people in places where rice often gets wet during storage generally know that yellow rice is dangerous.  Telling them that yellow rice is safe—a message Golden Rice will have to trumpet–sounds like a typical self-serving message that has the additional disadvantage of putting people in danger. Teaching them WHICH appearance safe vs unsafe rice has is again getting into pretty great detail and expense.

In Bangladesh I was involved with a communication NGO, the Worldview International Foundation, that worked with 10 million people to convince them to grow and consume high-carotene foods. We conducted a large-scale evaluation to see if it worked. It did. It cost only $0.15 per capita—though this was over two decades ago. But it also had many side benefits, such as the other nutrients contained in fresh vegetables (Greiner and Mitra, 1995).

The signatures of 107 Nobel Laureates do not prove that Golden Rice is safe or effective—but they do prove that, no matter how good scientists are in their own narrow fields, they are often no smarter than any of the rest of us about many other things. Sometimes their egos even get the best of them and they go out on a limb and say things without properly researching them first, especially when other smart people have already come out and done so. The people who designed Golden Rice clearly were also unaware of “yellow rice disease”, with much less excuse. (Or they were and had no scruples.)

And if you have read this far, pat yourself on the back! You now know more than 107 Nobel Laureates about something concerning which they signed a letter; sadly putting their scientific reputations on the line.

Ted Greiner, PhD is former Professor of Nutrition, Hanyang University, Korea


Encyclopedia of Food Mycotoxins  (2001) by Martin Weidenbörner.

Greiner T. and Mitra S.N. (1995) Evaluation of the impact of a food-based approach to solving Vitamin A deficiency in Bangladesh. Food and Nutrition Bulletin 16 (3) 193-205.

Rosa et al., (2010) Production of citreoviridin by Penicillium citreonigrum strains associated with rice consumption and beriberi cases in the Maranhão State, Brazil. Food Additives & Contaminants: Part A. 27 (2):

Jul 062016

by Jonathan Latham, PhD (Independent Science News)

Greenpeace was denied entrance yesterday (June 30) to a National Press Club Event in Washington, DC of 107 Nobel Laureates. The event was ostensibly organised by a scientific group calling itself Support Precision Agriculture to publicise a letter signed by 107 Nobel Laureates demanding that Greenpeace cease its opposition to “golden rice” and GMO technology in general. Greenpeace was attempting to attend the event. However, senior research specialist on GMOs, Charlie Cray, accompanied by Tim Schwab, senior researcher from Food and Water Watch were both physically prevented from entering the Press Club.

We were told that only credentialed Press were allowed.” Schwab told Independent Science News.

According to Schwab “I then saw Greg Jaffe from the NGO Center for Science in The Public Interest (CSPI) entering the room.” Informed of this, the security person changed his story: some NGO’s were invited to attend.

National Press Club, Washington, DC

National Press Club, Washington, DC

Afterwords, Schwab told us “Some NGOs were invited: Really?  Why not Greenpeace—the subject of this campaign?

Nor was the security person just anyone. Schwab and Cray recognised him as Jay Byrne. Byrne is the former head of corporate communications for Monsanto (1997-2001).

Byrne now heads the biotech public relations outfit v-Fluence and is heavily involved in biotech-academic PR. Typical of his style was a contribution to the book “Let Them Eat Precaution” published in 2005 by the American Enterprise Institute and edited by Jon Entine of the Genetic Literacy Project.

The Genetic Literacy Project promotes biotechnology. Its strapline is “Science Trumps Ideology”. Asked by Cray and Schwab why he was minding the door, Byrne claimed he was “strictly a volunteer“.

Charlie Cray, the Greenpeace researcher later tweeted this:

Charlie Cray Tweet re Jay Byrne

Charlie Cray Tweet re Jay Byrne

According to the website GMWatch, the url: has an inoperative sister: that is traceable back to the Genetic Literacy Project.

Addendum (12:56 pm): The list of signatories includes Alfred G Gilman, who died last year (on Dec 23 2015).

Jun 292016

160622-esveltDisclaimer: This article is interesting as it expresses the concerns of a scientist deeply involved in the synbio and in particular gene-drive fields (his team figured out how to make dene-drives work!), and highlights just how under-regulated current experiments are.  We don’t condone the research described in the article, or necessarily agree with the alternative regulation proposed. Please see Friends of the Earth US’s blog post on why gene-drives should not be used outside of the lab.


When queried about the present state of biotechnology, Kevin Esvelt tends to sound more like a science skeptic than a pioneer of one of the most subversive genetic engineering technologies of all time.

“We are walking forwards blind,” Esvelt told me recently, chastising his field. “We are opening boxes without thinking about consequences. We are going to fall off the tightrope and lose the trust of public. Lots of people are going to die.”

Two years ago, Esvelt and his colleagues were the first to suggest that the gene-editing technology Crispr could be used to create what’s known as a gene drive, a formidable tool that can be used to override natural gene selection during reproduction to ensure that a desired trait is passed down throughout generations. Using gene drives, scientists could potentially alter the entire population of a species. It is a proposition that is at once both spectacular and terrifying.

Ever since putting the idea out there, Esvelt has been hard at work warning the world just how dangerous it might be. He worries that a lab might let loose a genetically modified species that dramatically reshapes the natural world as we know it. Worse, he worries that there’s nothing in the scientific community’s current system of regulation that would prevent that from happening. Unless it’s research happening on humans, gene drive work contained within the lab is not subject to very much regulatory scrutiny. The current system, he warns, is outmoded and “too risky.”

“I occupy a strange position,” said Esvelt, who at 33 heads up MIT’s Sculpting Evolution Lab. “I am probably the foremost critic of genetic engineering and yet I am also someone at the forefront of the work I critique.”


“We are opening boxes without thinking about consequences.”

You are unlikely to find a work of modern science that more clearly demonstrates man’s prowess over nature than the gene drive. In nature, the odds of either parent bestowing their own genetic characteristics upon their offspring are a 50-50 split. The gene drive is a genetic hack that subverts the very nature of reproduction, forcing propagating genes to prioritize the genetics of one parent over the other so that nearly every offspring receives a particular gene-driven trait. Scientists could, for example, engineer a mosquito to produce only male offspring, drastically limiting the ability of diseases like malaria or Zika to spread.

Wyss Institute at Harvard

In A, an organism carrying one copy of an altered gene only passes it along to half of its offspring. In B, using a gene drive, nearly all offspring receive the altered gene.

Gene drives exist in nature, and scientists have talked about replicating them for years, but Esvelt is the guy that figured out how to actually make it work. Using the highly precise Crispr-CAS 9 gene-editing system, Esvelt and his colleagues discovered they could make a desired trait cut and copy itself into every future generation. Esvelt’s technique means that scientists now have the power to change a species’ genetic make-up over just a few generations.

Let your imagination run wild and the allure of this idea is limitless. Save people from malaria! Save Hawaii’s wild birds! Save redheads from going extinct!

But the potential consequences are as perilous as the possibilities are glittering. As those malaria-fighting male mosquitos go on to mate with other mosquitos in the wild, they could also wind up wiping out the global mosquito population. What would happen if we accidentally killed off all the mosquitos? What else would die with them? What scientist alone is equipped to decide to take that kind of risk? This is the thought experiment with which Esvelt is concerned.

“It is impossible for a single scientist to anticipate the consequences of their work,” he said. “We need a different approach.”

The approach Esvelt is advocating for is to open the lab coat, so to speak.

When Esvelt and his colleagues published their 2014 paper floating the idea of using Crispr to make gene drives viable, it was just theoretical. They hadn’t actually created a gene drive in the lab. But in the two years since their paper came out, gene drives have been demonstrated to work in four different species. That wasn’t what Esvelt wanted. He had hoped other scientists would follow their lead, allowing fellow scientists and the public to vet experiment proposals and their potential consequences before putting the gene drive to use.

The root of Esvelt’s concern is that scientists, like the rest of us, sometimes make mistakes. Those accidents can result in incredible discoveries, such as when Alexander Fleming discovered penicillin in 1928 by, essentially, leaving his lab window open. Other mistakes breed disaster. Many suspect, for example, that the 1977 flu epidemic was the result of a laboratory accident.

Esvelt would like to see scientists thinking not just about science, but about the ethics of science—about what might happen should their experiment go awry. This month Esvelt, along with MIT political scientist Kenneth Oye and Harvard social scientist Sam Weiss Evans, launched Responsive Science. The project is an online space where they hope competing scientists will publish research plans and proposals before going ahead with them. Then, he hopes, other experts in the field will weigh in, giving them feedback on their proposals.

Esvelt and colleagues published their first paper there last week, about a way to create gene drives with a kind of self-destruct button, which would, in theory, reduce the amount of harm a gene drive could do to a wild population.

“How much better would it be if all this research was just out there online?” he said. “Science would become more efficient and faster and we would have a better sense of what the consequences of the work would be.”

The project, said Christopher Scott, a biomedical ethicist at Baylor University who is not associated with Esvelt, is just common sense.

“Scientists should be more upfront and engaged in their research in public,” said Scott. But there are forces that work against that transparency. Because of the pressures on scientists to be the first to publish on a new discovery, scientists often keep their work secret until the last minute.

“Thoughtful and thorough engagement with issues like gene drives requires thinking well beyond the science involved, and that takes time, but that is time that traditional metrics of advancement in academia are against,” Responsive Science founder Evans told me.

“To proceed with technology that will shape the global commons without public discussion is not only unethical, it’s delusional.”

But Esvelt’s concerns go beyond the potential catastrophic screw up: scientists, he believes, should not be in charge of making ethical decisions about technologies that could change the world. Imagine how the public would have responded had scientists of the Manhattan Project disclosed that they were working on a nuclear bomb. Would that research have moved forward? Would we have dropped bombs on Japan or entered the nuclear arms standoff that still exists today?

Esvelt wants to see scientists working more with local communities where their experiments might take place. As part of a plan to engineer mice that are immune to Lyme disease in an attempt to curb the disease’s spread in the wild, Esvelt talked about the project at a community meeting in Nantucket, where he might eventually release such mice, before even going ahead with early stages of the experiment.

“To proceed with technology that will shape the global commons without public discussion is not only unethical, it’s delusional,” said Esvelt’s collaborator, Oye.

Esvelt realized a more aggressive strategy for promoting caution among scientists was needed after he got wind of an unpublished paper by researchers who had created a gene drive to turn normal fruit flies yellow after a reporter forwarded a copy to his mentor, the eminent Harvard geneticist George Church.

Church’s own lab, where Esvelt once worked, has long advocated openness when it comes to high-risk experiments. Church told me that it’s important to “encourage multiple views of all proposals in advance.” This he said, will “reduce corner-cutting,” stimulate public engagement, and increase the chances of someone noticing something either “unexpectedly risky” or beneficial.

Both Esvelt and Church were horrified to find that the original paper—with the ominous-sounding title “The mutagenic chain reaction”—barely discussed the precautions necessary when working with gene drives. The researchers had been cautious in their own work to make sure that their mutant yellow flies didn’t get out, but Esvelt felt that they hadn’t taken enough steps to ensure containment. And most alarming, their paper offered little advice to researchers who might try to replicate their work about the importance of making sure the yellow flies never escape. (In the version of the paper published, the cautionary tone was significantly amped up.)

Evelt called the fruit fly experiment a “case study” in the dangers of closed-door science—when working at lab-level, it can be difficult to anticipate the consequences from a bird’s-eye view.

“Fruit fly geneticists are not especially known for keeping their flies in the lab. It’s nearly impossible,” he said. “I thought to myself, ‘If someone releases a gene drive into wild fruit flies, people will not trust us to do fruit fly genetics anymore.’”

Historically in genetic engineering, Mother Nature kills off mutant traits that escape into the wild. If a yellow fruit fly mated with a wild fruit fly, natural selection would likely weed out that yellow gene in favor of the color that has over time evolved to help the fly best survive its natural habitat. But add in a gene drive, and you could turn every fruit fly in the world a lovely shade of mustard.

For this reason, earlier this month, the federal National Academies of Sciences issued a report assessing the risks of gene drive technology. “The fast-moving nature of this field is both encouraging and a point of concern,” the report said, asking that scientists take heed of “social, environmental, legal, and ethical considerations” to develop the technology responsibly. The report ultimately concluded that the potential benefits are too great to not proceed with “carefully controlled field trials.”

Esvelt thinks that the report missed a major point: there’s not really a great way to “control” experiments in the wild. At least not yet.

Efforts are already moving along to develop gene drives that could eliminate mosquitos carrying malaria, Zika, and dengue fever. The malaria project, being conducted by Imperial College London, has received more than $40 million in funding from the Gates Foundation and hopes to release its mosquitos in Africa by 2029.

“We haven’t seriously screwed up in the laboratory yet. Sometimes that surprises me.”

The real hurdle to enacting Esvelt’s open-source science plan will be convincing enough scientists to sign on. Esvelt hopes that journals and grant funders like the Gates Foundation will start requiring scientists to vet their experiments via a method like his before experimenting.

“It will take a while,” said Church, whose lab is also committed to the project. “[But] all it takes is one fairly major player like the Gates Foundation to get on board in order to nudge it along.”

(When asked about Esvelt’s proposal, Scott Miller, deputy director of R&D for the Gates Foundation’s malaria program, said that while they support “a transparent and inclusive approach to the development of guidance on gene drive research,” it seems “premature to comment on specific proposals to regulate R&D.”)

Other scientists, in fact, have previously argued for the opposite. At a meeting of the National Academies back in 2014 where Oye was presenting gene drives and public safety, he recalls one scientist who stood up and said, essentially, “don’t tell the Muggles what’s going on here with the dark arts.”

And in a comment on a piece by Esvelt and Oye in Science arguing for openness, the neuroscientist David Gurwitz argued that all technical information concerning gene drives should be kept confidential. This, he said, was because “in the wrong hands” such technology might be used for nefarious purposes.

That risk, Esvelt believes, is far smaller than the risk that an unwitting scientist might accidentally make a devastating mistake—perhaps not a mistake large enough to wreck the ecosystem, but certainly one large enough to stymy scientific progress.

“We haven’t seriously screwed up in the laboratory yet. Sometimes that surprises me,” he said. “And we can’t afford that right now. We need science. Our world is fundamentally unsustainable and we need to invent our way out of it. If we misuse our power, we lose the trust. That is the tightrope we walk.”

Jun 152016
Sugars derived from stevia are being widely incorporated into leading soft drinks such as Coca Cola Life and Pepsi True. Mike Mozart via Flickr

Sugars derived from stevia are being widely incorporated into leading soft drinks such as Coca Cola Life and Pepsi True. Mike Mozart via Flickr

by Stacy Malkan (The Huffington Post)

Our culture is smitten with the notion that technology can save us – or at least create great business opportunities! Cargill, for example, is working on a new food technology that mimics stevia, a sugar substitute derived from plant leaves, for the “exploding sports nutrition market.”

Cargill’s new product, EverSweet, uses genetically engineered yeast to convert sugar molecules to mimic the properties of stevia, with no need for the plant itself.

It was developed using synthetic biology (or “synbio” for short), a new form of genetic engineering that involves changing or creating DNA to artificially synthesize compounds rather than extract them from natural sources – a process sometimes referred to as GMOs 2.0.

On June 1, U.S. Food and Drug Administration cleared the way for EverSweet with a “generally recognized as safe” (GRAS) designation. Eventually it could be used in “everything from dairy to tabletop sweeteners and alcoholic beverages, but low or zero calorie beverages are the sweet spot,” according to Food Navigator.

And so begins the next new food technology revolution: corporations racing to move food production from the land to the lab without laws or regulations in place that require scientific assessments or transparency.

How will they sell synthetic biology to consumers?

A big challenge facing synthetic biology is that today’s consumers want fresh natural foods with simple clear labels – what Food Business News dubbed the “trend of the year” last year.

“Why would we want synbio foods?” Eve Turrow Paul, a writer and corporate brand advisor, asked rhetorically in The Huffington Post. “Well, a few reasons. Number one on the list is climate change.”

Climate change is the number one reason for synthetic biology? What about capturing the exploding sports nutrition market?

Therein lies the PR challenge facing new food technologies: how to position food products created with strange-sounding lab techniques for the purposes of patents and profits as something safe that actually benefits consumers.

The largest agribusiness, food and synthetic biology companies got together in San Francisco in 2014 to discuss this PR challenge.

Dana Perls of Friends of the Earth, who attended the meeting, described it as “an alarming insight into the synthetic biology industry’s process of creating a sugar-coated media narrative to confuse the public, ignore the risks, and claim the mantle of ‘sustainability’ for potentially profitable new synthetic biology products.”

PR strategists at the meeting recommended avoiding terms like “synthetic biology” and “genetic engineering” (too scary, too much backlash), and suggested going with more vague descriptions such as “fermentation derived” and “nature identical.”

They recommended focusing the media on stories of hope and promise, capturing public emotion, and making food activists “feel like we are we are all marching under the same banner” for food sustainability, transparency and food sovereignty.

Targeting transparency

Somebody was listening. The story about Cargill’s big stevia opportunity didn’t mention genetic engineering or synthetic biology, but did describe “fermentation as a path.” It ended with a promise that Cargill has nothing to hide about how the ingredients are made and will clearly and accurately label products.

“We have targeted this space in a completely transparent manner,” said Steve Fabro, Cargill global programs marketing manager.

The new ingredient coincides with big changes at Cargill. After two years of declining profits, America’s largest private company is repositioning itself “to satisfy consumers in Western markets who are shying away from the mainstream food brands that rely on low-cost, commoditized ingredients that have been the specialty of companies like Cargill,” reported Jacob Bunge in the Wall Street Journal.

Consumers “want to know what’s in their food, who made it, what kind of company is it, are they ethical, how do they treat animals?” Cargill Chief Executive David MacLennan told Bunge.

With synthetic biology ingredients, that could prove to be a challenge.

When asked exactly how they plan to label EverSweet, Cargill communications lead Kelly Sheehan responded via email,

Consumers should be able to tell the difference on a label between stevia from leaf and steviol glycosides produced through fermentation. Stevia from leaf in the US is currently labeled as ‘stevia leaf extract.’ EverSweet will be labeled in the US as ‘steviol glycosides’ or ‘Reb M and Reb D.’ In the EU the expectation is EverSweet would receive a modified E number to differentiate the two products.

Sheehan added, “Cargill is committed to transparency and sharing product information at from ‘stevia leaf extract’ to ‘non-GMO stevia leaf extract.’”

Confusing? Perhaps, but labeling decisions may be left up to the companies. As with first-generation GMOs, labeling is not required in the U.S. (although Vermont will require GMO labeling starting July 1 unless Congress intervenes) and companies are free to market their products as “natural” (although FDA is reviewing use of that term). There are no safety standards and no testing requirements for foods developed with synthetic biology.

This lax system pleases the companies eager to patent new food technologies.

As Perls described the synthetic biology PR meeting, “A clear theme at the meeting was that the fewer government regulations the better, and industry self-regulation is best. There was a general consensus in the room that the public should not be concerned about a lack of data on safety; however, the internal and self-funded corporate studies are proprietary and cannot be shared with the public.”

Where have we heard this story before?

Proprietary information, patents, lack of transparency and industry self-scrutiny have been the hallmarks of first-generation GMOs – and the fuel for growing consumer distrust and demands for transparency that have caught the food industry off guard.

The corporations that profit from traditional GMOs – primarily Monsanto, Dow and other big chemical-seed companies – have responded to the backlash as big corporations often do: by throwing huge amounts of money at PR operations to attack critics and spin their products as necessary to feed the world.

The marketing promises have failed to materialize. A May 2016 report by the National Academy of Sciences found no evidence that GMO crops had changed the rate of increase in yields, and no clear benefits for small, impoverished farms in developing countries.

Nevertheless, GMO proponents claim, as Bill Gates did in a Wall Street Journal interview, that Africans will starve unless they embrace climate-friendly, vitamin-enriched GMO crops. Gates neglected to mention that these crops still don’t exist after 20 years of trials and promises.

Instead, most genetically engineered crops are herbicide-tolerant crops that are raising concerns about health problems linked to chemical exposures. These crops have increased sales of chemicals owned by the same corporations that own the patents for GMO seeds – an excellent profit model, but one that is turning out to be not so great for health and ecology.

The promise of synthetic biology

The same sorts of promises that failed to materialize in 20 years of GMO crops are fueling the buzz around next-generation genetic engineering.

Synthetic biology techniques “could deliver more-nutritious crops that thrive with less water, land, and energy, and fewer chemical inputs, in more variable climates and on lands that otherwise would not support intensive farming,” reported Josie Garthwaite in The Atlantic.

While proponents focus on possible future benefits, skeptics are raising concerns about risks and unintended consequences. With no pre-market safety assessments for synthetic biology foods, environmental and health impacts are largely unknown, but critics say there is one area in which the dangers are already apparent: economic damage to indigenous farmers as lab-grown compounds replace field-grown crops. Farmers in Paraguay and Kenya, for example, depend on stevia crops.

“By competing with poor farmers and misleading consumers about the origins of its ingredients, EverSweet and other examples of synthetic biology are generating bitterness at both ends of the product chain,” wrote Jim Thomas and Silvia Rabiero of The ETC Group in Project Syndicate.

The path forward for synthetic biology

As battle lines get drawn on the new food frontier, some difficult questions arise. How can we ensure that innovations in agriculture benefit society and consumers? How can new food technologies developed to capture markets, patents and corporate profits ever prioritize sustainability, food security and climate change solutions?

It’s going to take more than marketing slogans, and the clock is ticking to figure it out as new technologies race forward.

As Adele Peters reported in Fast Company, a new gene morphing technology called CRISPR, which makes it “possible to quickly and easily edit DNA,” is coming to a supermarket near you.

“If editing a single gene might have taken years with older techniques, now it can happen in a matter of days with a single grad student,” Peters reported.

What could possibly go wrong?

In April, the U.S. Department of Agriculture decided that a CRISPR mushroom will not be subject to regulation.

On June 1, scientists announced the start of a 10-year project that aims to synthetically create an entire human genome. The project is called Human Genome Project – Write, “because it is aimed at writing the DNA of life,” reported Andrew Pollack in The New York Times.

On June 8, the National Academy of Sciences released a report about “gene drives,” a new type of genetic engineering that can spread gene modifications throughout an entire population of organisms, permanently altering a species.

Gene drives “are not ready to be released into the environment,” NAS said in its press release calling for “more research and robust assessment.” Unfortunately, the NAS report failed to articulate a precautionary regulatory framework that would protect people and the environment.

Could synthetic biology, gene editing and gene drives have benefits for society? Possibly yes. But will they? And what are the risks?

If corporations are allowed to deploy genetic engineering technologies for commercial gain with no government oversight, no independent scientific assessments, and no transparency, benefits to society will be left off the menu and consumers will be in the dark about what we’re eating and feeding our families.

Stacy Malkan is the co-director of U.S. Right to Know, a nonprofit food industry research group. She also does consulting work with Friends of the Earth. Follow her on Twitter @StacyMalkan

Jun 102016

mosquitoby Jim Thomas (The Guardian): ‘Gene drives’ seem to be the ultimate high-leverage technology. Yesterday’s report from the US National Academies begun the job of describing what is at stake, but it missed some important questions.

If there is a prize for the fastest emerging tech controversy of the century the ‘gene drive’ may have just won it. In under eighteen months the sci-fi concept of a ‘mutagenic chain reaction’ that can drive a genetic trait through an entire species (and maybe eradicate that species too) has gone from theory to published proof of principle to massively-shared TED talk (apparently an important step these days) to the subject of a US National Academy of Sciences high profile study – complete with committees, hearings, public inputs and a glossy 216 page report release. Previous technology controversies have taken anywhere from a decade to over a century to reach that level of policy attention. So why were Gene Drives put on the turbo track to science academy report status? One word: leverage.

What a gene drive does is simple: it ensures that a chosen genetic trait will reliably be passed on to the next generation and every generation thereafter. This overcomes normal Mendelian genetics where a trait may be diluted or lost through the generations. The effect is that the engineered trait is driven through an entire population, re-engineering not just single organisms but enforcing the change in every descendant – re-shaping entire species and ecosystems at will.

It’s a perfect case of a very high-leverage technology. Archimedes famously said “Give me a lever long enough and a fulcrum on which to place it, and I shall move the world. ” Gene drive developers are in effect saying “Give me a gene drive and an organism to put it in and I can wipe out species, alter ecosystems and cause large-scale modifications.” Gene drive pioneer Kevin Esvelt calls gene drives “an experiment where if you screw up, it affects the whole world”.

Its not the first very high-leverage technology. Nuclear power is similar, and solar geoengineering holds the promise of global changes from small interventions. Indeed historians may well look back on last year’s proof of the ‘mutagenic chain reaction’ as biology’s ‘nuclear’ moment – analogous to Enrico Fermi’s proof of the nuclear chain reaction three quarters of a century earlier. Like the nuclear chain reaction, initiating a mutagenic chain reaction denotes awesome power over the future and has significant geopolitical ramifications. From an evolutionary perspective a gene drive might be better regarded as a ‘gene bomb’: dropped into the normal course of inheritance, it annihilates natural variety and captures the course of a species evolution from that point in time onwards. It may even annihilate the species itself. Because it spreads in the environment, a gene drive also exerts power over geography and may be a tool for controlling agriculture, food security and land. Were the National Academy of Sciences right to rush out a gene drive policy study at high speed? You betchya.

And yet reading the final result , ‘Gene Drives on the Horizon’ it appears that the very thing that drove the politics to get such a report published, that awesome and troubling political power that gene drives hold, is bizarrely underplayed. Its not that it is a bad report – it is even excellent in places: it takes seriously the threat to biodiversity and warns strongly against environmental release. It has important things to say about the need for both ecological assessment and genuine public engagement . It even dares to assert that “the outcomes of engagement may be as crucial as the scientific outcomes to decisions about whether to release a gene-drive modified organism into the environment.”

Yet for all that (and 200 pages of text too) the NAS’s report fails to deliver a robust policy study because it ducks some of the most important questions. It would be fair to say that there are at least four explosive issues looming “on the horizon’ for the topic of gene drives: Militarization, Commercialization, Food Security and Biodiversity. The report tackles only the last of these and downplays or entirely ignores the remaining three. Why it looked the other way on these crucial questions is hard to fathom. The NAS study was co-funded by DARPA ( a US military agency) and the Bill and Melinda Gates Foundation. Both institutions are significantly invested in gene drive research. Is there a connection?

Directly addressing militarization should have been obvious. There are many scenarios for potential weaponisation of gene drives as well as serious potential ramifications from unintended effects. Imagine for a moment that a hostile actor could crash the harvest of an island state by quietly introducing a gene drive or could insert a gene drive into a biting insect population to deliver toxins. Gene drive technology will quickly and inevitably end up controlled by powerful military actors and decisions on gene drive use and development will be determined by geopolitical and security considerations as well as commercial and trade interests. The same US defense research agency (DARPA) who paid for the NAS study have made it known that they are going all-in on gene drive research and development of ‘robust’ synthetic organisms. There is good reason to be worried.

As a result of playing down weaponisation concerns the report entirely failed to recommend two of the most highly relevant international governance instruments that will need to brought into play to respond to the security threats posed by gene drives. The UN Environmental Modification treaty (ENMOD) was negotiated to address exactly the sort of intentional environmental modifications that gene drives would deliver. ‘Environmental modification’ includes any technique for deliberate manipulation of natural processes – the dynamics, composition or structure of the earth, “including its biota” – so ENMOD fits gene drive governance perfectly. Meanwhile the Biological Weapons Convention (BWC) has already begun to discuss gene drives.

The report also entirely fails to acknowledge the strong commercial drivers that may bring gene drives into agricultural use. Here commercial interests could potentially derail precautionary governance. So far, public discussion of gene drives has been intentionally framed by speculative health and conservation applications such as eradicating malarial mosquitoes. However it is the agricultural applications that could eventually come to dominate. The NAS committee considered one agricultural case study of engineering wild pigweed to be susceptible to Roundup herbicide, but failed to address how an application like this would clearly enhance the agricultural monopoly of Monsanto – the maker of Roundup – and how its use would transform agriculture and food systems. The report did note that if pigweed in North America was suppressed by a gene drive it could inadvertently end up reducing harvests of its close relative amaranth, an important food source in South America. Ouch.

This lack of of consideration of food security implications is a particularly significant gap since the key published patent application on gene drives, held by Harvard University, includes a long list of over 50 weeds and almost 200 herbicides that the technology could be used for, thereby laying out a business case for licensing the patent to agrochemical companies. Neither Harvard nor any other private entity should have the power to license this high leverage technology to private agribusiness. Ideally all intellectual property relating to gene drives should be surrendered to a neutral international body under multilateral UN governance. This would be analogous to the steps that taken by governments to control intellectual property around nuclear technologies.

The NAS report correctly states that “a gene drive knows no political boundaries” and identifies the UN Convention on Biological Diversity (CBD) and its protocols as one of the key international governance bodies that must address gene drive governance (the three that it fails to mention are ENMOD, the Biological weapons Convention and the UN Committee on World Food Security).

This debate now has to move quickly to that international arena. In Cancun in December 2016 the 194 countries that are parties to the CBD will be making decisions on governance of synthetic biology at the thirteenth conference of the Parties (COP13). Gene Drives are synthetic biology and should be addressed there too. At the least the CBD should take note of this NAS report and also the warning comments about gene drives made by its own Ad Hoc Technical Expert Group on Synthetic Biology in order to agree an international moratorium on release of gene drives. Luckily, this would be in line with the NAS’s key recommendation that “there is insufficient evidence to support the environmental release of gene drives.” Could Gene Drives go from proof of principle to UN decision in under two years? Now that would be responsive governance.

Jun 092016
Friends of the Earth US

Friends of the Earth US

by Dana Perls, Food and Technology campaigner (Friends of the Earth US)

No commercial or environmental release of gene drives, says Friends of the Earth

The National Academies of Sciences released a new report today, which calls for robust safety assessments for “gene drive modified organisms.” The NAS says the controversial new genetic engineering technology is not ready for release into the environment.

These genetic engineering technologies under development go far beyond genetic engineering as we’ve seen it, and raise threats to food security, biodiversity and human safety. The NAS describes gene drives as “stimulating biased inheritance of particular genes to alter entire populations.” In other words, gene drives force a genetically engineered trait to be expressed in every single generation, driving engineered traits through an entire species to permanently change it or cause it to go extinct.

What could possibly go wrong?

While the NAS report offers thoughtful insights and useful warnings about gene drives, it falls far short of offering a blueprint for responsible governance to ensure that the technology will not be used for hostile purposes, reckless corporate profit or at the expense of health and the environment.

There is only one responsible path forward for gene drives — we need a moratorium on commercial or environmental releases of this technology. There must be strong and clear international regulations and oversight. We must ensure that corporations and governments (particularly militaries) are not developing gene drives and cannot misuse this technology in ways that could have profound ecological, health or socio-economic impacts. There must be strict regulations on lab research, especially given the risk of accidental escape of gene drive organisms, even from high security labs.

Gene drives are a brand new technology, with the first example of a working gene drive announced in January 2015. Development is racing forward, however, to date, there are no environmental assessments of gene drives. Although there are no scheduled environmental or commercial releases yet, the push for development, commercialization and intellectual property rights is moving fast. Already researchers and investors are proposing releases of gene drives in the U.S., in Hawaii (in mosquitoes) and Nantucket (in mice), absent of conversation about alternatives, less risky and more vetted conservation and health strategies.

The NAS report notes that public engagement is important, but the issue of gene drives goes far beyond public dialogue or notification. The morals and ethics of reengineering life in this way must be at the forefront of creating strict regulatory frameworks that will ensure strong global governance to prevent hostile or dangerous misuse.

We aren’t talking about manipulating nature with conventional breeding. Gene drives allow biotech companies to engineer and manipulate life in ways that traditional breeding never could or will do. As discussed in the report, gene drives could be released into wild pigweed, for example, to make all pigweed more susceptible to man-made herbicides like RoundUp, or to exterminate pigweed populations altogether, with little understanding of the broader implications.

How is the technology most likely to be used? Although public discussion has focused mostly on the potential for reengineering insects to not carry disease, funding of the NAS report by the Defense Advanced Research Projects Agency and the Gates Foundation indicates the interest for military use and agricultural purposes.

Gene drives raise many ethical, environmental and moral concerns. Below are a few:

  • Effects are irreversible — Gene drives intend to permanently alter a species, with the potential for irreversible ripple effects, including possibly wiping out a species entirely, whether intentionally or by accident. Driving a specific trait through a population, plants or other organisms could also lose the natural diversity that enables survival and adaptation in different environments and under different environmental pressures.
  • Unintended consequences of permanently changing species —  The NAS report clearly points to many unresolved problems, such as off-target and non-target effects, or horizontal gene transfer. For example, how would engineered mosquitoes continue to evolve? How would they impact the ecosystem? If a mosquito species were to be eradicated, would a more invasive species fill the space? What would the impact be on all of the species that feed on mosquitoes?
  • Agricultural impacts could be severe — Gene drives have huge potential for big agribusinesses, which have a special interest in redesigning a seed or plant for maximum profit potential. Applications might include engineering wild plants to respond to use of particular chemicals or wiping out a weed or insect entirely. The report uses the example of eradicating pigweed, a weed in the U.S. that is closely related to the South American crop amaranth. If an engineered gene to eradicate pigweed were to cross-pollinate with amaranth and spread into South America, drastic problems affecting livelihoods of farmers and food security could result. Secure food systems, particularly in a climate uncertain future, will require maximum diversity and resilience.
  • Potential for military or commercial misuse — Gene drives obviously have the potential to be misused (think bioweapons). Insects engineered to carry disease? Seeds designed to deliberately suppress food crops or crash a harvest? These scenarios could have widespread and profound impacts. We need systems in place to prevent them.
  • There are no regulations to prevent accidental escape or use of gene drives, and voluntary regulations are guaranteed to fail  — As the NAS report states, “a gene drive knows no political boundaries.” Therefore we need international regulations, not a patchwork of national regulations from countries where corporations dominate politics.

What is needed?

Gene drives present more extreme risks than previous forms of genetic engineering; the technology is designed to spread through generations of species and would be irreversible. Given there have been no environmental assessments or even an understanding of how gene drives would actually work (or if they would work), it is also critical to avoid a patchwork of overlapping regulations and agencies which already have large gaps of oversight. Instead there must be clearly delineated international regulations that prioritize protection of the environment, food security and people first. Only after these regulations are firmly in place should we assess IF processes for independent scientific assessment, regulatory oversight and commercial control can protect people and the planet.

The first step we must take is a moratorium on commercialization and environmental releases of gene drive modified organisms.

This is not an issue for the U.S. to determine on its own. In the same way that international bodies like the United Nations govern nuclear materials, decisions about how and if to use gene drives should be housed with a neutral body, not a military or profit-driven company.

In December 2016, 194 countries party to the Convention on Biodiversity will be making decisions about how to address synthetic biology, including gene drives. This meeting should result in an international regulatory framework and processes to assess new developments like gene drives, and the potential environmental, health, and socio-economic impacts that synthetic biology developments could have. Given the implications for military use and bioweapons, the United Nations Environmental Modification Convention treaty (ENMOD) and the Biological Weapons Convention are also important venues to look at how to regulate gene drives.

We cannot afford to experiment with gene drives that have the potential to be gene bombs without fully understanding the long-term impacts on our health, the environment and livelihoods.

Jun 092016
Stefano via Flickr

Stefano via Flickr

The National Academy of Sciences is releasing a report about “gene drives”, which are attempts to cause entire populations to inherit certain traits, such as reducing reproductive capacity, and which can cause species crashes, or even extinction. ETC Group have countered with this news release on the topic:

8th June 2016

· First study on gene drive governance avoids the explosive issues: Militarization, Commercialization, Food Security.

· ETC Group urges that gene drive patents and governance be handed to the United Nations.

Coming in at over 200 pages, today’s National Academy of Sciences (NAS) report, ‘Gene Drives on the Horizon’ is weighty, thoughtful but disappointing. It fails to properly address three of the most pressing issues raised by the controversial new technology of CRISPR-CAS9 gene drives. Dubbed, the ‘mutagenic chain reaction’ by its inventors, RNA-guided gene drives are a high-leverage synthetic biology technology invented only last year. They are designed to relentlessly drive a specific genetic trait through an entire species or population – potentially driving species to extinction. This capability to reshape entire natural populations and ecosystems raises significant threats to peace, biodiversity and food security which is why a high profile study of this kind was mobilized in such record time. Yet, inexplicably the NAS’s report entirely fails to address the problems that will follow from agricultural commercialization of the technology and gives short shrift to the military and security implications of gene drive development. Since commercialization, food security and militarization are among the most explosive issues raised by these developments, their near absence in the report is puzzling. The NAS study was co-funded by DARPA ( a US military agency) and the Bill and Melinda Gates Foundation (a global agricultural funder). Both institutions are heavily invested in gene drive research.

“Historians may come to see last year’s invention of a working Gene Drive as biology’s ‘nuclear’ moment. Like the the first nuclear chain reaction three quarters of a century ago, the ‘mutagenic chain reaction’ denotes awesome power, potential widespread destruction and has significant geopolitical ramifications.” Explains Jim Thomas, Programme Director with ETC Group. “The current handful of gene drive pioneers argue that their new tool could wipe out malaria or save endangered birds however it is clear to all that any promises by the inventors come bundled with enormous threats”

Militarization: There are many scenarios for potential weaponisation of gene drives (eg via engineered insects, targeting the human microbiome or intentional suppression of food harvests or pollinators) as well as serious potential ramifications from unintended effects. This means that gene drive technology will quickly and inevitably end up controlled by powerful military actors and that decisions on gene drive use and deployment will come to be primarily determined by geopolitical and security concerns (as well as commercial and trade interests). It is relevant that half of the funding for this study came from a US Defense agency (DARPA) who have made it known that they themselves are going all-in on research and development of gene drives and ‘robust’ synthetic organisms .

It is however astonishing that this report (which surveyed governance) entirely failed to mention two of the most relevant international governance instruments that will need to brought into play to respond to the security and peace threats posed by gene drives: The UN Environmental Modification treaty (ENMOD) was negotiated to address exactly the sort of widespread environmental modifications that gene drives could effect. While ENMOD hasn’t met for some years it could be reconvened fairly easily. The Biological Weapons Convention (BWC) already began to discuss gene drives at its most recent meeting in Geneva last December.

Agricultural Commercialization: The report entirely fails to acknowledge the strong commercial drivers that may bring gene drives into agricultural use, potentially derailing precautionary governance. While public discussion of gene drives has been intentionally dominated by speculative health and conservation applications, it is the agricultural applications that could eventually come to dominate in view of the commercial interests of large agribusiness companies. The NAS report considered one agricultural case study (case study 6) of engineering pigweed to be susceptible to glyphosate but oddly failed to address how such an application would enhance agricultural monopoly (eg for Monsanto ). There was also no consideration of how gene drives might transform agriculture and food systems or impact farmer’s rights and food sovereignty. The report did note that if pigweed in North America was suppressed by a gene drive it could inadvertently end up reducing harvests of amaranth, an important food source in South America.

The lack of of consideration of food security implications is a particularly troubling gap in light of the claims in the existing published patent application on gene drives (WO2015105928). This patent application by the University of Harvard includes a long list of over 50 weeds and almost 200 herbicides that the technology could be used against, thereby laying out a business case for licensing the patent to major agrochemical companies.

“ETC Group understands from its research that both Monsanto and Syngenta are closely watching this technology.” Explains ETC Group’s Asia Director , Neth Dano, “Neither Harvard nor any other private entity should have that power to license gene drive technology to agribusiness nor indeed anyone else”

Given the power and significance of these techniques, ETC Group proposes that all intellectual property relating to gene drives that should be surrendered to a neutral international body under multilateral UN governance. This would be analogous to the steps that were taken by governments to control intellectual property around nuclear technologies seventy five years. The topic of gene drives should also urgently be taken up by the UN Committee on World Food Security when it meets in Rome in October.

Global Biodiversity Governance: One thing the the NAS report gets right is the importance of global governance for biodiversity implications, stating in several places that “a gene drive knows no political boundaries.“. The committee correctly identifies the UN Convention on Biological Diversity (CBD) and its protocols as one of the key international governance bodies that must address gene drive governance (the other three that it fails to mention are ENMOD , the Biological Weapons Convention and the Committee on World Food Security).

ETC Group agrees and believes that strong international governance over gene drive research should be established swiftly at the CBD, beginning with a global moratorium on the release and commercial development of gene drives. This would be in line with this report’s key recommendation that there is insufficient evidence to support the environmental release of gene drives .

The 194 countries that are parties to the CBD will be making decisions on governance of synthetic biology at its conference of the Parties (COP13) in Cancun in December 2016. (gene drives are a synthetic biology application) The CBD’s own expert group on Synthetic Biology (the Ad Hoc Technical Expert Group on Synthetic Biology) has already raised the topic of gene drives and should look in more depth at this topic. The expert risk assessment body of the Cartagena Protocol (the AHTEG on Risk Assessment) should also address risk assessment of gene drives in its current review of risk assessment of Synthetic Biology techniques.

ETC Group has more detailed comments on the 200 page NAS report that we are happy to share with reporters.

For more information contact:

Jim Thomas, Programme Director, ETC Group (Montreal, Canada) phone: +1 819 322-5627

Pat Mooney, Executive Director , ETC Group (Ottawa, Canada) phone +1 613 240 0045

Neth Dano, Asia Director, ETC Group (currently in New York)

May 252016

USDA photo by Bob Nichols via Flickr

This is an investigation of Mascoma Corporation, a start-up biofuels company which may have misspent more public funds intended for building advanced biofuels refineries than any other company in North America.

Download the investigation


Mascoma took at least $100m and possibly over $155m in public funding intended for building integrated biorefineries. Their biggest donor was the US Department of Energy (DoE), including the DoE funded BioenergyScience Center. They also received $14.8 million from New York State, at least $20 million from the State of Michigan, around $1 million from the State of Minnesota, and over C$1m in total from Alberta Province and the National Research Council of Canada.

The $14.8 million from New York State was for a cellulosic ethanol plant that Mascoma did build, but which has never sold any ethanol. The plant has since been closed down and sold to a biotech company that intends to use it for a different purpose.

The vast majority of the grants received by Mascoma were intended for commercial-scale cellulosic ethanol refineries which were never built at all. Mascoma announced and then abandoned a series of such plants in Tennessee, Minnesota, Michigan and Alberta, but nonetheless spent grant funding that had been earmarked for them.

Biofuelwatch’s investigation shows that:

  • Links between Mascoma and their academic ‘partners’, namely Dartmouth College, went well beyond ordinary collaboration: Mascoma was co-founded by leading synthetic biologists at Dartmouth College and co-founder Lee Lynd used his simultaneous positions in the company and at Dartmouth College to attract millions of dollars of public funds, which were paid to Mascoma but transferred to Dartmouth’s synthetic biology laboratory. Financial agreements between the company and Dartmouth College extended to Mascoma obtaining a licence not just for Dartmouth’s existing intellectual property rights, but ones which the university might obtain in future. Dartmouth College, in exchange, obtained an equity interest as a co-founder of Mascoma;
  • Mascoma’s co-founder Lee Lynd continues to occupy a position on the management team of the BioenergyScience Center (BESC), set up and funded by the DoE, which would have put him in a prime position to attract funding via the BESC itself and, likely, for persuading the DoE to make the much larger grants for Mascoma’s proposed biofuel refineries available;
  • Mascoma’s failure to build any commercial cellulosic refineries cannot be explained by economic problems. According to the figures published by Mascoma, they had sufficient finance to build at least one if not two of their proposed commercial plants;
  • Mascoma’s business model relied on a proposed cellulosic ethanol technology called Consolidated Bioprocessing (CBP). Mascoma co-founder and director Lee Lynd acknowledged in a scientific review he co-authored in 2011 that there were major hurdles to be overcome and that years of fundamental research into CBP were still needed. This strongly indicates that Lee Lynd at least was well aware that the technology was not commercially viable at the time;
  • There is a serious lack of transparency on the part of the grant-giving authorities, especially the DoE. This makes it impossible to ascertain whether Mascoma broke any terms of the grant agreements, or whether those terms were worded so weakly that they could not be used to force Mascoma to either build the proposed plants or repay the money. It is clear however that there was a serious lack of due diligence on the part of all of the public authorities that gave grants to Mascoma, with the possible exception of New York State.

Biofuelwatch believes that a full investigation, with disclosure of all relevant public documents, is vital to understand how such large sums of money could have been misspent on biofuels plants that were never built, and what the implications for the DoE’s overall funding programme for industrial biorefineries are. Biofuelwatch believes that such funds should instead be spent on measures proven to reduce greenhouse gas emissions, such as sustainable solar energy or home insulation.

Download the investigation