Dec 082016

mosquitoby Friends of the Earth US

Citizens/environment will not be impacted by novel experiment releasing millions of GE mosquitoes

WASHINGTON, D.C. — The Food and Drug Administration announced that it will not move forward with the controversial release of millions of genetically engineered mosquitoes in the community of Key Haven in Monroe County, Florida. The release of the GE mosquitoes would have been the first-ever in the United States, but the FDA failed to conduct adequate testing for potential impacts to people, threatened and endangered species, and the environment. During the November 2016 election, local citizens voted against the release of the insects.

A coalition of public interest groups – including Center for Food Safety, Friends of the Earth, Foundation Earth, the International Center for Technology Assessment, the Florida Keys Environmental Coalition, and Food & Water Watch – yesterday received a response to their 60-day notice of intent to sue the FDA under the Endangered Species Act for failing to take into account impacts to federally listed species in a fast-tracked approval of the release of the GE mosquitoes.

In a letter to CFS attorneys, counsel from the FDA noted, “per the public referendums which took place on November 8, 2016, and the subsequent board meeting of the Florida Keys Mosquito Control District (FKMCD) on November 19, 2016, the proposed field trial is no longer moving forward in Key Haven, FL. Because residents of Key Haven voted against the trial, FKMCD commissioners agreed that the trial will not be conducted there.”

Release of GE mosquitoes elsewhere in Monroe Country will require the manufacturers, Oxitec, to resubmit a new application for a trial release with environmental data for the new site. If the FDA considers alternate locations proposed by Oxitec for a trial release, it will need to conduct the mandatory Environmental Assessment and indicate Findings of No Significant Impact for any new site.

“FDA knew it was reckless to approve the release of a novel species without first assessing the potential impacts. The agency didn’t do its homework so the local community spoke up and they had the law on their side,” said Jaydee Hanson, Senior Policy Analyst at the Center for Food Safety.

“This is a victory that protects local communities from reckless experiments,” said Dana Perls, senior food and technology campaigner with Friends of the Earth U.S. “The FDA should never let people and ecosystems be treated as laboratories. We need long-term and sustainable solutions to prevent mosquito breeding grounds.”

“We are glad the FDA finally recognized that it should not allow a company to release experimental GE mosquitoes into a community without their consent,” said Patty Lovera, assistant director of Food & Water Watch. “The FDA needs an entirely new approach to evaluating the potential risks form GE insects.”

“We expect Oxitec will reapply for a permit to include all of Monroe County. FDA must push Oxitec to answer questions the company has avoided, like why have the mosquitos not been tested for pre-existing disease, especially when Zika transfers to eggs; and what is the likelihood of antibiotic-resistant bacteria promotion. Finally, FDA must require a full Environmental Impact Statement on the long term effects of the GE Mosquito DNA entering the sustainable wild populations,” said Barry Wray, Executive Director, Florida Keys Environmental Coalition.


On November 9, residents of Key Haven, Florida, the proposed release site of the GE mosquitoes, voted against the release of the insects, which were not adequately assessed for risk before being approved by the FDA.

The lack of independent scientific research on the release of GE mosquitoes constitutes a most troubling factor in the drive to release millions of these insects. While the desire to control viral diseases like zika and dengue is understandable, Oxitec, the company manufacturing the GE mosquitoes, has not demonstrated that its release of the mosquitoes in Brazil, Cayman Islands and Malaysia has reduced disease. Few studies, if any, have been done to understand the unintended evolutionary effects of introducing new genes into a species. GE mosquitoes are intended to be sterile, but not all are.

In addition to potential threats to sensitive ecosystems and a lack of evidence to support the GE mosquitoes’ efficacy at minimizing the spread of disease, there is little information about what ingesting these insects could do to people. So many mosquitoes are released in the Oxitec trials (millions are released multiple times a week) that people complain of being forced to breathe in and eat mosquitoes.

Center for Food Safety’s mission is to empower people, support farmers, and protect the earth from the harmful impacts of industrial agriculture. Through groundbreaking legal, scientific, and grassroots action, we protect and promote your right to safe food and the environment. Please join our more than 750,000 consumer and farmer advocates across the country at Twitter: @CFSTrueFood, @CFS_Press

Friends of the Earth fights to create a more healthy and just world. Our current campaigns focus on promoting clean energy and solutions to climate change, ensuring the food we eat and products we use are safe and sustainable, and protecting marine ecosystems and the people who live and work near them.

Food & Water Watch champions healthy food and clean water for all. We stand up to corporations that put profits before people, and advocate for a democracy that improves people’s lives and protects our environment.

The Mission of the Florida Keys Environmental Coalition is to coordinate and support organizations, businesses and individuals, who work to protect the coral reefs and ecosystems of the Florida Keys and to provide a unified voice for our community.within our island environment, do everything we can to protect it.


Courtney Sexton; (202) 547-9359,
Kate Colwell, (202) 222-0744,

Dec 052016
Webridge (revised from) CC BY 2.0, via Wikimedia Commons

Webridge (revised from) CC BY 2.0, via Wikimedia Commons

CANCUN, MEXICO – This week, international conservation and environmental leaders are calling on governments at the 2016 UN Convention on Biodiversity to establish a moratorium on the controversial genetic extinction technology called gene drives.

More resources on gene drives and campaigns at CBD COP13

Gene drives, developed through new gene-editing techniques- are designed to force a particular genetically engineered trait to spread through an entire wild population – potentially changing entire species or even causing deliberate extinctions. The statement urges governments to put in place an urgent, global moratorium on the development and release of the new technology, which poses serious and potentially irreversible threats to biodiversity, as well as national sovereignty, peace and food security.

Over 160 civil society organisations from six continents have joined the call. Among them were environmental organizations including Friends of the Earth International; International Union of Food Workers representing over 10 million workers in 127 countries ; organizations representing millions of small-scale famers around the world, such as the La Via Campesina International and the International Federation of Organic Agricultural Movements; the international indigenous peoples’ organization Tebtebba; scientist coalitions including European Network of Scientists for Social and Environmental Responsibility and Unión de Científicos Comprometidos con la Sociedad (Mexico); as well as ETC Group and Third World Network.

“We lack the knowledge and understanding to release gene drives into the environment – we don’t even know what questions to ask. To deliberately drive a species to extinction has major ethical, social and environmental implications,” says Dr. Steinbrecher, representing the Federation of German Scientists. “It is essential that we pause, to allow the scientific community, local communities and society at large to debate and reflect. We can’t allow ourselves to be led by a novel technique. In the meantime, a moratorium is essential.”

“These genetic extinction technologies are false solutions to our conservation challenges,” said Dana Perls of Friends of the Earth. “We want to support truly sustainable and community driven conservation efforts. Gene drives could be co-opted by agribusiness and military interests. We need a moratorium on irreversible and irresponsible technologies such as gene drives.”

“Gene drives will be one of the fiercest debates at CBD this year,” says Jim Thomas of ETC Group. “Gene drives are advancing far too quickly in the real world, and so far are unregulated. There are already hundreds of millions of dollars pouring into gene drive development, and even reckless proposals to release gene drives within next four years.”

“The CBD is the premier international treaty for protecting biodiversity and life on earth from new threats,” said Lim Li Ching of Third World Network. “It is within the mandate of the CBD to adopt this moratorium, and countries that are party to this agreement must act now to avoid serious or irreversible harm.”

A press conference on the Call for a Moratorium will be held on December 5, 2016 at 3pm EST in the Press Conference Room. It can be live-streamed at


Expert contacts:

English: Jim Thomas, (514) 516-5759,; Dana Perls, +1 (925) 705-1074,; Dr. Ricarda Steinbrecher, +44 (776) 973-3594,

Spanish: Silvia Ribeiro, +52 55 2653 3330,; Veronica Villa, +52 1 55 5432 4679,

Communications contacts: Trudi Zundel, (226) 979-0993,; Marie-Pia Rieublanc (se habla español), +52 1 967 140 4432,

Note to Editors:

  1. A copy of the Call for a Global Moratorium on Gene Drives is available with a complete list of signatories, and a short briefing outlining the arguments for a global moratorium on gene drives prepared by the Civil Society Working Group on Gene Drives is available at
  2. The organizers of the letter are still inviting organizations to join as signatories. Additional organizational signatures can be sent to:
  3. The UN Convention on Biodiversity (CBD) is meeting from December 4-17 in Cancun, Mexico. Other synthetic biology topics are being negotiated – more background found in this media advisory: dna-challenged
  4. In the lead up to COP 13, German Minister for the Environment Barbara Hendricks wrote a statement saying she would not support the release of gene drives into the environment.
  5. In September 2016, the International Union for Conservation of Nature (IUCN) adopted a de facto moratorium on the support or endorsement of research into gene drives for conservation or other purposes. At the same time, 30 leading conservationists and environmentalists called for a moratorium. More information on this moratorium is available at international-group-of-scientists.
  6. In June 2016, the US National Academy of Sciences released “Gene Drives on the Horizon,” a report that explored the environmental and social concerns of gene drives, and warned against the environmental release of gene drives. More information on the report can be found at
Dec 012016

workshop-flyerThere’s an exciting program of events covering synthetic biology, GMO 2.0, biosafety, gene drives and lots more at the Convention on Biological Diversity COP13 in Cancun over the next 2 weeks. If you’re going to be in Cancun it’s well worth checking these out!

Download the flyer









Nov 302016


“Genetic engineering is passé. Today, scientists aren’t just mapping genomes and manipulating genes,
they’re building life from scratch – and they’re doing it in the absence of societal debate and regulatory oversight.”
– Pat Mooney, Executive Director of ETC Group, whose mission is to access the consequences and impacts of new technologies.

Listen to the podcast here:

KWMR Post Carbon Radio:

Our two guests are: Claire Hope Cummings, author of Uncertain Peril: Genetic Engineering and the Future of Seeds. Her concerns are how gene drives are proposed for use in conservation (Island Conservation’s daughterless mouse) and the whole idea of the eradication of the female (daughterless anything) and anything people need to know about the regulatory issues – most notably that there is no regulatory response to these new developments and the response to GMOs was terribly inadequate and facilitated widespread contamination, among other risks which are still a problem.

Jim Thomas is a Research Programme Manager and Writer at ETC Group, located in Ottawa, Canada. His background is in communications, writing on emerging technologies and international campaigning. For the seven years previous to joining ETC Group Jim was a researcher and campaigner on Genetic Engineering and food issues for Greenpeace International – working in Europe, North America, Australia/New Zealand and South East Asia. He has extensive experience on issues around transgenic crops and nanotechnologies has written articles, chapters and technical reports in the media and online.

Nov 212016

vat-768x432by Mary Lou McDonald (Safe Food Matters)

New words like “synthetic biology”, “GMOs 2.0”, “CRISPR”, and “new biology” are being heard.  And new compounds are in our fragrances, flavourings, cosmetics and foods.

The new words are for new techniques of genetic engineering. What are the techniques and their products, and should we be concerned?

New Techniques­

The old techniques of genetic engineering (GMOs 1.0) dealt with organisms, and inserted genes by either blasting them into an organism or transferring them via a virus. This was not very precise.

1. Gene Editing. A new technique is called “gene editing”. It is more on target. It can cut the genetic code of organisms with greater precision, insert new code, remove a code and swap out genes with others. Tools used in gene editing include “CRISPR-Cas9”, “Zinc Finger Nucleus” and “TALEN”.

2. Synthetic Biology. Another new technique is the creation of genetic code from scratch, without involving living organisms. This is called “synthetic biology” or “put together life”. It uses computer design technology to engineer and produce new codes in the lab.

Applications and Technologies

These techniques, when applied, have resulted in far-reaching technologies.

a) Applications of Gene Editing

Gene Drives.  A much talked-about technology is “gene drives”.  It drives the particular gene down to the offspring and doesn’t allow space for an alternate to arise, as would occur in natural evolution. Once a trait is forced down at the expense of the alternatives, the extinction of the “alternate” offspring is the ultimate result.

Gene drives have so far been used on yeast, fruit flies and 2 mosquito species, but have not yet been released to ecosystems. There is widespread discussion about using them to eradicate mice on islands, mosquitoes, and pests.

GMOs 2.0.  Gene editing is also used in agriculture, the old domain of GMOs 1.0. With GMOs 2.0, food is being engineered to insert, delete or replace DNA, and entirely new sequences are being created. Gene edited mushrooms (deletions in a gene for non-browning) and canola oil (a gene removed to tolerate herbicide) have both been commercialized. Monsanto in September, 2016 licensed the use of CRISPR to engineer food and Dupont in October 2015 predicted that CRISPR plants would be on dinner plates within 5 years. Proponents of gene editing argue that the resulting organisms are not “GM” or “novel substances”, and therefore aren’t subject to current regulation.

b) Applications of SynBio

Foods, Flavours, Fragrances. The synbio technique has spawned many new applications, including the creation of new compounds in consumer products that are so similar to existing products consumers can’t tell the difference.  The method used is to engineer artificial code into microbes and then ferment them on a large scale in vats. Manufacturers use the word “natural” because fermentation is involved.

Some existing and proposed products resulting from this application are artificial biofuels, vanilla, stevia, ginseng, wine, mint, cocoa, caffeine, scents, cleansers and soaps. (See “Are GMOs 2.0 in your Food and Cosmetics”; “What is Synthetic Biology: The Comic Book”).

New Life Forms. Another application is the engineering of completely new genetic codes and life forms. Current players in this sphere include the “DIY” community, students, and start-ups.  A code can be created on the computer and 3-D printed. The International Genetically Engineered Machine Competition (IGEM) is a university and high school competition for building “biobricks” (like lego) to operate in living cells. A recent commercial example of a new life form is a plant that glows in the dark.

Bio Weapons. A third application is military.  In the US, the Defense Advanced Research Projects Agency (DARPA) provides the most funding for synthetic biology in the US government (although the extent to which this is funnelled to bioweapons is not known). In the US, the Army, Navy and Office of the Secretary of State are also funding synbio. (See Extreme Genetic Engineering and the Human Future, p 31).

What is the Concern?

The concern is we don’t know if the new technologies are safe. Why not? Because we don’t completely understand the interactions that occur in living organisms and ecological systems.

Organisms are complex systems in which chemical reactions “fire” at different times and places along interconnected pathways. They do not behave in linear “cause and equal effect” ways, in either space or time. A gene is part of this system. It is a strand of DNA that messages or “fires” at times (or refrains from “firing”) and brings about an action or change in an organism. Similarly, ecological systems are complex systems.  They rely on species interconnections and interactions which also don’t behave in linear “cause and equal effect” ways.

If a complex system does not behave in a linear fashion, the workings of the systems cannot be known ahead of time and its effects cannot be predicted.  Similarly, the effects resulting from a change to one aspect of a system cannot be predicted. The effects can only be known “after the fact”, and, depending on the system, these effects may vary.

This inability to predict the results of a change in the system was the problem with GMOs 1.0, and is the same problem with these new techniques.  The concern will exist every time one of the new techniques is used in a complex living system. The scientific literature even acknowledges that there are often “unintended” or “unpredicted effects” associated with the products of genetic manipulation.  New substances are often created. Even CRISPR-Cas9 technology admittedly has the problem of being “off-target”.

Historical Examples 

The concern of unpredictability is underlined by historical examples of GMOs 1.0 gone wrong. In the late 1990s and early 2000s several people died as a result of reactions to gene therapy procedures, the most notable of which was 18 year old Jesse Gelsinger.  He died from a severe immune reaction to the viral vector used to transport engineered genes. Another example is the food supplement L-Tryptophan.  Genetic modification of the supplement created a new toxin that is linked to EMS, a disease that killed 80 people and afflicted thousands in the late 1980s, early 1990s.  (See “L-Tryptophan”).

Examples of agriculture GMOs 1.0 gone wrong include the case of canola. In 1995 Canada became the first country to approve commercialization of genetically engineered canola. GM canola has now spread and eliminated natural canola almost everywhere in Canada. Other examples of GM plants that have spread uncontrollably are: creeping bentgrass in the USA; cotton and maize in Mexico; BT poplar in China; Bt rice in China; and canola in Japan, the US, Australia and the EU. (See Transgene Escape by TestBiotech).

Supersized Concerns

The concern of unpredictability is more pronounced with these new synbio and gene editing techniques than with GMOs 1.0. Reason? The applications of these new techniques are very broad in scope, and their effects can be devastating.

Gene Drives. The scope of gene drives is obviously major. It extends to the possible extinction of a species, and resulting degradation of its ecosystem.  Even the National Academy of Sciences of the US, in a June 2016 report (at 86), admits that: “[R]eleasing a gene-drive modified organism into the environment means that a complex molecular system will be introduced into complex ecological systems, potentially setting off a cascade of population dynamics and evolutionary processes that could have numerous reverberating effects”.

GMOs 2.0. The scope of GMOs 2.0 extends to the food humans and animals eat and to the environment. The lack of current regulation and the speed at which the products are being advanced means the GMO 2.0 technologies and products will likely be used before they are assessed. This is even though the effects with GMOs 2.0 are compounded.  Testbiotech indicates that with the new gene editing techniques, a single step can be applied several times, causing large changes; plants and animals with genetic changes can be crossed with each other;  different techniques can be used in combination with each other; and that even small steps, if repeated, enable radical changes in the genome.

Foods, Flavours, Fragrances. The scope of the synbio application is enormous, on many fronts. The flavours and fragrance market is advancing quickly:  it was a US $26.5 billion market in 2016 and is expected to grow to over US $35 billion by 2019. Lux Research indicates synbio will be a “permanent and growing aspect” of the flavours market. A major socioeconomic effect is the displacement of natural botanical farmers: 95% of varieties of natural crops are grown by small-scale farmers, more than 20 million of whom depend on these crops for their livelihood.

The new compounds themselves are pervasive in our consumer products without being identified (except they might be called “natural”).  Common names include:  method, Ecover, patchouli, PeterThomasRoth, Evolva, Clearwood, TerraVia, Neossance Biossance, Eversweet (in Coca Cola Life), Agarwood Oil, Muufri animal free milk, among others.  The effect of these compounds on human beings has not been subject to regulatory assessment, even though they are biologically different than the natural botanical substances.

New Life Forms.  The synbio creation of new life forms in the DIY community is advancing, and there is no way to monitor the proliferation of this technology. The September 2016 report of Genome editing: an ethical review points out that a number of websites provide lab and other support services for amateurs, and DIY CRISPR kits are available on line.  A code can be 3-D printed and Fedexed for less than $100. The seeds and kit for the new glowing plant can be ordered on-line. The potential for intentional and unintentional release obviously exists, again with no regulations in place.

BioWeapons. The scope of the military application of synbio is not known, but appears to be growing as increasing amounts of government funding are directed toward the technology. The obvious risks are the inability to recall a release, and the potential for a release to be off-target.

In Sum

New technologies are advancing quickly and new products and substances are in our world.  Genes can now be created from scratch, a wide array of new products and foods can be created with greater precision, and whole species can be affected. The concerns around safety and unpredictability are the same, but the resulting risk profile has increased dramatically. We would do well to learn the new words.

Nov 082016

hook-awards-image-2-2016The Coalition Against Biopiracy (CAB) will host the 6th Captain Hook Awards ceremony at the Thirteenth Conference of the Parties (COP13) to the Convention on Biological Diversity (CBD) in Cancun, Mexico, 4-17 December 2016.

Nominate your least-favourite pirate for a 2016 Captain Hook Award, and your most admired biopiracy resistors for a 2016 Cog Award now!

This award ceremony comes as high-tech ‘digital’ biopiracy is becoming easier than ever. With the accelerating tools of genome-editing and synthetic biology, today’s biopirates no longer need to carry their booty offshore in boats and airplanes – they can swiftly upload DNA as digital sequences in one location and then recreate it as synthetic DNA on the other side of the planet. As the CBD meets to discuss what to do about Synthetic Biology it’s high time to take on the new cyberthieves of the biodiversity commons.

Previous Captain Hook Award winners have included:

  • In 2014 the UK and Canada received a “Pirates Cove” award for sheltering the syn bio industry and aggressively promoting the industry’s interests at CBD’s COP 12.
  • The World Intellectual Property Organization (WIPO) won the 2004 honour of “Worst International Convention” for proposing a new global patent system to facilitate a one-stop shop for exclusive monopolies.
  • Synthetic biology pioneer Craig Venter has won the lifetime achievement award.

Previous Cog Awards have honoured:

  • In 2008, the “Best Organized Advocacy” Award was given to Filipino / Philippine civil society organizations, fisherfolk and individuals who stood up for the Sulu Sea
  • Percy Schmeiser, a Canadian farmer, won the 2004 honour of “Best Advocate” for defending Farmers’ Rights in the field and the courts
  • COMPITCH and other indigenous peoples’ organizations in Mexico won in 2002 for defeating the US government’s $2.5 million bioprospecting project in Chiapas.

See here for full lists of previous winners.

About Biopiracy

For the first time, the Oxford English Dictionary now includes “biopiracy,” The OED defines “biopiracy” as “bioprospecting, regarded as a form of exploitation of developing countries.”

Biopiracy refers to the monopolization of genetic resources such as seeds and genes taken from the peoples or farming communities that have nurtured those resources. It also refers to the theft of traditional knowledge from those cultures.

Today the main source of biopiracy occurs by corporations, academic institutes and governments claiming intellectual property over genetic resources – patents on life (eg gene patents) or claiming plant breeders rights. The introduction of new biotechnologies such as genetic engineering has facilitated a new wave of biopiracy.

With the advent of nanotechnology ownership of nature has now reached a more fundamental level. As well as gene sequences, nanopirates are claiming ownership of the molecules and even the elements that everything is made from.

Meanwhile the culture industry has been commercially exploiting the art, culture, language and symbols of indigenous cultures – often claiming trademarks on knowledge which they have stolen.

For some Biopiracy only refers to the unauthorised and illegal theft of knowledge and resources, claiming that legal bioprospecting agreements can be worked out to share commercial benefits. The Convention on Biological Diversity (CBD) takes the view that agreements can be made on “access and benefit sharing” to overcome biopiracy. Many Indigenous groups disagree:

“Contractual benefit sharing is like waking up in the middle of the night to find your house being robbed. On the way out the door, the thieves tell you not to worry because they promise to give you a share of whatever profit they make selling what used to belong to you.” – Alejandro Argumedo, Quechua activist

Check out wikipedia’s definition of Biopiracy

For an introduction to Biopiracy and the state of global discussions check out this briefing from ETC Group



Oct 282016


Documents revealed under Freedom of Information laws show that the Office of the Gene Technology Regulator (OGTR) has been colluding with industry for years to deregulate a range of new genetic modification (GM) techniques. And now the rest of us have just 6 weeks to make the case why they should be regulated!

If the OGTR deregulates these new GM techniques there will be no monitoring or surveillance. Anyone from amateur biohackers – to industry – to terror groups would be free to use them to genetically modify plants, animals and microbes. Entirely new diseases and poisons could be made. And they could enter our food chain and our environment with no safety testing and no labelling. The risks could be catastrophic.

Reviews commissioned by the Austrian and Norwegian governments concluded that not enough is known about the risks posed by these new GM techniques. They recommended that products derived from them require comprehensive case-by-case risk assessments.

Take action here!


Oct 202016

Tobacco plantation. Ikhlasul Amal/Flickr CC

by Chee Yoke Ling and Edward Hammond (Project Syndicate)

AUSTIN, TEXAS – Four hundred years ago, John Rolfe used tobacco seeds pilfered from the West Indies to develop Virginia’s first profitable export, undermining the tobacco trade of Spain’s Caribbean colonies. More than 200 years later, another Briton, Henry Wickham, took seeds for a rubber-bearing tree from Brazil to Asia – via that great colonialist institution, London’s Royal Botanic Gardens – thereby setting the stage for the eventual demise of the Amazonian rubber boom.

At a time of unregulated plant exports, all it took was a suitcase full of seeds to damage livelihoods and even entire economies. Thanks to advances in genetics, it may soon take even less.

To be sure, over the last few decades, great strides have been made in regulating the deliberate movement of the genetic material of animals, plants, and other living things across borders. The 1992 United Nations Convention on Biological Diversity, in particular, has helped to safeguard the rights of providers of genetic resources – such as (ideally) the farmers and indigenous people who have protected and nurtured valuable genes – by enshrining national sovereignty over biodiversity.

While some people surely manage to evade regulations, laboriously developed legal systems ensure that it is far from easy. The majority of international exchanges of seeds, plants, animals, microbes, and other biological goods are accompanied by the requisite permits, including a material transfer agreement.

But what if one did not have to send any material at all? What if all it took to usurp the desired seeds was a simple email? What if, with only gene sequences, scientists could “animate” the appropriate genetic material? Such Internet-facilitated exchanges of biodiversity would clearly be much harder to regulate. And, with gene sequencing becoming faster and cheaper than ever, and gene-editing technology advancing rapidly, such exchanges may be possible sooner than you think.

In fact, genes, even entire organisms, can already move virtually – squishy and biological at each end, but nothing more than a series of ones and zeros while en route. The tiny virus that causes influenza is a leading-edge example of technical developments.

Today, when a new strain of influenza appears in Asia, scientists collect a throat swab, isolate the virus, and run the strain’s genetic sequence. If they then post that strain’s sequence on the Internet, American and European laboratories may be able to synthesize the new virus from the downloaded data faster and more easily than if they wait for a courier to deliver a physical sample. The virus can spread faster electronically than it does in nature.

More complicated viruses and some bacteria are in the range of such techniques today, though wholly synthesizing a higher organism with a more complex genome, such as maize, is many years away. But that may not matter, as new gene-editing technologies, like CRISPR-Cas9, enable scientists to stitch together complicated new organisms, using gene sequence information from organisms to which they do not have physical access.

For example, the key traits of a drought-resistant maize from a Zapotec community in Oaxaca, Mexico, might be reproduced by editing the genes of another maize variety. No major new advance in the technology is needed to unlock this possibility.

What is needed is the genetic sequences of thousands of types of maize. Those data act as a sort of roadmap and resource pool, enabling scientists to compare sequences on a computer screen and identify pertinent variations. The selected adjustments might then be made to, say, the parents of a new Monsanto or DuPont Pioneer maize hybrid.

Managing access to large genomic databases thus becomes critically important to prevent a virtual version of the theft carried out by Rolfe and Wickham. And, indeed, in an unguarded e-mail released under the US Freedom of Information Act, one of the US Department of Agriculture’s top maize scientists, Edward Buckler, called such management “the big issue of our time” for plant breeding.

If agricultural biotechnology corporations like Monsanto and DuPont Pioneer – not to mention other firms that work with genetic resources, including pharmaceutical companies and synthetic biology startups – have free access to such databases, the providers of the desired genes are very likely to lose out. These are, after all, wholly capitalist enterprises, with little financial incentive to look out for the little guy.

In this case, that “little guy” could be African sorghum growers, traditional medicinal practitioners, forest peoples, or other traditional communities – people who have created and nurtured biodiversity, but never had the hubris or greed to claim the genes as proprietary, patented inventions. All it would take is for someone to sequence their creations, and share the data in open databases.

Yet open access is the mode du jour in sharing research data. The US government’s GenBank, for example, doesn’t even have an agreement banning misappropriation. This must change. After all, such no-strings-attached databases do not just facilitate sharing; they enable stealing.

The question of how to regulate access to genetic sequence data is now cropping up in international discussions, including at the World Health Organization and the Food and Agriculture Organization. Perhaps the most important forum for such discussions is the Conference of the Parties to the Convention on Biological Diversity, the main treaty regulating access to biodiversity. The next meeting (COP 13) will take place in Cancún, Mexico, in early December.

Participants at COP 13 must focus on the need to protect the rights of resource providers. To this end, they should pursue a careful assessment of existing policies and craft the necessary changes – before synthetic biology outpaces legal systems and renders them impotent.

Arrangements must be made to supervise access to genetic sequences in a way that ensures fair and equitable sharing of benefits from their use. Otherwise, decades of work to promote conservation and prevent piracy will be undermined, endangering the biodiversity convention – and those it protects

Oct 102016

gene-editingby Melody Meyer (Organic Matters)

In an early morning jaunt to Sacramento last week my car was rear ended.  I serve on the California Organic Products Advisory Committee (who by the way are looking for new members), and was on my way to attend a subcommittee meeting when boom—a fine young man rammed me in the rear. As I recuperate from the trauma, I wax philosophical and wonder why this happened and what the long term unintended consequences will be. The same ruminations can be applied to the novel gene editing techniques that are racing towards us with accelerating speed. Are we all on a genetic collision course with unintended consequences? 

As I mull over the details of that 5am departure, I wonder how two strangers woke up, made coffee, and rambled into their cars just to crash into each other at that moment in space and time. What trajectory was I launched on when I circled back and grabbed my lunch bag? What velocity did I drive just so I arrived at that spot for him to anoint me with pounding steel; up the bottom of the carriage so to speak?

The same musings can be mulled over for many of the new gene editing techniques that aren’t classified as GMO’s. From the first time we stood up on the Savanna and picked up that primal tool, were we fatefully launched on a trajectory course that would end in manipulating the very core of life itself? Our propensity for tinkering coupled with our big brains has landed us now in a godlike place where we can alter the very genetic code of life. Will there be unintended consequences?

History (and my sore neck) tells me that there always will be unintended consequences. If you look at the history of DDT, Agent Orange and TNT, they all have had negative accidental aftereffects. We now know that the rise of (traditionally) genetically engineered, herbicide-resistant crops has resulted in a huge increase in herbicide use and the rise of superweeds as a result. Chuck Benbrook has made that point many times.

The hottest and most cutting-edge GMO techniques aren’t even recognized as GMO’s. Scientists can now precisely edit unique traits within one species by using a technique called Crispr-cas9, which works like a pair of molecular scissors, snipping away this trait and inserting yet another. In fact the technology goes so far that it can now force the trait to persist forever more by using “gene drives.” Entire populations can now be genetically altered to always inherit that unique trait or even make the entire species crash. Sound like science fiction? Nope it’s here today and throttling towards us at breakneck speed.

My young driver was good hearted and intended me no harm. Just so the scientists working on these novel techniques are well intentioned mavens of research and genius, hoping to make the world a better place. Gene drives have been proposed as a technique for changing wild populations, for instance to combat mosquitoes that spread malaria and zika, to control invasive species, or to eliminate herbicide and or pesticide resistance in superweeds.

These cutting-edge gene editing techniques could potentially block the inheritance of many diseases such as cystic fibrosis. They could also lead to custom-made children where parents pick and choose the traits of their progeny.

The problem I have is that none of these techniques are regulated or transparently tested for safety. In fact many of these techniques are readily available and easily accessible to anyone who has access to the internet and half a propensity for scientific tinkering. A report by Nuffield Council on Bioethics warns that the simplicity and low cost of tools to edit the genetic code means that “garage scientists” pose a potential risk from the release of GM bugs. Sounds like unintended consequences barreling down upon us.

The report goes on to state and I quote “Genome-edited organisms (as with all genetically modified organisms or GMOs) pose a possible risk of harm to those handling them, and to others or to natural ecosystems if they are released or escape from controlled environments. Most countries have layers of regulation which cover the handling, transport and release of GMOs, but there are concerns about how these can be managed outside of regulated environments.”

Genetically modifying plants is far from harmless as this article points out. “Techniques of genetic modification, old or new, are not fully mastered: if they do allow bringing some new traits to a living organism (such as herbicide tolerance), they also produce unexpected modifications: ‘off-targets’ effects caused by the techniques such as mutations and epigenetic mutations, because of the techniques implemented during the process.”

What do we do now that we are crashing through the penetrable walls of subatomic DNA barriers with no regulation or oversight? Should we step outside the vehicle and access the possible damage? We are no longer messing around with a lone area of our ecosystem but potentially the very building blocks of our genetic heritage and legacy. We can and are impacting life itself on the planet.

The first path to regulations is to become aware of the speeding carriage barreling towards us. Friends of The Earth and ETC Group recently published the Shopper’s Guide to Synthetic Biology to help consumers like you avoid the new wave of GMOs in food and cosmetics, and find truly natural and sustainable options.

The National Organic Program and the National Organic Standards Board are requesting comments on whether these new techniques should be allowed in organic production.

The unintended consequences of this new technological collision course must be explored and challenged. If you need a license to drive a car, shouldn’t you have a license and some rules of the road to do gene editing? Shouldn’t we have safety tests, belts and cameras in place to assure we don’t crash our genetic inheritance?

Let’s urge governments worldwide to put some restraints on these new technologies while putting processes in place to evaluate those we cannot yet dream of. The speeding vehicle is coming.

Oct 032016
Waag Society/Flickr CC

Waag Society/Flickr CC

by Eric Meunier (Inf’OGM)

Several new techniques of genetic modification (also called NBT) are currently being discussed worldwide to decide whether to define products obtained from them as GMOs and to regulate them as such, or not. Following a parliamentary hearing in France [1] in April 2016, Inf’OGM tries to figure out some of the potential risks linked to the use of any technique of genetic modification on a plant cells culture.

Techniques of genetic modification, old or new, are not fully mastered : if they do allow bringing some new traits to a living organism (such as herbicide tolerance), they also produce unexpected modifications : ‘off-targets’ effects caused by the techniques of genetic modification themselves as they do not occur in the targeted area of the genome and unintended effects (mutations and epigenetic mutations, also called epimutations) due to other techniques implemented during the different steps of the process.

On April 2016 the 6th, echoing Yves Bertheau’s remarks back in late 2015 (a former member of the French High Council of Biotechnology (HCB) after having resigned), Jean-Christophe Pagès, Head of the HCB’s scientific committee, told the French Parliamentary Office for Science and Technology Assessment about Crispr/Cas 9 that “the difficulties to use it should not be forgotten […] especially regarding in vivo use on animals as you need to provide a matrix and you usually face issues linked to the process of insertion into the cell. In vitro culture is much easier and this is why the majority of its uses are in research and, eventually, organisms are regenerated from in vitro culture. And here, it indeed concerns some plants”… A surprising comment as, after a careful reading, the HCB’s scientific committee document dated from February 2016 the 4th – now downgraded to an interim report status after having been presented by the Scientific Committee as an advice to the French government – do not state such difficulties in vivo, or ease in vitro.

Inf’OGM provides here in a first series of two papers as an overview of the unintended and uncontrolled effects occurring along the steps of a genetic modification process. We will focus in these first paper on the process of insertion step as quoted by Jean-Christophe Pagès, aiming at bringing into a cell the requisite material to generate the intended genetic modification. We will also focus on preliminary steps which are indeed stressful and thus induce mutations and epigenetic mutations (see the box below).

In a next wave of papers we will focus on the unexpected changes called ‘off-targets’ due to the NBT techniques themselves. Several scientific papers will be rapidly cited to help the reader to go more in depth in the details.

Mutation, epigenetic mutation (epimutation) = what is it ?

A mutation is usually defined as a change in the genetic information of an organism, whether it be as DNA or RNA. Mutations are hereditary. They can be “silenced”, meaning without any observable consequences on the organism’s metabolism. They can also change the expression of one or several genes, modifying the metabolism. Epigenetic mutations belong to the class of mutation affecting the expression of a genetic sequence but which are not due to a change in the nucleotide sequence itself. They can be due to a change of the chemical composition of DNA nucleotides or chromatin.

Preparing the cells to be transformed

Before being able to bring some material into the cells (the process of insertion Jean-Christophe Pagès refers to), the first step is to prepare those cells. The lab workers will have to break cells wall, maybe even to remove them entirely. Plant cells without walls – called protoplasts – become transformable and engineers can now bring into those cells tools such as large proteins (such as Cas9), RNAs and/or coding DNAs. But, as Yves Bertheau explains, this creation of protoplasts induces mutations and epimutations, a widely observed phenomenon according to scientific literature [2].

Cell culture induces mutations

The second step is to cultivate those protoplasts. But culturing cells generates also mutations and epigenetic mutations. The scientific literature surprisingly shows that the mechanisms through which those mutations and epigenetic mutations appear is still little-known despite decades of use [3]. This phenomenon, called somaclonal variation, is such that it was previously used by seed companies to create the needed “genetic diversity” to “breed” plants according to the seed companies’ usual language. The French Association for Seeds and Seedlings (GNIS, “a privately funded organization which delivers public services”) points out that “somaclonal variation is the observed modification in some cells after a long cycle of in vitro culture without regeneration. These are therefore no longer identical to the parent plant. This variation can be due to a modification in the nucleus genome or in the genome of cytoplasmic plastids [4].

In other words, plants obtained from those cells have different characteristics. GNIS provides one last interesting detail : “the obtained modifications of traits are barely stable and not always found in the regenerated plant or its progeny”. Why ? The occurrence of other modifications (epigenetic mutations) can make those mutations disappear [5]… As Yves Bertheau tells us, “in such conditions, it looks rather difficult to foresee the impacts this step of cell culture could perform when using a new technique of genetic modification”.

The process of insertion, at last… also called vectorization

Once the cells are prepared and cultivated, we are ready to bring in the biological material to generate the intended modification. Depending on the techniques, this material may be proteins and / or genetic sequences such as RNAs or encoding DNAs (oligonucleotides, plasmids, virus…) – the most frequently used molecules for plants. Bringing this material into the cells needs merely making large holes in the membranes (cytoplasmic and nuclear) of the cell. But, as Yves Bertheau explains us, making such holes induce once again mutations and epimutations [6]. The researcher considers thus impossible to draw a general grid for risk assessment. A choice must be made among several techniques of insertion, different types of material, the genetic sequences to be introduced and the species targeted. Therefore only a case by case analysis for such GMOs would allow the assessment of all the potential risks linked to unintended effects.

HCB’s scientific committee’s interim report says nothing about those mutations

In a scientific paper of 2011, scientists estimated that 35% of all the observed unintended effects following the genetic modification by transgenesis of Senia rice were due to the cells transformation process itself [7]. The phenomenon is therefore not negligible.

Surprisingly, and despite the hearing of its Head in front of the OPECST, the HCB’s Scientific Committee did not deal with those risks in its interim report on risks linked to the new techniques [8]. If the process of insertion is indeed described in the appendix for each technique, it’s only to outline the tools used for a technique and to describe how the material is brought into the cells. Possible mutations and epimutations arising from the different transformation steps are not covered. As the HCB scientific committee is in charge of risk evaluation for the French government, we would have expected this committee to discuss and provide explanations, not to disregard such documented issues. Especially considering that the transformation process – to refer to the only point present in the interim report – doesn’t seem to be fully controlled depending on the techniques. The scientific committee even states that for the oligodirected mutagenesis technique (OdM), “many molecules or molecular mixtures are currently tested to improve the process of insertion which works fairly well in vitro but not well on full organisms (Liang et al., 2012) [9]


[2« Stress induces plant somatic cells to acquire some features of stem cells accompanied by selective chromatin reorganization », Florentin, A. et al. (2013), Developmental Dynamics, 242(10), 1121-1133 ;
« Developmental stage specificity and the role of mitochondrial metabolism in the response of Arabidopsis leaves to prolonged mild osmotic stress », Skirycz, A. et al., (2010). Plant Physiology, 152(1), 226-244 ;
« Arabidopsis mesophyll protoplasts : a versatile cell system for transient gene expression analysis », Yoo, al. (2007). Nat. Protocols, 2(7), 1565-1572.

[3« Cell culture-induced gradual and frequent epigenetic reprogramming of invertedly repeated tobacco transgene epialleles », Krizova, K. et al., (2009). Plant Physiology, 149(3), 1493-1504 ;
« Extended metAFLP approach in studies of tissue culture induced variation (TCIV) in triticale », Machczyńska, J. et al., (2014). Molecular Breeding, 34(3), 845-854 ;
« Tissue culture-induced novel epialleles of a Myb transcription factor encoded by pericarp color1 in maize », Rhee, Y. et al., (2010). Genetics, 186(3), 843-855 ;
« Transformation-induced mutations in transgenic plants : analysis and biosafety implications », Wilson, A.K. et al., (2006). Biotechnol Genet Eng Rev, 23(1), 209-238 ;
« A whole-genome analysis of a transgenic rice seed-based edible vaccine against cedar pollen allergy », Kawakatsu, T. et al., (2013).. DNA Research 20, 623-631 ;
« Recent progress in the understanding of tissue culture-induced genome level changes in plants and potential applications », Neelakandan et al.,, 2012,. Plant Cell Reports, 31(4), 597-620

[5« Meiotic transmission of epigenetic changes in the cell-division factor requirement of plant cells », Meins, F. et al., (2003). Development, 130(25), 6201-6208.

[6« Cell biology : delivering tough cargo into cells », Marx, V. (2016). Nat Meth, 13(1), 37-40.

[7« Only half the transcriptomic differences between resistant genetically modified and conventional rice are associated with the transgene », Montero, M. et al., (2011). Plant Biotechnology Journal, 9(6), 693-702.