By Jeff Kirkpatrick
This is a working post that will be updated periodically.
Last update: July 18, 2018
“GMO Reports: New Plant Breeding Techniques (NPBTs)” is a working post of a list of reports, fact sheets, issue briefs, studies, articles and other publications about New Plant Breeding Techniques that are an emerging set of scientific approaches that can be used to create GMOs. Some techniques, such as CRISPR, have applications that go beyond biotechnology in agriculture. For example, CRISPR (often referred to as a type of “gene editing” – an association that critics say is inaccurate and misleading), is a technique that is being studied for the potential use in gene drives which can alter an entire species in a targeted location, but which may result in extending beyond that targeted environment. An example might be altering the DNA of mosquitoes in a way that they would no longer be able to transmit malaria. In addition, CRISPR can be used to alter human DNA – something that has already happened in China with human embryos.
This science is progressing much faster than the full impact of any potential adverse events from any products from these methods can be fully understood. This is an echo of the history of GMOs in agriculture and food products. The ethics of applying these methods in real world conditions is not at the forefront of research – ethics are hardly incorporated into any public dialogue and the decision making process by a relatively select few. There is, after all, money to be made.
Note: There are publications that use the abbreviated term, “New Breeding Techniques” (NBTs) instead of NPBTs. I don’t necessarily endorse or support all the views and statements within the publications listed; this list is provided as a means to assist anyone who would like to do research into these topics.
GeneWatch UK also has a list of resources on NPBTs here: “New Genetic Engineering Techniques”
“CRISPR/cas9i – Fact Sheet,” by Friends of the Earth (One page, undated)
“Differences: Genome editing and mutagenesis,” by Testbiotech, May 2, 2018 (2 pages)
What is ‘gene-editing’?
Gene-editing (or ‘genome-editing’) techniques allow the direct modification of plant genetic material (usually DNA) at specific locations in the genome. They generally use nucleases, often called ‘molecular scissors’, which cleave DNA at specific sites and trigger the plant’s own repair mechanisms. Techniques involving this molecular scissors include zinc finger nucleases (ZFNs), transcription activator-like effector nucleases (TALENs), meganucleases (MN) and the clustered regularly interspaced short palindromic repeat (CRISPR/Cas) system. In contrast, oligonucleotide-directed mutagenesis (ODM) is a gene-editing technique that does not use molecular scissors. With ODM, short DNA (or DNA-RNA) fragments (oligonucleotides) are introduced into cells where they trigger the cell to modify its own DNA to match the introduced DNA fragments. All gene-editing techniques (including ODM) can change, insert or delete one or a few base pairs of DNA1. Some applications of these techniques can also insert novel genes into the plant genetic code, similarly to ‘traditional’ genetic engineering. SEE: “Gene-editing of plants – GM through the back door?“ by Greenpeace; November 30, 2015 (3 pages)
“New methods of genetic engineering and the ‘poisonous CRISPR mushroom’,” by Testbiotech; July 18, 2018
“CRISPR causes greater genetic damage than previously thought,” by GMWatch; July 17, 2018
Excerpt: Commenting on the findings, London-based molecular biologist Dr Michael Antoniou said, “The main point to bear in mind about CRISPR is that all events after the CRISPR has cut the DNA occur independently of the CRISPR and are due to the cell’s innate DNA repair machinery. Thus it doesn’t matter how much you tweak the CRISPR to make it more ‘specific’ – you’ll be faced with the same spectrum of downstream problems that are inherent to the non-homologous end joining (NHEJ) DNA repair system.
“These findings also do not bode well for the other genome editing tools (TALENs, ZFNs), as presumably the same things will happen after they too have produced a double strand DNA break and the NHEJ repair pathway kicks in.
“In addition, these findings suggest that we need to re-visit/re-evaluate the outcomes from NHEJ DNA repair in general. Do the outcomes reported in this latest study with CRISPR-generated double strand breaks also occur when the DNA is cut by other means, e.g. radiation or mutagenic chemicals? Or do they occur only when double strand breaks are brought about by editing tools?”
Dr Antoniou pointed out that some of our food plants have been produced through the older methods of radiation- or chemical-induced mutagenesis and if similar genetic damage to that seen when using CRISPR also occurs with the older methods, this could have implications for the food safety of those plants.
“Genetically modifying future children isn’t just wrong. It would harm all of us,” by Marcy Darnovsky, The Guardian; July 17, 2018
“CRISPR Could Be Causing Extensive Mutations and Genetic Damage After All,” by Peter Dockrill, Science Alert; July 16, 2018
“A Serious New Hurdle for CRISPR: Edited Cells Might Cause Cancer, Find Two Studies,” by Sustainable Pulse; June 11, 2018
“CRISPR/Cas9 targeting events cause complex deletions and insertions at 17 sites in the mouse genome,” by Ha Youn Shin, Chaochen Wang, Hye Kyung Lee, Kyung Hyun Yoo, Xianke Zeng, Tyler Kuhns, Chul Min Yang, Teresa Mohr, Chengyu Liu & Lothar Hennighausen, Nature Communications, Vol. 8, Article 15464, May 31, 2017 (10 pages); this publication can also be found HERE. This publication is also HERE and HERE in HTML format.
“Biosafety Considerations of Novel Plant Breeding Techniques,” by African Centre for Biodiversity (ACB); February 2017 (13 pages)
“Biosafety Risks of Genome Editing Techniques in Plant Breeding,” by African Centre for Biodiversity (ACB); February 2017 (13 pages)
“Playing Russian Roulette with Biodiversity: Uncontrolled applications of gene editing threaten biodiversity, the rights of consumers and farmers, as well as the future of animal and plant breeding,” by Christoph Then & Andreas Bauer-Panskus, Testbiotech; September 2017 (28 pages); this publication can also be found HERE.
Excerpt: As things currently stand, our generation needs to make a decision which could affect the future for years to come. If we get this wrong, it could rob future generations of being able to decide for themselves on the future of breeding, agriculture and food production. Indeed, our hubris around genetic technology could potentially lead us to leave our fingerprint on biodiversity and change it forever.
“New Genetic Engineering Techniques: Precaution, Risk, and the Need to Develop Prior Societal Technology Assessment,” by Ricarda A. Steinbrecher & Helena Paul, Environment: Science and Policy for Sustainable Development, Vol. 59, No. 5; August 18, 2017 (10 pages)
“Gene-editing companies attack research revealing unintended CRISPR effects,” by Claire Robinson, GMWatch; July 4, 2017
“Informing USDA’s and FDA’s Thinking About Crops/Foods Derived From Plant Varieties Produced Using Genome Editing Techniques Like CRISPR-Cas9,” by Belinda Martineau, Biotech Salon; June 16, 2017
“CRISPR-induced mutations – what do they mean for food safety?” by Claire Robinson, GMWatch; June 1, 2017
“CRISPR Gene-Editing Can Cause Hundreds of Unexpected Mutations,” by BEC CREW, ScienceAlert; May 30, 2017
“CRISPR gene editing can cause hundreds of unintended mutations,” by Phys.org; May 29, 2017
“CRISPR DNA Editing Can Cause Hundreds of Off-Target Mutations,” by David Roos, Seeker; June 6, 2017
“U.S. biotechnology regulations are woefully out of date,” by Brooke Borel, Slate; April 21, 2017
“University of California files appeal over CRISPR patents,” by Julie Steenhuysen, Reuters; April 13, 2017
“‘New Breeding Techniques’ and synthetic biology – genetic engineering by another name,” by Helena Paul, Elisabeth Bücking & Ricarda A. Steinbrecher, The Ecologist; April 4, 2017
Excerpt: Proponents of genetic engineering are keen to circumvent the public scepticism surrounding GMOs. They want to avoid the term GM in relation to gene- and genome-editing techniques in particular, hoping that such modified organisms will be excluded from GMO regulation.
Clearly, this would be completely inappropriate, since these resulting GMOs would then not be subject to risk assessment, detectability and labelling rules. It would mean giving up the scientific safeguards of the precautionary principle and exposing citizens and the environment to unpredictable risks.
Genetic engineering, whether it’s called GM, Synbio or NBTs, involves the application of an engineering mindset to the natural world. It means that living things are seen as composed of parts that may be disassembled and reassembled in an ‘improved’ or novel form.
Living organisms are being re-imagined as data and software platforms. They may be added to or removed from an ecosystem, be reshaped or reprogrammed – without taking into account what impacts such changes have on the whole system.
Proponents claim that GMOs, including the new techniques, are essential to help feed a growing global population, develop plants that can withstand climate change and replace fossil fuels with better alternatives.
However, what would be the consequences of such approaches? Moreover, none of these promises have so far been fulfilled in over 20 years of GMO crop research and development. Proponents respond that we (society) need to reduce or remove regulation and increase the speed of application.
The problems predicted by GMO critics, on the other hand, have to a large extent materialised. These include the contamination of non-GM crops; the emergence of pesticide-resistant pests and secondary pests (in response to pesticide-producing GM crops), requiring ever more pesticides; and the development of herbicide-tolerant persistent weeds, sometimes in invasive proportions (in response to herbicide-tolerant GM crops).
These have all had negative impacts on farmers and communities, including serious health impacts from the multiple spraying of toxins (herbicides and pesticides), eg Argentina. [Citations omitted, please see the original publication HERE].
“Gene editing in legal limbo in Europe,” by Nature, Vol. 542; February 23, 2017
“Gene drives: to a land of milk and honey or the apocalypse?” by Lawrence Woodward, Beyond GM; February 19, 2017
Excerpt: Gene drives have the potential to spread genetically engineered genes through wild species causing massive ecological disruption and even “re-engineering” entire populations.
Currently they are largely unregulated with no international framework governing their use or agreed procedures for risk assessment and monitoring.
According to the leading science journal, Nature: “Since the introduction of new tools such as the popular gene-editing technique called CRISPR–Cas9 it has been possible to spread or “drive” a given gene through a population almost exponentially”
Unknown risks and not understood
This has caused widespread concern and not just amongst environmental groups; some governments and many researchers – including those who see potential benefits in the technology – have urged caution and called for a robust and unified system of monitoring and governance.
Some researchers have argued that the concerns are being overstated and that natural and technical constraints will limit the application of gene drives – not least the evolution of natural resistance.
Nonetheless, in 2016 a specially convened committee of the US National Academies of Sciences, Engineering and Medicine warned that ‘gene drives pose complex ecological risks that are not yet fully understood”, that the technology “is not ready – and we are not ready – for any kind of release,”
The committee’s chair, Elizabeth Heitman wrote that “molecular biology research on gene drives has surged forward, it has outpaced our understanding of their ecological consequences, Even a small, accidental release from a laboratory holds the potential to spread around the globe: After release into the environment, a gene drive knows no political boundaries”.
Read the full article HERE.
“Human Genome Editing (Pre-publication): Science, Ethics, and Governance,” by the National Academy of Sciences; February 2017 (261 pages)
This is a prepublication version of the report. The NAS may modify this report and publish a finalized version during the next several months.
This publication can also be downloaded from HERE.
Also see: “Summary Brief – Human Genome Editing – Science, Ethics, and Governance,” by the National Academy of Sciences; February 2017 (4 pages)
Excerpt: Because germline genome editing would result in genetic changes being inherited by the next generation, it raises concerns about safety and unintended effects. It has also been argued that this degree of control in human reproduction crosses an ethically inviolable line. These discussions move the conversation about genome editing beyond individual-level risks and benefits and toward significantly more complex deliberations that touch on technical, social, and religious concerns about the appropriateness of this degree of intervention.
Given both the technical and societal concerns, the committee concludes there is a need for caution in any move toward germline editing, but that caution does not mean prohibition. It recommends that germline editing research trials might be permitted, but only after much more research to meet appropriate risk/benefit standards for authorizing clinical trials. Even then, germline editing should only be permitted for compelling reasons and under strict oversight. In the United States, authorities are currently unable to consider proposals for this research due to an ongoing prohibition on use of federal funds by FDA to review “research in which a human embryo is intentionally created or modified to include a heritable genetic modification.”
A press release article is here: A press release article is here: “Consensus Study, Human Genome Editing – Science, Ethics, and Governance,” by the National Academy of Sciences; February 14, 2017
This publication was cited in these related articles:
“A Groundbreaking Report on Gene Editing says we Shouldn’t Create Enhanced Humans,” by Alex Pearlman, Motherboard; February 14, 2017
“U.S. Panel Endorses Designer Babies to Avoid Serious Disease,” by Antonio Regalado, MIT Technology Review; February 14, 2017
“Gene Drives: A Scientific Case for a Complete and Perpetual Ban,” by Jonathan Latham, PhD, Independent Science News; February 13, 2017
This article was republished here: “Gene Drives: A Scientific Case for a Complete and Perpetual Ban,” by Jonathan Latham, Truthout; February 18, 2017
This article was originally published in “CRISPR & Gene Drives,” by GeneWatch, Vol. 30 No. 1; January-February 2017
“CRISPR & Gene Drives,” by GeneWatch, Vol. 30 No. 1; January-February 2017 (22 pages)
This issue includes the following articles which can also be accessed online individually:
“CRISPR will never be good enough to improve people,” by Stuart Newman
“The Social and Political Dangers of Human Germline Interventions,” by Marcy Darnovsky and Elliot Hosman
“Gene Drives: A Scientific Case for a Complete and Perpetual Ban,” by Jonathan Latham
“Gene Drive and Collective Oversight,” by Kevin Esvelt
“Sterile Insect Techniques, GE Mosquitoes and Gene Drives,” by Jaydee Hanson
An excerpt from: “A Call for Conservation with a Conscience: No Place for Gene Drives in Conservation,” by Dr. David Suzuki, Dr. Fritjof Capra, Dr. Angelika Hilbeck, Dr. Vandana Shiva, Nell Newman et al, Civil Society Working Group on Gene Drives; September 2016 (2 pages)
“Guest Editor’s Note,” by Andrew Kimbrell, GeneWatch, Vol. 30 No. 1; January-February 2017
“How CRISPR and Gene Editing Could Ruin Human Evolution,” by Jim Kozubek, Time; January 9, 2017
“Biodiversity Convention call to block new ‘genetic extinction’ GMOs,” by GMWatch and The Ecologist; The Ecologist; December 6, 2016
This article is an expanded and edited version of one originally published by GMWatch: “160 global groups call for moratorium on new genetic extinction technology at UN convention,” by GMWatch; December 5, 2016
Excerpt: 160 global groups have called for a moratorium on new ‘genetic extinction’ technology at the UN Convention on Biological Diversity meeting in Cancun, Mexico. Gene drive technology, they say, poses serious and irreversible threats to biodiversity, national sovereignty, peace and food security.
International conservation and environmental leaders from over 160 organisation are calling on governments at the 2016 COP13 of the Biodiversity Convention to establish a moratorium on the controversial genetic extinction technology called ‘gene drives’.
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, they say, poses “serious and potentially irreversible threats to biodiversity, as well as national sovereignty, peace, and food security.”
Dr. Ricarda Steinbrecher, representing the Federation of German Scientists, said: “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.
“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.”
“Gene drives will be one of the fiercest debates at CBD this year”, added 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.”…..
“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.”
Supporters also include organizations representing millions of small-scale famers around the world, such as Via Campesina International, the International Federation of Organic Agricultural Movements, the international indigenous peoples’ organization Tebtebba, and Third World Network.
“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.”
Scientist coalitions including European Network of Scientists for Social and Environmental Responsibility (ENSSER), Unión de Científicos Comprometidos con la Sociedad (Mexico) and ETC Group are also among the signatories.
“Gene drives are basically a technology that aims for a targeted species to go extinct”, said ecologist and entomologist Dr. Angelika Hilbeck, ENSSER president.
“While this may appear to some conservationist professionals to be a ‘good’ thing and a ‘silver bullet’ to handle complicated problems, there are high risks of unintended consequences that could be worse than the problems they are trying to fix.”
“The perils of planned extinctions,” by Claire Hope Cummins, Heinrich Boell Foundation; November 14, 2016
“Gene Editing and Seed Stealing,” by Chee Yoke Ling and Edward Hammond, Heinrich Boell Foundation; November 3, 2016
“Biosafety aspects of genome-editing techniques,” by Sarah Z. Agapito-Tenfen, Biosafety Briefing, Third World Network; November 2016 (10 pages)
Excerpt: Recent scientific and technical developments in modern biotechnology have intensified the debate about the regulation of organisms resulting from new techniques. More specifically, the debate is addressing whether or not organisms resulting from new techniques fall within the scope of legislation regulating genetically modified organisms (GMOs). This debate is taking place at national (e.g., Brazil, Germany, Sweden, USA, etc.), regional (e.g., European Union) and international (i.e., Convention on Biological Diversity and its Protocols) levels.
In general terms, GMO regulations set mandatory approval and risk assessment requirements, sometimes also taking into account socioeconomic and ethical considerations. They were originally established in response to the modern biotechnological techniques emerging in the 1970s and have evolved over time and jurisdiction to better capture the scope of coverage. The question now is whether variations of certain techniques are creating potential products for release into the environment that might not be subject to current GMO regulations and/or if these regulations require revision and adaptation (Heinemann 2015).
New biotechnological techniques can be described as a range of techniques that create organisms with novel traits or alter the expression of an already existing trait. Up until now, these techniques have mainly been used on yeast and bacteria, but most environmentally released products will be plants. Although the terms used to define these new techniques vary among regulators and scientists, the New Techniques Working Group established by the European Commission in 2007 has identified several new techniques that have obtained consensus in the discussions (EC 2012).
Among the new techniques, genome-editing … specifically CRISPR (clustered regularly interspaced short palindromic repeats), is gaining special attention due to its various possibilities and relatively easy manipulation. The CRISPR technique has rapidly emerged as a leading tool for investigating gene function and for creating genetic variation using site-directed genomic alterations (Travis 2015).
“Should Organic Agriculture Maintain its Opposition to GM? New Techniques Writing the Same Old Story,” by Fern Wickson, Rosa Binimelis and Amaranta Herrero, Sustainability, Vol. 8, No. 1; October 28, 2016 (19 pages)
Excerpt: A range of new plant breeding techniques (NPBTs) are now available, especially for what is being referred to as “genome editing”. This includes the use of site directed nucleases (SDN) and oligonucleotide directed mutagenesis (ODM). Both of these types of techniques for genome editing create breaks in DNA and then employ the natural repair mechanisms of cells to integrate desired changes. SDNs use agrobacterium, particle bombardment, or agro-infiltration methods to insert enzyme complexes (such as zinc finger nucleases, TALENs, and the CRISPR-Cas system) into cells to target chosen sequences of DNA and make single or double stranded breaks, which when repaired by the cell can lead to the deletion, substitution or insertion of desired genetic sequences. ODM techniques in contrast, deliver oligonucleotides into cells (typically either by particle bombardment or electroporation) in which the introduced DNA is the same as the target organism’s, except for a particular insertion, deletion or mismatch. The oligonucleotide then attaches to the targeted DNA sequence and triggers the repair mechanism of the cell to use the oligo insert as the correct template to rewrite the native genome.
Both of these new techniques enable more directed and targeted alterations in the genome than has previously been possible with rDNA technology. However, unintended off-target effects resulting from the technology still require thorough investigation. This is necessary because despite the widespread assumption (and regular declaration) that these novel techniques are precise, little research has been done on their effects across the entire genome and the limited available information to date has already indicated the potential for off-target changes. While some will dismiss the significance of such changes by highlighting that genetic mutations can also arise naturally, this does not mean that any potential off target effects from the use of genome editing techniques will necessarily be harmless. Experience teaches us that even small genetic changes can have large consequences. Our knowledge of how the genome functions is continually evolving and our experience with these new tools is simply too limited at this point to declare that potential off-target effects will not happen or will be irrelevant if they do. Unintended changes brought about by the use of these new techniques needs to be studied scientifically rather than simply assumed not to occur or to be harmless because mutation is a natural phenomenon. Context matters and it is, therefore, important to examine the significance of any off-target effects on a case by case basis. It is also crucial that researchers sequence the entire genome and perform omic forms of analysis (e.g., proteomics and transcriptomics) if we are to truly understand the operation and impact of these novel technologies in detail. Furthermore, to understand what impact the induced changes may have on the organisms involved or what risks such organisms may pose, we would also ideally study them over generations and across different environmental contexts. [Emphasis added, citations omitted]
“CRISPR – briefly explained,” by Dr. Sarah Agapito-Tenfen, GenØk; October 21, 2016
Excerpt: CRISPR stands for ‘Clustered Regularly Interspaced Short Palindromic Repeats’ and it is originally a bacterial immune system that confers resistance to foreign genetic elements such as those from viral infections. Recently, CRISPR technology has emerged as a powerful tool for targeted genome modification in virtually any species. It allows scientists to make changes in the DNA in cells that has the potential to cure genetic diseases in animals or develop new traits in plants. The technology works through a protein called Cas9 that is bound to an RNA molecule and thus forming a complex. RNA is a chemical cousin of DNA and it enables interaction with DNA molecules that have a matching sequence. The complex functions like a sentinel in the cell and searches through the entire DNA in the cell that matches the sequences in the bound RNA. When the sites are found, it allows the protein complex to cut and break DNA at that site. Its success is much due to its ability to be easy programmable to target different sites.
“Genetically modifying a plant is far from harmless (with follow-up),” by Eric Meunier, Inf’OGM; September 30, 2016 (8 pages)
This publication is also in two articles in HTML format:
“Genetically modifying a plant is far from harmless,” by Eric Meunier, Inf’OGM; September 30, 2016
“Genetically modifying a plant is far from being harmless (follow-up),” by Eric Meunier, Inf’OGM; September 30, 2016
“Reckless Driving: Gene Drives and the End of Nature,” by the Civil Society Working Group on Gene Drives; September 1, 2016 (6 pages)
This publication is also HERE in HTML format.
“CRISPR/Cas9 gene drives in genetically variable and non-randomly mating wild populations,” by Douglas W. Drury, Dylan J. Siniard, Gabriel E. Zentner, Michael J. Wade, bioRxiv; August 25, 2016 (18 pages)
This publication is also HERE in HTML format.
Excerpt: In sum, our analyses suggest that standing genetic variation and inbreeding could have wide-ranging and sometimes severe consequences on the efficiency of drive propagation in a wild population. Inbreeding, which in our analyses had the most profound impact on drive propagation, may be most effectively overcome by saturation of the target population with drive individuals through repeated, high-volume releases. To minimize the potential impacts of ITDs on drive spread, propose that a survey of genetic diversity at the locus of interest in the target population is a necessary first step in designing a CRISPR-based gene drive. If a target region of a locus of interest is highly variable, it may be prudent to select a different region of the gene to be disrupted to avoid the potential complications of ITDs described here. However, if targeting of a region with an altered PAM is highly desirable, a Cas9 variant engineered to alter its PAM specificity may be used. While the impediments posed to CRISPR/Cas9-based gene drives described here are substantial, we are confident that with appropriate consideration of population structure and genetic diversity such drives can be effectively used to spread beneficial genetic modifications through wild populations. [Citation omitted]
“They’re going to CRISPR people. What could go wrong?” by Sharon Begley, Stat News; June 23, 2016
“This scientist is trying to stop a lab-created global disaster,” by Kristen V. Brown, Fusion; June 27, 2016
[Also see an article written by the scientist featured in this article: “Gene Drive and Collective Oversight,” by Kevin Esvelt, GeneWatch, Vol. 30 No. 1; January-February 2017]
Excerpt: 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.”
If that happens, Esvelt said, lots of people who might have otherwise been saved 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.”
“Gene Drives on the Horizon: Advancing Science, Navigating Uncertainty, and Aligning Research with Public Values,” by the National Academies of Sciences (NAS); June 2016 (231 pages). This publication can be downloaded from HERE.
But see: “The National Academies’ Gene Drive study has ignored important and obvious issues,” by Jim Thomas, The Guardian; June 9, 2016
Excerpt: 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…
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 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.
“CRISPR has off-target effects that researchers have been ignoring,” by Sharon Begley, Stat News; July 18, 2016
“Biodiversity, GMOs, Gene Drives and the Militarized Mind,” by Vandana Shiva, Common Dreams; July 10, 2016
This was also published here: “Biodiversity, GMOs, & Gene Drives of the Militarized Mind,” by Vandana Shiva, Medium; July 7, 2016
Excerpt: Industrial agriculture – promoted by United States Foreign Policy – treated amaranth greens as “weeds”, and tried to exterminate with herbicides. Then came Monsanto, with Roundup Ready crops, genetically engineered to resist the spraying of Roundup so that the GMO crop would survive the otherwise lethal chemical, while everything else that was green perished. As was stated by a Monsanto spokesman during the negotiations of the Convention on Biodiversity (CBD), Herbicide resistant GMOs “prevent the weeds from stealing the sunshine”…. When the sun shines on the earth and plants grow, Monsanto would like to define it as a plants “stealing” the sunshine, while Monsanto Co. privateers our biodiversity.
This is exactly how seed famine and food famine are engineered through a world view which transforms the richness of diversity into monocultures, abundance into scarcity. The paradigm of Genetic Engineering is based on Genetic Determinism and Genetic Reductionism. It is based on a denial of the self-organized, evolutionary potential of living organisms. It treats living organisms as a Lego set. But life is not Lego, Meccano, or Stratego. It is life – complex, self-organized, dynamic evolution – auto poetic.
The right to food and nutrition of the people outside the US, and the right of the amaranth to continue to grow and evolve and nourish people, can be extinguished by powerful men in the US because they messed up their agriculture with Roundup Ready crops, and now want to mess up the planet, its biodiversity, and food and agriculture systems of the world with the tool of gene drives to push species to extinction.
As in the case of GMOs, the rush for Gene Drives, and CRISPR-based Gene Editing are linked to patents. Bill Gates is financing the research that is leading to patents. And he with other billionaires has invested $130 million in a company – EDITAS – to promote these technologies. Bayer, the new face on Monsanto & Co, has invested $35 million in the new GMO Technologies, and committed $300 million over the next 5 years.
Of the publications listed, I highly recommend that anyone who is interested in learning more about CRISPR read this one:
“God’s Red Pencil? CRISPR and the Three Myths of Precise Genome Editing,” by Jonathan Latham, PhD, Independent Science News; April 25, 2016
Excerpt: Why is this discussion of precision important? Because for the last seventy years all chemical and biological technologies, from genetic engineering to pesticides, have been built on a myth of precision and specificity. They have all been adopted under the pretense that they would function without side effects or unexpected complications. Yet the extraordinary disasters and repercussions of DDT, leaded paint, agent orange, atrazine, C8, asbestos, chlordane, PCBs, and so on, when all is said and done, have been stories of the steady unraveling of a founding myth of precision and specificity.
Nevertheless, with the help of industry propagandists, their friends in the media, even the United Nations, we are once again being preached the gospel of precision. But no matter how you look at it, precision is a fable and should be treated as such.
The issues of CRISPR and other related new “genome editing” biotechnologies are the subject of intense activity behind the scenes. The US Department of Agriculture has just explained that it will not be regulating organisms whose genomes have been edited since it doesn’t consider them to be GMOs at all. The EU was about to call them GMOs but the US has caused them to blink, meanwhile the US is in the process of revisiting its GMO regulatory environment entirely. Will future safety regulations of GMOs be based on a schoolboy version of genetics and an interpretation of genome editing crafted in a corporate public relations department? If history is any guide it will.
“New Plant Breeding Techniques – Ethical Considerations,” by Federal Ethics Committee on Non-Human Biotechnology (ECNH) [Swiss Federation], edited by Ariane Willemsen; March 2016 (32 pages)
“Synthetic Gene Technologies Applied in Plants & Animals used for Food Production: Overview on Patent Applications on New Techniques for Genetic Engineering & Risks Associated with these Methods,” by Christoph Then, Testbiotech; March 2016 (26 pages)
This publication can also be found HERE.
A summary article is here: “Seed Giants active around new methods of genetic engineering,” by Testbiotech; March 2, 2016
“New techniques of genetic engineering,” by Greenpeace et al; March 2016 (6 pages)
“Gene-editing – a GMO by any other name…” by Dr. Janet Cotter, Beyond GM; February 26, 2016
Excerpt: There is a considerable amount of hype regarding the ability of gene-edited crops and animals to transform agriculture. But what are those promises and do we really need gene-edited crops and animals?
The promises of gene-editing include crops “that better withstand pests, that have enhanced nutritional value, and that are able to grow on marginal lands” and “extending the shelf life of fruits, vegetables, and cut flowers; altering the plant architecture of fruit trees, ornamental flowers, and trees; improving yield potential; and enhancing plant pest and disease resistance”.
Animals too can be improved; proof-of-concept scientific papers have appeared on gene-edited goats, sheep, pigs, monkeys and dogs, as well as hornless cattle. Companies such as DuPont are ready to develop (and patent) gene-edited crops, predicting they will be on our dinner plates in 5 years’ time.
If that’s the case then we owe it to ourselves to understand something about them…..
Gene-editing techniques may differ in their details but the outcome is a product that is a GMO, and needs to be regulated as a GMO. This is because the genetic material of the organism has been directly modified in the laboratory by in vitro processes, just like the older genetic engineering techniques. The use of laboratory techniques (as opposed to breeding) to change the genetic make-up of an organism is one of the ways GMOs are defined in both the EU and the UN treaty which regulates trade on living GMOs, the Cartagena Protocol on Biosafety.
Despite this, some developers assert that, because only small changes to the DNA are involved or the final product doesn’t contain genes from another organism (so-called ‘foreign’ genes), gene-edited crops and animals should be exempt from the GMO regulations, and hence exempt from environmental or human and animal health risk assessment.
Risk assessment isn’t perfect. Many of us think GMOs should never be released to the environment of food chain, with or without a risk assessment, and many don’t want GMOs in our food. But if gene-edited crops and animals aren’t regulated as GMOs, there would be no requirement to assess the risks these GMOs might pose to the environment or human and animal health – nor any requirement to label any foods produced by gene-edited crops as derived from GMOs. Gene-edited crops and animals would be released to our environment and, unknowingly, in the food chain without any consideration of the risks they might pose.
“Top U.S. Intelligence Official Calls Gene Editing a WMD Threat,” by Antonio Regalado; MIT Technology Review; February 9, 2016
Excerpt: Genome editing is a weapon of mass destruction.
That’s according to James Clapper, U.S. director of national intelligence, who on Tuesday, in the annual worldwide threat assessment report of the U.S. intelligence community, added gene editing to a list of threats posed by “weapons of mass destruction and proliferation.”….
It is gene editing’s relative ease of use that worries the U.S. intelligence community, according to the assessment. “Given the broad distribution, low cost, and accelerated pace of development of this dual-use technology, its deliberate or unintentional misuse might lead to far-reaching economic and national security implications,” the report said….
Although the report doesn’t mention CRISPR by name, Clapper clearly had the newest and the most versatile of the gene-editing systems in mind. The CRISPR technique’s low cost and relative ease of use—the basic ingredients can be bought online for $60—seems to have spooked intelligence agencies.
“Research in genome editing conducted by countries with different regulatory or ethical standards than those of Western countries probably increases the risk of the creation of potentially harmful biological agents or products,” the report said.
The concern is that biotechnology is a “dual use” technology—meaning normal scientific developments could also be harnessed as weapons. The report noted that new discoveries “move easily in the globalized economy, as do personnel with the scientific expertise to design and use them.”
“Biotech lobby’s push for new GMOs to escape regulation,” by Nina Holland, Corporate Europe Observatory; February 2016 (32 pages)
Another version in HTML format can be found here: “Biotech lobby’s push for new GMOs to escape regulation,” by the Corporate Europe Observatory; February 2, 2016
“GM 2.0? ‘Gene-editing’ produces GMOs that must be regulated as GMOs,” by Janet Cotter & Ricarda Steinbrecher, The Ecologist; January 13, 2016
Excerpt: Just like traditional genetic engineering, gene-editing techniques can cause unintended alterations in the DNA. For example, several gene-editing techniques use so-called ‘molecular scissors’ to cut DNA as part of the editing process.
These molecular scissors sometimes have what is known as ‘off-target’ effects. This means the DNA is cut in unintended places as well as the intended places, accidentally causing additional genetic alterations.
Other gene editing techniques such as ODM could also edit DNA in the wrong place. In addition, the newly edited gene could interact with other genes in different ways, affecting protein composition and production, chemistry and metabolism.
Many of the gene-editing techniques are so new that it is not yet possible to fully evaluate the potential for and consequences of unintended changes. Importantly, just because gene-edited organisms don’t contain foreign DNA, this doesn’t make them safe.
Furthermore, there is increasing evidence of ‘off-target’ effects. The intended change (e.g. tolerance to a herbicide or cattle without horns) may be clear to see, but the unintended changes aren’t immediately apparent, and certainly not apparent if they aren’t looked for. It’s a case of ‘don’t look, won’t find’.
“CRISPR Too Fast for Comfort,” by Dr. Mae-Wan Ho, Institute of Science in Society; January 12, 2016.
This publication can also be found HERE.
Excerpt: The new gene-editing technique CRISPR has taken the world by storm. It enables geneticists to disable or change the sequence of specific genes in the genome of practically all animals including humans faster, more efficiently than ever before, promising to improve our understanding of how genes work, delete genes that cause diseases, even modify human embryos to rid them of diseases or to ‘enhance ‘ them. The applications are moving ahead so fast that many scientists are calling for caution as major safety and ethical concerns need to be addressed.
The issue came to a head when a team of Chinese researchers created the first genetically modified human embryos using the technology…
Just before an International summit in December 2015 co-sponsored by the US National Academy of Sciences, the US National Academy of Medicine, the UK Royal Society and the Chinese Academy of Sciences to consider the scientific and social implications of genome editing, Jennifer Doudna, a researcher at University of California Berkeley who helped invent CRISPR/Cas9, and a signatory on the editorial in Science, wrote in a commentary in Nature stating that “we do not yet know enough about the capabilities and limits of the new technologies, especially when it comes to creating heritable mutations.” Hence, “human-germline editing for the purposes of creating genome-modified humans should not proceed at this time, partly because of the unknown social consequences, but also because the technology and our knowledge of the human genome are simply not ready to do so safely.” She also stated that future discussions should address other potentially harmful applications of genome editing in non-human system, such as “the alteration of insect DNA to ‘drive’ certain genes into a population”…
Finally, the ecological risks of gene drives are enormous, so warns conservation scientists from Australia’s Commonwealth Scientific and Industrial Research Organisation. They stated: “The question is no longer whether we can control invasive species using gene drive, but whether we should.” As the gene drive can in principle lead to the extinction of a species, this could involve the species in its native habitat as well as where it is considered invasive. As distinct from conventional biological control, which can be applied locally, there is no way to control gene flow. They point out that because the CRISPR/Cas gene drive remains fully functional in the mutated strain after it is created, the chance of off-target mutations also remain and the likelihood increases with every generation. “If there is any risk of gene flow between the target species and other species, then there is also a risk that the modified sequence could be transferred and the adverse trait manifested in nontarget organisms.” (This commentary has not even begun to consider horizontal gene flow, which would multiply the risks many-fold.)
There is also increasing awareness that many invasive species will have considerable niche overlap, such that removal of one species will enable another to rapidly take its place.
They call for a thorough ecological risk assessment before any application of CRISPR/Cas gene drive is contemplated in the control of alien species, to prevent a ‘silver bullet’ becoming a ‘conservation threat’.
“New Plant Breeding Techniques Position paper,” by International Federation of Organic Agriculture Movements – Europe (IFOAM EU); December 10, 2015 (6 pages)
“Why scientists are calling for caution on a powerful new gene-editing technology,” by Julia Belluz, Vox; December 3, 2015
“Gene-editing and plants & animals used in food production: some technical, socio-economic and legal aspects,” by Christoph Then, Testbiotech; December 1, 2015 (3 pages)
“Genetic Engineering in Plants and the ‘New Breeding Techniques (NBTs)’ Inherent risks and the need to regulate,” by Dr. Ricarda A. Steinbrecher, EcoNexus; December 2015 (10 pages)
“Gene-editing of plants – GM through the back door?“ by Greenpeace; November 30, 2015 (3 pages)
Gene-editing techniques may be more precise than ‘traditional’ genetic engineering in their positioning of the intended alteration to genetic material. However, the newly created organisms can still display unexpected and unpredictable effects, which can have implications for their food, feed or environmental safety. If these new techniques were to be exempted from the EU’s regulations for genetically modified organisms (GMOs), there would be no requirement to detect and assess such unintended changes or to assess any potential negative safety effects. Also, there would be no requirement to make the products traceable and label them as GMOs. The GMO regulations in the EU must be interpreted in their intended sense, to encompass all modern biotechnological processes that directly modify genomes. Otherwise, the EU would be failing its citizens.
“CRISPR Democracy: Gene Editing and the Need for Inclusive Deliberation,” by Sheila Jasanoff, J. Benjamin Hurlbut, Krishanu Saha, Issues in Science and Technology, Volume XXXII Issue 1, Fall 2015
Excerpt: Asilomar* shows how under the guise of responsible self-regulation science steps in to shape the forms of governance that societies are allowed to consider. As a first step, questions are narrowed to the risks that scientists know best, thereby demanding that wider publics defer to scientists’ understandings of what is at stake. Even where there are calls for “broad public dialogue,” these are constrained by expert accounts of what is proper (and not proper) to talk about in ensuing deliberations. When larger questions arise, as they often do, dissent is dismissed as evidence that publics just do not get the science. But studies of technical controversies have repeatedly shown that public opposition reflects not technical misunderstanding but different ideas from those of experts about how to live well with emerging technologies. The impulse to dismiss public views as simply ill-informed is not only itself ill-informed, but is problematic because it deprives society of the freedom to decide what forms of progress are culturally and morally acceptable. Instead of looking backward to a mythic construct that we would call “Asilomar-in-memory,” future deliberations on CRISPR should actively rethink the relationship between science and democracy. That reflection, we suggest, should take note of four themes that would help steer study and deliberation in more democratic directions: envisioning futures, distribution, trust, and provisionality.
[*] To understand the reference to Asilomar, see: “From Asilomar to Industrial Biotechnology: Risks, Reductionism and Regulation,” by Sheldon Krimsky, Science as Culture Vol. 14, No. 4; December 2005 (15 pages) – Jeff K.
“Legal Analysis of the applicability of Directive 2001/18/EC on genome editing technologies [EU],” by Dr. Tade Matthias Spranger, Commissioned by the German Federal Agency for Nature Conservation; October 2015 (51 pages)
“Extreme Genetic Engineering and the Human Future: Reclaiming Emerging Biotechnologies for the Common Good,” by Pete Shanks, Center for Genetics & Society & Friends of the Earth; November, 2015 (51 pages)
This publication can also be found HERE.
Summary: Recent research in genetic engineering and “synthetic biology” has enabled scientists to artificially redesign life — everything from microbes to people. Amid the breakneck speed of recent developments in genetic engineering and synthetic biology that could be used to alter human DNA, this report examines health, regulatory, social and ethical questions about proposals ranging from genetically altering human gut bacteria to implementing germline editing — altering human embryos and reproductive cells to produce permanent, hereditary genetic modification of future children and generations. It also examines the systemic and commercial incentives to rush newly discovered biotechnologies to market, regardless of their social utility and ahead of appropriate, transparent assessment and oversight.
The report calls for:
- National and international prohibitions on the use of gene editing and synthetic biology to alter human embryos or gametes for reproductive purposes. This call is especially relevant in those countries, like the U.S., that have not already enacted such a prohibition.
- Explicit and expansive public engagement on the human applications of synthetic biology, including and going beyond safety thresholds and addressing the social and ethical concerns.
- An ongoing, transparent, democratic process with which to evaluate and appropriately regulate new, emerging and proposed human applications of synthetic biology.
- Increased investment in more socially just and less risky solutions to environmental, health and social problems.
“Expert scientific opinion on the status of certain new techniques of genetic modification under Directive,” by Professor Jack A. Heinemann, PhD, Centre for Integrated Research in Biosafety; October 30, 2015 (46 pages) [“This report was commissioned from the University of Canterbury by Greenpeace International”]
This publication can also be downloaded from HERE.
This publication is cited in this related article: “Oligonucleotide directed mutagenesis (ODM) is a GM technique,” by GMWatch; April 27, 2016
Excerpt: Big agrochemical companies such as Dow, Bayer and Monsanto are experimenting with a range of new genetic engineering (GE) techniques that they misleadingly refer to as ‘New Plant Breeding Techniques’. These are being used to introduce traits such as herbicide and pathogen resistance and changed nutritional properties into commercial crop varieties that will ultimately end up in our food. By arguing that these techniques are precise, just like conventional breeding, and not really genetic engineering at all, these companies are attempting to circumvent regulation, labelling and public opposition.
Sound familiar? Well that’s because it is. These are exactly the same arguments that these companies used to defend GE crops. Only − according to industry − this time it’s actually true. These new techniques include cisgenics, zinc-finger nucleases (ZFNs) and CRISPR/Cas9 (clustered regularly interspaced palindromic repeats). Much of what has been written on them has been highly technical and fairly impenetrable to the layperson – which is of course exactly the way industry wants to keep it. Where these techniques have received mainstream media attention, unfortunately journalists have largely uncritically parroted industry’s claims that these techniques can be used to precisely edit DNA.
However, you don’t have to delve too deep to find that − as in the case of traditional genetic engineering – industry claims don’t stand up to scrutiny. Both ZFNs and CRISPR/Cas9 have been touted as precise gene editing techniques, but scientists have been reporting unexpected effects because the techniques also affect genes other than the target genes. For example, a recent study found that CRISPR-Cas9 can result in hundreds of unexpected mutations.
CRISPR-Cas9 received mainstream media coverage earlier this year when Chinese scientists used the technique to genetically engineer human embryos. The technique didn’t work too well – prompting scientists to call for a moratorium on its use because it’s not safe. Unfortunately however scientists don’t seem to have similar qualms about conducting uncontrolled experiments with our staple food crops.
So what are our regulators doing?
Most alarmingly of all it appears that these techniques are not and – on current course – may not be regulated in Australia. Furthermore, genetic engineers are arguing that these techniques are not really genetic engineering in an effort to bypass the existing regulation of genetically modified organisms (GMOs).
On its website dedicated to ZFN techniques (which it dubs “EzxactPrecision” technology), Dow claims: “The Australian Government, Office of the Gene Technology Regulator has responded to Dow AgroSciences stating that crops developed using EXZACT Delete technology would not contain introduced foreign nucleic acid, once the ZFN genes are no longer present, and would not be considered GMO and not subject to regulation under the Gene Technology Act 2000.”
In 2012 our food regulator Food Standards Australia New Zealand convened an expert panel – comprised almost entirely of genetic engineers with a vested interest in the technology – to look at whether these new techniques would be considered genetic engineering. The panel concluded that: “The changes introduced using ZFN-1 and ZFN-2 [using zinc-finger nuclease to delete, substitute or insert a few base pairs] will be small, definable and the outcomes predictable. Food derived from plants modified using ZFN-1 and ZFN- 2 would be similar to food produced using traditional mutagenic techniques, and should therefore not be regarded as GM food.”
This conclusion is in marked contrast to recent research papers on the topic, which have found numerous unintended mutations in organisms modified by ZFN and CRISPR-Cas9. As one of the researchers investigating these effects in CRISPR-Ca9 observes, “you only find things where you look for them.” It also contradicts the definition of gene technology in the Australia New Zealand Food Standards Code. This defines gene technology as “recombinant DNA techniques that alter the heritable genetic material of living cells or organisms.”
GE proponents have also argued that cisgenics – which is genetic engineering where the introduced traits/genetic material are from the same or closely related species pose no greater risks than conventional breeding. However cisgenic techniques allow for genetic material from within the same species to be so significantly rearranged that the result could be genetic constructs and traits equally as foreign as when donor DNA from outside the species is used.
As Professor of Genetics and Molecular Biology at Canterbury University, Jack Heinemann, points out: “The cisgeneticist is confined to no minimum string length for manipulation and thus, from the raw building blocks common to all genomes, can create strings just as “foreign” to that same genome as any that came from a different species. Any gene from a human being could be rearranged to become 2%, 50% or 70% different from itself and as different as the average gene from a human was to the average gene from a single-celled soil microorganism.” [Citations omitted]
“Legal Questions Concerning New Methods for Changing the Genetic Conditions in Plants,” by Professor Dr. Ludwig Krämer, Testbiotech; September 2015 (23 pages)
“Editing Human Embryos: So This Happened,” by Carl Zimmer, Phenomena: The Loom (National Geographic); May 22, 2015
“Last scientist in Congress has human genetic engineering warning,” by Representative Bill Foster, The Hill; July 8, 2015
Excerpt: The breakthrough in question relates to human genetic engineering. This has long been a theoretical possibility assumed to be decades away from practicality. In the last several years this has changed significantly due to recent breakthroughs that allow inexpensive and precise editing of chromosomal DNA. The technological potential has been amplified by the widespread adoption of in vitro fertilization, the rapid decline in the cost of genome sequencing, increasing use of Big Data to understand the relationship between genetic variations and behavior and the rapid spread of these technologies throughout the world.
It’s time for leaders in government to take notice.
The ability to modify DNA has been around for decades, but until recently it was expensive and time consuming, and required a very high level of technical skill. That has changed significantly in the last few years with the development of new gene editing tools such as CRISPR/Cas9, introduced by Jennifer Doudna and others. These tools have been rapidly adopted by researchers around the world.
These tools are revolutionary because they enable any researcher with basic capabilities in molecular biology to edit genomes. Therein lies the promise and the danger. Anyone with $300 and Internet access can now buy their own CRISPR kit to begin primitive genome editing of plants and animals…..
We are on the verge of a technological breakthrough that could change the future of humankind; we must not blindly charge ahead. Now is the time to engage in serious and thoughtful discussion about what this means for the future of the human race.
“Application of the EU and Cartagena definitions of a GMO to the classification of plants developed by cisgenesis and gene-editing techniques,” by Janet Cotter, Dirk Zimmermann and Herman van Bekkem, Greenpeace Research Laboratories; July, 2015 (18 pages)
This publication can also be found HERE.
Excerpt: Like traditional genetic engineering techniques (including those used for cisgenesis/ intragenesis), unintended changes to plant chemistry arising from the use of gene-editing techniques may result from: unforeseen interactions between the new or altered gene(s) and the plant’s endogenous genes; genomic irregularities arising from the genetic engineering process itself and unintended alterations to plant biochemical pathways arising from the changed or new function(s) of the altered or novel gene(s).
Unintended changes could impact food, feed and environmental safety but there would be no requirement for these to be detected and assessed under a product based approach, or if such plants are exempt from the GMO regulations. Exemption from the EU GMO regulations would also exempt products of NPBTs from GMO labelling requirements, which could restrict, or remove, consumer choice…
Detection and identification of a GMO are essential for the labelling of food and feed ingredients derived from the GMO. They are also essential for traceability, which allows for detection of any GM contamination and post-market monitoring of GMOs, a cornerstone of the EU GMO legislation. It is the legislation that requires GM foodstuffs to be detectable, rather than detectability being a trigger for labelling or for defining an organism as a GMO.
“New Sequencing Methods Reveal Off-Target Effects of CRISPR/Cas9,” by Andrew Han, Genome Web; March 9, 2015
“Current status of emerging technologies for plant breeding: Biosafety and knowledge gaps of site directed nucleases and oligonucleotide-directed mutagenesis,” by Sarah Z. Agapito-Tenfen and Odd-Gunnar Wikmark, GenØk Biosafety report; February, 2015 (44 pages)
A summary article is here: “Biosafety Report: Current status of emerging technologies for plant breeding: Biosafety and knowledge gaps of site directed nucleases and oligonucleotide-directed mutagenesis,” by GenØk; June 25, 2015
Excerpt: International regulations, such as the Cartagena Protocol on Biosafety, operate with definitions of GMOs that may not be applicable to products arising from some of these new techniques. The question then arises on how society and regulatory bodies should view and regulate the products.
This report does not approach that problem per se, but as a crucial step in management, we sum up the current scientific understanding of two new plant breeding techniques, site directed nucleases (SDN) and oligonucleotide directed mutagenesis (ODM). The underlying mode of action of both of these techniques are the plants natural repair systems and how this can be utilized to achieve genomic modifications. Herein also lies the main challenge for risk assessment – our limited knowledge about the function of these systems, factors involved and potential off-target effects.
This report aims at providing an overview of the current status of scientific knowledge concerning SDN and ODM. We have reviewed up to date peer reviewed scientific publications on the mechanisms and natural functions that are utilized by SDN and ODM techniques in an effort to understand potential risks such as unintentional changes in the genome of plants. Finally, recommendations for action are outlined.
“By ‘Editing’ Plant Genes, Companies Avoid Regulation,” by Andrew Pollack, New York Times; January 1, 2015
Excerpt: Its first attempt to develop genetically engineered grass ended disastrously for the Scotts Miracle-Gro Company. The grass escaped into the wild from test plots in Oregon in 2003, dooming the chances that the government would approve the product for commercial use.
Yet Scotts is once again developing genetically modified grass that would need less mowing, be a deeper green and be resistant to damage from the popular weedkiller Roundup. But this time the grass will not need federal approval before it can be field-tested and marketed.
Scotts and several other companies are developing genetically modified crops using techniques that either are outside the jurisdiction of the Agriculture Department or use new methods — like “genome editing” — that were not envisioned when the regulations were created.
The department has said, for example, that it has no authority over a new herbicide-resistant canola, a corn that would create less pollution from livestock waste, switch grass tailored for biofuel production, and even an ornamental plant that glows in the dark.
The trend alarms critics of biotech crops, who say genetic modification can have unintended effects, regardless of the process.
“They are using a technical loophole so that what are clearly genetically engineered crops and organisms are escaping regulation,” said Michael Hansen, a senior scientist at Consumers Union. He said the grass “can have all sorts of ecological impact and no one is required to look at it.”
Even some people who say the crops are safe and the regulations overly burdensome have expressed concern that because some crops can be left unregulated, the whole oversight process is confusing and illogical, in some cases doing more harm than good….
But critics of biotech crops say the genome-editing techniques can make changes in plant DNA other than the intended one. Also, the gene editing is typically done on plant cells or plant tissues growing in a dish. The process of then turning those genetically altered cells or tissues into a full plant can itself induce mutations.
“New Plant Breeding Techniques and Risks Associated with their Application,” by Michael Eckerstorfer, Marianne Miklau and Helmut Gaugitsch, Umweltbundesamt GmbH [Environment Agency Austria]; 2014 (94 pages)
This publication can also be found HERE.
Excerpt: This study addresses new plant breeding techniques (NPBTs) and, in particular, issues relevant for the assessment of potential risks associated with crops obtained through NPBTs. These issues are an emerging topic in ongoing biosafety discussions at European and global level.
The report provides an overview of different NPBT approaches and highlights specific aspects that are relevant when considering the potential adverse effects of NPBT- crops. The study investigates whether the current requirements for a risk assessment of genetically modified organisms contained e.g. in EU-regulations would provide an appropriate framework for addressing the potential risks associated with NPBT- crops. A set of criteria for the assessment of NPBT- crops is presented and open questions on the risk assessment of NPBT-crops are identified.
“New Techniques for the Alteration of the Living,” by Eric Meunier, Guy Kastler, Frederic Jacquemart, Robert Ali Brac de la Perrière & Sylvie Pouteau, International Federation of Organic Agriculture Movements (IFOAM); 2012 (40 pages)
This publication can also be found HERE.
“Are some scientists just taking the cis out of genetic engineering? Pt I,” by Prof. Jack Heinemann, SciBlog; February 11, 2010
“Are some scientists just taking the cis out of genetic engineering? Pt II,” by Prof. Jack Heinemann, SciBlog; February 12, 2010
सत्यमेव जयते – Satyameva Jayate
(Truth Ultimately Triumphs)
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