The safety of such genome-editing techniques relies on two premises: 1) Changes only in the intended places and 2) Only the changes intended. However, off-target effects may occur, and the more off-target activity there is, the more likely unintended and potentially adverse effects might arise. In addition, the DNA modification that results may show large variation, with many knowledge gaps remaining.

The author calls for proper regulation and mandatory risk assessment for genome-edited products. It is crucial that regulators ask for experimental evidence to address potential adverse effects of genome-editing techniques in order to avoid a vacuum in the risk assessment of such organisms.

Parties to the Convention on Biological Diversity and the Cartagena Protocol on Biosafety will meet in Cancún, Mexico from 4th to 17th December, where the issue of synthetic biology, of which genome-editing is a supporting technology, will be discussed. It is critical that the biosafety and risk assessment aspects of genome-editing techniques are considered, so as to ensure that robust and comprehensive regulatory oversight is provided for synthetic biology.

Companies disregarding EU regulation

Thursday, 24 November 2016

The EU Commission wants to allow the cultivation of genetically engineered maize before the growing season 2017 starts. Three variants of transgenic maize producing insecticidal toxins, registered as MON810, Maize 1507 and Bt 11, are being considered. Monsanto, DuPont/Pioneer and Syngenta are pushing for the market introduction of the seeds. EU Member States are expected to vote on this issue on 9 December.

As shown in a new Testbiotech backgrounder, large-scale cultivation of the transgenic plants can result in risks to health and agro-ecosystems, none of which have ever been assessed in detail, including various combinatorial effects. Moreover, the transgene may spread into the environment via gene flow to teosinte, a wild relative of maize. In addition experts put in question if the transgenic plants provide any benefits to the farmers.

The Testbiotech analysis shows that all the above-mentioned companies are intentionally breaching EU regulations; for several years, they concealed the fact that teosinte plants had appeared in Spanish maize fields.

Results

Our results showed differences in cytosine methylation levels in the FMV promoter and cry2Ab2 transgene of the four Bt-expressing hybrid varieties. The comparison between single and stacked hybrids under the same genetic background showed differences in the 35S promoter sequence. The results of transgene transcript accumulation levels showed differences in both cry1A.105 and cry2Ab2 transgenes among the four Bt-expressing hybrid varieties. The comparison between single and stacked hybrids showed difference for the cry2Ab2 transgene only.

Conclusions

Overall, our results show differences in DNA methylation patterns in all varieties, as well as in transgene transcript accumulation levels. Although the detection of changes in DNA methylation and transgenic accumulation levels does not present a safety issue per se, it demonstrates the need for additional studies that focus on detecting possible safety implications of such changes.

Results

Our results showed differences in cytosine methylation levels in the FMV promoter and cry2Ab2 transgene of the four Bt-expressing hybrid varieties. The comparison between single and stacked hybrids under the same genetic background showed differences in the 35S promoter sequence. The results of transgene transcript accumulation levels showed differences in both cry1A.105 and cry2Ab2 transgenes among the four Bt-expressing hybrid varieties. The comparison between single and stacked hybrids showed difference for the cry2Ab2 transgene only.

Conclusions

Overall, our results show differences in DNA methylation patterns in all varieties, as well as in transgene transcript accumulation levels. Although the detection of changes in DNA methylation and transgenic accumulation levels does not present a safety issue per se, it demonstrates the need for additional studies that focus on detecting possible safety implications of such changes.

The European Union should apply strict approval standards to new generations of gene-edited crops similar to those for genetically modified organisms (GMOs), Germany's junior environment minister said on Tuesday.

Gene-editing technology such as CRISPR/Cas9 allows scientists to edit genes by using biological "scissors" which can find and replace selected stretches of DNA.

Disease-resistant pigs and field crops are being developed but there have been calls for the new techniques to be subjected to the strict approval system for GMO plants.

The German government, traditionally skeptical of GMOs and other biotech food, is still formulating its policy toward the new generation of gene-edited agricultural products.

"It is important that GMO approval criteria should be applied here," junior environment minister Jochen Flasbarth told Reuters.

This is because the changes in the plants can have a significant impact and the possibly to turn back changes may not be available without a strict approval process, he said.

The EU is also still considering whether to class gene-edited plants as genetically modified. Supporters of the new technology maintain this is unneeded as no extra genes are added to the crops.

An example of the benefit of gene drives is that they can be designed so that female mosquitoes express infertility eventually reducing the spread of mosquito-borne pathogens such as those that cause Zika, malaria, dengue, and yellow fever. However, this ability to rapidly alter wild populations could also be misused, which poses novel security risks for entomological warfare, agro-sabotage, and ecocide. The authors offer a case study of how scientists could use synthetic engineering to change the eye color of subsequent generations of mosquitoes.

WASHINGTON, D.C. – The National Organic Standards Board voted unanimously on Friday to update U.S. organic standards to exclude ingredients derived from next generation genetic engineering and gene editing.

This recommendation to the US Department of Agriculture’s National Organic Program will ensure that ingredients derived from new genetic engineering techniques, including synthetic biology, will not be allowed in the production or final product of foods and beverages that are certified organic. Synthetic biology is a new set of genetic engineering techniques that include using synthetic DNA to re-engineer organisms to produce substances they would not normally produce or to edit DNA so as to silence the expression of certain traits.

“The Board’s hard-fought proactive stance on synthetic biology will both help preserve the integrity of organic standards and raise awareness about this virtually unregulated and unlabeled form of genetic engineering,” said Dana Perls, food and technology policy campaigner with Friends of the Earth. “It’s critical that organic standards treat new types of genetic engineering that are rapidly entering our food and consumer products as rigorously as the first generation of GMOs.”

The U.S. Court of Appeals for the Ninth Circuit issued its decisions Friday on whether federal and Hawai'i state laws preempt Hawai'i counties' authority to regulate genetically engineered (GE) crops and pesticide use. Of significance to state and local communities throughout the U.S., the Ninth Circuit ruled that federal law—specifically, the Plant Protection Act—does not prohibit states and counties from passing local laws to regulate and ban commercially-grown GE crops.

"Today's decision to allow states and counties to ban or regulate GE crops is an important victory for GE-free seed sanctuaries and small communities and farmers around the country," George Kimbrell, senior attorney for the Center for Food Safety, said.

In granting its decision the court recognized potential harm to farmers and environment from the widespread planting of GE crops, asserting, "the cultivation and testing of GE plants raise several well-documented concerns." Notably, the court affirmed, "transgenic contamination has previously caused significant economic impacts on farmers of conventional, non-GE crops."

This Four-page document summarises the recent report published by the African Centre for Biodiversity: Transitioning out of GM maize: to agroecology for sustainable, socially just and nutritional food systems, that argues that we need to urgently shift away from the mono-focus on a maize towards embracing a diversity of crops – particularly indigenous African summer grain crops such as sorghum and millet – and diverse agricultural practices that support healthy ecosystems, economies and societies

This is the first set of easily-to-read and share material, and is available in 5 languages: English, Afrikaans, isiZulu, isiXhosa and Sesotho.

Carlsberg claims barley and beer as its invention

17 November 2016

In 2016, the European Patent Office (EPO) granted three patents to the Danish brewery, Carlsberg. The patents cover barley plants derived from conventional breeding, their usage in brewing as well as the beer brewed thereof. In a joint letter, several civil society organisations are now calling on Carlsberg to drop these patents. They consider the patents to be an abuse of patent law and in conflict with the interests of consumers.

“There should be no patents on beer and barley. Breeding plants and brewing beer are not inventions, but based on centuries-old tradition,” says Erling Frederiksen from Friends of the Earth in Denmark (NOAH). “Carlsberg should make it clear that they just want to produce good beer and are not acting against the interests of citizens and consumers. We do not want corporate control of our food or patent monopolies. No matter whether they are held by Monsanto, Bayer or Carlsberg.”

The letter to Carlsberg is supported by: Arbeitsgemeinschaft bäuerliche Landwirtschaft, AbL (Germany), Arche Noah (Austria), BioAustria (Austria), Bund für Umwelt und Naturschutz, BUND, Friends of the Earth (Germany), Frøsamlerne/Danish Seed Savers (Denmark), Die Freien Bäcker (Germany), GAIA - Environmental Action and Intervention Group (Portugal), GeneWatch UK (Great Britain), Gesellschaft für ökologische Forschung (Germany), IG Saatgut (Germany), IG Nachbau (Germany), NOAH – Friends of the Earth (Denmark), No Patents on Life! (Germany), Plataforma Transgénicos Fora, PTF (Portugal), PublicEye (Switzerland), ProSpecieRara (Switzerland), Pro Regenwald (Germany), Safe our Seeds, SOS (Germany), Sambucus (Germany), SWISSAID (Switzerland), Umweltinstitut München (Germany), Utviklingsfondet / The Development Fund (Norway), Verband Katholisches Landvolk e.V. (Germany), WeMove (EU), Zivilcourage Miesbach (Germany).