The authors of the interdisciplinary Gene Drive Report (2019) are holding webinars on social, technological & scientific, environmental, ethical and legal questions of this new technique in June 2020 via Zoom – for free.

02 June 2020 15:00 – 16:30

«What are gene drives? How do they work?» by Ricarda Steinbrecher

04 June 2020 15:00 – 16:30

«Gene drives: What problems are they intended to solve and what are the risks?» by Mark Wells

10 June 2020 15:00 – 16:30

«Gene drives in a social context: promises, precaution & public engagement» by Tamara Lebrecht

12 June 2020 16:00 – 17:30 [sic!]

«Ethical Questions about Gene Drives» by Christopher Preston

16 June 2020 15:00 – 16:30

«Are governments keeping an eye on gene drives?» by Lim Li Ching

Enlarged Board of Appeal agrees with restrictive interpretation of patent law

14 May 2020 / Patents on plants and animals derived from conventional breeding can be fully prohibited in Europe. This is the result of a verdict published today by the Enlarged Board of Appeal, the highest legal body of the European Patent Office (EPO). The Board concluded that plants and animals obtained by ‘essentially biological processes’ are not patentable, with the exception of patent applications filed before July 2017. This verdict is in line with the interpretation of European patent law as decided by the 38 member states of the EPO in 2017. No Patents on Seeds! welcomes the verdict but is also demanding further political decisions to close still existing loopholes. Access to biological diversity needed for further breeding must not be controlled, hampered or blocked by any patents.

“For more than ten years we have been fighting against patents such as those on broccoli, tomatoes, peppers, melons and cereals. Therefore, we welcome this verdict in the name of the European public, gardeners, farmers and consumers. Knowledge of methods of breeding plants and animals continues to evolve as a common good from the activities of farmers and breeders over centuries, it is not invented by industry. In future, conventionally bred plants and animals have to be kept available for further breeding,” Martha Mertens says for Friends of the Earth Germany.

ABSTRACT

Gene drive organisms are a recent development created by using methods of genetic engineering; they inherit genetic constructs that are passed on to future generations with a higher probability than with Mendelian inheritance. There are some specific challenges inherent to the environmental risk assessment (ERA) of genetically engineered (GE) gene drive organisms, since subsequent generations of these GE organisms might show effects that were not observed or intended in the former generations. Unintended effects can emerge from interaction of the gene drive construct with the heterogeneous genetic background of natural populations and/or be triggered by changing environmental conditions. This is especially relevant in case of gene drives with invasive characteristics and typically takes dozens of generations to render the desired effect. Under these circumstances, ‘next generation effects’ can substantially increase the spatial and temporal complexity associated with a high level of uncertainty in ERA.

New publication on technology assessment of gene drives

27 April 2020 / The GeneTip research project was a joint enterprise carried out from 2017 until 2019 by the Universities of Bremen and Vechta, the University of Natural Resources and Life Sciences, Vienna and Testbiotech, Munich. The researchers focused on risks associated with the spread of newly designed genetically engineered organisms into the environment. In particular, the project examined plants and animals with a so-called gene drive. The results have now been published in full by the Springer Publishing Company in a book titled “Gene Drives at Tipping Points“ (open access).

The project was funded by the German Federal Ministry of Education and Research (BMBF) and coordinated by the University of Bremen (project code 01LC1724). The published results give a detailed overview of the technical characteristics of gene drives as well as associated risks.

Gene drives are designed to spread genetically engineered organisms rapidly through natural populations. In populations with sexual reproduction, genetic characteristics are normally distributed with a 50% probability to the offspring. The gene drive mechanism, however, interferes with process of natural inheritance, aiming to pass on new genetic information to almost 100% of following generations. There are ongoing debates about using gene drives to combat insects such as mosquitoes and fruit flies, or rodents such as mice and rats. The aim is to suppress or eradicate the target species within a region, or to replace it with genetically engineered populations.

Environmental impacts of CRISPR/Cas and its challenges for risk assessment

17 March 2020 / In a new report, Testbiotech provides an overview of the latest research developments in environmental risk assessment and new methods of genetic engineering (also known as ‘genome editing’ or ‘new genomic technicques’). The authors come to the conclusion there are imperative scientific reasons for all organisms derived from these new techniques to undergo mandatory risk assessment before they can be released or marketed. Therefore, regulation requirements foreseen by current GMO law in the EU must be mandatory whether or not additional DNA sequences are inserted. In addition, a broad range of ethical and social issues must be taken into account by the regulatory decision-makers.

The report focuses on possible impacts that new methods of genetic engineering (genome editing) can have on the environment. It is primarily concerned with CRISPR/Cas nucleases classified as ‘site directed nucleases’ SDN-1 and SDN -2. These applications are not meant to introduce additional gene sequences. Nevertheless, the pattern of intended and unintended changes and the resulting new combinations of genetic information arising from genome editing will, in most cases, be different in comparison to those derived from conventional breeding. These differences co-occur with biological characteristics and risks that need to be fully investigated before any conclusions on the safety of the new organisms can be drawn.

Bayer AG Chairman Werner Wenning is leaving the German drugs and chemicals company before his term expires, capping a half-century of dealmaking that culminated in the contentious Monsanto acquisition and a blizzard of lawsuits over its Roundup weedkiller.

Wenning, 73, will be succeeded in April by Norbert Winkeljohann, 62, who joined Bayer’s supervisory board in May 2018 just before the Monsanto deal closed. The $63 billion purchase was the brainchild of Wenning and Chief Executive Officer Werner Baumann, who was censured by shareholders at last year’s annual meeting.

(.....)

Winkeljohann is the first outsider to head the Bayer board. While the new chairman is relatively new to Bayer, he is no stranger to companies in turmoil. He joined the Deutsche Bank AG board in August 2018, as part of a management shakeup amid tensions between Chairman Paul Achleitner and then-CEO John Cryan. He has also sat on a Bayer board committee charged with overseeing the Roundup litigation response since last June.

Genetically modified organisms (GMOs), predominantly plants, have been commercially grown in some countries, notably the Americas, since the mid-1990s. Current GMOs have been developed using ‘first generation’ genetic engineering technologies. More recently, new applications of GMOs and new modes of creating novel traits have been developed alongside new genetic engineering technologies. Grafting, cisgenesis and intragenesis, reverse breeding and RNA-directed DNA

methylation (RdDM) either utilise GMOs created using first generation techniques as an intermediary stage or can, in the case of agro-infiltration, unintentionally give rise to GMOs. Most, if not all, of the principal concerns regarding first generation GMOs apply to these new types of GMOs and new genetic engineering techniques. Some novel types of GMOs (e.g. RNA interference (RNAi)-based GM plants) present additional challenges for risk assessment, as do new genetic engineering techniques, such as genome editing.

Five thousand tractors caused severe disruption in Berlin last week as farmers protested against the German government’s environmental protection policies. These include plans to limit the use of fertiliser in order to tackle nitrate pollution in groundwater, and to phase out glyphosate by 2023 to protect biodiversity.

Meet fake Farmer Willi

One of the German government’s most outspoken critics is Dr Wilhelm Kremer-Schillings, or “Farmer Willi”, as he styles himself. Through his blogging and campaigning against pesticide restrictions, in favour of GMOs, and in defence of companies like Bayer/Monsanto, he has become one of Germany’s best known farmers.

The EU should give higher priority to the protection of health and the environment, but when it comes to genetically engineered plants, the current standards of risk assessment are not sufficient to fulfil the legal requirements, writes Christoph Then, executive director at Testbiotech.

(.....)

Currently, more than 70 genetically engineered plants have approval for import into the EU. Most of these plants have more than one trait. One typical example is maize “SmartStax“, developed and marketed by Monsanto (Bayer) and DowDupont (Corteva): it produces six insecticidal Bt toxins and is tolerant to several herbicides.

The gaps in current risk assessment can be exemplified by the fact that this maize was allowed for import into the EU without a single feeding study with the whole food and feed to assess its potential health effects.

There is a long list of gaps in EFSA risk assessment.

European Network of Scientists for Social and Environmental Responsibility

Conference on the Precautionary Principle:

“Science, Precaution, Innovation - towards the integrated governance of new technologies”

When: 14-15 October 2019

Where: Center for Interdisciplinary Research (ZiF), Methoden 1, 33615 Bielefeld, Germany

Program: www.ensser.org/pp-conference

Register at registration [at] ensser.org

The Precautionary Principle (PP) concerns situations where the available scientific information about possible harm from human-made innovations gives decision-makers reasonable grounds to suspect possible harm to human health, the environment or biodiversity, but where scientific certainty is lacking. The PP in such situations lawfully justifies decision makers taking precautionary measures to avoid such harm.

Although enshrined in the EU treaty and formally a pillar of EU policy, the PP is often ignored, misinterpreted or violated by the EU Commission and member states. The introduction in recent years of a so called “innovation principle” may well erode this science-based standard and prioritize particularly powerful incumbent economic interests over the high level of protection provided in the EU Treaty. Truly sustainable innovations, however, require conformity with the PP, and a more comprehensive assessment of what (if any) social benefits, and which social needs, may be met.

In this conference we will present and critically appraise examples which illustrate the importance of the PP and discuss what is required to ensure that it will be used wisely and more frequently. Viable paths to a reasonable confidence of no harm to public health, biodiversity and the environment will be identified and explored by reference to currently available knowledge, while acknowledging that strict proof of safety is an illusory goal. Examples including pesticide use, genetically modified crops, electromagnetic fields, endocrine disrupting compounds and nanotechnology will be presented by eminent speakers and explored by the participants.