Margret Engelhard

• Dr., Dipl. Biol.
• Head of Department at Bundesamt für Naturschutz

In recent years, the interest in developing genetically modified microorganisms (GMMs), including GMMs developed by genome editing, for use in the environment has significantly increased. However, the scientific knowledge on the ecology of such GMMs is severely limited. There is also little experience at the hands of regulators on how to evaluate t...

Supporting information relating to protection goals in the EU legislation which are relevant for the assessment of GM microorganisms referred to in the following article: Eckerstorfer et al. (2025) Environmental Applications of GM Microorganisms: Tiny Critters Posing Huge Challenges for Risk Assessment and Governance. Int. J. Mol. Sci. 2025, 26, 3...

The poster explains that an increasing number of genetically modified organisms (GMOs) is designed in wild species and meant to persist in nature. We argue that such GMO applications challenge the nature conservation and governance. We provide key points to inform the current IUCN policy process on synthetic biology.

To date, most genetically modified organisms (GMOs) outside closed systems are crops, which have the potential to become harmful to ecosystems for example by releasing toxins or becoming invasive, and therefore ought not to spread outside agricultural areas. However, the contrary paradigm is currently attracting attention in research and policy: In...

Recently, the European Commission (EC) published a regulatory proposal on plants generated with new genomic techniques (NGTs) (5 July 2023). According to this proposal, NGT plant applications are categorized into category 1 NGT (NGT1) and category 2 NGT (NGT2) based on their molecular characteristics, which diverges from the current legislation cen...

Key Messages: 1)The precautionary principle enshrined in primary law of the EU must remain central in the regulation on plants obtained by certain new genetic techniques (NGT). The current legislative proposal does not fulfil this requirement. 2) It is impossible to exclude potential risks of NGT plants just from the size and number of changes of...

The release of novel genetically modified (GM) virus applications into the environment for agricultural, veterinary, and nature-conservation purposes poses a number of significant challenges for risk assessors and regulatory authorities. Continuous efforts to scan the horizon for emerging applications are needed to gain an overview of new GM virus...

The broad and rapid application of new genomic techniques (NGTs) such as CRISPR-Cas has led to a fast increase in the number of genetically modified crops. With the recently published EU Commission’s (EC) regulatory proposal on plants generated with NGTs (July 5, 2023) the process of admission of such genetically modified plants is aimed to get acc...

If genetically modified organisms (GMOs) are approved in the EU for experimental release or marketing authorization (placing on the market), a risk assessment (RA) is carried out beforehand to determine whether this may be associated with negative effects on human health, nature or the environment. Applications are reviewed by the European Food Saf...

The current initiative of the European Commission (EC) concerning plants produced using certain new genomic techniques, in particular, targeted mutagenesis and cisgenesis, underlines that a high level of protection for human and animal health and the environment needs to be maintained when using such applications. The current EU biosafety regulatio...

In this paper, Germany’s Federal Agency for Nature Conservation (Bundesamt für Naturschutz, BfN) presents its position on an international discussion surrounding research approaches to the genetic modification of wild organisms, which are being developed in part for nature conservation purposes. These research approaches are new in three ways: They...

Synthetic biology is a topic of discussion under the Convention on Biological Diversity (CBD) as well as its Cartagena Protocol on Biosafety. This report, published by the German Federal Agency for Nature Conservation, is dedicated to recent technological developments and the mechanism by which the CBD can improve international governance: broad an...

Risky research on lab-modified self-spreading viruses has yet to present credible paths to upsides

An intensely debated question is whether or how a mandatory environmental risk assessment (ERA) should be conducted for plants obtained through novel genomic techniques, including genome editing (GE). Some countries have already exempted certain types of GE applications from their regulations addressing genetically modified organisms (GMOs). In the...

Molecular biological methods have been used for some time in nature conservation to analyse the genetics of populations. New genetic engineering methods may expand the range of possible applications of molecular methods. Some of these proposed applications are intended to modify wild populations in the field, for example to exterminate invasive spe...

The present report 'Gene Drive Organisms - Implications for the Environment and Nature Conservation' has been initated and guided by the Joint EPA/ENCA Interest Group on Genetically Modified Organisms (IG GMO). The IG GMO (https://www.bafu.admin.ch/bafu/en/home/topics/biotechnology/info-specialists/ig-gmo.html) promotes the exchange of informati...

Aktuelle Forschungsansätze propagieren immer häufiger die Anwendung neuer molekularbiologischer Methoden zur Veränderung wild lebender Organismen. Damit verbunden ist die Frage, wie gentechnische Veränderung wild lebender Populationen eine Rolle im Naturschutz spielen kann. Wir fordern eine tiefgreifende Analyse der potentiellen Risiken sowie der g...

The development of new genetic modification techniques (nGMs), also referred to as “new (breeding) techniques” in other sources, has raised worldwide discussions regarding their regulation. Different existing regulatory frameworks for genetically modified organisms (GMO) cover nGMs to varying degrees. Coverage of nGMs depends mostly on the regulato...

Supplementary information on interviews with regulatory experts To supplement the available published information qualitative interviews were conducted with regulatory experts from non-EU countries included in this study. The selected experts are involved in the respective national biosafety regulation in different capacities, e.g. as regulators,...

http://science.sciencemag.org/content/362/6418/1007.2

Molecular biology has developed at an increasing speed in the last years and now offers the possibility to generate artificial gene drives (GD) to alter or eliminate wild populations. There are now concrete research projects seeking to utilise GD as a ‘silver bullet’ to combat invasive alien species, such as invasive rodents on islands. Here we int...

In this editorial, we situate the 17 chapters of the book in the context of ambivalences of synthetic biology: the uses of the label, the significance of the associated metaphors and visions, critical and public engagement, and reasons for unease. Hype and metaphors in synthetic biology may sometimes skew the debate, but they should nevertheless no...

Prerequisite for any evaluation of synthetic biology is the precise description of its scientific rationale and its biological objects. Here, we develop a layer model that helps to categorize subfields of synthetic biology along their operative procedures and based on the biological status of the organisms generated by synthetic biology. The layer...

Synthetic biology is a young and heterogeneous field that is constantly on the move. This makes societal evaluation of synthetic biology a challenging task and prone to misunderstandings. Confusions arise not only on the level of what part of synthetic biology the discussion is on, but also on the level of the underlying concepts in use: concepts,...

When approaching the discussion on possible risks that might be elicited by synthetic biology we face two problems: The first one is the fluid definition of synthetic biology and the associated difficulties structuring the discussion. In the context of benefit/risk assessment this problem is even aggravated, since the label of synthetic biology is...

Synthetic biology is a dynamic, young, ambitious, attractive, and heterogeneous scientific discipline. It is constantly developing and changing, which makes societal evaluation of this emerging new science a challenging task, prone to misunderstandings. Synthetic biology is difficult to capture, and confusion arises not only regarding which part of...

Most pharmaceuticals are either chemically synthesized small molecules or are derived directly from natural sources such as plants and human blood. An increasing number of drugs comprising recombinant proteins, antibodies and nucleic acids are also produced in living organisms that have been genetically engineered for the purpose (Walsh, 2006). In...

Recent scientific advances have made it possible to produce biopharmaceuticals in genetically modified plants and animals, such as maize, tobacco, goats, and chickens. This new branch of biotechnology is termed pharming, composed of the terms pharmaceuticals and farming. Pharming constitutes an overlap of red and green biotechnology. It offers the...

Recent scientific advances have made it possible to produce biopharmaceuticals in genetically modified plants and animals, such as maize, tobacco, goats, and chickens. This new branch of biotechnology is termed pharming, composed of the terms pharmaceuticals and farming. Pharming constitutes an overlap of red and green biotechnology. It offers the...

Recently, the first "zoopharming" product has reached market approval: it is a recombinant human protein for medical use that is produced in the milk of transgenic goats. In addition, other transgenic animals, including faster-growing salmon and „environmentally friendly" pigs with reduced levels of phosphate in their faeces are awaiting regulatory...

“Pharming” is a new branch of biotechnology where plants or animals are genetically engineered to produce pharmaceutical proteins. It is hoped that pharming may lead to new, better or cheaper drugs. However, questions remain with regard to the choice of plants or animals, environmental and pharmacological safety, the welfare of pharming animals, th...

Der Mangel an Spenderorganen in der Transplantationsmedizin ist ein Thema von hoher gesellschaftlicher Relevanz. Da jedes Jahr in Deutschland nahezu 1.000 Patienten auf der Warteliste sterben und etwa 12.000 Patienten auf der Warteliste teilweise grosses Leid ertragen, darf die Gesellschaft den Organmangel nicht ignorieren, sondern muss immer wiede...

Several diazotrophic species of Azoarcus spp. occur as endophytes in the pioneer plant Kallar grass. The purpose of this study was to screen Asian wild rice and cultivated Oryza sativa varieties for natural association with these endophytes. Populations of culturable diazotrophs in surface-sterilized roots were characterized by 16S rDNA sequence an...

Diss. Naturwiss. Basel (kein Austausch). Literaturverz. Universität