Most of our projects are covered by strict confidentiality. However, we also perform and contribute to studies that aim for broad information sharing.
The use of existing environmental networks for the post-market monitoring of GM crop cultivation in the EU
European Union Directive 2001/18/EC requires that General Surveillance, including existing environmental networks, is considered as post-market implementing measures of Genetically Modified (GM) crop cultivation. In this paper the availability of existing monitoring networks for this purpose is evaluated.
By cataloguing the existing environmental monitoring networks in the EU, it can be concluded that they can only be used, in the context of GM crop cultivation monitoring, as secondary tools to collect baseline information.
Alternatives to Antibiotic Resistance Marker Genes for In Vitro Selection of Genetically Modified Plants - Scientific Developments, Current Use, Operational Access and Biosafety Considerations
Genes conferring resistance to antibiotics have been widely used as markers for the selection of transformed cells in the development of genetically modified (GM) plants. Their presence in GM plants released in the environment or used as food or feed has raised concerns over the past years regarding possible risks for human health and the environment.
The paper by Breyer et al. present the results of a three-step analysis of selectable markers and reporter genes as well as methods aiming at developing marker-free GM plants.
Perseus supported this study by performing a survey of developers and users of GM plants. A terrific review paper and we endorse the final conclusion that replacement of selection approaches that make use of ARMGs such as nptII will make sense only if the new approaches have at least the same degree of scientific knowledge and safety confidence.
Recombinant Allergens: working safely with recombinant allergenic biologicals
Allergens are a specific group of compounds within the toxic substances, since not everyone who comes in contact with these compounds develops an allergy. There are models for predicting allergenicity of low molecular weight (skin) contact allergens, but not for respiratory and food allergens. Scientists are more and more interested in allergens, since allergy is a growing concern in modern society.
Genetic modification can be used to produce and modify allergens for scientific, diagnostic and therapeutic purposes. Allergens may also be introduced unknowingly as a result of genetic modification. The most important exposure routes are inhalation of aerosols and contact via skin or mucosa. In this research report, an overview is presented on the hazards of working with allergens in contained use (CU) conditions. Furthermore, the implications of safety measures that are necessary during the production of allergens are discussed.
Addressing biosafety and regulatory issues throughout the product life cycle of a GM crop
Products of genetic engineering have been identified as a special class that may potentially cause harm to human health and the environment. This paper presents a review of the consequences of this classification and the related regulatory requirements during the product life cycle of a genetically modified (GM) crop.
The life cycle is divided into 4 stages, namely exploratory research, development, large-scale deployment and product discontinuation. For each stage, the extent to which regulatory requirements influence project decisions is reviewed, which regulatory approvals are required, which studies/activities must be foreseen, which material must be produced, and the need for specific documentation. Each product life cycle stage requires tight planning and coordination.
For projects involving many parties, planning, coordination and management are even more crucial. Depending upon the type of developer (large corporations, small companies, humanitarian aid projects or academic groups) and the target market for the crop/trait combination (global markets, local relevance, niche markets), different approaches may be followed. Irrespectively, the components reported in this paper will still need to be addressed.
Challenges when facing global markets should provide further impetus to streamlining of GMO regulatory frameworks and a return to the fundamental question of whether these GMO-specific requirements are justified.
Gene therapy clinical trials: what about the environment? A comparison between the Netherlands and North America
Gene therapy offers perspectives for the treatment of diseases that are difficult to cure, such as cancer and various genetic disorders. Experimental gene therapy studies have been conducted for over twenty years. The majority of these studies take place in North America. Although it is fairly clear which experiments take place, it is not always clear how the environmental risk assessment is performed.
This report presents an overview of gene therapy trials conducted in North America and describes how the risk assessment is performed. It also describes the application procedures. The data are compared to the situation in the Netherlands in order to learn from the different approaches.
Methodology for environmental risk assessments in medical and veterinary biotechnology
Over time, the COGEM has composed and reviewed a large number of ERAs relating to human and veterinary medicine research and development. While each case has been evaluated on the basis of its specific characteristics, a general methodology evolved. This review presents a synopsis of the COGEM methodology based on a thorough analysis of its advices, as well as legal and scientific instruments underlying the formulation of an advice to the competent authority.
One of the difficulties encountered in conducting an ERA is the quantification of risks or the lack thereof. In many cases the ERA is qualitative or a ranking system is used with indications like “high”, “moderate”, “low”, and “negligible” for estimates of the magnitude, likelihood, and risk of adverse effects and their consequences. Yet, in many cases, quantification may not be possible or required, and the costs of gaining more precise information may not be proportionate to the gain in certainty of the ERA.
Reflecting a cautious attitude, many ERAs take into account hypothetical cases because it cannot be concluded that the risk is negligible. In some cases, this results in imposing protective measures that subsequently may prove to have been excessive. Fully appreciating this weakness on some ERAs, the COGEM prefers to err on the side of caution until more information is available to fine-tune the ERA.
Agricultural Biotechnology in Africa: Stewardship Case Studies.
The project on Strengthening Capacity for Safe Biotechnology Management in Sub-Saharan Africa (SABIMA) intended to build stewardship capacity that will be valuable if and when countries decide to admit biotech products for commercial use.
A special feature of the project was its emphasis on the creation of awareness for issues of stewardship in biotechnology and the provision of training to scientists, policymakers and farmers in stewardship and its application to the development of improved crops. The training in biotechnology stewardship was unique in Africa.
The idea of using case studies came at the end-of-year review meeting for SABIMA in 2010, as a way to share stewardship experiences. The stewardship leaders had applied stewardship principles in their biotechnology laboratories and trained coworkers and scientists, and were enthusiastic to share learnings and lessons to an ever-increasing audience throughout Africa and the world. In these 12 case studies, the stewardship leaders share first-hand accounts of the challenges they faced and the solutions they found. They tell how stewardship helped their labs run more efficiently, ensured product integrity and improved regulatory compliance.
Anticipating the Environmental Risk Assessment of crops modified to enhance or preserve yield.
In this study performed for the Dutch Commission on Genetic Modification, we review developments in the field of genetically modified (GM) yield-enhancing crops, known as ‘second generation GM crops’.
We also looked into the question of whether the current environmental risk analysis (ERA) is sufficient to cover all possible effects on the environment. Looking at the structure of the ERA the answer is mostly positive, although there are some features, which make it necessary to take other aspects into account than for an agronomic trait like herbicide tolerance or insect resistance. This requires adapted designs for product characterization. Different environmental conditions are also needed to observe specific behaviour in stress tolerant plants. The complex phenotypic effects of different traits therefore need to be looked at on a case-by-case basis.