Molecular Farming

Plants as a production platform: EFSA publishes guidance for risk assessments

For years, researchers around the world have been concentrating on modifying crop plants genetically in such a way that they can produce active pharmaceutical ingredients, vaccines and fine chemicals economically. The name given to this new field of application is molecular farming. So far, no applications have been submitted in the EU for approval of molecular farming plants. However, to be prepared, the European Food Safety Authority (EFSA) has now described the risk assessment requirements for molecular farming plants in greater detail.

Transgenic plants can be used to produce active pharmaceutical ingredients. Insulin, for instance, can be produced in safflower plants.

A large number of research teams are attempting to use tobacco as a production plant. The advantage of using tobacco plants is that they are not used for food or feed production.

Developments in the area of genetically modified plants for non-food and feed applications has accelerated considerably over the past ten years. Around two per cent of all field trials worldwide have tested genetically modified plants for the production of medicinal products, vaccines or other substances for industrial use. More than 300 such deliberate releases have been registered in the USA and Canada, and 30 in Europe. Preferred production plants are maize, potatoes, oilseed rape, soya and rice. Recently, however, more plants are being used that are not normally used for food production. These include tobacco, safflower and thale cress.

The range of products that researchers are hoping to produce in these plants is wide and ranges from dietary supplements, such as anti-inflammatories and immune stimulants, to chemicals for research and diagnosis, including enzymes like lysozyme and trypsin, to medicinal products and vaccines against cancer, rabies, diabetes and illnesses that cause diarrhoea. With the exception of a vaccine for hens, the only products that have been approved so far are ones that are used solely as chemicals in the laboratory and diagnostics field. Around 20 active pharmaceutical ingredients produced in plants are currently undergoing clinical testing worldwide.

Until now, researchers and companies that want to test or release genetically modified plants in the EU have been following the EFSA guidance for the risk assessment of genetically modified plants. However, this document was produced solely in relation to plants used for food or feed purposes. EFSA’s GMO Panel therefore saw a need to produce preliminary guidelines for the risk assessment of GM plants intended for medical and industrial applications.

Risk assessment of molecular farming plants: Every case is different

The results have now been published: In the view of the GMO Panel, the fundamental principle of comparative assessment – comparing the properties of a genetically modified plant with its unmodified parent line – is valid for assessing the safety of molecular farming plants.

Any new properties of the GM plant detected in the assessment are then subjected to a separate analysis. The focus will usually be on assessing the toxicity and allergenicity of the new plant substances. In particular, the risks associated with accidental intake of these substances by humans and animals must be assessed in detail. In the case of pharmaceutical plants, EFSA therefore asks plant manufacturers to provide them with a comprehensive description of the active substance and its properties – as is the case with drug approvals. Risk assessments will also look at the probability of environmental exposure to the new substances and how high this exposure could be, e.g. through adventitious contamination of food products, or via pollen dispersal.

If EFSA identifies new risks associated with a GM plant, it will recommend special measures, such as monitoring, precautionary measures and biological and physical confinement measures. It is possible to minimise, if not prevent, spreading by e.g. cultivating the plants in a greenhouse or using male-sterile plants to prevent pollen dispersal. These confinement measures also have to be tested to see whether they are effective under a range of different environmental conditions (e.g. temperature fluctuations) and are therefore reliable. Where necessary, the applicants also have to state what measures they intend to introduce to keep wild animals away from the plants and to prevent substances leaching away through the soil. EFSA also advises applicants to limit their application to a specific geographic area.

Plants as a production platform: EFSA publishes guidance for risk assessments

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