Biotech
Primer

Background
Before any GM crops can be sown, or food produced from GM crops can be sold, they must go through a rigorous approval process, involving several expert committees.

The main committees responsible for food safety aspects of GM crops in the UK are:

• The Advisory Committee on Novel Foods and Processes (ACNFP)

• The committee on Toxicity of Chemicals in Foods, Consumer Products and the Environment (COT)

• The Food Advisory Committee (FAC)

These food safety bodies are now controlled by the Food Standards Agency (FSA).

Transparency
In order to ensure transparency and accountability, the proceedings of all of these committees are available to the public, and they also hold public meetings.

What tests are done?
The food safety assessment carried out by the ACNFP requires biotechnology companies like Monsanto to submit genetically modified crops for extensive independent studies. These include:

• "Mechanism of Action" test: A study to understand precisely what the added protein that has been inserted into the plant is intended to do. This is critical as it shows whether the protein added will cause any harmful effects (such as the production of toxic chemicals)

• A digestibility study - to establish, for example, how quickly the added protein is broken down inside the gut (in the case of GM soya, for example, this is around 60 seconds)

• A study to screen for known allergens and toxins (called "Bioinformatics Screening")

• An acute oral toxicity study - comprising a two week toxicology study in which the additional protein is fed in its pure form to mice, at a rate at least 1000 times higher than a humans would ever be exposed to.

• Nutritional (wholesomeness) animal feeding studies - to establish that the new variety, for example GM soya, is equivalent in its composition, nutrition and functionality as non-GM soya.

• Non-target animal studies - for pesticidal proteins only. (These studies involve extensive ecotoxicological evaluations based on testing both pure protein and/or the GM plant for toxic effects and desirable insects and/or animals that are important in the eco-system)

Where the above studies reveal that there are unique or unresolved issues concerning the added protein, the regulatory authorities can demand that further studies are carried out. These can include:

• Sub-chronic animal feeding studies - comprising medium-term feeding studies in animals, including chickens, ruminants and mono-gastrics

• Case-specific in vitro (ie. outside a living organism) toxicology studies

• Further studies of the "Mechanism of Action" of the protein

• In vivo (ie. inside a living organism) protein fate studies

• Human clinical trials (eg. food allergy evaluations) - though these tests are rarely required because of the extensive evidence which results from the other tests

More information about Genetic Engineering and The Allergy Issue.