The Safety Assessment of Novel and GM Foods Research Programme (G03)

Research funded by the Novel Foods, Additives and Supplements Division of the FSA supports the Agency's role in the rigorous safety assessment of all novel and genetically modified (GM) food. This research ensures that sound science is applied to consumer safety issues concerning novel and GM foods.

The G03 programme will build on and continue to support the mandatory safety assessment of GM and novel foods in order that the most up to date scientific knowledge may be used. This programme fulfils the Agency's policy objective to ensure food safety through the rigorous assessment of GM and novel foods. It also forms part of the Agency's strategic plan to ensure that food is safe, food safety legislation is effectively enforced, and that the evidence base is strengthened by taking account of the best available science.

Specifically the programme aims to:

• Develop further, the profiling technologies for GM plants, established under the G02 programme, for use in the safety assessment of both novel and GM foods particularly focussing on metabolomics and their potential in toxicological assessment. Also, to investigate the use of Multidimensional protein identification technology (MudPIT) as a quantitative method for protein analysis in GM and non-GM safety assessments.
• Build upon the success of the G02 programme by collating the data generated into easily utilisable internet accessible databases. This will ensure that the knowledge gained in G02 is maintained and can be specifically applied to research being carried out in the international arena (e.g. setting baselines for metabolite variation in GM crop plants in order to inform safety assessment under the GM Food and Feed Regulation). Such information can be easily used by others in the Agency such as for nutritional profiling and authenticity work.
• Build upon the outcome of project G01021 (which looked at the use of commercial databases and their potential for post-market monitoring) to investigate methods for examining how newly introduced foods are consumed by subsets of the population. Use these methods to carry out post market monitoring activities on specific food products such as the expanding range of products containing phytosterol and phytostanol ingredients. This will directly address concerns raised by the Advisory Committee on Novel Foods and Processes (ACNFP) regarding the consumption of these products by non-target groups.
• In collaboration with the E01 Data Quality and Improved Methods of Analysis programme, fund work to improve sampling approaches and validation of detection methods for use in the enforcement of the GM Food and Feed regulation.
• Investigate further the potential for horizontal gene transfer from GM food to bacteria and cells in the gastrointestinal tract by considering recommendations made by the GM Science Review Panel.
• Improve our understanding of how properties of the food matrix can have an effect in determining the allergenic potential of foods, with a particular focus on GM and novel foods.
• Assess emerging, novel techniques for food production in relation to their effect on food safety and the assessment procedures that may be necessary
• Address more specific and contentious areas of the safety assessment of GM foods such as:
  • the implications of transgene insertion (in regions flanking the new gene)
  • whether transgenic proteins expressed in GM plants are truly equivalent to those produced in microbes
  • whether the allergenicity assessments that are currently carried out, using existing bioinformatic techniques, can be improved.

Drivers for the programme are:

• Stakeholder concerns - especially with regard to consumer's concerns for potential horizontal gene transfer from GM foods, and post-market monitoring of novel foods in relation to identifying which sub-sets of the population consume these foods. Of particular interest to the ACNFP are the extended range of products containing phytosterols. They are concerned as to whether these products are being consumed by relevant groups.
• Recommendations for future research - these have been identified by a panel of scientific experts which met in July 2004 to discuss work carried out to date and the future direction of research in this area and by the ACNFP which includes consumer representatives. The Government's GM Science Review panel has also identified certain areas as requiring further study, including those listed in the previous section.
• Requirements to support existing legislation

1. As both scientific knowledge and techniques advance, more information is required to continue supporting the safety assessment process under two sets of EU legislation (the Novel Foods Regulation and GM Food and Feed Regulation) to ensure that the most up to date knowledge is applied. The Agency is the competent authority within the UK for both regulations. Improving molecular and bioinformatic methods could reduce the need for animal experimentation (e.g. in assessing toxicity).

2. Further development of methods are needed for the detection of GM material in food and feed ingredients.

The Government's GM Science Review Panel report outlined a number of areas where further information would be valuable in the safety assessment of GM food and feed:

• better methods for assessing nutritional and toxicological differences between GM and non-GM crops
• better methods for predicting allergenic effects of GM crops
• further information on the fate of transgenic DNA in the gastrointestinal tract
• the effect of GM derived feed in the human food chain.

The Agency has considered the recommendations from the GM Science Review and sought further advice by holding a meeting with independent external scientific experts and other bodies that fund work in similar areas (such as the Biotechnology and Biological Sciences Research Council (BBSRC) and Defra). The ACNFP (including consumer experts) was also consulted on the recommendations made by the panel at this meeting. The Agency is aware of the many views of its various stakeholders, through the regular correspondence it receives. Other sources of information in identifying research needs have been research contractors, the views of other bodies and the expertise of Agency staff and the G01/G02 programme advisor.

The areas that have been identified fall under the broad remit of safety assessment of novel foods and safety assessment of GM foods.

G03 mid-programme review report
Each programme of research commissioned by the FSA has a mid-programme review to evaluate its success and current progression. A review of the G03 research programme was carried out in September 2008. The full report of the review can be found at the link below.

Name: David Jefferies
Tel: 0207 276 8573
Email: David.Jefferies@foodstandards.gsi.gov.uk