Abstract
GM risk assessments (GMRAs) play an important role in the decision-making process surrounding the regulation, notification and permission to handle Genetically Modified Organisms (GMOs). Ultimately the role of each GMRA will be able to ensure the safe handling and containment of the GMO; and to asses any potential impacts on the environment and human health. A risk assessment should answer all “what if” scenarios, based on scientific evidence. This article sets out to provide researchers with helpful guidance notes on producing their own GMRA. While reference is made to UK and EU regulations, the underlying principles and points to consider are generic to most countries.
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Notes
Poly-tunnels, and/or greenhouses where plants are directly planted into ground soil, would potentially be considered a deliberate environmental release and as such would require notification to the relevant competent authorities.
Directive 90/219/EEC as amended by Directive 98/81/EC.
In the UK, the competent authority would be the Health and Safety Executive (www.hse.gov.uk). However, the Department for Environment, Food and Rural Affairs (Defra), the Scottish Executive, and the National Assembly for Wales are also involved in the scrutiny of notifications.
An example of a notifiable activity may be a GM plant containing virus sequences, under such circumstances a Plant Health licence may be required, and a higher level of containment would be needed. Note ubiquitous virus sequences such as the 35S promoter from CaMV would not warrant notification.
For example, one could write ‘work will include the transformation of genotypes/subspecies X, Y, Z using disarmed strains of Agrobacterium (strains 1, 2 or 3), containing the gene of interest (plant or bacterial source), with selectable markers (nptII, hpt, etc.)’.
The detailed information required in notifications is set out in an Annex II of the 2001/18/EC Directive, for the EU, or Annex III of The Cartagena Protocol on Biosafety (CPB). The CPB is the internationally recognized protocol for biosafety (http://www.biodiv.org/biosafety/).
see footnote 10
Many competent authorities have excellent websites with information on notification and permit or approval procedures. However, in cases where a notification is made for the first time, it is always advisable to contact the competent authority, to explain the intended activities and to seek guidance about the procedure of notifying.
The key difference between Part B and Part C is that for research and development releases, decisions are made by individual Member States, whereas for placing GMO products on the market, decisions are made by all Member States, which often necessitates a voting procedure to address differences in opinion on risk. The European Food Standard Agency (EFSA) also oversees at this stage. EFSA oversee all Food and Feed applications (under directive 1829/2003/EC); as well as non-food and feed cases, where agreement has not been met by all member states.
SNIF reports are also a useful source of information for helping you write your own risk assessment, e.g. if you are writing a GMRA for maize—look up a maize SNIF for good descriptions of the biology of the crop—see also reference source 1.
PRRI “Guide on notification and risk assessment” pdf available via http://pubresreg.org/index.php?option=com_docman&task=cat_view&gid=48&Itemid=58. Annex I of this guide provides useful “biology of the crop” summaries for a number of major crops. While Annex II provides examples of information for a number of frequently used genes, extracted from the web based pilot database “The Gene Files” (www.genefiles.org—this website was no longer active at the time of print). The database contains information on the identity and function of the genes as well as information on environmental risk assessments that have been carried out earlier in relation to those genes.
For example, within the UK, this would be the Department for Environment Food and Rural Affairs (Defra). (http://www.defra.gov.uk/environment/quality/gm/regulation/index.htm).
A legal person is an artificial entity through which the law allows a group of individuals to act as if it were one person for certain purposes.
Examples of protein-based testing methods include: Western blot; ELISA Lateral flow strip; Magnetic particles; Protein chips. DNA-based testing methods include: Southern blot; Qualitative PCR; Quantitative end-point PCR; Quantitative real-time PCR.
Reference Sources and Further Information
http://www.gmoinfo.jrc.ec.europa.eu—summary notifications of all deliberate field trials and placing on the market of GMOs in Europe (SNIF—summary notification information format). This site is managed by the Joint Research Centre of the European Commission on behalf of the Directorate General for the Environment.
http://www.pubresreg.org—Public Research and Regulation Initiative (PRRI)—a forum for public researchers to be informed about, and to be involved in, international regulations and discussions on modern biotechnology.
http://www.efsa.europa.eu—European Food Standard Agency (EFSA). The European Food Safety Authority (EFSA) is an independent European agency funded by the EU budget that operates separately from the European Commission, European Parliament and EU Member States. In close collaboration with national authorities and in open consultation with its stakeholders, EFSA provides independent scientific advice and clear communication on existing and emerging risks regarding food and feed safety.
EFSA’s GM. http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1178621456978.htm.
http://www.defra.gov.uk/environment/quality/gm/regulation/index.htm—Department for Environment Food and Rural Affairs (Defra) the UK competent national authority for GM releases.
http://www.biodiv.org/biosafety/—The Cartagena Protocol on Biosafety (CPB) the internationally recognized protocol for biosafety.
Acknowledgements
A number of Internet resources have been used to write this article, in particular thanks go to the many unknown people who contributed to the guidance notes available via The Health and Safety Executive (HSE); The Advisory Committee on Releases to the Environment (ACRE); and in particular the Public Research and Regulation Initiative (PRRI), for the useful information provided. These resources have been used extensively, and in some places reproduced, within this article.
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Sparrow, P.A.C. GM Risk Assessment. Mol Biotechnol 44, 267–275 (2010). https://doi.org/10.1007/s12033-009-9237-x
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DOI: https://doi.org/10.1007/s12033-009-9237-x