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Desk study to review methods for sampling seed lots to determine the presence of GM material - VS0130

Most EU Member States have agreed in principle to implement the European Commission Scientific Committee on Plants' voluntary 'interim measures' to govern the presence of adventitious genetically modified (GM) seeds in non-GM seed lots. The levels of adventitious GM need to conform to set thresholds ranging from 0% to 0.5% depending upon the seed identity and approval status of the transformation event. In addition, current information indicates that the European moratorium on the marketing of transgenic crops may soon be dropped (1). The European Standing Committee on Plants concedes that ensuring the proposed EU labelling thresholds for contamination of conventional seeds by GM material will in practice be difficult; increasingly so as GM crop production increases in Europe (2).

A range of sampling and testing methods is currently being used around the world to detect GM seeds in non-GM seed lots and research is actively improving current methods and developing new approaches. A European Commission working group draft protocol for the sampling and detection of GM in conventional seed lots been laid out. These documents were compiled in a report by the Central Science Laboratory (CSL) (3). Unresolved concerns remain regarding the appropriateness, accuracy, validation and in particular, the cost of proposed methods to member authorities responsible for compliance with EU Directives.
This desk study will take a whole system approach and is designed to build on previously reported testing and sampling information (3) through inclusion of proposed future developments. The study will determine within a cost-risk framework, how appropriate and feasible procedures are for use within a UK monitoring system. Where currently available methods are clearly inappropriate, alternative approaches will be investigated. The study will focus on species relevant to the UK.

A range of issues needs to be addressed from a number of stakeholder viewpoints in order to assess appropriate sampling and testing systems and methods to assure compliance with current and future statutory, technical and industry needs in the UK. Each element of the desk study will assess the cost vs risk for the UK and will address the requirements of different interest groups (Department for Environment, Food & Rural Affairs (DEFRA), UK seed producers, UK seed growers and environmental groups / UK public). The following key issues will be addressed:

Evaluation of the applicability of current seed-lot sampling strategies in the context of the implications for cost vs final estimate accuracy as well as the ability to meet current and future needs. This will encompass an evaluation of potential sources and the likelihood of GM seed entering non-GM seed lots during seed production and the implications for sampling approaches.

An evaluation of the suitability for use in the UK statutory system of currently available GM detection approaches and laboratory sampling procedures. The implications for final estimate accuracy as well as ability to meet future testing requirements and developments will be considered. While the emphasis will be on the most promising PCR and immunoassay techniques, where other methods are appropriate, they will be included in the assessment. A statistical appraisal of the cost vs risk inherent in potential sampling and testing systems will result from this evaluation. The assessment will include laboratory requirements and examine the scope for centralised vs officially regulated de-centralised laboratory testing in the UK.

Evaluation of the scope of current seed certification systems (relating to seed production, sampling and testing) to include routine GM detection testing. This will consider the risk management framework that will be appropriate to the material being tested. The study will include an examination of the scope of current UK seed certification administrative systems to provide a platform for a verification system between the farm gate and the seed product.

Evaluation of how far research is addressing future needs and an assessment of the current levels of research co-ordination in the field.

The thrust of the study will be to collate and assess widely dispersed and varied regulatory and scientific published material in order to make practical recommendations for UK implementation of EU Directives on the presence of adventitious GM material. This study will provide vital guidance in the development of effective, reliable, cost-effective systems for GM detection in the UK. The system must be capable of assuring adequate compliance with statutory requirements and the needs of a range of UK stakeholders (e.g. DEFRA, UK seed producers, UK seed growers and environmental groups / UK public) both now and in the future. It will embrace consideration of molecular PCR methods, quick 'dip-stick' style immunoassay technology, as well as technologies such as fluorescent probes, microarrays and DNA chips. The examination of methodologies will be placed in the context of defining recommendations for an efficient and cost-effective administrative tracking system for seed lots in the UK. As such, it will provide vital technical recommendations embracing a whole system approach and considering cost as well as risk in the rapidly evolving field of GM technology.
1 Review current and future methods for sampling a range of seed lots for determination of adventitious presence of GM at the thresholds for approved, non-approved and non-GM contaminants that could give a false positive. Review of potential sources of adventitious GM seed in non-GM seed lots.

2. Determine the range, sensitivity, cost and reliability of testing procedures and the use of different laboratory sampling platforms in terms of both qualitative and quantitative requirements. I his will necessitate collection of data from a range of sources including the FSA, DEFRA, the EC, BBSRC, ISTA, BSPB and a range of testing organisations such as CSL and RHM.

3. Determine the current and future needs of UK stakeholders (including consideration of current and future research) and whether a risk management framework should be designed that will be appropriate to the material being tested currently and in the future.
Time-Scale and Cost
From: 2001

To: 2003

Cost: £23,990
Contractor / Funded Organisations
National Institute of Agricultural Botany
GM Risk Assessment              
Plant Varieties and Seeds              
Plants and Animals              
Fields of Study
Plant Varieties and Seeds