PLANT HEALTH RISK ASSESSMENT OF Living Modified Organisms IN THE UK

1. PLANT HEALTH RISK ASSESSMENT OF Living Modified Organisms IN THE UK Alison J Wright & Paul W Bartlett Plant Health Consultants Defra, Central Science Laboratory, York, England - United Kingdom International Plant Health Risk Analysis workshop 24 - 28 October 2005 Niagara Falls, Canada

2. Outline • Legislative & administrative procedures: • LMO approval process for contained use & • deliberate release in the UK/EU; • To explain role of different authorities; In UK PH scientists directly responsible for PH assessment aligned with: • Risk analysis procedures: use of ISPM 11; • Risk of ‘Non-approved illegal LMOs’;

3. APPROVAL OF LMOS:LEGISLATIVE BACKGROUND • LMOs intended for contained use • (EC Council Directive 90/218/EEC, as amended). • LMOs intended for deliberate release • (EC Council Directive 2001/18/EC & Regulation EC/1829/2003 on GM food & feed). • LMOs as plant pests (EC Council Directive 2000/29/EC).

4. Legislation • Note these Directives have to be enacted as legislation in each Member State: • Thus UK has own legislation. Legislation recognises two different types of uses: • Contained use - specific containment measures are used to limit LMOs contact with the general population and the environment; • Deliberate release ‘no specific containment measures are used to limit LMOs contact with the general population & the environment;

5. Contained Use - Approval of LMOs • In Britain, the Health & Safety Executive(HSE) is ‘competent authority’ responsible for approvals; • Persons wanting to handle a GMO must provide an Environmental risk assessments for proposed contained use of GM micro-organisms and GM plants; • How they do this is to assign a risk category for the proposed work: • Class 1 (no/negligible risk), • Class 2 (low risk), • Class 3 (moderate risk) and • Class 4 (high risk)

6. Contained Use - Approval of MICRO-ORGANISM LMOs • If a Class 3 or 4 Environmental risk assessment on GM micro-organisms these passed to government technical advisers for comment on risks to humans, animals, plants etc.; Comment on plant health risks is provided by CSL plant health scientists; • Consent issued by HSE; If Class 1 or 2 (low risks) a risk assessment prepared but work starts – no prior approval. Most work on Plant pathogens are class 1 or 2.

7. Contained Use - Approval of PLANT LMOs • For contained use of GM plants an environmental risk assessment (ERA) is required; • The ERA has to be retained for 10 years but the work does not have to be notified, even if risks are identified. Considered to be a weakness but Plant Health licensing currently requires prior notification and approval.

8. Control of LMO plant pests under Plant Health legislation • In Great Britain, the Plant Health Authorities of the Department of Food & Rural Affairs (Defra) are responsible; • Plant Health licences are issued for work on plant pathogens ‘not normally present in Great Britain’. This includes LMOs. • This includes modified plant pests and LMO plants thay may contain pathogenic sequence; • Work can only commence once a licence is issued with details of containment requirements. • (being reviewed with legislation change)

9. Examples of contained use of LMOs • LMO fungi – mutation of specific genes to examine the process of infection; • LMO viruses – Viral vectors (e.g. PVX, TNV) used to introduce novel proteins of pharmaceutical use or toxins; • LMO invertebrates – the development of a new version of Sterile insect technique.

10. Deliberate ReleaseApproval of LMOs • In all UK, the Defra GM unit is responsible for approvals; • Separate applications for experimental releases and for marketing; • Risk assessments submitted by applicants; • Assessments sent on to government technical advisers (AH, PH, Fish, Vet. Medicines) for comment; • includes CSL Plant Health scientists; • Separate applications for either ‘experimental’ or for ‘marketing’.

11. Deliberate Release Approval of LMOs Experimental Purposes For Research or Development. • Original risk assessment + Comments by government advisers submitted to an independent advisory body of leading scientists for examination and approval: = Advisory Committee for Releases to the Environment (ACRE) Provides advice to Ministers on risk to human health & environment; • Authorisation of experimental releases under specific conditions. (similar system for bio-control organisms but no EC legislation)

12. Deliberate ReleasePlant health concerns • Genotypic make-up. Use of plant pathogens & pathogenic sequences e.g. Agrobacterium tumeifaciens,Cauliflower mosaic virus sequences. • Environmental. Gene flow of herbicide tolerant gene flow to soil fungi . • E.g. In Fusarium resistance work. • Concern addressed by small scale release. • Or Plant pathogen per se. • E.g. the GM bacterium produced may be pathogenic.

13. Deliberate ReleaseExamples of UK GMO releases • Herbicide tolerance sugar beet/maize oilseed rape (canola) • Starch/carbohydrate change Potato • Virus/nematode/blight resistance Potato • Fungal resistance Wheat • Biocontrol against ‘damping-off’ fungus Bacterium [wild type Pseudomonas fluorescens used does not cause disease in (animals or) plants]

14. Deliberate Release Approval of LMOs Marketing • Approval for marketing of LMOs and LMO products given at EC level; • May be import & processing only; • From 2004 single EC procedure for authorisation of all food & feed derived from GMO. • Member States comment on applications; • As with experimental releases, CSL plant health scientists comment and ACRE provides an opinion on environmental risks to European Food Safety Authority (EFSA) of EC Commission. • Business operators only need do one application for all EU.

15. Examples of EU marketing consents for LMOs • For import & processing only (not to be grown in the EU): • Soya bean (herbicide tolerant); • Oilseed rape (herbicide tolerant); • Maize (insect resistant & herbicide tolerant). • For cultivation in the EU: • Tobacco (herbicide tolerant); • Maize (insect resistant & herbicide tolerant); • Carnations (modified flower colour).

16. PLANT HEALTH RISK ASSESSMENT PROCEDURES (1) • ISPM 11 ‘PRA for quarantine pests , including analysis of environmental risks and living modified organisms’. • Principles of ISPM 11 used by plant health specialists whatever the regulatory approval process involved.

17. PLANT HEALTH RISK ASSESSMENT PROCEDURES (2) Consider using ISPM 11. • Can the LMO be considered a plant pest? If yes, • Have the risks been adequately recognised? and • Are the risk management procedures adequate?

18. ISPM 11 : PRA for Quarantine pestsStage 1: Initiation Can the LMO be considered a plant pest? Two types of LMOs of concern:- (i) Direct modification of a plant pest; (ii) Plants/other organisms e.g. biological control agents, which have been modified using a plant pest or modified to contain/express material derived from a plant pest.

19. ISPM 11: PRA for Quarantine pests Stage 1: Initiation Agrobacterium tumefaciens or A. rhizogenes or other plant pests/parts of plant pests (e.g. cauliflower mosaic virus) are widely used to construct transgenic plants: BUT • Usually this is ‘disarmed’ i.e. plant pathogenic sequences removed, or • use of wild type Agrobacterium - an appropriate post-transformation antibiotic treatment has been done, => LMO is a priori considered not to be a plant pest BUT Environmental risks may still need to be examined.

20. ISPM 11: PRA for Quarantine pests Stage 1: Initiation Construction of transgenic plants e.g. • Use of transgenes derived from plant pests e.g. virus coat proteins to convey disease resistance; • Use of modified virus as a vector for gene delivery into plants e.g. for synthesis of novel proteins of pharmaceutical use. => LMO plant considered a potential plant pest

21. ISPM 11: PRA for Quarantine pests Stage 2: Pest Risk Assessment Risk criteria for LMOs in Annex 3 to ISPM 11 include consideration of :- • Changes in adaptive characteristics; • Adverse effects of gene transfer or gene flow; • Adverse effects on non-target organisms; • Genotypic instability or phenotypic instability; • Other e.g. enhanced capacity for virus recombination.

22. ISPM 11: PRA for Quarantine pests Stage 2: Pest Risk Assessment RA generally concerned with phenotypic characteristics but Genotypic characteristics also need to be considered: e.g. use of wild type Agrobacterium tumefaciens Also if non-indigenous source used for construction, the PH risk of the genetic material has to be assessed.

23. ISPM 11: PRA for Quarantine pests Stage 3: Pest Risk Management What is the acceptable level of risk? • Refer to level of risk accepted for similar (parent) organisms; • Depends on intended use:- • For Contained use? • For planting or not?

24. ISPM 11: PRA for Quarantine pests Stage 3: Pest Risk Management Examples from marketing approvals: Oil seed rape (canola) for processing - controls on transport to processing plant; Maize for planting - Low risk of viable seed being produced in the UK (no volunteers).

25. RISK ANALYSIS OF NON-APPROVED LMOs ‘Risk alert’ of a non-approved LMO by:- • PRA of commodity pathway as a result of an import request; • Monitoring by the LMO authority for imports of non-approved LMOs or by plant health inspection services in their routine import checks.

26. RISK ANALYSIS OF NON-APPROVED LMOs LMO issues for a PRA of a commodity pathway: • Knowledge of worldwide LMO releases? E.g. in Asia? • Direct risk from LMO plants. E.g. altered host range cf. parent plant; • Hitch-hiker risk from a e.g. LMO biological control agents.

27. RISK ANALYSIS OF NON-APPROVED LMOs LMO issues arises from LMO monitoring/plant health import checks: Need for good molecular diagnostic techniques to distinguish non-approved LMO from either non-modified parent plant or any similar approved LMO plants.

28. Compliance • In UK have combined inspectorate for • Border; • Exports; • Marketing/Certification of planting material; • Seeds; • Containment facilities for Research etc.. • The Plant Health & Seeds Inspectorate • Field control of Deliberate release of GM by the GM Inspectorate in CSL Plant Health Group

29. Conclusions • In the UK, scientists of the plant health service are directly involved in risk analysis for risks to plants and the environment. • ISPM 11 provides the framework for phytosanitary PRA for LMOs (micro-organisms & plants). • Under current EC legislation, consents for importation of LMO plants are handled by GM authorities in UK/EFSA at EU level. Plant health authorities are consulted. • Plant health services will need to consider how they incorporate assessment of LMO risks in import commodity PRAs.