International Plant Health Risk Analysis workshop 24 —

International Plant Health Risk Analysis workshop 24 - 28 October 2005 Niagara Falls, Canada 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

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

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

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

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

Contained Use Approval of MICRO-ORGANISM LMOs Ø 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; Ø 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.

Contained Use Approval of PLANT LMOs Ø For contained use of GM plants an environmental risk assessment (ERA) is required; Ø 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.

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

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

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

Deliberate Release Approval of LMOs Experimental Purposes For Research or Development. Ø 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; Ø Authorisation of experimental releases under specific conditions. (similar system for bio-control organisms but no EC legislation)

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

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

Deliberate Release Approval of LMOs Marketing Ø Approval for marketing of LMOs and LMO products given at EC level; Ø Ø May be import & processing only; From 2004 single EC procedure for authorisation of all food & feed derived from GMO. Ø Member States comment on applications; Ø 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. Ø Business operators only need do one application for all EU.

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

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

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

ISPM 11 : PRA for Quarantine pests Stage 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.

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 Ø Usually this is ‘disarmed’ i. e. plant pathogenic sequences removed, or Ø use of wild type Agrobacterium - an appropriate posttransformation 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.

ISPM 11: PRA for Quarantine pests Stage 1: Initiation Construction of transgenic plants e. g. Ø Use of transgenes derived from plant pests e. g. virus coat proteins to convey disease resistance; Ø 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

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

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.

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

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).

RISK ANALYSIS OF NON-APPROVED LMOs ‘Risk alert’ of a non-approved LMO by: 1. PRA of commodity pathway as a result of an import request; 2. Monitoring by the LMO authority for imports of non-approved LMOs or by plant health inspection services in their routine import checks.

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

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.

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

Conclusions Ø In the UK, scientists of the plant health service are directly involved in risk analysis for risks to plants and the environment. Ø ISPM 11 provides the framework for phytosanitary PRA for LMOs (micro-organisms & plants). Ø 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. Ø Plant health services will need to consider how they incorporate assessment of LMO risks in import commodity PRAs.