PLANT HEALTH RISK ASSESSMENT OF PLANT HEALTH RISK ASSESSMENT OF Living Modified Organisms IN THE UKLiving 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

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’;

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).

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;

Contained Use -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)

Contained UseContained Use - Approval of MICRO-ORGANISM 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.

Contained Use -Contained Use - Approval of PLANT 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.

Control of LMO plant pestsplant 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)

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.

Deliberate ReleaseDeliberate Release Approval 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’.

Deliberate ReleaseDeliberate Release Approval of LMOs Experimental PurposesExperimental 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)

Deliberate ReleaseDeliberate Release Plant 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.

Deliberate ReleaseDeliberate Release Examples 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]

Deliberate ReleaseDeliberate Release Approval of LMOs MarketingMarketing

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.

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).

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.

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?

ISPM 11 : PRA for Quarantine pestsStage 1: InitiationStage 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: InitiationStage 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.

ISPM 11: PRA for Quarantine pests Stage 1: InitiationStage 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

ISPM 11: PRA for Quarantine pests Stage 2: Pest Risk AssessmentStage 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.

ISPM 11: PRA for Quarantine pests Stage 2: Pest Risk AssessmentStage 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 ManagementStage 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?

ISPM 11: PRA for Quarantine pests Stage 3: Pest Risk ManagementStage 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: 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.

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

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

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.