PLANT HEALTH RISK ASSESSMENT OF Living Modified Organisms IN THE UK

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PLANT HEALTH RISK ASSESSMENT OF Living Modified
Organisms IN THE UK

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

Alison J Wright Paul W Bartlett Plant Health
Consultants Defra, Central Science Laboratory,
York, England - United Kingdom
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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

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APPROVAL OF LMOSLEGISLATIVE 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).

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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

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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)

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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.

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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.

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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)

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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.

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Deliberate 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.

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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)

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Deliberate 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.

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Deliberate 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

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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.

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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).

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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.

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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?

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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.

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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,
• gt LMO is a priori considered not to be a plant
  pest
• BUT Environmental risks may still need to be
  examined.

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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.
• gt LMO plant considered a potential plant pest

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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.

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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.

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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?

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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).

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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.

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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.

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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.

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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

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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.