Evaluation of Living Modified Organisms as Potential Plant Pests

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Evaluation of Living Modified Organisms as
Potential Plant Pests
International Plant Health Risk Analysis
Workshop October 26, 2005 Niagara Falls
Terri Dunahay, Ph.D. Team Leader
International Policy Biotechnology Regulatory
Services Animal and Plant Health Inspection
Service Terri.G.Dunahay_at_usda.gov
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Overview

• What is an living modified organism (LMO)?
• Evaluation of LMOs as potential plant pests
• Why?
• ISPM-11
• Risk assessment of LMOs in the United States
  comparison to ISPM-11

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What is an LMO?

• Living modified organism" means any living
  organism that possesses a novel combination of
  genetic material obtained through the use of
  modern biotechnology
• Modern biotechnology includes
• Recombinant DNA and direct injection of nucleic
  acid into cells or organelles, or
• Fusion of cells beyond the taxonomic family
• Genetically engineered organisms, genetically
  modified organisms, GMOs, transgenic
  organisms biotech crops

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Global Adoption of Genetically Engineered Crops
(2004)

• (million hectares)
• USA 47.6
• Argentina 16.2
• Canada 5.4
• Brazil 5.0
• China 3.7
• Paraguay 1.2
• India 0.5
• South Africa 0.5
• Uruguay 0.3
• Australia 0.2
• Romania 0.1
• Mexico 0.1
• Spain 0.1
• Philippines 0.1

• Soybeans
• herbicide tolerant
• Corn
• insect resistant (Bt)
• herbicide tolerant
• Cotton
• insect resistant (Bt)
• herbicide tolerant
• Canola
• herbicide tolerant

(ISAAA, 2004)
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• ISPM-11

• Revised 2004 Pest risk analysis of quarantine
  pests including analysis of environmental risks
  and living modified organisms
• Provides guidance on evaluating LMOs as potential
  plant pests
• There has been little discussion about practical
  implementation of this guidance and relationship
  of LMO risk assessment to the conventional PRA
  process

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• Why evaluate LMOs as potential plant pests?

• LMOs are generally common plants that have been
  modified using modern biotechnology techniques to
  add or alter a trait affecting agronomic
  properties or product quality
• Risk assessment process asks whether this change
  could intentionally or unintentionally cause the
  engineered organism to be harmful to plants in
  agriculture or the environment, as compared to
  the non-engineered organism.

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• Use of ISPM-11 for assessment of LMOs

• Initiation Stage of ISPM-11 identification of
  pests and pathways of quarantine concern
• Most LMOs are not pests
• Often familiar organism with one or more new
  traits
• Does this trait change the probability that the
  organism could cause harm to plants?
• Conventional crops first step is to request
  Pest List
• For LMOs, first determine if the LMO is a
  potential pest
• Go to Annex 3 provides guidance for determining
  the potential for a LMO to be a pest

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• Annex 3 - What characteristics of LMOs might
  contribute to increased plant pest risk?

• Donor or recipient organism is a plant pest
• Nucleic acid vector is derived from a plant pest
• Introduced trait increases likelihood for
  organisms to become weedy or invasive, for
  example, by changing the reproductive or survival
  potential
• Gene transfer to weedy relatives
• Effects on non-target organisms
• Changes in agronomic practices
• Production of toxins or anti-nutrients

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• Possible conclusions of pest assessment of LMOs
  as per Annex 3

• YES - the LMO is found to be a potential pest
• LMO would be subject to Stages 2 and 3 of the
  PRA as a potential quarantine pest
• NO - LMO is not found to be a pest
• LMO is not subject to further assessment under
  ISPM-11
• organism would be subject to same phytosanitary
  requirements as conventional counterpart

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How does risk assessment of LMOs in the United
States relate to PRA under ISPM-11?
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• Regulation of LMOs by USDA/APHIS

• Regulated Articles
• If the organism has been produced or modified
  using genetic engineering
• If there is a possibility that the organism could
  be a plant pest (cause harm to plants)
• Authorizations are required for importation,
  interstate movement, or field testing of
  regulated articles

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• Pest risk assessment to allow unconfined
  environmental release (commercialization)

• Developers can apply for non-regulated status
  for a genetically engineered organism if they
  want to import or grow it without oversight by
  Biotechnology Regulatory Services
• Must provide data to demonstrate the organism
  will not present a greater plant pest risk than
  the conventional plant

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• Systematic reviews of new genetically engineered
  organisms

• Molecular characterization of each new gene and
  protein produced
• What is likelihood this new gene or trait will
  increase the potential of the organism to pose a
  pest risk?
• What are the characteristics of the whole
  organism that could make this organism more of a
  pest than the non-engineered organism?

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• Data requirements to determine non-regulated
  status

• Data must include comparison to conventional crop
  regarding
• Potential weediness
• Effect of gene transfer to compatible relatives
• Production of new products or enzymes, or changes
  in plant metabolism
• Harm to non-target organisms
• Possible change in cultivation practices

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• Non-regulated status of genetically engineered
  organisms

• Non-regulated status is granted if risk
  assessment results in conclusion that the
  organism poses no greater risk as a plant pest
  than its conventional counterpart
• Comparison to ISPM-11 - To date, all LMOs
  subjected to this review by APHIS have been
  determined not to pose a pest risk, (OR product
  withdrawn from review)
• No situation where a LMO was determined to be a
  potential pest and the developer wanted to
  release or import that product for
  commercialization.
• No need to go past Stage 1 initiation

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Regulation of LMOs in APHIS

• Plant Protection and Quarantine (PPQ)
• Does the conventional variety of that organism
  pose a pest risk (directly, or as a vector for
  pests?)

• Biotechnology Regulatory Services (BRS)
• Does the genetic modification alter pest
  potential of the organism?

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• Conclusions

• Increasing international development and
  adoption of LMOs will result in more requests for
  decisions regarding importation and use of these
  products
• PRA framework under the IPPC is an appropriate
  mechanism for assessing potential plant pest
  risks of LMOs
• There is a need for increased awareness and
  discussion by NPPOs about LMO risk assessment and
  the relationship of LMO risk assessment to PRA as
  performed for conventional pests

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For More Information

• www.aphis.usda.gov/brs
  (APHIS biotechnology regulation)
• www.aphis.usda.gov/ppq/pra (APHIS
  PRAs)
• www.usbiotechreg.nbii.gov
  (USG unified site on biotechnology)