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Evaluation of Living Modified Organisms as Potential Plant Pests

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

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Evaluation of Living Modified Organisms as Potential Plant Pests

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  1. 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@usda.gov

  2. 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

  3. 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”

  4. (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 Global Adoption of Genetically Engineered Crops (2004) (ISAAA, 2004)

  5. 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

  6. 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.

  7. 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

  8. 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

  9. 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

  10. How does risk assessment of LMOs in the United States relate to PRA under ISPM-11?

  11. 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

  12. 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

  13. 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?

  14. 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

  15. 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”

  16. 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? Regulation of LMOs in APHIS

  17. 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

  18. 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)

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