Questions and Topics to be Considered by Breakout Groups

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 Plants – Impact and management of gene flow
Plants – Pest resistance development and management

Breakout group: PLANTS—Unintended effects


(Refers to unintended effects on organisms that feed or live on the plant or its products or which are otherwise exposed to its products)

Discussion questions

1. Summarize and clarify the information needs for assessing and managing environmental risks from unintended effects of transgenic plants.

2. What methodologies, information, and data address the regulatory needs for assessing and managing environmental risks from unintended effects of transgenic plants?

3. What is the state of the science that addresses the regulatory needs for assessing and managing environmental risks from unintended effects of transgenic plants?

4. What research needs on environmental risks from unintended effects of transgenic plants might be predicted over the next 5 years, based on current agricultural trends and emerging biotechnology products?

5. Are there other topics that are not included that should be a priority for assessing and managing environmental risks from unintended effects of transgenic plants?

6. What research gaps exist for assessing and managing environmental risks from unintended effects of transgenic plants and how might these best be addressed?

7. What priority rankings (high, medium, low, or not a priority) should be placed on any topic identified as a research gap?


Topics that may be addressed:

  1. Risk Assessment
    1. Indicator species using maximum hazard dose
    2. Types of studies to use
      1. Field studies
      2. Confined field studies
      3. Toxicity assays
    3. Appropriate data on unintended effects from transgenic plants, including PHARM products
      1. Toxicity
      2. Bioactivity
      3. Physiological effects (including endocrine disruption) (long term vs. short term)
      4. Effects on fitness
    4. Addressing impacts on endangered species
    5. What are appropriate controls for transgenic comparisons?

  2. Risk Management
    1. Confinement strategies
      1. Physical
        1. Buffers
      2. Biological (e.g., male sterility, autosuicidal mechanisms, chloroplast transformation)
        1. restricted gene expression
          1. tissue specific
          2. temporally restricted
    2. State restrictions
    3. Mitigation

  3. Monitoring
    1. Factors affecting the decision to monitor
    2. Data/methodologies that would effectively monitor unintended effects