Discussion questions

1. Summarize and clarify the information needs for assessing and managing the environmental risks of transgenic microorganisms.

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

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

4. What research needs for assessing and managing environmental risks of transgenic microorganisms might emerge over the next five years, based on current trends and potential applications for transgenic microorganisms?

5. Are there other topics that are not included in the listings below that should be a priority for assessing and managing environmental risks of transgenic microorganisms?

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

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

Topics that may be addressed:

1. Risk Assessment
   1. Product identification and characterization
   2. Capacity to survive and spread to other habitats, including:
      1. Ecological fitness relative to wild-type populations (host range)
      2. Competition with other organisms/ecology (niche definitions)
      3. Population dynamics
      4. Impacts on organisms that feed on or live in association with the microorganism
   3. Phenotypic and genotypic stability
   4. Potential for and consequences of transfer of the inserted genetic material (vertical and horizontal)
   5. Viral recombination
   6. What are appropriate controls for transgenic comparisons?

2. Risk Management
   1. Ability to predict and monitor the distribution of the transgenic microorganism after release
   2. Physical containment strategies (organism or vector)
   3. Biosecurity
   4. Impacts of intentional release
   5. Mitigations, including operations management

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