Discussion questions

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

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

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

4. What research needs on environmental risks might be predicted for the next five years, based on current agricultural trends and the potential to produce human pharmaceuticals or other biochemicals in animals?

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 animals?

6. What research gaps, with respect to environmental risk assessment, exist 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 (consider transgenic animals for BioPHARMing or agricultural food production):

1. Risk Assessment
   1. Capacity to survive, breed, establish, and spread to other habitats, including:
      1. Ecological fitness relative to wild populations
         1. Juvenile viability
         2. Adult viability
         3. Fecundity
         4. Fertility
         5. Mating success
         6. Age at sexual maturity
         7. Models (based on a-f) to predict environmental risk (e.g. Muir & Howard)
      2. The potential to develop feral populations
      3. Effects on food chain and on biodiversity
         1. Competition with other organisms for food, other resources (niche)
   2. Morphological, physiological, and behavioral changes in the modified animal
      1. Predator/prey interactions (unintended effects)
   3. Phenotypic and genotypic stability
   4. Potential for and consequences of transfer of the inserted genetic material to other animals or other organisms (including creation of disease resistant populations or new animal diseases)
   5. Potential changes in land use patterns (manure management, disposal of exhausted or surplus animals, etc.)
   6. What are appropriate controls for transgenic comparisons?

2. Risk Management
   1. Ability to predict and monitor the distribution of the transgenic animal after release
   2. Physical and biological containment strategies (organism or vector)
   3. Biosecurity
   4. Impacts of intentional release
   5. Ability to mitigate, recall, or depopulate problematic transgenic animals, including operations management
   6. Disposal of exhausted or surplus transgenic animals

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