NOTE: Each group first should establish terms of reference with regard to the purpose and scope of its work as a biosafety review committee (15 minutes). See pages 11-15 of Part One of this workbook for further details on terms of reference.

A. Read the case-study application proposing release of a GMO to the environment. For the purpose of these exercises, assume that data referred to in the text, but not found in the case document, were submitted with the application.

B. Evaluate the proposal in the step-by-step procedure outlined below. Use the worksheets provided to record the group's findings.

1. Identify genes and other DNA sequences inserted in the recipient organism, their source of origin, and the resultant phenotype(s).

2. List key details of the proposed release pertaining to the nature of the crop species, introduced trait(s), and local environment.

3. Identify potential risks arising from crop-trait-environment interactions.

4. List questions to be asked of the applicant for clarification.

5. Determine if the information provided is sufficient; describe what is missing.

6. Assess the probability and potential consequences of any identified risk.

7. Identify proposed risk-management procedures and evaluate their adequacy.

8. Determine what conditions or restrictions should be imposed and why.

9. Specify monitoring and follow-up procedures, if indicated.

10. Recommend a response to the application and justify it.

C. Using the worksheets provided, answer the following questions:

1. What nonsafety issues are raised by the proposed release?

2. What scientific expertise is needed to review the application?

3. What resources are needed to meet the conditions and requirements for approval?

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