If an activity will potentially involve the use of genetically modified organisms in research, field trials, or dissemination, the activity must be reviewed and approved for compliance with applicable U.S. requirements by the USAID Biosafety Officer in Washington prior to obligation of funds and prior to the transfer, testing, or release of biotechnology products into the environment. This review and approval is limited to the safety aspects of the proposed activity and may involve external peer review or demonstration of comparable safety oversight by other expert U.S. federal agencies. Therefore, adequate time should be budgeted for this approval process. This biosafety determination is separate from, and precedes and informs, the 22 CFR 216 environmental impact assessment determination.

Since it precedes the 22 CFR 216 process, Operating Units and Strategic Objective Teams are responsible for budgeting adequate time in the design process for this review. It is difficult to predict the amount of time needed, since reviews are highly dependent on the amount of analysis and information provided, whether other expert Federal Agency biosafety reviews have been completed, and whether additional information will be required, and whether external peer reviews will be undertaken. Therefore, it is important for an Operating Unit or SO Team to contact USAID/Washington as early in a design process as possible to ensure timely handling. Biosafety review cannot be waived or delegated to the field.

Note: Additional guidance on compliance with this requirement is in development.