Agency Procedures for Safe Use of Genetically Engineered
Organisms
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.
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