| Popis: |
A full Environmental Assessment (EA) is required under 21 CFR Part 25.31a for proposed actions to approve food/color additives, drugs, biological products, animal drugs and Class III medical devices. The heart of the EA is found in Sections 6, 7, and 8, which addresses, in order, the intro- duction of substances into the environment, the fate of emitted substances, and the effects of released substances on the envirornnent. The major goal is to prevent harmful environmental effects from the projected use of a new drug substance. Simulation or field experiments, while useful, cannot be used to evaluate environmental migration and depletion for every possible situation. It is much easier to project environmental movement from an analysis based on chemical and physical properties of the chemical(s) introduced, then proceed to simulation experiments when confirmation is required. |
