Code of Federal Regulations Title 21. Food and Drugs § 21.25.45 Responsible agency official

(a) The responsible agency official prepares the environmental documents or ensures that they are prepared.

(b) The responsible agency official will weigh any environmental impacts of each alternative course of action, including possible mitigation measures, and will balance environmental impacts with the agency's objectives in choosing an appropriate course of action. The weighing of any environmental impacts of alternatives in selecting a final course of action will be reflected in the agency's record of formal decisionmaking as required by 40 CFR 1505.2.