21 C.F.R. § 25.43 Records of decision.
Title 21 - Food and Drugs
(a) In cases requiring environmental impact statements, at the time of its decision, the agency shall prepare a concise public record of decision. (b) The record of decision shall: (1) State what the decision was; (2) Identify and discuss alternatives considered by the agency in reaching its decision; (3) State whether all practicable means to avoid or minimize environmental harm have been adopted, and if not, why not; and (4) Summarize the program for monitoring and enforcing the practicable means adopted to avoid or minimize the environmental harm.
Title 21: Food and Drugs
PART 25—ENVIRONMENTAL IMPACT CONSIDERATIONS
Subpart D—Preparation of Environmental Documents
§ 25.43 Records of decision.