CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER A—GENERAL (parts 1 to 99) > PART 25—ENVIRONMENTAL IMPACT CONSIDERATIONS > SUBPART D—Preparation of Environmental Documents (§25.40 to §25.45) > 25.43—Records of decision.

25.43—Records of decision.

(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.