Code of Federal Regulations Title 21. Food and Drugs § 21.25.43 Records of decision

(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.