CFR - Code of Federal Regulations Title 21

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[Code of Federal Regulations]

[Title 21, Volume 1]

[CITE: 21CFR25.43]

TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER A - GENERAL

Subpart D - Preparation of Environmental Documents

Sec. 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.