eCFR Reference Browser

---

title: "21 CFR §25.43"

source: "https://www.ecfr.gov/current/title-21/section-25.43"

title_number: "21"

volume_number: "1"

chapter_number: "Unknown"

subchapter_code: "A"

subchapter_subject: "GENERAL"

part_code: "25"

part_subject: "ENVIRONMENTAL IMPACT CONSIDERATIONS"

subpart_code: "D"

subpart_subject: "Preparation of Environmental Documents"

section_number: "25.43"

section_subject: "Records of decision."

cfr_reference: "21 CFR 25.43"

title_name: "Title 21"

title_subject: "Food and Drugs"

parts_covered: "Parts 1 to 99"

revised_date: "Revised as of April 1, 2019"

publication_date: "As of April 1, 2019"

contains_description: "Containing a codification of documents of general applicability and future effect"

publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"

---

(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.

§25.43 - Records of decision.