Revocation of Methods of Analysis Regulation FRIA (Final Rule)

This final rule will revoke 21 CFR 2.19 methods of analysis. The regulation states that it is FDA policy to use the 1980 edition of the AOAC publication’s methods of analysis in FDA enforcement programs, when the method is not otherwise specified in a regulation. FDA believes it is more appropriate, flexible, and efficient to identify the Agency’s preferred methods of analysis in documents such as the ORA Laboratory Procedures Manual and other resources. There may be qualitative benefits to removing 21 CFR 2.19 because there will no longer be any inefficiencies due to retaining unnecessary regulations. Revocation of 21 CFR 2.19 will not change Agency current practice; therefore, there are no costs. Annualized over 10 years, the estimated benefits (i.e., cost savings) of the final rule will be $0 at both the 3 and 7 percent discount rate. The annualized costs of the final rule will be $0 at both 3 and 7 percent discount rate.

Regulatory Impact Analysis

Revocation of Methods of Analysis Regulation (PDF- 205KB)

Federal Register: 91 FR 7829
Publication Date: 2/19/2026
Docket: FDA-2020-N-1383