21 C.F.R. § 112.151

Current through October 31, 2024
Section 112.151 - What methods must I use to test the quality of water to satisfy the requirements of subpart E of this part?

You must test the quality of water using:

(a) The method of analysis published by the U.S. Environmental Protection Agency (EPA), "Method 1603: Escherichia coli (E. coli) in Water by Membrane Filtration Using Modified membrane-Thermotolerant Escherichia coli Agar (Modified mTEC), EPA-821-R-09-007)," December, 2009. The Director of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain a copy from EPA, Office of Water (4303T), 1200 Pennsylvania Avenue NW., Washington, DC 20460. You may inspect a copy at FDA's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html; or
(b)
(1) A scientifically valid method that is at least equivalent to the method of analysis in § 112.151(a) in accuracy, precision, and sensitivity; or
(2) For any other indicator of fecal contamination, index organism, or other analyte you may test for pursuant to § 112.43(d) , a scientifically valid method.

21 C.F.R. §112.151

89 FR 37518 , 7/5/2024