21 CFR § 112.151 - What methods must I use to test the quality of water to satisfy the requirements of subpart E of this part?

---
identifier: "/us/cfr/t21/s112.151"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 112.151 - What methods must I use to test the quality of water to satisfy the requirements of subpart E of this part?"
title_number: 21
title_name: "Food and Drugs"
section_number: "112.151"
section_name: "What methods must I use to test the quality of water to satisfy the requirements of subpart E of this part?"
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "B"
subchapter_name: "FOOD FOR HUMAN CONSUMPTION"
part_number: "112"
part_name: "STANDARDS FOR THE GROWING, HARVESTING, PACKING, AND HOLDING OF PRODUCE FOR HUMAN CONSUMPTION"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 321, 331, 342, 350h, 371; 42 U.S.C. 243, 264, 271."
regulatory_source: "80 FR 74547, Nov. 27, 2015, unless otherwise noted."
cfr_part: "112"
---


# 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.

[80 FR 74547, Nov. 27, 2015, as amended at 89 FR 37518, May 6, 2024]