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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of Jul 20, 2022.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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[Code of Federal Regulations]
[Title 21, Volume 2]
[CITE: 21CFR112]





TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER B - FOOD FOR HUMAN CONSUMPTION
 
PART 112STANDARDS FOR THE GROWING, HARVESTING, PACKING, AND HOLDING OF PRODUCE FOR HUMAN CONSUMPTION
 

Subpart N - Analytical Methods

Sec. 112.151 What methods must I use to test the quality of water to satisfy the requirements of 112.46?

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 you may test for pursuant to § 112.49(a), a scientifically valid method.

Sec. 112.152 What methods must I use to test the growing, harvesting, packing, and holding environment for Listeria species or L. monocytogenes to satisfy the requirements of 112.144(a)?

You must test the growing, harvesting, packing, and holding environment for Listeria species or L. monocytogenes using:

(a) The method of analysis described in "Testing Methodology for Listeria species or L. monocytogenes in Environmental Samples," Version 1, October 2015, U.S. Food and Drug Administration. The Director of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 5. You may obtain a copy from, and/or inspect a copy at, the Division of Produce Safety, Center for Food Safety and Applied Nutrition (CFSAN), U.S. Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1600; FDA's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039; http://www.fda.gov/fsma ; 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) A scientifically valid method that is at least equivalent to the method of analysis in § 112.152(a) in accuracy, precision, and sensitivity.

Sec. 112.153 What methods must I use to test spent sprout irrigation water (or sprouts) from each production batch of sprouts for pathogens to satisfy the requirements of 112.144(b) and (c)?

You must test spent sprout irrigation water (or sprouts) from each production batch for pathogens using:

(a) For E. coli O157:H7, Salmonella species:

(1) The method of analysis described in "Testing Methodologies for E. coli O157:H7 and Salmonella species in Spent Sprout Irrigation Water (or Sprouts)," Version 1, October 2015, U.S. Food and Drug Administration. The Director of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 5. You may obtain a copy from, and/or inspect a copy at, the Division of Produce Safety, Center for Food Safety and Applied Nutrition (CFSAN), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1600; FDA's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039; http://www.fda.gov/fsma ; 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

(2) A scientifically valid method that is at least equivalent to the method of analysis in § 112.153(a)(1) in accuracy, precision, and sensitivity; and

(b) For any other pathogen(s) meeting the criteria in § 112.144(c), a scientifically valid method.

Authority: 21 U.S.C. 321, 331, 342, 350h, 371; 42 U.S.C. 243, 264, 271.
Source: 80 FR 74547, Nov. 27, 2015, unless otherwise noted.

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