FDA FACT SHEET
Produce Safety Rule (21 CFR 112)
EQUIVALENT TESTING METHODOLOGY FOR AGRICULTURAL WATER
FDA has determined that the following quantification methods are scientifically valid and at least equivalent to
the method of analysis in § 112.151(a), “Method 1603: Escherichia coli (E. coli) in Water by Membrane
Filtration Using Modified membrane-Thermotolerant Escherichia coli Agar (Modified mTEC)” (December 2009),
in accuracy, precision, and sensitivity in quantifying generic Escherichia coli in agricultural water when used in
connection with the criteria described in § 112.44(a) or § 112.44(b).
1. Method 1603: Escherichia coli (E. coli) in Water by Membrane Filtration Using Modified membrane-
Thermotolerant Escherichia coli Agar (Modified mTEC) (September 2014). U.S. Environmental Protection
Agency. EPA-821-R-14-010.
2. Method 1103.1: Escherichia coli (E. coli) in Water by Membrane Filtration Using membrane-
Thermotolerant Escherichia coli Agar (mTEC) (March 2010). U.S. Environmental Protection Agency. EPA-
821-R-10-002.
3. Method 1604: Total Coliforms and Escherichia coli in Water by Membrane Filtration Using a Simultaneous
Detection Technique (MI Medium) (September 2002). U.S. Environmental Protection Agency. EPA-821-R-
02-024.
4. 9213 D – Natural Bathing Beaches (2007). In: Standard Methods for the Examination of Water and
Wastewater, 22nd Edition (Rice E.W., et al., Ed.), 9-46 – 9-48. Washington, DC: American Public Health
Association. (2012).
5. 9222 B – Standard Total Coliform Membrane Filter Procedure (1997), followed by 9222 G – MF Partition
Procedures (1997) using NA-MUG media. In: Standard Methods for the Examination of Water and
Wastewater, 21st Edition (Eaton A.D., et al., Ed.), 9-60 – 9-65, and 9-70 – 9-71, respectively. Washington,
DC: American Public Health Association. (2005).
6. D 5392-93 – Standard Test Method for Isolation and Enumeration of Escherichia coli in Water by the Two-
Step Membrane Filter Procedure. In: Annual Book of ASTM Standards, Volume 11.02. ASTM International.
(1996, 1999, 2000).
7. Hach Method 10029 for Coliforms – Total and E. coli, using m-ColiBlue24 Broth PourRite Ampules.
8. IDEXX Colilert Test Kit, but only if using IDEXX Quanti-Tray/2000 for quantification.
9. IDEXX Colilert-18 Test Kit, but only if using IDEXX Quanti-Tray/2000 for quantification.
U.S. Food and Drug Administration
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College Park, MD, 20740
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With regard to criteria described only in § 112.44(a), FDA has determined that the following presence/absence
methods are scientifically valid and at least equivalent to the method of analysis in § 112.151(a), “Method
1603: Escherichia coli (E. coli) in Water by Membrane Filtration Using Modified membrane-Thermotolerant
Escherichia coli Agar (Modified mTEC)” (December 2009), in accuracy, precision, and sensitivity in detecting
generic Escherichia coli in agricultural water.
1. TECTATM EC/TC medium and the TECTATM Instrument: A Presence/Absence Method for the Simultaneous
Detection of Total Coliforms and Escherichia coli (E. coli) in Drinking Water. (2014).
2. Modified ColitagTM Test Method for the Simultaneous Detection of E. coli and other Total Coliforms in
Water. ATP D05-0035. (2009).
3. IDEXX Colilert Test Kit
4. IDEXX Colilert-18 Test Kit
5. IDEXX Colisure Test Kit
6. E*Colite Bag or Vial Test for Total Coliforms and E. coli in Potable Water. Charm Sciences, Inc.
7. 101298 Readycult Coliforms 100. EMD Millipore (division of Merck KGaA, Darmstadt, Germany).
For more information:
• FSMA Final Rule on Produce Safety.
https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm334114.htm
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effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The
agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, and products that give off
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U.S. Food and Drug Administration
5001 Campus Drive
College Park, MD, 20740
www.fda.gov
