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  1. Laboratory Methods (Food)

Equivalent Testing Methodology for Agricultural Water - Produce Safety Rule (21 CFR 112)

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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 E. coli in agricultural water.

  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.

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 E. 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. 101298 Readycult Coliforms 100. EMD Millipore (division of Merck KGaA, Darmstadt, Germany).

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