Produce Safety Rule Updates

In the last two months, the U.S. Food and Drug Administration (FDA) has released several communications dealing with the Produce Safety Rule (PRS). The following is a brief summary of those communications:

Guidance

On September 5, FDA released Guidance for Industry: Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption: What You Need to Know About the FDA Regulation – Small Entity Compliance Guide. This is a compliance guide, prepared by FDA, to assist small entities in complying with the PSR. Copies of the document may be downloaded at https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm574281.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery.

Testing of Agricultural Water

On September 11, FDA announced that it had determined that the following water testing methods are “scientifically valid” and “at least equivalent” to the method of analysis (EPA Method 1603) in §112.151(a) in accuracy, precision, and sensitivity:

  1. Method 1103.1Escherichia coli ( 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.
  2. 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.
  3. 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).
  4. 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).
  5. 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).
  6. Hach Method 10029 for Coliforms – Total and coli, using m-ColiBlue24® Broth PourRite Ampules.
  7. IDEXX Colilert® Test Kit, but only if using IDEXX Quanti-Tray/2000 for quantification.
  8. IDEXX Colilert-18® Test Kit, but only if using IDEXX Quanti-Tray/2000 for quantification.

These methods may be used as an alternative to EPA Method 1603 for purposes of complying with the water testing requirements of the PSR. If you are covered by the water testing provisions of the PSR, contact your testing laboratory to make sure that they are using one of these methods when testing your water samples.

Compliance Inspections

In a recent speech to the National Association of State Departments of Agriculture (NASDA) on September 12, FDA Commissioner Scott Gottlieb, M.D., announced that large farming operations will still be expected to meet all produce safety requirements of the PSR, except those related to agricultural water, by the original compliance date. However, inspections to assess compliance with the non-water requirements of the PSR will not begin until 2019. This effectively delays inspections for one year after the compliance date for large farming operations. Details can be found on FDA’s website at https://www.fda.gov/Food/NewsEvents/ConstituentUpdates/ucm575532.htm.

Extension of Compliance Dates

On September 13, FDA published a proposed extension of compliance dates for subpart E of the water testing provisions of the PSR in the Federal Register. FDA is proposing an additional two years for growers to comply with subpart E of the water testing provisions of the PSR for agricultural water.  The entire proposal may be viewed in the federal register at https://www.federalregister.gov/documents/2017/09/13/2017-19434/standards-for-the-growing-harvesting-packing-and-holding-of-produce-for-human-consumption-extension. Stakeholders may submit comments on this proposed extension until November 13, 2017.

It should be noted that sprouts are not included in the proposed changes to compliance times or the extension of compliance inspection dates. Sprout growers will need to be in compliance with the PSR by the originally published compliance dates.

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