Update on Proposed Changes to Subpart E of the Produce Safety Rule – Vegetable Crops Hotline

Update on Proposed Changes to Subpart E of the Produce Safety Rule

Water is an essential component of crop production. However, water may also contain or transmit human pathogens. As a result, management of any food safety risks presented by water is critical. As part of the Produce Safety Rule (PSR) (21 CFR 112), Subpart E deals with the management of both production and postharvest water on covered farms.

On December 2, 2021, the FDA released proposed revisions to the parts of Subpart E dealing with water used for the production of produce on covered farms (those held to the PSR). The proposed revisions, if finalized as written, would move growers from using water testing as the primary means of understanding water quality and uses to an assessment-based system.  Growers would be required annually to do a complete assessment of their water systems. The assessment would include:

  1. Ag Water Systems – Growers would assess water sources, distribution system, and degree of protection from possible contamination.
  2. Ag Water Practices – The method of application and time interval between the last water application and harvest would need to be assessed.
  3. Crop Characteristics – Growers covered by the PSR will need to consider crops grown and their susceptibility to surface adhesion or internalization of bacteria.
  4. Environmental Conditions – Frequency and intensity of rain events, as well as air temperature and sun exposure during the growing season, would need to be considered.
  5. Other Factors – Factors, such as water testing, that are not considered in other parts of the assessment.

As of the time of this writing, FDA has not released a final rule. Once a final rule is released, farms will have 9 months to be in compliance. Small farms (those with $250,000-$500,000 in annual food sales) and very small farms ($25,000-$250,000 annually) would get 1 and 2 extra years, respectively, to be in compliance. Growers who are covered by the PSR should plan to adhere to current standards found in Subpart E until the final rule is released. While waiting for the release of the final rule, growers should:

  1. Continue adherence to current Subpart E requirements if your farm is covered by the PSR.
  2. Regardless of legal obligations, use Good Agricultural Practices (GAPs) to reduce risk of crop contamination from production or postharvest water.
  3. As part of GAPs, assess water systems annually, looking for areas where there may be a risk of contamination.
  4. Even if not required to do so legally, test water sources for generic coli at least annually.

Growers with food safety questions are encouraged to contact any member of the Safe Produce Indiana team. Our group is available to assist with grower training, On-Farm Readiness Reviews, GAPs implementation, worker training, food safety plan writing, mock third-party audits, or whatever your food safety needs may be.

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