FSMA Produce Safety Rule Update – Proposed Water Provisions Released in December, 2021

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At the time of this update (January, 2022), the regulatory compliance dates for most provisions within the Food Safety Modernization Act (FSMA), Produce Safety Rule (PSR) have been met and farms of all sizes are currently subject to inspection under this rule. Because there were many comments made to the FDA regarding the requirements of Subpart E – Agricultural Water, in March, 2019, the FDA extended the compliance dates for this portion of the PSR (FDA–2011–N–0921) in order to gather more information about the types of water used on farms and how the provisions could be structured to make them easier for growers to understand and implement while still providing a measure of public health safety for consumers. This announcement extended all provisions of Subpart E – Agricultural Water, other than sprouts, for two additional years and included the safe and sanitary quality, annual inspection, and post-harvest water monitoring requirements. With this extension, the new compliance dates for subpart E – Agricultural Water became January, 2022 for large farms, January, 2023 for small farms, and January, 2024 for very small farms. Even though these provisions were extended, all farms are still responsible for the safe growing, harvesting, and holding of fresh produce and should consider the sanitary quality of the water that they use because both pre- and post-harvest water has been linked with many produce-related, foodborne outbreaks and recalls.

In December, 2021, the FDA released their updated Subpart E – Agricultural Water requirements that are proposed as a replacement for the original provisions (FDA–2021–N–0471). In addition to the Federal Register notice, the FDA also published an article and factsheet to announce and better explain their rationale for the proposed Subpart E – Agricultural Water provision. Their proposal would rely on a water risk assessment to make judgements about how water could and should be used on farms. In addition to the article and factsheet mentioned above, the FDA also published a factsheet outlining the factors that growers should consider when assessing the water that they use on their farms.

Given that this FDA constituent update was released on December 2, 2021, we are currently within a 120 day comment period during which growers or any others can make comments about the proposed Subpart E – Agricultural Water provisions – this comment period will extend through April 5, 2022. Comments can be submitted directly to the FDA in reference to docket FDA-2021-N-0471 on Regulations.gov. 

In addition to the websites referenced above, the FDA will hold two virtual listening sessions to discuss and better describe their thoughts related to this newly proposed Subpart E – Agricultural Water provision. These online listening sessions will take place on February 14, 2022 and February 25, 2022.  Growers are encouraged to register and attend these listening session regarding the proposed revisions for the FSMA PSR Subpart E – Agricultural Water provision.

While these proposed revisions are still being discussed and the comment period is open, the originally extended compliance dates for Subpart E – Agricultural Water have been met for large farms. For farm inspections that occur during this time, the FDA intends that inspectors use enforcement discretion and has suggested that the compliance dates may be further extended while working on the final version of these provisions.

We plan to offer multiple educational opportunities for growers to better inform them of the requirements the Subpart E – Agricultural Water provisions in the Spring and Summer of 2022 – these opportunities will be listed on our website as they are scheduled. If you have questions about the proposed Subpart E – Agricultural Water provision, please reach out to Area Specialized Agents Chip Simmons (919-414-5632) or Elena Rogers (352-316-4445).