September 27, 2022

Volume XII, Number 270


September 26, 2022

Subscribe to Latest Legal News and Analysis

Release of Paper-Based Version of FDA’s Agricultural Water Assessment Builder

  • FDA has made halting progress in establishing and implementing “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption,” as mandated by the Food Safety Modernization Act (FSMA) of 2011.  It has been especially challenging to come up with key requirements for agricultural water used with covered produce (other than sprouts).  In this regard, we have reported  on FDA’s December 6, 2021 proposed rule that would replace the microbial criteria and testing requirements for pre-harvest agricultural water under the Produce Safety Rule (PSR), finalized in 2015, with new systems-based assessments.

  • On August 11, 2022, FDA announced the release of a paper-based version of its Agricultural Water Assessment Builder (also available in Spanish).  FDA’s intent is to make the content of its Agricultural Water Assessment Builder that was released on-line in March 2022 more accessible to a broader array of users.  All versions of the tool, available here, are designed to help farms understand the proposed, systems-based pre-harvest agricultural water requirements by guiding them through an assessment of the main elements as follows:

    • Agricultural Water System Components

    • Animal Impacts and Activities

    • Biological Soil Amendments of Animal Origin (BSAAOs)

    • Human Waste

    • Other Water Users

    • Other Potential Sources of Hazards

    • Crop Characteristics

    • Agricultural Water Use Practices

    • Environmental Conditions

    • Other Relevant Factors

    • Outcomes and Measures

  • FDA has not made any further announcements since the notice discussed here about proposed compliance dates for the pre-harvest agricultural water provisions for covered produce (other than sprouts) and its enforcement discretion policy applicable to the harvest and post-harvest agricultural water provisions of the PSR. 

© 2022 Keller and Heckman LLPNational Law Review, Volume XII, Number 227

About this Author

Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...