FDA Regulations
FSMA Produce Safety Rule
The FDA Food Safety Modernization Act Produce Safety Rule (FSMA Produce Safety Rule) establishes, for the first time, science-based minimum standards for the safe growing, harvesting, packing, and holding of fruits and vegetables grown for human consumption. The rule is part of the FDA’s ongoing efforts to implement the FDA Food Safety Modernization Act. The final rule went into effect January 26, 2016. The FDA has developed numerous resources to explain the Produce Safety Rule requirements and address common questions related to the rule.
- Agricultural water defined in the Food Safety Modernization Act (FSMA) Produce Safety Rule
- FDA definition of agricultural water: "Agricultural water is water used in covered activities on covered produce where water is intended to, or is likely to, contact covered produce or food contact surfaces, including water used in growing activities and in harvesting, packing, and holding activities."
- “Harvest and post-harvest agricultural water” refers to water used in harvesting, packing, and holding activities, such as water used to prevent dehydration, for transport, cooling, and washing. This includes water used to make ice that contacts covered produce or food contact surfaces and water used for handwashing.
- “Pre-harvest agricultural water” refers to water used during growing activities, such as irrigation and crop protection sprays.
- Introduction – production agricultural water (DiCaprio YouTube video, 13:56 min., posted June 23, 2021).
- CDFA approach to agricultural water in farm inspections (DiCaprio YouTube video, 42:42 min., posted June 23, 2021).
- FDA definition of agricultural water: "Agricultural water is water used in covered activities on covered produce where water is intended to, or is likely to, contact covered produce or food contact surfaces, including water used in growing activities and in harvesting, packing, and holding activities."
- Pre-harvest water
- Current Produce Safety Rule subpart E
- The Produce Safety Rule (PSR) requires growers to initially establish a Microbial Water Quality Profile (MWQP) for each untreated agricultural water source used during growing activities of covered produce (other than sprouts) using a direct water application method and conduct annual surveys for that water source in subsequent years. The water quality profile is based on the levels of generic E. coli in your agricultural water. There are different requirements for agricultural water that comes from surface or ground (well) sources.
- Microbial Water Quality Profile (MWQP) for Agricultural Water (UC Food Safety)
- Testing agricultural water for fruit and vegetable production and postharvest handling (Washington State University Extension, Critzer and Wszelaki 2021)
- FSMA Produce Safety Rule and Pre-Harvest Agricultural Water. (DiCaprio YouTube video, 23:37 min., posted June 23, 2021).
- New Proposed Subpart E
- FDA Proposes Changes to Food Safety Modernization Act Rule to Enhance Safety of Agricultural Water Used on Produce (FDA, Dec. 2, 2021)
- International Fresh Produce Association Harmonized Ag Water Risk Assessment. United Fresh’s Food Safety Council and Harmonized Calibration Committee agreed that the industry would benefit from a document that a grower can use to guide their thought process through the assessment of their agricultural water risk. The following document is a compilation of existing resources and approaches developed by the volunteer workgroup.
- Assessing Risk of Pre-harvest Agricultural Water (International Fresh Produce Association) (PDF 236 KB)
- Example Documentation for Ag Water Risk Assessment (International Fresh Produce Association) (PDF 197 KB)
- Agricultural Production Water Risk Assessment (DiCaprio YouTube video, 28:19 min., posted June 23, 2021).
- International Fresh Produce Association Harmonized Ag Water Risk Assessment. United Fresh’s Food Safety Council and Harmonized Calibration Committee agreed that the industry would benefit from a document that a grower can use to guide their thought process through the assessment of their agricultural water risk. The following document is a compilation of existing resources and approaches developed by the volunteer workgroup.
- FDA Proposes Changes to Food Safety Modernization Act Rule to Enhance Safety of Agricultural Water Used on Produce (FDA, Dec. 2, 2021)
- Current Produce Safety Rule subpart E
- Post-harvest water
- Post-harvest water requirements under Produce Safety Rule subpart E
- Post-harvest use of surface water
- Considerations for the postharvest use of surface water (International Fresh Produce Association issue summary, 2/22/21) (PDF 198 KB)