• U.S. Food and Drug Administration 2024. Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Relating to Agricultural Water. (Final Rule).
  Use this resource to find revisions to the codified language for Subpart E: Agricultural Water, including changes to the provision numbers and codified language of harvest and postharvest agricultural water requirements.
• U.S. Food and Drug Administration 2019. Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption; Extension of Compliance Dates for Subpart E.
  This is where the currently applicable compliance dates for harvest and pre-harvest are found.
• U.S. Food and Drug Administration 2015. Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption. (Final Rule).
  Although the provision numbers and codified language changed in 2024, this resource has important explanations written in the preamble that help explain why harvest and postharvest agricultural water requirements were developed as well as guidance for compliance.
• Bihn, E., Wall, G., Acuña-Maldonado, L., Fisk, C., Humiston, M., Pahl, D., Stoeckel, D., Way, R., and Woods, K. 2019. Produce Safety Alliance National Curriculum. Version 1.2 - Version 1.2a. 
  See Module 5.2 for requirements related to harvest and postharvest agricultural water.

• International Fresh Produce Association. Undated. Food Safety Commodity-specific Resources
• Fogarty, S. 2023. Produce Safety in Hydroponic and Aquaponic Operations: Harvest and Postharvest Handling

§ 112.40 Codified language

• Key element within § 112.40: a table that shows which requirements apply when agricultural water is used for growing covered produce (other than sprouts) (also known as pre-harvest water), for sprout irrigation water, and for harvesting, packing, or holding covered produce (also known as harvest and postharvest water).

§ 112.41 Codified language 

• Key element of § 112.41: All agricultural water must be safe and of adequate sanitary quality for its intended use
• Resource:
  • Clarifying information is found in the U.S. Food and Drug Administration. 2015. Preamble to the Produce Safety Rule, response to comment 180, where the requirement in § 112.44(a) is about the no detectable generic E. coli in 100 mL water criterion.
    
    “In this regard, we consider the agricultural water that does not meet the microbial quality requirement in final § 112.44(a) also does not meet the general requirement of safe and of adequate sanitary quality in final § 112.41.” 
    
    “… agricultural water that meets the microbial water quality criterion in § 112.44(a) may not necessarily be safe or of adequate sanitary quality for its intended use.”
    
    “That is, agricultural water that meets § 112.44(a) may not be safe or of adequate sanitary quality, for example, due to the presence of pathogenic organisms.”

§ 112.42 Codified language 

• Key element within § 112.42(a): Inspection of your agricultural water systems: 
  • At the beginning of a growing season, at least once annually, a written water systems inspection that includes specific listed considerations must be done for all agricultural water systems.
• Resources:
  • Produce Safety Alliance. Updated February 2025. FSMA Produce Safety Rule: Agricultural Water Systems Inspection is Different from the Agricultural Water Assessment
  • Tocco, P. 2022. Water System Inspections
• Key elements within § 112.42(b): Maintenance of your agricultural water systems:
  • Specific items related to maintenance and repair are listed.
• Resource:
  • Callahan, C. 2020. Backflow Prevention for Produce Farms

§ 112.44 Codified language 

• Key elements within § 112.44(a) Microbial quality criterion:
  • For agricultural water used during harvest or postharvest: no detectable generic E. coli in 100 mL water sample.
  • You must not use untreated surface water “during or after harvest activities in a manner that directly contacts covered produce … to contact food contact surfaces or to make ice that will contact food contact surfaces … (or) for washing hands during and after harvest activities”
• Resource:
  • Produce Safety Alliance. Updated November 2023. FSMA Produce Safety Rule Water Requirements: Insights to Get You Organized! Focus on Harvest and Postharvest Uses
• Key element within § 112.44(b):  Untreated ground water.
  • For untreated ground water sources used as agricultural water during harvest or postharvest, testing frequency is four or more times initially then one or more times per year.
• Key elements within § 112.44(c) Exemptions
  • For public water supply, no testing needed so long as required record in § 112.50(b)(6) is kept and supports eligibility for the exemption.
  • For treated water, as described in § 112.46, no testing needed if requirements of § 112.46 are met and required records in § 112.50(b)(10) and (11) are kept.
• Resource:
  • Produce Safety Alliance. Updated November 2023. FSMA Produce Safety Rule Water Requirements: Insights to Get You Organized! Focus on Harvest and Postharvest Uses
• Key elements within § 112.44(d) Additional management and monitoring practices:
  • Manage water to maintain safe and adequate quality, including by establishing and following water change schedules for recirculated and reused water (non-single-pass water).
  • Visually monitor the water for build-up of organic material, including soil and plant debris
  • Maintain and monitor the temperature of water to minimize the potential for infiltration of pathogens into covered produce during submersion
• Resources:
  • Produce Safety Alliance. 2022. Managing Post-Harvest Water and Change Schedules: Illustration and Teaching Notes
  • Suslow, T. 2012. Top FAQs about Produce Wash Water Management for Small-Scale and Direct Market Farms
  • Estrada, E., Zuchel, J., Vallotton, A., and Strawn, L. 2019. Susceptibility of Produce to Infiltration: Risk Factors and Mitigations
  • Texas International Produce Association and United Fresh Produce Association (now International Fresh Produce Association, IFPA). 2020. Food Safety Best Practices Guide for the Growing and Handling of Mexican Papaya First Edition (see page 15 for temperature)
  • United Fresh Produce Association (now IFPA). 2018. Commodity Specific Food Safety Guidelines for the Fresh Tomato Supply Chain, Third Edition (see page 30-31 for temperature)

§ 112.45 Codified language 

• Key element within § 112.45(a) Discontinue use:
  For agricultural water used during harvest or postharvest that does not meet the requirement of § 112.41 (not safe or sanitary) or § 112.44(a) (detectable generic E. coli), two corrective measures are described:
  • Re-inspect, identify issues that may have led to introduction of E. coli and (or) pathogens, make necessary changes, and determine if changes were effective
  • Treat the water as described in § 112.46
• Resource:
  • Produce Safety Alliance. Updated November 2023. FSMA Produce Safety Rule Water Requirements: Insights to Get You Organized! Focus on Harvest and Postharvest Uses

§ 112.46 Codified language 

• Key element within § 112.46: Treatments must be effective to achieve standards of § 112.41 (safe and sanitary) and/or § 112.44(a) (no detectable generic E. coli in 100 mL)
  • Treatments can be chemical or physical
  • Delivery of treatment must be done properly, and monitored with recordkeeping
• Resources:
  • Produce Safety Alliance. 2018. Introduction to Selecting an EPA-Labeled Sanitizer
  • Produce Safety Alliance. 2024. EPA-Labeled Sanitizers for Produce – Web Tool
  • Callahan, C. 2021. Web/Mobile Sanitizer Dose Calculator
  • Critzer, F. and Wszelaki, A. 2021. Food safety considerations for postharvest washing of produce and sanitation of packing areas
  • Callahan, C. 2020. Safely Dispensing Sanitizers

§ 112.47 Codified language 

• Key element within § 112.47: Aseptic sample collection and testing using acceptable methods can be done by you or others, or you can use third-party data that meets requirements of Subpart E.
• Resources:
  • National Good Agricultural Practices Program. 2020. Sampling Agricultural Water Used for Production
    The example standard operating procedure for sampling well water used for production/ pre-harvest activities can also be used when sampling well water that is used for harvest and postharvest activities.
  • U.S. Food and Drug Administration. Undated. Equivalent Testing Methodology for Agricultural Water Produce Safety Rule (21 CFR 112) 
  • Produce Safety Alliance. 2019. The Water Analysis Method Requirement in the FSMA Produce Safety Rule
  • Northeast Center to Advance Food Safety. 2023. National Water Quality Testing Labs Map

§ 112.50 Codified language 

• Resources:
  • Produce Safety Alliance. 2025. Records Required by the FSMA Produce Safety Rule
  • Produce Safety Alliance. 2023. FSMA Produce Safety Rule: Documentation Requirements for Water Laboratory Analysis Results