The passage of the Produce Safety rule (officially entitled Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption) establishes, for the first time, science-based minimum standards for the safety of fruits and vegetables grown for human consumption. It is fulfillment of the Congressional mandate (through FSMA) for these standards for raw agricultural commodities (RACs) for which the Agency determined that such standards would minimize the risk of serious adverse health consequences or death. The provisions of the final rule are focused on microbiological risks, and are intended to prevent the introduction of known or reasonably foreseeable hazards into produce and to provide reasonable assurances that produce is not adulterated. In the rule, the definition of “farm” and related terms follow those established in the Preventive Controls rule. These establishments are, thus, not subject to preventive controls regulations, but rather are held to the Produce Safety rule which focuses on biological hazards related to produce growing, harvesting, packing, and holding produce, both domestic and imported. As in the proposed rule, the final rule lists out produce that is subject to the rule and what FDA terms an “exhaustive” list of product that is exempt from the rule. As before, produce that is subject to further commercial processing that adequately control microbiological risk is also exempt. The rule includes six key sections; in this newsletter we focus just on the agricultural water requirements because they are some of the most complex. We will do the rest in subsequent newsletters. In the sections below we pose the same questions that are in the final rule and provide a digest of the regulatory requirements. Agricultural water (Subpart E) The overarching mandate of the requirements for agricultural water quality is that it must be safe and of adequate sanitary quality for its intended use. Following are additional questions with answers from the rule to help you digest the full extent of these requirements. What requirements apply to my agricultural water sources, water distribution system, and pooling of water? You must inspect all of your agricultural water systems, to the extent they are under your control at the beginning of each growing season, but at least once annually. The purpose is to identify conditions that are reasonably likely to introduce known or reasonably foreseeable hazards considering the nature of each agricultural water source, and for each: the extent of your control over it; its degree of protection; any use of adjacent and nearby land, and the likelihood of introduction of known or reasonably foreseeable hazards by another user of agricultural water before it reaches your farm. You must adequately maintain, inspect and store equipment of all agricultural water distribution systems under your control and adequately maintain all agricultural water sources to the extent they are under your control (such as wells). This includes regularly inspection to identify any conditions that are reasonably likely to introduce known or reasonably foreseeable hazards into or onto covered produce or food contact surfaces; correcting any significant deficiencies (e.g., repairs to well cap, well casing, sanitary seals, piping tanks and treatment equipment, and control of cross-connections); and keeping the source free of debris, trash, domesticated animals, and other possible sources of contamination. You also must implement measures reasonably necessary to reduce the potential for contamination from pooled water. Some examples are use of protective barriers or staking to keep covered produce from touching the ground or using an alternative irrigation method. What requirements apply to treating agricultural water? Any method used to treat agricultural water (e.g., pesticide devices, antimicrobials, etc.) must be effective to make the water safe and of adequate sanitary quality for its intended use and/or meet the relevant microbial quality criteria. Treatment must be delivered in a manner that ensures the water is consistently safe and of adequate sanitary quality and/or consistently meets the relevant microbial quality criteria, and monitored frequently enough to ensure the same. What are the microbial quality criteria of the new rule? For covered produce, you cannot use agricultural water with any detectable generic Escherichia coli (E. coli) in 100 milliliters (mL) of agricultural water or any untreated surface water for sprout irrigation, handwashing, or in a manner that directly contacts covered produce during or after harvest activities (e.g., for washing or cooling produce, on harvested crops to prevent dehydration, for ice that directly contacts covered produce or food contact surfaces). For agricultural water that is directly applied to growing produce (other than sprouts), the criteria are based on the geometric mean (GM) and the statistical threshold (STV). The GM of samples is 126 or less CFU of generic E. coli per 100 mL of water and the STV of samples is 410 CFU or less of generic E. coli in 100 mL of water. The GM is, essentially, the average amount of generic E. coli in a water source. STV reflects the amount of variability in the water quality (indicating E. coli levels when adverse conditions come into play—like rainfall or a high river stage that can wash waste into rivers and canals). In very general terms, it is the level at which 90 percent of the samples are below the value. If the water does not meet these criteria, corrective actions are required as soon as is practicable, but no later than the following year. What do I have to do if my agricultural water doesn’t meet requirements? If your agricultural water is found or believed to not be safe, of adequate sanitary quality, or not meet the microbial quality criteria, you must immediately discontinue that related use(s) and before reuse, either: Re-inspect the entire affected agricultural water system under your control, identify any conditions that may introduce hazards, take corrective action, and verify the efficacy of the action(s) to ensure that your agricultural water meets the microbial quality criterion in § 112.44(a) (in answer #3) Treat the water in accordance with the requirements of § 112.43 (in answer #2) If your agricultural water does not meet the microbial quality criteria, you must, as soon as practicable and no later than the following year, discontinue use or: Apply a time interval (of no more than 4 consecutive days) between last irrigation and harvest using a microbial die-off rate of 0.5 log per day to achieve a (calculated) log reduction of your geometric mean (GM) and statistical threshold value (STV) to meet the microbial quality criteria Apply an alternative microbial die-off rate and any accompanying maximum time interval, in accordance with § 112.49. (in answer #8) Apply a time interval between harvest and end of storage using an appropriate microbial die-off rate between harvest and end of storage, and/or applying a (calculated) log reduction using appropriate microbial removal rates during activities such as commercial washing, to meet the microbial quality criteria and any scientifically validated/documented accompanying maximum time interval or log reduction. Re-inspect the entire affected agricultural water system under your control, identify any hazardous conditions, make necessary changes, and ensure the changes were effective and adequately ensure that your agricultural water meets the microbial quality criteria. Treat the water in accordance with the requirements of § 112.43 (in answer #2) How often do I need to test agricultural water? Although the final rule adopts the general approach that was in the proposed rule for testing and its frequency based on the type of water source, there were some changes. The rule requires: For testing of untreated surface water that is directly applied to growing produce (other than sprouts), the FDA requires farms to do an initial survey, of at least 20 samples, collected as close as is practicable to harvest over the course of two to four years. The initial survey findings are used to calculate the GM and STV and determine if the water meets the required microbial quality criteria. Following that, an annual survey of at least five samples is required to update the calculations of GM and STV. The calculations on these five samples, plus the previous most recent 15, create a rolling dataset of 20 samples for use in confirming that that the water is still used appropriately. For untreated ground water that is directly applied to growing produce (other than sprouts), farms must do an initial survey of at least four samples, collected as close as is practicable to harvest, during the growing season or over a period of one year. The initial survey findings are used to calculate the GM and STV and determine if the water meets the required microbial quality criteria. Following that an annual survey of at least one sample per year is required to update the calculations of GM and STV. This new sample, plus the previous most recent three samples, create a rolling dataset of four samples for use in confirming that that the water is still used appropriately. For untreated ground water that is used for the purposes for which no detectable generic coli is allowed, farms must initially test the untreated ground water at least four times during the growing season or over a period of one year and determine if the water can be used based on the results. If the four initial sample results meet the no detectable genericE. coli criterion, testing can be done once annually thereafter, using at least one sample. Farms must resume testing at least four times if any annual test fails to meet the microbial quality criterion. There is no requirement to test agricultural water that is received from public water systems or supplies that meet requirements established in the rule (provided that the farm has Public Water System results or certificates of compliance demonstrating that the water meets relevant requirements), or if the water is treated in compliance with the rule’s treatment requirements. Who can perform the tests? Agricultural water samples can be aseptically collected and tested by you, or by a person or entity acting on your behalf. The water source(s) sampled must adequately represent your agricultural water source(s) and meet all other applicable requirements of this part are met. (b) A using a method as set forth in Subpart N § 112.151. What else do I need to do for water? For water used during harvest, packing, or holding of covered produce, you must: Establish and follow water-change schedules for recirculated water to maintain its safety and sanitary quality and minimize the potential for contamination (e.g., for hazards that may be introduced into the water from soil adhering to the covered produce). Visually monitor the water quality or buildup of organic material, such as soil and plant debris (e.g., of water used for washing covered produce in dump tanks, flumes, or wash tanks, and water used for cooling the produce in hydrocoolers). Maintain and monitor the water temperature as appropriate for the commodity and operation (considering the time and depth of submersion) that minimizes the potential for microorganisms of public health significance. Are there any alternatives to these requirements? As long as you satisfy the requirements of § 112.12 of the rule and identify measures that are suitable for your operations that provide the same level of public health protection as the applicable requirement, you may establish and use alternative: Microbial quality criterion (or criteria) using an appropriate indicator of fecal contamination [§ 112.44(b)]. Microbial die-off rate and accompanying maximum time interval [§ 112.45(b)(1)(i)]. Minimum number of samples used in the initial survey for an untreated surface water source [§ 112.46(b)(1)(i)(A)]. Minimum number of samples used in the annual survey for an untreated surface water source [§ 112.46(b)(2)(i)(A)]. What records do I need to keep? You must establish and keep records on: The findings of the inspection of your agricultural water system. Documenting the results of all analytical tests conducted on agricultural water for purposes of compliance with this subpart. Scientific data or information you rely on to support the adequacy of a method used to treat the water. Documenting the results of water treatment monitoring. Scientific data or information supporting the microbial die-off or removal rate(s). Documenting actions taken with respect to any time interval or (calculated) log reduction applied. Annual documentation of the results or certificates of compliance from a public water system. Scientific data or information supporting any alternative that you establish and use Any analytical methods you use in lieu of the required method. The Produce Rule: Focus on the Water Requirements by David Acheson is licensed under aCreative Commons Attribution-ShareAlike 4.0 International License. About The Acheson Group (TAG) Led by Former FDA Associate Commissioner for Foods Dr. David Acheson, TAG is a food safety consulting group that provides guidance and expertise worldwide for companies throughout the food supply chain. With in-depth industry knowledge combined with real-world experience, TAG’s team of food safety experts help companies more effectively mitigate risk, improve operational efficiencies, and ensure regulatory and standards compliance. Learn more at: www.AchesonGroup.com
