Code of Federal Regulations (Last Updated: November 8, 2024) |
Title 21 - Food and Drugs |
Chapter I—Food and Drug Administration, Department of Health and Human Services |
SubChapter B—Food for Human Consumption |
Part 112 - Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption |
Subpart E - Agricultural Water |
§ 112.44 - What requirements apply to agricultural water used as sprout irrigation water and in harvesting, packing, and holding covered produce?
-
§ 112.44 What specific microbial quality criteria requirements apply to agricultural water used for certain intended usesas sprout irrigation water and in harvesting, packing, and holding covered produce?
(a) Microbial quality criterion. When you use agricultural water for any one or more of these the following purposes, you must ensure there is no detectable generic Escherichia coli (E. coli) in 100 milliliters (mL) of agricultural water, and you must not use untreated surface water for any of these purposes:
(1) Used as sprout irrigation water;
(2) Applied in any Used during or after harvest activities in a manner that directly contacts covered produce during or after harvest activities (for example, water that is applied to covered produce for washing or cooling activities, and water that is applied to harvested crops to prevent dehydration before cooling), including when , and water that is used to make ice that directly contacts covered produce during or after harvest activities);
(3) Used to contact food contact surfaces , or to make ice that will contact food contact surfaces; and
(4) Used for washing hands during and after harvest activities.
(b) When you use agricultural water during growing activities for covered produce (other than sprouts) using a direct water application method, the following criteria apply (unless you establish and use alternative criteria Untreated ground water. You must test any untreated ground water used as sprout irrigation water or for harvesting, packing, or holding covered produce to determine if it meets the microbial quality criterion in paragraph (a) of this section, as follows:
49):(1) You must initially test the microbial quality of each source of the untreated ground water at least four times during the growing season or over a period of 1 year, using a minimum total of four samples collected aseptically and representative of the intended use(s). Based on these results, you must determine whether the water can be used for the intended purpose(s), in accordance with § 112.
(2) A statistical threshold value (STV) of your agricultural water samples of 410 or less CFU of generic E. coli per 100 mL of water (STV is a measure of variability of your water quality distribution, derived as a model-based calculation approximating the 90th percentile using the lognormal distribution)(1) A geometric mean (GM) of your agricultural water samples of 126 or less colony forming units (CFU) of generic E. coli per 100 mL of water (GM is a measure of the central tendency of your water quality distribution); and
(2) If your four initial sample results meet the microbial quality criterion, you may test once annually thereafter, using a minimum of one sample collected aseptically and representative of the intended use(s).
(3) If any annual test fails to meet the microbial quality criterion, you must:
(i) Immediately discontinue the use(s) and meet the requirements of § 112.45(a) before resuming such use(s); and
(ii) Resume testing at least four times per growing season or year, as required under paragraph (b)(1) of this section, until all of the survey results collected in a year meet the microbial quality criterion.
(4) You may meet these testing requirements using test results or data collected by a third party, as provided in § 112.47.
(c) Exemptions. There is no requirement to test agricultural water that is used as sprout irrigation water or for harvesting, packing, or holding covered produce when:
(1) You receive the water from a public water system, as defined under the Safe Drinking Water Act (SDWA) regulations, 40 CFR part 141, that furnishes water that meets the microbial requirements under those regulations or under the regulations of a State (as defined in 40 CFR 141.2) approved to administer the SDWA public water supply program, and you have public water system results or certificates of compliance that demonstrate that the water meets those microbial requirements;
(2) You receive the water from a public water supply that furnishes water that meets the microbial quality criterion in paragraph (a) of this section, and you have public water system results or certificates of compliance that demonstrate that the water meets that requirement; or
(3) You treat water in accordance with the requirements of § 112.46.
(d) Additional management and monitoring practices.
(1) You must manage water used in harvesting, packing, and holding covered produce as necessary, including by establishing and following water change schedules for non-single-pass water (including recirculated water or reused water) to maintain its safe and adequate sanitary quality and minimize the potential for contamination of covered produce and food contact surfaces with known or reasonably foreseeable hazards (for example, hazards that may be introduced into the water from soil adhering to the covered produce).
(2) You must visually monitor the quality of water that you use during harvesting, packing, and holding activities for covered produce (for example, water used for washing covered produce in dump tanks, flumes, or wash tanks; and water used for cooling covered produce in hydrocoolers) for buildup of organic material (such as soil and plant debris).
(3) You must maintain and monitor the temperature of water that you use during harvesting, packing, and holding activities for covered produce at a temperature that is appropriate for the commodity and operation (considering the time and depth of submersion) and that is adequate to minimize the potential for infiltration of microorganisms of public health significance into covered produce.