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Federal Register / Vol. 86, No. 231 / Monday, December 6, 2021 / Proposed Rules 67. Theofel, C.G., T.R. Williams, E.
Gutierrez, et al., Microorganisms Move a Short Distance Into an Almond Orchard From an Adjacent Upwind Poultry Operation. Applied and Environmental Microbiology 86, no. 15
2020: 113.
68. Muirhead, R.W., R.J. Davies-Colley, A.M.
Donnison, et al., Faecal Bacteria Yields in Artificial Flood Events: Quantifying In-Stream Stores. Water Research 38
2004: 12151224.
69. Allende, I., I. Castro-Ibanez, R. Lindqvist, et al., Quantitative Contamination Assessment of Escherichia coli in Baby Spinach Primary Production in Spain:
Effects of Weather Conditions and Agricultural Practices. International Journal of Food Microbiology 257 2017:
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70. USDA, Harmonized GAP Plus+
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71. Blackburn, T., Memorandum: Revised Protocol Review for Reg. No. 94151PA7;
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1044629. April 29, 2020. EPA.
Available at: https www.fda.gov/media/
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72. EPA, Recreational Water Quality Criteria, 2012. Available at: https
www.epa.gov/sites/production/files/
2015-10/documents/rwqc2012.pdf.
73. EPA, 2017 Five-Year Review of the 2012 Recreational Water Quality Criteria, May 2018. Available at:
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files/2018-05/documents/2017-5yearreview-rwqc.pdf.
74. Bowers, J., Memorandum to the File Minimum Sample Size for Rolling Calculation of Microbial Water Quality Profile of Surface Water Sources to be Used for Agricultural Water. September 24, 2015. FDA.
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Final%20Release%208.2.17.pdf.
76. Chhetri, V.S., K. Fontenot, R. Strahan, et al., Effect of Surrounding Vegetation on Microbial Survival or Die-Off on Watermelon Surface in an Agriculture Setting. Journal of Food Safety 38, no.
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77. Chhetri, V.S., K. Fontenot, R. Strahan, et al., Attachment Strength and OnFarm Die-Off Rate of Escherichia coli on Watermelon Surfaces. PLOS One 14, no.
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79. FDA, Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Relating to Agricultural Water, Preliminary Regulatory Impact Analysis,
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List of Subjects in 21 CFR Part 112
Dietary foods, Food grades and standards, Foods, Fruits, Incorporation by reference, Packaging and containers, Reporting and recordkeeping requirements, Safety, Vegetables.
Therefore, under the Federal Food, Drug, and Cosmetic Act, and under authority delegated to the Commissioner of Food and Drugs, we propose that 21
CFR part 112 be amended as follows:
PART 112STANDARDS FOR THE
GROWING, HARVESTING, PACKING, AND HOLDING OF PRODUCE FOR
HUMAN CONSUMPTION
1. The authority citation for part 112
continues to read as follows:

Authority: 21 U.S.C. 321, 331, 342, 350h, 371; 42 U.S.C. 243, 264, 271.

2. Amend 112.3 by adding in alphabetical order the definitions for Agricultural water assessment and Agricultural water system to read as follows:

112.3

What definitions apply to this part?

Agricultural water assessment means an evaluation of an agricultural water system, agricultural water practices, crop characteristics, environmental conditions, and other relevant factors including test results, where appropriate related to growing activities for covered produce other than sprouts to:
1 Identify any conditions that are reasonably likely to introduce known or reasonably foreseeable hazards into or onto covered produce or food contact surfaces; and 2 Determine whether measures are reasonably necessary to reduce the
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potential for contamination of covered produce or food contact surfaces with such known or reasonably foreseeable hazards.
Agricultural water system means a source of agricultural water, the water distribution system, any building or structure that is part of the water distribution system such as a well house, pump station, or shed, and any equipment used for application of agricultural water to covered produce during growing, harvesting, packing, or holding activities.

3. In 112.12, revise paragraph a to read as follows:
112.12 Are there any alternatives to the requirements established in this part?

a You may establish alternatives to certain specific requirements of subpart E of this part, as specified in 112.45b, provided that you satisfy the requirements of paragraphs b and c of this section.

4. Revise subpart E to read as follows:
Subpart EAgricultural Water Sec.
112.40 What requirements of this subpart apply to my covered farm?
112.41 What requirements apply to the quality of agricultural water?
112.42 What requirements apply to inspecting and maintaining my agricultural water systems?
112.43 What requirements apply to assessing agricultural water used in growing covered produce other than sprouts?
112.44 What requirements apply to agricultural water used as sprout irrigation water and in harvesting, packing, and holding covered produce?
112.45 What measures must I take for agricultural water to reduce the potential for contamination of covered produce or food contact surfaces with known or reasonably foreseeable hazards?
112.46 What requirements apply to treating agricultural water?
112.47 Who must perform the tests required under this subpart?
112.48112.49 Reserved 112.50 Under this subpart, what requirements apply regarding records?

Subpart EAgricultural Water 112.40 What requirements of this subpart apply to my covered farm?

This subpart applies to agricultural water used for, or intended for use in, growing, harvesting, packing, or holding covered produce. If you are using agricultural water for a covered activity listed in the first column, then you must meet the requirements in the second column. You also must meet the
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