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Federal Register / Vol. 86, No. 231 / Monday, December 6, 2021 / Proposed Rules
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1. Agricultural Water Assessment We propose to add a new definition of agricultural water assessment. As proposed, the term agricultural water assessment would be defined to mean an evaluation, conducted by a covered farm, of its agricultural water system used during growing activities for nonsprout covered produce, its agricultural water practices for such pre-harvest water, crop characteristics, environmental conditions, and other relevant factors including test results, where appropriate 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 corrective or mitigation measures for pre-harvest agricultural water are necessary to reduce the potential for contamination with such known or reasonably foreseeable hazards.
A definition of agricultural water assessment is needed to provide clarity, particularly in light of widespread use of similar terms that may have different meanings than the definition in this proposal. For example, the definition of agricultural water assessment we are proposing includes crop characteristics. By contrast, an ag water system assessment, as described by Western Growers Ref. 31, or a sanitary survey, as described by some stakeholders Ref. 3 do not consider this factor.
Crop characteristics also are a factor mentioned in the QAR Ref. 11. Crop characteristics have long been identified as a factor influencing the potential for water to contaminate produce. In the 1998 FDA Good Agricultural Practices Guide, for example, we explained that produce that has a large surface area such as leafy vegetables and produce with topographical features such as rough surfaces that foster attachment or entrapment may be at greater risk from pathogens, if they are present, especially if contact with agricultural water occurs close to harvest or during post-harvest handling Ref. 32. In light of the role that crop characteristics may play in contamination of produce, this would be an important component of an agricultural water assessment under this proposed rule.
2. Agricultural Water System We are proposing to define the term agricultural water system to provide greater clarity and increase consistency in the interpretation of what comprises an agricultural water system that a covered farm must inspect under 112.42a, to the extent that the system
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is under the farms control. In this proposed rule, an 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.
We developed the proposed definition of agricultural water system based on elements listed in 112.42a of the produce safety regulation, which provides that an agricultural water system includes water sources, water distribution systems, facilities, and equipment. We also incorporated language from the definition of water distribution system in 112.3 of the produce safety regulation, which describes a system for carrying water from its source to its point of use.
Additionally, we added examples of buildings or structures that may be part of a water distribution systemfor example, a well house, pump station, or shedto clarify the meaning of facilities as a component of an agricultural water system. We expect that adding a definition that clearly describes the scope of agricultural water system will help covered farms ensure that inspections and maintenance activities under proposed 112.42 would be of adequate scope and rigor.
We are seeking comment on the definitions of agricultural water assessment and agricultural water system in proposed 112.3.
D. Applicability Proposed 112.40
We are proposing to add new 112.40
to summarize the requirements that would apply to a covered farm. The provision would include an explanatory table presenting the following:
If you are a covered farm using preharvest agricultural water in growing covered produce, other than sprouts:
You must meet the requirements of 112.41 water quality standard, 112.42 inspections and maintenance of agricultural water systems, 112.43
agricultural water assessment, and 112.50 records and As applicable, you must meet the requirements of 112.45 measures, 112.47 who may test, and 112.151
methods. Any water treatment must be in accordance with 112.46.
If you are a covered farm using agricultural water for sprout irrigation:
You must meet the requirements of 112.41 water quality standard, 112.42 inspections and maintenance of agricultural water systems, 112.44a
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microbial quality criterion, unless excepted under 112.44c, and 112.50
records and As applicable, you also must meet the requirements of 112.44b untreated ground water testing, 112.44c exceptions from testing requirement, 112.45 measures, 112.47
who may test, and 112.151 test methods. Any water treatment must be in accordance with 112.46.
If you are a covered farm using agricultural water for harvesting, packing, or holding covered produce:
You must meet the requirements of 112.41 water quality standard, 112.42 inspections and maintenance of agricultural water systems, 112.44a microbial quality criterion, unless excepted under 112.44c, 112.44e additional management and monitoring practices, and 112.50 records and As applicable, you also must meet the requirements of 112.44b testing untreated ground water, 112.44c exceptions from testing requirement, 112.45 measures, 112.47 who may test, and 112.151 test methods. Any water treatment must be in accordance with 112.46.
E. Pre-Harvest Agricultural Water Assessments Proposed 112.43
Proposed 112.43 would require covered farms to conduct agricultural water assessments for the pre-harvest agricultural water for non-sprout covered produce. The proposed assessments would be conducted annually and more frequently as needed, documented in writing, and used for hazard identification and risk management decision-making purposes in lieu of the pre-harvest microbial water quality criteria and testing requirements in 112.44b and 112.46b of the produce safety regulation.
Covered farms would be exempt from the proposed agricultural water assessment requirement if they can demonstrate that their pre-harvest agricultural water for non-sprout covered produce:
Meets the requirements for harvest and post-harvest agricultural water proposed 112.44a and, as applicable, 112.44b, 112.47, and 112.151;
Meets the requirements for water from a Public Water System or public water supply proposed 112.44c; or Is treated in accordance with 112.46.
Unless exempt as described above, covered farms using pre-harvest agricultural water for non-sprout covered produce would evaluate their pre-harvest agricultural water systems, agricultural water practices, crop
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