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Federal Register / Vol. 86, No. 231 / Monday, December 6, 2021 / Proposed Rules agricultural water would need to consider the potential for known or reasonably foreseeable hazards to be introduced by the prior use of the water.
This would include consideration of impacts relating to the nature of the prior use. We note that the requirements for agricultural water quality in proposed 112.41 and 112.43 apply regardless of the source or type of water used as agricultural water. If finalized, a covered farm would determine the appropriate use of the recycled water in light of the conditions and practices on the farm by assessment as required under 112.43, taking into account the standard in 112.41 that all agricultural water must be safe and of adequate sanitary quality for its intended use.
We anticipate that some covered farms would treat the recycled water themselves or through a third party acting on their behalf in accordance with the proposed treatment requirements. Proposed 112.46 would require the treatment method to be effective and delivered in a manner to ensure that the treated water is consistently safe and of adequate sanitary quality for its intended uses.
If finalized as proposed, the treated water would be monitored using an adequate method and frequency to ensure that it is consistently safe and of adequate sanitary quality for its intended uses.
We seek comment on the types of water reuse that covered farms might use for pre-harvest agricultural water.
We also seek comment from interested parties on providing greater specificity on testing for water reuse, such as by setting quantitative thresholds in the final rule, or by providing testing recommendations in guidance, for recycled water applied during growing activities for covered produce other than sprouts, consistent with our mandate to establish science-based minimum standards for agricultural water that are reasonably necessary to minimize the risk of serious adverse health consequences or death from the use of, or exposure to, covered produce, including those reasonably necessary to prevent the introduction of known or reasonably foreseeable hazards into covered produce, and to provide reasonable assurances that the produce is not adulterated under section 402 of the FD&C Act.
a. Animal impacts. Under proposed 112.43a1, a covered farm would consider the potential for hazards to be introduced into its pre-harvest agricultural water sources or distribution systems from animals, including grazing animals, working
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animals, and wild animal intrusion on the farm.
As discussed in the QAR Ref. 11, both wild and domesticated animals may be a source of human pathogens, including animals that only sporadically show symptoms Ref. 39 or that may be asymptomatic shedders Refs. 40 and 41. Animal waste has been shown to harbor many bacterial pathogensfor example, the predominant source of E.
coli O157:H7 in animal feces is cattle, and the predominant source of Salmonella in animal feces is poultry Ref. 11. The QAR Ref. 11 identifies other domesticated animals including sheep, goats, and swine and wild animals can carry human pathogens as well, such as pathogenic E. coli in deer, feral swine, pigeons, and seagulls, and Salmonella in rodents and wild birds.
FDA acknowledges the longstanding co-location of animals and plant food production systems in agriculture. This proposed rule would not prohibit the presence of animals such as grazing animals or working animals on a covered farm, nor would it require the destruction of wildlife habitat or the clearing of farm borders. Rather, the proposed rule would require a covered farm to evaluate and take measures to prevent the introduction of known or reasonably foreseeable hazards into or onto non-sprout covered produce or food contact surfaces by pre-harvest agricultural water.
Proposed 112.43a1 is intended to provide a covered farm with information about animal impacts on its pre-harvest agricultural water systems and to facilitate measures as needed under proposed 112.45. Some covered farms will be aware of potential animal impacts from grazing animals, working animals, or animal intrusion through assessments done under subpart I
112.81112.84 of the produce safety regulationwhich, under certain circumstances, requires a covered farm to assess the relevant areas used for a covered activity for evidence of potential contamination of covered produce such as observation of significant quantities of animals, significant amounts of animal excreta, or significant crop destruction. See 80
FR 74354 at 7447874485. When determining the probability that animals will contaminate its covered produce under subpart I of the produce safety regulation, a covered farm may consider the presence of animal attractants such as water sources or standing water on or near the farm Ref. 42. Visual observations by a covered farm for purposes of 112.81112.83 could provide useful information for evaluating the degree of protection of a
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pre-harvest agricultural water system under proposed 112.43a1. For example, if a covered farm determines that there is a reasonable probability that wild animals will contaminate their crop, the covered farm must assess the relevant growing area for evidence of potential contamination in accordance with 112.83b1 of the produce safety regulation. The covered farm could consider findings from this assessmentfor example, whether significant amounts of animal excreta are observedwhen evaluating the likelihood of hazards being introduced into their pre-harvest agricultural water sources.
Additionally, a covered farm would be aware of potential animal impacts on agricultural water systems through inspections and maintenance performed on agricultural water sources and agricultural water systems it controls under proposed 112.42. For example, pooled water in close proximity to the crop may serve as an attractant for pests and other animals which may in turn introduce hazards into pooled water that may contaminate produce. See 80
FR 74354 at 74434.
b. Adjacent and nearby land uses.
Proposed 112.43a1 would require a covered farm to consider whether it is reasonably likely that known or reasonably foreseeable hazards would be introduced into agricultural water systems by activities conducted on lands adjacent to or nearby its sources or distribution systems for pre-harvest agricultural water for non-sprout covered produce.
By adjacent land, we are referring to land sharing a common border with the water source or distribution system.
By nearby land, we are referring to a broader category of land, including land that does not adjoin the water source or distribution system but has the potential to affect the covered farms agricultural water source or distribution system based on the lands location 80 FR
74354 at 74433.
Under proposed 112.43a1, covered farms would be required to consider the likelihood of introduction of known or reasonably foreseeable hazards related to animal activity on adjacent and nearby lands, for example:
Grazing on public or private lands;
Commercial animal feeding operations of any size; and Other animal activity, such as dairy production, poultry production, barnyards, and significant wildlife intrusion or habitat.
Animal activities on adjacent and nearby landsincluding grazing, livestock operations, and wildlife intrusionmay introduce
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