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Federal Register / Vol. 86, No. 231 / Monday, December 6, 2021 / Proposed Rules
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contamination to surface and ground water through runoff and through direct access by animals to waterways Refs.
4346. Strong associations have been reported with E. coli O157:H7
originating from upstream pastures with unrestricted access to waterways Ref.
47. Indicators of fecal contamination in water systems have been reported to be related to various types of livestock operationsfor swine Ref. 48, poultry Ref. 49, and cattle Ref. 50. Animals from densely populated farms or farms with a high population of immature animals have an increased likelihood of harboring various pathogens Ref. 51.
Runoff has the potential to increase the number of pathogens in the water column if its origins include human, livestock or wildlife feces, because it has the potential to increase the amount of suspended sediments which are likely to harbor pathogens Ref. 43.
c. Animal activities as possible contributing factors in outbreaks. FDA
investigators have identified animal operations of various sizes as possible contributing factors in several produce outbreaks.6 In particular, animal operations in proximity to, or upstream of, an agricultural water source or distribution system may pose a significant risk in some circumstances.
Topography is another important factor to consider in evaluating whether adjacent or nearby lands may serve as a source of contamination. For example, animal grazing was identified as a possible contributing factor in investigations of three 2019 E. coli O157:H7 outbreaks linked to romaine lettuce, in which one of the outbreak strains was detected in a fecal-soil composite sample taken from a cattle grate on public land less than 2 miles upslope from a farm with multiple fields tied to the outbreaks by traceback investigations Ref. 16. Additional STEC strains were found in two samples collected from cattle grazing land in the hills above leafy greens fields identified by traceback evidence, though neither of the strains were linked to human illness. During collection of these samples, investigators observed cattle grazing on hills above the identified leafy greens fields, but far fewer than 6 In many instances, these operations did not meet the EPAs definition of large CAFO. Under 40
CFR 122.23b, a CAFO is a lot or facility other than an aquatic animal production facility where animals have been, are, or will be stabled or confined and fed or maintained for a total of 45
days or more in any 12-month period; and crops, vegetation, forage growth, or post-harvest residues are not sustained in the normal growing season over any portion of the lot or facility. A large CAFO
stables or confines 1,000 or more cattle other than mature dairy cows or veal calves; 700 dairy cows;
or 500 horses, for example.

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would be present on a large CAFO.
Investigators estimated that each of these adjacent grazing lands had between 50 and 150 head of cattle.
Cattle and horse grazing on adjacent lands were identified as potential contributing factors in an investigation of a Fall 2018 E. coli O157:H7 outbreak linked to romaine lettuce, in which the outbreak strain was detected in a sediment sample from an on-farm water reservoir Ref. 15. Although investigators were not able to determine how the contamination was introduced into the water reservoir, they identified several risk factors, including between 250 and 500 cattle grazing on land adjacent to romaine lettuce production on a farm identified by traceback investigation. This was a notable observation given that FDAs outbreak investigations have repeatedly demonstrated the heightened risk of contamination associated with grazing activities near produce growing areas and agricultural water sources, unless appropriate measures are taken to mitigate the risks.
In the investigation of the Spring 2018
E. coli O157:H7 outbreak, a large cattle CAFO was located adjacent to the 3.5mile stretch of irrigation canal where the outbreak strain was found Ref. 12.
One of these samples was collected immediately downstream from where shallow ground water is pumped into the irrigation canal. The EA
investigators also found an area where ground water may have been seeping directly into unlined sections of the canal within the 3.5-mile stretch where the outbreak strain was detected.
Investigators identified on-farm wells at the CAFO as a possible route of ground water contamination Ref. 13.
Nearby cattle feeding operations also were identified as a possible source of contamination during an investigation of a 2013 E. coli O157:H7 outbreak, with 33 reported illnesses, linked to ready-toeat salads Ref. 52. Based on traceback information, investigators conducted on-farm sampling and investigation. Of the ten soil and water samples collected, five were positive for E. coli O157:H7
but not the outbreak strain.
Feral swine and cattle were identified as possible vectors for surface water contamination in an investigation of a 2006 E. coli O157:H7 outbreak traced to bagged spinach Ref. 20 The outbreak strain was detected in feral swine feces, cattle feces, surface water, and river sediment samples collected from a ranch with cattle pastures located adjacent to a leased field where spinach implicated by traceback was grown.
Samples were matched by pulsed-field gel electrophoresis and multilocus
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variable number tandem repeat analysis Ref. 20. Although investigators made no definitive determination on the route of contamination, they concluded that fecal loading of surface waterways by livestock and wildlife with subsequent contamination of wells used for irrigation was one possible route of transmission to plants in the field Ref.
20.
Under proposed 112.43a1, a covered farm would evaluate animal activity on adjacent and nearby lands, such as grazing or commercial animal operations of any size, to identify any conditions that may introduce a known or reasonably foreseeable hazard into a source or distribution system used for pre-harvest agricultural water for non-sprout covered produce. Animal activities that may introduce contamination into sources or distribution systems include, but are not limited to, livestock feeding operations of any size, dairy production, poultry production, barnyards, or significant wildlife intrusion or wildlife habitat. In evaluating adjacent and nearby land uses under proposed 112.43a1, a covered farm could, for example, consider the effects of any fencing, containment, or other measures employed to prevent animal access to water sources or distribution systems, or earthen diversion berms, ditches, or other barriers to help minimize the influence of runoff on sources and distribution systems. Information on adjacent or nearby land uses could be acquired through visual observations, discussions with local extension agents or associations, online resources such as mapping tools, or other means that are appropriate to the circumstances.
The factors a covered farm might consider in evaluating the likelihood of hazards being introduced from adjacent or nearby lands may depend on the specific animal activity in question. For example, if a covered farm draws water from a stream with upstream grazing and pasturing of animals, the covered farm might consider the proximity of the grazing and pasture areas to the stream, whether the animals have direct access to the stream for loafing and drinking, and whether runoff from the grazed and pastured lands is likely to be introduced into the stream.
While a covered farm might consider similar factors to these if it draws water from a canal with an upstream dairy operation, there may be additional factors to consider when evaluating the likelihood of introduction of hazards, such as whether the operation has any best management practices in place such as to prevent overflow of manure lagoons, the locations of waste storage
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