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Federal Register / Vol. 86, No. 231 / Monday, December 6, 2021 / Proposed Rules
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focus on identifying possible causes, contributing factors, and measures to prevent reoccurrence of a similar event.
We assess potential sources of microbial hazards not only in growing fields identified through traceback investigation of contaminated product but also potential sources in the larger growing area within the geographic area of interest. This commonly includes assessment of water sources and distribution systems used by growers during growing, harvesting, or postharvesting activities. These investigations allow us to consider how a pathogen may be transported from a source in the surrounding area to the field and ultimately the product. FDAs investigations underscore decades of scientific research that pre-harvest agricultural water is a potential contributing factor in the introduction and spread of contamination to produce.
See, e.g., the QAR Ref. 11, 2013
proposed rule 78 FR 3504 at 35593563, 2015 final rule 80 FR at 74354 at 74441
74446, and the discussion in section III.E. The proposed rule reflects new information and findings on the potential routes of microbial contamination of pre-harvest agricultural water from investigations of several recent outbreaks linked to consumption of produce.
1. Spring 2018 E. Coli O157:H7
Outbreak Linked to Romaine Lettuce From the Yuma Growing Region In collaboration with the Centers for Disease Control and Prevention CDC
and State partners, FDA led an EA of the Yuma growing region associated with the spring 2018 E. coli O157:H7
outbreak linked to consumption of romaine lettuce. Investigators found the outbreak strain in water samples from three locations along a 3.5-mile stretch of an open irrigation canal adjacent to a Concentrated Animal Feeding Operation CAFO Ref. 12. One of these samples was collected immediately downstream from where shallow ground water is pumped into the irrigation canal Ref. 13. 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.
Although no obvious route of contamination was determined, the investigators identified onsite wells at the CAFO as a potential route of ground water contamination from the CAFO
Ref. 13.
The EA team also found Salmonella spp. and other Shiga toxin-producing E.
coli STEC strains in water samples collected during the investigation of the
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Yuma growing region, including Salmonella Agona, S. Typhimurium, and E. coli O178:H19, O6:H34, O181:H49, O153:H25, and O157:H7
which did not match the outbreak strain Ref. 13.
The findings of the Yuma EA led FDA
to issue a letter to State partners and the leafy greens industry that highlighted, in part, the importance of assessing and mitigating risks related to land uses near or adjacent to growing fields that may contaminate agricultural water or leafy greens crops directly such as nearby cattle operations, dairy farms, manure, and composting facilities Ref. 14.
2. Fall 2018 E. Coli O157:H7 Outbreak Linked to Romaine Lettuce From California Following a romaine lettuce outbreak in Fall 2018, FDA led an EA, in collaboration with CDC and the States, that found the outbreak strain in the sediment of an on-farm water reservoir in Santa Barbara County, CA Ref. 15.
We concluded that the water from the on-farm water reservoir where the outbreak strain was found most likely led to contamination of some romaine lettuce consumed during this outbreak.
Investigators noted extensive wild animal activity in the area; adjacent land use, including the use of soil amendments; and animal grazing on nearby land by cattle and horses. They were unable to determine, though, how the outbreak strain of E. coli O157:H7
was introduced into this on-farm water reservoir.
3. Fall 2019 E. Coli O157:H7 Outbreaks Linked to Romaine Lettuce From late 2019 to early 2020, FDA
and state and federal partners conducted multiple on-farm investigations of contamination of romaine lettuce with several strains of E. coli O157:H7 that resulted in three outbreaks of foodborne illness beginning in September and ending in December 2019 Ref. 16. These outbreaks, which were all traced back to farms located in the Salinas, CA, growing region, collectively resulted in 188 people falling ill. As a result of sampling during the investigations, one of the outbreak strains of E. coli O157:H7 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. Other STEC
strains, while not linked to the 2019
outbreaks, were found in closer proximity to where romaine lettuce crops were grown, including two samples from a border area of a farm immediately next to cattle grazing land
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in the hills above leafy greens fields and two samples from on-farm water drainage basins. Of note, the number of cattle we observed on nearby lands during the 2019 investigations was far lower than the volume of what is considered a large concentrated animal feeding operation.
4. Fall 2020 E. Coli O157:H7 Outbreak Linked to Leafy Greens From August to December 2020, FDA
and multiple state and federal partners investigated a multi-state E. coli O157:H7 outbreak associated with the consumption of leafy greens Ref. 17.
The outbreak, which caused 40 reported illnesses in the U.S., was linked via genetic sequencing and geography to the 2019 outbreak Ref. 16 and the 2018
leafy greens outbreak in which the outbreak strain was detected in the sediment of an on-farm water reservoir Ref. 15. The investigation identified the outbreak strain in a cattle feces composite sample taken alongside a road approximately 1.3 miles upslope from a produce farm with multiple fields tied to the outbreaks by the traceback investigations. Three water samples tested positive for other STEC
strains not linked to the outbreak Ref.
17.
5. Summer 2020 Salmonella Newport Outbreak Linked to Red Onions From June to October 2020, federal and state agencies investigated a Salmonella Newport foodborne illness outbreak associated with consumption of red onions from the Southern San Joaquin Valley and Imperial Valley in California Ref. 18. The outbreak, which caused 1,127 reported domestic illnesses and 515 reported Canadian cases, was the largest Salmonella outbreak in over a decade. The FDA, alongside state and federal partners, investigated the outbreak to identify potential contributing factors that may have led to red onion contamination with Salmonella Newport. While the outbreak strain specific whole genome sequence WGS was not identified in any of the nearly 2,000 subsamples tested, a total of 11 subsamples 10
water and 1 sediment collected near one of the growing fields identified in the traceback were positive for Salmonella Newport, representing a total of three different genotypical strains unique WGS patterns.
Although a conclusive root cause could not be identified, several potential contributing factors to the 2020 red onion outbreak were identified, including a leading hypothesis that contaminated irrigation water used in a growing field in Holtville, California,
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