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Federal Register / Vol. 86, No. 231 / Monday, December 6, 2021 / Proposed Rules may have led to contamination of the onions.
While our investigation did not occur during any harvesting activities, visual observations of the implicated red onion growing fields suggested several plausible opportunities for contamination including irrigation water, sheep grazing on adjacent land, as well as signs of animal intrusion, such as scat and large flocks of birds which may spread contamination.
Similarly, the investigation did not occur while packing activities were ongoing. However, visual observations and records review of packing house practices confirmed numerous opportunities for spread of foodborne pathogens such as Salmonella, including signs of animal and pest intrusion as well as food contact surfaces which had not been inspected, maintained, cleaned, or sanitized as frequently as necessary to protect against the contamination of produce.
While these outbreaks serve as recent examples of the role that water quality may play in produce safety, the potential for water to serve as a source or route of contamination in produce outbreaks has been a longstanding concern. For example, investigators identified several risk factors potentially related to a 2006 outbreak of E. coli O157:H7 associated with pre-packaged spinach, including the proximity of irrigation wells to surface water exposed to cattle and wildlife feces Ref. 19. The outbreak strain was detected in river water, cattle feces, wild pig feces, and soil samples collected from one of the investigated farms. The outbreak strain also was detected in two surface water samples analyzed as part of a separate study Ref. 20. See also section VI.E.
During investigation of a 2006
outbreak of E. coli O157:H7 associated with iceberg lettuce, the outbreak strain was detected in water samples collected close to a suspect growing field and from a nearby dairy Ref. 20.
Investigators found that the dairy wastewater blending and distribution system used by the farm had inadequate backflow protection and presented a possible route for conveyance of contaminated water to fields adjacent to the suspect lettuce growing fields, as described more fully in section VI.E.
Investigators also found the outbreak strain of Salmonella Saintpaul in agricultural water during investigation of a 2008 produce outbreak Ref. 22.
Persistent pathogens in agricultural water may serve as a recurring source of contamination. For example, two multistate outbreaks linked to tomatoes in 2002 and 2005 were caused by the same strain of Salmonella Newport,
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which was also detected in ponds used to irrigate tomato growing fields. Ref.
23. On at least one of the farms investigated, pond water was used to dilute pesticides sprayed on tomato plants. Investigators isolated the outbreak strain in irrigation ponds through sampling conducted 2 years apart, suggesting persistent contamination Ref. 23.
FDA outbreak investigations underscore the importance of preharvest agricultural water quality and the potential impacts of adjacent and nearby land uses on agricultural water, which can serve as a route of contamination of produce. This NPRM
is designed to address those concerns by proposing to require covered farms to conduct comprehensive pre-harvest agricultural water assessments and implement mitigation measures that minimize the risk of serious adverse health consequences or death, including those reasonably necessary to prevent the introduction of known or reasonably foreseeable biological hazards into or onto produce, and provide reasonable assurances that the produce is not adulterated on account of those hazards.
E. Recent Information on Relative Food Safety Risks of Produce FDA outlined the history of contamination associated with produce, predominantly during growing, harvesting, packing, and holding, during the rulemaking to establish the produce safety regulations in part 112. See. e.g., 78 FR 3504 at 3507, 80 FR 74354 at 74731.
Recent estimates by the Interagency Food Safety Analytics Collaboration IFSAC indicate that many foodborne illnesses are attributed to contaminated produce. A tri-agency group created by the CDC, FDA, and the U.S. Department of Agricultures USDA Food Safety and Inspection Service, IFSAC
developed a method to estimate the sources of foodborne illness using outbreak data for four priority pathogens: Salmonella, E. coli O157, Listeria monocytogenes, and Campylobacter Ref. 24.
In its 2019 Report Ref. 25, IFSAC
estimated that produce commodities cause 65 percent of foodborne E. coli O157 illnesses and over 40 percent of foodborne Salmonella illnesses. IFSAC
attributed approximately 56 percent of E. coli O157 illnesses to vegetable row crops such as leafy greens and approximately 9 percent to fruits and other types of produce. IFSAC
concluded that Salmonella illnesses came from a broad variety of foods, including more than 13 percent from fruits and more than 12 percent from
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seeded vegetables such as tomatoes and cucumbers Ref. 25.
IFSAC derived estimates for 2018, its most recent reporting year, based on outbreaks that occurred from 1998
through 2018, relying most heavily on the most recent 5 years of outbreak data Ref. 25. The analysis included 1,459
foodborne disease outbreaks, for which each confirmed or suspected implicated food fell into a single food category.
Foods were categorized using a scheme IFSAC created to classify foods into 17
categories that closely align with the U.S. food regulatory agencies classification needs Ref. 26.
More recently, FDA tentatively identified certain FDA-regulated foods including certain produce commodities for inclusion on a Food Traceability List Ref. 27 for which additional traceability recordkeeping requirements will be required, in accordance with FSMA section 204d2A.3
To determine which foods should be included on the Food Traceability List Ref. 27, FDA developed a risk-ranking model for food tracing the Model, based on the following factors that Congress identified in the statute:
Known safety risks of a particular food, including the history and severity of foodborne illness outbreaks attributed to such food, taking into consideration foodborne illness data collected by the CDC;
Likelihood that a particular food has a high potential risk for microbiological or chemical contamination or would support the growth of pathogenic microorganisms due to the nature of the food or the processes used to produce the food;
Point in the manufacturing process of the food where contamination is most likely to occur;
Likelihood of contamination and steps taken during the manufacturing process to reduce the possibility of contamination;
Likelihood that consuming a particular food will result in a foodborne illness due to contamination of the food; and Likely or known severity, including health and economic impacts, of a foodborne illness attributed to a particular food.
The Model was designed to be flexible and to consider a wide range of contaminants in FDA-regulated human 3 In the Federal Register of September 23, 2020
85 FR 59984, FDA published a proposed rule to establish additional traceability recordkeeping requirements for entities that manufacture, process, pack, or hold foods the Agency has designated as high risk in accordance with FSMA section 204d2A.

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