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Federal Register / Vol. 86, No. 231 / Monday, December 6, 2021 / Proposed Rules
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as if adjacent and nearby land users are not willing to share information, farms should consider accounting for the increased likelihood of hazard introduction to the water systems from such land uses when making decisions around the safe use of their pre-harvest agricultural water.
We note that in the United States, the use and disposal of treated sewage sludge biosolids, including domestic septage, are regulated under 40 CFR part 503. Subpart D of the Part 503
regulation protects public health and the environment through requirements designed to reduce the potential for contact with the disease-bearing microorganisms pathogens in sewage sludge and domestic septage applied to the land or placed on a surface disposal site Ref. 54.
8. Agricultural Water Practices a. Time to harvest. In evaluating any conditions that are reasonably likely to introduce known or reasonably foreseeable hazards into or onto covered produce other than sprouts or food contact surfaces under proposed 112.43a2, a covered farm would consider the interval between the last time pre-harvest agricultural water was applied to the covered produce and the date of harvest. For example, a covered farm that uses furrow irrigation and crop protection sprays for its non-sprout covered produce would consider the timing of both types of applications.
As explained in the QAR Ref. 11, the timing of water application is an important factor in determining the likelihood of contamination, because pathogens die off over time on the surface of produce. Generally, bacteria or pathogens in water that is applied early in the growing cycle are subject to die-off from several environmental forces, such as UV exposure, temperature, humidity, and the presence of competitive organisms Ref.
55. In contrast, pathogens present in agricultural water that is applied shortly before harvest may not be exposed to the same environmental conditions for sufficient time to provide a similar magnitude of die-off Ref. 11. For more discussion of microbial die off rates, see section VI.F.
b. Method of application. Proposed 112.43a2 also would require a covered farm to evaluate the methods by which pre-harvest agricultural water is applied to non-sprout covered produce during growing activities.
The most frequently used irrigation methods include overhead sprinkler or spray, surface and subsurface drip, furrow, flood, and seep irrigation Ref.
56. The QAR Ref. 11 explains that
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different irrigation methods present different risks based on the extent to which the irrigation water is directly applied to the harvestable portion of the crop.7 Overhead sprinkler irrigation increases the risk of contamination as compared with furrow and subsurface drip irrigation Ref. 57. The location of the harvestable portion of a plant in relation to irrigation water plays a significant role in contamination in studies of lettuce, cantaloupe, and bell pepper Ref. 58. The likelihood of produce contamination may be reduced if irrigation water is delivered by subsurface drip irrigation as compared to using the same water to irrigate by overhead spray Refs. 33 and 59.
Pathogenic E. coli has been recovered from lettuce tissue after surface irrigation and spray irrigation with suspensions of E. coli O157:H7; the level of contamination was lower from drip than from sprinkler irrigation Ref.
60. The lettuce leaves remained contaminated with E. coli O157:H7 even after washing, indicating that surface and spray irrigation of food crops with water of unknown microbiological quality may introduce risk.
9. Crop Characteristics Under proposed 112.43a3, a covered farm would be required to evaluate whether the covered produce has any characteristics that make it vulnerable to contamination, such as whether it is susceptible to surface adhesion of bacteria or internalization of microbial hazards. This includes increased susceptibility to internalization of hazards due to physical damage from weather events such as freezing of an epidermal peel and hail damage or biological damage such as phytopathogens.
The QAR Ref. 11 concluded that:
The physical characteristics of the crop is one of the likely factors contributing to the likelihood of contamination, exposure, and illness.
In particular, the growth characteristics e.g., near to the ground and surface properties e.g., porosity affect the probability and degree of contamination.
No physical characteristics were identified that would be protective against contamination.
As discussed in the QAR Ref. 11, although some physical characteristics of produce commodities e.g., netted rind of cantaloupe or large, rough surface area of some leafy greens may 7 Irrigation water as described in the QAR is broader than the definition of agricultural water in 112.3 of the produce safety regulations that would apply under this proposed rule.

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increase the likelihood of contaminants being trapped and surviving long enough to cause illness, physical characteristics that could alter the potential for contamination e.g., smooth surfaces do not always appear to do so. For example, while honeydew melon has a smooth rind, seemingly making it less likely to harbor pathogens, it has been associated with outbreaks. Some crops are more susceptible to the persistence and growth of human pathogens, including co-infections with plant pathogens Ref.
61. See also, the Codex Alimentarius Commission, Code of Hygienic Practice for Fresh Fruits and Vegetables CXC
532003 the Codex Code section 3.2.1.1.1 Ref. 62. We anticipate that as more information is learned about how commodity characteristics can impact produce safety, covered farms would use this information to further inform their pre-harvest agricultural water assessments.
10. Environmental Conditions Proposed 112.43a4 would require a covered farm to evaluate the potential impacts of weather conditions, including seasonal rainfall patterns, the frequency of extreme weather events such as heavy winds or rain, and other relevant agro-ecological conditions such as temperature, sunlight UV
exposure. As described in the QAR
Ref. 11, survival of pathogens in the environment is influenced by complex physical, chemical, and biological interactions. Some pathogens are widely distributed and naturally capable of long-term survival under a wide range of natural conditions e.g., Listeria monocytogenes while the distribution of others e.g., Salmonella, E. coli H7:O157 may be more narrowly defined by temperature, sunlight UV
exposure, moisture level, pH, available nutrients and related factors, each of which may limit survival to some degree.
Changes in temperature and seasonality are expected to impact persistence of foodborne pathogens in the environment Ref. 56. In general, the survival of pathogens in water sources decreases with increasing temperatures Ref. 56. For example, in mid-latitude areas, it is thought that the overall survival of foodborne pathogens in soils, manure-amended soils and surface waters is likely to decrease with increasing temperatures Ref. 63.
However, exceptions may be observed in certain geographic areas and/or on certain farm environments due to factors that confound the effects of temperature, such as nutrient levels and humidity Refs. 63 and 64.

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