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Federal Register / Vol. 86, No. 231 / Monday, December 6, 2021 / Proposed Rules Airborne transmission may also result in contamination of the environment such as agricultural water and growing areasparticularly when dry, windy conditions are present Ref. 65. One study Ref. 66 found that E. coli was present in air samples from the edge of a beef cattle feedlot, indicating that airborne transfer of microorganisms can occur. Another study Ref. 67 found that E. coli was recovered from 20
percent of air samples from an almond orchard downwind from a poultry operation and from 0.48 percent of air samples from an almond orchard not located near an animal operation.
Increased levels of global dust activity due to desertification as well as increased wind speeds associated with storm systems may promote the dispersal and persistence of some microbial hazards in the environment, especially those that demonstrate higher levels of resistance to environmental conditions, such as spore-formers Ref.
63.
Precipitation and its effects e.g., discharge and flow rate, along with temperature, are common factors reported to affect the microbial quality of watersheds with agricultural land inputs. Seasonal changes in rainfall particularly heavy rainfall and flooding eventscan greatly affect surface water quality Refs. 33 and 62 and may result in sediments, which can serve as reservoirs for pathogens, being dispersed within the water column Ref.
68. One study Ref. 48 found that that as rainfall increases, populations of various indicators fecal coliforms, generic E. coli, Enterococcus increased;
moreover, swine-specific markers were detected more frequently in water samples in the 48 hours following a rainfall event greater than the mean.
Rainfall events are reported to result in enhanced loading of fecal pollutants from adjacent lands into water systems Ref. 63 and increased transport of pathogens onto growing fields Ref. 63.
Alternately, rainfall may also have a dilution effect on pathogens or indicator organisms that are already present in growing areas Ref. 63. Although more research is needed, the possibility of splash dispersal and internalization of pathogens may also become problematic during periods of rainfall Refs. 62 and 69, especially when increased levels of pathogens are transported to growing areas.

foreseeable hazards into or onto covered produce other than sprouts or food contact surfaces. Those relevant factors may include, for example, whether the covered farm elected to conduct testing under 112.43d to help inform its agricultural water assessment, as discussed below.

11. Other Relevant Factors Under proposed 112.43a5, covered farms would consider any other factors relevant to identifying any conditions that are reasonably likely to introduce known or reasonably
Proposed 112.43b would create various exemptions from the requirement to conduct an assessment of pre-harvest agricultural water for application to non-sprout covered produce.

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12. Written Annual Assessments Under proposed 112.43a, covered farms using pre-harvest agricultural water for non-sprout covered produce would prepare a written assessment of their pre-harvest agricultural water, at least once each year, to identify any conditions that would be reasonably likely to introduce known or reasonably foreseeable hazards into or onto nonsprout covered produce or food contact surfaces, unless the farm is exempt under proposed 112.43b.
A written agricultural water assessment would help FDA to verify that covered farms conducted comprehensive assessments that included all of the elements required by proposed 112.43a and made a written determination as required by proposed 112.43c. A written agricultural water assessment also would allow covered farms using pre-harvest water for nonsprout produce to more effectively manage their agricultural water such as in evaluating the effectiveness of any mitigation measures, identify trends and changes impacting their agricultural water systems such as a change in nearby land use that might introduce known or reasonably foreseeable hazards, and help identify potential sources of contamination of the water system and covered produce. Records of annual agricultural water assessments also would help covered farms in determining whether changed conditions would require covered farms to conduct a reassessment under proposed 112.43f2, prior to an annual reassessment.
The proposed requirement for an annual, written agricultural water assessment for pre-harvest agricultural water, with the elements described in paragraphs a15, aligns with the Codex Code Section 3.2.1.1 Ref. 63, which recommends the assessment of agricultural water for suitability for use, and the USDA Harmonized GAP Plus+
Standard, section F4.1 Ref. 70.
13. Proposed 112.43bExemptions
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Under proposed 112.43b1, a covered farm would be exempt from the requirement to conduct an assessment for pre-harvest agricultural water if the farm can demonstrate that the agricultural water meets the requirements of proposed 112.44a, which is applicable to agricultural water used for sprout irrigation or for harvest or post-harvest usesi.e., untreated ground water that meets the microbial water quality criterion of no detectable generic E. coli, based on testing requirements in proposed 112.44b, 112.47, and 112.151. The exclusion in proposed 112.43b1 does not apply to untreated surface water, because proposed 112.44a prohibits the use of untreated surface water for sprout irrigation or harvest or post-harvest application on covered produce.
For example, if a covered farm uses the same untreated ground water source for pre-harvest and harvest application to non-sprout covered produce, the farm would be exempt from conducting an agricultural water assessment for the untreated ground water provided that the farm could demonstrate, through results of testing as required by proposed 112.44b, 112.47, and 112.151, that its agricultural water meets microbial water quality criterion in proposed 112.44a.
Ground water obtained from deep underground aquifers with properly designed, located, and constructed wells, is not subject to the impacts of runoff from adjacent and nearby lands and similar conditions evaluated as part of an agricultural water assessment. As explained in the 2015 produce safety final rule 80 FR 74354 at 74430, the microbial quality requirement of no detectable generic E. coli in 112.44a in untreated ground water is intended to address the known or reasonably foreseeable hazards associated with fecal contamination of agricultural water. The stringency of the requirements in proposed 112.44a is commensurate with the risks associated with using contaminated water for sprout irrigation and for harvest and post-harvest uses.
Proposed 112.43b2 would exempt a covered farm from the requirement to conduct an agricultural water assessment for pre-harvest agricultural water for non-sprout covered produce that a covered farm receives from a public water system that the covered farm can demonstrate:
Meets the microbial requirements of EPA Safe Drinking Water Act SDWA
regulations in 40 CFR part 141 or the regulations of a State approved to administer the SDWA program through
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