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Federal Register / Vol. 86, No. 231 / Monday, December 6, 2021 / Proposed Rules agricultural water systems under proposed 112.42, and conduct a written agricultural water assessment annually and whenever a significant change occurs such as a change in the manner or timing of water application that would increase the likelihood that a known or reasonably foreseeable hazard would be introduced into or onto covered produce or food contact surface.
We are maintaining the requirements for corrective measures in 112.45a, as explained and supported by the 2015
produce safety final rule 80 FR 74354
at 7442974431, 7444074441, including the requirement that if a covered farm determines or has reason to believe that the agricultural water is not safe or of adequate sanitary quality for its intended use, then the farm must immediately discontinue such use. For example, if in performing the agricultural water assessment a covered farm finds that there is a dead and decaying sheep in the canal upstream and at a close distance from where it draws water, the farm would have reason to believe that the agricultural water is not safe or of adequate sanitary quality for its intended use because the water is reasonably likely to contain human pathogens transferred by the dead and decaying sheep. Therefore, the farm would have to immediately discontinue that use of the water and take corrective measures under proposed 112.45a before resuming such uses.
We also are maintaining the requirements to mitigate other risks as soon as practicable and no later than the following year, also supported by the produce safety final rule 80 FR 74354
at 7444174446, except that a covered farm would be required to implement mitigation measures under proposed 112.45b for known or reasonably foreseeable hazards related to animal activity, the application of BSAAOs, or the presence of untreated or improperly treated human waste on adjacent or nearby lands promptly, and no later than the same growing season as the agricultural water assessment. For example, if in performing their agricultural water assessment, a covered farm identifies upstream lands used for animal grazing from which runoff is likely to introduce known or reasonably foreseeable hazards into the water source based on the topography of the land, the farm would be required to implement mitigation measures promptly, and no later than the same growing season as the agricultural water assessment. We note that proposed 112.43c2 is not intended to include those situations in which animal or human waste impacts result in water no
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longer being safe or of adequate sanitary quality for its intended use under 112.41. In those instances, a covered farm would be required under 112.43c1 to immediately discontinue that use of the water and take corrective measures under 112.45a before resuming such use.
Animal activity, BSAAOs, and untreated or improperly treated human waste have been identified as possible causal or contributing factors in several large produce outbreaks in recent years.
The pathogens associated with animal and human waste are well established, as are the risks associated with introduction of animal or human waste into agricultural water used in growing covered produce Ref. 11.
Subparts B, F, I, and L of the produce safety regulation require covered farms to take appropriate measures to minimize the risk of serious adverse health consequences or death from the use of, or exposure to, covered produce, including those measures reasonably necessary to prevent the introduction of known or reasonably foreseeable hazards associated with animal activity, BSAAOs, and untreated and improperly treated human waste on the covered farm.
In considering how best to achieve public health protections under this proposed approach, we determined that animal activity, BSAAOs, or human waste impacts on water sources and systems related to adjacent or nearby lands should elicit an expedited timeline for implementation of mitigation measures. We recognize that activities associated with adjacent or nearby lands that introduce contaminants into a water source or distribution system are often not under a covered farms control. While the covered farm may not have control over potential hazards at their point of introduction into a water source or system, the potential hazards are no less important for the farm to consider when determining the safe use of agricultural water on covered produce. Therefore, it is important that the covered farm not only implement mitigation measures that are under its control to reduce the risk associated with that water source or system, but that it do so on an expedited basis to protect public health.
15. Proposed 112.43dTesting for Assessment Purposes Proposed 112.43d would establish the requirements applicable to testing that a covered farm chooses to conduct to provide additional information for its agricultural water assessment. The testing option for pre-harvest agricultural water for non-sprout
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covered produce under proposed 112.43d is science-based and also provides for flexibility as science evolves. For example, a covered farm that opts to test pre-harvest agricultural water under this provision would be required to test its agricultural water for generic E. coli as an indicator of fecal contamination, but also may test for another scientifically valid indicator organism, index organism, or other analyte.
Proposed 112.43d also would require that samples of pre-harvest agricultural water tested as part of an agricultural water assessment be collected aseptically immediately prior to or during the growing season, representative of the water used in growing non-sprout covered produce, and tested using a scientifically valid method.
Additionally, proposed 112.43d would require that the frequency of testing and any microbial criteria applied be scientifically valid and appropriate to assist in determining, in conjunction with other data and information evaluated under paragraph 112.43a, whether measures under 112.45 are reasonably necessary to reduce the potential for contamination of non-sprout covered produce or food contact surfaces with known or reasonably foreseeable hazards associated with pre-harvest agricultural water.
a. Generic E. coli. Generic E. coli remains a commonly used analyte used as an indicator of fecal contamination and currently is the preferred indicator for monitoring water quality 80 FR
74354 at 74428. However, the potential use of other indicator organisms, index organisms, or other analytes for monitoring water quality continues to be of interest for agricultural water, as well as related disciplines. For example, in its 2012 Recreational Water Quality Criteria RWQC EPA provided various examples of possible alternate indicators, including Bacteroidales, Clostridium perfringens, human enteric viruses, and coliphages Ref. 72.
Additionally, as part of the 2017 5-year review of the 2012 RWQC, EPA
evaluated the science related to the recreational waters and public health to determine if revisions to the criteria which specify densities for enterococci and generic E. coli were appropriate Ref. 73. While it did not ultimately revise the 2012 RWQC during the 2017
review cycle, EPA emphasized that further scientific research and analysis is likely to contribute to future reviews of the 2012 RWQC. EPA noted, in part, that with further scientific development, the use of viral indicators such as
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