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Federal Register / Vol. 86, No. 231 / Monday, December 6, 2021 / Proposed Rules
coliphages may help to further advance public health protections. FDA
anticipates that as science evolves and more information about other indicator or index organisms is learned, testing for other organisms may be used to inform pre-harvest agricultural water assessments by covered farms, if finalized as proposed.
b. Frequency of sampling. The 2015
produce safety final rule established sampling frequencies for covered farms to use in developing microbial water quality profiles for pre-harvest agricultural water for non-sprout covered produce. For untreated surface waters, this consists of an initial profile of at least 20 samples collected over a 24-year period, followed by at least 5
annual samples thereafter; for untreated ground water sources, this consists of an initial profile of at least 4 samples collected during the growing season or over a period of one year, followed by at least 1 annual sample thereafter 80
FR 74354 at 74452 Ref. 74.
During outreach activities, some stakeholders, including covered farms and some State regulators, indicated that they found the pre-harvest microbial water quality criteria and testing requirements in the 2015
produce safety final rule to be overly complex. See section III.B. through III.C. Some farms anticipated that it would be infeasible to implement the pre-harvest agricultural water testing requirements in their operations and asked for additional flexibilityin addition to the alternatives and variances already allowed by the produce safety regulation. Moreover, various stakeholders shared the opinion that, as new science continues to become available in the realm of water quality monitoring, farms should have the flexibility to take those findings into account when establishing or updating their sampling programs Refs. 3 and 75.
We continue to believe that the information used to support the sampling frequencies in the 2015
produce safety final rule for pre-harvest agricultural water for non-sprout covered produce is well-grounded, broadly-applicable science. Therefore, for purposes of proposed 112.43d, covered farms that opt to test their untreated surface water for purposes of proposed 112.43d may initially collect at least 20 samples over a 24year period, with at least 5 samples collected annually thereafter; covered farms that opt to test their untreated ground water may initially collect at least 4 samples over a growing season or year, with at least 1 sample collected annually thereafter. Depending on the
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conditions that may affect their preharvest agricultural water, covered farms may consider collecting additional samples as needed to better understand whether measures are reasonably necessary to reduce the potential for contamination of covered produce other than sprouts or food contact surfaces with known or reasonably foreseeable hazards associated with their pre-harvest agricultural water for non-sprout covered produce.
We recognize that there are circumstancesfor example, when access to a body of water varies from year to yearin which some covered farms may not be able to collect samples spanning multiple years. In situations such as these, covered farms may consider collecting at least 5 samples per year for untreated surface water sources, or at least 4 samples per year for untreated ground water sources used for pre-harvest application to nonsprout covered produce.
However, we are also providing flexibility in proposed 112.43d3 for covered farms to use any sampling frequency when testing under proposed 112.43d3, provided that it is adequate to assist in determining, in conjunction with other data and information evaluated under 112.43a, whether measures under 112.45 are reasonably necessary to reduce the potential for contamination of nonsprout covered produce or food contact surfaces with known or reasonably foreseeable hazards associated with preharvest agricultural water for non-sprout covered produce. For example, other options could include sampling frequencies a covered farm establishes based on its historical data and/or knowledge of water quality variability within its source. A covered farm also could, for example, include consideration for other siteor regionspecific data or information indicating that a certain sampling frequency is appropriate. We expect that as covered farms learn more about water quality relevant to their sources, systems, and operationsfor example, through an evaluation of data shared between farms, within water systems, and/or within regionsthat such information may be used to establish sampling frequencies that are appropriate to their specific circumstances and conditions.
c. Microbial water quality criteria. The microbial water quality criteria established by the 2015 produce safety final rule for pre-harvest agricultural water consist of a GM of 126 colony forming units CFU generic E. coli per 100 milliliters mL, and an STV of 410
CFU generic E. coli per 100 mLusing
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the science underlying EPAs RWQC 80
FR 74354 at 7444174442.
The information used to support the pre-harvest agricultural water quality criteria in the 2015 produce safety final rule is the best science currently available that is broadly applicable to the range of conditions that exist across the diversity of operations, agricultural water sources, and agricultural water uses of domestic and foreign covered farms. Therefore, if a covered farm decides to test its pre-harvest agricultural water for generic E. coli under proposed 112.43d to inform its agricultural water assessment, the farm may use a GM of 126 or less CFU
generic E. coli per 100 mL and an STV
of 410 or less CFU generic E. coli per 100 mL as microbial criteria.
However, we acknowledge stakeholder concerns and recognize that the science around agricultural water quality criteria continues to evolve Ref.
3. We recognize that there may be other options for microbial water quality criteria for example, alternative criteria relevant to an indicator organism other than generic E. coli.
Proposed 112.43d would offer additional flexibility to apply any microbial criterion or criteria that would be scientifically valid and appropriate to assist in determining, in conjunction with other data and information evaluated under proposed 112.43a, whether measures under 112.45 are reasonably necessary to reduce the potential for contamination of nonsprout covered produce or food contact surfaces with known or reasonably foreseeable hazards associated with preharvest agricultural water. We are not proposing to require that covered farms notify or seek approval from FDA prior to applying a microbial criterion or criteria when electing to test their preharvest agricultural water. Rather, we would provide flexibility for a covered farm to determine which microbial criterion or criteria to apply, when supported by scientific data or information demonstrating scientific validity and appropriateness under proposed 112.43d. For example, a covered farm could rely on microbial criterion or criteria available in the scientific literature or made available by a third party, such as a trade association, provided that the microbial criterion or criteria would be scientifically valid and appropriate based on the circumstances.
When possible, covered farms may continue to collect water quality data over timewhether historical data, new data, or boththat can assist in analyzing trends. For example, this approach may be useful in situations in
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