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Federal Register / Vol. 86, No. 231 / Monday, December 6, 2021 / Proposed Rules the 2015 produce safety final rule that practices and conditions on a covered farm and circumstances unique to a specific commodity could result in higher die-off rates between last irrigation and harvest, especially with little or no precipitation, coupled with high ultraviolet radiation, high temperature exposures, or low humidity.
Moreover, during outreach activities related to agricultural water as described in section III.C, stakeholders described the diversity of pathogens, commodities, and climates that may be associated with different microbial dieoff rates and/or time intervals. We also are aware that further research on the various conditions that exist is likely to impact the appropriate use of a preharvest application interval Ref. 3. As more studies are conducted that examine in-field die-off in various circumstances Refs. 7678, we expect that this is an area where science will continue to evolve.
Therefore, to provide additional flexibility to allow for future science while continuing to protect public health, we are proposing to allow covered farms to use a time interval other than the minimum 4 days between last direct water application and harvest as a mitigation measure, if they have adequate supporting scientific data and information. We expect that any microbial die-off rate and accompanying maximum time interval that a covered farm establishes and uses would be supported by an equally robust and rigorous scientific analysis to that described above for the 0.5 log per day die-off rate with accompanying 4-day time interval. We expect that scientific data and information used to support a pre-harvest time interval would be relevant to conditions on the covered farm such as the region, crop, and environment, and be similarly characterized in a manner that addresses the likely biphasic nature of microbial die-off i.e., the two different decay constants of a rapid short-term die-off and a gradual long-term die-off.
We also expect that the scientific approach would not increase the likelihood that the covered produce will be adulterated compared to the microbial die-off rate standard in 112.45b1iA of the produce safety regulation.
Consistent with 112.45b1ii of the produce safety regulation, we are proposing to allow covered farms to increase the time interval between harvest and the end of storage to allow for microbial die-off, and/or adopt activities such as commercial washing that result in microbial removal as a
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mitigation measure. This proposed revision reflects our proposal to remove the pre-harvest microbial quality criteria and testing requirements from the produce safety regulation and would allow a covered farm to use microbial die-off or removal post-harvest i.e., between harvest and end of storage, and during activities such as commercial washing as a mitigation measure, provided the covered farm has adequate supporting scientific data and information.
We are not proposing to establish a specific microbial die-off rates between harvest and end of storage or specific microbial removal rates during postharvest activities such as commercial washing. The World Health Organization has attributed a 1-log reduction in microbial load to washing Ref. 55. See also 79 FR 58434 at 58446. As discussed in the produce safety supplemental notice and final rule, we do not have sufficient information to support the derivation of appropriate, broadly-applicable microbial die-off or removal rates for this purpose. While it is reasonable to expect some die-off during post-harvest storage, the rate and accompanying time interval would be highly dependent upon the conditions of storage. Covered farms would be able to more narrowly define die-off and/or removal rates associated with their specific production practices, and apply an appropriate time interval between harvest and end of storage and/or adopt activities such as commercial washing that result in microbial removal, as applicable to their circumstances. We are proposing to provide this option so that a covered farm may account for microbial die-off or removal during post-harvest activities i.e., between harvest and end of storage, and during activities such as commercial washing, provided the farm has adequate scientific data or information to support the conclusions in accordance with proposed 112.12.
In light of recent produce outbreaks including the outbreaks described in section III.D., we are proposing in 112.45b1 to require expedited mitigation for known or reasonably foreseeable hazards from animal activity, BSAAOs, or untreated or improperly treated human waste associated with adjacent or nearby lands.
For any other identified hazards, proposed 112.45b1 would require covered farms to implement mitigation measures as soon as practicable and no later than one year after the date of the agricultural water assessment as required by proposed 112.43. This
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requirement aligns with 112.45b of the produce safety regulation, which requires mitigation measures to be implemented as soon as practicable and no later than the following year.
Proposed 112.45b2 would provide that if a covered farm failed to implement appropriate mitigation measures, or if the farm determined that the measures were not effective to reduce the potential for contamination of non-sprout covered produce or food contact surfaces with any known or reasonably foreseeable hazards, the farm must discontinue use of the pre-harvest agricultural water until it has implemented mitigation measures adequate to reduce the potential for such contamination, consistent with 112.41.
We note that while not considered agricultural water for purposes of subpart E, indirect water application methods, such as the use of drip tape in a manner that water is not likely to contact the harvestable portion of the crop, remain subject to section 402 of the FD&C Act. That is, indirect water application may adulterate produce if, considering the water quality and the manner of its application, the use of the water causes produce to be prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth or rendered injurious to health under section 402a4 of the FD&C Act. For example, if a farm uses drip tape in a way that water does not normally contact the harvestable portion of the crop, unintentional contact may still occur if the drip tape begins to leak sprays water on the crop. Although not considered agricultural water for purposes of subpart E, the farm should consider whether the source of water may have caused the produce to become adulterated under section 402 of the FD&C Act for example, the farm may consider the conditions described in proposed 112.43a1 and, if so, dispose of the product appropriately.
G. Records Requirements for PreHarvest Agricultural Water Assessments Proposed 112.50
We propose to amend the records requirements in 112.50 of the produce safety regulation to conform with proposed subpart E and to add new requirements for records relating to preharvest agricultural water assessments and the optional testing that certain covered farms may elect to conduct under proposed 112.43.

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