(Comment 24) Several comments request greater specificity on when farms should conduct their annual agricultural water assessment (for example, prior to planting, prior to harvest, between planting and harvest, or prior to water use). Some comments request clarity on how frequently FDA expects farms to determine the likelihood of any given hazard (for example, at least annually). Other comments suggest that farms should be required to prepare an agricultural water assessment at least annually, with an additional assessment within a week prior to harvest.
However, another farm that uses agricultural water from a surface water source may determine that quantification methods are appropriate to use, as surface water sources are subject to the influence of various environmental factors that can impact and change the system continually (Ref. 17).
Rather, we require that any increased time interval between harvest and the end of storage and/or other post-harvest activities used in accordance with § 112.45(b)(1)(iii) be supported by scientifically valid data or information.
We proposed that the assessments would be conducted annually (and more frequently as needed), documented in writing, and used for hazard identification and risk management decision-making purposes.
As such, we are revising the requirement to clarify that considering whether a water source is ground water or surface water is just one example of the information farms might consider in evaluating the location and nature of the water source (see § 112.43(a)(1)(i)).
For example, the California Agricultural Neighbors (CAN) Initiative is designed to provide an opportunity to foster collaboration and discuss enhanced neighborly food safety practices when various agricultural operations such as leafy green fields, cattle ranches, vineyards and compost sites are adjacent to one another (Ref. 38).
Reducing excess inventory
Comments regarding other relevant factors, with the exception of those related to testing as part of an assessment under § 112.43(d), are discussed below.
For example, some operations introduce a new production raft to a growing pond when another raft is removed for harvest.
Further, under the 2015 produce safety final rule, farms were required to test pre-harvest agricultural water as close in time as practicable to, but prior to harvest, and use those results to determine whether to implement mitigation measures without the benefit of the written systems-based evaluation of potential sources of contamination we are requiring in this final rule.
With smart, scalable and dependable point of sale systems, it’s an all-in-one solution that helps restaurants and retailers sell across channels, manage operations, engage with consumers, accept payments and grow their business.
Many comments ask whether records used for water system inspections can also be used to satisfy the agricultural water assessment recordkeeping requirements.
Section 112.42(b)(4) requires that farms, as necessary and appropriate, implement measures reasonably necessary to reduce the potential for contamination of covered produce resulting from contact of covered produce with pooled water.
Comments also seek clarity as to when FDA would expect the testing to be completed (for example, before the season starts). Further, some comments question whether historical water testing data could be used for the purposes of an exemption from preparing an agricultural water assessment. Comments also request clarification on whether this exemption could be used for a farm that only uses pre-harvest water, but tests to the same standard as post-harvest water and meets all other relevant requirements. (Response 35) We recognize that not all farms (including, for example, new farms and those growing covered produce on land under short-term lease), will have a historic understanding of their agricultural water systems, including uses of adjacent and nearby lands.
Reorder Point in Practice: Use an inventory management system
Several comments focused on other topics, such as alternative options to the regulatory approach for pre-harvest agricultural water and the shift from mandated agricultural water testing in the 2015 produce safety final rule to the proposed approach for pre-harvest agricultural water assessments. (Response 108) If a farm treats its pre-harvest agricultural water based on its agricultural water assessment, the necessary timing for implementing agricultural water treatment will depend on the specific conditions at the farm. For example, if the farm treats its pre-harvest agricultural water in response to a condition in which there may be ongoing introduction of known or reasonably foreseeable hazards into the agricultural water system, it may be an appropriate response for the https://www.bookstime.com/ farm to treat that water each time it is used as pre-harvest agricultural water. For example, in situations where runoff introduces known or reasonably foreseeable hazards into the agricultural water system, and the farm is not able to prevent such events from occurring, it may be appropriate for the farm to treat the water each time it is used. Or, depending on the nature of the potential source of hazards as well as other information evaluated under § 112.43(a), treatment of agricultural water only during certain times of the growing season may be sufficient to reduce the potential for contamination of covered produce. For example, depending on the circumstances, the farm might determine that treatment is only necessary when agricultural water is applied close to harvest.
H. Testing as Part of an Assessment (§ 112.43(d))
A few comments suggest specific compliance dates from 1 to 3 years after the final rule publishes based on farm size would be appropriate, whereas others suggest that a single compliance date for all agricultural water provisions 2 years after publication of the final rule would be more appropriate. (Response 130) As discussed in the 2015 produce safety final rule, although some antimicrobial substances are regulated by FDA, most antimicrobial substances that might be used by farms in agricultural water are regulated by the EPA (Ref. 85) (80 FR at 74439). We anticipate that the treatment efficacy protocol (Ref. 82), which EPA approved, will facilitate the registration of chemical treatments and increase the options for corrective and mitigation measures available to farms. We anticipate that having several chemical treatment options available encompassing a range of chemistries and applications will help ensure coverage over an industry with such variable practices and conditions. (Comment 116) Several comments assert that a time interval for in-field microbial die-off only makes sense if preceded by microbial water testing, which would allow farms to calculate an acceptable die-off interval rate that may differ from 4 days. These comments note that the 2015 final rule indicated the importance of sampling water sources when a die-off period is used as a mitigation measure, whereas the 2021 proposed rule did not propose to require sampling to establish a baseline understanding of the microbial presence in the water.
This subpart applies to agricultural water used for, or intended for use in, growing, harvesting, packing, or holding covered produce.
When you replenish inventory at its reorder point instead of waiting until it’s out of stock, you’ll still have enough of that product in stock to sell to customers while you wait for the new shipment to arrive.
These comments note that the 2015 final rule indicated the importance of sampling water sources when a die-off period is used as a mitigation measure, whereas the 2021 proposed rule did not propose to require sampling to establish a baseline understanding of the microbial presence in the water.
Among other things, participants questioned the role of water testing, what the information tells farms about risks, and how farms would use that information to make water use management decisions.
(Comment 71) One comment asserts that weather and climate conditions vary by region, and it is unreasonable to expect farmers in one area of the country be required to account for potential weather events that do not apply to their region.
A. FDA Food Safety Modernization Act
If the four initial sample results meet the microbial quality criterion under § 112.44(a), the farm may test once annually thereafter. As such, in order to be eligible for the exemption in § 112.43(b)(1)(i), the farm must test the source of untreated ground water each growing season or year. We received numerous comments on the exemptions in proposed § 112.43(b) and respond to those comments below. As discussed below, we are finalizing the exemptions from the requirement to prepare a pre-harvest agricultural water assessment and clarifying that an exemption which one of these would not be a factor in determining the reorder point? only applies if it is reasonably likely that the relevant quality of water will not change prior to the water being used as agricultural water. Further, as discussed in section V.K., FDA has collaborated with EPA to develop a testing protocol for evaluating the efficacy of antimicrobial chemical treatments against certain foodborne pathogens in agricultural water sources. We recognize the value of collaborating with Federal partners in related disciplines, and will consider additional collaborative efforts related to the requirements we are finalizing here.
In § 112.43(e)(2), we proposed that a farm must conduct a reassessment whenever a significant change occurs in its agricultural water system(s), agricultural water practices, crop characteristics, environmental conditions, or other relevant factors that would impact hazard identification or a risk management determination, as described in proposed § 112.43(c).
As efforts such as these progress, farms may consider participating as an additional means to help address crosscutting food safety issues.
The requirements for comprehensive, systems-based pre-harvest agricultural water assessments and appropriate corrective and mitigation measures as needed will help farms identify potential sources of contamination and effectively manage their water.
(Response 134) We agree that flexibility with respect to records of certain mitigation measures is warranted and are revising proposed § 112.50(b)(7) to remove specific reference to § 112.45(b)(1)(ii) and (iii) (regarding a time interval between last water application and harvest, and a time interval between harvest and end of storage (and/or conducting other post-harvest activities), respectively).
(Comment 49) Some comments suggest that farms with agricultural water systems that span long distances from source to point of delivery (such as some irrigation canals) will face challenges when preparing agricultural water assessments, as certain portions of the water system, such as those that relate to adjacent and nearby lands and/or other water users, may not be under the farm’s control.
(Response 38) In the U.S., Public Water Systems are required under NPDWR in 40 CFR part 141 to provide safe, clean water suitable for drinking and thus are at the lowest likelihood for pathogen contamination (Ref. 17).
FIFO vs. LIFO: Choose the Right Inventory Valuation Method
Reorder Point Formula: How to Calculate This Critical Inventory Metric
(Comment 24) Several comments request greater specificity on when farms should conduct their annual agricultural water assessment (for example, prior to planting, prior to harvest, between planting and harvest, or prior to water use). Some comments request clarity on how frequently FDA expects farms to determine the likelihood of any given hazard (for example, at least annually). Other comments suggest that farms should be required to prepare an agricultural water assessment at least annually, with an additional assessment within a week prior to harvest.
Reducing excess inventory
Comments also seek clarity as to when FDA would expect the testing to be completed (for example, before the season starts). Further, some comments question whether historical water testing data could be used for the purposes of an exemption from preparing an agricultural water assessment. Comments also request clarification on whether this exemption could be used for a farm that only uses pre-harvest water, but tests to the same standard as post-harvest water and meets all other relevant requirements. (Response 35) We recognize that not all farms (including, for example, new farms and those growing covered produce on land under short-term lease), will have a historic understanding of their agricultural water systems, including uses of adjacent and nearby lands.
Reorder Point in Practice: Use an inventory management system
Several comments focused on other topics, such as alternative options to the regulatory approach for pre-harvest agricultural water and the shift from mandated agricultural water testing in the 2015 produce safety final rule to the proposed approach for pre-harvest agricultural water assessments. (Response 108) If a farm treats its pre-harvest agricultural water based on its agricultural water assessment, the necessary timing for implementing agricultural water treatment will depend on the specific conditions at the farm. For example, if the farm treats its pre-harvest agricultural water in response to a condition in which there may be ongoing introduction of known or reasonably foreseeable hazards into the agricultural water system, it may be an appropriate response for the https://www.bookstime.com/ farm to treat that water each time it is used as pre-harvest agricultural water. For example, in situations where runoff introduces known or reasonably foreseeable hazards into the agricultural water system, and the farm is not able to prevent such events from occurring, it may be appropriate for the farm to treat the water each time it is used. Or, depending on the nature of the potential source of hazards as well as other information evaluated under § 112.43(a), treatment of agricultural water only during certain times of the growing season may be sufficient to reduce the potential for contamination of covered produce. For example, depending on the circumstances, the farm might determine that treatment is only necessary when agricultural water is applied close to harvest.
H. Testing as Part of an Assessment (§ 112.43(d))
A few comments suggest specific compliance dates from 1 to 3 years after the final rule publishes based on farm size would be appropriate, whereas others suggest that a single compliance date for all agricultural water provisions 2 years after publication of the final rule would be more appropriate. (Response 130) As discussed in the 2015 produce safety final rule, although some antimicrobial substances are regulated by FDA, most antimicrobial substances that might be used by farms in agricultural water are regulated by the EPA (Ref. 85) (80 FR at 74439). We anticipate that the treatment efficacy protocol (Ref. 82), which EPA approved, will facilitate the registration of chemical treatments and increase the options for corrective and mitigation measures available to farms. We anticipate that having several chemical treatment options available encompassing a range of chemistries and applications will help ensure coverage over an industry with such variable practices and conditions. (Comment 116) Several comments assert that a time interval for in-field microbial die-off only makes sense if preceded by microbial water testing, which would allow farms to calculate an acceptable die-off interval rate that may differ from 4 days. These comments note that the 2015 final rule indicated the importance of sampling water sources when a die-off period is used as a mitigation measure, whereas the 2021 proposed rule did not propose to require sampling to establish a baseline understanding of the microbial presence in the water.
A. FDA Food Safety Modernization Act
If the four initial sample results meet the microbial quality criterion under § 112.44(a), the farm may test once annually thereafter. As such, in order to be eligible for the exemption in § 112.43(b)(1)(i), the farm must test the source of untreated ground water each growing season or year. We received numerous comments on the exemptions in proposed § 112.43(b) and respond to those comments below. As discussed below, we are finalizing the exemptions from the requirement to prepare a pre-harvest agricultural water assessment and clarifying that an exemption which one of these would not be a factor in determining the reorder point? only applies if it is reasonably likely that the relevant quality of water will not change prior to the water being used as agricultural water. Further, as discussed in section V.K., FDA has collaborated with EPA to develop a testing protocol for evaluating the efficacy of antimicrobial chemical treatments against certain foodborne pathogens in agricultural water sources. We recognize the value of collaborating with Federal partners in related disciplines, and will consider additional collaborative efforts related to the requirements we are finalizing here.
FIFO vs. LIFO: Choose the Right Inventory Valuation Method
G. General Overview of Changes in the Final Rule