Search results for: ag water

  • On May 2, 2024, FDA published a final rule on agricultural water to enhance produce safety. The rule, titled Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Relating to Agricultural Water, amends the agricultural water provisions of the 2015 produce safety regulation by replacing microbial criteria and testing requirements for pre-harvest water with a systems-based assessment approach.
  • As we have previously blogged, FDA issued the proposed rule in December 2021 followed by an announcement in January 2022 that the Agency would exercise enforcement discretion for agricultural water requirements for covered produce other than sprouts.
  • Specifically, the final rule:
    • Establishes requirements for agricultural water assessments that evaluate a variety of factors that are key determinants of contamination risks associated with pre-harvest agricultural water, including the water system, water use practices, crop characteristics, environmental conditions, potential impacts of water from adjacent and nearby land, and other relevant factors.
    • Includes testing pre-harvest agricultural water as part of an assessment in certain circumstances.
    • Requires farms to implement effective mitigation measures within specific timeframes based on findings from the assessments.
    • Adds new options for mitigation measures, providing additional flexibility in responding to findings from pre-harvest agricultural water assessments.
  • The rule also finalizes compliance dates as follows:
    • 2 years and 9 months after the effective date for very small farms;
    • 1 year and 9 months after the effective date for small farms;
    • 9 months after the effective date for all other farms.
  • The final rule is effective July 5, 2024.
  • We reported on FDA’s July 30, 2020 release of a testing protocol for the development of new antimicrobial products that could be registered with EPA to treat preharvest agricultural water.  More specifically, the FDA protocol is for use in evaluating treatments for inactivating shiga toxin-producing E. coli (STEC), including E. coli O157:H7, and other pathogens that may contaminate water used on agricultural fields.  The protocol is an important part of FDA’s 2020 Leafy Greens STEC Action Plan.  It was formally updated on May 17, 2022 to reflect an April 2021 allowance for some data that do not comply with good laboratory practices (GLP) and an April 2022 amendment changing the maximum contact time from 1 minute to “up to 5 minutes.” 
  • On January 6, 2022, in agreement with EPA, FDA updated the protocol once again to remove Listeria monocytogenes from the organism test panel based on pilot studies finding that sanitizer treatments that will likely be effective for E. coli and Salmonella may be different from those that are most effective for L. monocytogenes.  The April 20, 2020, EPA memorandum shows this change to the protocol at page 2.  The agencies expect that removing L. monocytogenes from the test panel will facilitate the registration of antimicrobial treatments against STECs (and other E. coli) and Salmonella in pre-harvest agricultural water. 
  • FDA concurrently states that companies may continue testing against L. monocytogenes for inclusion in their registration with EPA at their option.   We will continue to monitor developments impacting FDA’s Leafy Greens STEC Action Plan. 
  •  FDA has made halting progress in establishing and implementing “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption,” as mandated by the Food Safety Modernization Act (FSMA) of 2011.  It has been especially challenging to come up with key requirements for agricultural water used with covered produce (other than sprouts).  In this regard, we have reported  on FDA’s December 6, 2021 proposed rule that would replace the microbial criteria and testing requirements for pre-harvest agricultural water under the Produce Safety Rule (PSR), finalized in 2015, with new systems-based assessments.
  • On August 11, 2022, FDA announced the release of a paper-based version of its Agricultural Water Assessment Builder (also available in Spanish).  FDA’s intent is to make the content of its Agricultural Water Assessment Builder that was released on-line in March 2022 more accessible to a broader array of users.  All versions of the tool, available here, are designed to help farms understand the proposed, systems-based pre-harvest agricultural water requirements by guiding them through an assessment of the main elements as follows:
    • Agricultural Water System Components
    • Animal Impacts and Activities
    • Biological Soil Amendments of Animal Origin (BSAAOs)
    • Human Waste
    • Other Water Users
    • Other Potential Sources of Hazards
    • Crop Characteristics
    • Agricultural Water Use Practices
    • Environmental Conditions
    • Other Relevant Factors
    • Outcomes and Measures
  • FDA has not made any further announcements since the notice discussed here about proposed compliance dates for the pre-harvest agricultural water provisions for covered produce (other than sprouts) and its enforcement discretion policy applicable to the harvest and post-harvest agricultural water provisions of the PSR.  Please feel free to contact Keller and Heckman at fooddrug@khlaw.com with any questions regarding the PSR or other FDA rules implementing FSMA.

 

  • In December 2021, FDA published a notice of proposed rulemaking to amend the agricultural water provisions of the “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption” (i.e., the “Produce Safety Rule”). The proposed revisions were in response to stakeholder concerns that the pre-harvest agricultural water provisions were too complex and prescriptive. As we have previously blogged, the proposed amendment would replace the detailed pre-harvest agricultural testing requirements in the Produce Safety Rule with provisions that allow for a systems-based agricultural water assessment that are designed to be more feasible to implement and adaptable to future advancements.
  • FDA has now announced a supplemental notice of proposed rulemaking in which it is requesting comment on only the compliance dates for the proposed pre-harvest agricultural water provisions for covered produce other than sprouts. The proposed compliance dates would allow time for covered farms to prepare for compliance and for other stakeholders, including state regulators, to develop education, outreaching, training, and other tools to facilitate understanding and compliance. The proposed compliance dates are as follows:
    • 2 years and 9 months after the effective date of a final rule for very small businesses, defined in 21 CFR 112.3 to mean “a farm that is subject to any of the requirements of this part [the Produce Safety Rule] and, on a rolling basis, the average annual monetary value of produce (as defined in this section) the farm sold during the previous 3-year period is no more than $250,000.”
    • 1 year and 9 months after the effective date of a final rule for small businesses, defined in 21 CFR 112.3 to mean “a farm that is subject to any of the requirements of this part and, on a rolling basis, the average annual monetary value of produce (as defined in this section) the farm sold during the previous 3-year period is no more than $500,000; and the farm is not a very small business as defined in this section.”
    • 9 months after the effective date of a final rule for all other businesses.
  • In addition, although no changes to the harvest and post-harvest requirements have been proposed, to allow for adequate preparations, FDA also announced that it intends to continue to exercise enforcement discretion for the harvest and post-harvest agricultural water provisions for covered produce other than sprouts until the following dates:
    • January 26, 2025 for very small businesses.
    • January 26, 2024 for small businesses.
    • January 26, 2023 for all other businesses.
  • Comments to the proposed compliance dates can be submitted until September 19, 2022
  • As previously reported, on July 30, 2020, FDA worked with EPA to release a protocol to evaluate the efficacy of antimicrobial pesticides in agricultural water. The protocol established an agricultural water panel assay that companies could use to test the capability of their water treatment processes to combat strains of Listeria, Salmonella and E. coli frequently responsible for foodborne illnesses.
  • On May 17, 2022, FDA announced that it had formally updated its protocol to reflect two earlier changes that had been made since the protocol was first released.  In April 2021, FDA updated the protocol to allow companies and other agricultural water stakeholders to use data that did not comply with good laboratory practices (non-GLP) in their submissions, provided that the submissions accurately represented how the study differed from GLP standards. This change was intended to give companies and agricultural stakeholders access to more laboratories.  In April 2022, FDA amended the contact time in the protocol, changing the maximum from 1 minute to “up to 5 minutes.” This change was intended to meet current practical and scientific needs.
  • The changes are now reflected in the Efficacy Protocol and EPA Protocol Review although this document continues to be dated April 29, 2020.
  • On January 26, 2022, FDA published a constituent update reminding produce stakeholders about FDA’s intention to exercise enforcement discretion for agriculture water requirements for covered produce, except for those related to sprouts, which are subject to unique requirements.  The agricultural water regulations apply to farms subject to the Food Safety Modernization Act (FSMA) Produce Safety Rules.
  • As previously reported, the enforcement discretion was initially announced in a proposed rule on agricultural water in which FDA proposed to replace pre-harvest microbial quality criteria and testing requirements with new system-based pre-harvest agricultural water assessments.
  • In the proposed rule, FDA acknowledged that current agricultural water compliance dates are set to begin in January 2022 and that, in turn, the agency intends to exercise enforcement discretion for covered produce (except sprouts). FDA will work to complete compliance date rulemaking as soon as possible. In the meantime, FDA reminds covered farms that they should continue implementing good agricultural practices to maintain the quality of their water sources.
  • FDA’s Produce Safety Rule (PSR), finalized in 2015 under the Food Safety Modernization Act (FSMA), established “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption,” including requirements applicable to agricultural water using a direct application method during growing activities (commonly referred to as ‘‘pre-harvest agricultural water’’).  As we have discussed, FDA was criticized, following foodborne illness outbreaks linked to lettuce, for extending the compliance dates for the agricultural water requirements applicable to covered produce (other than sprouts) until January 26, 2022 for the largest farms, and one or two years later for small and very small farms, respectively.
  • On December 6, 2021, FDA published a proposed rule that would replace the pre-harvest microbial water quality criteria and testing requirements of the 2015 rule, which stakeholders complained were too complex, with new rules that would require farms covered by the PSR to assess their pre-harvest agricultural water system annually, and whenever a significant change occurs, to identify any conditions likely to introduce known or reasonably foreseeable hazards into or onto covered produce or food contact surfaces and, based on their assessments, determine whether corrective or mitigation measures are needed to reduce the potential for contamination.  The proposed rule includes:
    • New provisions requiring consideration of agricultural water sources, distribution systems, and practices, as well as adjacent and nearby land uses, and other relevant factors in conducting pre-harvest agricultural water assessments for hazard identification and risk management decision making;
    • A testing option for certain covered farms that elect to test their pre-harvest agricultural water for generic Escherichia coli (E. coli) (or other appropriate indicator organism, index organism, or analyte) to help inform their agricultural water assessments;
    • Flexible options for mitigation measures, such as, for example, using 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;
    • Expedited implementation of mitigation measures for known or reasonably foreseeable hazards related to certain adjacent and nearby land uses, such as animal grazing and the presence of livestock and wildlife; and
    • Required management review of pre-harvest agricultural water assessments.
  • Information on proposed compliance dates will be announced in a forthcoming notice.  In the meantime, FDA intends to exercise enforcement discretion for the agricultural water requirements for covered produce (other than sprouts).  Additionally, FDA is working on plans to hold two virtual public meetings to discuss the proposal and hear feedback and is developing an online tool to assist farms in evaluating potential risks posed by their water sources and in determining potential management options.  The solicitation period for comments on the proposed amendments is scheduled to close on April 5, 2022.  Please feel free to contact Keller and Heckman at fooddrug@khlaw.com for assistance providing FDA comments.
  • In the United States between 2009 and 2018, the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) identified 40 outbreaks of food-borne illness with a confirmed or suspected link to leafy greens and Shiga toxin-producing E. coli (STEC).  Although agricultural water is one of the main vehicles through which leafy greens and other produce can become contaminated with E. coli O157:H7 and other foodborne pathogens, there are no antimicrobial treatment products registered with the Environmental Protection Agency (EPA) for use in agricultural water sources.
  • On July 30, 2020, FDA announced the release of a new testing protocol, formed in partnership with EPA, to facilitate companies’ efforts to develop and register antimicrobial products designed to treat preharvest agricultural water.  The protocol was first revealed during an FDA Center for Food Safety and Applied Nutrition webinar on its 2020 Leafy Greens STEC Action Plan, and was introduced as a way to address the identified need to further protect agricultural water sources from pathogen contamination.  The new protocol establishes an agricultural water panel assay that companies can use to test the capability of their water treatment products to combat strains of Listeria, Salmonella, and E. coli frequently responsible for foodborne illnesses.  EPA’s endorsement of this protocol enables companies that follow its steps to use the testing data generated to support an application for registration of new products or to revise the labels of existing products as being for use against microbial contamination in preharvest agricultural water.
  • FDA cites the new EPA-approved protocol for evaluating the efficacy of antimicrobial pesticides in agricultural water as an important prevention step towards food safety, taken as part of its Leafy Greens STEC Action Plan and New Era of Smarter Food Safety Initiative (which includes a 10-year blueprint released on July 13, 2020, as discussed here).
  • FDA’s Produce Safety Rule, implemented under the Food Safety Modernization Act (FSMA), establishes science-based minimum standards for the safe growing, harvesting, packing, and holding of produce, meaning fruits and vegetables grown for human consumption.  Our detailed summary of the rule is available here. FDA’s Produce Safety Rule, implemented under the Food Safety Modernization Act (FSMA), establishes agricultural water standards.  In particular, the Produce Safety Rule sets microbial quality standards for agricultural water, including irrigation water that comes into contact with produce.  In March 2017, the U.S. Food and Drug Administration (FDA) announced that it was exploring ways to simplify the agricultural water standards established by FSMA’s Produce Safety Rule in light of feedback from stakeholders that some of the requirements were too complex to understand and implement. Earlier this summer, FDA announced its intention to extend the compliance dates for agricultural water requirements in the Produce Safety Rule (other than for sprouts).
  • Today FDA issued a proposed rule (82 FR 42963) that, if finalized, would extend the compliance dates for the agricultural water requirements by an additional two to four years (for produce other than sprouts). The proposed extension will give the Agency time to take another look at the water standards to ensure that they are feasible for farmers in all regions of the country, while protecting public health. The new agricultural water compliance date the FDA is proposing for the largest farms is January 26, 2022. Small farms and very small farms would have until January 26, 2023 and January 26, 2024, respectively.
  • The Agency notes that the proposed extension would also simplify the compliance framework to give all of the water requirements a four-year delay compared to farms’ primary compliance dates. The produce rule currently includes a delay of two years in the compliance dates for certain agricultural water requirements, but for others there is no delay.  The FDA indicates that it does not intend to take action to enforce the agricultural water requirements for produce other than sprouts while the rulemaking to extend the compliance dates is underway. Sprouts remain subject to applicable agricultural water requirements in the final rule and their original compliance dates due to their unique vulnerability to contamination.
  • The publication of the proposed rule comes on the heels of a speech by FDA Commissioner Scott Gottlieb to the annual conference of the National Association of State Departments of Agriculture (NASDA), yesterday, outlining a number of immediate next steps in a comprehensive approach to ensuring successful implementation of the Produce Safety Rule.  Gottlieb noted that these steps included measures the Agency will be taking in such areas as compliance dates for agricultural water standards, recognized water-testing methods, and inspections related to non-water requirements of the produce rule.
  • FDA will be accepting comments on the proposed rule for the next 60 days (i.e., through November 13, 2017).
  • Agricultural water can be a major conduit of pathogens that can contaminate produce. FDA’s Produce Safety Rule, implemented under the Food Safety Modernization Act (FSMA), establishes agricultural water standards.  In particular, the Produce Safety Rule sets microbial quality standards for agricultural water, including irrigation water that comes into contact with produce.  In March 2017, the U.S. Food and Drug Administration (FDA) announced that it was exploring ways to simplify the agricultural water standards established by FSMA’s Produce Safety Rule in light of feedback from stakeholders that some of the requirements were too complex to understand and implement.
  • Today, FDA announced its intention to extend the compliance dates for agricultural water requirements in the Produce Safety Rule (other than for sprouts).  According to the announcement, FDA intends to use this additional time to work with industry to develop an approach that addresses stakeholder concerns while achieving the Agency’s enumerated public health goals.
  • FDA intends to extend the compliance dates using appropriate administrative procedures at a later time.  We will be sure to report these developments to you here when they unfold.