Category: Regulation

Are You Prepared for the Pre-Harvest Agricultural Water Requirements?

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CDFA Produce Safety Program Logos above Pre-Harvest Agricultural Water Rule Resources text in front of a produce field irrigated with overhead sprinklers

The compliance date for the pre-harvest agricultural water requirements of the U.S. Food and Drug Administration (FDA) Food Safety Modernization Act (FSMA) Produce Safety Rule (PSR) has begun for Large Farms[1] starting on April 7, 2025. Compliance dates for Small Farms[2] and Very Small Farms[3] will follow in 2026 and 2027, respectively.

Pre-Harvest Agricultural Final Rule Compliance Dates

  • Large Farms: April 7, 2025
  • Small Farms: April 6, 2026
  • Very Small Farms: April 5, 2027

Resources including educational materials, Produce Safety Alliance (PSA) Grower Trainings, On-Farm Readiness Reviews and the California Department of Agriculture (CDFA) Technical Assistance Program are available to assist you with preparing for the pre-harvest agricultural water requirements.

Educational Resource Materials

Produce Safety Alliance Grower Trainings

The current PSA Grower Training Course curriculum includes the new pre-harvest agricultural water rule requirements.

The CDFA Produce Safety Program (PSP) offers PSA Grower Training courses at no cost for all California residents. If you have not yet completed a PSA Grower Training course or would like to receive a refresher, please visit https://www.cdfa.ca.gov/producesafety/growertraining/ for course dates.

PSA is also hosting update webinars at no cost for past course participants to understand the new pre-harvest agricultural water requirements. A certificate of completion will be emailed to webinar participants who attend one full session (only one session needs to be attended). Registration is required and participants must join the webinar within 15 minutes of the start time to receive a certificate. Participants can download handouts (English) | (Spanish) to take notes. If you have any questions on these webinars, please contact the PSA team at psatrainers@cornell.edu.

Upcoming live webinars in English:

Upcoming live webinars in Spanish:

Pre-recorded PSA webinars:

On-Farm Readiness Reviews

Produce growers and handlers that have not yet undergone their initial PSR inspections are encouraged to request an On-Farm Readiness Review (OFRR) to aid in their preparation process.

An OFRR is a free, voluntary, customized assessment conducted before an initial regulatory inspection that includes a farm walk-around and one-on-one conversations with CDFA PSP staff to discuss how the PSR applies to your operation in a confidential, educational format.

OFRRs can be requested by emailing producesafety@cdfa.ca.gov. Additional information on OFRRs can be found on our OFRR Blog Post.

CDFA Technical Assistance Program

Produce growers and handlers can receive one-on-one technical assistance at no cost by requesting to be connected to the CDFA Technical Assistance Program (TAP). CDFA TAP is a service that offers educational resources and food safety support for produce operators in California.

CDFA TAP participants will be connected to a Technical Assistance Provider from the University of California Cooperative Extension team who can provide customized support on pre-harvest agricultural water rule compliance and inspection preparation.

Request CDFA TAP support by emailing producesafety@cdfa.ca.gov and learn more at https://www.cdfa.ca.gov/is/technicalassistance/.

What is Pre-Harvest Agricultural Water?

Pre-Harvest Agricultural Water refers to water used during growing activities where water is intended to, or is likely to, contact covered produce or food contact surfaces.

Examples of growing activities can include irrigation, crop sprays, fertigation, cooling, frost protection, dust abatement and any other uses where water directly contacts produce or food contact surfaces.

Covered produce means produce that is subject to the requirements of the Produce Safety Rule including the harvestable or harvested part of the crop. 

Background on the Pre-Harvest Agricultural Water Final Rule

On May 6, 2024, FDA published a final rule on pre-harvest agricultural water revising certain requirements in Subpart E of the FSMA Produce Safety Rule (PSR) for covered produce (other than sprouts) for enhanced produce safety. The new rule moves from an emphasis on testing pre-harvest water to performing an agricultural water assessment. It does not change existing agricultural water requirements for sprouts or harvest and post-harvest water uses. The final rule went into effect on July 5, 2024.

[1] Under the FSMA Produce Safety Rule, farms sizes are classified by the average annual gross produce sales adjusted for inflation over a 3-year period. Click here to learn more about the FSMA Inflation Adjusted Cut Offs. “Large” farms have average annual produce sales above $500,000 adjusted for inflation.

[2] “Small” farms have average annual produce sales above $250,000 and up to $500,000 adjusted for inflation.

[3] “Very Small” farms have average annual produce sales above $25,000 and up to $250,000 adjusted for inflation.

FDA Publishes Final Rule on Pre-Harvest Agricultural Water

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On May 6, 2024, the U.S. Food and Drug Administration (FDA) published a final rule on pre-harvest agricultural water revising certain requirements in Subpart E of the FSMA Produce Safety Rule (PSR) for covered produce (other than sprouts) for enhanced produce safety.

The new rule replaces the prior pre-harvest water microbial quality criteria and testing requirements with requirements for systems-based agricultural water assessments for hazard identification and risk management. Agricultural water assessments will now need to be conducted once annually, and whenever a significant change occurs that increases the likelihood of hazards being introduced to produce or food contact surfaces. The new rule does not change existing agricultural water requirements for sprouts or harvest and post-harvest water uses.

FDA states this new 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. This includes an evaluation of the water system, water use practices, crop characteristics, environmental conditions, potential impacts on 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 their assessments. Hazards related to certain activities associated with adjacent and nearby land uses are subject to expedited mitigation.
  • Adds new options for mitigation measures, providing farms with additional flexibility in responding to findings from their pre-harvest agricultural water assessments.

The final rule is effective July 5, 2024. Compliance dates for the pre-harvest agricultural water requirements for covered produce (other than sprouts) are as follows[1]:

  • For Large farms: April 7, 2025 (9 months after the effective date of the final rule)
  • For Small farms: April 6, 2026 (1 year, 9 months after the effective date of the final rule)
  • For Very Small farms: April 5, 2027 (2 years, 9 months after the effective date of the final rule)

If you have questions about the Produce Safety Rule, please contact producesafety@cdfa.ca.gov.

Additional Resources:

[1] Under the FSMA Produce Safety Rule, farms sizes are classified by the average annual gross produce sales adjusted for inflation over a 3-year period. Click here to learn more about the FSMA Inflation Adjusted Cut Offs. “Large” farms have average annual produce sales above $500,000 adjusted for inflation. “Small” farms have average annual produce sales above $250,000 and up to $500,000 adjusted for inflation. “Very Small” farms have average annual produce sales above $25,000 and up to $250,000 adjusted for inflation.

FDA Launches Agricultural Water Assessment Builder to Help Farms Understand Agricultural Water Proposed Rule Requirements

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From the U.S. Food and Drug Administration

The U.S. Food and Drug Administration (FDA) released a new user-friendly online Agricultural Water Assessment Builder to help farms understand the proposed requirements for an agricultural water assessment in the Agricultural Water Proposed Rule.  Use of the tool is optional.

If finalized, the proposed rule would require farms to conduct systems-based agricultural water assessments to determine and guide appropriate measures to minimize potential risks associated with pre-harvest agricultural water. The assessment would include an evaluation of the water system, agricultural water use practices, crop characteristics, environmental conditions, potential impacts on source water by activities conducted on adjacent and nearby land, and other relevant factors, such as the results of optional testing. Covered farms would be required to conduct pre-harvest agricultural water assessments annually, and whenever a significant change occurs that affects the likelihood that a known or reasonably foreseeable hazard will be introduced into or onto produce or food contact surfaces.

The Agricultural Water Assessment Builder prompts users to answer questions and/or fill in information specific to their farms. Information entered into the tool is not shared with the FDA and will not be saved. However, users have the opportunity save or print the information they provide to their local computers.

This user-friendly tool incorporates information from the Agricultural Water Proposed Rule, the Final Qualitative Assessment of Risk to Public Health from On-Farm Contamination of Produce, and the 2015 Produce Safety Final Rule.

The development of this tool is consistent with our objectives in the New Era of Smarter Food Safety Blueprint to look for smarter tools and approaches for food safety. We welcome feedback on this optional tool, such as suggestions related to the tool’s functionality and, usability. Feedback on the tool can be sent to agwaterbuilder@fda.hhs.gov.

For Additional Information

Save the Date – March 11 webinar offers discussion about proposed agricultural water requirements for Produce Safety Rule

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Western States Webinar on Proposed Agricultural Water Rule

Save the date for a western states webinar 10-11 a.m. (PST) March 11 on a revision proposed by the U.S. Food and Drug Administration (FDA) to Subpart E of its Food Safety Modernization Act (FSMA) Produce Safety Rule that would change the pre-harvest agricultural water requirements for covered produce (other than sprouts).

The webinar is co-hosted by the National Association of State Departments of Agriculture (NASDA) and California Department of Food and Agriculture (CDFA) for the western states of Arizona, California, Colorado, Hawaii, Nevada, New Mexico and Utah.

FDA’s proposed revision, for which FDA developed an Agricultural Water Assessment Fact Sheet, is intended to address stakeholder concerns about the complexity and practical implementation of certain pre-harvest agricultural water requirements. The proposed revision does not change requirements for agricultural water used during and after harvest, or for sprouts. If enacted as proposed, the revision would introduce a systems-based, pre-harvest agricultural water assessment to evaluate potential hazards and guide risk management decision-making on the farm. Public comments about the FDA’s proposed revision may be submitted via the Federal Register until April 5, 2022.

During the webinar, CDFA Secretary Karen Ross will give opening remarks, then a subject matter expert from FDA will provide a brief overview of the proposed revision. Attendees will have the opportunity to ask FDA officials questions about the proposed revision. In California, the Produce Safety Rule is regulated on FDA’s behalf by the CDFA Produce Safety Program. Questions may be shared with presenters and hosts ahead of the webinar by submitting them to producesafety@cdfa.ca.gov. Visit https://www.surveymonkey.com/r/WesternProposedAgWater to receive login instructions for the March 11 webinar. Participation is limited to 500 people on a first-come, first-served basis.

Proposed revision to Produce Safety Rule agricultural water requirements — comment period open through April 5

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The U.S. Food and Drug Administration (FDA) is proposing a revision of the Food Safety Modernization Act (FSMA) Produce Safety Rule that would change the pre-harvest agricultural water requirements for farms covered by the Produce Safety Rule (other than sprouts). Most California fruit, vegetable and nut farms are covered by the Produce Safety Rule, including those with more than $25,000 in average annual produce sales, with some exceptions.

FDA’s proposed revision is intended to address stakeholder concerns about the complexity and practical implementation of certain pre-harvest agricultural water requirements. The proposed revision does not change requirements for agricultural water used during and after harvest, or for sprouts. It would introduce a systems-based, pre-harvest agricultural water assessment to evaluate potential hazards and guide risk management decision-making on the farm. Public comments about the FDA’s proposed revision may be submitted via the Federal Register until April 5, 2022.

In California, the Produce Safety Rule is regulated on FDA’s behalf by the California Department of Food and Agriculture (CDFA) Produce Safety Program. During the proposed revision’s comment period and until the FDA rulemaking process has been completed, CDFA’s Produce Safety Program will maintain the current inspection process related to this section of the Produce Safety Rule.

Visit CDFA’s Produce Safety Program webpage for more information about farms covered by the Produce Safety Rule.

Food Safety E-Learning Series: attend sessions this week about production agricultural water, view previous sessions about biological soil amendments of animal origin

Posted in Announcements, Education, Regulation

Register now to attend three free, online courses starting this week about production agricultural water. These courses are part of the California Farm Food Safety E-Learning series created by the UC Davis Department of Food Science and Technology, funded by the California Department of Food and Agriculture Produce Safety Program. Also visit the UC Davis website to view session recordings from the initial sessions in this series about biological soil amendments of animal origin (BSAAO).

In all sessions, several speakers provide short presentations during a two-hour window with time dedicated to answering questions from participants. Pre-registration is required for the free sessions held online via Zoom.

The Production Agricultural Water Series starting May 13 will provide information on risks associated with production agricultural water, current best practices for agricultural water management, treatment options for agricultural water, and updates on agricultural water requirements in the Food Safety Modernization Act Produce Safety Rule. This series is tailored to Californians, with specific agricultural water regulatory and enforcement information relevant to California growers.

  • Session 1: 1-3 p.m. May 13 – Assessing on-farm risks associated with agricultural water systems
  • Session 2: 1-3 p.m. May 20 – Introduction to options for treating agricultural water
  • Session 3: 10 a.m. to 12 p.m. June 17 – Update on agricultural water requirements within the Produce Safety Rule (tentative topic, pending availability of proposed revisions)
  • Sign up for the free Production Agricultural Water Series here

The BSAAO Series provided information about the benefits and risks of BSAAO use during production. This series was tailored to Californians, with specific regulatory and enforcement information relevant to California growers.