Tag: Food Safety Modernization Act

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.

CDFA Produce Safety Program Launches Phase 1 of the Online PSP Portal Including California Produce Grower Notifications

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The California Department of Food and Agriculture (CDFA) Produce Safety Program (PSP) announces the launch of Phase 1 of the Farm Data Repository website, also known as the PSP Portal.

Beginning in April 2024, California produce farms required to comply with the U.S. Food and Drug Administration (FDA) Food Safety Modernization Act (FSMA) Produce Safety Rule will be added into the system on an ongoing, rolling basis. Once added, growers can anticipate receiving a welcome email notification with instructions on how to create an online account and verify their account information.

Growers who receive a welcome email are encouraged to login and verify the information listed for their farm to ensure accurate information regarding their own operations is on file with CDFA PSP.

Questions and technical support requests regarding the PSP Portal can be submitted to producesafety@cdfa.ca.gov.

In January 2024, CDFA PSP announced the development of a new, digital data repository system for California farms and farm inspections to support statewide compliance with the FSMA Produce Safety Rule.

The PSP Portal website will result in California farmers having password-protected access to the data CDFA PSP collects on their farms and operations, including inspection reports and educational communications. Additionally, this system will allow CDFA PSP to efficiently allocate inspection efforts based on food safety risk factors to help ensure a safe and quality food supply for the people of California and beyond. 

CDFA Produce Safety Program Announces Development of New Digital Farm Data Repository Website

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The California Department of Food and Agriculture (CDFA) Produce Safety Program (PSP) announces the development of a new digital pathway for fresh produce farmers in California to access their own inspection records and produce safety resources online.

Starting in late 2024, California fresh produce farmers will be able to log into a new cloud-based PSP farm data repository website to view their own farm information and have on-demand access to their digital produce safety inspection reports related to their own farms.

In addition, the PSP farm data repository website will provide resources to support on-farm compliance with the requirements of the federal Food Safety Modernization Act’s Produce Safety Rule and provide a convenient way for California farmers to connect with PSP staff. The new technology will also allow the Produce Safety Program to focus inspection efforts based on food safety risk factors to help ensure a safe and quality food supply for all consumers.

This project will be delivered in two phases. Phase 1 is planned for release in early 2024, with Phase 2 expected to be in development throughout the year and a full system launch anticipated in late 2024.

The CDFA Produce Safety Program’s mission is to ensure California produce farmers understand how to comply with the requirements of the Produce Safety Rule, resulting in a safer food supply for the people of California and beyond. The central PSP farm data repository website helps to put the “M” in the Food Safety Modernization Act for a safer produce supply chain and to align with the U.S. Food and Drug Administration’s New Era of Smarter Food Safety.

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

Produce Safety Program Supervisor Discusses Produce Safety Rule Impact on California Farmers in Radio Interview

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CDFA Produce Safety Program Regulates the FDA Food Modernization Act

California Department of Food and Agriculture (CDFA) Produce Safety Program (PSP) Supervisor Shelley Phillips was recently interviewed by “Farmer Fred” Hoffman on KSTE radio’s “Farm Hour” program to discuss the impact of the federal Food Safety Modernization Act (FSMA) Produce Safety Rule (PSR) on California farmers.

CDFA created the PSP to “Educate then Regulate” California farmers about the PSR under the authority of the U.S. Food & Drug Administration (FDA), in partnership with the California Department of Public Health (CDPH). FSMA was passed in 2011 to help prevent foodborne illness outbreaks. PSR implementation and enforcement is occurring in stages between 2019 and 2021.

“It’s a way for the FDA to be proactive about food safety rather than being reactive when we have outbreaks or other issues surrounding food safety,” Phillips says about the PSR during the interview.

Items Phillips discusses during the 10-minute interview include:

  • Which farms are required to verify PSR compliance and which farms are PSR exempt
  • What proactive measures farmers are required to follow under the PSR
  • The current stage of PSR implementation and inspections
  • How “small” farmers (average annual sales of $250,000–$500,000 during the previous three-year period) should fill out and submit a recent questionnaire that the CDFA mailed, in order to be prepared for the next stage of PSR inspections
  • What farmers should expect during all stages of a PSP inspection, from initial contact to a follow-up inspection report
  • The educational resources available on www.cdfa.ca.gov/producesafety to help farmers understand and prepare for PSR compliance, including scheduling an On-Farm Readiness Review

“The inspector is there to assist the farmer, so any questions that the farmer may have is fair game,” Phillips says at the interview’s conclusion. 

Click here to hear the full interview.