Tag: Produce Safety Program

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. 

Produce Safety Program Offers Flooding Response Resources for California Produce Growers

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The California Department of Food and Agriculture (CDFA) Produce Safety Program announces a new Flooding Response Resources section has been added to its PSP Educate webpage.

As seasonal storms are underway, this new section offers several educational resources related to flooding and produce safety on farms. The California agricultural community is encouraged to visit this site regularly as new resources become available.

In Guidance for Industry: Evaluating the Safety of Flood-affected Food Crops for Human Consumption, the U.S. Food and Drug Administration (FDA) defines flooding in the context of produce safety as the flowing or overflowing of water from sources outside a farmer’s control onto lands used to grow, harvest, pack, or hold produce. Flooding events can pose a public health risk as flood waters may contain sewage, chemicals, heavy metals, pathogenic microorganisms, and other contaminants.

If the edible portion of a crop is exposed to floodwaters, it is considered adulterated under section 402(a)(4) (21 U.S.C. 342(a)(4)) of the Federal Food, Drug, and Cosmetic Act and should not enter human food channels. For crops that were in or near flooded areas but whose edible portion did NOT contact flood waters, growers should evaluate the safety of the crops for human consumption on a case-by-case basis for possible adulteration.

If you are impacted by flooding or would like to receive more information on how to respond to flooding with regards to produce safety, please reach out to us at producesafety@cdfa.ca.gov. The CDFA Produce Safety Program can provide technical assistance to California produce growers and can help connect you with experts through the CDFA Technical Assistance Program.

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.

How California produce farmers can prepare for Produce Safety Rule inspection

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Image of Sarah Standiford with the words "Interview with Produce Safety Program inspector gives tips on how to prepare for Produce Safety Rule inspection," with reference to the interview linked in the article and the CDFA Produce Safety Program logo

The Community Alliance with Family Farmers (CAFF) has published an interview with Sarah Standiford of CDFA’s Produce Safety Program as part of a Food Safety Modernization Act (FSMA) case study series. The interview highlights how California farms can prepare for a FSMA Produce Safety Rule inspection.

The article’s Q&A format reviews the background of why CDFA performs these inspections on behalf of the U.S. Food and Drug Administration, the steps that occur during an inspection, and tips for farmers preparing for an inspection.

“CDFA really values ‘soft skills’ in their inspectors and we understand that growers’ farms are their livelihoods,” Standiford says in the interview. “CDFA’s Produce Safety Program is here to help farms feel comfortable with the FSMA produce safety requirements and to foster compliance with the Produce Safety Rule. It’s a shared responsibility between growers, inspectors and farm employees – we all need to work together to keep our food safe.”

Click here to read the CAFF interview, “FSMA Inspection Case Study: CDFA FMSA PSP Inspector.” 

Click here to view this original post on CDFA’s Planting Seeds blog.

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.