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Are you prepared for your produce safety regulatory inspection? Are you wondering how the requirements of the Food Safety Modernization Act (FSMA) Produce Safety Rule (PSR) apply to your farm and food safety practices?

Get answers to these questions and more by scheduling a free On-Farm Readiness Review!

Produce farms nationwide that are covered under the federal FSMA Produce Safety Rule are required to comply with the requirements of the Produce Safety Rule and are subject to mandatory regulatory inspections as required by the U.S. Food and Drug Administration (FDA) under the jurisdiction of the Federal Food, Drug, and Cosmetic Act. In California, the California Department of Food and Agriculture (CDFA) Produce Safety Program (PSP) inspectors are duly appointed officers authorized to conduct on-farm produce safety regulatory inspections on behalf of the FDA.

To prepare for a produce safety inspection, California farm operators are encouraged to request an On-Farm Readiness Review (OFRR). An OFRR is a free, voluntary, customized assessment conducted before an initial regulatory inspection. An OFRR includes a farm walk-around and one-on-one conversations with CDFA PSP staff to discuss how the Produce Safety Rule applies to your operation.

An OFRR is not a regulatory inspection. Instead, it aims to help prepare you for your upcoming produce safety inspection and discuss enhanced food safety practices tailored to your unique farm needs. Farms that request an OFRR will receive a free OFRR produce safety manual, FSMA Produce Safety Rule regulatory pocket handbook, and recordkeeping templates. “Small”[1] and “Very Small”[2] farms that have not yet undergone an initial FSMA Produce Safety Rule regulatory inspection can especially benefit from an OFRR to aid in their preparation plan for their subsequent initial inspection.

In California, farm operators are encouraged to request a free OFRR assessment after completing the Produce Safety Alliance (PSA) Grower Training Course. Scheduling an OFRR is easy! Simply email producesafety@cdfa.ca.gov or call our Produce Safety Rule and Outreach Specialist, Angela Terrazas, at 916-809-0245. When requesting an OFRR, please be prepared to provide the following information to support a seamless scheduling process:

  1. Farm name and location
  2. A contact person and how to contact you
  3. What produce do you grow, harvest, pack, or hold?
  4. When are you harvesting?
  5. Have you completed the PSA Grower Training?

Questions? Please contact producesafety@cdfa.ca.gov or Angela Terrazas at 916-809-0245.

The CDFA Produce Safety Program is a unit operating under the CDFA Inspection Services Division with a mission to ensure California produce farmers understand how to comply with the requirements of the FSMA Produce Safety Rule, resulting in a safer food supply for the people of California and beyond.

Under the FSMA Produce Safety Rule, farms sizes are classified by the average annual gross produce sales adjusted for inflation over a three-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.

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

[2] “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

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

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

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

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.

Schedule free On-Farm Readiness Review to ensure compliance with Produce Safety Rule

Produce Safety Rule On-Farm Readiness Review

Are your farm’s food safety practices compliant with the Produce Safety Rule? A good way to find out is to schedule a free, non-regulatory On-Farm Readiness Review (OFRR) with the California Department of Food and Agriculture (CDFA) Produce Safety Program.

OFRRs are available to “small” farms (average annual gross produce sales within the last three years of $250,000 – $500,000) or “very small” farms (average annual gross produce sales within the last three years of $25,000 – $250,000).

OFRRs are designed to give farmers a better understanding of what they can expect from a routine Produce Safety Rule inspection. The U.S. Food and Drug Administration (FDA), pursuant to the Food Safety Modernization Act (FSMA), developed the Produce Safety Rule to regulate the production of nearly all fruits, nuts and vegetables. The Produce Safety Rule establishes a set of practices that farmers must follow that are designed to minimize the potential of foodborne illnesses. In California, CDFA’s Produce Safety Program conducts Produce Safety Rule inspections on behalf of the FDA.

Produce Safety Rule inspections are underway. To help ensure your “small” or “very small” farm is compliant, please contact CDFA’s Produce Safety Program at producesafety@cdfa.ca.gov or (916) 900-5322 to schedule an On-Farm Readiness Review (OFRR).