Produce Safety Rule – Page 4 – Produce Safety Rules!

FDA Publishes Final Rule on Pre-Harvest Agricultural Water

May 16, 2024May 16, 2024Posted in Announcements, Education, Implementation, RegulationTagged agricultural water requirements, CDFA, final rule, final rule agricultural water, final rule pre-harvest agricultural water, final rule pre-harvest water, Food Safety, Food Safety Modernization Act, FSMA, pre-harvest, pre-harvest agricultural water, Produce Safety Program, Produce Safety Rule

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.

To stay up to date with news related to the California Department of Food and Agriculture (CDFA) Produce Safety Program, sign up for the Produce Safety Program Mailing List by checking the Inspection Services Division (ISD) / Produce Safety box
To learn more about CDFA’s Produce Safety Program, please visit https://www.cdfa.ca.gov/producesafety/

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

March 25, 2022March 28, 2022Posted in Announcements, RegulationTagged Agricultural Water Proposed Rule, agricultural water requirements, FDA, Food Safety Modernization Act, Produce Safety Rule

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

February 10, 2022Posted in Announcements, Education, RegulationTagged agricultural water requirements, NASDA, Produce Safety Program, Produce Safety Rule, Proposed Revision

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

January 21, 2022Posted in Announcements, RegulationTagged agricultural water requirements, Produce Safety Rule

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

June 1, 2021Posted in Announcements, EducationTagged CDFA On-Farm Readiness Review, OFRR, On Farm Readiness Review, On-Farm Readiness Review, Produce Safety Rule, Produce Safety Rule On-Farm Readiness Review

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).

PRODUCE SAFETY RULE UPDATE – CDFA MAILS QUESTIONNAIRES TO SMALLER PRODUCE FARMS

July 25, 2019July 25, 2019Posted in Announcements, Education, Implementation, RegulationTagged CDFA, FSMA, Produce Safety Program, Produce Safety Rule

Small and Very Small Produce Farmer Questionnaire

SACRAMENTO, July 25, 2019 – The California Department of Food and Agriculture (CDFA) is announcing that starting next week, 8,000 “small” and “very small” produce farms throughout California are being mailed educational letters about their roles in upholding the Produce Safety Rule (PSR) of the federal Food Safety Modernization Act (FSMA), passed in 2011 to help prevent foodborne illness outbreaks. Accompanying the letters are questionnaires to be returned to the CDFA by August 31 in order to verify commodities grown, determine whether annual sales qualify farms for a PSR exemption, and to help prioritize future inspections. The current stage of inspections to verify PSR compliance has been taking place since April for “large” farms.

“California has many more produce farms than any other state in the nation,” said CDFA Secretary Karen Ross. “Approximately 20,000 farms in the Golden State will now be subject to new food safety regulations under the Produce Safety Rule.”

PSR regulations include ensuring produce is properly handled by workers, that farm equipment is sanitary, that produce is grown with safe soil inputs, and that measures are in place to prevent contamination of produce by wildlife or domesticated animals. These regulations are similar to food safety plans that many farmers have been implementing for years, and that most grocery stores and restaurants already require. However, the Produce Safety Rule now makes food safety on farms federal law.

To help implement the PSR, CDFA created the Produce Safety Program (PSP) to educate farmers and then conduct on-farm inspections on behalf of the U.S. Food and Drug Administration (FDA). PSP farmer education resources include a website, a Facebook page and an e-newsletter. Website features include the ability to schedule an On-Farm Readiness Review, and to register for a Produce Safety Rule Grower Training Course. This course is mandatory for at least one employee of every produce farm covered under the new regulations and is the best way for farmers to learn about required food safety practices.

In the current PSR stage:

Inspections are underway for “large” produce farms with average annual sales of $500,000 or greater during the previous three-year period.
“Small” farms with average annual sales of $250,000–$500,000 during the previous three-year period are now expected to be in PSR compliance, with inspections set to begin in January 2020.
“Very small” farms with average annual sales of $25,000–$250,000 during the previous three-year period must be in general compliance by January 2020, with inspections set to begin in January 2021.

Any farm that does not comply with the Produce Safety Rule may face economic, regulatory and legal consequences. Minor violations will be handled through on-site education, in line with an “Educate Then Regulate” commitment. However, if there is significant and imminent threat to public health, a PSP inspector will inform the FDA and the California Department of Public Health, which may perform accelerated on-farm follow-up inspections or administrative detention orders up to and including seizure of the product that could cause people to get sick.

Visit www.cdfa.ca.gov/producesafety