FDA’s Seesaw of Action on the Produce Safety RulE
Updated: Oct 17, 2019
With the Produce Safety Rule in effect for nearly three years for larger farmers (about eight months for even the smallest), inspections having started just this spring, and the water quality requirements pushed a further two years back, FDA is continuing a seesaw of efforts to increase the food safety and mitigate the risks of this grounding link of the food supply chain.
Most recently was a positive move with the awarding of a formalized cooperative agreement with the National Association of State Departments of Agriculture (NASDA) to provide information and resources to state and territorial regulatory agencies to help in the planning and implementation of the Produce Safety Rule. FDA has had cooperative agreements with a number of states and territories, providing technical support and funding, but this new agreement is intended to align these programs under a comprehensive and nationally consistent system of support and resources.
As part of the five-year agreement, NASDA will work with FDA to plan and host an annual National Consortium meeting of state and territorial regulatory agencies involved with implementation of the Produce Safety Rule, to provide program updates, share best practices, and give feedback to FDA on program enhancements and adjustments.
NASDA also will work closely with FDA to develop a national program that promotes a uniform foundation of produce safety and to implement and update the On-Farm Readiness Review (OFRR) system. Voluntary OFRR visits by FDA began last summer (2018) to help farmers assess how prepared they are to comply with the Produce Safety Rule. FDA also has worked with NASDA on the creation of an Inspectional Documentation and Dispute Mitigation and Resolution Procedures, exploring new ways of ensuring objectivity and consistency for produce inspections and handling disagreements between regulatory agencies conducting inspections. One aspect of this is the development of a produce-specific 483 Inspectional Observation form that recognizes the unique issues associated with produce farm inspections.
In brief, the intended outcomes of the new FDA/NASDA agreement are to:
Provide a system of support and related outputs for national consistency in produce safety regulatory programs.
Hold an annual National Consortium meeting of all regulatory parties involved in produce implementation.
Coordinate, implement, and update the On-Farm Readiness Review system within the first two years of the program.
In years three to five, develop a national produce safety regulatory program to establish and promote a uniform foundation of produce safety, including research on and leveraging of existing programs.
Though also positive in its primary purpose of reassessing the science behind the Produce Safety Rule water quality standards requirements, because FDA said, “the science under which the original rule was developed was flawed,” there is a line of negativity in the fact that this further pushes back the dates for industry compliance with agricultural water standards. FDA announced, in March, that it would delay for two years the Produce Safety Rule water quality standards regulation. During that time, the agency intends to address questions about the practical implementation of compliance with certain provisions, consider how the regulatory burden can be reduced or flexibility increased, and ensure that the standards “are strong enough to protect public health but practical enough to be effective on farms of all size and type.” The extension also is due to numerous comments FDA received about the practicality of some of the requirements related to the testing requirements for pre-harvest agricultural water.
At an IAFP keynote presentation in July, Deputy Commissioner for Food Policy and Response Frank Yiannas acknowledged the concerns about the delay given the role that agricultural water has played in recent outbreaks, and stated, “Let me assure you that working with the produce industry to make agricultural water as safe as it can possibly be is a priority for FDA and it is a priority for me personally.” He noted the work FDA is doing with industry groups to help minimize the risk of pathogen contamination, the spring start of routine inspections of large farms and inspection of foreign farms, and its collaborative research investigations to sample agricultural water in the U.S. and internationally.
As often happens with the produce industry and FDA regulatory progress, the industry cannot wait for FDA to put in new enforceable water standards. So the Leafy Green Marketing Agreement got out in front by publishing its own standards in March. As usual the industry is applauded for pushing this important issue forward – yet, as often happens with produce, the industry is only as good as its weakest link – or in this case its most resistant grower, and thus produce risks and reputational vulnerabilities remain high.
Although the new agricultural water compliance dates for covered produce other than sprouts, are now January 26, 2024, for very small businesses; January 26, 2023, for small businesses; and January 26, 2022, for all other businesses – all other Produce Safety Rule provisions are in effect and FDA is inspecting. If you aren’t sure if your business is in compliance, give TAG a call today. We can help!
About The Acheson Group (TAG)
Led by Former FDA Associate Commissioner for Foods Dr. David Acheson, TAG is a food safety consulting group that provides guidance and expertise worldwide for companies throughout the food supply chain. With in-depth industry knowledge combined with real-world experience, TAG's team of food safety experts help companies more effectively mitigate risk, improve operational efficiencies, and ensure regulatory and standards compliance. www.AchesonGroup.com