March 17, 2018

Are You “Produce Safety Rule” Ready?

It’s been a long road since the signing of the Food Safety Modernization Act (FSMA) in 2011, and recently you’ve more than likely been hearing much talk about preparation and compliance. FSMA has resulted in several food safety regulations, of which seven are relevant to the produce sector.

January 26, 2018, was the compliance deadline for large businesses to meet the majority of provisions in one of these rules, the Produce Safety Rule, which includes requirements for farms growing, harvesting, packing and/or holding produce grown for consumption in the United States (domestic and imported produce). “Large” businesses, as FDA defined them in these rules, are farming operations that make more than $500,000 in produce sales. Small and very small businesses, as defined by the Food and Drug Administration (FDA), have more time to comply with this rule. So if you’re a large business and you lack confidence or are uncertain in your readiness, do not wait any longer to explore and utilize tools, resources and training available.

Throughout the rule development process, Western Growers has worked extensively with produce companies, other produce trade associations, universities and government agencies including the FDA, USDA, and state agriculture departments to inform and provide feedback on the provisions of the Produce Safety Rule so they contain food safety practices that are both protective to the consumer and also feasible for the produce sector. Some of these efforts are ongoing and the FDA has recognized that more clarity and guidance is needed for the produce sector on certain requirements.

For instance, there has been a lot of confusion around FDA’s “farm” definition, especially in relation to what is considered a “Secondary Activities Farm.” Western Growers and other produce associations are working with the FDA to clarify the confusion around ownership issues related to the farm definition.

For the Produce Safety Rule, the FDA has published the following announcements:

•   A delay of farm inspections until January 2019. Large farming operations are still expected to be in compliance by the January 26, 2018, deadline, but official inspections are not likely until 2019, providing produce companies with an opportunity to ensure their food safety programs are operating in alignment with this Rule.

•   A review of the agriculture water requirements. The FDA has not provided clarification on these requirements, and the first compliance date has been moved to January 26, 2020, for large companies. Also, a Water Summit took place on February 27–28, 2018, in Covington, KY, to address challenges and potential solutions associated with these requirements. In the meantime, producers are encouraged to understand and monitor the quality of their water.

•   Enforcement discretion of written assurances. These assurances apply to produce that will receive commercial processing that adequately reduces microbial hazards. In light of supply chain complexities and resources needed to meet those requirements, the FDA has announced it intends to exercise enforcement discretion while it reviews the rules to ensure other approaches or changes are considered regarding the application of these provisions.

•   Water testing methods. The FDA published a list of water testing methods that they consider equivalent to the EPA 1603 Method required in the Rule.


So, if you are a farm, what should your company be focusing on in the coming year before farm inspections begin? If you have not already assigned someone in your organization to be responsible for your food safety program, that should be your first priority. This person must receive training under FDA-standardized curriculum such as the one developed by the Produce Safety Alliance. Western Growers is working with AgSafe to provide training in English and Spanish at locations in Northern and Central California from now through May 2018 at a reduced cost. This opportunity is possible through funds the California Department and Food and Agriculture (CDFA) is providing for a limited time. After May, trainings may still be offered, but pricing will increase. For more information, visit our website:

In addition, the FDA, in coordination with the National Association of State Departments of Agriculture, is offering an On-Farm Readiness Review—a voluntary program for farmers. If you’re ready to test your readiness, a team of state and FDA regulators and educators will visit your farm—not to inspect it, but to assess it and provide insight, advice, and technical assistance regarding your specific operations. The only way you would be involved in any regulatory action would be if something is considered a public health threat.

You may also wish to consider conducting your own self-assessment, in which case we suggest the use of the Western Growers self-audit checklist that accompanies the WG’s Produce Safety Rule Implementation Guide. This guide recently published by Western Growers, provides, in addition to the checklist, an outline of requirements, helpful illustrations, and decision trees to walk you through your readiness evaluation. Finally, we also encourage attending workshops and webinars, such as the one recently offered on February 26, 2018, which featured an FDA expert to provide an update on compliance and enforcement activities.

For more information about the Produce Safety Rule and Western Growers’ resources, visit our website at, or contact me, Sonia Salas, at 949-885-2251 or by email at [email protected].