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Sarah Everhart

FSMA - Updates and Produce Safety Rule Training


Image of apple orchard at WMREC.
Photo Credit Edwin Remsberg

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September offered up several FSMA updates for growers, including the first injunction against a food producer for food safety violations, a new proposed rule for food traceability, and the first Maryland Produce Safety Rule Grower Training opportunity for the 2020-2021 winter season.


FDA Issues First FSMA Permanent Injunction

The U.S. Food and Drug Administration (FDA) on September 15, announced the first consent decree of a permanent injunction issued by the U.S. District Court for the Northern District of Illinois against Fortune Food Product, Inc., an Illinois-based processor of sprouts and soy products, for violating public safety standards under the Produce Safety Rule (PSR) enacted under the Food Safety Modernization Act (FSMA). The Fortune Food Product, Inc. will need to take corrective actions and notify FDA before they are able to resume operations.


According to FDA, the PSR requires, among other things, that covered sprout operations take measures to prevent the introduction of dangerous microbes into seeds or beans used for sprouting; test spent sprout irrigation water (or, in some cases, in-process sprouts) for the presence of certain pathogens; test the growing, harvesting, packing and holding environment for the presence of the Listeria species or Listeria monocytogenes; and take corrective actions when needed. The injunction came after several inspections and the issuance of a warning letter outlining the PSR, Current Good Manufacturing, and misbranding violations. Two of the PSR violations cited that are also requirements for non-sprout growers are: 1) maintaining agricultural water distribution systems to prevent water the systems from being a source of contamination; and 2) protecting covered produce, food contact surfaces, and food-packing materials from contamination by pests in buildings. (For information on how to apply the PSR to your operation check out the Food Safety Friday How-To Webinar Series).


Proposed Food Traceability Rule

On September 21, the FDA announced a proposed rule to establish additional traceability recordkeeping requirements for certain foods. The FDA also published a draft “Food Traceability List,” which describes the foods that would be subject to the proposed requirements. The list includes leafy greens, fresh-cut fruits and vegetables, some types of fish, shell eggs, nut butters, and more. If finalized, the proposal would standardize the data elements and information that firms must establish and maintain, and the information they would need to send to the next entity in the supply chain to facilitate rapid and accurate traceability. The proposed rule requires those who manufacture, process, pack, or holds food on the Food Traceability List (FTL) to establish and maintain records associated with specific Critical Tracking Events (CTEs), which include: growing, receiving, transforming, creating, and shipping. The proposed rule and draft Food Traceability List are available for public comment for 120 days from September 23, 2020 (until January 21, 2021).


Maryland PSR Grower Training Remote Workshop

This year, due to restrictions related to COVID, the first PSR Grower Training Workshop will be done online over the course of two half-day sessions. The first day on November 4, 11:30 AM – 5:00 PM & November 5th, 11:30 AM - 4:30 PM. Growers may register now and will need to be registered by October 30th so that materials can be mailed prior to the Workshop. If you still need to attend a PSR training this is a great opportunity to do so from the comfort of your home.



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