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Produce Continues to Prompt Regulation and Recalls

From recalls to regulation, produce has been getting a lot of attention in recent months. Since March, FDA has released an online agricultural water assessment tool, announced ag water treatment protocol updates, and issued final guidance on microbial food safety in sprouts. Related or not, these followed a few major Listeria-caused recalls over the winter, including two for packaged salad and one for enoki mushrooms.

Let’s take a look first at FDA’s actions. While FDA continues to develop the final amended rule for the microbial criteria and testing requirements for pre-harvest agricultural water of FSMA’s Produce Safety Rule (as proposed December 6, 2021, with comments closed April 5, 2022), the agency released an online Agricultural Water Assessment Builder tool in March. Use of the interactive tool is optional, but is intended to help farms understand the proposed requirements. Guiding the user through the elements of a pre-harvest ag water assessment, the tool includes questions and fill-in-the-blank sections to guide users toward solutions focused on their unique conditions. While the tool requests some identifying information, those questions are optional, and no entered information is shared with FDA or saved on the site, but can be printed or downloaded to the user’s computer.

Very soon in the click-through tool is a question asking if the user is able to demonstrate one of three listed exemptions for the proposed rule. If the answer is yes, the user is asked to explain their response and the assessment is complete, with the following page stating: “If one of these exemptions applies to a covered farm, it would not be required to prepare a written agricultural water assessment” under the proposed rule. If the answer is no, the user begins the assessment by considering the components of the covered farm’s agricultural water system, then moves through a systemic assessment of 11 key elements.

In May 2022, FDA announced further updates to the July 30, 2020, issued Protocol for the Development and Registration of Treatments for Preharvest Agricultural Water. Following its April 2021 update which allows companies to use non-GLP (Good Laboratory Practice) data in their submissions with certain provisions, FDA further amended the protocol in April 2022, amending the contact time from a maximum of 1-minute to “up to 5 minutes.”

Also in May, FDA issued the final “Reducing Microbial Food Safety Hazards in the Production of Seed for Sprouting: Guidance for Industry” intended to inform the sprout industry of its “serious concerns over foodborne illness outbreaks associated with the consumption of raw and lightly-cooked sprouts, ” and to provide recommendations to firms throughout the production chain of seed for sprouting.

Noting that the practices and conditions needed for producing seed for sprouting likely requires a higher level of food safety than does seed for other purposes, FDA recommends that “everyone in the sprout seed supply chain” become as informed as possible about the food safety practices, processes, and procedures followed by the firm(s) from which seed is sourced, to which it is distributed, and whether it will be used to produce sprouts for human consumption. The guidance further identifies contamination sources implicated in previous outbreaks as being rodent and bird activity, use of chicken manure, unsanitary transport, and use of irrigation water contaminated by manure used in neighboring fields.

While FDA appears to have a focus on produce, we have to wonder what the agency may do next, as the risks continue with new issues emerging regularly as recent Listeria monocytogenes (Lm) outbreaks have shown. In two of the outbreaks, packaged salads were implicated – one traced back to the presence of Listeria on a piece of equipment used in the harvesting of the iceberg lettuce, the other was initiated due to the detection of Lm in a bag of romaine during routine product sampling. An additional Lm outbreak occurred with several brands of enoki mushrooms in March.

While leafy greens tend to be the most frequently contaminated of produce, all fruits and vegetables can be susceptible to pathogenic contamination, in many cases from the agricultural water – as has frequently been the case in produce recalls. Whether FDA’s continued adaptations of the ag water amendments of the produce safety rule help or hinder the reduction of such contamination is yet to be seen, but one thing is certain – we won’t know until the proposed rule becomes final, effective, and enforced.


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