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    What Is FSMA’s Produce Safety Rule All About? (Part Two)

    What is FSMA's Produce Safety Rule All About?

    This post is part two in our two-part series.You can find part one here.

    In our previous post, What Is FSMA’s Produce Safety Rule All About?, we outlined the details regarding agricultural water, biological soil amendments, and sprouts. This article digs deeper into the other sections of this rule: worker health/hygiene, standards for food contact surfaces, and standards for domesticated/wild animals.

    The Food Safety Modernization Act’s (FSMA) Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption rule really focuses on microbial contamination. When you look at some of the other FSMA rules, they are focused on chemical, physical and biological hazards, but here, the FDA really hones in on micro hazards more so than any other FSMA rule.

    These standards listed below are a lot like “best practices” and are more practical and pragmatic as compared to the other pieces to this rule (mentioned in our previous post), which are far more technical in nature.

    Standards for Grazing and Working Animals

    • Assess for animal contamination (excrement, destruction, etc.)
    • Significant evidence of potential contamination + measures to assist during harvest
    • Voluntary interval between grazing and harvest
    • No coverage for wild animals, including no authorization to “take” wild animals

    When it comes to grazing and working animals, the FDA is basically asking you to identify and assess which animals are likely to be present in the produce area, and then determine the likelihood of potential contamination risks – whether from feces or destruction. Like in the Preventive Controls rule, you will then need to determine the necessary procedures to put in place to mitigate these potential risks during harvest.

    For example, do you need to mark certain areas of the farm as areas where you cannot plant, or do you simply mark certain areas with something like flags to indicate that produce needs to be handled differently in these designated spaces? 

    This section of the Produce Safety rule does not, however, require you to set up intervals for grazing and harvest like you would under the biological soil amendments. With the biological soil amendments, if you’re intentionally adding compost or raw manure, then you have a requirement to do an interval. But if you are just referring to wild animals or even domesticated animals grazing near harvest, you don’t have those same interval requirements.

    When the FDA sates that you need to identify and control these potential risks, it is careful to state that “control” does not mean to set up barriers or use different means to “take” wild animals. The FDA does not have this license authority. For purposes of this section, you just need to take measures to identify animal patterns on the farm to ensure there is no contamination. 

    Standards for Worker Health and Hygiene

    • Training on managing ill or infected workers
    • Hygienic practices when handling produce or covered surfaces
    • Hygienic practices for visitors
    • Worker training + experience and education for assigned responsibilities

    The training and education required under this section are very similar to what we would see in manufacturing plants, and the FDA is in a sense bringing this out of the manufacturing plants and onto the farm. So if you’ve had any experience inside a manufacturing plant, the worker training and health/hygiene is going to be something that you’re completely familiar with, as the standards are very similar.

    This rule outlines concepts like training and education to ensure workers are not touching produce when they have cuts, are ill, etc., which can lead to potentially contaminated produce.

    And FDA wants to also make sure there are appropriate hygiene practices, like washing hands between bathroom breaks or after lunch, in place when workers are actually handling produce.

    Additionally, this section of the rule requires hygiene practices for visitors. Some farms covered under the Produce Safety rule are “you pick” farms, and some of them might double as event locations for tastings or weddings as well. When this is the case, you need to ensure that if visitors are getting near produce or covered surfaces, you have proper hygiene practices in place. 

    Standards for Equipment, Tools, Buildings, and Sanitation 

    • Examples of covered areas: greenhouses, germination chambers, toilet, hand washing facilities
    • Equipment designed and constructed to allow adequate cleaning and maintenance
    • FCS must be inspected, maintained, cleaned and sanitized
    • Building size, design and construction must accommodate maintenance and sanitary operations
    • Toilet/Hand-Washing facilities must be adequate and readily accessible during covered activities

    As with worker hygiene and health, food contact surfaces (tools, buildings, equipment, etc.) under this rule are also very similar to manufacturing facilities.

    Numerous areas are going to be covered under this section of the rule, including greenhouses and hand-washing facilities. You want to make sure anything with the potential to contact produce is designed, constructed, and inspected to ensure cleaning and maintenance is properly executed. 

    This particular section is emphasized in the Produce Safety rule, and it’s not just referring to holding activities. Each of these steps need to be required for all stages in production: growing, harvesting, holding, and packing. 

    These aren’t the most technical pieces to the Produce Safety rule, but are still necessary to ensure you meet compliance requirements and provide safe produce to consumers.

    If you’d like more information on the Produce Safety rule, take a look at our on-demand webinars, Produce Safety: An In-Depth Analysis Part 1 and Part 2.

    Download the FSVP Outline

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