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Food Safety Modernization Act Produce Safety Rule

Food Safety Modernization Act (FSMA) Produce Safety Rule

The Produce Safety Rule establishes, for the first time, science-based minimum standards for the safe growing, harvesting, packing and holding of fruits and vegetables grown for human consumption.

Key elements of the new rule include:

Subpart C and D: Personnel qualifications and training, worker health and hygiene

Farm workers (including supervisors) who handle covered produce and/or food contact surfaces must be trained on the importance of health and hygiene. Farms must take steps to prevent contamination of produce and food-contact surfaces by people who are sick. This includes instructing farm workers to notify their supervisors if there’s an issue with their health or hygiene that could compromise the safety of the produce.

Subpart E: Agricultural water, for production and post-harvest uses

Requirements for agricultural water quality and testing are designed to detect contamination by feces, which may be accompanied by bacteria that cause disease.

The U.S. Food and Drug Administration is proposing to amend the agricultural water provisions of the produce safety regulation that covered farms have found complex and challenging to implement. This proposal would replace the microbial criteria and testing requirements for pre-harvest agricultural water for covered produce (other than sprouts). Under the proposed requirements, covered farms would be required to conduct pre-harvest agricultural water assessments once annually, and whenever a change occurs that increases the likelihood that a known or reasonably foreseeable hazard will be introduced into or onto produce or food contact surfaces. As part of their pre-harvest agricultural water assessments, these farms would be required to evaluate certain factors that could impact produce safety. The new provisions for systems-based agricultural water assessments are designed to be more feasible to implement across the wide variety of agricultural water systems, uses, and practices, while also being adaptable to future advancements in agricultural water quality science and achieving improved public health protection. These proposed revisions to the produce safety regulation, if finalized, would more comprehensively address a known route of microbial contamination that can lead to preventable foodborne illness that is a significant public health problem.

Resources:

Questions regarding the proposed rule may be directed to Vivien McCurdy at the Indiana Department of Health by calling 317-233-3220. We will continue to communicate updates as they become available.

Subpart F: Biological soil amendments

There are requirements for the use of biological soil amendments of animal origin, including manure and compost, which are added to soil to improve its ability to support plant growth. Meeting these requirements will help reduce the likelihood of potentially dangerous bacteria entering the food supply.

Subpart I: Domesticated and wild animals

There are often animals on farms, such as livestock, and even wild animals, like deer. During harvest, farmers are required to take all reasonably necessary steps to identify potential contamination (including contamination by animals) and not harvest the affected produce. In some circumstances, farmers must also take steps to assess potential contamination by animals during the growing season, in anticipation of these requirements at harvest.

Subpart K: Growing, Harvesting, Packing and Holding Activities

Farmers must be able to recognize contaminated produce in the field and know when not to harvest.  They are also required to separate covered produce from excluded produce, and handle covered produce in a manner that protects it from contamination. Packaging and food packing materials should also be considered during packing and holding activities.

Subpart L: Equipment, tools, buildings and sanitation

Finally, there are standards related to equipment, tools and buildings to prevent problems, such as poor sanitation, from contaminating produce. Buildings covered by these requirements include greenhouses and germination chambers.

Subpart M: Sprout production

Sprouts have been associated frequently with foodborne illness outbreaks. The final rule includes testing and other standards for producing sprouts to prevent contamination with dangerous microbes, such as Listeria monocytogenes.

Subpart O: Records, retention and accessibility

Records that are required in other subparts must be complete, legible and kept for at least 2 years after the date the record was created.  They may be stored offsite if they can be retrieved and available onsite within 24 hours of request.  Records are required to document personnel training, water test results, water system inspection, cleaning/sanitizing of equipment and tools, and treatment of biological soil amendments of animal origin.  Records must also be kept to establish eligibility for a qualified exemption.

Subpart Q: Compliance and enforcement

This subpart outlines provisions for education and enforcement of the Produce Safety Rule when produce is considered adulterated.

Subpart R: Withdrawal of qualified exemption

IDOH may withdraw a farm’s qualified exemption in the event of an active investigation of a foodborne illness outbreak that is directly linked to your farm, or if IDOH determines that it is necessary in order to protect public health and prevent or mitigate a foodborne illness outbreak based on the conduct or conditions of the farm.

  • Is your farm subject to regulation under the Produce Safety Rule?

    If your farm has on average $28,075 or more in annual produce sales, and you produce one of the commodities that the FDA has identified as generally consumed raw (typically eaten without a cook step, see below), your farm is likely subject to regulation under the PSR; however, there are exemptions to the rule:

    • The rule does not apply to certain types of produce that are rarely consumed raw (see below).
    • The rule does not apply to produce that is used for personal or on-farm consumption, or that is not a Raw Agricultural Commodity (RAC).
    • The rule does not cover produce farms that have an average annual value of produce sold during the previous 3-year period of $28,075 or less, adjusted for inflation.
    • The rule provides an exemption for produce that receives commercial processing that adequately reduces the presence of microorganisms of public health significance (e.g., via a “kill step”) as long as certain disclosures are made and written assurances are received.
    • The rule provides a “qualified exemption” and modified requirements for farms that (1) have food sales averaging less than $571,214 per year during the previous 3 years; and (2) the farm’s sales to qualified end-users exceed sales to others. A qualified end-user is either: (1) the consumer of the food or (2) a restaurant or retail food establishment that is located in the same state as the farm or not more than 275 miles away.

    Note: Proving eligibility for the qualified exemption requires three years of sales records to support the exemption. If you plan to use the qualified exemption, you will need to have sales records beginning on your compliance date.

    To help determine if you are subject to inspection, see FDA’s Produce Rule Coverage and Exemptions fact sheet or visit this interactive questionnaire. You can provide documentation of your eligibility by completing the Qualified Exemption Worksheet and keeping it in your records. You will need to complete one worksheet for each of the last three years of operation.

    For more detailed information, see the Qualified Exemption FAQ.

  • What produce is covered by the Produce Safety Rule?

    In brief, all generally consumed raw produce are covered by the Produce Safety Rule. Examples of covered produces are: almonds, apples, apricots, apriums, Artichokes-globe-type, Asian pears, avocados, babacos, bananas, Belgian endive, blackberries, blueberries, boysenberries, brazil nuts, broad beans, broccoli, Brussels sprouts, burdock, cabbages, Chinese cabbages (Boy Choy, mustard, and Napa), cantaloupes, carambolas, carrots, cauliflower, celeriac, celery, chayote fruit, cherries (sweet), chestnuts, chicory (roots and tops), citrus (such as clementine, grapefruit, lemons, limes, mandarin, oranges, tangerines, tangors, and uniq fruit), cowpea beans, cress-garden, cucumbers, curly endive, currants, dandelion leaves, fennel-Florence, garlic, genip, gooseberries, grapes, green beans, guavas, herbs (such as basil, chives, cilantro, oregano, and parsley), honeydews, huckleberries, Jerusalem artichoke, kale, kiwifruit, kohlrabi, kumquats, leek, lettuce, lychees, macadamia nuts, mangos, other melons (such as Canary, Crenshaw and Persian), mulberries, mushrooms, mustard greens, nectarines, onions, papayas, parsnips, passion fruit, peaches, pears, peas, peas-pigeon, peppers (such as bell and  hot), pine nuts, pineapples, plantains, plums, plumcots, quince, radishes, raspberries, rhubarb, rutabagas, scallions, shallots, snow peas, soursop, spinach, sprouts (such as alfalfa and mung bean), strawberries, summer squash (such as patty pan, yellow and zucchini), sweetsop, Swiss chard, taro, tomatoes, turmeric, turnips (roots and tops), walnuts, watercress, watermelons, and yams.

  • What produce is not covered by the Produce Safety Rule?

    The following produce are classified as rarely consumed raw and therefore are the only commodities that are not covered by the rule:  Asparagus, Black Beans, Great Northern Beans, Kidney Beans, Lima Beans, Navy Beans, Pinto Beans, Garden Beets (roots and tops), Sugar Beets, Cashews, Sour Cherries, Chickpeas, Cocoa Beans, Coffee Beans, Collards, Sweet Corn, Cranberries, Dates, Dill (seeds and weed), Eggplants, Figs, Ginger, Hazelnuts, Horseradish, Lentils, Okra, Peanuts, Pecans, Peppermint, Potatoes, Pumpkins, Winter Squash, Sweet Potatoes, and Water Chestnuts.

    FDA Rarely Consumed Raw Fact Sheet