Is Your Farm Covered by the FSMA Produce Rule?
The FSMA Produce Rule lays out many actions that farms are responsible for implementing (to learn more about those actions, see our other blog posts on FSMA). It’s critical to understand what the FSMA Produce Rule means, and it’s just as critical to know what sorts of farms need to comply. Here’s an explanation of who is covered under the rule:
- If your farm does not grow, harvest, pack, or hold produce; or does not have average annual sales of $25,000 per year over the last three years, then you are not subject to the Produce Rule.
- If your farm grows any types of produce that have been identified by the FDA as “rarely consumed raw,” then operations solely involving those types of produce are not subject to the Produce Rule. Note that if your farm grows multiple types of produce, some of which are not identified as “rarely consumed raw,” then operations involving those types still may be subject to the Produce Rule.
- The following produce commodities have been identified by the FDA as “rarely consumed raw,” and operations solely involving them are not subject to the Produce Rule: asparagus; black beans, great Northern beans, kidney beans, lima beans, navy beans, and pinto beans; garden beets (roots and tops) and sugar beets; cashews; sour cherries; chickpeas; cocoa beans; coffee beans; collards; sweet corn; cranberries; dates; dill (seeds and weed); eggplants; figs; horseradish; hazelnuts; lentils; okra; peanuts; pecans; peppermint; potatoes; pumpkins; winter squash; sweet potatoes; and water chestnuts.
- Operations solely involving food grains are also not subject to the Produce Rule. This includes barley, dent- or flint-corn, sorghum, oats, rice, rye, wheat, amaranth, quinoa, buckwheat, and oilseeds (e.g. cotton seed, flax seed, rapeseed, soybean, and sunflower seed).
- The following commodities are considered to be often consumed raw by the FDA, and operations involving them are subject to the Produce Rule: 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 (Bok 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), honeydew, huckleberries, Jerusalem artichokes, 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. (via SustainableAgriculture.net)
- Any produce that is solely intended for personal or on-farm consumption is not subject to the Produce Rule.
- If your produce is solely intended for commercial processing that follows sanitary standards, such as processing that uses a “kill step,” your produce may be exemption-eligible from the Produce Rule, provided that you maintain proper documentation.
- If your farm has on average less than $500,000 in annual sales over a three-year period as well as a majority of its sales going towards “qualified end-users,” then your farm may be eligible for a qualified exemption to the Produce Rule, meaning that there are still some requirements to follow. (“Qualified end-users” are defined as individual consumers, restaurants, or retail establishments that are located either in the same state or Indian reservation as your farm or not more than 275 miles from your farm).
If your farm did not fall into any of the above categories, your farm is subject to the Produce Rule. If some of your produce did not fall into the second through fourth categories, operations involving that produce is subject to the Produce Rule.
As a general summary, farms that are subject to the Produce Rule are those that do any of the following: grow, harvest, pack, or hold produce; have average sales of at least $25,000 per year over the last three years; grow produce that is often consumed raw, is not commercially processed to reduce pathogens, and is intended for outside consumption; or have either: sales over $500,000 per year over a three-year period or a majority of sales going to sources other than qualified end-users.
We hope this guide helps to clarify your firm’s status under FSMA! For additional information on what types of farms are covered under the FSMA Produce Rule: