Within the scope of FSMA’s Produce Safety Rule, produce is defined as any fruit or vegetable (including mixes of
intact fruits and vegetables) and includes mushrooms, sprouts (irrespective of seed source), peanuts, tree nuts and
Under the Produce Safety Rule produce can be classified as:
A) Covered Produce
Produce that is considered a raw agricultural commodity (RAC) and that is grown domestically or that is imported
or offered for import in any State or territory of the United States, the District of Columbia, or the Commonwealth of
Puerto Rico is considered “covered produce” – meaning that its covered by FSMA’s Produce Safety Rule.
A raw agricultural commodity (RAC) is any food in its raw or natural state, including all fruits that are washed,
colored, or otherwise treated in their unpeeled natural form prior to marketing.
The following are examples of covered produce (Note: this is a non-exhaustive list. Just because you may not find a produce on this list, it may still be covered):
(1) Fruits and vegetables such as almonds, apples, apricots, apriums, Artichokes-globe-type, Asian pears, avocados, babacos, bananas, Belgian endive, blackberries, blueberries, boysenberries, brazil nuts, breadfruit (‘ulu), 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, mamaki, 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 belland 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; and
(2) Mixes of intact fruits and vegetables (such as fruit baskets).
B) Produce Not Covered
1. Thirty commodities have been identified by the FDA as exempt from the Produce Safety Rule because they are rarely consumed raw. Farms exclusively producing these commodities are not covered by the Produce Safety Rule.
Asparagus; beans, black; beans, great Northern; beans, kidney; beans, lima; beans, navy; beans, pinto; beets, garden (roots and tops); beets, sugar; cashews; cherries, sour; chickpeas; cocoa beans; coffee beans; collards; corn, sweet; cranberries; dates; dill (seeds and weeds); eggplants; figs; ginger; hazelnuts; horseradish; lentils; okra; peanuts; pecans; peppermint; potatoes; pumpkins; squash, winter; sweet potatoes; and water chestnuts.
Note, that Almonds, pulses, hops and wine grapes are currently under enforcement discretion. Taro, Breadfruit, Turmeric, and Macadamia Nuts, while commonly cooked in local cuisine and mildly poisonous (or causing digestion problems) when eaten raw, have either historically or culturally been eaten raw or, through selective breeding or wild cultivars, have varieties that can be eaten raw somewhere in the world.
Raw nutritional information to determine rarely consumed raw status can be found here:
USDA: Food and Nutrient Database for Dietary Studies
USDA: Food Data Central
2. Farms that grow produce only for personal consumption may also be exempt from the Produce Safety Rule.
3. Produce that is not a raw agricultural commodity.
C) Produce Eligible for Commercial Processing Exemption
If the produce receives commercial processing that adequately reduces the presence of microorganisms of public
health significance (E. coli, Listeria, Salmonella) it is eligible for exemption from the requirements for covered produce. Examples of commercial processing that adequately reduces the presence of microorganisms of public health significance are processing in accordance with the requirements of part 113, 114, or 120 of the CFR 21 (THERMALLY PROCESSED LOW-ACID FOODS PACKAGED IN HERMETICALLY SEALED CONTAINERS, ACIDIFIED FOODS AND HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEMS) treating with a validated process to eliminate spore-forming microorganisms (such as processing to produce tomato paste or shelf-stable tomatoes), and processing such as refining, distilling, or otherwise manufacturing/processing produce into products such as sugar, oil, spirits, wine, beer or similar products.
Farms must disclose in documents accompanying the produce, in accordance with the practice of the trade, that the
food is “not processed to adequately reduce the presence of microorganisms of public health significance”; and must
(i) Annually obtain written assurance from the customer that performs the commercial processing that the
customer has established and is following procedures that adequately reduce the presence of organisms of public
health significance or
(ii) Annually obtain written assurance from your customer that an entity in the distribution chain subsequent to
the customer will perform commercial processing as required by the Rule.
For more information on this topic: See Subpart A- General Provisions of the Produce Safety Rule, Sections 112.1 and
112.2 or visit our FAQ page to get more detailed information on if your farm is covered, exempt, or not covered!
Taro growers must provide certain disclosures and obtain certain written assurances to be eligible for this exemption. Click on Taro_PSR_Exemption to access a downloadable fact sheet of the more thorough explanation below:
- Taro growers must disclose in documents accompanying the taro, that the taro are “not processed to adequately reduce the presence of microorganisms of public health significance.” The documents that accompany the produce could be bills of lading or other papers that accompany the produce, or the containers may be labeled with this information.
- Taro Growers must either:
- Annually obtain a written assurance from Customer “A” that performs the commercial processing that the customer has established and is following procedures (identified in the written assurance) that adequately reduce the presence of microorganisms of public health significance; or
- Annually obtain a written assurance from Customer “A” that an entity (e.g. Customer “B”) in the distribution chain subsequent to Customer “A” will perform commercial processing, and that Customer “A”:
- Will disclose in documents accompanying the taro, in accordance with the practice of the trade, that the taro are “not processed to adequately reduce the presence of microorganisms of public health significance”; and
- Will only sell to another entity (e.g. Customer “B”) that agrees, in writing, it will either:
- Follow procedures (identified in a written assurance) that adequately reduce the presence of microorganisms of public health significance; or
- It will obtain a similar written assurance from its customer (e.g., Customer “C”) that the taro will receive commercial processing that adequately reduces the presence of microorganisms of public health significance and that there will be disclosure in documents accompanying the taro, that they are “not processed to adequately reduce the presence of microorganisms of public health significance.”