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 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 they are not on this
list, they 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, 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 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. Produce that is rarely consumed raw is not covered by the Produce Safety Rule. The following crops are rarely
consumed raw crops, specifically the produce on the following exhaustive list:
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.
2. Produce that is grown for personal consumption or produced for consumption on the farm or another farm under
the same management.
3. Produce that is not a raw agricultural commodity.
C) Produce Eligible for Exemption from the requirements of covered produce because it will be further processed.
If the produce receives commercial processing that adequately reduces the presence of microorganisms of public
health significance 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
Taro growers must provide certain disclosures and obtain certain written assurances to be eligible for this exemption. Specifically:
- 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.”
Note: On January 5, 2018, FDA issued a guidance document in which it stated its intention to initiate a rulemaking related to written assurances. To provide sufficient time to pursue that rulemaking, in the guidance FDA also stated its intention to exercise enforcement discretion with regard to the written assurance requirements in the Produce Safety Rule (and three other FSMA rules), until completion of that rulemaking process. This means that taro growers still need to disclose to customers that their taro are not processed to adequately reduce the presence of microorganisms of public health significance; but FDA does not intend to enforce the requirement for taro growers to obtain written assurances from their customers. However, those customers (and other customers thereafter) will still be required to comply with all other applicable requirements in federal and/or state and local laws, including the prohibition against the introduction of adulterated food into interstate commerce.