FSMA Compliance Flowchart

These are just examples, as this list is not exhaustive!

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 uniqfruit), 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; and mixes of intact fruits and vegetables (such as fruit baskets).

An establishment that grows and harvests crops or raises animals and may conduct other activities within the farm definition, but also conducts activities that require the establishment to register with FDA under section 415 of the FD&C Act [Preventive Controls Rule].

Harvesting applies to farms and farm mixed-type facilities and means activities that are traditionally performed on farms for the purpose of removing raw agricultural commodities from the place they were grown or raised and preparing them for use as food. Harvesting is limited to activities performed on raw agricultural commodities, or on processed foods created by drying/dehydrating a raw agricultural commodity without additional manufacturing/processing, on a farm. Harvesting does not include activities that transform a raw agricultural commodity into a processed food as defined in section 201(gg) of the Federal Food, Drug, and Cosmetic Act.

Examples of harvesting include cutting (or otherwise separating) the edible portion of the raw agricultural commodity from the crop plant and removing or trimming part of the raw agricultural commodity (e.g., foliage, husks, roots or stems). Examples of harvesting also include cooling, field coring, filtering, gathering, hulling, shelling, sifting, threshing,  trimming the outer leaves of, and washing raw agricultural commodities grown on a farm.

Holding means storage of food and also includes activities performed incidental to storage of a food (e.g., activities performed for the safe or effective storage of that food, such as fumigating food during storage, and drying/dehydrating raw agricultural commodities when the drying/dehydrating does not create a distinct commodity (such as drying/dehydrating hay or alfalfa)). Holding also includes activities performed as a practical necessity for the distribution of that food (such as blending of the same raw agricultural commodity and breaking down pallets)), but does not include activities that transform a raw agricultural commodity into a processed food as defined in section 201(gg) of the Federal Food, Drug, and Cosmetic Act. Holding facilities could include warehouses, cold storage facilities, storage silos, grain elevators, and liquid storage tanks.

This is an exhaustive list of manufacturing/processing activities that a farm-mixed-type facility may do and still qualify for a partial exemption under the PCR (if they also meet the test for either a small or very small business).

•  Boiling gums, latexes, and resins;
• Chopping, coring, cutting, peeling, pitting, shredding, and slicing acid fruits and vegetables that have a pH less than 4.2 (e.g., cutting lemons and limes), baked goods (e.g., slicing bread), dried/dehydrated fruit and vegetable products (e.g., pitting dried plums), dried herbs and other spices (e.g., chopping intact, dried basil), game meat jerky, gums/latexes/resins, other grain products (e.g., shredding dried cereal), peanuts and tree nuts, and peanut and tree nut products (e.g., chopping roasted peanuts);
• Coating dried/dehydrated fruit and vegetable products (e.g., coating raisins with chocolate), other fruit and vegetable products except for non-dried, non-intact fruits and vegetables (e.g., coating dried plum pieces, dried pitted cherries, and dried pitted apricots with chocolate are low-risk activity/food combinations but coating apples on a stick with caramel is not a low-risk activity/food combination), other grain products (e.g., adding caramel to popcorn or adding seasonings to popcorn provided that the seasonings have been treated to significantly minimize pathogens, peanuts and tree nuts (e.g., adding seasonings provided that the seasonings have been treated to significantly minimize pathogens), and peanut and tree nut products (e.g., adding seasonings provided that the seasonings have been treated to significantly minimize pathogens));
• Drying/dehydrating (that includes additional manufacturing or is performed on processed foods) other fruit and vegetable products with pH less than 4.2 (e.g., drying cut fruit and vegetables with pH less than 4.2), and other herb and spice products (e.g., drying chopped fresh herbs, including tea);
• Extracting (including by pressing, by distilling, and by solvent extraction) dried/dehydrated herb and spice products (e.g., dried mint), fresh herbs (e.g., fresh mint), fruits and vegetables (e.g., olives, avocados), grains (e.g., oilseeds), and other herb and spice products (e.g., chopped fresh mint, chopped dried mint);
• Freezing acid fruits and vegetables with pH less than 4.2 and other fruit and vegetable products with pH less than 4.2 (e.g., cut fruits and vegetables);
• Grinding/cracking/crushing/milling baked goods (e.g., crackers), cocoa beans (roasted), coffee beans (roasted), dried/dehydrated fruit and vegetable products (e.g., raisins and dried legumes), dried/dehydrated herb and spice products (e.g., intact dried basil), grains (e.g., oats, rice, rye, wheat), other fruit and vegetable products (e.g., dried, pitted dates), other grain products (e.g., dried cereal), other herb and spice products (e.g., chopped dried herbs), peanuts and tree nuts, and peanut and tree nut products (e.g., roasted peanuts);
• Labeling baked goods that do not contain food allergens, candy that does not contain food allergens, cocoa beans (roasted), cocoa products that do not contain food allergens), coffee beans (roasted), game meat jerky, gums/latexes/resins that are processed foods, honey (pasteurized), jams/jellies/preserves, milled grain products that do not contain food allergens (e.g., corn meal) or that are single-ingredient foods (e.g., wheat flour, wheat bran), molasses and treacle, oils, other fruit and vegetable products that do not contain food allergens (e.g., snack chips made from potatoes or plantains), other grain products that do not contain food allergens (e.g., popcorn), other herb and spice products (e.g., chopped or ground dried herbs), peanut or tree nut products, (provided that they are single-ingredient, or are in forms in which the consumer can reasonably be expected to recognize the food allergen(s) without label declaration, or both (e.g., roasted or seasoned whole nuts, single-ingredient peanut or tree nut flours)), processed seeds for direct consumption, soft drinks and carbonated water, sugar, syrups, trail mix and granola (other than those containing milk chocolate and provided that peanuts and/or tree nuts are in forms in which the consumer can reasonably be expected to recognize the food allergen(s) without label declaration), vinegar, and any other processed food that does not require time/temperature control for safety and that does not contain food allergens (e.g., vitamins, minerals, and dietary ingredients (e.g., bone meal) in powdered, granular, or other solid form)
• Making baked goods from milled grain products (e.g., breads and cookies);
• Making candy from peanuts and tree nuts (e.g., nut brittles), sugar/syrups (e.g., taffy, toffee),and saps (e.g., maple candy, maple cream);
• Making cocoa products from roasted cocoa beans;
• Making dried pasta from grains;
• Making jams, jellies, and preserves from acid fruits and vegetables with a pH of 4.6 or below;
• Making molasses and treacle from sugar beets and sugarcane;
• Making oat flakes from grains;
• Making popcorn from grains;
• Making snack chips from fruits and vegetables (e.g., making plantain and potato chips);
• Making soft drinks and carbonated water from sugar, syrups, and water;
• Making sugars and syrups from fruits and vegetables (e.g., dates), grains (e.g., rice, sorghum), other grain products (e.g., malted grains such as barley), saps (e.g., agave, birch, maple, palm), sugar beets, and sugarcane;
• Making trail mix and granola from cocoa products (e.g., chocolate), dried/dehydrated fruit and vegetable products (e.g., raisins), other fruit and vegetable products (e.g., chopped dried fruits), other grain products (e.g., oat flakes), peanut and tree nut products, and processed seeds for direct consumption, provided that peanuts, tree nuts, and processed seeds are treated to significantly minimize pathogens;
• Making vinegar from fruits and vegetables, other fruit and vegetable products (e.g., fruit wines, apple cider), and other grain products (e.g., malt);
• Mixing baked goods (e.g., types of cookies), candy (e.g., varieties of taffy), cocoa beans (roasted), coffee beans (roasted), dried/dehydrated fruit and vegetable products (e.g., dried blueberries, dried currants, and raisins), dried/dehydrated herb and spice products (e.g., dried, intact basil and dried, intact oregano), honey (pasteurized), milled grain products (e.g., flour, bran, and corn meal), other fruit and vegetable products (e.g., dried, sliced apples and dried, sliced peaches), other grain products (e.g., different types of dried pasta), other herb and spice products (e.g., chopped or ground dried herbs, dried herb- or spice-infused honey, and dried herb- or spice-infused oils and/or vinegars), peanut and tree nut products, sugar, syrups, vinegar, and any other processed food that does not require time/temperature control for safety (e.g., vitamins, minerals, and dietary ingredients (e.g., bone meal) in powdered, granular, or othersolid form);
• Packaging baked goods (e.g., bread and cookies), candy, cocoa beans (roasted), cocoa products, coffee beans (roasted), game meat jerky, gums/latexes/resins that are processed foods, honey (pasteurized), jams/jellies/preserves, milled grain products (e.g., flour, bran, corn meal), molasses and treacle, oils, other fruit and vegetable products (e.g., pitted, dried fruits; sliced, dried apples; snack chips), other grain products (e.g., popcorn), other herb and spice products (e.g., chopped or ground dried herbs), peanut and tree nut products, processed seeds for direct consumption, soft drinks and carbonated water, sugar, syrups, trail mix and granola, vinegar, and any other processed food that does not require time/temperature control for safety (e.g., vitamins, minerals, and dietary ingredients (e.g., bone meal) in powdered, granular, or other solid form).
• Pasteurizing honey;
• Roasting and toasting baked goods (e.g., toasting bread for croutons);
• Salting other grain products (e.g., soy nuts), peanut and tree nut products, and processed seeds for direct consumption; and
• Sifting milled grain products (e.g., flour, bran, corn meal), other fruit and vegetable products (e.g., chickpea flour), and peanut and tree nut products (e.g., peanut flour, almond flour).

This is an exhaustive list of packing/holding activities that a farm-mixed-type facility may do and still qualify for a partial exemption under the PCR (if they also meet the test for either a small or very small business).

• Baked goods (e.g., bread and cookies);
• Candy (e.g., hard candy, fudge, maple candy, maple cream, nut brittles, taffy, and toffee);
• Cocoa beans (roasted);
• Cocoa products;
• Coffee beans (roasted);
• Game meat jerky;
• Gums, latexes, and resins that are processed foods;
• Honey (pasteurized);
• Jams, jellies, and preserves;
• Milled grain products (e.g., flour, bran, and corn meal);
• Molasses and treacle;
• Oils (e.g., olive oil and sunflower seed oil);
• Other fruits and vegetable products (e.g., flours made from legumes; pitted, dried fruits; sliced, dried apples; snack chips);
• Other grain products (e.g., dried pasta, oat flakes, and popcorn);
• Other herb and spice products (e.g., chopped or ground dried herbs, herbal extracts);
• Peanut and tree nut products (e.g., roasted peanuts and tree nut flours);
• Processed seeds for direct consumption (e.g., roasted pumpkin seeds);
• Soft drinks and carbonated water;
• Sugar;
• Syrups (e.g., maple syrup and agave syrup);
• Trail mix and granola;
• Vinegar; and
• Any other processed food that does not require time/temperature control for safety (e.g., vitamins, mineral, and dietary ingredients (e.g., bone meal) in powdered, granular, or other solid form).

Manufacturing/processing means making food from one or more ingredients, or synthesizing, preparing, treating, modifying or manipulating food, including food crops or ingredients. Examples of manufacturing/processing activities include: Baking, boiling, bottling, canning, cooking, cooling, cutting, distilling, drying/dehydrating raw agricultural commodities to create a distinct commodity (such as drying/dehydrating grapes to produce raisins), evaporating, eviscerating, extracting juice, formulating, freezing, grinding, homogenizing, irradiating, labeling, milling, mixing, packaging (including modified atmosphere packaging), pasteurizing, peeling, rendering, treating to manipulate ripening, trimming, washing, or waxing. For farms and farm-mixed-type facilities, manufacturing/processing does not include activities that are a part of harvesting, packing, or holding.

Packing means placing food into a container other than packaging the food and also includes re- packing and activities performed incidental to packing or re-packing a food (e.g., activities performed for the safe or effective packing or-repacking of that food (such as sorting, culling, grading, and weighing or conveying incidental to packing or re-packing)), but does not include activities that transform a raw agricultural commodity, as defined in section 201(r) of the Federal

Food, Drug, and Cosmetic Act, into a processed food as defined in Section 201 (gg) of the Federal Food, Drug, and Cosmetic Act. Packaging (when used as a verb) means placing food into a container that directly contacts the food and that the consumer receives.

An operation that is in one general area, although it may include multiple non-contiguous parcels, with the principal focus of growing or harvesting crops and/or raising livestock, including seafood.

In addition, a Primary Production Farm may pack and hold raw agricultural commodities (RACs, defined as a food crop in its raw or natural state), including RACs grown on that farm and RACs supplied from other farms; dry/dehydrate RACs to create a distinct product with no other processing (for example drying grapes to make raisins); artificially ripen RACs (for example tomatoes in controlled storage); manufacture/ process food provided that all food is consumed on that farm or another farm under the same management.

Produce means any fruit or vegetable (including mixes of intact fruits and vegetables) and includes mushrooms, sprouts (irrespective of seed source), peanuts, tree nuts, and herbs. A fruit is the edible reproductive body of a seed plant or tree nut (such as apple, orange, and almond) such that fruit means the harvestable or harvested part of a plant developed from a flower. A vegetable is the edible part of an herbaceous plant (such as cabbage or potato) or fleshy fruiting body of a fungus (such as white button or shiitake) grown for an edible part such that vegetable means the harvestable or harvested part of any plant or fungus whose fruit, fleshy fruiting bodies, seeds, roots, tubers, bulbs, stems, leaves, or flower parts are used as food and includes mushrooms, sprouts, and herbs (such as basil or cilantro). Produce does not include food grains meaning the small, hard fruits or seeds of arable crops, or the crops bearing these fruits or seeds, that are primarily grown and processed for use as meal, flour, baked goods, cereals and oils rather than for direct consumption as small, hard fruits or seeds (including cereal grains, pseudo cereals, oilseeds and other plants used in the same fashion). Examples of food grains include 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.)

Produce that is rarely consumed raw is NOT covered by the Produce Rule. The following list are the ONLY crops that are FSMA-defined ‘rarely consumed raw.’ This IS an exhaustive list; if the crop is not on this list, then it is covered produce (unless it falls under another not covered category, for example, doesn’t meet the definition of produce, is only for personal consumption, will be sold to be processed, or is not a raw agricultural commodity).

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.

Retail food establishment means an establishment that sells food products directly to consumers as its primary function. The term “retail food establishment” includes facilities that manufacture, process, pack, or hold food if the establishment’s primary function is to sell from that establishment food, including food that it manufactures, processes, packs, or holds, directly to consumers. A retail food establishment’s primary function is to sell food directly to consumers if the annual monetary value of sales of food products directly to consumers exceeds the annual monetary value of sales of food products to all other buyers. The term “consumers” does not include businesses. A “retail food establishment” includes grocery stores, convenience stores, and vending machine locations. A “retail food establishment” also includes certain farm-operated businesses selling food directly to consumers as their primary function.

1. Sale of food directly to consumers from an establishment located on a farm includes sales by that establishment directly to consumers.
   • At a roadside stand (a stand situated on the side of or near a road or thoroughfare at which a farmer sells food from his or her farm directly to consumers) or farmers’ market (a location where one or more local farmers assemble to sell food from their farms directly to consumers);
   • Through a community supported agriculture program. Community supported agriculture (CSA) program means a program under which a farmer or group of farmers grows food for a group of shareholders (or subscribers) who pledge to buy a portion of the farmer’s crop(s) for that season. This includes CSA programs in which a group of farmers consolidate their crops at a central location for distribution to shareholders or subscribers; and
   • At other such direct-to-consumer sales platforms, including door-to-door sales; mail, catalog and Internet order, including online farmers markets and online grocery delivery; religious or other organization bazaars; and State and local fairs.
2. Sale of food directly to consumers by a farm-operated business includes the sale of food by that farm-operated business directly to consumers:
   • At a roadside stand (a stand situated on the side of or near a road or thoroughfare at which a farmer sells food from his or her farm directly to consumers) or farmers’ market (a location where one or more local farmers assemble to sell food from their farms directly to consumers);
   • Through a community supported agriculture program. Community supported agriculture (CSA) program means a program under which a farmer or group of farmers grows food for a group of shareholders (or subscribers) who pledge to buy a portion of the farmer’s crop(s) for that season. This includes CSA programs in which a group of farmers consolidate their crops at a central location for distribution to shareholders or subscribers; and
   • At other such direct-to-consumer sales platforms, including door-to-door sales; mail, catalog and Internet order, including online farmers markets and online grocery delivery; religious or other organization bazaars; and State and local fairs.

For the purposes of this definition, “farm-operated business” means a business that is managed by one or more farms and conducts manufacturing/processing not on the farm(s).

A Secondary Activities Farm is an operation that is not located on a Primary Production Farm; majority-owned by the operator of a Primary Production Farm, or by multiple Primary Production Farm operators together; where the Primary Production Farms of the majority-owner or owners also provide the majority of the RACs handled by the Secondary Activities Farm; and that harvests, shells, hulls, washes, packs, holds, packages, and labels RACs, and/or artificially ripens RACs or dries RACs to create a distinct product with no other processing (such as grapes into raisins).

The rule provides a definition of produce. The definition specifies that grains and oilseeds are not covered by the rule, but things like mushrooms and sprouts are. The rule includes a non-exhaustive list of produce that’s generally consumed raw to offer examples of what’s covered by the rule. The rule also provides an exhaustive list of produce that’s not generally consumed raw (i.e., not covered). Take a look at these lists, as it’s not intuitive. When in doubt, unless you’re ONLY growing produce on the exhaustive list, assume that the produce you grow is generally consumed raw!

The FDA’s definition of a farm is not easy to decipher. The FDA has defined farms as two different types—either primary production or secondary activities. Check the definition of both above. Their definition has evolved over time to address the sustainable farming community’s concerns about aggregator and co-managed farming arrangements, such as cooperatives. Visit FDA’s Frequently Asked Questions page for more information.

These activities are limited to: (1) packaging and labeling raw agricultural commodities (RACs), (2) drying/dehydrating RACs (but CANNOT slice or dice) and packaging and labeling, and (3) treating RACs to manipulate ripening. You can also do activities that fall within the definition of harvesting, packing, or holding—which includes things like coating for storage/transportation.

Check out the National Sustainable Agricultural Coalition (NSAC)’s FSMA Resource Center for the latest updates and resources.

Read relevant FDA-answered questions through their Technical Assistance Network (TAN).

The Produce Safety Alliance has a Grower Training Course Page where you can stay up to date on offerings across the U.S. for farmers to learn more about Produce Rule requirements.

Watch for workshops and classes offered by Extension offices and other GAP/GMP training providers.