The FDA Food Safety Modernization Act (FSMA) Produce Safety rule was published on  November 27, 2015.   The rule establishes science-based minimum standards for the safe growing, harvesting, packing, and holding of fruits and vegetables grown for human consumption. Information about the rule and the implementation of the rule can be found on the FDA website.

All Colorado farmers who grow, harvest or pack raw produce and sell more than $25,000/year in produce sales may be covered under the rule. Some growers may be eligible for an exemption based on:

• Commodities grown (produce rarely consumed raw)
• Processing activities that include a “kill step” (canning, refining, etc.)
• Annual produce sales (less than $25,000)
• Average annual food sales and sales to “qualified end users”

For farms who grow covered produce, the FDA has created three categories based on average annual produce sales (based on a rolling average, over a 3-year period), with different compliance dates for each category. See updated compliance dates here.

*See inflation-adjusted sales values for 2019-2021 here.

FDA has a partial (non-exhaustive) list of covered produce, which includes:

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, mangoes, 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.

FDA has a complete (exhaustive) list of produce that is “rarely consumed raw,” including:

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.

FDA also has a fact sheet providing more detail on “Rarely Consumed Raw” produce.

The rule does not apply to:

• Produce that is NOT a raw agricultural commodity, as defined by the FDA. This includes produce that receives commercial processing that adequately reduces the presence of microorganisms of public health significance, under certain conditions.
• Food grains, including 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 used for personal or on-farm consumption.
• Farms that have an average annual value of produce sold during the previous three-year period of $25,000 or less.

The rule also provides a qualified exemption and modified requirements for certain farms.

• To be eligible for a qualified exemption, the farm must meet two requirements:

1. The farm must have food sales (all food, not produce alone) averaging less than $500,000 per year during the previous three years; AND 

2. The farm’s sales to qualified end-users must exceed sales to all others combined during the previous three years. A qualified end-user is either (a) the consumer of the food or (b) a restaurant or retail food establishment that is located in the same state or the same Indian reservation as the farm or not more than 275 miles away.

• A farm with the qualified exemption must still meet certain modified requirements, including:
  • Record keeping:
    1. Keep records demonstrating sales and customer base — 3 years for rolling average calculation; and
    2. Review records annually to demonstrate qualification for exemption.
  • Labeling
    1. Products that require a label must include complete business name and address; and
    2. If a label is not required, complete business address must be prominently displayed. 

Under the Produce Safety Rule, covered farms must follow the standards set for worker health and hygiene, agricultural water, biological soil amendments, domesticated and wild animals, equipment, tools, sanitation and growing, harvesting, packing and holding activities. Below is a brief explanation of the key requirements.

Worker health and hygiene.  Workers can carry, introduce and spread contamination to fresh produce so it is critical to have specific processes in place for employees and visitors. Farms are required to develop, implement and document a training program that focuses on proper health and hygiene practices such as washing hands after using the restroom and notifying their supervisor when they are ill or have been injured.

Biological soil amendments.  Soil amendments can introduce produce safety risks, especially amendments containing raw manure. Proper training of employees who handle soil amendments, and sanitation steps for tools and equipment minimizes the risk of contamination. Farms will need documentation of worker processes and training and records of soil amendment applications and treatments.

Domesticated and wild animals.  Produce growing areas must be visually monitored for signs of animal intrusion, and steps should be taken to reduce risks from animals. Co-management should be used to balance food safety and conservation goals. All actions taken to reduce risks from animals and adjacent land uses must be documented. Worker training on not harvesting produce that is likely contaminated will also need to be implemented and documented.

Equipment, tools and buildings and sanitation.  The Produce Safety Rule establishes standards related to equipment, tools and buildings to prevent contaminating produce. It requires measures to prevent contamination of covered produce and food contact surfaces by appropriate storage, maintenance and cleaning of equipment and tools.

Agricultural water used during growing, harvesting, packing and holding.  Water is a potential source of contamination if it is not monitored or used appropriately. The Produce Safety Rule addresses production water (e.g. irrigation) and post-harvest water (e.g. rinsing) standards.  Note- the FDA is currently re-evaluating the water requirements for production water. Additional guidance will be released by FDA in the future.

Recordkeeping.  Certain records are required for compliance under the Produce Safety Rule and will be reviewed during on-farm inspections. In general, records should be accurate, legible, dated and signed by the person who performed the activity; and should be created at the time of the activity. Records should be keep for at least two years.

Additional Produce Safety Rule resources can be found here.