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Bulletin #4281, Food Safety Modernization Act (FSMA) Produce Safety Rule Exemptions

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Food Safety Modernization Act (FSMA) Produce Safety Rule Exemptions

Apples in cratesDeveloped by Robson Machado, Assistant Extension Professor and Food Science Specialist, University of Maine Cooperative Extension; and Christina Howard, Produce Safety Specialist, University of Maine Cooperative Extension.
Reviewed by Leah Cook, Food Inspection Supervisor, Maine Department of Agriculture, Conservation & Forestry; and Linda Titus, AgMatters LLC.

For information about UMaine Extension programs and resources, visit extension.umaine.edu.
Find more of our publications and books at extensionpubs.umext.maine.edu.

The goal of this factsheet is to help you determine if your farm, your produce, and/or your farming activities fall under the requirements of the Produce Safety Rule.

What is subject to the Produce Safety Rule?

The Produce Safety Rule (PSR) is one of the sections of the Food Safety Modernization Act. The PSR sets science-based standards for the safe growing, harvesting, packing, and holding of fruits and vegetables. This rule regulates fresh produce grown domestically, or internationally and imported into the United States and its territories. The PSR provides basic food safety oversight for certain types of fresh produce, to prevent foodborne illness. The ultimate goal is to protect public health by protecting our fresh produce supply from contamination. In general, the requirements of the Produce Safety Rule apply when three conditions are present: “covered produce,” “covered farms,” and “covered activities,” terms we will define for you below. The PSR applies to farms with more than $25,000 in average annual produce sales during the previous three years (adjusted for inflation). However, some produce is not “covered,” and your farm or your produce may be eligible for an exemption. First, we will define some terms; then we will go through different exemptions.

Part 1. What is Covered Produce?

Under the Produce Safety Rule, “produce” generally means any fresh fruit or vegetable, and includes mushrooms, sprouts, rhubarb, tree nuts, and herbs. When we talk about produce we are referring to the harvestable or harvested part of the crop, which may include parts that are not edible. For example, when talking about tree nuts, the entire unit (nut or kernel, hull, and shell) would be the “harvestable” or the harvested part.

The term Covered Produce is produce that falls within the conditions of the Produce Safety Rule and is a raw agricultural commodity (RAC) that FDA has determined is usually eaten raw.

The following produce is covered by the PSR (other produce may be added to this list by the FDA):

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.

Part 2. What produce is not Covered Produce?

While most produce is subject to the Produce Safety Rule, some produce is “not covered” or is eligible for an exemption. Produce that is ‘not covered’ is not subject to the Produce Safety Rule at all and does not have to meet any of the requirements of the Rule.

Crops “not covered” by the rule include produce that is:

  • Designated as rarely consumed raw (RCR) within the Produce Safety Rule.
  • Grown for personal or on-farm consumption
  • Produce designated for on-farm processing
  • Produce designated for commercial processing
  • Food grains

Part 3. What farm activities are Covered Activities?

“Covered” activities include growing, harvesting, packing or holding “covered” produce on a farm.

Harvesting means activities that are usually performed on farms to remove raw agricultural commodities from the place they were grown or raised.

Packing means the activities done after harvesting (other than just transporting it from the field) and before final packaging (see definition below). Examples are repacking, sorting, culling, grading, and weighing, but does not include chopping or peeling or cooking in any way.

Packaging (when used as a verb) means placing food into its final container that directly contacts the food and is the container that the consumer will buy.

Holding means storage of food and also includes activities performed in storage (e.g., 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 that make it easier to transport or distribute the produce (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.

Part 4. Is your farm a Covered Farm?

Let’s go through the flowchart that will determine if your farm is subject to the Produce Safety Rule (PSR) and/or if you qualify for an exemption.

Q1: Does your farm grow, harvest, pack, or hold produce?

If YES, go to Q2.

If NO, then your farm is not covered by the PSR.

Q2: Does your farm on average (in the previous three years) have more than $25,000 (adjusted by inflation) in annual produce only sales?

If YES, go to Q3.

If NO, your farm is NOT covered by the PSR. PLEASE NOTE: If your farm sells less than the adjusted $25,000 threshold mentioned above, you are not covered by the Rule and are not subject to any of its requirements. You do not need to save your sales records to prove it. However, you are not exempt from producing a safe product and could still face liability issues if you are ever involved in a foodborne outbreak.

How do I answer Q2?

The Produce Safety Rule applies to farms and certain farm mixed-type facilities that averaged more than $25,000 in annual produce sales during the previous three-year period. Farmers should note that the $25,000 threshold set when the FDA Food Safety Modernization Act was enacted in 2011 must keep up with the pace of inflation. This information is available using the federal calculation for inflation adjustments provided by the U.S Bureau of Economic Analysis or by FDA on its website for FSMA Inflation Adjusted Cutoffs.

Table 1: Using $25,000 in 2011 as a baseline, this table lists the values adjusted for inflation for each year.

2011 2016 2017 2018 3-year average 2016-2018
$25,000 $26,956 $27,433 $28,106 $27,528

All figures have been obtained from the FDA website. For an updated version, check FSMA Inflation Adjusted Cut Offs.

In your annual calculation of total produce sales to determine whether the three-year average of $27,528 threshold is met, including the following:

  • All produce sold, not just produce covered by the Produce Safety Rule
  • Produce that you purchased or otherwise obtained and then resold
  • Produce sold directly to consumers or online
  • Produce sold at farmers’ markets or to grocery stores, restaurants, or to other qualified end users.
  • Produce sold by a third-party on your behalf, such as through a cooperative that takes possession, but not ownership, of your produce
  • Retail sales, wholesale sales, intrastate sales, and interstate sales (including produce offered for import to the U.S. or exported from the U.S.)

Do not include the following in the calculation:

  • Produce for which no payment was received (i.e., produce held without sale, or produce donated. Produce that was traded for other commodities (i.e., bartered) still has value and is not considered donated nor free of value.)
  • The value of produce from other entities when a third-party is selling produce on your behalf along with produce from other entities. For example, when your produce is sold by a cooperative, along with produce from other growers, you should only consider the value from your produce sales.

Q3: Of all the crops you grow, are any of the produce crops on the list of the commodities that FDA has identified as Rarely Consumed Raw?

If NO, go to Q4.

If YES, The produce on the RCR list is NOT covered by the PSR. But if you grow other produce crops that are not on the RCR list, they ARE covered by the PSR and you should continue to Q4.

How do I answer Q3?

Rarely Consumed Raw (RCR) Produce includes produce that the FDA determined are almost always eaten after being cooked. Unlike the commercial processing exemption, which requires records, you do not need any documentation of the cooking process for the produce to be considered RCR because the FDA already did this leg-work.

FDA’s complete list of RCR produce includes: asparagus; black, great northern, kidney, lima, navy and pinto beans; garden beet (root and top); sugar beet; cashew; sour cherry; chickpea; cocoa bean; coffee bean; collard; sweet corn; cranberry; date; dill (seed and weed); eggplant; fig; ginger; hazelnut; horseradish; lentil; okra; peanut; pecan; peppermint; potato; pumpkin; winter squash; sweet potato; and water chestnut.

This list of Rarely Consumed Raw produce was developed by survey results from consumers about their produce usage and eating habits. The produce on this list were the only ones determined to have statistical data supporting that they are unlikely to be consumed raw, and will likely be cooked before eating, providing a kill-step for pathogens. The FDA considers this list of Rarely Consumed Raw produce to be “exhaustive,” meaning if a crop is not on this list, it is considered to be covered produce by the Produce Safety Rule.

“Covered Produce” also does not include food grains — meaning the small, hard fruits or seeds or the crops bearing these fruit or seeds — that are primarily grown and processed for use as meal, flour, baked goods, cereals, or oils rather than for direct consumption. Examples of food grains include barley, dent-or flint corn, sorghum, oats, rye, wheat, amaranth, quinoa, buckwheat, and oilseeds (e.g., flax seed, rapeseed, soybean, and sunflower seed).

Q4: Is your produce for personal/on-farm consumption or use?

If NO, go to Q5.

If YES, this produce is NOT covered by this rule.

How do I answer Q4?

Produce that is produced by an individual for personal consumption, or for consumption on the farm on which it was produced or on another farm under the same management, is not subject to the Produce Safety Rule. Examples include:

  1. A farmer has a separate garden on the farm’s property for growing produce for personal consumption by family members and employees, the fruits and vegetables in that garden would not be subject to the rule.
  2. Produce that is grown for use at an on-farm restaurant, dining event, or dinner club.
  3. On-Farm Processing Exemption
    • Examples of activities that change covered produce into processed foods include chopping, cooking, cutting, homogenization, irradiation, and pasteurization. The step where produce is processed and all following steps are subject to other food safety regulations, depending on the nature of the processed food. The following examples show the difference between produce in its raw and natural state and processed foods:
      • Whole heads of lettuce are considered covered produce; however, they are no longer covered by the PSR once they are chopped into smaller pieces. Chopped lettuce is a processed food and likely fall under the Preventive Controls for Human Foods Rule (PC Rule).
      • Fresh blueberries are covered produce; however, they are no longer covered by the PSR once they are cooked into blueberry jam. Blueberry Jam is a processed food and likely fall under the PC Rule. You can get more information about the PC Rule in Bulletin #4280, FSMA Preventive Controls for Human Food Rule Exemptions.

Q5: Is your produce intended for commercial processing that adequately reduces pathogens (for example, commercial processing with a “kill step” such as cooking or canning)?

If NO, go to Q6.

If YES, This produce is eligible for exemption from the rule provided you make certain statements in documents accompanying the produce, obtain certain written assurances, and keep certain documentation, as per section 112.2(b)(2) through (b)(6).

How do I answer Q5?

Some produce may be eligible for a ‘commercial processing exemption’ if it receives commercial processing that adequately reduces the presence of pathogens. This processed produce is eligible for exemption from most provisions of the Produce Safety Rule. To be eligible for the exemption, the commercial processing must adequately reduce the presence of pathogens (such as disease-causing bacteria).

If the farmer knows their produce will be commercially processed by their customers, they are not required to treat that produce according to the full requirements of the Produce Safety Rule. They will need to make a disclosure statement on the paperwork that travels with the produce:

“This produce has not been processed to adequately reduce the presence of microorganisms of public health significance.”

This requirement intends to prevent produce that has not been treated according to the basic minimum food safety standards laid out in the Rule from getting out into fresh markets where they may be consumed without adequate food safety controls.

The requirement for farmers to get written assurances from their commercial processing customers has been delayed for another two years in recognition of the paperwork burden this will impose throughout the value chain. See the compliances dates in part 6 for the current deadlines to obtain written assurances.

Q6: Does your farm, on average, (in the previous three years): Have less than $500k annual food sales, AND a majority of the food (by value) is sold directly to “qualified end users”?

If NO, your farm is covered by the PSR.

If YES, your farm is eligible for a qualified exemption from this rule.

How do I answer Q6?

Please note: This is the only time in the PSR that they ask for your annual food sales as a whole.

A produce farm is eligible for a qualified exemption if it meets the following three criteria:

  1. The farm’s 3-year average of annual produce sales is above the $25,000 (adjusted for inflation) threshold. (See Table 1, above.)
  2. The farm’s 3-year average of total food sales is below the $500,000 cap (adjusted for inflation) (see table 2, below.)
  3. The farm’s 3-year average of total food sales to qualified end users is more than its sales to all other customers.

Table 2: Using $500,000 in 2011 as a baseline, this table lists the values adjusted for inflation for each year.

2011 2016 2017 2018 3-year average 2016-2018
$500,000 $539,672 $549,863 $562,119 $550,551

All figures have been obtained from the FDA website. For an updated version, check FSMA Inflation Adjusted Cut Offs.

Qualified exemptions are based on a farm’s sales of all food products, including produce sales. Food encompasses all food or drinks used for humans or animals, including any food sold at restaurants, cafes, ice cream stands, etc., on your farm. Examples of food products include livestock, meat, dairy products, hay, grains, wine, and other food. Live animals are within the definition of food.

Qualified end-users are either:

  1. The actual consumer of the food.
    OR
  2. A restaurant or retail food establishment (e.g., grocery store, hospital, nursing home, school) that is purchasing the food for future sales directly to consumers as long as that restaurant or retail food establishment is located:
    1. In the same state or the Indian reservation as the qualified farm that sold the food;
      OR
    2. Not more than 275 miles from the farm.

A restaurant is a facility that prepares and sells food directly to consumers to eat Immediately. (See 21 CFR 1.227).

A retail food establishment’s primary function is to sell food directly to consumers. (See 21 CFR 1.227). Examples include roadside farm stands, meal kit services, grocery stores, convenience stores, schools, hospitals, and farmer’s markets that fit the definition. Sales over the internet are considered sales to a qualified end-user as well, even if the purchaser is not in the same state or within the 275 miles radius.

To help you understand the criteria for the qualified exemption, we created an illustration to clarify what “qualified end-user” means. If your customers are buying for their own consumption, they are a qualified end-user. If they are buying to sell it, but are a restaurant or a retail food establishment, and they are in your state or within 275 miles “as the crow flies” from your farm, they are also “qualified end-users.”

In the example illustrated below, a farm in Kittery, Maine, can sell to a customer from Fort Kent, Maine, because it is in-state (even if it is further away than 275 miles). The Kittery farm can also sell to anyone in Vermont, New Hampshire, Massachusetts, Connecticut, Rhode Island, and parts of Pennsylvania, New Jersey, and New York, including New York City, which is inside the 275 miles limit. In addition to U.S. sales, international sales that are inside the 275 miles, like sales to Quebec City and Montreal in Canada for this example, also qualify for the exemption if the other criteria are met. In the illustration, the farm in Kittery can sell to anyone in the green zone.

illustration showing that a farm in Kittery can sell to anyone in in a 275-mile radius

To determine the radius for your business, use the radius map tool (see “links” at the end of this fact-sheet in case you are reading in print). You use this tool by entering the address of your facility, the radius (275 miles), and clicking on “New Circle.” Add the radius area to the area of your state that is outside such radius, and you should have a map of your qualified end-users (assuming they are someone who is buying for their consumption, a restaurant, or a retail food establishment).

Now that you know the area for your qualified end-users, use the sales calculations to check if you are a qualified exempt farm using our calculator tool. This tool was created to be as simple as possible. To use it, you will need to have the following information (the tool will calculate for inflation automatically):

A – Average annual TOTAL PRODUCE sales over the last three years.

B – Average annual FOOD sales to qualified end-users over the last three years.

C – Average annual FOOD sales to NON-qualified end-users over the last three years.

After entering this data on the Microsoft Excel® spreadsheet tool, you will be answered about your eligibility to the qualified exemption. Download the calculator tool (Excel).

Part 5. What are the Modified Requirements for Qualified Exempt Farms?

If your farm is eligible for a qualified exemption, you will not have to meet the full requirements of the Produce Safety Rule, but you will still be subject to three modified requirements. If your farm is qualified exempt, you will need to:

  • Label your product at the point of sale with your farm name and complete business address.
  • Maintain annual sales records that demonstrate your continued eligibility for qualified exempt status. Receipts need to be dated, and the location of the sale needs to be noted on the receipt somehow to prove that more than 50% of your sales were within the 275 miles radius to qualified end users.  All records should include the name and address of the farm.
  • Perform a documented annual verification that your farm continues to meet the criteria for a qualified exemption.

Part 6. What are the Compliance Deadlines?

Compliance Deadlines

Business Size (Values must be adjusted by inflation) Compliance Dates for Sprouts Compliance Dates for Covered Produce Water Regulation Compliance Dates Compliance Date for Qualified Exemption Labeling Requirement Compliance Date for Retention of Records Supporting a Qualified Exemption Compliance Inspections to Begin
Large (>$500K) 1/26/17 1/26/18 1/26/22 1/1/20 1/26/16 Spring 2019
Small (<$250K-500K) 1/26/18 1/28/19 1/26/23 1/1/20 1/26/16 Spring 2020
Very Small (>$25K-250K) 1/28/19 1/27/20 1/26/24 1/1/20 1/26/16 Spring 2021
Not covered (<$25K)

 

Resources and References


Information in this publication is provided purely for educational purposes. No responsibility is assumed for any problems associated with the use of products or services mentioned. No endorsement of products or companies is intended, nor is criticism of unnamed products or companies implied.

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