PSR.1 What are the key requirements and compliance dates?

More information about the final rule can be found on the FSMA Final Rule on Produce Safety webpage.

PSR.2 Is extra time allowed for smaller farms to come into compliance with the requirements?

The FDA has staggered the compliance dates, based on the size of farms, to provide additional time for small and very small farms to come into compliance with the requirements. Additionally, FDA has issued a final rule extending, for covered produce other than sprouts, the dates for compliance with the agricultural water requirements in Subpart E. Because they present special safety concerns, operations growing sprouts have less time to come into compliance than other farms and do not get additional time to come into compliance with any of the water requirements. Farms with an average annual value of produce sold of $25,000 or less (adjusted for inflation) during the previous three-year period are not covered by the rule.

Produce: Covered and Not Covered

PSR.3 What produce is covered by this rule, and what produce is not covered?

The rule covers produce as that term is defined in 21 CFR 112.3. However, certain produce is excluded from the rule. Specifically, the rule does not cover produce that:

• is grown for personal or on-farm consumption
• is not a “raw agricultural commodity.” (A raw agricultural commodity is any food in its raw or natural state. See Section 201(r) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
• is identified as “rarely consumed raw”.  The “rarely consumed raw” list at 21 CFR 112.2(a)(1) is exhaustive and contains the following fruits and vegetables: 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.

In addition, produce that will receive commercial processing that adequately reduces microorganisms of public health concern (i.e., a “kill step”) is eligible for exemption from the rest of the rule if certain requirements are followed, including making a disclosure statement and keeping certain documentation.

PSR.4 Are hemp products covered under the produce safety rule?

Hemp greens (including microgreens) used for human consumption would meet the definition of produce and, therefore, would be covered produce and subject to the Produce Safety Rule (PSR) (21 CFR Part 112). Hemp seed sprouts used for human consumption would also be subject to the PSR, because sprouts, regardless of seed source, meet the definition of covered produce in 21 CFR 112.3.

However, hemp can contain cannabinoids such as delta-9 tetrahydrocannabinol (THC) and cannabidiol (CBD), both of which can be hazardous to health. A food that bears or contains non‐added poisonous or deleterious substances in quantities that would ordinarily make the food injurious to health would be considered adulterated. Selling such a product is prohibited. The cannabinoid content of hemp food products can vary widely and there is a lack of safety data regarding their consumption. It is the responsibility of all food producers to make sure that their products are safe and not adulterated.

COVERED FARMS

PSR.5 Is my farm covered by the Produce Safety Rule?

The Produce Safety Rule does not cover farms that have an average annual value of produce sold during the previous 3-year period of $25,000 or less, adjusted for inflation. To determine whether a farm is potentially a covered farm with respect to the $25,000 threshold in 21 CFR 112.4(a), the farm would need to calculate the average annual monetary value of their produce sales during the previous three years. Available resources include: the flowchart, to determine if the farm may be subject to the Produce Safety Rule; and the webpage, “FSMA Inflation Adjusted Cut Offs”.

QUALIFIED EXEMPTION

PSR.6 Is my farm eligible for a qualified exemption from the Produce Safety Rule?

If a farm’s average annual produce sales exceed $25,000, the farm may still be eligible for a qualified exemption and modified requirements if it meets two requirements: (1) The farm must have food sales averaging less than $500,000 (adjusted for inflation) per year during the previous 3 years; and (2) during that time, the farm’s sales directly to qualified end-users must have exceed sales to others (see 21 CFR 112.5). A qualified end-user is either: (1) The consumer of the food or (2) a restaurant or retail food establishment (as those terms are defined in 21 CFR 1.227) that is located in the same State or the same Indian reservation as the farm or not more than 275 miles from the farm (see 21 CFR 112.3). Read more about the current dollar value for food sales adjusted for inflation related to a qualified exemption.

QUALIFIED END-USER

PSR.7 What is a qualified end-user?

A qualified end-user, with respect to a food, means either the consumer of the food (does not include a business); or a restaurant or retail food establishment (as defined in 21 CFR 1.227) that is located:

(1) In the same State or the same Indian reservation as the farm that produced the food; or
(2) Not more than 275 miles from such farm.

According to 21 CFR 1.227, restaurant means a facility that prepares and sells food directly to consumers for immediate consumption and does not include facilities that provide food to interstate conveyances, central kitchens, and other similar facilities that do not prepare and serve food directly to consumers.

(1) Entities in which food is provided to humans, such as cafeterias, lunchrooms, cafes, bistros, fast food establishments, food stands, saloons, taverns, bars, lounges, catering facilities, hospital kitchens, day care kitchens, and nursing home kitchens are restaurants; and
(2) Pet shelters, kennels, and veterinary facilities in which food is provided to animals are restaurants.

A retail food establishment is an establishment that sells food products directly to consumers as its primary function, i.e., 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 (see full definition at 21 CFR 1.227). Grocery stores and convenience stores are examples of retail food establishments. The definition of retail food establishment was recently revised in the final rule, Amendments to Registration of Food Facilities (81 FR 45912, July 14, 2016), to provide certain clarifications about what types of sales may be considered sales directly to consumers for purposes of this definition.

More information about the terms “restaurant” and “retail food establishment” can be found in FDA’s guidance document titled Questions and Answers Regarding Food Facility Registration (Seventh Edition): Guidance for Industry.