Produce Safety Rule

FDA Food Safety Modernization Act (FSMA) Produce Safety rule became effective January 26, 2016. 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 web site.


All sales ranges used for compliance dates and exemptions are based on the previous three-year average sales, adjusted for inflation. The base year for inflation determination is 2011. Go to the Consumer Price Index (CPI) site for an online calculator that can help you determine the current, inflation-based dollar amounts tied to compliance dates and exemptions.


Who/What is covered by the PSR?

The Produce Safety Rule applies to covered farms doing covered activities on covered produce. 

  • Covered farms are all farms selling over $25,000 worth of produce averaged over the previous 3 years and adjusted for inflation.
  • Covered activities are growing, harvesting, packing, or holding covered produce on a farm.
  • Covered produce (any fruit or vegetable, and includes mushrooms, sprouts, peanuts, tree nuts, and herbs) means produce that is subject to these rules: produce that is in its unprocessed state, and is usually consumed raw.

Who/what is NOT covered by the PSR?

  • If you sell less than $25,000, you are not obligated by regulation to comply with any part of the PSR.  It would be prudent to keep financial records that prove you fit into this category.
  • Produce that is not generally eaten raw and described as such in the rule is not covered.

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; ginger; hazelnuts; horseradish; lentils; okra; peanuts; pecans; peppermint; potatoes; pumpkins; winter squash; sweet potatoes; and water chestnuts.

  • Produce that is used for personal or on-farm consumption is not covered by the rule.
  • 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) are not covered by the rule.

Exemptions from provisions of the rule

The rule provides an exemption for produce that receives commercial processing that adequately reduces the presence of microorganisms of public health significance, under certain conditions. For example canning tomatoes or making tomato sauce.

  • If you do send product to be cooked, canned, brewed or distilled, you must keep good records of that produce and where it is being processed.  You must also send a disclosure statement (keep a copy) to the processor stating that the produce has not been treated to destroy microorganisms of public health significance.
  • Freezing processes, dehydration and washing (such as in a flume or dump tank) are commercial processes that generally do not significantly reduce the presence of microorganisms (Ref. 3) (Ref. 8) (Ref. 9) (Ref. 61) (Ref. 90)., according to the guidance document you 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.”

The rule also provides a qualified exemption and modified requirements for certain farms. The qualified exemption, outlined in the original Food Safety Modernization Act, which applies to processed foods as well as fresh produce, uses “FOOD” sales as the basis for eligibility. “Food” means food as defined in section 201(f) of the Federal Food, Drug, and Cosmetic Act and includes seeds and beans used to grow sprouts. The term “food” means articles used for food or drink for humans or other animals; chewing gum; and articles used for components of any such article.

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

  • The farm must have food sales averaging less than $500,000 per year during The farm must have food sales averaging less than $500,000 per year during the previous three years; AND
  • 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, foodservice establishment 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. At least 51% of the farm’s food sales must be to qualified end users.

A farm with the qualified exemption must still meet certain modified requirements, including disclosing the name and the complete business address of the farm where the produce was grown either on the label of the produce or at the point of purchase. These farms are also required to establish and keep certain documentation to prove eligibility for the exemption.

Produce Safety Rule FDA guidance documents

There are two guidance documents, written by the Food and Drug Administration (FDA), focused on helping farmers comply with the PSR.  They are linked here:

Record requirements

To comply with the PSR, FDA requires farms to keep some specific records.  You can find a list of the records as well as sample record forms on the Produce Safety Alliance website here:  Records Required by the FSMA Produce Safety Rule.pdf