FSMA Produce Safety Rule (PSR) Exemptions: Are You Exempt?

Achyut Adhikari, Burke, Briana

Decorative banner that says "Are You Exempt" featuring a hand-drawn farm.

No farm is exempt from producing safe food, but some are exempt from fully complying with the FDA Food Safety and Modernization Act (FSMA) Produce Safety Rule. If your farm is qualified exempt, or the produce item is commercially processed with a kill step, that means you may have to comply with only a few of the requirements of the FSMA Rule for those produce items. To determine if your farm is a part of the exemption community, see if the following questions are applicable to you.

  • Did your farm have an average gross value of $25,000 or less during the previous three years? You are not covered under the rule! (Keep records to prove your exemptions.)
  • Did your farm gross between $25,000 and $500,000 and the majority of food was sold to qualified end-users* during the previous three years? You are qualified exempt! (Keep records to prove your exemptions and identify yourself at points of sale.)
  • Do you produce any of the rarely consumed fruits, vegetables or grains in the list below? They are not covered under the rule!
  • Is your produce used for personal or on-farm consumption? Produce grown for personal or on-farm consumption are not covered under the rule!
  • Are the fruits or vegetables you grow going to be commercially processed? You may qualify for exemption! (You need a letter from the buyer saying the produce will be processed in a manner to adequately reduce the presence of microorganisms of public health significance, according to the FDA CFR Title 21 ยง112.2.)

*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. (FSMA Final Rule)

Things to remember:

Keep in mind that the FDA has the authority to revoke exemptions if there is a possibility of a potential risk of foodborne illness or if an active investigation is directly related to the farm. To get a withdrawn exemption reinstated, the FDA must determine that the outbreak is not directly related to the farm or determine that the problem has been adequately resolved.

Although you may be exempt, qualified exempt or process exempt from the FSMA Rule, you must still provide records to prove your exemption and disclose 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 to identify yourself at points of sale.

Produce That Is Rarely Consumed Raw:

  • Asparagus
  • Black beans
  • Great northern beans
  • Kidney beans
  • Lima beans
  • Navy beans
  • Pinto beans
  • Garden beets (roots and tops)
  • 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
  • Water chestnuts
12/5/2019 3:35:50 PM
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