Menu

FSMA Produce Rule Compliance Guide

Who needs to comply?

1. You are not covered by the Produce Safety Rule if…

  • Your gross produce sales are less than $25,000* (produce is defined as intact fruit, vegetables, herbs, mushrooms, and nuts – it does not include crops like ornamental pumpkins or gourds that are not for human consumption).

                OR

  • All your produce is on the FDA’s list of produce rarely consumed raw,** and/or is destined for processing (provided you comply with certain customer disclosure and verification requirements outlined here).

2. You are fully covered by the rule if you do not meet either of the criteria in #1, AND…

  • Your gross food sales (which includes animal feed and value-added products) are $500,000* or more.

                OR

  • At least half of your gross food sales are 1) sold wholesale to buyers that don’t sell directly to consumers (e.g. distributors, store distribution centers) or 2) sold to buyers that are located over 275 miles from the farm.

3. You are “qualified exempt” if you do not meet either of the criteria in #1, AND…

  • Your gross food sales are less than $500,000.*

                AND

  • More than half of your gross food sales are sold within 275 miles of the farm, either directly to consumers or to wholesale outlets that sell directly to consumers.

Note that the qualified exemption can be removed if there is an outbreak or if the FDA otherwise deems it necessary to protect public health. Qualified exempt farms are required to:

  • Label – Prominently display the name and full address of the farm where the produce was grown on the label or at the point of purchase.
  • Keep records – Maintain records starting January 27, 2016 to prove that you meet both criteria needed to be eligible for a qualified exemption. All records must be detailed, accurate, legible, accessible within 24 hours, dated, and signed or initialed by the person performing the documented activity (except sales receipts).

When do you need to comply?

1. If you have a qualified exemption…

  • Record-keeping compliance date: January 26, 2016
  • Labeling compliance date: January 1, 2020

2. If you’re fully covered, you DON’T grow sprouts, and you gross…

  • more than $500,000 in produce sales* –
    Compliance date for all but water: January 26, 2018 (but routine inspections will not begin until 2019)
    Water compliance date: January 26, 2022
  • between $250,000 and $500,000 in produce sales* –
    Compliance date for all but water: January 28, 2019
    Water compliance date: January 26, 2023
  • between $25,000 and $250,000 in produce sales* –
    Compliance date for all but water: January 27, 2020
    Water compliance date: January 26, 2024

3. If you’re fully covered, you DO grow sprouts, and you gross…

  • more than $500,000 in produce sales* – Full compliance date: January 26, 2017
  • between $250,000 and $500,000 in produce sales* – Full compliance date: January 26, 2018
  • between $25,000 and $250,000 in produce sales* – Full compliance date: January 28, 2019

*All sales totals are figured by taking an average of the previous three years and adjusting for inflation. For 2018, you will fall under the inflation-adjusted equivalent to the $500,000 cutoff if the average of 2015-2017 food sales totals is under 539,982; and you will fall under the inflation-adjusted equivalent to the $25,000 cutoff if the average of 2015-2017 produce sales totals is $26,999. You can visit this page to see the FDA’s up-to-date inflation-adjusted cutoffs.

**The FDA’s exhaustive list of produce rarely consumed raw includes the following crops grown in Massachusetts: asparagus, beets, collards, cranberries, dill, dry beans, eggplants, figs, ginger, hazelnuts, horseradish, okra, peppermint, potatoes, pumpkins, sour cherries, sweet corn, sweet potatoes, and winter squash.

Find It Locally

Search CISA’s online guide to local farms, food, and more!

Find Local Food
Click here to return to the main food safety page.