FSMA Coverage Status Under the Produce Safety Rule
On this page:
- Coverage Status Overview
- Produce Not Covered Under the Produce Safety Rule
- Covered Activities
- Types of Coverage Status
- Determining Your Coverage Status
- Coverage Status Resources
The Produce Safety Rule (21 CFR Part 112) lays out minimum food safety standards for covered farms doing covered activities with covered produce. Each of these has a technical regulatory meaning.
In this case, the word "covered" means included in the scope of the Rule and subject to its regulations. It doesn’t refer to crops grown under row cover or in hoophouses or under other kinds of cover we might think of in farming.
"Covered produce" is all produce that is generally consumed raw, based on quantified national consumer surveys. Almost every fruit, vegetable, herb, or wild foraged crop is likely to be included. It refers to the harvested or harvestable portion of the crop.
There are types of produce that are not covered under the scope of the Produce Safety Rule, including:
- Food grown for on-farm or personal consumption.
- Seeds and arable food grains.
- Crops grown for animal feed.
- Produce that is rarely consumed raw, as quantified by national consumer surveys.
There is a list of rarely consumed raw produce in the text of the Produce Safety Rule, and it is considered exhaustive. That means if it is not included on that list, it should be considered produce that is subject to the Produce Safety Rule. See our Library of Resources for the complete list of rarely consumed raw produce.
"Covered activities" included in the scope of Produce Safety Rule include all growing, harvesting, packing, and holding activities. Holding is a regulatory term that most commonly means a broad variety of storage activities.
You don’t have to be doing all four of these activities to be covered by the Rule. If you wild harvest and pack a crop, you’re doing covered activities even if you’re not ‘growing’ the wild crop. Similarly, if you grow the crop and someone else harvests it for you, you may still be covered by the Produce Safety Rule.
A covered farm is one performing covered activities on covered produce. The definition of a farm is based on ownership structure, location, and management of activities. There are a lot of nuances in the many ways farms are structured and run. We recommend that you get in touch with us directly if you’re not sure if you meet the definition of a covered farm.
There are three coverage statuses for farms under the Produce Safety Rule. Your farm’s status under the regulation largely depends on what your annual produce sales and your annual total food sales are as a 3-yr average. Your farm can be:
- NOT COVERED if:
- Your total produce sales are under the $25,000* threshold for coverage.
- QUALIFIED EXEMPT if:
- Your produce sales are over the $25,000* threshold;
- Your total food sales are under the $500,000* cap;
- And you are primarily selling to direct markets.
- FULLY COVERED if:
- Your produce sales are over the $25,000* threshold;
- You are primarily selling to intermediary markets;
- OR your total food sales are over the $500,000* cap.
In addition, some produce may be eligible for a COMMERCIAL PROCESSING EXEMPTION. We will explain each of these below.
NOTE: All monetary values marked with an asterisk* are 3-yr averages, adjusted for inflation from 2011 values. Use the last three years prior to the calendar year we're in. See below for current 3-yr averages adjusted for inflation.
|Baseline Value for Cut-offs (2011)||Value in 2017||Value in 2018||Value in 2019||Average 3 Year Value for 2017 - 2019|
Not Covered Farm: $25,000
Qualified Exemption: $500,000
For more information about exemptions and non-coverage visit FDA.gov: FSMA Inflation Adjusted Cut Offs.
Your requirements under the Produce Safety Rule depend upon your coverage status.
Farms Not Covered Based on Produce Sales
Farms that are not covered based on their produce sales do not have to follow the requirements in the Produce Safety Rule regulation. They do still have to produce safe food and prevent the introduction of any adulterated food into commerce under the Federal Food Drug & Cosmetic Act (FD&C Act).
Qualified Exempt Farms
Farms that are qualified exempt based on their sales figures and primarily direct market channels need to meet modified requirements of the Produce Safety Rule. They are required to:
- Label products with their farm name and full business address:
- On the food packaging label if the food requires a packaging label.
- Prominently and conspicuously at the point of sale if the food does not require a food packaging label. (This can include on signs by the register, on bills of lading, by product displays, on posters, etc.)
- Maintain sales records that support their qualified exempt status.
- Do an annual written review and verification that they still meet the qualified exempt eligibility criteria.
Fully Covered Farms
Farms that are fully covered will need to:
- Comply with the full requirements the Produce Safety Rule.
- Have at least one supervisor or responsible party attend an approved grower training.
- Be inspected for their regulatory compliance by our inspectors.
As a reminder, ALL food businesses in the United States are required by the FD&C Act to produce food that is fit for consumption and to prevent adulterated food from entering commerce.
Commercial Processing Exemption
If you are selling covered produce under a commerical processing exemption, you must include a disclosure statement in the paperwork accompanying the product. You must disclose that the produce is: “…not processed to adequately reduce the presence of microorganisms of public health significance.”
Additionally, you will need to get written assurances from your commercial processing customers that they will be processing your produce to adequately reduce the presence of microorganisms of public health significance, or will only sell to other commercial processors who will do that processing themselves.
Because the FDA has recognized the complications in providing these written assurances for commercial processing exempt produce throughout the food chain, they have announced a delayed compliance date for commercial processing customers to provide those written assurances. Currently it is only the disclosure statements from the farms selling the produce that are required.
If you would like to talk directly with one of our team to help determine your coverage status, we’re happy to have a conversation over the phone. Contact us at: 207-764-2100.
You can also follow our Choose-Your-Own-Adventure questions to see what your coverage status is likely to be. Always call us to confirm if you want to know for sure you’re on the right track.
You may want to sit down with something you can digest to figure out your farm’s coverage status. We’ve linked a few resources to help you do that:
- FSMA Coverage Appendix (PDF) - Our full coverage status appendix, complete with decisions trees and the regulatory requirements for each coverage status
- FDA’s coverage and exemption flow chart
Again, we strongly encourage any farm to feel free to call us up. We’ll help you determine your coverage status with all the variations in farm model that may exist, and get you started with whatever resources you need. Please don’t hesitate to get in touch!
For more information on the Produce Safety Rule continue exploring this website
- The Produce Safety Rule
- Library of Resources - Helpful links and documents from around the nation.
- Maine's FSMA Team - Your resource team for produce safety in Maine and the Northeast.
Reach out to our team any time for help navigating the FSMA regulations. We are happy to support Maine’s food safety culture every way we can!