What is a "Qualified Exemption" and what does it mean?
The Qualified Exemption is a provision, which allows very small to small-size farms to be eligible to certain modified requirements of the Rule. Keep in mind, even if your farm meets the requirements to claima qualified exemption you are still responsible for producing safe food. Regardless of your status with the Produce Safety Rule, it is always best to understand the food safety risks on your farm and have a plan to mitigate them.
Who is eligible for a Qualified Exemption?
A farm is eligible for a qualified exemption and the associated modified requirements in a calendar year if:
During the previous 3-year period the majority of your average food sales were directly to qualified end-users, AND
During the previous 3-year period your average annual sales for all food sold was less than $500,000 (adjusted for inflation based on 2011 dollars). The inflation adjusted value is updated annually by FDA and posted as FSMA Inflation Adjusted Cut Offs.
What's a "qualified end-user?"
Qualified end-users can be either the consumer of your food, or they can be restaurants or retail food establishments located in the same state or Indian reservation as the farm that produced the food, or not more than 275 miles from the farm. Common examples of sales to qualified end-users include: sales direct to consumers through farmers' markets, CSAs, and U-pick operations. Schools, restaurants, and sales directly to grocery stores in your state (or within 275 miles of your farm) would also be considered qualified end-users.
What requirements apply to me as a Qualified Exempt farm?
Qualified exempt farms are subject to fewer provisions of the Produce Safety Rule than fully covered farms, but still must meet certain modified requirements to protect public health:
Record Keeping: You must establish and maintain certain documentation (see below).
Consumer Notice: You must prominently display the name and complete business address including the street, post office box, city, state, and zip code of your farm at the point of sale. Common examples include a sign at a farmers' market stand, on an invoice, or on any label attached to the product package. If your annual produce sales are between $250,000 and $500,000, you must start providing this notice in Jan. 2019. If your annual produce sales are less than $250,000, you have until Jan. 2020.
Labelling: If you sell foods which already require product labels. Labels must include your farm's name, complete business address, common or usual name, count or net weight. All qualified exempt farms have until Jan. 2020 to implement this part of the labelling requirement.
What records must I keep as a Qualified Exempt farm?
You must keep records which demonstrate that you satisfy the criteria for a qualified exemption, including a written record showing that you performed an annual review of your eligibility and have verified that your farm continues to meet the requirements listed above. Please note that these records must be kept for 3 years because eligibility is based, in part, on three-year averages.
All records must be dated, legible and accurately identify the locations and times where you carried out activities relating to food safety. Existing records may be used, combined, or supplemented to include all necessary information. Records can be kept on paper or electronically and do not need to be kept in one set, but they must be available within 24 hours of official request.
Can my Qualified Exemption be withdrawn?
In situations where it is determined necessary to protect the public health or mitigate a foodborne illness outbreak, a farm's qualified exemption may be withdrawn if:
There is an active investigation of a foodborne illness outbreak directly linked to a farm; or
The FDA or other authorized agency determines that it is necessary to protect public health and to prevent or mitigate a foodborne illness outbreak that is traced back to your farm.
Depending on the situation, one or more other actions to protect the public health may be taken prior to withdrawing a qualified exemption. These can include a warning letter, product recall, seizure of product, etc. The point of contact for the farm will be notified of any circumstances that may lead to the withdrawal of the exemption, and provide the owner the opportunity to address the situation.