So, you’ve been categorized as a Qualified Exempt Farm, but no one has told you exactly what that means, or what you should do next. Luckily for you, we’ve already gone through all the red tape and put all the information you need to know in one place.
A Brief Overview
While some farms must adhere to all the regulations listed in the FSMA Produce Rule, others, called “qualified exempt farms,” may only need to follow modified requirements. In order to be considered for these adjustments, your farm must be grossing less than $500,000 a year (based on an average of the previous three years). More than half of those sales must have been earned through transactions with a consumer through CSA, a farmers market or some other direct marketing platform, or a retail food establishment like a restaurant or a grocery store that is either in the same state or within 275 miles of the farm that grew the produce.
If those two criteria are fulfilled, the farm may be considered “qualified exempt” (QE) and will only be subject to certain, adapted requirements. The modifications that will apply to your farm will affect four main components. These include:
- Compliance and Enforcement
- Withdrawal and Reinstatement (of a Qualified Exemption)
There are two instances in which labeling regulations will apply; when the produce does require a food packaging label and when it doesn’t.
When Produce Requires a Label
The label must be displayed “prominently and conspicuously,” and must include the name and complete business address of the farm that grew the produce. The date by which all QE farms must comply is January 1st, 2020.
When Produce Does Not Require a Label
The name and complete business address of the farm that grew the produce must be “prominently and conspicuously” displayed on a label, sign, poster, placard, or some sort of documents that are to be delivered with the produce. In the case of internet sales, such documentation may include an electronic notice. For farms that gross $250,000 at most in produce sales annually (based on the average of the past three years), the date to comply by is January 2020. For farms that gross $500,000 at most in produce sales annually (based on the average of the past three years), the date to comply by is January 2019.
For these purposes, the complete business address can be defined as the street address and/or P.O. box, city, state, and zip code of the farm.
In order to be sure that farms claiming exemptions are truly qualified, record-keeping is crucial. A QE farm must keep “adequate records necessary to demonstrate that the farm satisfies the criteria.” Put simply, “adequate records” will prove that all the standards required of qualified exempt farms are being met and should show that the farm is below the sales threshold, is selling to more qualified users than not, and that all purchasers are qualified end users. The date to start keeping such records and claim exemption is January 26th, 2016.
In addition to keeping adequate records, QE farms are required to keep a written record that contains an annual review and verification of the farm’s eligibility for exemptions. Farms only need to begin keeping the written record a year before their compliance date. For those that gross less than or equal to $250,000 annually, this date is January 2019. For farms that gross less than or equal to $500,000 annually, this date is January 2018.
While none of these records need to be sent to the FDA, they should all be readily available upon request. The records may be kept on- or off-site, however, if kept off-site, the documents must be retrievable within 24 hours of the call for an official review.
Any records kept in order to satisfy the Produce Rule must be detailed, accurate, and legible, as well as dated, signed, and initialed. Sales receipts do not need to be initialed for the purpose of documenting the monetary threshold, but they should be kept long enough (to calculate the average sales over the past three years) to properly document and confirm the qualified exempt status of the farm.
Compliance and Enforcement
All QE farms are subject to compliance and enforcement measures. The Produce rule states that any “failure to comply with the requirements of the [Produce Rule] is prohibited,” and will be treated as a federal offense. This makes any violation of the Produce Rule punishable by fines or incarceration. For QE farms, a transgression would mean neglecting to keep up with the record-keeping and labeling requirements.
Withdrawal and Reinstatement (of a Qualified Exemption)
This section will include a brief overview of the withdrawal and reinstatement process, but if you would like a more in-depth description, click here.
All QE farms are subject to the process and circumstances under which the FDA may withdraw their exempted status. Though the FDA has repeatedly stated that the withdrawal of a farm’s qualified exempt status is seen as a last resort, it is important to beware of the pitfalls that could lead to a withdrawal. There are two primary instances in which qualified exempt statuses may be lost. These are:
- In the event of an active investigation of a foodborne illness outbreak that is directly linked to your farm
- If it is determined that the withdrawal is necessary to protect the public health and prevent or control the outbreak of a foodborne illness based on conduct or conditions associated with your farm that are material to the safety of the produce your farm is growing, harvesting, packing, or holding
Before issuing an order of withdrawal to remove QE status, the FDA will attempt to assist the farm in rectifying the food safety problems. If all else fails, the FDA will issue the farm owner or operator a written notice of the circumstances that may lead the FDA to proceed in withdrawal. If the QE status is withdrawn, the farm must come into full compliance with the Produce Rule in under 120 days.
There are three different ways in which a farm’s QE status may be reinstated, depending on the reason the status was first revoked.
- In the case of conduct or conditions threatening to food safety
If the FDA finds that the farm has resolved the issues that led to withdrawal, the FDA may reinstate the farm’s QE status on its own initiative or at the request of the farm. The FDA must determine that the withdrawal is no longer necessary to protect public health or mitigate a foodborne illness outbreak before returning the QE status.
- In the case of an active foodborne illness investigation directly linked to the farm
If the FDA decides that the outbreak was not directly linked to the farm, the FDA will reinstate the QE status and notify the farm in writing.
- In the case of a withdrawal based on a combination of the both of the above scenarios
If the FDA concludes that the outbreak was not directly linked to the farm, then the FDA will notify the farm, but will not reinstate the farm’s QE status unless specifically requested to do so by the farm.
In order for a farm to request reinstatement, a written statement must be submitted along with data and information that demonstrates the resolution of any former problems that caused the initial withdrawal.
It is imperative that each and every farm takes on the duty it has to minimize contamination risks on the farm and in processing in order to keep adulterated food from being distributed across the country. Keeping consumers safe and food pathogen free should be of the utmost priority to all farms, regardless of exemption status.