January 2016 compliance date to claim exempt status under FSMA
It may come as a surprise to small produce growers that are exempt from the FDA’s new Produce Safety Rule that they need documentation of their status by Jan. 26, 2016
If your farm is exempt from FSMA’s Produce Safety Rule, you are not off the hook with the FDA. You’ll need specific documentation on file to prove your exemption. The rule calls for these records to be in place by Jan.26, 2016.
These records can be originals, photocopies, scans, pictures, microfilm, microfiche or electronic records and must be retained as long as necessary to support the farm’s exempt status. No matter the format, they need to be accurate, legible, and as specific as possible, including the farm name and address, date, and a description of what was sold. Records must be readily available and accessible for inspection and copying by FDA upon request.
In order to be eligible for a qualified exemption, a farm must have records that prove that it sold less than $500,000 in all food over a three year period and that more of that food was sold to “qualified end-users” than other customers. Let’s break apart that statement for ease of interpretation:
- it sold less than $500,000 in all food—Note that this goes beyond produce covered under rule. Food is defined here by section 201(f) of the Federal Food, Drug, and Cosmetic Act which reads:
- “The term “food” means (1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article.”
- over a three year period— This is calculated by taking the average annual monetary value, in other words gross sales, of all food (as defined above) sold during the previous three calendar years. For a farm that only sells food products, a way to get these values would be to refer to section 1a on the Schedule F tax form. Annual monetary values should be adjusted for inflation with a baseline year of 2011. This can be done by using the Bureau of Labor Statistics online inflation calculator.
more of that food was sold to “qualified end-users” than other customers—a “qualified end-user” is a buyer that is located in the same State or the same Indian reservation as the farm or is no more than 275 miles from the farm. The buyer must also be:
- A consumer, not including a business
- A restaurant, meaning “a facility that prepares and sells food directly to consumers for immediate consumption.” Examples covered under this broad definition include cafeterias, food stands, and catering facilities. Pet shelters, kennels, and veterinary facilities in which food is provided to animals are also considered restaurants.
- A retail food establishment, meaning “an establishment that sells food products directly to consumers as its primary function.” Examples include grocery stores, convenience stores, and vending machine locations.
To prove that you sold a majority of your food to qualified end users, you will need supporting documents. These could take the form of invoices, sales receipts, or records of farmers market sales.
For assistance in FSMA Produce Safety rule compliance, contact a Michigan State University Extension agrifood safety educator. Michigan State University’s Community Food Systems work team supports the development of local food systems in Michigan. To connect with a local foods educator near you, visit the expert page or call 1-888-678-3464.