URBANA, Ill. — By now, specialty fruit and vegetable growers in Illinois should be aware of the Food Safety Modernization Act (FSMA) Produce Rule, which was signed into law in 2011, became effective in 2016, and is the first mandatory federal standard for growing, harvesting, packing, and holding of fresh produce.
Early compliance efforts focused on working with businesses selling more than $250,000 in produce sales. State regulators are now focusing their efforts on small businesses, selling between $25,000 and $250,000 in produce sales, who must meet compliance standards by Jan. 26, 2020, explains Laurie George, a University of Illinois Extension local food systems and small farms educator. Farms selling less than $25,000 (adjusted for inflation) are exempt from the Produce Safety Alliance (PSA) Grower Training, but are still required to have documentation showing their exempt status.
In Illinois, the regulatory agency that oversees farm compliance is the Food and Drug Administration (FDA). Starting in spring 2019, the FDA initiated a farm inventory survey for all specialty growers to determine whether they fall under the FSMA Produce Rule. The FDA will be contacting growers via phone and email with a customized questionnaire. Answering the questions will help create an inspection priority to determine who falls under the regulation, and whether they will require an inspection this year. If the grower does not respond to the initial contact, the FDA may show up on the farm unannounced to gather the information, George says.
Because the compliance deadlines have passed for those farms that sell more than $500,000 in produce sales, there is a good chance that the FDA will be calling to set up a farm inspection starting this summer. For small farmers (farms with a three-year average of annual produce sales between $250,000 and $500,000), routine inspections should begin in spring 2020. Those farms selling between $25,000 and $250,000 in produce sales will see inspections starting around spring 2021. Routine inspections ensure that the specialty grower is compliant with the FSMA Produce Rule.
There are several different types of inspections that may occur:
- Routine inspections, as mentioned above.
- If there are any past food safety issues on the farm that have not been corrected.
- If a routine farm inspection found food safety issues that needed to be addressed, the FDA may show up unannounced to see that a correction has been made.
- If a farm fails to respond to an inspector’s call to schedule a routine inspection, the FDA may show up on the farm unannounced within five business days after the initial contact.
- If there is a complaint, recall, or foodborne outbreak investigation linked to a farm.
Information on FDA Produce Safety inspections is available to growers. The website talks about the inspections in general, links to the Produce Rule and related resources, and provides guidance documents and inspection-related documents, including form 4056 that the FDA will use during the farm inspection process.
If a farm operation is conducting processing or manufacturing activities that fall within the scope of the Preventative Controls Rule for Human Food, a separate inspection will most likely occur.
Key items to keep in mind:
- Designate someone from the farm to be the food safety representative when the FDA calls or arrives on the farm. This person should be familiar with the FSMA Produce Rule, and have taken a Produce Safety Alliance Grower Training class.
- The food safety representative (or a designee) should be diligent in checking the farm email and phone message system should the FDA call for an inspection date. Remember, the FDA will show up unannounced at the farm if their initial contacts are ignored.
- If you are interested in learning more about a farm inspection and what it entails, check out the FDA Produce Safety Inspections website.
If you have already taken a Produce Safety Alliance Grower Training, and want to make sure your farm is in compliance with the FSMA Produce Rules, the FDA is offering an On-Farm Readiness Review (OFRR). This review provides an opportunity for farmers to get individual feedback on their readiness for compliance before they receive their first inspection. This tool is consistent with the FDA’s, “Educate Before and While We Regulate” approach.
Farmers who have an interest in scheduling an OFRR of their farm should contact the FDA at RequestAnOFRR@fda.hhs.gov or by mail:
U.S. Food and Drug Administration
c/o Produce Safety Network
Center for Food Safety and Applied Nutrition
Fresh Produce Safety Branch (HFS 317)
5001 Campus Drive
College Park, MD 20740
For additional information concerning the FSMA Produce Rule, or the OFRR process in Illinois, please contact George at firstname.lastname@example.org or call (618) 242-0780.
— University of Illinois Extension
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