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. Compliance dates for businesses selling over $250,000 in produce sales have passed, and very small businesses, selling between $25,000 to $250,000 in produce sales, must be compliant with this new law by January 26, 2020. Farms selling under $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 will be overseeing compliance by farms is the Food and Drug Administration (FDA). Starting in spring 2019, FDA will be initiating a farm inventory survey for all specialty growers to determine whether they fall under the FSMA Produce Rule. FDA will be contacting growers via phone and email with a customized questionnaire. Answering the questions will help create an inspection priority for FDA 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, FDA may show up on the farm unannounced to gather the information.

Since the compliance dates have passed for those farms that sell over $500,000 in produce sales, there is a good chance that 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 - $500,000), routine inspections should begin in Spring 2020. Those farms selling between $25,000 to $250,000 in produce sales will see inspections starting around Spring 2021. Routine inspections are to ensure that the specialty grower is compliant with the FSMA Produce Rule.

There are several different types of inspections that may occur:

1. Routine inspections, as mentioned above
2. If there are any "past issues" with food safety on the farm that has not been corrected
3. If a routine farm inspection found food safety issues that needed to be addressed, FDA may show up unannounced to see that a correction has been made
4. If a farm fails to respond to an inspector's call to schedule a routine inspection, FDA may show up on the farm unannounced with five (5) business days after the initial contact
5. 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 will talk about the inspections in general, will give links to the Produce Rule and related resources, as well as guidance documents and inspection-related documents. This latter section will talk more specifically about the form 4056 that FDA will use during the farm inspection process.

If a farm operation is conducting any processing or manufacturing activities that fall within the scope of the Preventive Controls Rule for Human Food, a separate inspection will most likely occur.

Key items to keep in mind:

1. Designate someone from the farm to be the food safety representative when 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.
2. The food safety representative (or a designee) should be diligent in checking the farm email and phone message system should FDA call for an inspection date. Remember, FDA will show up unannounced at the farm if their initial contacts are ignored.
3. 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, 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 FDA's "Educate Before and While We Regulate" approach. Farmers who have an interest in scheduling an OFRR of their farm should contact 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

Additional questions concerning the FSMA Produce Rule, or the OFRR process in Illinois, please contact Laurie George at ljgeorge@illinois.edu or call (618) 242-0780.