MT. VERNON, Ill. — Now that the first produce farms are certified under the federal Food Safety Modernization Act Produce Rule, inspections by the Food and Drug Administration can literally happen any day.

“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,” said Laurie George.

She’s a University of Illinois Extension educator who’s become expert on FSMA regulations.

“If the grower does not respond to the initial contact, the FDA may show up on the farm unannounced to gather the information,” she warned, adding that there are only certain circumstances leading to an unannounced inspection.

Effective in 2016, FSMA is the FDA’s new regulations on growing, harvesting, packing and holding of fresh produce. The agency set up a series of compliance dates for farms to earn FSMA certification based on annual sales.

First to qualify were big farms selling $250,000 or more a year by January 2019 and then those selling $25,000 to $250,000 by Jan. 26, 2020. Small farms selling less than $25,000 are exempt.

So, now it’s time for FDA officials to follow up and inspect farms to ensure they are complaint. George explained that the inspection process is detailed.

Here’s what to expect when the FDA calls.

Starting in spring 2019, George said the FDA initiated what is called a farm inventory survey for all specialty growers to determine whether they fall under FSMA rules.

FDA officials will be contacting growers by phone and email with a customized questionnaire.

“Answering the questions will help create an inspection priority for the FDA to determine who falls under the regulation and whether they will require an inspection this year,” George explained.

Routine inspections start this season for farms with a three-year average of annual produce sales between $250,000 and $500,000.

Those farms selling between $25,000 and $250,000 will see inspections starting around Spring 2021.

Several different types of inspections that may occur:

  • Routine inspections, as George described.
  • If there are any “past issues” with food safety on the farm that have not been corrected.
  • 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.
  • If a farm fails to respond to an inspector’s call to schedule a routine inspection, FDA may show up on the farm unannounced within five business days after the initial contact.
  • If there is a complaint, recall, or foodborne illness outbreak investigation linked to a farm.

Information on FDA Produce Safety inspections is available to growers online. The website talks about the inspections in general and offers links to the Produce Rule and related resources, as well as providing guidance documents and inspection-related documents.

There’s also detailed information about the form 4056 that FDA officials will use during the farm inspection process.

If a farm operation is conducting any processing or manufacturing activities that fall under the Preventive Controls Rule for Human Food, a separate inspection likely will occur, George said.

And here are tips if there’s an FDA site visit to the farm:

  • 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 rules and taken a Produce Safety Alliance Grower Training class.
  • The food safety representative 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: tinyurl.com/y5kdjqxm.

Reviews can be requested: Anyone who’s already taken a Produce Safety Alliance Grower Training and want to make sure your farm is in compliance, the FDA is offering an On-Farm Readiness Review.

“This review provides an opportunity for farmers to get individual feedback on their readiness for compliance before they receive their first inspection,” George said.

This tool is consistent with FDA’s “Educate Before and While We Regulate” approach. Farmers who have an interest in scheduling a review 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.

George also shared one last tip: Those small farms which are exempt must keep documentation handy of their exempt status.

Contact Laurie George with questions at 618-242-0780, or ljgeorge@illinois.edu.

Karen Binder can be reached at 618-534-0614 or kbinder@agrinews-pubs.com. Follow her on Twitter at: @AgNews_Binder.

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