FSMA Inspections Are Underway. Are You Ready?
Updated: Nov 5, 2020
By Nicole Cook
This article is not a substitute for legal advice. See here for the site’s reposting policy.
Nearly 10 years after the Federal Food Safety Modernization Act, or “FSMA,” was signed into law, and nearly 5 years after the Food and Drug Administration (“FDA”) published the final Produce Safety Rule (“PSR”) implementing FSMA, the new routine inspections to verify compliance with the PSR have begun. Routine inspections of produce farms (other than sprout operations) and packing houses averaging more than $500,000 in annual gross sales began last spring, and inspections of farms (other than sprout operations) averaging more than $250,000 but not more than $500,000 in annual gross sales are scheduled to begin this spring. It’s the perfect time to register for a Produce Safety Grower’s Training if you haven’t yet obtained the PSR-required training certificate, or to schedule a voluntary On-Farm Readiness Review for your farm if you have completed the Produce Safety Grower’s Training.
In all states except Oregon, Wyoming, North Dakota, South Dakota, Iowa, and Illinois, the state Agriculture Department conducts the new routine FSMA inspections. According to what FDA and state inspectors have said, the inspections aren’t heavy-handed actions aimed at doling out penalties. The goal, according to the FDA, is to educate farmers and even collaborate with farmers about how to best implement food safety measures on their farm to ensure compliance with the PSR.
But, that doesn’t mean that farms and packing sheds that pose an immediate danger to public health won’t be subject to penalties. After all, the inspections are aimed at preventing conditions that could lead to foodborne diseases. That’s what FSMA is all about: preventing health problems, not just reacting to them, as was the case before the act was signed into law.
The PSR is one of seven rules established by the FSMA. The PSR requires all farms subject to the law to have at least one supervisor or responsible party to attend a grower training for certification from the Association of Food and Drug Officials. To receive this certificate, one must attend the entire training and submit the appropriate paperwork to the trainer at the end of the course.
If you still need to attend a Produce Safety Grower’s Training to get the certificate required to comply with the PSR, or you would like to refresh and maybe update your knowledge, the Maryland Department of Agriculture (MDA), the University of Maryland Extension and the Agriculture Law Education Initiative are offering the following trainings to producers in Maryland and surrounding states:
December 4, 2019, at the University of Maryland Eastern Shore in Princess Anne, MD (find more information and register here);
January 24, 2020, at the Harford County Extension Office in Street, MD (find more info. and register here);
February 6, 2020, at the Montgomery County Extension Office in Derwood, MD (find more info. and register here); and
March 5, 2020, at Garrett College in McHenry, MD (find more info. and register here).
The trainings are from 8AM-5PM. The cost is $25, which covers training materials, food and the training certificate.
Also, farms that have completed the Produce Safety Grower’s Training and have their certificates can request an On-Farm Readiness Review (OFRR) to help assess how prepared they are for inspection. The review is free and completely voluntary. It’s purely for the purpose of helping producers ensure they’re ready to pass inspection.
While at the farm, the OFRR reviewer observes growing conditions, harvesting practices, packinghouse operations, water sources and discusses common food-safety “touchpoints.” The visit is scheduled at the farmer’s convenience and generally takes only several hours. At the end of the review, the assessor gives the farmer his or her top three suggestions for the farm to improve its food-safety practices. After the review, the farmer is also connected with educational materials and resources to guide him or her toward becoming compliant with the PSR.
Maryland farmers can find out more about an OFRR by contacting Deanna Baldwin at MDA at 410-841-5769. Farmers in other states can go to https://www.nasda.org/foundation/food-safety-cooperative-agreements/on-farm-readiness-review for a state-by-state rundown about scheduling an OFRR.
For more information about what to expect during a routine inspection, the FDA recently provided materials on its Produce Inspections Webpage to help producers prepare for inspection. On the webpage, you can review a fact sheet entitled “What to Expect of a Regulatory Inspection.” The handout is for produce farmers and provides an overview of the steps that state inspectors or federal investigators will take when conducting routine inspections for compliance with the PSR. You can also go to https://www.youtube.com/watch?v=Q_KXS5pXHIs to view a “Produce Inspections for Regulators Virtual Produce Tour” that takes you to a YouTube video that covers the fundamental elements of a routine farm inspection under the PSR.
Additional information about FSMA and the PSR is available at ALEI’s Food Safety webpage at umaglaw.org and also by searching under “food safety” on this blog.