By Michelle Rivera and Kara Timmins
Since routine inspections of farms subject to the Produce Safety Rule (PSR) began in 2019, the U.S. Food and Drug Administration (FDA) and National Association of Departments of Agriculture (NASDA) have worked closely with state and industry partners to prepare regulators and farms for inspections through training, technical assistance, educational visits, and On-Farm Readiness Review (OFRR).
According to the FDA, routine inspections have been educational to assist farmers with becoming more familiar with the PSR requirements and have only captured egregious observations in the FDA 4056 form. However, this initial approach is changing regarding how inspection observations are captured. Since March 18th, these inspections have continued with the assumption that growers understand the change on the approach and forms are filled out accordingly. While inspections will continue to provide educational resources to farms to understand and meet the PSR requirements, all significant observations, not just egregious, will be document during all inspections. The agency is working with all states to emphasize consistent implementation and a process to clearly communicate to growers how to prioritize observations noted in the FDA 4056 form.
FDA and NASDA encourage the use of OFRR, especially for those operations that have not had their initial inspection yet. Below are additional resources to assist with the inspection process:
- FDA Fact Sheet: Produce Safety Rule (21 CFR 112) What to Expect of a Regulatory Inspection
- Produce Safety Inspections | FDA
- Food Compliance Programs | FDA
- About On-Farm Readiness Review – NASDA
If you have any questions or issues associated with this change, contact Sonia Salas at firstname.lastname@example.org.