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  1. Inspection References

Produce Safety Inspections

FDA and States receiving Path B and Path C funding as part of the State Produce Implementation Cooperative Agreement Program (CAP) began routine inspections of farms other than sprouts operations subject to the Produce Safety Rule (PSR) in Spring 2019, in a staggered approach based on farm size. As has been done with other FSMA rules, the FDA and state partners took an “educate before and while we regulate” posture with regard to the PSR.  Over the past several years, FDA and the National Association of State Departments of Agriculture (NASDA) worked closely with state and industry partners to advance training, technical assistance, educational visits and On-Farm Readiness Review (OFRR) to prepare regulators and farms for PSR inspections. To this point, initial routine inspections have been considered educational in nature with the goal of familiarizing farmers with the PSR and helping ensure prompt and consistent implementation of the PSR while allowing for farms to become familiar with the requirements.  During these initial routine inspections, only egregious observations have been captured on the Produce Farm Inspection Observation Form FDA 4056 or state equivalent form.  Significant, but not egregious, observations have been verbally communicated to the farm and documented in the produce inspection report.  Beginning on March 18, 2023, inspections will continue to be an opportunity to provide educational resources to farms to assist them in understanding and meeting the PSR requirements but all significant observations, not just egregious, will be documented on the FDA Form 4056 or state equivalent form during all inspections (including initial routine inspections). 

We appreciate the close collaboration with NASDA and our state partners as we approach this important milestone in our produce regulatory program. The voluntary On-Farm Readiness Review (OFRR) program will continue to be available to farms.

In FDA Voices, Former FDA Commissioner Scott Gottlieb, M.D., Associate Commissioner for Regulatory Affairs Melinda Plaisier, MSW, and Deputy Commissioner for Food Policy and Response Frank Yiannas, MPH, explain what FDA has been doing to support stakeholders’ work to comply with this rule.  Below are a variety of resources to continue to help prepare farmers and regulators for inspections.

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