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 About On-Farm Readiness Review - NASDA to prepare regulators and farms for PSR inspections. The voluntary OFRR program continues to be available to farms.
The links below provides information on what to expect during an inspection.
- "What to Expect of a Regulatory Inspection” - Informational Handout for Farmers
- Spanish Translation of "What to Expect of a Regulatory Inspection” - Informational Handout for Farmers (en español, PDF - 162KB)
The link below provides information about the Final Rule on the Standards for the Growing, Harvesting, Packing, and Holding of Produce including questions and answers, key requirements, translations, assistance to industry, related guidance, fact sheets, and more.
The link below provides information on the end dates to the enforcement discretion for the harvest and post-harvest agricultural water requirements for non-sprout covered produce in Subpart E of the Produce Safety Rule.
The link below provides information about the Rule on Pre-Harvest Agricultural Water which published on July 05, 2024.
The draft Produce Safety Rule guidance, published in October 2018, provides a broad range of recommendations on how to meet the requirements for most subparts of the rule. It also provides recommendations on how to determine eligibility for a qualified exemption and modified requirements of the rule and recommendations on how to determine whether a farm is covered by the rule.
Additional guidance can be found at FSMA Final Rule on Produce Safety under the “Related Guidance” section.
The FDA and National Association of State Departments of Agriculture (NASDA) and our state partners have collaborated to develop two documents that are used in support of produce inspections.
Form 4056 (Produce Farm Inspection Observations)
The first document is the Form FDA 4056, “Produce Farm Inspection Observations.” This form provides feedback to farms and documenting observations that is different from FDA's traditional process of reporting observations made during an inspection, which has historically been through the FDA 483 Inspectional Observations Form. The form (FDA 4056) is designed around the specific provisions in the Produce Safety Rule and was developed to help farmers better understand what is being examined in an inspection. FDA will issue the FDA 4056 at the end of every farm inspection, whether or not any non-compliance issues were identified, to help farmers understand what is being examined in an inspection and how any observation relates to the regulation. FDA is working with states to promote consistency among inspections through use of the form.
Dispute Mitigation and Resolution
For the produce inspections being conducted by FDA, the agency has developed a Dispute Mitigation and Resolution procedure, which is formalized as Field Management Directive 152. This provides a process for resolving differences between FDA and state regulatory authorities during inspections.
FDA is providing resources for farmers and regulators through internal and external partnerships.
- Produce Inspections for Regulators Virtual Produce Tour
- Produce Safety Alliance (PSA)
- Produce International Partnership for Education and Outreach (PIP)
- Produce Safety Network
- FSMA Collaborative Training Forum
- On-Farm Readiness Reviews (NASDA)
- National Association of State Departments of Agriculture (NASDA)
- FoodSHIELD