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.
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 about the Proposed Rule on Agricultural Water including an overview, exemptions, implementation, contact and related information.
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.
- Draft Guidance for Industry: Standards for the Growing, Harvesting, Packing and Holding of Produce for Human Consumption
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 represents a new way of providing 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 new 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 new 4056 form 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 new 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)
FDA has prepared fact sheets and charts that explain various aspects of produce safety oversight.
- What to Expect of a Regulatory Inspection
- Coverage and Exemptions/Exclusions Flowchart (Colorized Flowchart) (PDF - 58KB)
- Coverage and Exemptions/Exclusions Flowchart (Black & White Flowchart) (PDF - 67KB)
- Fact Sheet: Cyclosporiasis and Fresh Produce (English) (PDF - 203KB)
- Fact Sheet: Cyclosporiasis and Fresh Produce (Spanish) (PDF - 484KB)
- Fact Sheet: Biological Soil Amendments of Animal Origin (English) (PDF - 154KB)
- Fact Sheet: Biological Soil Amendments of Animal Origin (Spanish) (PDF - 170KB)
- Fact Sheet: Rarely Consumed Raw Produce (English) (PDF - 160KB)
- Fact Sheet: Rarely Consumed Raw (Spanish) (PDF - 156KB)
- Fact Sheet: Equivalent Testing Methodologies for Agricultural Water (English) (PDF - 152KB)
- Fact Sheet: Equivalent Testing Methodologies for Agricultural Water (Spanish) (PDF - 148KB)
- Fact Sheet: Required Training for Covered Farms (PDF - 175KB)
- Fact Sheet: Required Training for Covered Farms [Spanish (PDF - 151KB)]