The first major compliance date for large farms subject to the Produce Safety Rule, other than sprout operations, arrived on January 26, 2018 (large farms are those that, on a rolling basis, have sold an average of more than $500,000 a year in produce over the past three years). However, FDA conveyed in a previous announcement that routine inspections associated with the rule would not begin until Spring 2019. This action was intended to allow FDA and its state partners time to provide additional opportunities for education and outreach, such as through the On-Farm Readiness Review (OFRR) program.
FDA began routine inspections of large farms other than sprouts operations subject to the Produce Safety Rule, including large produce farms in other countries, in Spring 2019. States receiving Competition A/B funding as part of the State Produce Implementation Cooperative Agreement Program (CAP) were asked to use Spring 2019 as their starting dates for routine inspections of large produce farms.
Routine inspections of small farms, other than sprouts operations, subject to the Produce Safety Rule, for which the compliance date arrived on January 28, 2019, will generally begin in Spring 2020; however, states may begin routine inspections as early as January 1, 2020. This date is intended to give states the flexibility to align routine inspections with the winter growing season where applicable. Individual states will make final decisions on whether to initiate their first inspections of small farms at the earlier date in January 2020.
States utilizing the earlier date of January 1, 2020 should prioritize completing planned inspections of large farms subject to the rule, prior to inspecting small farms. (Small farms are those that, on a rolling basis, have sold an average of more than $250,000 but not more than $500,000 a year in produce over the past three years.)
FDA began routine Foreign Supplier Verification Programs inspections of importers of produce from large farms in other countries in Fall 2019.
We appreciate the close collaboration with the National Association of State Departments of Agriculture (NASDA) and our state partners as we approach this important milestone in our produce regulatory program. The voluntary OFRR program will continue to be available to industry as inspections begin.
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 help prepare farmers and regulators for the start of inspections.
The link below provides information about the Final Rule on the Standards for the Growing, Harvesting, Packing, and Holding of Produce including related guidance, fact sheets, correspondence, news releases and more.
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
The FDA and National Association of State Departments of Agriculture (NASDA) and our state partners have collaborated to develop two new documents to be 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)
- *NEW*:Fact Sheet: Required Training for Covered Farms (PDF - 175KB)
- *NEW*:Fact Sheet: Required Training for Covered Farms [Spanish (PDF - 151KB)]