Complying With The FSMA Produce Safety Rule – The Records You Need To Keep
Updated: Jul 23
By Sarah Everhart
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If you grow produce consumed raw (produce rarely consumed raw is not subject to the law, for example, potatoes), you need to understand the Produce Safety Rule of the Food Safety Modernization Act (FSMA) and the records to keep to comply with this federal law. For more detail on the Produce Safety Rule and whether your operation is subject to the law, check out this recently released FDA guidance document and this video. If you are subject to the Produce Safety Rule, you must keep certain records related to your operation. If you are not subject to the Produce Safety Rule or are eligible for a qualified exemption, you also need to keep certain records to prove your status.
In general, all records kept for the Produce Safety Rule must include the name and address of the farm, actual values and observation obtained during monitoring, an adequate description (variety, lot number, etc.) of the covered produce applicable to the record, and the date and time of the activity documented, and all records should be signed or initialed by the person making the record. Records should be retained at least two years; records being used to prove a three-year average should be retained three years.
If you believe you are not subject to the Produce Safety Rule because the produce you grow is sent for further processing which involves a “kill step,” you must keep a copy of documentation sent with the produce stating the “produce is not processed to adequately reduce the presence of microorganisms of public health significance” and obtain written assurance from the processor annually that “the produce will be processed to adequately reduce microorganisms of public health significance.”
If you believe you are not subject to the Produce Safety Rule because your operation earned less than $25,000 (adjusted for inflation, $26,632) in annual produce sales averaged over the past three years, you must retain records such as receipts and a written record reflecting an annual review and verification of the farm’s continued eligibility.
If you believe you are eligible for a qualified exemption, you must retain copies of all receipts for food sales for the previous three-year period as well as a calculation of the percentage of food sold to qualified end users. Here is a record template which can be used by growers eligible for a qualified exemption.
For growers subject to the Produce Safety Rule, categories of required records include:
· Worker Training
· Agricultural Water (System Inspection, Water Monitoring and Corrective Measures)
· Biological Soil Amendments of Animal Origin
· Cleaning and Sanitizing of Equipment Used in Harvesting, Packing & Handling
Although the federal Food and Drug Administration has not yet created any records templates, the Produce Safety Alliance, an organization tasked with developing the standardized national produce safety training program to prepare growers to comply with FSMA, has created easy-to-use record templates for all the required categories listed above.
For more detail on this subject, check out this Mid-Atlantic Women in Agriculture webinar.