Meeting FSMA Produce Safety Rule Regulations
Many farmers wonder if their farm will be subject to regulation under the FSMA Produce Safety Rule. If you grow, pack, process or sell fresh produce, this regulation may apply to you. Review these sections of the regulation 112.1—112.7 of the Produce Safety Rule to determine if your farm and the commodities you grow are subject to the regulation. You can also refer to the FDA’s fact sheet on coverage, exclusions and exemptions to help you determine whether you are subject to the regulation.
- The rule does not apply to certain specified produce commodities that are rarely consumed raw. You can find the list of produce not covered by the regulation in § 112.2.
- The rule does not apply to produce that is used for personal or on-farm consumption, or that is not a raw agricultural commodity (RAC).
- The rule provides an exemption for produce that receives commercial processing that adequately reduces the presence of microorganisms of public health significance (e.g., via a “kill step”) as long as certain disclosures are made and written assurances are received, with appropriate documentation.
- The rule does not cover produce farms that have an average annual value of produce sold during the previous three-year period of $25,000* or less.
- The rule provides a qualified exemption and modified requirements for farms that meet two requirements: (1) the farm must have food sales averaging less than $500,000* per year during the previous three years; and (2) the farm’s sales to qualified end-users must exceed sales to others.
Produce Safety Inspections
For complete information regarding FSMA Produce Safety Rule compliance, please see the following:
- FSMA Inflation Expanded Cut Offs
- Coverage and Exemptions/Exclusion Flow Chart
- Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption
- Important FSMA Compliance Timelines (PDF)
- What you need to know about the FDA Regulations — Small Entity Compliance Guide
- Decision Tree: Farm Food Safety Decision-Making Made Easy
- FDA Federal Register Notices