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.
Here are a few key exemptions and
- 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
- 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
- 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
Produce Safety Inspections 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 sell an average of more than $500,000 a year in produce).
the FSMA Inflation Expanded Cut Offs for the value adjusted for inflation and
averaged over three years.
complete information regarding FSMA Produce Safety Rule compliance, please see
Inflation Expanded Cut Offs
- Coverage and Exemptions/Exclusion Flow Chart
- Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption
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
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