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.

See the FDA Federal Register Notices  and review § 112.1—112.7 of the regulation  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 exclusions:
  • 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

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).

*See the FSMA Inflation Expanded Cut Offs for the value adjusted for inflation and averaged over three years.

A qualified end-user is either: (1) the consumer of the food or (2) a restaurant or retail food establishment that is located in the same state or the same Indian reservation as the farm or not more than 275 miles away. Instead, these farms are required to include their name and complete business address either on the label of the produce that would otherwise be covered (if a label is required under the FD&C Act and its implementing regulations) or to display the same information at the point-of-purchase. These farms are also required to establish and keep certain documentation (See § 112.7).

For complete information regarding FSMA Produce Safety Rule compliance, please see the following:

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