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  1. Food Safety Modernization Act (FSMA)

FSMA Final Rule on Produce Safety

Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption

Introduction

The Produce Safety rule establishes, for the first time, science-based minimum standards for the safe growing, harvesting, packing, and holding of fruits and vegetables grown for human consumption. The rule is part of the agency’s ongoing efforts to implement the FDA Food Safety Modernization Act. The final rule went into effect January 26, 2016.

Compliance Dates

For covered activities, other than those involving sprouts (which have additional requirements and earlier compliance dates):

  • January 26, 2018: Covered farms for which, on a rolling basis, the average annual monetary value of produce the farm sold during the previous 3-year period is more than $500,000.
  • January 28, 2019: Covered farms for which, on a rolling basis, the average annual monetary value of produce the farm sold during the previous 3-year period is more than $250,000 but not more than $500,000 (small businesses).
  • January 27, 2020: Covered farms for which, on a rolling basis, the average annual monetary value of produce the farm sold during the previous 3-year period is more than $25,000 but no more than $250,000 (very small businesses).

Covered activities involving sprouts covered under Subpart M have separate compliance dates and are subject to all the requirements in the Produce Safety rule including specific requirements for sprout operations noted in Subpart M. The compliance dates for sprout operations are as follows:

  • January 26, 2017: Covered farms for which, on a rolling basis, the average annual monetary value of produce the farm sold during the previous 3-year period is more than $500,000.
  • January 26, 2018: Covered farms for which, on a rolling basis, the average annual monetary value of produce the farm sold during the previous 3-year period is more than $250,000 but not more than $500,000 (small businesses).
  • January 28, 2019: Covered farms for which, on a rolling basis, the average annual monetary value of produce the farm sold during the previous 3-year period is more than $25,000 but no more than $250,000 (very small businesses).

Additional compliance dates for farms eligible for certain exemptions can be found on the FDA’s FSMA Compliance Dates web page.

The definition of “farm” and related terms were revised in the final Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule (PC Human Food), and the same definitions of those terms are used in this rule to establish produce safety standards. Operations whose only activities are within the farm definition are not required to register with FDA as food facilities and thus are not subject to the preventive controls regulations. However, on January 4, 2018, FDA announced its intention to initiate rulemaking that could change the way the requirements in both the PC Human Food and PC Animal Food rules apply to certain facilities that conduct activities similar to those that occur on farms. The FDA intends to exercise enforcement discretion for the requirements in the PC rules for these specific entities and activities until the completion of future rulemaking related to farm activities. For more information see: Enforcement Discretion for Certain FSMA Provisions fact sheet.

For operations that meet the farm definition, exemptions and modified requirements for the Produce Safety rule are explained in “Exemptions and Variances” and in the Coverage and Exemptions/Exclusions flowchart (PDF - 95KB)

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