FDA Releases Compliance Guide for Small Businesses under FSMA Produce Safety Rule

The FDA Food Safety Modernization Act (FSMA) 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 definition of “farm” and related terms were revised in the final Preventive Controls for Human Food rule, 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. For operations that meet the farm definition, exemptions and modified requirements for the Produce Safety are explained in “Exemptions and Variances” and in the Coverage and Exemptions/Exclusions flowchart (PDF: 95KB).

Small Entity Compliance Guides (SECGs) are designed to help small businesses meet federal standards. They are among the resources that the FDA is providing to support compliance with the new FDA Food Safety Modernization Act (FSMA) standards. The SECG provides information that can help small and very small businesses understand how the requirements of the Produce Safety Rule apply to them. Specifically, the SECG can help farmers determine whether they are eligible for a qualified exemption, which would modify the requirements they are subject to under the Produce Safety Rule. The SECG can also help them understand those modified requirements

The main compliance dates for small businesses and very small businesses under the Produce Safety Rule are January 28, 2019, and January 27, 2020, respectively, but certain agricultural water requirements have extended compliance dates. Sprout operations also have different compliance dates, and sprout operations that are small businesses and very small businesses have compliance dates of January 26, 2018, and January 28, 2019, respectively.  Businesses that intend to claim a qualified exemption by their primary compliance date were required to begin keeping documentation supporting their eligibility for a qualified exemption on January 26, 2016.

 

 

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