FDA Guidance Documents to Industry Issued for the FSMA Produce Safety Rule

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While the Food Safety Modernization Act (FSMA) Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption, commonly known as the Produce Safety Rule (PSR), was finalized on November 27, 2015, and became effective on January 26, 2016, the FDA has been slow to release further information as guidance to the industry. Guidance documents represent FDA’s current thinking on a topic and help describe FDA’s interpretation of a policy or regulatory issue. FDA guidance documents usually discuss specific products, issues, or situations as examples of how a regulatory document might be interpreted and applied to those situations. While these documents help industry better understand the regulations, these documents are not legally binding. With the passing of compliance dates for large businesses (>$500,000) in 2018 and small businesses ($250,000 – $500,000) in early 2019, guidance for industry is vitally important for farms as they prepare to meet the provisions within the Produce Safety Rule and ultimately for future farm inspections.

On October 22, 2018, the FDA released the Draft Guidance for Industry: Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption. This is a 152-page document that provides examples of practices, tools, equipment, and situations that may commonly be found on farms and how each of these might be interpreted under the regulatory provisions within the PSR. It is important to note that this is still in draft form and the FDA is encouraging comments from the public during the 180 comment period for this document – through April 22, 2019. Electronic comments can be made on the Regulations website. Comments in writing can be submitted to: Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Regardless of whether comments are submitted electronically or in writing, all comments should be identified with the Federal Register docket number FDA-2018-D-3631. In addition, the FDA also released a series of At-a-Glance Overviews of the Produce Safety Rule Draft Guidance chapters – these are available in the Resources box on the right side of the FDA Draft Guidance for Industry webpage.