The purpose of this draft compliance and implementation guidance document is to help covered farms comply with the requirements of the Produce Safety Rule, which establishes science-based minimum standards for the safe growing, harvesting, packing, and holding of produce. Entitled “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption,” the rule is part of FDA’s implementation of the FDA Food Safety Modernization Act (FSMA).
The draft guidance provides a broad range of recommendations on how to meet the requirements for most subparts of the rule. It also outlines how to determine whether produce or farms may be eligible for exemptions from certain requirements, or from the rule in its entirety.
Specific regulatory or statutory requirements are cited, and in some cases, specified using the word must. The use of the word should indicates that something is recommended, but not required. The use of the word including means options that are not limited to the described items.
You are encouraged to submit comments on the draft guidance within 180 days of the publish date to ensure your comments are considered while FDA works on the final version of the guidance.
In addition to the draft guidance, there is an At-a-Glance overview of key points in each of the nine chapters described below, as well as a glossary of key terms. The overviews summarize important aspects of each chapter. It is recommended that you review the draft guidance itself for complete information.