Food Safety Modernization Act (FSMA) Produce Safety Rule
The rule focuses on the growing, harvesting, packing and holding of produce and is very similar to the requirements of USDA Good Agricultural Practices (GAP) certification. This is the first time there have been federal governmental regulations in this area. At least one supervisor or responsible party for covered farms must have successfully completed food safety training at least equivalent to the standard curriculum. The Produce Safety Alliance Grower Training course is the standard training and certification meets this requirement (regardless if you have GAP or other certifications, have been to other trainings, etc). FSMA does NOT require a full on-farm food safety plan or an audit/inspection; rather those covered by FSMA will need to follow the food safety practices and testing required by FSMA. If there is a food borne disease outbreak associated with your farm, you will no longer be exempt from the rule. Any processing of produce beyond washing and normal harvesting (such as chopping, peeling, or roasting) would be covered by the Preventive Controls rule.
Produce Safety Rule Subpart E Final Rule
The FDA has released the final rule on pre-harvest agricultural water. This rule replaces water testing and the microbial water quality profile with the creation of Pre-harvest Agricultural Water Assessment.
The assessment takes into consideration the agricultural water system as whole, agricultural water practices, crop characteristics, environmental conditions, and other relevant factors (testing).
- Factors for Agricultural Water Assessment to Consider - Food and Drug Administration
- Corrective and Mitigation Measures for Pre-harvest Agricultural Water for Non-Sprout Covered Produce - Food and Drug Administration
- Agricultural Water Assessment Builder - Food and Drug Administration
Understanding the Coverage and Exemptions
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- PSR Coverage and Exemptions/Exclusions Flowchart - Food and Drug Administration
- FSMA Inflation Adjusted Cut-Off - Food and Drug Administration
- Are there any exemptions of who will be covered by this rule?
- Qualified Exemption Worksheet (Fillable) 2024 - Kansas State University
- Processing Exemption - Missouri Department of Agriculture
- Annual Exclusion Worksheet (Fillable) 2024 - Kansas State University
Produce Safety Rule General Information
- FDA Guidance - Food and Drug Administration
- Produce Inspections - Regulators Virtual Produce Tour
- Small Farm Guidance Guide - Food and Drug Administration
Have a FSMA Question?
The Technical Assistance Network (TAN) is a central source of information for questions related to the FSMA Rules, programs, and implementation strategies.
- FSMA Technical Assistance Network - Food and Drug Administration
Templates for Record Requirements
- Records Required- Produce Safety Alliance
Funding for this website and the listed workshops are made possible in part by grant KS5895 from the FDA. Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the FDA.