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New FDA Tools to Assist With FSMA Implementation

Updated: Jul 23, 2020

By Sarah Everhart

Person holding an iPhone (Photo by Edwin Remsberg).

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The U.S. Food and Drug Administration (FDA) recently released two tools to help with the implementation of the Preventive Controls and Produce Safety Rules of the Food Safety Modernization Act (FSMA).

As we have previously posted, the Preventive Controls Rule of FSMA is a federal food safety law applicable to facilities that manufacture, process, pack, or hold food for consumption.

Farms are generally exempt. If a farm engages in processing activities, however, it may be subject to the law. Retail establishments selling directly to consumers (in the agricultural context this includes farmers’ markets, community supported agriculture programs (CSA), and other direct-to-consumer sale structures) are also exempt from the Preventive Controls Rule. Check out this past post for more detail on when certain farms and retail establishments are exempt. The FDA has also created this draft guidance document to provide further detail on the types of activities a farm can engage in without it amounting to processing.

If a farm engages in processing and is subject to the law, it must register with the FDA as a covered facility, implement a food safety system including an analysis of hazards and risk-based preventive controls as defined by law (21 C.F.R. 117), and have a written food safety plan. The food safety plan must include an analysis of known hazards and the preventive controls or measures to be taken to minimize the risks.

To assist those subject to the law, the FDA has created an optional tool, the Food Safety Plan Builder. This tool guides the user through the following sections of the plan:

· Facility Information

· Preliminary Steps

· Good Manufacturing Practices (GMP) & Prerequisite Programs

· Hazard Analysis & Preventive Controls Determination

· Process Preventive Controls

· Food Allergen Preventive Controls

· Sanitation Preventive Controls

· Supply-Chain Preventive Controls

· Recall Plan

· Reanalysis of Food Safety Plan

· Food Safety Plan Report

· Signature

· Recordkeeping Procedures

· Important Contacts

· Supporting Documents

The compliance dates for the Preventive Controls Rule are staggered based on the size of the business. To understand when you must be in compliance with the rule, go to FDA’s website and calculate the date of compliance from the date of publication of the final rule (November 16, 2015).

The FDA has also released a small entity compliance guide for the Produce Safety Rule of FSMA. The Produce Safety Rule applies to all farmers who have annual produce sales for the previous three-year period (2014-2016) in excess of $25,000 (adjusted for inflation $26, 632) and grow foods typically consumed raw. For a summary on what Maryland produce growers need to know about the Produce Safety Rule, check out this ALEI video. FDA’s small entity compliance guide provides a detailed review of compliance details and is a very helpful resource for farmers subject to this new law.

Growers with questions about FSMA may contact a ALEI legal specialist at 410-706-7377 or by email at

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