To comprehensively review the answers to each of the FSMA Preventive Controls Rule Frequently Asked Questions, please see the following:

All files have been updated as of Dec. 2019.

 

The Preventive Controls Rule FAQs were created by the Carolina Farm Stewardship Association and the National Farmers Union Local Food Safety Collaborative. Financial support for these documents was provided by the Local Food Producer Outreach, Education, and Training to Enhance Food Safety and the project described was supported by the FSMA Compliance Cooperative Agreement 1U01FD005770 from the U.S. Food and Drug Administration, which was awarded to the National Farmers Union Foundation. However, these documents have not been approved by the U.S. Food and Drug Administration and their contents are solely the responsibility of the authors and do not necessarily represent the official views of the U.S. Food and Drug Administration. These FAQs were written to provide you with accurate information on the limited subject matters covered. However, all content was not necessarily prepared by a person licensed to practice law in your particular jurisdiction. This guide is designed to provide general information on pertinent compliance topics, and the statements made here are for educational purposes only. These statements do not constitute legal advice.

To comprehensively review the answers to each of the FSMA Produce Rule Frequently Asked Questions, please see the following:

All files have been updated as of Apr. 2018.

1.       I’ve heard FSMA has different rules for farms versus other businesses. How do I know if my business is a farm?

This may seem obvious, but getting the answer right is critically important, because if your business is a farm, then it is not a food ‘facility’.  If your business is a ‘facility’ under FSMA, then it may be subject to FDA’s Preventive Controls for Human Food or Animal Feed (PC) Rules, which cover food processing.  The costs of compliance with the PC Rules can be tens of thousands of dollars a year for a small business.

If your business meet FDA’s definition of either a Primary Production Farm (PPF) or a Secondary Activities Farm (SAF), then the PC Rule does not apply to you.  The upshot of these definitions is that things that farmers and groups of farmers do to grow raw produce crops and to prepare them for market are treated as ‘farm’ activities, not ‘facility’ activities.

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1. I run a farm, but I also make foods on-farm.  How are my food processing activities regulated?

If you are making processed foods on farm, your operation likely can be classified as either a retail food establishment or a farm-mixed type facility.

A retail food establishment is a business that manufactures foods and sells more than half those products directly to consumers, including through on-premises sales, farmers markets, community-supported agriculture, roadside stands, online, mail-order and other direct marketing platforms.  Depending on state law and the kind of foods made, a retail food establishments may be regulated by the local health department or may be subject to a ‘cottage food’ law if there is one in your state.  FSMA does not apply to retail food establishments.

If less than half of your processed food sales are directly to consumers, you are likely operating a farm mixed-type facility.  A farm mixed-type facility is required to register with the US Food and Drug Administration (FDA), and the food processing done on-farm may be subject to at least portions of FSMA’s Preventive Controls Rules (PC Rules) for Human Food (or for Animal Feed if the only processed foods you make are for animals).

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1.     How do I know if my farm is covered by the FSMA Produce Rule?

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1.      My business packs and distributes fruits and vegetables.  What does FSMA mean for me?

The first thing to understand is whether your business is a ‘farm’ or not, as defined by FDA.  This may seem obvious, but getting the answer right is critically important, because if your business is a farm, then it is not a food ‘facility’.  If your business is treated as a ‘facility’ under FSMA, then it may be subject to FDA’s Preventive Controls for Human Food or Animal Feed (PC) Rules, which cover food processing.  According to the FDA, the costs of compliance with the PC Rules can run into tens of thousands of dollars a year for a small business.

If your business meets FDA’s definition of either a Primary Production Farm (PPF) or a Secondary Activities Farm (SAF), then the PC Rule does not apply to you.  The upshot of these definitions is that things that farmers and groups of farmers do not just to grow raw produce crops but also prepare them for market are, in general, protected as ‘farm’ activities.

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1.    My farm meets the criteria for a Qualified Exempt Farm.  Does FSMA still apply to me?

Qualified Exempt Farms (QEFs) do not have to comply with FSMA’s regulations that govern growing, harvesting, holding and packing produce.  However, there are special requirements for QEFs related to record-keeping, notice to customers, and losing QEF status.

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