FSMA Frequently Asked Questions

fsma-faqs-header_notitle

The Food Safety Modernization Act (FSMA) gives the U.S. Food and Drug Administration expansive new powers to regulate produce farms and food manufacturing businesses.  FSMA rules are incredibly complex, leaving producers and farmers confused about what to do.  On this page you will find answers to some of the most frequently asked questions about FSMA.  Check back often, as we are continually updating this page with new material on both the FSMA Produce Rule, which governs on-farm food safety practices, and the FSMA Preventive Controls Rules for Human Food and for Animal Feed, which govern food manufacturing.

Perhaps the most urgent thing farmers need to know is that very few farms are subject to the main provisions of the Produce Rule right now. It’s unlikely that you need to take “required” trainings on FSMA in the near future. According to the FDA, most produce farms won’t even be covered by most of FSMA. What most produce farms need right now is basic food safety education on implementing Good Agricultural Practices (GAPs). Some of these practices may be new to you, and since implementing effective food safety improvements on the farm can take time, it makes sense to start preparing now, whether you are subject to FSMA or not.

 

DOWNLOAD – 

Are You a Farm? (.pdf)

Is Your Farm Covered by the Produce Rule? (.pdf)

Is Your Produce-Packing Operation a Farm? (.pdf)

Are You a Farm Mixed-Type Facility? (.pdf)

What Are The Special Requirements for Qualified Exempt Farms? (.pdf)

What Are The Basic Requirements of the Produce Rule? (.pdf)

Produce Rule Compliance Dates By Farm Size (.pdf)

Are you Required under FSMA to Take a Farm Food Safety Training? (.pdf)

FSMA Frequently Asked Questions – Are You A Farm?

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.

Learn More

FSMA Frequently Asked Questions – Are You a Farm Mixed-Type Facility?

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).

Learn More

FSMA Frequently Asked Questions – Is Your Produce Packing Operation a Farm?

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.

Learn More

FSMA Frequently Asked Questions – What are the Basic Requirements of the Produce Rule?

Regulations under the FSMA Produce Rule require covered farms to address six potential routes of contamination for fresh produce: Workers, water, animal-derived soil amendments, animals, tools and equipment, and post-harvest handling.[1]  This document provides a top-level overview of those requirements; for a more in-depth discussion of the specifics of each area, see the report from the National Sustainable Agriculture Coalition, “Understanding FDA’s FSMA Rule for Produce Farms.”

Learn More