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.
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).
The Food Safety Modernization Act (FSMA) will heap unnecessary and expensive regulation on small food processors. FSMA is a federal law that passed Congress in 2011. The law directed the US Food and Drug Administration to write regulations that will require food processing facilities to engage in expensive, and time consuming practices.
Food processing facilities include cheese makers, coffee roasters, produce distribution companies and many more. The Food and Drug Administration estimates that it will cost very small food processing companies about $31,000 to comply with FSMA.
“[FDA] concludes that the proposed rule will have a significant economic impact on a substantial number of small entities… The regulatory costs of this proposed rule may discourage at least some new small businesses from entering the industry.”
This is bad news for the growing local food economy. But there is hope! Thanks to advocacy by CFSA and other organizations that represent small food processors, Congress gave states permission to regulate very small food processors using their own food safety regulations.
The South Carolina General Assembly is currently considering Senate Bill 284, which would allow South Carolina to regulate small food processing businesses using existing laws that are working for food processing businesses and consumers.
Many growers are asking this question. As of today, the answer, unfortunately, is “no.”
by Patricia Tripp, CFSA Local Produce Safety Coordinator
Understanding the difference between GAPs certification and The Food Safety Modernization Act (FSMA) will be essential for growers. Simply put, Good Agricultural Practices (GAPs) is a voluntary food safety program driven by buyers, whereas FSMA is law. Learn More
At the Carolina Farm Stewardship Association, we believe that local and regional food networks do the best job of protecting your family’s health and safety because they deliver fresher, more nutritious foods. That’s why it’s so important that we protect our small and organic food producers from being crushed by regulations meant for industrial farms and factories.
Making ‘Food Safety’ Safe for Small Farms and Local Food
In 2010, CFSA helped lead the successful effort to protect small farms and businesses serving local food markets from new federal authority under the Food Safety Modernization Act (FSMA). FSMA gives the US Food and Drug Administration new powers to dictate farming practices for fresh produce, and to put a wide range of food-making businesses out of business. But the legislation was just the first step.
In 2013, the FDA published proposed rules for implementing FSMA. These rules were badly flawed and threatened to put many small, sustainable farmers out of business. CFSA and our allies rallied farmers, entrepreneurs and consumers nation-wide to protest these bad proposals—over 20,000 comments poured in demanding major changes. In another huge victory for our movement, FDA went back to the drawing board.
In fall 2014, FDA issued revised proposed regulations relating to several key issues, including the use of compost and manure, food hubs and cooperatives, the definition of a farm, water standards, animal feed, conservation practices and record-keeping. Again, CFSA and other sustainable ag organization’s rallied local organic farming supporters to demand further changes. The comment period on those rules ended in December, with another 4,000 comments from the public.