The Food Safety Modernization Act, aka FSMA [pronounced fizz-ma], is a large piece of legislation aimed at ensuring the safety and security of the U.S. food supply.
Most of FSMA focuses on companies that run food processing facilities, like Kraft Heinz and Hershey’s. But some of the rules do affect farmers — in particular, farming operations over a particular size. Wading through all of the regulations can be daunting. In this article, we’ll look at the two rules of most interest to farmers and help you understand whether they apply to you.
Note: If you grow food just for you and your family, none of these rules apply. FSMA is only for food intended for sale in the United States.
Preventive Controls for Human Food Rule
This rule probably doesn’t apply to you.
The first rule, which started to come into effect late last year, is the FSMA Final Rule for Preventive Controls for Human Food. This rule specifically targets food facilities, and as a farmer, you probably don’t need to worry about it.
According to the FDA, a food facility is any facility that manufactures, processes, packs, or holds food for consumption in the United States. Farms, defined as a “physical location devoted to the growing of crops, the harvesting of crops, the raising of animals (including seafood), or any combination of these activities,” are exempt from the rule.
Farms are allowed to perform certain processing activities without being considered a food facility. They can:
- Pack or hold raw agricultural commodities.
- Pack or hold processed food as long as it’s consumed on the farm.
- Manufacture/process food as long as it’s consumed on the farm.
- Manufacture/process food to be consumed elsewhere as long as those activities are limited to:
- Drying/dehydrating raw agricultural commodities to create a distinct commodity (e.g., drying grapes to produce raisins) and packaging and labeling the dried products without further processing (e.g., slicing).
- Treating the raw agricultural commodities to manipulate the ripening (e.g. treating produce with ethylene gas) and packaging and labeling the treated products without further processing.
- Packaging and labeling raw agricultural commodities without further processing.
As you can see, most typical farm activities are exempt from the Preventive Controls Rule. Unless you do a lot of further processing of food intended for consumption off of the farm, this rule doesn’t apply to you.
Produce Safety Rule
This rule might apply to you.
The FSMA Final Rule on Produce Safety covers farms that grow, harvest, pack, or hold produce for human consumption. It establishes “science-based minimum standards” for food safety, including provisions about water quality and biological soil amendments.
However, not all farms that participate in these activities need to comply with the rule. There are three main exemptions:
- You grow produce that’s not usually consumed raw. The rule targets foods that are usually consumed raw. For example, if you grow apples, grapes, herbs, or peppers, the rule applies (see the full list of covered produce here). On the other hand, if you grow food that is not usually consumed raw, like rhubarb, cranberries, potatoes, and turnips, the rule does not apply (see the full list of exempt produce here). You also don’t have to worry about the rule if you grow food grains (e.g., oats, wheat, rice).
- You send your produce for further processing. If you sell your produce to a processor for further processing (rather than to the public at large), you are exempt.
- You sell less than $25,000 worth of produce annually. Your revenue is determined based on a three-year average. If you averaged less than $25,000 in sales over the past three years, you are exempt from the rule.
If you’re not exempt based on the criteria above, you may still be eligible for a qualified exemption if both of the following conditions apply:
- Your food sales average less than $500,000 per year. This isn’t just produce sales — it’s all food sales. So, if you make pies or jams with your berries, this revenue is included in the total. Again, the sales are calculated based on a three-year average.
- The majority of your sales (i.e., at least 50.1%) must be to local “qualified end users.” A qualified end user is either the consumer of the food or a restaurant or retail establishment, located not more than 275 miles away.
If you have a qualified exemption, you still have to meet certain modified requirements, including disclosing where the food was grown and keeping documentation.
Let’s look at a few scenarios to help clarify.
Scenario 1: CSA
You run a CSA in your community that delivers weekly food boxes to 100 customers in a nearby city. This is the only channel you use to sell your produce and your sales total $400,000 per year.
You are eligible for a qualified exemption.
Your sales are less than $500,000 a year and they are all to qualified end users. You don’t have to comply with the full rule, but you do need to meet the modified requirements.
Scenario 2: Seasonal farmers market
You grow seasonal crops, including greens and herbs, which you sell once a week at the local farmers market. You average about $20,000 in sales per year.
You are exempt.
Since your annual sales are less than $25,000, your farm isn’t covered under the new rule.
Scenario 3: On-farm market
You grow crops year-round in large hoophouses that you sell at a market located on your premises. In addition to your fresh fruits and vegetables, you sell fresh eggs, honey, and cheese. You also make and sell jams and a variety of baked goods. Once a week, you take your products to a farmers market, where you’ve gained quite a following for your pepper jams, which you also sell online. Your annual revenue from fresh produce alone is $250,000, and when you add in the other products, the total is just under $600,000.
You must comply with the rule.
Even though your produce sales are only $250,000, the rule applies to you because your total food sales are above $500,000.
We hope this helps! If you still aren’t sure if the rules apply to you, download this flowchart from the National Sustainable Agriculture Coalition.