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Just like state food safety laws, federal food safety laws prohibit the selling of “adulterated” foods. The federal definition of adulterated is quite broad and includes food that is simply held or processed under insanitary conditions. If a food is adulterated, the Food and Drug Administration (FDA) and the USDA’s Food Safety Inspection Service (FSIS) have a number of enforcement tools. These include seizing and condemning the product, enjoining persons from manufacturing or distributing the product, or requesting a recall. Farmers can also face fines and the risk of criminal prosecution. Enforcement action is usually preceded by a warning letter from the FDA or FSIS.
Most if not all farmers have heard about FSMA by now. FSMA gives the FDA broad new powers to prevent food safety problems and respond to food safety issues. It’s a big deal for farmers as for the first time the FDA now has authority to regulate on-farm practices. Congress passed FSMA back in 2011. It’s since taken the FDA quite some time to develop the final rules, or implementing regulations. These rules are now considered “final” and the implementation and enforcement phase has begun.
While FSMA involves seven major rules, two are the most relevant to sustainable farmers: the Produce Safety Rule and the Preventive Controls Rule (also known as the Facilities Rule). Now that these laws are officially in effect, farmers will want to pay attention to whether they must comply with them now or in the future, especially as they expand or enter new markets.
The Produce Safety Rule sets food safety standards for farms that grow, harvest, pack, and hold fresh produce. The rule sets guidelines and standards in five areas: water quality; employee health and hygiene; wild and domesticated animals; biological soil amendments of animal origin (such as compost and manure); and equipment, tools, and buildings. There’s also a section governing sprouts.
Farms that engage in value-added processing or handle other farms’ produce might have to comply with the Preventive Controls Rule
The Preventive Controls Rule sets standards for food processing operations, which could include farms depending on the degree they engage in value-added processing or handle other farms’ produce. This rule basically requires facilities that process and handle raw agricultural products to register with the FDA, follow current good manufacturing practices (GMPs), and implement a food safety plan.
A number of full and partial exemptions to the Produce Safety Rule and the Preventive Controls Rule exist for small farm operations. For example, farms that have $25,000 or less in all produce sales are entirely exempt from the Produce Safety Rule. Farms that have less than $500,000 in all food sales and sell mostly direct-to-consumer—for example, through roadside stands, farmers’ markets, and community-supported agriculture (CSA) programs—might be eligible for what’s called a “qualified exemption.” This means they don’t necessarily have to comply with the substantive requirements of the rule—such as the water testing requirements and so on—but they will need to follow certain recordkeeping and labeling requirements. Also, the FDA can still take enforcement action if an incident is linked to the farm.
Farms that are doing limited processing (e.g., dehydrating grapes to make raisins) are exempt from the Preventive Controls Rule. So are farms that mostly sell their products direct-to-consumer, which again includes roadside stands, farmers’ markets, and CSA programs. In addition, partial exemptions are available for farms that perform “low-risk activities” and have less than $1 million in all food sales. “Low-risk activities” include chopping or slicing fruits and veggies, making maple syrup, making baked goods, and extracting olive oil. These farms must register with the FDA and keep records to support their exemption (e.g., sales receipts, etc.). They must also comply with the updated GMPs and employee training and qualification requirements.
This is just a summary! In reality, it can be challenging for some farms to navigate these exemptions and determine whether they must comply with these rules, and if so, which parts and by when. This is especially the case for diversified farms that either partner with other farmers to offer more variety of products or engage in value-added processing.
As a first action step, farmers can set aside 15 minutes to walk through Farm Commons’ resource Whether and When Farms Must Comply with FSMA: Flowchart. By answering a set of questions, farmers can learn whether one or both of these rules apply to them. It also provides a list of resources where farmers can learn more.
As the implementation process is now underway, farmers are often left with more questions than answers about what certain substantive requirements mean as well as how the FDA will enforce these rules. This can be frustrating!
The FDA is working with the USDA, agencies, centers, associations, universities, and others funded by the FDA and USDA to develop and deliver FSMA trainings. Much of these trainings are geared toward larger operations, which is the unfortunate reality for small, sustainable farms. Nevertheless, the FDA has entered cooperative agreements with the National Farmers Union Foundation and the University of Arkansas-Fayetteville to develop training curricula and delivery for local and tribal food producers. Farmers can be on the lookout for such trainings in their area.
To find out whether and when your farm must comply with FSMA:
Take 15 minutes to complete Farm Commons’ resource FSMA Compliance Flowchart.
To stay up-to-date on FSMA interpretations, compliance, and enforcement issues:
To find out more about upcoming local trainings in your area, contact your local extension agent. Or, if you’re in Washington, Idaho, or Montana, reach out to the following organizations:
Washington:
It remains to be seen how the FDA will ultimately enforce the FSMA rules. It’s quite possible, though not probable, that the FDA will administer inspections of all farms that must comply with the Produce Safety Rule. Or, the FDA could conduct random or surprise inspections. They could also do inspections only for farms where an incident or complaint arises. After all, the FDA’s resources are limited.
The FDA has indicated that it plans to target its inspection resources based on risk, and it plans to rely heavily on states to conduct a large portion of on-farm inspections. Keep in mind that the FDA’s approach to enforcement, whatever it turns out to be, could change at any time—whether through a change in administration or budget appropriations.
What happens if farmers fail to comply with FSMA when required? The penalties can be steep. Just as with violating federal adulteration laws, farmers face fines and even criminal prosecution for failing to comply with the FSMA rules. Products could also be seized or condemned.
A good approach is to keep good records and document how the farm is complying with the FSMA rules. The better the records, the easier it is to demonstrate that the farm is meeting the legal standard. More importantly, it helps the farm put processes and procedures in place to prevent problems in the first place. Adopting and implementing a robust food safety plan, with systems for maintaining adequate records and documentation to show how the plan is being followed, can be an optimal way to do this.
One thing is certain: compliance with FSMA does not affect personal liability potential in any significant way. Similarly, a farm that is entirely or partially exempt from the FSMA rules is not off the hook for food safety legal liability risks! Regardless of whether FSMA applies, a farmer can still face a personal injury lawsuit if a foodborne illness is linked to the farm. In addition, the state and federal government can still pursue enforcement action under adulteration laws! When it comes to managing food safety legal liability risks, FSMA is just a small piece of the puzzle.
Farmer Sally’s produce sales for the past three years have averaged about $30,000. Most of those sales (i.e., more than $15,000) have been through her CSA and farmers’ market sales.
Sally walks through the Farm Commons resource Whether and When Farms Must Comply with FSMA: Flowchart and learns that her farm falls within the “qualified exemption” of the Produce Safety Rule given her gross produce sales fall below the threshold AND most of these sales were directly to consumers.
Sally sets some time aside to make a placard with her farm’s address to post at the farmers’ market and her CSA pick-up sites, as required under the qualified exemption. She also puts systems in place to keep records of her sales to prove that the qualified exemption applies.
Even though Sally does not have to follow the substantive requirements of the Produce Safety Rule, such as water quality testing and so on, she decides to learn about these standards and gradually incorporate them as best she can. She signs up for a local workshop and commits some time over the winter months to decide which aspects of the Produce Safety Rule are most practical and affordable to pursue first, given the needs and limitations of her particular farm. As an extra step, she decides to get systems in place to document how she’s complying with her food safety plan in case a food safety incident ever arises.
When walking through Farm Commons’ flowchart, Sally also learns that the Preventive Controls Rule would apply to her if she pursues her fresh-cut bagged lettuce operation! She learns that chopping the lettuce—a second cut—to create fresh-cut lettuce/greens is considered a manufacturing/processing activity. It’s not specifically listed as an activity a farm can perform without being subject to the rule.
However, she would be eligible for a “qualified exemption” because her total food sales are less than $1 million a year. She realizes that to sell her fresh-cut bagged lettuce she must do the following:
Sally feels frustrated and intimidated! She decides to play it safe and hold off selling her fresh-cut bagged lettuce until she looks into all that she needs to do to comply with the rule. She writes down a list of questions to ask at the upcoming FSMA training workshop. She also plans to contact her local extension office to see if they can provide some answers. In the meantime, she’s considering simply bagging and selling intact lettuce that she cuts, cores, or trims from the field when harvesting. Cutting the stems, coring the lettuce, or trimming outer leaves of the lettuce/greens in the field; washing the intact lettuce/greens; and placing the intact lettuce/greens in a bag are all listed as activities that a farm can perform without being subject to the rule.
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