With the comment period finally closed on the Food Safety Modernization Act’s (FSMA) Produce Safety Rule, the U.S. Food and Drug Administration (FDA) is one step closer to implementing FSMA. FDA must now review the comments as it considers final changes to the proposed rule, which sets standards for the safe production and harvesting of raw agricultural commodities. A heavily debated topic among commenters has been FDA’s framework for implementing exemptions for small farms. When Congress decided to exempt certain small farms from FSMA, it was not without controversy. Those who supported the exemption argued that FSMA is too expensive, too burdensome, and unnecessary for small producers. Those who opposed the exemption argued that it creates a dangerous loophole in a law designed to protect consumers from unnecessary risks. But the controversy surrounding the exemption did not end when FSMA was signed into law in 2011. As the comments on the produce rule show, food and farm advocates continue to debate how FDA should interpret and implement small farm exemptions. On one hand, some commenters suggest that the Produce Safety Rule does not set forth clear enough standards to comply with the spirit of the statutory exemption. Others suggest that FDA should construe the exemption even more narrowly than it has thus far. Both sides, however, seem to agree that the exact framework for the exemption remains unclear. Overall, this debate begs a key question: What exactly are the exemptions for small farms under the Produce Safety Rule? Background on the exemptions FSMA was signed into law in 2011 to create a comprehensive food safety framework that prevents, rather than only reacts to, foodborne illnesses. As part of this framework, FSMA requires FDA to monitor and regulate food safety through each step of the food chain. Thus, FSMA gave FDA its first real mandate to regulate food safety at the farm level. But bringing FDA food safety regulation to farms means that farmers will have to meet the costs and burdens of FSMA if they want to stay in business. From the start of FSMA discussions, small farmers expressed concerns about how the additional costs would affect their economic viability. They also feared that the extra burdens of FSMA would further marginalize their ability to compete with larger farms. Moreover, small farm representatives argued that such intrusive technical regulation was unnecessary for producers who have more personal, direct oversight, as well as for products that are easily traced back to the farms of origin. In the end, Congress compromised with small farms in two ways. First, it gave FDA flexibility to implement rules and standards that realistically address differently sized operations, as well as to take into account the distances food travels for sales. Second, Congress passed FSMA with a statutory exemption for certain small farms which sell local food under the Tester-Hagan Amendment. According to Patty Lovera, assistant director of Food and Water Watch, hammering out the definition of “small” and “local” farms was a painstaking process. “We participated in countless debates, online forums, and conferences,” says Lovera, adding, “What may be a giant farm in Vermont is still a small farm in California.” As a result of many long discussions, the Tester-Hagan Amendment consists of a two-part test to determine whether a farm qualifies for the exemption:
- First, the farm must have average annual gross revenue of less than $500,000. The average is calculated based on the previous three-year period.
- Second, the farm must sell the majority of its products to qualified end users. Qualified end users are consumers, restaurants, or grocery stores that are in the same state as the farm or that are within 275 miles of the farm.
Farms that qualify for an exemption under the Tester-Hagan Amendment must still give their customers notice of their business name and address at the point of sale. But they do not have to comply with the more stringent FSMA requirements such as record-keeping and plan development. How FDA implements the small farm exemption When FDA proposed the Produce Safety Rule, it created two categories of exemptions. In doing so, it exercised its discretion to create flexible standards, as well as incorporated the Tester-Hagan Amendment exemption. While the two-part test under the amendment is a statutory mandate, FDA also has a degree of flexibility in how it chooses to implement it. For instance, FDA can define “farm” in such a way that affects who qualifies for the exemption. Exemptions in the Produce Safety Rule First of all, FSMA mandates that the produce rule applies to farms that grow, harvest, pack, or hold produce for consumption in the U.S. But the rule does not apply to produce for personal or on-farm consumption, so the rule is completely irrelevant for home gardens or hobby farms. Additionally, FDA used its discretion to establish exemptions for what it considers relatively low-risk produce. This includes two categories: 1) produce rarely consumed raw, such as squash, and 2) produce that receives commercial processing to kill microorganisms. The third type of exemption is sometimes referred to as the “outright exemption.” Here, FDA used its discretion to exempt very small farms. To qualify, a farm must have an average annual value of food sold during the previous three-year period of $25,000 or less, regardless of the type of produce sold. In other words, to qualify for a complete exemption from FSMA requirements, a farmer needs to either not sell produce at all, sell only low-risk or processed produce, or meet the $25,000 revenue cap. In addition to these complete exemptions, the produce rule also has a “qualified exemption.” This exemption directly implements the Tester-Hagan Amendment, and it includes the same two-part test as laid out above. What does ‘exemption’ mean? “People tend to use the term ‘exemption’ really loosely,” says Ariane Lotti, assistant policy director of the National Sustainable Agriculture Coalition (NSAC). Lotti makes three points about the term “exemption.” First, under the qualified exemption, e.g., the Tester-Hagan Amendment, producers must give consumers their business address at the point of sale. This ensures that if a problem arises, the products can then be traced back to the farm, Lotti says. Second, a farm that is exempt from the Produce Safety Rule might not be exempt from the Preventive Controls Rule. The Preventive Controls Rule is another proposed FSMA rule that focuses on processors rather than producers. Lotti notes that the Produce and Preventive Controls Rules are interrelated, but many people believe FDA has not clarified when each rule will or will not apply. Groups such as NSAC want FDA to further define and clarify terms in the rules. Finally, Lotti emphasizes that an exemption under the Produce Safety Rule only means that the producer or farmer will have to meet much less onerous requirements than the requirements of the full rule. But, no farmer, no matter how small, is lawfully allowed to sell adulterated food. “It is an exemption from the majority of requirements of the produce rule,” she says. “It is not an exemption from having to provide safe food.”