Food and farm advocates seem to agree that the U.S. Food and Drug Administration (FDA) is somewhat limited in what it can do for small farmers and producers as it implements the Food Safety Modernization Act (FSMA). When Congress passed FSMA in 2011, it gave FDA a statutory mandate, as well as a degree of discretion, to create standards that take into account different size operations and different types of food sales. As a result, FDA has included exemptions for certain small farmers and producers in its proposed FSMA rules. Overall, comments on the proposed rules show a wide range of opinions as to how FDA should implement small farm exemptions. But, despite the range of opinions, commenters on all sides of the issue seem to recognize several mitigating factors that limit what these exemptions will mean to small businesses. Farms of all sizes have to meet market demands Perhaps the most important mitigating factor is changing market demands. As consumers and industry have become increasingly weary of foodborne illnesses, the market has demanded food safety. For this reason, Produce Safety Alliance (PSA), a group at Cornell University commissioned by the FDA to develop FSMA training programs, is prepared to train all producers, regardless of whether they qualify for exemptions. “From our education and training standpoint, an exemption doesn’t mean that [FSMA] requirements are not going to effect you. Food safety is the direction of the market. Even if you are exempt, buyers still want food safety,” said Elizabeth A. Bihn, Ph.D., PSA director. And the market changes are happening at all levels of food sales. Some regional supermarkets, along with school districts, have some type of food safety requirements for their suppliers, according to Patty Lovera, assistant director of Food & Water Watch. Even the most local markets have stepped up food safety requirements. “We are already seeing a lot of farmers markets putting independent standards in place to make sure the product going out to their buyers doesn’t make a lot of people sick,” said David Plunkett, senior food safety staff attorney at the Center for Science in the Public Interest. Growing businesses will eventually have to come into full compliance Another mitigating factor is that producers who currently qualify for exemptions will eventually come into full FSMA compliance as their business grows. Under FDA’s current framework, farms lose exempt status when they cross a certain revenue threshold. Plunkett explains that it makes sense to bring expanding operations into full FSMA compliance. “If you are large enough, you should be able to meet these standards,” he says. And most commenters seem to agree that FSMA exemptions are not meant to be permanent place markers. “We hope [the small farm exemption] gives some people some breathing room and time. And by the time they cross that exemption threshold, they can figure out what they need to do to be in full FSMA compliance,” says Lovera. But while everyone seems to agree that growing businesses eventually need to come into full compliance, many disagree about when a producer should move from exempt status to full compliance status. For instance, some have asked FDA to clarify when a farmer will no longer qualify as exempt and also to reconsider what thresholds realistically reflect when a farmer can manage full FSMA compliance, according to Ariane Lotti, assistant policy director of the National Sustainable Agriculture Coalition (NSAC). FDA retains power to withdraw exemptions A third mitigating factor is that, under FSMA, FDA retains power to withdraw exemptions. As FDA’s proposed rules now stand, if the agency withdraws an exemption, then the farm or producer would have to very quickly come into full FSMA compliance. Organizations such as Food & Water Watch have asked FDA to create a fairer withdrawal process. “FDA has not clearly defined a number of important issues around when the agency might withdraw a farm’s exempt status,” Lovera says. “If there is not clarity around when an exemption could be withdrawn, then the farm would have to come into FSMA compliance quickly and face costs not suited to the production or supply chain.” But, notably, FSMA specifically grants FDA withdrawal power. So while FDA must consider comments on how it plans to implement this power, comments on the withdrawal process will not result in losing this power altogether. No one is exempt from food safety The final mitigating factor is that farmers and producers must continue to provide safe food even if they are exempt from FSMA requirements. Jason Foscolo of The Food Law Firm published a blog post in which he points out that even exempt farmers could face strict tort liability. He also notes that food safety compliance is good for business. “Compliance is still a very good idea even if a business qualifies for the exemption,” Foscolo wrote. “Most of the new regs impose some common-sense procedures and practices.” Additionally, 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. And, beyond liability reasons, no one seems to doubt that farmers and producers will continue to strive to put safe food on the market. “I don’t think any farmer out there is in the business of making customers sick. He is going to do anything he can to make his products safe,” said Plunkett.