Small Businesses Tip the Scales for FSMA Exemptions

Small Businesses Tip the Scales for FSMA Exemption

About three-quarters of the U.S. farms that grow, harvest, pack or hold produce, as well as food companies that manufacture, process, pack, or hold food, are likely to be ­exempt from all or most of the requirements of Food Safety and Modernization Act (FSMA). This is because these farms and facilities will be considered to be “small” or “very small” businesses based on the value of their annual sales, end customers, or both.

On Jan. 4, 2013, the FDA published draft regulations on produce safety (“Standards for the Growing, Harvesting, Packing and Holding of Produce for Human Consumption”) and for preventive controls (“Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food”). The two proposed rules, which total more than 1,200 pages, are the first of at least four regulations to implement FSMA. Rules on preventive standards for animal food facilities and on foreign supplier verification requirements are expected sometime this year.

But thus far, it appears that most U.S. farms and food companies will dodge many FSMA requirements. Despite this, the FDA estimates that about 90 percent of the produce grown and consumed in the U.S. will either be covered by FSMA, be consumed cooked, or be processed in plants capable of handling biological hazards associated with produce. However, while family-owned farms, small growers, and small business alliances laud the exemptions, many other food safety experts do not.

“Being a public health agency, FDA knows full well that small places can cause big problems,” says David Acheson, director of the food and import safety practice at Leavitt Partners and former FDA associate commissioner of foods. “I don’t honestly believe that FDA is very comfortable with this, but they have to do what they’ve been told and so will default to using Small Business Administration-type definitions, such as fewer than 500 employees or certain dollar amounts so there will be some consistency across the federal government as to how ‘small’ and ‘very small’ businesses are defined,” Acheson tells Food Quality magazine.

Tester Amendment

As happens with nearly all major pieces of legislation, a variety of interest groups and lobbyists sought to influence FSMA as it was being crafted in Congress. For example, supporters of sustainable agriculture and family-owned farms urged Congress to exempt small growers and small processors, while many large corporations and trade groups urged inclusion regardless of size. In this case, the small farms won. The Tester-Hagan Amendment exempts small farms from having to comply with most FSMA requirements. Named after its cosponsors, Democratic Senators Jon Tester of Montana and Kay

Hagan of North Carolina, the amendment is based on two premises: That FSMA’s requirements would be too burdensome and expensive for small-scale growers and producers, and that food products from small farms and businesses aren’t as risky as those produced by large operators.

“Let’s face it: Dangerous foodborne outbreaks don’t start with family agriculture,” Tester said after introducing the amendment in 2010. “Food produced on that scale shouldn’t be subject to the same expensive federal regulations as some big factory that mass produces food for the entire country.”

The Tester Amendment exempts farms from most FSMA requirements if they have less than $500,000 in average annual sales and more than half the sales go to “qualified end-users,” defined as consumers anywhere or to restaurants or retail food establishments in the same state as the farm or not more than 275 miles away. (These farms may need to comply with certain labeling requirements even if they are exempt.) FDA can withdraw the exemption if the farm is directly linked to a food-related outbreak or to mitigate or prevent an outbreak.

About Ted Agres

Ted Agres is an award-winning writer who covers food safety regulatory and legislative issues from the nation’s capital. He has 40 years of experience in reporting on issues such as health policy, medical technology, and pharmaceutical development. He holds an MBA from Johns Hopkins University and a bachelor’s degree from the University of Chicago. He enjoys playing the piano, amateur radio, and paintball. He lives in Laurel, MD. Reach him at

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