Food Safety Modernization Act: Chapter One – A Brief History of FSMA
By Stephen Phelan
In the United States each year, about 76 million Americans get sick, 325,000 are hospitalized, and 3,000 die from food-borne diseases, according to the Centers for Disease Control and Prevention  (these figures are quite sensitive to exactly which illnesses are included in the count – these numbers are at the top end of the range). This public health burden is largely preventable. In January 2011 the Food Safety Modernization Act (FSMA) was signed into law. This legislation represents a far-reaching change in the regulatory environment for all participants in the food chain, from field to fork. Why was this law considered to be necessary? What are its major provisions? And most important, what steps can those in the food chain take to be sure they are in compliance?
In this blog chapter, I’ll look at the history of FSMA and how it came to be, as well as its major provisions. In succeeding chapters, I’ll write about the key provisions of FSMA; and suggest where software from SAP might help you comply with FSMA; and highlight the opportunity to realize a return on your compliance investment. FSMA need not be just another compliance expense.
How Did FSMA Happen?
The Food Safety Modernization Act was signed into law on 4 January, 2011), and is the first major piece of federal legislation addressing food safety since 1938 when Congress gave the FDA the power to regulate most foods . Despite a highly polarized Congress, the Food Safety Modernization Act passed with large majorities (215 to 144 in the House, 73 to 25 in the Senate). Politically, how was it possible to pass such a bill in a time of congressional deadlock?
The incidence and severity of product safety issues has increased in recent years (see figure), and the public reaction to them has intensified. In turn, the pressure on lawmakers to “do something about food safety” has increased considerably. In short, food safety is generally seen to be a real and growing problem, and one that requires federal intervention to solve. Consumers, farmers, manufacturers and retailers have all endorsed FSMA, for a variety of reasons.
Consumers, obviously, include farmers, manufacturers and retailers as well, so their concerns cut across the spectrum. In short, consumers don’t want to have their families get sick and die. Pretty simple. And there are more things around these days that are more dangerous than in times past – microbes evolve, and new strains are reported every year, some with lethal potential. In part, though, consumers’ perceptions of risk are affected by what they read and hear, and how much time they take to put recent reports into perspective. That means that the role of social media is becoming increasingly important. The time between an initial media report and a panic reaction seems to be declining all the time.
Farmers, manufacturers, retailers, and others involved in the food chain have an additional set of worries that revolve around the economics of providing food to the world: How can I keep my costs down? What about foreign competition? How can I avoid the costs of a recall? How expensive and effective is quality testing? These questions mostly boil down to: How can I provide good, safe food to my customers and make a profit doing so?
There have been various reports in the press about manufacturers’ opposition to FSMA. However, I find it impossible to believe that the legislation could have passed without support from virtually all stakeholders concerned. There are numerous provisions in the Act that reflect the concerns of manufacturers, farmers, retailers and consumers, and that deal with a variety of difficult issues like lower regulatory costs of foreign food suppliers. Although the Act is still tied up in the Office of Management and Budget, this is most likely due to its complexity, rather than political opposition (but I’m sure there are other opinions on that topic). Most bills are reported out within 90 days, but there are still a few months remaining on the time-out clock of 270 days. According to the Food Safety News, “all the players along the food chain, from farm-to-fork, have been highly engaged with FDA on these issues and lobbied for Congress to pass FSMA. ‘That’s an interesting case. That tends not to happen’ said [Katie Greenshaw, a federal regulatory policy analyst at OMB Watch].” 
In the next chapter, I’ll recap the primary provisions of FSMA and what it means to everyone in the food chain, from farm to fork.