The Food Safety Modernization Act is Just the Beginning of the FDA Compliance We’ve Been Waiting For

Manisha Reddy
Associate Editor
Loyola University Chicago School of Law, J.D. 2019

Despite the United States having one of the safest food supplies in the world, more than 48 million Americans get sick from foodborne illnesses and diseases each year, and more than 128,000 are hospitalized and 3,000 die from similar issues that are largely preventable. On January 04, 2011 President Obama signed the Food Safety Modernization Act (“FSMA”) into law. This enactment was called the “most sweeping reform” of U.S. Food Safety laws in more than seventy years. But seven years later, the act is still only partially enforced as the FDA has faced resistance from the government as well as a lack of funding. The FMSA was and is intended to enable the FDA to protect the health of the public by strengthening the food system in the United States. While change and reform in the industry are necessary, what good are new reforms if they will not be enforced for years to come?

Recent outbreaks of foodborne illnesses

Even though the U.S. has some of the safest food in the world, the Center for Disease Control and Prevention has found that the country is currently tackling some of the most high profile and deadly outbreaks of foodborne illnesses. In 2008 and 2009, over 700 people in 46 states were sickened and 9 people died from Salmonella Typhimurium in peanut products. The outbreak wasn’t a result of one company’s lack of management, rather 361 companies were found to be a potential cause and the FDA is currently pursuing a criminal case against all of the companies. In 2010, about 500 million eggs produced in Iowa were recalled after officials became suspicious that they were contaminated with Salmonella Enteritidis, sickening more than 1,900 people. One of the most widely known foodborne related outbreaks is that of the Denver-based chain Chipotle Mexican Grill. Incidences of a string of foodborne illnesses included outbreaks of E. coli, Salmonella, and norovirus within a six-month period beginning 2015 and caused temporary closures of more 2,000 locations in February 2016 to conduct food-safety training. These outbreaks caused Chipotle’s stocks to fall more than thirty-percent in 2015. Most recently, in April 2018, more than 98 people across 22 states have fallen ill due to a large E. coli outbreak in romaine lettuce. While the infected romaine was mostly found to come from Yuma, Arizona the CDC is warning everyone to not eat or buy romaine lettuce, and this outbreak is being called the largest outbreak since 2006. If these outbreaks remain uncontrolled, not only are companies going to suffer financially, but more lives will be lost, many due to preventable illnesses.

New FMSA regulations

The FDA regulates about 80% of all domestic and imported foods, while the U.S. Department of Agriculture (“USDA”) regulates most meats, poultry, and processed egg products. A large part of the FSMA is to enhance the regulation of produce from farm to sale and other foods from processing to sale. Instead of reacting to outbreaks, the FSMA now hopes to prevent these foodborne illnesses by requiring the FDA to mandate “comprehensive, prevention-based controls across the food supply and provide new authority to prevent intentional contamination.” The act also grants the FDA more authority to conduct frequent comprehensive inspections to ensure that restaurants and farms are complying with the rules. As soon as the FDA learns of anything suspicious they will have immediate recall authority. The FDA will continue to strengthen their relationships with other food agencies and private entities to enhance the rule making process. While it is the job of the FDA to regulate food safety in the country and it is the job of each company to regulate their own products, it is clear that this chain of command is not working and that something needs to change, hopefully the FMSA can bridge the gap.

Implications and rollout of the FMSA

Each new mandate has a compliance date that companies must meet; the earliest date began in 2015 and a complete rollout will not occur until at least 2019 and may even 2020. With full enforcement not for almost 10 years after President Obama signed the FMSA, it might be even longer before we notice any results that may come as a result of the FMSA. Even if it may take a long time, change in the food industry in the U.S. is clearly necessary. Even though change is necessary, some smaller farms and smaller companies fear that the financial impact that the FMSA will have on their business will destroy them; estimated costs for complying with FMSA total more than $368 million for domestic farms.  Recognizing the high costs, preventative foodborne illnesses should not be as common as they are and the FMSA is the first step in changing the food industry in the U.S.

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