In the 1990s and early 2000s, the United States experienced a series of high-profile foodborne illness outbreaks. These incidents posed a significant public health risk and threatened the economic well-being of the food and beverage industry.
For instance, according to the Department of Agriculture, “In 2006, an outbreak of spinach contaminated with E. coli O157:H7 resulted in over 300 illnesses and 3 deaths. For about 2 weeks, most of the spinach in the United States was off the market following government warnings not to eat bagged or fresh spinach.”
Such calamities — which were largely preventable in retrospect — highlighted the need for stronger, more robust food safety measures. As a result, the Food Safety Modernization Act (FSMA) of 2011 was passed.
Today, we’ll review this law and its history, its impacts on manufacturers, the consequences of noncompliance, and how to ensure that your business remains compliant.
In response to several national food-related safety outbreaks, lawmakers and government agencies collaborated to design a program to proactively reduce the frequency and severity of commercial food poisoning in the U.S. With its passage, the FSMA ushered in a new era of regulation and oversight meant to improve the safety of food from producer to table.
It signaled a focused policy shift from simply responding to foodborne illness to instead trying to prevent it. Rather than waiting for food safety issues to arise and issuing a recall, the FSMA sought to:
According to the bill, manufacturers were expected to implement food safety plans designed to prevent contamination, identify causal factors, and correct any problems that arose.
The FSMA is iterative. Since it was signed in 2011, the law has undergone a phase review cycle between key stakeholders, including members of the food industry, academia, the FDA, the CDC, and other interested parties. As such, they have slowly rolled out new measures and enforcement mechanisms.
That said, the FSMA is still evolving. Thus far, the FSMA has established seven primary rules:
Additionally, supplemental programs such as food traceability requirements, Good Manufacturing Practices (GMP), Hazard Analysis and Risk-Based Preventive Controls (HARPC) have also been added to the bill.
FSMA applies to all food manufacturers, including those that produce human and animal foods.
All domestic and foreign food facilities that are required to register with the FDA fall under its jurisdiction. This includes facilities that do not have to register but engage in activities such as manufacturing, processing, packing, or holding food that will be consumed in the U.S.
However, as previously mentioned, the FSMA has not yet been fully implemented or fully enforced. Some companies may be exempt from certain rules due to their activities and processes and may be given additional time to comply with certain regulations based on factors such as their size or financial status. Smaller companies, in particular, have more time to adjust to new regulations and ensure their compliance.
Similarly, companies that produce meat, poultry, eggs, and other products regulated by the USDA or — or those that operate juice facilities — are not required to have a Preventive Controls and Qualified Individual (PCQI). This is because they are already required to conduct a full Hazard Analysis Critical Control Points (HACCP) and have the efficacy of their HACCP system verified by the USDA.
As a business grows, food safety becomes more expensive and intensive. A larger customer base represents a greater number of potential consumers who could be harmed if food safety standards are not met. And when you reach orders of a large magnitude, it can become a national concern.
That is why smaller manufacturers may be automatically exempt from certain (or all) requirements of the FSMA or may apply for an exemption.
For example, a local Mexican restaurant that sells its special hot sauce packaged on-site and sold directly to customers would not pose a significant threat to public health at a national or state level. As a result, this type of business would be exempt from federal regulations.
What qualifies a business as a small manufacturer? According to the FSMA, a business qualifies if it:
You can apply for the Qualified [or Approved] Supplier Program if you meet certain criteria. And, if you are accepted into the program, you may be exempt from the PCQI regulation.
In recent years, federal regulators have increased scrutiny and imposed stricter penalties on qualifying companies that fail to comply with food safety protocols. This is part of an effort to pierce the corporate veil and hold the individuals behind these companies accountable for their actions.
In addition to misdemeanor fines of up to $500,000, the FDA has three other mechanisms for enforcement when it comes to imposing direct penalties for noncompliance:
If a facility is found to be in violation of FDA regulations, the FDA may issue a warning letter and make it publicly available on its website. The facility has 15 days to come into compliance after receiving a warning letter. After that time, the FDA may conduct a re-inspection of the facility to verify compliance and charge fees to cover the additional inspection costs.
If a food contamination problem is widespread, the FDA has the authority to issue a food recall order and to assess and collect fees associated with the recall. In cases where the hazard to the public is particularly severe, the FDA may even seize the contaminated food.
In the most serious cases, the FDA may pursue criminal charges against the responsible party for negligence and misconduct, which could result in the arrest of key members of the company, an audit of the company's practices, and even the potential shutdown of the facility.
It’s both smart and a moral imperative to comply with food safety laws. In doing so, you can protect your business and, most importantly, the consumer. Should the FDA issue a recall, consumer illness and negative media attention could significantly damage your company's reputation. And this could lead to a loss of consumer trust and ultimately result in reduced profits, loss of market share, and potential liability suits.
If you’re a small operator working on a local level, you may not need to take many steps to ensure compliance with the FSMA. However, if you do fall under its jurisdiction, you should take the following steps to ensure compliance:
The FSMA was created to enhance the safety of the food supply chain in the United States. By implementing stronger food safety measures and adopting a proactive approach, manufacturers can protect consumers from foodborne illness, ensure their food is safe for consumption, and build trust in the food industry.
Need FSMA compliance guidance? Contact us today!
Looking for more information? Listen to the Shifting Gears podcast episode, A Closer Look at the Food Safety Moderniation Act. FIBR Food Safety Council Lead Trainer Bill Huntley discusses the FSMA, its impact on SMMs, & the steps you can take to ensure your compliance.