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.

What Is the FSMA?

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:

  • Establish procedures and processes that championed rapid detection and response
  • Identify causal factors and implement measures to prevent a recurrence  

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.

How Has the FSMA Evolved?

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

  1.  Preventive controls for human food
  2.  Preventive controls for animal food
  3.  Produce safety
  4.  Foreign supplier verification program 
  5.  Third-party certification 
  6.  Food defense 
  7.  Sanitary transportation 

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.

Who Does FSMA Apply To?

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.

How Does FSMA Impact Manufacturers?

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:

  • Averages less than 1 million in revenue annually, adjusted for inflation, including any subsidiaries or affiliates
  • Runs a facility that is solely engaged in packaging and holding activities of ready-to-eat products

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.

What Are the Consequences of FSMA Noncompliance?

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:

  1. Hourly re-inspection fees 
  2. Product recalls
  3. Suspension of facility registration

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.

How Manufacturers Can Ensure Their Compliance

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: 

  1. Receive Training from the PCQI for food: A Preventive Controls Qualified Individual (PCQI) is a person who has completed the necessary training to develop and implement a food safety program compliant with the FSMA. The PCQI will play a key role in representing your company if a consumer ever claims harm done by your products. They may help resolve the claim or even defend the company in the case of a civil lawsuit. 
  2. Review your risks: Are you intimately familiar with your sourcing partners and their safety practices? Are you purchasing goods from outside the company and having them imported? Questions such as this will help you identify contributing risk factors.  
  3. Consider the intentional adulteration rule: This rule requires the development of a food defense plan and  mitigation strategies for processes in certain registered food facilities. The Intentional Adulteration (IA) rule is aimed at preventing intentional adulteration from acts intended to cause wide-scale harm to public health, including acts of terrorism targeting the food supply. Such acts, while not likely to occur, could cause illness, death, and economic disruption of the food supply absent mitigation strategies. Food facilities must realize that a potential risk factor could be employees contaminating the food — whether on purpose or by accident. 
  4. Earn relevant certifications: Today, there are several certifications you can apply for to demonstrate your compliance and adherence to proper food safety practices. Key certifications include the Global Food Safety Initiative (GFSI), Safe Quality Food (SQF), and Primus Foods in California.
  5. Install audit schemes: To have an audit scheme, you must have SQF or one of the other certifications. Once the SQF audit group performs the audit, you will receive a certificate of compliance.

How CMTC Helps SMMs With FSMA 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!

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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.

About the Author

Gregg Profozich

Gregg Profozich is a manufacturing, operations and technology executive who believes that manufacturing is the key creator of wealth in the economy and that a strong manufacturing sector is critical to our nation’s prosperity and security now, and for future generations. Across his 20-year plus career in manufacturing, operations and technology consulting, Mr. Profozich helped manufacturing companies from the Fortune 500 to the small, independents significantly improve their productivity and competitiveness.

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