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, the Department of Agriculture states, “In 2006, an outbreak of spinach contaminated with E. coli O157:H7 resulted in over 300 illnesses and three deaths. For about two 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 — 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 the table. 

It signaled a focused policy shift from simply responding to foodborne illness to trying to prevent it instead. 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 enforced. Some companies may be exempt from specific rules due to their activities and processes and may be given additional time to comply with specific regulations based on their size or financial status. Smaller companies, in particular, have more time to adjust to new rules and ensure 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 of Critical Control Points (HACCP) and have the efficacy of their HACCP system verified by the USDA.

How Does FSMA Impact Washington State Food and Beverage Manufacturers?

As a business grows, food safety becomes more expensive and intensive. A more extensive customer base represents a more significant 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 specific 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 violate FDA regulations, the FDA may issue a warning letter and make it publicly available on its website. The facility has 15 days to comply after receiving a warning letter. After that, 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 severe 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.

Complying with food safety laws is both intelligent and a moral imperative. 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 Washington Food and Beverage 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 requires developing a food defense plan and mitigation strategies for processes in certain registered food facilities. The Intentional Adulteration (IA) rule aims to prevent intentional adulteration from acts intended to cause wide-scale harm to public health, including acts of terrorism targeting the food supply. While not likely to occur, such acts 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)
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 Impact Washington Helps SMMs With FSMA Compliance

The FSMA was created to enhance the safety of the food supply chain in the United States. By implementing more robust 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.

Impact Washington has built an accomplished team of carefully selected food scientists and specialists who know the food industry and excel at working across the entire food supply chain. Our team averages over 30 years of hands-on experience working for the industry as consultants and operational managers. We have dealt with many of the challenges our clients face; we have lived the types of processes we help design and implement. Our Certified Food Scientists (CFS) certifications include FSPCA, HACCP, Internal Audit, BRC, FSSC22000, SQF, and IFS.

Our Chief Food Scientist, Craig Doan, has 40+ years in the food and beverage industry and academics specializing in food safety, processing, and product innovation. Craig has developed, launched, and reformulated over 300 products for the retail, small business, and food service markets. He is an FSPCA Preventive Controls for Human Food Lead Instructor, an FSPCA Preventive Controls Lead Instructor for Animal Food, an FSPCA Foreign Supplier Verification Lead Instructor, and a Lead Trainer for the Produce Safety Alliance Produce Safety Rule, and a Seafood HACCP Alliance Lead Trainer for Seafood HACCP and Seafood Sanitation Control Procedures serving the MEP National Network in Washington, Montana, Idaho, Utah, Nevada, Wyoming, California, Oregon, Alaska, and Hawaii.

Need FSMA compliance guidance? Contact us today!