How an FSMS Ensures Compliance with Food Safety Laws

In our previous post about key food safety laws, we surveyed the history of legislation that has resulted in the need for food producers, distributors, and retailers to comply with detailed regulations to ensure food integrity and public health. In this follow up post, we review the importance of compliance to these laws for the health of your business, and how a Food Safety Management System (FSMS) can best ensure that your operations, employees, and suppliers use the right Good Manufacturing Practices (GMP) to meet both FDA and USDA compliance requirements.

Federal Enforcement of Food Safety Standards

The passage of the Food Safety Modernization Act (FSMA) significantly increased the Federal Drug Administration’s legal mandate to regulate food safety by shifting from reactive to proactive methods. FSMA requires food production, distribution, and retail facilities to develop a preventative controls plan and improved traceability for domestic and imported food products to better respond to foodborne illness outbreaks.

The model for FDA and USDA standards has been a collective group of regulations called “good manufacturing practices (GMP).” GMPs related specifically to food safety usually take the form of either a “food safety management system” (FSMS), of which there are several approved formats, or the very specific protocol, “Hazard Analysis and Critical Control Points” (HACCP).

To enforce compliance with food safety laws, the USDA and FDA use a variety of enforcement tools including adverse publicity, warning letters, court injunctions, and perhaps its most useful tool, product recalls. The FDA now has the authority to mandate recalls, while recalls administered by the USDA remain voluntary.

Still, the ultimate enforcement tool – although rarely employed – is the threat of criminal prosecution. Offenses may be prosecuted as misdemeanors or felonies, and penalties may involve fines or imprisonment. In fact, the U.S. Supreme Court has ruled that corporate officials can be held responsible for outbreaks of foodborne illness, even if they had no knowledge of the violation.

The Costs of Non-Compliance

Although the United States generally has a safe food supply, foodborne illness caused by contaminated foods is still an undeniable public health problem. Even though processes such as pasteurization and irradiation have reduced many infections, new foodborne pathogens have since emerged. In fact, more than 250 different foodborne diseases still exist, caused by a variety of bacteria, viruses, and parasites.

Adding to the situation is the ever-changing nature of foodborne illness outbreaks, which are increasingly complex and widespread. Before the advent of the global food market, an outbreak was usually contained to a single community, and typically caused by under-cooked meat. Today, with such radical innovations in food transportation, storage, preparation, and service, outbreaks can be nationwide and typically occur over weeks or months, rather than days.

As we all know from the headlines, foodborne illness outbreaks can be costly for the food industry. Injured consumers can demand compensation if they can trace their illness to a particular food. And in the majority of states, consumers benefit from the doctrine of strict product liability – meaning that they don’t have to prove any fault on the part of the retailer.

Grocery stores and restaurants, therefore, risk enormous public relations disasters if they sell food that is said or believed to be unsafe. Consumers are known to shun entire categories of food products for fear of contamination – for instance, all leafy greens during recalls of Romaine lettuce. Unfortunately, since many unprocessed foods don’t carry brand names, a food safety failure can harm both diligent and negligent retailers alike. Given the costs of risk, smart chain grocers and restaurants coordinate with suppliers to make sure that the products they sell arrive in a safe condition at their loading docks.

Hazard Analysis and Critical Control Points (HACCP)

To ensure compliance with food safety regulations along the entire supply chain, from farm to table, the FDA has mandated that all participating companies must put in place good manufacturing practices (GMP) that can prevent or control instances of contamination. The best known GMP is Hazard Analysis and Critical Control Points (HACCP), which was first adopted in the 1990s.

HACCP is based on seven principles and the application of technical analysis of operations within each food company. Studies have proven that, If HACCP programs are correctly implemented, they significantly improve compliance. In particular, HACCP is much more effective than traditional visual inspections to ensure food safety. HACCP identifies microbiological hazards in the food supply, whereas visual inspections cannot detect invisible – that is, microscopic – contaminants.

Food Safety Management System (FSMS)

The FDA and USDA evaluate if HACCP programs are effective by regularly inspecting records indicating how each control point has been maintained over time. Since the 1990s, both agencies have recognized that not all companies in the supply chain need the rigor of HACCP, and since then, have approved a variety of food safety management systems better suited to their scale.

Designing and implementing an FSMS helps companies improve not only compliance to food safety laws, but also food quality and operational efficiency. It’s critical, therefore, that your company find the right FSMS that aligns with your own specific business needs. Regardless of the FSMS you choose, all of them require the following initiatives to be effective:

• Identify and categorize your company’s specific food safety risks. In this way, management can prioritize the risks and decide how to reduce business liabilities to acceptable levels.
• Create a strong training program for your employees. Most often, foodborne illness outbreaks occur when an employee accidentally makes a mistake, usually out of ignorance.
• Develop appropriate monitoring and measurement practices. Let’s face it – the days of manual systems are over. Given the complexity of the supply chain and the need for rapid traceability, digital tools are the only solution for continuous monitoring, statistical analysis, data storage, retrieval, and real-time sharing.
• Strive for continuous improvement. Create realistic short-term objectives that you know you can accomplish now, but also idealistic long-term goals as benchmarks to hit over time.

The most important benefit for any company that goes through the process of designing and implementing a compliant FSMS is knowing that management has done everything possible to maintain its business in a manner that meets all food safety laws. Truly, that knowledge is priceless.

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