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Meeting the challenges of the Food Safety Modernization Act

Intensified regulations and a greater focus on preventing contamination has created challenges for Wisconsin food and beverage manufacturers.

The U.S. Food and Drug Administration’s Food Safety Modernization Act, the most sweeping reform of our food safety laws in more than 70 years, was signed into law by then-President Obama in January 2011. It aims to ensure the U.S. food supply is safe by shifting the focus from responding to contamination to outright preventing it.

The law provides the FDA with new enforcement power designed to achieve higher rates of compliance with prevention- and risk-based food safety standards and to better respond to and contain problems when they do occur. After five years of rule-making, the law finally has reached the point where it can be proactively implemented to prevent foodborne illnesses, instead of just reacting to contamination once it already has occurred. Those who manufacture canned goods must inspect and maintain their can seamer and other equipment to ensure that their food products are clean and safe to consume.

The law only began being enforced in earnest last year (2016) with the completion of the foundational rules necessary to implement it. Those rules include preventative controls for animal food; produce safety; foreign supplier verification; third-party certification; sanitary transportation; and intentional adulteration.

All rules that are part of the law are in effect, although there are staggered compliance and enforcement dates, some tied to the size of the business. A key aspect is federal enforcement of rules and regulations against poor food safety practices.

A cautionary tale is Chipotle Mexican Grill, which had successive food poisoning outbreaks in late 2015 and early 2016 that made hundreds of people across the country sick. At one point, sales reportedly dropped an estimated 30 percent and caused Chipotle’s stock price to plummet. The company also had to deal with a federal investigation and a lawsuit filed by shareholders.

The Food Safety Modernization Act requires a risk assessment and preventative controls for any food-related manufacturer that has $1 million or more in annual sales.

The risk assessment typically takes the form of a Hazard Analysis Critical Control Point (HACCP) plan. A HACCP plan essentially is an analysis of what risks ingredients and processes pose.

A HACCP plan addresses food safety through the analysis and control of biological, chemical (including radiation), and physical hazards from raw material production, procurement and handling, to manufacturing, distribution and consumption of the finished product.

The Wisconsin Manufacturing Extension Partnership (WMEP) offers a one-day, hands-on public HACCP training, as well as on-site training at food manufacturing plants.

The WMEP also provides Preventative Controls Qualified Individual (PCQI) training. Having a critical and highly essential role within a food processing facility, the PCQI is crucial to the management and preparation of any food safety plan, as well as the validation of preventive controls.

The specialized training offered by the WMEP follows a standardized curriculum that is recognized by the FDA.

The HACCP plan is vitally important to small and midsize manufacturers and is the basis of a strong food safety management program. Every food company should have a HACCP plan. A HACCP plan has benefits for companies that manufacture, process, pack or store food.

The WMEP’s HACCP training is designed to help food industry professionals understand the requirements for hazard analysis, preventative controls and how the Food Safety Modernization Act is affecting their operations.

The WMEP can provide an objective review of a company’s existing preventative controls and provide the business with a plan to achieve its food safety objectives. Call (920) 850-6590 for more information and/or to set up an appointment.

For more information about food safety programs and other offerings from the Wisconsin Manufacturing Extension Partnership, go to


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Peg Dorn is a Manufacturing Consultant for Wisconsin Manufacturing Extension Partnership (WMEP).

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