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Food Safety: FSMA, Hazard Analysis, & Sanitation Controls

Contamination and the risks associated with contamination are one of the biggest factors at play for food and pet food processors. One incident can set off a chain-reaction of fallout that derails production and poses risk to people or pets. Part of the role of the Food Safety Modernization Act (FSMA) is to reduce the risk for these types of incidents. This, combined with setting the stage for food safety and shifting the focus of food safety from reactive to proactive, are all reasons why FMSA plays such a major role in keeping our, and our pet’s food, safe.

FSMA signed into law by President Obama in January 2011, is the most sweeping reform of U.S. safety laws in more than 70 years. It enables the U.S. FDA the ability to protect the public more thoroughly by focusing on prevention of food safety issues. In short, in means that for the past 10 years, food safety and protecting the contamination of the food supply has shifted from a reactive to a proactive stance.


The shift in focus from response to prevention has changed how food manufacturers construct their facilities; how the materials are sourced; how packaging is approached, and on and on. And, since the FDA regulates pet food manufacturing as well as human food and beverages, there is a good deal of crossover between pet and human food manufacturing regarding safety and compliance with FSMA. In addition, the law provides the FDA with the authority to conduct facility inspections to verify FSMA compliance and to ensure imported foods meets U.S. food safety standards.


Importance of Hazard Analysis: HACCP & HARPC


According to the Centers for Disease Control & Prevention (CDC), nearly 128,000 people in America are hospitalized and approximately 3,000 people die each year from foodborne diseases. One in six are estimated by the CDC to suffer from some form of food-borne illness, yearly. This makes it essential to identify and remediate problems before food products ever get to the consumer. With FSMA’s shift from reactive to preventative, risk detection and sanitation are now at the forefront of plans to assure compliance.


It’s important to understand what hazard analysis can do to help achieve these goals. Hazard Analysis and Critical Control Points (HACCP), according to the Safe Food Alliance, is an internationally recognized standard method of assessing food safety-related risks.


HARPC, on the other hand, stands for Hazard Analysis and Risk-Based Preventative Controls. This newer standard is mandated by FSMA regulations for all food establishments, unless specifically exempted. HARPC is not a replacement for HACCP: both currently are in effect, and each has specified applications. HARPC should be viewed as providing additional guidance to develop preventative control plans.


On the flipside, HACCP covers three major food safety hazards, which include biological, physical hazards, and chemical hazards. These hazards can be tackled through prevention, elimination, and reduction to a safe level. The following principles are one reason why we’re seeing a surge of new and revamped processing operations.

The CDC says nearly 128,000 people are hospitalized annually from foodborne illness making it essential to identify and remediate problems before food products ever get to the consumer.

Seven Principles of HACCP


The FDA outlines seven principles of HACCP that work together and build upon one another to lead to safe food handling. Each of them logically leads to the next; this helps to instill processes where food safety is the paramount concern:


  • Hazard analysis
  • Critical control points (CCPs)
  • Critical limits
  • Monitoring procedures
  • Corrective actions
  • Verification procedures
  • Record-keeping and documentation procedures


There are sometimes references to the “12 steps of HACCP” which, according to Food Safety Magazine, refers to five steps that should happen before the seven principles listed above. They include assembling an HACCP team; describing the product; defining its intended use; developing a flow diagram; and physically verifying the flow diagram at the plant.


HARPC includes additional concern areas, covering hazards such as radiation, naturally occurring toxins, parasites and pesticides, allergens, drug residues, certain food/color additives, and decomposed material.


To make things somewhat more confusing, there are also seven steps of HARPC, which in many ways resemble some of the seven principles of HACCP, albeit with some important differences. For example, “assess the hazards” is akin to “conduct a hazard analysis;” verification and recordkeeping requirements are also alike. However, HARPC’s second step is “institute preventative controls,” which includes items like sanitation procedures, staff hygiene training, and verifying suppliers. These differ from HACCP.


FSMA and Sanitation


Sanitation efforts are a key part of successful compliance with FSMA regulations—and an integral part of safeguarding a plant from contaminants. Microbes that cause food-related illnesses carry a DNA profile; this means they can be traced back to raw materials used in the product and the manufacturing plant that produced it.


It is extremely important to have good sanitation protocols in place, since that is one of the hallmarks of FSMA compliance. Again, the shift to prevention makes sanitation testing more important than ever. The FDA uses the term “preventative controls” for plants’ required steps in handling food. If and when a hazard assessment turns up a preventative control-required hazard, that facility must have a written plan toward mitigating said hazard. The plan must not only include the processes to correct the problem, but also outline procedures to that end.


A written plan for sanitation control goes a long way toward prevention. This plan should cover monitoring, corrective actions, as well as record-keeping and verification (both of which are in HACCP and HARPC). A monitoring plan should include frequent testing of surfaces, as well as hygiene verification. The process of sanitation should occur daily.

Sanitation efforts are a key part of successful compliance with FSMA regulations and an integral part of safeguarding a plant from contaminants.



It is possible to overcome contamination through hazard analysis as outlined by FSMA’s guidelines. Understanding FSMA’s impact and its specific requirements (as well as the similarities and differences between HARPC and HACCP) are essential to ensuring product integrity and, ultimately, safe foods for consumers.

    Some opinions expressed in this article may be those of a contributing author and not necessarily Gray.

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