FSMA Compliance

2021-05-12 18:10:48 admin
FSMA Compliance

The Food Safety Modernization Act, or FSMA, was signed into law by former president Barack Obama in January 2011.

The FSMA gives the Food and Drug Administration (FDA) the authority to regulate how food is grown, harvested, processed, and transported.

With the cold supply chain rising and showing no signs of slowing down, the FSMA is needed now more than ever.

Why is the FSMA Necessary?

According to the Center for Disease Control and Prevention (CDC), 48 million people get sick due to a foodborne illness every year, with 128,000 hospitalizations and 3,000 deaths.

Instead of focusing on how to respond to foodborne illnesses, the FSMA was designed to prevent them altogether by having a standardized recall or action plan in case of a discovered illness. They allow the FDA to have mandatory recall authority, giving them new powers to keep the public safe from contaminated products.

Food producers and importers must pay an annual $500 registration fee. This fee will go towards the funding of FDA inspections, enforcement, and other food-safety activities we’ll mention later on.

What is Changing?

FDA inspections are changing – and for the better. Although the FDA is conducting fewer audits, greater attention to detail is being implemented. They are also looking deeper into company operations to make sure they are keeping proper records and documentation, as well as actions towards the safety of the consumers.

The FDA is also starting to focus more on industry accountability rather than individual accountability. If a product is recalled, everyone involved in the manufacturing and delivery of that product will be held accountable.

With all of the necessary requirements and guidelines, FSMA compliance can be overwhelming. We’ve taken the time to break down all of the information and highlight the essential points so your company will be in proper compliance.

Written Safety Plan


As a food company, you will be required to develop a FSMA safety plan based on the type of foods you are selling. Fresh produce that can easily go bad or cause sickness must be evaluated more thoroughly and you must take into account the packaging, processing, and manufacturing.

Companies then must identify and implement preventative controls to try and prevent any possible hazards. For example, if you sell deli meat then a preventive control could include employee training on hygiene and environmental awareness.

This will provide anyone with an idea of how your company works, where your food goes, and how it is handled. This written plan should be extremely detailed.

This plan not only ensures you are doing everything you can for the safety of consumers, but it also helps you better understand what you can do to make sure others in the industry are complying to the same rules. If you have more than one facility, you should have a plan for each one.

If one part of the supply chain drops the ball, it doesn’t matter if the rest of the chain takes precautions to ensure the freshness of the food, it would have already been ruined.

Because the supply chain consists of so many different pieces, the FDA is focusing on the industry keeping each other accountable. If a product is recalled and causes harm to consumers, everyone involved is now held responsible for it.

With a written plan, you can detail exactly what your company does for food safety and you can explain what you ask of your suppliers or other companies. The main part of the plan that the FSMA wants are any foreseeable hazards and how those hazards will be monitored or handled in case of an emergency.

Your plan should include equipment used, the layout of your facility, and how your company operates on a daily basis.

Product Testing and Environmental Monitoring


The FSMA requires that your company has preventive measures in place for a facility. They want to make sure any hazards are being controlled and actions are being taken to prevent contamination. This includes product testing and environmental monitoring.

The frequency of tests will be facility based, but your company’s past records will be taken into account. If your facility has been linked to outbreaks in the past, you will have to have product testing more often than others.

The same policy goes for environmental monitoring. The FSMA wants to make sure you are using your facility and the equipment inside of it safely and sanitarily.

Have a Preventive Controls Qualified Individual


A preventive control qualified individual (PCQI) is someone who has completed specific training in the development and application of preventive controls. However, they can also be qualified through prior job experience they may have had if they’ve developed and applied a food safety system.

A written safety plan, as mentioned above, must be prepared or helped prepared by one of these individuals and it is their responsibility to document and follow the plan.

If you need a PCQI, you can get certification from the Food Safety Preventive Controls Alliance. In this training, you will learn how to develop a food safety plan and will gain insight on how to follow through with that plan.

If your company has several facilities, you are allowed to have the same PCQI for multiple locations. There are no restrictions on the proximity of the facilities. However, each facility must have a unique food safety plan and must be implemented to the specific facility.