FSMA Compliance

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.


Training is a big part of FSMA compliance. It’s essential your employees are trained on all the food safety policies you want to enforce.

However, training isn’t entirely up to your company. The FDA works with partners around the world to promote training to all food suppliers. Any participants in their training receive documentation of completion.

All these new FSMA regulations can be confusing, and the FDA is also offering training on understanding the requirements of these new preventive controls and regulations.

If you are a carrier, you are responsible for providing training for your employees. This includes making them aware of potential food safety problems, sanitary practices, and correct logging practices.

The FSMA requires that you establish and maintain all records of training. This is so the FSMA can go back and make sure the correct people were trained in a correct manner.

It’s vital you keep records of everything your company does. Records can be kept as original documents, copies, or electronic records.

Transportation of Products

Transportation is a huge part of the supply chain and must have rules and regulations as well.

Trucks must be checked to make sure they are in an appropriate sanitary condition before the transportation of any food not completely enclosed by its container. The food that goes inside the truck must also be checked to make sure they haven’t gone bad or been infected with pests. This is crucial because bugs could easily contaminate other food on a truck as well as any future food that goes onto that truck.

The drivers must have written procedures for them and they have to keep records of everything they do in case the FDA wants to review those records.

To ensure the safety of food in the cold supply chain, it is required that the transportation vehicle is pre-cooled and kept cold during loading and unloading as well as the actual transportation stage.

After transportation, vehicles must be cleaned to eliminate cross-contamination from different foods.

Since transportation is such an important part of the supply chain, the FDA is using its partnership with other federal agencies to help enforce these new rules. The US Department of Transportation, along with other state, local, and tribal entities, will be helping implement these new rules.

The FDA will be carrying out inspections while the Department of Transportation will be establishing procedures for the inspections to be conducted by the FDA or other agencies.

Here are some of the things the FDA will be looking for:

  • Vehicles and equipment used must meet specific temperatures to prevent food from going bad during transportation.
  • Records that the required temperature was pre-cooled and maintained during transportation.
  • Information that shows how and when cleaning is done on the vehicles.
  • Records of training any personnel involved in transportation.

Accurate and Reliable Labels

Thermal transfer labels require thermal ribbon to print while direct thermal labels do not require thermal ribbon

The FDA is currently working on implementing traceability regulations to implement to the FSMA.

While the FDA works on regulations, the industry has begun a voluntary program, the Produce Traceability Initiative (PTI),  designed to help the industry maximize tracking and tracing strategies while aiming towards a standardized industry approach.

Although being part of the PTI isn’t a requirement, it is recommended to start implementing the PTI now because it is likely the FDA will put it into new regulations.  The most popular PTI labels are 4×2 thermal labels, however, you don’t need to use that size.  As long as you are buying factory direct, and getting discounted thermal labels, the cost is negligible. 

Labels that allow for barcode reads will make it easier for the FDA and the industry as a whole to stop foodborne illnesses and save time and money during a product recall.

The use of labels will give companies an accurate look at where a product has been and where the product is going, along with what other products it may have come into contact with during transportation.

FSMA Compliance Dates for Preventive Controls of Human Food

Very Small Businesses

A very small business is any business that earned less than $1 million a year during a three year period. Preventive controls for food need to be FSMA compliant by September 17th, 2018. However, there are some extended compliance dates. A new compliance date of January 27th, 2020 will apply to the following facilities:

  • Facilities that handle packaging or holding activities on produce RACs

  • Facilities that qualify as secondary activities farms

  • Facilities that could qualify as farms if they didn’t color RACs

Other Businesses

A business in this category must average equal to or more than $1 million per year during a three year period and they must have more than 500 full-time employees.

The compliance date for other businesses was September 19th, 2016. Unfortunately, if you missed that date you have also missed the extended compliance date of January 26th, 2018 if you are one of the following facilities:

  • Facilities that handle packaging or holding activities on produce RACs

  • Facilities that qualify as secondary activities farms

  • Facilities that could qualify as farms if they didn’t color RACs

Small Businesses

A small business is any business that employs fewer than 500 full -time employees and their compliance date was September 18th, 2017.

However, don’t panic yet – you may qualify for an extended compliance date if you are one of the following facilities:

  • Facilities that handle packaging or holding activities on produce RACs

  • Facilities that qualify as secondary activities farms

  • Facilities that could qualify as farms if they didn’t color RACs

Businesses Subject to the PMO

Pasteurized Milk Ordinance, or PMO,  businesses must sell Grade A milk and milk products that are covered by the National Conference of Interstate Milk Shipments (NCISMS).

The compliance date for these businesses is September 17th, 2018.