FDA’s Food Safety Modernization Act (FSMA), Explained

One of the most important things for a country to safeguard is the health and safety of its residents. Hazards don’t always arrive in plain sight and are most often hidden in things we trust and consume on a daily basis. The biggest example of this is the food we eat. 

Food has the ability to nourish us and provide us with the energy to thrive in our existence, but it can also severely damage our health if not mandated properly. This is the main reason why the FDA’s Food Safety Modernization Act (FSMA) was enacted in 2011 by President Obama.

The specifics of the act are complicated, and the nature of the subject matter requires extensive regulations to be upheld. In this article, we’ll give you an overview of everything worth knowing about the FSMA guidelines. We’ll show you the importance of food regulation standards, we’ll get into each aspect of the FSMA in more detail and we’ll end with what’s changed for 2021.

The Need for Safety Standards and the FSMA

In 2011, the CDC reported that a staggering 48 million people get sick from food borne problems while 128,000 are hospitalized and 3,000 lose their lives. These numbers are hard to hear because they can be completely prevented. Keep in mind that these figures are for people who got sick from eating food for whatever reason, not people who were already sick.

Food-related illnesses are carried by 31 pathogens according to experts and known offenders include certain microbes and chemicals found in produce and meat. 30% of our population is at risk for these illnesses and as 14% of the food supply in the US is imported, this risk increases substantially. All these reasons made the FSMA a necessity as the situation might have gotten out of the government’s hands.

The FSMA greatly helps the FDA in its efforts to safeguard public health by creating foolproof food safety standards for everyone to follow. Before the FSMA, the FDA would focus on damage control and solving the problems after they would arise. The new guidelines enable the FDA to stop the problems from occurring in the first place making the entire system more efficient and sustainable.

Another big advantage of increased regulation is that controlling the influx of food from foreign countries becomes easier as well. Besides stopping health hazards, this enables the authorities to crack down on illegal operations and shady overseas production practices.

FSMA Explained

We’ve understood that the FSMA was created to make regulating food safety standards easy and traceable at all levels of the economy. Now, let’s take a closer look at each aspect of the act to better understand how it hopes to accomplish its lofty goals.

Preventative Controls

The first and most obvious part of the FSMA is having preventative controls in place across the US food system to stop the problems from arising in the first place.

Food Facilities

Any entity producing food will be required to implement a Hazard Analysis and Risk Based Preventive Controls Plan (HARPC). This involves certain key parts to be carried out successfully:

1) Evaluating hazards that compromise food safety

2) Outline steps that should be enacted to minimize or prevent said hazards

3) Describe how the facility will monitor these steps to gauge their effectiveness

4) Routinely recording the monitoring procedure

5) Specify corrective actions to take place in case of unforeseen problems

Produce Safety Standards

This involves firmly establishing safe producing and harvesting practices that apply to both fruits and vegetables. Natural hazards should be taken into consideration alongside unintentional problems that can occur. Soil amendments must also be upheld as well as the product’s cleanliness, packing, temperature control, and nearby wildlife.

Radiological Hazards

A modern problem, radioactive contamination has the potential to be incredibly dangerous, which is why the FSMA requires producers to carry out extensive hazard analysis on chemical safety. For example, facilities should regularly test their water to check for the presence of heavy metal contaminants.

Intentional Contamination

The intentional tampering of food is something that is taken into consideration by the FDA as well. The food supply chain should be protected in key vulnerable areas to prevent this from happening as the alternative could give enemies of the state the ability to severely hurt the health of US citizens.

Inspection Standards

In a perfect world, there would be no need to enforce safety standards and guidelines, but the FDA recognizes that strict compliance is the only way the FSMA will succeed long term. 

Mandatory Inspections

The FSMA requires that all high-risk facilities involved in producing food products be inspected within five years of enactment and at least once every three years afterwards. To accomplish this, the FDA will enlist the help of outside governing bodies as the demand far outweighs the resources required to keep up with it.

Access to Records

The FDA reserves the right to have complete access to a producer’s records which includes food safety plans and implementation documentation which we’ve already discussed previously.

Extensive Testing

Certain food products have to be tested by accredited laboratories. In its efforts to meet high quality standards as laid out by the government, the FDA will ensure the testing procedure is reliable and unaltered.

Visual Cues

Random unannounced inspections will also be conducted by an FDA official. The building and equipment being used as well as any condensation leaks and production line inconsistencies will all be checked to reduce the possibilities of widespread contamination from occurring.

Environmental Checks

The FDA agent, during their random inspection, will also check the neighboring environment of the facility’s premise to identify harborage points for certain bacteria. The agent is allowed to take anywhere from 150-200 swabs of samples during this procedure to test.

In Case of Contamination/Foul Play

The measures we’ve outlined in the previous sections are designed to make this part of the guidelines redundant but, in a food system as large as the US, certain violations and problems are bound to happen. The FSMA has protocols to follow for these circumstances too:

Full Recall of the Product

Under the FSMA guidelines, the FDA has the authority to enforce mandatory recalls if a producer is unable to do so themselves after being asked by the authorities.

Administrative Detention

The FDA can also detain products that violate the FSMA guidelines in any capacity. This helps keep suspect food items from being supplied to consumers.


If a supplied food item results in consumers suffering from extreme health problems or death, the FDA will suspend the facility that failed to catch the problem. Vendors that are suspended are not allowed to distribute food in any capacity till their restriction is revoked by the relevant authorities.

Robust Tracing

In today’s day and age having a reliable tracing and tracking system for both domestic and imported foods is very important. The FDA is working on solutions to make this process simpler. The end goal would be to have a dependable system that effectively identifies the recipients of food to control illness outbreaks from occurring.

Record Keeping for “Risky” Food

This involves issuing rules to make record keeping for high-risk foods that have the potential for contamination easier. These guidelines would encompass everything the product is exposed to including the manufacturing process, the packaging, and holding containers.

Imported Goods

Foods that come into the US from other countries are also likely to cause health related problems if left unaccounted for. The FSMA has the goal of ensuring that imported foods are safe for US consumers and it hopes to achieve this by implementing the following guidelines: 

Increased Accountability

Importers will need to verify that their suppliers are taking the necessary precautions to ensure their produce is safe for consumption. 


The FSMA has programs that allow qualified third parties to give foreign food facilities certifications of complying with US food safety standards. This can be very useful for the safe entry of imports into the country.

Besides this, the FSMA allows the FDA to ask for credible third-party certification for high-risk foods before their distribution. This can be enforced as a mandatory condition for importers.

Qualified Importer Program

To streamline the process of verifying goods coming into the US, the FDA can expedite the review and entry of foods distributed by approved importers. There are many factors that go into getting approved but the most important one is offering food from facilities that have been certified as safe.

Denying Entry 

Under the FSMA guidelines, the FDA reserves the right to deny entry to any facility that does not agree to compliance or safety standard certification.

Progress So Far – and What to Expect for the Remainder of 2021

The FSMA was put into effect almost ten years ago and became the largest recorded overhaul to the US food system in over seventy years. 

Because of the FSMA guidelines, producers are much more aware of the products they’re distributing and as a result, the risks of contamination have been greatly reduced. An underrated benefit of FSMA is the fact that many more people and organizations have started taking an interest in food safety and regulation. This interest has created better working environments for farmers and has extended to almost all parts of the food supply network.

From the start, FSMA guidelines were scientifically grounded to ensure that growing, harvesting, packing, and holding both local and imported produce was seamless and safe. Food defensive practices also created fruitful results as a potentially lethal avenue for disruption was discovered and then patched up to avoid adulteration. In times where terrorists are employing novel ideas to bring harm to the public the importance of this can’t be stressed enough.

As our technology has progressed significantly since 2011, traceability efforts have been put into effect from September 2020. Having a system of identifying and recalling defective products is critical for public safety and the FDA’s goal is to emulate the pharmaceutical industry and how they meticulously track the drugs in their own supply chains.

The New Era of Smarter Food Safety blueprint outlines a 10-year plan designed to reach this very goal.

Besides just discussing the efficacy of tracing the food, the blueprint also has the potential for creating solutions like conducting remote inspections by using sensor technology to check for critical control points. The need for this is even more important during the COVID 19 pandemic. 

The progress in these 10 years has been phenomenal and the US food system is in a much better state now than when the FSMA was enacted. However, there are always improvements to be made and things to be tweaked. 

For 2021, the efforts of the FDA to bring tracking and tracing to the food system continue and newer technological breakthroughs are making the journey even easier. From March 2021, routine inspections of small businesses will commence as scheduled to confirm compliance with FSMA standards and regulations. 

The inspection had to be postponed last year due to the virus outbreak but started again from July 2020 in phases, depending on the size of the producer in question.

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About the Author:
Christian Souza is the
Co-Founder of TrackTraceRx