Home-Food Safety Modernization Act FDA FSMA-ISO PROS #16



FDA Food Safety Modernization Act (FSMA) Implementation

According to the statistics from the Center for Disease and Prevention (CDC), over 48 million people in the United States get sick from food-related diseases. Out of this number, about 128,000 get seriously sick while about 3, 000 people die yearly. Given the total United States population, this translates to at least one for every group of 6 people get sick from food contamination in a year.

This has posed a challenge to many manufactures and all those who are involved in the food supply chain as they are people with the biggest role to play to ensure that the food products that get to the final consumers are safe. To control and regulate food manufacturing companies and distributors, the Food Safety Modernization Act (FSMA) came into effect.

FSMA came into effect on 4th January 2011 after being signed into law by former President Obama. This act gave more power to the Food and Drug Administration (FDA) more power to oversee and regulate the production and distribution of food products. FSMA, on the other hand, changed its main focus to treating the foodborne diseases to implementing the prevention measures that ensure the safety of the food products that get to the consumers.

FSMA has many impacts on your food manufacturing and distribution business. If you are sure that you don’t get the role that this body has to play in your business, then keep reading. Every question will be answered in this article. And if there is something that you wanted to know but not explained here, then you can contact experts at ISO-Pros for the best services that you need.

Home-Food Safety Modernization Act FDA FSMA-ISO PROS #16

What Is the Food Safety Modernization Act?

FDA established 7 major rules that are meant to implement the FDA. These rules put the acts into real practice that help in reducing food contamination at every stage in the supply chain.  That is exactly what we are going to discuss in this section. The seven rules of the FDA are as follows:

Food Safety Rule

These rules majorly provide minimum food safety standards for growing, harvesting, picking, and h9olding different foods that are intended to be consumed by a human being. On the list, we have vegetables, fruits, mushrooms, and sprouts, etc. This rule directly addresses the producers that are prodding food on a large scale for the market mainly the growers or farmers.

Food Defense

This rule controls all those involved in the production, transport, storage, or distribution of food products, especially those that are already registered with the FDA. The main objective of this rule is to ensure that every person involved at any stage of the supply chain stated to establish appropriate control measures that are to eliminate or reduce the chances of food contamination that can happen either intentionally or unintentionally. We have heard in the past where a group or an individual intentionally contaminates food to cause harm to the general public. That is exactly what this rule is aiming to prevent.

Preventive Controls for Human Food

This rule requires all the food processors and produce packing bases to establish and impellent the most effective safety systems that will analyze if there are any potential hazards in the food being processed or packed. They are also required to establish preventive control measures that will keep the food contamination free.

Sanitary Transportation of Human and Animal Food

This rule addresses malpractices such as failure to properly refrigerate foods that require refrigeration while on transit.  Also, the rule ensures that all vehicles that carry food are adequately cleaned and food is properly protected from any source of contamination. There are also other malpractices that this rule seeks to prevent or stop.

Preventive Control for Animal Food

This directly addresses manufacturers and processors of animal feeds to establish a standard system and implement it to help in the analysis of any risks or hazards that are in those feeds. Also, the control measures should be in place to ensure that the safe feeds do not get contaminated with the germs that will affect the animals or humans that depend on them for food or handling them.

Third-party certification

FDA has the responsibility to offer accreditation to third parties to offer auditing and consultative services that different companies in the food sector may need. That is all defined under this rule. The accredited third parties are permitted to offer a certificate of compliance to all companies and individuals that meet the set standards.

Foreign Supplier Verification Program (FSVP)

FSVP requires that any person involves in the importation of food products conduct some risk-based testing to verify that any food that gets into the United States from any country around the world is safe and according to the US standards. So, all the importers are also directly affected by the FSMA.

Who is affected by the FSMA rules?


Unlike some of the ISO standards that are generic, FSMA rules only apply to a section of food products that are regulated by the FDA. This section constitutes about 75% of all foods that are available in the United States. These are considered as the high-risk foods that require proper care and close monitoring to avoid contamination of any kind. You may be wondering what is done with the remaining 25% of the foods. Do they remain unregulated? NO! They are also regulated by other bodies apart from the FSMA. The most common one is the United States Department of Agriculture (USDA), which is responsible for setting rules and regulations for poultry, meat, and tons of dairy products. Remember that these remaining foods can be regulated with more than one body. And if you are dealing with products regulated by USDA or any other body, then FSMA rules will not apply in your case.

You may be then asking yourself what is covered by FSMA. To answer you, if you are a commercial producer, or involved in a packing operation, or operates a food processing facility in the United States, then know that you are directly being controlled by the FSMA rules. Basically speaking, all those manufacturing companies that are registered with the FDA have to comply with the FSMA rules and standards. Also, you have to take note that not all companies qualify for regulation by FSMA depending on the scale of production. There is usually a threshold that you have to meet to even get registered with the FDA. If you are not so sure whether your company is qualified for FDA registration or not, then you can confirm it with us. ISO-Pros has experts with answers to your every question.

What are the exceptions?


Not everyone that grows and processes food products and registered by the FDA is regulated by the FSMA. We have exceptions such as those home gardeners and food preservers. This group of people is controlled or regulated mainly by local laws. You may not know where you are as all these now confuse the most. The best thing to do is to consult an expert if you want to always be on the right side of the law.

We have traders, producers, and food processors that already have Hazard Analysis and Critical Control Point (HACCP) in place. If you are in this category, then know that FSMA rules automatically apply to you. the only thing that you will need to do is to improve your HACCP plan to comply with the standards of FSMA. Just for your information, HACCP is a management system that is defined for the manufacture of specific products including, but not limited to, juice and seafood.

When did the FSMA come into effect?

We have already hinted at the date that FSMA was signed into law by President Obama. The FSMA was passed by the Congress in December before it became law on 4th January 2011. It was then passed to the FDA that took about four years figuring out how it will be implemented. It eventually became into full force in the year 2015.

Different compliance dates were set to give time to both small and large operations and processing companies to adjust their standards and comply. In summary, companies with over 500 employees were considered to be at a higher risk, and therefore, expected to achieve compliance by 2016. Those companies with less than 500 employees were given one more year taking the compliance date to 2017. The compliance dates broken down according to company size give small businesses much more time, requiring them to comply with FSMA by 2018.

What are the effects of non-compliance with your business?

Just like any other law, you are expected to comply, failure of which is treated as a criminal act and won’t be taken kindly. FDA is responsible for checking for nonconformities and will issue a warning letter directing the company in question to comply within 15 days. the same information is published on the FDA website to create public awareness. That in itself is a serious punishment as it will greatly affect your reputation, but that is not all. FDA will conduct a second round of audits at your own cost.

In cases where the situation at hand is serious, then FDA may be forced to recall the food batches produced during the period specified or identified as there is possible contamination that can cause serious health problems. The food may be seized or the responsible persons arrested in severe cases where it poses threats to public health. The facility can even be deregistered and operation license recalled.

The problems do not end with the punishments that FDA will throw your way. What if you have managed to take all the punishment only to find out that your company’s reputation is already badly damaged?  You should try to conform at all costs for the sake of your company or organization, and also for the sake of the lives or safety of the public. Don’t let something as simple as nonconformity throw you out of business since people will be avoiding your products.

How do you comply with the FSMA standards?

This is a big question to respond to for sure. If you are not yet sure of what you should do to comply with these rules, then contact our experts. It is very difficult to present steps or procedures for compliance in a general article such as this as they are specific to each company or business. That is the reason why we are directing to seek consultation from experts with specific details of your business and products that you are dealing with.

Complying to FSMA rules is not a difficult process and should not take much of your resources. Contact us at ISO-Pros to get any help that you need regarding FSMA rules and compliance. Our professionals are ready to offer any type of help that you need when you need it.

Our services are FSMA consultations and FSMA certification. We are an accredited company that is mandated to issue certificates to all the businesses and companies that comply with these standards.