Food safety

FSMA & how can it help your food business

The main aim of FSMA is to shift the focus of manufacturers and governing agencies towards the prevention of potential ...

  • The main aim of FSMA is to shift the focus of manufacturers and governing agencies towards the prevention of potential food safety issues rather than addressing them as they happen.
  • Non-compliance to the provided rules may put the safety and intent of consumers at risk.
  • Comprehensive, science-based preventive controls are emphasized by the FSMA to create a food safety program and establish preventive controls to reduce risks.

Foodborne illnesses are significant factors in the lower productivity of a community and create a public health burden. As such, the Food and Drug Authority (FDA) under the government ruling in 2011, worked out the Food Modernization Act (FSMA) and it was signed into law in response to the many cases of foodborne illnesses in the United States. This law has been a groundbreaking and major improvement of the FDA’s approach towards food safety regulations and acts as guidance for industry.

Cases of contamination and foodborne diseases are a tell-tale sign of bad food safety processes or breach of safety protocols. These issues in food safety and non-compliance with food laws have plagued the food industry and have become the downfall of some manufacturers. When a food company is entangled in a case of foodborne illness, it can harm its reputation and cause damages.
In the United States alone, the Center for Diseases Control has estimated that at least 48 million people are afflicted with foodborne illnesses, of which 3,000 of these people die. In a nutshell, that means at least 1 in 6 people in the US get sick because of foodborne illness. Of the numerous cases of foodborne illnesses, some of the most common pathogens include Norovirus, Salmonella, Campylobacter, Clostridium, and Staphylococcus aureus.

In this article, we will give you the most important details related to FSMA, also what can it do for your business and the whole supply chain.


What is FSMA?

The Food Safety Modernization Act (FSMA) is the FDA's attempt to reform the food safety approach of the industries in the United States. The law is composed of several sections aiming to address the different concerns of each sector in the food industry. It outlines the important roles that manufacturers perform in maintaining public safety through safe food production.

Since the regulation's signing into law, it has been continuously developed to encompass a broader range of the industry and include the whole supply chain. The FSMA focuses on proactively preventing factors that could compromise safety rather than acting on them as they happen. It works on the basis of the farm-to-table concept to ensure that it covers all the involved businesses from raw material production and supply to the distribution of products.

The provisions of FSMA requirements emphasize the following:

  • Establishment of programs preventing food safety hazards;
  • Detection and proper response to food safety issues;
  • Importation of food safety programs;
  • Third-party accreditations; and
  • Mandate the FDA to guide manufacturers to comply with FSMA.


FSMA compliance means having a strong and working Food Safety Management System in your company. At FoodDocs, we will help you understand and implement top-quality FSMS guidelines and give you an overview of what is FSMA compliance. We help you get food safety certifications with minimum effort.

FSMA compliance

The main aim of FSMA is to shift the focus of manufacturers and governing agencies towards the prevention of potential food safety issues from a reactive approach. Under the FDA Food Safety Modernization Act, the strictness of monitoring and imposing firm foreign and domestic supplier verification programs have been significantly strengthened to protect the public.

The law requires both foreign and local suppliers to adhere to the food safety regulations set out by the FDA. In addition to emphasizing the role of manufacturers towards achieving food safety, the law is also a tool that strengthened the jurisdiction and capabilities of the FDA to impose sanctions on non-complying companies. Under this law, the FDA is given approximately 50 regulations and guidelines covering provisions for entities operating and those with transactions in the country. 

With exemptions to some industries, the FSMA compliance requires all food processors to create a risk-based hazard analysis. Within the food processing flow, a manufacturing company is required to create a preventive control program for significant and foreseeable hazards under the FSMA.

Additionally, the FSMA rules require all governing agencies to create regulations on safe harvesting and handling of raw materials, importation of foods, and increase inspections.

In order to promote the preventive approach, manufacturers and suppliers are required by this law to provide a detailed list of corrective actions to the identified hazards as well as a Food Defense plan. The FSMA also promotes the use of scientific methods to establish regulations on food safety.

It specifically requires all concerned industries to comply and create an FSMA food safety plan, hazard and critical control point identification,  the establishment of controls and preventive food safety measures, monitoring, recall plan, and more stringent documentation of inspection reports.


Why was the FSMA established?

One of the most significant reforms in the FDA mandates was made after the 9-11 attack in 2001 - the Bioterrorism Law. This event prompted the United States government to create a law that granted the FDA the capability to impose detention over food products that have questionable integrity and may pose threat to people or animals. Soon after the establishment of the Bioterrorism Law, the continuous rise in food-borne illnesses in the country proved that stricter food safety laws were needed.

To address this food safety issue, the U.S. governing administration and concerned food safety regulating bodies drafted several food law proposals and came up with the FSMA in 2009. The law was formulated as a response to the significant changes in the food industry globally including the higher risk of foodborne illnesses they carry. 


Who is the FSMA for?

The FSMA regulations aim to protect consumers from potential food safety hazards. To do this, the law mandates all food manufacturers and suppliers who are regulated by the FDA to comply with their provisions. This accounts for about 75% of the U.S. food supply, leaving the other 25% under the care of the USDA. This means that all domestic and foreign food establishments that have transactions with the country must comply with the FSMA.

Food industries dealing with meat, dairy products, and poultry that are under the USDA are not included in the provisions of FSMA. Basically, if you are a commercial farm owner, in the packaging and label industry, or food processing industry, the FSMA applies to your business.

Additionally, food businesses with an established HACCP plan must comply with the FSMA. Regular updates and enhancements of your HACCP plan are all included under the FSMA regulations.
To uphold fairness in the implementation of the law, certain provisions are available to qualify for an FSMA exemption for certain types of food. Under the law, farms and food producers dealing with raw agricultural domestic foods will not be subjected to the regulations of FSMA. Farms with records of sold products on an annual basis with $25,000 or less are also included in the FSMA exemption.
The FSMA does not apply to home-based gardeners, preservers, and processors. Similarly, retail food establishments and restaurants operating with direct-to-consumer sales are not covered by the law. The FSMA frequently uses the terms small, very small, and other businesses to categorize compliance dates, fees, and extensiveness of implementation.
The law identifies these terms as follows:
  • Small businesses - entities that house less than 500 full-time employees under their main facility, subsidiaries, and affiliates.
  • Very small business  - food production companies that gain less than $1 million per year within a three-year period before the applicable calendar year for human food sales.
  • Other businesses - companies that employ more the 500 full-time workers and gain a total revenue of $1 million or more per year within a three-year period before the applicable calendar year for human food sales.

FSMA 7 rules

7 Major Rules of FSMA

In order to make the law more efficient and effective, seven major rules were designed to ensure clear resolutions are made to address food safety concerns. Below are brief explanations and an overview of these rules.

1. Produce safety

(Finalized in November 2015) 
This safety rule states that science-based minimum food safety standards will be set for food safety practices including growing, harvesting, post-harvest controls, and packing of commodities such as fruits and vegetables grown for human consumption at the farm level. Under the FSMA, microbial and chemical analysis and minimum requirements for maintenance of agricultural water used for irrigation, biological soil amendments, sprouts, domesticated and wild animals are established. All practices intended to result in the production of food for humans are regulated under this provision. This rule also requires increasing worker education in health and hygiene by undergoing training.

2. Foreign supplier verification program (FSVP)

(Finalized in November 2015)
In order to achieve FSMA certification, food importers are required to perform risk-based verification activities. These processes aim to verify that the imported products comply with the same level of health protection concerning food safety as stated by FDA regulatory requirements. Where applicable, the FSMA also regulates adulteration of food and misbranding to prevent issues such as undeclared allergen information.


3. Sanitary Transportation Rule

(Finalized in April 2016)
This rule under the Food Safety Modernization Act aims to prevent food safety issues concerning improper conditions during transport. It emphasizes the protection of different types of foods during transportation against contamination or spoiling while in transit. Some provisions include requirements for food refrigeration, sanitation of vehicles in between loads, and proper recording of these conditions. Note that this rule does not apply to food supply being shipped through the air due to limitations of the law.

In addition, compliance with basic food safety practices such as the current Good Manufacturing Practices (cGMP) would significantly help in complying with the Food Safety Modernization Act. Stricter implementation of training for employee education on food safety is also part of the law. All company employees are mandated to undergo orientation and familiarization of preventive controls and other areas such as allergen management requirements and cross-contamination issues. The law mandates businesses agree to the significant authority of the FDA to suspend operations once issues of rule breaches have been reported.

4. Protection Against Intentional Adulteration

(Finalized in May 2016)
The FSMA has taken into consideration events of terrorism concerning food which can be achieved through adulteration. Such actions can cause serious health issues and economic disturbances. As such, the FSMA requires concerned businesses to build and implement a Food Defense Plan containing strategies on how to prevent these acts and evaluate vulnerable points of the food processing line. The mandated time of compliance with this rule depends on the size of the firm. That is, very small businesses, small businesses, and others are categorically required to comply after five, four, and three years after the publication of the rule, respectively.

5. Accredited Third-Party Certification

(Finalized in November 2015)
This rule aims to establish volunteer third-party certification bodies to monitor and evaluate foreign firms. Once certified, auditors are given the authority to perform consultations in preparation for regulatory audits. The certification acquired from this rule can be used to participate in the FDA's Voluntary Qualified Imported Program (VQIP) to gain expedited reviews for food entry. This rule, as stated by the FDA, encompasses competency, capacity, conflict-of-interest safeguards, and legal authority as requirements for accreditation.

6. Preventive Control Rule for Human and Animal Food

(Finalized in September 2015)
The FSMA mandates FDA to require a written Food Safety Plan from concerned food businesses making food for people and animals. This rule aims to reduce any biological, physical, and chemical hazards which could pose health concerns. Risk-based assessments are required to be used to create preventive controls for animal food as well as humans'. The Food Safety Plan must include analysis and proper preventive controls for hazards, monitoring, and a recall plan. This rule also requires the adequate implementation of the current Good Manufacturing Process.

7. Voluntary Qualified Importer Program (VQIP)

(Finalized in 2016)
This provision aims to provide food importers with a way to speed up and review the analysis of their products. This is a voluntary program that comes at a fee. Participating food importers are required to qualify to the FDA criteria to gain eligibility to the program. This rule gives priority to participating importance in terms of releasing laboratory analyses results and faster sampling.


Non-Compliance to FSMA

Under the completed FSMA, different time frames and compliance dates have been provided to allow concerned businesses to comply. Because FSMA is a law, all businesses under the regulations of the FDA are mandated to adhere to its provisions.

Non-compliance to the provided rules may put the safety and intent of consumers at risk. Because the FSMA aims to reduce hazards and risks in a food company's production, failure to comply can result in overlooking potential contaminations and breaches of food safety protocols.

The following are some of the potential risks of non-compliance to your business and consumers:

  • Foodborne disease outbreaks
  • Customer complaints
  • Product recalls
  • Suspension of production 
  • Repeated inspections from the FDA
  • Suspension of the license to operate
  • Loss of productivity and revenue

In cases of detection of adulteration in food products, recalls are rightfully issued by the FDA. Non-compliance to the FSMA rule regarding intended adulteration can lead to the suspension of your company's registration. This removes the company's authorization to legally produce and sell its products for a period of time.

For less severe issues with non-compliance to the FSMA, re-inspection of food facilities and reevaluation of documents may be imposed by the FDA. This kind of process entails fees that can be charged to your company and are currently at around $231 to $285 per hour.

Other examples of violation and non-compliance to FSMA include refusal to comply to recall orders, inadequate FSMA Food Safety Plan and Food Defense Regulations, and importing products from suppliers without a risk-based evaluation of their food product safety. To an extent, criminal penalties for non-compliance can include fines of up to $250,000 should serious injuries incur from the issue.

This kind of cases can also lead to temporary restrictions of operations that can lead to a significant loss in revenues. In extreme cases, those which involve the death of a consumer or serious hospitalization due to non-compliance, companies can be shut down for good.


Food Safety Modernization Act summary

This law has emphasized the authority of the FDA to impose recalls on contaminated foods or products that do not adhere to the rules of the law. It has also mandated the FDA to require involved businesses to submit to new preventive protocols and safety plans. Additionally, the Food Safety Modernization Act increased the capacity of the FDA to inspect businesses and their authority to oversee overseas transactions. 

Under the newly reformed rules of the FDA and as a mandate from the Food Safety Modernization Act, food manufacturers are required to submit to register with the FDA every two years as compliance. In addition, the FDA requires businesses to create a Food Safety Plan as well as a Food Defense Plan that is science-based and come up with preventive controls strategies for hazards and potential vulnerabilities. The Food Safety Modernization Act also includes the rule for the FDA to establish laboratory testing regulations to detect and respond to food safety issues promptly.

Compliance with the Food Safety Modernization Act does not only mean registering to the FDA. It also means complying with the rules they set out and submit essential plans.

As an example, making a food safety plan would require you to submit a report of your whole processing functions and create a plan with the following elements:

  • Risk Identification
  • Hazard analysis
  • Preventive controls for identified hazards
  • Plans on how to monitor these hazards
  • Corrective actions
  • Verification process
  • Proper documentation

If you want help with any of these elements then sign up for our free trial, FoodDocs Food Safety Management System is a tool for all your food safety needs.


FSMS is a Must

Foodborne illnesses are signs of breaches in the food safety system of a company. Food safety systems help to ensure that issues that can create significant food safety concerns are addressed. Fortifying such goals, the Food Safety Modernization Act of 2011, which has been passed into law, has shifted the focus of manufacturers and the FDA towards preventing potential hazards from creating food safety concerns. To achieve FSMA compliance, it is vital to have proper training on how to identify hazards and implement preventive measures.

The FSMA requires that a company must have an adequate food safety plan which mandates all employees, as well as suppliers and logistics personnel that can either be in-house or third-party, to uphold the integrity of the product being produced. Science-based hazard analyses are emphasized by the FSMA to create a food safety plan and establish risk-based preventive controls to reduce food safety risks. Included in the FSMA regulations are monitoring procedures to ensure the implementation of the plans and ensure that accepted corrective actions are applied.

The key to becoming well-prepared for FSMA compliance is to learn all about its principles and have an expert help you lead the way. Complying with the FSMA regulations means having a strong Food Safety Management System with which FoodDocs is an expert. Let us help you build a working and well-rounded FSMS plan.

Be up-to-date with the most recent developments on food safety issues and compliance challenges and standards by using our online FSMS planner. More than just a law, the FSMA is an investment towards the benefit of the whole company by upholding product safety and brand integrity.




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