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FSMA - Food safety modernization act & how it can help your food business
The main aim of the FDA Food Safety Modernization Act is to shift the focus of manufacturers and food safety agencies ...
- The main aim of the FDA Food Safety Modernization Act is to shift the focus of manufacturers and food safety 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.
- The FSMA emphasizes comprehensive, science-based preventive controls to create a food safety program and establish preventive controls to reduce risks.
Foodborne illnesses from unsafe food are significant factors in the lower productivity of a community and create public health burden. As such, the U.S. Food and Drug Administration (FDA) under the government ruling in 2011, worked out the FDA Food Safety Modernization Act (FSMA) as a more stringent approach to food safety.
It was signed into law as a science-based mitigation strategy response to the many cases of foodborne illnesses from unsafe food and their adverse health consequences in the United States. This law has been a groundbreaking and major improvement of the FDA’s approach toward food safety regulations and acts as guidance for the multifaceted food supply chain. It has given the FDA more capabilities to cease reliance on inspections from federal, state, and local agency reports for actions.
WHAT WE'LL COVER:
Cases of contamination and foodborne diseases from the US food markets are a tell-tale sign of bad food safety processes or breaches of safety protocols. These issues in food safety and manufacturing practice non-compliance with federal food safety 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 damage.
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 from unsafe food. Of the numerous cases of foodborne illnesses, some of the most common pathogens include Norovirus, Salmonella, Campylobacter, Clostridium, and Staphylococcus aureus. These reports prompted the US government to strengthen the U.S. food safety system for high-risk facilities through the FSMA.
In this article, learn what does FSMA stand for and the most important information about this law related to your food business.
What is FSMA?
The FDA Food Safety Modernization Act (FSMA) is the US government'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 for the production of safer products in domestic facilities and imported products. The FSMA meaning outlines the important roles that manufacturers perform in maintaining public safety through safe food production and the food safety standards that they need to uphold.
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 based on the farm-to-table concept to ensure that it covers all the involved businesses from raw material manufacturing process and supply to the whole food chain distribution channel of products.
The provisions of applicable requirements of FSMA 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 through our digital Food Safety Management System.
The main aim of FSMA is to shift the focus of manufacturers and government 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 activities have been significantly strengthened to achieve public health goals.
Food safety requirements of the law both foreign facilities and local suppliers to adhere to the food safety regulations and supplier verification activities set out by the FDA for manufacturing practice of high-risk foods. In addition to emphasizing the role of manufacturers in 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 assurance of 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. This program may include practices such as stringent sanitation procedures for food contact surfaces, a food allergen control program, lab accreditation, and a recall plan.
What foods does the FSMA cover?
Additionally, the FSMA rules require all government agencies to create regulations on safe harvesting and handling of raw materials, importation of foods, and increased oversight of food products. These products that are regulated by the FDA account for at least 75% of the US food supply and include human and animal foods. Particularly, the Produce Safety Rule under the FSMA law covers raw agricultural commodities (RAC) such as grains, corn, sorghum, rice, wheat, fresh fruit, and others.
To promote the preventive approach of the law, concerned manufacturers and suppliers are required by this law to provide a detailed list of corrective actions to the identified hazards from high-risk foods 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, complete product tracing system, and more stringent record-keeping requirements of inspection reports. These requirements are built to address any unintentional and intentionally produced food safety issues with reasonable probability, including acts of terrorism.
In the UK, a similarly-natured food safety law is in effect. This law, the Food Safety Act 1990, aims to protect consumers from the malpractice of food businesses. Unlike the FSMA, it applies to all food businesses in the UK, whether big or very small. The Food Safety Act 1990 similarly ensures that the food being produced by food businesses and imported into the UK is safe and will not do any harm to public health. This law does not involve the monitoring and regulation of food hygiene practices.
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 federal food safety laws were needed.
To address the threats to food safety, the U.S. governing administration and concerned food safety regulating bodies drafted many 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 needs to comply with FSMA?
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 comply with their provisions. This accounts for the majority of the U.S. food supply as only 25% is 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. 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 companies and high-risk facilities 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, any farm and food produce dealing with raw agricultural domestic foods will not be subjected to the regulations of FSMA. Farms with routine 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, the law does not cover any retail food establishment and restaurant operating with direct-to-consumer sales as qualified facilities. The FSMA frequently uses the terms like 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 three years before the applicable calendar year for human food sales (e.g. farmer's markets or roadside stands).
- Other businesses - companies that employ more the 500 full-time workers and gain a total revenue of $1 million or more per year within three years before the applicable calendar year for human food sales.
7 Major Rules of FSMA
To make the law more efficient and effective for food processors, seven major rules were designed to ensure clear resolutions are made to address food safety. Below are brief explanations and an overview of these rules.
1. Produce safety
(Finalized in November 2015) This provision aims to create a rule for science-based produce standards that will be set for food safety practices including growing, harvesting, post-harvest controls, and packing of any products such as any fresh fruit and vegetable grown for human consumption product at the farm level. Under the FSMA, microbial and chemical analysis and minimum food safety requirements for maintenance of agricultural water used for irrigation, biological soil amendments, sprouts, and domesticated and wild animals are established for food producers. Any practice intended to result in the manufacturing process of food for people is regulated under this provision. This legislative mandate also aims to produce better-equipped food handlers by increasing worker education in health and hygiene through training.
2. Foreign Supplier Verification Program (FSVP)
(Finalized in November 2015) To achieve FSMA certification, the Foreign Supplier Verification Program safety rule requires foreign facilities and food producers to perform risk-based verification activities to reduce the reasonable probability of food issues. These processes aim to verify that the imported products comply with the same activity level of health protection concerning food safety as stated by FDA regulatory food requirements. Where applicable under the Foreign Supplier Verification Program, the FSMA also regulates intentional adulteration of food and misbranding to prevent issues such as undeclared allergen information. This rule helps foreign governments expand their capacity to provide products in the US.
3. Sanitary Transportation Rule
(Finalized in April 2016) This rule under the FDA Food Safety Modernization Act aims to prevent different types of 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 food safety requirements for food refrigeration, sanitation controls of vehicles in between loads, and proper recording of these conditions in qualified facilities. 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 FDA Food Safety Modernization Act. Stricter implementation of training for employee education on food safety and sanitation control procedures for food contact surfaces and the whole facility is also part of the law. All company employees of qualified facilities are mandated to undergo orientation and familiarization with preventive controls and other areas such as allergen management requirements for facilities and cross-contamination threats to food safety. The law mandates businesses agree to the significant authority of the FDA to suspend operations and detain suspect food once issues of rule breaches have been reported.
4. Protection Against Intentional Adulteration
(Finalized in May 2016) The FSMA has taken into consideration events and acts of terrorism concerning food that 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. Included in this is a food allergen control program as undeclared allergens are considered adulterants by this law. 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 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 a voluntary program for third-party accreditation bodies to monitor and evaluate foreign facilities. Once certified, accredited third-party auditors are given the authority to perform consultations in preparation for regulatory food safety audits. The certification acquired from third-party certification bodies can be used to participate in the FDA's Voluntary Qualified Imported Program (VQIP) to gain expedited reviews for entry of imports. This rule, as stated by the FDA, encompasses competency, capacity, conflict-of-interest safeguards, and legal authority as requirements from accreditation bodies to strengthen international agreements.
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 animals and humans. This rule aims to reduce any reasonable probability of biological, physical, and chemical hazards on high-risk foods which could pose health concerns. Risk-based assessments are required to be used to create risk-based preventive controls for animal food as well as humans to address potential problems such as adulteration of food. The Food Safety Plan must include analysis and proper risk-based preventive controls for hazards, monitoring, inspection reports, and a recall plan. This rule also requires the adequate implementation of the current Good Manufacturing Process and a produce traceability plan for the control of agricultural problems such as antibiotic resistance.
7. Voluntary Qualified Importer Program (VQIP)
(Finalized in 2016) This program for importers aims to provide foreign food facilities with a way to speed up and review the analysis of their products before entry of food into the country. This is a voluntary program that comes at a fee. Participating food importers are required to qualify to the FDA criteria to gain eligibility for the program. This rule gives priority to participating importance in terms of releasing laboratory analysis results and faster sampling.
Read more about FSMA regulations.
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 food safety regulation 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 of high-risk foods, 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 illness outbreak
- Customer complaints
- Mandatory recall authority
- 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 some time.
For less severe issues with non-compliance to the FSMA, re-inspection mandate of food processing 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 entry of food 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 case can also lead to temporary restrictions on manufacturing practices that can lead to a significant loss in revenue. 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 controls for human food. Additionally, the FDA Food Safety Modernization Act increased the capacity of the FDA to inspect food companies and their authority to oversee overseas transactions.
Under the newly reformed rules of the FDA and as a legislative mandate from the FDA 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 FDA Food Safety Modernization Act also includes the rule for the FDA to establish laboratory testing regulations to detect and respond to threats to food safety promptly.
Compliance with the FDA Food Safety Modernization Act does not only mean registering with the FDA. It also means complying with the rules they set out and submitting essential plans.
As an example, making improvements in a food safety measures plan would require you to submit a report with strategies for 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
Learn more about the FSMA compliance checklist.
If you want help with any of these elements then sign up for our free trial. FoodDocs digital Food Safety Management System is a tool for all your food safety needs.
FSMS is a Must
Foodborne illness outbreaks 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 FDA 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 issued food requirements where 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 for a safer product. The FSMA emphasizes science-based hazard analyses to create a food safety plan with sound strategies and establish risk-based preventive controls to reduce food safety risks. Included in the FSMA regulations are continuous monitoring procedures and product traceability to ensure the implementation of the plans and ensure that accepted corrective actions are applied.
FDA Food Safety Modernization Act overview
Need a bit more clarification about what is the FDA Food Safety Modernization Act? We got you! Here is an FDA Food Safety Modernization Act summary using the most frequently asked questions about this topic.
What is the purpose of FSMA?
The FSMA's main purpose is to secure a safe food supply, including animal feed, for the US by shifting the focus of the food industry and government inspectors from a reactive stance in terms of food safety to a proactive one. The law established food safety measures and requirements for facilities under the jurisdiction of the US FDA.
Is FSMA the same as HACCP?
Generally, HACCP and FSMA are not the same. The HACCP is a food safety system that is used to identify, evaluate, and control food safety hazards, whereas the FSMA is a law that contains preventive controls (HARPC) for the production, processing, transportation, and import of foods in the US food chain.
Is FSMA required?
All food producers, growers, processors, and distributors of high-risk imported foods and domestic products regulated by the FDA are required to comply with the key requirements of FSMA for public health protection.
Why was the Food Safety Modernization Act passed?
The FSMA was the US Congress' response to the globalization of the food industry and the subsequently increasing risks and reports of any foodborne illness in the country. Included in this realization is the significant impact of threats to food safety on the economy of the food industry.
Who falls under FSMA?
All foods and food and beverage businesses, including animal food manufacturers, regulated by the FDA, which is at least 75% of the US food supply, are subject to the food safety measure rules of the FSMA. This group excludes food companies regulated by the USDA.
Which food safety regulations have been created by the passage of the Food Safety Modernization Act?
The FSMA gave the U.S. Food and Drug Administration more power to control how millions of food products are produced, collected, and processed as well as enforce sanctions in the supply chain to achieve the national food safety goals of public health protection. This law also provides protections and improvements in food safety operations in the food industry including the authority to detain suspect food in foodborne illness cases.
Does FSMA apply to restaurants?
Despite not applying to any restaurant and retail food establishment, some of the FSMA rules such as the Sanitary Transportation Rule may apply. The preventive food safety measures and food requirements of the FSMA can prove to be more than useful and effective in achieving public health goals for the restaurant industry.
Does FSMA apply to meat?
The FDA Food Safety Modernization Act does not have authority over food items that include meat, poultry, dairy, and related products produced by human and animal food facilities as this food group is regulated by the USDA.
Does FSMA apply to food packaging?
Not all rules and sub-provisions of the FSMA include food packaging industries. In general, any manufacturing practice related to food packaging is not regulated by the FDA FSMA rules.
What are the five key elements of FSMA?
The major highlights of the regulatory requirements of the FDA Food Safety Modernization Act include five key elements:
- Preventive controls
- Stepped-up FDA inspections
- Regulation of importation
- The more stringent response towards non-compliance
- Stronger collaborations and agreements with food industry associations and food safety agencies
How do consumers benefit from the FSMA?
The FSMA strengthens the authority of the FDA and expands its capabilities for public health protection from the malpractice of food producers. The law focuses on preventing food safety issues from happening as a result of providing imported and domestic products rather than reacting to them to save more healthy recipients of food from any foodborne illness.
Who is affected by FSMA?
After the rulemaking process was finalized, the FSMA food safety requirements now take effect on all of the food companies that deal with products regulated by the FDA for the protection of the recipients of food products.
Food safety compliance using digital solutions
The US Food Safety Modernization Act focuses on food safety practices that help prevent foodborne illnesses even before they happen. 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 and food safety systems regulations means having a strong Food Safety Management System as one of the many application requirements.
At FoodDocs, our objective is for every food business to become food safety compliant. Our digital Food Safety Management System was built by food safety experts who have seen the food industry evolve even further. Using our system, you can get a comprehensive digital FSMS in just an average of 15 minutes. The whole process would only require you to answer a few questions regarding your operations.
After this process, you can enjoy a complete digital FSMS built based on your everyday operations. You do not need to go through any more hassle of building your own monitoring forms, traceability system, and other important food safety documents for compliance.
What exactly would you get when you sign up with us?
- Complete and intuitive digital monitoring forms. These forms can be set to automatically be filled with the data you need based on your previous data entries. Save your employees' time as they would only need to verify the information.
- Smart notification system. Using our mobile application, your employees will get timely notifications as a reminder for food safety tasks that are due.
- Real-time dashboard. Save up to 20% of your time from managing your food safety operations by pinpointing exactly where the areas that need improvement are. This dashboard gives you a quick overview of your daily operations.
- Cloud storage for all of your digital data. When you join us at FoodDocs, you will also have cloud storage where you can store, organize, and access all of your documents in one place.
Let us help you build a working and well-rounded digital FSMS plan in a matter of 15 minutes. Be up-to-date with the most recent developments on food safety and applied measures, threats to food safety, compliance challenges, and food safety standards by using our digital FSMS. More than just a law, the FSMA is an investment towards the benefit of the whole company by upholding product safety and brand integrity and we can help you stay compliant!
If you want to personally experience how our digital FSMS can help you maintain food safety compliance, you can avail of our free, 14-day trial. Test our digital features and join our list of more than 15,000 customers who have shared thousands of comments on how our system has helped them.