Food safety

What are the 7 FSMA regulations?

Improper food handling is one of the leading causes of foodborne illnesses. FSMA regulations aim to shift the focus of ...

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  • Improper food handling is one of the leading causes of foodborne illnesses.
  • FSMA regulations aim to shift the focus of food producers and handlers towards the prevention of food safety issues before they happen.
  • The FSMA laws gave more authority to the FDA to implement food safety regulations.

As a way to address the increasing rise of foodborne illnesses, the government of the USA together with the help of the Food and Drug Administration (FDA) signed the FSMA regulations into law in 2011. The Food Safety Modernization Act (FSMA) was the country's solution to control outbreaks of foodborne illnesses by establishing a set of regulations.

What changed when the FSMA regulations were signed into law was the way the whole food safety system viewed how to look at food safety hazards. Instead of focusing on how to solve foodborne diseases that are currently happening, the food safety law emphasizes their prevention through correct food safety practices and regulations.

The importance of the FSMA regulations cannot be more emphasized by the number of foodborne illnesses around the globe. The Centers for Disease Control and Prevention (CDC) estimates that at least 48 million foodborne illnesses occur each year in the US alone, whereas the World Health Organization estimates at least 600 million cases happen each year. 

Because some of the most common causes of these foodborne illnesses are rooted in improper food handling in general, the FDA FSMA was made to provide regulations to food establishments within the whole food supply chain. 

In this article, we will run over the 7 major FSMA rules and a few new FSMA regulations.


Is FSMA part of the FDA?

The FDA is the main implementing regulatory agency of the FSMA law. This means that all food establishments that are regulated by the FDA must comply with the FDA FSMA regulations which account for at least 75% of the food industry.

The FSMA regulations are considered as some of the most significant and notable reformations of the FDA's rules for over 70 years. This law was built by the FDA to focus more on preventing food safety problems by establishing regulations on proper food handling and programs that aim to certify qualified auditing bodies.

Under the FSMA law, the FDA is given new implementation capabilities for higher compliance rates. It has also strengthened the authority of the FDA to impose sanctions such as recalls and investigations on cases of probable food safety issues. 


what are the 7 FSMA rules


What are the 7 FSMA rules?

To keep up with the spontaneous globalization of the food industry and the increasing risks of foodborne illnesses due to failures in food safety programs, seven major rules were crafted under the FSMA law. Compliance with each law is dependent on the scale of your food business. 

Under the FSMA regulations, businesses are categorized into small, very small, and other businesses. Major differences are seen in the number of employees and net income per year of your business. If you want to learn more, check out our article about ways on how can FSMA help your food business.

Below are some pointers on what are the 7 FSMA rules.

1. FSMA rule: Produce safety rule

The final rule on produce safety has established minimum standards for food safety practices such as growing, harvesting, packing, and holding food for human consumption. These standards are science-based and have undergone comprehensive evaluation to address food safety hazards in food handling practices. This food safety law covers farms that produce raw agricultural commodities or those that can be consumed in their raw state.

This rule applies to any farm growing fruits and vegetables meant for human consumption. Under the produce safety FSMA regulation, the following points are emphasized:

  • Microbiological count as an indication of agricultural water quality at the farm level (especially for the presence of E.coli)
  • Standard water testing procedure (for surface and groundwater)
  • Standards for application and microbial count of raw manure and compost or any biological soil amendments of animal origin in farm
  • Handling, growing, and microbial testing standards for sprouts
  • Standards for using domesticated and wild animals for various purposes such as grazing.
  • Employee training opportunities on health, hygiene, and food safety hazards (applies to all farm personnel)
  • Minimum safety standards for equipment and food handling facilities

2. FSMA rule: Foreign supplier verification program (FSVP)

The foreign supplier verification rule requires foreign suppliers to uphold the food safety standards established by the country for public health protection. It requires importers to submit to risk-based verification activities. The FSVP rule regulates the possibilities of hazards from adulteration and misbranding such as the undeclared presence of allergens. Some of the specific scopes of this FSMA regulation include:

  • The importer must have a plan of risk-based preventive controls concerned with hazard analysis and control which include corrective and monitoring records and procedures.
  • The imported foods must be protected from adulteration.
  • No misbranding is allowed. Food allergens must be properly declared.

3. FSMA rule: Sanitary transportation rule

The sanitary transportation rule requires food producers to uphold the application of risk-based preventive controls for hazards to protect the public from any potential contamination during transport. This FSMA regulation requires concerned parties to comply with transportation standards such as proper keeping temperature, sanitary operations and conditions of vehicles, and other good manufacturing practices.

This rule applies to logistics entities including carriers by motor or rail vehicles as well as the receivers of food products. Sanitary transportation practices guidelines do not apply to vehicles traveling by ship or air.

Under the sanitary transportation rule, the following standard regulatory requirements are needed to be established by food handlers:

  • Proper design and maintenance of vehicles and transport terminals. They must be easy to clean have working temperature controls.
  • Implement proper conditions for food during transportation including temperature controls, prevention of cross-contamination, and protection against unintentional or intentional adulteration.
  • Logistics personnel must have proper and adequate training opportunities related to sanitary transport practices.
  • Proper record-keeping practices for important agreements, monitoring forms, training, and written procedures with standards. 

Additionally, the FSMA law also requires food businesses to submit to the FDA's authority for on-site visual inspection in case of reports of probable food safety issues from your business.


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4. FSMA rule: Protection against intentional adulteration

This finalized law requires every concerned food manufacturing company to build a Food Defense Plan. This strategic document aims to address the probability of an outbreak due to potential food safety risks of intentional adulteration and any form of food supply chain-targeted terrorism. 

This FSMA rule focuses on prevention strategies by gaining more information on potentially high-risk processes in a food production line. It is applicable to foreign and local food manufacturers producing large volumes of products that are required to report to the FDA, thereby small businesses including farms are not bound by it.

The main components of a Food Defense Plan include:

  • Identification of processing steps that are vulnerable to potential adulteration. This step includes the assessment of the scale of public health issues should such problems occur. The rule aims to identify and list the routes of distribution and evaluate how many illnesses or complications can a hazard from this step causes.
  • Preventive steps must be appropriate for the vulnerable processing steps to ensure food safety. 
  • Management components for preventive steps must include monitoring procedures, corrective actions in case of non-compliance, and verification procedures.
  • Assigned personnel must have adequate training opportunities and record-keeping proficiency to ensure proper implementation of food defense plan.

5. FSMA rule: Accredited third-party certification

This FSMA regulation is a volunteer program for companies who want to become accredited third-party auditors of foreign facilities. Third-party certification bodies are responsible for conducting safety audits and become responsible for issuing safe food certifications to foreign importers of food for humans and animals alike. The rule aims to increase importer accountability on any potentially harmful food that they may be carrying.

Certifications provided from third-party accreditors may be used as proof of eligibility for the Voluntary Qualified Importer Program. Its main use is to serve as evidence of quality. 

The regulation covers legal authorities, competency, conflict-of-interest conditions, and quality assurance steps for entities seeking to become accredited auditors and companies who want to be accredited. As an accredited certification body, your company will be given the authority to perform the following tasks and report to the FDA:

  • Evaluate the third-party certification bodies for accreditation,
  • Monitor performance of the certification bodies and report any changes to the accreditations they have granted.
  • Perform on-site observations, revoke previous accreditations of companies under specific conditions, and evaluate and suggest corrections in their practices. 
  • Submit the monitoring and assessment reports to the FDA

Accredited certification bodies will be allowed to perform both consultative and regulatory accreditations. The former type is an auditing activity to prepare a company for regulatory food safety audits and internal use. It evaluates the suitability of a company being accredited based on industry standards. Accredited certification bodies can be a foreign government.

6. FSMA rule: Preventive control rule for human and animal food

The FSMA regulation on preventive control applies to both foods for human and animal consumption. This rule requires producers to have a comprehensive hazard analysis program and establish comprehensive, science-based preventive controls for these standards.

This rule under the FSMA regulations contains amendments to the previous provisions of the current good manufacturing practices. One of the most notable amendments is the legislative mandate to conduct education and training for food handling employees which was previously not binding. Training requirements involve the basic principles of food hygiene and food safety as well as the importance of their health status and food handling practices.

In terms of animal food safety control, FSMA regulations require food handlers processing animal by-products to make as feeds must adhere to current Good Manufacturing Practices (cGMP). Farmers can choose whether to use their preexisting cGMP regulations for human foods or create an entirely new plan for animal foods.

The preventive control rule requires food processing owners to have a comprehensive food safety plan. This document will be a food safety management system composed of the following components:

  • Hazard analysis
  • Preventive controls for human food (processes, food allergen control, sanitation, and others)
  • Preventive controls for animal food (processes, food allergen control, sanitation, and others)
  • Oversight and management (monitoring, corrective actions, verification)
  • Supply-chain control program (hazard analysis and preventive controls for raw material receiving from suppliers and brokers)
  • Recall plan

7. FSMA rule: Voluntary qualified importer program (VQIP)

The VQIP is a fee-based program provided by the FDA FSMA to foreign food facilities that intend to import their products to the country. The main purpose of this FSMA rule is to speed up the process of inspection and evaluation of their products whether intended for human or for animal consumption.

Requirements for safe food certifications under the VQIP ensure that the importer adheres to the food safety regulations of the country. This also assures the consumers that the imported products have passed the local food safety regulatory requirements.

We at FoodDocs have taken all of the considerations and regulations in complying with the FSMA law and have built our own system to help you build your own Food Safety Management System. We guide and show you how food safety management can be an effective way to increase consumer loyalty by trying our 14-day free trial.

In addition to this, we can even help you build your own HACCP plan by using our built-in HACCP plan builder. By answering just a few straightforward questions, we will build a HACCP plan that is fit for your business in just 1 hour. You can manage the suggested plan yourself and make it more accustomed to your business.


new FSMA regulations


New FSMA regulations

In addition to the 7 major FDA FSMA regulations, the food agency has also amended some of the preexisting regulations to strengthen their food safety regulation aspect. Included in these related programs are proposed new federal food safety laws that are undergoing discussions and reviews by the related government agencies. Currently, some of the proposed food regulations in this list are yet to be approved to take effect.

Food Traceability program (Proposed)

This proposed FSMA rule serves as an additional requirement to the previously established traceability program of the FDA. This amendment is considered as one of the key requirements of the FDA's New Era of Smarter Food Safety Blueprint. It aims to devise a way to easily track down recipients of contaminated products and effectively mitigate the chances of an outbreak. 

The center of this amendment is the required establishment of records containing Key Data Elements associated with different Critical Tracking events analyzed by the FDA. Manufacturers who process and handle foods under the Food Traceability List (FTL) are required to comply with this rule. The FTL is a peer-reviewed list of high-risk foods and was generated by a risk-ranking model developed by the FDA.

The list of foods was generated from a model which counted the frequency of outbreaks, the severity of potential illnesses, the likelihood of contamination, and other hazard-based criteria. Never worry about traceability issues by allowing us at FoodDocs to help you with your Food Safety Management System in preparation for this proposed rule.

Laboratory accreditation (Proposed)

Among the FSMA regulations, a new proposal that aims to establish a program for the microbial and chemical testing of foods by laboratories is being developed. Once approved, the rule will require food analysis to be conducted by laboratories that have voluntarily applied for accreditation.

Laboratories accredited under this program will be given the authority to give evidence in cases of questionable food items, analyze food items under suspicion of a food safety hazard, respond to food testing orders by the FDA, and address any identified import alert related to food safety.

Registration of food facilities (Final rule)

This final FDA FSMA rule is an amendment to a preexisting rule on the food safety requirements for food processing facilities registration. It aims to collect more information and build a more accurate registration base for food companies reporting under the FDA. 

Some of the notable revisions include requiring an email address for registration, a mandatory renewal of your processing facility registration every two years, and giving the FDA absolute permission to conduct an inspection as stated by the guidelines of the Federal Food, Drug, and Cosmetic Act.

Record availability requirements

The purpose of this final FSMA rule is to expand the access of the FDA to records related to foods that have shown a reasonable possibility of food safety risks. In addition, the FDA is also granted access to the records of other food products from a single company that they believe has the possibility of having the same potential risk.  

Information required in prior notice of imported foods

Under this final rule, importers of human and animal food are required to submit additional requirements which will serve as prior notice. The notice will include information if the product has been previously refused entry by a different country and requires the importer to declare this country. The rule strengthens the FDA's resolve to address any potential food safety risks even before they happen. In this case, even before they enter the country. 

Criteria to order administrative detention of human and animal foods

The approval of this final rule has given the FDA stronger authority to recall, detain, and analyze any food article that has shown even just a slight potential of having food safety hazards. Reasons for recall may be signs of adulteration or misbranding.


FSMA regulations compliance in no time

Compliance with all FSMA regulations is generally based on a good food safety management system and a comprehensive HACCP food safety plan. 

At FoodDocs, we can help you build a solid food safety management system for your food business. Get up-to-date solutions for any food safety issues in your manufacturing process from our expert software and comply with FSMA regulations in no time. Our food safety management system is built through the experiences and inputs of food business experts and powerful machine-learning software. Implementing your food safety management system can be done in just 1 hour by using our system and our customer service can help you through every step.

Our HACCP food safety plan builder can also help you build one for your company in just one hour. Our system tailors all analyses, corrective actions, critical control points, and monitoring forms based on your food business. If you ever see anything that you want to change, our HACCP plans can be even edited to fit your company requirements. Make your own monitoring forms and other important documents related to food safety through our services.

Hesitant to start your food safety journey? Test our services with our 14-day free trial.




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