Food safety

FSMA: What is it and who has to comply with it?

The FSMA aims to shift the focus of manufacturers and governing agencies toward the prevention of foodborne illnesses ...

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The FSMA aims to shift the focus of manufacturers and governing agencies toward the prevention of foodborne illnesses rather than addressing them as they occur.

  • The FSMA rules apply to all food businesses reporting under the FDA.
  • Non-compliance to the provided rules may put the safety and intent of consumers at risk.
  • The FSMA emphasizes the need to develop comprehensive, science-based preventive controls and create a food safety program to reduce risks in food safety.


Foodborne illness outbreaks are key determinants that 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. The law acts as guidance for industry practices.

Cases of contamination and foodborne diseases are tell-tale signs of bad food safety processes or breaches of safety protocols. These issues in food safety and non-compliance with food laws burden the food industry. They 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.
The FSMA was signed into law as a science-based mitigation strategy in 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.
In the United States alone, the Centers for Diseases Control has estimated that at least 48 million people are afflicted with foodborne illnesses, of which 3,000 of these people die. These food safety statistics mean 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 human pathogens include Norovirus, Salmonella, Campylobacter, Clostridium, and Staphylococcus aureus.

In this article, we will give you the most important details related to FSMA. We also introduce our HACCP-based digital Food Safety Management System that you can use to comply with all the major FSMA rules.



What is the Food Safety Modernization Act (FSMA)?

The FDA Food Safety Modernization Act (FSMA) is the US government's attempt to reform the food safety approach of industries in the United States. The law is composed of several sections that address the different concerns of each sector in the food industry. It aims to minimize the potential impacts of foodborne illnesses and protect the economic well-being of the nation's food system.

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 includes the whole supply chain. It aims to emphasize that food safety is an important element of running a business.

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 production and supply to the distribution of products.


The critical 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 (FSMS) in your company. We will help you understand and implement top-quality FSMS guidelines and give you an overview of what FSMA compliance is. We will help you get food safety certifications with minimum effort.




The main aim of FSMA is to shift the focus of manufacturers and governing agencies toward 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 facilities and local suppliers to follow food safety regulations set out by the FDA. 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 for businesses operating and those with transactions in the country. 

With exemptions to some industries, FSMA compliance requires all food processors to create a risk-based hazard analysis program. 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 departments of health and human services to create regulations on the safe harvesting and handling of raw materials, importation of foods, and increased inspections.

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.


What is the purpose of FSMA? 

The FSMA's main purpose is to secure a safe food supply, including animal feed. The law's main method is shifting the focus of the U.S. food industry and government inspectors from a reactive stance to a proactive one. The law established food safety measures and requirements for facilities under the jurisdiction of the US FDA.


Food Safety Modernization Act summary

This law emphasizes 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 and 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 control strategies for hazards and potential vulnerabilities. The Food Safety Modernization Act also includes a 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 with the FDA. It also means complying with the rules they set out and submitting 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 Software is a tool for all your food safety needs. We can help you build a comprehensive food safety plan and a food safety management system, including all the previously mentioned documents. 

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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 for consumption that has questionable integrity and may pose a 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. 


When was the FSMA established?

The FSMA was signed into law by former U.S. President Barrack Obama in 2011. The law and its many rules were not finalized until after several years of signing. 

To date, some of the rules under the FSMA are still being finalized. The FSMA law is continuously undergoing constant improvements. 


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 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 facilities and foreign food establishments that have transactions with the country must comply with the FSMA. Food industries dealing with fresh produce, such as meat, dairy products, and poultry, that are under the USDA are not included in the provisions of the FSMA. Basically, if you are a commercial farm owner in the food packaging 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 exemptionfor certain types of food. Under the law, farms and food producers dealing with raw agricultural commodities and 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 businesses - food production companies that gain less than $1 million per year within a three-year period before the applicable calendar year for annual sales of human food.
  • 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.


What are the 7 rules of FSMA?

In this section, we discuss the 7 rules of FSMA:

  1. Produce safety rule
  2. Foreign supplier verification programs (FSVP)
  3. Sanitary Transportation Rule
  4. Protection Against Intentional Adulteration
  5. Accredited Third-Party Certification
  6. Preventive Control Rule for Human and Animal Food
  7. Voluntary Qualified Importer Program (VQIP)

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 rule

This safety-produce rule states that science-based minimum standards for food safety will be set for food safety practices, including farm manufacturing, growing, harvesting, post-harvest controls, and holding of produce for human consumption. Products include fruits and vegetables grown for human consumption at the farm level.

The FDA rule requires farms to perform an initial survey on their own farm practices and material sources.

  • Microbiological count as an indication of agricultural water quality at the farm level (especially for the presence of E.coli).
  • Standard irrigation water testing procedure (for surface and ground water). Agricultural water standards include specifications for sprout irrigation water. The FDA requires any farm that uses untreated ground water to submit samples for testing.
  • Standards for application and microbial count of raw manure and compost or any biological soil amendments of animal origin on the 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.

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 food safety training.

While the agency provides educational programs on FSMA rules, the responsibility of training employees on food safetyis a major job for business owners.


2. Foreign supplier verification programs (FSVP) 

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. 

The Foreign Supplier Verification Program rule regulates the possibilities of hazards from adulteration and misbranding, such as the undeclared presence of allergens. Some of the specific scopes and enforcement actions of this FSMA regulation include:

  • The FSVP food supplier and importer must have a plan of risk-based preventive controls concerned with the analysis of hazards 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. Sanitary Transportation of Human and Animal Food Rule

This rule under the Food Safety Modernization Act aims to prevent food safety issues concerning improper sanitary conditions during transport. It emphasizes the protection of food during transportation against contamination or spoiling while in transit. Some provisions include applicable requirements for food refrigeration, sanitation of vehicle and food contact surfaces 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.

This rule applies to logistics operations, including carriers by motor or rail vehicles as well as the receivers of food products. 

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 and have working temperature controls.
  • Implement proper conditions for food during transportation, including temperature controls, prevention of cross-contamination between raw and ready-to-eat food products, 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.

In addition, compliance with basic food safety practices, such as the current Good Manufacturing Practices (cGMP) for covered facilities, 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 policy.

All company employees are mandated to be oriented and familiarized with FSMA preventive controls requirements. This includes allergen management requirements and cross - contact issues to prevent the risk of food allergy. The law mandates businesses to agree to the significant authority of the FDA to suspend operations once transportation of food under conditions that are unsafe for humans is reported.


4. Protection Against Intentional Adulteration

The FSMA has considered acts of terrorism concerning adulterated food. Unfavorable personnel 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 mitigation strategies on how to prevent acts of terrorism and evaluate vulnerable points of the food processing line.

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 applies 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 and procedures for Food Defense 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 food defense 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 the food defense plan.

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

This rule aims to establish volunteer third-party certification bodies to monitor and evaluate foreign firms. Once certified, auditors and subject matter experts 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.

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

  • Evaluate the third-party certification bodies for direct accreditation,
  • Monitor the 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

This rule, as stated by the FDA, contains competency, capacity, conflict-of-interest safeguards, and legal authority as applicable requirements for accreditation.

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 foreign governments.


6. Preventive Controls Rule for Human and Animal Food

The FSMA regulation on preventive control requirements applies to both foods for human and animal consumption. This federal 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 health and food safety control, FSMA regulations and enforcement policy 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 (supplier verification activities, such as hazard analysis and preventive controls for raw material receiving from suppliers and brokers)
  • Recall plan


7. 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 federal regulations in complying with the FSMA law and have created a system to help you build your own digital 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 digital 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.



What are the possible consequences of FSMA non-compliance?

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:

In cases of detection of adulteration in articles of food, food recall activities are rightfully issued by the FDA. Non-compliance with 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 physical locations and reevaluation of guidance 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 with recalling 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 case can also lead to temporary restrictions on 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.


Updates on the FSMA regulations

In this section, we discuss some of the other regulations included in the FSMA:

  1. Food Traceability program (Final rule)

  2. Laboratory accreditation (Final rule)

  3. Registration of food facilities (Final rule)

  4. Record availability requirements

  5. Information required in prior notice of imported foods

  6. Criteria to order administrative detention of human and animal foods

In addition to the 7 major FDA FSMA regulations, the regulatory agency has also amended some of the preexisting regulations to strengthen its 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 and health departments. Currently, some of the proposed food regulations in this list are yet to be approved to take effect.

Food Traceability program (Final rule)

The temporary policy on food traceability was approved in November 2022. This FSMA rule serves as an additional requirement to the previously established traceability program of the FDA. This amendment is considered 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 additional recordkeeping requirement for 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 (Final rule)

Among the FSMA regulations, this rule aims to establish a program for the microbial and chemical testing of foods by laboratories. The rule will require food analysis to be conducted by laboratories that have voluntarily applied for evaluation by accreditation bodies.

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 articlethat has shown even just a slight potential of having food safety hazards. Reasons for recall may be signs of adulteration or misbranding.

More detailed information on the FSMA Rules, including final compliance dates and enforcement action, is available on the FDA central source website.


FSMA compliance checklist

Inspection by the FDA can come at any time. This fact means that your business must have a solid and working food safety system at all times. Your food safety plan must have a proactive approach to tackle potential food hazards.

For your food business to ensure FSMA compliance, a set of documented processes are needed to be prepared. An established food safety plan contains elements consisting of identified food safety hazards, activities that ensure food safety, corrective and recall plans, and others.


Below, we give you a checklist of what you need to comply with the FSMA:

  • Food safety plan - FSMA compliance requires your business to create a product and facility plan, which includes hazard identification, established critical control points, and specifications. This plan includes information about your product, such as its intended use and ingredients.

Hazards are properly identified as a result of raw materials, manufacturing practices, sanitation controls for food contact surfaces, and equipment maintenance procedures. Your food safety plan must also include a proper risk assessment to determine the severity of the identified hazards.

  • Preventive and corrective controls - identified and analyzed hazards must also be accompanied by a set of preventive controls to control them. FSMA compliance requires more than the usual preventive controls for critical control points. Under the FSMA ruling, preventive controls for processes, supply chains, allergens, sanitation procedures, and recall procedures are also required.
  • Supply chain program - under the FSMA, your company is also required to ensure that the suppliers you are dealing with apply equally strict food safety plans. Your suppliers are required to submit proof that they conduct a proper hazard analysis and apply adequate preventive controls. They must secure supply chain program requirements and co-manufacturer supplier approval documents.
  • Recall plan - to maintain the high integrity of your food safety plan, a well-structured recall strategy is required. This plan will contribute to FSMA compliance by presenting steps on how to address and perform recalls by the responsible party.

Steps may include notification of consignees of the article of food in question, potential directives on how to dispose or return contaminated food, notifying the public about the potential leak of contaminated products, and verifying the effectiveness of the plan. The plan must be set to immediately control the further release of the food products in question and quickly retrieve batches that are already circulating the market.

  • Traceability system - This program will allow food business owners to keep track of their material and product's movement throughout the supply chain. It is based on the additional recordkeeping requirements of the new FSMA FDA rule The system must be able to capture information about the product, such as the formulation or recipe used, production batch number, the quantity of the batch, destination, and maximum shelf-life.
  • Monitoring and verification procedures - to provide proof that the current FSMA food safety plan implemented on your business is effective, records of monitoring and verification are needed. Reports, records, and forms on tracking the progress and application of the food safety plan must always be ready in case of an audit of company practices.

This checklist only proves that FSMA compliance requires your business and all personnel to have all of their hands on deck and participate in making a well-rounded food safety plan. This also tells you that a ton of paperwork needs to be compiled and filed, let alone all the information on the FSMA compliance you have to familiarize yourself with.

We bring you the most recent innovation for food safety management systems compliance. Powered by the knowledge of several food safety experts stored in our software and equipped with established tools for making a food safety plan, we can do the work for you in just 1 hour. We can provide food safety plans for all types of food businesses, most especially one that will suit yours.

In addition to a food safety plan, you can easily tick off all the boxes in this checklist with our digital software. Using our HACCP-based digital Food Safety Management System, you can get a recipe management, traceability system, recall program, and monitoring system in one software

We will help you get ready for an audit at any time by tracking all of your progress on food safety activities. It even helps you monitor your business activities in just one place.



FSMA compliance statement

Once your food business has ticked most of the boxes in your FSMA compliance checklist, your business is required to create an FSMA compliance statement. This document states which conditions and rules of the FSMA have your company already complied with.

The FSMA compliance statement is used to list which of the seven major rules and related programs your business is compliant with. Along with the rules are the compliance dates when your food business has fully complied. It must also contain which among the food safety plan checklist you have fulfilled (e.g., hazard analysis, preventive controls, recall plan, etc.).

This in-house document does not have to be too technical, but it must be forwarded if asked as proof of your FSMA compliance. Your FSMA compliance statement is somehow similar to what the Preparedness and Response Act of 2002 (Bioterrorism Law) requires you to provide your customers. Upon request or delivery of some products, this document must be provided.


FSMA training

In line with the FDA's objective to transform the nation's food safety system, the agency initiated extensive partnerships with related government and private organizations. The partnerships mainly aimed to create training programs for food business owners and food producers to help them comply with the FSMA requirements. 

While it is every business owner's responsibility to seek the necessary training for FSMA, the FDA and its partner organizations launched training opportunities for farm operators, food processors, retail merchants, and wholesalers. 

The Food Safety Preventive Controls Alliance (FSPCA), a partner organization of the FDA, developed an educational training program for domestic and foreign food industries. The program included distance training modules with curricula that mainly involves the following:

  • preliminary steps for developing a food safety plan,
  • conducting hazard analysis and fulfilling preventive controls requirements,
  • establishing monitoring procedures for controls, verification, and corrective actions,
  • recordkeeping, and
  • regulatory requirements

The FDA is also working with corporate agreements to develop training programs fit for the other businesses in the industry. The programs aim to promote industry understanding of the law. Since 2015, the FDA has collaborated with the USDA National Institute of Food and Agriculture to provide grant programs to eligible food business owners. 

To date, the FDA and its partner organizations are providing training programs, paid and free, to help familiarize and prepare business owners with the regulatory requirements of the food law.


Who needs FSMA training?

The FSMA applies to businesses that are categorized as commercial farms, including farm packing operations and food processing facilities. Under each FSMA final rule, specific guidelines for training requirements are outlined.

At least one trained individual must be present in a food facility. In particular, every food facility is required to have a preventive controls qualified individual (PCQI). A PCQI is a trained regulatory personnel who has received training on performing risk assessments and developing a food safety plan. 

Food businesses must also note that the FDA specifically reviews the suitability of the facility's food safety plan and not the qualifications of an assigned PCQI. 


How to comply with FSMA digitally?

Foodborne illness outbreaks and their adverse health consequences 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.

Strengthening such goals, the Food Safety Modernization Act of 2011, which has been passed into law, has shifted the focus of manufacturers and the FDA toward preventing potential hazards from creating food safety concerns. To achieve FSMA compliance, it is important 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. 

Learn about food safety trends from our detailed article.

Food safety compliance using digital solutions

The US Food Safety Modernization Act focuses on food safety practices that help prevent foodborne illness outbreaks 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 Systemin your business's central location for distribution and branches as one of the many 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.


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What exactly would you get when you sign up with us?

  • Complete digital monitoring forms. The forms that our system will automatically generate for you are built based on the most important food safety documents that can help you comply with FSMA requirements. Some of these monitoring forms include the following:
    • Cooking temperature log

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Cooking temperature log from FoodDocs


    • Fridge/ Freezer temperature log
    • Master sanitation checklist


Master sanitation schedule from FoodDocs

    • Receiving chilled goods log

  • 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.

  • Every automatically generated monitoring form and checklist is equipped with detailed instructions on how to perform the tasks and monitor them. With this feature, you can ensure that every food safety task is duly followed at all times.

  • Smart notification system. Using our mobile application, your employees will get timely notifications as a reminder for food safety tasks that are due. This feature can help you ensure that no food safety task is left undone. Be audit-ready at all times.
  • Traceability system. Our smart software comes with a traceability solution that will allow your team to keep track of your product status. This system complies with the requirements for the FSMA traceability rule.



Product traceability system from FoodDocs


In addition to features that will help food employees fulfill every food safety task, our digital FSMS can also help managers improve the efficiency of their operations.

  • Real-time dashboard. Save up to 20% of your time 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.


Food safety system set up by FoodDocs


  • Production management solution. Manage production schedules in real time with our software. Digitally calculate production quantities accurately, track shelf-life, and monitor your product movement using our mobile app.
  • 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.

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 monitoring forms, traceability system, and other important food safety documents for compliance.

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



Frequently Asked Questions

The topic of FSMA is very wide and includes a lot of sub-topics. To help you understand the food safety regulation more clearly, here are some of the most frequently asked questions about FSMA.


What is the meaning of FSMA?

The term FSMA stands for Food Safety Modernization Act.


What is an FSMA food safety plan?

The FSMA food safety plan is a comprehensive document that consists of preventive controls and a systematic approach for identifying and analyzing food safety hazards. The plan is established to minimize the likelihood of causing foodborne illnesses as a result of consuming your products.


What is the FSMA rule?

The main objective of the FDA FSMA is to shift the focus of the nation's food industry into preventing foodborne illnesses rather than responding to them as they occur.


Is FSMA mandatory to comply with?

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.


What's the difference between HACCP and FSMA?

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 part of 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.


What are the FDA seven major rules to implement FDA?

The seven major rules of the FDA FSMA include the following:

  1. Produce safety rule
  2. Foreign supplier verification program (FSVP)
  3. Sanitary Transportation Rule
  4. Protection Against Intentional Adulteration
  5. Accredited Third-Party Certification
  6. Preventive Control Rule for Human and Animal Food
  7. Voluntary Qualified Importer Program (VQIP)


Who is complying with FSMA preventive controls for human food?

All responsible parties and food businesses registered under the FDA are required to have a food safety plan that is based on the requirements of the preventive controls rule for human food.


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 human health goals for the restaurant industry.


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:

  1. Preventive controls
  2. Stepped-up FDA inspections
  3. Regulation of importation
  4. The more stringent response towards non-compliance
  5. Stronger collaborations and agreements with food industry associations and food safety agencies


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. Qualified facilities handling this food group are regulated by the enforcement discretion of 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.


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.


What is FSMA certification?

The Accredited Third-Party Certification Rule provides a voluntary program for evaluating and recognizing entities that will conduct third-party certification for foreign facilities. The FSMA certification program aims to ensure the competency of the accredited third-party auditors under the program.



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