The FSMA regulates food production and manufacturing processes within the US food supply chain to prevent food safety issues. This article provides an overview of employer responsibilities for complying with this law.
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The Food Safety Modernization Act (FSMA) protects food supply chain safety and places significant requirements on businesses in the food industry. The FSMA is important, but its regulations can be tricky to understand.
Putting these regulations into practice can feel like a significant administrative burden for your business. However, failing to comply can lead to public health dangers and even a complete business shutdown.
In this article, we explore the importance of the FSMA and its impact on employers. This primer will prepare you to tackle FSMA compliance in your business—from helping you identify hazards to providing guidance on training employees.
Key Takeaways
- The FSMA, meaning the Food Safety Modernization Act, regulates food production and manufacturing processes within the United States’ food supply chain.
- The FSMA requires businesses to evaluate their operations for potential hazards and establish proactive measures for preventing contamination.
- Employers are responsible for establishing robust employee training and choosing trained specialists to monitor safety protocols.
- Failing to comply with the FSMA can lead to fines, government interventions, or mandatory business shutdowns.
FSMA History
The FSMA was signed into law in 2011, marking an important milestone in the United States’ commitment to food supply safety.
Before its enactment, food safety regulations in the US were primarily reactive. They tended to focus on responding to foodborne illness or contamination outbreaks after they’d already occurred.
Several news-making outbreaks between 2006 and 2009, including E. coli in fresh spinach and a nationwide Salmonella outbreak, highlighted the need for stronger food safety measures. Meanwhile, advancements in science and technology made identifying and preventing contamination easier and consumer demands pushed for government action.
FSMA Key Objectives
The FSMA was designed to prevent food safety issues proactively. It introduced several key objectives in its final rules to achieve this goal. These include:
Preventive controls
The FSMA requires food producers and manufacturers to implement preventive controls to proactively identify and prevent hazards. Covered businesses must identify potential hazards in their processes, establish measures to prevent them, and regularly verify the effectiveness of the measures.
Inspection requirements
The US Food and Drug Administration (FDA) enforces the FSMA and has the authority to inspect and monitor businesses for compliance with the law.
Import regulations
The FSMA created stricter oversight of imported foods. Importers must address potential risks associated with imported products and verify that foreign suppliers meet US safety standards.
Enhanced traceability
Under the food traceability final rule, FSMA 204, covered businesses must maintain enhanced records for any food on the Food Traceability List (FTL). These records must trace food products and their ingredients.
Businesses must share key data elements (KDEs)—which outline details from these records—with other suppliers at certain stages in the supply chain, called critical tracking events (CTEs).
Businesses have until January 20, 2026, to comply with this rule.
Risk-based approach
The FSMA recognizes that not all foods pose the same level of risk and imposes greater requirements on high-risk foods and facilities. For example, raw produce farms and foods linked to several foodborne illnesses are subject to greater scrutiny.
Who does FSMA apply to?
The FSMA applies across the food supply chain and encompasses a wide range of businesses, including:
Food manufacturers
This category includes businesses involved in the processing and manufacturing of food products. When you process food for human or animal consumption, FSMA applies to you—whether you produce canned goods, baked goods, dairy products, or anything in between.
Produce farmers
The FSMA includes regulations tailored to farms and facilities that grow and handle fresh produce. Even if you’re a small family farm, you may still have FSMA compliance requirements. The FSMA doesn’t apply to farming practices for meat, poultry, or dairy products, though these are subject to other regulations.
Importers
When you import food products into the US, you’re subject to FSMA’s Foreign Supplier Verification Program (FSVP). This places the responsibility on importers to ensure the safety of the food they bring into the country.
Distributors and transporters
Entities involved in distributing and transporting food products must also adhere to certain FSMA requirements to prevent contamination during transit.
Storage facilities
Facilities and warehouses that store and handle food products must implement preventive controls and meet FSMA standards.
🧠 Did You Know?
The FSMA doesn’t apply directly to food retailers or restaurants. However, food retailers should verify that their suppliers follow FSMA requirements. Restaurants should also follow robust food safety practices to protect their customers and their own reputation.
Overview of Employer Responsibilities
Employers covered by the FSMA must ensure their businesses follow safety protocols correctly. Follow these steps to ensure your business is compliant.
Hazard analysis
You must conduct a thorough hazard analysis to identify potential biological, chemical, or physical hazards associated with your food products and operations. For instance, you must identify any part of your operation that could be contaminated with bacteria or at risk for broken machinery damage. A refrigeration unit that isn’t maintaining the proper temperature, for example, could pose a biological risk.
Preventive controls
Based on the hazard analysis, you’re required to establish preventive controls to minimize or eliminate the identified hazards. For example, you may need to implement process adjustments or revise sanitation procedures. Should a hazard analysis reveal potential chemical contamination from cleaning agents, for instance, you might introduce a procedure to ensure thorough rinsing after cleaning.
Monitoring and verification
Review preventive controls regularly to ensure they’re working effectively. The FSMA requires that you establish monitoring procedures, maintain records of monitoring activities, and verify that your employees follow preventive controls consistently.
🧠 Did You Know?
Checklists are a great way to verify that your employees are following preventive controls. Connecteam lets you create and share digital checklists and other forms with ease. You can even require eSignatures from your employees to increase accountability. Geolocation ensures that your employees fill out forms and check off items when they’re onsite.
Recordkeeping
You must maintain detailed records of your food safety plans, monitoring activities, verification results, and other relevant documentation. Accurate recordkeeping is essential for demonstrating compliance with FSMA.
🧠Did You Know?
Connecteam offers unlimited document storage, so you can easily save all FSMA records, including food safety plans.
Supplier verification (for importers)
Importers must verify that foreign suppliers meet US food safety standards. This involves conducting risk assessments, obtaining documentation, and ensuring that imported food meets US safety requirements.
Employee training
Your employees must receive appropriate training in your food safety system and practices. A key component of employee training is ensuring they understand their roles in preventing contamination.
🧠 Did You Know?
Connecteam lets you build training courses on any topic. Customize food safety training to meet your business’s needs, and quiz your employees to ensure they’ve retained your FSMA protocols.
Compliance with specific rules
Depending on your business type, you may need to comply with specific FSMA rules, such as the Preventive Controls for Human Food, Preventive Controls for Animal Food, or Produce Safety rules.
However, FSMA compliance is not a one-size-fits-all endeavor. The specific requirements and steps you must take can vary depending on your role in the food supply chain and the type of food products you handle. So, do your research and consult with food safety experts if necessary.
FSMA Training Requirements
One of the cornerstones of the FSMA is the emphasis on training and education. Ensuring all employees receive proper training is essential for ensuring compliance and food safety.
Who Needs FSMA Training?
You must tailor FSMA training to your business. Specific training requirements can vary depending on the type of business, the roles of employees, and the nature of the products your business handles.
That said, you can get started by training these key groups:
Preventive Controls Qualified Individuals (PCQIs)
PCQIs are the individuals responsible for developing and overseeing the food safety plan. Their role includes conducting hazard analyses and determining preventive controls.
Any employee can become a PCQI, but they must complete a specialized, FDA-recognized training course to gain FSMA certification.
Frontline employees
All employees involved in food production, handling, or distribution should receive basic training on food safety principles and practices. This training ensures everyone in the workplace adheres to proper food safety protocols.
🧠 Did You Know?
Manufacturing employers can manage their workforce and production processes easily and efficiently using Connecteam. With Connecteam, you can store FSMA protocols in a single, secure place and share them directly with workers. You can also train staff on current FSMA safety and compliance standards and monitor their progress in real time.
Importers
Most businesses that import goods are subject to the Foreign Supplier Verification Program (FSVP). FSVP importers must have staff with specialized knowledge and training.
As an employer, you’re required to have qualified individuals who understand FSMA requirements and can verify that foreign suppliers meet US safety standards.
Farm workers
Workers on farms and facilities covered by the Produce Safety Rule should receive training on topics like hygiene, sanitation, and safe practices for growing and harvesting produce.
Transportation personnel
Those involved in transporting food products must receive training on sanitary transportation practices. This training should emphasize processes to prevent contamination during transit.
FSMA Training Topics
General FSMA training covers a range of topics that are critical for ensuring food safety. These topics typically include:
- Basic food safety principles. Employees who handle food must learn fundamental concepts like handwashing, sanitation, and cross-contamination prevention.
- Hazard analysis and preventive controls. Your PCQIs need detailed training on identifying and mitigating potential hazards in the food production process. Accredited, FDA-recognized training is required for FSMA compliance.
- Recordkeeping. You must train any employee who creates, modifies, or maintains your records to ensure the appropriate management of records. Records required by the FSMA include proper documentation of food safety plans, monitoring activities, and verification results.
- Supplier verification. Businesses that import food products must train employees to verify the safety of foreign suppliers and their products.
FSMA Challenges and Common Mistakes
Complying with the FSMA presents several challenges for business owners. Let’s consider some common mistakes that can lead to compliance failures in your business—and solutions to each.
Mistake: Sloppy hazard analysis
One of the most common mistakes is conducting a superficial hazard analysis or failing to identify all potential hazards in the food production process. This oversight can lead to inadequate preventive controls that lead to damaging results like contamination.
Solution: Invest time and resources into your process
Take the time to conduct a comprehensive hazard analysis. Engage with food safety experts, if needed, to identify all potential hazards, and prioritize preventive measures accordingly.
This will keep you compliant with the FSMA’s proactive requirements. Plus, should an unexpected problem arise, you’ll be able to show it wasn’t due to a lack of diligence on your part.
Mistake: Not verifying your preventive controls
You must design preventive controls effectively to limit the potential for hazards. Your hazard analysis should identify the hazard risks in your operation. Preventive controls are effective only if they actually address and prevent the identified hazards.
Solution: Thoughtful implementation and regular review of preventive controls
Work through your hazard analysis methodically and ensure you’ve implemented preventive controls that address every hazard. Each preventive control needs to be well-documented and communicated to employees. Also, review your measures regularly to ensure your employees follow preventive control processes.
Mistake: Insufficient employee training
Poor training is a major risk for your business. It can result in employees who are unaware of proper procedures and more likely to make mistakes that could compromise food safety.
Solution: Up-to-date, effectively communicated employee training
Invest in employee training that ensures all your employees are clear on food safety processes.
Ensure your frontline employees have easy access to preventive control processes and safety details to reinforce their learning. In addition, regularly update training materials to keep employees informed about the latest standards and procedures.
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Check out our guides on 10 ways to foster workplace compliance and the best tools to use for compliance training.
Mistake: Neglecting records and documentation
Proper recordkeeping is a fundamental aspect of FSMA compliance. Failing to maintain accurate records of hazard analysis, preventive controls, and verification activities can lead to major compliance issues. These are straightforward violations that will land your business in a heap of trouble. You might also need to adhere to additional recordkeeping requirements if your business handles high-risk foods, like raw produce.
Solution: Establish a robust recordkeeping system
The goal of your recordkeeping system should be to track all relevant information accurately. Recordkeeping requirements vary based on business type, but they should at least include your hazard analysis, preventive controls, and food safety plans for the past 2 years. The FSMA allows digital recordkeeping, which can streamline your recordkeeping system.
Mistake: Not monitoring import suppliers
Ensuring the safety of imported products can be challenging, especially if foreign suppliers don’t meet US standards. However, struggling to verify your suppliers isn’t a valid defense for importing products that you should exclude under FSMA requirements.
Solution: Develop supplier relationships and audit for compliance
Develop strong relationships with suppliers and clearly communicate your expectations regarding food safety standards. Consider third-party audits of foreign suppliers to ensure compliance, especially if you’re not confident in your ability to monitor the imports yourself.
Mistake: Avoiding steps to save on costs
Complying with FSMA can be costly, particularly for small and medium-sized businesses. You have to invest in equipment, training, and recordkeeping systems, which can strain resources. You might be tempted to skip steps to avoid costs, but this is inadvisable.
Failing to comply could result in serious action by the FDA, including shutting down your operations. Even minor violations could result in damage to your business reputation and costly corrections.
Solution: Adopt cost-effective solutions
While compliance is never free, it’s possible to adopt cost-effective solutions that will ensure your business does its part to protect the food supply chain.
Consider adopting digital tools that streamline training, recordkeeping, and employee communication. The savings on previously time-consuming administration can go a long way to lowering your compliance costs.
🧠 Did You Know?
Connecteam can streamline your recordkeeping, support efficient employee training, and keep all your employees in the loop on food safety practices. With the right tools at your disposal, FSMA compliance becomes a lot less intimidating. Get started with Connecteam for free today to see how your business can benefit.
The Bottom Line on FSMA Compliance
FSMA compliance is vital for safeguarding the country’s food supply chain and public health. Yet, navigating the complexities of these regulations can be challenging. The stakes are high, as non-compliance can lead to serious consequences, including business shutdowns.
By understanding your responsibilities, effectively training your employees, and avoiding common mistakes, you can reduce the risk of non-compliance and keep your consumers and your business safe.
Get started with Connecteam for free today!
Disclaimer
The information presented on this website about the Food Safety Modernization Act in the United States is intended to be accurate and informative. However, laws and regulations can change and may vary depending on individual circumstances. While we have made every effort to ensure the information provided is up to date and reliable, we cannot guarantee its completeness or accuracy. Therefore, we strongly recommend that readers seek guidance from their legal department or a qualified attorney to ensure compliance with applicable laws and regulations. Please note that we cannot be held liable for any actions taken or not taken based on the information presented on this website.