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The Food Safety Modernization Act (FSMA) refers to the food production and processing regulations that came into effect on June 4, 2011. FSMA aims to bolster the US food safety system through prevention, surveillance, and enhanced response and recovery. The act empowers the Food and Drug Administration (FDA) to enforce its many provisions, among them fines and recalls for non-complying industry players.

What is the Food Safety Modernization Act?

The food safety act extends the FDA’s regulatory powers to protect public health and strengthen food safety systems. Under FSMA, the FDA can effectively conduct in-depth surveillance and track foodborne illness outbreaks. FSMA establishes preventive controls and food safety requirements for farms and food processing facilities as the final rule. 

What is FSMA?

The US Congress enacted FSMA to reverse the alarming trends of food contamination and the spread of foodborne illness. The act transforms the nation’s food chain system from reactionary to preventive when it comes to food contamination.

Food Safety Plan FSMA: The 7 Foundational Rules

Listed below are the 7 fundamental principles that FSMA compliance entails. 

  1. Protective controls for human food
  2. Protective controls for animal food
  3. Produce Safety
  4. Foreign supplier standards
  5. Third-party certification
  6. Sanitary transportation
  7. Intentional adulteration

What Does FSMA Stand For?

FSMA stands for the Food Safety Modernization Act (FSMA). It is a set of new laws enacted under President Barack Obama in 2011 that enlarge the scope of the FDA to cover food safety oversight and regulation.

Food Safety Modernization Act Controversy

While trade and public health organizations in the United States are in full support of the FMSA, it wasn’t received warmly by farms and small businesses in the food and beverage industry. 

The controversy with FSMA relates to the exemption granted to small scale producers, as dissenting voices say that consumers could still be at risk.  The FDA is also yet to issue guidelines on science-based produce standards and foreign supplier verification rule requirements.

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What is FSMA compliance?

Every manufacturer, processor, or packer of food for consumption in the US is required to adhere to the new FDA Food Safety Modernization Act guidelines. FMSA empowers FDA to revoke registrations for companies that fail to comply with the food safety standards. FSMA compliance is about the implementation of the food safety requirements, and the testing and documentation of the effectiveness of your control measures.

Preventive Controls for FDA Food Safety Modernization

These are detailed in section 103 of the FSMA act. Every registered facility needs to conduct hazard evaluations to identify known and foreseeable hazards for FSMA assurance. These include chemical, physical, biological, and radiological hazards, pesticides, toxins, decomposition, and other risks to food safety. 

After inspection, you are required to implement risk-based preventive controls to minimize the identified hazards and ensuring the safety of end consumers.

FSMA implementation measures, in this case, would include:

  • Proper sanitation
  • Environmental controls
  • Adherence to FSMA 21 CFR part 117 good manufacturing practices
  • Recall contingency plan
  • Supplier verification activities
  • Staff training
  • Allergen control
  • Process control (cooking, refrigeration or acidifying foods)

An FSMA compliant company needs to monitor hazards, implement corrective measures, and test to ensure that the preventive controls are working efficiently. The performance of your preventive controls needs to be documented in writing and made available to the FDA when they come to inspect your facility.

Produce Safety

The FSMA produce safety rule guides on the safe growing and harvesting of human and animal food. Produce safety FSMA compliance requirements include:

The agricultural water used in the growing crops should have no detectable E-coli. The same applies to water that comes into contact with food during and after harvest.

There needs to be a 120-day interval between the application of raw manure and harvesting to minimize the likelihood of contamination.

Untreated biological soil amendments of animal origin should be applied in a way that minimizes contact with covered produce during and after application.

The FSMA law requires farmers to prevent the introduction of hazardous microbes on the seeds used for sprouting.

Intentional Adulteration

Sections 106 and 420 of the Food Safety Modernization Act (FSMA) require that you identify and protect against hazards that could be intentionally introduced in your food manufacturing processes. These include acts of terrorism. The IA rule requires you to have a food defense plan. An FSMA food defense plan entails:

  • Vulnerability assessments
  • Preventive strategies
  • Food defense monitoring, corrective actions, and verification
  • Personnel training
  • Maintaining records of testing, instances of non-compliance to preventive controls rules and the corrective measures taken to ensure food safety

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Sanitary Transportation

The FSMA sanitary transportation rule aims to safeguard food from harm and contamination during transportation. The FSMA regulations target notorious unsafe practices such as improper refrigeration of food and inadequate cleaning of trucks between loads.

  • Your vehicle should be cleanable and capable of maintaining the right temperature for food safety
  • You will need to take transportation measures such as proper temperature controls, separation of ready to eat from raw food and prevention of cross-contact contamination 
  • Transportation personnel training
  • Record keeping of all the above measures and their effectiveness

Third-Party Certification

Through the FSMA certification program, the FDA endorses accreditation bodies responsible for conducting food safety tests and issuing certifications to foreign food facilities.

What is FSMA certification?

The FSMA certification can serve as a mark for eligibility into the Voluntary Qualified Importer Program (VQIP). The latter offers industry players quick entry of food. In some cases, the FDA may demand that the suppliers be FSMA certified to keep harmful foods from entering the US.

Foreign Supplier Verification

If you import food products, the FSMA act requires that you perform due diligence to ensure that food imported into the US meets the FDA’s safety standards. Essential FSMA compliance requirements in this case include:

  • Identifying known and foreseeable hazards in each food item
  • Assessing the risk posed by contaminated food
  • Using the above analyses to choose the right suppliers
  • Implementing additional supplier verification measures and corrective actions
  • Conducting hazards analysis on the supplier’s food process from farm to storage and distribution
  • Review supplier’s food safety records

FSMA Checklist

In summary, your FSMA compliance measures should entail:

  • Hazard analysis and risk-based preventive controls
  • Good manufacturing practices
  • Decontamination standards and plans
  • Process controls
  • Food allergen controls
  • Sanitation controls
  • Supplier verification

What is Food Safety Modernization Act? Achieving FDA FSMA Compliance

Food supply chains can be complex and difficult to track with manual processes. An ERP system for food manufacturers can help bring visibility at each stage of the supply chain and thereby attain cost-effective Food Safety Modernization Act Compliance

IFS, for example, is a robust ERP software that’s proven to drive FSMA compliance. Its features include hazard analyses and vulnerability identification as well as allergen control through sequencing capabilities. 

IFS software can also help to:

  • Track food safety and quality at each handover stage
  • Provide farm to warehouse food supply traceability
  • Attain efficiency in blend operations management
  • Streamline safety incident management
  • Attain accuracy and consistency in compliance reporting and documentation

 

IFS food and beverage ERP functionality comes with capabilities to enhance operational efficiency. These include modules for logistics, order management, inventory management, and pricing, among others. The end result is both FSMA food safety compliance and a highly efficient production line.

It’s important to note that the responsibility for food safety falls on all players in the food chain from farm to table. Compliance should be a top priority as not only does it avert FDA fines, it’s an important factor for outreach and branding purposes, too. Consumers are more conscious than ever about what they eat, whether their food is sustainably-sourced, and if it’s free from allergens. 

The above FDA FSMA guidance should help you achieve expedient compliance.