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The Food Safety Modernization Act (FSMA), signed into law in 2011 through the U.S. government and enforced by the U.S. Food and Drug Administration (FDA), represents the most comprehensive overhaul of food safety statutes since the mid-1930s. FSMA's central objective is to shift the focus of food safety from reactive measures after contamination has occurred to proactive preventive controls. The FSMA aims to enhance public health by improving the safety of both human and animal food across the entire food supply chain. This blog will explore the general requirements of FSMA and their impact on the food industry.
Preventive Controls for Human and Animal Food
It is also based on preventive controls. The law requires that all registered food facilities maintain scientific, comprehensive controls over food safety hazards. Food manufacturers are obligated to:
- Develop and implement written food safety plans, including a Hazard Analysis and Risk-Based Preventive Controls (HARPC) plan.
- Identify potential hazards that can impact food safety, including biological, chemical, or physical contaminants.
- Implement preventive controls.
- Monitor the effectiveness of these controls.
- Take corrective actions when preventive controls are not successful.
Food companies must also document and maintain records demonstrating compliance with these requirements. The preventive measures outlined in the Preventive Controls Rule apply to both human food (21 CFR Part 117) and animal food (21 CFR Part 507), safeguarding all types of food from foodborne illness and other safety hazards.
Food companies must also document and maintain records demonstrating compliance with these requirements, ensuring that records are kept for a minimum of two years under FSMA regulations. The preventive measures outlined in the law apply not only to human food but also extend to animal food, safeguarding all types of food from safety hazards.
Safe Standards for Growing, Harvesting, Packing and Holding Produce
The Produce Safety Rule (21 CFR Part 112) under FSMA establishes safe practices for the growing, harvesting, packing, and holding of fruits and vegetables intended for human consumption, specifically those consumed raw. To ensure that best practices are observed, the following key areas are emphasized:
- Agricultural Water: All water used for irrigation or washing fruits and vegetables must be safe and sanitary.
- Biological Soil Amendments: Practices for manure and compost management are required to minimize contamination risks.
- Worker Hygiene: Workers must follow hygiene practices, including proper handwashing and the use of protective clothing, to prevent contamination.
- Equipment and Tools: Tools and equipment used in handling produce must be regularly cleaned and maintained.
These standards are designed to reduce the risk of contamination and foodborne illnesses at the farm level, specifically addressing the unique risks associated with fresh produce.
Foreign Supplier Verification Program (FSVP)
In light of globalization, the FSMA established a Foreign Supplier Verification Program so that imported foods comply with U.S. safety standards. Importers of food must verify that their foreign suppliers are producing food that meets similar safety standards as the domestic producers. The two fundamental elements of FSVP include:
- Hazard analysis of imported foods
- Evaluation and approval of suppliers.
- Verification activities, such as audits and testing, are routinely carried out.
This program assures safety for imported foods because importers are liable for verification of the firms from which they obtain their suppliers to ensure that these firms conform to the FDA food safety standards.
Accredited Third-Party Certification
FSMA has established an accredited third-party certification system to support the growing import of food. This system enables foreign food facilities to be certified by auditors from accredited third parties, who verify compliance with U.S. food safety standards. This accreditation streamlines the import process, ensuring that food entering the United States meets the stringent safety standards set by FSMA.
The third-party certification is particularly beneficial for suppliers aiming to participate in the FDA's Voluntary Qualified Importer Program (VQIP), which allows for expedited entry of products from certified foreign suppliers. While certification is not mandatory, it assists importers in demonstrating high standards of food safety and compliance.
Intentional Adulteration Protection
FSMA also compels food facilities to evaluate and address potential vulnerabilities to intentional adulteration, including terrorism. The rule focuses on:
- Identifying significant vulnerabilities in the food production process.
- Implementing mitigation strategies to protect against intentional adulteration.
- Install monitoring and corrective action plans when there are intentional contaminants.
The FSMA puts in place measures that ensure food manufacturers can protect the food supply from both accidental and intentional contaminants by addressing potential risks of intentional contamination.
Sanitary Transportation of Food
FSMA has guidelines that directly specify sanitary transportation of foods. The regulations are primarily aimed at avoiding food from getting contaminated during transportation. Some of the key areas in this respect include:
- Refrigeration of perishable products.
- Cross contamination between raw and cooked foodstuffs will not be allowed.
- Keep the vehicles clean and service them before use
Train transport employees.
Foods should be ensured at all points, from the farms to several points in the supply chain, for safety and wholesomeness to finally hit the grocery shelves.
Food Defense and Protection Plans
FSMA imposes a requirement of food defense plans. Again, this is protection for the human food and animal feed supply from intentional adulteration and other kind of threats. Food facilities need to do the following:
- Conduct vulnerability assessments to identify every most vulnerable point on the supply chain.
- Develop strategies for mitigating threats.
- Implement monitoring and verification of food defense procedures.
This guarantees the food supply in the U.S. is protected from any terrorism and sabotage that could endanger national security and public health.
Traceability and Recordkeeping
FSMA has further strengthened traceability and recordkeeping for food producers. Now, faster identification and remediation of food safety incidents can be done because companies must have:
- Records of detailed process information concerning their production, including ingredient sourcing and distribution chains.
- Enable traceable efficient systems to be able to fast track the recalled contaminated products.
Thus, FSMA decreases the chances of foodborne diseases reaching pandemic levels by quickly tracing sources of contamination and further reducing the costs of food recalls.
Conclusion
The Food Safety Modernization Act (FSMA) represents a significant shift in food safety regulations, transitioning from a reactive to a proactive approach. This comprehensive law encompasses the entire food supply chain, from farms and processing facilities to importers.
For companies in the food industry, compliance with FSMA is essential, with specific deadlines established for meeting various requirements. Failure to comply can result in substantial penalties, underscoring the seriousness of adhering to these regulations. Freyr’s regulatory experts assist businesses in understanding and implementing the complex preventive controls and recordkeeping requirements that can be overwhelming for many organizations.
While third-party certification is voluntary, it offers significant advantages for importers, demonstrating a commitment to high food safety standards. Beyond legal obligations, compliance ensures ethical responsibility in protecting public health.
Businesses navigating these regulatory challenges can rely on Freyr’s expertise to simplify the process. From developing food safety plans to implementing supplier verification programs, Freyr helps ensure smooth compliance with FSMA standards, safeguarding both the business and consumers.
