FSMA (Food Safety Modernization Act) was signed by the President in January 2011. The very first rule released under FSMA was Current Good Manufacturing Practices and Risk Based Preventive Controls for Human Food. This was in September 2015. Later that year in November, the FDA released additional regulations under FSMA. Those included the Foreign Supplier Verification Program (FSVP), Produce Safety Rule, Sanitary Transport and Preventive Controls for Animal Food.
In the following years the FDA released additional rules including Intentional Adulteration that focuses on food defense and Traceability Rule (section 204). Food Defense regulations (Intentional Adulteration Rule) are in effect and FDA started conducting the full scope inspections in August 2024. Traceability Rule will become a requirement in January 2026.
For all the FSMA regulations the FDA published guidance documents providing the industry with additional information needed for compliance. At the beginning when the rules were released, FDA took an educational approach in enforcing compliance. With initial inspections, the facilities without proper documentation were instructed to take training courses or become familiar with relevant legislation through reading the code of federal regulation or the guidance documents.
The grace period is over and currently the FDA is expected to use available tools to enforce compliance.
Prior to FSMA the agency did not have the legal ability to access all food safety records, efficiently mandate recalls or even to revoke the registration of non-compliant facilities without going through a lengthy process.
This has changed as FSMA provided the agency with power of authority. FDA was given the number of tools to ensure FDA registered facilities comply with relevant legislation. Those include full access to food safety records, issuing warning letters, refusing imports of potentially unsafe foods, recalling unsafe products from the market and finally revoking facility’s registration.
FDA inspection process starts with issuing form 482 requesting food safety records. Keep in mind that the FDA has the right to take copies or even seize the records when conducting investigations. After the inspection, facilities have the right to discuss the non – conformances issued to them and documented on form 483. It does happen that some of the findings are removed from the document based on additional evidence or explanation provided to the FDA by the company. For final non – conformities that FDA issued the sites have 14 days to respond either electronically or in a form of a letter.
Failure to provide corrective actions or to correct the deficiencies with subsequent inspections will result in additional enforcement actions. Those include warning letters, import alerts with FSVP Inspections, or finally revoking registration for manufacturing / processing facilities.
The FDA is expected to conduct regulatory verification inspections at least every 3 years for high-risk facilities producing or importing RTE products and every 5 years for low-risk establishments.
The FDA inspected facilities are responsible for educating their personnel on FDA regulatory compliance. This can be achieved through number of FSPCA training courses such as Preventive Controls for Human Food training known as PCQI training, FSVP Training (Foreign Supplier Verification Program), IAVA Training (Intentional Adulteration Vulnerability Assessment) and others. Facilities may also use external consulting services to help them develop risk – based food safety or food defense programs.
Food Safety Preventive Controls Alliance provides outreach programs and additional self-paced training curricula along with Technical Assistance Network. As a food facility you are urged to use all available resources to ensure compliance with FDA FSMA regulations and avoid potential regulatory actions taken by the agency.
At BD Food Safety Consultants, our team of trained professionals (Instructors and Consultants) can assist in meeting the legislative requirements. We work with our clients nationwide and internationally to help them achieve their food safety goals through number of training programs and consulting initiatives. Reach out at https://bdfoodsafety.com/contact-us/ or call 815-641-6404 to learn more about training and consulting service we offer.