Food Safety (Food Safety Modernization Act)

The Food Safety Modernization Act (FSMA) is the most significant regulatory change/challenge the food industry is facing since the inception of FDA. This new law gave FDA many new “tools” to enforce the seven (7) major FSMA regulations including civil penalties and suspension of the FSMA permit in addition to the existing warning letters, consent decrees, etc. This legislation was intended to strengthen the safety of the U.S. food supply by requiring preventative controls at all levels, from the grower, supplier, manufacturer, distributor, importer and so on.

Critical questions for food manufacturers to answer are whether their existing written and operational food safety programs comply with FSMA and its new regulations. EAS is available to provide answers to these important questions, based on an evaluation of the food manufacturer’s current operational mode to determine compliance with the FSMA “Preventive Controls for Human Foods”, “Preventive Controls for Animal Feed/Food” as well as the Produce Safety, Food Defense and Sanitary Transport regulations. This EAS assistance extends from growers to food manufacturer to warehouses, distributor, and retailers, with each category having industry-specific rules that apply. EAS provides on-site assessment services which consist of an in-depth review of current manufacturing facility norms versus FSMA requirements. This assessment includes documents, policies, and procedures with written recommendations on improvements benchmarked against FSMA requirements and industry best practices to provide a regulatory pathway for meeting detailed demands of FSMA.

In addition, EAS offers services in the area of the FSMA Foreign Supplier Verification Program (FSVP) which requires new regulatory systems for US-based “Importers” to have the foreign food manufacturer’s food safety documents available at the Importer’s US office for FDA inspection, upon request. Of interest to larger food importers may be the Voluntary Qualified Importer Program (VQIP) which is designed to assist in the ease of entry of food shipments for companies meeting certain rigid requirements. EAS assists importers in a wide variety of areas and can provide a conduit of information between the agency and company.

Choose EAS to lead your firm through the new FSMA regulatory requirements:

  • FSMA Readiness Assessments
  • Hazard Analysis and Risk-based Preventive Controls (HARPC)
  • FSVP Qualified Individual Requirements
  • Food Safety Plans
  • Documenting and maintaining records of food safety practices
  • Verifying Supply Chain Management Program
  • General FSVP compliance
  • Voluntary Qualified Importer Program assessments
  • Food Traceability and Recall Program
  • Allergen Controls