Foreign food facilities required to register with section 415 of the Food, Drug and Cosmetic Act will need to comply with the requirements for risk-based preventive controls mandated by the FDA Food Safety Modernization Act (FSMA) and the modernized Current Good Manufacturing Practices (CGMPs). This requires a food facility to have a documented food safety plan, prepared by a Preventative Controls Qualified Individual (PCQI) with a comprehensive analysis of hazards and risk-based preventive controls to minimize or prevent the identified hazards unique to your product(s) and process(es).
The FSMA (In compliance with the FDA requirements) scopes of certification apply to:
- Preventive Controls for Human Food (PC) (Part 117)
TPP (BSI Third Party Program Certification) Modules
- Standards for the Growing, Harvesting, Packing and Holding of Produce for Human Consumption (Part 112)
- Hazard Analysis and Critical Control Point (HACCP) Systems - Juice HACCP (Part 120)
- Current Food Manufacturing Practice, Hazard Analysis, and Risk-based Preventive Controls for Human Food (Part 117)
- Fish and Fishery Products - Seafood HACCP (Part 123)
BSI Qualified Importer Program (QIP) Modules
- HACCP (Juice) (Part 120)
- HACCP (Seafood) (Part 123)
- Produce (Part 112) - except entities growing, harvesting packing or holding Almonds
- Acidified Foods (Part 114)
- Low Acid Canned Food (Part 113)
- Infant Formula (Part 106)
- Produce (Part 112)
- Shell Eggs (Part 115, Part 118)
- PC for Animal Food (Part 507)
- Dietary Supplements (Part 111)
The FSMA (In compliance with the FDA requirements) scheme excludes:
- Meat, Poultry, Breaking Eggs and Alcoholic Beverages
- Entities growing, harvesting packing or holding Almonds of the Produce (Part 112) module.
FSMA (In compliance with the FDA requirements) compliance dates are staggered, based on the size of the business, with separate dates for the requirements of the supply chain program.