FSMA (Food Safety Modernization Act) is the most significant reform of U.S. food safety legislation in over 70 years. Signed in 2011 with progressive implementation, it shifts focus from responding to contamination to preventing it. Includes rules such as Preventive Controls for Human Food (21 CFR 117), Produce Safety Rule, FSVP (Foreign Supplier Verification Program), and Sanitary Transportation Rule. The PCQI (Preventive Controls Qualified Individual) role is mandatory on the team.
- Legally export food, beverages, or supplements to the United States
- Meet the mandatory PCQI role with accredited training
- Be prepared for FDA inspections on-site or at the border
- Cover FSVP for foreign suppliers selling to U.S. importers
- Align with FSMA 204 (high-risk traceability) effective 2026
Food, beverage, and supplement processors selling in the U.S. or exporting. Applies to operations both in U.S. territory and to foreign suppliers under FSVP. Exceptions for very small producers (Qualified Facility Exemption).
Mexican manufacturer exporting to U.S. supermarkets
Agricultural company shipping produce to U.S. distributors
U.S. importer needing to verify foreign suppliers (FSVP)
Food supplement processor with FDA facility registration
FSMA is not a third-party certification; it is regulatory compliance verifiable by FDA. PCQI training is a requirement for the role and is obtained with an accredited FSPCA Lead Instructor.
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