Food Safety Modernization Act Explained: How FSMA Changed US Food Imports Forever

The Food Safety Modernization Act, signed into law by President Obama on January 4, 2011, is the most sweeping reform of US food safety law since the Federal Food, Drug, and Cosmetic Act was enacted in 1938. FSMA fundamentally changed the FDA's approach to food safety from one of responding to contamination after it occurs to one of preventing contamination before it happens. For foreign food manufacturers, FSMA's impact is enormous — it gave the FDA new authority to require preventive controls at food facilities, to mandate importer verification of foreign suppliers, to set standards for produce safety, to accredit third-party auditors, and to refuse entry of food from foreign facilities that refuse FDA inspection. Understanding FSMA is no longer optional for any foreign manufacturer that exports to the United States.

The seven foundational rules of FSMA

FSMA directed the FDA to develop and implement seven major rules that together create the modern US food safety framework. These rules are: (1) Preventive Controls for Human Food (21 CFR Part 117), (2) Preventive Controls for Animal Food (21 CFR Part 507), (3) Produce Safety Rule (21 CFR Part 112), (4) Foreign Supplier Verification Programs (21 CFR Part 1, Subpart L), (5) Accredited Third-Party Certification (21 CFR Part 1, Subpart M), (6) Intentional Adulteration (21 CFR Part 121), and (7) Sanitary Transportation of Human and Animal Food (21 CFR Part 1, Subpart O). Each rule addresses a different aspect of the food safety chain, and many of them directly impose obligations on foreign manufacturers or create indirect obligations through their US importers.

Preventive Controls for Human Food

The Preventive Controls rule (21 CFR Part 117) replaced the outdated Good Manufacturing Practice regulations under 21 CFR Part 110 with a modernized framework that requires every food facility to develop a written Food Safety Plan. The Food Safety Plan must include a hazard analysis identifying biological, chemical, and physical hazards that are known or reasonably foreseeable for each product; preventive controls to address those hazards (including process controls, allergen controls, sanitation controls, and supply-chain controls); monitoring procedures for each preventive control; corrective action procedures; verification activities; a recall plan; and records documenting all of these elements. The plan must be developed or overseen by a Preventive Controls Qualified Individual (PCQI) who has completed FDA-recognized training.

Foreign Supplier Verification Programs

The FSVP rule (21 CFR Part 1, Subpart L) is the mechanism by which FSMA extends its preventive approach to imported food. Under FSVP, the US importer — defined as the US owner or consignee at the time of entry — must evaluate the risks posed by each imported food and each foreign supplier, and must conduct verification activities to ensure that the foreign supplier produces food that meets US safety standards. Verification activities may include on-site audits of the foreign facility, sampling and testing of the food, review of the supplier's food safety records, or other appropriate measures. The importer must also promptly correct any non-compliance and must reassess suppliers periodically. For foreign manufacturers, FSVP means that your US importer will demand documentation of your food safety program, and your ability to provide that documentation directly affects your access to the US market.

Accredited third-party certification

FSMA established a program for accredited third-party certification of foreign food facilities. Under this program, accreditation bodies recognized by the FDA accredit third-party certification bodies (also called auditing organizations), which in turn audit and certify foreign food facilities. Certification under this program can be used to support eligibility for the Voluntary Qualified Importer Program (VQIP), which provides expedited import entry for foods from facilities with a strong compliance record. Certification can also be required by the FDA as a condition of import for specific foods from specific countries — so-called mandatory certification under Section 303 of FSMA. While the accredited third-party certification program remains smaller than GFSI-benchmarked audit schemes, FDA has signaled that it will increasingly rely on this program to manage the volume of food imports.

FDA authority to refuse foreign facility inspections

One of FSMA's most significant provisions is Section 306, which authorizes the FDA to refuse admission of all food from a foreign facility that refuses or delays an FDA inspection. Before FSMA, a foreign facility could effectively avoid FDA inspection with limited consequences. Under FSMA, the refusal to permit timely inspection results in all food from that facility being refused entry at US ports — a consequence that is immediate and comprehensive. This provision is enforced through Import Alert 99-32, which lists facilities that have refused or otherwise impeded FDA inspection. Once listed, the facility's products are subject to detention without physical examination (DWPE), meaning every shipment is automatically held until the facility allows inspection and is removed from the alert.

How FDABridge helps foreign manufacturers navigate FSMA

FDABridge provides FDA food facility registration, US Agent appointment, and FSMA compliance guidance for foreign food manufacturers. We help our clients understand which FSMA rules apply to their operations, ensure their facility registrations are current, and prepare for the documentation demands that FSVP creates between foreign suppliers and US importers. Visit fdabridge.com/food to see our food services or fdabridge.com/contact to discuss your FSMA compliance needs.