The Food Drugs & Cosmetic Act (FDCA), issued by the Senate has been the only framework regulation on food safety until 2010. Forty-fourth President of the US, Barack Obama signed into law the Food Safety Modernization Act – FSMA; the most sweeping reform of FDA’s food safety authority in more than 70 years.
FSMA will gradually replace FDCA by the application of its seven Rules, also called “Seven Pillars” (fig.1) which will become completely effective on January 2022. This new regulation, promoted and issued by FDA will cover all companies, registered with FDA (i.e. under its direct jurisdiction) involved in the primary primary production and/or processing of food products.
The FSMA Seven Pillars are:
- Accredited Third-Party Certification, it is a Rule that will allow foreign food companies to be FSMA certified, avoiding them to go to through customs provided that they are certified by a certification body which has been accredited by FDA. Alternatively, it will allow importers to be certified through accredited body, to join the VQIP (Voluntary Qualified Importer Program) and to control their own foreign supply-chain;
- Current Good Manufacturing Practices and Hazard Analysis and Risk-Based Preventive Controls for Human Food, this Rule covers processors of food for human consumption, and introduces the position of the Preventive Controls Qualified Individual (PCQI) together with the obligation to have a Food Safety Program in place (Plan, System and Food Defence);
- Current Good Manufacturing Practices and Hazard Analysis and Risk-Based Preventive Controls for Animal Food, this Rule covers processors of food for animal consumption, and introduces the position of the Preventive Controls Qualified Individual (PCQI) together with the obligation to have a Food Safety Program in place (Plan, System and Food Defence);
- Foreign Supplier Verification Program (FSVP), for the first time this Rule regulates food import under the FDA jurisdiction and introduces the role of the FSVP Importer (owner of the food product at the moment of entry in the United States and/or subscriber of a written purchase commitment for the product and/or the consignee of the product);
- Mitigation Strategies to Protect Food Against Intentional Adulteration, it is the new US Food Defence, focused on defending the products from Economic Frauds
- Sanitary Transportation of Human and Animal Food, it is the new Rule on transportation hygiene that enters into force the moment food products land on the US soil; it also set the obligation to maintain room temperature at a maximum of +25°C.
- Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption, it is the groundbreaking Rule on Produce, Seeds and Sprouts Hygiene, introducing the concept of Zoning in farms.
Key-features of the new regulation are:
The integrated application of Seven Pillars (they are meant to work together in an integrated fashion);
The fact that the new regulation overlaps the previous one without repealing it (see the different 8 HACCP Regulations for Meat, Poultry, Eggs, Flour, Milk, Juice, Confectionery, Seafood for which mandatory courses are required);
The new “Current Good Manufacturing Practices also known as GMPs”, introduced with the Preventive Controls for Human Food (PCHF), which replace the generic ones described in Title 21 CFR Part. 110 and the vertical ones specific for Canned Food, Seafood and Juice (a specific course designed by the Cornell University is available on-line).
Therefore, FSMA overlaps different sections regulated by FDA in Title 21 of Code of Federal Regulation (CFR): These now become 62 while the regulation itself updates the C-GMPs. Through the centralization of the educational material, FDA has designed a Pyramid-shaped system to promote mandatory training regarding the Seven Pillars: by training and appointing Trainers of Trainers (ToT) to coach Lead Instructors that will instruct food companies’ operators worldwide. FDA requires a mandatory documentation for each Rule; that must be written and made available by the trained operators within the food companies covered by the rule. (A food processing company, for example, shall train a PCQI in charge to write the company Food Safety Program).