FSMA’s 7 Major Rules
Following the interest in the recent paper on the FDA Rule on traceability, over the coming months RQA and Perigon will provide a number of articles covering FDA’s Major Rules and other rules that support the implementation of the Food Safety Modernization Act (FSMA). This article focuses on the background to the development of FSMA and lists the Major Rules.
The regulatory structure in the US is somewhat complex and confusing at times with different agencies covering different categories dependent on product category, product type and source. For example, the FDA regulates most seafood and the USDA regulates catfish, whereas the USDA regulates meat, but the FDA regulates game meat. Also, a pizza is regulated by the FDA unless it is topped with 2% or more of cooked meat or poultry, in which case it is USDA regulated!
Of course, in addition to food, the FDA also regulates cosmetics, human and animal drugs, tobacco products and other goods. Rules and guidance are published by the FDA to provide clarity on what the food industry is expected to do in order to comply with certain aspects of FSMA. The primary rules published initially were termed the “7 Major Rules”.