On September 17, FDA formally published the first major final rule under the Food Safety Modernization Act (FSMA) in the Federal Register.
This final rule addresses the standards for “facilities” that sell food for human consumption. The rule has staggered deadlines for compliance, so that large businesses will have to come into compliance in November 2016, while small businesses will have an additional one to two years depending on their size.
(The Produce Safety Rule, the other major rule under FSMA, is supposed to be finalized by late October of this year.)
This first published final rule implements FSMA’s requirement that businesses that manufacture, process, pack, hold or store food implement “hazard analysis and risk-based preventive controls” (HARPC), including a written food safety plan that identifies the possible problems that could affect the safety of their products and outlines steps the facility would take to prevent or significantly minimize the likelihood of those problems occurring.…