FSMA Roundup: An Overview Of The FDA's Seven Major Rules

By Rick Barham, food safety specialist, Registrar Corp

In 2011, President Obama signed FSMA — a body of regulatory works that quickly became the most sweeping reform of the U.S. food safety system in over 70 years — into law. The FDA published seven major rules under FSMA, each of which created new requirements that put more responsibility on industry to prevent contamination of the U.S. food supply rather than reacting to it. This article will review all of FSMA’s seven final rules and briefly cover points of compliance, as well as each rule’s compliance dates.

Preventive Controls Rules for Human and Animal Food

Proposed: January 2013 (Human) and October 2013 (Animal)                            
Finalized: September 17, 2015
Compliance Dates:

• Very-small businesses (businesses that have less than $1,000,000 in total annual sales of human food, adjusted for inflation): September 2018
• Businesses subject to the Pasteurized Milk Ordinance: September 2018
• Small businesses (businesses with fewer than 500 full-time equivalent employees): September 2017
• All other businesses: September 2016

The FDA's Preventive Controls Rules apply to all facilities required to register with the FDA as a food facility, unless covered by an exemption (See page 19 of the final rule for a complete list of exemptions). A covered facility must implement a written Food Safety Plan that identifies known or reasonably foreseeable biological, chemical, and physical hazards related to foods in the facility. For each identified hazard, the Food Safety Plan must determine whether the hazard requires preventive controls and, if so, outline preventive controls to minimize or prevent that hazard.