- FDA Releases Two Final Food Safety Rules: What You Need to Know
- September 21, 2015
- Law Firm: Mintz Levin Cohn Ferris Glovsky Popeo P.C. - Boston Office
Progress on Final Rules implementing the Food Safety Modernization Act (FSMA) took a significant step forward last week when FDA released its first two, comprising the final rules on Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food and Food for Animals.
The final rule on Preventive Controls for Human Food creates and revises requirements for covered food facilities in three ways. The final rule:
- Modernizes FDA’s current good manufacturing practice (cGMP) regulations, which govern the manufacturing, processing, packing, or holding of human food;
- Requires covered facilities to establish and implement hazard analysis and risk-based preventive controls for human food; and
- Clarifies the scope of the exemption for farms in FDA’s current food facility registration regulations and makes corresponding revisions to FDA’s current regulations for the establishment, maintenance, and availability of records.
- Creates new cGMP regulations that, for the first time, specifically address the manufacturing, processing, packing, and holding of food for animals; and
- Requires covered facilities to establish and implement hazard analysis and risk-based preventive controls for food for animals.
To continue its outreach and engagement with the regulated community on FSMA, FDA is hosting a series of three webinars on the two Preventive Controls final rules. The first webinar on September 15 focused on who is covered by the rules and the final definition of “farm.” The other two webinars, on September 16 & 17, will discuss the significant provisions of the Preventive Controls for Human Food and the Preventive Controls for Animal Food final rules, respectively. A public meeting about both Preventive Controls final rules will be held in Chicago on October 20, 2015.
These final rules and notices of the availability of the qualitative risk assessments will be published in the Federal Register on September 17, 2015 - an important date to keep in mind in order to accurately calculate compliance dates for your business as you work towards the new post-FSMA world.