As part of its continuing implementation of the Food Safety Modernization Act (FSMA), on October 31, the FDA announced the availability of a draft guidance document titled “Draft Guidance for Industry: Describing a Hazard That Needs Control in Documents Accompanying the Food, as Required by Four Rules Implementing FSMA” (Guidance).
The Guidance is meant to provide industry with more information on the content of the disclosure statements required by four of the seven foundational FSMA rules. Additionally, it identifies the types of documents that would and would not be appropriate vehicles for such disclosure statements.
The four relevant foundational FSMA rules are:
- Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food (Human PC Final Rule)
- Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals (Animal PC Final Rule)
- Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (Product Safety Final Rule)
- Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals (FSVP Final Rule)