The FDA last week issued two highly anticipated proposed rules relating to food process safety, with a stated goal of preventing foodborne illnesses. Readers will recall our posts on the litigation that can arise from food safety issues. FDA has now released for public comment a proposed rule on Preventive Controls for Human Food and a proposed rule on Standards for Produce Safety.
These rules are two of the proposed rules that FDA says are key to the preventive food safety approach established by the 2011 FDA Food Safety Modernization Act. The proposed rules build on existing voluntary industry guidelines for food safety, which many producers, growers and others currently follow. FDA expects to soon issue its proposed rule on importer foreign supplier verification; future proposed rules will address preventive controls for animal food, and accreditation of third-party auditors.
The FDA will accept comments on the proposals for 120 days. While the effective date for the rules would be 60 days from publication of the final rule, the general compliance date would be two years after the effective date. For small businesses, the compliance date would be three years after the effective date, and for very small businesses four years after the effective date.
The proposed rule on preventive controls for human food would apply to facilities that manufacture, process, pack or hold human food. In general, with some exceptions, the new preventive control provisions would apply to facilities that are required to register with FDA under FDA’s current food facility registration regulations. The rule proposes firms have written plans in place to identify potential hazards, put in place steps to address them, verify that the steps are working, and outline how to correct any problems that arise. FDA says the proposed hazard analysis rules are similar to the "HACCP” (Hazard Analysis and Critical Control Points) regulations that govern the production of certain seafoods and meats. The proposed produce rule covers all fruits and vegetables except those rarely consumed raw, produced for personal consumption, or destined for commercial processing that will reduce microorganisms of public health concern.
FDA estimates that the total annual compliance costs for the two regulations will exceed $1 billion. million, depending on the scope of the exemption for “very small businesses.” The draft appears not to offer an estimate of the benefits that might result from the new rules.