Executive summary: preventive controls rule - The Packer

Executive summary: preventive controls rule

01/10/2013 03:21:00 PM
Tom Karst

In the same manner of the produce safety rule earlier published on Fresh Talk, here is the executive summary of the Preventive Controls Rule.

Executive Summary of Preventive Controls Rule


Purpose and Coverage of the Proposed Rule

The proposed rule would revise FDA’s current good manufacturing practice (CGMP) regulations regarding the manufacturing, processing, packing, or holding of human food in two fundamental ways. First, it would add new preventive controls provisions as required by the FDA Food Safety Modernization Act (FSMA).

In general, with some exceptions the new preventive controls provisions would apply to facilities that are required to register with FDA under FDA’s current food facility registration regulations. These preventive controls would include requirements for covered facilities to maintain a food safety plan, perform a hazard analysis, and institute preventive controls for the mitigation of those hazards.

Facilities would also be required to monitor their controls, verify that they were effective, take any appropriate corrective actions, and maintain records documenting these actions. Second, the proposed rule would update, revise, or otherwise clarify certain requirements of our CGMP regulations, which were last updated in 1986.

In addition, this proposed rule would clarify the scope of the exemption for “farms” in FDA’s current food facility registration regulations and make corresponding clarifications to FDA’s current regulations for the establishment, maintenance, and availability of records.

These clarifications would affect who would be subject to the current regulations for registration and recordkeeping as well as the new preventive controls requirements that would be established by this proposed rule. To put these changes in context, and to provide legal, regulatory, scientific, and technical information relevant to the new provisions, we provide several sections of background.

This background discusses the history of food regulation and current regulatory framework, provides an overview of the provisions of FSMA applicable to this proposed rule, explains the principles and history of the use of Hazard Analysis and Critical Control Point (HACCP) systems, and describes a variety of hazards that have been associated with foods and food safety problems (including outbreaks of foodborne illness) that have resulted from these hazards. An Appendix also describes the role of testing as a verification measure in a food safety system, and the role of supplier approval and verification programs in a food safety system.

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