Executive summary: preventive controls rule

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

Facilities that are solely engaged in the storage of raw agricultural commodities (other than fruits and vegetables) intended for further distribution or processing

A facility that stores raw agricultural commodities that are fruits and vegetables would not be exempt.

A facility solely engaged in the storage of packaged food that is not exposed to the environment

Modified requirements would apply for the storage of refrigerated packaged food.

The proposed rule also would establish the conditions under which an exemption granted to a “qualified facility” could be withdrawn, and the procedures that would be followed to withdraw such an exemption. The proposed rule would establish requirements that would apply to all records that would be required by the various proposed provisions. The proposed recordkeeping provisions would implement specific requirements of FSMA regarding records associated with the new provisions for hazard analysis and risk-based preventive controls and would allow facilities to show, and FDA to determine, compliance with the regulatory requirements. The proposed rule would require that a qualified individual prepare the food safety plan,validate preventive controls, review records for implementation and effectiveness of preventive controls and the appropriateness of corrective actions, and perform the required reanalysis of a food safety plan. The proposed rule also would establish minimum requirements for the “qualified individual,” who would be required to successfully complete training with a standardized curriculum or be otherwise qualified through job experience to develop and apply a food safety system. Only a trained individual or individual qualified by job experience is capable of effectively executing these activities.

FDA is requesting comment on when and how other elements of a preventive controls system are an appropriate means of implementing the statutory directives, including: a product testing program, an environmental monitoring program, and a supplier approval and verification program, as appropriate.

 Costs and Benefits


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