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proposed rule also would establish the conditions under which an exemption granted to a "qualified facility" could be withdrawn, and the procedures that would be followed to withdraw such an exemption.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
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
The summary of the costs and potential benefits of the proposed rule are presented in the table that follows.
Total domestic costs annualized at 7 per cent over 10 years (millions) Proposed Rule with Very Small Business
$95Defined as Less Than or Equal to $500,000in Annual Revenue Proposed Rule with Very Small Business 89 Defined as Less Than or Equal to $1,000,000in Annual Revenue Proposed Rule with Very Small Business 65 Defined as Less Than or Equal to $2,500,000in Annual Revenue
This new law continues efforts by the human and animal food industries and government to protect and improve the safety of the nation's food supply. At the Federal level, these efforts go back to the Pure Food and Drug Act of 1906,