Conformance project agreement to meet and enhance Manufactured Food Regulatory Program standards

Wisconsin Dept/Agri/Trade/Consum/ Prot, Madison WI

Investigators

Abstract

Project Abstract Wisconsin?s Department of Agriculture, Trade and Consumer Protection (DATCP) requests $375,000 for one year to achieve, maintain and enhance full conformance with the Manufactured Food Regulatory Program Standards (MFRPS) and further increase the capacity of Wisconsin?s food safety regulatory program to protect public health and safeguard the food supply. The US Food and Drug Administration (FDA) developed the MFRPS program as a tool to promote uniformity and cooperation among federal, state and local agencies responsible for regulating manufactured food establishments. The Bureau of Food and Recreational Businesses first enrolled in the MFRPS program in 2007 as one of five states to pilot the standards. The Bureau completed an initial baseline assessment, developed a strategic improvement plan, and participated in an FDA Program Assessment Validation Audit (PAVA). In 2012 the Bureau participated in its 36-month PAVA, and at its 60- month audit in 2014, Wisconsin was found in full conformance with all 10 Standards (2013 version). In 2016, at the 84-month audit, FDA auditors found room for improvement in Standard 2, training records. Since then the Bureau has implemented most of the additional requirements of the 2016 MFRPS. This one-year cooperative agreement will allow Wisconsin to continue its efforts to implement its strategic improvement plan and achieve, maintain and enhance full-conformance with the standards through such tasks as: ? Modernizing our regulatory foundation by adopting the modernized GMP?s and Preventive Controls for Human Food (CFR 117) into our Wisconsin Administrative Code ? Maintaining and expanding our quality assurance system that includes annual program audits of inspection reports, field inspections, and sampling, and an annual performance review of the compliance system ? Improving document control and record-keeping by implementing a document control policy via SharePoint, and better reporting and tracking training, particularly field training ? Incorporating MFRPS processes and FSMA risk categorization into our inspections and licensing system In addition, Wisconsin will actively participate in MFRPS meetings, training, and audits to share information with other regulatory agencies.