Continuation of Cooperative Agreement between U.S. FDA and S.C. DHEC to Achieve Conformance with Last Standard, Maintain Conformance with Other Nine Standards, and Complete Special Projects.

South Carolina Department Of Public Health, Columbia SC

Investigators

Abstract

If Conformance with the Manufactured Food Regulatory Program Standards (MFRPS) Cooperative Agreement is awarded, DHEC will achieve conformance with Standard 6 and continue to maintain conformance with the other nine Standards by identifying and resolving gaps in the program. Furthermore, this project will allow DHEC to pursue special projects dedicated to enhancing the manufactured food regulatory program to protect public health and secure the safety of the State?s food supply. During DHEC?s last audit, a gap in Standard 6 was identified, thereby inhibiting conformance with that Standard. It was found that DHEC is not sufficiently monitoring chronic violations and violators. Receiving this Cooperative Agreement would provide the MFRPS Coordinator with the opportunity to address that gap. Violations and violators are documented in Microsoft Excel workbooks; these will be enhanced to include a new spreadsheet on which violations and violators will be monitored using Excel formulas and functions. Having this on a single spreadsheet will facilitate the MFRPS Coordinator in determining if there are violations and/or violators that meet the chronic violation and chronic violator definitions, respectively. The long-term plan is to use the new ?e-permitting? system under development by the agency to identify chronic violations and chronic violators. The future system will be able to create reports that can be run by the MFRPS Coordinator, or designee, that would identify these chronic violations and violators. To further advance the program, two special projects have been discussed and will be implemented during this Cooperative Agreement. Both special projects primarily address Standard 1 but will affect all Standards either directly or indirectly. First, the good manufacturing practices in the current manufactured food regulations (61-32, 61-36, and 61-54) are based on 21 CFR Part 110. These are being replaced by the modernized Current Good Manufacturing Practices (cGMPs) in the new 21 CFR Part 117. Therefore, DHEC?s manufactured food regulations must be amended to reflect the changes in good manufacturing practices. Second, DHEC recently acquired jurisdiction over cheese manufacturing facilities and butter manufacturing facilities. Regulations must either be created for these types of facilities or existing regulations must be amended to include these product types. Furthermore, as a part of each of these projects, standard operating procedures and inspection documentation must be updated and new ones created to reflect the new cGMPs and product types, respectively. The MFRPS Coordinator will work with the Dairy & Manufactured Food staff and BEHS management to amend regulations as well as update and create new SOPs and the new inspection forms that will be needed for the e-permitting system. Stakeholder meetings will be organized by the MFRPS Coordinator and hosted by DHEC to discuss these regulatory changes.