MFRPS Lesson Learned North Carolina Jim Melvin NCDA&CS Food and Drug Protection Division Jim.Melvin@ncagr.gov

NCDA&CS MFRPS Timeline Stop video at 0:50.

NCDA&CS MFRPS Standard One Current Status Legal authority to perform inspections and investigations, gather evidence, collect samples, and take enforcement actions Adoption by reference of the current FD&C Act, Title 21 Code of Federal Regulations (CFR) or other Federal laws. A legal review by the State agency’s counsel A process to incorporate changes to State’s laws and regulations in order to maintain the state’s regulatory base equivalency Remaining Challenges Resources for the adoption of 21 CFR 112 and 117 (21 CFR 115 and 118 took 2 years to navigate through the rule making process) Owners/operators

NCDA&CS MFRPS Standard Two Current Status A fully documented and implemented training Plan Documented through policies and procedures Records maintained as hard copy and in an online database. Coursework for the inspector training that encompasses: Basic Level Education for all inspectors validated by joint inspections with qualified trainers. Advanced Training for inspectors that perform complex or advance technique inspections validated by joint inspections with qualified trainers. Continuing Education training that enhances the skills and knowledge of the inspection staff Ongoing classroom training that enhances skills and knowledge Joint inspections with qualified trainers that provide hands on training and verification of techniques and skills. Owners/operators

NCDA&CS MFRPS Standard Two Remaining Challenges NCDA&CS online training database is cumbersome to use and will be replaced. Getting all of staff through FD180 and FD152 (non issue) DHRD has worked with States to make classes available. Both Technical Trainer(s) have retired over the last three months. Owners/operators

NCDA&CS MFRPS Standard Three Current Status Risk-based inspection program Food Firms data system that maintains the current firm inventory Documented inspectional policies and procedures Initiating Pilot Program for Online Establishment Inspection Report system based on FDA EIR Food recall system that shares information with affected government agencies with documentation of events. Online consumer and industry complaint tracking system Owners/operators

NCDA&CS MFRPS Standard Three Remaining Challenges Implementation of inspectional procedure based on FDA Job Task Analysis. Complete implementation of the online EIR system using the Food Firms Database. Owners/operators

NCDA&CS MFRPS Standard Four Current Status Implemented audit program which covers the three following inspectional program functions: (Phase III) Field Inspections (17 per year) Establishment Inspection Reports (75+ per year) Sample Reports (75+ per year) Implemented corrective action process Remaining Challenges Lead auditor and trainer/auditor retired Revision of procedure for EIR audits for new online system. Owners/operators

NCDA&CS MFRPS Standard Five Current Status Implemented system to conduct illness or injury investigations Implemented RRT Implemented communication processes with FDA and other State, Federal and Local authorities Laboratory capabilities that provide support for investigations of illness, injury, or outbreaks Remaining Challenges Development of forward leaning preventive system to minimum effect of food emergencies Owners/operators

NCDA&CS MFRPS Standard Six Current Status Implemented risk based enforcement strategy with established timeline for progressive regulatory actions A compliance information system that track firms with critical and chronic compliance history Remaining Challenges Automating the trigger systems within the database for critical and chronic offenders Audit process of the Compliance system equal to the processes for the inspectional staff. Owners/operators

NCDA&CS MFRPS Standard Seven Current Status Staff participates in activities include the sponsoring or actively participating in meetings such as task forces, advisory boards, or advisory committees Online activity tracking program conforms to Standard’s requirements. Remaining Challenges Capturing documentation required by Standard Seven Owners/operators

NCDA&CS MFRPS Standard Eight Current Status Implemented systems that ensure that staff, equipment, and funding are managed to accomplish the elements detailed in the MFRP Standards. Remaining Challenges Continued funding of program Expanding firm base without expansion of staff (more firms, no additional staff) Funding to implement FSMA Owners/operators

NCDA&CS MFRPS Standard Nine Current Status Ongoing assessment of program and corrective action in non conformities or implementation gaps Completed 60 month PAVA Remaining Challenges Unknown FDA Program requirements and funding Owners/operators

NCDA&CS MFRPS Standard Ten Current Status ISO 17025 primary servicing lab Relationships established with all servicing laboratories defined through written contracts, agreements, MOUs or customer supplier agreements. Remaining Challenges Maintaining existing capacities and relationships Owners/operators

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