Egg Safety Regulatory Program Standards Development – CAP Update

1. Egg Safety Regulatory Program Standards Development – CAP Update Michelle Boyd – Iowa Department of Agriculture & Land Stewardship Emma Middlemiss – California Department of Food & Agriculture February 25, 2019 Savannah, Georgia

2. FDA Egg CAP Collaborative Effort

3. Egg Safety Regulatory Program Standards (ESRPS) Goals • Recommend & establish Egg Safety Regulatory Program Standards (similar to MFRPS or AFRPS) to create a uniform foundation for the design and management of State programs for the regulation of egg safety

4. ESRPS Goals

5. Project Objectives • Conduct baseline program self-assessments (using MFRPS & AFRPS) & develop an improvement plan – completed in Jan. 2017 • Identify gaps and areas of improvement between Federal and States – completed in Aug. 2017 • Develop and implement an agreement and protocol for the electronic sharing of egg regulatory information between State and FDA – on going • Conduct joint inspections between FDA and the State – on going • Make recommendations for national egg regulatory program standards – completed recommendations for standards 1 through 5, 8 & 10

6. ESRPS Recommendations * This standard is currently in development

7. Standard 1 - Regulatory Foundation The State program evaluates the scope of its legal authority and regulatory provisions that correspond to the sections of the FD&C and CFR to ensure the protection of shell eggs within its jurisdiction The State Program conducts an evaluation to determine if State laws and regulations are EQUIVALENT, EQUIVALENT IN EFFECT, or NOT EQUIVALENT to Federal statutes and regulations

8. Standard 2 - Training The State Program maintains training records and establishes a training plan that promotes development and demonstrates that all inspectors who will conduct shell egg inspections complete the following to adequately perform their work: • Course Work – within 24 mo. of the start date, the inspector must complete courses available online or in classroom through Pathlore, Compliance Wire, IFPTI, or FEMA • Field Training – within 24 mo. of the start date, the inspector must complete a checklist of competencies and number of joint inspections specified by the State Program • Continuing education – every 36 mo. a total of 20 contact hrs. are required for each inspector to complete in continuing education

10. Standard 3 – Inspection Program This standard describes the foundation for inspecting shell egg producers and handlers to determine compliance with the laws administered by Federal and State jurisdictions. The State program has: • a risk based inspection program • an inspection protocol • a system to respond to consumer & industry complaints • a recall system • a sampling procedure (optional)

11. Standard 3 – Inspection Program Example of a Risk-based Assessment for Shell Egg Producers and Handlers This Risk-based Inspection Matrix is intended solely to assist State programs with establishing their own risk-based assessment system.

12. Standard 4 – Inspection Audit Program The State program has a process that conducts audits to assess the effectiveness and accuracy of its inspections and sample collections (optional) which includes: • a field inspection audit component • a desk audit component • a corrective action plan

13. Standard 4 – Inspection Audit Program

14. Standard 5 – Egg-Related Illness, Outbreak and Emergency Response The State program has written procedures for documenting and investigating egg-related illnesses, outbreaks, and emergencies within the program’s authority to: • communicate with appropriate agencies; • determine, initiate, and complete the appropriate response; • manages an event using formalized Incident Command System structure;

15. Standard 5 – Egg-Related Illness, Outbreak and Emergency Response • maintain a list of relevant agencies and emergency contacts; • rapidly notify government agencies, law enforcement, departments, and/or appropriate parties; • release information to the public; and • coordinate media information with other jurisdictions

16. Standard 6 – Compliance & Enforcement This Standard is currently in draft form. We are working on the following elements to be incorporated for this Standard: • Compliance history • Responsiveness • Scope • Nature of the Violation • Impact of the Violation • Resources

17. Standard 7 – Industry & Community Outreach This Standard is currently in draft form. We are working on the following elements to be incorporated for this Standard: • Workshops – commercial & small flock producers • Seminars – educational seminars put on by academia, regulators, & poultry organizations • Training courses – for local government or industry • Online educational opportunities – pamphlets, FAQs, videos • Poultry shows & fairs – provide handouts & education

18. Small Producer Workshop Example

19. Standard 8 – Program Resources This standard describes the elements of resource evaluation used to support a shell egg safety regulatory program. The State program conducts an assessment of resource needs for staffing, equipment, and funding and is required to have a documented workplan which includes: • an inspectional plan – includes number & type of inspections, risk category of facility, and frequency; • a sample plan (optional) – includes number & type of samples; and • a timeframe that the workplan is applicable The State Program has a documented procedure for evaluating the workplan and for identifying and reviewing its resources within the applicable timeframe

20. Standard 9 – Program Assessment This standard describes the process a State program uses to assess and demonstrate its conformancewith each of the program standards In the first year the program conducts a baseline self-assessment to: • identify if the program meets the elements of each standard; • determine areas of the State program that need improvement; • develop a strategic improvement plan; and • establish timeframes for making improvements Subsequent self-assessments are used to track progress toward meeting and maintaining conformance with the program standards

21. Standard 10 – Comprehensive Sampling & Laboratory Program (optional) • This optional standard describes the elements of comprehensive sampling and the laboratory program used to support a shell egg safety regulatory program • The State program must have elements of comprehensive sampling including sampling support, plan, & procedures in place

22. Standard 10 – Comprehensive Sampling & Laboratory Program (optional) • The State program must have access to a laboratory including: • a lab that is capable of analyzing a variety of samples including egg or environmental samples; • a maintained list of routine and non-routine analytical services; • a contract or written agreement with each primary servicing laboratory; and • regulatory testing laboratories that • have a current accreditation to ISO/IEC 17025 standards or • have a quality system in place which incorporates the management and technical requirements of ISO/IEC 17025

23. Potential Benefits for State’s to get Involved

24. Next Steps for Recommended Egg Standards NERO • Timeframe – approx. 1 year • Subcommittee specific to Standards • Elevate organizational structure nationwide • MOU or FDA • Timeframe – at least 2 or more years • Public comment period

25. Contacts

26. Questions?