1. Comparison of 2013 to 2016 Manufactured Food Regulatory Program Standards (MFRPS) Guy Delius, CSO FDA-OP/SIS Morgan Poloni, CSO FDA-OP/SIS Clint Priestley, CSO FDA-OO/AS February 3, 2016 1:30-3:00 pm

2. Overview Background Timeline – what’s next? Summary of 2016 MFRPS and changes What do these changes mean to you? Questions

3. MFRPS Cycle of Revisions On a 3 year cycle for renewal and revision Three revisions to date: – 2007 MFRPS – 2010 MFRPS – 2013 MFRPS – Proposed 2016 MFRPS

4. 2016 MFRPS Revisions More collaboration with FDA and their partners. MFRPS Alliance developed a vetting process Active MFRPS enrollee participation Laid the foundation for future revisions

5. Where did the changes come from? 2013 MFRPS Interpretation Document Submitted Issues to Alliance Awareness and the need for clarification Alliance Workgroups: – Workgroup 1: Standards 1, 7, and 8 – Workgroup 2: Standards 2, 3, 4, and 6 – Workgroup 3: Standards 5 and 10

6. Where did the changes go next? MFRPA Workgroups MFRPA Board PFP Governing Council FDA Internal Review Process

7. 2016 MFRPS Overall Changes “The Merge” Blend the three Alliance Workgroup outcomes into one document – Consistent writing style throughout – Clarify language – Content consistency check across all Standards – Matching Program Elements to Appendices

8. What’s Next? 12/31/2015 OP/SIS Prep for OMB Submission 1/15/2016 Submit to OMB for 60 Day Federal Registry Posting 3/1/2016 – 5/1/2016 Public Open Comment Period 5/1/2016 – 7/1/2016 FDA Respond to OMB Comments 7/1/2016 – 7/31/2016 Submit to OMB 30 Day Submission 9/30/2016 OMB Approval and 2016 MFRPS Release

9. Disclaimer This is a summary – not word for word 2016 MFRPS is still subject to change based on the OMB process.

10. 2016 MFRPS Overall Changes Updated Intro and Background Section Definitions Section – Definitions noted in Standards by SMALL CAPS. Sequential Numbering System 2.3.1 2.3.1.1 2.3.1.1.1

11. 2016 MFRPS Overall Changes Each Standard was reviewed: – Purpose – Requirement Summary – Program Element – Outcome – Documentation

12. 2016 MFRPS Summary Format Defined Terms New Sections New Appendices Updates to Standard Updates to Appendices/Worksheets

13. 2016 Standard 1 Changes Defined Terms – Equivalent – Equivalent in Effect – Not Equivalent – Regulatory Foundation No new sections or appendices added

14. 2016 Standard 1 Changes Updates to 1.3 Program Elements – Added a written procedure for Evaluation of Legal Authority (1.3.1) – Removed the CFRs and FD&C Act that reference Tobacco. – Optional: consultation with legal counsel for review of equivalent laws.

15. 2016 Standard 1 Changes Updates to Appendix 1 – New look and feel – Table has new columns: equivalent, equivalent in effect, and not equivalent – Added 21 CFR 117 Current Good Manufacturing Practice and Hazard Analysis and Risk Based Preventative Controls for Human Food

16. 2016 Standard 2 Changes Defined Terms – Contact hours – Current Experienced Staff – Evaluations – Joint field training inspections – Newly Experienced Staff – Qualified field inspection trainer – Qualified date – Start date

17. 2016 Standard 2 Changes New Sections in 2.3 – Training Plan and Training Records (2.3.1) – New section for inspectors who inspect non high risk food warehouses. (2.3.2.3.2 ) – Experienced inspectors (2.3.3.3) – Coursework sources (2.3.5)

18. 2016 Standard 2 Changes New Appendices – Appendix 2.1 – Self Assessment Worksheet – Appendix 2.4 – Example Curriculum for Basic Food Inspector Training

19. 2016 Standard 2 Changes Updates to 2.3 Program Elements – No time limit on completing Basic Field Training. (2.3.2.3.4) – Option to subdivide the basic course curriculum for inspectors who only inspect low risk warehouses. (2.3.2.3.2) – Removed Nutritional Labeling from Advanced Training Curriculum – Traceback Investigations and Foodborne Illness Investigations - not subject to Advanced Field Training requirements. (2.3.3.1) – Modified the Advanced Field Training requirement to 1 passing eval/audit prior to independent inspections and a 2 nd within one year. (2.3.3.2)

20. 2016 Standard 2 Changes Updates to 2.3 Program Elements (con’t) – Continuing education section was expanded. (2.3.4) – Alternate time frame for tracking contact hours may be established. (2.3.4.3) – Removed the two joint inspections from Continuing Education.

21. 2016 Standard 2 Changes Updates to Appendices and Worksheets – Appendix 2.2 State Training Record Summary Worksheet – Appendix 2.3 Inspector Training Record

22. 2016 Standard 3 Changes Defined Terms – Consumer Complaint – Industry Complaint – Recall Audit Checks – Sampling Program

23. 2016 Standard 3 Changes New Sections – Inspection Report (3.3.3) Outlines what should be in a protocol for writing inspection reports. – Sampling Procedure (3.3.7) Based on the Partnership for Food Protection’s Food/Feed Testing Laboratories Best Practices Manual. – Records Retention(3.3.8) Describes specific record requirements for Standard 3. No new appendices added

24. 2016 Standard 3 Changes Updates to 3.3 Program Elements – Risk Based Inspection Program - option for other risk factor and classification criteria. (3.3.1.2) – Inspection Procedure - removed FDA specific terminology and added info on verification of equipment. (3.3.2) – Food Recalls - reformatted and references PFP Best Practices for Improving FDA and State Communication during Recalls.(3.3.4) – Renamed “Food Industry Inspection Complaints” to “Complaints Resulting from State Program Inspection Activities”. (3.3.6)

25. 2016 Standard 3 Changes Updates to Appendix 3.1 – Self Assessment Worksheet – Updated to reflect changes in program elements Updates to Appendix 3.2 - Risk Classification Criteria for Food Plants – Removed specific FDA terminology

26. 2016 Standard 4 Changes Defined Terms – Field Inspection Audit – Qualified Field Inspection Auditor – Verification Audit Inspection No new sections added

27. 2016 Standard 4 Changes New Appendices – The 2013 Appendix 4.1 Self-Assessment Worksheet was removed. – Replaced with new Appendix 4.1 – Self Assessment Worksheet.

28. 2016 Standard 4 Changes Updates to 4.3 Program Elements – Clarified requirements for a written quality assurance protocol. (4.3.1) – Allows use of Appendix 4.5 or a State audit form that meets the Standard 3, Program Element 3.3.2. (4.3.2) – The minimum number of Inspection Reports and Sample Reports to be audited is now a scale based on the total number of inspections/samples conducted in 12 months. (4.3.3, 4.3.4) – Clarified when corrective action must be taken. (4.3.5)

29. 2016 Standard 4 Changes Updates to Appendix 4.6 Inspection Report Audit Form – Aligns with Program Elements Standard 3, section 3.3.3. Updates to Appendix 4.7 Sample Report Audit Form – Aligns with Program Elements in Standard 3, section 3.3.7.

30. 2016 Standard 5 Changes Defined Terms – Environmental Assessment – Food Related Incidents – Hazards – Traceback – Traceforward No new sections or appendices added

31. 2016 Standard 5 Changes Updates to 5.3 Program Elements – Response elements are listed as: 1) coordination with other authorities, 2) surveillance, 3) investigation/environmental assessment, 4) control measures and 5) post response. – Now addresses coordination in all food-related incidents beyond foodborne illness investigation and intentional tampering. – Added maintaining notification of food-related incidents in complaint log(s) or database(s). (5.3.2.2) – Emphasizes collection of environmental versus epidemiological data during investigations. (5.3.3.2)

32. 2016 Standard 5 Changes Updates to 5.3 Program Elements (con’t) – Tracebacks and traceforwards have been expanded from “food implicated in a FBI” to “foods containing a hazard.” (5.3.3.3) – Expand lab support for investigations to include all food-related incidents. (5.3.3.4) – Amended language to focus on environmental assessment data. (5.3.3.5) – Includes the distribution of recommendations from environmental assessments and investigation reports with stakeholders for prevention. (5.3.5.3)

33. 2016 Standard 5 Changes Updates to Appendices – Appendix 5.1- Self-Assessment Summary Report Reflects updated Program Elements. – Appendix 5.2 – Sample MOU Has been removed.

34. 2016 Standard 6 Changes Defined Terms – Critical Violations No new sections added New Appendices – Appendix 6.1 – Self Assessment Worksheet Redesigned into a self-assessment worksheet.

35. 2016 Standard 6 Changes Updates to 6.3 Program Elements – Provide a clear requirement for a written compliance and enforcement program. (6.3.1) – Removed the requirement to monitor “critical violators”. – Amended language throughout to provide clarification.

36. 2016 Standard 6 Changes Updates to Appendices – Appendix 6.2 Calculation of the Level of Conformance to Compliance Procedures, instead of a worksheet. – Worksheet 6.2a Performance Review of Enforcement Actions is now a worksheet and not an Appendix.

37. 2016 Standard 7 Changes Defined Terms – Outreach Activity Event No new sections added New Appendices – Appendix 7.1 – Self-Assessment Worksheet

38. 2016 Standard 7 Changes Updates to 7.3 Program Elements – Now requires a written procedure of methods that will be used for communication with the food industry, stakeholders and consumers. (7.3.1) – Amended to add the requirement to document and evaluate Outreach Activity Events using Appendix 7.2 or equivalent form.

39. 2016 Standard 7 Changes Updates to the Appendices – The 2013 Appendix 7.1 was renumbered as 7.2.

40. 2016 Standard 8 Changes No Defined Terms No new sections added New Appendices – Appendix 8.1a – Self Assessment Worksheet Instructions

41. 2016 Standard 8 Changes Updates to Standard – Amended to simplify and clarify in three parts: Program Assessment Staffing Equipment

42. 2016 Standard 8 Changes Updates to Appendix 8.3 Inspection Equipment – New column to indicate if equipment will be verified.

43. 2016 Standard 9 Changes Defined Terms – Assessments – Conformance – Current and Fit-for-Use – Document Control – Implementation – Strategic Improvement Plan No new sections or appendices added

44. 2016 Standard 9 Changes Updates to 9.3 Program Elements – A written document control procedure is required. (9.3.2.1) – New language clarifies that a state’s record retention laws or specific language in another Standard may supersede the 3-year requirement. (9.3.2.2) – New requirements for the strategic improvement plan including: Personnel responsible for completing the task and date the task is completed (9.3.3.4 and 9.3.3.5) An annual review (9.3.4) Address FDA assessment observations and to add corrective actions to the strategic plan, if necessary (9.3.5)

45. 2016 Standard 9 Changes Updates to 9.3 Program Elements (con’t) – Now an annual review/update to appendices (9.3.4) – FDA Assessments has replaced “FDA Program Assessment Validation Audit” and “comprehensive program audit.” (9.3.5) – Removed the language for audit procedures and audit timeframes. (9.3.5) – Added the 3-year record retention requirement and expanded it to include previous versions of SOPs. (9.3.2.2)

46. 2016 Standard 10 Changes Defined Terms – Primary Servicing Laboratory New Section – 10.3.2 Non-ISO Accredited Laboratories. Describes requirements for labs that do not have an ISO Accreditation. No new appendices added

47. 2016 Standard 10 Changes Updates to 10.3 Program Elements – Includes what should be in a contract or written agreement with a primary servicing labs. (10.3.1.3) – The requirement for documentation from non- primary servicing labs. (10.3.1.3) – The requirement for labs to be accredited by a body that is a full signatory to the ILAC Mutual Recognition Arrangement (MFA). (10.3.2) – For non-ISO accredited labs there is now a defined quality system. (10.3.3)

48. 2016 Standard 10 Changes Updates to Appendix 10.1 Self Assessment Worksheet – Reflects changes in 10.3 Program Elements

49. Phasing in 2016 MFRPS When will the 2016 MFRPS go into effect? – October 1, 2016

50. Phasing in 2016 MFRPS Will there be further education/outreach? – Yes. – Starting Spring, 2016 Webinars Conference Calls Discussion during SIS visits

51. Phasing in 2016 MFRPS Will there be an Assessment Phase in? – Yes. – The FDA/OO Audit Staff will work to schedule FY17 MFRPS Assessments after January 1, 2017.

52. What can you do now? Gain better understanding of the 2016 MFRPS Start thinking about the SIP and what needs to be updated Continue to make progress

54. Questions?

55. Contact Information Guy F. Delius Guy.Delius@fda.hhs.gov Morgan Poloni Morgan.Poloni@fda.hhs.gov Clint Priestley Clinton.Priestley@fda.hhs.gov