1. Import Controls Phase 2 Workgroup http://www.fda.gov/fsma 1

2. Past Import Paradigm Border focused Virtually all of the information used to assess admissibility comes from the import submission FDA makes a decision about the compliance status of the product at the time of entry with limited time, resources, and information 2

3. Modernized Import System Focus on prevention –The border can no longer be our primary line of defense. It should only serve as a final checkpoint on other controls FSMA creates a multilayered safety net –Role of manufacturer –Role of importers –Role of third parties –Role of foreign regulatory bodies –Role of FDA 3

4. FSMA Imports-Related Sections Sec. 201. Inspection frequency Sec. 301. Foreign supplier verification program Sec. 302. Voluntary qualified importer program Sec. 303. Certification for food imports Sec. 304. Prior notice of imported food shipments Sec. 305. Capacity building Sec. 306. Inspection of foreign food facilities Sec. 307. Accreditation of third-party auditors Sec. 308. Foreign offices of the FDA Sec. 309. Smuggled food Sec. 404. Compliance with international agreements 4

5. Programs Under Import Controls Phase II Workgroup 5

6. Import Controls Phase II Workgroup Operational Areas in each sub-workgroup: Inspections, Compliance and Enforcement │ Regulator Training │ Workforce Planning │ Information Technology │ External Outreach and Technical Assistance 6

7. ROM Strategic Framework High Level Results for Import Controls 7

8. Critical Operational Considerations Work planning/staffing for industry oversight to help ensure compliance, i.e. inspections, audits, sample collections and import program data integration to target resources Industry/stakeholder education, outreach, and technical assistance Regulator training and technical support IT, integration of domestic and import systems International trade context Requested $25.5 M in FY16 for modernized import system 8

9. FSVP: Inspections, Compliance, Enforcement Accomplishments –Developing inspectional protocol for importers –Significant progress in identifying modifications to current entry process Challenges –Awaiting final rule publication –Unknown inventory of importers –Importers may not have been previously inspected by FDA –Balancing “new” and “old” work as we transition 9

10. FSVP: Regulator Training Accomplishments –Initial draft of a job task analysis for FDA staff Challenges –Identifying and training FDA experts –Identifying locations for regional training hubs that work for FSVP and Preventive Controls 10

11. FSVP: External Outreach and Technical Assistance Accomplishments –Developing a comprehensive outreach plan (meetings, industry training, fact sheets, etc.) Challenges –Reaching the appropriate audiences (Importer awareness) –Numerous requests for outreach and training 11

12. FSVP: Information Technology Accomplishments –Developing data requirements for FDA systems –Developing “one-stop shop” to help importers assess compliance status of suppliers Challenges –Integration of IT systems –FSMA rule interdependencies 12

13. FSVP: Workforce Planning Accomplishments Developing long-term staffing projections for FDA Challenges –Projections may have to be modified once a true inventory of importers subject to inspection is developed –Need to balance new import work with current import work 13

14. Third Party: Compliance, Enforcement Not an inspection program Accomplishments: –Developing communication and operational strategies linked with other FDA imports programs and foreign inspections Challenges: –Concurrent program development makes it difficult to finalize strategies 14

15. Third Party: Regulator Training Accomplishments: –Developed training strategy for FDA third- party program staff that will include internal and external training Challenges: –Developing plans for FY 17-18 training needs, which depend on program participation 15

16. Third Party: External Outreach and Technical Assistance Accomplishments: –Outreach to certification bodies, scheme owners, accreditation bodies, foreign governments, consumer groups, trade associations, other stakeholders Challenges: –Voluntary program –New program needs significant outreach –Identifying new stakeholders 16

17. Third Party: Information Technology Accomplishments: –Significant progress in building an integrated IT system –Interface with imports operations and foreign inspections –Support for VQIP and Import Certification –Will accept external submissions, integrate with internal systems, and serve as internal workflow manager Challenges: –Business needs evolve while IT requirements lock down 17

18. Third Party: Workforce Planning Accomplishments: –Initial staffing needs identified –Hiring approved in FY 15 Challenges: –Significant hiring demands across the food and feed program 18

19. Breakout Sessions Session 1 FSVP Discussions Session 2 Third-Party Auditor Discussions 19