FDA's current thinking on operational strategy for implementation work plans. Presentation from workshops held on April 23 ~ 24, 2015 at the Washington Marriott Hotel, DC.

1. Import Controls
Phase 2 Workgroup
http://www.fda.gov/fsma
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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
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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
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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
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5. Programs Under Import Controls
Phase II Workgroup
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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19. Breakout Sessions
• Session 1
FSVP Discussions
• Session 2
Third-­Party Auditor Discussions
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