import controls phase 2 workgroup 1

Import ControlsPhase 2 Workgroup

http://www.fda.gov/fsma

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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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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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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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Programs Under Import ControlsPhase II Workgroup

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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

ROM Strategic Framework High Level Results for Import

Controls

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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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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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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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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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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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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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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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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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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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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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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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Breakout Sessions

• Session 1FSVP Discussions

• Session 2

Third-Party Auditor Discussions

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