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  OperationalConsiderations

• 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  2Third-­Party  Auditor  Discussions

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