Focus  on  Phase  2  FSMA  Implementation

http://www.fda.gov/fsma  

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Topics• Guiding    FSMA  Implementation

− Program  Alignment  Initiative− FSMA  Operational  Strategy

• FSMA  Implementation  in  Phases

• Focus  on  FSMA  Phase  2

Collaboration  within  FDA’s  Food  Program

Office  of  the  CommissionerActing  Commissioner  of  Food

and  DrugsStephen  Ostroff,  M.D.

Directorate  of  Foods  and  Veterinary  MedicineDeputy  CommissionerMichael  Taylor,  J.D.

Center  for  Food  Safety  and  Applied  Nutrition

DirectorSusan  Mayne,  Ph.D.

Center  for  Veterinary  Medicine

DirectorBernadette  Dunham,  

D.V.M.,    Ph.D.

Directorate  of  Global  Regulatory  Operations  and  

PolicyDeputy  CommissionerHoward  Sklamberg,  J.D.

Office  of  Regulatory  Affairs  

Associate  CommissionerMelinda  Plaisier

Office  of  International  Programs  

Associate  CommissionerMary  Lou  Valdez

Program  Alignment  • Program  Alignment  Initiative  Announced  in  February  2014  Memo  by  Commissioner− Vertically  integrated,  commodity-­based  programs  − Specialization  of  inspection/compliance  staff,  regulatory  labs

− Clear,  current,  consistently  applied  policy− Roles,  responsibilities,  streamlined  decision-­making− Risk-­based  allocation  of  program  resources− Agreed-­upon  performance/public  health  metrics

• Result:  Successful  FSMA  Implementation

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FSMA  Operational  Strategy• Foundation  for  Developing  and  Implementing  FSMA  Standards  − Regulations,  guidance,  protocols  

• Captures  in  Broad,  High-­Level  Terms  Our  Current  Thinking  on  Strategy  and  Guiding  Principles  for  Implementation  

• Made  public  May  2014− View  at  http://www.fda.gov/fsma  

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FSMA  Implementation  as  a  Continuum

• Phase  1:  Set  Standards− Regulations,  guidance,    policy

• Phase  2:  Planning/Implementation  − Design  strategies  and  begin  implementation  to  gain/maintain  industry  compliance  with    FSMA  rules

• Phase  3:  Implementation,  Monitor,  Evaluate,  Refresh

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Transition  to  Phase  2:  Planning/Implementation

• Phase  1  Teams  Continue  Rulemaking,  Guidance  and  Policy  Work  until  Completed

• Concurrently,  Phase  2  Structure  Established/Work  Initiated− Design  strategies/frameworks  and  develop  operational  plans  for  gaining  and  maintaining  industry  compliance  with  the  foundational  FSMA  rules

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Phase  2:    Operations  and  Policy  Working  Together

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FDA  Strategic  Program  Planning  

Focus  on  Steps  1-­3    5  Steps

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Implementation  Process

Update  Strategic  Planning  Materials

Develop  Strategic  Goals

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Develop  Strategic  

Framework

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Conduct  Evaluation  &  Strategic  Refresh

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Develop  Performance  Measures

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Monitor  Implementation

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Planning  Process

Monitoring  and  Evaluating  Process

Phase  2:  Workgroup  Charge

Multi-­Year  Plan  • Industry  Education,  Outreach,  Technical  Assistance  

• Training  for  Regulators• Inspections,  Compliance  and  Enforcement• Data  Collection,  Analysis,  Updated  Information  Technology  (IT)

• Performance  Goals  and  Metrics

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Phase  2  Guiding  Principles  

• FDA  Will  Speak  With  One  Voice• Inspection,  Compliance  Functions  Specialized

• Investigators  and  Subject  Matter  Experts  Work  Together  to  Drive  Correction  of  Problems

• Invest  in  Regulator  Training  to  Promote  Consistent  Inspections,  Decision  Making

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Phase  2  Guiding  Principles  

• Robust  Data  Integration,  Analysis  and  Information  Sharing

• Work  Closely  With  Government  Counterparts  and  Other  Food  Safety  System  Stakeholders

• Public  Health  Metrics

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Phase  2  Guiding  Principles  Education  Before  Regulation

• Facilitate  Industry  Implementation  of  Modern,  Preventive  Practices  Through:− Commodity  and  sector-­specific  guidance− Education,  outreach  and  technical  assistance− Regulatory  incentives  for  compliance

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Phase  2  Guiding  PrinciplesApproach  to  Operational  Activities

• Improved  Risk-­Based  Work  Planning  Through  Targeted  Data  Collection  and  More  Timely  Data  Analysis  and  Program  Evaluation

• Targeted,  Risk-­Based  Inspection  models• Range  of  Inspection,  Sampling,  Testing,  Data  Collection  Activities

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Stakeholder  Engagement• Transparency  Remains  a  Priority• Next  Phase:  Inclusive/Coalition  Approach

− Engage  FDA  employees,  key  partners,  the  public  to  determine  ways  to  implement  provisions  before  rules  become  final

• Future:  Partnerships/Collaboration  Key    − Establish  mechanisms  through  partnerships  and  collaboration    to  foster  industry  understanding  of  final  rules/guidance  and  to  encourage  firms  to  comply  and  initiate  any  corrections  on  their  own  

• Web  site:  http://www.fda.gov/fsma  • Subscription  feature  available• Send  questions  to  FSMA@fda.hhs.gov

Public  Information  Available

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