FSMA Implementation

FSMA Implementation
Where We’ve Been, Where We’re Going
Roberta F. Wagner, MS
Deputy Director for Regulatory Affairs
FDA/Center for Food Safety and Nutrition
March 10, 2015
• Guiding FSMA Implementation
– Program Alignment Initiative
– FSMA Operational Strategy
• FSMA Implementation in Phases
• Stakeholder Engagement Remains a Priority
• Impacts of FSMA on MFRPS
• President’s FY2016 Budget Proposal for FSMA
FDA’s Food/Feed Program
Spans Two Directorates and Four Offices/Centers
Office of the Commissioner
Commissioner of Food and Drugs
Dr. Margaret Hamburg, M.D.
Directorate of Foods and
Veterinary Medicine
Directorate of Global Regulatory
Operations and Policy
Deputy Commissioner
Deputy Commissioner
Michael Taylor, J.D.
Howard Sklamberg, J.D.
Center for Food Safety and
Applied Nutrition
Susan T. Mayne, PhD.
Center for Veterinary
Bernadette Dunham,
D.V.M., Ph.D.
Office of Regulatory
Office of International
Associate Commissioner
Melinda Plaisier
Associate Commissioner
Mary Lou Valdez
FDA Program Alignment Initiative
• Program Alignment Initiative Announced in February 2014
Memo from the Commissioner
Vertically Integrated, Commodity Specific Programs
Specialization of Inspection/Compliance Staff, Regulatory Labs
Clear, Current, Consistently Applied Technical/Operational Policy
Clear Roles, Responsibilities, Streamlined Decision Making
Risk Based Allocation of Program Resources
Agreed Upon Performance/Public Health Metrics
• Program Alignment will set the Agency up for Successful
FSMA Implementation
FDA’s FSMA Operational Strategy
• Provides a foundation for fully developing and
implementing FSMA standards
– Regulations, guidance, protocols
• Captures in broad, high-level terms our current thinking
on strategy and guiding principles for the
implementation of FSMA standards
• Made Public May 2014; View at fda.gov/fsma
FSMA Implementation is a Continuum
• Phase 1: Set standards
– Develop regulations, guidance, protocols for new
administrative enforcement tools
• Phase 2: Implement standards
– Design strategies to implement standards
– Fully develop and implement the standards
• Phase 3: Monitor, evaluate, refresh
Phase 1: Standard Setting
(consent decree)
Preventive Controls (Human
Preventive Controls (Animal
Produce Safety*
Jan 16, 2013
Aug 30, 2015
Oct 29, 2013
Aug 30, 2015
Jan 16, 2013
Oct 31, 2015
Foreign Supplier Verification Jul 29, 2013
Third Party Accreditation
Jul 29, 2013
Oct 31, 2015
Sanitary Transport
Feb 5, 2014
Mar 31, 2016
Intentional Adulteration
Dec 24, 2013
May 31, 2016
Oct 31, 2015
proposals published September 2014
Phase 2: Operations and Policy
Working Together
Phase 2: Workgroups Charge
• Develop a framework and multi-year
implementation plan for ensuring
compliance with regulations:
• Education, outreach and technical assistance for industry
– Alliances
• Training for regulators
• Data collection, analysis, updated IT
• Performance goals and metrics
• Inspections, compliance and enforcement
How FDA Will Operate Differently
• 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
PC Training Plan: FY15 PC Rule Readiness Plan &
FY 15-18 PC Regulator Plan
Develop PC Regulator Training in FY2015
Develop & Deliver PC Rule Readiness Training
Mar-Apr 2015
Behavior & Systems Thinking
Deliver PC Regulator in FY2016-2018
Applied Soft Skills
May-Jul 2015
Jul-Sept 2015
Technical Knowledge
Oct-Dec 2015
FSPCA Training
FSPCA Course for FDA Staff
FDA TTT for FDA Trainers
FSPCA TTT for FDA Trainers
Cooperative Inspections
Negotiation / Persuasion
Systems Thinking
Allergens Controls 7/16/2015
Supply Chain Management 6/18/2015
Environmental Monitoring 5/21/2015
Food Safety Culture Webinar – 3/19/2015
Technical Updates
1-hr Webinars
& Systems
Skills &
Jan. 2016 thru Sept 2018
Inspection Skills & Knowledge
FY2015 PC Rule Readiness Training
PC Rule Readiness FSMATChats
Typically Third Thursday of the Month
Speakers: Academia, Industry and Government
State Participation; Webinars Limited to 1000 Lines
Recordings of FSMA Chats posted on Food Shield & FDA Intranet
• Tentative Schedule
March 19:
May 21:
June 18:
July 16:
Food Safety Culture Series (5 Webinars)
Environmental Monitoring: Industry Best Practices
Supply Chain Management: Industry Best Practices
Minimizing Allergen Risks: Industry Best Practices
FY2015 PC Rules Regulator Training
FY2015: Develop PC Rule Regulatory Curriculum Centrally
• State Involvement; PFP to Provide State Representatives
FY2015 – FY2016: Complete Pre-requisite Training/FSPCA
Industry Training
FY2016: Deliver PC Rule Regulatory Training/Training Hubs
• What: Human Food: GMPs/PC; Animal Food: GMPs Followed by PC?
• How: TTT/Training Cadre; Criteria for Inclusion; Pre-requisite Training;
Periodic “Evaluation” of Trainers
• Who: Federal/State Investigators/Inspectors/Food Safety Staff
Performing Food Inspections in FDA/States Under Contract
• Where: Nationwide Based on Location of Large Firms
How FDA Will Operate Differently
• Robust data integration, analysis and
information sharing
• Public health metrics
• Work closely with government counterparts
and other food safety system stakeholders
How FDA Will Operate Differently
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
How FDA Will Operate Differently
Approach to Operational Activities
• Targeted, risk-based inspection models
• Wider range of inspection, sampling, testing
and data collection activities
• Improved risk-based work planning through
targeted data collection and more timely
data analysis and program evaluation
PC Rule Inspection “Concepts”
• PC Inspection Program “Must Haves”
Federal/State Food Safety Staff Train Together
Multi-Year Work Planning Prioritization/Planning
Integrated Strategy for Federal/State Inspections
Integrated Data Collection Strategy/Structured Data
Explicit Compliance Strategy; Agreement on Critical/Non-Critical Deviations
• Dynamic” Inspection Approach
– Timely Follow Up to Critical Deviations
• Tiered PC Inspections for Large Facilities
– Not One Size Fits All
– Adequacy of Food Safety Plan; Implementation of Plan
– Review of Corporate Programs; Implementation at Facility Level
• Focus on Gaining Industry Compliance
– “Incentives” for Compliance
– Better Tracking/Reporting of Corrective Actions
– Investigators Kept Abreast of Industry Best Practices
FSMA Integrated Master Schedule
• Is a living document and is regularly updated and maintained
• Provides an integrated view to support effective planning,
monitoring, and control of implementation progress
• Identifies key milestones, deliverables, and dependencies
• Helps connect tasks to activities to costs and enables data-driven
trade-off decisions
• Consists of data consolidated from supporting schedules
• Enables FDA to organize and manage plans and schedules
comprehensively and consistently across FSMA
• Identifies issues and risks
• Is a communications tool
• Integrated with FSMA Decision Tracker and Work Group Milestone
• Posted on FDA’s FSMA Program Management SharePoint Site
and Regulatory Laboratories
Detection and Surveillance
• Sec. 202. Laboratory Accreditation**
• Sec. 203. Integrated Consortium of
Laboratory Networks
• Sec. 205. Surveillance
Why Sample/Test Food Under FSMA
• Surveillance
 Risk based targeting of operational resources
 Emerging issues
 Baseline/prevalence data for risk analysis/policy decisions
• Verification (Emphasis Under FSMA)
• Environmental sampling programs are robust
• Preventive controls/mitigation strategies/corrective actions
• Import controls are effective: FSVP, Third Party Accreditation,
VQIP, Import Certification, Systems Recognition
• Compliance (Public Health Focus Under FSMA)
• Support removal of adulterated/misbranded foods from market
• Environmental assessments / root cause(s) of contamination
events/foodborne outbreaks
• Enforcement actions, including import actions
FSMA Stakeholder Engagement
• Transparency Remains a Priority
• Next Phase: Inclusive/Coalition Approach
– Engage FDA employees, key partners, and the public
to help determine ways to implement provisions and
concepts before rules become final.
• Future: Partnerships/Collaboration Key
– Establish mechanisms, including working with
multiple partners, to foster industry understanding
of final rules/guidance and encourage firms to
comply and initiate any corrections on their own.
Standard 1: Regulatory Foundation
Standard 2: Training Program
Standard 3: Inspection Program
Standard 4: Inspection Audit Program
Standard 5: Food Related Illness , Outbreaks and Response
Standard 6: Compliance and Enforcement Program
Standard 7: Industry and Community Relations
Standard 8: Program Resources
Standard 9: Program Assessment
Standard 10: Laboratory Support
President’s FY2016 Budget Proposal
• An increase of 109.5 million requested in the President’s
budget for FSMA implementation
• FDA plans to continue to make improvements in the following
– Inspection Modernization and Training 25 million
– National Integrated Food Safety System 32 million
– Industry Education and Technical Assistance 11.5 million
– Technical Staffing and Guidance Development at FDA 4 million
– Modernized Import Safety Programs/System 25.5 million
– Risk Analytics and Evaluation 4.5 million
And ** 7 million for necessary infrastructure costs
Thank You For You Attention!
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