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FSMA ImplementationWhere We’ve Been, Where We’re Going
AND MFRPS
March 10, 2015
Roberta F. Wagner, MSDeputy Director for Regulatory Affairs
FDA/Center for Food Safety and Nutrition
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Topics• 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 Implementation
FDA’s Food/Feed ProgramSpans Two Directorates and Four Offices/Centers
Office of the CommissionerCommissioner of Food and Drugs
Dr. Margaret Hamburg, M.D.
Directorate of Foods and Veterinary Medicine
Deputy CommissionerMichael Taylor, J.D.
Center for Food Safety and Applied Nutrition
DirectorSusan T. Mayne, PhD.
Center for Veterinary Medicine
Director
Bernadette Dunham, D.V.M., Ph.D.
Directorate of Global Regulatory Operations and Policy Deputy CommissionerHoward Sklamberg, J.D.
Office of Regulatory Affairs
Associate CommissionerMelinda Plaisier
Office of International Programs
Associate CommissionerMary Lou Valdez
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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
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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
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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
Regulation Proposal Final (consent decree)
Preventive Controls (Human Food)*
Jan 16, 2013 Aug 30, 2015
Preventive Controls (Animal Food)*
Oct 29, 2013 Aug 30, 2015
Produce Safety* Jan 16, 2013 Oct 31, 2015
Foreign Supplier Verification Program*
Jul 29, 2013 Oct 31, 2015
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
*Supplemental proposals published September 2014
Phase 1: Standard Setting
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Phase 2: Operations and Policy Working Together
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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
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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
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Mar-Apr 2015 May-Jul 2015 Jul-Sept 2015 Oct-Dec 2015
Food
Saf
ety
Cultu
re W
ebin
ar –
3/1
9/20
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Develop & Deliver PC Rule Readiness Training
Envi
ronm
enta
l Mon
itorin
g 5
/21/
2015
Supp
ly C
hain
Man
agem
ent 6
/18/
2015
Technical Updates 1-hr Webinars
Syst
ems
Thin
king
Neg
otiati
on /
Per
suas
ion
Coop
erati
ve In
spec
tions
Applied Soft Skills
PC Training Plan: FY15 PC Rule Readiness Plan & FY 15-18 PC Regulator Plan
Deliver PC Regulator in FY2016-2018
Technical Knowledge
Behavior& Systems
Thinking
Inspectional Skills & knowledge
Alle
rgen
s Co
ntro
ls 7
/16/
2015
FSPC
A TT
T fo
r FDA
Tra
iner
s
FSPC
A Co
urse
for F
DA S
taff
Jan. 2016 thru Sept 2018
Technical Knowledge Inspection Skills & KnowledgeBehavior & Systems Thinking FSPCA Training
FDA
TTT
for F
DA T
rain
ers
Develop PC Regulator Training in FY2015
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FY2015 PC Rule Readiness Training T• PC Rule Readiness FSMA Chats
– 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: Food Safety Culture Series (5 Webinars)– May 21: Environmental Monitoring: Industry Best Practices – June 18: Supply Chain Management: Industry Best Practices – July 16: Minimizing Allergen Risks: Industry Best Practices
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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
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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
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How FDA Will Operate DifferentlyEducation 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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How FDA Will Operate DifferentlyApproach 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
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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
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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 Timelines• Posted on FDA’s FSMA Program Management SharePoint Site
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FSMAand Regulatory Laboratories
Detection and Surveillance• Sec. 202. Laboratory Accreditation** • Sec. 203. Integrated Consortium of
Laboratory Networks • Sec. 205. Surveillance
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Why Sample/Test Food Under FSMA
• Surveillance Risk based targeting of operational resourcesEmerging issuesBaseline/prevalence data for risk analysis/policy decisions
• Verification (Emphasis Under FSMA) • Environmental sampling programs are robust• Preventive controls/mitigation strategies/corrective actions effective• 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
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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.
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MFRPS and FSMAStandard 1: Regulatory FoundationStandard 2: Training ProgramStandard 3: Inspection ProgramStandard 4: Inspection Audit ProgramStandard 5: Food Related Illness , Outbreaks and Response Standard 6: Compliance and Enforcement ProgramStandard 7: Industry and Community RelationsStandard 8: Program ResourcesStandard 9: Program AssessmentStandard 10: Laboratory Support
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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
areas:– 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 millionAnd ** 7 million for necessary infrastructure costs
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