1. Emphasis on Enforcement of FSMA ABA Food & Supplements Fifth Annual Workshop June 9, 2015 Comments by: Roberta F. Wagner, B.S., M.S Associate Director for FSMA Operations FDA Center for Food Safety and Applied Nutrition (CFSAN) 1

2. Topics FDA’s Enforcement Tools FY2014 FDA Enforcement Statistics –Enforcement and Outbreaks Enforcement with FSMA – What will Change? –New Authority/Tools –Guiding Principles for Phase 2 FSMA Implementation Program Alignment Initiative FSMA Operational Strategy Document Stakeholder Engagement and Input

3. FDA Enforcement Tools Advisory Untitled Letters Warning Letters Administrative Import Detentions/Refusals Administrative Detentions /Domestic Mandatory Recalls Suspensions of Registration Judicial Debarments Seizures Injunctions Prosecutions (OCI) Transparency: Available on FDA’s Webpage Warning Letters/Recalls Press releases issued for administrative, judicial actions, other

4. FDA Enforcement Statistics Summary Fiscal Year 2014 Seizures4 Injunctions10 Warning Letters8690 Recall Events2924 Recalled Products8,061 Debarments1

5. CFSAN Enforcement Statistics - FY2014 154Warning Letters 1 Suspension of Registration 2/4*Seizures 8/10*Injunctions 1-3On-going Prosecutions 221Class I Recalls (1117 products) 557Total Recalls (2549 products)

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8. FY2014 Class I Food Recalls: Reasons Microbial Pathogens Salmonella, Listeria monocytogenes, E. Coli (STECs) Undeclared Allergens Allergen, Cross-Contact FALCPA Labelling Undeclared Non-Allergenic Ingredients Sulfites, Colors

9. Enforcement and Foodborne Outbreaks Use combination of enforcement tools in response to foodborne outbreaks FDA’s Strategy: First prevent further illnesses while responding to outbreaks; then deter recurrence Do not expect this to change under FSMA

10. Enforcement and Outbreaks Misdemeanor Prosecutions (Park Doctrine) Jensen Farms – 147 ill in 28 States; 33 deaths – Charged September 2013; Sentenced January 2014 – Plead guilty, in part, to introducing adulterated food into interstate commerce – Maximum Penalty: 6 years in prison; $1.5 million in fines – 5 years probation, 6 months home detention, $150,000 restitution Quality Egg LLC – Over 1,900 illnesses; Recall of 550 million eggs – Charged June 2014; Sentenced April 2015 – Guilty of bribing USDA inspector, introducing adulterated and misbranded food into interstate commerce – $6.8 million fine; several months in prison

11. Summary of Peanut Butter Outbreaks PCA Final CDC Report 4/29/2009 Sunland Final CDC Report 1/30/2012 Outbreak StrainSalmonella TyphimuriumSalmonella Bredeney Product(s) Implicated Peanut Butter Peanut Paste Peanut Butter Illness Date Range 9/1/08-3/31/09 7 months 6/11/12-11/18/12 5 months # of Illnesses71442 # of States46 & Canada20 # Hospitalizations24% *28% of confirmed cases # of Deaths90 Ages of Reported Illnesses < 1-98 years Median – 16 years 21% < age 5 < 1-79 years Median – 6 years 61% < age 10

12. Enforcement and Outbreaks Peanut Corporation of America (PCA) – Invoked 414 records access authority – Environmental and product sampling performed per client specifications; use of multiple labs/test, released positive product – Rolling voluntary recalls – Ingredient based – Filed for bankruptcy during investigation – FDA/State of Texas left to carry out recalls related to TX facility – Felony prosecution Sunland – Provided sampling records indicating findings of Salmonella – outbreak strain, reaction to results not adequate – Rolling voluntary recalls – finished product based – Suspended facility registration – Consent Decree of Permanent Injunction concurrent with lifting of suspension of registration

13. Enforcement with FSMA What Changes with FSMA? New Authority/Tools Guiding Principles – Phase 2 FSMA Implementation Program Alignment Initiative FSMA Operational Strategy Document Stakeholder Engagement and Input

14. Enforcement: What Changes with FSMA? Availability of New Enforcement Tools Sec. 101: Inspection of Records/Enhanced 414 Records Access Authority – Applies to firms required to register – Standard: Reasonable probability of SAHCODHA – Access to records related to a food AND any food effected in a similar manner Sec. 102: Suspension of Registration – Standard: Reasonable probability of SAHCODHA Sec. 206: Mandatory Recall Authority – Standard: Reasonable probability a food is adulterated/misbranded AND use or exposure to such food will cause SACHODDA; Must seek voluntary recall first Sec. 207: Administrative Detention of Food – Standard: Reason to believe food is adulterated/misbranded

15. Enforcement: What Changes with FSMA? Availability of New Enforcement Tools – Focus on Imports Sec. 202: Laboratory Accreditation for the Analysis of Foods – Food testing must be conducted by laboratories accredited through FDA recognized accreditation body when testing is conducted by/on behalf of an owner/consignee: in response to specific FDA testing requirement; to address identified/suspected food safety problem, to support admission of an article of food under section 801(a) and under an Import Alert – Results of such testing must be sent directly to FDA Sec. 303: Authority to Require Import Certifications for Food – Can require an entity to provide a certification/other assurances that food complies with FDA requirements to grant admission of imported food into the U.S. – Food subject to mandatory certification but not compliant will be refused Sec. 304: Prior Notice of Imported Food Entries Previously Refused – Requires information on prior refusals from other countries be added to the U.S. prior notice submission Sec. 306: Inspection of Foreign Facilities – Food will be refused admission into U.S. from foreign firms when owners, operators, agents in charge, or foreign governments refuse entry of U.S. inspectors

16. What Else Changes with FSMA? Sec 103: Hazard Analysis and Risk-Based Preventive Controls ** Proposed Rules: Current Good Manufacturing Practices and Hazard Analysis and Risk-Based Preventive Controls for Human and Animal Food Facilities Enhanced Records Access in Covered Facilities – Facility inspections no longer a snapshot in time Preventive Controls Required – Process, Food Allergen, Sanitation, Recall, Supplier Approval/Verification Verification Required – Validation, Calibration, Review of Records; Finished Product and Environmental Testing Modernized GMPs – Allergen cross contact – human food

17. What Else Changes with FSMA? Sec 301: Foreign Supplier Verification Program – Importers responsible for ensuring the food they bring into the U.S. meets FDA food safety standards (418 and 419, not adulterated or misbranded relative to allergen labeling); some flexibility in manner in which standards are met abroad – Importers will be subject to DWPE and unable to import food if not in compliance with FSVP

18. Regulation ProposalFinal (consent decree) Preventive Controls (Human Food)* Jan 16, 2013Aug 30, 2015 Preventive Controls (Animal Food)* Oct 29, 2013Aug 30, 2015 Produce Safety*Jan 16, 2013Oct 31, 2015 Foreign Supplier Verification Program* Jul 29, 2013Oct 31, 2015 Third Party AccreditationJul 29, 2013Oct 31, 2015 Sanitary TransportFeb 5, 2014Mar 31, 2016 Intentional AdulterationDec 24, 2013May 31, 2016 * Supplemental proposals published September 2014 Phase 1: Standard Setting

19. Guiding Phase 2 FSMA Implementation 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

20. Guiding Phase 2 FSMA Implementation FDA’s FSMA Operational Strategy Made Public May 2014 − View at fda.gov/fsma 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

21. Phase 2 FSMA Implementation Guiding Principles: Industry/Regulator Education, Outreach and Technical Assistance Facilitate industry compliance with prevention oriented standards (rules) through: commodity/sector-specific guidance; education, outreach and technical assistance; regulatory incentives for compliance – Alliances – Technical Assistance Networks Invest in regulator training/continuing education, on-going calibration of regulators to promote consistent inspections and decision making

22. Phase 2 FSMA Implementation Guiding Principles: Conduct of Regulatory Inspections Goal: Gain Industry Compliance Not a “One Size Fits All Approach” – Wider range of inspection, sampling, testing and data collection activities – Risk-based inspection models consider firm’s food safety culture, compliance history, work of public-private third parties to establish frequency/scope of inspections Systems Based/Prevention Oriented Inspections, Not “Observation Focused” – Observations do not present same risk; Noncompliance reviewed in context of firm’s food safety programs/systems and public health risk/impact; identification of systems/program failures important – Review of self identified non-conformances and the firm’s response critical – Recognize firms for finding/fixing problems, culture of continuous improvement Interactive, Cooperative Inspections – Open dialogue with firm employees during inspections – Investigators and Center subject matter experts work together to gain firm compliance/corrective actions

23. Phase 2 FSMA Implementation Guiding Principles: Compliance/Regulatory Strategies Clearly Defined Compliance Strategy Linked to Public Health Outcomes Encourage Industry to Comply and Make Corrections on its Own – Noncompliance identified; prompt, adequate industry corrective action to gain compliance – Swift enforcement action when, timely/adequate corrective actions not forthcoming Recognition that Not all Observations are Equal Relative to Risk and Potential for Public Health Impact – Deviations from regulations categorized as critical, major, minor and linked to public health outcomes – Varied industry corrective action timeframes/FDA verification of corrective action timeframes based on categorization of deviations and potential risk to consumers

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