Emphasis on Enforcement of FSMA

ABA Food & Supplements Fifth Annual WorkshopJune 9, 2015

Comments by: Roberta F. Wagner, B.S., M.SAssociate Director for FSMA Operations

FDA Center for Food Safety and Applied Nutrition (CFSAN)

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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

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

FDA Enforcement Statistics SummaryFiscal Year 2014

Seizures 4

Injunctions 10

Warning Letters 8690

Recall Events 2924

Recalled Products 8,061

Debarments 1

CFSAN Enforcement Statistics - FY2014

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

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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

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

Enforcement and OutbreaksMisdemeanor 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

Summary of Peanut Butter Outbreaks PCA

Final CDC Report4/29/2009

Sunland Final CDC Report1/30/2012

Outbreak Strain Salmonella Typhimurium Salmonella Bredeney

Product(s) Implicated Peanut ButterPeanut Paste Peanut Butter

Illness Date Range 9/1/08-3/31/097 months

6/11/12-11/18/125 months

# of Illnesses 714 42

# of States 46 & Canada 20

# Hospitalizations 24% * 28% of confirmed cases

# of Deaths 9 0

Ages of Reported Illnesses

< 1-98 yearsMedian – 16 years21% < age 5

< 1-79 yearsMedian – 6 years61% < age 10

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

Enforcement with FSMAWhat Changes with FSMA?

• New Authority/Tools• Guiding Principles – Phase 2 FSMA

Implementation• Program Alignment Initiative• FSMA Operational Strategy Document• Stakeholder Engagement and Input

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

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

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

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

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

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

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

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

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

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

Thank You For Your Attention!